JP2015181704A - treatment device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a treatment device capable of performing treatment of blocking a lumen of a living body efficiently.SOLUTION: A treatment device includes a shaft (long body) 18 which can be inserted to a lumen of a living body, a flat part formation part 22 which forms a flat part in the lumen of a living body according to an expansion in the lumen of a living body, a tip opening 18a (hardener supply part) which supplies hardener M to a flat part F of the lumen of a living body, and a balloon 104 (closing part) which is supported by the flat part formation part 22 and can close temporarily a lumen of the flat part F according to an expansion.

Description

  The present invention relates to a treatment device for occluding a body lumen such as a blood vessel.

  One of the diseases that occur in the body lumen is varicose veins. Each vein in the living body has a venous valve for returning blood to the heart against gravity, and when the venous valve is damaged, blood flows back to increase the venous pressure and dilate the vein. An aneurysm develops.

  Methods for treating varicose veins include, for example, (1) compression therapy that compresses varicose veins with an elastic bandage, etc., and improves blood stasis, and (2) injection of a sclerosing agent into veins to damage the vascular wall (3) Stripping to remove veins (vein extraction), (4) Laser therapy to occlude veins with heat from laser irradiation, (5) High frequency from electrode ( RF), and RF treatment for causing heat to flow and occlude veins.

  In Patent Document 1 below, after injecting TLA anesthesia from a syringe into a tissue around a blood vessel to be treated, a catheter having an electrode at the tip is inserted into the blood vessel, and the electrode is brought into contact with the blood vessel wall. Then, a treatment method is disclosed in which the blood vessel is occluded by flowing a high frequency current to cauterize the blood vessel tissue. In this case, the purpose of TLA anesthesia is to suppress pain, prevent skin burns, and reduce blood vessel diameter.

US Pat. No. 7,396,355

  In the case of the method disclosed in Patent Document 1, it is difficult to uniformly inject TLA anesthesia around the blood vessel to be treated. When TLA anesthesia is injected non-uniformly, the blood vessel contraction is uneven depending on the location. Thus, the blood vessels cannot be sufficiently contracted. For this reason, cauterization due to heating by applying a high-frequency current becomes insufficient, and there is a possibility that the occluded portion of the blood vessel will re-communicate after treatment.

  The present invention has been made in consideration of such problems, and an object of the present invention is to provide a therapeutic device capable of efficiently performing a treatment for occluding a living body lumen.

  In order to achieve the above object, the present invention provides a treatment device for occluding a biological lumen, a long body that can be inserted into the biological lumen, a long body supported by the long body, and a width direction. A flat forming part that forms a flat part in the living body lumen as it expands in the living body lumen, and a hardening agent that supplies a hardening agent toward the flat part of the living body lumen It is provided with the supply part and the obstruction | occlusion part which is supported by the said flat formation part and can be expanded, and can obstruct | occlude the lumen | bore of the said flat part temporarily in connection with expansion.

  According to the configuration of the present invention, the flat portion is formed in the living body lumen by applying the flat forming portion in the living body lumen, and the flat portion is formed by applying the curing agent to the formed flat portion. Can be effectively occluded. Moreover, since the flow path by the lumen of the flat portion can be temporarily blocked (blocked) by disposing the blocking portion in the lumen of the flat portion, dilution of the curing agent is suppressed, and a curing agent having a suitable concentration can be obtained. It can supply efficiently to a flat part. Therefore, while being able to exhibit the obstruction | occlusion effect by a hardening | curing agent, the usage-amount of a hardening | curing agent can be reduced.

  In the treatment device, the flat forming portion is expandable in the width direction on the distal end side with respect to the elongated body, and flattened on the biological lumen at the distal end portion with expansion in the biological lumen. Forming a portion, and the blocking portion may be supported at a tip of the flat forming portion. With this configuration, when the treatment device is moved backward after the flat portion is formed, the tip of the device is not caught on the flat portion. Therefore, it is possible to prevent the flat portion from expanding due to the backward movement of the treatment device.

  In the treatment device, the elongate body is a hollow shaft in which the flat forming portion is inserted so as to be displaceable in the longitudinal direction, and the flat forming portion can be projected and retracted from a distal end opening of the shaft and in the width direction. A pair of arms that can be expanded to each other, and the distance between the outer ends of the pair of arms is maximized at the distal ends of the pair of arms in the expanded state. May be arranged. With this configuration, a flat portion can be easily and reliably formed in the living body lumen at the most distal portion of the treatment device.

  In the treatment device, each of the pair of arms is configured to be elastically deformable, and the pair of arms expands in the width direction by an elastic restoring force as it protrudes from the distal end opening of the shaft, The occlusion portion may be disposed inside the flat portion of the living body lumen as the pair of arms are expanded. With this configuration, the expansion operation of the pair of arms can be easily and reliably performed only by relatively moving the pair of arms and the shaft in the axial direction.

  In the above treatment device, separately from the occlusion portion as the first occlusion portion, the outer periphery of the elongate body is temporarily occluded between the elongate body and the living body lumen with expansion. The possible 2nd obstruction | occlusion part is provided, and the said hardening | curing agent supply part may supply the said hardening | curing agent to the area | region between the said 1st obstruction | occlusion part and the said 2nd obstruction | occlusion part. With this configuration, the supplied curing agent can be contained between the first blocking portion and the second blocking portion, and a curing agent having a suitable concentration can be more efficiently supplied to the flat portion.

  In the treatment device, the occlusion may be a balloon that can be expanded and contracted. With this configuration, the lumen of the flat portion can be suitably sealed by controlling the expansion of the balloon.

  In the treatment device, the second occlusion may be a balloon that can be expanded and contracted. With this configuration, by controlling the expansion of the balloon, the lumen of the living body lumen can be suitably sealed at a position closer to the proximal end side of the treatment device than the flat portion.

  (1) The biological lumen occlusion method according to the first aspect includes an insertion step of inserting a treatment device into a biological lumen to cause the distal end portion of the treatment device to reach a treatment site, and a hollow of the treatment device By extending the pair of arms together with the pair of arms protruding from the shaft, a flattening step for forming a flat portion in the living body lumen, and by expanding the occlusion portion inside the flat portion, An occlusion step for temporarily occluding the lumen of the flat portion; a supply step for supplying a curing agent toward the flat portion in a state where the flat portion is temporarily occluded by the occlusion portion; And a moving step of moving the arm in the proximal direction in the expanded state.

  (2) In the biological lumen occlusion method according to (1), in the insertion step, the treatment device may be advanced in the biological lumen under an ultrasonic guide.

  (3) In the living body lumen occlusion method of (1), in the flattening step, the degree of flatness of the living body lumen may be confirmed by ultrasound.

  (4) In the living body lumen occlusion method according to (1), in the supplying step, the curing agent may be continuously blown out at a constant flow rate from the distal end opening of the shaft or the distal end opening of a tube inserted through the shaft. Good. In this case, the blowing out of the curing agent is stopped when the movement is stopped by the moving step or after that.

  (5) In the biological lumen occlusion method according to (1), in the moving step, the treatment device may be pulled in a proximal direction at a constant speed.

  (6) The biological lumen occlusion method according to the second aspect includes an insertion step of causing the distal end portion of the treatment device to reach the treatment site by inserting the treatment device into the biological lumen, and the hollow of the treatment device The pair of arms are expanded by projecting the pair of arms from the shaft, and a flattening step for forming a flat portion in the living body lumen, and the pair of arms in the expanded state inside the flat portion An arm-side closing step for temporarily closing the lumen of the flat portion by expanding the first closing portion provided at the tip of the shaft, and a second closing portion provided on the outer peripheral portion of the shaft By expanding, the shaft side blocking step for temporarily blocking between the shaft and the biological lumen, the flat portion is temporarily blocked by the first blocking portion, and the front In a state where the space between the shaft and the living body lumen is temporarily blocked by the second blocking portion, a curing agent is supplied to a region between the first blocking portion and the second blocking portion. And a moving step of moving the pair of arms in the expanded state, the first closed portion in the expanded state, the second closed portion in the expanded state, and the shaft in the proximal direction.

  (7) In the biological lumen occlusion method according to (6), in the insertion step, the treatment device may be advanced in the biological lumen under an ultrasonic guide.

  (8) In the living body lumen occlusion method of (6), in the flattening step, the degree of flatness of the living body lumen may be confirmed by ultrasound.

  (9) In the biological lumen occlusion method according to (6), in the supplying step, the curing agent may be continuously blown out at a constant flow rate from the distal end opening of the shaft or the distal end opening of a tube inserted through the shaft. Good. In this case, the blowing out of the curing agent is stopped when the movement is stopped by the moving step or after that.

  (10) In the living body lumen occlusion method of (6), in the moving step, the treatment device may be pulled in a proximal direction at a constant speed.

  According to the therapeutic device of the present invention, it is possible to efficiently perform a treatment for occluding a biological lumen.

It is a partial omission schematic diagram showing composition of a treatment device. It is a perspective view of the front-end | tip part of the treatment device shown in FIG. 3A is a partial cross-sectional view of a state in which a pair of arms in the treatment device of FIG. 1 is housed in a shaft, and FIG. 3B is a partial cross-sectional view of a state in which the pair of arms in the treatment device of FIG. FIG. 4A is a first diagram illustrating how to use the treatment device of FIG. 1, FIG. 4B is a second diagram illustrating how to use the treatment device of FIG. 1, and FIG. 4C is similar to FIG. It is a 3rd figure explaining the usage method of this treatment device. It is sectional drawing along the VV line in FIG. 4B. FIG. 6A is a diagram showing another electrode portion, and FIG. 6B is a diagram showing yet another electrode portion. FIG. 7A is a partial cross-sectional view of the distal end portion of the treatment device including the extendable electrode portion according to the first configuration example, and FIG. 7B is a diagram showing a state in which a pair of arms in the treatment device of FIG. It is. It is sectional drawing which shows the retaining structure between the element members which comprise the electrode part of the treatment device of FIG. 7A. FIG. 9A is a partial cross-sectional view illustrating a configuration of a distal end portion of a treatment device including an extendable electrode portion according to a second configuration example, and FIG. 9B is an expansion of a pair of arms in the treatment device of FIG. 9A. FIG. 9C is a front view of the treatment device in the state of FIG. 9B. 10A is a perspective view of adjacent element members among a plurality of element members constituting the electrode portion of the treatment device of FIG. 9A, and FIG. 10B is a cross-sectional view taken along line XB-XB in FIG. 10A. FIG. 11A is a partial cross-sectional view of a distal end portion of a treatment device including an extendable electrode portion according to a third configuration example, and FIG. 11B is a diagram showing a state in which a pair of arms in the treatment device of FIG. It is. FIG. 12A is a partial cross-sectional view of a distal end portion of a treatment device including an expandable electrode part according to a fourth configuration example, and FIG. 12B is a diagram showing a state where a pair of arms in the treatment device of FIG. 12A is expanded. It is. It is a partial omission schematic diagram of another treatment device. 14A is a partial cross-sectional view of a state in which a pair of arms in the treatment device of FIG. 13 is housed in a shaft, and FIG. 14B is a view of a state in which the pair of arms in the treatment device of FIG. 13 is expanded. . 15A is a first diagram for explaining how to use the treatment device of FIG. 13, FIG. 15B is a second diagram for explaining how to use the treatment device of FIG. 13, and FIG. 15C is FIG. It is a 3rd figure explaining the usage method of this treatment device. 16A is a partial cross-sectional view of a state in which a pair of arms in still another treatment device is housed in a shaft, and FIG. 16B is a state in which the pair of arms in the treatment device of FIG. 16A is expanded in the width direction. FIG. It is a partial omission schematic diagram of another treatment device. 18A is a view showing a state where a pair of arms in the treatment device of FIG. 17 is expanded in a vein, and FIG. 18B is a cross-sectional view taken along line XVIIIB-XVIIIB in FIG. 18A. It is a figure of the state which a pair of arm in another treatment device expands in a vein, and is irradiating the flat part of a vein with a laser beam. It is a partial omission schematic diagram of another treatment device. 21A is a first diagram for explaining how to use the treatment device of FIG. 20, FIG. 21B is a second diagram for explaining how to use the treatment device of FIG. 20, and FIG. 21C is FIG. It is a 3rd figure explaining the usage method of this treatment device. Furthermore, it is a figure of the state which a pair of arm in another treatment device expands in a vein, and is discharging the hardening | curing agent toward the flat part of a vein. It is a partial omission schematic diagram of another treatment device. 24A is a partial cross-sectional view of a state where a pair of arms in the treatment device of FIG. 23 is housed in a shaft, and FIG. 24B is a state where the pair of arms of the treatment device of FIG. 23 is expanded in a vein. FIG. It is a partial omission schematic diagram of another treatment device. FIG. 26 is a partial cross-sectional view of the distal end portion of the treatment device of FIG. 25. FIG. 26 is a cross-sectional view of the proximal end of the treatment device of FIG. 25. FIG. 28A is a first diagram illustrating how to use the treatment device of FIG. 25, FIG. 28B is a second diagram illustrating how to use the treatment device of FIG. 25, and FIG. FIG. 28D is a fourth diagram illustrating a method of using the treatment device of FIG. 25. FIG. 28C is a cross-sectional view taken along line XXIX-XXIX in FIG. 28C. It is a partial omission schematic diagram of another treatment device. It is a partial cross section figure of the front-end | tip part of the treatment device of FIG. FIG. 31 is a cross-sectional view of the proximal end of the treatment device of FIG. 30. 33A is a first diagram for explaining how to use the treatment device of FIG. 30, FIG. 33B is a second diagram for explaining how to use the treatment device of FIG. 30, and FIG. 33C is FIG. It is a 3rd figure explaining the usage method of this treatment device. 34A is a fourth diagram for explaining how to use the treatment device of FIG. 30, FIG. 34B is a fifth diagram for explaining how to use the treatment device of FIG. 30, and FIG. 34C is FIG. It is a 6th figure explaining the usage method of this treatment device. It is a partial omission schematic diagram of another treatment device. 36A is a view of the treatment device (locked state) of FIG. 35 viewed from the distal end opening side, and FIG. 36B is a view of the treatment device (unlocked state) of FIG. 35 viewed from the distal end opening side. It is a partial cross section figure of the front-end | tip part of another treatment device. 38A is a side view of the restraining member of the treatment device shown in FIG. 37 and its peripheral portion, and FIG. 38B is a cross-sectional view taken along the line XXXVIIIB-XXXVIIIB in FIG. 38A. FIG. 38 is a partial cross-sectional view of the treatment device shown in FIG. 37 when the arm is extended. It is a perspective view of a pair of arm to which a reinforcement part was added. FIG. 41A is a partial cross-sectional view showing a pair of arms according to another configuration example, and FIG. 41B is a view of the pair of arms shown in FIG. 41A as viewed from the front end opening side of the shaft. 42A is a partial cross-sectional view showing a pair of arms according to still another configuration example, and FIG. 42B is a view of the pair of arms shown in FIG. 42A as viewed from the front end opening side of the shaft.

