Temperature-controlled heating treatment system

Abstract

This invention provides a temperature-controlled heating therapy system that connects to a commercial power supply, minimizing the risk of dangerous electric shock to the human body, and safely and reliably delivering therapeutic effects by heating the lesion with a thermal probe. [Solution] The control device 20 includes a microheater 2 in which a heater body 230 and a temperature detection element 240 are housed in an air core formed inside a heat transfer tube 210, and a thermal probe 10, which is detachably connected to the lesion to heat the lesion by puncturing, inserting, or pressing against the lesion, converts the commercial power supply into a low-voltage DC power supply for driving the heater using an isolated power supply unit 30, and controls the DC power supplied to the microheater equipped with the thermal probe using a heater power control unit 40, based on the temperature detection result of the temperature detection element arranged in the microheater, so that the temperature is above the temperature at which the proteins in the lesion irreversibly denature and below the temperature at which the lesion locally boils.

Description

Technical Field

[0001] The present invention relates to a heating treatment system capable of temperature control, such as a line power type cautery used for hemostasis, tissue resection, cauterization, etc. In particular, it relates to a heating treatment system capable of temperature control, which punctures, inserts or presses a thermal probe into a lesion, where a microheater inserted inside is heated by energization to heat the lesion.

Background Art

[0002] Conventionally, as a medical device used for hemostasis, tissue resection, cauterization, etc., an electric cautery that generates heat to a target using a high-frequency current in the radio wave (300 kHz to 5 MHz) band and generates high heat by contact with tissue is used to perform radiofrequency ablation (RFA) on the tissue.

[0003] For example, in percutaneous, laparoscopic, or surgical procedures, the Cool-tip RFA system E series of Medtronic, which flows a high-frequency current in the radio wave band from a single-needle electrode to the lesion tissue (tumor) to cauterize part or all of the lesion tissue (tumor), or the bipolar RFA system (Celon POWER(R)) of Olympus Winter & Ibe, which percutaneously punctures one or more applicators (electrode needles) in percutaneous or surgical operations and flows a high-frequency current in the radio wave band through them to cause coagulative necrosis of liver cancer, etc. have been put into practical use. TM RFA system E series or, in percutaneous or surgical operations, the bipolar RFA system (Celon POWER(R)) of Olympus Winter & Ibe, which percutaneously punctures one or more applicators (electrode needles) and flows a high-frequency current in the radio wave band through them to cause coagulative necrosis of liver cancer, etc. have been put into practical use.

[0004] Cool-tip TMThe RFA System E Series is a monopolar, line-powered ablation device that uses a high-frequency current (472kHz frequency) supplied from a high-frequency generator (200W output) connected to the line power supply. This current is passed from a single active electrode through the lesional tissue (tumor) to a return pad (counter electrode). By rinsing the active electrode with sterile cooling water using a pump, the electrode temperature rise is prevented. Monitoring of temperature and impedance suppresses the increase in impedance due to carbonization of the surrounding tissue, ensuring good transmission of high-frequency current in the radio wave band. This allows for efficient heating of a wide area of ​​tissue, making it an effective therapeutic electrosurgical device for large tumors and irregularly shaped tumors. However, it requires a return pad (counter electrode) that is placed outside the patient's body.

[0005] The bipolar RFA system (Celon POWER(R)) is a bipolar line-powered ablation device that uses a high-frequency current (470kHz) supplied from a high-frequency generator (250W output) connected to a line power supply (100-240V AC) to flow between closely positioned active and return electrodes. One or more applicators (electrode needles) with closely positioned active and return electrodes are used in combination with a dedicated RF ablation catheter. The dedicated RF ablation catheter is inserted into the organ to supply RF energy to the target myocardial area. Because the high-frequency current flows between the closely positioned active and return electrodes, it is a medical device that enables more localized and controlled tissue heating, and is particularly used for the treatment of cardiac arrhythmias such as atrial fibrillation (AF). In a bipolar line-powered ablation device, since the high-frequency current flows between the closely positioned active and return electrodes, there is no need to place a return pad (counter electrode plate) outside the patient's body.

[0006] Furthermore, the applicant has previously proposed a minimally invasive bio-heating device and temperature control method that can reliably cauterize a lesion by puncturing or inserting a needle portion with a built-in heater into the lesion and heating it with the heater (see, for example, Patent Documents 1-5).

[0007] In the technology disclosed in Patent Document 1, a needle with a built-in heater is inserted into or punctured into the lesion, and the lesion can be cauterized by heating with the heater.

[0008] The technology disclosed in Patent Document 2 involves inserting or puncturing a puncture needle into a lesion in a living body and performing appropriate temperature control to reliably heat the lesion over a predetermined area. Furthermore, multiple needles can be easily inserted or punctured at predetermined intervals, allowing for substantially uniform heating of the lesion over a predetermined area. The puncture needle is also effective when heating lesions in deep organs or when heating lesions using a laparoscope. In addition, the puncture needle can be inserted or punctured into the lesion using a catheter, and the lesion can be cauterized by heating it.

[0009] The technologies disclosed in Patent Documents 3 and 4 provide a minimally invasive bio-heating device that can reliably heat a lesion by puncturing or inserting the needle portion into the lesion, and can reliably coagulate the separated surface when punctured or inserted into the peripheral area of ​​a tumor or along the line of separation, and can also provide a tissue coagulation device and temperature control method that is small enough to be used in endoscopic surgery.

[0010] The technology disclosed in Patent Document 5 is an endoscopic cancer treatment system that treats cancerous tissue in internal organs such as the pancreas by heating, and when treating internal organ cancers such as pancreatic cancer, it is possible to more reliably heat and treat only the cancerous tissue with pinpoint accuracy. [Prior art documents] [Patent Documents]

[0011] [Patent Document 1] International Publication No. 2011 / 037235 [Patent Document 2] Patent No. 5750044 [Patent Document 3] Patent No. 6009779 [Patent Document 4] Patent No. 6116666 [Patent Document 5] Patent No. 6663461 [Overview of the project] [Problems that the invention aims to solve]

[0012] The above Cool-tip TM Electrical ablation devices that perform radiofrequency ablation (RFA) on tissue, such as the RFA System E Series and the Bipolar RFA System (Celon POWER(R)), require a high-frequency generator to supply high-frequency current in the radio frequency band. Furthermore, to prevent overheating of the electrodes through which the high-frequency current flows and to improve the accuracy of treatment, a dedicated cooling liquid or cooling device is required to cool the electrodes.

[0013] The above Cool-tip TM The RFA system E series prevents the electrode temperature from rising by rinsing the active electrode with sterile cooling water via a pump. By monitoring temperature and impedance, it suppresses the increase in impedance due to carbonization of the surrounding tissue, ensuring good transmission of high-frequency currents in the radio wave band. However, it does not have a temperature control function.

[0014] Furthermore, the above-mentioned bipolar RFA system (Celon POWER(R)) controls the high-frequency current by impedance measurement and circulates sterile cooling water inside the applicator to prevent the electrode temperature from rising. This prevents excessive coagulation around the electrode and the resulting rapid increase in electrical resistance caused by tissue drying and carbonization, which can lead to electrical failure. However, it does not have a temperature display function or temperature control function.

[0015] Furthermore, electric cautery devices that use high-frequency generators may cause electromagnetic interference (EMI) to other equipment in a medical environment where many electronic devices are used, due to unwanted radiation from the high-frequency generator, and there is a risk of malfunction of monitoring equipment and other treatment equipment.

[0016] In addition, in a line power type ablation device, since a line power is used, there is a risk of electric shock to the user or patient, especially when the device is damaged or not properly insulated, this risk increases.

[0017] The above Cool-tip TM In a monopolar type line power ablation device such as the RFA system E series, when current passes through the body, if there is no electrode plate, the current will flow unevenly, and there is a risk of causing burns or other injuries to the patient. Therefore, in order to reduce this risk, the electrode plate needs to be correctly attached.

[0018] Here, in IEC60364-4 (Electrical installation of building - Part 4: Protection for safety), the safety extra-low voltage that can minimize the risk of dangerous electric shock to the human body is 60V or less for direct current and 25V or less for alternating current.

[0019] Also, according to J60598-1 which is the standard of the Electrical Appliance and Material Safety Act in Japan, the safe voltage is 30V or less for alternating current and 45V or less for direct current.

[0020] In view of the above-mentioned conventional situation, the problem of the present invention is to suppress the risk of dangerous electric shock to the human body, and heat the lesion site with a thermal probe in which a micro heater inserted inside is heated by energization, so as to provide a temperature control capable heating treatment system that can safely and surely exert a therapeutic effect.

[0021] Other objects of the present invention and specific advantages obtained by the present invention will be further clarified from the description of the embodiments described below.

Means for Solving the Problems

[0022] The present invention relates to a temperature-controllable heating therapy system comprising a microheater in which a heater body and a temperature detection element are housed in the internal space of a heat transfer element while maintaining an insulating distance, a thermal probe for puncturing, inserting, or pressing against a lesion to heat the lesion, and a control device to which the thermal probe is detachably connected. The control device comprises an isolated power supply unit connected to a commercial power supply, which converts the commercial power supply into a DC power supply and supplies DC power to the microheater provided in the thermal probe, and a heater power control unit that controls the DC power supplied from the isolated power supply unit to the microheater so that the microheater generates a predetermined amount of heat based on the temperature detection result of the temperature detection element arranged on the microheater, and the heater power control unit controls the DC power supplied from the isolated power supply unit to the microheater based on the temperature detection result so that the temperature is at least above body temperature, thereby heating the lesion.

[0023] In the temperature-controlled heating treatment system according to the present invention, the heater power control unit can control the DC power supplied from the isolated power supply unit to the microheater based on the temperature detection result, such that the temperature is above the temperature at which the proteins in the lesion irreversibly denature and below the temperature at which the lesion locally boils, thereby heating the lesion.

[0024] Furthermore, in the temperature-controllable heating treatment system according to the present invention, the heater power control unit can control the DC power supplied from the insulated power supply unit to the microheater based on the temperature detection result so that the temperature is above body temperature and below the temperature at which proteins irreversibly denature, thereby heating the lesion.

[0025] Furthermore, in the temperature-controllable heating treatment system according to the present invention, the heater power control unit can control the DC power supplied from the insulated power supply unit to the microheater based on the temperature detection result so that the temperature is above the temperature at which a cauterizing effect can be obtained by thermal coagulation of the lesion, thereby heating the lesion.

