Analysis of data for implanted restricting device and devices for data registration

FIELD: medicine.

SUBSTANCE: group of inventions relates to medicine. In realisation of methods implanted gastric restricting device is implanted into patient's body. Data, containing information about values of parameter, perceived inside the body, are collected for a time period. In the first version of method realisation determined are values of perceived parameter, which exceed the first threshold, are below the first threshold or below the second threshold in such a way that pulse is determined by time between values, which exceed the first threshold and values, which are below the first threshold or below the second threshold. In the second version of the method additional values of perceived parameter, accompanied by decreasing values, are determined. In the third version of the method areas under the curve of pressure dependence on time are determined, compared and the result of comparison is correlated with the state. In the fourth version of the method values of perceived pressure are formed for demonstration on display or further analysis. In the fifth version of the method average value of pressure for time X within the specified time period is calculated on the basis of values of perceived pressure within the window of averaging in specified period of time.

EFFECT: group of inventions makes it possible to increase treatment safety and efficiency due to control of implanted device.

32 cl, 77 dwg

 

The technical field

The present invention relates generally to implantable limiting device with a hole and, more specifically, to a communication system for monitoring physiological parameters associated with the implantable device limitations meal.

The level of technology

Obesity is becoming a subject of increasing concern, especially in the United States, as the number of obese people continues to increase, and people are learning more about the negative effects of obesity on health. Morbid obesity in which a person's weight by 100 pounds (40 kg) or more over the ideal body weight, creates, in particular, the significant risks of serious health problems. Accordingly, the treatment of obese patients in the spotlight. One of the ways to treat morbid obesity was that around the upper part of the stomach were established limiting device type stretchable band. Gastric bands are usually kept filled with fluid medium elastic cylinder with fixed endpoints, which covers the stomach directly under the junction of the esophagus with the stomach to form a small gastric pouch above the band and a small opening in the stomach. When the container is poured fluid bandage rasshiryaet the relative stomach, creating a limitation for meals or holes in the stomach. To reduce this limitation, fluid is removed from the bandage. The action of the bandage should be to reduce the available volume of the stomach and, thus, the amount of food that can be consumed to achieve satiety.

Restricting device for restricting the passage of food at the reception also included a mechanically adjustable bandages, which similarly covers the upper part of the stomach. These bands include any number of flexible materials or provided with a drive device and the drive elements for the regulation of bandages. Additionally were developed gastric bands containing both hydraulic and mechanical drive elements. An example of such an adjustable gastric band is disclosed in U.S. patent No. 6067991, "Mechanical Food Intake Restriction Device", issued may 30, 2000 and incorporated herein by reference. To limit the passage of the proposed volume of food in the stomach cavity is also known implantation pumped elastic cylinder inside the cavity of the stomach. The cylinder is filled with fluid medium to expand relative to the walls of the stomach and thus reduce the available food volume inside the stomach.

With respect to any of the above devices limitations por the walking food safe and effective treatment requires regular monitoring and control device to vary the degree of restriction applied to the stomach. In respect of the retaining devices, isolated ventricle above the bandage will significantly increase in size after the initial implantation. Accordingly, the hole for the passage into the stomach initially should be large enough to allow the patient to receive adequate nutrition at a time, until the stomach adapts to the retaining device. As individual ventricle increases in size, the brace can be adjusted to change the size of the hole. In addition, it is desirable to change the size of the hole, to accommodate changes in the patient's body or in the treatment or, in a more urgent case, to resolve overlapping or adverse stretching of the stomach. Traditionally, the regulation of hydraulic gastric band demanded a planned visit to the Clinician during which the used needle and syringe Governor for penetration through the skin of the patient and adding or removing the fluid in the container through the injection. Recently been developed implantable pumps, allowing non-invasive regulation of the bandage. The external programmer communicates with an implanted pump using telemetry to control the pump. During a routine visit to the doctor puts the portable part of the programmer near the gastric implant and transmits power signals and commands to the implant. The implant, in turn, regulates the levels of fluid in the band and transmits a response command to the programmer.

During these regulations gastric bands was difficult to determine how goes the progress of the regulation and whether the regulation to give the expected effect. Trying to determine the effectiveness of regulation, some physicians use x-rays with barium as the regulation, although fluoroscopy can be expensive and may raise concern regarding the dosage of irradiation. Other doctors had prescribed to the patient to drink a glass of water during or after the regulation to determine whether the water is adjusted to pass through the hole. This method, however, guarantees only that the patient has not blocked the passage of food, and provides no information about the effectiveness of regulation. Often the doctor can simply use the method of "try as You can, based on his previous experience and the results of the regulation may not be discovered until hours or days, when the patient will feel full overlap of the stomach cavity, or when the bandage will cause erosion of tissue infection is and due to excessive pressure on the tissue walls.

In addition, tracking, or monitoring long-term performance of a gastric band and/or patient in the past was difficult, but their presence promises a wide range of benefits. For example, receiving, and displaying data received from a gastric band or associated with it, for some period of time (or real time data) can be useful for control, diagnostics, control or other purposes. Additionally, it may be advantageous to store such data, to process them to get other types of significant data, and/or transfer them to another place, away. Opportunity for a physician or patient to manipulate or monitor such information should give new momentum to the treatment of obesity or other forms of treatment. The preceding examples are merely illustrative and not exhaustive. Although for the treatment of obesity used different methods and devices, it is believed that no one prior to the inventors has not done previously or used an invention as described in the accompanying claims.

Accordingly, methods and devices for use with implantable limiting device and, in particular, for recording, displaying, analyzing and/or processing data received from the implantable limiting device or associated with them.

The invention

In one aspect is provided a display device for physiological monitoring, displaying the information received from the implantable limiting device or associated with it. An example of a display may present a simulated graphical representation of the location of the area covered by the implantable limiting device, such as an adjustable gastric band, and simulated graphic can specify the size of locations across the area. The specified size can be based at least partly on the parameter taken implantable limiting device and transmitted to the physiological monitoring device. The perceived parameters in this and other embodiments, implementation, described herein, can contain a wide variety of parameters, such as pressure, reference number of pulses, pulse widths, pulse duration, pulse amplitude, pulse frequency, perceived electrical characteristics and so on. In some embodiments, the implementation of the simulated graphical image may contain one or more isobars displayed on the graphical representation of the areas covered, isobars representing the perceived value of the parameter, so that the perimeter of the locations in the area which is a sign of the perceived option. Isobars can change the color to report the status associated with the perceived values of the parameter. In other embodiments, implementation of the simulated graphical image may contain an image of the cross section of the hole, the image limiting device positioned around anatomical lumen, the image of lumps of food, badges, marks, and/or three-dimensional images. Simulated graphic image may also contain a video to show the changes of the size of the hole in accordance with the pressure (or other parameter), perceived implantable limiting device for a period of time. Simulated graphic image may also be based on the image obtained from the patient's body, in which implanted implantable limiting device. The display may further comprise a text indicator of the perceived option, the data is perceived parameter displayed on the chart or on a dial indicator, and/or status indication restrictions given by the implantable limiting device.

In another aspect, an example of the display can contain a schedule of the perceived argument in time, the graph contains a graphical representation of data representing parameter values, identify aimie implantable limiting device, for example, adjustable gastric band, and transmitted to the control device of physiological parameters. The display may also contain one or more marker annotation is placed on the graphical representation to indicate the presence of annotations for the selected point in time, one or more markers, annotations, each of which is associated with the description of the type of text or image. Accompanying the description may contain, for example, a description of the medical event, a description of the physiological condition, the description of the symptom, the comments of the patient and/or comments of a physician. The graphical representation may include a curve representing the graph of the adopted values of pressure. The display can optionally contain a list of events with pre-defined annotations, from which the user can select description.

In another aspect, an example of the display can contain many graphic representations of data sets parameter/volume (e.g., datasets, parameters such as pressure, number of pulses, pulse width, pulse amplitude, pulse frequency, and so on), each set of data parameters/volume corresponds implanted in the patient's limiting device, such as an adjustable gastric band, and contains one or more links (a) volume filling for uti is antiseepage limiting device (b) option perceived implantable limiting device when the volume filling and transferred to the physiological monitoring device. One of the many graphical representations can represent a data set of pressure/volume for the current patient, and other graphical representations can represent a data set parameter/volume to another patient.

In some embodiments, the implementation of one of the many graphical representations of the data set parameter/volume represents the current patient, and the rest from a variety of graphical representations are sets of parameter/volume for a group of patients. The graphical representation can be, for example, the curves drawn on the graph of dependence of the parameter of the volume filling. The graphical representation may also contain curves drawn on the graph of dependence of the parameter of the volume of the filling, which is one of the many graphical representations represents a data set parameter/volume for the current patient, and the other is a graphical representation represents the set of averaged data parameter/volume for a group of patients, a set of averaged data parameter/volume that contains one or more links (a) volume filling and (b) the average value of the parameter (such as pressure), perceived implantable and limiting devices in the volume filling for a group of patients. The display may further comprise a bounding from above the trend line and bounding from below the trend line and definition around the line representing the graph of the averaged data set/volume.

May also be provided a method of controlling an implantable limiting device, which in one embodiment may include providing multiple sets of parameter data volume, each of which corresponds to the implantable in the patient's limiting device and includes one or more links (a) the filling volume of the implantable limiting device and (b) setting, perceived implantable limiting device in the volume of the filling and transmitted to an external device. The method may also include displaying a graphical representation of the selected data set/volume corresponding to the selected implantable limiting device, together with one or more other graphical representations of one or more other sets of parameter data volume corresponding to one or more other implantable limiting devices. The method may also include the calculation of the average pressure for each volume on one or more other data sets parameter/volume, averaged to create the set the data parameter/volume and displaying a graphical representation of the averaged data set/volume.

In still another aspect, an example of the display can contain a schedule containing the parameter axis and the axis of counting the number of pulses for communication parameter, perceived implantable limiting device, such as an adjustable gastric band, with the number of pulses. Counts the number of pulses may represent the sequence number of the pulse of the received parameter within the sequence of pulses in case of swallowing. The display may also contain multiple discrete indicators on the chart at the intersection of parameter and counting the number of pulses, where each discrete indicator is a predetermined amplitude parameter, and the set of discrete indicators, thus representing the total amplitude of the parameter measured for each pulse in the pulse sequence. In some embodiments, the implementation may display the timestamp of the at least one pulse in the sequence of pulses. The timestamp may indicate a time at which the pulse appeared, pulse duration, time within a pulse or other measured parameters.

In still another aspect, an example of the display can contain a graph of the dependence of the parameter on the time, p the parameter (such as pressure or any other parameter, as mentioned earlier), perceived implantable limiting device, a graphical representation indicating the value associated with the parameter received implantable limiting device, such as an adjustable gastric band during the first time period, and a graphical representation indicating the value associated with the parameter adopted implantable limiting device during the second and subsequent periods of time. In some embodiments, the implementation of the graphical representation of the first period of time overlaps, at least partially, on a graphical representation for the second period of time. The first period of time may be preceded by a medical intervention, and the second and subsequent periods of time may correspond to a time after the medical intervention, medical intervention may be the regulation of implantable limiting device. In some embodiments, the implementation of the graphical representation for a first period of time and for the second and subsequent time periods contain curves, drawn on a graph having one or more pulses of the parameter inside it. Graphical representation for a first time period and second time period may overlap, so that, at the very measures which, one pulse parameter in the graphical representations for a first period of time overlaps at least one pulse parameter in the graphical representations for the second time.

In still another aspect, an example of the display can contain screen pressure, reflecting the perceived pressure, perceived pressure, perceived implantable limiting device (such as the adjustable gastric band) and passed to the physiological monitoring device, and the display of counting the number of pulses indicating the number of pulses in the perceived pressure that occur during the event of swallowing, and/or display of pressure, with the indicator of perceived pressure indicator falling within one of the many pressure ranges corresponding to the state of the implantable limiting device. Display pressure may contain, for example, a graph showing the dependence of pressure on time, which is perceived by the pressure seems to be drawn curve, the meter with a linear scale, containing a number of discrete indicators, where each discrete indicator corresponds to a predetermined perceived pressure indicator is configured to change color to indicate status of the pressure gauge with a dial scale or a text indicator. Pressure ranges can correspond to the States of implantable limiting device filled with fluid medium, which contain the state filling in "crowded", "optimum" and "incomplete". In some embodiments, the implementation schedule, a meter with a linear scale, a pressure gauge with a dial scale and/or text indicator can be configured to alarm with visual alert or alarm condition. In other embodiments, implementation of the audible alarm can be configured to activate when a graph meter with a linear scale, blood pressure meter with dial dial or text indicator indicates a value greater than the threshold.

In still another aspect, an example method may include receiving physiological monitoring devices, having any of the above displays or attributes, and reconfigure the physiological monitoring device and/or display. Reconfiguration may include, for example, the recovery device or display, changing, programming, or erasing the device configuration or display the specific requirements. Reconfiguration may also include the repair, restoration or sterilization device or display.

Data received from the implanted device, the IO is ut be used processed and/or analyzed in various ways. For example, one example of a method of obtaining information about the physiological parameter can include collecting data from an implantable limiting device for a period of time, the data collected and containing information about the value of a parameter (such as pressure), perceived inside the body over a period of time, and analyze the data in the processing unit to determine information about the physiological parameter (e.g., heart rate, respiration rate, pulse frequency, caused by the peristaltic phenomenon, initial setting, and so on), at least for some period of time. Certain information may contain, for example, the frequency value, amplitude, changing the value, at least part of the time period and the average value over a period of time. In one embodiment, the method may include determining a frequency spectrum of changes in the values obtained parameter over a period of time and identifying one or more frequencies in the frequency spectrum as the frequency of the physiological parameter. The method may further comprise comparing one or more frequencies (or their average) with one or more predetermined frequencies, defined as the frequency associated with fisiologicas the m parameter. In some embodiments, the implementation of the method may include determining the frequency spectrum of changes in the values of pressure, at least part of the time period, selecting one or more frequencies present in the frequency spectrum that fall within a predefined range of frequencies, defined as possible norms physiological parameter (e.g., normal heart rate, normal breathing rate and so on), and identification of standards for the physiological parameter based on one or more selected frequencies. Determination of the frequency spectrum can optionally be carried out using Fourier analysis. In other embodiments, implementation of the method may include calculating the frequency, change the values of pressure, at least part of the time period, and comparing the frequency with a predetermined frequency range, indicated as a possible physiological parameter to determine whether the frequency is within the range. The frequency calculation can be achieved, for example, by recording at least two points in time when the pressure reaches a local maximum or minimum, and calculate the frequency based on the difference, at least between the two at times. The method may further comprise determining the amplitude is of izmenenii values of pressure at the calculated frequency and comparing the amplitude to a predetermined amplitude range, certain as possible the amplitude of the physiological parameter to determine whether the amplitude is within the range. In other embodiments, implementation of the method may include calculating the difference between (i) the value of pressure at the moment in time within a period of time and (ii) the average pressure value during the time in which the difference represents the value corresponding to the physiological parameter. The average value can be calculated, for example, based on the values that fall within a time window. Additionally, determination of physiological parameters or norms may lead to alarm, or can cause the processing unit to generate the message.

In another aspect, an example method of analyzing the data received from the implantable limiting device to determine the initial values of the physiological parameter may include collecting data from an implantable limiting device for a period of time, the data collected and containing information about the parameter values, perceived inside the body over a period of time. The method may also include determining a range of values to represent the tolerance range and comparing one or more received values of the parameter over a period of time with a tolerance range to determine whether all or the larger the number of values within the tolerance range, and, if so, identification of the initial values as installed. The range of values can be defined in many different ways, including in relation to the current mean value, or by setting the upper limit value, which exceeds the current average value and lower limit value that is less than the current average. In some embodiments, the implementation of the method may further comprise calculating a current average value, based on the values obtained parameter during the window of averaging within a period of time, and the identification of the current average value as the initial value. In other embodiments, implementation of the method may include the generation of an alarm signal or message event occurs, such as (i) identification of the initial value; (ii) failure to identify the initial value within a threshold time; and (iii) identification of the initial value and the initial value passes the threshold value. In some embodiments, the implementation of the fluid can be added or removed from the implantable limiting device, and/or a certain initial value can be correlated with the state of the implantable limiting device state, which is one of the following: "optimal voltage is lanoe", "crowded," or "not filled" (or "optimally tightened", "tapered", "free").

In another aspect may be provided with an example of how analysis of the data received from the implantable limiting device to determine information about the initial value of the physiological parameter. The method can include collecting data from an implantable limiting device for a period of time, the data collected and containing information about the parameter values, taken inside the body over a period of time. The method may further comprise calculating, based at least in part, on one or more of the perceived values of the parameter during the time period, the predicted time until the moment when the values of the physiological parameter will be the rate of change is close to zero. In some embodiments, the exercise of calculating the predicted time may entail calculating the rate of change of the values obtained parameter for window within the time period, calculating a rate of change of the rate of change of the values obtained parameter for the window and calculating the predicted time until then, so long as the values obtained parameter will not have the rate of change is close to zero, based at least in part, on karasti changes and rate of change rate of change. In some embodiments, the implementation of the predicted initial value can be calculated, for example, by extrapolating one or more values within the predicted to the initial value of the obtained parameter and by multiplying the rate of change of the values obtained parameter for window within the time period and the predicted time. In some embodiments, the implementation of an alarm signal or message may be generated if the rate of change passes a threshold value. Additionally, the rate of change can be correlated with the state of the implantable limiting device state, which is one of the following: "optimally filled", "full", or "not filled" (or "optimally tightened", "tapered", "free").

In another aspect may be provided with an example of how analysis of the data received from the implantable limiting device to identify the presence of a pulse. The method can include collecting data from an implantable limiting device for a period of time, the data collected and containing information about the parameter values, taken inside the body over a period of time, identifying the presence of a pulse in the values of the passed parameter. Identification may contain OBN is ruzena one or more values obtained parameter, which exceed the first threshold value, and detecting one or more subsequent values of the obtained parameters that fall below the first threshold or the second threshold (such thresholds can be defined in relation to the initial parameter value and/or may be different or the same values). In some embodiments, the implementation of identification may further comprise detection of one or more consecutive values of the received parameter that fall below the second threshold within a time window begins at the moment of time associated with one or more values that exceeded the first threshold. Another example of a method of analysis of data obtained from the implantable limiting device to determine the presence of a pulse may include collecting data from an implantable limiting device for a period of time, the data collected and containing information about the parameter values obtained inside the body over a period of time, and the identification of the presence of a pulse in the values of the obtained parameter. Identification may include detecting one or more values obtained parameter exceeding the first threshold value, the detection of one or more subsequent values of the received parameter, which accompanied the tsya low values, one or more subsequent values representing the peak value, and detecting one or more subsequent values of the obtained parameters that fall below the second threshold within a time window. The time window may be within a period of time that begins virtually at any time, such as occurs when the peak value, or something else. In some embodiments, the implementation of the identification pulse or if the number of pulses passes the threshold value within a predetermined period of time, can generate an alarm or message. Additionally, such information may be correlated with the state of the implantable limiting device state, which is one of the following: "optimally filled", "full", or "not filled" (or "optimally tightened", "tapered", "free").

In another aspect may provide an example of how analysis of the data received from the implantable limiting device to detect the presence of a physiological condition or state associated with implantable limiting device. The method can include collecting data from an implantable limiting device for a period of time, the data collected and contains information about C is Azaniah parameter, received within the body over a period of time, finding one or more areas corresponding to the area below the curve of the pressure of time and the comparison areas, the correlation of the comparison with the condition. In some embodiments, the exercise of finding one or more areas may contain for each of one or more regions being integral (including numerical integration in some embodiments, implementation), based on the values obtained parameter for each window within the time period, the evaluation result obtained by integrating, representing the area under the curve of pressure dependence on time (which can be the area under one or more pulses). The method may further comprise the correlation decreasing sequence of squares, which occurs with the first predetermined speed is optimally filled implantable limiting device, the correlation sequence regions that are essentially equal to the crowded implantable limiting device, and/or may contain correlation decreasing sequence of squares, which is the second predetermined speed that is not completely filled with the implantable limiting device.