  FIG. 1 is a partially omitted schematic diagram showing the configuration of the treatment device 10A. This therapeutic device 10A is used to occlude a biological lumen such as a blood vessel. The treatment device 10A includes a catheter 12 that can be inserted into a living body lumen, an internal device 14 that is slidably inserted in the catheter 12 in a longitudinal direction, and an electrode that functions as a heating unit provided at the distal end of the internal device 14 Part 16.

  The catheter 12 includes a flexible hollow shaft 18 (long body) constituting a catheter body, and a hub 20 connected to a proximal end portion of the shaft 18. The shaft 18 has a lumen 19 that extends from the distal end to the proximal end of the shaft 18. The length of the shaft 18 varies depending on the treatment target of the treatment device 10A. For example, when the treatment target is a varicose vein that has developed in the lower limb, the length of the shaft 18 is set to about 500 to 4000 mm, for example.

  The constituent material of the shaft 18 is not particularly limited. For example, polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), Examples thereof include polymer materials such as polyvinyl chloride, polyamide, polyamide elastomer, polyurethane, polyurethane elastomer, polyimide, fluororesin, or a mixture thereof, or a multilayer tube made of the above two or more polymer materials.

  The hub 20 connected to the proximal end portion of the shaft 18 is a portion for an operator who uses the treatment device 10A to grip and operate the catheter 12, and may be configured of, for example, a hard resin. The hub 20 has a hollow structure and has a lumen 21 penetrating in the axial direction. The lumen 21 of the hub 20 communicates with the lumen 19 of the shaft 18.

  The internal device 14 includes a flat forming portion 22 that forms a flat portion F (see FIG. 5) in a living body lumen, and a long support 24 that supports the flat forming portion 22. The flat forming portion 22 can be expanded in the width direction (outward direction) on the distal end side of the shaft 18 of the catheter 12, and the living body lumen at a substantially front-end position of the treatment device 10 </ b> A with expansion in the living body lumen. It has a function of forming a flat portion F (for example, a vein).

  Specifically, the flat forming portion 22 is a pair of arms 26 (26a) that can extend and retract from the tip opening 18a of the shaft 18 and can extend in the width direction (X direction in FIG. 1) and extend opposite to each other. 26b). Each arm 26 is configured to be elastically deformable.

  The inner diameter of the shaft 18 is 1.0 mm to 2.5 mm, the outer diameter of each arm 26 is 0.3 mm to 1.0 mm, the inner diameter of the vein is 2.0 mm to 20.0 mm (the inner diameter of the vein after flattening is 2π mm to 20πmm). Accordingly, the pair of arms 26 has a housed width of 0.6 mm to 2.0 mm, and the arms 26 are displaced in the opposite directions to expand to 2π mm to 20π mm.

  In FIG. 3A, the pair of arms 26 is housed in the shaft 18 and is in a contracted state (a state in which the pair of arms 26 is closed) by restricting expansion by the inner peripheral surface of the tube. As shown in FIGS. 1, 2, and 3 </ b> B, when the pair of arms 26 protrudes from the tip opening 18 a of the shaft 18, the pair of arms 26 expands in the width direction by an elastic restoring force. The pair of arms 26 in the expanded state has the maximum distance between the outer ends at the free end (tip portion 27).

  The free end portion (tip portion 27) of each arm 26 is bent inward (inward in the width direction of the flat forming portion 22) so that the outer surface of the tip is rounded. Thereby, when the front-end | tip part 27 of each arm 26 contacts the inner wall of a biological lumen, it can prevent that an inner wall is damaged and can prevent penetration of the blood vessel.

  The material constituting each arm 26 may be a metal or resin having sufficient elasticity to expand in the width direction with an elastic restoring force. For example, examples of such a metal include metals having normal elasticity such as stainless steel, tantalum, cobalt alloy, and copper alloy, and superelastic alloys. In particular, a superelastic alloy is suitable as a constituent material of the arm 26 because a sufficient elastic restoring force can be obtained. Superelastic alloys include Ni-Ti alloys, Ti-Ni-Fe alloys, Cu-Zn alloys, Cu-Zn-Al alloys, Cu-Al-Ni alloys, Cu-Au-Zn alloys, Cu -Sn alloy, Ni-Al alloy, Ag-Cd alloy, Au-Cd alloy, In-Ti alloy, In-Cd alloy, and the like.

  The long support 24 that supports the pair of arms 26 is a flexible member that is slidably inserted in the catheter 12 in the longitudinal direction. With the pair of arms 26 projecting from the distal end opening 18a of the shaft 18 and expanding, the support 24 projects (exposes) in the proximal direction from the proximal end of the catheter 12 (the proximal end of the hub 20). An operator who uses the treatment device 10 </ b> A can grasp the support 24 protruding from the proximal end of the catheter 12. The constituent material of the support 24 can be selected from the materials exemplified as the constituent material of the shaft 18 of the catheter 12. Note that the support 24 is not limited to a member configured separately from each arm 26, and is configured such that each arm 26 extends in the proximal direction and protrudes from the proximal end of the hub 20, that is, each arm 26. The support 24 may be integrally formed continuously.

  Inside the proximal end of the hub 20 is provided a seal member 28 that seals the space between the hub 20 and the support 24 in a liquid-tight manner, and fluid such as blood leaks from the proximal end of the hub 20 to the outside of the treatment device 10A. There is no such thing.

  In the treatment device 10 </ b> A, the electrode portion 16 cauterizes the flat portion F by flowing and heating an electric current (for example, high-frequency current) through the flat portion F formed in the living body lumen by the flat forming portion 22. Therefore, the electrode part 16 functions as a providing part that provides the flat part F with an action (in this case, electric energy) that acts to close the flat part F formed by the flat forming part 22. The electrode portion 16 is made of a conductive material, has flexibility, and both ends are connected to the tip portions 27 of the pair of arms 26.

  As shown in FIG. 3A, the electrode portion 16 bends in the shaft 18 in a state where the pair of arms 26 are accommodated in the shaft 18. As shown in FIG. 3B, in a state where the pair of arms 26 protrudes from the tip opening 18a of the shaft 18 and the pair of arms 26 expands, the electrode portion 16 is pulled by the pair of arms 26 (or elastically by itself). After restoration, it extends in the width direction (X direction) of the flat forming portion 22 between the distal end portions 27 of the pair of arms 26 in the expanded state. In FIG. 3B, the electrode part 16 exhibits linear form between the front-end | tip parts 27 of a pair of arms 26 of an expanded state.

  As shown in FIG. 1, a high frequency power supply device 32 is connected to a base end portion of the support body 24 (a portion of the support body 24 that protrudes from the base end of the hub 20) via an energization cable 30. One arm 26 and the support 24 are provided with a wiring 34 that forms an energization path E between the energization cable 30 and the electrode portion 16. Specifically, the wiring 34 is connected to one end of the electrode portion 16 on the distal end side, and is disposed along one arm 26 and the support 24 (see FIG. 3B). Further, the wiring 34 is connected to the energizing cable 30 on the proximal end side.

  The electrode section 16 and the pair of arms 26, the pair of arms 26 and the wiring 34, and the support 24 and the wiring 34 are electrically insulated from each other. In order to construct such an insulating structure, for example, the pair of arms 26 and the support 24 may be made of an insulating material. When the pair of arms 26 and the support 24 are made of a conductive material, an insulating member is interposed between the electrode portion 16 and the pair of arms 26, and the periphery of the wiring 34 is covered with an insulating material. The insulating structure may be constructed by being covered with a material.

  Next, taking treatment of varicose veins as an example, a treatment method (biological lumen occlusion method) using the treatment device 10A will be described.

  A treatment device 10 </ b> A (see FIG. 3A) in a state where the pair of arms 26 and the electrode portion 16 are accommodated in the shaft 18 is prepared. Next, an insertion step is performed in which the treatment device 10A is inserted into the vein VE so that the tip of the treatment device 10A reaches the treatment site T (target site). Specifically, in the insertion step, the introducer sheath is punctured into the patient, and the treatment device 10A is inserted through the introducer sheath into the vein VE that has developed varicose veins. In this case, the treatment device 10A may be inserted while confirming the tip position of the treatment device 10A under an ultrasonic guide. Then, as shown in FIG. 4A, the distal end portion of the treatment device 10A is made to reach the treatment site T of the vein VE.

  Next, a flattening step for forming a flat portion F in the vein VE is performed. Specifically, in the flattening step, as shown in FIG. 4B, the catheter 12 is moved in the proximal direction by a predetermined distance while the position of the internal device 14 is fixed. Then, as the pair of arms 26 protrude from the tip opening 18a of the shaft 18, the tip portions 27 are displaced in opposite directions within one plane by elastic restoring force, and are expanded (expanded) in the width direction. ). Due to the expansion of the pair of arms 26, the wall of the vein VE located outside each arm 26 is expanded radially outward and bulges outward.

  As a result, as shown in FIG. 5 (a cross-sectional view taken along line VV in FIG. 4B), the cross-sectional shape of the vein VE receiving the force from the pair of arms 26 is deformed flat. That is, the distance between the walls W1 of the vein VE in the portion pushed by the pair of arms 26 is increased, whereby the distance between the walls W2 of the vein VE existing in the direction orthogonal to the separating direction of the pair of arms 26. As the value becomes smaller, the cross-sectional shape of the vein VE becomes flat.

  Next, a heating step of heating the flat portion F by the electrode portion 16 is performed. Specifically, in the heating step, a current (high-frequency current) generated by the high-frequency power supply device 32 is applied to the flat portion F of the vein VE by the electrode unit 16 in order to perform a treatment for blockage. The flat portion F is cauterized by supplying the electrode portion 16 through the energization path E (wiring 34) and applying current to the flat portion F of the vein VE to heat it. This heating step can also be referred to as a providing step for providing the flat portion F with something that acts to close the flat portion F (in this case, electric energy). In the heating step, the electrode portion 16 and the inner wall of the flat portion F of the vein VE may not be in contact with each other. In this case as well, current flows in the blood, so that the flat portion F is energized through the blood. be able to.

  In parallel with the heating step, a moving step is performed in which the pair of arms 26 are moved in the proximal direction while being in the expanded state. Specifically, as shown in FIG. 4C, the entire treatment device 10A with the pair of arms 26 expanded is moved in the proximal direction. Thereby, formation of the flat part F and cauterization are continuously performed along the vein VE. The tissue of the flat portion F is coagulated and denatured by cauterization.