[0026] Furthermore, in the temperature-controllable heating treatment system according to the present invention, the thermal probe may have a shape that allows it to directly reach the affected area for treatment.

[0027] Furthermore, in the temperature-controllable heating treatment system according to the present invention, the thermal probe may have a shape that allows it to be passed through an endoscope for treatment.

[0028] Furthermore, in the temperature-controllable heating treatment system according to the present invention, the thermal probe may have a shape that allows it to be inserted into a laparoscope for treatment.

[0029] In the temperature-controllable heating treatment system according to the present invention, the thermal probe may have a shape that allows it to be passed through a catheter for treatment.

[0030] Furthermore, in the temperature-controllable heating treatment system according to the present invention, the isolated power supply unit may consist of an isolated AC / DC converter connected to a commercial power supply and converting the commercial power supply into a DC power supply of safe extra-low voltage or lower, and a DC / DC converter that converts the DC power supply of safe extra-low voltage or lower, obtained by the isolated AC / DC converter, into a low-voltage DC power supply for heater driving and supplies DC power to the microheater provided in the thermal probe.

[0031] Furthermore, in the temperature-controllable heating treatment system according to the present invention, the circuit board on which the isolated power supply unit and the heater power control unit are provided is installed in a floating state insulated from the exterior of the control device, and the isolated power supply unit can be made capable of supplying DC power of 24V or less and a maximum of 1A to the microheater of the thermal probe.

[0032] Furthermore, in the temperature-controllable heating treatment system according to the present invention, the heater power control unit includes means for setting the temperature and / or heating time of the microheater, and can control the DC power supplied from the DC / DC converter to the microheater in accordance with the thermal denaturation of the lesion, based on the temperature detection result of the temperature detection element arranged on the microheater, so that the set temperature and / or heating time is achieved.

[0033] Furthermore, in the temperature-controllable heating treatment system according to the present invention, the isolated power supply unit has the function of supplying DC power to a plurality of thermal probes, and the heater power control unit includes means for setting the temperature and / or heating time of each microheater of the plurality of thermal probes, and can independently control the DC power supplied from the DC / DC converter to the microheater in accordance with the thermal denaturation of the lesion, based on the temperature detection result of the temperature detection element arranged in each microheater, so as to achieve the set temperature and / or heating time. [Effects of the Invention]

[0034] The present invention provides a temperature-controlled heating therapy system that includes a microheater in which the heater body and temperature detection element are housed in the internal space of a heat transfer body while maintaining an insulating distance, a thermal probe that is inserted into or pressed against a lesion to heat the lesion, an isolated power supply unit connected to a commercial power supply that converts the commercial power supply into a DC power supply and supplies DC power to the microheater provided in the thermal probe, and a heater power control unit that controls the DC power supplied from the isolated power supply unit to the microheater so that the microheater generates a predetermined amount of heat based on the temperature detection result of the temperature detection element arranged on the microheater, the heater power control unit controls the DC power supplied from the isolated power supply unit to the microheater based on the temperature detection result so that the temperature is at least above body temperature, thereby heating the lesion and reducing the risk of dangerous electric shock to the human body. The microheater inserted inside is heated by the current flowing through the puncture needle, causing thermal denaturation of the lesion, thereby providing a safe and reliable thermotherapy effect.

[0035] In other words, in this temperature-controlled heating treatment system, the DC power supplied from an isolated power supply unit to a microheater equipped with a thermal probe that is inserted into, punctured, or pressed against the lesion to heat the lesion is controlled so that the microheater generates a predetermined amount of heat, thereby heating the lesion. As such, the DC current flows only within the thermal probe without making the living body part of the electrical circuit, and no current or anything is passed through the living body, as in radiofrequency ablation (RFA). Therefore, it is inherently safe and has a lower risk of perforation compared to RFA. Consequently, it can safely and reliably achieve therapeutic effects by thermally denaturing the lesion without requiring a counter electrode plate like a monopolar line-powered ablation device. Furthermore, it does not require a high-frequency generator to supply high-frequency current in the radio frequency band, as is required for electric ablation devices that perform radiofrequency ablation (RFA) on tissue, nor does it require a dedicated coolant or cooling device for cooling the electrodes.

[0036] Furthermore, in this temperature-controllable heating treatment system, the heater power control unit controls the DC power supplied from the isolated power supply unit to the microheater based on the temperature detection result, and heats the lesion to a temperature above the temperature at which the proteins in the lesion irreversibly denature and below the temperature at which the lesion locally boils, thereby safely and reliably achieving a thermotherapy effect.

[0037] Furthermore, in this temperature-controllable heating therapy system, the heater power control unit controls the DC power supplied from the isolated power supply unit to the microheater based on the temperature detection result, and heats the lesion to a temperature above body temperature and below the temperature at which proteins irreversibly denature, thereby safely and reliably achieving a thermotherapy effect.

[0038] Furthermore, in this temperature-controllable heating treatment system, the heater power control unit controls the DC power supplied from the isolated power supply unit to the microheater based on the temperature detection result, and heats the lesion to a temperature above which a cauterization effect can be obtained by thermal coagulation of the lesion, thereby safely and reliably achieving a cauterization treatment effect.

[0039] Furthermore, in this temperature-controlled heating treatment system, the thermal probe can be shaped to allow it to directly reach the affected area for treatment.

[0040] Furthermore, in this temperature-controlled heating treatment system, the thermal probe can have a shape suitable for the intended procedure using an endoscope, laparoscope, catheter, or the like.

[0041] Furthermore, in this temperature-controlled heating treatment system, the heater power control unit controls the DC power supplied to the microheater from the insulated power supply unit based on the temperature detection result of the temperature detection element placed on the microheater, so that the microheater generates a predetermined amount of heat. This is done so that the temperature is above the temperature at which the proteins in the lesion irreversibly denature, and below the temperature at which the lesion boils locally. As a result, no bubbles or steam are generated in the lesion when it is thermally denatured, clear, non-cloudy echo (ultrasound) images and CT images can be obtained, and the procedure can be performed reliably while performing imaging examinations. The amount of heat required for thermal denaturation varies depending on the biological tissue and its condition, but the DC power supplied to the microheater can be automatically controlled by setting the temperature and time.

[0042] Furthermore, in this temperature-controlled heating treatment system, DC power is supplied to a microheater equipped in the thermal probe, causing the microheater to generate a predetermined amount of heat and thus thermally denaturing the lesion. Unlike electric cauterizers that use high-frequency generators, there is no risk of electromagnetic interference (EMI) to other equipment due to unwanted radiation from the high-frequency generator, and there is no risk of malfunction of monitoring equipment or other treatment equipment. In addition, since there is no electromagnetic interference between thermal probes when using multiple thermal probes, multiple thermal probes can be freely positioned during treatment. [Brief explanation of the drawing]

[0043] [Figure 1] Figure 1 is a schematic diagram showing the basic configuration of a temperature-controlled heating treatment system to which the present invention is applied. [Figure 2] Figure 2 is a circuit diagram showing the circuit configuration of a temperature-controlled heating treatment system to which the present invention is applied. [Figure 3] Figure 3 is an external perspective view of the above-described temperature-controlled heating treatment system. [Figure 4] Figure 4 is an exploded perspective view showing the structure of a thermal probe in the above-described temperature-controlled heating treatment system. [Figure 5] Figures 5(A), (B), (C), and (D) illustrate the structure of the microheater provided in the thermal probe described above. (A) is a perspective view of the main part of the microheater, (B) is a cross-sectional view of the microheater shown in (A), (C) is a cross-sectional view of a modified microheater with a one-way heater, and (D) is a cross-sectional view of a modified microheater with a partially heating structure. [Figure 6] Figures 6(A) and 6(B) illustrate the structure of other modified examples of the microheater provided in the thermal probe, where (A) is a cross-sectional view of the microheater and (B) is a longitudinal cross-sectional view of the microheater. [Figure 7] Figure 7 is a schematic diagram showing the functional configuration of the heat treatment system capable of temperature control described above. [Figure 8] Figure 8 is a flowchart illustrating the thermal denaturation process using the thermal probe described above. [Figure 9] Figure 9 is a schematic diagram showing the general configuration of an endoscopic treatment system using the above-described temperature-controllable heating treatment system. [Figure 10] Figures 10(A) and (B) are schematic diagrams illustrating the usage of the thermal probe in the endoscopic treatment system described above. (A) shows the thermal probe with the heating element located inside the guide needle, and (B) shows the thermal probe with only the guide needle retracted to expose the heating element. [Figure 11] Figure 11 shows an example of an endoscopic procedure (passage obstruction) using the endoscopic treatment system described above. [Figure 12] Figures 12(A), (B), and (C) are schematic diagrams showing treatment examples using the endoscopic treatment system described above, where (A) is a gastrointestinal endoscope, (B) is a colonoscope, and (C) is a bronchoscope. [Figure 13] Figure 13 is a schematic diagram showing the general configuration of a laparoscopic treatment system using the above-mentioned temperature-controllable heating treatment system. [Figure 14] Figure 14 is a schematic diagram of catheter treatment using the above-described temperature-controlled heating treatment system. [Figure 15] Figures 15(A) to (F) are schematic diagrams illustrating the process of reducing the volume of tissue in the affected area. [Figure 16] Figures 16(A) and (B) are schematic diagrams showing other configuration examples of the thermal probe for the temperature-controlled heating treatment system described above. (A) shows an example of a thermal probe with heating elements installed in multiple locations, and (B) shows an example of a thermal probe with a long heating element installed. [Modes for carrying out the invention]

[0044] Embodiments of the present invention will be described in detail below with reference to the drawings. Common components will be denoted by common reference numerals in the drawings. Furthermore, it goes without saying that the present invention is not limited to the following examples and can be modified as needed without departing from the spirit of the invention.

[0045] Figure 1 is a schematic diagram showing the basic configuration of a temperature-controlled heating treatment system 100 to which the present invention is applied.

[0046] As shown in the schematic diagram of Figure 1, this temperature-controlled heating treatment system 100 consists of a thermal probe 10 that is inserted into, pressed against, or used to heat a lesion, and a control device 20 that is supplied with commercial power via a three-wire power cable 120 having a three-pin power plug 121 that plugs into a three-pin power outlet 31.

