JPH07275376A - Hyperthermic treatment apparatus - Google Patents

Abstract

PURPOSE:To prevent the diseased part from being warmed excessively, even when the temperature rises to a level beyond control. CONSTITUTION:The apparatus is provided with an applicator 1 to warm up the diseased part, a temperature sensor 11 to detect the temperature of the diseased part to be warmed up by the applicator 1 and an oscillator controller 19 to control the temperature detected by said temperature sensor 11 to be maintained at the temperature set previously. The apparatus is further provided with a detective means 20 to calculate the temperature fluctuation ratio based on the temperature detected by the temperature sensor 11 and to detect the state of warming up of the diseased part from the calculated temperature fluctuation ratio.

Description

Detailed Description of the Invention

[0001]

FIELD OF THE INVENTION The present invention relates to a thermotherapy device.

[0002]

2. Description of the Related Art In recent years, hyperthermia treatment for treating cancer and benign prostatic hyperplasia (benign tumor) by heating has been known. The device used for this kind of hyperthermia treatment is a heating means for heating / maintaining the affected part at a set temperature, a temperature sensor for detecting the affected part temperature, and heating according to the affected part temperature detected by the temperature sensor. It comprises a control means for increasing and decreasing the output and a cooling means for not heating other than the affected part, and the device is stopped when the affected part temperature rises above a set temperature.

[0003]

However, when the above-mentioned conventional thermotherapy apparatus compares the measured temperature of the affected part with the set temperature and controls the output, for example, the failure of the heating means or the output set value is mistaken. If the temperature is too high or the surroundings of the affected area cannot be cooled due to an abnormality in the cooling means, the rate of temperature increase due to heating becomes large and the temperature cannot be controlled by the control means, causing the temperature of the affected area to overshoot and exceed the required temperature. The affected area may be heated.

The hyperthermia treatment apparatus of the present invention has been made in view of such problems, and its purpose is to detect the temperature rise rate of the affected area and control the heating temperature within an appropriate range. Accordingly, it is an object of the present invention to provide a hyperthermia treatment apparatus capable of preventing the affected part from being excessively heated even when the temperature rises at a level where temperature control is impossible.

[0005]

In order to achieve the above object, the present invention provides a heating means for heating an affected area, and a temperature detecting means for detecting the temperature of the affected area heated by the heating means. And a thermotherapy device comprising control means for controlling the temperature detected by the temperature detection means to be a preset temperature, the temperature change rate is calculated from the temperature detected by the temperature detection means. Further, there is further provided detection means for detecting the heating state of the affected part based on the calculated temperature change rate.

[0006]

That is, according to the present invention, the temperature of the affected part heated by the heating means is detected, and the temperature change rate is calculated from the detected temperature. Then, the heating state of the affected area is detected based on the calculated temperature change rate.

[0007]

Embodiments of the present invention will be described below with reference to the drawings. First, a first embodiment of the present invention will be described with reference to FIGS. In this embodiment, when the temperature rises to a level where the temperature control means cannot control the temperature, the apparatus is stopped to prevent excessive heating of the patient.

In the figure, reference numeral 1 is an applicator as a heating means for performing thermotherapy for prostatic hypertrophy through the transurethra, which is provided with an outer sheath 2, and the outer peripheral surface of the outer sheath 2 is expanded. -A deflated balloon 3 is provided. Further, inside the outer sheath 2, a perfusion hole 4 having a sealed tip and an air supply hole 5 extending parallel to the perfusion hole 4 are provided.
And are provided. An opening 6 formed on the outer peripheral surface of the tip of the outer sheath 2 is provided at the tip of the air supply hole 5, and the opening 6 is provided inside the balloon 3.

A tube-shaped inner sheath 7 is inserted into the inside of the perfusion hole 4, and the tip opening portion of the inner sheath 7 extends to near the tip sealing portion of the perfusion hole 4. further,
A coaxial cable 8 for microwave transmission is inserted into the inner sheath 7, and an antenna portion 9 capable of irradiating microwaves is formed at the tip of the coaxial cable 8. The antenna part 9 is, for example, 3
Microwaves can be irradiated in the outer peripheral direction of the applicator 1 within a range of 0 to 60 mm.

