Tissue heating device and system

Abstract

To locally heat an object tissue.SOLUTION: A tissue heating device configured to be capable of heating an object tissue includes a first part and a second part mutually disposed in different parts in a contact part coming into contact with the object tissue, where the first part and the second part have mutually different heat conductivity and / or thicknesses.SELECTED DRAWING: Figure 3

Description

[Technical field]

[0001] The present invention relates to tissue heating devices and systems. [Background technology]

[0002] Fibrous stenosis is known in which fibrosis of the treated area progresses after gastrointestinal treatment, resulting in stenosis. Fibrous stenosis can be removed by surgery. For example, a non-invasive treatment method for fibrous stenosis is balloon dilation, in which a balloon catheter is placed at the stenotic area of ​​the gastrointestinal tract and the balloon is inflated to expand the stenotic area. For example, balloon ablation is also known as a treatment method using a balloon catheter, in which a balloon is guided to the lesion and the lesion is cauterized by heating the balloon. For example, Patent Document 1 discloses a balloon catheter that employs a balloon portion having a balloon-inside-balloon structure. This balloon catheter includes a catheter shaft composed of an outer cylindrical shaft, a middle cylindrical shaft, and an inner cylindrical shaft that are slidable relative to each other, an outer balloon disposed between the tip of the outer cylindrical shaft and the tip of the inner cylindrical shaft, an inner balloon disposed between the tip of the middle cylindrical shaft and the tip of the inner cylindrical shaft and housed inside the outer balloon, an electrode and a temperature sensor disposed inside the inner balloon, a liquid feed path formed between the middle cylindrical shaft and the inner cylindrical shaft and leading to the inside of the inner balloon, an air feed path formed between the outer cylindrical shaft and the middle cylindrical shaft and leading between the outer balloon and the inner balloon, a high-frequency generator that supplies power to the electrode while measuring the internal temperature of the inner balloon via a lead wire of the temperature sensor, a liquid injector that feeds a filling liquid into the inner balloon via the liquid feed path, a vibration generator that transmits vibration waves into the inner balloon via the liquid feed path, and a gas injector that feeds gas between the outer balloon and the inner balloon via the air feed path. The balloon portion consisting of the outer balloon and the inner balloon forms an adhesive part where the expanded inner balloon can partially adhere to the expanded outer balloon. The filling liquid filled inside the inner balloon is heated by high frequency when power is supplied to the electrodes. The outer balloon maintains its position within the tubular organ and blocks thermal conduction of the inner balloon. The thermal energy of the inner balloon cauterizes the target tissue through the adhesive part with the outer balloon. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] JP 2013-132364 A Summary of the Invention [Problem to be solved by the invention]

[0004] However, in a configuration in which the target tissue is cauterized through a contact part formed in the balloon part of a balloon-within-a-balloon structure, there is a high possibility that heat will reach the surroundings of the target tissue (target tissue) due to thermal conduction in the contact part, making it difficult to locally heat the target tissue.

[0005] Therefore, an object of the present invention is to provide a tissue heating device and system capable of locally heating target tissue. [Means for solving the problem]

[0006] A tissue heating device according to one embodiment of the present invention is a tissue heating device configured to be able to heat target tissue, and has a contact portion that contacts the target tissue, a first portion and a second portion that are positioned at different locations, and the first portion and the second portion have different thermal conductivities and / or thicknesses. Effect of the Invention

[0007] According to the above aspect, it is possible to locally heat the target tissue. [Brief description of the drawings]

[0008] [Figure 1] FIG. 1 is a configuration diagram of a system according to a first embodiment. [Diagram 2] FIG. 2 is an explanatory diagram of the internal circulation structure of the balloon according to the first embodiment. [Diagram 3] FIG. 1 is a perspective view showing an example of a balloon catheter according to a first embodiment. [Figure 4] FIG. 2 is an explanatory diagram of the mechanism by which restenosis is suppressed by local heating and expansion according to the embodiment. [Diagram 5] An explanatory diagram of the mechanism of restenosis inhibition, following Figure 4. [Figure 6] FIG. 6 is an explanatory diagram of the mechanism of restenosis inhibition, following FIG. 5 . [Figure 7] FIG. 11 is a perspective view showing an example of a balloon catheter according to a second embodiment. [Figure 8] FIG. 13 is a diagram showing the state after one week of heating (entire area) of the narrowed esophagus in the embodiment. [Figure 9] FIG. 13 is a diagram showing the results two weeks after heating (localized) the esophageal stricture in the embodiment. [Figure 10] FIG. 13 shows an example of MT staining of a heated site of the esophageal stricture of pig A in the embodiment. [Figure 11] FIG. 2 shows an example of HE staining of a heated site in the esophageal stricture of pig A in the embodiment. [Figure 12] FIG. 13 is a diagram showing the directionality of collagen fibers at a heated site in the esophageal stricture of pig A according to the embodiment, in addition to that in normal tissue. [Figure 13] FIG. 2 is a diagram showing the thickness of each layer of the esophageal wall of pig B in the embodiment. [Figure 14] FIG. 13 is a diagram showing the average blue intensity of the collagen fiber layer in the submucosa of the esophageal wall of pig B in an embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] Hereinafter, an embodiment of the present invention will be described with reference to the drawings. In the embodiment, a system including a balloon catheter will be described as an example of a system including a tissue heating device configured to be able to heat a target tissue such as a digestive tract.

[0010] First Embodiment <System> Fig. 1 is a configuration diagram of a system 1 according to an embodiment of the present invention. Fig. 2 is an explanatory diagram of a circulation structure inside a balloon according to an embodiment of the present invention. Referring to both Figures 1 and 2, system 1 includes a balloon catheter 2 (an example of a tissue heating device), multiple containers 3A, 3B, a flow control valve 4, a compressor 5, a pressure regulator 6, a pressurization exhaust valve 7, temperature measurement units 8A, 8B, heat source units 9A, 9B, a conductive valve 10, a pressure reduction mechanism 11, an on-off valve 12, multiple pipes 30-36, 40, 44, and a control device 50.

[0011] <Balloon catheter> The balloon catheter 2 is configured to be capable of controlling the temperature and pressure applied to the digestive tract (an example of a target tissue) and expanding and fixing the digestive tract. The balloon catheter 2 has an inlet flow path 22 that allows a fluid to flow into the inside of a contact portion that contacts the digestive tract, and an outlet flow path 23 that allows the fluid that has flowed in from the inlet flow path 22 to flow out to the outside.

[0012] The balloon catheter 2 includes a balloon 20 and a flow path member 21. The balloon 20 has a contact portion (e.g., an outer surface) that contacts the digestive tract. The balloon 20 expands when a fluid (e.g., a liquid such as a heat medium) is supplied. The flow path member 21 has an inlet flow path 22 that allows the fluid to flow into the balloon 20, and an outlet flow path 23 that allows the fluid to flow out of the balloon 20.

[0013] The flow path member 21 is composed of a single member. The flow path member 21 is an axial member having a longitudinal direction in one direction. For example, the inlet flow path 22 and the outlet flow path 23 are formed inside the flow path member 21 having a cylindrical shape. For example, the inlet flow path 22 and the outlet flow path 23 are separated by a partition wall (not shown) inside the flow path member 21.

[0014] The flow path member 21 extends from the base end to near the tip of the balloon catheter 2. The balloon 20 is provided so as to cover the tip of the flow path member 21. The balloon 20 is provided so as to cover the flow path member 21 from the base end side of the flow path member 21 to a portion beyond the tip. The inlet flow path 22 opens from the base end to the tip of the flow path member 21.

[0015] The flow path member 21 has a blocking portion 25 that blocks the portion of the outlet flow path 23 near the tip opening of the inlet flow path 22, and an opening 26 that connects the portion of the outlet flow path 23 near the base end of the balloon 20 to the inside of the balloon 20.