[0047] The thermal probe 10 of this temperature-controllable heating treatment system 100 consists of a puncture needle 1 with an internal air core 13 and a microheater 2 inserted into the air core 13 of the puncture needle 1. When inserted into a lesion, the microheater 2 is supplied with DC power from the control device 20, generating heat and causing thermal denaturation of the biological tissue at the lesion site. The microheater 2 is constructed by housing a linear heater body 230 and a temperature sensing element 240 within an air core 220 formed inside a heat transfer tube 210, while ensuring an insulating distance between them. A four-wire power cord 270 is led out from the needle base 260 of the thermal probe 10, and it is detachably connected to the control device 20 via a four-pin plug jack.

[0048] Furthermore, the control device 20 of this temperature-controllable heating treatment system 100 consists of an isolated power supply unit 30 connected to a commercial power supply (AC 100~240V ±10%) via a power cable 120, a heater power control unit 40 that controls the DC power supplied from the isolated power supply unit 30 to the microheater 2 of the thermal probe 10, and a control unit 50 that has a setting function for setting the operation of the heater power control unit 40.

[0049] The isolated power supply unit 30 converts commercial power (AC 100~240V ±10%) via the power cable 120 into a constant DC power supply of, for example, 12V or less, which is below the safe extra-low voltage, and supplies it to the microheater 2.

[0050] The heater power control unit 40 controls the DC power supplied from the isolated power supply unit 30 to the microheater 2 based on the temperature detection result from the temperature detection element 240 arranged on the microheater 2, so that the temperature is above the temperature at which the proteins in the lesion irreversibly denature and below the temperature at which the lesion locally boils, so that the microheater 2 generates a predetermined amount of heat. The heater power control unit 40 is given the temperature and time for the scorching treatment by heating the microheater 2, which is set by the control unit 50.

[0051] Here, although the amount of heat required for thermal denaturation of biological tissue differs, the heater power control unit 40, given the temperature and time of the thermal denaturation process by heating the microheater 2 set by the control unit 50, controls the DC power supplied from the isolated power supply unit 30 to the microheater 2 based on the temperature detection result from the temperature detection element 240 arranged on the microheater 2, so that the microheater 2 generates a predetermined amount of heat, thereby ensuring that the temperature is above the temperature at which the proteins in the lesion irreversibly denature and below the temperature at which the lesion localizes and boils.

[0052] In other words, in this temperature-controllable heating treatment system 100, based on the temperature detection result from a temperature detection element 240 located on a microheater 2 provided in a thermal probe 10 that is inserted into, punctured, or pressed against the lesion to heat the lesion, the heater power control unit 40 controls the DC power supplied from the isolated power supply unit 30 to the microheater 2. By heating the lesion to a temperature above the temperature at which the proteins in the lesion irreversibly denature and below the temperature at which the lesion locally boils, the microheater 2 generates a predetermined amount of heat, thereby reducing the risk of dangerous electric shock to the human body. The puncture needle 1, with the microheater 2 inserted inside and heated by the current, denatures the lesion, allowing for safe and reliable therapeutic effects.

[0053] Furthermore, in this temperature-controllable heating treatment system 100, the heater power control unit 40 controls the DC power supplied from the isolated power supply unit 30 to the microheater 2 provided on the thermal probe 10 that heats the lesion, so that the microheater 2 generates a predetermined amount of heat and heats the lesion. As a result, the DC current flows only within the thermal probe 10 without making the living body part of the electrical circuit, and no current or anything is passed through the living body like in radiofrequency ablation (RFA), making it inherently safe and lowering the risk of perforation compared to RFA. Therefore, it is possible to cauterize the lesion safely and reliably without requiring a counter electrode plate like a monopolar line-powered cauterization device. In addition, as with electric cauterization devices that perform radiofrequency ablation (RFA) on tissue, it does not require a high-frequency generator to supply high-frequency current in the radio frequency band, nor does it require a dedicated coolant or cooling device for cooling the electrodes.

[0054] Furthermore, in this temperature-controllable heating treatment system 100, the heater power control unit 40 controls the DC power supplied from the isolated power supply unit 30 to the microheater 2 based on the temperature detection result of the temperature detection element 240 arranged on the microheater 2, so that the microheater 2 generates a predetermined amount of heat. This is done so that the temperature is above the temperature at which the proteins in the lesion irreversibly denature and below the temperature at which the lesion locally boils. As a result, no bubbles or steam are generated in the lesion when the lesion is thermally denatured, clear, non-cloudy echo (ultrasound) images and CT images can be obtained, and the procedure can be performed reliably while performing image examinations. The amount of heat required for thermal denaturation varies depending on the biological tissue and its condition, but the DC power supplied to the microheater 2 can be automatically controlled by setting the temperature and time.

[0055] Furthermore, in this temperature-controllable heating treatment system 100, DC power is supplied to the microheater 2 provided on the thermal probe 10, causing the microheater 2 to generate a predetermined amount of heat, thereby thermally denaturing the lesion. Unlike electric cauterizers that use high-frequency generators, there is no risk of electromagnetic interference (EMI) to other equipment due to unwanted radiation from the high-frequency generator, and there is no risk of malfunction of monitoring equipment or other treatment equipment. In addition, since there is no electromagnetic interference between thermal probes when multiple thermal probes are used simultaneously, multiple thermal probes can be freely positioned during treatment.

[0056] Next, Figure 2 is a circuit diagram showing the specific circuit configuration of a temperature-controllable heating treatment system 100 that is connected to a commercial power supply and to which the present invention is applied, and Figure 3 is an external perspective view of this temperature-controllable heating treatment system 100.

[0057] As shown in the circuit diagram of Figure 2, the control device 20 of this temperature-controllable heating treatment system 100 has an isolated power supply unit 30 connected to a 3-pin power outlet 31 via a fuse 32 and a power switch 33, a heater power control unit 40 equipped with a sub-CPU 41 mounted on a heater control board, and a control unit 50 equipped with a main CPU 51 mounted on a main board, etc., which are installed in a floating state insulated from the outer casing 21 of the control device 20, and the isolated power supply unit 30 is connected to the commercial power supply (AC 100~240V ±10%) via a 3-wire power cable 120 into which a 3-pin power plug 121 is inserted into the power outlet 31.

[0058] The isolated power supply unit 30 of this control device 20 consists of an isolated AC / DC converter 34 that converts commercial power (AC 100~240V ±10%) supplied from the power outlet 31 via a fuse 32 and a power switch 33 into a DC power supply of safety extra-low voltage or lower, and a DC / DC converter 37 that converts the DC power supply of safety extra-low voltage or lower, which has been converted from the commercial power supply by the isolated AC / DC converter 34, into a low-voltage DC power supply for driving the heater.

[0059] The outer casing 21 of the control device 20 is grounded, and the ground contact of the 3-pin power outlet 31 is connected to the shield case 30A of the isolated AC / DA converter 34.

[0060] The isolated AC / DC converter 34 of this isolated power supply unit 30 converts commercial power (AC 100~240V ±10%) into a constant 12V DC power supply below the safety extra-low voltage. It consists of an isolation transformer 35 and a switching regulator 36, and supplies the constant 12V DC power to the DC / DC converter 37, as well as to the heater power control unit 40 and the control unit 50.

[0061] Furthermore, the DC / DC converter 37 of this isolated power supply unit 30 is a 4-channel output DC / DC converter equipped with four DC / DC converters 37A, 37B, 37C, and 37D mounted together with the heater power control unit 40 on the heater control board equipped with the sub-CPU 41, and can individually output low-voltage DC power for heater driving via four jacks 39A, 39B, 39C, and 39D for connecting the thermal probe 10 to CH1. The DC / DC converter 37 is also provided with four isolation amplifiers 38A, 38B, 38C, and 38D to which the temperature sensing element 240 of the thermal probe 10 is connected via the four jacks 39A, 39B, 39C, and 39D.

[0062] In this control device 20, the four jacks 39A, 39B, 39C, and 39D are located on the lower side of the front panel, as shown in the external perspective view of Figure 3, for external connection of the thermal probe 10.

[0063] The DC / DC converter 37 supplies DC power to the microheater 2 of the thermal probe 10, which is externally connected to the four jacks 39A, 39B, 39C, and 39D. The temperature signals obtained by the temperature sensing element 240 of the thermal probe 10 are individually amplified by the isolation amplifiers 38A, 38B, 38C, and 38D and supplied to the heater power control unit 40.

[0064] Furthermore, as shown in the external perspective view in Figure 3, the control unit 50 of the control device 20 is connected to a start switch 52, a stop switch 53, a setting / display unit 54, etc., which are located on the front panel of the control device 20.

[0065] The control unit 50 receives a treatment start command to begin treatment using the thermal probe 10 by operating the start switch 52, and a treatment stop command to stop treatment by operating the stop switch 53. The setting / display unit 54 connected to the control unit 50 consists of a liquid crystal display module equipped with a touch panel and has various display functions such as temperature display for each of the four channels CH1 to CH4 (set temperature / measured temperature), operation selection display, treatment time display (set time, elapsed time), treatment temperature numerical display, treatment temperature graph display, error display, and treatment operation display, as well as various operation input functions such as temperature selection, time selection, numeric keypad input, heater test, and operation selection for each of the four channels CH1 to CH4 via the touch panel.

[0066] Furthermore, the control unit 50 is provided with a maintenance RS232C port 55 for connecting a PC externally to extract treatment records and setting parameters to an external source.

[0067] The control unit 50 then receives user input through the operation of the start switch 52, stop switch 53, setting / display unit 54, etc., and controls the operation of the heater power control unit 40 according to the set conditions.

[0068] Information is exchanged between the heater power control unit 40 and the control unit 50 via serial transmission using optical communication.

[0069] The heater power control unit 40 of the control device 20 individually controls the operation of the four DC / DC converters 37A, 37B, 37C, and 37D of the isolated power supply unit 30 according to the control commands from the control unit 50, and independently controls the DC power supplied to each of the four microheaters 2 of the thermal probes 10 so that the temperature and / or heating time set in the control unit 50 is the same for each microheater 2. The control of the DC power supplied to the microheaters 2 is performed by PID control (proportional-integral-derivative control) based on the temperature detected by the temperature detection element 240.

[0070] As shown in the external perspective view of Figure 3, the control device 20 is provided with a handle 110 and an emergency stop button 42A on the top plate, and an emergency stop switch 42 operated by the emergency stop button 42A is connected to the heater power control unit 40.

[0071] Here, Figure 4 is an exploded perspective view showing the structure of the thermal probe 10 in the temperature-controlled heating treatment system 100 described above.