In another aspect can be the t provided an example of how data analysis, received from the implantable limiting device for removing noise contained in the data. Such a method may include collecting data from an implantable limiting device for a period of time, the data collected and containing information about the parameter values obtained inside the body over a period of time, and forming the obtained parameter values for display or further analysis. The formation may include filtering and/or converting the received parameters from a first sample rate to a second and lower frequency of sampling and/or may contain a calculation of the RMS values of the received parameters or perform regression analysis for perceived parameters. In some embodiments, the implementation of the formation may contain a calculation of the average values of the obtained parameters in each time period based on the group surrounding values obtained parameter. In other embodiments, implementation of the formation may include dividing at least part of the period of time set UPS averaging a predetermined size and to calculate the average value of the obtained parameter in each window averaging. Generated values can be stored as compressed data.

In another aspect, an example method analizowanych, received from the implantable limiting device may include the collection of data received from the implantable limiting device for a period of time, the data collected and containing information about the parameter values, taken inside the body over a period of time. The method may further comprise calculating an average value of the physiological parameter for time X within a period of time, the average value calculated on the basis of one or more values obtained parameter within a window of averaging in the time period. In some embodiments, the implementation of the window averaging (i) may be preceded by a time X, or (ii) may cover the time X. the Method may further comprise displaying the average value on the graph according to the perceived option from time to time.

In still another aspect, an example method may include receiving data processing units for processing data as described in any of the preceding embodiments, and reconfigure the device. Reconfiguration may include, for example, preconstruction device, changing, programming, or erasing the custom hardware/software devices. Reconfiguration may also include the repair, restoration or sterilization of the device.

M the office of the inspector General other examples, the features, aspects, and embodiments of, and advantages of the invention will become apparent to experts in the art from the following description, which contains as an illustration of one of the best embodiments of the invention, considered for carrying out the invention. Depending on the implementation of the invention is suitable for various obvious aspects, completely without departing from the invention. Accordingly, the drawings and descriptions in nature should be considered as illustrative and not restrictive.

Brief description of drawings

Although the description ends with the formula of the invention, which is specifically and distinctly claim the invention, it is assumed that the present invention will be better understood from the following description of some examples, considered in conjunction with the accompanying drawings, in which similar reference numbers identify the same elements and in which:

figure 1 - simplified diagram of implanted limiting device with a hole and a bidirectional communication system between an implanted device and a remote control;

figure 2 is a more detailed perspective view of the implantable portion of the device, restricting food intake, shown in figure 1;

figure 3 is a side view with partial the slit injection port, shown in figure 2;

4 is a side view with a partial section along the line a-a shown in figure 3, showing an example of a pressure sensor for measuring pressure of fluid in the constraining device shown in figure 2;

5 is a simplified diagram of the variable resistor for the pressure sensor, shown in figure 4;

6 is a cross-section of an alternative bidirectional device infusion device for limiting food intake, shown in figure 2;

figa diagram mechanically adjustable limiting device containing a pressure sensor;

FIGU is a cross section along the line B-B mechanically adjustable device shown in figa;

Fig - block diagram of the major internal and external components limiting device shown in figure 1;

Fig.9 is a diagram of several different lines of communication between local and remote devices, shown in figure 1;

figure 10 - block diagram of the sequence of operations of an example of a communication Protocol between the local and remote devices for manually adjustable limiting device;

11 is a block diagram of the sequence of operations of an example of a communication Protocol between the local and remote devices to remotely adjustable limiting device;

Fig is a block diagram posledovatelnostei operation example of the communication Protocol, in which communication is initiated by the patient;

Fig is a simplified diagram of a recording device for recording pressure measurements received from the implanted limiting device;

Fig - block diagram of the main components of the recording device shown in Fig;

Fig is a graphical representation of the measurement result of the pressure of the fluid sensor, shown in figure 4, transmitted through the system corresponding to the present invention;

Fig is a simplified diagram of the system of registration data to register the measurement results of the pressure-limiting devices meal, shown in figure 1;

Fig is a block diagram showing several components of the system of registration data shown in Fig; and

Fig is a simplified diagram showing a system of registration data shown in Fig, in the assembled state with many different communication lines;

figa is an example of the graph display pressure for the graphical user interface;

figv is an example of the display of the pressure gauge for the graphical user interface;

figs is an example of a counter display of number of pulses for the graphical user interface;

Fig is another example of the pressure graph display for a graphical user interface;

Fig - other primarily pressure gauge for the graphical user interface;

Fig is another another example of the display of the pressure gauge for the graphical user interface;

figa is another example of a counter display of number of pulses for the graphical user interface;

figv display counter of the number of pulses shown in figa for the passage of the two-pulse sequence;

figa is an example of display apertures for passage of food covered by a limiting device;

figv display shown in figa, after changing pressure, perceived limiting device;

figs display shown in figa, after another change of pressure, perceived limiting device;

Fig is an example plot of pressure against time, which can be correlated with the displays shown in figa-C;

figa is an example of a display of implanted limiting device;

figv display shown in figa, after changing pressure, perceived limiting device;

figs display shown in figa, after another change of pressure, perceived limiting device;

figa is another example of the display of implanted limiting device;

figv display shown in figa, after the change of pressure;

Fig is another another example of the display of implanted limits the feeder;

Fig is an example of a display with a single set of data, overlapping with another set of data;

Fig is another example of the display with a single set of data, overlapping with another set of data;

figa - sample plot data group associated with the limiting devices;

figw - other schedule data group associated with the limiting devices;

Fig - display device with a screen showing the annotated data values and menu event annotation;

Fig - display device with a screen showing data values that can be annotated with text entered in the text field via the input device;

Fig the display device shown in Fig, with another example of the screen data values;

figa is an example plot of pressure values from time collected from limiting device when the data transfer rate 100 Hz;

figv is an example plot of pressure values from the time shown on figa, which were converted to the data transfer rate 10 Hz;

figs is an example plot of pressure values from the time shown on figa, which were converted to the data transfer rate 5 Hz;

fig.35D is an example plot of pressure values from the time shown on figa that were preobrazovany to the data transfer rate 3 Hz;

file is an example plot of pressure values from the time shown on figa, which were converted to a data rate of 1 Hz;

fig.35F is an example of a flowchart of a sequence of operations to transform the data collected from the restriction device, other data transfer speeds;

figa is an example plot of pressure values from time collected from limiting device, superimposed on the current graphics averages computed for values of pressure according to the first method;

figv is an example plot of pressure values from time collected from limiting device, superimposed on the current graphics averages computed for values of pressure according to the second method;

figs is an example of a flowchart of a sequence of operations to perform the calculation of the current average values of data collected from limiting device;

figa is an example plot of pressure values from time collected from limiting device, with annotations associated with the calculation of the initial values;

figv is an example of a flowchart of a sequence of operations to determine the initial parameter values for the data collected from the restriction device.

figs - example Gras the ICA based pressures from time showing the change of the initial values;

figa is an example plot of pressure values from time collected from limiting device, with annotations associated with the prediction of the characteristics of the starting value;

figv is an example of a flowchart of the sequence of operations for prediction of characteristics associated with the initial value of the parameter for the data collected from the restriction device.

figa is an example plot of pressure values from time collected from limiting device, showing the superimposed pulses of different frequencies;

figv is another example plot of pressure values from time collected from limiting device, showing the superimposed pulses of different frequencies;

figs is an example of a flowchart of a sequence of operations to determine information about the physiological parameter according to the data collected from the restriction device.

fig.39D is another example of a flowchart of a sequence of operations to determine information about the physiological parameter according to the data collected from the restriction device.

figa is an example plot of pressure values from time collected from limiting device, information about the physiological parameter, sulecin the th of them;

figv is an example plot of pressure values from time collected from the restriction device, and the averaged data imposed on him;

figs is an example graph of the dependence of the pressures of time, extracted from the data shown in figv;

fig.40D is an example of a flowchart of the sequence of operations for determining a physiological parameter according to the data collected from the restriction device.

figa is an example plot of pressure values from time collected from limiting device, showing the superimposed pulses of different frequencies;

figw - detailed view of the graph shown in figa;

figs is another detailed view of the graph shown in figa;

figa is an example plot of pressure values from time collected from limiting device, with annotations associated with the presence of impulse;

figv is an example of a flowchart of a sequence of operations to determine the presence of a pulse in the data collected from the restriction device.

figa is another example plot of pressure values from time collected from limiting device, with annotations associated with the presence of a pulse in another way;

figv is another example of a flowchart of the sequence in the execution of transactions to determine the way described with reference to figa, the presence of a pulse in the data collected from the restriction device.

figa is another another example plot of pressure values from time collected from limiting device, with annotations associated with the presence of the pulse is still one other way;

figv is another another example of a flowchart of a sequence of operations to determine the manner described with reference to figa, the presence of a pulse in the data collected from the restriction device.

figa is another example plot of pressure values over time collected from limiting device, with annotations associated with the comparison of the areas of the pulses; and

figv is an example of a flowchart of the sequence of operations for area comparisons pulses, using the data collected from the restriction device.

Detailed description of the invention

The following description of some examples of the invention should not be used to limit the scope of the present invention. Other examples, features, aspects, and embodiments of, and advantages of the invention will become apparent to experts in the art from the following description used to illustrate one of the best examples of the implementation of alleged what's to perform the invention. As will be understood, the invention is suitable for various obvious aspects, it is not departing from the invention. Accordingly, the drawings and descriptions in nature should be regarded as illustrative material and do not serve to limit. Signs, illustrated or described in connection with one example of a variant of implementation, may be combined with features of other embodiments. Such modifications and variations are intended to be contained in the scope of the present invention.

Now, with detailed reference to the drawings, in which similar numerals indicate the same elements in all the views, figure 1 shows a simplified diagram of a bidirectional system 20 to transfer the data between the implanted limiting device with a hole and a remote control. Through the system 20, data and commands can be transferred between an implanted device and located on the destruction of the physician to control and influence the treatment of the patient. The communication system corresponding to the invention allows the physician to control the device from the restrictive orifice and control treatment, without meeting with the patient personally. For the purpose of disclosure here, the terms "remote" and "set on destruction" is defined as being at a distance of ballsiest feet (2 meters). Figure 1 and in the subsequent disclosure of the device with the restrictive orifice is shown and described as being a device 22 limitations meal for use in bariatric treatment. The use of the device limits food intake is only one example of application, however, the present invention can be used with other types of implanted devices with restrictive hole, without departing from the scope of the invention. In addition, it should be understood that limiting device 22 may be (or contain) any category of restrictive device, such as device constraints filled with fluid medium, the limiting device based on mechanical devices, and so on.

As shown in figure 1, the first part 24 of the restrictive device 22 are implanted under the skin of the patient 27, while the second part 26 is located outside of the patient's skin. Planted part 24 contains an adjustable restrictive brace 28, which is implanted around the gastro-intestinal treatise for the treatment of morbid obesity. In this application, the adjustable brace 28 forms a loop around the outside of the stomach wall 30, to create a hole for the passage of food between the upper ventricle 32 and the lower ventricle 34 of the stomach. Adjustable band 28 can contain alost, made of silicone rubber or other biocompatible material which is inflated inside the stomach 30, when filled with fluid medium. Alternatively, the brace 28 may contain mechanically adjustable device having a cavity for the fluid that is subjected to pressure change with adjustments bandage, or a combination hydraulic/mechanical adjustable band.

Injection port 36, which will be described in more detail below, are implanted in the body area available for injection with a needle and telemetry signals. In the shown embodiment, the injection port 36 in fluid communicates with adjustable band 28 through the catheter 40. The surgeon can position and implant injection port 36 for permanent residence inside the patient's body to perform the adjustment limits of the meal or the passage for food. Injection port 36 typically is implanted in the side, podnebennoy the abdominal cavity of the patient, under the skin and layers of fatty tissue. Alternatively, the surgeon can implant injection port 36 on the sternum of the patient.

Figure 2 adjustable band 28 is shown in more detail. In this embodiment, the brace 28 includes a cavity 42 of variable volume, which expands or contracts relates the flax external wall of the stomach, in order to form an adjustable opening for the passage of food, controlled by restricting the passage of food into the stomach. The doctor may reduce the size of the hole for the passage of food, adding the fluid in the cavity 42 of variable volume, or, alternatively, may increase the size of the hole, removing the fluid from the cavity. Fluid can be added or decrease in inserting the needle into the injection port 36. Fluid can be, in particular, of 0.9% saline solution.

Returning now to figure 1, the outer portion 26 of the restrictive device 22 contains a miniature antenna 54 is electrically connected (in this embodiment, through the hub 56 of the electrical cable with a local device 60. The node 56 of the electrical cable can join with the possibility of its removal to the local device 60 or the antenna 54 to facilitate cleaning, maintenance, use, and retention of the outer part 26. Local device 60 is controlled by the microprocessor device that communicates with the implanted device 22 and the device 170 remote control, as will be described later. Via the antenna 54 of the local device 60 associated with non-invasive implanted injection port 36. The antenna 54 can be kept near the patient's skin near the location of injecti the frame of the port 36, to transmit telemetry signals and power into the injection port 36.

Refer now to figure 3, which depicts a side view with partial section of the sample injection port 36. As shown in figure 3, the injection port 36 includes a rigid housing 70 having a circular flange 72 that contains many of the mounting holes 74 for attaching injection port to the patient's tissue. The surgeon may attach the injection port 36 to the tissue, such as fascia that covers the abdominal muscle, using any of the numerous surgical fastening means, including surgical thread, staples and paper clips. Injection port 36 further comprises a partition 76, typically made of silicone rubber and in a compressed state remaining in the housing 70. The partition 76 is permeable to needle Governor or injection tool such Tapa for adding or removing fluid from the port. The partition 76 self-seals and does after removing the needle of the syringe to maintain the volume of fluid within the injection port 36. Injection port 36 further comprises a reservoir 80 for storing the fluid and the connector 82 of the catheter. The connector 82 is attached to the catheter 40 shown in figure 2, to form a closed hydraulic circuit between the reservoir 80 and the cavity 42. The housing 70 and the connector 82 can be the ü molded together from a biologically compatible polymer or made of metal such as titanium or stainless steel.

Injection port 36 also includes a sensor 84 pressure for measuring the pressure of fluid within the device. The pressure measured by the sensor 84, corresponds to the constraints created by the brace 28 to the patient's stomach or other body cavity. The measurement result of the pressure transmitted from the sensor 84 on the local device 60 using telemetric signals using the antenna 54. Local device 60 can display, print and/or transmit the measurement result of the pressure on the remote control to assess, as will be described in more detail below. In the embodiment shown in figure 3, the sensor 84, the pressure is on the bottom of the tank 80 to the fluid inside the housing 70. Supporting the cover 86 is located above the pressure sensor 84 to essentially separate the surface of the probe from the tank 80 and to protect the sensor from the penetration of the needle. Supporting the cover 86 may be made of a ceramic material, such as, for example, alumina, which prevents the penetration of the needle, but does not affect the electronic communication between the pressure sensor 84 and antenna 54. Supporting cap 86 includes a ventilation hole 90, which allows fluid within the tank 80 to flow and to act on the surface of the sensor 84 pressure.

Figure 4 is a side view of the sensor 84 press the Oia in section along the line a-a, as shown in figure 3, illustrating a variant example of implementation of the measure the pressure of the fluid. The sensor 84 pressure is hermetically sealed inside the housing 94 to prevent leakage of the fluid and to operate the sensor. The outer part of the sensor 84 pressure contains the aperture 92 with a deformable surface. Aperture 92 formed subtle part of the bottom of the Titanic tank 80 with a thickness of between 0.001 inches and 0.002 inches. As the fluid passes through the vent hole 90 in the tank 80, the fluid acts on the surface of the diaphragm 92, causing mechanical movement of the surface of the diaphragm. Mechanical movement of the diaphragm 92 is converted into an electrical signal using a pair of variable resistors, silicone adhesive strips with strain sensors 96, 98. Strips with strain sensors 96, 98 are attached to the diaphragm 92 on the side opposite the working fluid in the reservoir 80. Strain gauge 96 is attached to the middle portion of the diaphragm 92 to measure the displacement of the diaphragm. The second agreed strain gauge 98 is fastened around the outer edge of the diaphragm 92. Strain gauges 96, 98 can be attached to the diaphragm 92 glue or can diffentiate in the diaphragm structure. As the pressure of the fluid HV the three brace 28 varies, the surface of the diaphragm 92 is deformed upward or downward on the bottom of the tank 80. Deformation of the diaphragm 92 creates a resistance change of a Central stripe with strain gauge 96.

As shown in figure 5, strain gauges 96, 98 form two upper resistive element prokomentirovat circuit 100 of the Wheatstone bridge. As the strain gauge 96 responds to the mechanical displacement of the diaphragm 92, the resistance of the strain gauge changes the potential on the upper part of the bridge circuit. Strain gauge 98 is aligned with strain gauge sensor 96, and make the circuit of the Wheatstone bridge is insensitive to temperature. Differential amplifiers 102, 104 are connected to a bridge circuit 100, to measure the change in potential across the bridge circuit due to the change in resistance of the strain gauges. In particular, the differential amplifier 102 measures the voltage across a bridge circuit, while the differential amplifier 104 measures the differential voltage across the strain gauge half bridge circuit 100. The greater the difference between the stress strain sensors for DC voltage on the bridge scheme, the greater the pressure difference. If desirable, can also be used fully compensated diagram of the Wheatstone bridge, Thu is to improve the sensitivity and accuracy of the sensor 84 pressure. Fully compensated bridge circuit to the surface of the diaphragm 92 are mounted four strain gauge, as opposed to only two strain gages, as shown in figure 4.

Returning to figure 4, the output signals of the differential amplifiers 102, 104 are fed to the microcontroller 106. The microcontroller 106 is mounted on the circuit Board 110 inside the housing 94. The sensor 112 measures the temperature inside temperature of the injection port 36 and sends a temperature signal to the microcontroller 106. The microcontroller 106 uses the temperature signal from the sensor 112 to compensate for changes in body temperature and residual temperature error that is not accounted strain sensor 98. The compensation signal of the pressure measurement to changes in body temperature increases the accuracy of the sensor 84 pressure. Additionally, inside the housing 94 is located coil 114 TET/telemetry. Coil 114 is connected to the capacitor 116 to form a tuned resonant circuit for receiving power and transmitting physiological data, including the measured fluid pressure at the local device 60. Figure 3-5 shows one example of a variant of implementation for measuring the pressure of the fluid inside the bounding device. Additional options for implementation for measuring the pressure of the fluid is described in section the patent application U.S. No. 11/065410, entitled "Non-invasive Measurement of Fluid Pressure in a Bariatric Device" (now published as patent publication U.S. No. 2006/0189888), the disclosure of which is contained here by reference.

As an alternative to the injection port 36, planted portion 24 may include a bi-directional device infusion for changes in the level of fluid inside the adjustable band 28. Using the device of the infusion fluid can be added or removed from the brace 28 by using the commands telemetry, without having to enter the syringe through the patient's skin and the septum of the port. Figure 6 shows a view in cross section of an example device 115 infusion. As shown in Fig.6, the infusion device 115 includes a pump, indicated in General as 118, for non-invasive pumping fluid in band or out in response to commands telemetry. The pump 118 is enclosed in a cylindrical outer casing 120 having an annular cover 121, covering the entire top. Sliding corrugated membrane 122 is securely attached to the upper peripheral edge of the cover 121. The membrane 122 is made of a suitable material such as titanium, which allows repeated bending in the bending of the membrane, but tough enough not to submit to pressure changes. The lower peripheral edge of the corrugated membrane 122 is attached to Crewe the new cover 123 of the membrane, which moves vertically inside the pump 118. The combination of the cover 121, the membrane 122 and the cover 123 of the membrane determines the volume of the tank 124 to the fluid. The connector 119 of the catheter is attached to the catheter 40 (shown in figure 2)to form a closed hydraulic circuit between the brace and the reservoir 124 to the fluid. The volume in the tank 124 may be increased by moving the cover 123 of the membrane in a downward direction from the lid 121. As the cover membrane 123 is omitted, the folds of the membrane 122 straightened, creating a vacuum to pull the fluid out of the bandage through the catheter 40 and the connector 119 to the reservoir 124. Similarly, the volume in the tank 124 may be reduced by moving the cover 123 of the membrane in the direction up to the cover 121, thus compressing the folds of the membrane 122 and pushing the fluid from the reservoir through the catheter 40 and the connector 119 in the brace 28.

Cover 123 membrane consists entirely part 125 of the lead screw, which operatively engages with a matching thread on the cylindrical nut 126. The outer circumference of the nut 126 is securely fastened to the axial hole of the rotating drive disc 127. A cylindrical guide ring 128, in turn, is installed around the outer annular edge of the rotating drive disc 127. Nut 126, drive plate 127 and guide ring 128,all, securely fastened together by any suitable means to form a unit, rotating as a unit about an axis formed by a part 125 of the screw. Short frame 129 contains a coil TET and telemetry (not shown) for transmitting power and data signals between the antenna 54 and the pump 118.