  When such ablation on the vein VE is performed within a desired range, the pair of arms 26 and the electrode portion 16 are then re-accommodated in the shaft 18 (accommodating step), and the treatment device 10A is pulled out from the body (venous VE). (Extraction step). When re-accommodating the pair of arms 26 and the electrode unit 16 in the shaft 18, the catheter 12 may be moved in the distal direction while the position of the internal device 14 is fixed, and the position of the catheter 12 is fixed while the internal device 14 is fixed. The device 14 may be moved in the proximal direction.

  Thus, according to the therapeutic device 10A, the flat portion F is formed in the living body lumen by the flat forming portion 22 in the living body lumen, and then the formed flat portion F is subjected to a treatment for blocking. Therefore, the flat portion F can be efficiently blocked. Moreover, since the flat formation part 22 forms the flat part F in the living body lumen at the substantially front-end position of the treatment device 10A, when the treatment device 10A is moved backward after the flat part F is formed, The tip does not get caught. Therefore, the expansion (recanalization) of the flat portion F accompanying the backward movement of the treatment device 10A can be prevented.

  Further, in the case of the treatment device 10A, the flat forming portion 22 has a pair of arms 26 that can extend and retract from the distal end opening 18a of the shaft 18 and can be expanded in the width direction. The distance between the outer ends of the pair of arms 26 is maximized. With this configuration, it is possible to easily and reliably form the flat portion F in the living body lumen at the substantially frontmost portion of the treatment device 10A.

  Further, in the case of the treatment device 10 </ b> A, the pair of elastically deformable arms 26 expands in the width direction by an elastic restoring force as they protrude from the tip opening 18 a of the shaft 18. For this reason, the expansion operation of the pair of arms 26 can be easily and reliably performed only by relatively moving the pair of arms 26 and the shaft 18 in the axial direction.

  In the case of the treatment device 10A, the living body lumen is heat-treated (cauterized) by providing electric energy to the flat portion F of the living body lumen, so that the living body lumen can be suitably closed.

  In the treatment device 10A, the electrode unit 36 shown in FIG. 6A may be applied instead of the electrode unit 16 described above. The thickness of the electrode part 36 is set to be equal to or greater than the thickness of the arm 26 (dimension in the Y direction). When such an electrode part 36 is applied, when the flat part F is formed in the living body lumen by the expansion of the pair of arms 26, the electrode part 36 contacts the inner surface of the wall W2 of the flat part F. With this configuration, current can be efficiently passed through the flat portion F. Therefore, cauterization with respect to the flat part F can be performed effectively.

  In the treatment device 10A, electrode portions 38a and 38b shown in FIG. 6B may be applied instead of the electrode portion 16 described above. In FIG. 6B, specifically, two electrode portions 38a and 38b are provided apart from each other in the thickness direction (Y direction) of the pair of arms 26. When the flat portion F is formed in the living body lumen by the expansion of the pair of arms 26, one electrode portion 38a contacts the inner surface of one flat wall W2 constituting the flat portion F, and the other electrode portion 38b. Contacts the inner surface of the other flat wall W2 constituting the flat portion F. With this configuration, current can be efficiently passed through the flat portion F. Therefore, cauterization with respect to the flat part F can be performed effectively.

  Next, another treatment device provided with an electrode part that functions as a heating part for heat-treating a living body lumen and that can expand and contract in the width direction of the flat forming part 22 will be described.

  FIG. 7A is a partial cross-sectional view of the distal end portion of the treatment device 10B including the extendable electrode portion 40 according to the first configuration example. In FIG. 7A, the electrode portion 40 is in a contracted state between the pair of arms 26 accommodated in the shaft 18. In FIG. 7B, the electrode part 40 is in an extended state between the pair of arms 26. The electrode unit 40 is connected to the end of the wiring 34 disposed along the arm 26.

  The electrode part 40 functions as a providing part that provides the flat part F with what (electrical energy) acts to close the flat part F formed by the flat forming part 22. The electrode portion 16 is provided at the distal end portion of the flat forming portion 22 (specifically, between the distal end portions 27 of the pair of arms 26), and extends as the pair of arms 26 expands in the living body lumen.

  The electrode portion 40 includes a plurality (five in the illustrated example) of element members 42 that can be displaced relative to each other in the width direction of the flat forming portion 22 and output a current. The adjacent element member 42 can slide in the width direction (X direction) of the flat forming portion 22. The plurality of element members 42 are a plurality of hollow cylindrical members having different thicknesses (diameters), and the plurality of cylindrical members constitute a telescopic structure.

  As shown in FIG. 8, an inner locking protrusion 43 and an outer locking protrusion are provided at the end of each element member 42 as a restricting means (a retaining structure) for restricting the extension limit between adjacent element members 42. 44 is provided. When each element member 42 is relatively moved by a predetermined distance in the direction in which the electrode portion 40 extends, the inner locking protrusions 43 and the outer locking protrusions 44 provided on the adjacent element members 42 come into contact with each other. Relative displacement is regulated. This prevents the element member 42 from separating.

  When the treatment device 10B is used, a treatment for a living body lumen can be performed by a procedure (see FIGS. 4A to 4C) substantially similar to the treatment device 10A shown in FIG. Specifically, first, when using the treatment device 10B, the insertion step is performed in the same manner as when using the treatment device 10A.

  Next, a flattening step for forming a flat portion F in the living body lumen is performed. Specifically, as the pair of arms 26 protrude from the shaft 18, the pair of arms 26 are expanded to form a flat portion F in the living body lumen, and the pair of arms 26 expands and contracts in the width direction. The heating part (electrode part 40) provided as possible is extended. In this case, as the pair of arms 26 protrude from the tip opening 18 a of the shaft 18, the pair of arms 26 expands in the width direction by the elastic restoring force, and the plurality of element members 42 extend in the width direction of the flat forming portion 22. Are displaced relative to each other. Thereby, the electrode part 40 which consists of the some element member 42 expand | extends.

  Next, a heating step of heating the flat part F is performed by a heating part (electrode part 40) arranged in an extended state inside the flat part F. This heating step can also be referred to as a providing step for providing the flat portion F with something that acts to close the flat portion F (in this case, electric energy).

  In parallel with the heating step, a moving step of moving the entire treatment device 10B with the pair of arms 26 in the expanded state in the proximal direction is performed.

  Thereafter, as in the case of using the treatment device 10A, an accommodation step and an extraction step are performed.

  According to the treatment device 10 </ b> B configured as described above, the electrode unit 40 is compactly accommodated in the contracted state inside the shaft 18, but can be extended with the expansion of the pair of arms 26 outside the shaft 18. . Therefore, the electrode part 40 can earn an energy discharge | release area, enabling accommodation in the shaft 18, and can perform an efficient treatment with respect to the flat part F formed in the biological lumen.

  Moreover, since the electrode part 40 has the some element member 42 which can mutually be displaced in the width direction of the flat formation part 22, and outputs an energy, it can enlarge an energy discharge | release area outside the shaft 18 by simple structure. Is possible.

  Furthermore, since the electrode part 40 has a telescopic structure comprised by several cylindrical members (element member 42), there is no clearance in the width direction of the flat formation part 22 in the expansion | extension state. For this reason, the heat treatment can be effectively performed on the flat portion F.

  9A and 9B are partial cross-sectional views illustrating the configuration of the distal end portion of the treatment device 10C including the expandable electrode unit 46 according to the second configuration example. In FIG. 9A, the electrode portion 46 is in a contracted state between the pair of arms 26 accommodated in the shaft 18. In FIG. 9B, the electrode portion 46 is in an extended state between the pair of arms 26.

  The electrode part 46 functions as a providing part that provides the flat part F with what (electrical energy) acts to close the flat part F formed by the flat forming part 22. The electrode portion 46 is provided at the distal end portion of the flat forming portion 22 and extends as the pair of arms 26 expand in the living body lumen.

  The electrode portion 46 includes a plurality (five in the illustrated example) of element members 48 that can be displaced relative to each other in the width direction of the flat forming portion 22 and output a current. Specifically, the plurality of element members 48 are stacked in a predetermined direction (in the illustrated example, the longitudinal direction of the flat forming portion 22). The adjacent element members 48 can slide in the width direction (X direction) of the flat forming portion 22.

  Among the plurality of element members 48, their width (dimension along the longitudinal direction of the flat forming portion 22) and length (dimension along the width direction of the flat forming portion 22) are set to be the same. Therefore, the area of each element member 48 in plan view is the same, and the amount of energy released from each element member 48 is uniform.

  FIG. 10A is a perspective view of adjacent element members 48. 10B is a cross-sectional view taken along line XB-XB in FIG. 10A. As a guide structure for guiding the slide between adjacent element members 48, each element member 48 has a guide rail 50 and a guide groove 52 corresponding to the shape of the guide rail 50 along the longitudinal direction of the element member 48. Provided. The guide rail 50 and the guide groove 52 are slidably engaged with each other and engaged so as to restrict relative displacement in a direction orthogonal to the sliding direction. The guide rail 50 and the guide groove 52 are formed in a concavo-convex shape that enables such engagement.

  As shown in FIG. 10A, a locking protrusion 54 is provided at the end of each element member 48 as a restricting means (a retaining structure) for restricting the extension limit between adjacent element members 48. When each element member 48 is relatively moved by a predetermined distance in the direction in which the electrode portion 46 is extended, the relative protrusions are further restricted by contact between the locking projections 54 provided on the adjacent element members 48. This prevents the element member 48 from separating.

  Even when the treatment device 10C is used, the treatment of the living body lumen can be performed by a procedure (see FIGS. 4A to 4C) substantially similar to the method of using the treatment device 10A shown in FIG. Specifically, first, when the treatment device 10C is used, the insertion step is performed in the same manner as when the treatment device 10A is used.

  Next, a flattening step for forming a flat portion F in the living body lumen is performed. Specifically, as the pair of arms 26 protrude from the shaft 18, the pair of arms 26 is expanded to form a flat portion F in the living body lumen, and the electrode portion 46 is arranged in the width direction of the arm 26. Elongate. In this case, as the pair of arms 26 protrude from the tip opening 18 a of the shaft 18, the pair of arms 26 expands in the width direction by the elastic restoring force, and the plurality of element members 48 extend in the width direction of the flat forming portion 22. Are displaced relative to each other. Thereby, the electrode part 46 which consists of the some element member 48 expand | extends.

  Next, the heating step of heating the flat part F is performed by the electrode part 40 arranged in an extended state inside the flat part F. This heating step can also be referred to as a providing step for providing the flat portion F with something that acts to close the flat portion F (in this case, electric energy).

  In parallel with the heating step, a moving step is performed in which the entire treatment device 10C with the pair of arms 26 in the expanded state is moved in the proximal direction.

  Similarly to the electrode part 40, the electrode part 46 configured as described above can be stored in the shaft 18 while increasing the energy release area, and an efficient treatment can be performed on the flat part F. It can be carried out. In addition, since the electrode portion 46 includes a plurality of element members 48 that can be displaced relative to each other in the width direction of the flat forming portion 22, it is possible to widen the energy emission area outside the shaft 18 with a simple configuration. The amount of energy released from each element member 48 can be made uniform.

  In particular, in the case of the treatment device 10 </ b> C, the plurality of element members 48 are stacked in the longitudinal direction of the pair of arms 26. For this reason, as shown in FIG. 9C, by adopting a configuration in which there is no step in the thickness direction of the flat forming portion 22, the flat portion F of the biological lumen formed by the expansion of the pair of arms 26 in the width direction. Heat treatment can be performed uniformly.

  FIG. 11A and FIG. 11B are partial cross-sectional views of the distal end portion of the treatment device 10D provided with the extendable electrode portion 56 (heating portion) according to the third configuration example. In FIG. 11A, the electrode portion 56 is in a contracted state between the pair of arms 26 accommodated in the shaft 18. In FIG. 11B, the electrode portion 56 is in an extended state between the pair of arms 26.

  The electrode portion 56 is provided at the distal end portion of the flat forming portion 22 (specifically, between the distal end portions 27 of the pair of arms 26), and extends as the pair of arms 26 expands in the living body lumen. Similar to the electrode portion 46 described above, the electrode portion 56 includes a plurality of element members 58 made of a conductive material and slidable in the width direction (X direction) of the flat forming portion 22, and can be expanded and contracted. On the other hand, in the electrode portion 56, the plurality of element members 58 are stacked in the thickness direction (Y direction) of the flat forming portion 22.

  Although not shown in detail, the plurality of element members 58 constituting the electrode portion 56 also have a guide structure and a retaining structure, similarly to the plurality of element members 42 constituting the electrode portion 40.

  Even when the treatment device 10D is used, the treatment of the living body lumen can be performed by the same procedure as the method of using the treatment device 10C shown in FIG. 9A and the like.

  Similarly to the electrode unit 46 shown in FIG. 9A and the like, the electrode unit 56 configured as described above can be stored in the shaft 18 and can gain an energy release area, and is formed in the living body lumen. An efficient treatment can be performed on the flat portion F.