[0072] In other words, the thermal probe 10 in this temperature-controllable heating treatment system 100 consists of a hollow puncture needle 1 having a puncture portion 11 at its tip, and a microheater 2 that is detachably inserted into the puncture needle 1, as shown in the exploded perspective view of Figure 4.

[0073] The puncture needle 1 into which the microheater 2 is inserted is the outer needle (guide needle) of the microheater 2 and has a needle portion 12 with a puncture portion 11 at the tip of the needle tube that is sharply formed so that it can be punctured or inserted into the lesion.

[0074] The needle portion 12 is cylindrical, and its thickness is formed to be approximately 18G (outer diameter 1.2mm / inner diameter 0.94mm) to 23G (outer diameter 0.65mm / inner diameter 0.4mm). Furthermore, the needle portion 12 of the puncture needle 1 and the needle portion 250 of the microheater 2 are formed to be approximately the same length, i.e., the total length is approximately 150mm to 200mm, so that the cutting edge aligns with the cutting edge of the microheater 2 when the microheater 2 is inserted.

[0075] The tip of this puncture needle 1 is closed so that the lesion does not communicate with the hollow core 13 of the needle portion 12 when the puncture portion 11 is inserted into or into the lesion.

[0076] Furthermore, the puncture needle 1 is provided with a needle base 15 at its proximal end, which serves as a gripping portion and has an insertion hole 14 for the microheater 2.

[0077] The needle base 15 of the puncture needle 1 is made of a synthetic resin material such as polymethylpentene or polypropylene, which has electrical insulation and biocompatibility, or a metal material such as brass plated with nickel. The needle base 15 of the puncture needle 1 is formed to be thicker than the needle portion 11 and serves as an external needle handling portion that facilitates the puncture, insertion, or withdrawal of the needle from the lesion using medical instruments such as probes or by hand. In this case, the cutting edge of the puncture needle 1 is cut so that the cutting surface is sloped and sharp. Of course, the shape of the cutting surface is not limited to this.

[0078] The needle portion 12 of the puncture needle 1 is made of a biocompatible metal with good thermal conductivity, such as a stainless steel tube or a titanium tube, because it is used to puncture or insert into a lesion. A microheater 2 is inserted into the hollow core portion 13 of the needle portion 12, extending from the proximal end to the tip.

[0079] Furthermore, as described above, the needle portion 12 does not need to have its tip in communication with the hollow core portion 13. For example, a regular injection needle may be used as the needle portion 12, and the hole at its tip may be sealed with a biocompatible material or the like.

[0080] Furthermore, the needle portion 12 is not limited to the size described above, and it is preferable that its outer diameter be as small as possible to minimize pain associated with puncture or insertion. The length should be appropriate to the puncture or insertion site. In cases where there are concerns about increased pain associated with puncture or insertion, the tip of the needle portion 12 may be made, for example, spindle-shaped.

[0081] The needle base 15, which is provided at the base end of the needle portion 12, is fixed to the base end of the needle portion 12 by adhesive or the like. The needle portion 12 is the gripping portion when handling the puncture needle 1 alone, and is also the part into which the microheater 2 is inserted. Note that the needle base 15 is not necessarily required.

[0082] The microheater 2 inserted into the needle portion 12 of the puncture needle 1, as shown in Figure 4, an exploded perspective view of the thermal probe 10, comprises a needle portion 250 in which a linear heater body 230 and a temperature sensing element 240 are housed and arranged within an air core portion 220 formed inside a heat transfer tube 210, while maintaining an insulating distance. The heater body 230 and the temperature sensing element 240 are connected to the control device 20 via the power line cord 270 by inserting a plug 280 at the tip of a power line cord 270 led out from the needle base portion 260 into one of the jacks 39A, 39B, 39C, or 39D provided on the front panel of the control device 20.

[0083] Here, Figures 5(A), (B), (C), and (D) are diagrams illustrating the structure of the microheater 2 provided in the thermal probe 10, where (A) is a perspective view of the main part of the microheater 2, (B) is a cross-sectional view of the AA of the microheater 2 shown in (A), (C) is a cross-sectional view of a modified microheater 2 with a one-way heater, and (D) is a cross-sectional view of a modified microheater 2 with a partially heating structure.

[0084] As shown in Figures 5(A) and 5(B), the microheater 2 of the thermal probe 10 comprises a heat transfer tube 210 and a needle portion 250 which is constructed by housing a linear heater body 230 and a temperature sensing element 240 in an air core portion 220 formed inside the heat transfer tube 210 while ensuring an insulating distance between them.

[0085] The heat transfer tube 210 has a sharp tip 211 so that it can be punctured or inserted into the lesion, and the tip 211 is closed so that it does not communicate with the air core 220. Since the heat transfer tube 210 is punctured or inserted into the lesion, it is made of a biocompatible metal with good thermal conductivity, such as stainless steel or titanium. The heater body 230 and temperature sensing element 240 are inserted into the air core 220 of the heat transfer tube 210, from the base end to the tip 211. The heat transfer tube 210 only needs to be large enough to be punctured or inserted into the lesion and to accommodate the heater body 230 and temperature sensing element 240 in the air core 220.

[0086] Furthermore, as described above, the heat transfer tube 210 only needs to have its tip portion 211 not in communication with the air core portion 220. For example, a regular hypodermic needle may be used as the heat transfer tube 210, and the hole at its tip may be sealed with a biocompatible material or the like.

[0087] Furthermore, the heat transfer tube 210 is not limited to the size described above, and it is preferable that its outer diameter be as small as possible to minimize pain associated with puncture or insertion. The length can be appropriate to the puncture or insertion site, for example, between 10 mm and 80 mm. In cases where there are concerns about increased pain associated with puncture or insertion, the tip 211 of the heat transfer tube 210 may be shaped, for example, into a spindle shape.

[0088] The heating element 235 of the heater body 230 is provided over substantially the entire air core portion 220 of the heat transfer tube 210, and is formed so that the entire heat transfer tube 210 generates heat. The heating element 235 has a heating wire, such as nickel-chromium alloy wire, wound in a coil around a core material made of, for example, glass fiber. Furthermore, as shown in Figures 5(A) and (B), the heating element 235 is folded back near the tip portion 211 of the heat transfer tube 210 so that both ends are located at the base end of the heat transfer tube 210.

[0089] Furthermore, the heating element 235 does not necessarily need to be folded back near the tip of the heat transfer tube 210. To reduce the amount of heat generated, it may be passed vertically into the tip 211 and stopped in one direction. In this case, the electrical return wire 230b would be installed along the heating element 235. Specifically, in the example shown in Figure 5(C), the heating element 235 is passed through the heat transfer tube 210 in one direction without being folded back. The heating element 235 here can be constructed, for example, by winding a heating wire around a ceramic insulator and covering it with an insulating material 235a. A return wire 230b covered with an insulating tube 230a is led out from the tip of the heater body 230, and this return wire 230b is folded back towards the base end of the heat transfer tube 210. In this example shown in Figure 5(C), the diameter of the heat transfer tube 210 can be reduced by the amount that the heater body 230 passes in one direction.

[0090] Furthermore, as shown in Figures 5(B) and (C), the heating element 235 is covered with an insulating material 235a. This insulating material 235a is, for example, a polyimide tube.

[0091] Furthermore, when this coiled heating wire is partially installed, the heat transfer tube 210 can be partially heated. Specifically, in the example shown in Figure 5(D), the tip of the heat transfer tube 210 is not used as the heating element, but rather the middle section is used as the heating element. That is, the air core portion 220 inside the heat transfer tube 210 contains a heater body 230 in which a heating wire 235c, such as a nickel-chromium alloy wire, is wound around a core material 235b such as ceramic, and this heater body 230 is covered with an insulating tube 235d such as polyimide. A return wire 230b covered with an insulating tube 230a is led out from the tip of the heater body 230, and this return wire 230b is folded back towards the base end of the heat transfer tube 210.

[0092] An insulating tube 214a made of polyimide or the like is provided on the inner circumferential surface of the air core portion 220 of the heat transfer tube 210, and the heater body 230 covered with an insulating tube 235d and the return wire 230b covered with an insulating tube 230a extend within this insulating tube 214a. Furthermore, the tip of the air core portion 220 of the heat transfer tube 210 is filled with an insulating material 214b made of resin or the like, adjacent to one end of the heater body 230. The insulating material 214b prevents the heat-generating area from extending to the tip of the heat transfer tube 210 and becoming a heat-generating area.

[0093] In the example shown in Figure 5(D), this method is effective when heating lesions in deep organs or when heating lesions using a laparoscope. In addition, since the heater body 230 is not folded, it is possible to reduce the diameter of the heat transfer tube 210.

[0094] For example, if only the middle section of the heat transfer tube 210 is to be used as the heating element, the insulating material 214b can be provided at both ends of the heater body 230. In this way, within the heat transfer tube 210, the size of the heater body 230 can be adjusted, and the insulating material 214b can be positioned adjacent to the ends of the heater body 230 to adjust the position and range of the heating element.

[0095] The temperature sensing element 240, inserted into the air core portion 220 of the heat transfer tube 210, is, for example, a thermocouple. As shown in Figures 5(B) and (C), it is constructed by inserting a pair of strands 248, 248 made of two different types of metal wires from the base end to the tip end 211 of the heat transfer tube 210. The ends of the pair of strands 248, 248 are joined together at the tip end to form a temperature sensing junction or a temperature junction. The temperature sensing element 240 is also covered with an insulating material. This insulating material 248a is, for example, a polyimide tube.

[0096] Furthermore, the temperature detection element 240 of the thermal probe 10 is not limited to a thermocouple as described above, but may be any device capable of detecting temperature, such as a thermistor.

[0097] Furthermore, the insulating materials 235a and 248a covering the heater body 230 and temperature sensing element 240 are not limited to polyimide tubes as described above; any material with heat resistance and insulating properties may be used.

[0098] Figures 6(A) and 6(B) illustrate the structure of other modified examples of the microheater 2 provided in the thermal probe 10, where (A) is a cross-sectional view of the microheater 2 and (B) is a longitudinal cross-sectional view of the microheater 2.