Guide ring 128 can rotate with the drive of one or more piezoelectric harmonic engines. In the embodiment shown in Fig.6, two harmonic motor 131 is designed so that the lugs 113 of each engine have frictional contact with the inner circumference of the guide ring 128. When the motors 131 serves power, the lugs 113 vibrate relative to the guide ring 128, creating movement in the direction along the inner circumference of the ring, which rotates the ring. The microcontroller (not shown) in the pump 118 is electrically connected with the coils TET and telemetry for receiving power to drive motors 131 and the transmission and reception of data signals to the pump. To change the level of the fluid in the cavity 42 of the brace, team regulation is transmitted via telemetry from the antenna 54. The telemetry coil in the infusion device 115 detects and transmits the command signal to the microcontroller. The microcontroller, in turn, actuates the motors 131 to lane is pitching the appropriate number, compressing or expanding the membrane 122 and transferring a desired amount of fluid in the band 28 or brace 28.

To measure changes in pressure inside the device 115 infusion and, thus, to determine the size of the hole for the passage of food, a pressure sensor, designated as block 84', is introduced into the membrane 122. The pressure sensor 84' is similar to the pressure sensor 84, as described above. As the pressure on the brace 28 is changed due to, for example, peristaltic pressure by swallowing, fluid in the brace 28 is experiencing changes in pressure. These pressure changes are transmitted back through the fluid in the catheter 40 to the membrane 122. The diaphragm in the pressure sensor 84' bends in response to changes in fluid pressure inside the membrane 122. The flexing of the diaphragm is converted into an electrical signal representing the applied pressure in the manner described above with reference to figure 4 and 5. The pressure signal is input to the microcontroller infusion device that transmits pressure data to the control device, external to the patient, via the telemetry coil. Additional details concerning the operation of the bidirectional device 115 infusion can be found in co-assigned, are in the process of simultaneous consideration of the patent application U.S. No. 11/065410 titled "Non-invasive Measurement of luid Pressure in a Bariatric Device", included here by reference.

On figa and 7B shows a mechanically adjustable brace 153 to create limitations meal in the stomach of the patient. Mechanical brace 153 can be used as an alternative to hydraulically adjustable brace 28 to create a hole for the passage of food. Mechanically adjustable brace 153 contains essentially all of the elastic core 133 having overlapping end portion 135, 137. Core 133 essentially placed in the filled fluid medium appropriate housing 139. Site 149, able to be locked and released from the core 133, speaks from the ends of the housing 139 to give the opportunity to put the core and the casing around the esophagus or stomach of the patient, to form a hole. The implanted engine 141 spatially separated from the core 133 to mechanically adjust the overlapping end portions 135, 137 of the core and, accordingly, the size of the hole formed by the core. Engine 141 adjusts the size of the core 133 with the drive shaft 143 attached to the drive wheel (not shown) inside the housing 139. Engine 141 laminated together with a remote-controlled unit 145 of the power source in the body 147 made of silicone rubber or other similar material.

As the motor 141 changes the size of the core 133, the pressure of the fluid inside the housing 139 is changed. To measure changes in pressure, a pressure sensor, such as those described above and associated with the fluid medium located in the housing 139. The pressure sensor may be placed inside the housing 139, as shown by block 84, so that changes in pressure inside the orifice passage for food, is transferred through the fluid in the housing 139 to the diaphragm of the sensor. The sensor 84 converts the flexing of the diaphragm to the measuring signal of the pressure transmitted to an external device via telemetry as described above. In an alternative scenario, the pressure sensor can be placed inside the body 147 implanted engine, as indicated by block 84"', and fluid to be connected to the housing 139 through the tube 151, passing near the shaft 143 of the drive. As the pressure in the housing 139 is changed due to pressure changes inside the hole for the passage of food, changes in the pressure transmitted through the fluid in the tube 151 to the sensor 84"'. The sensor 84"' creates an electrical signal representing the pressure of the fluid. This signal is transmitted from the patient to an external device as described above.

On Fig is a block diagram showing the main components of the implanted and external parts 24, 26 of the restrictive device 22. As shown in Fig, the outer part 26 contains p is richnow coil 130 TET for signal transmission 132 power implantirovannoi part 24. Coil 144 telemetry also introduced for transmission of data signals in implantirovannoi part 24. The primary coil 130 TET and coil 144 telemetry are combined to form the antenna 54, as shown in the drawing. Local device 60 of the outer part 26 contains the schema 134 launch TET to control the supply of power to the primary coil 130 TET. The circuit 134 launch TET is controlled by the microprocessor 136. The GUI 140 user is connected to the microprocessor 136 to enter information about the patient, and displaying and/or printing data and doctor's prescriptions. Through the interface 140 of the user, the patient or Clinician may send a request to the regulation of physician and also specify the reasons for the request. Additionally, the interface 140 user gives the patient the opportunity to read and respond to a doctor's appointment.

Local device 60 also includes a primary transceiver 142 telemetry to transmit the commands query and receiving the response data containing the perceived pressure of the fluid from an implanted microcontroller 106. The primary transceiver 142 is electrically connected to the microprocessor 136 to enter and receive commands and data. The primary transceiver 142 telemetry starts coil 144 telemetry to resonate at the selected radio frequency communication. Resonant circuit creates a downward alternating the magnetic field 146, sending data commands to the implanted microcontroller 106. Alternatively, the transceiver 142 can receive telemetry signals transmitted from the secondary coil 114. The received data can be stored in a storage device 138, associated with the microprocessor 136. The source 150 power supply provides the energy for the local device 60 to provide power to the restrictive device 22. The sensor 152 ambient pressure associated with the microprocessor 136. The microprocessor 136 uses the signal from the sensor 152 ambient pressure, to regulate the received measurement result of the pressure of the fluid to account for changes in atmospheric pressure, for example, because of changes in barometric conditions or changes in the height.

On Fig also shows the main components of the implanted portion 24 of the device 22. As shown in Fig, the secondary coil 114 TET/telemetry takes power and communication signals from an external antenna 54. Coil 114 forms a tuned resonant circuit which is inductively associated with the primary coil 130 TET to power the implant, or with the primary coil 144 telemetry to transmit and receive data. The transceiver 158 telemetry controls the exchange of data through the coil 114. Additionally, planted part 24 contains a rectifier/regulator capacity 160, micro is controller 106, as described above, the storage device 162 associated with the microcontroller, the sensor 112 temperature sensor 84 pressure and circuit 164 signal for amplifying the signal received from the pressure sensor. Implanted components pass adjusted to the temperature measurement result of the pressure sensor 84 on the local device 60 via the antenna 54. The measurement result of the pressure can be stored in the storage device 138 within the local device 60 shown on the local display device 60, or may be transmitted in real time in place of the remote control.

As mentioned above, it is desirable to provide a communication system for remote control and restraint. Through the system, the doctor can establish the chronology of the measurement results of the pressure of fluid obtained for restrictive device to evaluate the effectiveness of bariatric treatment. Additionally, your doctor may send commands to control the device. Located at a distance Clinician can access the command control via local device 60. Using commands, the Clinician can enter the syringe into the injection port 36 and add saline solution into the tank 80 to the fluid or remove fluid medium to produce a regulation is the use of the device. Alternatively, the patient, using the antenna 54 may obtain access to commands through the local device 60 and non-invasive way to execute commands on the device 115 infusion or mechanically adjustable brace 153. The pressure measurements in real time can be transferred back to the doctor while adjusting for immediate feedback on the effects of regulation. Alternatively, a patient or Clinician may send the measurement results of the pressure the doctor after adjusting for confirmation and assessment regulation.

As shown in figure 1, the communication system 20 includes a local device 60 and the device 170 remote control, also referred to here as the base device. The device 170 remote control can be placed in the doctor's office, hospital or clinic, or elsewhere. The device 170 remote control in this example is the device type personal computer containing a microprocessor 172, which may be, for example, the Pentium microprocessor Intel.RTM or similar. Alternatively, the device 170 of the remote control may contain specialized or non-specialized server accessible through a network the Internet. In this example, the system bus 171 connects the microprocessor 172 with the storage device 174 for storing data, such as the, for example, physiological parameters and instructions for the patient. Graphical interface 176 user also connects to the microprocessor 172 for displaying data and input instructions and messages for the patient. Interface 176 may include a video monitor, touch screen or other display device, keyboard or stylus to enter information into the device 170 remote control. Other devices and configurations that are suitable to ensure the device 170 of the remote control must be obvious to a person skilled in this technical field.

Numerous peripheral device 178 can interact directly with the local device 60 to enter the physiological data related to the patient's condition. These physiological data can be stored in the local device 60 and transmitted to the device 170 remote control at the time of the survey or other data exchange. Examples of peripheral devices that can be used in conjunction with the present invention, are the scales, blood pressure monitor, thermometer, monitor blood glucose, or any other type of device that can be used outside a physician's office to provide input related to the current physiological condition of the patient. Scales, for example, can be the ü is electrically connected with the local device 60 directly or wirelessly via the antenna 54, to create a report on reducing the weight of the patient. Report on the reduction of weight can be saved in a storage device 138 local device 60. During the subsequent survey device 170 remote control or automatically at pre-planned intervals a report on the weight loss can be unloaded by the microprocessor 136 to the device 170 remote control. Report on weight reduction can be stored in the storage device 174 170 remote control up until to contact the doctor.

Also, as shown in figure 1, line 180 connection established between the local device 60 and the device 170 remote control to transfer data between devices, including voice signals, video signals, information about the commands and commands. Line 180 may contain any means for transferring data from a wide range, including systems based on web of networks that use high-speed cable or telephone line, the subscriber line communications, wireless networks, satellite, T1 line or any other type of communication means, capable of transferring data between remote locations. Figure 9 depicts the various means for communication lines 180. As shown in Fig.9, the local and remote devices 60, 170 can be contacted through a variety of direct and be the wire connections. In particular, the device can be contacted through the Internet 190, using a cable or dial-up modems 192, 194, or through any other suitable device(s). In this case, data may be transmitted via any appropriate means of communication the Internet, such as, for example, e-mail, instant messaging, web pages, or send documents. Alternatively, the local and remote devices 60, 170 can be contacted through telephone network 196 General use, using modems 200, 202. Device 60, 170 can also be reached via microwave or radio frequency antenna 204 on the waves 206, 210 custom frequencies. The communication line may also be installed via satellite 209 on the waves 212, 214 custom frequencies. In addition to the lines described above, it is assumed that you can also use other types of communication means that are known in the art or that may be developed later to provide the desired data transfer between local and remote devices 60, 170 without deviation from the scope of the invention.

Figure 10 shows a block diagram of an example communications using bidirectional communication system 20. In this interaction, the doctor may send the instruction regulation, which then has to be manually performed by the attending Clinician with the patient. Doctor initsiiruetsya communication between the device 170 remote control and local device 60, as shown in step 220. The communication session may be initiated by transmitting a message by e-mail or instant messaging via line 190 connection, the Internet or via any other communication lines described with reference to Fig.9. During the communication session, the doctor may send a command to the storage device 138, or may transmit the pre-stored data received from the device 22 or peripheral devices 178, as shown in step 222. These data may contain pressure fluid, the chronology of weight or message to the patient about adherence. After data is transferred, the doctor can assess the data and determine the need for regulation device, as shown in step 234. If regulation is required, your doctor may send a command instructing the regulation on the local device 60, as shown in step 224. Local device 60 stores the instruction in the storage device 138 for later execution by the Clinician, as shown in step 226. Along with attending the patient, the Clinician accesses the instruction in the storage device 138. The Clinician then inserts the syringe into the wall 76 of the injection port 36 and adds or takes away the volume of fluid that is specified in the order. After adjusting the Clinician places the antenna 54 on top of the implant and the network to which the Anda to the microcontroller 106 to transmit the pressure measurements from the sensor 84 on the local device 60. The pressure measurements are transmitted by the microprocessor 136 local device 60 to the device 170 remote control, as shown in step 230, to ensure the doctor confirmed that the team management were performed, and to report the resulting impact on the patient. When the Autonomous regulation of the underlying device stops communicating with the local device 60 after the transfer regulations on the regulation, as shown by line 229, or after receiving the patient data, if the regulation is not assigned, as shown by line 231.

In addition to the offline session management stages 220-234, the physician can initiate interactive regulation in real time, as shown in step 236 to monitor the patient's condition before, during and after regulation. In this case, the doctor passes a prescribed regulation, as shown in step 237, when the patient is present with the Clinician. The Clinician inserts the syringe into the wall 76 of the injection port 36 and adds or takes a specific amount of fluid from the reservoir 80, as shown in step 238 to execute the instruction. After injection, the doctor instructs the Clinician to place the antenna 54 on top of the implant, as shown in step 241 to transmit the results of the pressure measurements received from the implant to the local device 60, the pressure measurements are then sent to the physician via line 180, as shown in step 243. The doctor evaluates the results of the measurement of the pressure at step 245. Based on the evaluation, the doctor can pass additional command through line 180 to re-adjust the brace, as indicated by line 242. Additionally, the doctor may send the patient team to take concrete action type of food or drink, to check the adjustment, as shown in step 244. When the patient performs the test, the doctor can be sent to the pressure measurements from the implant, as shown in step 246, to assess the peristaltic pressure on the bandage, when food or liquid trying to get through the hole for the passage of food. If the pressure measurement is too high, indicating a possible overlap, the physician can immediately transmit the Clinician additional commands to adjust the brace and to eliminate overlap, as indicated by line 249. Once your doctor is satisfied with the results of the regulation, the session ends at step 232. As shown in the block diagram, line 180 connection allows the physician and the patient to interact in the virtual communication session of treatment, during which the doctor may prescribe regulations and to receive feedback in the form of pressure measurements in real time to assess the effectiveness of the treatment.

In the second example of the interaction shown in 11, the doctor passes a prescription regulation for remotely controlled device, such as device 115 injections, is shown in Fig.6. The doctor initiates the communication session through the line 180 connection, as shown at step 220. After transmission of the message initiating communication doctor unloads saved data, such as the chronology of pressure fluid from the storage device 138 local device 60. The doctor evaluates the data and determines to assign the regulation. If the doctor chooses Autonomous regulation, control is transferred to the local device 60 and is stored in the storage device 138, as indicated at step 224. Having instruction stored in the storage device 138, the patient, when he conveniently puts the antenna 54 over the area of the implant and initiates regulation through local device 60, as indicated at step 233. Local device 60 then transmits power and command signals to the implanted microcontroller 106 to perform the regulation. After adjusting the patient establishes communication with the device 170 remote control and transmits the results of the pressure measurements received from the implant, on the remote control. These results of pressure measurements can be stored in zapominayusche the device 174 device 170 remote control, while they didn't ask the doctor.

In an alternative scenario, the patient can adjust in real time during the communication session with the doctor for the virtual treatment. In this situation, the doctor establishes a relationship with the patient through line 180 connected. After the connection through the line 180 connection, the doctor gives the patient to place the antenna 54 to the area of the implant, as shown in step 250. After the antenna 54 is in place, the doctor passes a command to control the infusion device 115 via line 180 connection, as shown in step 252. During and/or after the regulation device 115 infusion is made, the number of pressure measurements is passed back from the device 115 infusion doctor through line 180 connection, as shown in step 254. The doctor immediately undertaking a review of changes in the pressure of the fluid, the resulting regulation. If the resultant pressure levels of the fluid is too high or too low, the physician may immediately re-adjust the restrictive bandage, as shown by line 255. The doctor may also give the patient a command to perform a specific action to verify the regulation, the type of drink or food intake, as shown in step 256. As soon as the patient performs the test, the doctor can be transferred to the pressure measurements, Poluchenie pressure sensor, as shown in step 258, to assess the peristaltic pressure on the bandage as the patient tries to skip food or liquid through the opening for the passage of food. If the pressure measurements are too high, indicating a possible overlap, the physician can immediately send additional commands to re-adjust the brace and to eliminate overlap, as shown by line 259. Once your doctor is satisfied with the results of the regulation, the session ends at step 232. In the present invention, the local device 60 is always subordinate to the device 170 remote control so that only a doctor could prescribe adjustment, and thus, the patient is protected from independently performed adjustments through the local device 60.

In the third example of the communication session, shown in Fig, the patient may initiate communication with the device 170 of the remote control by entering a request via the interface 140 of the user, as shown at step 260. This request can be in the form of emails or other electronic messages. At step 262 the request of the patient is passed through line 180 communication device 170 remote control. In the device 170 remote control the patient's request is stored in the storage device 174, until the Bud is t called in a convenient for the physician time (step 264). After the doctor reviewed the patient's request (step 266), commands can be entered through the interface 176 user and transmitted to the local device 60. The doctor can communicate with the patient regarding treatment or the decision to follow or reject the specific request of the regulation, as shown in step 268. If at step 269, the doctor decides that the regulation is required, the physician may initiate the communication session, such as those shown in the block diagrams in figure 10 and 11. If the regulation is not assigned, the base device terminates the communication session after the response message at step 268.

In addition to the above scenarios, the doctor may apply to the local device 60 at any time, to verify the observation of previous commands, regulation, or to remind the patient about the implementation of the regulation. In these interactions the doctor can get in touch with the local device 60, to request a data transfer from the storage device 138, or send a reminder that should be stored in a storage device 138 and displayed the next time the patient will include local device 60. Additionally, the local device 60 may contain a sign of alarm to remind the patient of the scheduled regular regulations, such as fluorescent RA is clubline.

As mentioned above, the system 20 may be used to transfer the chronology of pressure fluid to the device 170 remote control to allow the physician to evaluate the performance of the device 22 for the set period of time. On Fig shows a recording device 270, which may be used with the communication system 20 of the present invention to record the results of measurement of the pressure in time. In the present example, the recording device 270 is external to the patient and is located over the area, under which the injection port 36 are implanted inside the patient. In another embodiment, the recording device 270 also implanted inside the patient. As shown in Fig, recording device 270 includes coil 285, 272 TET and telemetry that can be worn by the patient, as it should be next to the implanted part 24. Coil 285 TET provides power to the implant, while the coil 272 telemetry requests implant and receives the data signals, including pressure measurement of the fluid through the secondary coil 114 telemetry. In another embodiment, the coil 285 TET and coil 272 telemetry combined into a single coil that switches between functions TET and telemetry with any acceptable what korostil within any acceptable time.

The results of measuring the pressure of the fluid inside the bounding band 28 is repeatedly perceived and transmitted to a recording device 270 with the refresh period sufficient to measure the peristaltic pulses relative to the brace. Typically, the refresh period is in the range of 10-20 pressure measurements per second. As shown in Fig, recording device 270 can be worn on the belt 274 around the waist of the patient to position the coil 272 near the injection port 36 when the port is implanted in the abdominal region of the patient. Alternatively, the recording device 270 can be worn on the neck of the patient, as shown for device 270', when the injection port 36 is implanted in the chest of the patient. Recording device 270 is worn during periods of wakefulness, in order to register changes in the pressure of the fluid during patients will receive the food and daily routine. At the end of the day or other specified period of time recording device 270 may be withdrawn, and the registered data on the pressure of the liquid transferred to the storage device 138 local device 60. Chronology of pressure fluid may be transferred from the storage device 138 to the device 170 remote control in the next session tie is. Alternatively, the data of the pressure of the fluid can be directly transferred from the recording device 270 to the device 170 remote control using line 180 connected.

On Fig recording device 270 shown in more detail. As shown in Fig, recording device 270 includes a microprocessor 276 to control telemetry communication with an implanted device 24. The microprocessor 276 is connected with the storage device 280 to, among other functions, to store the results of pressure measurements obtained from the device 24. In the present example, the storage device 280 includes a static storage device SRAM capacity of 40 MB, completed with the ability to store 100 hours pressure data with a time stamp. Of course, you can use any other type of storage device 280, and a storage device 280 can store a certain amount of any other data type. For example only, can be used with any other type of volatile memory or any type of non-volatile memory, including, in particular, flash memory, storage device, hard disk, etc. When recording device 270 in this example is in operation, the data on the pressure of the fluid medium is read and stored in the storage device 280 when notnecessarily data managed by the microprocessor 276. The microprocessor 276 receives power from a source 282 power. In one embodiment, the source 282 power supply includes a rechargeable element (not shown) of the type of the rechargeable battery. In one version of this variant implementation of the rechargeable element can be removed and recharged using a charger, and at that time, when discharged, the charging element, be replaced by others of the rechargeable element. In another version of this case for the charged element is charged by connecting the charger to the register 270 and the wall Jack. In another another version of this case for the charged element is charged wirelessly using a wireless charger. In another embodiment, the source 282 power supply includes a capacitor of large capacity, which can also be charged. Of course, you can use any other type of source 282 power.