  12A and 12B are diagrams illustrating a configuration of the distal end portion of the treatment device 10E including the extendable electrode unit 60 (heating unit) according to the fourth configuration example. In FIG. 12A, the electrode part 60 is in a contracted state between the pair of arms 26 accommodated in the shaft 18. In FIG. 12B, the electrode part 60 is in an extended state between the pair of arms 26.

  The electrode part 60 functions as a providing part that provides the flat part F with what (electrical energy) acts to close the flat part F formed by the flat forming part 22. The electrode portion 60 is provided at the distal end portion of the flat forming portion 22, has a plurality of element members 62 made of a conductive material, and extends as the pair of arms 26 expand in the body lumen.

  In particular, in the case of this electrode part 60, it has a bendable connecting part 64 that connects adjacent element members 62 to each other. The connecting portion 64 has conductivity, and all the element members 62 are energized by energization from the wiring 34. In the example of illustration, each connection part 64 consists of a member which has flexibility, and connects the edge parts of the element member 62 which adjoins. The element members 62 constituting both ends of the electrode part 60 are connected to each arm 26 via a connecting part 66 having flexibility and conductivity. The connecting portion 66 is fixed to the approximate center of each arm 26 in the thickness direction (Y direction).

  As shown in FIG. 12A, in the state where the flat forming portion 22 (the pair of arms 26) is accommodated in the shaft 18, the electrode portion 60 is alternately bent in the opposite direction at the location of the connecting portion 64, thereby The element members 62 are arranged in the thickness direction of the flat forming portion 22. That is, the electrode part 60 is folded between the pair of arms 26 so as to meander in the width direction of the flat forming part 22.

  When the flat forming portion 22 protrudes outside the shaft 18, as shown in FIG. 12B, each connecting portion 64 is straightly extended, and the plurality of element members 62 are substantially along the width direction (X direction) of the flat forming portion 22. Line up on a straight line. Thereby, the electrode part 16 extends in the width direction of the flat forming part 22.

  Even when the treatment device 10E is used, it is possible to perform treatment on the living body lumen by substantially the same procedure as the method of using the treatment device 10A shown in FIG.

  Specifically, when using the treatment device 10E, first, the insertion step is performed in the same manner as when the treatment device 10A is used.

  Next, a flattening step for forming a flat portion F in the living body lumen is performed. Specifically, as the pair of arms 26 protrude from the shaft 18, the pair of arms 26 is expanded to form a flat portion F in the living body lumen, and the electrode portion 60 is arranged in the width direction of the arm 26. Elongate. In this case, as the pair of arms 26 protrude from the tip opening 18 a of the shaft 18, the pair of arms 26 expands in the width direction by the elastic restoring force, and the plurality of element members 62 extend in the width direction of the flat forming portion 22. Are aligned in a substantially straight line (see FIG. 12B). Thereby, the electrode part 60 which consists of the some element member 62 expand | extends.

  Next, a heating step of heating the flat portion F is performed by the electrode portion 60 disposed in an extended state inside the flat portion F. This heating step can also be referred to as a providing step for providing the flat portion F with something that acts to close the flat portion F (in this case, electric energy).

  In parallel with the heating step, a moving step of moving the entire treatment device 10E with the pair of arms 26 in the expanded state in the proximal direction is performed.

  Similarly to the other extendable and contractible electrode portions 40, 46, and 56, the electrode portion 60 configured as described above can also be stored in the shaft 18 and gain an energy release area. An efficient treatment can be performed on the flat portion F formed in the cavity.

  FIG. 13 is a partially omitted schematic view of still another treatment device 10F. This treatment device 10F includes an electrode part 68 as a heating part movable with respect to the flat forming part 22, wires 72a and 72b as flexible power transmission members connected to the electrode part 68, wires 72a, And a drive unit 74 for driving 72b. The catheter 12, the flat forming part 22, the support 24, the energization cable 30, and the high frequency power supply device 32 in the treatment device 10F have the same configuration as the treatment device 10A shown in FIG.

  The electrode portion 68 includes a pair of flexible heating pieces 70a and 70b. Each heating piece 70a, 70b is made of an elastically deformable material. One heating piece 70a is cantilevered by one arm 26a at one end thereof. The other heating piece 70b is cantilevered by the other arm 26b at one end thereof.

  In FIG. 14A, the flat forming portion 22 is accommodated in the shaft 18, and the pair of heating pieces 70 a and 70 b are bent so that the free ends are directed to the proximal end side of the flat forming portion 22. At this time, each heating piece 70a, 70b is elastically deformed.

  In FIG. 14B, the pair of arms 26 constituting the flat forming portion 22 protruding from the tip opening 18a of the shaft 18 are expanded in the width direction (X direction), and the electrode portion 68 includes a pair of heating pieces 70a and 70b. By restoring elastically and aligning in the width direction of the flat forming part 22, it exhibits a substantially straight line shape. The free ends of the heating pieces 70 a and 70 b are formed obliquely and partially overlap in the width direction of the flat forming portion 22. Note that the free ends of the heating pieces 70a and 70b may be in contact with each other or may be close to each other with a slight gap.

  Each heating piece 70a, 70b is rotatable about the axis in the width direction of the flat forming portion 22 with respect to each arm 26 (rotatable in the A direction in FIG. 14B), or with respect to each arm 26 The flat forming portion 22 can reciprocate in the width direction (reciprocating in the direction B in FIG. 14B). Each heating piece 70a, 70b may be rotatable about the axis in the width direction of the flat forming portion 22 with respect to each arm 26, and may be reciprocated in the width direction of the flat forming portion 22. .

  The pair of heating pieces 70a and 70b are connected to the wires 72a and 72b, respectively, and operate in a predetermined direction in conjunction with the wires 72a and 72b. The wires 72a and 72b are slidably inserted into the lumens of the arm 26 and the support 24, and extend to a drive unit 74 (see FIG. 13) provided at the base end of the support 24.

  The drive unit 74 can drive the wires 72a and 72b to rotate around the axis, or can reciprocate the wires 72a and 72b in the axial direction. The drive unit 74 may be capable of rotating the wires 72a and 72b around the axis and reciprocating in the axial direction. Although details are not shown, the drive unit 74 includes one or more motors (which may be a rotary type or a linear type), and transmits power between the motor and the wires 72a and 72b as necessary. A mechanism (for example, a gear, a pulley, a belt, etc.) is provided.

  When the drive unit 74 rotationally drives the wires 72a and 72b around the axis, torque is transmitted from the drive unit 74 to the heating pieces 70a and 70b via the wires 72a and 72b, so that each heating piece 70a. , 70b rotate around the axis of the flat forming portion 22 in the width direction.

  When the drive unit 74 reciprocally drives the wires 72a and 72b, the axial force is transmitted from the drive unit 74 to the heating pieces 70a and 70b via the wires 72a and 72b, whereby the heating pieces 70a and 70b are transmitted. Reciprocates in the width direction of the flat forming portion 22.

  As shown in FIGS. 14A and 14B, traction members 78a and 78b are connected to the heating pieces 70a and 70b. When the flat forming portion 22 and the electrode portion 68 are re-accommodated in the shaft 18, the heating pieces 70a, 70b are oriented so that the free ends are oriented in the proximal direction by pulling the pulling members 78a, 78b in the proximal direction. Can be forcibly elastically deformed. Thereby, the flat formation part 22 and the electrode part 68 can be easily accommodated in the shaft 18. Although detailed illustration is omitted in FIG. 13, the pulling members 78 a and 78 b are inserted into the catheter 12 (the shaft 18 and the hub 20) and pulled out from the proximal end of the hub 20.

  When the heating pieces 70a and 70b are configured to rotate about the axis in the width direction of the flat forming portion 22, the connection structure between the pulling members 78a and 78b and the heating pieces 70a and 70b is a continuous structure of the heating pieces 70a and 70b. It may be configured so as not to prevent proper rotation. For example, as shown in FIGS. 14A and 14B, an annular groove 76 is provided on the free end side of the heating pieces 70a and 70b, and a ring 79 that engages with the annular groove 76 in a relatively rotatable manner is provided at each end of the pulling members 78a and 78b. If provided, even if the traction members 78a and 78b are connected, rotation of the heating pieces 70a and 70b is not hindered.

  Each of the wires 72 a and 72 b is made of a conductive material, and is electrically connected to the energizing cable 30 on the base end side of the support 24. Accordingly, when the wires 72a and 72b function as the energization path E, the current (high-frequency current) from the high-frequency power supply device 32 can be energized to the heating pieces 70a and 70b via the wires 72a and 72b. it can.

  Next, taking treatment of varicose veins as an example, a treatment method (biological lumen occlusion method) using the treatment device 10F will be described. In addition, the part which overlaps with the treatment method using 10 A of treatment devices is demonstrated easily.

  A treatment device 10 </ b> F (FIG. 14A) in a state where the pair of arms 26 and the electrode portion 68 are accommodated in the shaft 18 is prepared. Next, an insertion step is performed. Specifically, the treatment device 10F is inserted into the vein VE that has developed varicose veins through an introducer sheath punctured by the patient. Then, under the ultrasonic guide, the treatment device 10F is advanced, and as shown in FIG. 15A, the distal end portion of the treatment device 10F is made to reach the treatment site T (target site) of the vein VE.

  Next, a flattening step for forming a flat portion F in the living body lumen is performed. Specifically, as shown in FIG. 15B, while the position of the internal device 14 is fixed, the pair of arms 26 are protruded from the distal end opening 18a of the shaft 18 by moving the catheter 12 in the proximal direction by a predetermined distance. . As a result, the pair of arms 26 is expanded to form a flat portion F (see also FIG. 5) in the vein VE.

  On the other hand, as the pair of arms 26 protrude from the tip opening 18a of the shaft 18 and expand, the heating pieces 70a and 70b constituting the electrode portion 68 are elastically restored and exhibit a linear shape. Thereby, the electrode part 68 is arrange | positioned inside the flat part F. FIG.

  Next, a heating step of heating the flat part F by the electrode part 68 inside the flat part F is performed while moving the electrode part 68 with respect to the flat forming part 22. This heating step can also be referred to as a providing step for providing the flat portion F with something that acts to close the flat portion F (in this case, electric energy). Specifically, in the heating step, a current (high-frequency current) generated by the high-frequency power supply device 32 is supplied to the electrode portion 68 via the energizing cable 30 and the energizing path E (wires 72a and 72b), and the current is supplied to the vein VE. The flat portion F is caused to flow to generate heat, and the flat portion F is cauterized.

  In parallel with the heating step, a moving step of moving the pair of arms 26 in the expanded state and the electrode portion 68 in the heated state along the living body lumen is performed. Specifically, as shown in FIG. 15C, the entire treatment device 10F with the pair of arms 26 expanded is moved in the proximal direction while cauterizing. Thereby, formation of the flat part F and cauterization are continuously performed along the vein VE.

  As described above, in the heating step, while the vein VE is cauterized by the electrode portion 68, the electrode portion 68 is attached to the flat forming portion 22 in order to prevent the electrode portion 68 from sticking to the tissue of the vein VE. move. Specifically, each heating piece 70a, 70b connected to each wire 72a, 72b is rotated or reciprocated by the driving unit 74 (see FIG. 13) to rotate or reciprocate each wire 72a, 72b. Are rotated around the axis in the width direction or reciprocated in small increments in the width direction of the flat forming portion 22. This suppresses or prevents the heating pieces 70a and 70b from sticking to the tissue of the vein VE. In other words, each heating piece 70a, 70b always moves relative to the flat portion F at a speed that does not stick to the tissue of the flat portion F while the flat portion F is heated. Therefore, an efficient treatment can be performed on the flat portion F.

  A therapeutic device 10G shown in FIGS. 16A and 16B is a modification of the therapeutic device 10F shown in FIG. Specifically, this treatment device 10 </ b> G corresponds to a configuration in which the electrode portion 68 as a heating portion in the treatment device 10 </ b> F is replaced with a flexible electrode portion 80 spanned between the pair of arms 26. One end and the other end of the electrode unit 80 are supported by the respective distal end portions 27 of the pair of arms 26.

  In FIG. 16A, the flat forming part 22 is accommodated in the shaft 18, and the electrode part 80 is bent. As shown in FIG. 16B, in a state where the pair of arms 26 protrudes from the tip opening 18a of the shaft 18 and the pair of arms 26 expands, the electrode portion 80 is pulled by the pair of arms 26 (or is elastically restored by itself). To be straight). That is, the electrode portion 80 extends in the width direction (X direction) of the flat forming portion 22 between the distal end portions 27 of the pair of arms 26 in the expanded state.