[0099] The microheater 2 shown in Figures 6(A) and (B) is constructed by housing a linear heater body 230 and a temperature sensing element 240 within an air core 220 formed inside a heat transfer tube 210, while ensuring an insulating distance between them. The heat transfer tube 210 is made of a material with good thermal conductivity (for example, a metal material such as stainless steel or copper), and has openings 211 and 212 at both ends. The diameter of the heat transfer tube 210 is not particularly limited, but for example, an ultra-fine tube with an outer diameter of about 0.3 mm can be used. The heat transfer tube 210 preferably has self-supporting and flexible properties so that it can be easily inserted into narrow spaces.

[0100] The heater body 230 has a heating element 235 and a lead element 236 connected along its longitudinal direction, and a folded portion 234 is formed by bending either the heating element 235 or the lead element 236.

[0101] The heater body 230 is constructed by covering a portion of the surface of a linear body made of a metal material with high electrical resistivity with a metal plating film or metal foil made of a metal material with lower electrical resistivity than the linear body. The portion of the linear body covered by the low-resistivity metal material constitutes the lead portion 236, and the portion of the linear body that is exposed constitutes the heating portion 235. The position of the heating portion 235 on the heater body 230 is not particularly limited and may be formed in multiple locations rather than just one. However, it is preferable that at least the folded portion 234, which is the tip of the heater body 230, is formed on the heating portion 235, as this allows for accurate positioning of the heating portion 235 within the body. The heater body 230 can also be constructed, for example, by arranging a heating portion made of a linear member between multiple lead portions made of cylindrical members, and crimping and fixing both ends of the heating portion to the open ends of each lead portion.

[0102] Examples of high-resistance metal materials for the wire constituting the heating element 235 include nickel, iron, platinum, chromium, titanium, and their alloys (such as stainless steel and nichrome). The wire is preferably a single wire for thinning purposes, but may also be made of multiple single wires twisted together. On the other hand, examples of low-resistance metal materials for the coating that covers the wire and constitutes the lead element 236 include gold, silver, copper, aluminum, and their alloys.

[0103] The heating element 235 and the lead element 236 are covered by an outer casing 238. The outer casing 238 preferably has excellent thermal conductivity, heat resistance, and electrical insulation properties. In this embodiment, a polyimide resin is used, but other examples include fluororesins, olefin resins, polystyrene resins, polyester resins, polyurethane resins, ABS resins, and polymer alloys of polyamide resin and ABS resin. The outer casing 238 can be formed by a tube or coating that covers the heating element 235 and the lead element 236. The thickness of the outer casing 238 is preferably about 0.5 to 10 μm, as too much thickness reduces thermal conductivity, while too little thickness tends to reduce electrical insulation.

[0104] The heater body 230 is arranged such that a pair of ends 236a and 236b of the lead portion 326 are led out from an opening 211 on one end of the heat transfer tube 210, and the folded portion 234 is positioned near the opening 212 on the other end of the heat transfer tube 210. With the folded portion 234 of the heater body 230 pre-formed, the pair of ends 236a and 236b are inserted from the opening 212 on the other end of the heat transfer tube 210, and the amount they are pulled out from the opening 211 on one end can be adjusted to easily position the folded portion 234 inside the heat transfer tube 210.

[0105] The pair of ends 236a and 236b of the lead portion 236 are connected to a power line cord 270 via a power supply line (not shown) at a needle base portion 260 attached to the end of the heat transfer tube 210. A 4-pin plug 280 provided at the tip of the power line cord 270 leading out from the needle base portion 260 is inserted into one of the jacks 39A, 39B, 39C, and 39D provided on the front panel of the control device 20, thereby connecting the heater body 230 and the temperature sensing element 240 to the control device 20 via the power line cord 270.

[0106] Inside the heat transfer tube 210, in addition to the heater body 230, a temperature sensing element 240 such as a thermocouple is housed. The temperature sensing element 240 is inserted into the heat transfer tube 210 through an opening 211 at one end, and the temperature sensing part 241 at the tip is positioned near the heating element 235 of the heater body 230. The temperature sensing element 240 is also connected to the power line cord 270 within the needle base 260.

[0107] In the control device 20 to which the microheater 2 is connected via the power line cord 270, the temperature detection element 240 detects the temperature near the heating element 235, thereby enabling accurate power supply control to heat the object to be heated to a desired temperature.

[0108] The gap formed between the inner surface of the heat transfer tube 210 and the heater body 230 and temperature sensing element 240 is filled with sealing resin 214. The sealing resin 214 preferably has good thermal conductivity, and for example, epoxy resins, imide resins, silicone resins, and fluororesins can be suitably used. In particular, epoxy resins can be suitably used as sealing resin 214 because, by selecting one with low viscosity, it is easy to fill the heat transfer tube 210, and it has good thermal conductivity (about 10 times that of air), high heat resistance (heat resistance temperature of about 200°C), and low shrinkage during curing. The thermal conductivity of the sealing resin 214 can be further improved by adding additives such as alumina and silica.

[0109] When the inner diameter of the heat transfer tube 210 is small, the sealing resin 214 can be filled into the gaps of the heat transfer tube 210 by using a low-viscosity resin solution to allow it to penetrate using capillary action, and then solidifying it. Alternatively, the sealing resin 214 can be injected into the heat transfer tube 210 under pressure. The inside of the heat transfer tube 210 may be filled with a filler other than resin. The filler is preferably one with a thermal conductivity higher than air, and can be, for example, metal or ceramics, and can be solid (powder, granular) or liquid, regardless of its shape. The heat transfer tube 210 can also be used with one end closed.

[0110] With the microheater 2 having this configuration, the heating element 235 is formed to follow a part of the heat transfer tube 210 when the heater body 230 is housed in the heat transfer tube 210. This makes it possible to create a desired temperature distribution along the longitudinal direction of the heat transfer tube 210, allowing for localized and efficient heating of the object to be heated. Furthermore, by extending the lead portion 236 that connects the heating element 235 to the outside of the heat transfer tube 210, the heat transfer tube 210 can be easily made longer. This allows for easy insertion into spaces with small openings and long depths, such as hypodermic needles, and enables selective heating of only the affected area.

[0111] In this thermal probe 10, the microheater 2 is housed in an air core 220 formed inside the heat transfer tube 210, with the linear heater body 230 and temperature sensing element 240 arranged while maintaining an insulating distance. However, the heater body 230 and temperature sensing element 240 may also be housed in the internal space of the heat transfer body, with maintaining an insulating distance.

[0112] This temperature-controlled heating treatment system 100 is equipped with three types of microheaters 2 with heating elements 235 lengths of 10 mm, 20 mm, and 30 mm. A 27G (outer diameter 0.42 mm) microheater 2 is inserted inside a minimally invasive 22G (diameter 0.72 mm) puncture needle 1 to heat the tip of the puncture needle 1 from 10 mm to 30 mm, allowing for irreversible thermal denaturation of cells through heat conduction to the lesion. Up to four punctures can be performed simultaneously, and there are no restrictions on the orientation of the needles.

[0113] As described above, the control device 20 of this temperature-controllable heating treatment system 100 comprises an isolated AC / DC converter 34 connected to a commercial power supply that converts the commercial power supply to a DC power supply of safety extra-low voltage or lower, and an isolated power supply unit 30 consisting of a DC / DC converter 37 that converts the DC power supply of safety extra-low voltage or lower obtained by the isolated AC / DC converter 34 into a low-voltage DC power supply for heater driving and supplies DC power to the microheater 2 provided in the thermal probe 10. The heater power control unit 40 controls the DC power supplied from the isolated power supply unit 30 to the microheater 2 based on the temperature detection result of the temperature detection element 240 arranged in the microheater 2 so that the microheater 2 generates a predetermined amount of heat, so that the temperature is above the temperature at which the proteins in the lesion irreversibly denature and below the temperature at which the lesion localizes and boils.

[0114] In other words, this temperature-controllable heating treatment system 100 is a line-powered cautery device that heats and denatures a lesion by puncturing, inserting, or pressing the thermal probe 10 against the lesion and heating the lesion. Based on the temperature detection result, the heater power control unit 40 controls the DC power supplied from the isolated power supply unit 30 to the microheater 2 so that the amount of heat is greater than or equal to the amount of heat required to irreversibly denature the proteins in the lesion, and less than or equal to the temperature at which the lesion localizes and boils.

[0115] In this control device 20, the heater power control unit 40 exchanges information with the control unit 50 via serial transmission using optical communication, and controls the DC power supplied from the isolated power supply unit 30 to the microheater 2 according to the control commands given by the control unit 50.

[0116] In this temperature-controlled heating treatment system 100, the control unit 50 allows the treatment time to be selected in 1-second increments from 0 minutes 00 seconds to 10 minutes 00 seconds, and the doctor selects the time each time a treatment is performed. To change the treatment time, touching the treatment time display value for each channel on the touch panel displays a numeric keypad, allowing for numerical input, confirmation, and cancellation. In the treatment state, the system has a timer function that adds the selected time in 1-second increments, and when the sum reaches the treatment time, it transitions the state of the treatment channel to the standby state. The timer function also has a count-up display function that starts counting from the moment the treatment temperature reaches the target temperature and displays the time.

[0117] Furthermore, in this temperature-controlled heating treatment system 100, the treatment temperature can be selected in 1°C increments within the range of 50°C to 99°C by the control unit 50, and the doctor selects the temperature each time a treatment is performed. To change the treatment temperature, touching the treatment temperature display value for each channel on the touch panel will display a numeric keypad, allowing for numerical input, confirmation, and cancellation.

[0118] Furthermore, in this temperature-controlled heating treatment system 100, the microheater 2 used is selected by the physician according to the treatment area. The length of the heating element 235 is 10 mm and the heater resistance value is HR. 10 The heating element 235 has a length of 20 mm and a heater resistance value of HR. 20 The heating element 235 has a length of 30 mm and a heater resistance value of HR. 30 Three types of microheaters 2 are available, and the control unit 50 has the function of identifying and displaying the heater type based on the heater resistance value HR of the microheater 2 connected via jacks 39A, 39B, 39C, and 39D provided on the front panel.

[0119] The temperature-controlled heating treatment system 100 supplies DC power from the isolated power supply unit 30 to the microheater 2 during the period the treatment timer is operating, heating the tip of the microheater 2. Upon commencement of the DC power supply to the microheater 2, the temperature of the microheater 2 is quickly raised to the set treatment temperature, and this temperature is maintained for the period the treatment timer is operating. The treatment temperature is measured by a temperature detection element 240 inside the microheater 2 and displayed on the front panel by the control unit 50. The treatment timer counts time from the moment the treatment temperature is reached.