A temperature sensor 11 as a temperature detecting means is arranged in the space between the outer sheath 2 and the inner sheath 7, and a temperature measuring portion at the tip of the temperature sensor 11 is formed at the tip portion of the outer sheath 2. It is fixed with an adhesive or the like in a state of being exposed on the outer peripheral surface of the outer sheath 2 through the sensor hole 10. The temperature sensor 11 is pulled out from the sensor hole 10 of the outer sheath 2 in the range of about 15 to 30 mm from the tip of the antenna unit 9 toward the hand side.

A ring-shaped first cooling liquid flow space 4a is formed between the outer sheath 2 and the inner sheath 7, and a ring-shaped second cooling liquid flow space 4a is provided between the inner sheath 6 and the coaxial cable 8.
The cooling liquid circulation space 4b is formed. In addition, a communication portion 4c that communicates between the first cooling liquid circulation space 4a and the second cooling liquid circulation space 4b is formed near the tip sealing portion of the perfusion hole 4. Further, one end of the liquid feeding tube 15 is airtightly connected to the base end of the cooling liquid flow space 4a, and one end of the recovery tube 16 is airtightly connected to the base end of the cooling liquid flow space 4b. It The other ends of the liquid supply tube 15 and the collection tube 16 are connected to the perfusion device 14. Further, the base end of the air supply hole 5 is an air supply mouthpiece 17 on the near side.
Is in communication with.

The temperature sensor 11 is connected to the temperature measuring means 18. The temperature measuring means 18 converts a signal (for example, an electric signal or an optical signal) output from the temperature sensor 11 into a corresponding electric temperature signal and displays the measured temperature, and at the same time, the oscillator controller 19, the detecting means 20, and the perfusion. It is connected to a control unit 22 including an apparatus controller 21.

Oscillator controller 19 as control means
Is connected to a high frequency oscillator 13 that generates a microwave of 2450 MHz and transmits a high frequency to the coaxial cable 8,
Electrical temperature signal from temperature measuring means 18 and detecting means 20
It functions to increase or decrease or stop the output of the high-frequency oscillator 13 according to the control signal from.

Further, the perfusion device controller 21 controls the perfusion rate of the perfusion device 14 according to the electric temperature signal from the temperature measuring means 18. As shown in FIG. 3, the detection means 20 is an I / O bus 26 to which the temperature measurement means 18, the oscillator controller 19 and the warning display means 20a are connected,
ROM with control program and reference temperature rise rate data
27, a RAM 28 for recording temperature data and the like, a timer 29, these I / O bus 26, ROM 27 and RAM
28 and a timer 29 are connected to a computing means 30 such as a microcomputer, and when an abnormal temperature rise is observed, the warning display means 20a notifies the user of the abnormality by light or sound, and the oscillator controller 19 To stop the output of the high frequency oscillator 13.

Next, the operation of the first embodiment of the present invention will be described. The hyperthermia treatment by the hyperthermia treatment apparatus according to the present embodiment is performed by transurethrally inserting the applicator 1 into the urethra 25, and after the tip of the applicator 1 reaches the inside of the bladder 24, a syringe or the like is supplied from the air delivery mouthpiece 17. Insufflate with a balloon 3
Inflate. After that, pull out the applicator 1 until you feel a resistance, and then feel the resistance.
Stop pulling action of. At this time, the tip temperature measuring portion of the temperature sensor 11 of the applicator 1 is positioned and fixed in a state of being in contact with the inner wall of the enlarged prostate portion 23a.

Then, the controller 22 is driven in this state. When the control unit 22 is driven, the perfusion device controller 2
1 drives the perfusion device 14, the oscillator controller 19 drives the high frequency oscillator 13, the detection means 20 starts a timer, and starts the control program in the ROM 27.

Along with the driving of the perfusion device 14, the cooling liquid is supplied from the perfusion device 14 into the applicator 1 via the liquid supply tube 15, and the high temperature cooling liquid that has undergone heat exchange in the applicator 1 is recovered. Collected via tube 16.