[0016] For example, the blocking portion 25 may be detachably attached to the tip opening of the outlet flow path 23. For example, the blocking portion 25 may be a plug or the like. For example, the blocking portion 25 is not limited to the above, and may be integrally formed with the flow path member 21 using the same member. For example, the form of the blocking portion 25 can be changed according to design specifications.

[0017] For example, the opening 26 is a through hole formed in a portion of the outlet flow path 23 near the base end of the balloon 20. In the example shown in the figure, one opening 26 is formed, but this is not limited to this. For example, a plurality of openings 26 may be formed. For example, the number (mode) of the openings 26 can be changed according to the design specifications.

[0018] According to the above configuration, the blocking portion 25 blocks a portion of the outlet flow path 23 near the tip opening of the inlet flow path 22. Therefore, the fluid flowing in from the tip opening of the inlet flow path 22 does not enter the tip opening of the outlet flow path 23. In addition, the opening 26 allows the portion of the outlet flow path 23 near the base end of the balloon 20 to communicate with the inside of the balloon 20. Therefore, the fluid that has flowed into the inside of the balloon 20 flows to the vicinity of the base end of the balloon 20 before entering the outlet flow path 23. In FIG. 2, an example of the flow of the fluid is shown by arrows. Therefore, the fluid can be circulated over a wide range inside the balloon 20.

[0019] <Container> The system 1 includes two (one example of a plurality of) containers 3A, 3B that store heat media of different temperatures as fluids. The two containers 3A, 3B are a first tank 3A that stores a first heat medium (e.g., hot water) to be supplied to the balloon catheter 2, and a second tank 3B that stores a second heat medium (e.g., cold water) that is at a lower temperature than the first heat medium.

[0020] For example, the temperature of the hot water is set to a temperature of 40°C or higher (e.g., about 95°C). For example, the temperature of the cold water is set to a temperature below 40°C (e.g., about 20°C). For example, the first heat medium and the second heat medium may be a diluted contrast medium, distilled water, etc. For example, the first tank 3A and the second tank 3B are preferably metal containers having excellent heat resistance and pressure resistance.

[0021] In the illustrated example, the system 1 includes two containers 3A and 3B, but is not limited thereto. For example, the system 1 may include three or more containers 3A and 3B. For example, it is sufficient that a plurality of containers 3A and 3B are provided. For example, the number of containers 3A and 3B can be changed according to design specifications.

[0022] <Flow control valve> The flow rate regulating valve 4 regulates the flow rate of the heat medium flowing from the multiple containers 3A, 3B into the balloon 20. The flow rate regulating valve 4 is electrically connected to the control device 50. For example, the flow rate regulating valve 4 may be an electrically operated three-way valve.

[0023] A first heat medium pipe 33 (hereinafter also referred to as "hot water supply pipe 33") for supplying a first heat medium and a second heat medium pipe 34 (hereinafter also referred to as "cold water supply pipe 34") for supplying a second heat medium are provided between the multiple containers 3A, 3B and the flow rate control valve 4. The hot water supply pipe 33 and the cold water supply pipe 34 are included in the multiple pipes that make up the system 1.

[0024] One end (upstream end) of the hot water supply pipe 33 is disposed inside the first tank 3A (specifically, below the level of the hot water). The other end (downstream end) of the hot water supply pipe 33 is connected to the flow rate adjustment valve 4. One end (upstream end) of the cold water supply pipe 34 is disposed inside the second tank 3B (specifically, below the level of the cold water). The other end (downstream end) of the cold water supply pipe 34 is connected to the flow rate adjustment valve 4.

[0025] <Compressor> The compressor 5 supplies compressed air to the multiple containers 3A, 3B so that the heat medium flows from the multiple containers 3A, 3B into the balloon 20. For example, the output of the compressor 5 (the pressure at which the compressed air is supplied) may be set to 2 MPa or less (for example, about 0.4 MPa). The compressor 5 is electrically connected to the control device 50.

[0026] An air supply pipe 30 for supplying compressed air is provided between the compressor 5 and the multiple containers 3A, 3B. The air supply pipe 30 is included in the multiple pipes that make up the system 1. One end (upstream end) of the air supply pipe 30 is connected to the compressor 5.

[0027] The air supply pipe 30 includes a first branch pipe 31 branching to the first tank 3A side and a second branch pipe 32 branching to the second tank 3B side. One end (upstream end) of the first branch pipe 31 and one end (upstream end) of the second branch pipe 32 correspond to a branching portion where the first branch pipe 31 and the second branch pipe 32 branch off in the air supply pipe 30. The other end (downstream end) of the first branch pipe 31 is disposed inside the first tank 3A (specifically, above the level of the hot water). The other end (downstream end) of the second branch pipe 32 is disposed inside the second tank 3B (specifically, above the level of the cold water).

[0028] <Pressure Regulator> The pressure regulator 6 adjusts the pressure of the compressed air supplied from the compressor 5. The pressure regulator 6 is electrically connected to the control device 50. The pressure regulator 6 is provided midway through the air supply pipe 30. The pressure regulator 6 is disposed downstream of the compressor 5 and upstream of the branching portion.

[0029] <Pressure exhaust valve> The pressurization exhaust valve 7 is a valve for discharging the compressed air supplied from the compressor 5. For example, the pressurization exhaust valve 7 may be configured to be manually operable. For example, by operating the pressurization exhaust valve 7, a part of the compressed air can be discharged from inside the air supply pipe 30. For example, by adjusting the opening degree of the pressurization exhaust valve 7, the pressure of the compressed air supplied to the multiple containers 3A, 3B can be adjusted.

[0030] <Temperature measurement section> The temperature measuring units 8A, 8B measure the temperature of the heat medium stored in the multiple containers 3A, 3B. The temperature measuring units 8A, 8B are electrically connected to the control device 50. In the example shown in the figure, two temperature measuring units 8A, 8B are provided corresponding to the number of containers 3A, 3B. The two temperature measuring units 8A, 8B are a hot water temperature measuring unit 8A that measures the temperature of the hot water stored in the first tank 3A, and a cold water temperature measuring unit 8B that measures the temperature of the cold water stored in the second tank 3B. For example, the temperature measuring units 8A, 8B may be composed of a thermocouple and a thermometer.

[0031] <Heat source> The heat sources 9A, 9B impart thermal energy to the heat medium stored in the multiple containers 3A, 3B. The heat sources 9A, 9B are electrically connected to the control device 50. In the illustrated example, two heat sources 9A, 9B are provided corresponding to the number of containers 3A, 3B. The two heat sources 9A, 9B are a hot water side heat source 9A that imparts thermal energy to the hot water stored in the first tank 3A, and a cold water side heat source 9B that imparts thermal energy to the cold water stored in the second tank 3B. For example, the heat sources 9A, 9B may be composed of electric heating wires.

[0032] <Conduit valve> The conduit valve 10 is a valve for guiding the fluid regulated by the flow rate regulating valve 4 into the balloon 20. For example, the conduit valve 10 may be configured to guide the fluid in a direction perpendicular to the flow direction of the fluid regulated by the flow rate regulating valve 4. A conduit pipe 35 for guiding the fluid is provided between the conduit valve 10 and the flow rate regulating valve 4. The conduit pipe 35 is included in the multiple pipes that constitute the system 1. One end (upstream end) of the conduit pipe 35 is connected to the flow rate regulating valve 4. The other end (downstream end) of the conduit pipe 35 is connected to the conduit valve 10.

[0033] A two-line tube 40 for flowing fluid is provided between the conduction valve 10 and the balloon catheter 2. The two-line tube 40 is included in a plurality of pipes that make up the system 1. One end (the upstream end when fluid is supplied) of the two-line tube 40 is connected to the conduction valve 10. The other end (the downstream end when fluid is supplied) of the two-line tube 40 is connected to the balloon catheter 2 (e.g., the base end of the flow path member 21).