[0120] Here, Figure 7 is a schematic diagram showing the functional configuration of the above-described temperature-controlled heating treatment system 100.

[0121] In the above-described temperature-controllable heating treatment system 100, the power supply function F1 is a function of an isolated power supply unit 30 consisting of an isolated AC / DC converter 34 connected to a commercial power supply and converting the commercial power supply to a DC power supply of safety extra-low voltage or lower, and a DC / DC converter 37 that converts the DC power supply of safety extra-low voltage or lower obtained by the isolated AC / DC converter 34 into a low-voltage DC power supply for heater driving and supplies DC power to the microheater 2 provided on the thermal probe 10. The heater power control unit 40, which operates according to control commands from the control unit 50, individually controls the operation of the four channels DC / DC converters 37A, 37B, 37C, and 37D of the isolated power supply unit 30, and independently controls the DC power supplied to each of the four microheaters 2 of the thermal probe 10 so as to achieve the temperature and / or heating time set in the control unit 50.

[0122] Furthermore, the standby state F2 is a state in which the supply of DC power from the DC / DC converter 37 of the power supply unit 32 to the microheater 2 provided in the thermal probe 10 is stopped, and the system can transition to various function stages such as temperature setting F3, time setting F4, calendar setting F5, heater test F6, and treatment start F7.

[0123] In other words, in this control device 20, the control unit 50 has a temperature setting function F3 for independently setting the temperature of the thermal denaturation process using the thermal probe 10 for each channel, and a time setting function F4 for setting the elapsed time for each channel to be controlled at the set temperature. All channels start and stop simultaneously. However, the temperature is controlled according to the temperature set for each channel.

[0124] The control unit 50, upon receiving an operation input for the heater test switch from the setting / display unit 54, transitions from standby state F2 to heater test state F3, tests whether the microheater 2 to be used is operating normally, and displays the heater test result on the screen via the setting / display unit 54.

[0125] Furthermore, the control unit 50 transitions from standby state F2 to treatment start state F7 when it receives an input from the setting / display unit 54 to the start switch 52 which instructs the start of treatment, and sends a control command to the heater power control unit 40 to instruct the start of treatment.

[0126] When the heater power control unit 40 receives a control command from the control unit 50 to initiate treatment F7, it individually controls the operation of the four DC / DC converters 37A, 37B, 37C, and 37D of the isolated power supply unit 30 to start supplying DC power to each microheater 2, quickly raising the temperature of the microheater 2 to the set treatment temperature and maintaining that temperature for the duration that the treatment timer is operating. The treatment temperature is measured by a temperature detection element 240 inside the microheater 2 and displayed on the front panel by the control unit 50.

[0127] Then, the control unit 50 counts time using a treatment timer from the moment the treatment temperature is reached, and when the set time has elapsed, it transitions from the treatment start state to the treatment end state F8 and sends a control command to the heater power control unit 40 to indicate the end of treatment F8.

[0128] When the heater power control unit 40 receives a control command from the control unit 50 indicating the end of treatment F8, it stops the operation of the four DC / DC converters 37A, 37B, 37C, and 37D of the isolated power supply unit 30 and stops supplying DC power from the isolated power supply unit 30 to the microheater 2.

[0129] Furthermore, the heater power control unit 40, upon receiving an input from the emergency stop switch 42, initiates an interrupt from any stage and transitions to emergency stop F10, thereby emergency stopping the operation of the four DC / DC converters 37A, 37B, 37C, and 37D of the isolated power supply unit 30, and emergency stopping the supply of DC power from the isolated power supply unit 30 to the microheater 2. The control unit 50 displays the emergency stop F10 state on the screen using the setting / display unit 54.

[0130] Furthermore, the control unit 50 performs error processing F11 according to the judgment conditions. When an error occurs, it stops all channels, emits an alarm sound, and displays an error screen via the setting / display unit 54. This screen remains displayed until the error is cleared. To ensure safety, it does not have an error avoidance function using a backup circuit.

[0131] Figure 8 is a flowchart illustrating the thermal denaturation process using the thermal probe 10 described above.

[0132] In this temperature-controllable heating treatment system 100, when performing thermal denaturation treatment using the thermal probe 10, the user, such as a physician, is assumed to have obtained basic information such as the location and size of the lesion.

[0133] In the thermal denaturation process of this temperature-controllable heating treatment system 100, first, in a standby state F2 in which the supply of DC power from the DC / DC converter 37 of the isolated power supply unit 30 to the microheater 2 provided on the thermal probe 10 is stopped, the heating temperature of the thermal probe 10, for example 60°C, is input to the control unit 50 via the setting / display unit 54 (step S1). Also, the heating time, for example 10 minutes, is input (step S2). The control unit 50 stores the heating temperature and heating time input in steps S1 and S2 in memory.

[0134] Then, the control unit 50 detects the connection status and type of the microheater 2 equipped with a thermal probe 10 connected to the temperature-controllable heating treatment system 100 (step S3), and displays the connection status and type of the microheater 2 along with the heating temperature and heating time on the setting / display unit 54 (step S4).

[0135] Next, the user punctures or inserts the required number (up to 4) of thermal probes 10 connected to the temperature-controllable heating treatment system 100 into the appropriate location on the lesion (step S5).

[0136] Then, after the thermal probe 10 is punctured or inserted into a predetermined position, the user initiates the heating start operation, and the setting / display unit 54 receives an input from the start switch 52 to instruct the start of treatment. The control unit 50 then transitions from standby state F2 to treatment start state F7, sends a control command to the heater power control unit 40 to instruct the start of treatment, starts the treatment timer count, and turns on the microheater 2 of the thermal probe 10 (step S6). At this time, the control unit 50 receives the temperature detected by the temperature detection element 240 as input, and according to the detected temperature, the heater power control unit 40 controls the operation of the DC / DC converter 37 to control the DC power supplied to the microheater 2. PID control (proportional, integral, and differential control) based on the temperature detected by the temperature detection element 240 is used to ensure that the temperature of the lesion reaches the desired set temperature.

[0137] Next, the control unit 50 determines whether the treatment time, which is counted by the treatment timer, has elapsed since the start of heating, for example, 10 minutes (step S7). If it determines that the set time has elapsed, it proceeds to step S8; otherwise, it repeats step S7.

[0138] Finally, the control unit 50 stops supplying DC power to the microheater 2, turns off the microheater 2, and ends the heating (step S8). The control unit 50 may also provide a step to notify the user of the end of heating via the setting / display unit 54.

[0139] This temperature-controllable heating therapy system 100 can control the output of each thermal probe 10's microheater 2 independently using PID control according to the temperature detected by the temperature sensing element 240 of each thermal probe 10, thereby controlling each thermal probe 10 unit to reach a desired set temperature. Therefore, this temperature-controllable heating therapy system 100 can reliably maintain the desired heating temperature even if there is a temperature loss in a part of the lesion due to blood flow or heat conduction. In other words, this temperature-controllable heating therapy system 100 can irreversibly denature proteins by applying a predetermined amount of heat (heating time and heating temperature) to the lesion. Furthermore, this temperature-controllable heating therapy system 100 can also kill or necrotize cancer stem cells.

[0140] As described above, the control device 20 of this temperature-controllable heating treatment system 100 has a circuit board installed inside the casing 21 of the control device 20 in a floating state insulated from the casing 21. This circuit board includes an isolated power supply unit 30 connected to a 3-pin power outlet 31 via a fuse 32 and a power switch 33, a heater power control unit 40 equipped with a sub-CPU 41 mounted on a heater control board, and a control unit 50 equipped with a main CPU 51 mounted on a main board. The isolated power supply unit 30 is connected to the commercial power supply (AC 100~240V ±10%) via a 3-wire power cable 120 into which a 3-pin power plug 121 is inserted into the power outlet 31, and the casing 21 of the control device 20, to which the ground contact of the 3-pin power outlet 31 is connected and the shield case 30A of the isolated AC / DA converter 34 is connected, is grounded.

[0141] As shown in the circuit diagram in Figure 2 above, in this temperature-controllable heating treatment system 100, the circuit board installed in a floating state insulated from the casing 21 of the control device 20 has a protection level of 1 MOPP (Means of Patient Protection) as a means of patient protection for medical electrical equipment as defined in the "IEC60601-1" standard. However, the control device 20 of this temperature-controllable heating treatment system 100 converts commercial power (AC100~240V±10%) into a constant 12V DC power supply below the safety extra-low voltage by an isolated AC / DC converter 34 equipped with an isolation transformer 35 insulated from the primary and secondary sides of the isolated power supply unit 30. Therefore, the AC side and DC side are insulated, and the DC side has a protection level of 2 MOPP (Means of Patient Protection). Furthermore, on the DC side, the heater control board, which is equipped with the heater power control unit 40 and the 4-channel DC / DC converter 37, is also isolated and has a protection level of 2 MOPP (Means of Patient). In addition, the thermal probe 10, which is connected via power line cord 270 to jacks 39A, 39B, 39C, and 39D provided on the front panel of the control device 20 and to which the DC power supply from the 4-channel DC / DC converter 37 is supplied to the microheater 2, has a protection level of 1 MOPP (Means of Patient Protection) to the casing 21 of the control device 20, but has a protection level of 2 MOPP (Means of Patient Protection) to the AC side and DC side within the casing 21, respectively.

[0142] This temperature-controllable heating treatment system 100 is a line-powered cautery device that operates using power from a commercial power supply, which operates at a frequency of 50Hz or 60Hz and has an effective value ranging from 100V±10% to 240V±10%. It heats the lesion using a microheater 2 provided on a thermal probe 10 to cause thermal denaturation. The system is connected to a commercial power supply via an isolated AC / DC converter 34 that converts the commercial power supply to a DC power supply below the safe extra-low voltage, and the DC power supply below the safe extra-low voltage converted by the isolated AC / DC converter 34 is converted to a low-voltage DC power supply for driving the heater. The device includes an isolated power supply unit 30 consisting of a DC / DC converter 37 that supplies DC power to the heater 2, and a heater power control unit 40 that controls the DC power supplied from the isolated power supply unit 30 to the microheater 2 based on the temperature detection result of a temperature detection element 240 arranged on the microheater 2, so that the microheater 2 generates a predetermined amount of heat. The DC power supplied from the isolated power supply unit 30 to the microheater 2 is controlled so that it is above the amount of heat that irreversibly denatures the proteins in the lesion, and below the temperature at which the lesion boils locally. This reduces the risk of dangerous electric shock to the human body, and the microheater 2 inserted inside is heated by the current flowing through the puncture needle 1, which denatures the lesion by heat, thereby safely and reliably achieving a therapeutic effect.