Further, when the driving of the high frequency oscillator 13 is started and the microwave is radiated from the applicator 1, the temperature of the inner wall of the enlarged prostate portion 23a and the urethral sphincter muscle 23b gradually rises. While the high frequency oscillator 13 is being driven, the oscillator controller 19 and the perfusion device controller 21 control the outputs of the high frequency oscillator 13 and the perfusion device 14, respectively, based on the temperature measured by the temperature sensor 11.

The detecting means 20 monitors the heating state according to the control program shown in FIG. The control program includes initialization processing (S1, S2), interrupt processing routines (S3 to S9), and end processing routine (S1).
0, S11). After the start, first, the measured temperature T1 and the counter t1 are cleared in the initialization process. Then, the interrupt processing routine is executed, for example, every one second by the signal from the timer 29. In the interrupt processing routine, the electric temperature signal from the temperature measuring means 18 is recorded in the measured temperature T2 through the I / O bus 26, the counter value is incremented by 1 and the value is recorded in the counter t2.
Then, in step S6, ΔT is calculated and compared with the reference temperature increase rate ΔTs. If ΔT> ΔTs, the termination processing routine is entered, and a warning signal is transmitted to activate the warning display means 20a, and a high frequency output is output. A stop signal is sent to the oscillator controller 19 so as to stop the output of the high frequency oscillator 13 and the operation of the detecting means 20 is stopped. Δ
If T <ΔTs, after performing the setting process, the process returns from the interrupt processing routine.

FIG. 5A shows a graph in which the temperature measured by the temperature sensor 11 is plotted on the vertical axis and the heating time is plotted on the horizontal axis. Further, FIG. 5B shows the same data with the rate of temperature rise on the vertical axis and the heating time on the horizontal axis. In a normal heating state, the temperature rise rate shows a value equal to or lower than the reference temperature rise rate ΔTs, and the measured temperature also falls within the set value.

However, when the output is abnormally large due to an abnormality of the high frequency oscillator 13 or an incorrect output setting,
In the case where the cooling capacity is insufficient due to a failure of the perfusion device 14, the heating condition cannot be controlled only by the output control by the oscillator controller 19 as shown in FIG. There is a risk of heating the affected area. The temperature rise rate in this case is shown in FIG.
As shown in (b), since the value is larger than the reference temperature increase rate ΔTs, the abnormality can be detected before the affected part is excessively heated. Therefore, a stop signal is sent to the oscillator controller 19 to stop the output of the high-frequency oscillator 13 when the rate of temperature rise is larger than the reference rate of temperature rise, and the warning display means 20a informs the user that the apparatus is abnormal. Inform.

On the contrary, when the output is abnormally small due to an abnormality of the high frequency oscillator 13 or the output setting is wrong, or in the case of a supercooled state due to a failure of the perfusion device 14, FIG.
As shown in, it will not be heated to the set temperature. In this case, the temperature increase rate is lower than the lower limit value ΔTs2 of the reference temperature increase rate, as shown in FIG. 7B. For example,
If the temperature rise rate is lower than ΔTs2 even when the temperature rise rate reaches a constant value, a stop signal is sent to the oscillator controller 19 to stop the output of the high frequency oscillator 13, and the warning display means 20a informs the user. Notify the device is abnormal. In this case, in S7 of FIG. 4, the temperature rise rate ΔT
Is larger or smaller than the lower limit value ΔTs2.

According to the above-described first embodiment, when the heating control is performed according to the magnitude relationship between the measured temperature and the set temperature as in the conventional control method, when the high frequency output is abnormally large, the cooling capacity is insufficient, etc. When the heating speed increases, the temperature control cannot be completed and there is a possibility that the temperature will rise above the set temperature. On the other hand,
In this example, since the heating abnormality is detected from the temperature rise rate, the abnormality is detected before the living body is heated to the set temperature or higher.
Since the heating can be stopped, the safety is higher than that of the conventional thermotherapy device.

Further, when the high frequency output is abnormally small, or when the heating rate becomes low due to a supercooling condition, it takes a very long time to warm up to the set temperature, or the set temperature cannot be reached. is there. The conventional control method may not be able to detect such an abnormality, but in the present embodiment, the abnormality in the temperature rise rate is detected at the beginning of heating, so that the abnormality can be detected at a relatively early stage after the start of heating. .