[0034] For example, the conduction valve 10 may be configured to conduct the fluid in a direction perpendicular to the flow direction of the fluid in the two-line tube 40. The two-line tube 40 includes an inlet pipe section 41 that communicates with the inlet flow passage 22 of the flow passage member 21, and an outlet pipe section 42 that communicates with the outlet flow passage 23 of the flow passage member 21. The outlet pipe section 42 is closed near the conduction valve 10 with a plug 43 or the like.

[0035] <Pressure reduction mechanism> The decompression mechanism 11 is a mechanism for reducing the pressure inside the balloon 20. For example, the decompression mechanism 11 is a piston for reducing the pressure inside the balloon. The decompression mechanism 11 is configured to be manually operable. For example, the pressure inside the balloon 20 can be reduced by operating the decompression mechanism 11. For example, the liquid inside the balloon 20 can be released by operating the decompression mechanism 11.

[0036] A pressure reduction pipe 36 for reducing the pressure inside the balloon 20 is provided between the conduit valve 10 and the pressure reduction mechanism 11. The pressure reduction pipe 36 is included in a plurality of pipes constituting the system 1. One end (upstream end) of the pressure reduction pipe 36 is connected to the conduit valve 10. The other end (downstream end) of the pressure reduction pipe 36 is connected to the pressure reduction mechanism 11 (specifically, the bottom of the cylinder that accommodates the piston). For example, the conduit valve 10 may be configured to guide the fluid in a direction perpendicular to the flow direction of the fluid in the pressure reduction pipe 36.

[0037] <Shut-off valve> The on-off valve 12 is a valve for opening and closing the portion leading to the outlet flow path 23. The on-off valve 12 is provided midway along a drain pipe 44 branching off from the outlet pipe portion 42 of the two-line tube 40. The drain pipe 44 is included in a plurality of pipes that make up the system 1. The lower end (downstream end) of the drain pipe 44 opens into a drain bin 45.

[0038] For example, the on-off valve 12 may be configured to be manually operable. For example, by operating the on-off valve 12, liquid can be discharged from inside the balloon 20 into the drain bottle 45. For example, the pressure inside the balloon 20 may be adjusted by adjusting the opening degree of the on-off valve 12.

[0039] <Control device> The control device 50 includes a flow rate control unit 51, a pressure control unit 52, a heat source control unit 53, and a memory unit . The flow control unit 51 controls the flow control valve 4. The flow control unit 51 causes the flow control valve 4 to adjust the flow rate of the heat medium based on previously acquired data indicating the relationship between the time during which the heat medium is flowed inside the balloon 20 and the temperature inside the balloon 20. For example, the data indicating the relationship between the time during which the heat medium is flowed inside the balloon 20 and the temperature inside the balloon 20 may be stored in advance in the storage unit 54.

[0040] The pressure control unit 52 controls the pressure regulator 6. The pressure control unit 52 causes the pressure regulator 6 to adjust the pressure of the compressed air based on the target pressure inside the balloon 20. For example, the target pressure inside the balloon 20 may be stored in advance in the storage unit 54.

[0041] The heat source control unit 53 controls the heat source units 9A and 9B. The heat source control unit 53 causes the heat source units 9A and 9B to apply thermal energy based on the temperatures measured by the temperature measurement units 8A and 8B so that the temperatures of the heat media stored in the multiple containers 3A and 3B are within a preset temperature range. For example, data regarding the preset temperature range may be stored in the storage unit 54 in advance.

[0042] <An example of a balloon catheter> Fig. 3 is a perspective view showing an example of the balloon catheter 2 according to the first embodiment. In Fig. 3, the balloon 20 is indicated by a two-dot chain line. 3, the balloon catheter 2 is configured to be able to heat the digestive tract. The balloon catheter 2 has first portions 110A, 110B and a second portion 120 that are disposed at different positions in a contact portion that contacts the digestive tract. The first portions 110A, 110B and the second portion 120 have different thermal conductivities.

[0043] In this embodiment, the thermal conductivity of the first portions 110A and 110B is higher than that of the second portion 120. The first portions 110A and 110B correspond to the portions of the first and second portions that have higher thermal conductivity. The second portion 120 corresponds to the portions of the first and second portions that have lower thermal conductivity.

[0044] The balloon catheter 2 includes a balloon 20 that has a contact portion and expands when a fluid is supplied thereto. For example, the thickness of the balloon 20 is set to a value between 0.01 mm and 1.0 mm. For example, the thickness of the balloon 20 is preferably set within a range that satisfies the strength, rigidity, thermal conductivity, and other requirements of the balloon 20. The thickness of the balloon 20 is not limited to the above and can be changed according to design specifications.

[0045] In this embodiment, the first portions 110A, 110B are disposed on the outer surface of the balloon 20. For example, the thickness of the first portions 110A, 110B is preferably set to a thickness of 0.05 mm or more and 0.5 mm or less, and more preferably set to a thickness of 0.08 mm or more and 0.12 mm or less. Note that the thickness of the first portions 110A, 110B is not limited to the above and can be changed according to design specifications.

[0046] For example, the first portions 110A, 110B are made of a metal. For example, the metal may be a metal mainly composed of copper (Cu), gold (Au), silver (Ag), aluminum (Al), tungsten (W), or an alloy containing at least one of these. In this embodiment, the first portions 110A, 110B are made of copper (for example, thermal conductivity of 386 to 402 W / m·K). Note that the material for forming the first portions 110A, 110B is not limited to the above and can be changed according to design specifications.

[0047] For example, the second portion 120 is made of a resin. For example, the resin may be a resin mainly composed of polyimide (PI), polyamide (PA), methacrylic resin (PMMA), polypropylene (PP), polyethylene (PE), or a synthetic resin containing at least one of these. In this embodiment, the second portion 120 is made of polyimide (for example, thermal conductivity of 0.28 to 0.34 W / m·K). The material for forming the second portion 120 is not limited to the above and can be changed according to design specifications.

[0048] The balloon 20 has a tube portion 20C that becomes cylindrical when inflated. In the illustrated example, a part of the tube portion 20C is cylindrical. The first portions 110A, 110B are arranged at equal intervals in the circumferential direction of the tube portion 20C. In the illustrated example, two first portions 110A, 110B are arranged at equal intervals in the circumferential direction of the tube portion 20C. The number of the first portions 110A, 110B is not limited to the above, and may be three or more. For example, the number of the first portions 110A, 110B can be changed according to the design specifications.

[0049] The first portions 110A, 110B and at least a part of the second portion 120 are alternately arranged in the circumferential direction of the cylindrical portion 20C. In the example shown in the figure, the two first portions 110A, 110B and a part of the second portion 120 are alternately arranged in the circumferential direction of the cylindrical portion 20C. In the example shown in the figure, a part of the second portion 120 has two parts (areas) interposed between the two first portions 110A, 110B. Note that the number of parts of the second portion 120 interposed between the multiple first portions 110A, 110B is not limited to the above, and can be changed according to the number of the first portions 110A, 110B and the design specifications.

[0050] The first portions 110A, 110B are shorter in the circumferential direction of the tube portion 20C than the second portion 120. For example, the length W1 of the first portions 110A, 110B in the circumferential direction of the tube portion 20C (hereinafter also referred to as the "width W1 of the first portions 110A, 110B") is preferably set to a width of 1.0 mm or more and 3.0 mm or less, and more preferably set to a width of 1.5 mm or more and 2.5 mm or less. The width W1 of the first portions 110A, 110B is not limited to the above and can be changed according to design specifications.

