Medical system and use method thereof

Abstract

To provide a medical system capable of obtaining a desired cautery depth and forming a stable shunt, and a use method thereof.SOLUTION: A medical system 1 includes: a medical system 10 including an expansion body 21, a shaft part 31 having a base end of the expansion body 21 fixed thereto, an energy transmission part 22 provided along the expansion body 21, and a displacement mechanism 26 compressing the expansion body 21 in an axial direction; and an electricity supply device 190 including a control unit 193 controlling supply of electricity to the energy transmission part 22. A tip side standing part 72 and a proximal end side standing part 73 which form a recess 55 in a midway position in the axial direction of the expansion body 21 are configured to grip a biological tissue by compression in the axial direction of the expansion body 21 by means of the displacement mechanism 26. The energy transmission part 22 is arranged along the proximal end side standing part 73. The control unit 193 supplies electricity corresponding to 1.1 to 2.8 W / mm2 to the energy transmission part 22 for 3 to 45 seconds in a state that the expansion body 21 is compressed in the axial direction by the displacement mechanism.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to a medical system including an expandable body on which electrodes are arranged to be inserted into a living body and cauterize living tissue, and a method of using the same. [Background technology]

[0002] Chronic heart failure is known as one type of heart disease. Chronic heart failure is broadly divided into systolic dysfunction and diastolic dysfunction based on indicators of cardiac function. In patients with diastolic dysfunction, the myocardium becomes enlarged and stiff, causing an increase in blood pressure in the left atrium and a decrease in the pumping function of the heart. This causes the patient to exhibit symptoms of heart failure such as pulmonary edema. There are also heart diseases in which the blood pressure in the right atrium increases due to pulmonary hypertension, etc., causing a decrease in the pumping function of the heart, resulting in symptoms of heart failure.

[0003] In recent years, shunt therapy has been attracting attention for these patients with heart failure, which forms a shunt (a through hole) in the atrial septum as an escape route for the elevated atrial pressure, thereby alleviating the symptoms of heart failure. In shunt therapy, the atrial septum is accessed via a transvenous approach, and a through hole of a desired size is formed. For example, Patent Document 1 lists a medical device for performing such a shunt therapy on the atrial septum. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] US Patent Application Publication No. 2020 / 0261704 Summary of the Invention [Problem to be solved by the invention]

[0005] The medical device described in Patent Document 1 has an expandable body that can be inserted into a living body and expanded, and a recess having a small expansion diameter is formed in the recess, and an electrode is disposed in the recess. Then, with biological tissue received in the recess of the expandable body, the expandable body is compressed in the axial direction to grasp the biological tissue with the expandable body, and the periphery of the through-hole of the grasped biological tissue is cauterized by the electrode disposed in the recess.

[0006] However, if the power applied to the electrode is too weak, cauterization is not possible, and if the power applied is too high, the tissue surface is dehydrated or carbonized, making it impossible to deepen the cauterization depth in the thickness direction of the atrial septum. Furthermore, if the conditions of the supplied energy are inappropriate, the cauterization depth becomes insufficient, making it impossible to maintain the formed shunt, which may lead to a decrease in the therapeutic effect.

[0007] The present invention has been made to solve the above-mentioned problems, and has an object to provide a medical system and a method for using the same that can obtain a desired ablation depth and form a stable shunt. [Means for solving the problem]

[0008] The medical system according to the present invention, which achieves the above-mentioned object, comprises a medical device including an expansion body having a central axis and capable of expanding and contracting in a radial direction, a long shaft portion having a tip portion to which a base end of the expansion body is fixed, an energy transmission portion provided along the expansion body, and a displacement mechanism that compresses the expansion body in an axial direction by displacing the base end of the expansion body relatively to the tip end of the expansion body approximately along the central axis, and a power supply device including a control portion that controls the supply of power to the energy transmission portion, wherein the expansion body has a recess recessed radially inward midway in the axial direction, and the recess defines a receiving space capable of receiving biological tissue. The distal upright portion and the proximal upright portion are configured to grasp the biological tissue by compressing the expansion body in the axial direction by the displacement mechanism, and the energy transmission unit is disposed along one of the distal upright portion and the proximal upright portion so as to face the receiving space. The control unit controls the energy transmission unit to have an energy output of 1.1 to 2.8 W / mm when the expansion body is compressed in the axial direction by the displacement mechanism. 2 It is configured to supply power equivalent to 3 to 45 seconds.

[0009] A method of using a medical system according to the present invention for achieving the above-mentioned object includes an expansion body having a central axis and capable of expanding and contracting in a radial direction, a long shaft portion having a tip portion to which a base end of the expansion body is fixed, an energy transmission portion provided along the expansion body, and a displacement mechanism for compressing the expansion body in an axial direction by displacing the base end of the expansion body relatively to the tip end of the expansion body approximately along the central axis, wherein the expansion body has a recess recessed radially inward midway in the axial direction, and the recess is configured to define a receiving space capable of receiving biological tissue. The expansion body has a distal upright portion, a proximal upright portion, and a bottom portion located radially innermost between the distal upright portion and the proximal upright portion, and the energy transmission portion is disposed along one of the distal upright portion and the proximal upright portion so as to face the receiving space. The expansion body is compressed in the axial direction by the displacement mechanism, thereby reducing the distance between the distal upright portion and the proximal upright portion along the axial direction and compressing the receiving space in the axial direction. In a state in which the receiving space is compressed, the energy transmission portion is provided with an energy of 1.1 to 2.8 W / mm 2 It supplies power equivalent to 3 to 45 seconds. Effect of the Invention

[0010] The medical system and the method for using the medical system configured as above provide an energy transmission section with an output of 1.1 to 2.8 W / mm 2 By delivering a power equivalent to 1000 W for 3 to 45 seconds, the desired ablation depth can be achieved and a stable shunt can be formed.

[0011] The control unit controls the energy transfer unit to have a power output of 1.1 to 2.8 W / mm 2 in a state where the expansion body is compressed in the axial direction by the displacement mechanism. 2 Alternatively, a power equivalent to 10 ...

