medical devices

Abstract

Provided is a medical device which, when a living tissue is pinched with an expandable body, enables the pressing force to be applied on the living tissue by an electrode part, to be set at an appropriate level. The present invention comprises an expandable body (21), a shaft part (20), and an electrode part (22). The expandable body (21) has a recessed part (51). The recessed part (51) comprises a bottom section (51a), a base-end-side erect section (52), and a leading-end-side erect section (53). One of the base-end-side erect section (52) and the leading-end-side erect section (53) is provided with the electrode part (22), while the other of the base-end-side erect section (52) and the leading-end-side erect section (53) is provided with: a forked outer rim section (55); a back support section (56) which has a receiving surface (56a) and which is disposed inside the outer rim section (55); and an arm section (57) which extends from the back support section (56). The arm section (57) is connected to the outer rim section (55), and limits the amount of tilt of the receiving surface (56a) by being deformed when the receiving surface (56a) of the back support section (56) is tilted.

Description

[Technical Field]

[0001] The present invention relates to a medical device for applying energy to living tissue. [Background technology]

[0002] Known medical devices include an electrode placed in an expandable body that expands and contracts within the body, and ablation treatment is performed by cauterizing biological tissue with high-frequency current from the electrode. One known ablation treatment is atrial septal shunt treatment. Shunt treatment involves creating a shunt (puncture hole) in the atrial septum to provide an escape route for elevated atrial pressure in patients with heart failure, thereby alleviating the symptoms of heart failure. In shunt treatment, the atrial septum is accessed via a transvenous approach, and a puncture hole of the desired size is created. Such a medical device is disclosed, for example, in Patent Document 1. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] International Publication No. 2020-94087 Summary of the Invention [Problem to be solved by the invention]

[0004] In this medical device, the expandable body has a recess that recesses radially inward during expansion to define a receiving space capable of receiving biological tissue. An electrode is provided on the proximal or distal upright portion that defines the recess. When biological tissue is clamped in the recess, the electrode moves so as to be pressed against the biological tissue. This pressure also causes the receiving surface, which is the surface of the recess opposite the electrode, to move in the same direction as the electrode. When the expandable body is made of mesh, as in Patent Document 1, both the electrode and receiving surface can move in the same direction. However, because the mesh expandable body is easily deformed, the shape of the recess may become distorted, preventing sufficient cauterization and potentially preventing the shunt from achieving the desired size. On the other hand, if the expandable body is made rigid, the electrode and receiving surface may twist, potentially reducing the electrode's pressing force against the biological tissue.

[0005] The present invention has been made to solve the above-mentioned problems, and aims to provide a medical device that can adjust the pressing force of the electrode portion against biological tissue when the biological tissue is clamped with an expandable body. [Means for solving the problem]

[0006] The medical device according to the present invention, which achieves the above-mentioned object, comprises an expandable body that can expand and contract in a radial direction, a long shaft portion having a tip portion including a base end fixing portion to which the base end of the expandable body is fixed, and an electrode portion provided along the expandable body, wherein the expandable body has a recess that is recessed radially inward when the expandable body is expanded and defines a receiving space that can receive biological tissue, the recess having a bottom portion located at the innermost radial direction, a base end side upright portion extending radially outward from the base end of the bottom, and a tip end side upright portion extending radially outward from the tip of the bottom, the electrode portion being provided on one of the base end side upright portion and the tip end side upright portion, and the other of the base end side upright portion and the tip end side upright portion having an outer edge portion that branches into two from the vicinity of the bottom and extends radially outward, and a back support portion that is located within the outer edge portion and has a receiving surface that faces the electrode portion when the expandable body is expanded, fromand an arm portion extending from the backrest portion, and the receiving surface of the backrest portion is inclined so as to be substantially parallel to the electrode portion via an object sandwiched between the electrode portion and the backrest portion when the electrode portion moves toward the backrest portion, The backrest portion extends radially outward in a plate-like shape from the outer edge portion near the bottom, and the arm portion branches into two from the radially outer end of the backrest portion, extends symmetrically around the axis of the extension direction of the backrest portion while curving or bending, and connects to the outer edge portion, and deforms when the receiving surface of the backrest portion tilts, thereby limiting the amount of tilt of the receiving surface. [Effects of the Invention]

[0007] In the medical device configured as described above, the arms limit the amount of tilt when the receiving surface of the backrest tilts, preventing the backrest from tilting too much. This allows the electrode to apply an appropriate pressure to the biological tissue when the biological tissue is clamped between the electrode and receiving surface. This allows the electrode to be cauterized with sufficient pressure against the biological tissue, ensuring a reliable increase in impedance during current application and allowing a clear determination of the end of cauterization. Furthermore, the biological tissue can be effectively cauterized, allowing a shunt of stable size to be formed. Additionally, the electrode, biological tissue, and backrest are in close contact with each other, preventing energy from the electrode from being transmitted to blood or other biological tissue.

[0008] The back support portion may extend radially outward from the outer edge portion near the bottom portion in a plate shape, thereby more reliably ensuring that the receiving surface of the back support portion is inclined substantially parallel to the electrode portion.