[0051] The first portions 110A and 110B have an extension portion 111 extending in a direction parallel to the axial direction of the tube portion 20C. In the example shown in the figure, the extension portion 111 (first portions 110A and 110B) is rectangular when viewed from the radial direction of the tube portion 20C. The shape of the first portions 110A and 110B is not limited to the above, and may be a rectangle other than a rectangle (for example, a square), a circle such as a perfect circle, an ellipse, or an oval, or a shape that combines a plurality of shapes. For example, the shape of the first portions 110A and 110B can be changed according to design specifications.

[0052] For example, the first portions 110A, 110B are formed by attaching a metal sheet to a part of the outer surface of the balloon 20 made of resin. In this case, the portion of the balloon 20 other than the area where the first portions 110A, 110B are attached becomes the second portion 120. Note that the method of forming the first portions 110A, 110B is not limited to the above, and may be coating using a mask (e.g., screen printing), etching, sputtering, vapor deposition, or other methods. For example, the method of forming the first portions 110A, 110B can be changed according to design specifications.

[0053] In this embodiment, the first portions 110A, 110B are made of copper (for example, thermal conductivity 386 to 402 W / m·K), and the second portion 120 is made of polyimide (for example, thermal conductivity 0.28 to 0.34 W / m·K). For example, by replacing a part of the balloon 20 made of resin (for example, polyimide) with a metal sheet (for example, a copper sheet), the thermal conductivity of the replaced part (first portions 110A, 110B) increases several hundred times, making it possible to locally heat the part.

[0054] In addition, when a part of the balloon 20 made of resin (e.g., polyimide) is replaced with a metal sheet (e.g., a copper sheet), the part other than the replaced part may be covered with, for example, a urethane covering layer (not shown). For example, the installation mode of the covering layer can be changed according to the design specifications.

[0055] <Action and effect> As described above, the balloon catheter 2 of this embodiment is configured to be able to heat the digestive tract. The balloon catheter 2 has the first portions 110A, 110B and the second portion 120, which are disposed at different positions in a contact portion that contacts the digestive tract. The first portions 110A, 110B and the second portion 120 have different thermal conductivities. According to this configuration, the first portions 110A, 110B and the second portion 120 have different thermal conductivities, so that a gradient in the amount of heat supplied occurs at the contact portion of the balloon catheter 2, and a temperature difference can be applied to the contacting digestive tract. Therefore, localized heating can be performed on the digestive tract. In addition, it is easy to deal with cases where the temperature of only a certain portion of the digestive tract needs to be increased while the temperature of other portions needs not to be increased. For example, it is possible to locally heat only the minimum necessary portions while minimizing the temperature rise in other portions.

[0056] In this embodiment, the balloon catheter 2 includes a balloon 20 having a contact portion and inflated by the supply of a fluid. The first portions 110A and 110B, which are the portions having higher thermal conductivity than the second portion 120, are disposed on the outer surface of the balloon 20. According to this configuration, the balloon catheter 2 can be manufactured more easily than when the first portions 110A, 110B are disposed on the inner surface (back surface) of the balloon 20 opposite to the outer surface.

[0057] In this embodiment, the first portions 110A and 110B are made of metal. With this configuration, compared to when the first portions 110A, 110B are made of resin (for example, when the first portions 110A, 110B and the second portion 120 are each made of resin), a difference in thermal conductivity of about several tens to several hundreds times occurs between the first portions 110A, 110B and the second portion 120. As a result, a larger gradient in the amount of heat supplied occurs at the contact portion of the balloon catheter 2, and a larger temperature difference can be applied to the digestive tract in contact. This makes it easier to locally heat the digestive tract.

[0058] In this embodiment, the second portion 120 is made of resin. With this configuration, compared to when the second portion 120 is made of metal (for example, when the first portions 110A, 110B and the second portion 120 are each made of metal), a difference in thermal conductivity of about several tens to several hundreds of times occurs between the first portions 110A, 110B and the second portion 120. As a result, a larger gradient in the amount of heat supplied occurs at the contact portion of the balloon catheter 2, and a larger temperature difference can be applied to the digestive tract in contact. This makes it easier to locally heat the digestive tract.

[0059] In this embodiment, the balloon 20 has a tubular portion 20C that becomes cylindrical when inflated. The first portions 110A, 110B are arranged at equal intervals in the circumferential direction of the tubular portion 20C. For example, when only one first portion 110A, 110B is arranged, or when multiple first portions 110A, 110B are arranged at unequal intervals in the circumferential direction of the tube portion 20C, it is difficult to locally heat only the minimum necessary locations. In contrast, according to the present configuration, the multiple first portions 110A, 110B are arranged at equal intervals in the circumferential direction of the tube portion 20C, making it easy to bring any of the multiple first portions 110A, 110B into contact with only the locations to be heated. Therefore, it is easy to locally heat only the minimum necessary locations.

[0060] In this embodiment, the first portions 110A, 110B and a part of the second portion 120 are arranged alternately in the circumferential direction of the tubular portion 20C. According to this configuration, even when the areas to be heated and other areas are arranged alternately in the circumferential direction of the digestive tract, it is easy to locally heat only the minimum necessary areas.

[0061] In this embodiment, the first portions 110A and 110B are shorter in length than the second portion 120 in the circumferential direction of the tubular portion 20C. For example, if the first portions 110A, 110B are longer in the circumferential direction of the tube portion 20C than the second portion 120, the heat from the first portions 110A, 110B is more likely to flow to areas other than the areas to be heated (areas not required to be heated). In contrast, according to the present configuration, the first portions 110A, 110B are shorter in the circumferential direction of the tube portion 20C than the second portion 120, so that the heat from the first portions 110A, 110B is less likely to flow to areas not required to be heated. Therefore, it is easy to locally heat only the minimum necessary areas.

[0062] In this embodiment, the first portions 110A and 110B have an extension portion 111 that extends in a direction parallel to the axial direction of the tube portion 20C. With this configuration, even if the area to be heated is located along the direction in which the digestive tract extends, the extending parts 111 of the first parts 110A, 110B can be easily brought into contact with only the area to be heated. Therefore, it is easy to locally heat only the minimum necessary areas.

[0063] The system 1 of this embodiment includes the above-mentioned balloon catheter 2, and a plurality of containers 3A, 3B that store heat transfer media at different temperatures as fluids. According to this configuration, the heat medium can be caused to flow from the multiple containers 3A, 3B into the balloon 20. Therefore, compared to a case where only one container is provided, the heat medium at a desired temperature can be caused to flow into the balloon 20 more quickly.

[0064] In this embodiment, the system 1 further includes a flow rate adjustment valve 4 that adjusts the flow rate of the heat medium flowing from the multiple containers 3A, 3B into the balloon 20, and a flow rate control unit 51 that controls the flow rate adjustment valve 4. The flow rate control unit 51 causes the flow rate adjustment valve 4 to adjust the flow rate of the heat medium based on previously acquired data indicating the relationship between the time for which the heat medium is flowed into the balloon 20 and the temperature inside the balloon 20. According to this configuration, the flow rate control unit 51 controls the flow rate adjustment valve 4 based on previously acquired data, so no manual operation is required. This contributes to the automation of the system 1. For example, the flow rate of the heat medium flowing inside the balloon 20 can be automatically adjusted.

[0065] In this embodiment, the system 1 further includes a compressor 5 that supplies compressed air to the multiple containers 3A, 3B so that the heat medium flows from the multiple containers 3A, 3B into the balloon 20, a pressure regulator 6 that adjusts the pressure of the compressed air supplied from the compressor 5, and a pressure control unit 52 that controls the pressure regulator 6. The pressure control unit 52 causes the pressure regulator 6 to adjust the pressure of the compressed air based on a target pressure inside the balloon 20. According to this configuration, the pressure regulator 6 does not require manual operation due to the control of the pressure control unit 52 based on the target pressure inside the balloon 20. This contributes to the automation of the system 1. For example, the pressure inside the balloon 20 can be automatically adjusted.