[0012] The compression force with which the displacement mechanism compresses the expansion body in the axial direction may be 2 to 9 N. This allows the energy transmission unit to be brought into close contact with biological tissue with an appropriate force in order to form a desired cauterization depth and a stable shunt. [Brief description of the drawings]

[0013] [Figure 1] 1 is a side view illustrating an overall configuration of a medical system according to an embodiment of the present invention. [Diagram 2] FIG. 2 is a side view showing the tip of a medical device. [Diagram 3] 3A and 3B are diagrams showing the inside of the operation unit before the operation knob is operated, in which (A) is a vertical cross-sectional view and (B) is a cross-sectional view taken along line AA in FIG. 3A. [Figure 4] 4A and 4B are diagrams showing the inside of the operation unit after the operation knob is operated, in which (A) is a vertical cross-sectional view and (B) is a cross-sectional view taken along line BB in FIG. 4A. [Diagram 5] 1A and 1B are plan views showing a switch mechanism of a medical device, in which (A) shows the side with terminals and (B) shows the side with a switch body. [Figure 6] 1A and 1B are circuit diagrams showing a switch mechanism of a medical device, in which (A) shows a supply circuit of the switch mechanism in an OFF state, and (B) shows a supply circuit in an ON state. [Figure 7] FIG. 13 is a schematic diagram showing a state in which an expandable body is placed in a through-hole in the atrial septum. [Figure 8] 1 is a cross-sectional view showing a state in which a balloon is inserted into the atrial septum. [Figure 9] 1 is a cross-sectional view showing the state in which the tip portion of the medical device is inserted into the atrial septum. [Figure 10] 13 is a cross-sectional view showing the state in which the expansion body is placed in the atrial septum. FIG. [Figure 11] 13 is a cross-sectional view showing the state in which the energy transmission section, which is placed in the recess of the expandable body, is in close contact with biological tissue. FIG. [Figure 12] 11 is a flowchart illustrating a method of using the medical system. [Figure 13] FIG. 1 is a schematic diagram showing an experimental setup. [Figure 14] 1 is a graph showing ablation depth versus applied power. [Figure 15] 13 is a graph showing ablation depth versus power per unit area of ​​the energy delivery portion. [Figure 16] 1 is a graph showing impedance versus power application time. [Figure 17] 1A and 1B are diagrams showing a first modified example, in which (A) is a vertical cross-sectional view showing the inside of an operating portion, and (B) is a circuit diagram of a switch mechanism. [Figure 18] 13A and 13B are plan views showing the distal end of a medical device in a second modified example, in which (A) shows the state before the expandable body grasps the biological tissue, and (B) shows the state after the biological tissue has been grasped by the expandable body. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] Hereinafter, an embodiment of the present invention will be described with reference to the drawings. Note that the dimensional ratios in the drawings may be exaggerated for convenience of explanation and may differ from the actual ratios. In addition, in this specification, the side of the medical device that is inserted into the body cavity is referred to as the "distal side" and the side that is operated is referred to as the "base side". In addition, in this specification, "X to Y" indicating a range includes X and Y and means "X or more and Y or less".

[0015] As shown in Figure 7, the medical system 1 of this embodiment is configured to be able to perform a maintenance procedure to maintain the size of the through hole Hh formed in the atrial septum HA, which is the biological tissue of the patient's heart H, and expanded by a balloon.

[0016] As shown in FIGS. 1 and 2, a medical system 1 according to this embodiment includes a medical device 10 that is inserted into a living body to cauterize living tissue, and a power supply unit 190 that supplies power to the medical device 10.

[0017] First, the medical device 10 will be described. The medical device 10 has a long section 20 extending from the base end to the tip, an expansion body 21 provided at the tip of the long section 20, an energy transmission section 22 provided with a plurality of electrodes 24 along the expansion body 21, an operation section 23 connected to the base end of the long section 20, and a connection cable 25 connectable to a power supply device 190.

[0018] The long portion 20 has a shaft portion 31 that holds the expansion body 21 at its tip, an outer tube 30 that houses the shaft portion 31, a displacement shaft 33, and a traction portion 35 that is fixed to the tip of the displacement shaft 33.

[0019] The shaft portion 31 is a long tubular body extending from the operation portion 23 to the expansion body 21. The base end of the shaft portion 31 is fixed to the tip end of the operation portion 23. The tip end of the shaft portion 31 is fixed to the base end of the expansion body 21.

[0020] The outer tube 30 is a long tubular body that covers the shaft portion 31, and is movable forward and backward in the axial direction (the direction of the axis of the long portion 20) relative to the shaft portion 31. When the outer tube 30 is moved to the tip side of the long portion 20, the outer tube 30 can store the expansion body 21 that has been contracted in the radial direction inside. Note that the radial direction is a direction perpendicular to the axis of the shaft portion 31. The surgeon can expose the expansion body 21 from the outer tube 30 and expand it in the radial direction by moving the outer tube 30 to the base end side from a state in which the expansion body 21 is stored.

[0021] The displacement shaft 33 is a long tubular body disposed inside the shaft portion 31, and is movable forward and backward in the axial direction relative to the shaft portion 31. The displacement shaft 33 protrudes toward the distal end from the distal end of the shaft portion 31, and protrudes toward the distal end from the distal end of the expansion body 21. The distal end of the displacement shaft 33, which is located on the distal side of the expansion body 21, is fixed to the traction portion 35. The base end of the displacement shaft 33 is led out toward the proximal end side from the operation portion 23. A guidewire lumen is formed inside the displacement shaft 33 along the axial direction, and a guidewire 11 (see FIGS. 7 to 9) can be inserted therethrough.

[0022] The traction part 35 is an annular member fixed to the outer circumferential surface of the tip of the displacement shaft 33, and protrudes radially outward from the outer circumferential surface of the displacement shaft 33. The traction part 35 is not fixed to the expansion body 21. The outer diameter of the traction part 35 is larger than the inner diameter of the tip of the expansion body 21. For this reason, the traction part 35 abuts on the tip of the expansion body 21 from the tip side, and pulls the expansion body 21 toward the base end, thereby applying a compressive force to the expansion body 21 that compresses it along the axial direction of the shaft part 31.

[0023] As shown in Figures 1 and 3-4, the operation unit 23 has a housing 100 held by the surgeon, an operation knob 110 that can be moved by the surgeon along the axial direction, an elastic body 120 that transmits the movement of the operation knob 110 to the displacement shaft 33, a detection unit 130 that detects the compression of the expansion body 21, an electric wire 160 that transmits power from a power supply device 190 to the electrode 24, and a shaft connection unit 180 that connects the shaft unit 31 to the housing 100.

[0024] The housing 100 has a guide rail 101 that holds the operation knob 110 so that the operation knob 110 can slide linearly in the axial direction, and an opening 102 that exposes a part of the operation knob 110 to the outside.

[0025] The operation knob 110 is disposed slidably along the axial direction of the shaft portion 31 relative to the housing 100. The operation knob 110 can move from an initial position (see FIG. 3) where the expansion body 21 is not compressed to a compression position (see FIG. 4) where the expansion body 21 is compressed. The operation knob 110 has a knob body 111 exposed to the outside from an opening 102 of the housing 100 so that the surgeon can operate it, a sliding portion 112 that contacts the guide rail 101 linearly and slidably in the axial direction inside the housing 100, and a contact portion 113 that can contact the pressing portion 150. The operation knob 110 further has an action portion 114 that can contact the tip of the elastic body 120 from the tip side, and a stopper 115 that can contact the base end surface of a ring-shaped fixing member 170 fixed to the displacement shaft 33. The contact portion 113 is provided only in a part of the axial direction of the operation knob 110. In this embodiment, the contact portion 113 is formed on the outer circumferential surface of a portion surrounding the displacement shaft 33 in the vicinity of the action portion 114. When the operation knob 110 moves to the compressed position, the contact portion 113 comes into contact with the pressing portion 150 and can press the pressing portion 150. The action portion 114 is a portion that applies a traction force in the base end direction to the displacement shaft 33 via the elastic body 120. The stopper 115 is disposed on the base end side of the action portion 114. The stopper 115 comes into contact with a base end surface of a fixing member 170 fixed to the displacement shaft 33, thereby restricting the displacement shaft 33 from moving more than necessary in the base end direction relative to the operation knob 110.