[0009] The arm portion may be bifurcated from the radially outer end of the backrest portion, extend symmetrically around the axis of the extension direction of the backrest portion while curving or bending, and connect to the outer edge portion, and deform when the receiving surface of the backrest portion tilts, thereby limiting the amount of tilt of the receiving surface. This makes it possible to prevent the receiving surface of the backrest portion from twisting left and right when tilting, and to reliably clamp the biological tissue between the backrest portion and the electrode portion.

[0010] The arm portion may extend from a radially outer end of the backrest portion and abut against the outer edge portion when the receiving surface of the backrest portion tilts, thereby limiting the amount of tilt of the receiving surface. In this way, the arm portion abuts against the outer edge portion, thereby reliably limiting the amount of tilt of the receiving surface.

[0011] The outer edge may have a confluence where the two meet at an end opposite to the bottom, the extension body may have an extension extending radially inward from the confluence of the outer edge, and the arm may extend from a radially outer end of the backrest and abut against an inner surface of the extension when the receiving surface of the backrest tilts, thereby limiting the amount of tilt of the receiving surface. In this way, the arm abutting against the inner surface of the extension reliably limits the amount of tilt of the receiving surface.

[0012] The arm may extend to connect the bifurcated portion of the outer edge and contact the surface of the backrest opposite to the surface facing the electrode when the support surface of the backrest tilts, thereby limiting the amount of tilt of the support surface. In this way, the arm formed on the outer edge reliably limits the amount of tilt of the support surface.

[0013] The outer edge may have a junction where the two meet at an end opposite to the bottom, and the arm may extend from the junction of the outer edge toward the backrest, and when the receiving surface of the backrest tilts, the arm may come into contact with a surface of the backrest opposite to the surface facing the electrode, thereby limiting the amount of tilt of the receiving surface. This ensures that the arm extending from the junction reliably limits the amount of tilt of the receiving surface.

[0014] The backrest may have a plurality of rods extending substantially perpendicular to the radial direction of the expandable body and substantially parallel to the surface of the electrode portion facing the recess, and arranged substantially parallel to one another, the arms having a plurality of connecting arms connecting both ends of each of the rods to the outer edge portion so as to form a U-shape with each of the rods opening toward the bottom, the receiving surface of the backrest may be formed on an imaginary plane including at least a portion of each of the rods, and each of the connecting arms may rotate about a connecting portion with the outer edge portion as a fulcrum when the receiving surface of the backrest tilts, thereby restricting the amount of tilt of the receiving surface. This reliably restricts the amount of tilt of the receiving surface of a backrest made of a plurality of rods by the connecting arms. [Brief explanation of the drawings]

[0015] [Figure 1] 1 is a front view 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 development view of the vicinity of the recess of the expansion body. [Figure 4] FIG. 10 is an enlarged oblique view of the back support portion of the expansion body. [Figure 5] 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 6] 1 is a flowchart of a procedure using a medical device. [Figure 7] 7A and 7B are diagrams showing the state of S2 in FIG. 6, in which (a) is an enlarged view of the atrial septum in cross section near the balloon, and (b) is a cross section of the atrial septum showing the shape of the puncture hole. [Figure 8] 7A and 7B are diagrams showing the state S3 in FIG. 6, in which (a) is a cross-sectional view of the atrial septum and an enlarged view of the expandable body with the inside of the storage sheath shown perspectively, and (b) is a cross-sectional view of the atrial septum with the storage sheath inserted through the puncture hole. [Figure 9] FIG. 7 is a diagram showing the state S4 in FIG. 6, and is an enlarged view of the atrial septum in cross section near the expansion body. [Figure 10] FIG. 7 is a diagram illustrating the state S4 in FIG. 6, and is a cross-sectional view of the atrial septum in a state where the puncture hole has been expanded by an expandable body. [Figure 11] FIG. 7 is a diagram showing the state S5 in FIG. 6, and is an enlarged view of the atrial septum in cross section near the expansion body. [Figure 12] 1A and 1B are enlarged cross-sectional views showing the atrial septum and the expansion body, in which (a) shows the state before the atrial septum is clamped between the distal and proximal erection portions, and (b) shows the state after the atrial septum is clamped between the distal and proximal erection portions. [Figure 13] 12(a) and 12(b) are enlarged cross-sectional views showing the atrial septum and the expansion body, where FIG. 12(a) is a cross-sectional view taken along line AA in FIG. 12(a), and FIG. 12(b) is a cross-sectional view taken along line BB in FIG. 12(b). [Figure 14] FIG. 10 is an enlarged perspective view of the back support portion and its vicinity in the expandable body of the first modified example. [Figure 15] FIG. 10 is an enlarged perspective view of the back support portion and its vicinity in the expandable body of the second modified example. [Figure 16] FIG. 11 is an enlarged perspective view of the back support portion and its vicinity in the expandable body of the third modified example. [Figure 17] FIG. 11 is an enlarged perspective view of the back support portion and its vicinity in the expandable body of the fourth modified example. [Figure 18] FIG. 13 is an enlarged perspective view of the back support portion and its vicinity in the expandable body of the fifth modified example. [Figure 19] FIG. 13 is an enlarged perspective view of the back support portion and its vicinity in the expandable body of the sixth modified example. [Figure 20] FIG. 13 is an enlarged perspective view of the back support portion and its vicinity in the expandable body of the seventh modified example. [Figure 21] FIG. 13 is an enlarged perspective view of the back support portion and its vicinity in the expandable body of the eighth modified example. [Figure 22] FIG. 13 is an enlarged perspective view of the back support portion and its vicinity in the expandable body of the ninth modified example. [Figure 23] FIG. 13 is a cross-sectional view of the state in which the atrial septum is sandwiched between the proximal erection portion and the distal erection portion of the expandable body of the ninth modified example. DETAILED DESCRIPTION OF THE INVENTION

[0016] 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."