[0066] In this embodiment, the system 1 further includes temperature measuring units 8A, 8B that measure the temperature of the heat medium stored in the multiple containers 3A, 3B, heat source units 9A, 9B that impart thermal energy to the heat medium stored in the multiple containers 3A, 3B, and a heat source control unit 53 that controls the heat source units 9A, 9B. The heat source control unit 53 causes the heat source units 9A, 9B to impart thermal energy based on the temperatures measured by the temperature measuring units 8A, 8B so that the temperature of the heat medium stored in the multiple containers 3A, 3B falls within a preset temperature range. According to this configuration, the heat source control unit 53 controls the heat source units 9A and 9B based on the measured temperatures of the temperature measuring units 8A and 8B, so that no human labor is required to operate the heat source units 9A and 9B. This contributes to the automation of the system 1. For example, the temperature of the heat medium stored in the multiple containers 3A and 3B can be automatically adjusted.

[0067] In this embodiment, the system 1 further includes a pressure reduction mechanism 11 for reducing the pressure inside the balloon 20 . According to this configuration, the pressure inside the balloon 20 can be reduced by operating the decompression mechanism 11. For example, compared to a case where a new compressor or the like is provided to reduce the pressure inside the balloon 20, the configuration of the system 1 can be simplified. For example, when the balloon 20 is to be removed from an endoscope or the like, if there is fluid inside the balloon 20, it is difficult to remove the balloon 20. In contrast, according to the present configuration, the decompression mechanism 11 can expel the fluid inside the balloon 20, so that the balloon 20 can be easily removed.

[0068] In this embodiment, the system 1 further includes an on-off valve 12 for opening and closing a portion communicating with the outlet passage 23 . According to this configuration, by operating the on-off valve 12, it is possible to discharge the liquid from inside the balloon 20. For example, by adjusting the opening degree of the on-off valve 12, it is possible to adjust the pressure inside the balloon 20.

[0069] <An example of controlling the temperature and pressure inside a balloon> For example, the temperature and pressure inside the balloon may be controlled in the following manner. A user of the balloon catheter (e.g., a doctor) first inserts an endoscope into the patient's body. For example, the tip of the endoscope is positioned near the stenosis. The user injects a contrast agent into the stenosis through the forceps channel of the endoscope. The stenosis is then imaged with an X-ray to obtain information about the length and diameter of the stenosis. Next, the user passes the balloon catheter through the forceps channel of the endoscope. For example, the user advances the balloon catheter so that the balloon is positioned across the stenosis. The user operates the control device to start expansion control by the control device.

[0070] When expansion control is started, first, hot water at or above the thermal denaturation temperature of the target tissue (e.g., 65°C) is supplied to the inside of the balloon. This heats the inside of the balloon to a predetermined temperature. After heating, cold water (e.g., water with a temperature of 0°C or higher and 37°C or lower) is supplied to the inside of the balloon.

[0071] For example, simply heating the target tissue causes the proteins to shrink, whereas according to this embodiment, the proteins in the target tissue can be expanded and solidified in the expanded state by cooling after heating.

[0072] For example, the fluid supplied to the inside of the balloon is switched from hot water to cold water before the temperature inside the balloon exceeds 65° C. The timing of switching to cold water is not limited to the above and can be changed according to the required specifications.

[0073] Next, the pressure inside the balloon is adjusted. For example, the pressure inside the balloon is adjusted to a pressure of 0 MPa or more and 0.7 MPa or less. By such a procedure, the temperature and pressure inside the balloon can be independently controlled.

[0074] <Examples of balloon catheter applications> For example, balloon catheters are used to expand stenoses in the body lumen. A method has been proposed in which the inside of the balloon is heated to cause thermal denaturation of the luminal tissue and mitigate mechanical damage during expansion. To implement this method, it is necessary to independently control the temperature and pressure inside the balloon.

[0075] For example, a known configuration for independently controlling the temperature and pressure inside a balloon is to provide a heating element (e.g., an RF power source, a laser emitter, etc.) inside or on the surface of the balloon and adjust the pressure of the heat medium sent inside the balloon. However, such a configuration requires an expensive and complicated control device, and is highly likely to pose a safety risk.

[0076] In contrast, in the present embodiment, the heated fluid is circulated by a balloon catheter equipped with a flow path member having an inlet flow path and an outlet flow path as two lumens (tubes), which makes it possible to dispense with the conventional expensive and complicated control device, thereby realizing an inexpensive and safe device.

[0077] For example, when the balloon catheter of this embodiment is applied to a narrowed portion of the esophagus, the following effects can be obtained: The collagen fibers of the scar tissue with a thickened wall are gelatinized by heating, and the tissue is softened, allowing the balloon to expand without damaging the esophageal wall. This makes it possible to prevent restenosis.

[0078] For example, one method of heating the inside of a living body is to insert a balloon catheter into the body and apply heat. In many cases, the temperature inside the balloon rises, causing the temperature of the living tissue in contact with the balloon to rise. If the tissue exceeds a temperature threshold (e.g., 42.5°C), it can cause extensive burns and serious complications such as subsequent inflammatory reactions and ulcer formation. In other words, there is a trade-off between the benefits of heating and the complications (side effects).

[0079] In contrast, in this embodiment, the first and second parts constituting the contact portion of the balloon catheter have different thermal conductivities, so that a temperature difference can be applied to the contacting digestive tract, and localized heating of the digestive tract can be performed. In other words, localized heating can be performed only in the minimum necessary areas, and temperature rise in other areas can be minimized. This makes it possible to avoid widespread burns to tissue and complications.

[0080] <Mechanism of restenosis inhibition by local heating and expansion> Fig. 4 is an explanatory diagram of the mechanism of restenosis inhibition by local heating and expansion according to the embodiment. Fig. 5 is an explanatory diagram of the mechanism of restenosis inhibition following Fig. 4. Fig. 6 is an explanatory diagram of the mechanism of restenosis inhibition following Fig. 5. Referring to Figs. 4 to 6, in this embodiment, of the first and second parts constituting the contact portion of the balloon catheter, only the tissue in contact with the first part is locally heated.

[0081] In the example shown in the figure, an epithelial layer is placed on top of the muscle layer via a collagen layer, and only a portion of these tissues is locally heated. In the example shown in Figure 4, the heating area has a width (length in the horizontal direction of the figure) of about 2.0 mm corresponding to the width of the first part (e.g., metal sheet), and a depth (length in the vertical direction of the figure) of about 1.5 mm.

[0082] At the tissue level, thermal denaturation of collagen fibers occurs only in the area corresponding to the first portion (e.g., metal sheet). This causes the fiber layer to gelatinize and stretch in the circumferential direction. For example, as shown in Figure 5, the locally heated collagen layer is thermally denatured and turns into gelatin, and the tissue stretches from that point. As a result, the epithelial layer is restored as shown in Figure 6.

[0083] <Second embodiment> Fig. 7 is a perspective view showing an example of a balloon catheter 202 according to the second embodiment. In Fig. 7, the balloon 20 is indicated by a two-dot chain line. A balloon catheter 202 according to a second embodiment will be described below with reference to Fig. 7. In the configuration shown in Fig. 7, the same components as those in the above-described embodiment are denoted by the same reference numerals, and detailed description thereof will be omitted.

[0084] 7, a balloon catheter 202 has a first portion 210 and a second portion 120 that are disposed at different positions in a contact portion that contacts the digestive tract. The first portion 210 and the second portion 120 have different thermal conductivities.

[0085] In this embodiment, the thermal conductivity of the first portion 210 is higher than the thermal conductivity of the second portion 120. The first portion 210 corresponds to the portion of the first portion and the second portion that has the higher thermal conductivity. The second portion 120 corresponds to the portion of the first portion and the second portion that has the lower thermal conductivity.