[0026] As shown in FIGS. 3 and 4, the elastic body 120 is disposed between the operation knob 110 and the displacement shaft 33 in order to adjust the traction force transmitted from the operation knob 110 to the displacement shaft 33. The elastic body 120 is a coil spring disposed so as to surround the displacement shaft 33. The elastic body 120 can elastically expand and contract along the axial direction of the displacement shaft 33. The tip of the elastic body 120 can abut against the base end surface of the action portion 114 of the operation knob 110. The base end of the elastic body 120 can abut against the tip surface of a fixing member 170 fixed to the displacement shaft 33.

[0027] 3 to 6, the detection unit 130 has a detection switch 131 whose state changes in response to the displacement of the displacement shaft 33 by the operation knob 110, and an output unit 132 that outputs the state change of the detection switch 131 to the power supply device 190. The detection switch 131 and the output unit 132 are electrically independent from the electric wire 160.

[0028] The state of the detection switch 131 changes in response to the displacement of the displacement shaft 33 from the initial position (see FIG. 3) to the compressed position (see FIG. 4) by the operation knob 110. The detection switch 131 has a pressing part 150 that moves in response to the displacement of the operation knob 110, and a switch body 133 that can be pressed by the pressing part 150.

[0029] The pressing portion 150 has a rotating shaft 151 rotatably connected to the housing 100, a pressing input portion 152 that can contact the contact portion 113 of the operation knob 110, and a pressing output portion 153 that can contact the switch body 133 of the detection switch 131. The rotating shaft 151 can rotate about an axis parallel to the central axis of the displacement shaft 33. The pressing input portion 152 is disposed at a compressed position that can contact the contact portion 113 as shown in FIG. 4 by the operation knob 110 moving from the initial position shown in FIG. 3 toward the base end side along the axial direction. The pressing input portion 152 moves by being pressed by the contact portion 113, and rotates the pressing portion 150. When the pressing portion 150 rotates by the contact portion 113 being pressed by the pressing input portion 152, the pressing output portion 153 can press the switch body 133. In other words, the pressing portion 150 can be displaced between a pressed state in which it presses the switch body 133 described below and a non-pressed state in which it does not press the switch body 133, in accordance with the operation of the operating knob 110 that moves the displacement shaft 33 from the initial position to the compressed position.

[0030] When no external force is applied, the switch body 133 is biased by the force of a spring. When the switch body 133 is pressed by the pressing output portion 153 of the pressing portion 150, the spring is compressed and the switch body 133 is pressed in.

[0031] As shown in Figs. 5 and 6, the output unit 132 outputs the state change of the detection switch 131 to the power supply device 190 via the cable 25. The output unit 132 has an output circuit 134 on a circuit board that is electrically independent from the supply circuit 161 that supplies power to the electrode 24. The output circuit 134 has a first fixed contact 135 and a second fixed contact 136 that are arranged separately on the circuit board, a movable contact 137 that is pressed down by the switch body 133 and can contact both the first fixed contact 135 and the second fixed contact 136, and two second terminals 138 that are electrically connected to the first fixed contact 135 and the second fixed contact 136, respectively. Each of the first fixed contact 135 and the second fixed contact 136 can be connected to the power supply device 190 from one of the two second terminals 138 via the connection cable 25.

[0032] The movable contact 137 is normally separated from the first fixed contact 135 and the second fixed contact 136, but when the switch body 133 is pressed in, the movable contact 137 moves accordingly and comes into contact with both the first fixed contact 135 and the second fixed contact 136. As a result, the first fixed contact 135 and the second fixed contact 136 are electrically connected via the movable contact 137.

[0033] The electric wire 160 has a supply circuit 161 arranged on the circuit board, and an electric wire main body 162 extending along the shaft portion 31 from the supply circuit 161 to the energy transmission unit 22. The supply circuit 161 has two first terminals 163 connectable to a power supply device, two energy output terminals 164 connected to the electric wire main body 162, and two connecting electric wire portions 165 extending from the first terminals 163 to the energy output terminals 164.

[0034] The two first terminals 163 are connectable to a power supply device 190 via a connection cable 25 .

[0035] The two energy output terminals 164 are electrically connected to the respective electrode pairs of the bipolar energy transmission unit 22 via an electric wire main body 162 extending from the detection switch 131 along the shaft portion 31 to the energy transmission unit 22 .

[0036] As shown in Figs. 3 and 4, the shaft connecting part 180 has a holding part 181 fixed and held inside the housing 100, and a seal member 182 arranged inside the holding part 181. The holding part 181 is a substantially cylindrical member that is connected in close contact with the base end of the shaft part 31. The seal member 182 is an annular member that is arranged inside the holding part 181 on the base end side of the shaft part 31 and that is in slidable contact with the outer circumferential surface of the displacement shaft 33. The seal member 182 prevents blood and the like from flowing into the housing 100 from between the shaft part 31 and the displacement shaft 33.

[0037] As shown in Figures 1 and 2, the extension body 21 has a force receiving portion 51 arranged at the tip of the extension body 21, a base end connecting portion 52 arranged at the base end of the extension body 21, a second connecting portion 53 connected to the force receiving portion 51, a first connecting portion 54 connected to the base end connecting portion 52, and a recess 55 arranged between the second connecting portion 53 and the first connecting portion 54.

[0038] The force receiving portion 51 is annular, and can receive a force directed toward the base end from the traction portion 35 arranged on the tip side. The base end connecting portion 52 is annular, and is fixed to the tip portion of the shaft portion 31.

[0039] The second connecting portion 53 is flexibly deformable. The second connecting portion 53 has a tip-side expanding portion 56 that extends radially outward from the force-receiving portion 51 toward the base end, and a tip-side apex portion 57 that is disposed on the base end side of the tip-side expanding portion 56 and curves radially outward in a convex shape.

[0040] The second connecting portion 53 extends radially outward from the force receiving portion 51 towards the base end and has a plurality of distal strut structures 60 that form the distal expansion portion 56. The plurality of distal strut structures 60 are aligned at approximately equal intervals in the circumferential direction of the expandable body 21 when expanded.

[0041] Each of the multiple tip strut structures 60 has a first strut 61 extending from the force receiving portion 51 toward the base end, and a second strut 62 extending from the base end of the first strut 61 toward the base end and connected to the tip apex 57.