[0017] 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.

[0018] 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 a handheld operation unit 23 provided at the proximal end of the shaft portion 20. The expansion body 21 is provided with an electrode portion 22, which is an energy transmission element for performing the maintenance treatment described above.

[0019] 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.

[0020] 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.

[0021] 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.

[0022] The handheld 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 handheld 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.

[0023] The expandable body 21 will be described in more detail. As shown in FIGS. 2 and 3, 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 extends from the base end fixing portion 31 toward the distal end. The distal end of each wire portion 50 extends from the base end of the distal end fixing portion 33 toward the proximal end. The wire portion 50 is inclined so that it becomes larger in the radial direction 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 portion 51a. The recess 51 defines a receiving space 51b that can receive biological tissue when the expandable body 21 is expanded.

[0024] The recess 51 has a base-side upright portion 52 extending radially outward from the base end of the bottom portion 51a, and a tip-side upright portion 53 extending radially outward from the tip of the bottom portion 51a. The electrode portion 22 is arranged on the base-side upright portion 52 or the tip-side upright portion 53 so as to face the receiving space 51b. The tip-side upright portion 53 has an outer edge portion 55 that branches into two from near the bottom portion 51a and extends radially outward, and a backrest portion 56 that is arranged between the two outer edge portions 55. The backrest portion 56 has a receiving surface 56a that faces the electrode portion 22 when the expandable body 21 is expanded. The backrest portion 56 is formed in a plate shape.

[0025] 3 and 4, the expandable body 21 has an arm 57 that extends from the backrest 56 while curving and is connected to the outer edge 55. The arm 57 branches into two from the radially outer end of the backrest 56 and extends symmetrically while curving around the axis corresponding to the extension direction of the backrest 56. Therefore, the arm 57 has a curved bent portion 57a. The bent portion 57a ​​of the arm 57 may be bent in a crank shape.

[0026] 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.

[0027] The electrode section 22 is configured, for example, as a bipolar electrode that receives electrical energy from an external energy supply device (not shown). In this case, electricity is passed between the electrode sections 22 arranged in each wire section 50. The electrode section 22 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 handheld operation section 23 and connected to the energy supply device.

[0028] Alternatively, the electrode unit 22 may be configured as a monopolar electrode. In this case, electricity is passed between the electrode unit 22 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 22. In this case, electricity is passed between the heat generating elements disposed in each wire unit 50. Furthermore, the electrode unit 22 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.

[0029] 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.

[0030] 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.

[0031] The traction shaft 26 can be formed from a long wire material such as a superelastic alloy, such as a nickel-titanium alloy or a copper-zinc alloy, a metal material, such as stainless steel, or a resin material with relatively high rigidity.

[0032] The tip member 35 can be formed, for example, from a superelastic alloy such as a nickel-titanium alloy or a copper-zinc alloy, a metal material such as stainless steel, a polymer material such as polyolefin, polyvinyl chloride, polyamide, polyamide elastomer, polyurethane, polyurethane elastomer, polyimide, or fluororesin, or a mixture of these, or a multi-layer tube made of two or more types of polymer materials.

[0033] 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. 5, 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.

[0034] As shown in FIG. 6, first, a puncture hole Hh is created in the atrial septum HA (S1). When forming the puncture hole Hh, the surgeon delivers an introducer 210, which is a combination of a guiding sheath and a dilator, to the vicinity of the atrial septum HA. The introducer 210 can be delivered to the right atrium HRa, for example, via the inferior vena cava IV. The introducer can also be delivered using a guidewire 11. The surgeon can insert the guidewire 11 through the dilator and deliver the introducer along the guidewire 11. Note that 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.

[0035] 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. The puncture device is passed through a dilator and delivered to the atrial septum HA.

[0036] Next, the surgeon delivers the balloon catheter 150 to the vicinity of the atrial septum HA along the pre-inserted guide wire 11. As shown in FIG. 7, the balloon catheter 150 has a balloon 152 at the tip of a shaft portion 151. Once the balloon 152 is positioned in the atrial septum HA, it is expanded radially as shown in FIG. 7(a) to push open the puncture hole Hh (S2). At this time, due to the influence of the fibers of the septal tissue, the puncture hole Hh expands to a diameter equivalent to the maximum diameter of the expanded balloon 152 in the direction along the fibers, but is difficult to expand in other directions, resulting in an elongated shape as shown in FIG. 7(b).

[0037] Next, the medical device 10 is delivered near the atrial septum HA, and the expandable body 21 is positioned at the position of the puncture hole Hh (S3). A guidewire is not used when delivering the medical device 10, but a guidewire may be used for stable operation under pulsation. At this time, the distal end of the medical device 10 penetrates the atrial septum HA and reaches the left atrium HLa. As shown in FIG. 8(a), when the medical device 10 is inserted, the expandable body 21 is housed in the storage sheath 25. As shown in FIG. 8(b), the puncture hole Hh is expanded by the balloon 152, allowing the storage sheath 25 to be inserted through the puncture hole Hh.