[0086] The first portion 210 has annular portions 212A, 212B extending along the circumferential direction of the tubular portion 20C. In the example shown in the figure, the annular portions 212A, 212B are annular along the circumferential direction of the tubular portion. The shape of the annular portions 212A, 212B is not limited to the above and can be changed according to design specifications.

[0087] The annular portions 212A and 212B are connected to the longitudinal ends of the extending portions 211A to 211F. In the illustrated example, the annular portions 212A and 212B are connected to both longitudinal ends of the extending portions 211A to 211F. The annular portions 212A and 212B are not limited to the above, and may be connected to one longitudinal end of the extending portions 211A to 211F, but not to the other end. For example, the annular portions 212A and 212B may be connected to only one longitudinal end of the extending portions 211A to 211F. For example, the connection mode of the annular portions 212A and 212B can be changed according to design specifications.

[0088] In the illustrated example, six extension portions 211A-211F are arranged at equal intervals in the circumferential direction of the tube portion 20C. The number of extension portions 211A-211F is not limited to the above, and may be five or less, or seven or more. For example, the number of extension portions 211A-211F can be changed according to design specifications.

[0089] In this embodiment, the first portion 210 has annular portions 212A and 212B extending along the circumferential direction of the tubular portion 20C. With this configuration, even when the areas to be heated are arranged along the circumferential direction of the digestive tract, it is easy to bring the annular portions 212A, 212B of the first portion 210 into contact with only the areas to be heated. Therefore, it is easy to locally heat only the minimum necessary areas.

[0090] In this embodiment, the annular portions 212A and 212B are connected to the longitudinal ends of the extending portions 211A to 211F. According to this configuration, since the annular portions 212A, 212B are integrated with the extending portions 211A-211F, it is easier to align the annular portions 212A, 212B and the extending portions 211A-211F with respect to the balloon 20, compared to a case in which the annular portions 212A, 212B are not connected to the extending portions 211A-211F. Therefore, it is easier to position the first portion 210 with respect to the balloon 20.

[0091] <Modification> In the above-described embodiment, the tissue heating device is described as a balloon catheter, but is not limited thereto. For example, the tissue heating device may be another device such as a bougie. For example, the tissue heating device may be configured to control the temperature and pressure applied to the target tissue and to expand and fix the target tissue. For example, the configuration of the tissue heating device may be changed according to the design specifications.

[0092] In the above-mentioned embodiment, the first part and the second part have different thermal conductivities, but the present invention is not limited to this. For example, the first part and the second part may have the same thermal conductivities. For example, the first part and the second part may have different thicknesses. For example, the first part and the second part may have different thermal conductivities and thicknesses. For example, by making the thickness of a part of the balloon thinner than the thickness of the other parts, the thinner part is more likely to transmit heat than the other parts, so that localized heating is possible. For example, the first part and the second part may have different thermal conductivities and / or thicknesses. For example, the thermal conductivity and / or thickness of the first part and the second part may be changed according to the design specifications.

[0093] In the above-described embodiment, the balloon catheter has a contact portion and includes a balloon that expands when a fluid is supplied thereto, and the first and second parts that have a higher thermal conductivity are disposed on the outer surface of the balloon. However, the present invention is not limited to this. For example, the first and second parts that have a higher thermal conductivity may be disposed on the inner surface (back surface) of the balloon, opposite the outer surface. For example, the arrangement of the first and second parts that have a higher thermal conductivity may be changed according to design specifications.

[0094] In the above-described embodiment, the portion with high thermal conductivity is formed of metal, but this is not limited thereto. For example, the portion with high thermal conductivity may be formed of resin. For example, each of the first portion and the second portion may be formed of resin. For example, the form of the first portion and the second portion can be changed according to the design specifications.

[0095] In the above-described embodiment, the parts of the first and second parts with low thermal conductivity are formed of resin, but the present invention is not limited to this. For example, the parts with low thermal conductivity may be formed of a resin. For example, each of the first and second parts may be formed of a metal. For example, the form of the first and second parts may be changed according to the design specifications.

[0096] In the above-described embodiment, the balloon has a cylindrical portion that becomes cylindrical when inflated, and the high thermal conductivity portions are arranged at equal intervals in the circumferential direction of the cylindrical portion. However, the present invention is not limited to this. For example, only one high thermal conductivity portion may be arranged. For example, multiple high thermal conductivity portions may be arranged at unequal intervals in the circumferential direction of the cylindrical portion. For example, the number and arrangement of the high thermal conductivity portions may be changed according to the design specifications.

[0097] In the above-described embodiment, an example has been described in which the high thermal conductivity parts and at least a part of the low thermal conductivity parts of the first and second parts are alternately arranged in the circumferential direction of the cylindrical portion, but this is not limited thereto. For example, the high thermal conductivity parts and at least a part of the low thermal conductivity parts of the first and second parts do not have to be alternately arranged in the circumferential direction of the cylindrical portion. For example, the arrangement of the high thermal conductivity parts and the low thermal conductivity parts in the circumferential direction of the cylindrical portion can be changed according to the design specifications.

[0098] In the above embodiment, the portion with high thermal conductivity is shorter in the circumferential direction of the tube than the portion with low thermal conductivity, but this is not limited thereto. For example, the portion with high thermal conductivity may be longer in the circumferential direction of the tube than the portion with low thermal conductivity. For example, the length relationship between the portion with high thermal conductivity and the portion with low thermal conductivity in the circumferential direction of the tube can be changed according to the design specifications.

[0099] In the above embodiment, the portion with high thermal conductivity has an extension portion extending in a direction parallel to the axial direction of the tube portion, but this is not limited thereto. For example, the portion with high thermal conductivity may not have an extension portion. For example, the installation mode of the extension portion in the portion with high thermal conductivity may be changed according to the design specifications.

[0100] In the above embodiment, the portion with high thermal conductivity has an annular portion extending along the circumferential direction of the tube portion, but this is not limited thereto. For example, the portion with high thermal conductivity may not have an annular portion. For example, the installation mode of the annular portion in the portion with high thermal conductivity may be changed according to the design specifications.

[0101] In the above-described embodiment, the annular portion is connected to the longitudinal end of the extension portion, but the present invention is not limited thereto. For example, the annular portion may not be connected to the extension portion. For example, the annular portion may not be integrated with the extension portion. For example, the connection mode between the annular portion and the extension portion may be changed according to design specifications.

[0102] In the above-described embodiment, the flow path member is described as being composed of a single member, but the present invention is not limited thereto. For example, the flow path member may be composed of a plurality of members. For example, the flow path member may be composed of an inlet pipe having an inlet flow path formed therein, and an outlet pipe having an outlet flow path formed therein. For example, the configuration of the flow path member may be changed according to design specifications.

[0103] In the above-mentioned embodiment, the flow path member has an example having a blocking portion that blocks a portion of the outlet flow path near the tip opening of the inlet flow path and an opening that connects a portion of the outlet flow path near the base end of the balloon to the inside of the balloon, but this is not limited to the above. For example, both the inlet flow path and the outlet flow path may be open from the base end to the tip of the flow path member. For example, the flow path member may not have a blocking portion that blocks a portion of the outlet flow path near the tip opening of the inlet flow path. For example, the flow path member may not have an opening that connects a portion of the outlet flow path near the base end of the balloon to the inside of the balloon. For example, the opening mode of the inlet flow path and the outlet flow path, and the installation mode of the blocking portion and the opening can be changed according to the design specifications.

[0104] In the above embodiment, the system is described as including the tissue heating device and a plurality of containers that store heat media of different temperatures as fluids, but is not limited thereto. For example, the system may include only one container. For example, the installation mode of the container can be changed according to design specifications.

[0105] In the above-described embodiment, the system further includes a flow rate adjustment valve that adjusts the flow rate of the heat medium flowing from the multiple containers into the contact portion, and a flow rate control unit that controls the flow rate adjustment valve, but the system is not limited to this. For example, the flow rate adjustment valve may require manual operation. For example, the flow rate adjustment of the heat medium flowing into the contact portion may be performed manually. For example, the installation mode of the flow rate adjustment valve and the flow rate control valve may be changed according to the design specifications.

