medical devices

Abstract

A medical device (10) is provided with an expanding body (21), a long shaft part (20), and a plurality of electrode assemblies (22), wherein: the expanding body (21) has a recess (51) indented radially inward; the recess (51) has a bottom (52) that is located at the most radially-inward position and includes a base end-side curved section (52a) and a tip end-side curved section (52b), a base end-side upright section (53), and a tip end-side upright section (54); the plurality of electrode assemblies (22) each have electrodes (61) arranged along the expanding body (21) from the base end-side upright section (53) / the tip end-side upright section (54) to the bottom (52) so as to face a receiving space (51a) that is defined by the recess (51); the base end-side curved section (52a) and the tip end-side curved section (52b) deform according to the expansion / contraction of the expanding body (21); and the electrodes (61) are in a floating state with respect to the tip end-side curved section (52b) and the base end-side curved section (42a).

Description

[Technical Field]

[0001] The present invention relates to medical devices for delivering energy to living tissue. [Background technology]

[0002] Chronic heart failure is known as a 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 increased blood pressure in the left atrium and a decrease in the heart's pumping function. This can lead to the patient exhibiting symptoms of heart failure, such as pulmonary edema. There are also heart diseases in which increased blood pressure in the right atrium due to pulmonary hypertension and other conditions can cause the heart's pumping function to decrease, resulting in symptoms of heart failure.

[0003] In recent years, shunt therapy has been attracting attention for these heart failure patients, in which a shunt (a through-hole) is formed in the atrial septum as an escape route for 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. Examples of medical devices for performing such atrial septal shunt therapy include those described in Patent Document 1. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] International Publication No. 2019-85841 Summary of the Invention [Problem to be solved by the invention]

[0005] In the medical device of Patent Document 1, the electrode portion is fixed to the recess of the expandable body. When the expandable body expands and contracts radially, the area near the bottom of the recess is significantly deformed, making it difficult to position the electrode portion near the bottom. If the electrode portion is positioned away from the bottom of the recess, when high-frequency energy is applied from the electrode portion to the through-hole in the atrial septum, it may not be possible to sufficiently heat and cauterize the edge of the through-hole. If the edge of the through-hole is not sufficiently cauterized, it is not possible to obtain a through-hole of the desired size after cauterization.

[0006] The present invention has been made to solve the above-mentioned problems, and aims to provide a medical device in which the electrode portion provided on the expansion body can be positioned close to the bottom of the recess. [Means for solving the problem]

[0007] The medical device according to the present invention, which achieves the above-mentioned object, comprises an expandable body that can be expanded and contracted in a radial direction, a long shaft portion having a distal end portion including a base end fixing portion to which a base end of the expandable body is fixed, and a plurality of electrode assemblies extending from the base end fixing portion of the shaft portion along at least a part of the expandable body, wherein the expandable body has a recess that is recessed radially inward and defines an accepting space that can accept biological tissue when the expandable body is expanded, and the recess has a bottom that is located at the innermost position in the radial direction and includes a base end side curved portion and a tip end side curved portion. a base-side upright portion extending radially outward from the base-side curved portion, and a tip-side upright portion extending radially outward from the tip-side curved portion, and the plurality of electrode assemblies each have an electrode portion arranged along the expandable body from the base-side upright portion or the tip-side upright portion to the bottom portion so as to face the receiving space, the base-side curved portion and the tip-side curved portion deform in response to expansion and contraction of the expandable body, and the electrode portion is in a loose state relative to the tip-side curved portion and the base-side curved portion. The expansion body has a plurality of electrode engaging portions that engage the plurality of electrode assemblies with the expansion body, and the plurality of electrode assemblies each have an engaged portion that engages with the electrode engaging portion, and the electrode engaging portion is provided on at least one of the bottom portion, the base end side standing portion, and the tip end side standing portion. . [Effects of the Invention]

[0008] In the medical device configured as described above, the electrode portion is provided in an electrode assembly separate from the expandable body, so that the electrode portion can be positioned at the radially innermost position of the recess, close to the bottom. Furthermore, since the electrode portion is not fixed to the proximal curved portion and distal curved portion, which deform as the expandable body expands and contracts, and is in a floating state, the electrode portion positioned close to the bottom can be prevented from being damaged by deformation of the expandable body.

[0009] The expansion body may have a plurality of electrode engaging portions that engage each of the plurality of electrode assemblies with the expansion body, and the plurality of electrode assemblies may each have an engaged portion that engages with the electrode engaging portion, and the electrode engaging portion may be provided on at least one of the bottom portion, the base-side standing portion, and the tip-side standing portion. In this way, the electrode assemblies are engaged with and fixed to the plurality of electrode engaging portions of the expansion body, so that the electrode portions can be fixed so as not to shift position relative to the expansion body.

[0010] The expandable body has a base-end expanding portion extending radially outward from the base-end fixing portion of the shaft portion toward the tip, the base-end expanding portion has a tip connected to the outer end of the base-end standing portion and has an outward curved portion that is convexly curved radially outward, the base-end standing portion has a first through hole that penetrates the expandable body, and at least one of the plurality of electrode assemblies has an inner arranged portion that extends along the inside of the expandable body from the tip portion of the shaft portion via the vicinity of the outward curved portion of the base-end expanding portion to the first through hole, and an outer arranged portion that extends along the expandable body from the first through hole to at least the bottom so as to face the receiving space, and the outward curved portion of the base-end expanding portion changes in shape in response to expansion and contraction of the expandable body. The inner portion may be deformed so as to be spaced apart from the outwardly curved portion of the base-side expansion portion at least when the expansion body is expanded, and the outer portion may be in a loose state relative to the distal-side curved portion and the proximal-side curved portion, thereby preventing the electrode assembly from interfering with the expansion body and being damaged.

[0011] The expandable body may have a second through-hole in the proximal curved portion and a third through-hole in the distal curved portion, the plurality of electrode engaging portions may have a first engaging portion between the second through-hole and the third through-hole in the bottom portion, and at least one of the plurality of electrode assemblies may have a first hook portion that functions as the engaged portion and that extends from the extending end of the outer placement portion through the second through-hole, passes through the third through-hole via a position radially inward from the first engaging portion, and extends to the outside of the expandable body to engage with the first engaging portion. This allows the electrode portion to be positioned near the bottom of the expandable body, while allowing the electrode assembly to follow the expansion and contraction of the expandable body, preventing them from rubbing against each other and being damaged.

[0012] The extension body may have a fourth through hole in the distal upright portion, the plurality of electrode engagement portions may have second engagement portions formed from edges of the fourth through hole, and at least one of the plurality of electrode assemblies may have a second hook portion that extends from an extended end of the first hook portion and passes through the fourth through hole from the outside to the inside of the extension body, thereby engaging with the second engagement portion and functioning as the engaged portion. This makes it possible to more firmly fix the electrode assembly to the extension body and prevent the electrode portions from shifting in position.

[0013] The second hook portion may have a folded portion that passes through the fourth through-hole and extends inside the extension body toward the bottom portion, thereby enabling the electrode assembly to be more securely fixed to the extension body.

[0014] At least one of the plurality of electrode assemblies may have a third hook portion that functions as the engaged portion and engages with the first engaging portion by extending from the extended end of the second hook portion through the inside of the expandable body, passing through the second through-hole, and to the outside of the expandable body. This allows the electrode assembly to be fixed to the expandable body at a portion that extends further to the tip side than the electrode portion, thereby more effectively preventing displacement of the electrode portion.

[0015] At least one of the plurality of electrode assemblies may have a first extension portion extending from the extended end of the third hook portion and extending between the outer placement portion and the base-side upright portion toward the first through-hole, and the medical device may further include a first cover covering the base-side upright portion and the first extension portion. This allows the electrode assembly to reliably follow the movement of the base-side upright portion when the expandable body is expanded or contracted, and prevents the electrode assembly from coming into contact with an unintended location and being damaged.

[0016] At least one of the plurality of electrode assemblies may have the electrode portion in the outer arrangement portion, and the first cover may be arranged to be sandwiched between the outer arrangement portion and the first extension portion, thereby allowing the electrode assembly to follow the expansion and contraction of the expandable body while the electrode portion is exposed to the outside of the first cover.

[0017] The plurality of electrode engaging portions may have a third engaging portion formed from an edge of the first through hole, and at least one of the plurality of electrode assemblies may have a first extending portion extending from an extending end of the third hook portion and extending toward the first through hole between the outer arrangement portion and the base-end side standing portion, and a fourth hook portion extending from the extending end of the first extending portion, passing through the first through hole, and engaging with the third engaging portion, functioning as the engaged portion. This makes it possible to more reliably fix the electrode assembly to the extension body and prevent the electrode portion from shifting in position.

[0018] The fourth hook portion may have a crank portion extending from the extending end of the first extension portion through the first through-hole and along the inside of the expandable body, thereby enabling the electrode assembly to be more securely engaged with the expandable body.

[0019] At least one of the plurality of electrode assemblies may have a second extension portion extending from the extended end of the crank portion and extending radially inward from the inner placement portion along the inner placement portion, and the medical device may further include a second cover covering the second extension portion, the inner placement portion, and the base-end expansion portion. This allows the electrode assembly to move following the base-end expansion portion when the expansion body is expanded or contracted, thereby preventing the electrode assembly from coming into contact with an unintended location and being damaged.

[0020] The expandable body may have a second through hole in the bottom, the plurality of electrode engaging portions may have a first engaging portion formed from an edge of the second through hole, and at least one of the plurality of electrode assemblies may have a first hook portion that functions as the engaged portion and extends from an extended end of the outer placement portion through the second through hole to a radially inward direction of the bottom, the first hook portion having a width wider than a portion of the first hook portion that passes through the second through hole and having a wide portion that engages with the first engaging portion. This allows the electrode portion to be positioned near the bottom of the expandable body, while allowing the electrode assembly to follow the expansion and contraction of the expandable body, preventing them from rubbing against each other and being damaged.