To register the pressure of the fluid microprocessor 276 first transmits the signal power implantirovannoi part 24 through the circuit 283 launch TET and the coil 285 TET. After the signal power microprocessor 276 transmits the request signal to implantirovannoi part 24 via a transceiver 284 telemetry and coil 272 telemetry. The request signal of prelive the Xia coil 114 telemetry and transmitted to the microcontroller 106. The microcontroller 106 sends a response signal read pressure, adjusted to temperature sensor 84 through the transceiver 158 and the secondary coil 114 telemetry. The signal pressure reading is taken using the coil 272 and shall be sent by the transceiver to the microprocessor 284 276. The microprocessor 276 sequentially stores the measurement result of the pressure and initiates the following query poll.

When the patient has finished the measurement and recording of pressure fluid, the Registrar 270 is removed, and the registered pressure data is transmitted to the local device 60 or directly to the device 170 remote control. As shown in figures 9 and 14, the recording device 270 may include a modem 286 to transfer the received data pressure fluid directly to the device 170 remote control using telephone line 288. The patient may connect the modem 286 Registrar with a telephone line, dial the modem number of the physician and press the submit button "send" button on the interface 292 user. After connecting the microprocessor 276 passes memorized the chronology of the pressure data over the phone line to the microprocessor 172 device 170 remote control. Alternatively, the recording device 270 may include a port 290 USB to connect the recorder with the local device 60. the ORT 290 USB logger can be connected to the port 198 USB on the local device 60 (shown in Fig), and the switch sending the "send" can be enabled to transmit pressure data in the storage device 138 in the local device. After pressure data transferred, the logger 270 can be switched off via the interface 292 user or transferred in its original state and placed back on the patient's body for continuous measurement of the pressure.

On Fig shows a graphical representation of the example signal 294 pressure, as it is measured by the sensor 84 during the re-survey local device 60 or recording device 270 for a period of time of sampling. The signal 294 pressure may be displayed using a graphical interface 140 user's local device 60 or the graphical interface 176 user device 170 remote control. In the example shown in Fig, the fluid pressure in the brace 28 is initially measured when the patient is in a stable condition, which leads to a stable pressure reading as shown in the drawing. Then to the brace 28 is applied regulation, to reduce the size of the hole for the passage of food. During regulation of the bandage sensor 84, the pressure continues to measure the pressure of the fluid and to transmit the pressure readings through the patient's skin on the local device 60. As can be seen in the graph shown in Fig, followed by regulation of gangs is MS pressure of the fluid increases.

In the shown example, the patient is asked to drink the liquid after regulation, to verify the accuracy of regulation. As the patient drinks, the sensor 84, the pressure continues to measure the pressure peaks due to the peristaltic pressure when swallowing liquids. The doctor can assess these pressure peaks from a remote location to evaluate and guide treatment of the patient. If the graph shows the pressure peaks that exceed desired levels, the doctor may immediately take corrective action through the communication system 20 and to observe the results of the correction until then, until you have achieved the desired results. Accordingly, in the communication system 20, the doctor may perform regulation and visually see the results of regulation, even when it is at a considerable distance from the patient.

In addition to regulation, the system 20 may be used for tracking in time for the performance of the restrictive device. In particular, the results of measuring the pressure of the recording device 270 may be transmitted to the doctor's office for evaluation. The doctor can visually check the schedule data read pressure, in order to evaluate the performance of the restrictive device. It should be clear that the long-term data pressure measurement can be useful for viewers who research Institute, when and how much the patient is eating or drinking during the day. Such data can, thus, be useful for appropriate management.

Data register pressure measurement can also regularly transferred to the device 170 remote control to provide a diagnostic tool that ensures that the limiting device of the meal works effectively. For example, pressure data can be useful when observing how varies the pressure in the bandage 28 or density, torque, and whether the band 28 a tendency from time to time to create the overlap. If any abnormality, the physician can use the system 20 due to come into contact with the patient and to request additional physiological data, to prescribe regulations, or when the components are allowed to manage regulation. In particular, the system 20 may be used to detect the absence of fluid inside the brace 28, indicating leakage of fluid. Alternatively, system 20 may be used to detect excessive emissions of pressure inside the brace 28 or pressure, frozen at a constant level, which may indicate a loop in the catheter 40 or blocking the hole for the passage of food.

Local device 60, the other type of docking station 360, fix the TWT 170 remote control or some other device may further comprise logic, made with processing pressure and active security alarm alerts the physician to the patient or to someone else when it encounters a serious change in pressure or other pre-determined conditions. Such anxiety may contain any of the following: an email, a phone call, the audio signal or any other type of alarm. Conditions and/or the type of alarm can also be changed in accordance with the recipient of the alarm. For example, in relation to anxiety for physicians, such anxiety may be limited to those that are provided with the indication that some component implanted portion 24 structurally defective (for example, a loop in the catheter 40, the gap band 28 and so on). In relation to anxiety for patients, such anxiety may be limited to those that are provided with the indication that the patient is eating too much, eating too quickly, or if the sizes are too big. Many other conditions under which the alarm can be sent to the doctor or the patient should be obvious to experts in the given field of technology. In addition, it should be clear that doctors and patients can take the anxiety under similar conditions, or that any of the parties may simply not take alarm at all.

For the case when the local device 60 has a graphical user interface is on of the motor, allowing the patient to see pressure data, the local device 60 may be used by the patient to assess the pressure of the house and notification of physician, when the pressure in the bandage 28 falls below a given initial pressure, pointing to the need for regulation device. The communication system 20, therefore, has such advantages as a tool for diagnosis and monitoring in the treatment of patients with bariatric device. An assessment of the restrictive device 22 through the communication system 20 facilitates more frequent monitoring and enabling components to control the device.

The graphical user interface of the local device 60, the device 170 remote control or other external device or physiological monitoring system 20 may provide a wide variety of displays, based on or related data or information coming from the restrictive device 22. Additionally, in some embodiments, the implementation of such a graphical user interface may have a recording device 270. Displays may contain information on the results of measurements made restrictive device 22, such as the results of measuring the pressure of the fluid received within the bounding device order is of the fluid medium, pressure in mechanically adjustable restrictive device or other parameters (such as pulse duration, pulse duration, pulse amplitude, number of pulses or the pulse rate, perceived electrical characteristics and so on), or in relation to physiological events, States, for example, the restrictive device 22, such as given them a restriction or condition of fullness) or trends. On figa, for example, shows one example of a variant implementation of the display 1900 that can be used as part of a graphical user interface. As can be seen, the display displays a graph or chart 1902 according to pressure of time, shown as a line, but can also be a histogram, pointwise schedule or virtually any other graphical representation. The time scale on the horizontal axis 1901 may be installed automatically, corresponding to the amount of available pressure data, or can be adjusted by the user, for example, to investigate a certain period of time. Display 1900 may also contain text indicator 1904, which in digital form provides the current or instantaneous readings of pressure. On the display screen 1900 may also be presented with a wide variety of other types of information, including the dicator 1906 initial values, showing the value in steady state or initial pressure value, and the indicator 1908 pulses, showing that the number of pulses (for example, the pulses can be pulse fluctuations in blood pressure, which may represent or be caused by peristaltic contractions swallowing patient). In some embodiments, the implementation of this information can be obtained through user input (button 1912 "Set Baseline" (setting the initial value) or, for example, by entering visually detected pulses), but there are many ways to implement this information can be obtained by analyzing, filtering or otherwise processing pressure data or other data from the restrictive device 22 and/or recording device 270 using one or more algorithms that will be discussed below in more detail. Local device 60, the device 170 remote control or other device can implement these algorithms and to continuously update the display 1900, yielding new results. Display 1900 may also contain a group 1910 registration control to allow the user to perform control, when the pressure is recorded or registered in the file, and the location of this log file can be displayed in a window 1924. In addition, annotations can the t provided by means of 1914 control. In other embodiments, implementation of the display 1900 may contain the pressure readings obtained during previous visits (for example, during previous visits to the same patient or under the previous regulations restrictive device), and/or the pressure reading when the previous peristaltic events representing swallowing, heart rate, respiratory rate, or in fact any other physiological parameter. Display 1900 may also include the patient's name or other identifying information, along with notes, lists of actions or recommendations of the patient and so on.

On figa display 1900 has a menu 1916, which contains three graphics or icon 1918, 1920, 1922. Each of these icons may cause the performance of the various display screens. As shown in figa selected second icon 1920, and shows a graph 1902 according to the received pressure from time to time. The selection of the first icon 1918 may cause display 1930, shown in figv, which shows the pressure through the meter 1932. In this embodiment, the meter 1932 is vertical and linear, but can be used in a wide variety of other orientations and shapes such as horizontal gauge, dial gauge, and so on. Meter 1932 may contain discre the major indicators or segments of 1934, which can be divided into one or more zones or ranges 1936a-c. As shown in the drawing, are provided with three discrete pressure range 1936a-c with limit values (in this example, 80-140 mm RT. Art., 0-80 mm RT. Art. and-10-0 mm RT. Art.), but can be provided with any number of pressure ranges, and their sizes and end points can be adjusted. As should be understood specialists in a given field of technology ranges 1936a-c can be set by the physician or by another user and can vary depending on the patient. In some embodiments, the implementation of the pressure ranges 1936a-c can comply with the conditions associated with implantable restrictive device, for example, the high range may indicate that the limiting device is full or constricted, the average range may indicate optimally filled or optimally tightened restrictive device, and the lower range may indicate insufficiently filled or free of the restrictive device. When using the pressure can be indicated by marker 1937, which may represent the current pressure, average pressure, or other metric associated with pressure. In some embodiments, the implementation of the token 1937 may continuously move the meter 1932, while in other embodiments, the implementation of brand the 1937 may move discretely from a segment of 1934 for the segment 1934. Display 1930 can also contain many of the same or similar user interface elements that are available on the display 1900 shown in figa, such as group 1910 registration control box 1924, showing the location of the log file, and/or the tool 1914 control annotation.

Returning to figa, the selection of the third icon 1922 may cause display of 1940 counting the number of pulses, as shown in figs, for counting the number of pulses in the pulse sequence. The sequence of pulses may represent peristaltic event of swallowing. Display 1940 may contain a dial meter 1944 numbered or lights around its periphery. When using the arrow indicator 1932 may rotate inside the meter 1944, to provide an indication of the number of pulses detected in the sequence. Can also provide text indicators 1946, 1948, to specify the number of pulses in the current or last sequence of pulses. The tool 1950 control can set the account to its original state.

Can be provided with a wide variety of other displays for pressure, pulse and other physiological parameters and events. For example, on Fig shows an alternative display 2000 showing the waveform of pressure dependence on time, with both the cookies time scale, marked text tokens 2002 on x-axis Pressure, perceived restrictive device 22, can be presented on the display 2000 graphically as fluctuation 2004. In addition, any display or indicator, gauges, graphs, or other display elements within them, can be made with the possibility of an alert message. For example, the graph 1902 pressure indicator 1904, or measures 1932, 1944 (or other elements of the display may blink when the pressure or another parameter to pass the threshold. Anxiety can also be displayed by changing the display lighting (for example, can change color, intensity, hue, and so on) or a warning message or other visual indicator. The alarm may also be included in addition to or instead of the optical alarm. Any of the displays described herein, may use the green-yellow-red bar, circle, or other representative of a geometric figure, a graphical representation or display, in which there is a change in color as the resulting parameter changes. For example, the color indicator may be red as opening holes for the passage of food coming to the floor (that, for example, is indicated by pressure or otherwise), as this can be harmful to health the article, but can be yellow as restrictive device is weakened (for example, what is indicated by pressure or otherwise), because it may not be considered life-threatening. In some embodiments, the implementation of these colors can be achieved using screens with colored light emitting diodes (LED) or liquid crystal display (LCD).

On Fig shows an additional variant of the implementation of display 2100, which indicates the pressure (for example, the current pressure or the pressure at the selected point on the display 2000 etc). Display 2100 may include a vertical meter 2103, divided into discrete segments 2102. Each segment may represent a group of pressure, illuminating when the pressure is within the group. As shown in Fig, segment 2114 glows. Mark 2104, 2112 can identify the group. Segments 2102 can be grouped into zones or bands, which can be different colors. As shown in Fig, meter 2103 contains three ranges 2106, 2108, 2110 (e.g., red, yellow, green), which can correspond to high, medium and low pressure, respectively. Ranges 2106, 2108, 2110 can be configured as a tunable by the user, and may correspond to different States, for example, the upper range may correspond to the state of the restrictive device is TBA 22, when it is too tight, and so on. The average range, which can be green, may correspond to the area of optimal control restrictions. When using the 2100 meter can display static and/or dynamic pressure measurements. In static measurements, for example, the measuring device 2100 may represent the initial pressure or the pressure of the perceived restrictive device 22, which may be advantageous after implantation or regulating device 22. When dynamic or instantaneous measurements, for example, the measuring device 2100 can imagine the pressure detected in a restrictive device 22 during the event of swallowing. The result is a luminous segment 2102 may ascend and descend together with the pressure changes.

On Fig shows another alternative implementation of the display 2200, which indicates the pressure. In the embodiment shown in the drawing, the display 2200 has the form of a dial gauge 2202 with a rotating arrow 2206 and markings 2204 located on the periphery of the measuring device 2202. Measuring 2002 can be divided into multiple zones or ranges 2208, which can operate as described previously. When using the arrow 2206 can rotate to indicate the pressure readings, such as the beginning of the aspects of the pressure, the average pressure, static or dynamic pressure, and so forth.

On figa shows an alternative implementation of the display 2300, which represents information about the pulse sequence parameter, as it can occur with pulse fluctuations in blood pressure during the event of swallowing. As shown in the drawing, the display 2300 displays a graph 2302 dependence of the amplitude of the pulses from the number of reference pulses. In other embodiments, implementation instead of pressure may display the value of another parameter. The reference pulse may correspond to the number of pulse in the sequence. For example, as shown in the drawing, the pulse mark 2304 identifies the sixth pulse in the sequence of seven pulses. (It should be noted that although the example shown in figa shows 7 pulses may be determined and displayed by any number of pulses). When using vertical bars 2306 can specify the amplitude of the pulse for each pulse in the pulse sequence. Each vertical column 2306a-g can be composed of segments or discrete indicators 2308, each of which may be a pressure or pressures. The height of the vertical column may represent the magnitude or amplitude of the pressure, which may be an indication of absolute giving the program or pressure change relative to the initial pressure or other pressure, taken as a point of reference. When using vertical bars 2306a-g can appear as detection pulses. For example, as the pressure detected by the restrictive device 22 increases, the display 2300 on the left side of the chart 2302 may represent a growing vertical column 2306a signal pressure. If this pressure increase is considered as an impulse, which, for example, can be determined through the algorithms that will be discussed below, the vertical column 2306a can grow and stay at the peak of the pulse, and "1" as the number of timing pulses may appear on the bottom axis 2308. If you receive another pulse, another column 2306b you may receive a similar way, accompanied by the indication "2" of the pulse underneath. This can continue until the pressure no longer show the pulse of events until the user indicates that the event has ended, until the pulses will not be rare (measured, for example, as in pulse period periods)or until the expiry of the time defined by the timer, and so forth. On FIGU shows a series of displays 2312, which may appear during the two-pulse sequence.

The display may also contain timestamps for pulses. For example, as shown in figa, timestamp 2314 may be placed around numerische pulse, to specify the time at which the pulse was detected (for example, at the time after 4 seconds within the time period of the sample), or, alternatively, the label may indicate the measured pulse duration (for example, the pulse had a duration of 4 seconds), the time after the previous pulse (for example, 4 seconds from the beginning, peak or end or the other point of the previous pulse) or any of a wide variety of metrics of time-related pulses. As should be understood specialists in the art, although figa as the example shows one timestamp 2314, the timestamps may also be associated with other impulses.

On Fig-28 shows other examples of displays of the graphical user interface of the local device 60, the device 170 of the remote control, the recording device 270 or other device. In General, these displays can represent a static or dynamic image of the hole for the passage of food limiting device and/or environmental physiology, which may change or otherwise to represent the parameter (such as pressure), perceived limiting device. Displays can also be images displayed sequentially or at the appropriate times, video or other images. For example, on figa pok is Zan one example of the display 2400, having simulated graphical representation of the location area, closing the limiting device 2404, which in this example contains a cross-section of the esophagus and holes 2402 for the passage of the food, close the limiting device 2404. A graphic image can show the size, shape, configuration, effect of limiting device 2404 on the field or another aspect of the location area. The image of the oesophagus and holes 2402 for the passage of the food here is only for example, because it can actually be shown to any area inside the body and, in particular, any anatomical lumen.

When using the display 2400 may be changed in accordance with pressure, perceived limiting device. For example, on FIGU-C shows the display 2400, how can he look after increasing pressure, with a hole 2402 for the passage of food, reduced in size, and the surrounding tissue becomes compressed. In some embodiments, the implementation of the display 2400 can continuously be updated (like the live display), but in other embodiments, implementation, he may be composed of static or still images that appear as needed, and each image corresponds to a range of pressures. For example, on Fig shows an example graph C the dependence of the pressure of time, which contains three segments, labeled A, B, C, each of which shows different perceived pressure. Figa may correspond to A segment, figv might correspond to the segment B, and figs can match the segment C. In some embodiments, the implementation of the segments A, B, C can correspond to a condition limiting device 2404, such as the status of the restriction of food intake or the state of complete filling limiting device 2404, for example, the segment may be correlated with a limiting device that is too loose or not completely filled, the segment B may represent the optimal regulation, and segment C may represent an overly tightened or crowded, or too restrictive device. In other embodiments, implementation of the display 2400 may vary in accordance with different perceptual amplitudes of pulses, the number of counts pulses or pulse frequencies, and so forth (such information about the pulses is obtained, for example, in response to standardized tests, such as the swallowing of water, or by controlling the characteristics of the pulses for a prescribed time).

Display 2400 can have a wide variety of other configurations. In some embodiments, the implementation on the display 2400 may seem one or more lines of the reference is, Isobar or other indicators. For example, on the display 2400 may seem a circle (or one or more concentric circles), allowing the physician or other user easier to visualize the changes of the size of the hole 2402 for the passage of food or other changes in the location field. In some embodiments, the implementation of the size of the circles can be selected and marked to indicate the measured pressure, for example, the label on the circle can represent the perceived pressure, and when the size of the hole for the passage of food 2402 or opening, essentially corresponds to the size of the circle, the perceived pressure can, essentially, be it marked pressure. Information such as perceived pressure and/or the status of restrictive devices may also be presented on the display 2400 in the form of text or using color, for example, the image of the hole for the passage of food becomes red as opening holes for the passage of food approaches overlap, and so on.

Additionally, although figa-C display 2400 represents an image in cross-section, in other embodiments, the implementation can be provided by other two-dimensional image (such as a side view, a view only one restrictive device, and so on) or trahma the Naya graphics. On figa-C shows an example of display 2600 with the simulated three-dimensional graphic image. As shown in the drawing, the display 2600 contains a three-dimensional graphical representation of the location of the external side of the esophagus and stomach. You can see restrictive device 2602, closing the upper part of the stomach. Display 2600 may further comprise a graphic image 2604 restrictive device 2602, removed from the upper part of the stomach, which provides a view of the hole 2606 through restrictive device. Labels or other arrows can be used to provide information about the size and shape of the holes 2606. Three-dimensional display 2600 may be updated based on the changing pressure as described above with reference to figa-C and 25. For example, figa can display and correspond to the segment A (as shown in Fig), FIGU can display and correspond to the segment B, and figs can display and correspond to the segment of Arrow C. 2608, 2610, and 2612 indicate examples of presentation of food particles passing into the stomach, for example, after a SIP), which can be entered in each of figa, 26B and -26 C. As shown in this embodiment, figa shows the largest number of food particles, which corresponds to a lower pressure and/or freer inhaling limiting device (n is compared with pigv and -26 C). On figs shows the small amount of food particles that corresponds to a higher pressure and/or more dense the torque limiting device (compared to Figo and 26B). On FIGU shows the number of food particles between shows on figa and -26 C, which corresponds to the pressure and/or the tightness between the pressure and/or tightening for Figo and -26 C.