[0106] In the above-described embodiment, the system further includes a compressor that supplies compressed air to the multiple containers so that the heat medium flows from the multiple containers into the contact portion, a pressure regulator that adjusts the pressure of the compressed air supplied from the compressor, and a pressure control unit that controls the pressure regulator. However, the system is not limited to this. For example, the pressure regulator may require manual operation. For example, the pressure inside the contact portion may be adjusted manually. For example, the installation manner of the compressor, the pressure regulator, and the pressure control unit may be changed according to the design specifications.

[0107] In the above-described embodiment, the system further includes a temperature measuring unit that measures the temperature of the heat medium stored in the multiple containers, a heat source unit that imparts thermal energy to the heat medium stored in the multiple containers, and a heat source control unit that controls the heat source unit. However, the system is not limited to this. For example, the heat source unit may require manual operation. For example, the temperature of the heat medium stored in the multiple containers may be adjusted manually. For example, the installation mode of the temperature measuring unit, the heat source unit, and the heat source control unit may be changed according to the design specifications.

[0108] In the above-described embodiment, the system further includes a pressure reducing mechanism for reducing the pressure inside the contact portion, but the present invention is not limited to this. For example, the system does not need to include a pressure reducing mechanism. For example, the system may include a compressor or the like for reducing the pressure inside the contact portion. For example, the installation mode of the pressure reducing mechanism can be changed according to the design specifications.

[0109] In the above-described embodiment, the system further includes an on-off valve for opening and closing a portion that communicates with the outlet flow path, but the present invention is not limited to this. For example, the system does not need to include an on-off valve. For example, the system may include a stopper or the like for opening and closing a portion that communicates with the outlet flow path. For example, the installation mode of the on-off valve can be changed according to the design specifications.

[0110] <Computer configuration> The control device includes a processor, a memory, an auxiliary storage device (corresponding to a storage unit), etc., which are connected via a bus. The control device functions as a control device that controls the components of the system by executing a program. Examples of the processor include a CPU (Central Processing Unit), a GPU (Graphic Processing Unit), and a microprocessor. The program may be recorded on a computer-readable recording medium. The computer-readable recording medium is, for example, a storage device such as a magnetic disk, a magneto-optical disk, an optical disk, a semiconductor memory, etc. The program may be transmitted via a telecommunication line.

[0111] For example, all or part of the functions of the control device may be realized using a custom LSI (Large Scale Integrated Circuit) such as an ASIC (Application Specific Integrated Circuit) or a PLD (Programmable Logic Device). Examples of PLDs include PAL (Programmable Array Logic), GAL (Generic Array Logic), CPLD (Complex Programmable Logic Device), and FPGA (Field Programmable Gate Array). Such integrated circuits are also included in the scope of the processor.

[0112] Although the embodiments of the present invention have been described above, the present invention is not limited to these, and additions, omissions, substitutions, and other modifications of the configuration are possible without departing from the spirit of the present invention, and the above-described embodiments can also be combined as appropriate.

[0113] (Appendix 1) A tissue heating device configured to be able to heat a target tissue, A contact portion that contacts the target tissue has a first portion and a second portion that are arranged at different positions from each other, The first portion and the second portion have different thermal conductivities and / or thicknesses. Tissue heating device.

[0114] (Appendix 2) the tissue heating device is a balloon catheter; a balloon having the contact portion and inflated by supplying a fluid; The portion of the first portion and the second portion with high thermal conductivity is disposed on an outer surface of the balloon. 2. The tissue heating device of claim 1.

[0115] (Appendix 3) The portion with high thermal conductivity is formed of a metal. 3. The tissue heating apparatus of claim 2.

[0116] (Appendix 4) The portion of the first portion and the second portion having a low thermal conductivity is formed of a resin. 4. The tissue heating device of claim 2 or 3.

[0117] (Appendix 5) The balloon has a tubular portion that becomes tubular when inflated, The high thermal conductivity portion is disposed at equal intervals in a circumferential direction of the cylindrical portion. 5. The tissue heating device of claim 2.

[0118] (Appendix 6) At least a part of the high thermal conductivity portion and the low thermal conductivity portion of the first portion and the second portion are alternately arranged in a circumferential direction of the cylindrical portion. 6. The tissue heating apparatus of claim 5.

[0119] (Appendix 7) the portion with high thermal conductivity has a shorter length in the circumferential direction of the cylindrical portion than the portion with low thermal conductivity; 7. The tissue heating apparatus of claim 6.

[0120] (Appendix 8) The portion having high thermal conductivity has an extension portion extending along a direction parallel to an axial direction of the cylindrical portion. 8. A tissue heating device according to any one of claims 5 to 7.

[0121] (Appendix 9) The portion with high thermal conductivity has an annular portion extending along a circumferential direction of the cylindrical portion. 9. The tissue heating apparatus of claim 8.

[0122] (Appendix 10) The annular portion is connected to a longitudinal end of the extension portion. 10. The tissue heating apparatus of claim 9.

[0123] (Appendix 11) A tissue heating device according to any one of claims 1 to 10; A plurality of containers for storing heat transfer media having different temperatures as fluids are provided. system.

[0124] (Appendix 12) a flow rate regulating valve that regulates a flow rate of the heat medium flowing from the plurality of containers into the contact portion; A flow control unit that controls the flow rate regulating valve, the flow rate control unit controls the flow rate adjustment valve to adjust the flow rate of the heat medium based on previously acquired data indicating a relationship between a time for which the heat medium is flowed through the inside of the contact portion and a temperature inside the contact portion. 12. The system of claim 11.

[0125] (Appendix 13) a compressor that supplies compressed air to the plurality of containers such that the heat transfer medium flows from the plurality of containers into the contact portion; a pressure regulator that adjusts the pressure of the compressed air supplied from the compressor; A pressure control unit that controls the pressure regulator, The pressure control unit controls the pressure regulator to adjust the pressure of the compressed air based on a target pressure inside the contact unit. 13. The system of claim 11 or 12.

[0126] (Appendix 14) a temperature measuring unit for measuring a temperature of the heat medium stored in the plurality of containers; A heat source unit that imparts thermal energy to the heat medium stored in the plurality of containers; A heat source control unit that controls the heat source unit, the heat source control unit causes the heat source unit to apply the thermal energy so that the temperature of the heat medium stored in the plurality of containers falls within a preset temperature range based on the measured temperature of the temperature measuring unit. 14. A system according to any one of claims 11 to 13.

[0127] (Appendix 15) Further comprising a pressure reducing mechanism for reducing the pressure inside the contact portion. 15. A system according to any one of claims 11 to 14.

[0128] (Appendix 16) The tissue heating device comprises: an inlet flow path for introducing a fluid into the contact portion; an outlet flow path through which the fluid that has flowed in from the inlet flow path flows out to the outside, The system further includes an on-off valve for opening and closing a portion communicating with the outlet flow path. 16. The system of any of claims 11 to 15. EXAMPLES

[0129] The present invention will be described in more detail below with reference to examples and comparative examples, but the present invention is not limited to the following examples.

[0130] <Progression after heating the whole body vs. localized area> Fig. 8 is a diagram showing the state one week after heating (whole area) of the narrowed esophagus in accordance with an embodiment, and Fig. 9 is a diagram showing the state two weeks after heating (local area) of the narrowed esophagus in accordance with an embodiment. The present inventors conducted animal experiments to confirm the progression of heat treatment after total versus local heating.

[0131] 8 and 9, the experimental results confirmed the formation of ulcers one week after heating (overall) the narrowed esophagus. On the other hand, no ulcers were confirmed two weeks after heating (localized) the narrowed esophagus. This is believed to be because heating (localized) places less heat stress on the narrowed esophagus than heating (overall).