[0021] The plurality of electrode engagement portions may have second engagement portions formed from edges of the third through holes, and the first hook portion may have a wide portion that is wider than the portion of the first hook portion that passes through the third through hole and engages with the second engagement portion. This allows the electrode assembly to be engaged with the first engagement portion while also engaging with the second engagement portion via the wide portion, thereby more reliably fixing the electrode assembly to the expandable body.

[0022] The expansion body may have a second through-hole in the proximal curved portion and a fourth through-hole in the distal upright portion, the plurality of electrode engagement portions may have a first engagement portion formed from an edge of the second through-hole and a second engagement portion formed from an edge of the fourth through-hole, and at least one of the plurality of electrode assemblies may have a first hook portion that functions as the engaged portion and that extends from an extended end of the outer placement portion through the second through-hole, radially inward from the first engagement portion, through the fourth through-hole, and extends to the outside of the expansion body to engage with the first engagement portion, the first hook portion having a width wider than a portion of the first hook portion that passes through the fourth through-hole and that engages with the second engagement portion. This allows the electrode assembly to be fixed to the expansion body at a portion that extends further distally than the electrode portion, thereby more effectively preventing displacement of the electrode portion.

[0023] The expansion body may have a second through hole in the distal curved portion and a third through hole in the proximal curved portion, and the plurality of electrode engagement portions may have a first engagement portion formed between the second through hole and the third through hole and a fourth engagement portion formed from the edge of the first through hole, and at least one of the plurality of electrode assemblies may have a first hook portion that functions as the engaged portion, extending from the extending end of the outer placement portion through the second through hole, passing through the third through hole radially inward from the first engagement portion, and extending to the outside of the expansion body, thereby engaging with the first engaging portion, a first extension portion that extends from the extending end of the first hook portion and extends between the outer placement portion and the proximal upright portion toward the first through hole, and a fourth hook portion that functions as the engaged portion, extending from the extending end of the first extension portion, passing through the first through hole, and engaging with the fourth engaging portion. As a result, the electrode assembly is engaged and fixed at two locations, the first engaging portion and the fourth engaging portion, and the electrode portion can be fixed with a simple structure.

[0024] At least one of the plurality of electrode assemblies may be adhesively fixed to the expandable body at the base-side upright portion or the tip-side upright portion, thereby allowing the electrode to be fixed to the expandable body while leaving the bottom portion of the electrode loose relative to the expandable body.

[0025] The expandable body may have a first through-hole in the distal upright portion, and at least one of the plurality of electrode assemblies may have an inner arrangement portion extending along the inside of the expandable body from the distal end of the shaft portion, over the base-side upright portion, to the first through-hole in the distal upright portion, and an outer arrangement portion extending along the expandable body from the first through-hole to the bottom portion so as to be folded back relative to the inner arrangement portion and face the receiving space. This allows the electrode portion to be arranged on the distal upright portion side with a simple structure.

[0026] The shaft portion has a shaft extension portion that extends from the base end fixing portion along the central axis of the expansion body inside the expansion body, and a tip fixing portion to which the tip of the expansion body is fixed, the expansion body has a tip side expansion portion that extends radially outward from the tip fixing portion of the shaft portion toward the base end, the base end of the tip side expansion portion is connected to the outer end of the tip side upright portion and has an outward curved portion that is curved convexly radially outward, the tip side upright portion has a first through hole, and at least one of the plurality of electrode assemblies is the distal end of the expandable body 21 may have a shaft arrangement portion extending from the extending end of the shaft arrangement portion, an inner arrangement portion extending along the inside of the expandable body 21 to the first through-hole via a vicinity of the outwardly curved portion of the distal expansion portion, and an outer arrangement portion extending along the expandable body 21 from the first through-hole to at least the bottom so as to face the receiving space, wherein the outwardly curved portion of the distal expansion portion deforms in response to expansion and contraction of the expandable body, the inner arrangement portion is spaced apart from the outwardly curved portion of the distal expansion portion at least during expansion of the expandable body, and the outer arrangement portion is in a loose state relative to the distal curved portion and the base curved portion. This allows the electrode assembly to be positioned using the shaft portion, and makes it less likely that the electrode assembly will interfere with the expansion and contraction of the expandable body 21.

[0027] The expansion body has a second through hole in the base-end curved portion, a third through hole in the tip-end curved portion, and a fourth through hole in the tip-end upright portion, and the multiple electrode engagement portions have a first engagement portion formed between the second through hole and the third through hole in the bottom portion, and a second engagement portion formed by the edge of the fourth through hole, and at least one of the multiple electrode assemblies has a first hook portion that functions as the engaged portion, passing from the extending end of the outer placement portion through the second through hole, passing through the third through hole radially inward from the first engagement portion, and extending to the outside of the expansion body, thereby engaging with the first engaging portion, and a second hook portion that functions as the engaged portion, extending from the extending end of the first hook portion, passing through the fourth through hole from the outside to the inside of the expansion body, thereby engaging with the second engaging portion, and the electrode portion may be arranged between the first hook portion and the second hook portion. This allows the electrode assembly to be firmly engaged and fixed to the expansion body when the electrode section is positioned on the side of the distal standing section, thereby preventing the electrode section from shifting position.

[0028] The expansion body may be formed of a mesh made of a number of woven wires, and at least one of the plurality of electrode assemblies may be inserted between the wires and engaged and fixed, thereby allowing the electrode assembly to be fixed to the expansion body formed of mesh as well, and the electrode portion to be positioned near the bottom of the recess. [Brief explanation of the drawings]

[0029] [Figure 1] 1 is a diagram showing the overall configuration of a medical device according to an embodiment. [Figure 2] FIG. 10 is an enlarged perspective view of the vicinity of the expansion body. [Figure 3] FIG. 10 is a front view showing one of the wire rod portions extended flat. [Figure 4] 4(a) and 4(b) are a front view and a cross-sectional view of the electrode assembly, respectively. [Figure 5] FIG. 2 is a front view of the wire portion combined with the electrode assembly. [Figure 6]FIG. 10 is a partial cross-sectional view of the vicinity of the recess of the expansion body. [Figure 7] FIG. 10 is a diagram showing the expandable body housed in a storage sheath. [Figure 8] FIG. 10 is an explanatory diagram showing a state in which an expandable body is placed in the atrial septum, with the medical device shown in a front view and the biological tissue shown in a cross-sectional view. [Figure 9] FIG. 8 is an enlarged view of the vicinity of the expandable body in FIG. 7. [Figure 10] 9 is an explanatory view showing a state in which the expandable body is expanded in diameter at the atrial septum from the state shown in FIG. 8. FIG. [Figure 11] FIG. 10 is a partial cross-sectional view of the vicinity of a recess of an expansion body according to a first modified example. [Figure 12] 12(a) is a partial cross-sectional view of the vicinity of a recess of an expansion body according to a second modified example, and FIG. 12(b) is an enlarged front view of the vicinity of the distal end of an electrode assembly. [Figure 13] 12 is a partial cross-sectional view of the vicinity of the recess of the expansion body in which the fixing structure of the first hook portion is changed from that of FIG. 11. FIG. [Figure 14] 12 is a partial cross-sectional view of the vicinity of the recess of the expansion body in which the fixing structure of the first hook portion is changed from that of FIG. 11. FIG. [Figure 15] FIG. 11 is a partial cross-sectional view of the vicinity of a recess of an expandable body according to a third modified example. [Figure 16] FIG. 11 is a partial cross-sectional view of the vicinity of a recess of an expansion body according to a fourth modified example. [Figure 17] FIG. 13 is a partial cross-sectional view of the vicinity of a recess of an expansion body according to a fifth modified example. [Figure 18] FIG. 13 is a partially enlarged view of an expandable body according to a sixth modified example. [Figure 19] FIG. 13 is an enlarged view of the vicinity of an expandable body according to a seventh modified example. [Figure 20] FIG. 2 is an enlarged view of the vicinity of a fixed portion of the electrode portion. [Figure 21] FIG. 10 is a cross-sectional view of the vicinity of a fixing portion of the electrode portion. DETAILED DESCRIPTION OF THE INVENTION

[0030] Hereinafter, an embodiment of the present invention will be described with reference to the drawings. Note that the dimensional proportions in the drawings may be exaggerated for convenience of explanation and may differ from the actual proportions. In addition, in this specification, the side of the medical device 10 that is inserted into a body cavity will be referred to as the "distal end" or "distal side," and the side that is operated by the operator will be referred to as the "proximal end" or "proximal side."

[0031] The medical device in the following embodiments is configured to expand a puncture hole Hh formed in the atrial septum HA of a patient's heart H, and to perform a maintenance procedure to maintain the expanded puncture hole Hh at that size.

[0032] 1, the medical device 10 of this embodiment has a long shaft portion 20, an expansion body 21 provided at the distal end of the shaft portion 20, and an operation portion 23 provided at the proximal end of the shaft portion 20. The expansion body 21 is provided with an electrode portion 61, which is an energy transmission element for performing the maintenance treatment described above.

[0033] The shaft portion 20 has a distal portion 30 including a base end fixing portion 31 to which the base end of the expandable body 21 is fixed, and a distal end fixing portion 33 to which the distal end of the expandable body 21 is fixed. The distal portion 30 of the shaft portion 20 has a shaft extension portion 32 extending from the base end fixing portion 31 into the expandable body 21. The shaft portion 20 has a storage sheath 25 provided on the outermost periphery. The expandable body 21 is movable forward and backward in the axial direction relative to the storage sheath 25. The storage sheath 25 can store the expandable body 21 inside when it is moved toward the distal end of the shaft portion 20. The expandable body 21 can be exposed by moving the storage sheath 25 toward the base end from a state in which the expandable body 21 is stored.

[0034] The shaft portion 20 has a traction shaft 26. The traction shaft 26 is provided from the base end of the shaft portion 20 to the shaft extension portion 32, and its tip end is fixed to a tip member 35.