[0042] Each first strut 61 extends from the force receiving portion 51 approximately parallel to the axis of the expandable body 21 when viewed from the outside in the radial direction. Each second strut 62 branches into two so as to expand in the circumferential direction of the expandable body 21 while moving in the proximal direction from the base end of each first strut 61, and joins at a first junction 65 or a second junction 66. The first junctions 65 and the second junctions 66 are arranged alternately at approximately equal intervals in the circumferential direction of the expandable body 21 when expanded.

[0043] Each of the first junctions 65 is connected to a distal end apex 57 arranged in the same phase as the electrode 24 in the circumferential direction of the expandable body 21. Each of the second junctions 66 is connected to a distal end apex 57 arranged in a different phase from the electrode 24 in the circumferential direction of the expandable body 21.

[0044] The first connecting portion 54 is flexibly deformable. The first connecting portion 54 has a base-end expanding portion 58 that extends radially outward from the base-end connecting portion 52 toward the tip, and a base-end apex portion 59 that is disposed on the tip side of the base-end expanding portion 58 and curves radially outward in a convex shape.

[0045] The base-side expansion section 58 has a plurality of base-side strut structures 90. The base-side strut structures 90 and the plurality of electrode placement sections 81 are arranged in the same phase in the circumferential direction of the expansion body 21. Each of the base-side strut structures 90 has a plurality of third struts 91 extending from the tip of the shaft section 31 to the base-side apex 59, approximately parallel to the axis of the expansion body 21 when viewed from the outside in the radial direction, and a plurality of secondary struts 92 connecting the third struts 91 adjacent to each other in the circumferential direction. Each secondary strut 92 is connected to each of two third struts 91 adjacent to each other in the circumferential direction. Each secondary strut 92 is curved. Therefore, even if the distance between two adjacent third struts 91 becomes longer when the expansion body 21 expands, the secondary struts 92 can continue to support the two third struts 91 while deforming into a shape close to a straight line. Therefore, the expansion body 21 can be expanded by the compressive force applied by the displacement shaft 33 while spreading the third struts 91 apart at approximately equal intervals.

[0046] The recess 55 is flexibly deformable. When the expandable body 21 is expanded, the recess 55 is recessed radially inward and extends to connect the base end apex 59 and the tip end apex 57. The recess 55 defines a receiving space 74 capable of receiving biological tissue when the expandable body 21 is expanded.

[0047] The recess 55 has a bottom portion 71 located at the radially innermost position, a tip side upright portion 72 extending radially outward from the tip of the bottom portion 71 to the tip side apex 57, and a base side upright portion 73 extending radially outward from the base end of the bottom portion 71 to the base side apex 59.

[0048] It is preferable that the gap between the base-side standing portion 73 and the tip-side standing portion 72 is somewhat larger in the axial direction on the outer side than on the inner side in the radial direction when the expansion section is expanded. This makes it easy to place biological tissue between the base-side standing portion 73 and the tip-side standing portion 72 from the outer side in the radial direction.

[0049] The recess 55 has a plurality of recessed strut structures 80 aligned in the circumferential direction. Each of the plurality of recessed strut structures 80 has a plurality of electrode arrangement portions 81 arranged on the base end standing portion 73 and a plurality of opposing portions 82 arranged on the tip end standing portion 72, and has a plurality of bottom connecting portions 83 on the bottom 71 that connect pairs of electrode arrangement portions 81 and opposing portions 82.

[0050] The multiple electrode arrangement portions 81 are arranged at approximately equal intervals in the circumferential direction of the expansion body 21. The multiple opposing portions 82 are arranged at approximately equal intervals in the circumferential direction of the expansion body 21. The multiple bottom connecting portions 83 are arranged at approximately equal intervals in the circumferential direction of the expansion body 21.

[0051] Each of the facing parts 82 faces each of the electrodes 24 when the expansion body 21 is expanded. Each of the facing parts 82 has a plurality of tip side standing struts 84 that branch into two while spreading toward the tip direction from the respective tips of the bottom connecting parts 83 so as to be approximately along the circumferential direction of the expansion body 21, and a plurality of back support parts 85. The plurality of back support parts 85 connect the two tip side standing struts 84 that branch from each of the bottom connecting parts 83. The plurality of back support parts 85 are arranged side by side from the side closer to the bottom 71 to the side closer to the tip side apex 57. Each of the back support parts 85 is curved so that a portion between both ends connected to the two tip side standing struts 84 protrudes toward the tip side apex 57. Each of the back support parts 85 is easily bent on the side closer to the tip side apex 57 with both ends connected to the tip side standing struts 84 as fulcrums. Therefore, the backrest portion 85 can bend due to a force acting toward the tip side from the electrode 24 arranged on the base end side standing portion 73. Therefore, the biological tissue sandwiched between the electrode 24 and the backrest portion 85 can be brought into close contact with the electrode 24. Of the multiple backrest portions 85 forming each opposing portion 82, the backrest portion 85 closest to the tip apex 57 is connected to the tip apex 57 at a portion protruding toward the tip apex 57. The number of backrest portions 85 forming each opposing portion 82 is not particularly limited.

[0052] The energy transfer unit 22 has a plurality of electrodes 24. Each electrode 24 is arranged on a surface that forms the inside of the recess 55 of each electrode arrangement unit 81. The electrode 24 is arranged in close contact with the surface that forms the inside of the recess 55 of the electrode arrangement unit 81. At least a part of the surface of the electrode 24 that faces the receptive space 74 when expanded has a convex curved shape. Note that the surface of the electrode 24 that faces the receptive space 74 when expanded may have a flat shape.

[0053] When the expandable body 21 is expanded, the electrode 24 is disposed on the surface facing the tip side of the base-end standing portion 73. Since the electrode 24 is provided on the base-end standing portion 73, when the recess 55 clamps the atrial septum HA, energy from the electrode 24 is transmitted to the atrial septum HA from the right atrium side. Note that when the electrode 24 is provided on the tip-end standing portion 72, energy from the electrode 24 is transmitted to the atrial septum HA from the left atrium side.

[0054] The electrodes 24 are, for example, configured as bipolar electrodes that receive power from a power supply device 190. In this case, electricity is passed between the electrodes 24 arranged in each electrode arrangement portion 81.

[0055] Alternatively, the electrode 24 may be configured as a monopolar electrode. In this case, electricity is passed between the electrode 24 and a counter electrode plate prepared outside the body. The electrode 24 may also be a heating element (electrode tip) that receives high-frequency electric energy from an energy supply device and generates heat.

[0056] In this embodiment, the electrode 24 is provided on the base end standing portion 73 and the backrest portion 85 is provided on the tip end standing portion 72, but the electrode 24 may also be provided on the tip end standing portion 72 and the backrest portion 85 may also be provided on the base end standing portion 73.

[0057] In this embodiment, the operating knob 110, elastic body 120, displacement shaft 33 and traction section 35, which can move the tip of the expansion body 21, and the housing 100 and shaft section 31, which can move the base end of the expansion body 21, function as a displacement mechanism 26 that compresses the expansion body 21 in the axial direction by displacing the base end of the expansion body 21 relative to the tip of the expansion body 21 approximately along the central axis.