[0038] Next, as shown in Fig. 9, the housing sheath 25 is moved toward the proximal end to expose the expandable body 21. This causes the expandable body 21 to expand in diameter, and the recess 51 is positioned in the puncture hole Hh in the atrial septum HA, receiving the biological tissue surrounding the puncture hole Hh in the receiving space 51b (S4). As shown in Fig. 10, the expandable body 21 expands, causing the puncture hole Hh to expand to have a substantially uniform diameter along the circumferential direction. The expandable body 21 changes the shape of the puncture hole Hh, but does not expand the maximum diameter. Therefore, the maximum diameter of the puncture hole Hh is equal to the diameter in the longitudinal direction of the puncture hole Hh expanded by the balloon 152 in S2.

[0039] With the biological tissue received in the receiving space 51b, the surgeon operates the operating unit 23 to move the traction shaft 26 toward the proximal end. As a result, as shown in Fig. 11, the expandable body 21 is pulled in the compression direction by the distal member 35, and is compressed in the axial direction, and the atrial septum HA is grasped by the proximal side erection portion 52 and the distal side erection portion 53, and the electrode portion 22 is pressed against the biological tissue (S5).

[0040] As shown in FIGS. 12( a) and 13( a), when the proximal upright portion 52 and the distal upright portion 53 move closer to each other from a state in which they are separated, the atrial septum HA is sandwiched between the proximal upright portion 52 and the distal upright portion 53, as shown in FIGS. 12( b) and 13( b). The electrode unit 22 then presses the atrial septum HA toward the distal side. At this time, the distal upright portion 53 tilts the backrest portion 56 toward the distal side between the two outer edge portions 55, and receives the atrial septum HA pressed by the electrode unit 22 between the two outer edge portions 55. The receiving surface 56 a of the backrest portion 56 receives force from the electrode unit 22 via the atrial septum HA and tilts to be approximately parallel to the electrode unit 22. The backrest 56 flexes flexibly, exerting a repulsive force on the atrial septum HA, which is pressed by the electrode 22, in a direction opposite to the pushing direction of the electrode 22. This causes the electrode 22 to come into close contact with the atrial septum HA. At this time, the arm 57 deforms as the backrest 56 tilts. Because the arm 57 has a bent portion 57a, it deforms a certain amount in the pushing direction of the electrode 22 and does not deform any further. With the arm 57 no longer deforming, the backrest 56 also cannot tilt any further. In other words, the arm 57 limits the amount of tilt of the backrest 56. This allows the pushing force of the electrode 22 to be sufficiently transmitted to the atrial septum HA.

[0041] After the puncture hole Hh is dilated, the surgeon checks the hemodynamics (S6). As shown in FIG. 5, the surgeon delivers a hemodynamics checking device 220 to the right atrium HRa via the inferior vena cava Iv. A known echo catheter, for example, can be used as the hemodynamics checking device 220. The surgeon can display the echo image acquired by the hemodynamics checking device 220 on a display or other display device, and check the amount of blood passing through the puncture hole Hh based on the display results.

[0042] Next, the surgeon performs a maintenance procedure to maintain the size of the puncture hole Hh (S7). During the maintenance procedure, high-frequency energy is applied to the edge of the puncture hole Hh through the electrode unit 22, cauterizing (heating and cauterizing) the edge of the puncture hole Hh with the high-frequency energy. The high-frequency energy is applied by applying a voltage between circumferentially adjacent electrode units 22. As described above, the backrest unit 56 tilts against the pushing force of the electrode unit 22, and the amount of tilting is limited by the arm unit 57. This allows the electrode unit 22 to be cauterized while being sufficiently pressed against the atrial septum HA. This reliably increases impedance, allowing a clear determination of the end of cauterization. Furthermore, the atrial septum HA can be effectively cauterized, resulting in the formation of a shunt of stable size. Furthermore, the electrode unit 22 is in close contact with the atrial septum HA and the backrest unit 56, preventing the energy from the electrode unit 22 from being transmitted to blood or other biological tissues.

[0043] When the living tissue near the edge of the puncture hole Hh is cauterized through the electrode portion 22, 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 expander 21.

[0044] After the maintenance treatment, the surgeon checks the hemodynamics again (S8), and if the amount of blood passing through the puncture hole Hh is the desired amount, the expandable body 21 is reduced in diameter, stored in the storage sheath 25, and then removed from the puncture hole Hh. Furthermore, the entire medical device 10 is removed from the living body, and the treatment is completed.

[0045] Next, an expandable body according to a first modification will be described. As shown in FIG. 14, the distal-side upright portion 63 of the expandable body 60 according to a first modification is formed with an outer edge portion 65 and a back support portion 66. The outer edge portion 65 has a junction portion 65a where the two portions meet at the end opposite the bottom portion 62a of the recess 62. The expandable body 60 has an arm portion 67 that curves and extends from the back support portion 66 and is connected to the junction portion 65a of the outer edge portion 65. One arm portion 67 is provided from the radially outer end of the back support portion 66 to the junction portion 65a. Forming the arm portion 67 in this manner also limits the amount of tilt of the back support portion 66.