[0035] The tip member 35, to which the tip end of the traction shaft 26 is fixed, does not have to be fixed to the expandable body 21. This allows the tip member 35 to pull the expandable body 21 in the compression direction. Furthermore, when storing the expandable body 21 in the storage sheath 25, moving the tip member 35 away from the expandable body 21 toward the tip side facilitates movement of the expandable body 21 in the extension direction, improving storage ease.

[0036] The operation unit 23 has a housing 40 that is held by the surgeon, an operation dial 41 that can be rotated by the surgeon, and a conversion mechanism 42 that operates in conjunction with the rotation of the operation dial 41. The traction shaft 26 is held by the conversion mechanism 42 inside the operation unit 23. The conversion mechanism 42 can move the held traction shaft 26 forward and backward along the axial direction in accordance with the rotation of the operation dial 41. As the conversion mechanism 42, for example, a rack and pinion mechanism can be used.

[0037] The shaft portion 20 is preferably formed from a material having a certain degree of flexibility, such as 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.

[0038] The traction shaft 26 can be formed by, for example, covering a long wire made of a superelastic alloy such as a nickel-titanium alloy or a copper-zinc alloy, a metal material such as stainless steel, or a resin material with relatively high rigidity with a resin material such as polyvinyl chloride, polyethylene, polypropylene, or an ethylene-propylene copolymer.

[0039] The tip member 35 can be formed from, for example, a polymeric material such as polyolefin, polyvinyl chloride, polyamide, polyamide elastomer, polyurethane, polyurethane elastomer, polyimide, fluororesin, or a mixture of these, or a multi-layer tube made of two or more types of polymeric materials.

[0040] The expandable body 21 will be described in more detail. As shown in FIG. 2, the expandable body 21 has multiple wire portions 50 arranged in the circumferential direction. In this embodiment, four wire portions 50 are arranged in the circumferential direction. Each wire portion 50 is expandable and contractible in the radial direction. The base end of each wire portion 50 is fixed to the base end fixing portion 31 and extends from this base end fixing portion 31 toward the tip end. The tip of each wire portion 50 is fixed to the tip end fixing portion 33 and extends from this tip end fixing portion 33 toward the base end. The wire portion 50 is inclined radially from both axial ends toward the center. Furthermore, the wire portion 50 has a recess 51 at the axial center that is recessed radially inward of the expandable body 21. The radially innermost portion of the recess 51 is a bottom 52.

[0041] 3, the wire portion 50 has a second through hole 81 and a third through hole 82 in the portion that becomes the bottom portion 52, and a first engagement portion 83 that serves as an electrode engagement portion between them. A first through hole 80 is formed on the base end side of the second through hole 81, and a fourth through hole 84 is formed on the tip end side of the third through hole 82. The wire portion 50 on the tip end side of the bottom portion 52 has a slit-shaped central portion in the width direction, and has outer edge portions 58 on both sides and a back support portion 59 in the center.

[0042] The wire portion 50 forming the expandable body 21 has, for example, a flat plate shape cut out from a cylinder. The wire forming the expandable body 21 can have a thickness of 50 to 500 μm and a width of 0.3 to 2.0 mm. However, the wire portion 50 may have dimensions outside these ranges. The wire portion 50 may also have a circular cross-sectional shape or other cross-sectional shapes.

[0043] An electrode assembly 22, which is separate from the extension body 21, is attached to the extension body 21. As shown in FIG. 4(a), the electrode assembly 22 has a long wiring section 60, an electrode section 61 provided in the longitudinal middle of the wiring section 60, and a connection section 62 provided at the base end of the wiring section 60. As shown in FIG. 4(b), the wiring section 60 has a conductive electric wire section 60a. The electric wire section 60a, the electrode section 61, and the connection section 62 can be formed of a metal material. The electric wire section 60a is embedded in an adhesive layer 60b sandwiched between insulating layers 60c provided on both surfaces of the wiring section 60 in the thickness direction. The electrode section 61 is provided so as to be exposed on the surface of the insulating layer 60c and is electrically connected to the electric wire section 60a. In addition, the connection portion 62 is a portion that electrically connects the electrode assembly 22 to a connection wire (not shown) provided on the base end side of the medical device 1, and like the electrode portion 61, is exposed on the surface of the insulating layer 60c and is electrically connected to the wire portion 60a.

[0044] The electrode section 61 is configured, for example, as a bipolar electrode that receives electrical energy from an external device, an energy supply device (not shown). In this case, electricity is passed between the electrode sections 61 arranged on each wire section 50. The electrode sections 61 and the energy supply device are connected by a conductor (not shown) covered with an insulating coating material. The conductor is led out via the shaft section 20 and the operating section 23 and connected to the energy supply device.

[0045] Alternatively, the electrode unit 61 may be configured as a monopolar electrode. In this case, electricity is passed between the electrode unit 61 and a return electrode plate prepared outside the body. Alternatively, a heat generating element (electrode chip) that receives high-frequency electrical energy from an energy supply device and generates heat may be used instead of the electrode unit 61. In this case, electricity is passed between the heat generating elements disposed in each wire unit 50. Furthermore, the electrode unit 61 may be configured using an energy transfer element capable of applying energy to the puncture hole Hh, such as microwave energy, ultrasonic energy, coherent light such as a laser, a heated fluid, a cooled fluid, a device that exerts a heating or cooling effect using a chemical medium, a device that generates frictional heat, a heater equipped with an electric wire, etc., and the specific form is not particularly limited.

[0046] The wire portion 50 can be made of a metal material. Examples of such metal materials include titanium-based alloys (Ti-Ni, Ti-Pd, Ti-Nb-Sn, etc.), copper-based alloys, stainless steel, β-titanium steel, and Co-Cr alloys. It is preferable to use alloys with spring properties, such as nickel-titanium alloys. However, the material of the wire portion 50 is not limited to these, and other materials may also be used.

[0047] 5 and 6, the electrode assembly 22 is fixed by engaging the wiring portion 60 along the surface of the wire portion 50 with multiple electrode engaging portions of the expandable body 21 so that the wiring portion 60 is hooked onto them. The wire portion 50 has a recess 51 that is recessed radially inward and defines an receiving space 51a that can receive biological tissue when the expandable body 21 is expanded. The wire portion 50 has a base-side curved portion 52a that is the base-side portion of a bottom portion 52 that is the radially innermost portion of the recess 51, and a distal-side curved portion 52b that is the distal-side portion of the bottom portion 52. The wire portion 50 has a base-side upright portion 53 that extends radially outward from the base-side curved portion 52a toward the base end, and a distal-side upright portion 54 that extends radially outward from the distal-side curved portion 52b toward the distal end. The wire portion 50 also has a base-side expanding portion 55 extending radially outward from the base-side fixing portion 31 of the shaft portion 20 toward the tip side, and a tip-side expanding portion 56 extending radially outward from the tip-side fixing portion 33 of the shaft portion 20 toward the base side. The base-side expanding portion 55 has a tip connected to the outer end of the base-side upright portion 53, has an outwardly curved portion 57 that is curved convexly outward in the radial direction, and deforms in response to the expansion and contraction of the expandable body 21. The base end of the tip-side expanding portion 56 is connected to the outer end of the tip-side upright portion 54, and has an outwardly curved portion 57 that is curved convexly outward in the radial direction, and deforms in response to the expansion and contraction of the expandable body 21.

[0048] The base-side upright portion 53 has a first through-hole 80, the edge of which forms a third engagement portion 80a as an electrode engagement portion that engages the electrode assembly 22. The base-side curved portion 52a has a second through-hole 81, and the tip-side curved portion 52b has a third through-hole 82, and a first engagement portion 83 as an electrode engagement portion is formed between the second through-hole 81 and the third through-hole 82. The first engagement portion 83 has a form that bridges both widthwise ends at the bottom 52 of the wire portion 50. The tip-side upright portion 54 has a fourth through-hole 84, the edge of which forms a second engagement portion 84a as an electrode engagement portion.

[0049] The electrode assembly 22 has an inner placement portion 70 that extends from the distal end portion 30 of the shaft portion 20 toward the distal end, passing near the outwardly curved portion 57 of the base-end expansion portion 55, along the inside of the expandable body 21 to the first through-hole 80. The inner placement portion 70 is spaced apart from the outwardly curved portion 57 of the wire portion 50 when the expandable body 21 is expanded. Therefore, even if the outwardly curved portion 57 is deformed when the expandable body 21 is expanded or contracted, the electrode assembly 22 can be prevented from being damaged.

[0050] The electrode assembly 22 has an outer placement portion 71 that extends along the expandable body 21 from the first through-hole 80 to the bottom 52 of the recess 51 so as to face the receiving space 51a. The electrode portion 61 is disposed in the outer placement portion 71 and faces the receiving space 51a.

[0051] The electrode assembly 22 extends from the extending end of the outer placement portion 71 through the second through-hole 81, passes through the third through-hole 82 radially inward from the first engagement portion 83, and extends to the outside of the expandable body 21, thereby having a first hook portion 72 that hooks onto and engages with the first engagement portion 83. The first hook portion 72 functions as an engaged portion that engages with the first engagement portion 83, which is an electrode engaging portion. Here, in this specification, the "extending end" refers to the end in the extending direction of each of the multiple electrode assemblies 22 when they extend from the distal end of the shaft portion 20 or the distal end of the expandable body 21 along the expandable body 21. Note that one of the multiple electrode assemblies 22 may extend from the distal end of the expandable body 21, and the other electrode assemblies 22 may extend from the distal end of the shaft portion 20.

[0052] The electrode section 61 is provided in the electrode assembly 22, which is separate from the wire section 50 that forms the expansion body 21, and therefore the electrode section 61 can be positioned close to the bottom section 52, which is the innermost radial section of the recess 51. Furthermore, the electrode section 61 is not fixed to the base-end curved section 52a and the tip-end curved section 52b, which deform as the expansion body 21 expands and contracts, and is in a floating state, so that the electrode section 61 can be prevented from being damaged by deformation of the expansion body 21.