[0058] The expandable body 21 is formed integrally by, for example, cutting out from a cylinder. The struts forming the expandable body 21 may have a thickness of, for example, 50 to 500 μm and a width of, for example, 0.3 to 2.0 mm. However, the struts forming the expandable body 21 may have dimensions outside this range. In addition, the shape of the struts is not particularly limited, and may have, for example, a circular cross-sectional shape or other cross-sectional shapes.

[0059] The expandable body 21 can be made of a metal material. Examples of the metal material that can be used include titanium alloys (Ti-Ni, Ti-Pd, Ti-Nb-Sn, etc.), copper alloys, stainless steel, β-titanium steel, and Co-Cr alloys. It is more preferable to use alloys having spring properties such as nickel-titanium alloys. However, the material of the wire part is not limited to these, and other materials may be used.

[0060] The outer cylinder 30 and the shaft portion 31 of the long portion 20 are preferably made of a material having a certain degree of flexibility. Examples of such materials include polyolefins such as polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more of these, soft polyvinyl chloride resin, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, fluororesins such as polytetrafluoroethylene, polyimide, PEEK, silicone rubber, and latex rubber.

[0061] The displacement shaft 33 and the traction section 35 can be formed of a long wire material such as a superelastic alloy such as a nickel-titanium alloy or a copper-zinc alloy, a metal material such as stainless steel, a resin material with relatively high rigidity, etc. Also, the above may be coated with a resin material such as polyvinyl chloride, polyethylene, polypropylene, an ethylene-propylene copolymer, or a fluororesin.

[0062] Next, a description will be given of the power supply device 190. The power supply device 190 has a power output unit 191, a notification unit 192, and a control unit 193, as shown in FIG.

[0063] The power output unit 191 is a part that outputs power for performing a maintenance treatment. The power output unit 191 is controlled by the control unit 193 and can output a high-frequency current at any power for any period of time.

[0064] The notification unit 192 is a part that notifies the operator of the control status, warnings, and the like. The notification unit 192 is, for example, a speaker that notifies by sound, or an image monitor that notifies by image. The display method of the image monitor and the output method by the speaker are not particularly limited. The notification unit 192 may be an external device that is not configured in the power supply device 190 and is communicably connected to the power supply device 190.

[0065] The control unit 193 is configured with a CPU (Central Processing Unit), a storage circuit, and an operation program. Interfaces such as a keyboard and a mouse may be connected to the control unit 193. The control unit 193 is, for example, a computer.

[0066] The control unit 193 controls the power output unit 191 to control the output of high-frequency current from the power output unit 191. The control unit 193 can cause the power output unit 191 to output any power for any time. Therefore, the control unit 193 can supply, for example, 10 to 25 W of power. In this embodiment, the electrode surface of each electrode 24 that can contact biological tissue and supply power has a width (length along the circumferential direction of the extension body 21) of 0.75 mm and a length (length along the axial direction of the extension body 21) of 4 mm. Therefore, the area of ​​the electrode surface of each electrode 24 is 3 mm 2 The total area of ​​the electrode surfaces of the six electrodes 24 is 18 mm 2 In this embodiment, the energy transfer unit 22 has six electrodes 24 that are bipolar electrodes, and therefore the total area of ​​the transfer surface of the energy transfer unit 22 that transfers energy to biological tissue is 9 mm 2 Therefore, when a power of 10 to 25 W is supplied to the energy transfer section 22, the power per unit area on the transfer surface of the energy transfer section 22 is 1.1 to 2.8 W / mm 2 The application time during which the control unit 193 causes the power output unit 191 to output power is not particularly limited, but is preferably 3 to 45 seconds, and more preferably 5 to 25 seconds.

[0067] Moreover, the control unit 193 can calculate the bioimpedance value of the part being cauterized by acquiring the value of the high-frequency voltage to be output, as well as the value of the high-frequency current detected by a current sensor disposed in the power supply device 190, and dividing the value of the high-frequency voltage by the value of the high-frequency current. The control unit 193 can transmit information selected from various information such as the output power, voltage, current, calculated impedance value, threshold value, and elapsed time to the notification unit 192 to display it.

[0068] Next, a method of using the medical device 10 according to this embodiment will be described with reference to the flowchart shown in Fig. 12. This method is performed on a patient suffering from heart failure (left heart failure). More specifically, as shown in Fig. 4, this is a treatment method performed on a patient suffering from chronic heart failure in which the blood pressure of the left atrium HLa increases due to hypertrophy of the myocardium of the left ventricle of the heart H and increased stiffness.

[0069] The method of using the medical device 10 of this embodiment includes the steps of: forming a through hole Hh in the atrial septum HA (S1); placing an expansion body 21 in the through hole Hh (S2); receiving biological tissue in the receiving space 74 (S3); checking the hemodynamics near the through hole Hh (S4); grasping the through hole Hh with the expansion body 21 (S5); performing a maintenance procedure to maintain the size of the through hole Hh (S6); and checking the hemodynamics near the through hole Hh after the maintenance procedure has been performed (S7).

[0070] When forming the through-hole Hh, the surgeon delivers an introducer, which is a combination of a guiding sheath and a dilator, to the vicinity of the interatrial septum HA. The introducer can be delivered to the right atrium HRa via the inferior vena cava Iv, for example. The introducer can be delivered using a guidewire 11. The surgeon can insert the guidewire 11 through the dilator and deliver the introducer along the guidewire 11. The insertion of the introducer into the living body and the insertion of the guidewire 11 can be performed by a known method, such as using an introducer for introducing blood vessels.

[0071] In step S1, the surgeon penetrates a puncture device (not shown) from the right atrium HRa side toward the left atrium HLa side to form a through hole Hh in the fossa ovalis of the atrial septum HA. As the puncture device, for example, a device such as a wire with a sharp tip can be used. The puncture device is inserted through the dilator and delivered to the atrial septum HA. After the guide wire 11 is removed from the dilator, the puncture device can be delivered to the atrial septum HA in place of the guide wire 11.

[0072] Next, the surgeon delivers the balloon catheter 250 to the vicinity of the atrial septum HA along the pre-inserted guide wire 11. As shown in Fig. 8, the balloon catheter 250 has a balloon 252 at the tip of a shaft portion 251. After the balloon 252 is placed in the atrial septum HA, it is expanded radially to expand the through-hole Hh.

[0073] In step S2, as shown in FIG. 9, the medical device 10 is delivered near the atrial septum HA along the guide wire 11 inserted in advance. At this time, the tip of the medical device 10 is made to penetrate the atrial septum HA and reach the left atrium HLa. In addition, when the medical device 10 is inserted, the expansion body 21 is stored in the outer tube 30. The medical device 10 may be a device without the outer tube 30. In this case, a sheath corresponding to the outer tube 30 is separately prepared, and in step S2, the sheath is delivered in advance to the vicinity of the atrial septum HA along the guide wire 11 so that the tip of the sheath reaches the left atrium HLa through the through hole Hh of the atrial septum HA. Next, the expansion body 21 of the medical device 10 is inserted into the sheath from the base end of the sheath, and the tip of the expansion body 21 is delivered to the left atrium HLa through the through hole Hh of the atrial septum HA as in FIG. 9.

