Method for automatic adjustment of time-varying parameter warning

FIELD: medicine.

SUBSTANCE: group of inventions refers to medicine and can be used for patient's status monitoring. A method for setting a time-varying physiological parameter warning signal involves patient's controlled parameter monitoring, comparing the controlled parameter to an initial cut-off criterion, varying the cut-off criterion temporarily by a cut-off criterion of deterioration after the therapy, and then after a certain period of time, by the cut-off criterion after the administration. The time allowed involves comparing the controlled parameter to the cut-off criterion of deterioration, and after the time allowed - to the cut-off criterion after the administration. The warning signal is initiated in response to the controlled parameter of one or more initial cut-off criteria, the cut-off criterion of deterioration and the cut-off criterion after the administration. The group of inventions also refers to a machine-readable carrier with software for implementing the method and to a system for user warning on the controlled parameter variation.

EFFECT: group of inventions provides higher accuracy and rate of assessing the patient's status according to the conducted therapy.

15 cl, 6 dwg

 

The present invention finds application in patient monitoring systems, particularly in relation to the physiological systems of monitoring. However, one should take into account that the described methods may also find application in other monitoring systems, other ways of gathering medical information, other ways of monitoring the status, etc.

Modern physiological monitoring of the patient requires that each parameter had the power alarm alerts you that the parameter has exceeded the specified limits. Nominally these boundaries are set by the user, and alerts are generated for each time changing the physiology of the patient after the boundary is set. When you start therapy, such as angioplasty of the coronary arteries or start receiving vasoactive drugs, usually a caregiver, does not change the parameter boundaries. In some cases, the desired effect of the invention is to manually change the user for a target of physiology; however, there is an unexpected effect on other parameters that the user does not take into account when it sets new levels of prevention intervention has been initiated. In addition, the Clinician typically interested in to be notified about what clinical parameters are not Rea�irout appropriately on the ongoing intervention or therapy, or even wished to be notified if the intervention was successful. In addition, the Clinician is interested to know the changes in the current scheme of work based on the current response of the patient to therapy, including the need for new clinical data such as lab results, blood, or subjective response to therapy.

Many treatments do not provide instant improvement. More physiological signals, including indicators of life, often continue to deteriorate as long as the treatment will be useless. If the boundaries are left unchanged, then follow the false alarms. If the boundaries do not optimize for a projected physiological outcome of the intervention, we lose meaningful feedback as to whether the patient improve as expected.

These "deteriorating" or "not improved" criteria sometimes sold in the form of regulations to manually check for the considered parameter after a predetermined time range, and to contact the designated doctor if the parameter is not within the boundaries of the target range. In other cases, the absence of an improving or deteriorating detect late or not detected at all, which delays proper treatment. At this time, the alarms triggered by a monitoring system, because the intervention is still not effective, often ignored, is perceived as false or irrelevant, or the alarms are shut off.

In systems physiological monitoring which will trigger the alarm or alert in response to exceeding the threshold of one of the measured physiological parameters, the threshold is typically set by the Clinician, and it remains constant. After medical intervention or therapy expect that the patient will improve, typically with a delay. The delay depends on the initial state of the patient, physiological responses to intervention, and many other variables. Also Clinician's important to know when a patient will actually get better. Typical monitoring improvements in response to intervention or therapy is performed manually, and the lack of timely improvements easily miss.

In the present application is provided new and improved systems and methods to alert the Clinician about the patient's needs based on the comparison of the values of the monitored parameter with the threshold or boundary value as a function of time, which overcome the above and other problems.

In accordance with one aspect, a method of providing warning of time-varying physiological parameter includes monitoring physiologists�technical parameter patient data or clinical information of the patient and comparing the monitored parameter with the initial threshold criteria. After the introduction of the drug, event, intervention, or therapy initial threshold criteria temporarily change to a threshold criteria degraded condition which prevents deterioration of the monitored parameter within the allotted time period, and after the allotted time period before the threshold values after injection. During the allotted time period, the monitored parameter is compared with the threshold criteria degraded condition, and after the allotted time period, the monitored parameter is compared with the threshold criteria after the introduction. The method further comprises triggering an alarm in response to a breach of the observed parameter of one or more initial threshold criteria threshold criteria the deteriorating state and threshold criteria after the introduction.

In accordance with another aspect, a system that provides the user with a warning of time-varying physiological parameter comprises one or more sensors that monitor physiological parameter of the patient, and the processor is programmed to receive one or more items of patient data, the TC�technical laboratory data and the observed data or measurements, describe the physiological parameter. The processor is further programmed to compare the monitored parameter with the initial threshold criteria. After the introduction of the drug, event, intervention or therapy, the CPU temporarily changes the initial threshold criteria to a threshold criteria degraded condition which prevents deterioration of the monitored parameter within the allotted time period, and after the allotted time period before the threshold values after injection. During the allotted time period, the processor compares the monitored parameter with the threshold criteria degraded state. After the allotted time period, the processor compares the monitored parameter with the threshold criteria after the introduction. In response to the violation observed parameter of one or more initial threshold criteria threshold criteria the deteriorating state and threshold criteria after the introduction of the controller initiates an alarm.

In accordance with another aspect, the system initializes the scheme of work or the need for additional clinical information on the basis of reaction to the introduction of certain medicines, therapeutic or interventional event.

One advantage is that it decreases the time spent on the interpretation of the reactions of the patient started on therapy.

