Device for supplying heat to the body tissue

 

The device relates to medical equipment, namely, devices for carrying out hyperthermia. The device includes a heating device (10) and the first temperature transducer (11), which can be introduced into the tissue of the body, and that the heating device (10) is connected to the power source (13) controlled by a control device (14) through the catheter to the handle (12), which can be introduced into the body cavity, and the first temperature transducer (11) is connected with the opportunity to interact with the control device (14). The control device (14) is connected with the possibility of interaction with the first storage device (15) for storing data corresponding to survival of cells as function of cell temperature. The input device (16) connected with the opportunity to interact with the control device (14) to enter data, such as desired volume/mass of body tissue, to which should be summed up heat within such limits that the cells of this tissue perished. The control device (14) is connected with the possibility of interaction with the computing device (17) to determine the volume and mass of the body tissue, whose cells have died, as a function of temperature in the tissue at a certain R. the effect of heat exposure on the fabric. 8 C.p. f-crystals, 2 Il.

Field of invention the Invention relates to a device for supplying heat to the tissues of the body according to the preamble p. 1 claims.

Under certain kinds of conditions caused by diseases that involve unnatural growths in the tissues, the heat treatment gives good results after processing. The fabric is heated to such an extent that she dies. Examples of painful conditions of this kind are certain types of cancer and benign prostatic hyperplasia, national Department of standardization (benign prostate hyperplasia). When processing certain tissue is heated so that is the death of this tissue, while other parts of this tissue must or should be protected. Painful condition, which primarily focused attention, are the States that occur in the tissue surrounding the cavity in the body. As examples, in addition to the above, you can also mention cancer of the esophagus, trachea, urethra and intestines.

Appropriate painful condition can also occur in animals, to which you can apply a similar treatment. The most important may be the treatment of domestic animals, such as dogs who have laser, microwave (MW) and radio frequency antenna. There is also known a method which uses the introduction of the container with the liquid in the body cavity. This fluid is circulated to the container in such a way that achieves good contact with the surrounding tissue. Then this liquid is heated either by the supply of warm fluid through the circulation system, or by supplying energy to the heating device inside the container, from which heat is transferred in a certain way to liquid and then to fabric.

Because the amount of fabric that you want to process changes as well as the ability to absorb heat in the tissue and the adjacent tissue, which will not be processed, it is advisable that during processing was carried out continuous monitoring. When processed, is heated tissue. For best results, the heat treatment must occur within certain temperature ranges. At a very high temperature in the tissue is too much damage, and at a very low temperature treatment result is not achieved.

It is well known that the device for heating includes some form of temperature sensor, which is in the fabric. The disadvantage of this design is that the temperature sensor gives more information about the element temperature than the temperature of the tissue.

An example of this type of heating device shown and described in EP 0370890. This device includes a catheter contained within the microwave antenna, which is used to obtain RF energy into the tissue surrounding the antenna. This catheter is also provided with a cooling channel for cooling the tissue, which is located closest to this catheter. This catheter is temperature transducer for reading the temperature of the catheter. Therefore, the temperature does not correspond to the temperature of the tissue being treated.

A more sophisticated method of determining the temperature shown and described in PCT/SE96/00649. In order to be able to register a temperature increase directly into the tissues that need to be processed, the first temperature detector according to PCT/SE96/00649 connect with the first bearing device. The support device is withdrawn through the channel in the catheter, it is arranged so that it can be elongated through hole of the catheter. In this hole catheter accordingly built the Anh under the desired angle relative to the catheter. The processing carried out by the above-mentioned microwave device, often referred to as TOSFOT (transurethral microwave thermotherapy).

Or support device, or the temperature detector is equipped with a tip, which facilitates penetration into the fabric. Typically, the temperature detector may be in the form of a resistive transducer or semiconductor. Cable network required for converters of this type are conducted through the channels in the catheter. If you use the Converter optical type, then through the channel in the catheter is introduced fiber light guide.