[0046] As shown in FIG. 15 , the distal end side upright portion 73 of the expandable body 70 of the second modified example is formed with an outer edge portion 75 and a back support portion 76. The outer edge portion 75 has a junction portion 75a where the two portions join at the end opposite the bottom portion 72a of the recess 72. The expandable body 70 has an arm portion 77 that extends in a curved manner from the back support portion 76 and is connected to the junction portion 75a of the outer edge portion 75. The arm portion 77 has multiple bent portions 77a. In this way, the arm portion 77 may have multiple bent portions 77a.

[0047] As shown in FIG. 16, the tip-side upright portion 83 of the expandable body 80 of the third modified example is formed with an outer edge portion 85 and a backrest portion 86. The expandable body 80 has arms 87 extending from the backrest portion 86. The arms 87 extend symmetrically in two directions from the radially outer end of the backrest portion 86, curving around the axis of the extension direction of the backrest portion 86. The arms 87 are spaced apart from the outer edge portion 85 and other parts of the expandable body 80. By tilting the receiving surface 86a of the backrest portion 86, the arms 87 come into contact with the outer edge portion 85, thereby limiting the amount of tilt of the backrest portion 86.

[0048] As shown in Figure 17, the distal end side standing portion 93 of the expandable body 90 of the fourth modified example is formed with an outer edge portion 95 and a back support portion 96. The back support portion 96 has an arm portion 97 extending in the extension direction. The arm portion 97 is spaced apart from the outer edge portion 95 and other portions of the expandable body 90. By tilting the receiving surface 96a of the back support portion 96, the arm portion 97 comes into contact with the confluence portion 95a of the outer edge portion 95, thereby limiting the amount of tilt of the back support portion 96.

[0049] As shown in FIG. 18 , the distal upright portion 103 of the expandable body 100 of the fifth modified example is formed with an outer edge portion 105 and a back support portion 106. The back support portion 106 has an arm portion 107 extending from the radially outer end along the extension direction. The arm portion 107 is formed in a T-shape with a wider distal end 107a, and is separated from the outer edge portion 105 and other portions of the expandable body 100. As the receiving surface 106a of the back support portion 106 tilts, the distal end 107a of the arm portion 107 abuts against the junction 105a of the outer edge portion 105. This allows the arm portion 107 to limit the amount of tilt of the back support portion 106.

[0050] As shown in FIG. 19 , the distal upright portion 113 of the expandable body 110 of the sixth modified example is formed with an outer edge portion 115 and a back support portion 116. The outer edge portion 115 has a junction portion 115a where the two portions meet at the end opposite the bottom portion 112a of the recess 112. The expandable body 110 has an expansion portion 111a extending radially inward from the junction portion 115a of the outer edge portion 115. The arm portion 117 is formed to extend from the radially outer end of the back support portion 116 toward the inner surface of the expansion portion 111a. The distal end of the arm portion 117 is spaced apart from the expansion portion 111a. As the receiving surface 116a of the back support portion 116 tilts, the arm portion 117 abuts against the inner surface of the expansion portion 111a. This allows the arm portion 117 to limit the amount of tilt of the back support portion 116.

[0051] As shown in FIG. 20 , the distal end side standing portion 123 of the extension body 120 of the seventh modification is formed with an outer edge portion 125 and a back support portion 126. An arm portion 127 extends so as to connect the bifurcated portion of the outer edge portion 125. The back support portion 126 is spaced apart from the arm portion 127. By tilting the receiving surface 126a of the back support portion 126, the surface of the back support portion 126 opposite to the surface facing the electrode portion 22 comes into contact with the arm portion 127, thereby limiting the amount of tilt of the back support portion 126. In this way, the arm portion 127 may be provided on the outer edge portion 125 side.

[0052] As shown in FIG. 21 , distal end side standing portion 133 of expandable body 130 of the eighth modified example is formed with outer edge portion 135 and back support portion 136. Arm portion 137 extends from confluence portion 135a of outer edge portion 135 toward back support portion 136. Back support portion 136 is spaced apart from arm portion 137. By tilting receiving surface 136a of back support portion 136, the surface of back support portion 136 opposite the surface facing electrode portion 22 abuts against arm portion 137, thereby limiting the amount of tilt of back support portion 136.

[0053] As shown in FIG. 22, an outer edge portion 145 is formed on the tip-side upright portion 143 of the expandable body 140 of the ninth modified example. The back support portion 146 is formed by multiple rod portions 146b that extend approximately perpendicular to the radial direction of the expandable body 140 and approximately parallel to the surface facing the recessed portion 142 of the electrode portion 22. The multiple rod portions 146b are arranged approximately parallel to each other. Each of the rod portions 146b is connected to the outer edge portion 145 by connecting arm portions 147 on both sides. The arm portions 147 connect both ends of the rod portions 146b to the outer edge portion 145 so as to form a U-shape that opens toward the bottom portion 142a together with the rod portions 146b. The receiving surface 146a of the back support portion 146 is formed by an imaginary plane K on which the multiple rod portions 146b are connected.

[0054] 23, when the receiving surface 146a of the back support portion 146 facing the electrode portion 22 tilts, the connecting arm portion 147 rotates around the connecting portion with the outer edge portion 145 as a fulcrum, thereby limiting the amount of tilt of the receiving surface 146a.