Another advantage is that the lack of patient response to intervention find faster.

Another advantage is that the threshold boundary change along with the planned treatment outcomes.

Another advantage is that the reduced number of useless alerts and alarms.

Medium-sized specialists in this field will take into account other additional advantages of this invention after reading and understanding the following detailed description.

The drawings are intended only for the purpose of illustrating various aspects and should not be interpreted as limitations.

Fig.1 illustrates a system that facilitates providing time-varying characteristics of the alarm that can automatically be adjusted by the system or manually programmed by the user to adjust the alarm setting, which initiates the alarm message and notification of the patient's needs.

Fig.2 illustrates the sequence of operations for collecting and displaying physiological data using the system management alarm that compares the current values of the physiological parameter with the configured limits of the alarm.

Fig.3 illustrates a graph on which is�straut monitoring values of ST segment ECG waveform (e.g., by means of the sensor(s) of the patient), and the system automatically or the user manually, or via automated data interfaces), tells the system that performed the intervention, and recovery initiated the alarm about "not improving".

Fig.4 illustrates a graph where the border is worsening ST is a monotonically decreasing function from an initial higher value boundary ST to deterioration of the original boundary value or high limit values by default (target border reperfusion), and the result is how the alarm about the "deterioration" and "not improving".

Fig.5 illustrates a chart where a new high reduce the border in a series of stepped levels during the time interval to the threshold of improvement.

Fig.6 illustrates a graph which shows several physiological parameters and clinical laboratory results that generate alerts about relevant parameters and schemes of work.

Fig.1 illustrates a system 10, which promotes time-varying characteristics of the alarm that can automatically adjust the system or which can be manually programmed by the user to adjust the settings of the alarm which will trigger the message, and nearly one quarter�e, and notification of the patient's needs. For example, the system monitors the patient and initiates an alarm if the patient's condition does not improve within a predetermined period or time interval.

The system 10 includes a block 12 control alarm, coupled with one or more sensors 14 of the patient, clinical data 15, which may contain physiological information from the history, rules, knowledge, etc. the Sensor 14 is connected to the patient to perceive or to measure parameters of a patient (e.g., temperature, heart rate, respiratory rate, blood pressure, level of oxygen in blood (SpO2), blood sugar level, the level of metabolite in the blood to the desired metabolite, ECG curve, or any other measurable or subjective parameter's health). The monitoring device includes a processor 16 that executes, and a machine-readable medium 18, which stores executable computer instructions for implementing the various technologies, methods, actions, etc., described herein. The processor and memory connected with the user interface 20, which contains the display 22 to present information (e.g., information about the parameter of a patient, warnings, etc.) to the user, and the input device 24, the pic�edstam which the user enters information into the monitoring device. The input device may be a mouse, stylus, keyboard, touch screen, controlled by a voice input device or any other suitable device for inputting information into the user interface of the monitoring device.

The processor 16 receives the data about the measured parameter from the sensor 26(s) 14 of the patient and/or clinical data 15, and stores them in the memory 18, and displays on the device display 22. Additionally, the processor may receive data indicating the introduction of the intervention, medications and/or therapy, etc., from external systems and/or users. The system selects one or more parameters and stores the selected parameters 28 in the memory 18. The user then configures one or more boundaries of the warning parameter 30 (for example, ranges or thresholds, such as time range, the range of the value of the parameter, a temporary "improvement", the value of the threshold parameter, etc.) that are stored in the memory 16. Once activated by the user or the availability of necessary data for execution by the processor continuously executes an algorithm such as a set of executable computer instructions), which monitors the selected parameter(s) 28 to determine, overcome the range or whether the threshold is crossed the border. If Grand�s warning parameter includes a time range, the clock 34 (e.g., timer, real time clock, counter or the like) in the device monitor provides time information to the processor and/or algorithm(s) warning for use in determining expired whether a predefined or selected time or time range. After detecting that the selected parameter has exceeded the border or went beyond the designated range, the processor activates the alarm signal 36 in the user interface to alert the Clinician that the patient or the scheme of work requires attention.

According to one example, after the implementation of the intervention (e.g., drugs) or therapy selected parameter of the patient may deteriorate for some time. Then, when the intervention or therapy becomes active(Oh) (e.g., metabolized by the patient reaches a target organ or places, etc.), expect an improvement of the selected parameter. Through automatic interface (not shown) or via a user using the input device 24 to indicate the information describing what kind of intervention or therapy began. The system determines whether the available parameters 28 to modify the alarms or warnings. If so, then the system adjusts the parameter boundaries, thus �omitting a limited deterioration for the selected option in a limited latent period of time after the intervention (reduces false or premature alarms). Then, after a user configured time period for intervention or therapy is effective, the border automatically adjust (e.g., reduce or increase depending on the parameter and/or the expected effect of a drug or treatment) to a level that represents an improvement of the selected parameter. In one embodiment, the implementation of changes to the boundaries initially raise and then lower at the expiration of the period of time after which expect that the intervention will gain efficiency. In another embodiment, the implementation after the latent period for intervention or therapy is effective, adjust the border, so she repeated a smooth curve, which varies over time. In another embodiment, the implementation of border adjustments in a series of small steps over time. In all these embodiments, if the patient's condition does not improve as expected after the intervention or therapy, the processor 16 generates an alarm signal 36 to notify the Clinician that the treatment or therapy does not create the desired effect or that the condition is worsening, despite the intervention.