[0132] <Comparison of tissue at the area where thermal expansion was performed (heated area) and normal tissue> Fig. 10 is a diagram showing an example of MT staining (Masson's Trichrome staining) of the heated area of ​​the esophageal stricture of pig A according to the embodiment. Fig. 11 is a diagram showing an example of HE staining (hematoxylin-eosin staining) of the heated area of ​​the esophageal stricture of pig A according to the embodiment. Fig. 10 corresponds to a diagram showing, in a gradation of black and white images, the area of ​​locally heated collagen fibers stained blue by MT staining. Fig. 11 corresponds to a diagram showing, in a gradation of black and white images, the area of ​​locally heated collagen fibers that have been thermally denatured and turned into gelatin stained red by HE staining. The present inventors compared the tissue at the site where thermal expansion was performed (heated site) with normal tissue.

[0133] 10 and 11, it was confirmed that the blue color stained by MT staining (black in Fig. 10) locally became lighter in the heated areas. This is thought to be due to congestion, a decrease in collagen density, and the breakdown of normal structures such as the muscular plate. It was also confirmed that the red color stained by HE staining (black in Fig. 11) locally became darker in the heated areas. This is thought to be due to the collagen fibers being thermally denatured by local heating and turning into gelatin.

[0134] FIG. 12 is a diagram showing the directionality of collagen fibers at a heated site in the esophageal stricture of pig A according to the embodiment, together with that in normal tissue. The present inventors compared the directionality of collagen fibers at the site where thermal expansion was performed (heated site) with that of normal tissue.

[0135] Also referring to Figure 12, it was confirmed that the collagen fibers in the heated area were more directional than in normal tissue (collagen fibers were aligned in the circumferential direction). This is thought to be because the locally heated collagen fibers were softened by being thermally denatured and turned into gelatin, and were stretched in the circumferential direction.

[0136] <Comparison between scarred area and normal tissue> Fig. 13 is a diagram showing the thickness of each layer of the esophageal wall of pig B according to the example. Fig. 13 shows the thickness of each of the epithelium, submucosa, and muscular layer of the porcine esophageal wall in scarred and non-scarred areas (normal tissue). The present inventors compared the thickness of the epithelium, submucosa, and muscularis layer in scarred areas with that in non-scarred areas.

[0137] Also referring to Figure 13, it was confirmed that the thickness of each layer was thinner in the scarred area compared to the non-scarred area. This is thought to be because, in general, collagen fibers accumulate and harden in scarred areas, but the thickness of the epithelium and submucosa does not recover sufficiently during the recovery process after the epithelium and submucosa are excised.

[0138] FIG. 14 is a diagram showing the average blue intensity of the collagen fiber layer in the submucosa of the esophageal wall of pig B according to the embodiment. In FIG. 14, values ​​below 240 are excluded because they have a different distribution from the blue background color (gray). In FIG. 14, the horizontal axis shows the blue color tone. Strictly speaking, FIG. 14 shows a blue monochrome image generated by separating and extracting the blue component indicating collagen fibers from a color image of an MT-stained pathology slide, and further shows the blue color tone (intensity of blue coloring) of each pixel in the region of interest of the blue monochrome image as a histogram (frequency distribution). In this case, as described above, the horizontal axis of FIG. 14 is the "blue color tone," which indirectly represents the density of collagen fibers. The inventors compared the average fibrous layer blue intensity (strength of blue colouration) of scarred areas with that of non-scarred areas.

[0139] Also referring to FIG. 14, it was confirmed that the scarred area had a higher average fiber layer blue color intensity in the range of 245 or more and 254 or less than that of the non-scarred area. [Explanation of symbols]

[0140] 1...system, 2...balloon catheter (tissue heating device), 3A, 3B...container, 4...flow rate control valve, 5...compressor, 6...pressure regulator, 8A, 8B...temperature measurement unit, 9A, 9B...heat source unit, 11...pressure reduction mechanism, 12...opening and closing valve, 20...balloon, 20C...tubular portion, 22...inlet flow path, 23...outlet flow path, 51...flow rate control unit, 52...pressure control unit, 53...heat source control unit, 110A, 110B...first portion, 111...extension portion, 120...second portion, 202...balloon catheter (tissue heating device), 210...first portion, 211A to 211F...extension portion, 212A, 212B...annular portion, W1...width of first portion (length in the circumferential direction of the tubular portion of the first portion and the second portion having a high thermal conductivity)

Claims

1. A tissue heating device configured to be able to heat a target tissue, A contact portion that contacts the target tissue has a first portion and a second portion that are arranged at different positions from each other, The first portion and the second portion have different thermal conductivities and / or thicknesses. Tissue heating device.

2. the tissue heating device is a balloon catheter; a balloon having the contact portion and inflated by supplying a fluid; The portion of the first portion and the second portion with high thermal conductivity is disposed on an outer surface of the balloon. The tissue heating device of claim 1 .

3. The portion with high thermal conductivity is formed of a metal. The tissue heating device of claim 2 .

4. The portion of the first portion and the second portion having a low thermal conductivity is formed of a resin.

4. The tissue heating device of claim 2 or 3.

5. The balloon has a tubular portion that becomes tubular when inflated, The high thermal conductivity portion is disposed at equal intervals in a circumferential direction of the cylindrical portion.

4. The tissue heating device of claim 2 or 3.

6. At least a part of the high thermal conductivity portion and the low thermal conductivity portion of the first portion and the second portion are alternately arranged in a circumferential direction of the cylindrical portion. The tissue heating device of claim 5 .

7. the portion with high thermal conductivity has a shorter length in the circumferential direction of the cylindrical portion than the portion with low thermal conductivity; The tissue heating device of claim 6.

8. The portion having high thermal conductivity has an extension portion extending along a direction parallel to an axial direction of the cylindrical portion. The tissue heating device of claim 5 .

9. The portion with high thermal conductivity has an annular portion extending along a circumferential direction of the cylindrical portion. The tissue heating device of claim 8.

10. The annular portion is connected to a longitudinal end of the extension portion.

10. The tissue heating device of claim 9.

11. A tissue heating device according to any one of claims 1 to 3; A plurality of containers for storing heat transfer media having different temperatures as fluids are provided. system.

12. a flow rate regulating valve that regulates a flow rate of the heat medium flowing from the plurality of containers into the contact portion; A flow control unit that controls the flow rate regulating valve, the flow rate control unit controls the flow rate adjustment valve to adjust the flow rate of the heat medium based on previously acquired data indicating a relationship between a time for which the heat medium is flowed through the contact portion and a temperature inside the contact portion. The system of claim 11.

13. a compressor that supplies compressed air to the plurality of containers such that the heat transfer medium flows from the plurality of containers into the contact portion; a pressure regulator that adjusts the pressure of the compressed air supplied from the compressor; A pressure control unit that controls the pressure regulator, The pressure control unit controls the pressure regulator to adjust the pressure of the compressed air based on a target pressure inside the contact unit. The system of claim 11.

14. a temperature measuring unit for measuring a temperature of the heat medium stored in the plurality of containers; A heat source unit that imparts thermal energy to the heat medium stored in the plurality of containers; A heat source control unit that controls the heat source unit, the heat source control unit causes the heat source unit to apply the thermal energy so that the temperature of the heat medium stored in the plurality of containers falls within a preset temperature range based on the measured temperature of the temperature measuring unit. The system of claim 11.

15. Further comprising a pressure reducing mechanism for reducing the pressure inside the contact portion. The system of claim 11.

16. The tissue heating device comprises: an inlet flow path for introducing a fluid into the contact portion; an outlet flow path through which the fluid that has flowed in from the inlet flow path flows out to the outside, The system further includes an on-off valve for opening and closing a portion communicating with the outlet flow path. The system of claim 11.

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