Display 2600 may be based on actual images, or himself to be the actual images for the body, such as a fluoroscopic image, and may contain a still image or a continuously updated image (video image). In some embodiments, the implementation of the 2600 display can show the passage of barium sulfate through the opening defined by the limiting device 2606. Such a construction may be advantageous, allowing the user to see how the fabric during swallowing, and/or display of fluoroscopic x-ray image media (e.g., barium sulfate), passing through the limiting device 2606, installing limiting device (for example, when a known amount of filling). Fluoroscopic images may be based on their own x-ray of the patient, or universal images, any of which may be taken by the user is m and loaded into an external storage device. Images of a patient or a generic image, selected to match the body type of the patient (or a generic image can then be displayed in response to perceived pressure. On figa-B shows an example of the display 2700, representing a fluoroscopic image in accordance with the detected pressure. Figa, for example, might correspond to the segment And to Fig, while figv might correspond to the segment B. Fluoroscopic image on the display can also be beneficial for diagnosing physiological state associated with a limiting device. For example, Fig shows another example of display 2800, based on fluoroscopic images. The patient, fluoroscopic swallowing environment, but showing minor changes or pulses in the pressure (e.g. pressure, perceived limiting device)may suffer a depletion of gastric peristalsis, in which gravity is the only or primary force causing the substance to pass through the esophagus. Display 2800 shown in Fig that represents a graphic image limiting device 2802 and the bag 2804 lumps of food, can be used to diagnose this condition, or when this condition is detected. Can also use the sterile other forms of medical imaging, such as x-rays, displaying magnetic resonance imaging (MRI) and so on.

As mentioned earlier, the graphical user interface of the local device 60, the device 170 remote control or other external devices may be suitable to represent the chronological trends or analysis of data based on, for example, parameter data received by the registration device 270. Such functionality may be useful, for example, when the patient visits the doctor to review progress, determine what to do with complication and/or to adjust the implanted limiting device 22. In one variant example of implementation shown in Fig, the display 2900 can represent the graph or chart according to pressure of time, however, other physiological parameters such as heart rate, blood pressure, respiratory rate, etc. may also be displayed. The display 2900 may contain multiple data sets, for example, line 2902 trend or other graphical representation of the data from the first period of time (e.g., first visit) and another line 2904 trend or graphical representation of data obtained at a later period of time (for example, when the second doctor's visit), superimposed on the line 2902 trend from the first period is the time. Overlay data for two different periods of time may allow the user to compare the trend lines. In some embodiments, the implementation of a later period of time may follow after a significant medical event, such as regulation limiting device 22, and the overlay data allows you to evaluate the regulation limiting device 22. Although Fig shows an example with pressure for a period of time as the result of swallowing may be used pressure from any source or for any period of time. Additionally, this way you can present a wide variety of data, including weight, weight loss, body mass index, the results of measuring the body, the pressure inside the tyre, heart rate (rest and under load), breathing frequency (rest and under load). For purposes of illustration, on Fig shows an example of display 3000, which imposes the line 3002 trend, representing the respiratory rate of the patient after one regulation limiting device on the second line 3004 trend, representing the respiratory rate after adjustment made later. Overlay can be represented by different data types (for example, the trend line pressure imposed by the trend lines in heart rate).

On figa shows one example of display is 3100, represents the data for a population or group of patients. These groups may be taken from a wide variety of data sets, including data collected by a physician, regional data national data and/or data selected from a larger set of data to match the type of body (or other physiological/significant from a medical point of view, characteristics) of a particular patient. A variety of parameters can be plotted on the chart and compare, but, as shown, in this case, the display 3100 is a plot of the pressure from the filling volume of the limiting device filled with fluid medium. Other parameters, such as number of pulses, pulse amplitude, pulse duration, pulse amplitude and pulse frequency, can also be represented in graph form, depending on the filling volume, and, as mentioned earlier, such information about the pulses can be obtained, for example, in the type test of swallowing water or pieces of food that can be standardized volume and/or viscosity, or by controlling the characteristics of the pulses over time. Display 3100 may also contain several lines 3102 trends (although can be used and the histogram, pointwise graph or other graphical representation of data), presentada the trend line represents a graph of the data obtained from the patient, as indicated in the legend 3104. More specifically, line 3102 trends can imagine the pressure (primary pressure, secondary pressure, or any other result of pressure measurement)obtained for each patient for the data volume filling their limiting devices. In some embodiment, these data may come from the recording device 270, but in this example, line 3102 trends are static measurements of the amount received at the time of adding a known volume of liquid (e.g., 1 ml) in a limiting device 22, and measuring the resulting pressure. As you can see, the line 3102 trends show the range of pressures in each volume, which may be due to the variability of the anatomy or accommodation limiting device and adjusted depending on the patient. Display 3100 may be useful to allow the physician or other user to visualize how one patient compared with another patient or set of patients.

On FIGU shows another example of display 3150 representing the data for a group of patients. As shown in figv, display 3150 contains a plot of the pressure from the filling volume. The display contains 3150 line 3152 trend, representing the nominal value of d is the exercise for a group or population of patients. In this embodiment, the nominal value is the average value, but in other cases it may be the middle point of the weighted average value, minimum, maximum, range, standard deviation or the result of any mathematical calculations. Display 3150 may also contain upper bounding line 3154 trend and lower bounding line 3156 trend, which all together can determine the range 3158 around the nominal value. In some embodiments, the implementation of the trend line for a particular patient can be superimposed on the display 3152, showing where the patient loses against the group. In other embodiments, implementation of the display 3152 may be made without overlay data for a particular patient.

Displays can also provide the ability to supply historical data annotations, especially the data that is collected over a long period of time (for example, recording device). On Fig shows an external device 3200, such as local device 60, with display 3202. It should be understood that the external device 3200 may be any external device for display and/or physiological monitoring, including device 170 remote control. As shown in the drawing, the display 3200 is the schedule for the W ill of pressure for a period of time and provides the opportunity to provide a summary is presented on the chart values using the drop-down menu 3204. Menu 3204 can contain many descriptions of predefined events 3206, such as tests, symptoms, observations by the user or a physician, and so forth. For the purpose of illustration Fig abstract 3210 is located on the image 3208 shape fluctuations and contains the token 2310 annotation, which indicates that at a particular point in time was Swallowing water - 20 ml". The user can provide chronological data annotation in different ways. For example, the external device 3200 can be adapted to home use, and the patient can annotate events on a daily basis. Such an implementation option can be useful if the recording device 270 captures data, for example, for a few days. Alternatively, the external device 3200 may be updated by the physician during patient visits, or when adjustable limiting device 22. The doctor can annotate daily data or conduct additional tests (such as swallowing water)to create data logs, separate from any daily control. It should be clear that although the display 3200 provides for the annotation pre-defined event, and many variations of the implementation, the user can create their own user-defined is abitia for annotation and/or may enter a description for the data values in any form. On Fig shows one example of a variant implementation of the display 3300 external device 3200, in which descriptions can be entered in the text box 3302. In some embodiments, the implementation for the description you can also use an image or icon, such as icon bowls can specify event "Swallowing water."

The ability to present data with annotations is not limited to these pressures. For example, on Fig shows the display 3400 containing a graphical representation, in this case, a histogram of weight loss over time, with the amplitude of columns 3402 corresponding to the magnitude of weight loss. As shown in the drawing, the column 3402 is provided for multiple dates 3404. The user can enter in the text box 3406 comments or annotations associated with each column 3402 and/or date 3404, which can be useful for tracking and/or display of events in the life of the patient that affect weight loss. External device 3200 may include a keypad 3408 or other device user to enter data for this purpose.

Any or all of the preceding display can be provided in virtually any combination to create a graphical user interface for the local device 60, the device 170 of the remote control, the recording device 270 or other device physiologist who ical control. In some embodiments, the implementation can be provided by a remote server to allow users to upload displays and/or elements of the displays that they want, at a local device 60 or device 170 remote control. For example, to download may be available library of display screens, displays, visual shell, images, desktop, screen savers and other display configurations which allows the user to customize the graphical user interfaces of the devices. In addition, the remote server may provide the ability to save and categorize displays and/or elements of the displays that have been configured or designed and uploaded by the users. Such functionality may allow users to communicate with each other and share elements of the displays.

In addition, any or all of the graphical user interfaces and/or displays described herein may be reconfigured through modifications, changes, erasing, programming, updating, revisions, additions, and so on. For example, a device having a graphical user interface, can be obtained, and the desired modification can be done by programming the appropriate software through input port of the data or the dock (for example, port 198 USB, shown in Fig) local device 60, the device 170 remote control or other device for physiological monitoring. In other embodiments, the implementation of such modifications can be performed telemetry. For example, additional icons, charts, indicators, and so on can be added, the displays can be configured for a particular user, and so on. As the use of such methods, and the resulting device are within the scope of this application.

An alternative implementation of the system 300 registration data shown in Fig. In this example, the data-logging system 300 includes a head coil 354 and recording device 370. The head coil 354 and recording device 370 is connected by cable 356. Cable 356 can be disconnected from the head coil 354 and from the recording device 370. Of course, it should be understood that the cable 356 is just an example, and that can be used any suitable alternative, including, in particular, wireless system transmitter/receiver. In this example, the cylinder 354 reel is worn around the patient's neck and is usually located above the injection port 36. Recording device 370 is worn on the belt 274 around the waist of the patient. Of course, these corresponding locations are merely examples, and the should to understand the head coil 354 and recording device 370 can be located in any other place. For example only, when the injection port 36 is introduced into the abdominal cavity of the patient, the head 354 with the coil can be worn on the belt 274. You should also understand that the head coil 354 and recording device 370 presented on Fig as simple blocks for illustrative purposes only, and that the cylinder 354 coil or recording device 370 can be provided with many different shapes, sizes and configurations.

Examples of components of the system 300 registration data shown in Fig. As seen in the drawing, the recording device 370 includes a microprocessor 276, storage device 280, the source 282 supply port 290 and the USB interface 292 user. The head coil 354 contains the schema 283 launch TET, the transceiver 284 telemetry coil 285 TET and the coil 272 telemetry. Scheme 283 launch TET is configured to receive power from a source 282 power cable 356. Scheme launch TET additionally configured to receive signals from the microprocessor 276 cable 356. The transceiver 284 telemetry is configured to receive signals from the microprocessor 276 and transmitting signals to the microprocessor 276 cable 356. In another embodiment, the transceiver 284 telemetry performed in the possibility of only transmitting signals to the microprocessor 276. It should be understood that many of the components depicted in Fig, similar to those depicted in Fig and described in the accompanying text. Accordingly, the above discussion of such components with reference to Fig can also be applied to the components shown in Fig. In this example, the head coil 354 and recording device 370 can be considered as the separation of the components constituting the recording device 270 (described above), two physically separate devices. Additionally, it should be understood that any of the components shown in Fig, as well as their relations, functions, etc. can be modified in any suitable way.

In this example, the cylinder 354 coils are designed and operated in a manner similar to the antenna 54, described above. Coil 285 TET head coil 354 is arranged to supply power into the injection port 36. Of course, when implanted in the patient any other device (e.g., pump etc), configured to receive power from the coil 285 TET coil 285 TET can also provide supply of power to such devices. Power is provided by a coil 285 TET, may be supplied to the coil 285 TET and governed by the scheme 283 launch TET, which itself can receive power from a source 282 power by KAB the Lu 356. Such power supplied to the circuit 283 launch TET, can be adjusted by the microprocessor 276 cable 356. In addition, or as an alternative, the microprocessor 276 may regulate the manner in which the scheme 283 launch TET provides power to the coil 285 TET. Other suitable configurations and relationships between these components, as well as alternative ways in which they can act, must be obvious to experts in the given field of technology. It should also be understood that although this example involves the use of radio signaling through the coil 285 TET, can be used for any other type of way to supply power, as well as alternative mechanisms of transmission capacity.

Coil 272 telemetry head coil 354 is configured to receive signals from the coil 114 of the injection port 36, including signals representing the pressure of the fluid within implanted device (e.g., the pressure of the fluid within the injection port 36, the inside of the catheter 40 and/or inside the adjustable band 28, the pressure obtained using the sensor 84 pressure, etc.), and signals representing the temperature. It should be understood that the coil 272 telemetry may also take any other type of signal representing any other type of information from any other source. The signal p is inate coil 272 telemetry, transmitted to the transceiver 284 telemetry, made with the possibility of transmission of such signals to the microprocessor 276 cable 356. The transceiver 284 telemetry may perform any appropriate transmission or processing of the signals received from the coil 272 telemetry, before passing the signals to the microprocessor 276. Other suitable configurations and relationships between these components, as well as alternative ways in which they can act, must be obvious to experts in the given field of technology. It should also be understood that the components may be combined. For example only, the coil 285 TET and coil 272 telemetry can be combined into a single coil and switch between functions TET and telemetry from any desired speed at any desired time. In addition, although this example involves the use of radio signaling through the coil 272 telemetry, it should be understood that there may be any other types of communication (e.g., ultrasonic, magnetic and so on), as well as the transmission mechanisms other than the coil.

Recording device 370 can take pressure measurements during a given day and store them in the storage device 280, registering, thus, changes in the pressure of the fluid during a meal by the patient and routine. This item is the iMER storage device 280 includes SRAM capacity of 40 MB and can store 100 hours of pressure data with timestamps. Of course, you can use any other type of storage device 280, and a storage device 280 may store a number and any other data type. For example only, can be used with any other type of volatile memory or non-volatile memory, including, in particular, flash memory, storage device, hard disk, etc. At the time when the recording device 370 in this example is in working condition, pressure fluid medium is read and stored in the storage device 280 with the assigned data rate controlled by the microprocessor 276. In one embodiment, the pressure of the fluid repeatedly perceived and transmitted to the recording device 370, and then stored in the storage device 280, updated with an update rate sufficient to measure peristaltic pulses acting on the adjustable brace 28. Only for the purpose of example, the refresh period may be between approximately 10-20 pressure measurements per second. Can be used with other suitable periods of updates.

In another embodiment, planted part 24 includes a storage device (not shown). For example only, such implanted storage device can be the t to be placed in the injection port 36 or elsewhere. Such implanted storage device can be used for a variety of purposes when such storage device contains in its composition. For example, is implanted storage device can store the same data as the storage device 280 recording device 370, so that the implanted memory device provided backup to the storage device 280 recording device 370. In this version, such data may optionally be stored in implantirovannomu storage device for archival purposes, may be replaced on a daily basis, can be replaced or updated after the registration unit 370 transmits the same data to the device 170 remote control, or can be used otherwise. You should also understand that implanted a storage device that can be used to store pre-selection or pre-selected types of information. For example, implanted the memory device can store the maximum and minimum pressure measurements, x-ray images or video swallowing by the patient and/or any other information. Other information suitable for storage in implantirovannomu storage device is TBE, it will be obvious to experts in the given field of technology. You should also understand that it can be implanted any type of storage device, including, in particular, volatile (e.g., SRAM and so on), non-volatile (e.g. flash memory, hard drive, etc...) or other storage device.

In this example, the microprocessor 276 is fed from a source 282 power. In one embodiment, the source 282 power supply includes a rechargeable element (not shown) of the type of the rechargeable battery. In one version of this variant implementation of the rechargeable element is removable and can be charged using a charger with replacement on the other charge element at the time until expended element is charged. In another version of this case for the charged element is charged by connecting the charger to the registering device 370 and the wall outlet. In another another version of this case for the charged element is charged wirelessly using a wireless charger. In another embodiment, the source 282 power supply includes a capacitor of large capacity, which can also be charged. Of course, you can use any other type of source 282 power.

Recording device 370 in this example is can be configured to supply the patient alarm under different circumstances in different ways. For example, recording device 370 may provide audible and/or visual alarm when there is a sharp change in pressure of the fluid. Alternatively, the recording device 370 may provide audible and/or visual alarm when the determining based at least in part, data pressure that the patient eats too much, too fast, etc. Recording device 370 may also serve to alert the patient after determining that the cylinder 354 coil does not properly support the communication with the injection port 36. Other conditions under which a patient may be served alarm recording device 370, should be obvious to experts in the given field of technology. It should also be understood that the interface 292 may contain any number or any type of signs, including, in particular, loudspeaker, led and LCD display, switch on-off, etc. In the present example, the interface 292 user is arranged to supply an output signal only to the patient and does not allow the patient to submit input on the recording device 370. Interface 292 user in the present example, therefore, consists of a green led to show that the source 282 power eno is charged but, and red led to show that the source 282 power you need to recharge. Of course, the interface 292 user can alternatively allow the patient to provide input on the recording device 370, and may include any suitable components and features.

As shown in Fig, the system 300 registration data further comprises a docking station 360. Docking station 360 is configured to receive data transmitted from the recording device 370, and additionally has a capability to transfer data to your device 170 remote control. In the present example, the recording device 370 includes port 290 USB, such that docking station 360 may receive messages from the recording device 370 via the USB cable (not shown)that is connected to the port 290 USB. In one embodiment, docking station 360 contains a personal computer of the patient. Of course, iPod docking station 360 may receive messages from the recording device 370 in any other suitable way. For example, such messages may be transmitted wirelessly (e.g., using radio frequency systems, Bluetooth, ultra-wideband systems and so on).

In another embodiment, docking station 360 is allocated for communication with the external device 370 and includes a tool lever type (not shown), the implementation of the tion with the possibility of receiving data from the recording device 370. In this example, the tool arm-type contains the contacts made with the possibility of an electric circuit corresponding contacts on the recording device 370 to provide communication between the docking station 360 and recording device 370. Docking station 360 may thus communicate with the external device 370 in a manner similar to docking systems for personal digital assistants (PDA)devices BLACKBERRY.RTM, phones, etc. Other suitable ways in which the registering device 370, and a docking station 360 may contact or otherwise get in touch, should be obvious to experts in the given field of technology. It should also be understood that the docking station 360 is depicted on Fig in the form of a desktop computer for illustrative purposes only, and that the docking station 360 may be provided with a variety of alternative shapes, sizes and configurations.

In one embodiment, docking station 360 contains the local device 60 described above. Accordingly, it should be understood that the above discussion concerning the components depicted in figure 9, can also be applied to the components depicted in Fig. Similarly, methods such as those shown in figure 10-12 and described in the accompanying text, may also be implemented using a docking station 360. Another is the version of the implementation of the registering device 370 includes a local device 60. In yet another embodiment, the recording device 370 is provided by the AC adapter or similar device made with the possibility of a charge source 282 power, and recording device 370 further comprises an Ethernet port (not shown)that allows the registering device 370 to directly connect to a network such as the Internet to transmit information to the device 170 remote control. Therefore, it should be understood that any of the features and functions described herein with respect to local device 60 and/or docking station 360, can alternatively be contained in the registering device 370 or may be placed otherwise.

In one example, the patient wears during the day, the head coil 354 and recording device 370 to record the results of measuring the pressure in the storage device 280. At night the patient detaches the recording device 370 from head 354 coil and connects the recording device 370 to the docking station 360. At that time, when the recording device 370, and a docking station 360 is connected, the iPod docking station 360 transmits data received from the recording device 370, the device 170 remote control. When the source 282 power supply includes a rechargeable element, iPod docking station 360 may additionally is to be made with the possibility of a charge element at the time as a recording device 370 is connected to a docking station 360. Of course, specialists in the art will immediately should be clear that the patient is not necessary to disconnect the recording device 370 from head 354 coil to connect the recording device 370 with a docking station 360. Also it should be clear that the pressure measurements can be recorded in a storage device 280 during the night in addition to or as an alternative to the registration of such measurements during the day, and that pressure measurements may be logged even twenty-four hours a day. Thus, it is understood that the timing of the measurement of pressure and registration need not be limited to daytime hours. This also implies that there is no need to record every measurement result of the pressure.