The adjustment of the boundary(s) of the parameter over time can be performed in various ways. In one of the embodiments of the device monitor�ha determines variable time threshold boundary automatically through inference based on the observed physiological parameters, their importance in history and/or through interaction with other systems or databases (not shown). For example, if the device also monitors the intravenous pump from the designated drug, the monitoring device may receive information associated with the medication and the rate of discharge, and can make a conclusion about the desired improvement. Consequently, the media contains a knowledge base, or search the table 38, or similar curves for the different conditions and interventions or treatments based on what is known about the patient, physiology, history and initiated the intervention. Optionally, the search table can be stored remotely from the monitoring device, such as a network database (not shown), etc.

In another embodiment of the processor 16 displays the estimated boundary curve on the device display 22, and the operator can adjust the curve. In another embodiment, the change in the border depending on the time set manually using the input device 24.

According to another variant implementation, it is possible to monitor several physiological parameters. These parameters can be directly related to the physiological state of the patient or with effects that is maintained by a�and intervention or therapy. On the other hand, the change of the threshold or boundary option can also be based on physiological parameters that indicate the known side effects of the intervention or treatment. For example, drugs administered to increase blood pressure, also typically increases the heart rate. Thus, when the heart rate of the patient is maintained above the boundary settings during the selected time span since the introduction of the drug, but blood pressure falls below the minimum boundary settings blood pressure or heart rate increases temporarily permitted above the new level due to interference, the processor 16 can initiate the alarm 36 to alert the Clinician about the event.

Border warning option 30 can be in the form of a simple threshold (e.g., the alarm "High heart rate", if the heart rate > Upper limit of heart rate), or may be based on the severity, when various alerts are generated for one parameter based border alert with medium priority, the boundaries of alerts with high priority, complex algorithm that detects physiological alarm event, etc. Additionally, the monitoring device 12 may display�ü automatically or manually entered commands what started therapy or intervention, or the fact that the parameter has violated its current bounds. For example, via the interface device, or activation by the user, the system knowledge about the introduction of drugs or intervention, or the knowledge that the current value of the parameter exceeds the current boundary of the parameter can be displayed on the device display 22.

The system 10 also enables automatic or manual configuration to configure the alarm about the "deterioration", which temporarily weakens or allows a wider variation of the parameter for the current boundaries of the alarm. This is a temporary state permit until such time as a therapeutic intervention is still not effective, but if the parameter violates this new temporary boundary, the user can receive a notification about the deterioration. For example, if a patient receives a β-blocker to reduce heart rate and/or blood pressure and the patient a drug typically becomes effective in approximately 30 minutes, the user configures the setting of alarm about the deterioration of the blocking of the current alarm state (e.g., high blood pressure and/or heart rate) for 30 minutes. The system may allow the continuation of the increase is often�s heart rate of the patient to the frontiers of deterioration", but after 30 minutes, the heart rate and/or blood pressure of the patient is still above the expected boundaries of the improvement, it will sound an alarm to warn the user about "not improving" condition. Thus, the Clinician does not have to continuously check the patient, while remaining aware of these conditions, or as may be notified more quickly.

The system 10 allows for automatic or manual adjustment of the desired range of 30 warning parameter expected response curve and time function, which is expected to adhere to the chosen option. Additionally, the system allows for automatic or manual adjustment of the dangerous conditions associated with the intervention or the introduction of, as well as time functions, which selected parameters are expected to adhere to. These signs provide as a function of the parameters available to the system, a physiological model of the patient based on the knowledge from history about the behavior of the parameters, clinical guidelines, etc.

Thus, the collection of physiological data is facilitated by the functionality of the control alarm that is able to compare the current measured values of 26 parameter configured with borders 30 warning parameter. In addition, the system 10 has a set�p information to the patient about the intervention and therapy, including the introduction of the drug, the dose and pharmacotherapeutic group. Finally, the system facilitates the calculation of a therapeutic target as a function of time, as well as processing impairment criteria.

In relation to the CPU 16 and the carrier 18 it is clear that the CPU 16 executes, and the carrier 18 stores computer executable instructions for implementing the various functions and/or methods described herein. The carrier 18 may be a computer-readable medium in which is stored a control program, such as a disk, a hard disk drive or the like common forms of machine-readable media includes, for example, floppy disks, flexible disks, hard disks, magnetic tape or any other magnetic storage, CD-ROM, DVD or any other optical medium, RAM, ROM, PROM, EPROM, FLASH-EPROM, their variants, other chips or memory cartridges, or any other tangible medium from which a processor 16 can read and execute. In this context, the system 10 can be implemented on or as one or more General purpose computers, computer(s) a special purpose, a programmed microprocessor or microcontroller and peripheral elements of integrated circuits, an ASIC or other integrated circuit, digital signal processor, a hard wired electronic or logics�Oh scheme, such as scheme of discrete elements, a programmable logic device such as PLD, PLA, FPGA, CPU, graphics adapter (GPU), or PAL or etc.

Fig.2 shows that the sequence of operations 70 collects and displays physiologic data using the system management alarm that compares the current values of the physiological parameter with the configured limits of the alarm. In step 72 or find exercise intervention or the introduction (e.g., therapy, administration of medications, etc.). In step 74 determines, influences whether the detected event to one or more monitored parameters. For example, if the event injection is the introduction of vasoactive drugs, which increases blood pressure and monitoring blood pressure of a patient, the definition is in the affirmative.