When using the above devices, as well as in accordance with other known techniques, the physician usually determines the duration and temperature of treatment. Despite the possibility of a continuous determination of the temperature, there are problems with obtaining satisfactory results during the process, since the process of treatment can last up to several weeks or months. It is also hard to adjust the treatment process in accordance with the new conditions such as pain occurring in a patient, and to assess how it should be corrected arabnia object of the invention is a device for supplying heat to the body tissue, by means of which the aforementioned disadvantages are essentially eliminated. This task in accordance with the invention is solved by the characteristics mentioned in paragraphs.1-10 claims.

According to the invention it is also possible for an early adjustment of heat supply in various ways, as well as forecasting the best results. The device according to the invention is used in order to calculate the temperature distribution in the prostate as a whole on the basis of information about him at certain points in the measurement within the prostate, as well as information about the distribution of the absorption of energy from the energy source or heat in the body tissue. The temperature distribution is determined on the basis of the relationship between the temperature in the tissue and absorbed energy, flow and conductivity. The amount of tissue destroyed at certain points in time during the impact, determined by continuous measurement of the temperature and the time during which the applied heat, and with continuous monitoring of the temperature distribution on the information on the survival rate of cells experiencing heat.

In the preferred embodiment the temperature distribution is the seer, the doctor can always get information about current conditions. Heat is supplied to the tissue up until the tissue, which can be set in order, not destroyed.

Further advantages and specific features of the invention can be seen from the following description, graphic materials and the accompanying claims.

A brief description of graphic materials of the Invention hereinafter described in more detail with the aid of examples of embodiments with reference to the attached graphic materials, in which: Fig. 1 is a representation of a longitudinal section of the catheter for treatment, which may be included in the device according to the embodiment of the invention; Fig. 2 is a principal block diagram showing the device according to the embodiment of the invention.

Description Catheter for treatment of 12 introduced into the urethra according to Fig.1 so that the tip 23 penetrates into the bladder 28. Bubble or cylinder 29 connected to the catheter for processing, distributed within the bladder 28, it protects against inadvertent removal of the catheter for treatment during the procedure. The active portion of the catheter to the treatment, therefore, is located in the heart tissue, which should be processed, in this case prostate - 31. Catheter for>In Fig. 1 shows the container 19, is extended to its working volume through the fluid 20, which is served on him under pressure. The container 19 may be attached to pear-shaped in the longitudinal direction of the catheter for treatment with a thicker section in the part which is turned towards the bladder, or it may be more symmetrical in the axial direction according to the embodiment shown in Fig. 1. Its appearance matches the shape of the urethra in a given area or fitted to it. The container 19 is located on the outer side of the catheter for treatment and, accordingly, a larger area of the container 19 is located on the bottom side of the catheter for processing. When the container extension 19 of the catheter for treatment rises above that in the body means that the distance between the heating device 10 located in the container 19, and the rectum increases. The liquid 20 is directed through the channel 22, is constructed in the form of a tube, which passes through the catheter to the handle 12.

In order to be able to follow the development of temperature in the tissue during thermal processing, the host device 24 is first temperature transducer 11. Support device 24 is made with prob is eusto 24 or temperature transducer 11 is preferably provided with a tip, which can penetrate partially into the membrane or wall of the catheter for processing and partially into the fabric. The tube 25 is designed so that the support device 24 with temperature Converter 11 exiting the catheter for treatment at a suitable angle and can proceed at a suitable radial distance from the catheter for processing. To achieve the desired angle of the temperature sensor 11 may also ensuring the availability of special directional fixtures in the end portion of the tube 25. The catheter handle 12 may also be equipped with a second temperature transducer 30. Information about the temperature around the container 19 or tissue located in absolute proximity to the catheter to handle 12, receive from the second temperature sensor 30. In the embodiment according to Fig.1 and 2, the device according to the invention is also equipped with a third temperature transducer 34. The third temperature transducer 34 is preferably also located on the host device 24 between the first temperature transducer 10 and the second temperature transducer 30 so that it is possible to continuously determine the temperature at a certain distance from the Cato 29 and through it you can direct the fluid to the expansion of the container 29, when the catheter for treatment is in place. Channel for fluid 26 is also used for emptying the tank 29 at the end of treatment and before the catheter to handle remove from the urethra. For introduction of fluid and for emptying the container 29 preferably use a standard syringe or similar tool.