[0074] Next, in step S3, the outer tube 30 is moved toward the base end to expose the expandable body 21. As a result, as shown in Fig. 10, the expandable body 21 expands in diameter, the recess 55 is placed in the through-hole Hh of the atrial septum HA, and the receiving space 74 receives the biological tissue surrounding the through-hole Hh. Note that when the balloon 252 expands the through-hole Hh in step S1, the through-hole Hh may not be uniformly expanded in the radial direction and may become slit-shaped. In this case, when the expandable body 21 is expanded in diameter to receive the biological tissue surrounding the through-hole Hh into the receiving space 74, the expandable body 21 expands the through-hole Hh in a direction different from the direction in which the slit extends.

[0075] When the living tissue surrounding the through-hole Hh is received in the receiving space 74, the hemodynamics is confirmed in step S4. As shown in FIG. 7, the surgeon delivers the hemodynamics confirmation device 200 to the right atrium HRa via the inferior vena cava Iv. For example, a known echo catheter can be used as the hemodynamics confirmation device 200. The surgeon can display the echo image acquired by the hemodynamics confirmation device 200 on a display device such as a display, and confirm the amount of blood passing through the through-hole Hh based on the display result. At this time, if the amount of blood passing through the through-hole Hh does not reach the desired amount, the surgeon moves the outer tube 30 to the distal end side to store the expansion body 21 in the outer tube 30, and then removes the expansion body 21 together with the outer tube 30 from the through-hole Hh. Next, the through-hole Hh is expanded again using a balloon catheter having a balloon with a larger expansion diameter than the balloon 252 used in step S1, and the process returns to step S2.

[0076] In step S5, the operator operates the operation unit 23 with the atrial septum HA received in the receiving space 74 of the recess 55, and moves the knob body 111 toward the base end side relative to the housing 100. As a result, the operation knob 110 moves from the initial position shown in FIG. 3 to the compressed position shown in FIG. 4, and the action unit 114 provided on the operation knob 110 presses the tip of the elastic body 120 toward the base end. Therefore, the base end of the elastic body 120 presses the fixing member 170 toward the base end, and the displacement shaft 33 fixed to the fixing member 170 moves toward the base end. As a result, as shown in FIG. 11, the recess 55 of the expansion body 21 pinches the biological tissue. At this time, the biological tissue surrounding the through-hole Hh is pinched between the electrode unit 22 and the facing portion 82 and is well held. The operation knob 110 exerts a traction force on the displacement shaft 33 via the elastic body 120. This makes it possible to prevent a traction force that exceeds the force that can be supported by the elastic body 120 from acting on the displacement shaft 33. In other words, when the force with which the expansion body 21 pinches the biological tissue becomes excessive, the elastic body 120 contracts, and the compressive force that compresses the expansion body 21 in the axial direction is automatically adjusted. As a result, the force that pinches the biological tissue is automatically adjusted. The compressive force with which the displacement mechanism 26 compresses the expansion body 21 in the axial direction is not particularly limited, but is preferably 2 to 9 N.

[0077] When the knob body 111 in the initial position is moved toward the base end side with respect to the housing 100 to the compressed position, the contact portion 113 of the operation knob 110 comes into contact with the pressing input portion 152 of the pressing portion 150 as shown in FIG. 4. As a result, the pressing input portion 152 is pressed by the contact portion 113 and moves, causing the pressing portion 150 to rotate. When the pressing portion 150 rotates, the pressing output portion 153 presses the switch body 133 of the detection switch 131. As a result, the movable contact 137 arranged on the switch body 133 comes into contact with both the first fixed contact 135 and the second fixed contact 136 as shown in FIG. 6, causing them to be conductive. As a result, the control portion 193 (see FIG. 1) electrically connected to the first fixed contact 135 and the second fixed contact 136 can determine that the operation knob 110 has reached the compressed position from a change in the resistance value between the first fixed contact 135 and the second fixed contact 136.

[0078] When first fixed contact 135 and second fixed contact 136 become conductive, control unit 193 determines that operation knob 110 has reached the compressed position, and makes it possible to output power for cauterization, and causes notification unit 192 (see FIG. 1) to notify information indicating that it is possible to output power.

[0079] Next, in step S6, the surgeon performs a maintenance procedure to maintain the size of the through-hole Hh. In the maintenance procedure, high-frequency energy is applied to the edge of the through-hole Hh through the electrode 24, and the edge of the through-hole Hh is cauterized (heated and cauterized) by the high-frequency energy. The surgeon recognizes from the information obtained from the notification unit 192 that it has become possible to output power, and causes the power output unit 191 to output power using an interface such as a keyboard, mouse, or dedicated button connected to the control unit 193. The control unit 193 outputs power of 10 to 25 W for a predetermined time (for example, 3 to 45 seconds). The power per unit area on the contact surface of the electrode unit 22 is 1.1 to 2.8 W / mm 2 When the time for outputting power has elapsed, the control unit 193 stops the supply of power.

[0080] When the biological tissue near the edge of the through-hole Hh is cauterized through the electrode 24, a degenerated portion is formed near the edge where the biological tissue is degenerated. Since the biological tissue in the degenerated portion loses its elasticity, the through-hole Hh can maintain the shape it had when it was expanded by the expandable body 21. The through-hole Hh is held at an appropriate size by the expandable body 21 having a buffer portion and cauterized, so that the shape is maintained at an appropriate size. This allows the through-hole Hh to be used as a shunt.

[0081] After the maintenance treatment, the hemodynamics is checked again in step S7, and if the amount of blood passing through the through hole Hh is the desired amount, the surgeon reduces the diameter of the expandable body 21, stores it in the outer tube 30, and removes it from the through hole Hh. Furthermore, the entire medical device 10 is removed from the living body, and the treatment is completed.

[0082] As described above, the medical system 1 according to this embodiment includes a medical device 10 including an expansion body 21 that can expand and contract in the radial direction, a long shaft portion 31 having a tip portion to which the base end of the expansion body 21 is fixed, an energy transmission portion 22 provided along the expansion body 21, and a displacement mechanism 26 that compresses the expansion body 21 in the axial direction by displacing the base end of the expansion body 21 relatively to the tip of the expansion body 21 approximately along the central axis, and a power supply device 190 including a control unit 193 that controls the supply of power to the energy transmission portion 22. The expansion body 21 has a recess 55 recessed radially inward midway in the axial direction, and the recess 55 defines a receiving space capable of receiving biological tissue. The expansion body 21 has a distal upright portion 72, a proximal upright portion 73, and a bottom portion 71 located radially innermost between the distal upright portion 72 and the proximal upright portion 73 so as to define a gap 74 between the expansion body 21 and the base end upright portion 73. The distal upright portion 72 and the proximal upright portion 73 are configured to grasp biological tissue by compressing the expansion body 21 in the axial direction by the displacement mechanism 26. The energy transmission unit 22 is disposed along either the distal upright portion 72 or the proximal upright portion 73 so as to face the receiving space 74. The control unit 193 controls the energy transmission unit 22 to have an energy of 1.1 to 2.8 W / mm when the expansion body 21 is compressed in the axial direction by the displacement mechanism 26. 2 It is configured to supply power equivalent to 3 to 45 seconds.