[0053] The electrode assembly 22 has a second hook portion 73 that extends from the extended end of the first hook portion 72 and passes through a fourth through-hole 84 from the outside toward the inside of the expandable body 21, thereby engaging with the second engaging portion 84a. The second hook portion 73 functions as an engaged portion that engages with the second engaging portion 84a, which is an electrode engaging portion. The second hook portion 73 passes through the fourth through-hole 84 and has a folded portion 73a that extends inside the expandable body 21 toward the bottom portion 52. The second hook portion 73 securely fixes the electrode assembly 22 to the wire portion 50, preventing the electrode portion 61 from shifting position.

[0054] The electrode assembly 22 has a third hook portion 74 that extends from the extending end of the second hook portion 73 through the inside of the expandable body 21, passes through the second through-hole 81, and extends to the outside of the expandable body 21 to engage with the first engaging portion 83. The third hook portion 74 functions as an engaged portion that engages with the first engaging portion 83, which is an electrode engaging portion. Furthermore, the electrode assembly 22 has a first extending portion 84 that extends from the extending end of the third hook portion 74 and extends between the outer placement portion 71 and the base-end side upright portion 53 toward the first through-hole 80. The base-end side upright portion 53 and the first extending portion 84 are covered with a first cover 65. A heat-shrink tube or the like can be used for the first cover 65.

[0055] The first cover 65 allows the electrode assembly 22 to reliably follow the movement of the base-end standing portion 53 when the expansion body 21 is expanded or contracted. This prevents the electrode assembly 22 from coming into contact with unintended locations and being damaged. Furthermore, because the portion of the electrode assembly 22 covered by the first cover 65 is slidable in the length direction, it is possible to prevent excessive localized deformation force from being applied to the electrode assembly 22 when the expansion body 21 is expanded or contracted.

[0056] The electrode assembly 22 has a fourth hook portion 76 that extends from the extending end of the first extension portion 84, passes through the first through-hole 80, and engages with the third engagement portion 80a. The fourth hook portion 76 functions as an engaged portion that engages with the third engagement portion 80a, which is an electrode engaging portion. The fourth hook portion 76 has a crank portion 76a that extends from the extending end of the first extension portion 84, passes through the first through-hole 80, and extends along the inside of the expandable body 21.

[0057] The electrode assembly 22 has a second extension portion 77 that extends from the extending end of the crank portion 76a and extends radially inward from and along the inner disposed portion 70. The second extension portion 77, the inner disposed portion 70, and the base-end expansion portion 55 are covered with a second cover 66. A heat-shrink tube or the like can be used for the second cover 66. Like the first cover 65, the second cover 66 prevents the electrode assembly 22 from coming into contact with unintended locations and can prevent excessive localized deformation force from being applied to the electrode assembly 22 when the expansion body 21 is expanded or contracted.

[0058] The expandable body 21 housed in the housing sheath 25 is in a radially contracted state as shown in Fig. 7. When the expandable body 21 and the housing sheath 25 move relative to each other in the axial direction, the expandable body 21 is exposed to the outside of the housing sheath 25 and expands radially.

[0059] A treatment method using the medical device 10 will be described. The treatment method of this embodiment is performed on a patient suffering from heart failure (left ventricular failure). More specifically, as shown in Fig. 8, 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.

[0060] The treatment method of this embodiment includes the steps of: forming a puncture hole Hh in the atrial septum HA (S1); placing an expandable body 21 in the puncture hole Hh (S2); expanding the diameter of the puncture hole Hh using the expandable body 21 (S3); checking the hemodynamics near the puncture hole Hh (S4); performing maintenance treatment to maintain the size of the puncture hole Hh (S5); and checking the hemodynamics near the puncture hole Hh after the maintenance treatment has been performed (S6).

[0061] When forming the puncture hole Hh, the surgeon delivers an introducer 310, which is a combination of a guiding sheath and a dilator, to the vicinity of the interatrial septum HA. The introducer 310 can be delivered to the right atrium HRa, for example, via the inferior vena cava IV. The introducer can be delivered using a guidewire 11. The surgeon can insert the guidewire 11 into the dilator and deliver the introducer along the guidewire 11. The insertion of the introducer and the guidewire 11 into the living body can be performed by a known method, such as using an introducer for introducing blood vessels.

[0062] In step S1, the surgeon passes a puncture device (not shown) from the right atrium HRa side toward the left atrium HLa side to form a puncture hole Hh. 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.

[0063] In step S2, first, the medical device 10 is delivered to the vicinity of the atrial septum HA along the pre-inserted guide wire 11. At this time, the distal end of the medical device 10 penetrates the atrial septum HA and reaches the left atrium HLa. Furthermore, when the medical device 10 is inserted, the expandable body 21 is housed in the housing sheath 25.

[0064] 9, the housing sheath 25 is moved toward the proximal end to expose the expandable body 21. This causes the diameter of the expandable body 21 to expand, and the recess 51 is positioned at the puncture hole Hh in the atrial septum HA, receiving the biological tissue surrounding the puncture hole Hh in the receiving space 51a. As a result, the biological tissue is sandwiched between the proximal upright portion 53 having the electrode portion 61 and the distal upright portion 54.

[0065] In step S3, with the receiving space 51a receiving the biological tissue, the surgeon operates the operating unit 23 to move the traction shaft 26 toward the proximal end, thereby causing the expandable body 21 to further expand in the radial direction, and the puncture hole Hh to be pushed open in the radial direction, as shown in FIG.

[0066] After the puncture hole Hh is dilated, hemodynamics is confirmed in step S4. As shown in FIG. 8, the surgeon delivers a hemodynamics confirmation device 320 to the right atrium HRa via the inferior vena cava IV. A known echo catheter, for example, can be used as the hemodynamics confirmation device 320. The surgeon can display the echo image acquired by the hemodynamics confirmation device 320 on a display or other display device, and can confirm the amount of blood passing through the puncture hole Hh based on the display results.

[0067] Next, in step S5, the surgeon performs a maintenance procedure to maintain the size of the puncture hole Hh. In the maintenance procedure, high-frequency energy is applied to the edge of the puncture hole Hh through the electrode unit 61, thereby cauterizing (heating and cauterizing) the edge of the puncture hole Hh with the high-frequency energy.

[0068] When the living tissue near the edge of the puncture hole Hh is cauterized through the electrode portion 61, a denatured portion is formed near the edge where the living tissue is denatured. Because the living tissue in the denatured portion loses its elasticity, the puncture hole Hh can maintain the shape it had when it was expanded by the expandable body 21.

[0069] After the maintenance treatment, the hemodynamics is checked again in step S6, and if the amount of blood passing through the puncture hole Hh is the desired amount, the surgeon reduces the diameter of the expandable body 21, stores it in the storage sheath 25, and removes it from the puncture hole Hh. Then, the entire medical device 10 is removed from the living body, completing the treatment.

[0070] Next, modified examples of the expandable body and electrode assembly will be described. As shown in Fig. 11, the wire portion 101 of the expandable body 100 according to a first modified example has a base-side curved portion 103a and a distal-side curved portion 103b at the bottom 103 of the recess 102. A second through-hole 121 is formed in the distal-side curved portion 103b, and a third through-hole 122 is formed in the base-side curved portion 103a. A first engaging portion 123 is formed between the second through-hole 121 and the third through-hole 122. The first engaging portion 123 is positioned slightly toward the base end on the bottom 103 of the recess 102. A first through-hole 120 is formed in the base-side upright portion 104 of the wire portion 101.

[0071] The electrode assembly 110 has an inner placement portion 113 located proximally of the first through-hole 120 and an outer placement portion 114 located distally of the first through-hole 120. The electrode portion 112 is located in the outer placement portion 114 so as to face the receiving space 102b. The electrode assembly 110 extends from the extending end of the outer placement portion 114, passes through the second through-hole 121 of the distal curved portion 103b, passes radially inward from the first engagement portion 123, passes through the third through-hole 122 of the proximal curved portion 103a, and extends to the outside of the expandable body 100, thereby having a first hook portion 115 that engages with the first engagement portion 123. Because the first engagement portion 123 is located closer to the proximal end than the bottom portion 102a, the electrode portion 112 can be located along the proximal upright portion 104.

[0072] The wiring portion 111 has a first extension portion 116 that extends from the extending end of the first hook portion 115 and extends between the outer arrangement portion 114 and the base-end side standing portion 104 toward the first through-hole 120. Furthermore, the wiring portion 111 has a fourth hook portion 117 that extends from the extending end of the first extension portion 116, passes through the first through-hole 120, and engages with a fourth engagement portion 120a formed at the edge of the first through-hole 120. In this way, the electrode assembly 110 may be folded back at the first engagement portion 123 formed on the bottom portion 102a of the recess 102.

[0073] Next, an expansion body 130 and an electrode assembly 140 according to a second modification will be described. As shown in Fig. 12(a), the wire portion 131 of the expansion body 130 has a recess 132. A second through-hole 151 is formed in the bottom 133 of the recess 132. A first engagement portion 152 is formed on the edge of the second through-hole 151.

[0074] The electrode assembly 140 has an inner arrangement portion 143 located closer to the base end than the first through hole 150 and an outer arrangement portion 144 located closer to the tip end than the first through hole 150. The electrode portion 142 is located in the outer arrangement portion 144 so as to face the receiving space 132a. The wiring portion 141 has a first hook portion 145 that extends from the extended end of the outer arrangement portion 114, passes through the second through hole 151, and radially inward of the bottom portion 133. As shown in FIG. 12(b), the first hook portion 145 has a wide portion 145a that is wider than a passing portion 145b of the first hook portion 145 that passes through the second through hole 151, and that engages with the first engagement portion 152. The wide portion 145a engages with the first engagement portion 152 so as to be hooked, thereby fixing the first hook portion 145 to the wire portion 131. In this way, the electrode assembly 140 may have the wide portion 145a provided at the tip end as the engaged portion.