When performing the determination in step 74 using multiple data sources. For example, you can consider the available physiological information 76 (for example, the observed parameters, etc.), as well as knowledge about 78 medical effects or the impact of interventions on physiology (e.g., expected effects, measurable effects, etc.). Further, the history information 80 describing the physiology of the patient, and the history of signals Trev�GI can be used when performing the determination in step 74. If the determination is affirmative, then in step 82, the system 10 calculates some of the factors (Fig.1).

For example, in step 82 calculates the criteria of deterioration, not improvement or identified schemes of work for planned and/or unplanned settings. Also calculate the time period for the state of deterioration that it was discovered (for example, to achieve the threshold boundaries) of each parameter, the monitoring which is carried out or influenced. The system 10 further calculates a function of time for a state of deterioration that showed each parameter, the monitoring which is carried out or influenced by, as well as the target value for each parameter. In addition, the time period for reaching the target parameter value for each parameter, the monitoring which is carried out or influenced by, is calculated by the system, as a function of time to achieve the target parameter value for each parameter, the monitoring which is carried out or influenced. In step 82 also identify other conditions to be checked, the monitoring of which is not carried out. In step 84 activate variable bounds, and the user (e.g., Clinician, nurse, doctor, etc.) is cautioned by the referee about the change�AI state.

If the determination at step 74 is negative, then in step 86 does not perform automated changes of boundary values (although possible adjustment by the user), user input parameters impairment criteria (e.g., time, time functions, etc.) or target parameters (e.g., values, time, time functions, etc.). Then the sequence of operations proceeds to step 84, where it activates the variable bounds and the user (e.g., Clinician, nurse, doctor, etc.) is notified if necessary.

Fig.1 and 2, and Fig.3-6 illustrates a few of the chart examples in which the patient received percutaneous coronary intervention (PCI) (e.g., angioplasty, etc.) or through the interface devices, interface systems, or activation by the user of the system 10 (Fig.1) get the knowledge about administration of the drug, while pharmacotherapeutic group of the medicinal product and dose is classified as "thrombolytic" due to acute myocardial infarction with raised ST segment (for example, parts of the electrocardiogram between the end of the QRS complex and the beginning of the T wave).

Fig.3 illustrates a graph 100 of the monitoring values ST 102 (e.g., via sensor(s) of the patient 14, such as electrodes �La ECG (Fig.1)), and the system automatically or the user manually indicated to the system (or through the automatic data interfaces) that completed 104 intervention. After the occurrence of the initiating factor, the system independently computes criteria of deterioration and improvement and the time constant on the basis of clinical guidelines, such as, for example, 1 mm is a "deterioration", and 50% improvement for 60 minutes is an "improvement" or "reperfusion goal." The upper boundary ST "impairment" is a step change over time 108.

Fig.3 the observed value of ST is shown as a solid line 102. Reperfusion target action 104 initiates the start of the expected time period 106 of improvement. Also illustrated time fence 108 ST deterioration (for example, threshold limit), which is calculated by the boundary 112 of the alarm before the intervention and purpose of the 110 improve, which can be specified by the user or automatically configure the system. Top custom border 112 ST, which is the same as that of the upper boundary ST before the intervention, set up after the expected improvement. Lower custom border 114 ST describes the meaning of the ST below which will initiate the alarm about low ST. In this case, the modification of the boundaries of worsening/not improving need PR�to change only to leads, associated with caused this vessel involved in the intervention, and only to the leads with a raised ST (and not to lead with reduced ST). Additionally, a warning or alarm ST-X is not improving" initiate beyond the expected time period of improvement for the value ST of the patient, which has not improved below the upper target boundary 110 of improvement. It should be noted that the terms upper and lower bounds refer to the clinical scenario described in this document, and they are used to represent the clinical condition and the expected trajectory of the physiological parameter.

Fig.4 illustrates a graph 130, where 132 at the time of the implementation of therapeutic action of the upper limit of deterioration of the ST initially raised to a higher (relative to Fig.3) the values of the border 134 ST deterioration. Within the expected time 135 improving the upper bound ST decreases along a smooth, monotonically decreasing curve 136 to a new upper bound 138 ST, which in this example is lower than the original upper bound 140 ST. In this example, the warning "ST-X is deteriorating" initiated by subsystem 36 warnings when the upper limit 136 ST deterioration and the observed value of 144 ST patient intersect at point 146. Warning the ST-X is not improving" also initiate beyond the expected temporarily�period of 135 improvements.

Fig. 5 illustrates a graph 150, where the high boundary 152 ST step is changed to a new high boundary 154 (relative to Fig. 3) 156 at the time of therapeutic action. Threshold criterion 154 reduced over a sequence of uniformly decreasing speed levels 158 within the expected time 160 improvements to the new upper threshold 162 ST after injection. Warning the ST-X is deteriorating" initiate 164 at the time, when the upper limit 158 ST crosses observed value 166 ST patient. Warning the ST-X is not improving" initiate beyond the expected time period 160 improvements when the observed value of 164 ST still exceeds the upper threshold criterion 162.

In each of these examples set the threshold of a unique state, the inhibitory period and the delay time. Each state may lead to notification of the user about the state of deterioration, the condition does not improve within the boundaries of the scheduled time, or that the improvement is within the boundaries of the desired time using for the deterioration of various time functions, for which the tested criteria of deterioration.