[0055] As described above, the medical device 10 according to this embodiment comprises an expansion body 21 that can expand and contract radially, a long shaft portion 20 having a tip portion 30 including a base end fixing portion 31 to which the base end of the expansion body 21 is fixed, and an electrode portion 22 that is provided along the expansion body 21, and the expansion body 21 has a recess 51 that recesses radially inward when the expansion body 21 is expanded and defines a receiving space 51b that can receive biological tissue, and the recess 51 has a bottom portion 51a that is located at the innermost radial position, a base end side upright portion 52 that extends radially outward from the base end of the bottom portion 51a, and a tip end side upright portion 53 that extends radially outward from the tip of the bottom portion 51a, The electrode section 22 is provided on one of the base-side standing section 52 and the tip-side standing section 53, and the other of the base-side standing section 52 and the tip-side standing section 53 is provided with an outer edge section 55 that branches into two from the vicinity of the bottom section 51a and extends radially outward, a back support section 56 that is arranged within the outer edge section 55 and has a receiving surface 56a that faces the electrode section 22 when the expandable body 21 is expanded, and an arm section 57 that extends from the back support section 56 or the outer edge section 55, and when the electrode section 22 moves toward the back support section 56, the receiving surface 56a of the back support section 56 is inclined so as to be approximately parallel to the electrode section 22 via an object held between the electrode section 22 and the back support section 56, and the arm section 57 has the following features: i) a back support section 56a that faces the electrode section 22 when the expandable body 21 is expanded; The backrest portion 56 is configured as one of the following: a) extending while curving or bending from the support portion 56 and connecting to the outer edge portion 55, and when the receiving surface 56a of the backrest portion 56 tilts, it deforms, thereby limiting the amount of tilt of the receiving surface 56a; ii) extending from the backrest portion 56, and when the receiving surface 56a of the backrest portion 56 tilts, it abuts against the outer edge portion 55 or a part of the extension body 21, thereby limiting the amount of tilt of the receiving surface 56a; iii) extending from the outer edge portion 55, and when the receiving surface 56a of the backrest portion 56 tilts, it abuts against the backrest portion 56, thereby limiting the amount of tilt of the backrest portion 56; or iv) connecting the backrest portion 56 and the outer edge portion 55 together with the backrest portion 56 so as to form a U-shape that opens toward the bottom 51a, and when the receiving surface 56a of the backrest portion 56 tilts, it rotates around the connecting portion with the outer edge portion 55 as a fulcrum, thereby limiting the amount of tilt of the receiving surface 56a. In the medical device 10 configured in this manner, the arms 57 limit the amount of tilt of the receiving surface 56a of the backrest 56, preventing excessive tilting of the backrest 56. This allows the electrode 22 to apply an appropriate pressure to the biological tissue when the biological tissue is clamped between the electrode 22 and the receiving surface 56a. This allows the electrode 22 to be cauterized while being sufficiently pressed against the biological tissue, ensuring a reliable increase in impedance during current application and allowing a clear determination of the end of cauterization. Furthermore, the biological tissue can be effectively cauterized, allowing a shunt of stable size to be formed. Additionally, the electrode 22 is in close contact with the biological tissue and the backrest 56, preventing energy from the electrode 22 from being transmitted to blood or other biological tissue.

[0056] The back support portion 56 may extend radially outward from the outer edge portion 55 near the bottom portion 51a in a plate-like shape. This allows the receiving surface 56a of the back support portion 56 to be more reliably inclined substantially parallel to the electrode portion 22.

[0057] The arm portion 57 may be bifurcated from the radially outer end of the backrest portion 56, extend symmetrically around the axis of the extension direction of the backrest portion 56 while curving or bending, and connect to the outer edge portion 55, and deform when the receiving surface 56a of the backrest portion 56 tilts, thereby limiting the amount of tilt of the receiving surface 56a. This makes it possible to prevent the receiving surface 56a of the backrest portion 56 from twisting left and right when it tilts, and allows the backrest portion 56 to reliably clamp the living tissue together with the electrode portion 22.

[0058] The arm 87 may extend from the radially outer end of the backrest 86, and when the receiving surface 86a of the backrest 86 tilts, it abuts against the outer edge 85, thereby limiting the amount of tilt of the receiving surface 86a. In this way, the arm 87 abuts against the outer edge 85, thereby reliably limiting the amount of tilt of the receiving surface 86a.

[0059] Outer edge 115 has confluence 115a where they meet at the end opposite bottom 112a, expandable body 110 has expansion portion 111a extending radially inward from confluence 115a of outer edge 115, and arm 117 extends from the radially outer end of backrest 116 and may be configured to abut against the inner surface of expansion portion 111a when receiving surface 116a of backrest 116 tilts, thereby limiting the amount of tilt of receiving surface 116a. In this way, arm 117 abuts against the inner surface of expansion portion 111a, thereby reliably limiting the amount of tilt of receiving surface 116a.

[0060] Arm 127 may extend to connect the bifurcated portion of outer edge 125, and when receiving surface 126a of backrest 126 tilts, it may come into contact with the surface of backrest 126 opposite to the surface facing electrode 22, thereby limiting the amount of tilt of receiving surface 126a. In this way, arm 127 formed on the side of outer edge 125 reliably limits the amount of tilt of receiving surface 126a.