[0075] The fixing structure of the first hook portion 145 having the wide portion 145a may be different. As shown in FIG. 13 , the expandable body 130 has a second through-hole 155 in the proximal curved portion 133a and a third through-hole 156 in the distal curved portion 133b, and a first engagement portion 157 is formed between the second through-hole 155 and the third through-hole 156. The first hook portion 145 extends from the extending end of the outer placement portion 144 through the second through-hole 155, passes through the third through-hole 156 radially inward from the first engagement portion 157, and extends to the outside of the expandable body 130, thereby engaging with the first engagement portion 157. The wide portion 145a of the first hook portion 145 is hooked onto and engaged with a second engagement portion 156a formed at the edge of the third through-hole 156.

[0076] 14, the expandable body 130 may have a fourth through-hole 158 in the distal standing portion 135, and a second engaging portion 158a may be formed on the edge of this fourth through-hole 158. The first hook portion 145 that passes through the second through-hole 155 may be extended to the fourth through-hole 158 and engaged with the second engaging portion 158a at the wide portion 145a.

[0077] Next, an expansion body 170 and an electrode assembly 180 according to a third modification will be described. As shown in Fig. 15, the configuration of the expansion body 170 is the same as that shown in Fig. 6, and includes a first through-hole 190 in the base-side upright portion 174, a second through-hole 191 in the base-side curved portion 173a, a third through-hole 192 in the tip-side curved portion 173b, and a fourth through-hole 194 in the tip-side upright portion 175. The expansion body 170 has, as electrode engagement portions, a first engagement portion 193 formed between the second through-hole 191 and the third through-hole 192 in the bottom portion 173, and a second engagement portion 194a formed by the edge of the fourth through-hole 194.

[0078] The electrode assembly 180 has a first hook portion 185 that extends from the extending end of the outer placement portion 184 through the second through-hole 191, passes radially inward from the first engagement portion 193, passes through the third through-hole 192, and extends to the outside of the expandable body 170, thereby engaging with the first engagement portion 193. The electrode assembly 180 also has a second hook portion 187 that extends from the extending end of the first hook portion 185, passes through a fourth through-hole 194 from the outside to the inside of the expandable body 170, and engages with the second engagement portion 194a. The electrode portion 182 is disposed between the first hook portion 185 and the second hook portion 187. Therefore, the electrode portion 182 is disposed along the distal upright portion 175 of the recess 172. In this manner, the electrode portion 182 may be disposed on the distal side of the recess 172.

[0079] Next, an expansion body 200 and an electrode assembly 210 according to a fourth modified example will be described. As shown in FIG. 16 , the expansion body 200 has a first through-hole 205 in the base-side upright portion 204. The electrode assembly 210 has an inner arrangement portion 213 and an outer arrangement portion 214, with the first through-hole 205 sandwiched between them, and the outer arrangement portion 214 is arranged along the base-side upright portion 204. An electrode portion 212 is arranged in the outer arrangement portion 214. The electrode portion 212 faces the receiving space 202a, and its back side is adhesively fixed to the expansion body 200 by an adhesive portion 215. The adhesive portion 215 is provided in a radially outer region of the electrode portion 212 and is arranged so as not to reach the base-side curved portion 203a and the tip-side curved portion 203b of the expansion body 200. Therefore, the outer arrangement portion 214 on which the electrode portion 212 is arranged is in a loose state relative to the base-side curved portion 203 a and the tip-side curved portion 203 b. In this way, the electrode assembly 200 may be fixed by adhesive, and in this case too, by forming the adhesive portion 215 so that the electrode portion 212 is in a loose state relative to the base-side curved portion 203 a and the tip-side curved portion 203 b, the electrode portion 212 can be arranged to extend to the vicinity of the bottom portion 203.

[0080] Next, an expansion body 220 and an electrode assembly 230 according to a fifth modified example will be described. As shown in FIG. 17 , the expansion body 220 has a first through-hole 226 in the distal upright portion 225. The electrode assembly 230 has an inner placement portion 233 that extends along the inside of the expansion body 220 from the distal end portion 30 of the shaft portion 20, past the proximal upright portion 224, to the first through-hole 226 in the distal upright portion 230. The expansion body 220 also has an outer placement portion 234 that extends along the expansion body 220 from the first through-hole 226 to the bottom portion 223, folded back relative to the inner placement portion 233, and faces the receiving space 222a. The electrode portion 232 is arranged along the outer placement portion 234 and fixed to the outer placement portion 234 by an adhesive portion 235. The adhesive portion 235 is arranged so as not to reach the base-end curved portion 223a and the tip-end curved portion 223b, and the area of ​​the outer arrangement portion 234 on the bottom 223 side where the electrode portion 232 is arranged is loose relative to the base-end curved portion 223a and the tip-end curved portion 223b. In this way, the inner arrangement portion 233 may be made long so that the electrode portion 232 is arranged along the tip-end upright portion 225. In this case, the electrode assembly 230 is not limited to being fixed by adhesive, but may be fixed by the multiple electrode engaging portions described above.

[0081] Next, an expandable body 240 and an electrode assembly 250 according to a sixth modified example will be described. As shown in FIG. 18 , the distal upright portion 245 of the expandable body 240 has a first through-hole 246. The electrode assembly 250 has a shaft placement portion 253 extending along the shaft extension portion 32 from the base-end fixing portion 31 to the distal-end fixing portion 33 of the shaft portion 20. The electrode assembly 250 has an inner placement portion 254 extending along the inside of the expandable body 240 from the extending end of the shaft placement portion 253, via the vicinity of the outwardly curved portion 248 of the distal-end expanding portion 247, to the first through-hole 246, and an outer placement portion 255 extending along the expandable body 240 from the first through-hole 246 to the vicinity of the bottom portion 243 so as to face the receiving space 242a. The inner placement portion 254 is spaced apart from the outwardly curved portion 248 of the distal-end expanding portion 247 when the expandable body 240 is expanded. Furthermore, the outer placement portion 255 having the electrode portion 252 is adhesively fixed to the expandable body 240 by an adhesive portion 256. The adhesive portion 256 is arranged so as not to reach the base-end curved portion 243a and the tip-end curved portion 243b, and the area of ​​the outer placement portion 255 on the bottom 243 side is loose relative to the base-end curved portion 243a and the tip-end curved portion 243b. In this way, the electrode assembly 250 may have a portion that fits along the shaft portion 20. In this case, the electrode assembly 250 may be fixed not only by adhesive but also by the multiple electrode engaging portions described above.

[0082] Next, an expansion body 260 and an electrode assembly 270 according to a seventh modified example will be described. As shown in Fig. 19, the expansion body 260 is formed of a mesh made of a large number of woven wires 261. The expansion body 260 has a recess 262, and an electrode section 272 is disposed in its proximal upright section 264. As shown in Fig. 20, the electrode assembly 270 is engaged with the expansion body 260 by being inserted into the spaces between the wires 261.

[0083] 21 , in this example, the electrode assembly 270 has a first hook portion 274 that engages with the bottom portion 263, a second hook portion 275 that engages with the tip-side upright portion 265, a third hook portion 276 that passes radially inside the first hook portion 274 and engages with the bottom portion 263, and a fourth hook portion 277 that engages with the base-side upright portion 264. In addition, the outer arrangement portion 273 having the electrode portion 272 is arranged to face the receiving space 262a and is in a loose state with respect to the bottom portion 263.

[0084] In this way, the electrode assembly 270 can be fixed so as to conform to the outer shape of the expandable body 260 formed of mesh. The fixing of the electrode assembly 270 is not limited to this example, and any of the fixing methods using the multiple electrode engaging portions described above may be applied.

[0085] Furthermore, the expandable body may be different from the expandable body 21 in which multiple wire portions 50 are fixed to the proximal end fixing portion 31 and distal end fixing portion 33 of the shaft portion 20, as described above, or the expandable body 260 formed of a mesh. For example, an expandable body having multiple wire portions may have a proximal expandable portion and a distal expandable portion, and the proximal expandable portion may be fixed to the proximal end fixing portion of the shaft portion, while the distal expandable portion is not bundled or fixed. Furthermore, an expandable body having multiple wire portions may have a proximal expandable portion fixed to the proximal end fixing portion, but not have a distal expandable portion.

[0086] The electrode assembly may also have a wide portion wider than the electrode engaging portion of the extendable body at the end or intermediate position in the extension direction that serves as the engaged portion. For example, in the example of Figure 6, a wide portion may be provided on the fourth hook portion 76 to serve as the end of the electrode assembly 22. Also, wide portions may be provided on both the front and rear portions of the second hook portion 73 that pass through the fourth through-hole 84, and these wide portions may be engaged with the second engaging portion 84a.

[0087] Furthermore, the multiple electrode assemblies 22 may each have a different fixing structure. For example, the structure of the electrode assembly 22 shown in Fig. 6 may be adopted for two of the four wire portions 50, and the structure of the electrode assembly 180 shown in Fig. 15 may be adopted for the remaining two wire portions 50. Furthermore, the electrode assemblies 22 may employ other combinations.

[0088] As described above, the medical device 10 according to this embodiment comprises an expansion body 21 that can expand and contract in the radial direction, a long shaft portion 20 having a distal end portion 30 including a base end fixing portion 31 to which the base end of the expansion body 21 is fixed, and a plurality of electrode assemblies 22 extending from the base end fixing portion 31 of the shaft portion 20 along at least a portion of the expansion body 21, the expansion body 21 having a recess 51 that is recessed radially inward and defines a receiving space 51a that can receive biological tissue when the expansion body 21 is expanded, and the recess 51 is located at the innermost radial position including a base end side curved portion 52a and a tip end side curved portion 52b. The medical device 10 has a bottom portion 52 on which the expandable body 21 is placed, a base-side upright portion 53 extending radially outward from the base-side curved portion 52a, and a distal-side upright portion 54 extending radially outward from the distal-side curved portion 52b, and the plurality of electrode assemblies 22 each have an electrode portion 61 arranged along the expandable body 21 from the base-side upright portion 53 or the distal-side upright portion 54 to the bottom portion 52 so as to face the receiving space 51a, the base-side curved portion 52a and the distal-side curved portion 52b deforming in response to the expansion and contraction of the expandable body 21, and the electrode portion 61 is in a loose state relative to the distal-side curved portion 52b and the base-side curved portion 52a. In the medical device 10 configured in this manner, the electrode portion 61 is provided in an electrode assembly 22 separate from the expandable body 21, and therefore the electrode portion 61 can be arranged in a position closest to the bottom portion 52, which is the radially innermost position of the recess 51. Furthermore, the electrode portion 61 is not fixed to the base end curved portion 52a and the tip end curved portion 52b, which deform as the expansion and contraction of the expansion body 21 occurs, and is in a floating state, so that the electrode portion 61, which is positioned close to the bottom portion 52, can be prevented from being damaged by the deformation of the expansion body 21.