In one embodiment, the implementation monitor continuous infusion, where the pharmacotherapeutic group of the medicinal product and dose are classified as "vasopressor", and shelter�tion pressure (CD). The system calculates the difference (for example, change) between the target CD and the current CD of the patient and adjusts the "high" and "low" boundaries of alarm about KD to warn the user if KD drops, for example, immediately by 10% and/or not growing more than 30% in 20 minutes.

In another embodiment, the boundaries of the warning parameter heart rate (HR) is modified through the introduction of chronotropic drugs on the basis of the expected time of therapeutic action of the drug.

In another embodiment, the warning about the frequency of breathing is modified with the introduction of sedatives or opioid analgesic with a known activity of respiratory depression.

In another embodiment of the injected drug, which is known that it reduces or increases the level of glomerular filtration (UCF), and warnings about fluid balance (I/O) set at the expected level. If during this time do not reach the balance I/O, the Clinician is cautioned by the referee.

In another embodiment, the implementation through the interface devices, interface systems and/or user action use the system's knowledge about administration of the drug, known side effects of the drug and the dose are classified as "toxic DL� kidney". For example, if decreased urine output, increased creatinine clearance, or increased nitrogen blood urea (BU) (as the results of laboratory studies) in a certain period of time up to a specific limit, the user will receive a warning.

Fig.6 illustrates a graphical display 170, reflecting some of the observed parameters with multiple alarm settings. In accordance with the example, the intervention has scheduled primary effect (e.g., increased blood pressure (KD)) and two secondary unintended effect (e.g., increasing heart rate (HR), increased lactate). Target CDthe difference (Δ) (change) based on either absolute value or a percentage improvement relative to the value during the intervention. Impair the difference (Δ) CD (change) based on a fixed percentage below the value of KD during the intervention. Target CD same CD patient during the intervention plus the difference (Δ) of the target CD (change). Expected improvement based on the type of intervention. Impair the difference (Δ) curves based on the removal for a fixed percentage of the current border or the heart rate during the intervention. The upper limit of heart rate in this example is increased by a fixed percentage. Permissible time deviation based on the type vmeshatelstva the current value (or recent history). In this case, after the permissible time deviation to restore the previous limits of variation. This example also presents interference, which is known that it is associated with increased formation of lactate, therefore, on the basis of the last known values of lactate creates a permissible time 172 until its available laboratory data. This time based on the type of intervention, how far separated from interference recent laboratory study, and on the value of the last laboratory tests (normal, abnormal, critical value). Based on this example of physiological events resulting warnings (for example, high heart rate, lactate, KD low/not improving, etc.) are presented below the time axis. For example, sounds the alarm about the heart rate when the boundary heart rate exceeds deteriorating the difference (Δ) during the permissible time period of the deviation, and at the end of the permitted time period of the deviation, if the heart rate remains above the boundary curves. In this example, each parameter may have an independent calculation of the threshold, the time and improve the function of recovery time.

The invention is described with reference to several embodiments. Modifications and changes may occur after reading and understanding predshestvuyuschei�about a detailed description. It is understood that the invention be construed as including all such modifications and changes to such an extent that they are included in the scope of the applied claims of the invention or its equivalents.

1. Method of providing a warning signal of time-varying physiological parameter, where:
monitor a physiological parameter of patient data or clinical information(15, 26, 102, 144, 166, 172) patient;
conduct a comparison of the controlled parameter (26, 102, 144, 166) with the initial threshold criterion (112, 140, 152);
after the introduction of the drug, event, intervention, or therapy temporarily change the initial threshold criterion (112, 140, 152) on the threshold criteria (108, 134, 154) degraded condition that allows the deterioration of the controlled parameter within the allotted period (106, 135, 160) time, and after the allotted time period change to a threshold criterion (112, 138, 162) after administration;
during the allotted time period comparing the monitored parameter with the threshold criterion the deteriorating state;
after the allotted time period, comparing the monitored parameter with the threshold criteria after administration; and
in response to a violation of the controlled parameter of one or more of the initial threshold criteria threshold criteria uhusiano�about the condition and threshold after administration initiate an alarm signal (36).

2. A method according to claim 1, wherein performing at least one of:
the threshold criterion (108) degraded condition is permanent;
the threshold criterion (154) reduce the deteriorating state in a series of uniformly decreasing speed levels (158) to a new upper bound threshold (162) after administration; and
limit value (134) the deteriorating state changes with time.

3. A method according to claim 1 or 2, wherein the threshold criterion (134) the deteriorating state changes along a curve (136) is exponentially increasing or decreasing function of time.

4. A method according to claim 1 or 2, which further comprises:
initiating a warning when the monitored parameter is not improved by the end of the allotted time period.

5. A method according to claim 1 or 2, which further comprises determining, does the event of the introduction of the drug or therapy on the controlled variable, by estimating at least one of:
available physiological data (76) of the patient;
knowledge (78) on the event of the imposition or interference that affects the physiology of the patient; and
information (80) history of a laboratory study of the physiology of the patient and the history of alarms.

6. A method according to claim 1 or 2, wherein the controlled parameter (26, 102, 144, 166) comprises at least one of:
lifting or omissions segme�the ST;
blood pressure;
heart rate;
the level of oxygen in the blood;
respiration rate; and
the level of metabolite in the blood.

7. A method according to claim 1 or 2, in which the notice of administration of the drug, event, intervention, or therapy through at least one of:
manual introduction user; and
automated administration.