The second embodiment of the present invention will be described below. In the second embodiment, in addition to the purpose of the first embodiment, the therapeutic effect of hyperthermia treatment is simply confirmed. FIG. 8 is a diagram showing the configuration of the control unit 22 according to the second embodiment. This control unit 2
2 is an oscillator controller 19 and a perfusion device controller 2
1 and a detection means 20, and an external storage device 32 is connected to the detection means 20.

In the second embodiment, the thermal treatment is carried out by the same heating operation as in the first embodiment, the data of the temperature rise rate is recorded in the external storage device 32 for each treatment, and the temperature rise rate for each heat treatment is recorded. Estimate the therapeutic effect from the change of. For example, when a cancerous tumor shrinks due to hyperthermia, the blood flow around the affected area increases and the temperature rise rate decreases. Therefore, the treatment effect can be estimated by observing the temperature rise rate for each treatment.

According to the second embodiment, it is possible to confirm the therapeutic effect on cancerous tumors due to hyperthermia treatment by a simple method without using any other diagnostic method (for example, MRI or X-CT). The third embodiment of the present invention will be described below. In the third embodiment, the detection accuracy of the heating abnormality is improved, and the ROM 27 is used.
The data inside is the data of the reference temperature rise rate at each reference temperature as shown in FIG. That is, the reference temperature increase rates corresponding to the plurality of reference temperatures are set, and the detected temperature is compared with the reference temperature increase rate.

The operation of the third embodiment will be further described based on the flow chart (steps S20 to S33) shown in FIG. In this embodiment, the timer 2 is used as in the first embodiment.
Interrupt processing is performed by an interrupt from 9.
At this time, the measured temperature T2 and the reference temperature Ts1 are compared, the reference temperature Ts1 corresponding to the measured temperature T2 is detected, the temperature increase rate ΔT at the measured temperature T2 is calculated, and the reference temperature increase rate corresponding to the reference temperature Ts1. Compared with ΔTs1,
When T> Ts1, the termination processing routine is entered, a warning signal is transmitted to activate the warning means, a signal is transmitted to stop the high frequency output, and the operation of the detection means is stopped. When ΔT <ΔTs1, the process returns from the interrupt process routine after the predetermined process.

The third embodiment has the following effects.
That is, even if the temperature rise rate is high in the low temperature range, the temperature rise rate may decrease with the temperature rise, and finally the proper heating state may occur. In such a case, an accurate determination may not be possible by the method of determining the heating abnormality based on only the single temperature rise rate as in the first embodiment, but in the third embodiment described above, the measured temperature and the measured temperature Since the heating abnormality is evaluated from the rate of temperature rise, the heating abnormality can be detected more accurately.

The fourth embodiment of the present invention will be described below. The fourth embodiment has a simpler device configuration. FIG. 11 is a diagram showing the configuration of the fourth embodiment. In this embodiment, the control unit 22 is composed of an analog circuit, and includes a temperature measuring unit 18, a PID control circuit 33, a sample hold circuit 34 for holding the dT / dt output obtained from the PID control circuit 33, and a reference. A reference voltage source 36 that generates a reference voltage that indicates the temperature rise rate, and a comparison circuit 35 that compares the output from the sample hold circuit 34 with the output of the reference voltage source 36.
A warning / stop circuit 37 for generating a warning signal and a stop signal according to the output from the comparison circuit 35, a warning display means 39 for issuing a warning by the warning signal, and a PID control circuit 33.
Of the drive circuit 38 which controls the high frequency output by the output of the drive signal and stops the high frequency output by the stop signal.

In the fourth embodiment, the output of the temperature measuring means 18 is sent to the PID controller 33, and the output is sent to the drive circuit 38 according to the measured temperature. The drive circuit 38 is the PID controller 3
The output of the high-frequency oscillator 13 is controlled according to the output from 3.