[0089] The expansion body 21 may have a plurality of electrode engaging portions that engage each of the plurality of electrode assemblies 22 with the expansion body 21, and the plurality of electrode assemblies 22 may each have an engaged portion that engages with the electrode engaging portion, and the electrode engaging portion may be provided on at least one of the bottom portion 52, the base end side standing portion 52a, and the tip end side standing portion 52b. As a result, the electrode assembly is engaged with and fixed to the plurality of electrode engaging portions of the expansion body 21, so that the electrode portion 61 can be fixed so as not to shift position relative to the expansion body 21.

[0090] The expandable body 21 has a base-end expanding portion 55 extending radially outward from the base-end fixing portion 31 of the shaft portion 20 toward the tip, the base-end expanding portion 55 has a tip connected to the outer end of the base-end standing portion 53 and has an outwardly curved portion 57 that is curved convexly radially outward, the base-end standing portion 53 has a first through hole 80 that penetrates the expandable body 21, and at least one of the multiple electrode assemblies 22 has an inner-arranged portion 70 that extends along the inside of the expandable body 21 from the tip portion 30 of the shaft portion 20 via the vicinity of the outwardly curved portion 57 of the base-end expanding portion 55 to the first through hole 80, and an outer-arranged portion 71 that extends along the expandable body 21 from the first through hole 80 to at least the bottom 52 so as to face the receiving space 51a, The inner portion 70 may be spaced apart from the outward curved portion 57 of the base-end expanding portion 53 at least when the expandable body 21 is expanded, and the outer portion 71 may be loose relative to the distal curved portion 52b and the proximal curved portion 51a. This prevents the electrode assembly 22 from interfering with the expandable body 21 and being damaged.

[0091] The expansion body 21 may have a second through-hole 81 in the base-end curved portion 52a and a third through-hole 82 in the distal-end curved portion 52b, the plurality of electrode engagement portions have a first engagement portion 83 between the second through-hole 81 and the third through-hole 82 in the bottom portion 52, and at least one of the plurality of electrode assemblies 22 may have a first hook portion 72 that functions as an engaged portion that passes through the second through-hole 81 from the extending end of the outer placement portion 71, passes through the third through-hole 82 via a position radially inward from the first engagement portion 83, and extends to the outside of the expansion body 21, thereby engaging with the first engagement portion 83. This allows the electrode portion 61 to be positioned near the bottom portion 52 of the expansion body 21, while allowing the electrode assembly 22 to follow the expansion and contraction of the expansion body 21, preventing the two from rubbing against each other and being damaged.

[0092] The expansion body 21 may also have a fourth through-hole 84 in the distal standing portion 54, the plurality of electrode engagement portions having second engagement portions 84a formed from the edges of the fourth through-hole 84, and at least one of the plurality of electrode assemblies 22 may have a second hook portion 73 that functions as an engaged portion, extending from the extending end of the first hook portion 72 and passing through the fourth through-hole 84 from the outside to the inside of the expansion body 21, thereby engaging with the second engagement portion 84a. This allows the electrode assembly 22 to be more firmly fixed to the expansion body 21, and prevents the electrode portion 61 from shifting position.

[0093] The second hook portion 73 may also have a folded portion 73a that passes through the fourth through-hole 84 and extends inside the expandable body 21 toward the bottom portion 52. This allows the electrode assembly 22 to be fixed to the expandable body 21 more reliably.

[0094] Furthermore, at least one of the multiple electrode assemblies 22 may have a third hook portion 74 that functions as an engaged portion that engages with the first engaging portion 83 by extending from the extending end of the second hook portion 73 through the inside of the expansion body 21, passing through the second through-hole 81, and out the outside of the expansion body 21. This allows the electrode assembly 22 to be fixed to the expansion body 21 at a portion that extends further to the tip side than the electrode portion 61, thereby more effectively preventing the electrode portion 61 from shifting position.

[0095] Furthermore, at least one of the multiple electrode assemblies 22 has a first extension portion 75 that extends from the extending end of the third hook portion 74 and extends between the outer placement portion 71 and the base-end standing portion 53 toward the first through-hole 80, and the medical device 10 may further include a first cover 65 that covers the base-end standing portion 53 and the first extension portion 75. This allows the electrode assembly 22 to reliably follow the movement of the base-end standing portion 53 when the expandable body 21 is expanded or contracted, preventing the electrode assembly 22 from coming into contact with an unintended location and being damaged.

[0096] Furthermore, at least one of the multiple electrode assemblies 22 may have the electrode portion 61 in the outer placement portion 71, and the first cover 65 may be arranged so as to be sandwiched between the outer placement portion 71 and the first extension portion 75. This allows the electrode portion 61 to be exposed to the outside of the first cover 65, while allowing the electrode assembly 22 to follow the expansion and contraction of the expansion body 21.

[0097] Furthermore, the plurality of electrode engaging portions may have a third engaging portion 80a formed from the edge of the first through-hole 80, and at least one of the plurality of electrode assemblies 22 may have a first extending portion 75 extending from the extending end of the third hook portion 74 and extending between the outer placement portion 71 and the base-end side standing portion 53 toward the first through-hole 80, and a fourth hook portion 76 extending from the extending end of the first extending portion 75, passing through the first through-hole 80, and functioning as an engaged portion that engages with the third engaging portion 80a. This makes it possible to more reliably fix the electrode assembly 22 to the extension body 21 and prevent the electrode portion 61 from shifting position.

[0098] The fourth hook portion 76 may also have a crank portion 76a that extends from the extending end of the first extension portion 75, passes through the first through-hole 80, and extends along the inside of the expandable body 21. This allows the electrode assembly 22 to be engaged with the expandable body 21 more reliably.

[0099] Furthermore, at least one of the multiple electrode assemblies 22 has a second extension portion 77 that extends from the extending end of the crank portion 76a and extends radially inward from the inner placement portion 70 along the inner placement portion 70, and the medical device 10 may further include a second cover 66 that covers the second extension portion 77, the inner placement portion 70, and the base-end expansion portion 55. This allows the electrode assembly 22 to move following the base-end expansion portion 55 when the expansion body 21 expands or contracts, thereby preventing the electrode assembly 22 from coming into contact with an unintended location and being damaged.

[0100] Further, the expansion body 130 has a second through-hole 151 in the bottom 133, the multiple electrode engagement portions have first engagement portions 152 formed from the edges of the second through-holes 151, and at least one of the multiple electrode assemblies 140 has a first hook portion 145 that functions as an engaged portion and extends from the extended end of the outer placement portion 144 through the second through-hole 155 radially inward of the bottom 133, the first hook portion 145 having a width wider than the portion of the first hook portion 145 that passes through the second through-hole 151 and having a wide portion 145a that engages with the first engagement portion 152. This allows the electrode portion 142 to be positioned near the bottom 133 of the expansion body 130, while allowing the electrode assembly 140 to follow the expansion and contraction of the expansion body 130, preventing the two from rubbing against each other and being damaged.

[0101] Furthermore, the plurality of electrode engagement portions may have second engagement portions 156a formed from the edges of the third through-holes 156, and the first hook portions 145 may have wide portions 145a that are wider than the portions of the first hook portions 145 that pass through the third through-holes 156 and engage with the second engagement portions 156a. This allows the electrode assembly 140 to be engaged with the first engagement portions 157 while also engaging with the second engagement portions 156a via the wide portions 145a, thereby more reliably fixing the electrode assembly 140 to the extension body 130.

[0102] The expansion body 130 has a second through-hole 155 in the base-end curved portion 133a and a fourth through-hole 158 in the tip-end upright portion 134, and the plurality of electrode engagement portions have a first engagement portion 157 formed from the edge of the second through-hole 155 and a second engagement portion 158a formed from the edge of the fourth through-hole 158, and at least one of the plurality of electrode assemblies 140 has a first engagement portion 157 formed from the edge of the second through-hole 155 and a second engagement portion 158a formed from the edge of the fourth through-hole 158. 55, passes through the fourth through-hole 158 via the radially inner side of the first engaging portion 157, and extends to the outside of the expansion body 130, thereby having a first hook portion 145 that functions as an engaged portion that engages with the first engaging portion 157, and the first hook portion 145 may have a wider portion 145a that is wider than the portion of the first hook portion 145 that passes through the fourth through-hole 158 and engages with the second engaging portion 158a. This allows the electrode assembly 140 to be extended further to the tip side than the electrode portion 142 and fixed to the expansion body 130, thereby more effectively preventing the electrode portion 142 from shifting position.