The supply cable 21 through which the heating device 10 is supplied with energy, is heated in the heat loss. To avoid damage to tissue outside the field of processing, such as the sphincter that surrounds the urethra from outside the prostate, the power cable 21 is cooled. This is accomplished by providing a catheter for treatment of 12 cooling channels, preferably around the power cable 21. In the embodiment according to the invention the cooling channels have a limiting wall, which returns the coolant circulating in these cooling channels. In this way avoid cooling of the heating device 10, which in turn means that the power that must be supplied from the power source 13 may be smaller. At lower power levels reduces the risk of medical errors and damage to healthy tissue.

Heat is Jamaica in the container, which radiates heat directly into the adjacent tissue and partially at a greater distance by means of electromagnetic radiation. The total treatment area is greater than with conventional heating, which means that you can cover large areas of tissue.

At high temperatures in the range of 90-150oWith the fabric also hardens and forms a scab. This scab can prevent or reduce problems that may occur, if, in connection with the processing of the prostate gland swells. Since the highest temperature is reached in the tissue that is located closest to the container 19, the section of the urethra that passes through the prostate in the process area will be affected and damaged in a high degree. However, this part of the urethra is restored relatively quickly.

In the preferred embodiment of the heating device 10 includes a microwave antenna. Because processing the urethra is completely filled and have run out of space, then fitting this microwave antenna relative to the tissue will also be very good. The liquid in the container 19 is chosen so that it had essentially or completely the same characteristics as the tissue of the prostate in relation to the spread is very good, that simplifies compliance with the desired dimensions of the antenna and power source, and also facilitates the regulation of microwave power.

When processing is finished, the supply of energy to heating device 10 is interrupted, and the container is empty and give him the opportunity to return to normal body temperature. Do not remove the catheter for processing until the container has such a temperature that may cause damage during the passage of the container through the body. For this reason, monitoring the temperature of the container 19 is carried out continuously, so that the retrieval catheter for treatment can be done immediately, as soon as it reached the desired temperature.

In cases of processing, including the prostate or bladder, in accordance with which the catheter 12 having a tip, is introduced into the bladder 28, the drainage of urine and possibly other fluids from the bladder can be accomplished through the drainage channel available in the catheter 12. This drainage channel passes through the catheter 12 and ends with a hole 27 near the catheter tip 12. Under certain types of processing may be appropriate to leave the catheter 12 in place for some time after treatment. The Funai and dead tissue is reabsorbed or rejected, and is excreted in the urine. The cavity in the prostate, caused by destruction of tissue, ensures proper passage of urine. First, this cavity has a shape that conforms to the shape of the container 19 at the time of processing.

In addition to heat treatment or portion thereof as described above in the liquid container 19 can enter some forms of medicines. Liquid container 19 in such cases, modify so that it provided the possibility of passing this drug. Preferably liquid container 19 is performed so that the drug could diffuse through the wall of the container for the liquid 19, but also providing the walls of the filtration channels or the like. According to one of the types of processing liquid can include pain relievers. You can even use other drugs acting directly for processing.

According to an alternative embodiment of the liquid container 19 is not include. In this embodiment the heating is carried out directly by means of a heating device 10, which in this case is performed with radiation energy, which can Paglia microwave radiation. Can be considered also lasers and other types of radiation sources.

On the block diagram in Fig.2 schematically shows the various functional blocks that may be included in a kit for the treatment catheter for treatment according to the invention. As indicated above, the heating device 10 is supplied with energy from the power source 13. The Central control unit 14 is connected with the possibility of interaction with the power source 13 and the display 33 with the apparatus for supplying a liquid 32. The control unit 14 is additionally connected with the possibility of interaction with the input device, such as keyboard 16. The control device 14, keyboard 16 and display 33 may also be included in the standard computer monitor and keyboard.