[0061] Outer edge 135 has junction 135a where the two join at the end opposite the bottom, and arm 137 extends from junction 135a of outer edge 135 toward backrest 136, and may limit the amount of tilt of receiving surface 136a when receiving surface 136a of backrest 136 tilts by abutting against the surface of backrest 136 opposite to the surface facing electrode 22. In this way, arm 137 extending from junction 135a reliably limits the amount of tilt of receiving surface 136a.

[0062] The backrest portion 146 has a plurality of rod portions 146b that extend approximately perpendicular to the radial direction of the extension body 140 and approximately parallel to the surface facing the recess 142 of the electrode portion 22, and are arranged approximately parallel to each other, and the arm portion 147 has a plurality of connecting arms 147 that connect both ends of each of the plurality of rod portions 146b to the outer edge portion 145 so as to form a U-shape that opens toward the bottom 142a together with each of the plurality of rod portions 146b, and the receiving surface 146a of the backrest portion 146 is formed by an imaginary plane K that includes at least a portion of each of the plurality of rod portions 146b, and each of the plurality of connecting arms 147 may be configured to rotate around the connecting portion with the outer edge portion 145 as a fulcrum when the receiving surface 146a of the backrest portion 146 tilts, thereby limiting the amount of tilt of the receiving surface 146a. As a result, the connecting arm portion 147 reliably limits the amount of tilt of the receiving surface 146a of the back support portion 146 made up of a plurality of rod portions 146b.

[0063] 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.

[0064] This application is based on Japanese Patent Application No. 2021-36373 filed on March 8, 2021, the disclosures of which are incorporated by reference in their entirety. [Explanation of symbols]

[0065] 10 Medical Devices 11 Guidewire 20 Shaft section 21 Extension 22 Electrode section 23 Handheld operation unit 25 Storage sheath 26 Traction shaft 30 Tip 31 Base end fixing part 33 Tip fixing part 35 Tip member 40 cabinets 41 Operation dial 42 Conversion Mechanism 50 Wire section 51 Recess 51a bottom 51b Receptive Space 52 Proximal upright part 53 Tip side upright part 55 outer edge 56 Backrest 56a Receiving surface 57 Arm 57a Bend part

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; an electrode portion provided along the expansion body; Equipped with the expandable body has a recess that is recessed radially inward when the expandable body is expanded and defines a receiving space capable of receiving biological tissue, the recess has a bottom portion located at the innermost side in the radial direction, a base end side upright portion extending radially outward from a base end of the bottom portion, and a tip end side upright portion extending radially outward from a tip end of the bottom portion, The electrode portion is provided on one of the base end side standing portion and the tip end side standing portion, The other of the base-end side upright portion and the tip-end side upright portion is provided with an outer edge portion that branches into two from the vicinity of the bottom portion and extends radially outward, a back support portion that is disposed within the outer edge portion and has a receiving surface that faces the electrode portion when the expandable body is expanded, and an arm portion that extends from the back support portion, When the electrode section moves toward the backrest section, the receiving surface of the backrest section is inclined so as to be substantially parallel to the electrode section via an object sandwiched between the electrode section and the backrest section, The backrest portion extends radially outward from the outer edge portion near the bottom portion in a plate shape, The arm portion splits into two from the radially outer end of the backrest portion, extends symmetrically around the extension direction of the backrest portion while curving or bending, and connects to the outer edge portion, and deforms when the receiving surface of the backrest portion tilts, thereby limiting the amount of tilt of the receiving surface.This medical device.

2. An expandable body that can expand and contract 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; an electrode portion provided along the expansion body; Equipped with the expandable body has a recess that is recessed radially inward when the expandable body is expanded and defines a receiving space capable of receiving biological tissue, the recess has a bottom portion located at the innermost side in the radial direction, a base end side upright portion extending radially outward from a base end of the bottom portion, and a tip end side upright portion extending radially outward from a tip end of the bottom portion, The electrode portion is provided on one of the base end side standing portion and the tip end side standing portion, The other of the base-end side upright portion and the tip-end side upright portion is provided with an outer edge portion that branches into two from the vicinity of the bottom portion and extends radially outward, a back support portion that is disposed within the outer edge portion and has a receiving surface that faces the electrode portion when the expandable body is expanded, and an arm portion that extends from the back support portion, When the electrode section moves toward the backrest section, the receiving surface of the backrest section is inclined so as to be substantially parallel to the electrode section via an object sandwiched between the electrode section and the backrest section, The backrest portion extends radially outward from the outer edge portion near the bottom portion in a plate shape, The arm portion extends from the radially outer end of the backrest portion and abuts against the outer edge portion when the receiving surface of the backrest portion tilts, thereby limiting the amount of tilt of the receiving surface.

3. 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; an electrode portion provided along the expansion body; Equipped with the expandable body has a recess that is recessed radially inward when the expandable body is expanded and defines a receiving space capable of receiving biological tissue, the recess has a bottom portion located at the innermost side in the radial direction, a base end side upright portion extending radially outward from a base end of the bottom portion, and a tip end side upright portion extending radially outward from a tip end of the bottom portion, The electrode portion is provided on one of the base end side standing portion and the tip end side standing portion, The other of the base-end side upright portion and the tip-end side upright portion is provided with an outer edge portion that branches into two from the vicinity of the bottom portion and extends radially outward, a back support portion that is disposed within the outer edge portion and has a receiving surface that faces the electrode portion when the expandable body is expanded, and an arm portion that extends from the back support portion, When the electrode section moves toward the backrest section, the receiving surface of the backrest section is inclined so as to be substantially parallel to the electrode section via an object sandwiched between the electrode section and the backrest section, The backrest portion extends radially outward from the outer edge portion near the bottom portion in a plate shape, the outer edge portion has a joining portion where the outer edge portion joins with the bottom portion at an end opposite the bottom portion, The expansion body has an expansion portion extending radially inward from the joining portion of the outer edge portion, The arm portion extends from the radially outer end of the backrest portion and abuts against the inner surface of the extension portion when the receiving surface of the backrest portion tilts, thereby limiting the amount of tilt of the receiving surface.