[0103] The expandable body 100 also has a second through-hole 121 in the distal curved portion 103b and a third through-hole 122 in the proximal curved portion 103a, and the plurality of electrode engagement portions have a first engagement portion 123 formed between the second through-hole 121 and the third through-hole 122 and a fourth engagement portion 120a formed from the edge of the first through-hole 120, and at least one of the plurality of electrode assemblies 110 passes through the second through-hole 121 from the extended end of the outer placement portion 114, passes radially inward from the first engagement portion 123, and is engaged with the third engagement portion 120a. The electrode assembly 110 may have a first hook portion 115 that functions as an engaged portion, passing through the third through-hole 122 and extending to the outside of the expandable body 100 to engage with the first engaging portion 123, a first extension portion 116 that extends from the extending end of the first hook portion 115 and extends toward the first through-hole 120 between the outer placement portion 114 and the base-end standing portion 104, and a fourth hook portion 117 that functions as an engaged portion, extending from the extending end of the first extension portion 116 and passing through the first through-hole 120 to engage with the fourth engaging portion 120a. As a result, the electrode assembly 110 is engaged and fixed at two points, the first engaging portion 123 and the fourth engaging portion 120a, and the electrode portion can be fixed with a simple structure.

[0104] At least one of the multiple electrode assemblies 210 may be adhesively fixed to the expansion body 200 at the base-side upright portion 204 or the tip-side upright portion. This allows the electrode unit 212 to be fixed to the expansion body 200 while the portion of the electrode unit 212 on the bottom 203 side is left loose relative to the expansion body 200.

[0105] The extension body 220 may have a first through-hole 226 in the distal upright portion 225, and at least one of the multiple electrode assemblies 230 may have an inner arrangement portion 233 extending along the inside of the extension body 220 from the distal end portion 30 of the shaft portion 20, over the proximal upright portion 224, to the first through-hole 226 in the distal upright portion 225, and an outer arrangement portion 234 extending along the extension body 220 from the first through-hole 226 to the bottom portion 223 so as to be folded back relative to the inner arrangement portion 233 and face the receiving space 222a. This allows the electrode portion 232 to be arranged on the side of the distal upright portion 225 with a simple structure.

[0106] The shaft portion 20 has a shaft extension portion 32 extending from the base end fixing portion 31 to the inside of the expansion body 240 along the central axis of the expansion body 240, and a tip fixing portion 33 to which the tip of the expansion body 240 is fixed. The expansion body 240 has a tip side expansion portion 247 extending radially outward from the tip fixing portion 33 of the shaft portion 20 toward the base end. The tip side expansion portion 247 has a base end connected to the outer end of the tip side upright portion 245 and has an outward curved portion 248 that is curved convexly radially outward. The tip side upright portion 245 has a first through hole 246. At least one of the multiple electrode assemblies 250 is a shaft extension portion 32 extending from the base end fixing portion 31 of the shaft portion 20 to the tip fixing portion 33. The electrode assembly 250 may have a base-side curved portion 243 b and a base-side curved portion 243 a, an inner portion 254 extending from the extending end of the shaft portion 253 along the inside of the expandable body 240 to the first through-hole 246 via the vicinity of the outward curved portion 248 of the distal expanding portion 247, and an outer portion 255 extending from the first through-hole 246 along the expandable body 240 to at least the bottom 243 so as to face the receiving space 242 a, wherein the outward curved portion 248 of the distal expanding portion 247 deforms in response to expansion and contraction of the expandable body 240, the inner portion 254 is spaced from the outward curved portion 248 of the distal expanding portion 247 at least during expansion of the expandable body 240, and the outer portion 255 may be loose relative to the distal curved portion 243 b and the base-side curved portion 243 a. This allows the electrode assembly 250 to be positioned using the shaft portion 20, and makes it less likely that the electrode assembly 250 will interfere with the expansion and contraction of the expandable body 240.

[0107] The expandable body 170 has a second through-hole 191 in the base-end curved portion 173a, a third through-hole 192 in the distal curved portion 173b, and a fourth through-hole 194 in the distal upright portion 175, and the plurality of electrode engagement portions have a first engagement portion 193 formed between the second through-hole 191 and the third through-hole 192 of the bottom portion 173, and a second engagement portion 194a formed by the edge of the fourth through-hole 194, and at least one of the plurality of electrode assemblies 180 passes through the second through-hole 191 from the extended end of the outer placement portion 184, and engages the first engagement portion The electrode assembly 180 may have a first hook portion 185 that functions as an engaged portion, extending radially inward from the distal end of the extension body 170, passing through the third through-hole 192, and extending to the outside of the extension body 170 to engage with the first engaging portion 193, and a second hook portion 187 that functions as an engaged portion, extending from the extending end of the first hook portion 185, passing through the fourth through-hole 194 from the outside to the inside of the extension body 170, to engage with the second engaging portion 194a, and the electrode portion 182 may be arranged between the first hook portion 185 and the second hook portion 187. This allows the electrode assembly 180 to be firmly engaged and fixed to the extension body 170 when the electrode portion 182 is arranged on the side of the distal standing portion 175, preventing the electrode portion 182 from shifting position.

[0108] Further, the expansion body 260 may be formed of a mesh made of a large number of woven wires 261, and at least one of the plurality of electrode assemblies 270 may be inserted between the wires 261 and engaged and fixed. This allows the electrode assembly 270 to be fixed to the expansion body 260 formed of a mesh as well, and the electrode portion 272 to be positioned near the bottom 263 of the recess 262.

[0109] The present invention is not limited to the above-described embodiment, and various modifications can be made by those skilled in the art within the technical concept of the present invention.

[0110] This application is based on Japanese Patent Application No. 2020-142445 filed on August 26, 2020, the disclosures of which are incorporated herein by reference in their entirety. [Explanation of symbols]

[0111] 10 Medical Devices 11 Guidewire 20 Shaft section 21 Extension 22 Electrode Assembly 23 Control section 25 Storage sheath 26 Traction shaft 30 Tip 31 Base end fixing part 32 Shaft extension 33 Tip fixing part 35 Tip member 40 cabinets 41 Operation dial 42 Conversion Mechanism 50 Wire section 51 Recess 51a Receptive Space 52 Bottom 52a Proximal curved part 52b Tip side curved part 53 Proximal upright part 54 Tip side upright part 55 Proximal extension 57 Outward curve 58 outer edge 59 Backrest 60 Wiring section 60a Wire section 60b adhesive layer 60c insulation layer 61 Electrode section 62 Connection 65 1st cover 66 Second Cover 70 Inner placement part 71 Outside arrangement part 72 First hook part 73 Second hook part 73a Folded part 74 Third hook part 75 1st extension 76 4th hook part 76a Crank section 77 Second extension 80 First through hole 80a 3rd engaging part 81 Second through hole 82 3rd through hole 83 First Department 84 4th through hole 84a The second series

Claims

1. an expansion body that is radially expandable and contractible; a long shaft portion having a distal end portion including a base end fixing portion to which the base end of the expansion body is fixed; a plurality of electrode assemblies extending from a proximal end fixing portion of the shaft portion along at least a portion of the expansion body; Equipped with The expandable body has a recess that is recessed radially inward and defines a receiving space that can receive biological tissue when the expandable body is expanded, the recess has a bottom portion located at the innermost position in the radial direction including a base-side curved portion and a tip-side curved portion, a base-side upright portion extending radially outward from the base-side curved portion, and a tip-side upright portion extending radially outward from the tip-side curved portion, Each of the plurality of electrode assemblies has an electrode portion disposed along the extension body from the base end side upright portion or the tip end side upright portion to the bottom portion so as to face the receiving space, the proximal curved portion and the distal curved portion are deformed in response to expansion and contraction of the expandable body, the electrode portion is in a floating state with respect to the distal bending portion and the proximal bending portion, the extension body has a plurality of electrode engagement portions that engage the plurality of electrode assemblies with the extension body, each of the plurality of electrode assemblies has an engaged portion that engages with the electrode engaging portion; A medical device in which the electrode engagement portion is provided on at least one of the bottom portion, the base end side standing portion, and the tip end side standing portion.

2. the expansion body has a base-end expansion portion that extends radially outward from the base-end fixing portion of the shaft portion toward the tip, and the base-end expansion portion has a tip connected to the outer end of the base-end upright portion and has an outward curved portion that is curved convexly radially outward, The proximal upright portion has a first through-hole that penetrates the expansion body. At least one of the plurality of electrode assemblies has an inner arrangement portion extending along the inside of the expansion body from the tip end portion of the shaft portion through a vicinity of the outward curved portion of the base end side expansion portion to the first through hole, and an outer arrangement portion extending along the expansion body from the first through hole to at least the bottom portion so as to face the receiving space, the outwardly curved portion of the base-end expansion portion is deformed in response to expansion and contraction of the expansion body, the inner disposed portion is spaced apart from the outward curved portion of the base end side expansion portion at least when the expansion body is expanded, The medical device according to claim 1 , wherein the outer placement portion is free-moving relative to the distal curved portion and the proximal curved portion.

3. the expandable body has a second through-hole in the proximal curved portion and a third through-hole in the distal curved portion, the plurality of electrode engagement portions have a first engagement portion between the second through hole and the third through hole of the bottom portion, The medical device described in claim 2, wherein at least one of the multiple electrode assemblies has a first hook portion that functions as the engaged portion, passing from the extended end of the outer placement portion through the second through hole, passing through the third through hole radially inward from the first engagement portion, and extending outside the expandable body to engage with the first engagement portion.

4. the expansion body has a fourth through-hole in the distal end side upright portion, the plurality of electrode engagement portions include a second engagement portion formed from an edge portion of the fourth through hole, The medical device described in claim 3, wherein at least one of the multiple electrode assemblies has a second hook portion that functions as the engaged portion, extending from the extended end of the first hook portion and passing through the fourth through hole from the outside to the inside of the expansion body, thereby engaging with the second engaging portion.

5. The medical device according to claim 4 , wherein the second hook portion has a folded portion that passes through the fourth through-hole and extends inside the expandable body toward the bottom portion.

6. A medical device as described in claim 4 or 5, wherein at least one of the multiple electrode assemblies has a third hook portion that functions as the engaged portion and engages with the first engaging portion by extending from the extended end of the second hook portion through the inside of the expansion body, passing through the second through hole, and to the outside of the expansion body.

7. the at least one of the plurality of electrode assemblies has a first extension portion extending from an extended end of the third hook portion and extending between the outer placement portion and the base end side upright portion toward the first through hole; The medical device according to claim 6 , further comprising a first cover covering the proximal upstanding portion and the first extension portion.