  The electrode portion 80 is rotatable with respect to each arm 26 around the axis in the width direction of the flat forming portion 22 (rotatable in the A direction in FIG. 16B), or flat with respect to each arm 26. The part 22 can reciprocate in the width direction (reciprocating in the direction B in FIG. 16B). The electrode portion 16 may be rotatable about the axis in the width direction of the flat forming portion 22 with respect to each arm 26 and may be reciprocated in the width direction of the flat forming portion 22.

  The electrode unit 80 is connected to the wires 72a and 72b at both ends thereof, and operates in a predetermined direction in conjunction with the wires 72a and 72b.

  When the drive unit 74 (FIG. 13) rotationally drives the wires 72a and 72b around the axis line, torque is transmitted from the drive unit 74 to the electrode unit 80 via the wires 72a and 72b, thereby the electrode unit 80. Rotates about the axis in the width direction of the flat forming portion 22. In this case, in order to rotate the electrode unit 80 in a predetermined direction, the driving unit 74 drives one and the other wires 72a and 72b in opposite directions at the same rotational speed.

  When the drive unit 74 reciprocally drives the wires 72a and 72b, the axial force is transmitted from the drive unit 74 to the electrode unit 80 via the wires 72a and 72b. Reciprocates in the width direction. In this case, the drive unit 74 drives the one and the other wires 72a and 72b to reciprocate at the same speed in opposite directions in order to appropriately move the electrode unit 80 back and forth.

  Even when the treatment device 10G is used, the treatment of the living body lumen can be performed by the same procedure (see FIGS. 15A to 15C) as the method of using the treatment device 10F shown in FIG.

  Accordingly, the treatment device 10G also moves the electrode portion 80 relative to the flat formation portion 22 while applying energy to the flat portion F, similarly to the treatment device 10F (FIG. 13) including the electrode portion 68. Accordingly, the electrode portion 16 is also prevented from sticking to the tissue of the flat portion F because it moves with respect to the flat portion F. In other words, the electrode unit 80 always moves relative to the flat part F at a speed that does not stick to the tissue of the flat part F while the flat part F is heated. Thereby, an efficient treatment can be performed on the flat portion F.

  In particular, in the case of the treatment device 10G, since the electrode unit 80 is held between the pair of arms 26, the electrode unit 80 can be reliably disposed inside the flat portion F. Moreover, the electrode part 70 does not shift from the flat part F, and a stable treatment can be performed.

  In addition, in the treatment devices 10A to 10G described above, the heating unit that performs the heat treatment on the living body lumen includes the electrode units (16, 36, 38a, 38b, 40, 46, 56, 60, 68, 80), but instead of such an electrode part, it may be constituted as a heat generating part using resistance heating. In this case, the heat generating part itself generates heat due to resistance heating during energization of the heat generating part, and the living body lumen is heated by the heat. The heat generating part may have a stretchable structure similar to the electrode parts 40, 46, 56, 60, 68, 80 described above.

  FIG. 17 is a partially omitted schematic view of still another treatment device 10H. The treatment device 10H includes an irradiation unit 82 that irradiates the flat part F formed in the living body lumen by the flat forming unit 22 with the laser light L (see FIG. 18A). Therefore, the irradiation part 82 functions as a providing part that provides the flat part F with an action (in this case, light energy) that acts to close the flat part F formed by the flat forming part 22.

  As illustrated in FIG. 18A, in the treatment device 10 </ b> H, an irradiation unit 82 is provided inside each distal end portion 27 of the pair of arms 26. That is, two irradiation parts 82 are provided. Each irradiation unit 82 includes a lens 84 and irradiates laser light L transmitted via two optical fibers 86 toward the inside of the pair of arms 26.

  One end of the optical fiber 86 is connected to or close to the lens 84, and is disposed in the pair of arms 26 and the support 24. Further, the optical fiber 86 is pulled out from the base end of the support 24 and connected to the laser light source 88. The optical fiber 86 may be disposed on the outer surfaces of the pair of arms 26 and the support 24.

  The laser beam L to be applied, that is, the laser beam L generated by the laser light source 88 can be selected from wavelengths of 810, 940, 1064, 1320, 1470, 2000 nm, for example.

  Next, taking a varicose vein as an example, a treatment method (biological lumen occlusion method) using the treatment device 10H will be described.

  In the treatment method using the treatment device 10H, first, the insertion step is performed in the same manner as in the method of using the treatment device 10A. Specifically, the treatment device 10H in which the pair of arms 26 are housed in the shaft 18 is inserted into the vein VE through the introducer sheath, and the distal end portion of the treatment device 10H is vein VE with an ultrasonic guide. To the treatment site T.

  Next, a flattening step for forming a flat portion F in the vein VE is performed by expanding the pair of arms 26 (see FIGS. 18A and 18B). FIG. 18B is a cross-sectional view taken along line XVIIIB-XVIIIB in FIG. 18A.

  Next, an irradiation step of heating and cauterizing the flat portion F is performed by irradiating the laser beam L from the lens 84 constituting the irradiation unit 82 toward the inner peripheral surface of the flat portion F of the vein VE. This irradiation step can also be referred to as a providing step for providing the flat portion F with an action (in this case, light energy) that acts to close the flat portion F. The laser light L transmitted through the optical fiber 86 is diffused in the thickness direction (Y direction) of the flat forming portion 22 by the lens 84 and emitted, thereby effectively with respect to the inner peripheral surface of the flat portion F. Laser light L can be irradiated.

  Next, a moving step of moving the pair of arms 26 in the expanded state along the living body lumen is performed. Specifically, while maintaining the expanded state of the pair of arms 26, while irradiating the laser beam L toward the flat portion F, the entire treatment device 10H is moved in the proximal direction by an amount necessary for treatment, Stop in place. When the treatment is performed in a desired range with respect to the vein VE, the irradiation of the laser light L is stopped.

  Thereafter, the pair of arms 26 are re-accommodated in the shaft 18 (accommodating step), and the treatment device 10H is extracted from the body (vein VE) (extraction step).

  According to the treatment device 10H, since the tissue of the flat portion F is denatured by irradiating the flat portion F formed in the living body lumen by the flat forming portion 22 with the laser light L, the living lumen can be suitably occluded. it can.

  As shown in the treatment device 10I shown in FIG. 19, an optical fiber 86 is disposed along a long (rod-like) support member 90 having flexibility, and an irradiation unit 82 is provided at the tip of the support member 90. It is good also as a structure to which the lens 84 was attached. In this case, the optical fiber 86 may be inserted into the support member 90 or may be fixed to the outer surface of the support member 90. The support member 90 is inserted into the shaft 18 of the catheter 12 so as to be able to advance and retreat, and a distal end portion to which the lens 84 is attached can project from the distal end opening 18 a of the shaft 18 in the distal direction.

  Next, the method of using the treatment device 10I will be described focusing on the differences from the method of using the treatment device 10H.

  After forming the flat portion F in the vein VE by expanding the pair of arms 26 at the treatment site T of the vein VE (after the flattening step), the support member 90 is protruded from the distal end opening 18a of the shaft 18, and the lens 84 A proximity step is performed in which the is brought close to the flat portion F of the vein VE.

  Thereafter, similarly to the method of using the treatment device 10H, an irradiation step (providing step) and a moving step are performed. However, in the case of the treatment device 10I, the laser light L transmitted through the optical fiber 86 is diffused and emitted in the width direction and the thickness direction of the flat forming portion 22 by the lens 84. Thereby, the laser beam L can be effectively irradiated to the inner peripheral surface of the flat portion F.

  Thereafter, the pair of arms 26 and the support member 90 are re-accommodated in the shaft 18 (accommodating step), and the treatment device 10I is extracted from the body (vein VE) (extraction step).

  FIG. 20 is a partially omitted schematic view of still another treatment device 10J. The treatment device 10J does not include a configuration corresponding to the electrode portion 16 of the treatment device 10A illustrated in FIG. 1 and the like, and includes a branch tube 92 connected to the catheter 12. One end of the branch tube 92 is connected to the hub 20 of the catheter 12, and a connector 94 is provided at the other end. The lumen of the branch tube 92 communicates with the lumen of the catheter 12. The connector 94 can be connected to a supply device 96 (for example, a syringe) filled with the curing agent M.

  The sclerosing agent M is a chemical solution having a function of forming a thrombus by causing damage to the blood vessel wall, and examples thereof include polidocanol.

  Next, taking treatment of varicose veins as an example, a treatment method (biological lumen occlusion method) using the treatment device 10J will be described.

  The treatment device 10 </ b> J in a state where the pair of arms 26 are accommodated in the shaft 18 is prepared. Next, the insertion step is performed in the same manner as when the treatment device 10A is used. Specifically, the treatment device 10J is inserted into the vein VE that has developed varicose veins through an introducer sheath punctured by the patient. Then, under the ultrasound guide, the treatment device 10J is advanced, and as shown in FIG. 21A, the distal end portion of the treatment device 10J reaches the treatment site T (target site) of the vein VE.

  Next, a flattening step for forming a flat portion F in the living body lumen is performed. Specifically, as shown in FIG. 21B, a flat portion F is formed in the vein VE by expanding the pair of arms 26.

  Next, a curing agent supply step is performed, in which the curing agent M is caused to flow from the supply device 96 connected to the connector 94 to the branch tube 92 and the catheter 12, and the curing agent M is discharged from the distal end opening 18 a through the lumen 19 of the shaft 18. carry out. This curing agent supply step can also be referred to as a providing step for providing the flat portion F with the one that acts to close the flat portion F (in this case, the curing agent M). The hardening agent M is supplied to the flat portion F of the vein VE by the hardening agent supply step. Thus, the lumen 19 and the tip opening 18a of the shaft 18 function as a curing agent supply unit that supplies the curing agent M toward the flat portion F.

  Next, a moving step of moving the pair of arms 26 in the expanded state along the living body lumen is performed. Specifically, as shown in FIG. 21C, while maintaining the expanded state of the pair of arms 26, the entire treatment device 10J is moved in the proximal direction at a constant speed by the amount necessary for treatment and stopped at a predetermined position. Let Note that the sclerosing agent M may be discharged only once before the entire treatment device 10J is moved in the proximal direction, or once more while the entire treatment device 10J is moved in the proximal direction or You may make it discharge in multiple times.

  Alternatively, the sclerosing agent M may be discharged before the entire treatment device 10J is moved in the proximal direction, and continuously discharged at a predetermined flow rate during the movement in the proximal direction. In this case, the ejection of the sclerosing agent M is also stopped with the stop of the treatment device 10J.

  The blood vessel wall of the vein VE to which the sclerosing agent M is applied is damaged by the action of the sclerosing agent M and a thrombus is formed, so that the treated vein VE is eventually blocked. When the treatment is performed in a desired range with respect to the vein VE, the pair of arms 26 are re-accommodated in the shaft 18 (accommodating step), and the treatment device 10J is extracted from the body (venous VE) (extraction step).

  According to the treatment device 10J, since the sclerosing agent M is applied after the flat portion F is formed in the living body lumen, the flat portion F of the living body lumen can be efficiently blocked. In addition, the treatment device 10J can provide the same effects as those of the treatment device 10A shown in FIG.

  Like the treatment device 10K shown in FIG. 22, the sclerosing agent M may be supplied to the flat portion F of the vein VE using a long tube 98 having flexibility. The tube 98 is inserted into the shaft 18 of the catheter 12 so as to be able to advance and retreat, and the distal end portion can protrude from the distal end opening 18 a of the shaft 18 in the distal direction.

  Next, the method of using the treatment device 10K will be described focusing on the differences from the method of using the treatment device 10J.

  After forming the flat portion F in the vein VE by expanding the pair of arms 26 at the treatment site T of the vein VE (after the flattening step), the tube 98 is protruded from the distal end opening 18a of the shaft 18, and the vein VE is A curing agent supply step (providing step) in which the curing agent M is discharged from the tip opening 98a of the tube 98 toward the flat portion F is performed. Thus, the tube 98 and the tip opening 98a thereof function as a curing agent supply unit that supplies the curing agent M toward the flat portion F.

  Further, similarly to the method of using the treatment device 10J, a moving step of moving the pair of arms 26 in the expanded state along the living body lumen is performed.

  When the treatment is performed in a desired range with respect to the vein VE, the pair of arms 26 and the tube 98 are re-accommodated in the shaft 18 (accommodating step), and the treatment device 10K is extracted from the body (venous VE) (extraction step).

  According to the treatment device 10K, as compared with the treatment device 10J shown in FIG. 20, the sclerosing agent M can be discharged from a position close to the flat portion F of the vein VE, and therefore the sclerosing agent M is supplied to the flat portion F more effectively. can do.

  FIG. 23 is a partially omitted schematic view of still another treatment device 10L. This treatment device 10L is in common with the treatment device 10J of FIG. 20 in that the curing agent M is supplied to the flat portion F formed in the vein VE. On the other hand, the treatment device 10L includes a supply tube 100 supported by the distal end portions 27 of the pair of arms 26, and a supply device 96 filled with a sclerosing agent M can be connected to the proximal end of the support 24. A connector 102 is provided.