At this time, the output of dT / dt as the temperature rise rate is taken into the sample hold circuit 34 from the PID controller 33. Further, the reference voltage source 36 that outputs a voltage equivalent to the reference temperature rise rate and the output from the sample hold circuit 34 are compared by the comparison circuit 35, and the sample hold circuit 34 is compared.
If the output from is higher than the output of the reference voltage source 36, a warning /
A signal is sent to the stop circuit 37. The warning / stop circuit 37 that has received the signal sends a warning signal for activating the warning display means 39, and the warning display means 39 issues a warning by light or sound. At the same time, the warning / stop circuit 37 is connected to
3 sends a stop signal for stopping the output of No. 3 to the drive circuit 38, and the drive circuit 38 receiving the stop signal causes the high frequency oscillator 1
Stop the output from 3.

According to the fourth embodiment, since the detection circuit does not have an arithmetic circuit such as a microcomputer as in the first to third embodiments, the structure of the device is simplified. From the above specific examples, the technical idea of the following constitution is derived,
It has the following actions and purposes.

That is, the first configuration of the present thermotherapy apparatus has a temperature sensor, heating means for heating the affected area, high-frequency generating means for sending a high frequency to the heating means, and the temperature sensor. A thermotherapy apparatus comprising: a control means for controlling heating by controlling the output of a high-frequency generating means so that the temperature becomes a predetermined temperature, and a cooling means for preventing heating other than a target site. The temperature sensor includes a detection unit that calculates a temperature change rate from the temperature detected by the temperature sensor and detects an abnormality in the heating state based on the temperature change rate.

In addition to the first configuration, the second configuration of the present hyperthermia treatment device has a warning unit that warns the abnormality when the detection unit detects a heating abnormality. In addition to the first configuration, the third configuration of the present hyperthermia treatment device has a unit for stopping the device when a heating abnormality is detected by the detection unit.

Further, in the fourth constitution of the thermotherapy apparatus, in addition to the first constitution, the abnormality of the heating state detected by the detecting means is a heating rate higher than the normal state. In addition, in a fifth configuration of the present hyperthermia treatment apparatus, in addition to any one of the first to third configurations, an abnormality in the heating state detected by the detection means is
The heating rate is lower than normal.

In addition, in the sixth configuration of the present hyperthermia treatment apparatus, in addition to any one of the first to fifth configurations, the temperature change rate detected by the detecting means is the temperature increase rate. Further, a seventh configuration of the present hyperthermia treatment apparatus has, in addition to any one of the first to sixth configurations, a detection unit which is a microcomputer and has a unit for detecting a heating abnormality by digital calculation. ing.

In addition, in the eighth constitution of the present hyperthermia treatment device, in addition to any one of the first to sixth constitutions, the detecting means is an analog circuit, and means for detecting heating abnormality by an electric circuit. Have.

In addition, in the ninth constitution of the thermotherapy apparatus, in addition to any one of the first to eighth constitutions, the detecting means has a recording means for recording the temperature change rate. The tenth configuration of the present hyperthermia treatment apparatus has a unit for detecting heating abnormality from the temperature and the temperature change rate at that time, in addition to any one of the first to seventh configurations. ing.

The eleventh configuration of the present hyperthermia treatment apparatus is as follows:
The detection means of the first configuration compares the calculated rate of temperature change with a reference value, and warns and / or warns if it deviates from the reference value.
Alternatively, stop the high frequency output oscillation.

The twelfth structure of the thermotherapy device is as follows.
In the eleventh configuration, when the temperature increase rate is higher than the reference temperature increase rate, the warning and / or the oscillation of the high frequency output is stopped.

The thirteenth constitution of the thermotherapy apparatus is as follows.
In the eleventh configuration, when the temperature increase rate is smaller than the reference temperature increase rate, the warning and / or the oscillation of the high frequency output is stopped.

The operation of the first to eighth configurations is to monitor the rate of temperature rise to detect whether or not the heating is being performed within the controllable range by the control means, and when there is an abnormality. To prevent excessive heating of the affected area, stop the device.

The effect of the ninth structure is that when a cancerous tumor or the like is treated with a hyperthermia treatment device, when the tumor shrinks due to the treatment, the blood flow around the tumor increases and the cooling effect by the living body improves. Therefore, when heated under the same conditions, the rate of temperature rise decreases as the tumor shrinks. This decrease in the temperature rise rate is detected by observing the change in the temperature rise rate for each treatment, and the degree of treatment of the affected area is detected.