8. the at least one of the plurality of electrode assemblies has the electrode portion on the outer-disposed portion; The medical device according to claim 7 , wherein the first cover is disposed so as to be sandwiched between the outer portion and the first extension portion.

9. the plurality of electrode engagement portions include a third engagement portion formed from an edge portion of the first through hole, A medical device as described in any one of claims 6 to 8, wherein at least one of the multiple electrode assemblies has a first extension portion extending from the extended end of the third hook portion and extending between the outer placement portion and the base end side upright portion toward the first through hole, and a fourth hook portion extending from the extended end of the first extension portion, passing through the first through hole, and engaging with the third engagement portion, functioning as the engaged portion.

10. The medical device according to claim 9 , wherein the fourth hook portion has a crank portion that extends from the extending end of the first extension portion, passes through the first through hole, and extends along the inside of the expandable body.

11. the at least one of the plurality of electrode assemblies has a second extension portion extending from an extended end of the crank portion and extending radially inward from the inner disposed portion along the inner disposed portion, The medical device of claim 10 , further comprising a second cover covering the second extension, the inner-positioning portion, and the proximal extension.

12. The expansion body has a second through hole at the bottom, the plurality of electrode engagement portions include a first engagement portion formed from an edge portion of the second through hole, the at least one of the plurality of electrode assemblies has a first hook portion that functions as the engaged portion and that extends from an extended end of the outer placement portion through the second through hole to a radially inward direction of the bottom portion; The medical device according to claim 2 , wherein the first hook portion has a wide portion that is wider than a portion of the first hook portion that passes through the second through-hole and that engages with the first engaging portion.

13. the plurality of electrode engagement portions have second engagement portions formed from edge portions of the third through holes, The medical device according to claim 3 , wherein the first hook portion has a wide portion that is wider than a portion of the first hook portion that passes through the third through-hole and that engages with the second engaging portion.

14. the expansion body has a second through-hole in the proximal curved portion and a fourth through-hole in the distal upright portion, the plurality of electrode engagement portions include a first engagement portion formed from an edge portion of the second through hole and a second engagement portion formed from an edge portion of the fourth through hole, At least one of the plurality of electrode assemblies has a first hook portion that functions as the engaged portion, which extends from an extended end of the outer placement portion through the second through-hole, passes through the fourth through-hole via a position radially inward from the first engaging portion, and extends to the outside of the expandable body to engage with the first engaging portion, The medical device according to claim 2 , wherein the first hook portion has a wide portion that is wider than a portion of the first hook portion that passes through the fourth through-hole and that engages with the second engaging portion.

15. the expansion body has a second through-hole in the distal curved portion and a third through-hole in the proximal curved portion, the plurality of electrode engagement portions include a first engagement portion formed between the second through hole and the third through hole and a fourth engagement portion formed from an edge portion of the first through hole, The medical device of claim 2, wherein at least one of the plurality of electrode assemblies has a first hook portion that functions as the engaged portion, extending from the extending end of the outer placement portion through the second through hole, passing radially inward from the first engagement portion through the third through hole, and extending outside the expandable body to engage with the first engaging portion, a first extension portion that extends from the extending end of the first hook portion and extends between the outer placement portion and the base end side upright portion toward the first through hole, and a fourth hook portion that functions as the engaged portion, extending from the extending end of the first extension portion, passing through the first through hole, and engaging with the fourth engaging portion.

16. An expandable body that can be expanded or contracted in the radial direction; a long shaft portion having a distal end portion including a base end fixing portion to which the base end of the expansion body is fixed; a plurality of electrode assemblies extending from a proximal end fixing portion of the shaft portion along at least a portion of the expansion body; Equipped with The expandable body has a recess that is recessed radially inward and defines a receiving space that can receive biological tissue when the expandable body is expanded, the recess has a bottom portion located at the innermost position in the radial direction including a base-side curved portion and a tip-side curved portion, a base-side upright portion extending radially outward from the base-side curved portion, and a tip-side upright portion extending radially outward from the tip-side curved portion, Each of the plurality of electrode assemblies has an electrode portion disposed along the extension body from the base end side upright portion or the tip end side upright portion to the bottom portion so as to face the receiving space, the proximal curved portion and the distal curved portion are deformed in response to expansion and contraction of the expandable body, the electrode portion is in a floating state with respect to the distal bending portion and the proximal bending portion, A medical device in which at least one of the plurality of electrode assemblies is adhesively fixed to the expansion body at the base end upright portion or the tip end upright portion.

17. An expandable body that can be expanded or contracted in the radial direction; a long shaft portion having a distal end portion including a base end fixing portion to which the base end of the expansion body is fixed; a plurality of electrode assemblies extending from a proximal end fixing portion of the shaft portion along at least a portion of the expansion body; Equipped with The expandable body has a recess that is recessed radially inward and defines a receiving space that can receive biological tissue when the expandable body is expanded, the recess has a bottom portion located at the innermost position in the radial direction including a base-side curved portion and a tip-side curved portion, a base-side upright portion extending radially outward from the base-side curved portion, and a tip-side upright portion extending radially outward from the tip-side curved portion, Each of the plurality of electrode assemblies has an electrode portion disposed along the extension body from the base end side upright portion or the tip end side upright portion to the bottom portion so as to face the receiving space, the proximal curved portion and the distal curved portion are deformed in response to expansion and contraction of the expandable body, the electrode portion is in a floating state with respect to the distal bending portion and the proximal bending portion, the expansion body has a first through-hole in the distal upright portion, At least one of the multiple electrode assemblies is a medical device having an inner positioned portion extending along the inside of the expandable body from the tip end of the shaft portion, over the base end upright portion, to the first through hole of the tip end upright portion, and an outer positioned portion extending along the expandable body from the first through hole to the bottom so as to be folded back relative to the inner positioned portion and face the receiving space.

18. An expandable body that can be expanded or contracted in the radial direction; a long shaft portion having a distal end portion including a base end fixing portion to which the base end of the expansion body is fixed; a plurality of electrode assemblies extending from a proximal end fixing portion of the shaft portion along at least a portion of the expansion body; Equipped with The expandable body has a recess that is recessed radially inward and defines a receiving space that can receive biological tissue when the expandable body is expanded, the recess has a bottom portion located at the innermost position in the radial direction including a base-side curved portion and a tip-side curved portion, a base-side upright portion extending radially outward from the base-side curved portion, and a tip-side upright portion extending radially outward from the tip-side curved portion, Each of the plurality of electrode assemblies has an electrode portion disposed along the extension body from the base end side upright portion or the tip end side upright portion to the bottom portion so as to face the receiving space, the proximal curved portion and the distal curved portion are deformed in response to expansion and contraction of the expandable body, the electrode portion is in a floating state with respect to the distal bending portion and the proximal bending portion, the shaft portion has a shaft extension portion extending from the base end fixing portion to the inside of the expansion body along the central axis of the expansion body, and a tip fixing portion to which a tip of the expansion body is fixed, the expansion body has a distal expansion portion extending radially outward from the distal fixing portion of the shaft portion toward the proximal end, the distal extension portion has a base end connected to the outer end of the distal upright portion and has an outward curved portion that is curved convexly outward in the radial direction, the tip side standing portion has a first through hole, At least one of the plurality of electrode assemblies has a shaft arrangement portion extending along the shaft extension portion from the base end fixing portion of the shaft portion to the tip fixing portion, an inner arrangement portion extending along the inside of the expansion body from the extending end of the shaft arrangement portion through the vicinity of the outward curved portion of the tip side expansion portion to the first through hole, and an outer arrangement portion extending along the expansion body from the first through hole to at least the bottom portion so as to face the receiving space, The outward curved portion of the distal expansion portion deforms in response to expansion and contraction of the expansion body, the inner disposed portion is spaced apart from the outward curved portion of the distal end side expanding portion at least when the expanding body is expanded, The medical device is one in which the outer placement portion is in a loose state relative to the distal curved portion and the proximal curved portion.

19. the expandable body has a second through-hole in the base-end curved portion, a third through-hole in the distal-end curved portion, and a fourth through-hole in the distal-end upright portion, the plurality of electrode engagement portions include a first engagement portion formed between the second through hole and the third through hole in the bottom portion, and a second engagement portion formed by an edge portion of the fourth through hole, At least one of the plurality of electrode assemblies has a first hook portion that functions as the engaged portion, extending from the extending end of the outer placement portion through the second through hole, passing through the third through hole radially inward from the first engaging portion, and extending to the outside of the expansion body, thereby engaging with the first engaging portion, and a second hook portion that functions as the engaged portion, extending from the extending end of the first hook portion, passing through the fourth through hole from the outside to the inside of the expansion body, thereby engaging with the second engaging portion, The medical device according to claim 2 , wherein the electrode portion is disposed between the first hook portion and the second hook portion.

20. An expandable body that can be expanded or contracted in the radial direction; a long shaft portion having a distal end portion including a base end fixing portion to which the base end of the expansion body is fixed; a plurality of electrode assemblies extending from a proximal end fixing portion of the shaft portion along at least a portion of the expansion body; Equipped with The expandable body has a recess that is recessed radially inward and defines a receiving space that can receive biological tissue when the expandable body is expanded, the recess has a bottom portion located at the innermost position in the radial direction including a base-side curved portion and a tip-side curved portion, a base-side upright portion extending radially outward from the base-side curved portion, and a tip-side upright portion extending radially outward from the tip-side curved portion, Each of the plurality of electrode assemblies has an electrode portion disposed along the extension body from the base end side upright portion or the tip end side upright portion to the bottom portion so as to face the receiving space, the proximal curved portion and the distal curved portion are deformed in response to expansion and contraction of the expandable body, the electrode portion is in a floating state with respect to the distal bending portion and the proximal bending portion, The expansion body is formed of a mesh made of a number of wires, At least one of the plurality of electrode assemblies is inserted between the wires and engaged and fixed in place in the medical device.

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