  The supply pipe 100 is flexible and can be deformed following the degree of opening of the pair of arms 26. Therefore, as shown in FIG. 24A, in a state where the pair of arms 26 are closed in the shaft 18, the supply pipe 100 is accommodated in the shaft 18 in a bent state. On the other hand, as shown in FIG. 24B, when the pair of arms 26 protrudes from the tip opening 18a of the shaft 18 and expands in the width direction (X direction), they are pulled by the pair of arms 26 (or by their own elastic restoring force). A straight line shape is provided between the tip portions 27 of the pair of arms 26.

  The supply pipe 100 is provided with a plurality of outlets 101 for blowing out the curing agent M. Each air outlet 101 communicates with the lumen of the supply pipe 100. In the illustrated example, a plurality of outlets 101 are provided along the length direction of the supply pipe 100. The plurality of air outlets 101 are provided on both sides of the flat forming portion 22 in the thickness direction.

  Next, the method of using the treatment device 10L will be described focusing on the differences from the method of using the treatment device 10J.

  A treatment device 10 </ b> L (see FIG. 24A) in a state where the pair of arms 26 and the supply pipe 100 are accommodated in the shaft 18 is prepared. Next, similarly to the insertion step in the method of using the treatment device 10J, the distal end portion of the treatment device 10L is made to reach the treatment site T of the vein VE.

  Next, a flattening step for forming a flat portion F in the living body lumen is performed. Specifically, the pair of arms 26 are protruded from the tip opening 18a of the shaft 18 and the pair of arms 26 are expanded accordingly, thereby forming a flat portion F in the vein VE. At this time, the supply pipe 100 has a linear shape between the distal end portions 27 of the pair of arms 26 as shown in FIG. 24B and is arranged inside the flat portion F.

  Next, a curing agent supply step (providing step) in which the curing agent M is discharged toward the flat portion F of the vein VE is performed. Specifically, the curing agent M is discharged from the supply device 96 connected to the connector 94, the curing agent M is caused to flow to the supply pipe 100 through the support 24 and the arm 26, and further provided in the supply pipe 100. Curing agent M is discharged from each outlet 101. Thereby, the hardening | curing agent M is supplied to the flat part F of the vein VE. Thus, the blower outlet 101 provided in the supply pipe 100 functions as a curing agent supply unit that supplies the curing agent M toward the flat portion F.

  Next, similarly to the method of using the treatment device 10J, a moving step of moving the pair of expanded arms 26 in the proximal direction along the living body lumen is performed.

  When the treatment is performed in a desired range with respect to the vein VE, the pair of arms 26 and the supply tube 100 are re-accommodated in the shaft 18 (accommodating step), and the treatment device 10L is extracted from the body (venous VE) (extraction step). .

  According to the treatment device 10L configured as described above, the supply pipe 100 in which the air outlet 101 is formed is provided at the distal end of the arm 26, so that the flat portion F is formed from the inside of the flat portion F formed in the vein VE. Thus, the curing agent M can be blown out. Therefore, the flat portion F can be effectively closed.

  In particular, in the case of the treatment device 10L, since both ends of the supply tube 100 are connected to the distal end portions 27 of the pair of arms 26, the supply tube 100 is flattened as the pair of arms 26 is expanded in the living body lumen. It is securely arranged inside the part F. Therefore, the expansion of the pair of arms 26 and the arrangement of the supply pipe 100 inside the flat portion F can be executed by one operation.

  In addition, about the treatment device 10K (FIG. 22) and the treatment device 10L (FIG. 23) mentioned above, the example which uses the hardening | curing agent M as an obstruction | occlusion material applied in order to obstruct | occlude a biological lumen was demonstrated. Instead of this, an adhesive (emboli) may be used. In this case, in the treatment device 10K (or treatment device 10L), the adhesive is discharged from the distal end opening 98a of the tube 98 (or the air outlet 101 of the supply tube 100). The adhesive is in a liquid state before discharge and is cured after discharge to be solidified (or semi-solidified).

  The adhesive may be any of a polymerization type or a precipitation type, for example, a cyanoacrylate adhesive, a polyvinyl alcohol adhesive, a polyurethane adhesive, a gelatin adhesive, a fibrin adhesive (fibrin adhesive). Glue) and the like. Among these, the cyanoacrylate adhesive can be favorably applied because it exhibits an embolization effect immediately after being discharged from the shaft 18. Examples of the cyanoacrylate adhesive include NBCA (N-butyl-2-cyanoacrylate), Onyx (registered trademark), and the like.

  In the use of the treatment device 10K (FIG. 22) and the treatment device 10L (FIG. 23), the usage method in the case of applying an adhesive is substantially the same as each usage method of the treatment device 10K and the treatment device 10L described above. However, when the adhesive is applied, the tube is moved while the entire treatment device 10K (or the entire treatment device 10L) is moved in the proximal direction at a constant speed while maintaining the expanded state of the pair of arms 26 in the living body lumen. The adhesive may be continuously discharged at a predetermined flow rate from the 98 front end opening 98a (or the outlet 101 of the supply pipe 100).

  FIG. 25 is a partially omitted schematic view of still another treatment device 10M. 26 is a partial cross-sectional view of the distal end portion of the treatment device 10M, and FIG. 27 is a cross-sectional view of the distal end portion of the treatment device 10M.

  As shown in FIG. 25, this treatment device 10M is a modification of the treatment device 10J shown in FIG. 20, and includes a balloon 104 supported on each distal end portion 27 of a pair of arms 26. This balloon 104 is expandable, and functions as an occlusion portion that can temporarily occlude the lumen of the flat portion F formed in the living body lumen as it expands. In FIG. 25, the expanded balloon 104 is shown.

  The balloon 104 is deflated in an initial state, and is expandable as the expansion fluid is introduced. The expansion fluid supplied to the balloon 104 may be either liquid or gas. Examples of the expansion fluid include physiological saline and air. One end and the other end of the balloon 104 are connected to the tip portions 27 of the pair of arms 26, respectively. As shown in FIG. 26, the lumen 26 c of the arm 26 communicates with the lumen of the balloon 104 and the lumen 25 of the support 24.

  As shown in FIG. 25, a hub 108 (connector) to which the expansion / contraction operation device 106 can be connected is provided at the base end of the support 24. The expansion / contraction operation device 106 is a device for supplying an expansion fluid into the balloon 104 or discharging the expansion fluid from the balloon 104 via the lumen 25 of the support 24 and the lumen 26 c of the arm 26. is there.

  The expansion / contraction operation device 106 can be configured by, for example, a syringe, an indeflator, or the like. When the expansion / contraction operation device 106 is a syringe, the surgeon causes the expansion fluid to flow out of the syringe by an operation of pushing out the pusher (not shown) and releases the hand from the pusher (or pulls the pusher). Perform an operation to suck fluid.

  As the expansion fluid is introduced into the balloon 104, the balloon 104 expands as shown by the phantom line in FIG. When the expansion fluid is discharged from the inside of the balloon 104, the balloon 104 contracts as shown by a solid line in FIG.

  The balloon 104 may be made of a stretchable material. Examples of the elastic material include various rubber materials such as natural rubber, butyl rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, and silicone rubber, polyurethane, polyester, polyamide, olefin, and styrene. And various other thermoplastic elastomers or mixtures thereof. The balloon 104 may be made of a non-stretchable material.

  Next, taking treatment of varicose veins as an example, a treatment method for a living body lumen using the treatment device 10M (a living body lumen closing method according to the first aspect) will be described.

  First, an insertion step is performed in which the distal end portion of the treatment device 10M reaches the treatment site T (target site) by inserting the treatment device 10M into the living body lumen. Specifically, the treatment device 10M in a state where the flat forming portion 22 (the pair of arms 26) and the balloon 104 are housed in the shaft 18 is inserted into the vein VE via the introducer sheath. Then, under the ultrasonic guide, the distal end portion of the treatment device 10M is made to reach the treatment site T of the vein VE (see FIG. 28A). In this case, in the shaft 18, the balloon 104 is bent together with the pair of closed arms 26.

  Next, a flattening step for forming a flat portion F in the living body lumen is performed. Specifically, as shown in FIG. 28B, the pair of arms 26 is projected from the tip opening 18a of the shaft 18 and the pair of arms 26 is expanded accordingly, thereby forming a flat portion F in the vein VE. At this time, the balloon 104 has a straight line shape between the distal end portions 27 of the pair of arms 26 and is disposed inside the flat portion F. In addition, when forming the flat part F in the vein VE, you may confirm the flatness degree of the vein VE with an ultrasonic wave.

  Next, an occlusion step for temporarily occluding the lumen of the flat portion F is performed. Specifically, by supplying an expansion fluid into the balloon 104 under the action of the expansion / contraction operation device 106 connected to the hub 108, the balloon 104 is expanded at a predetermined pressure as shown in FIG. 28C. Thereby, as shown in FIG. 29, the flow path formed in the lumen of the flat portion F is temporarily blocked (blocked).

  In this case, the pressure may be controlled so that the balloon 104 expands to a thickness approximately equal to the thickness of the arm 26 (dimension in the Y direction). When the balloon 104 is made of a stretchable material, the expanded balloon 104 and the inner surface of the flat portion F are likely to be in close contact with each other, so that blood flow in the flat portion F can be effectively blocked.

  Further, when the balloon 104 is made of a sufficiently stretchable material, the expansion fluid is supplied to the balloon 104 beyond the amount corresponding to the thickness of the lumen of the flat portion F formed by the expansion of the pair of arms 26. Even when supplied, the balloon 104 expands not in the thickness direction of the flat portion F but in the extending direction of the vein VE. For this reason, the thickness of the flat part F can be maintained in the state when the pair of arms 26 is expanded, and obstruction due to the application of the curing agent M performed thereafter is not hindered.

  The occlusion by the balloon 104 is not limited to the state in which the lumen of the flat portion F is completely closed without any gap by the balloon 104 (100% occlusion), but most of the lumen of the flat portion F (for example, balloon This includes a state in which 70 to 90% or more, or 95% or more of the flow path cross-sectional area of the flat portion F when there is no blockage due to 104 is closed.

  Next, a curing agent supply step for supplying the curing agent M toward the flat portion F is performed. Specifically, the curing agent M is discharged from the supply device 96 connected to the connector 94, the curing agent M is caused to flow into the support 24, and the curing agent M is discharged from the tip opening 18 a of the shaft 18. Thereby, the hardening | curing agent M is supplied to the flat part F of the vein VE. In this case, the curing agent M may be discharged at least once, or the curing agent M may be continuously discharged at a constant flow rate.

  After the curing agent supply step or in parallel with the curing agent supply step, a moving step is performed in which the pair of arms 26 are moved in the proximal direction in the expanded state. Specifically, as shown in FIG. 28D, while maintaining the expanded state of the pair of arms 26, the entire treatment device 10M is moved at a constant speed in the proximal direction by an amount necessary for treatment and stopped at a predetermined position. Let Note that the sclerosing agent M may be discharged a plurality of times after the balloon 104 is expanded until the treatment device 10M is stopped at a predetermined position. In the case of a technique pattern in which the curing agent M is continuously discharged at a constant flow rate, the ejection of the curing agent M is also stopped when the treatment device 10M is stopped.

  When the treatment is performed in a desired range with respect to the vein VE, the balloon 104 is deflated by discharging the expansion fluid from the balloon 104 (deflation step). Thereafter, the pair of arms 26 and the balloon 104 are re-accommodated in the shaft 18 (accommodating step), and the treatment device 10M is extracted from the body (vein VE) (extraction step).

  According to the treatment device 10M configured as described above, the flow path formed by the lumen of the flat portion F is temporarily set by disposing the balloon 104 functioning as an occlusion portion in the lumen of the flat portion F. Since it can be blocked, dilution of the curing agent M is suppressed, and a suitable concentration of the curing agent M can be efficiently supplied to the flat portion F. Therefore, the blocking effect by the curing agent M can be suitably exhibited, and the amount of the curing agent M used can be reduced.

  In the case of this treatment device 10M, the lumen of the flat portion F can be suitably sealed by controlling the expansion of the balloon 104.

  FIG. 30 is a partially omitted schematic view of a treatment device 10N having still another configuration. FIG. 31 is a partial cross-sectional view of the distal end portion of the treatment device 10N, and FIG. 32 is a cross-sectional view of the proximal end portion of the treatment device 10N.

  This treatment device 10N is a modification of the treatment device 10M shown in FIG. 25, and a balloon 110 that can be expanded and contracted is provided on the outer peripheral portion of the shaft 18 separately from the balloon 104 provided at the tip of the flat forming portion 22. .