As described above, the recording device 370 has a capability of receiving, storing and transmitting data relating to the pressure of the fluid. However, the registration unit 370 may receive, store and/or transmit a variety of other data types. For example only, the recording device 370 may also receive, process, store and/or transmit data related to temperature, ECG measurements, the frequency is of Riem food by the patient, the volume of food consumed by the patient, the amount of walking done by the patient, etc. Therefore, it should be understood that the registering device 370 may be performed by processing the received data to create additional data for transmission to the docking station 360. For example, recording device 370 can handle the pressure data obtained through the cylinder 354 coil, to generate data representing the frequency of food intake by the patient. Also it should be understood that the registering device 370 may contain additional components to retrieve data, not related to pressure. For example, recording device 370 may include a pedometer or accelerometer (not shown)to receive data relating to the amount of walking done by the patient. Data obtained by such additional components may be stored in storage device 280 and transmitted to the docking station 360 in a manner similar to the method used for pressure data. Recording device 370 may also include components for receiving data, which should be fitted coefficients for measurements of internal pressure, in order to account for the influence of various conditions on the pressure of the fluid. For example, recording device 370 may include a barometer for measuring atmosfernoj the pressure. In another embodiment, the recording device 370 includes an inclinometer or similar device to determine the angle at which the patient is oriented (e.g., standing, lying, etc.), which can be accounted for by the coefficient in the pressure data, to account for the effects of hydrostatic pressure caused by the orientation of the patient. Alternatively, an inclinometer or other device to retrieve data, not related to the pressure, can be physically separate from the recording device 370 (e.g., implanted). Also other types of data, the ways in which such data can be obtained, and the ways that such data can be used, should be obvious to experts in the given field of technology.

Data received by the registration device 270 (or recording device 370, or any other recording device), can be processed and analyzed in various ways. In many embodiments, the local device 60, the device 170 remote monitoring, recording device 270, 370 or other external device can be configured to implement one or more data processing algorithms that can be used for tracking and analysis of physiological parameters and events and can also create the result is, which can be represented by the previously described displays the graphical user interface. It should be understood that the received and/or recorded data can provide information about a wide variety of perceived options, including, in particular, about the pressure (e.g., fluid or otherwise). The perceived parameters may also contain a count of the number of pulses, pulse width, pulse amplitude, pulse duration, pulse frequency, perceived electrical characteristics (e.g., voltage, capacitance, etc. and so forth.

Some of the ways data or algorithms can usually be aimed at smoothing or shaping data (e.g., transformation, filtering, or other formation) to bring them into a form suitable for subsequent analysis (computer or user) or for display. It is possible with a wide variety of algorithms. For example, on figa shows a graph 3500 values 3502 pressure, perceived limiting device 22, such as a brace 28 and the pressure sensor 84. In this example, the option exercise value 3502 pressure perceived, or making samples for a certain period of time of the pressure signal produced by the pressure sensor 84 in the constraining device 22 (to the / establishment, which, as previously mentioned, may be any kind of limiting devices, including device filled with fluid medium or device on a mechanical basis). Perceived value may be recorded in the recording device 270 through periodic surveys limiting device 22. It should be understood that although the pressure values are used as an example in this algorithm, or any other algorithms described here can be used any perceived value. On figa shows the values that had a sampling rate of 100 Hz, although in fact you can use any sample rate. The pressure values can be converted to a lower frequency, which, among other things, can be useful when presenting interesting phenomena (for example, the pulse in the event of swallowing may occur with a frequency of about 0.1 Hz), the noise in the data and/or compression of the data set size. The conversion can be performed in various ways, but in one example variant of the implementation of the values 3502 pressure can be averaged out in order to effectively reduce the frequency of sampling, the results of which are shown in figv, which represents a graph 3506 values 3502 pressure averaged to a frequency of 10 Hz. The average value can be calculated by defining a window of averaging within a period of time the graph 3500 (for example, by dividing the time period into a sequence of Windows 3504 averaging every 1/10 of a second) and taking the mean values 3502 pressure occurring in each box. The window can be defined by time (for example, every 10 seconds) or number of data points (for example, averaging every 10 values or data points). The window size for averaging may be user-defined and in some embodiments, the implementation may be determined based on any events or physiological parameter. How to understand the specialists in this field of technology can be used with a wide variety of mathematical methods, for example, instead of averaging 100 Hz data can be directly converted into data with a frequency of 10 Hz, producing sample values 3502 pressure with a frequency of 10 Hz, in other words, by reducing the frequency of sampling or filtering. On figs-E shows three graphs 3508, 3510 and 3512, representing the results of the transformation of values 3502 pressure shown on the chart on figa at lower frequencies. As shown in figa, some low-frequency phenomena, such as pulses 3514, 3516, are still visible, while small changes in the amplitude are eliminated. On fig.35F shows an example flowchart illustrating the averaging algorithm.

On figa-B shows the output of example, issue the log smoothing algorithm, which can be used for data received by the registration device 270, and figs shows an example execution of the averaging algorithm. The performance of the smoothing algorithm may take various forms, but in one embodiment it may contain a calculation of each value or data point for the current averaging, based on the window averaging, which can be defined by the user. Window averaging can be used to determine the number of data values (data values representing, for example, pressure values), which are averaged together to get every current average value. Window averaging may shift as accepted each new data point, so the current average value may be updated with the same frequency as the sampling frequency. In one embodiment, the current average value for a particular point in time can be calculated by averaging the data values that fall within a time window that appears before this point in time, in other words, the current average value with a delay. The current average value of the delay may be determined according to the following formula, where RA is the current average value, p - value data, and n is the number of samples in the window:

.

When using for each received data values can be applied window averaging, and the current average for this point in time can be calculated. The current average values can then be displayed, for example, alone or with the original data values. On figa shows the result of running this algorithm for pressure data. On figa shows a graph of 3600 containing the graph of the raw values 3602 data that have not been averaged. Also on the chart 3600 shows three graphs 3604, 3606, 3608, representing data values after applying the smoothing algorithm with delay. As shown in the drawing, graphic 3604 corresponds to the current average value, calculated by averaging 10 seconds, the graph 3606 corresponds to the window averaging 30 seconds, and schedule 3608 corresponds to the window averaging 60 seconds.

In another embodiment, the current average value for a particular point in time can be calculated by averaging the data values in the window averaging, which contains the data values before and after the point in time, in other words, how centralized the current average. If half of the window averaging precedes the point in time and half a time window follows the window averaging, centralized the current environment is its value can be determined by the following formula, where RA is the current average value, p - value data, and n is the number of samples in the window:

.

On FIGU shows the result of running this algorithm for pressure data. Schedule 3620 includes a schedule 3622 with raw data values, which are not averaged. The graph also 3620 shows three graphs 3624, 3626, 3628, representing the raw data after applying the algorithm centralized the current average. Schedule 3624 corresponds to the current average value calculated for a time window averaging 10 seconds, the graph 3626 corresponds to the window averaging 30 seconds, and schedule 3628 corresponds to the window averaging 60 seconds. Any other changes, when a window averaging is not zentrums at the point of time for which calculated the current average value, but covers the value of the data in some other proportion. For example, the current average value for a point in time can be calculated based on the data values in the window averaging, in which one quarter of the time window precedes, and three quarters of the window averaging follow the point in time. On figs shows an example of a flowchart illustrating the above-described example of the algorithm of the current averaging.

In other embodiments, implementation of the formation of data can be performed through various statistical and/who do mathematical calculations, including calculation of RMS value, calculate the absolute deviations regression analysis to perform the fitting curves (both linear and nonlinear), calculate the amplitude and shape factor and so on. These methods can be applied for values of the parameter data as described above to calculate the current average. The use of other statistical and/or mathematical calculations can be selected depending on the particular application. For example, calculation of RMS value can be particularly advantageous in embodiments of implementation, in which the parameters of the data created by the limiting device 22, have both positive and negative values (such as voltage).

Determining a current average value or any other value resulting from the calculation in the formation, can also run multiple alarm systems alarms or may be logged for reporting, ongoing local device 60, the device 170 remote control and/or system 20. For example, an alarm or notification may be generated if the current average value falls within a predetermined range if it exceeds or falls below the threshold, if it changes too quickly (for example the EP, its rate of change exceeds the threshold), and so on. Alternatively, the occurrence of such events may be recorded or remembered for the introduction of a report or log file generated by the local device 60, the device 170 remote control and/or system 20.

In some embodiments, the implementation of analog filters can be used as a complement or as an alternative to the mathematical treatment of the data parameter. The group of analog filters (or switched such filters) may be entered in one or more devices to remove noise or alarm about the undesirable frequencies. For example, the formation and filtering achieved in the embodiment shown in figa-35E, can be carried out by appropriate filtering of the low pass filter. As should be understood specialists in the art, embodiments of filters high-pass and bandpass filters are also possible and depend on the desired results. Filters can be installed in different places, such as injection port 36 (e.g., injection port 36, which serves as a communication line for restricting device 22), the local device 60, the device 170 remote control or any other device in the transmission path signals. In some embodiments, implementation of the foster placement of filters in the implant (such as an injection port 36 or limiting device 22) may be advantageous, because due to the pre-processing it is possible to reduce the bandwidth and/or power requirements needed for telemetry transmission (or reception) of such data. In addition, by reducing the amount of data through analog filtering requirements for the data processing devices (e.g. remote control) in the analysis of data can be reduced.

Data processing algorithms may also be useful to determine the initial levels of the physiological parameter, presents data obtained from the restriction device 22. For example, the initial pressure, perceived limiting device 22 filled with the fluid medium may be determined according to the obtained values of pressure. Can be used with a wide variety of ways to determine the initial values. However, in one variant example of implementation, which is shown using figa-B, the algorithm for finding the initial values may include the collection of data from limiting device (step 3710 on figv with the flowchart of the sequence of operations of the method) and calculate the current average value, based on past data values (step 3712). The data used to calculate the current average value, can be determined by averaging screen (for example, the window is m averaging, the previous point in time for which you are calculating the current average value, or overlapping a certain number of data values, for example, the last ten values.) Upon receipt of each new data value at the current average value can be updated. As shown in step 3714, the algorithm can determine whether the initial value is set by the comparison of data values within a window averaging with a tolerance range that can be defined around the current average value to determine whether all the values (or, alternatively, a part of them) were within the tolerance range. If so, then at step 3716, the algorithm can identify a current average value as an initial value. If not, at step 3718 can be collected more data values that can lead to the identification of a new window averaging or collecting a specified number of additional data values. New current average value can be calculated and the process can be repeated until a match is found the initial value. As should be understood specialists in the art, any or all of the previously mentioned thresholds, limits, times, window sizes or other variables can be defined by the user. On figa shows a graph 3700 data illustrating describe the tion above algorithm applied to the collected data, and also shows the range 3702 tolerance and box 3704 averaging in the context of the pressure values measured during the period 3706 time.

In some embodiments, the implementation of the occurrence of specific events can initiate the algorithm for determining or finding initial values. For example, it may be desirable to check or determine whether a new initial value at the beginning of data collection, the timer has expired or after conducted the regulation limiting device 22, which may include adding or removing fluid. On figs shows a graph 3720 pressure data over a period of time, which shows the offset 3722 up initial values by adding approximately 7.5 ml in limiting the device is filled with fluid medium. Regulation can start execution of the algorithm for determining the initial values, such as described above for finding a new starting value.

Another example of the algorithm for determining or predicting initial levels of the parameter shown on figa-B. figa shows an example graph the data over time to illustrate the application of the algorithm to the data set, and figv shows an example flowchart of the sequence of operations of the algorithm. In this embodiment, the algorithm can typically contain vicis the group specifies when the rate of change of the parameter values will be zero or essentially zero, and what is may have the option at this time. The rate of change of zero or essentially close to zero, can be considered as an indicator of the fact that the initial value is reached. More specifically, with reference to the stages 3802, 3804 and FIGU, the algorithm may contain a collection of values of the parameter data for a certain period of time and calculating the rate of change at a point of time or for a group of data values (group A) in the time window 3820 within a period of time. For example, the rate of change can be determined by calculating the slope, defined asdPandpandmetpAnddinpemIAnd. With reference to step 3806, the algorithm may further comprise calculating how fast the rate of change changes itself - in other words, the speed at which changes the speed of change. The speed at which changes the rate of change may be determined, for example, performing two calculations of the slope (for example, group A in the box 3820 and group B in the box 3822) and then Vice is the legitimacy of the change in steepness. Box 3820, 3822 can be defined by time (time window) or a group of data values, or any other means suitable for selecting part of the data values. For example:

The slope of A =dPandpandmetpAnddinpemIAnd

Slope =dPandpandmetpBdinpemIB

Δ = Slope - the Steepness of A.

Additionally, the rate of change and how quickly changes the very speed of change, can be used to determine when the rate of change is approximately equal to zero, and what will be the value of the parameter at this time. For example, as indicated at step 3808, the time required to achieve the rate of change close to zero (which in this example indicates that the initial value has been reached)can be predicted according to the following formula:

The time to reach the initial value =.

The predicted initial value can be calculated by extrapolation using the value of the parameter and the parameter value will change to the Time before reaching the initial value, as shown by the following formula:

Initial value = (time needed to reach the initial value) × (the Slope (B) + (Value in group B).

As should be understood specialists in the art, the above approach can vary considerably without departing from the scope of the method described here. For example, the formula for the Time to achieve the initial values and Initial values can be expressed in terms of Steepness and Period, as well As can be used for more than two Windows of data, and/or spacing between the Windows 3820, 3822 data may change. Additionally, the specialist in the art should understand that the above approach can be described in terms of the derivative (for example, to represent the rate of change) and second derivative (for example, to represent the speed with which smenyaetsya itself is the rate of change).

Determining initial values can run a variety of alarm signaling or may be logged for reporting, ongoing local device 60, the device 170 remote control and/or system 20. For example, alarm or notification sound may be generated if the initial pressure exceeds or falls below a threshold (for example, for a specified period of time), when there is a fluctuation of the initial pressure when the initial value cannot be found for the specified time when the rate of change of pressure exceeds a threshold value, and/or when the initial pressure is determined. Alternatively, the occurrence of such events may be recorded or remembered for the introduction message or log file generated by the local device 60, the device 170 remote control and/or system 20. In addition, the initial value may be correlated (either alone or together with other data, as described herein) with the state limiting device. The initial value may be specified as "constricted", "optimally tightened" or "free" state limiting device, which due to the restriction by the filling fluid medium can provide full optimally filled or unfilled state. For example, the initial value of which exceeds a predefined threshold (for example, the level that is considered "too high") can be an indicator of a crowded or constricted limiting device, while the initial value, which falls or remains below a predetermined threshold (for example, a level considered as "too low"), may be an indicator of "unfilled" or "free" limiting device, and so on. Pre-defined thresholds can be obtained using the historical data of the patient group data, or other clinical data. Also, in other embodiments, the implementation rate of change of pressure (as described above in the definitions of initial values) can be correlated with the state limiting device. For example, the rate of change that exceeds a predetermined rate of change, may indicate a crowded fluid medium bandage to limit food intake. The rate of change, which falls below another threshold, may indicate not completely filled band to restrict food intake.

Data values collected by the registering device 270 may be used to obtain information about the physiological parameters of a patient wearing a limiting device 22. For example, as mentioned previously, the recording device 270 may collect Dan is haunted, representing the pressure (or other parameter), perceived implanted limiting device 22. Information about the physiological parameters such as heart rate, breathing rate and other, can be determined from the collected pressure values (or values of another parameter). Information about peristaltic events or event of swallowing, which may occur in the pressure pulses or series of pulses, can also be determined, and such information may include the number, speed and duration of such pulses. As shown in figa-B in the set of pressure data may exist multiple frequencies (or other data). As shown in figa, relatively high frequency pulses 3904, which figa represent pressure changes caused by heartbeats (heart contraction can cause the power detected at limiting device 22), may be imposed on the low-frequency pulses 3902, which figa represent events swallowing. On FIGU shows the pulses 3906 heart contractions superimposed on the pulses 3908 due to breathing. As shown in the drawing, the pulse respiration occur approximately once every four seconds.

In one example variant of the implementation can be analyzed frequency spectrum of the pressure data. Often the and or frequency in the spectrum data can be selected and identified as the frequency of the physiological parameter of interest, for example, comparing the frequency with a frequency range which is defined as the possible range for a particular physiological parameter. The amplitude or other characteristics of the physiological parameter can also be determined by extracting or filtering data on the selected frequency. To analyze and extract information having a desired frequency spectrum, can be used many ways. The following examples relate to figa-C and sometimes use heart rate as an example, the physiological parameter, but a specialist in the art should understand that you can analyze the set of periodic physiological parameters, and that can use data that is different from the pressure data.

As shown in figs, one example algorithm may contain a calculation of the period of the pulses or changes in data values representing the perceived value. With reference to step 3920, the local maximum or minimum data can be identified, determining, for example, when the change of slope of the pass through zero. Time can be registered at this point (step 3922) and then subsequent maximum or minimum (step 3924). The period can be calculated based on the time between adjacent maxima and/or minima, and this period can be studied, that is s to see gets whether it is within the designated target range of possible frequencies associated with a physiological parameter of interest. For example, the heart rate may be associated with a frequency of from 65 to 150 strokes or cycles per minute or approximately 1.1 to 2.5 Hz. The range may be determined by device or user. If the calculated frequency falls within the range at step 3926, frequency can be identified or marked as the frequency of the physiological parameter. In some embodiments, the implementation of the algorithm may include a comparison of the values in the highs or the lows, to ensure that they are within the tolerance range for both. As can be seen with reference to figa, this approach may allow to distinguish between the maximum or peak pulse swallowing from the maximum or peak pulse for heart rate. The difference between these two parameters can determine the appropriate maximums, to be used when calculating the frequency for a particular physiological parameter. In some embodiments, the implementation of the parameter value to the maximum or minimum can also be used to calculate the amplitude of the pulses, and the algorithm may also contain a comparison of the amplitude in a predetermined target range, is provided with a physiological parameter, to see if he gets into range. For example, pulses of a pulse may have an amplitude of approximately 7-8 mm RT. Art., as shown in figv, and the range may be such that it contains at least 7-8 mm RT. Art. How to understand the specialist in the art, the target frequency and amplitude, as described above, vary depending on the physiological parameter, about which information is collected.

As shown in fig.39D, in another variant example of implementation of the discrete Fourier transform (in many cases be computed using fast Fourier transform) can be applied to the data values of the perceived parameter registered for a certain period of time. Data values can thus be converted from values in the time domain into the frequency domain. The frequency spectrum of the data values may be analyzed to identify the frequency or frequencies that exist in the data values that correspond to the frequency range associated with the range of the physiological parameter. In some embodiments, the implementation of the frequency spectrum may be analyzed to identify one or more frequencies that exist and exceed the threshold value and which correspond to the frequency range associated with the physiological parameter is. If the range has multiple frequencies can be selected frequency with the highest magnitude, or can be calculated weighted average value of frequency, which is denoted as the frequency of the physiological parameter. The amplitude may be defined by the Fourier coefficients for the identified frequencies. Alternatively, the frequency does not fall within the target range, can be removed from the data (for example, by setting the coefficients of the Fourier unselected frequencies to zero), and the perceived value of the parameter in the time domain can be recovered by performing an inverse Fourier transform. The data values in the time domain can be displayed or analyzed additionally, for example, by analyzing the amplitude by comparing the values in the highs and the lows, etc.

On figa-C shows the output of another algorithm that can extract information about the physiological parameter from the parameter value (such as pressure)obtained from the restriction device 22 and collected by the registering device 270, and fig.40D shows an example flowchart of the sequence of operations of this algorithm. In this example, the option exercise value of the obtained parameter, such as values 4002 pressure, can be averaged to generate mean values 4004. what about the many options exercise of the average value can be calculated by averaging the values within the window of averaging within a certain period of time, for example, taking the average of data for every X seconds or calculating an average value for a certain number of (groups of data) the values of surrounding data. The window size averaging can vary widely and can be installed relationships between interesting phenomena. For example, as shown in figa, the pressure values were collected with a frequency of approximately 100 Hz, while the event of swallowing may occur with a frequency of approximately 0.1 Hz, and the average value of the 4004 was calculated and presented graphically by averaging every 100 data values, for example, within the box 4008. Average values 4004 can be subtracted from the original data, for example, values 4002 pressure in this example, to obtain values 4006 physiological parameter, such as values representing the heart rate, breathing rate and so on. These values 4006 physiological parameter may be displayed on the display. In addition, the frequency, amplitude, variability, or other characteristics of physiological values 4006 can be analyzed additionally, for example, using one or more of the previously described algorithms. The above method of averaging and subtraction can be repeated on fisiologicas the data 4006 (for example, with a smaller averaging window), to extract a different set of physiological values (e.g., values of the pulse can be separated from the breathing frequency, then the frequency of breathing can be separated from the values of the heart rate).

On FIGU shows another set of values 4010 pressure and average values 4012 calculated from them. Averaged data 4012 may also be useful for analysis of physiological phenomena, such as relatively low-frequency phenomena and/or frequency of swallowing. On figs shown physiological values that can be obtained by taking the difference between the sample values 4010 pressure and average values 4012.