[0143] The isolated power supply unit 30 in this temperature-controllable heating treatment system 100 can be configured to supply a maximum of 1A of DC power per channel to the microheater 2 of the thermal probe 10 at a DC voltage of 24V or less.

[0144] Here, IEC60364-4 (Electrical installation of building - Part 4: Protection for safety) defines the safe extra-low voltage that minimizes the risk of electric shock to the human body as 60V or less for DC and 25V or less for AC. Furthermore, J60598-1, the standard of the Electrical Appliances and Materials Safety Act in Japan, defines a safe voltage as 30V or less for AC and 45V or less for DC. In the isolated power supply unit 30 of this control device 20, an isolated AC / DC converter 34 connected to the commercial power supply converts the commercial power supply to a DC power supply of, for example, 24V or 12V DC, which is below the safe extra-low voltage, and uses it as the DC power supply for driving the control device 20. The AC / DC converter 34 converts the commercial power supply to a DC power supply below the safety extra-low voltage, which is then converted again by the DC / DC converter 37 to obtain a low-voltage DC power supply for heater driving. This DC power is then supplied to the microheater 2 provided in the thermal probe 10. As a result, the low-voltage DC power supply for heater driving is isolated from the commercial power supply, and moreover, the DC power supplied to the microheater 2 is obtained from a low-voltage DC power supply for heater driving that is obtained by converting the DC power supply below the safety extra-low voltage again, thus reducing the risk of electric shock to the human body.

[0145] Furthermore, this temperature-controllable heating treatment system 100 can also function as a battery-powered temperature-controllable heating treatment system by replacing the isolated AC / DC converter 34 of the isolated power supply unit 30 connected to the commercial power supply provided in the control device 20 with a battery.

[0146] Furthermore, this temperature-controllable heating treatment system 100 uses a thermal probe 10 to heat tissue to a maximum of 250°C in a radius corresponding to the length of the heater body 230, with thermal energy transferred from the thermal probe 10 to the tissue. The thermal probe 10 is heated from the inside by DC power, preventing burns from the counter electrode plate during surgery and not causing electromagnetic effects on other medical devices or the patient.

[0147] This temperature-controlled heating treatment system 100 does not involve the living body as part of the electrical circuit. Current flows only within the thermal probe 10, and unlike radiofrequency ablation (RFA), no current is passed through the living body. Therefore, it is inherently safe, has a lower risk of perforation compared to RFA, and has a temperature control function that allows for thermal denaturation of the lesion while controlling the temperature locally. By thermally denaturing the lesion while controlling the temperature, no air bubbles are produced in the lesion, and the ultrasound image remains clear and clear without clouding. Furthermore, the process of thermal denaturation of the tissue can be observed on CT.

[0148] In this temperature-controllable heating therapy system 100, the thermal probe 10 is provided as having a microheater 2 inserted into the needle portion 12 of a puncture needle 1. However, any device that punctures, inserts, or presses against a lesion to heat the lesion and cause thermal denaturation of the biological tissue of the lesion is acceptable. For example, the microheater 2 may have blades of various shapes at its tip, or it may be used by inserting the microheater 2 into a trocar or catheter.

[0149] The above-described temperature-controllable heating treatment system 100 can be applied to an endoscopic treatment system 1000, whose schematic configuration is shown in the schematic diagram of Figure 9, by, for example, providing a thermal probe 10 that is shaped to be inserted into an endoscope for treatment.

[0150] Figure 9 is a schematic diagram showing the general configuration of an endoscopic treatment system 1000 in which an ultrasound endoscope 1010 is inserted into the patient's body through the esophagus via the patient's mouth or nostril, and the procedure is performed while viewing the image of the affected area obtained by the ultrasound endoscope 1010 on a monitoring device 1020. Figures 10(A) and (B) are schematic diagrams for explaining the usage state of the thermal probe 10 of the temperature-controllable heating treatment system 100 in the endoscopic treatment system 1000. (A) shows the thermal probe 10 with the heating element 235 located inside the guide needle 1030, and (B) shows the thermal probe 10 with only the guide needle 1030 retracted to expose the heating element 235. The guide needle 1030 also includes a biopsy needle.

[0151] Figure 11 shows an example of an endoscopic procedure (improvement of passage obstruction) performed using this endoscopic treatment system 1000.

[0152] In this endoscopic treatment system 1000, for example, heat therapy is performed according to the following procedure. Step 1: As shown in Figure 10(A), the thermal probe 10 (microheater 2) of the temperature-controllable heating treatment system 100 is passed through the guide needle 1030 in advance. Step 2: While viewing the image of the affected area obtained by the ultrasound endoscope 1010 on the monitoring device 1020, a guide needle 1030 is inserted through the forceps channel 1015 of the endoscope 1010, and it is confirmed that the tip of the guide needle 1030 has reached the target affected area. As shown in Figure 10(A), the heating element 235 of the thermal probe 10 is located inside the guide needle 1030 inserted through the forceps channel 1015. Step 3: Once the tip of the guide needle 1030 reaches the target affected area, as shown in Figure 10(B), only the guide needle 1030 is moved backward to expose the heating element 235 of the thermal probe 10 to the tissue in order to increase heat conduction efficiency. Step 4: The tip of the thermal probe 10, once it reaches the target affected area, is punctured, inserted, or pressed against the lesion, and heating is started at the temperature and time set in the control device 20 of the temperature-controllable heating treatment system 100. By heating the lesion, the biological tissue of the lesion is thermally denatured, and heating treatment is performed. Furthermore, these treatments may be performed using surgical assistance devices.

[0153] Here, the temperature-controlled heating treatment system 100 was applied to the endoscopic treatment system 1000 using the ultrasound endoscope 1010, but as shown in Figures 12(A), (B), and (C), it can also be applied to endoscopic treatment systems using conventional endoscopes other than ultrasound endoscopes.

[0154] Figures 12(A), (B), and (C) are schematic diagrams showing treatment examples using endoscopic treatment systems, where (A) is an oral or transnasal gastrointestinal endoscope 1050A, (B) is a colonoscope 1050B, and (C) is a bronchoscope 1050C.

[0155] Figure 13 is a schematic diagram showing the general configuration of a laparoscopic treatment system 2000 using the above-mentioned temperature-controllable heating treatment system 100.

[0156] In this laparoscopic treatment system 2000, as shown in Figure 13, a small incision of about 1 cm in diameter is made in the body surface, and a trocar 2010, which serves as a passage (tube) for inserting forceps and other instruments into the body, is inserted into the incision. By injecting carbon dioxide gas, the inside is inflated to create space in the abdominal cavity. Then, an endoscope is inserted through this trocar 2010, and after internal observation, forceps and other instruments are inserted into the body through the trocar 2010, and surgical procedures are performed while confirming the internal state displayed on the endoscope using a monitoring device. During this procedure, the thermal probe 10 of the temperature-controllable heating treatment system 100 is inserted into the trocar 2010, and the tip of the thermal probe 10 is punctured, inserted, or pressed against the lesion of an organ such as the liver or pancreas, and the lesion is heated, causing thermal denaturation of the biological tissue of the lesion, thereby performing heat treatment. In addition, in this laparoscopic treatment system 2000, the thermal probe 10 of the temperature-controlled heating treatment system 100 may also be used via a surgical support device.

[0157] Figure 14 is a schematic diagram of catheter ablation treatment using the above-described temperature-controllable heating treatment system 100.

[0158] In catheter ablation therapy using this temperature-controllable heating system 100, local anesthesia is administered, and a cauterizing catheter 3010, approximately 2 mm in diameter with a thermal probe 10 of the temperature-controllable heating system 100 inserted, is placed in a blood vessel running through the neck, below the collarbone, or in the groin. The catheter is then advanced along the blood vessel into the heart, and with the tip of the thermal probe 10 pressed against the lesion, heating is started at the temperature and time set in the control device 20 of the temperature-controllable heating system 100. By heating the lesion, the biological tissue of the lesion is thermally denatured, preventing the heart muscle from conducting electricity and thus suppressing the occurrence of arrhythmias. Furthermore, in catheter ablation therapy using this temperature-controllable heating system 100, the catheter 3010 can also be inserted into a blood vessel, and the thermal probe 10 can be used to heat and denaturate lesions such as inflammation, tumors, or varicose veins within the blood vessel. Furthermore, in catheter ablation treatment using this temperature-controllable heating treatment system 100, the thermal probe 10 of the temperature-controllable heating treatment system 100 may also be used via a surgical support device.

[0159] In treatment using this medical device 100, for example, the tip of the air core portion 13 can be sealed so that only the needle portion 12 is used for a single treatment.

[0160] The tip of the heat transfer tube 210 can be made sharp enough to puncture tissue. Alternatively, when inserting it into a guide needle 1030, the tip of the heat transfer tube 210 can be made blunt so that it can be inserted smoothly without damaging the inside of the guide needle 1030.

[0161] Figures 15(A) to (F) are schematic diagrams illustrating the process of reducing the volume of tissue in the affected area P, showing the volume reduction procedure.

[0162] The tip of the guide needle 1030, which has the heating element 235 pre-inserted, is confirmed by endoscopic images to have been punctured or pressed against the affected area P to be treated, as shown in (A) to (C). At this time, in order to enhance the heat transfer effect, the guide needle 1030 may be retracted to expose the heating element 235 into the tissue, as shown in (D). Similarly, in order to enhance the heat transfer effect, the heating element 235 may be pushed out from the tip of the guide needle 1030. To make the heating element 235 more visible, markers or other markings may be attached to the thermal probe 10 or the guide needle 1030, or they may be color-coded. After that, the start switch 52 is pressed to start heating. The tissue of the affected area P, which has been heated and denatured by heat, is phagocytosed by immune cells and its volume is reduced over time, as shown in (E) and (F).

[0163] Figures 16(A) and (B) are schematic diagrams showing other configuration examples of the thermal probe 10 of the temperature-controllable heating treatment system 100, where (A) shows an example of a thermal probe 10 with heating elements 235 installed in multiple locations, and (B) shows an example of a thermal probe 10 with a long heating element 235 installed.

[0164] In other words, the heat-generating element 235 built into the thermal probe 10 can be installed at multiple locations within the thermal probe 10, as shown in (A) of Figure 16, and the temperature detection element 240 can also be placed at multiple locations accordingly. Furthermore, if the length of the heat-generating element 235 is long, the temperature detection element 240 can be installed at multiple locations on the heat-generating element 235, as shown in (B).