8. Machine-readable medium (18), which has software which controls the processor (16) for implementing the method according to any one of claims. 1-7.

9. System that provides a warning about time-varying physiological parameter of the user that contains:
one or more sensors (14), that monitored physiological parameter (26, 102, 144, 166) of the patient;
the processor (16) programmed to:
receiving one or more of patient data, clinical laboratory data (15) and controlled by data or measurements that describe the physiological parameter(26, 102, 144, 166);
comparing the monitored parameter (26, 102, 144, 166) with the initial threshold criterion (112, 140, 152);
after the introduction of the drug, event, intervention, or therapy temporarily change the initial threshold criteria (112, 140, 152) on the threshold criteria (108, 134, 154) the aggravation�core state, that allows the deterioration of the controlled parameter within the allotted period (106, 135, 160) time, and after the allotted time period change to a threshold criterion (112, 138, 162) after administration;
during the allotted time period comparing the monitored parameter with the threshold criterion the deteriorating state;
after the allotted time period, comparing the monitored parameter with the threshold criteria after administration; and
in response to a violation of the controlled parameter of one or more of the initial threshold criteria threshold criteria the deteriorating state and threshold after the introduction of the initiation of the alarm signal (36).

10. A system according to claim 9, in which to execute at least one of:
the threshold criterion (108) degraded condition is permanent;
the threshold criterion (154) degraded condition is reduced to the upper border of the superior threshold (162) in a series of uniformly decreasing speed levels (158);
limit value (134) the deteriorating state changes over time; and
the threshold criterion (134) the deteriorating state changes along a curve (136) is exponentially increasing or decreasing function of time.

11. A system according to any one of claims. 9 or 10 in which the processor (16) initiates a warning when the monitored parameter (26, 102, 144, 166) not improved after the war�and allotted time period.

12. A system according to any one of claims. 9 or 10 in which the processor (16) defines, does the event of the introduction of the drug or therapy on the controlled variable, by estimating at least one of:
available physiological data (76) of the patient;
knowledge (78) about the event drug administration or intervention that affects the physiology of the patient; and
information (80) history about the physiology of the patient and the history of alarms.

13. A system according to any one of claims. 9 or 10, in which the controlled parameter (26, 102, 144, 166) comprises at least one of:
lifting or sagging of the ST segment;
blood pressure;
heart rate;
the level of oxygen in the blood;
respiration rate; and
the level of metabolite in the blood.

14. A system according to any one of claims. 9 or 10, which further comprises a user interface (20), which contains:
a display device on which the controlled variable information to present to the user, along with information about the threshold limit (30); and
the device (24) is input, whereby the user configures at least one threshold boundary (30).

15. A system according to any one of claims. 9 or 10 in which the notice of administration of the drug, event, intervention, or therapy of at least one of:
ru�tion of the introduction of the user; and
computer-aided introduction.



 

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4 ex

FIELD: medicine.

SUBSTANCE: invention represents a method for assessing the mucosal immunity state of open cavities accompanying the prediction of the clinical course of infectious-inflammatory processes, characterised by the fact that having a pathogenetic factor established, degrees of microbiocoenosis disturbances of a specific biotope are recorded with the use of a complex of methods for estimating colonisation resistance factors, namely normal microflora, opportunistic microflora, immunoglobulins G, M, A, secretory immunoglobulin A and sc component; the mucosal immunity state is assessed according to the degree of microbiocoenosis disturbance, and the favourable outcome implying agent eradication or chronisation with agent persistence is predicted. The invention also refers to a method for correcting the infectious-inflammatory processes with the Kipferon® immunomodulator added.

EFFECT: increasing the prediction accuracy of the clinical course of the disease, extending the range of the method for correcting the infectious-inflammatory processes.

2 cl, 3 ex, 6 tbl, 1 dwg

FIELD: medicine.

SUBSTANCE: content of calcium and protein in oral liquid is determined before and after physical load, as well as a day after physical load. Recovery of content of calcium ions and protein in oral liquid after physical load to initial values is considered to be a criterion of total recovery of athlete's-volleyball player's organism, with evaluating time interval, required for said process.

EFFECT: invention makes it possible to determine reserve abilities of organism and its adaptability in athletes-volleyball players to physical load.

2 dwg, 4 tbl

FIELD: medicine.

SUBSTANCE: invention relates to the field of veterinary and can be used to diagnose the presence of a pathological effect of iron dextran on the piglets' liver. The essence of the method consists in carrying out the morphological systemic step-by-step analysis of histological liver cuts with the description of its histological structure, measurement of the average quantity of binucleate hepatocytes, apoptotic bodies and cells of the mononuclear-macrophage system. If the complex of pathognomonic morphological changes, including the presence of blood filling of sinus capillaries, oedema of the Disse's space; swelling of the vascular endothelium, granular dystrophy of hepatocytes, increase of the average quantity of cells of the mononuclear-macrophage system, including haemosiderophages by two times and more, as well as an increase of the quantity of binucleate hepatocytes and apoptotic bodies by 2 times and more, the effect of iron dextran on the piglets' liver condition is considered to be pathological.

EFFECT: invention provides an increased accuracy of the post-mortem diagnostics of the presence of a pathological effect of iron dextran on the piglets' liver.

1 tbl

FIELD: medicine.