[0083] In the medical system 1 configured as described above, in a state where a living tissue is grasped by the distal side standing portion 72 and the proximal side standing portion 73 forming the recess 55 of the expandable body 21, the energy transmission unit 22 arranged on the distal side standing portion 72 or the proximal side standing portion 73 is applied with a power of 1.1 to 2.8 W / mm 2 By supplying power equivalent to this for 3 to 45 seconds, a desired cauterization depth (for example, about 1.0 to 2.0 mm) can be obtained and a stable shunt can be formed.

[0084] In addition, the control unit 193 controls the energy transfer unit 22 to transmit a power of 1.1 to 2.8 W / mm when the expansion body 21 is compressed in the axial direction by the displacement mechanism 26. 2 Alternatively, a power equivalent to 10 ...

[0085] Moreover, the compression force with which the displacement mechanism 26 compresses the expandable body 21 in the axial direction is 2 to 9 N. This allows the energy transmission unit 22 to be brought into close contact with the biological tissue with an appropriate force in order to form a desired cauterization depth and a stable shunt.

[0086] The present invention also provides a method of using the medical system 1. The method of using the medical system 1 includes an expansion body 21 having a central axis and capable of expanding and contracting in a radial direction, a long shaft portion 31 having a distal end to which the proximal end of the expansion body 21 is fixed, an energy transmission portion 22 provided along the expansion body 21, and a displacement mechanism 26 that compresses the expansion body 21 in the axial direction by relatively displacing the proximal end of the expansion body 21 with respect to the distal end of the expansion body 21 approximately along the central axis, and the expansion body 21 has a recess 55 recessed radially inward midway in the axial direction, and the recess 55 is recessed at the distal end so as to define a receiving space 74 capable of receiving biological tissue. The expandable body 21 has an end-side upright portion 72, a base-side upright portion 73, and a bottom portion 71 located radially innermost between the end-side upright portion 72 and the base-side upright portion 73. The energy transmission unit 22 is arranged along one of the end-side upright portion 72 and the base-side upright portion 73 so as to face the receptive space 74. The expansion body 21 is compressed in the axial direction by the displacement mechanism 26, thereby shortening the distance between the end-side upright portion 72 and the base-side upright portion 73 along the axial direction and compressing the receptive space 74 in the axial direction. With the receptive space 74 compressed, the energy transmission unit 22 is supplied with an energy of 1.1 to 2.8 W / mm 2 It supplies power equivalent to 3 to 45 seconds.

[0087] The method of using the medical system 1 configured as described above is to apply 1.1 to 2.8 W / mm 2 of the energy transmission unit 22 arranged on the distal side standing portion 72 or the proximal side standing portion 73 in a state where the biological tissue is grasped by the distal side standing portion 72 and the proximal side standing portion 73 forming the recess 55 of the expandable body 21. 2 By delivering a power equivalent to 1000 W for 3 to 45 seconds, the desired ablation depth can be achieved and a stable shunt can be formed. EXAMPLES

[0088] An experiment was conducted to cauterize biological tissue using an experimental apparatus 300 shown in FIG. 13. The biological tissue used was a test tissue 310 made by slicing the tissue from the left atrium of a pig to a thickness of 4.5 mm. The experimental apparatus 300 had a heart simulation bath 320 in which the test tissue 310 was placed to simulate a heart, a roller pump 330 for circulating physiological saline, a thermostatic bath 340 for maintaining the temperature of the physiological saline at a constant level, and a flow path 350 for circulating the physiological saline. The saline had a salt concentration of 0.9 mass percent. The heart simulation tank 320 had a tissue fixing part 321 for fixing the test tissue 310, a first inlet 323 and a first outlet 324 provided in the first tank 322 on one side of the test tissue 310, and a second inlet 326 and a second outlet 327 provided in the second tank 325 on the other side of the test tissue 310. The second tank 325 was placed above the first tank 322. The physiological saline solution pressurized by the roller pump 330 flowed through the flow path 350 into the thermostatic bath 340, where it was heated to 37°C, and then diverted and flowed from the first inlet 323 and the second inlet 326 into the first tank 322 and the second tank 325. The physiological saline solution that flowed into the first tank 322 and the second tank 325 flowed out from the first outlet 324 and the second outlet 327 into the flow path 350, where it merged and returned to the roller pump 330 where it was pressurized again. The flow rate of the roller pump 330 was 850 mL / min.

[0089] Next, the puncture device was inserted from above into the second chamber 325, and the test tissue 310 was punctured to form a through hole. Next, the puncture device was removed, and a balloon was inserted from above into the second chamber 325, and the through hole of the test tissue 310 was expanded by the balloon. After this, the balloon was removed, and the medical device 10, which is the specimen, was inserted from above into the second chamber 325, and the expansion body 21 was placed in the through hole with the recess 55 of the expansion body 21, and a maintenance treatment was performed. At this time, the compressive force compressing the expansion body 21 in the axial direction was 5N. Experiments were performed under conditions in which the power supplied to the energy transmission unit 22 was 5W, 10W, 15W, 20W, 25W, 35W, and 45W, while exchanging the test tissue 310. The maintenance treatment at each power was performed until the cauterization progressed and the measured impedance suddenly increased, making further cauterization difficult. The electrode surface of each electrode 24 that can contact the biological tissue and supply electric power has a width of 0.75 mm and a length of 4 mm, as in the above-mentioned embodiment. Therefore, the area of ​​the electrode surface of each electrode 24 is 3 mm 2 The total area of ​​the electrode surfaces of the six electrodes 24 is 18 mm 2 It was.

[0090] The test tissue 310 after the maintenance treatment under each condition was removed from the experimental apparatus 300, and the test tissue 310 was cut along the thickness direction. The cross-sectional tissue was observed to measure the ablation depth (the depth of the ablated and discolored tissue from the contact position with the electrode 24) at six points, and the average value was calculated. A graph showing the ablation depth versus the applied power is shown in FIG. 14. Also, a graph showing the ablation depth versus the applied power per unit area of ​​the energy transmission section 22 is shown in FIG. 15. From FIGS. 14 and 15, it can be seen that the ablation depth was approximately 10 to 25 W when the applied power was 10 to 25 W and the applied power per unit area was 1.1 to 2.8 W / mm2. 2 It was confirmed that when this is the case, a deep cauterization depth of about 1.0 to 2.0 mm can be obtained.