For processing by TOSFOT and similar ways of processing temperature of the tissue is determined to the greatest extent three different processes: 1) the generation of heat by absorption of microwave energy or other source of radiated energy, 2) the distribution of heat in the heat transfer in the tissue, and 3) loss of heat in the blood flow. Option 1) is determined using the catheter to the treatment used in Dan the SJ-known equation for biological heat:where(kgm-3) is the density of the prostate, with (jkg-1To-1represents the specific heat of the prostate, To(C) represents the temperature of the prostate at time t (seconds)(Wm-1K-1) represents thermal conductivity in the prostate,represents a Laplace operator,represents the perfusion tissue (m3kg-1c-1),b(kgm-3) is the density of blood, cb(Jkg-1To-1) is the specific heat capacity of blood, Tand(o(C) represents the arterial temperature, Qs(Wm-3) represents the generation of heat in the microwave absorption and Qm(Wm-3) represents the generation of heat through metabolism. When heat obreteniye water in it, which is over 80%. This equation or the corresponding data can be stored in the storage device 15 so that it could continuously be solved in the process of applying heat.

Because you can take that microwave absorption is symmetric in the radial orientation, for numerical solution of equation 1 used a cylindrical geometry. For solutions used finite differential. The value of Qsin equation 1 was determined using the specific power absorption (SAR, specific absorption rate in W/kg) in a catheter to handle 12. A practical way to determine the specific power absorption is the location TOSUCH catheter into tissue-like body, for example, made of material t-150, and the measurement of the temperature distribution in the body after heating output microwave power of 50 W for 60 seconds. One of the ways of measuring SAR are described in detail in the British Journal of Urology 78 (1996), R. 564-572.

In the first storage device 15 stores the known data on the survival of cells at different cell temperatures for different durations of treatment, for example, in the form of suitable equations, data tables, and the like. The first storage device 15 of the org is in how are you going to new results of operations. Tissue damage caused by processing can be described mathematically using equation Arrhenius equation as follows:
= AJe-Ea/(RT)dt(equation2),
whererepresents the degree of accumulated damage over time obrabotki t, And is a constant Arrhenius equation (3,11098with-1), Eandrepresents the activation energy cells (6,3106J.mol-1), R (jmol-1To-1) is the universal gas constant and T (K) is the temperature of the tissue. Accept that the tissue is destroyed when1.
Acceptable is tracking these data intervals after treatment, for example every month for a certain period. In the first storage device 15 are data relating to blood flow and other factors that affect heat absorption and dissipation in the type of tissue that is undergoing processing. When accurate data in the window of factors, the above, which is very close to the real fabric. Preferably these latter data is always complete and correct, even after processing.

Before heat treatment determine the current physical factors, such as the size of the prostate, the degree of narrowing of the prostate and the distance between the prostate and rectum. Having information about these conditions, define the appropriate type of catheter for processing and temperature is suitable for processing. In the processing, which is in accordance with previous devices was a decisive factor determining the magnitude of the desired volume/mass of tissue that needs to be processed so that she collapsed. This value is set so that it was available to the control device 14, for example, by the introduction into the input device 16. Preferably also set a higher value for temperature or average temperature processing or temperature range. The device can also be equipped with additional storage devices to preserve suitable combinations of volume/mass, and temperature processing. In the latter case, the normal value for the temperature of the processing selects the auto is doda liquid in the container 19, if you use this type of catheter for processing, and then sends a control signal to the power source 13, so that the heating device 10 begins to radiate energy to heat tissue. Apparatus for supplying fluid 32 is used when the liquid container 19 need to fill and expand. The control unit 14 can control the content, which is achieved by a corresponding pressure increase and the associated contraction of prostate tissue. The first temperature transducer 11 and preferably also the second temperature transducer 30 and the third temperature transducer 34 provide continuous information regarding the current temperature processing, such as near a heating device 10, and at a certain distance from him in the treated tissue.

The control device 14 is connected with the possibility of interaction with temperature Converter 11, and preferably also with the transducers 30 and 34, and may, depending on the current temperature in the processing to control the power source 13 so that a suitable output power was sent to the heating device 10. Through this it is possible to drastically raise with a good degree of Nai is desired. Temperature data from the temperature transducers 11 and 30 can also be displayed continuously on the display 33. Using the input device 16 may also specify the appropriate level of output power with a heating device 10 or how it can be controlled with the battery 13. The power output level affects the temperature, which is created in the tissue, and in certain cases may affect the level of pain experienced by the patient.