SUBSTANCE: after thymomegalia has been excluded, tissue specimens of three-day-old mature newborns are studied to evaluate areas of inflammation changes in points in the placental umbilical cord (A), in the foetal placenta (B), in the maternal placenta (C), in extraplacental membranes (D); then thymomegalia is predicted by a discriminant equation: DE=-0.350×A-1.176×B-1.690×C-1.203×D, wherein DE is a discriminator function with a threshold equal to - 15.00. If DE is equal to or more than the threshold, the absence of thymomegalia is predicted; if D is less than the threshold, thymomegalia is predicted, whereas the score is taken at: (A) - 1 point - no inflammation, 2 points - amnionitis, 3 points - leukocytic infiltration in the Wharton's jelly, 4 points - phlebitis, 5 points - arteriitis, 6 points - a combination of two or more areas of inflammation: in blood vessels or in vessels and in the Wharton's jelly, (B) - 1 point - no inflammation, 2 points - chorioamnionitis, 3 points - villusitis, 4 points - vasculitis, 5 points - intervillesitis, 6 points - a combination of two or more areas of inflammation, (C) - 1 point - no inflammation, 2 points - villusitis, 3 points - vasculitis, 4 points - intervillesitis, 5 points - deciduitis, 6 points - a combination of two or more areas of inflammation, (D) - 1 point - no inflammation, 2 points - amnionitis, 3 points - chorioamnionitis, 4 points - deciduitis, 5 points - choriodeciduitis, 6 points - a combination of two or more areas of inflammation.

EFFECT: enabling the prediction of thymomegalia in the three-month-old mature newborns suffered prenatal influenza B complicated by placentitis.

2 ex

FIELD: veterinary medicine.

SUBSTANCE: method consists in determining in the scales of concentration of Mn and/or Cu by the method of atomic-emission spectrometry. The regression equation is calculated, and on the content of Mn and/or Cu in the scales a copper concentration is determined.

EFFECT: method is accurate, atraumatic and non-invasive, simple and easy to use.

3 tbl, 1 ex

FIELD: medicine.

SUBSTANCE: after the ablation of the spleen, its weight is determined, the average area of a marginal zone of the spleen in histological cuts with coloration with hematoxylin and eosin is measured morphometrically. The obtained values are used to calculate the weight of the marginal zone and, if its values are ≤1.9 g, a favourable prognosis for the course of aplastic anaemia is made, if its value is >1.9 g, an unfavourable course of the disease is predicted.

EFFECT: prognosis of the aplastic anaemia course after splenectomy independent on the severity of the disease with the possibility to approach therapeutic treatment in a differential way.

2 ex

FIELD: medicine.

SUBSTANCE: blood serum fasting adiponectin and leptin concentrations are measured in the morning in the female adolescents diagnosed with oligomenorrhea and obesity. An adiponectin/leptin ratio is derived. If the ratio is 0.6 or less, insulin resistance is stated in the female patients suffering oligomenorrhea and obesity, and the therapy is started with prescribing metformin, an insulin sensitiser. The adiponectin/leptin ratio of more than 0.3 enables diagnosing the absence of insulin resistance and prescribing hormonal contraceptives with drospirenone.

EFFECT: effective treatment of oligomenorrhea and obesity by selecting the adequate treatment taking into account the carbohydrate metabolism status.

1 tbl, 3 ex

FIELD: medicine.

SUBSTANCE: gastric content pH is dynamically estimated with the use of a nasogastric tube; the total gastric content pH is measured and the efficacy of the antisecretory preparations is estimated for one day, or a longer period of time if needed, every 3 hours. The pH value is measured by means of an analogue display unit on an analogue scale at a pitch of 1.0 within 1.0 to 12.0 for 15 s as shown by discolouration, with matching to the analogue scale. The acid production suppression is considered to be effective at pH of more than 4.0 after planned surgeries, and more than 6.0 after emergency surgeries. If the acid production suppression is found to be ineffective, the antisecretory preparation is supposed to be changed or increased in dose.

EFFECT: method enables measuring the gastric content pH and estimating the efficacy of the antisecretory preparations in the patients in need thereof over a short period of time.

2 dwg, 2 tbl, 3 ex

FIELD: medicine, psychiatry.

SUBSTANCE: one should isolate DNA out of lymphocytes of peripheral venous blood, then due to the method of polymerase chain reaction of DNA synthesis one should amplify the fragments of hSERT locus of serotonin carrier gene and at detecting genotype 12/10 one should predict the risk for the development of hallucino-delirious forms of psychoses of cerebro-atherosclerotic genesis.

EFFECT: more objective prediction of disease development.

3 ex

FIELD: medicine, urology.

SUBSTANCE: one should conduct subcutaneous prevocational tuberculin test and, additionally, both before the test and 48 h later it is necessary to perform the mapping of prostatic vessels and at decreased values of hemodynamics one should diagnose tuberculosis. The information obtained should be documented due to printing dopplerograms.

EFFECT: more reliable and objective information.

1 ex, 1 tbl

FIELD: molecular biology.

SUBSTANCE: the suggested innovation deals with the fact that nucleic acids should be isolated directly out of the sample without pipetting stage but with the help of interconnected reservoirs being prepared beforehand. The above-mentioned vessels should be applied either separately or being interconnected according to standard microtitrating format. The sample should be mixed with a lyzing buffer and nucleic acids are bound with matrix in closed system including, at least, two interconnected reservoirs. Forced movement of sample's mixture and buffer back and forth from one reservoir into another one for several times through narrow passage provides their thorough intermixing. The method provides quick and safe isolation of nucleic acids.