4. 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; an electrode portion provided along the expansion body; Equipped with the expandable body has a recess that is recessed radially inward when the expandable body is expanded and defines a receiving space capable of receiving biological tissue, the recess has a bottom portion located at the innermost side in the radial direction, a base end side upright portion extending radially outward from a base end of the bottom portion, and a tip end side upright portion extending radially outward from a tip end of the bottom portion, The electrode portion is provided on one of the base end side standing portion and the tip end side standing portion, The other of the base-end side upright portion and the tip-end side upright portion is provided with an outer edge portion that branches into two from the vicinity of the bottom portion and extends radially outward, a back support portion that is disposed within the outer edge portion and has a receiving surface that faces the electrode portion when the expandable body is expanded, and an arm portion that extends from the outer edge portion, When the electrode section moves toward the backrest section, the receiving surface of the backrest section is inclined so as to be substantially parallel to the electrode section via an object sandwiched between the electrode section and the backrest section, The backrest portion extends radially outward from the outer edge portion near the bottom portion in a plate shape, The arm portion extends to connect the bifurcated portion of the outer edge, and when the receiving surface of the backrest portion tilts, it abuts against the surface opposite to the surface facing the electrode portion of the backrest portion, thereby limiting the amount of tilt of the receiving surface.

5. 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; an electrode portion provided along the expansion body; Equipped with the expandable body has a recess that is recessed radially inward when the expandable body is expanded and defines a receiving space capable of receiving biological tissue, the recess has a bottom portion located at the innermost side in the radial direction, a base end side upright portion extending radially outward from a base end of the bottom portion, and a tip end side upright portion extending radially outward from a tip end of the bottom portion, The electrode portion is provided on one of the base end side standing portion and the tip end side standing portion, The other of the base-end side upright portion and the tip-end side upright portion is provided with an outer edge portion that branches into two from the vicinity of the bottom portion and extends radially outward, a back support portion that is disposed within the outer edge portion and has a receiving surface that faces the electrode portion when the expandable body is expanded, and an arm portion that extends from the outer edge portion, When the electrode section moves toward the backrest section, the receiving surface of the backrest section is inclined so as to be substantially parallel to the electrode section via an object sandwiched between the electrode section and the backrest section, The backrest portion extends radially outward from the outer edge portion near the bottom portion in a plate shape, the outer edge portion has a joining portion where the outer edge portion joins with the bottom portion at an end opposite the bottom portion, The arm portion extends from the confluence of the outer edge portion toward the backrest portion, and when the receiving surface of the backrest portion tilts, it abuts against the surface opposite to the surface facing the electrode portion of the backrest portion, thereby limiting the amount of tilt of the receiving surface.

6. 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; an electrode portion provided along the expansion body; Equipped with the expandable body has a recess that is recessed radially inward when the expandable body is expanded and defines a receiving space capable of receiving biological tissue, the recess has a bottom portion located at the innermost side in the radial direction, a base end side upright portion extending radially outward from a base end of the bottom portion, and a tip end side upright portion extending radially outward from a tip end of the bottom portion, The electrode portion is provided on one of the base end side standing portion and the tip end side standing portion, The other of the base-end side upright portion and the tip-end side upright portion is provided with an outer edge portion that branches into two from the vicinity of the bottom portion and extends radially outward, a back support portion that is disposed within the outer edge portion and has a receiving surface that faces the electrode portion when the expandable body is expanded, and an arm portion that connects the back support portion and the outer edge portion, When the electrode unit moves toward the backrest unit, the receiving surface of the backrest unit is inclined so as to be substantially parallel to the electrode unit via an object sandwiched between the electrode unit and the backrest unit, The arm portion connects the backrest portion to the outer edge portion so that it forms a U-shape that opens toward the bottom, and when the receiving surface of the backrest portion tilts, the arm portion rotates around the connecting portion with the outer edge portion as a fulcrum, thereby limiting the amount of tilt of the receiving surface.

7. the back support portion has a plurality of rod portions that extend substantially perpendicular to the radial direction of the expansion body, substantially parallel to the surface of the electrode portion that faces the recess, and are arranged substantially parallel to each other; the arm portion has a plurality of connecting arm portions that connect both ends of each of the plurality of rod portions to the outer edge portion so as to form a U-shape that opens toward the bottom portion together with each of the plurality of rod portions, the receiving surface of the backrest portion is formed by an imaginary plane including at least a portion of each of the plurality of rod portions, The medical device according to claim 6 , wherein each of the plurality of connecting arms rotates around a connecting portion with the outer edge portion as a fulcrum when the receiving surface of the backrest portion tilts, thereby limiting the amount of tilt of the receiving surface.

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