Computing device 17 is continuously compares the data from the temperature transducers 11, 30 and 34 with the data stored in the first storage device 15, and the control unit 14 through may continuously calculate how temperature varies in prostate tissue at different distances from the catheter to the handle 12. In this way, computing device 17 may also continuously calculate the volume/mass of tissue that has already been processed as desired, and where in this tissue achieved the desired result of this processing.

Information calculated in this way is continuously sent to the display 33, so that, in addition to numerical data relating to the processed volume/mass, the attending physician has the image in the course of processing. K is Fig.1. The data relating to the prostate, which will be processed appropriately collected in advance, for example, x-ray, ultrasound or MR, so that the image which is displayed on the display 33, is in accordance with the actual conditions. The image corresponding to the catheter for treatment, which will be used, preferably superimposed on the image of tissue.

The temperature in the various sections of prostate tissue is continuously calculated based on the measured temperature and the current temperature is displayed on the image of the prostate, for example, by coloring in various colors. At the same time, it shows various graphs and/or tables relating to temperature, blood flows and volume/mass of the treated tissue. The physician can thus monitor the process and continuously receive instructions on how much tissue is processed and where the prostate occurred the death of tissue.

The timer 18, coupled with the opportunity to interact with the control device 14 continuously sends the time information, so that the measured data is correlated with processing time. When one of the values for volume/mass of the treated tissue is calculated vychislitel is the Ervan. Instead, with the help of the device display or other indicator device to indicate when it reaches the set value, so that the doctor can interrupt the supply of heat. The corresponding interrupt or instruction may also be performed, if the temperature measured or calculated in any area of the tissue exceeds a threshold value or if the other entered data, such as, for example, the temperature in the rectum or bladder, indicate a risk for the patient.

It is also possible to continuously change some settings during processing, for example, the desired temperature processing or input microwave power, without affecting the set value for volume/mass or without changes. Instead, the impact on processing time. When the method described above, the processing time may be enough to significantly vary depending on the physiological differences and does not impact significantly on treatment compared with the methods previously used.

The container 19 is fully closed and contains a certain amount of liquid 20 having suitable characteristics for the transmission of Thea or other material with appropriate characteristics of elasticity, for example latex. In the same way catheters to handle 12, and the cylinder 29 may be made of silicone or similar material.


Claims

1. Device for supplying heat to the body tissue containing the heating device, installed at one end of the catheter for treatment, and the first temperature transducer, placed so that it protrudes from the specified catheter into the tissue of the body, and this heating device is connected to the power source through the catheter and is controlled by a control device specified catheter is made with the possibility of introducing into the body cavity, and said first temperature transducer is connected with the ability to interact with device control, but such control device is connected with the possibility of interaction with the first storage device for storing data, the corresponding specific power absorption in body tissue created by the specified heating device, an input device connected with the opportunity to interact with the control device for entering data about the volume or mass of body tissue, which must be processed, and specify the value of the volume or mass of body tissue, cells which have died, as a function of temperature in the tissue at a certain distance from the heating device.

2. The device under item 1, characterized in that the said control device is connected with the possibility of interaction with the tool time measurement for the continuous determination of the point in time when the tissue is located at a certain distance from the heating device has reached a certain temperature.

3. The device under item 1, characterized in that the first storage device stores data related to the ability of certain tissues of the body to dissipate heat.

4. The device according to p. 1, wherein said first temperature Converter is implemented with the ability to penetrate and be inserted into the fabric, which should be fed warm.

5. The device under item 1, characterized in that near the heating device has a second temperature transducer for measuring temperature of the tissue near the specified catheter.

6. The device under item 5, characterized in that between the first and second temperature transducers at a distance from the specified catheter has a third temperature Converter made with vozmoznotsja fact, the heating device comprises a microwave antenna to heat the surrounding tissue.

8. The device according to p. 7, characterized in that the heating device is located in a container that contains a fluid for heating the specified fluid and the surrounding tissue.

9. The device according to p. 2, characterized in that the control device is connected with the opportunity to interact with the display to represent the temperature in different parts of the treated tissue, and said computing device is configured to determine the present temperature based on signals from the specified first temperature sensor and by calculation on the basis of how changes over time, the temperature of the tissue, which introduced the first temperature transducer.

 

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