  Hereinafter, the balloon 104 provided at the tip of the flat forming portion 22 is referred to as “first balloon 104”, and the balloon 110 provided on the outer peripheral portion of the shaft 18 is referred to as “second balloon 110”. The second balloon 110 functions as a second occlusion part that can temporarily occlude between the shaft 18 and the living body lumen.

  The second balloon 110 is deflated in the initial state and is expandable as the expansion fluid is introduced. The expansion fluid supplied to the second balloon 110 may be the same type of fluid as the expansion fluid supplied to the first balloon 104, or may be a different type of fluid.

  The second balloon 110 is preferably provided at or near the tip of the shaft 18. The second balloon 110 extends annularly in the circumferential direction along the outer periphery of the shaft 18. A passage 112 for flowing an expansion fluid is formed in the shaft 18, and the lumen of the second balloon 110 and the passage 112 communicate with each other. The distal end of the passage 112 has a side hole 113 that faces the lumen of the second balloon 110.

  In FIG. 31, the passage 112 is formed in the wall surrounding the lumen 19 of the shaft 18, but instead of such a structure, the inner tube and the outer tube constitute the shaft 18, A passage 112 may be formed between the tube and the outer tube.

  In FIG. 31, the second balloon 110 in the deflated state is drawn with a solid line. As the expansion fluid is supplied into the second balloon 110 via the passage 112, the second balloon 110 expands radially outward as indicated by phantom lines in FIG.

  As shown in FIG. 32, the passage 112 extends along the axial direction of the shaft 18 and reaches the proximal end surface of the shaft 18. The hub 20 of the catheter 12 is provided with a branch portion 20b branched from the hub body 20a, and a passage 115 communicating with the passage 112 of the shaft 18 is formed. The passage 115 is formed in the hub body 20a and the branch portion 20b, and opens at the free end of the branch portion 20b. Instead of the branch portion 20b formed integrally with the hub body 20a, a flexible tube (the same tube as the branch tube 92) connected to the hub 20 may be provided.

  As shown in FIG. 30, an expansion / contraction operation device 116 for expanding / contracting the second balloon 110 can be connected to the branch portion 20b. Hereinafter, the expansion / contraction operation device 106 for expanding / contracting the first balloon 104 is referred to as a “first expansion / contraction operation device 106”, and the expansion / contraction operation device 116 is referred to as a “second expansion / contraction operation device 116”. The second expansion / contraction operation device 116 supplies an expansion fluid into the second balloon 110 through the hub 20 (the passage 115 provided in the shaft) and the shaft 18 (the passage 112 provided in the shaft 18), or the second expansion / contraction operation device 116. 2 is a device for discharging the expansion fluid from the inside of the second balloon 110. Similar to the first expansion / contraction operation device 106, the second expansion / contraction operation device 116 may be configured by, for example, a syringe, an indeflator, or the like.

  The constituent material of the second balloon 110 can be selected from the materials exemplified as the constituent material of the first balloon 104. The second balloon 110 may be made of a stretchable material or may be made of a non-stretchable material.

  Next, taking a treatment for varicose veins as an example, a treatment method for a biological lumen using the treatment device 10N (a biological lumen occlusion method according to the second aspect) will be described.

  First, an insertion step is performed in which the distal end portion of the treatment device 10N reaches the treatment site T by inserting the treatment device 10N into the living body lumen. Specifically, the treatment device 10N in a state where the flat forming portion 22 (a pair of arms 26) and the balloon 104 are accommodated in the shaft 18 and the first balloon 104 and the second balloon 110 are contracted is introduced into the introducer sheath. And inserted into the vein VE.

  Then, under the ultrasonic guide, the distal end portion of the treatment device 10N reaches the target site of the vein VE (see FIG. 33A). In this case, in the shaft 18, the first balloon 104 is bent together with the pair of closed arms 26. Further, both the first balloon 104 and the second balloon 110 are in a deflated state.

  Next, a flattening step for forming a flat portion F in the living body lumen is performed. Specifically, as shown in FIG. 33B, the pair of arms 26 are projected from the tip opening 18a of the shaft 18 and the pair of arms 26 are expanded accordingly, thereby forming a flat portion F in the vein VE. At this time, the first balloon 104 is linear between the ends of the pair of arms 26 and is disposed inside the flat portion F. In addition, when forming the flat part F in the vein VE, you may confirm the flatness degree of the vein VE with an ultrasonic wave.

  Next, a shaft side blocking step for temporarily blocking between the shaft 18 and the living body lumen is performed. Specifically, by supplying the expansion fluid into the second balloon 110 under the action of the second expansion / contraction operation device 116, the second balloon 110 is expanded at a predetermined pressure as shown in FIG. 33C. Let As a result, the blood flow in the vein VE is temporarily blocked.

  Next, an arm side closing step for temporarily closing the lumen of the flat portion F is performed. Specifically, by supplying the expansion fluid into the first balloon 104 under the action of the first expansion / contraction operation device 106, the first balloon 104 is expanded at a predetermined pressure as shown in FIG. 34A. Let As a result, the flow path formed by the lumen of the flat portion F is temporarily blocked (see also FIG. 29 regarding the treatment device 10M).

  When the first balloon 104 is expanded after the second balloon 110 is expanded as described above, the blood flow in the vein VE is blocked by the second balloon 110 prior to the obstruction of the flat portion F. Is done. For this reason, it is easy to maintain the flat part F in a flat state by reducing the blood pressure acting on the flat part F. In contrast to the above, the second balloon 110 may be expanded after the first balloon 104 is expanded.

  Next, a supply step of supplying the curing agent M to a region between the first blocking part (first balloon 104) and the second blocking part (second balloon 110) is performed. Specifically, as shown in FIG. 34B, the curing agent M is discharged from the supply device 96 (see FIG. 30) connected to the connector 94 while maintaining the expanded state of the first balloon 104 and the second balloon 110. Then, the curing agent M is caused to flow through the lumen 25 of the support 24, the lumen 26 c of the arm 26, and the lumen of the supply pipe 100, and the curing agent M is discharged from the outlet 101 provided in the supply pipe 100. Thereby, the hardening | curing agent M is supplied to the flat part F of the vein VE. In this case, the curing agent M may be discharged at least once, or the curing agent M may be continuously discharged at a constant flow rate.

  Next, a moving step of moving the pair of arms 26 in the expanded state, the first closed portion in the expanded state, the second closed portion in the expanded state, and the shaft 18 in the proximal direction is performed. Specifically, as shown in FIG. 34C, while maintaining the expanded state of the pair of arms 26, the first balloon 104, and the second balloon 110, the entire treatment device 10 </ b> N is proximal to the extent necessary for treatment. It moves at a constant speed in the direction and stops at a predetermined position.

  Note that the sclerosing agent M may be discharged a plurality of times after the first balloon 104 is expanded until the treatment device 10N is stopped at a predetermined position. In the case of a technique pattern in which the sclerosing agent M is continuously discharged at a constant flow rate, the discharge of the sclerosing agent M is also stopped as the movement of the treatment device 10N is stopped.

  When the treatment is performed within a desired range for the vein VE, the first balloon 104 and the second balloon 110 are deflated by discharging the expansion fluid from the first balloon 104 and the second balloon 110, respectively. (Shrink step) In this case, the first balloon 104 may be deflated before or after the second balloon 110 is deflated, or the first balloon 104 and the second balloon 110 are deflated at the same time. Also good.

  After the deflation of the first balloon 104 and the second balloon 110, the pair of arms 26 and the first balloon 104 are re-accommodated in the shaft 18 (accommodating step), and the treatment device 10N is pulled out from the body (vein VE) ( Extraction step).

  According to the treatment device 10N configured as described above, the supplied sclerosing agent M is placed between the first occlusion portion (first balloon 104) and the second occlusion portion (second balloon 110). Since it is contained, a suitable concentration of the curing agent M can be supplied to the flat portion F more efficiently. In addition, the effect similar to the treatment device 10M shown in FIG.

  In the treatment device 10N and the treatment device 10M described above, as the occlusion portion (first occlusion portion), instead of the balloon 104 (first balloon 104), the lumen of the flat portion F can be temporarily occluded. The configuration may be adopted.

  Therefore, as another configuration of the blocking portion (first blocking portion), for example, a film-like member that expands (expands) like a sail by receiving blood flow when placed inside the flat portion F is employed. May be. In this case, both ends of the film-like member are fixed (connected) to the tip portions 27 of the pair of arms 26.

  In a state where the pair of arms 26 are closed and accommodated in the shaft 18, the membrane member is folded and accommodated in the shaft 18. As the pair of arms 26 protrudes from the tip openings 18 a of the shaft 18 and expands in the width direction, the membrane member is pulled by the tips of the pair of arms 26, and the tips 27 of the pair of arms 26. Deployed to extend between. When the entire treatment device 10N (or the entire treatment device 10N) is moved in the proximal direction in the living body lumen, the membranous member expands by receiving blood flow, and thereby the flat portion F is temporarily blocked. It will be in a state to be.

  Or the flexible sponge-like member which can be elastically deformed may be employ | adopted as another structure of the obstruction | occlusion part (1st obstruction | occlusion part). In this case, the sponge-like member is fixed (connected) between the tip portions 27 of the pair of arms 26.

  In a state where the pair of arms 26 are closed and accommodated in the shaft 18, the sponge-like member is folded (or compressed) and accommodated in the shaft 18. As the pair of arms 26 protrudes from the tip opening 18a of the shaft 18 and expands in the width direction, the sponge-like member is pulled by the tip portions 27 of the pair of arms 26 (or by its own elastic restoring force). ), And are deployed so as to extend between the tips of the pair of arms 26. Thereby, the flat portion F is temporarily closed by the sponge-like member.

  The membrane member or sponge member provided on the pair of arms 26 is blocked only when the lumen of the flat portion F is completely closed without gaps by the membrane member or sponge member (100% closure). Not limited to this, most of the lumen of the flat portion F (for example, 70 to 90% or more, or 95% or more of the flow path cross-sectional area of the flat portion F when there is no blockage by a membrane member or sponge-like member) Includes closed state.

  In the treatment device 10N described above, instead of the second balloon 110, another configuration that can temporarily close the shaft 18 and the living body lumen may be adopted as the second occlusion portion.

  Therefore, for example, a film-like member that expands (expands) like a sail by receiving a blood flow around the shaft 18 may be employed as another configuration of the second blocking portion. In this case, the film-like member is fixed (connected) to the outer peripheral portion of the shaft 18 and extends around the shaft 18 in an annular shape in the circumferential direction. When the entire treatment device 10M (or the entire treatment device 10N) is moved in the proximal direction in the living body lumen, the membranous member receives blood flow and spreads around the shaft 18, whereby the shaft 18 and the living body tube are spread. The space between the cavities is temporarily blocked.

  If a sheath that covers the periphery of the shaft 18 and is slidable in the axial direction with respect to the shaft 18 is provided, the expansion of the membrane member can be controlled at an arbitrary timing. That is, when the membrane member is covered with the sheath, the membrane member can be held in a contracted state (folded state), and when the membrane member is released from the sheath, the membrane member can be expanded. Can do.

  Alternatively, as another configuration of the second closing portion, a flexible sponge-like member that can be elastically deformed may be employed. In this case, the sponge-like member is fixed (connected) to the outer peripheral portion of the shaft 18 and extends around the shaft 18 in an annular shape in the circumferential direction. In the living body lumen, the state between the shaft 18 and the living body lumen is temporarily blocked by the sponge-like member.

  If a sheath that covers the periphery of the shaft 18 and is slidable in the axial direction with respect to the shaft 18 is provided, expansion of the sponge-like member can be controlled at an arbitrary timing. That is, when the membrane-like member is covered with the sheath, the sponge-like member can be held in a contracted state, and when the membrane-like member is released from the sheath, the sponge-like member can be expanded.

  Occlusion by a membrane-like member or sponge-like member provided on the outer peripheral portion of the shaft 18 is a state in which the shaft 18 and the living body lumen are completely closed without any gap by the membrane-like member or sponge-like member (100% occlusion). ), And most of the gap between the shaft 18 and the living body lumen (for example, 70 to 90% or more of the channel cross-sectional area of the gap when there is no blockage by a membrane member or a sponge-like member, or 95 % Or more) is closed.

  In the treatment device 10M or the treatment device 10N, the distal end of the tube 98 is replaced with a configuration in which the curing agent M is supplied from the distal opening 18a toward the flat portion F through the lumen 19 of the shaft 18 as in FIG. The structure which supplies the hardening | curing agent M toward the flat part F from the opening 98a may be employ | adopted.

  FIG. 35 is a partially omitted schematic view of a treatment device 10P having still another configuration. In FIG. 35, the pair of arms 26 are accommodated in the shaft 18. 36A is a view of the treatment device 10P (locked state) as viewed from the distal end opening 18a side, and FIG. 36B is a view of the treatment device 10P (unlocked state) as viewed from the distal end opening 18a side.