On figa-C presents another example of a dataset that shows how pressure data can be differentiated to share information about the different physiological reactions. As shown in figa, values 4100 pressure collected over some period of time, can be used to examine the total duration (for example, to investigate the amplitude and number of pulses) in the event of swallowing or peristaltic events, represented by a sequence of pulses 4102, mono-impulse 4104 when peristaltic event and/or imposed or small pulses 4106 representing other physiological parameters. Figv displays monoenoic 4104 more detail. As shown in the drawing, a smooth curve can be used (for example, by calculating the average)to analyze the amplitude, duration or other characteristics of the pulse 4104. On figs more shows small pulses 4106, which can be converted into a linear shape (for example, by using one of the previously described approaches, as shown by the arrow button 4108, to measure the frequency, amplitude or other characteristics.

To determine the physiological frequency, amplitude, or other parameter can be run multiple alarms or may be logged for reporting, ongoing local device 60, the device 170 remote control and/or system 20. For example, alarm or notification sound can be generated, if the heart rate or respiratory rate (or other frequency) is too high, too low, can not be detected, dramatically changed (for example, have a rate of change that exceeds the threshold), and so on. Alternatively, the occurrence of such events or conditions may be registered or stored for insertion into the message or log file generated by the local device 60, the device 170 remote control and/or system 20.

A wide variety of algorithms can be used to detect the Pris the aftermath of the pulses in the pressure values or other data values, the collected recording device 270. One example variant of this algorithm is shown in figa-B. figa shows a graph 4200 examples of values of pressure for a certain period of time, although there may be any parameter values. On FIGU shows the block diagram of the sequence of operations, representing example steps executed by the algorithm. As shown in the drawing, a predetermined threshold value 4202 may be determined relative to the initial values 4212 (steps 4222, 4224 on figv). (For example, the threshold value may be set at 10 mm RT. Art. above initial values 4212). On stage 4226 algorithm may determine the time 4206, during which the parameter exceeds the threshold value 4202. (Because the threshold 4202 can be determined relative to the initial value 4212 in absolute values, the time 4206, in which the parameter exceeds the threshold value 4202 may occur when the parameter exceeds the initial value 4212 plus the threshold value 4202.) If the parameter value is reduced so that it no longer exceeds the threshold value 4202 within a predetermined time 4210, the pulse can be considered pop (steps 4228-4230). A predetermined time 4210 may also be defined by the user.

On figa shown application is the development of an alternative implementation of the algorithm, which can be used to detect the presence of pulses in the data set, and figv shows an example flowchart of the sequence of operations for this algorithm. As seen in the drawing, the first threshold value 4302 and the second threshold value 4304 can be determined (steps 4324a, 4324b), both threshold is defined relative to the initial values 4308, as discussed with reference to figa-B. the First threshold value 4302 can be used when the parameter is increased (for example, before the peak of the pulse), and the second threshold value 4304 can be used when the parameter is reduced (for example, after the peak 4312). On stage 4326 algorithm may determine the time 4314, in which the parameter exceeds the first threshold value 4302. If the parameter value and then falls below the second threshold 4304 within a predetermined time 4306, the pulse can be considered to have a place (steps 4328-4330).

On figa shows the use of another alternative implementation of the algorithm that can be used to detect the presence of a pulse in the data set, and figv shows an example flowchart of the sequence of operations for this algorithm. In this embodiment, the first threshold 4402 can be determined relative to the initial values 4408, and the second threshold 4404 can be the ü is defined with respect to the peak value 4412 (steps 4424a b FIGU). Time 4414, when the parameter exceeds the first threshold 4402, and time 4412, when the parameter reaches a peak (for example, when there is a zero slope)can be registered (steps 4426, 4428a-b). If the parameter falls below a second threshold 4404 within a predetermined time 4406, then we can assume that the pulse takes place (steps 4430, 4432). There are many ways of implementing the second threshold 4404 can be defined as the quotient of the peak value 4412 (for example, 75% of the peak value), which the algorithm can then calculate when it finds the peak value 4412. In other embodiments, implementation of the second threshold 4404 can be determined directly (e.g., 10 mm RT. Art. below the peak value 4412).

The detection algorithm of the pulse can also run a variety of anxiety or can record the events of impulse occurrence reports maintained by the local device 60, the device 170 remote control and/or system 20. For example, alarm or notification sound can be generated when the pulse is detected, when there is no pulse can not be detected when the pulse appears at some points in time (such as time external eating)when the pulse count exceeds the threshold value when the pulses are detected within a specified period of time when the rate of change of pressure, which indicates the beginning of the pulse or the end of the pulse, and so forth. Alternatively, the occurrence of such events may be logged or stored for insertion into the message or log file created by local device 60, the device 170 remote control and/or system 20. In addition, the definition of what appeared one or more pulses may be correlated (alone or in combination with other data, as described herein) with the state limiting device. For example, if pulses continue to occur for some period of time (e.g., within a predetermined period of time, in some cases, such as a window 5-6 minutes, although any period of time), it may indicate that the limiting device is full or too long. The amplitude of the pulses and the time between pulses (either taken alone or together with other metrics) can also be used or be involved in such a determination, for example, can be considered a pulse with a threshold amplitude. In other embodiments, the implementation of a number of pulses in the sequence or the number of pulses within a certain period of time can be used to perform the correlation. Also, the absence of pulses in a predetermined period of time may indicate that the limiting device is too loose or "not filled". This analysis and the pulses may additionally be accompanied by issuing commands to the swallowing of food/water or on dry swallowing the patient, who wears a brace to limit food intake and controls the resulting pulse(s), or to determine the appropriate pre-determined period of time to monitor the pulses, in order to assess the state limiting device, or to do anything else.

The area under the pulse or sequence of pulses or other waveforms on the graph of dependence of the parameter from the time data can be used for analytical purposes. On figa shows an example graph 4500 dependence of the pressure of time; figv shows the block diagram of the sequence of operations, representing an example of an algorithm for creating such analysis. As shown in the drawing, pressure presents a graphical representation 4502, in this case, the waveform is represented by a number of pulses. The area under one or more pulses can be estimated. Square can be calculated by finding the integral for each pulse in the type window time window 4512, 4514, 4516, 4518. Area can be calculated relative to the initial values 4510 or zero values. In many variants of implementation, the window size can be set to cover the time of the pulse, for example, by the beginning of the window, when the parameter exceeds the threshold, and ends when the parameter value falls lower is the threshold value, or using any of the times discussed in connection with Fig-44, such as the times T2-T1, shown in figv, or peak-T1 on figv. The results of finding integrals can be compared and the nature of the sequence of squares (increase, decrease and so on), as well as their value can be correlated with conditions or events associated with the limiting device 22, the patient and so on. For example, the presence of pulses, essentially, with equal areas, generally denoted by the bracket 4506 on Fig, may be a sign limiting device filled with fluid medium, which is full, or, in General, a limiting device that is too tight. The presence of pulses with decreasing areas or areas decreasing from a predetermined speed, in General denoted by the bracket 4508 may be a sign optimally filled, or adjusted the bandage. The reduction of such areas from the second predetermined speed (for example, at a speed which is higher than that associated with optimally filled with bandage) can be correlated with a limiting device, which is not sufficiently filled. The presence of monopulse without any peaks after him, which in General is designated by the bracket 4504 may be a sign limiting device is AutoRAE insufficiently filled, or a sign of a cough or talk.

It should be understood that any or all of the above algorithms and methods can be integrated with a graphical user interface to allow the user to provide the input to the algorithm and show how intermediate and final results. For example, graphs of the pressure of time can be displayed to the user, and the user can manually define or select window averaging to calculate the slope or to calculate the area of the pulse (for example, manually marking the start and end times). In other embodiments, the implementation, the user can manually mark the initial value, adjusting a horizontal line on the display after consideration of the values of pressure for a set period of time. Such changes means contained in the scope of the present disclosure.

It should be understood that the several embodiments described herein may enable healthcare providers or others to use the pressure data as a feedback mechanism to identify, train, and/or to provide the patient with a recommendation about diet. This feedback mechanism can provide the data or used in any other way in many ways. For example, the inverse is th link for the pressure can be obtained, when the patient swallows a specific portion of food, and based on this feedback pressure, the patient can be trained to eat small portions, larger portions or portions, proven equal portions. Of course, the portion of food prescribed therefore, can be checked by evaluating the feedback pressure obtained when the patient swallows a prescribed portion of food, so the instruction portions of food can be specified by repeating. As another example, the patient can check the desired food for suitability based on the feedback pressure together with the portion size and/or based on any other parameters. You should also understand that continuous monitoring of pressure data can be used to allow you to control the size of portions, to control the compatibility of food (for example, the ratio between liquid and solid food) and/or frequency of meals. Other ways in which pressure data can be used to provide advice on diet, it should be obvious to experts in the given field of technology. It should also be understood that such applications can practice locally, remotely (e.g., through the device 170 remote control) or their combination.

Although the system 300 registration data described herein as carried out with the ing Clennam port 36, it should be understood that system 300 registration data may alternatively be implemented with any other type of the perception of pressure or other implanted systems. For example only, the system 300 registration data can be combined with any primary measuring the pressure sensor disclosed in patent publication U.S. No. 2006-0211914 (application No. 11/369 682), registered on March 7, 2006, entitled "System and Method for Determining Implanted Device Positioning and Obtaining Pressure Data", and the patent publication U.S. No., registered on March 6, 2007 and nepredvidatelne patent application U.S. 11/682 459, entitled "Pressure Sensors for Gastric Band and Adjacent Tissue" (attorney docket No. END6042USNP and attached to this application as the Application), the disclosure of both of them are here by reference for illustrative purposes. For example, the system 300 registration data can take the pressure measurements obtained by any of the pressure sensors described in this patent application. In addition, the head of the sensor that controls the arrow described in this patent application, can be used, at least part of the system 300 registration data to provide management with an arrow for local Clinician to adjust the pressure of the fluid in accordance with the commands of the remote physician, based on the measurement results of the pressure p is obtained by the sensor head, the management of the arrow, and informed the doctor away, essentially in real time. For example, the head of the sensor that controls the arrow, can be connected to a recording device 370, which can connect directly to the Internet (or via the docking station 360), in order to transmit the measurement results of the pressure the doctor away. Other ways in which the devices and components described herein may be combined with features described in the publications of patent applications U.S. 2006-0211912, 2006-0211913 and 2006-0211914, hereby introduced here by reference, will be obvious to experts in the given field of technology.

Specialists in the art will easily should be obvious that the above described invention is equally applicable to other types of implantable bandages. For example, bandages are used for the treatment of fecal incontinence. One such band is described in U.S. patent No. 6461292, which is hereby introduced here by reference. Bandages can also be used to treat urinary incontinence. One such band is described in patent application U.S. 2003/0105385, which is hereby introduced here by reference. Bandages can also be used to treat heartburn and/or acid reflux. One such band is described in patent application U.S. No. 6470892, which is hereby entered here group is a rotary links. Bandages can also be used for the treatment of impotence. One such band is described in patent application U.S. 2003/0114729, which is hereby introduced here by reference.

Any of the devices disclosed herein may also be designed to be disposed after a single use, or they can be designed to be used multiple times. The device, which can be external, such as local device remote monitoring, recording devices, and so forth, in many cases, suitable for repeated use. The device can be repaired or recovered for re-use, at least after one use. Repair or restoration can contain any combination of the steps of disassembly of the device, followed by the replacement, upgrading, cleaning or modification of specific parts (including mechanical components, computer hardware means and software and so on), and subsequent re-Assembly. In particular, the device can be disassembled, and any number of the specific part or parts of the device can be selectively replaced or removed in any combination. The device may be reassembled for subsequent use either at a repair company, is for the doctor before using the device on the patient. Experts in the art should understand that when repairing or restoring your device you can use various methods of disassembly, cleaning and/or replacement, and reassembly. Additionally, the repairs can be performed for devices and/or their components or parts. The use of such methods and the resulting repaired, restored or normalized device, all completely contained in the scope of this application.

Described here are devices, in particular those that can be implanted in the patient or imposed on the patient, before using preferably can be processed or sterilized. First get a new or used device (or part of it). Then the device can be sterilized. In one method of sterilization of the device is placed in a closed and sealed container, such as a plastic bag or TYVEK bag. The container and the device is then placed in a field of radiation that can penetrate the container, such as beta or gamma radiation, x-rays or the flow of electrons with high energy. The radiation kills bacteria on the instrument and in the container. Sterilized instruments can then be stored in a sterile container. Sealed container keeps the device of STERI inim until until it is opened in the medical facility. In other embodiments, the implementation of sterilization may be used ethylene oxide or steam.

Although there have been shown and described preferred embodiments of the present invention, for specialists in the art should be obvious that such embodiments of presents for example only. Specialists in the art will be many other variations, modifications and substitutions without departing from the invention. For example, as should be obvious to experts in the art, the disclosure made herein have equal application in surgery using robotics. In addition, it should be understood that each of the above-described structure has the function, and this structure may be referred to as a tool to perform this function. Accordingly, it is understood that the invention should be limited only by the nature and scope of the attached claims.

Although the present invention has been illustrated by description of several embodiments, with the intention of the applicant is not limiting or setting limits the nature and scope of the attached claims to such detail. Specialists in this field of technology will be made m ogochocinco other variations, changes and substitutions without departing from the essence and scope of the invention. For example, the apparatus and method of the present invention have been presented in relation to the transmission of pressure data from the implant to the remote device remote control. However, it can also transmit other types of data, to enable the physician to monitor many different aspects of the implant with the restrictive opening. Additionally, the present invention is described in relation to device limitations meal for bariatric treatment. The present invention is not limited to this application and can also be used with other implants with restrictive holes or artificial sphincters, without departing from the scope of the invention. The structure of each element associated with the present invention, can be described as alternative means of providing the function performed by the element. It should be understood that the above description is provided for example and that other modifications may be made by specialists in the art, without departing from the scope and essence of the attached claims.

1. The method of analysis of data obtained from the implantable gastric restrictive device to identify the presence of a pulse containing phases in which: plastiroute implantable gastric restrictive device in the patient's body for the formation of a restrictive orifice in the patient; collect data from implantable gastric restrictive device over a period of time, and the collected data contain information about the parameter values, perceived inside the body over a period of time,
in the device data identified the presence of a pulse in the perceived values of the parameter, where the identification includes the determination of one or more values of the perceived parameter exceeding the first threshold value, and the determination of one or more of the perceived values of the parameter, followed by one or more values that exceed a first threshold that fall below the first threshold or below a second threshold, so that the pulse is determined by the time between one or more values that exceed the first threshold, and one or more values that fall below the first threshold or below a second threshold.

2. The method according to claim 1, wherein the physiological parameter is pressure, perceived implantable gastric restrictive device.

3. The method according to claim 1, wherein identifying further comprises detecting one or more consecutive values of the perceived parameter that fall below the second threshold within a time window, while the time window is within the time period begins at the time BP is like, associated with one or more values that exceeded the first threshold.

4. The method according to claim 1, wherein the first threshold and the second threshold determined relative to the initial perceived value of the parameter.

5. The method according to claim 1, additionally containing a display of counting the number of pulses.

6. The method according to claim 1, additionally containing the create alarm or message in the identification pulse, or when the number of identified pulses exceeds the threshold value during the second predetermined period of time.

7. The method according to claim 1, wherein the implantable gastric restrictive device is a device filled with fluid medium, and further comprises the use of the identification pulse or pulses to determine the status of implantable gastric restrictive device status, which is one of the following conditions apply: "full", "optimum" and "incomplete".

8. The method according to claim 1, additionally containing the generation of an alarm signal indicating that the received pulse if the time between the specified one or more values that exceed the first threshold and the specified one or more values that fall below the first threshold or below a second threshold that is greater than the preset time for a pulse.

9. Method of data analysis, p is obtainable from the implantable gastric restrictive device to determine the presence of a pulse, containing phases in which:
collect data from implantable gastric restrictive device over a period of time, and the collected data contain information about the parameter values, perceived inside the body over a period of time,
in the device data identified the presence of a pulse in the perceived values of the parameter, in which the identification includes the steps are:
find one or more values of the perceived parameter exceeding the first threshold value,
find one or more additional perceived values of the parameter, followed by one or more values that exceed the first threshold, accompanied by decreasing values, and one or more consecutive values represent the maximum value, and
find one or more additional perceived values of the parameter, followed by the specified one or more additional values that fall below the second threshold within a time window.

10. The method according to claim 9, in which the time window is within the period of time begins at the moment of time associated with the maximum value.

11. The method according to claim 10, further containing the generation of an alarm signal indicating that the received pulse if the time window exceeds the backside of the TES threshold time for a pulse.

12. The method according to claim 9, in which the perceived parameter is pressure, perceived implantable gastric restrictive device.

13. The method according to claim 9, further containing a display of counting the number of pulses.

14. The method according to claim 9, in which the first threshold and the second threshold are the same value.

15. The method according to claim 9, in which the first threshold and the second threshold determined relative to the initial perceived value of the parameter.

16. The method according to claim 9, further containing the create alarm or message when an impulse identification, or if the number of identified pulses exceeds the threshold value during the second predetermined period of time.

17. The method according to claim 9, in which the implantable gastric restrictive device is a device filled with fluid medium, and further comprises the use of the identification pulse or pulses to determine the status of implantable gastric restrictive device status, which is one of the following conditions apply: "full", "optimum" and "incomplete".

18. The method of analysis of data obtained from the implantable gastric restrictive device, for detecting the presence of a physiological condition or state associated with implantable W is lotochnym limiting device, containing phases in which:
implanted gastric restrictive device around the stomach to create a hole in the stomach;
collect data from an implanted gastric restrictive device over a period of time, and the collected data contain information about the parameter values, perceived inside the body over a period of time,
find one or more areas corresponding to the area under the curve of pressure against time, and
the processing unit compares the square and the comparison results correlate with the condition.

19. The method according to p, in which is found the result holds for each of one or more squares estimation of integration, based on the perceived values of the parameter for each window within the time period, evaluation of integration that creates a result that represents the area under the curve of pressure vs. time.

20. The method according to claim 19, in which the evaluation of integration contains a numeric integration.

21. The method according to p, in which the perceived parameter is pressure, perceived an implanted gastric restrictive device.

22. The method according to p, in which one or more areas, each correspond to the area under the pulse is perceived in the parameter.

23. The method according to p in which gastric ogran is to provide a device is a device fill fluid medium, and further comprises any of the following:
correlation reduction sequence space, which occurs with the first predetermined speed is optimally filled gastric restrictive device; correlation sequence space, which is essentially equal to the crowded gastric restrictive device; and correlation reduction sequence space, which occurs with the second predetermined speed with incomplete gastric restrictive device.

24. The method according to item 23, in which the second predetermined speed greater than the first predefined speed.

25. The method according to p, in which the presence of one or more areas contain the presence of at least two of the areas corresponding to the area under the curve of pressure from time to time; and
the correlation of one or more areas with the state contains a comparison of the specified at least two areas, and the comparison results correlate with the condition.

26. Method of analysis data containing phases in which: collect data, obtained over a period of time from the adjustable gastric band implanted inside the body around the gastrointestinal tract, and the collected data contain information about the values of the pressure in Utri adjustable gastric band, perceived over a period of time, and
in the device of the data processing form values perceived pressure for display or further analysis, this formation contains the calculation of the average perceived value of the parameter at each point of time during the time period based on the group perceived pressures, which is not centered on the point in time for which the average value is calculated.

27. The method according to p when the formation contains conversion values perceived pressure from the first frequency-sampling the second and lower frequency sampling.

28. The method according to p, where the formation includes dividing at least part of the period of time set UPS averaging a predetermined size; and computing the mean value of perceived pressure in each window averaging.

29. The method according to p, optionally containing preservation averages as concise information about the values of perceived pressure, at least for some period of time.

30. The method according to p or 27, in which the perceived pressure, perceived adjustable gastric band.

31. Method of analysis the data received from the implantable gastric restrictive device, comprising stages, which are:
Sobir the ut data from the implantable gastric restrictive device over a period of time, moreover, implantable gastric restrictive device has an internal cavity containing the fluid, while the collected data containing information about values of pressure fluid, perceived inside the body over a period of time,
the processing unit calculates the average value of the pressure at time X within the specified time period, the average value is calculated based on one or more values of perceived pressure within a window of averaging in the specified period of time,
where the window averaging (i) is preceded by a time X, or (ii) contains the time X.