EFFECT: higher efficiency.

44 cl, 4 dwg, 1 ex

FIELD: medicine, phthisiology, microbiology.

SUBSTANCE: diagnostic material is poured preliminary with chlorohexidine bigluconium solution, homogenized, kept at room temperature for 10-12 h and centrifuged. Precipitate is poured with Shkolnikova's liquid medium, incubated at 37oC for 3 days, supernatant part of Shkolnokova's medium is removed, fresh Shkolnikova's medium is added, and precipitate is stirred and inoculated on the dense cellular egg media. Sensitivity of the strain is determined in 3 weeks by the presence of growth in the control tube only. Invention provides enhancing precision and reducing time for assay. Invention can be used in assay for medicinal sensitivity of tuberculosis mycobacterium.

EFFECT: improved assay method.

3 ex

FIELD: medicine, biotechnology, pharmacy.

SUBSTANCE: invention relates to agents used for treatment of pathological states associated with disorder of synthesis of neuromediating substances. Method involves the development of pharmaceutical composition and a method for it preparing. Pharmaceutical composition represents subcellular synaptosomal fractions: synaptic membranes, "light" synaptosomes and "heavy" synaptosomes prepared from gray matter of cerebral hemispheres from experimental animals based on the goal-seeking modification of humoral mediators of nerve endings transformed to synaptosomes in development and regression of malignant processes. The composition provides inhibiting the growth of tumor cells, to elevate span-life of patients with ascite Ehrlich's sarcoma, breast adenocarcinoma Ca-755, Wolker's carcinosarcoma-256.

EFFECT: valuable medicinal and anti-tumor properties of composition.

12 cl, 3 tbl, 3 ex

FIELD: medicine.

SUBSTANCE: method involves carrying out microscopic examination of blood serum samples taken from femoral vein and cubital vein. Femoral vein sample is taken on injured side. The examination is carried out before and after treatment. The blood serum samples are placed on fat-free glass slide in the amount of 0.01-0.02 ml as drops, dried at 18-30°C for 18-24 h. The set of pathological symptoms becoming larger or not changed after the treatment in comparison to sample taken before treatment, and morphological picture of samples under comparison taken from the cubital vein showing no changes or being changed to worse, the treatment is considered to be effective.

EFFECT: enabled medicamentous treatment evaluation in course of treatment to allow the treatment mode to be changed in due time; avoided surgical intervention (amputation); retained active life-style of aged patients.

4 dwg

FIELD: medicine, clinical toxicology.

SUBSTANCE: at patient's hospitalization one should gather the data of clinical and laboratory values: on the type of chemical substance, patient's age, data of clinical survey and laboratory values: body temperature, the presence or absence of dysphonia, oliguria being below 30 ml/h, hemoglobinuria, erythrocytic hemolysis, exotoxic shock, glucose level in blood, fibrinogen and creatinine concentration in blood serum, general bilirubin, prothrombin index (PTI), Ph-plasma, the state of blood clotting system. The state of every sign should be evaluated in points to be then summed up and at exceeding the sum of points being above "+20" one should predict unfavorable result. At the sum of "-13" prediction should be stated upon as favorable and at "-13" up to "+20" - prediction is considered to be doubtful.

EFFECT: higher accuracy of prediction.

2 ex, 3 tbl

FIELD: medicine, juvenile clinical nephrology.

SUBSTANCE: disease duration in case of obstructive pyelonephritis should be detected by two ways: either by detecting the value of NADPH-diaphorase activity, as the marker of nitroxide synthase activity in different renal department and comparing it to established norm, or by detecting clinico-laboratory values, such as: hemoglobin, leukocytes, eosinophils, urea, beta-lipoproteides, lymphocytes, neutrophils, the level of glomerular filtration, that of canalicular reabsorption, urinary specific weight, daily excretion of oxalates, arterial pressure, and estimating their deviation against average statistical values by taking into account a child's age.

EFFECT: higher efficiency of detection.

7 dwg, 1 ex, 6 tbl

FIELD: medicine, urology.

SUBSTANCE: the present innovation deals with differential diagnostics of prostatic cancer and other prostatic diseases at the stage of primary inspection. The method includes the detection of PCA and calculation of probability coefficient for prostatic cancer (PCC) by the following formula: where e - the foundation of natural logarithm (e=2.718…), PCA - the level of total blood PCA in ng/ml, V - patient's age in years. At PCC value being above 0.2 one should diagnose prostatic cancer and to establish final diagnosis one should perform polyfocal prostatic biopsy. The method enables to increase accuracy of diagnostics at decreased number of unjustified prostatic biopsies.

EFFECT: higher efficiency of diagnostics.

2 ex

FIELD: medicine, biology.

SUBSTANCE: invention relates to nutrient medium used for accumulation of cells for the following cytological and/or immunocytochemical analysis carrying out. Invention relates to medium containing salts NaCl, KCl, anhydrous CaCl2, MgSO4 x 6 H2O, MgCl2 x 6 H2O, Na2HPO4 x 2 H2O, KHPO4, NaHCO3, and also glucose and Henx's solution, 10% albumin solution and polyglucin taken in the ratio 1:1:1. Invention provides enhancing the preservation of cells.

EFFECT: improved an valuable properties of nutrient medium.

3 ex

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