[0091] Next, the applied power was increased to 15 W (applied power per unit area was 1.7 W / mm 2) and conducted 10 experiments to observe changes in impedance of the living body. Note that impedance was observed until the impedance dropped immediately after the start of the maintenance treatment, and then the cauterization progressed and tissue resistance increased rapidly, making further cauterization difficult. Note that the reason impedance drops immediately after the start of the maintenance treatment is thought to be that the living tissue is heated, cells are destroyed, intracellular fluid moves to the extracellular space, and the amount of electrically conductive material in the extracellular space increases temporarily, causing a decrease in tissue resistance.

[0092] The results of measuring the impedance versus application time are shown in Figure 16. This confirmed that the impedance had decreased to a certain extent when the application time was 3 seconds, and had decreased sufficiently at 5 seconds, indicating that cauterization had progressed sufficiently. It was also confirmed that at 25 seconds, cauterization had progressed until the impedance had increased sharply in all experiments except for three cases, and at 45 seconds, cauterization had progressed until the impedance had increased sharply in all experiments except for one case.

[0093] The present invention is not limited to the above-mentioned embodiment, and various modifications can be made by those skilled in the art within the technical concept of the present invention. Therefore, in the above-mentioned embodiment, the operation knob 110 is moved and the switch body 133 of the detection switch 131 is pressed, so that the surgeon can perform the maintenance treatment. However, as shown in the first modified example in FIG. 17, the operation knob 110 may be moved and the switch body 133 is pressed via the pressing part 150 to start the supply of power for the maintenance treatment. In this case, the switch mechanism is used to directly start and stop the power supply, rather than to make the power supply possible. Therefore, the circuit board is provided with a supply circuit 161 that supplies power to the electrode part 22, but unlike the above-mentioned embodiment, an output circuit that outputs information on whether the expansion body 2 is compressed or not to the power supply device 190 via the cable 25 is not provided. As an example of a configuration for this purpose, the first fixed contact 135 is electrically connected to one side of the first terminal 163 electrically connected to the power supply unit 191, and the second fixed contact 136 is electrically connected to one side of the energy output terminal 164 electrically connected to the electrode unit 22. The other side of the first terminal 163 and the other side of the energy output terminal 164 are directly electrically connected. As a result, when the operator moves the operation knob 110, the switch body 133 is pressed in, and the movable contact 137 comes into contact with both the first fixed contact 135 and the second fixed contact 136, and the first terminal 163 and the energy output terminal 164 are electrically connected. As a result, the supply of power to the energy transmission unit 22 is started. Also, when the operator moves the operation knob 110 from the compressed position toward the initial position, the switch body 133 returns, and the movable contact 137 moves away from both the first fixed contact 135 and the second fixed contact 136, and the supply of power is stopped.

[0094] Also, as in the second modified example shown in FIG. 18, the second connecting portion 53 and the first connecting portion 54 of the expansion body 21 may have different structures. The tip side standing portion 72 and the bottom portion 71 are arranged in the second connecting portion 53, and the base side standing portion 73 is arranged in the first connecting portion 54. The tip side standing portion 72, the bottom portion 71, and the base side standing portion 73 define the receiving space 74 of the recess 55. The bottom portion 71 may be arranged in the first connecting portion 54. The energy transmission portion 22 is arranged in the first connecting portion 54, but may also be arranged in the second connecting portion 53. The first connecting portion 54 and the second connecting portion 53 are housed in the outer tube 30 in an elastically deformed and contracted state, and are expanded by their own elastic expansion force (restoring force) when exposed from the outer tube 30. The shaft portion 31 is fixed to the base end of the first connecting portion 54, and the displacement shaft 33 is fixed to the base end of the second connecting portion 53. The displacement shaft 33 is slidable inside the shaft portion 31. Therefore, the displacement mechanism that compresses the expansion body 21 in the axial direction is a mechanism that pulls the displacement shaft 33 toward the base end side or pushes the shaft portion 31 toward the tip end side. By operating the displacement mechanism, as shown in FIG. 18(B), the tip side standing portion 72 and the base side standing portion 73 approach each other, reducing the receiving space 74, and the atrial septum HA, which is biological tissue, can be grasped between the tip side standing portion 72 and the base side standing portion 73. [Explanation of symbols]

[0095] 1. Healthcare system 10 Medical Devices 20 Long section 21 Extension 22 Energy transmission section 23 Control section 24 electrodes 25 Displacement Mechanism 31 Shaft section 33 Displacement shaft 55 Recess 71 Bottom 72 Tip side upright part 73 Proximal upright part 74 Receptive Space 190 Power supply equipment 191 Power output section 193 Control Unit

Claims

1. a medical device including an expansion body having a central axis and capable of expanding and contracting in a radial direction, a long shaft portion having a tip portion to which a base end of the expansion body is fixed, an energy transmission portion provided along the expansion body, and a displacement mechanism that compresses the expansion body in an axial direction by displacing the base end of the expansion body relative to the tip end of the expansion body approximately along the central axis; a power supply device including a control unit that controls the supply of power to the energy transfer unit; The expansion body has a recess recessed radially inwardly in the middle of the axial direction, The recess has a distal upright portion, a proximal upright portion, and a bottom portion located radially innermost between the distal upright portion and the proximal upright portion so as to define a receiving space capable of receiving biological tissue, The distal end side standing portion and the proximal end side standing portion are configured to grasp the biological tissue by compressing the expansion body in the axial direction by the displacement mechanism, the energy transmission portion is disposed along one of the distal end side standing portion and the proximal end side standing portion so as to face the receiving space, The control unit controls the energy transfer unit to have a compressible force of 1.1 to 2.8 W / mm ２ 2. A medical system configured to deliver electrical power equivalent to 100 W for 3 to 45 seconds.

2. The control unit controls the energy transfer unit to have a compressible force of 1.1 to 2.8 W / mm ２ The medical system according to claim 1, wherein the medical system supplies power equivalent to

3. 3. The medical system according to claim 1, wherein the compression force with which the displacement mechanism compresses the expansion body in the axial direction is 2 to 9 N.

4. A method of using a medical system including an expansion body having a central axis and capable of expanding and contracting in a radial direction, a long shaft portion having a tip portion to which a base end of the expansion body is fixed, an energy transmission portion provided along the expansion body, and a displacement mechanism that compresses the expansion body in an axial direction by displacing the base end of the expansion body relatively to the tip end of the expansion body approximately along the central axis, The expansion body has a recess recessed radially inwardly in the middle of the axial direction, The recess has a distal upright portion, a proximal upright portion, and a bottom portion located radially innermost between the distal upright portion and the proximal upright portion so as to define a receiving space capable of receiving biological tissue, the energy transmission portion is disposed along one of the distal end side standing portion and the proximal end side standing portion so as to face the receiving space, The displacement mechanism compresses the expansion body in the axial direction, thereby reducing the distance between the distal end side standing portion and the proximal end side standing portion along the axial direction, thereby compressing the receiving space in the axial direction; With the receiving space compressed, the energy transfer section is ２ A method of using a medical system to supply power equivalent to 3 to 45 seconds.

Images