[0165] This treatment device 100 can also be used for endovascular treatment, such as for varicose veins in the lower extremities. It approaches the lesion in a non-functional blood vessel either percutaneously or intravascularly, and thermally coagulates the tissue at the lesion site. It may also be used in conjunction with a surgical support device.

[0166] The thermal probe 10 can be used independently without passing through a guide needle 1030 or endoscope. Furthermore, during catheter treatment, the thermal probe 10 can be inserted into the catheter after the guide wire has reached the affected area and been removed, allowing for heat treatment only on the affected area.

[0167] In the above-described temperature-controllable heating treatment system 100, the heater power control unit 40 controls the DC power supplied from the isolated power supply unit 30 to the microheater 2 based on the temperature detection result from the temperature detection element 240 in the microheater 2, so that the temperature is above the temperature at which the proteins in the lesion irreversibly denature and below the temperature at which the lesion locally boils, thereby heating the lesion and performing heating treatment by thermally denaturering the biological tissue of the lesion. Alternatively, the heater power control unit 40 can control the DC power supplied from the isolated power supply unit 30 to the microheater based on the temperature detection result, so that the lesion is heated to at least body temperature, thereby performing heating treatment.

[0168] In other words, the above-mentioned temperature-controllable heating treatment system 100 includes a microheater 2 in which the heater body 230 and temperature sensing element 240 are housed and arranged in the space inside the heat transfer element, that is, in the air core portion 220 formed inside the heat transfer tube 210, with an insulating distance ensured between them, a thermal probe 10 that is punctured, inserted, or pressed against the lesion to heat the lesion, and a control device 20 to which the thermal probe 10 is detachably connected, the control device 20 being connected to a commercial power supply and converting the commercial power supply to a DC power supply, and the microheater 2 provided on the thermal probe 10 The device comprises an isolated power supply unit that supplies DC power to the microheater 2, and a heater power control unit 40 that controls the DC power supplied from the isolated power supply unit 30 to the microheater 2 so that the microheater 2 generates a predetermined amount of heat, based on the temperature detection result of a temperature detection element 240 arranged on the microheater 2. The heater power control unit 40 controls the DC power supplied from the isolated power supply unit 30 to the microheater 2 based on the temperature detection result so that the temperature is at least above body temperature, thereby safely and reliably providing a heating therapy effect by heating the lesion.

[0169] In the above-described temperature-controlled heating treatment system 100, the heater power control unit 40 controls the DC power supplied from the isolated power supply unit 30 to the microheater 2 based on the temperature detection result, so as described above, that the temperature is above the temperature at which the proteins in the lesion irreversibly denature and below the temperature at which the lesion locally boils, thereby heating the lesion and safely and reliably achieving a heating treatment effect.

[0170] Furthermore, in the above-described temperature-controllable heating therapy system 100, the heater power control unit 40 controls the DC power supplied from the insulated power supply unit 30 to the microheater 2 based on the temperature detection result, so that the temperature is above body temperature but below the temperature at which proteins irreversibly denature. By heating the affected area, the system can safely and reliably exert a thermotherapy effect that promotes blood flow, relieves muscle tension, and reduces pain. Thermotherapy can also contribute to relaxation, stress reduction, and mental stability through the pleasant warmth it provides.

[0171] Furthermore, in the above-described temperature-controllable heating treatment system 100, the heater power control unit 40 can control the DC power supplied from the isolated power supply unit 30 to the microheater 2 based on the temperature detection result so that the temperature is above the temperature at which a cauterizing effect can be obtained by thermal coagulation of the lesion, thereby heating the lesion.

[0172] Furthermore, in a temperature-controlled heating treatment system used in connection with a commercial power supply according to the present invention, the heater power control unit can control the DC power supplied from the isolated power supply unit to the microheater based on the temperature detection result so that the temperature is above body temperature and below the temperature at which proteins irreversibly denature, thereby heating the lesion.

[0173] Furthermore, in a temperature-controlled heating treatment system used in connection with a commercial power supply according to the present invention, the heater power control unit can control the DC power supplied from the isolated power supply unit to the microheater based on the temperature detection result so that the lesion reaches a temperature above which a cauterizing effect can be obtained by thermal coagulation, thereby heating the lesion.

[0174] In the above-described temperature-controllable heating treatment system 100, the control unit 50 allows the treatment temperature to be selected in 1°C increments within the range of 50°C to 99°C. However, the treatment temperature may also be increased to approximately 250°C, which is the heat resistance temperature of the heat transfer element constituting the microheater 2, that is, the heat resistance temperature of the sealing resin 214 that fills the gap in the air core portion 220 of the heat transfer tube 210, which is housed in a configuration that ensures an insulating distance between the heater body 230 and the temperature detection element 240.

[0175] Furthermore, the thermal probe 10 may also have a shape that allows it to directly reach the affected area for treatment. [Explanation of Symbols]

[0176] 1 Puncture needle, 2 Microheater, 10 Thermal probe, 11 Puncture area, 12 Needle section, 13 Air core section, 14 Insertion hole, 15 Needle base, 20 Control device, 30 Isolated power supply unit, 30A Shielded case, 31 Power outlet, 32 Fuse, 33 Power switch, 34 Isolated AC / DA converter, 35 Isolation transformer, 36 Switching regulator, 37, 37A~37D DC / DC converter, 38A, 38B, 38C, 38D Isolation amplifier, 39A, 39B, 39C, 39D Jack, 40 Heater power control unit, 41 Sub-CPU, 42 Emergency stop switch, 42A Emergency stop button, 50 Control unit, 51 Main CPU, 52 Start switch, 53 Stop switch, 54 Setting / Display unit, 55 RS232C port, 100 Temperature-controlled heating treatment system, 110 Handle, 120 Power cable, 210 Heat transfer tube, 211, 212 Opening, 214 Sealing resin, 220 Hollow core, 230 Heater body, 234 Folded part, 235 Heating part, 236 Lead part, 236a, 236b End part, 238 Outer casing, 240 Temperature sensing element, 241 Temperature measuring part, 250 Needle part, 260 Needle base, 270 Power line cord, 280 Plug, 1000 Endoscopic treatment system, 1010 Ultrasound endoscope, 1015 Forceps channel, 1020 Monitor device, 1030 Guide needle, 1050A Gastrointestinal endoscope, 1050B Colonoscope, 1050C Bronchoscope, 2000 Laparoscopic treatment system, 2010 Tracar, 3010 catheter

Claims

1. A microheater is provided in which the heater body and temperature sensing element are housed in the internal space of the heat transfer element while maintaining an insulating distance, and a thermal probe is used to heat the lesion by puncturing, inserting, or pressing it against the lesion. The control device to which the above thermal probe is detachably connected It consists of, The above control device is An isolated power supply unit connected to a commercial power supply, which converts the commercial power supply into a DC power supply and supplies DC power to the microheater provided in the thermal probe, The system includes a heater power control unit that controls the DC power supplied from the isolated power supply unit to the microheater so that the microheater generates a predetermined amount of heat, based on the temperature detection result of a temperature detection element placed on the microheater. The heater power control unit controls the DC power supplied from the isolated power supply unit to the microheater based on the temperature detection result so that the temperature is at least above body temperature, thereby heating the lesion in this temperature-controlled heating therapy system.

2. The heater power control unit controls the DC power supplied from the isolated power supply unit to the microheater based on the temperature detection result, so as to heat the lesion, such that the temperature is above the temperature at which the proteins in the lesion irreversibly denature and below the temperature at which the lesion locally boils, thereby enabling temperature control for the heating treatment system according to claim 1.

3. The heater power control unit controls the DC power supplied from the isolated power supply unit to the microheater based on the temperature detection result so that the temperature is above body temperature and below the temperature at which proteins irreversibly denature, thereby heating the lesion, as described in claim 1.

4. The heater power control unit controls the DC power supplied from the insulated power supply unit to the microheater based on the temperature detection result so that the temperature is above the temperature at which a cauterizing effect can be obtained by thermal coagulation of the lesion, thereby heating the lesion, as described in claim 1.

5. The thermal probe described above has a shape that allows it to reach the affected area directly for treatment, as described in claim 1, enabling temperature control for heating therapy.

6. The thermal probe described above has a shape that allows it to be inserted into an endoscope for treatment, and is characterized by the temperature-controllable heating treatment system according to claim 1.

7. The thermal probe described above has a shape that allows it to be inserted into a laparoscope for treatment, as described in claim 6, and is capable of temperature control.

8. The above-mentioned thermal probe has a shape that allows it to be passed through a catheter for treatment, as described in claim 1, enabling temperature control in the heating treatment system.

9. The above-mentioned isolated power supply unit comprises an isolated AC / DC converter connected to a commercial power supply and converting the commercial power supply into a DC power supply of safe extra-low voltage or lower, and a DC / DC converter that converts the DC power supply of safe extra-low voltage or lower obtained by the isolated AC / DC converter into a low-voltage DC power supply for heater driving and supplies DC power to the microheater provided in the thermal probe, characterized in that it is a temperature-controllable heating treatment system according to any one of claims 1 to 8.

10. The circuit board on which the above-mentioned isolated power supply unit and heater power control unit are installed inside the casing of the control device in a floating state that is insulated from the casing. The above-mentioned isolated power supply unit is capable of supplying DC power of up to 1A at a DC voltage of 24V or less to the microheater of the thermal probe, characterized in that it is a temperature-controllable heating treatment system according to claim 9.

11. The heater power control unit is equipped with means for setting the temperature and / or heating time of the microheater, and controls the DC power supplied from the DC / DC converter to the microheater in accordance with the thermal denaturation of the lesion, based on the temperature detection result of a temperature detection element arranged on the microheater, so that the set temperature and / or heating time is achieved. This is the heating treatment system with temperature control according to claim 10.

12. The above-mentioned isolated power supply unit has the function of supplying DC power to multiple thermal probes. The heater power control unit is equipped with means for setting the temperature and / or heating time of each of the plurality of thermal probes' microheaters, and independently controls the DC power supplied from the DC / DC converter to the microheater in accordance with the thermal denaturation of the lesion, based on the temperature detection result of the temperature detection element arranged in each microheater, so that the set temperature and / or heating time is achieved. This is the heating treatment system with temperature control according to claim 10.

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