Further, the operation of the tenth structure is such that, when the temperature rise rate is detected, the temperature rise rate decreases as the temperature rises even if the temperature rise rate shows a high temperature rise rate. It may become warm. Therefore, it is determined whether or not the temperature and the rate of temperature rise are within the proper range of the rate of temperature rise, and if there is an abnormality, the thermotherapy device is stopped.

The objects of the first to eighth configurations are as follows.
Monitor the temperature rise rate of the affected area separately from the temperature control means,
It is an object of the present invention to provide a hyperthermia treatment apparatus which prevents the affected part from being excessively heated by promptly stopping the apparatus when the temperature rises to a level where the temperature control by the control means is impossible.

The purpose of the ninth structure is to detect the degree of healing of the affected area from changes in the temperature rise rate. Further, the purpose of the tenth configuration is to prevent a normal heating state, which is determined to be a heating abnormality only by the temperature rise rate, from a temperature and a temperature rise rate so as not to judge it as a heating abnormality. Is to detect.

Further, the purpose of the eleventh to thirteenth constructions is to prevent the affected part from being excessively heated when the value deviates from the reference value, that is, when the rate of increase in the reference temperature is larger or smaller. At the same time, efficient heating can be performed.

[0049]

According to the invention described in claim 1, it is possible to prevent an excessive rise in the temperature of the affected area.

[Brief description of drawings]

FIG. 1 is a diagram showing a configuration of a first exemplary embodiment of the present invention.

FIG. 2 is a diagram showing an internal configuration of the applicator shown in FIG.

FIG. 3 is a diagram showing a configuration of a detection unit shown in FIG.

FIG. 4 is a flowchart showing an execution procedure of a control program for monitoring a heated state of an affected area.

FIG. 5 is a diagram showing changes in the measured temperature from the temperature sensor and changes in the temperature rise rate.

FIG. 6 is a diagram for explaining a problem when the output becomes excessively large.

FIG. 7 is a diagram for explaining a problem when the output becomes excessively small.

FIG. 8 is a diagram showing a configuration of a control unit according to a second embodiment of the present invention.

FIG. 9 is a diagram showing a data structure of a ROM according to a third embodiment of the present invention.

FIG. 10 is a flowchart showing the operation of the third embodiment of the present invention.

FIG. 11 is a flowchart showing the operation of the fourth embodiment of the present invention.

[Explanation of symbols]

1 ... Applicator, 2 ... Outer sheath, 3 ... Balloon, 4 ...
Perfusion hole, 5 ... Air supply hole, 6 ... Opening portion, 7 ... Inner sheath, 8 ...
Coaxial cable, 9 ... Antenna part, 10 ... Sensor hole, 11
... Temperature sensor, 13 ... High frequency oscillator, 14 ... Perfusion device,
15 ... Liquid supply tube, 16 ... Collection tube, 17 ... Air supply mouthpiece, 18 ... Temperature measuring means, 19 ... Oscillator controller, 20 ... Detection means, 21 ... Perfusion device controller, 2
2 ... Control part, 23a ... Prostatic hypertrophy part, 24 ... Bladder, 25
... urethra, 26 ... I / O bus, 27 ... ROM, 28 ... RA
M, 29 ... Timer, 30 ... Calculation means, 32 ... External storage device, 33 ... PID control circuit, 34 ... Sample hold circuit, 35 ... Comparison circuit, 36 ... Reference voltage source, 37 ... Warning / stop circuit, 38 ... Drive Circuit, 39 ... Warning display means, 4
a ... 1st cooling liquid distribution space, 4b ... 2nd cooling liquid distribution space, 4c ... Communication part, 20a ... Warning display means, 23b ... Urethral sphincter.

Claims (1)

[Claims] 1. A heating means for heating an affected area, a temperature detecting means for detecting a temperature of the affected area heated by the heating means, and a temperature detected by the temperature detecting means is a preset temperature. In the hyperthermia treatment apparatus comprising: a control means for controlling the temperature change rate to be set to a temperature change rate from the temperature detected by the temperature detection means, and the heating state for the affected area is calculated based on the calculated temperature change rate. A thermotherapy device, further comprising a detection means for detecting.