32. The method according to p, optionally containing displays the average values on the graph according to perceived pressure from time to time.



 

Same patents:

FIELD: medicine.

SUBSTANCE: group of inventions relates to medical equipment. Wireless system of cardiac control contains ECG monitor and mobile phone. ECG monitor contains transceiver for wireless transmission of ECG signal data. ECG monitor contains connected with transceiver unit of notification about status for transmission of notification in case of change of ECG monitor status. Mobile phone contains electronics, transceiver for wireless reception of ECG signal data or notifications from ECG monitor and controller for transmission of ECG signal data into the control centre by electronics via mobile connection net. Controller can respond to notification from ECG monitor by communicating notification to patient by means of mobile phone or transmission of notification into the control centre. Notification is communicated to patient by means of mobile phone display, tone signal or verbal prompt, formed by mobile phone. Controller can delay transmission of specified notification into the control centre to give time for reception of notification about status of disorder elimination. When patient is informed about change in status patient is given possibility to answer immediately or to delay respond to notification.

EFFECT: invention makes it possible for patient to recognize and correct situation with changed status without transmission of notification or response of the control centre.

6 cl, 38 dwg, 1 tbl

FIELD: oil and gas industry.

SUBSTANCE: system contains one or more sources providing data representing aggregated fractures in formation, processor of computer connected to one or more sources of data, at that processor of computer contains carriers containing output code of the computer consisting of the first program code for selection of variety of materials to control drill mud losses out of list of materials in compliance with data representing total number of fractures in formation and the second program code related to the first program code and purposed for determination of optimised mixture for selected materials to control drill mud losses to apply them for fractures; at that optimised mixture is based on comparison of statistical distribution for selected sizes of materials to control drill mud losses and sizes of aggregated fractures.

EFFECT: reducing loss of materials and improving operational efficiency of wells.

20 cl, 6 dwg

FIELD: medicine.

SUBSTANCE: invention relates to field of medicine. System of cardiac monitoring contains battery-supplied ECG monitor, which is worn by patient and has processor of patient's ECG signal, device for identification of arrhythmia and wireless transceiver for sending messages about the state and obtaining information about configuration of device of arrhythmia identification. System of cardiac control additionally contains mobile phone, which has electronic devices of mobile phone, transceiver and controller. In the process of method version realisation, parameter of specified arrhythmia to be identified, and limit of switching on alarm signals for specified arrhythmia, are determined and stored in configuration file in the centre of monitoring. ECG monitor is fixed to patient and activated to start ECG monitoring. Message about state is sent by wireless communication line from ECG monitor into the centre of monitoring. Reply to message, which includes only configuration file, is sent to ECG monitor. Configuration file is used to adjust device for arrhythmia identification.

EFFECT: invention makes it possible to provide completely wireless ECG monitoring to increase patient's comfort and convenience.

18 cl, 48 dwg, 1 tbl

FIELD: information technologies.

SUBSTANCE: in the method a type of the map is built and placed using logics determined by the map type component, corresponding to each visual element, besides, such logics may depend on one or more values of parameters of the map type component. Some of these values of parameters correspond to available values of map model parameters, and other ones are calculated using a model, which determines analytic ratios between parameters of the map model. Sequence of operations for building of map type may be fully controlled by data and may include a mechanism for canonisation of input data and linkage of canonised input data to model parameters.

EFFECT: expansion of functional capabilities, due to provision of generation of a layout controlled by infrastructure data, which depends on input data.

20 cl, 16 dwg

FIELD: medicine.

SUBSTANCE: invention relates to medicine. In method realisation current values of each of parameters of clinical data characterising current state of cardiovascular system are measured and fixed. Results of assessment of values of clinical data parameters are transformed. Results of assessment of current values of each parameter of clinical data are fixed depending on time of performed measurements. Results of transformation of assessment of current values of each parameter of clinical data are visualised on plane, coinciding with plane of displaying multicolour screen of videomonitor. Information about dynamics of cardiovascular system state is obtained. Also performed is digitisation and weighting of fixed instant values of each parameter of clinical data in physical values. Three-dimensional image of cardiovascular system state AN(t) is created in form of totality of geometrical places of points in N-dimensional space of cardiovascular system states, with coordinates of each point of N-dimensional space of cardiovascular system states being determined by totality of non-invasively and invasively measured in physical values digitised instant values of various clinical data, which characterise current state of cardiovascular system. Two-dimensional images of cardiovascular system states A2(t) are formed in form of projections of formed AN(t) on plane, coinciding with plane of displaying multicolour screen of videomonitor. Coordinates in 2-dimensional state of cardiovascular system states of each point of formed A2(t) are memorised. Virtual three-dimensional models of various nosologic forms of cardiovascular system diseases Bi are built in form of totality of M-geometrical places of points in N-dimensional space of cardiovascular system state, where i=1; 2; 3;…M is the number of displayed diseases of cardiovascular system. Coordinates of each point of each of B are determined by totality of values of various clinical data in physical values, describing characteristic clinical-morphological picture of corresponding disease and degree of CVS pathology manifestation, respectively. Coordinates in N-dimensional space of cardiovascular system state of all points of three-dimensional images Bi are memorised. Two-dimensional models of various nosologic forms of cardiovascular system diseases B2i are formed in form of projections, formed by B2i on plane, coinciding with plane of displaying multicolout screen of videomonitor. Coordinates in 2-dimensional space of cardiovascular system state of all points formed by B2i are memorised. Formed B2i are visualised on screen of multicolour videomonitor in such a way that colour of each point B2i in visible ranges of wavelengths Δλr, Δλo, Δλy, Δλg, Δλb…Δλ,m corresponds to certain type of disease, and degree of pathology is characterised by value, inversely proportional to wavelength of respective range. Visualisation on screen of multicolour videomonitor of successively formed in time values A2(t) is also performed, with each previous value A2(t) being connected by means of straight lines with their following values, and colour of A2(t) and connecting straight lines is formed by addition of red (Δλr), green (Δλg) and blue (Δλb) colours with similar amplitude proportion. Check of satisfaction of set of conditions A2(t) ⊂ B2i is carried out. Decision about cardiovascular system disease is taken in case of satisfaction of a condition from set A2(t) ⊂ B2i. Ambiguity of taking decision about cardiovascular system disease is excluded if mutual intersections B2i are present, when instant value A2(t) simultaneously belongs to two and more B2i, by formation on screen of multicolour videomonitor of each of new images of state A2k(t) and non-intersecting images of diseases в2ik by respective k transmissions of origin of coordinates of N-dimensional space of cardiovascular system state into selected by cardiologist points on plane of multicolour screen of videomonitor and carrying out procedure of projecting A(t) and Bi on plane coinciding with plane of displaying multicolour screen of videomonitor and after each of k transmissions of origin of coordinates of N-dimensional space of cardiovascular system state, where k=1; 2; 3;…j. Formed A2k(t) and в2ik are visualised on screen of multicolour videomonitor. procedure of A2k(t) and в2ik formation is stopped when condition, when A2k(t) belongs only to one в2ik is satisfied. Decision about absence of disease is taken if condition A2(t) ⊄ B2i is satisfied. Assessment of dynamics of change of cardiovascular system state is performed by results of analysis of preliminarily determined values of quantities Δτ=A2(t1)-A2(t2) and dΔτdτ for specified time interval, where t1; t2 are moments of time of beginning and end of specified time interval respectively.

EFFECT: invention makes it possible to simplify process of operative analysis of clinical data by set of measured clinical signs and avoid mistakes in generation of medical control decision for diagnosing.

5 dwg

FIELD: medicine.

SUBSTANCE: invention relates to means for diagnosing neurodegenerative diseases. Device contains module of obtaining images which receives visual data about patient's brain state, and image analyser, made with possibility of determining quantitative index, which shows degree of development of neurodegenerative disease of patient's brain on the basis of visual data with application of probability mask for determination of studied areas on the image, specified by visual data. Method of clinical assessment includes stages of obtaining visual data and their analysis for determination of quantitative index, which makes it possible to assess degree of development of neurodegenerative diseases of patient's brain with application of probability mask. Software carrier contains computer programme, settings of data processing device for its performance of at least one of method stages.

EFFECT: invention facilitates early diagnostics and control of neurodegenerative diseases, for instance, Alzheimer's disease.

25 cl, 8 dwg

FIELD: information technologies.

SUBSTANCE: method to support decision-making based on instances includes a stage of calculation of remoteness from likeness between the input case of requesting and the set of instances for extraction of similar cases, using the set of standard criteria and their weights for assessment of likeness. Then, in accordance with the method, a user is provided with similar instances and a set of standard criteria and weights. And also an input is received from the user, including a variable weight for one of the set of standard criteria and/or one new criterion in addition to the set of standard criteria. Besides, the calculation of remoteness from likeness is varied with a new set of criteria and weights for extraction of instances similar from the point of view of the user. At the same time a new set of criteria and weights is generated on the basis of clustering on the basis of likeness for variation of calculation of the remoteness from likeness by means of start-up of a genetic learning logic.

EFFECT: creation of a basis system of input estimates of likeness for adaptation of actual value of likeness to similar users with another experience or other opinion.

11 cl, 3 dwg

FIELD: information technologies.

SUBSTANCE: under clinical conditions, when at any time there are several patients, there are central stations (10) of patient control, for instance, nursing units, for combination of the collected information relative to physiological parameters of patients. Data is displayed in several subwindows (22) of the display (18) of the control station (10). Due to certain limitations for dimensions of the display (18), it is often difficult to distinguish data displayed in subwindows (22), or even display all collected data. The user may expand any such subwindow (22) into a scale-variable subwindow (32), which provides for more functions than any other subwindow (22), without full coverage or adjustment of size of any other subwindow (22).

EFFECT: improved access to information.

12 cl, 6 dwg

FIELD: chemistry.

SUBSTANCE: method of operating a device for measuring an analyte, having a display, a user interface, a processor, memory and user interface buttons includes steps of: measuring the analyte in the body fluid of a user using the analyte measuring device; displaying a value representing the analyte; prompting the user to select an indicator for linking with the displayed value; and pressing one of the user interface buttons only once to select an indicator linked with the value of the analyte, and storing the selected indicator together with the displayed value in the memory of the device. The group of inventions also relates to a method of operating the measuring device, which additionally includes a step of ignoring activation of any of the user interface buttons except the selected button.

EFFECT: more intuitive and easier use of the device for measuring an analyte, eg a glucometer.

20 cl, 12 dwg

FIELD: information technology.

SUBSTANCE: method of extracting a plurality of data layers from a set (5) of data of medical images, wherein the method includes the following steps: a) displaying an indicator (10, 20) associated with the plurality of data layers; b) selecting the indicator (10, 20) based on user input; and c) extracting the plurality of data layers associated with the indicator when said indicator is selected; wherein the link between the indicator and the plurality of layers is based on segmentation of the set of data of medical images, wherein the indicator is an object obtained during segmentation of the set of data of medical images, and the plurality of data layers include object data, wherein the object data are contained in the plurality of layers.

EFFECT: reducing the amount of data transmission.

12 cl, 7 dwg

FIELD: medicine.

SUBSTANCE: invention relates to field of medicine, namely to cardiology. To predict unfavorable annual outcome in patients with acute coronary syndrome with elevation of ST segment, subjected to percutaneous coronary intervention, results of clinical and laboratory examination methods are analysed. On the first day of disease presence of II-IV class of heart failure by Killip classification, impairment of rhythm and conductivity of heart, patient's smoking in anamnesis, as well as determination of TNF-α in patient's blood plasma are taken into account. On the tenth day IL1α and sP-selectin are determined in blood plasma. Value of TNF-α≥4.5 pg/ml is assessed in 8 points; level of IL1α≥0.69 pg/ml is assessed in 3 points; sP-selectin≥152.8 ng/ml - in 2 points; class of heart failure by Killip II-IV - in 3 points; presence of impairment of rhythm and conductivity - in 1 point; smoking in anamnesis - in 1 point. Patients with the sum of points from 0 to 4 are related to group I of low risk of development of unfavourable coronary events, group II, of intermediate risk, is determined by the sum 5-10 points; and patients with the sum of points 11-18 constitute group III, of high risk.

EFFECT: method makes it possible to predict unfavourable annual outcome in patients with acute coronary syndrome with elevation of ST segment after percutaneous coronary intervention.

2 ex, 2 tbl

FIELD: medicine.

SUBSTANCE: claimed invention relates to piercing device (1) for blood sampling, containing movable holder (5) for piercing means (4), drive means (12) of movable holder travel and trigger device (19) for performing piercing movement (13) by piecing means. When trigger device is brought into action manually movable holder can be moved in axial direction by force of drive spring (9) of drive means (12) and tightening device (22) in order to tighten drive spring. Tightening device contains tightening mechanism (23), containing means of fixation (24) for axial fixation of movable holder in the process of tightening drive spring and means (25) for carrying out actions while tightening drive spring, which provides possibility of convenient multiple application of piercing device.

EFFECT: invention ensures possibility of convenient multiple application of piecing device.

12 cl, 15 dwg

FIELD: medicine.

SUBSTANCE: invention relates to field of laboratory medical analysis, analytical instrument making and can be used for determination of total hemoglobin concentration in biological tissues. Transmission of radiation on tissue into one or more points is performed at wavelengths λ equal 524, 578 and 662 nm or 524, 578 and 773 nm. Signals of diffuse reflection P(Ln,λ) at three or more distances Ln (n=1, 2, 3 …) between points of transmission and registration of radiation are measured. Standard signals rn(λ)=P(Ln,λ)/P(L1,λ) and their main components are determined, and total hemoglobin concentration is calculated on the basis of multiple regression equation, connecting it with main components of rn(λ).

EFFECT: increased accuracy of determination of total hemoglobin concentration in biological tissues due to taking into account presence of oxyhemoglobin, deoxyhemoglobin, methemoglobin and carboxyhemoglobin in them, exclusion of impact of variations of thin upper tissue layer parameters (for instance, skin epidermis) and its diffusing properties, elimination of calibration measurements, as well as reduction of method cost.

2 dwg, 2 tbl

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to correction and medical psychology, psychophysiology, and can be used for prediction, objective assessment and dynamic monitoring of psychophysiological and somatic state of members of militarised groups, taking part in performing life-threatening or health-threatening operation and service, service and combat and other tasks. Psychological testing is carried out in accordance with MMPI by 566 questions, general blood test, general urine test, biochemical blood test are performed, heart rate, arterial pressure are determined, ultrasonic measurement of liver, pancreas, kidneys and prostate gland dimensions is carried out, after which psychophysical examination in accordance with methods of express-diagnostics of nervous system characteristics by psychomotor parameters by E.P.Ilyin (tapping-test) is performed, after which each characteristic is assessed in points. After that, obtained points are summed up. If the sum of points is 0-40, examined person is considered to be suitable for military service without any limitations, and not requiring rehabilitative procedures; with the sum of 50-80 points - conditionally suitable, with inconsiderable limitations, requiring rehabilitative procedures on outpatient basis, with 90 and more points - unsuitable, with considerable limitations, requiring rehabilitative procedures in hospital.

EFFECT: increased accuracy of determining psychosomatic status of members of militarised groups.

1 ex

FIELD: medicine.

SUBSTANCE: invention relates to medical equipment, namely to devices for optic detection of joint state. Method consists in irradiation of joint-containing body part and detection of local light weakening by body part in the place of joint location and on one more section of body part. During measurement blood flow is temporarily blocked in said parts and then opened again. Individual measurements of local weakening fo joint and other body part are performed before, during and after blood flow blocking. Device contains measuring module, module of blood flow blocking and module of device control.

EFFECT: detection of diseases of joints at early stage.

12 cl, 5 dwg

FIELD: information technology.

SUBSTANCE: disclosed is a medical intervention monitoring system (10) for real-time collection, storage and display of data elements relating to events in an interventional procedure, the system comprising: an input (11) for receiving, during the interventional procedure, data elements from at least two separate systems (16) used in the interventional procedure, said at least two separate systems being configured to receive data from different modalities; a clock (12) for registering the time of reception of the data elements, a storage (13) for storing items relating to respective events, each item containing the corresponding data element and the corresponding time of reception, a processor (15) for processing data elements and corresponding times of reception in order to generate a timeline (30) with item representations, and a display (14) for displaying the timeline and representations of the items sequentially along the timeline (30) in accordance with the respective times of reception.

EFFECT: more transparent and more useful review of data received from multiple separate systems.

10 cl, 8 dwg

FIELD: medicine.

SUBSTANCE: group of inventions relates to medical diagnostics. Auxiliary unit of analyte sensor contains case, analyte sensor, connected with case and having anode and cathode. Case contains canal, which contains analyte sensor. First electric connector has on first end first electric contact, connected with analyte sensor anode, and on second end - second electric contact, made with possibility to form electric connection with analyte sensor unit. Second electric connector has on first end first electric contact, connected with analyte sensor cathode, and on second end - second electric contact, made with possibility to form electric connection with analyte sensor unit. Described are guide of auxiliary unit of analyte sensor, instrument for analyte sensor introduction, method of analyte sensor introduction and unit of analyte sensor.

EFFECT: ensuring safe introduction of analyte sensor.

24 cl, 8 dwg

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to oncology and radiotherapy, and deals with prediction of efficiency of radiotherapy of malignant neoplasms of oropharyngeal zone. Before treatment index of blood microcirculation Im and average degree of oxygenation of mixed blood of microcirculature StO2 in tumour are registered. Said indices are used to determine perfusion oxygen saturation, and values of blood microcirculation index Im' and average degree of oxygenation of mixed blood of microcirculature StO2' in intact zone are measured. Average volume blood filling Vb in tumour and in intact region Vb' are registered, level of activity of oxygen metabolism in cells in examined areas MA, MA' is determined by given formulas. If MA/MA'≥2.5, efficiency of radiotherapy is predicted, if MA/MA'<2.5, conclusion about high probability of residual volume of tumour after carrying out radiotherapy is made.

EFFECT: method makes it possible to predict efficiency of tumour regression to impact of distant radiotherapy still at pre-hospital stage, which in its turn contributes to correct and timely selection of method of treatment in accordance with individual plan.

3 ex

FIELD: medicine.

SUBSTANCE: invention relates to field of medicine, namely to sportive medicine, anthropology, labour hygiene, pediatrics, and can be applied in measurement of chest circumference in people. Method consists in fixation of measuring tape on movable caliper bracket with its zero end. Movable cylinder with mark and area of transverse section 10 mm2 and spring, closed with metal threaded plug, are inserted into caliper. Caliper is initially calibrated by means of 100-gram weight, with marks being simultaneously applied on cylinder and movable bracket. After application of tape at required level of chest into one of metal staples, fixed on tape by hook, mounted with bolt into movable bracket, tape is tightened by approaching brackets by 1-st and 2-nd fingers, introduced into caliper rings. After that tightening is performed until said marks are matched. After that, result of performed measurement in centimetres is read from tape.

EFFECT: application of claimed invention makes it possible to examine people irrespective of their sex with increased accuracy and objectivity of chest circumference measurement.

2 dwg

FIELD: medicine.

SUBSTANCE: invention relates to fields of biology and medicine. In order to diagnose sterility in vertebrate animals and people of both sexes concentrations of urotensin-2 immunoreactivity in blood, determined by method of reaction of direct hemaglutination between sterile individuals and individuals capable of reproductive function, are compared. Sterility of individual is diagnosed when titre of urotensin-2 immunoreactivity is 16-64 times greater than in individuals giving offspring, in which it is in the range 1:4-1:8.

EFFECT: method makes it possible to diagnose sterility in vertebrate animals and people of both sexes.

1 tbl, 5 ex

FIELD: medicine.

SUBSTANCE: method involves carrying out ultrasonic scanning examination of subclavian artery over its whole extent in physiological arm position with arterial blood pressure being measured in the middle one third of the arm. Next, when applying compression tests, blood circulation parameters variations are recorded in distal segment of the subclavian artery with arterial blood pressure being concurrently measured. Three degrees of superior thorax aperture syndrome severity are diagnosed depending on reduction of linear blood circulation velocity and arterial blood pressure compared to their initial values. Mild one takes place when linear blood circulation velocity reduction reaches 40% and arterial blood pressure 20% of initial level, moderate one when linear blood circulation velocity reduction reaches 70% and arterial blood pressure 50% and heavy one when linear blood circulation velocity reduction is greater than 70% of initial level and arterial blood pressure is greater than 50% to the extent of no blood circulation manifestation being observed in the subclavian artery.

EFFECT: high accuracy of diagnosis.

Up!