  The therapeutic device 10P is configured based on the configuration of the therapeutic device 10A illustrated in FIG. 1 and the like, but may be configured based on other therapeutic devices 10B to 10N.

  The treatment device 10P includes a stopper 118 that holds the pair of arms 26 in the shaft 18 to a target site. The stopper 118 is provided at or near the tip of the shaft 18 and allows the pair of arms 26 to protrude from the shaft 18 according to the relative position in the circumferential direction between the shaft 18 and the pair of arms 26. Thus, the pair of arms 26 is prevented from protruding from the shaft 18.

  As shown in FIG. 35, the stopper 118 includes, for example, a locking piece 120 that protrudes inward from the inner peripheral surface of the shaft 18 at locations opposite to each other in the circumferential direction. As shown in FIGS. 35 and 36A, in a state where the relative positions of the arms 26 and the locking pieces 120 are overlapped in the circumferential direction, the forward movement of the arms 26 in the shaft 18 Blocked by strip 120. Therefore, the pair of arms 26 can be suitably prevented from protruding from the distal end opening 18a of the shaft 18 until the distal end portion of the treatment device 10 is delivered to the target site in the living body.

  When the distal end portion of the treatment device 10P is delivered to the target site in the living body, the internal device 14 is rotated by 90 ° relative to the catheter 12 in the circumferential direction. Then, as shown in FIG. 36B, the arms 26 and the locking pieces 120 do not overlap in the circumferential direction. That is, each arm 26 moves to a position shifted in the circumferential direction with respect to each locking piece 120. Therefore, when the internal device 14 is advanced with respect to the catheter 12, the pair of arms 26 passes between the locking pieces 120 constituting the stopper 118 and protrudes from the distal end opening 18 a of the shaft 18.

  Further, in the treatment device 10P, a distal end portion of each arm 26 is provided with a marker 122 (for example, an X-ray contrast marker or an ultrasonic marker) that can be fluoroscopically contrasted. When the pair of arms 26 protrudes from the distal end opening 18a of the shaft 18 and expands in the width direction within the living body lumen (blood vessel), the distance between the markers 122 provided at the distal ends of the pair of arms 26 increases. Thereby, it can be easily confirmed under fluoroscopic imaging that the pair of arms 26 has expanded in the width direction, and the flattening start position of the blood vessel can be known.

  In the treatment device 10P, a scale portion 124 indicating the length of the treated portion is provided in a certain axial range of the proximal end portion of the shaft 18. At least a part of the scale part 124 exists in the living body in a state where the distal end portion of the treatment device 10P has reached the target position (the position of the lesioned part) in the living body. The scale part 124 has a plurality of marks 126 (scale marks) arranged at intervals in the axial direction. The intervals between the plurality of marks 126 are equal, for example, 1 to 10 cm.

  In the use of the treatment device 10P, when the catheter 12 and the internal device 14 are moved together in the proximal direction in a state where the pair of arms 26 are expanded in the width direction in the blood vessel, the scale portion according to the amount of movement. 124 marks 126 appear outside the living body. The length of a lesion that requires treatment is known in advance from a fluoroscopic image (such as an ultrasound image). Therefore, the user can operate the treatment device 10P in the proximal direction while looking at the scale portion 124 so as to move the pair of arms 26 in the proximal direction by the length of the lesion. In addition, since the length of a lesioned part is about 5-50 cm, for example, the distance between the mark 126 on the most distal side and the mark 126 on the most proximal side is set, for example, at about 5-50 cm.

  Further, in the treatment device 10P, a position display unit 128 having a plurality of marks 129 arranged at intervals in the axial direction is provided in a certain axial range of the base end side portion of the support 24. The position display unit 128 indicates the degree of protrusion of the pair of arms 26 from the shaft 18. The position display unit 128 is configured so that the pair of arms 26 are sufficiently disengaged from the distal end opening 18a of the shaft 18 in a state where the axial position of the most proximal mark 126 coincides with the proximal end surface of the catheter 12 (the proximal end surface of the hub 20) Projects and expands in the width direction. Therefore, the position adjustment of the pair of arms 26 (projection length of the pair of arms 26 from the tip opening 18a of the shaft 18) can be easily performed.

  Like the treatment device 10Q shown in FIG. 37, a structure (reinforcing structure 130) for reinforcing expansion of the pair of arms 26 may be provided. The reinforcing structure 130 includes a pulling member 132 that pulls the distal ends of the pair of arms 26 in the proximal direction, a locking claw 134 provided on the pulling member 132, and a restraining member 136 that is slidably provided on each arm 26. And have.

  The pulling member 132 is a linear member having flexibility, and may be constituted by a wire, for example. The distal end portion 132 a of the pulling member 132 is fixed to the distal end portion of each arm 26. The pulling member 132 is disposed along each arm 26 halfway and extends to the base end portion of the support 24.

  As shown in FIG. 37, for example, the pulling member 132 enters each arm 26 in the vicinity of the base end portion of each arm 26, and extends in the support body 24 to the base end portion of the support body 24. The base end portion of the pulling member 132 is pulled out to the outside at the base end portion of the support body 24 or is connected to an operation portion provided separately at the base end portion of the support body 24, thereby The pulling member 132 can be pulled in the proximal direction by an operation on the proximal side.

  The locking claw 134 can pass through the restraining member 136 with the movement of the pulling member 132 in the proximal direction. It has a function to prevent reversion to As shown in FIG. 37, a plurality of locking claws 134 may be provided along the traction member 132 at intervals in each traction member 132. By providing a plurality of locking claws 134 in this way, the expansion of the pair of arms 26 can be reinforced according to the thickness of the blood vessel to be treated.

  The restraining member 136 is made of an elastically deformable material. 38A is a side view of the restraining member 136 and its peripheral portion, and FIG. 38B is a cross-sectional view taken along the line XXXVIIIB-XXXVIIIB in FIG. 38A.

  As shown in FIGS. 38A and 38B, the restraining member 136 is attached to a groove-shaped guide rail 138 provided on the outer surface of the base end side of each arm 26. The restraining member 136 includes, for example, a head portion 146, a shaft portion 148 that is thinner than the head portion 146, and an engagement flange portion 150 that is thicker than the shaft portion 148. A portion 150 is formed.

  In the initial state, the head 146 is positioned outside the arm 26, and the shaft portion 148 and the engagement flange 150 are disposed in the guide rail 138. The pulling member 132 is inserted into an insertion portion 136 a formed to penetrate the restraining member 136 and is inserted into a lumen formed in the arm 26. The insertion part 136a is formed in a slit shape or a hole shape, for example.

  The guide rail 138 provided on the arm 26 extends in the extending direction of the arm 26. The guide rail 138 includes a passage 140 that allows the movement of the restraining member 136 along the extending direction of the arm 26, a restriction guide 142 that is provided on both sides of the passage 140 and prevents the restraining member 136 from coming out of the passage 140, A release port 144 is provided on the distal end side of the regulation guide 142 and allows the restraining member 136 to come out of the passage 140.

  The opening width (diameter) between the restricting guides 142 is smaller than the width (diameter) of the engagement flange 150 of the restraining member 136. Thereby, the restraining member 136 is prevented from coming out of the passage 140.

  Further, on the proximal end side with respect to the regulation guide 142, a concave engaging portion 143 is provided in which the shaft portion 148 of the restraining member 136 is detachably engaged in the initial state. The opening width between the restricting guides 142 is smaller than the width (diameter) of the shaft portion 148 of the restraining member 136. As a result, the restraining member 136 is held by the engaging portion 143 unless a predetermined force or more on the release port 144 side (front end side) is applied to the restraining member 136.

  The release port 144 (the diameter thereof) is larger than the engagement flange 150 (the diameter thereof) of the restraining member 136. Thus, when the restraining member 136 reaches the position of the release port 144, the restraining member 136 can come out of the passage 140 (guide rail 138).

  Next, the operation of the reinforcing structure 130 configured as described above will be described. As shown in FIG. 37, the treatment device 10Q is inserted into the blood vessel of the patient with the pair of arms 26 housed in the shaft 18 (the pair of arms 26 contracted). And if the front-end | tip part of the treatment device 10Q reaches | attains the target position (treatment site | part) in the blood vessel, a pair of arms 26 will be expanded from the shaft 18 by expanding a pair of arms 26 in the width direction.

  At this time, the arm 26 may not be sufficiently expanded only by the expansion force of the arm 26 due to the reaction force from the blood vessel wall. Therefore, when the traction member 132 is pulled in the proximal direction by an operation on the proximal end side (hand side) of the treatment device 10Q, the traction member is interposed between the distal end portion of the arm 26 and the restraining member 136 as shown in FIG. The pulling member 132 having the tension 132 and the distal end portion 132a fixed to the arm 26 generates a force (expansion assisting force) in a direction in which the arm 26 is expanded. At this time, with the movement of the traction member 132, the locking claw 134 provided on the traction member 132 passes through the restriction member 136 and is caught by the restriction member 136 inside the arm 26. For this reason, even if a user cancels | releases the operating force with respect to the traction member 132, the expansion assistance force with respect to the arm 26 by the traction member 132 is maintained.

  After the treatment of the lesioned part, the shaft 18 is moved relative to the pair of arms 26 in the distal direction in order to re-accommodate the pair of arms 26 in the shaft 18. At this time, the distal end of the shaft 18 comes into contact with the restraining member 136, and the restraining member 136 is pushed toward the distal end side of the arm 26 by the distal end of the shaft 18. When a predetermined force or more in the distal direction is applied, the restraining member 136 is separated from the engaging portion 143, proceeds along the passage 140, and eventually reaches the release port 144.

  Then, the restraining member 136 is disengaged from the guide rail 138 when the engagement flange 150 smaller than the release port 144 passes through the release port 144. As a result, the pulling member 132 is loosened, and as a result, the extension assisting force on the arm 26 by the pulling member 132 is released. Therefore, re-housing of the pair of arms 26 into the shaft 18 can be performed without any trouble.

  The treatment device 10Q shown in FIG. 37 is the same as the treatment device 10A shown in FIG. 1 and the like except for the reinforcement structure 130. Similarly, the other treatment devices 10B to 10N and 10P have the reinforcement structure. 130 may be provided.

  As in the treatment device 10R shown in FIG. 40, each arm 26 is provided with the arm 26 so that expansion of the pair of arms 26 in the body lumen is not insufficient due to a reaction force from the wall of the body lumen (vein VE or the like). A reinforcing part 152 may be added. As shown in FIG. 40, the reinforcing portion 152 may be configured in a cover shape surrounding a part of each arm 26 in the longitudinal direction, for example. The reinforcing portion 152 may be made of the same material as the arm 26, or may be made of a material harder than the arm 26. The reinforcing portion 152 may be fixed to a part in the circumferential direction of each arm 26, for example, outside or inside each arm 26.

  By providing each arm 26 with the reinforcing body configured as described above, the expansion force of the pair of arms 26 is enhanced. Therefore, when the pair of arms 26 protrudes from the distal end opening 18a of the shaft 18 in the living body lumen, the pair of arms 26 are sufficiently expanded in the width direction without losing the reaction force from the wall of the living body lumen. The flat portion F can be effectively formed in the living body lumen.

  The therapeutic device 10R shown in FIG. 40 has the same configuration as the therapeutic device 10A shown in FIG. 1 and the like except for the reinforcing portion 152, but each arm similarly applies to the other therapeutic devices 10B to 10N and 10P. 26 may be provided with a reinforcing portion 152.

  As shown in FIG. 41A and FIG. 41B, the pair of arms 26 is configured so that the concave and convex shapes 154 provided on the inner side of each arm 26 mesh with each other along the longitudinal direction of the arm 26 while being accommodated in the shaft 18. There may be. 41B is a view of the pair of arms 26 in FIG. 41A as viewed from the tip opening 18a side of the shaft 18. In this way, in the configuration in which the concavo-convex shapes 154 mesh with each other, the width W during contraction (storage) can be reduced. If the width W when the pair of arms 26 is contracted is small (thin), the outer diameter of the shaft 18 can be reduced accordingly. Accordingly, the size of the hole opened in the patient for inserting the catheter 12 can be reduced and the invasiveness can be further reduced, so that the burden on the patient can be reduced.

  As shown in FIG. 42A and FIG. 42B, the contour shape of each inner side surface (side surfaces facing each other) in the cross section of the pair of arms 26 is a straight line extending in the thickness direction of the arm 26, and each outer side surface. The contour shape of each arm 26 is an arc shape, and the dimension L1 of each arm 26 along the thickness direction of the pair of arms 26 is larger than the dimension L2 of each arm 26 along the width direction of the pair of arms 26. Also good. In FIG. 42B, the width W when the pair of arms 26 is contracted (stored) is reduced in the shape indicated by the solid line compared to the arm 26 whose cross section indicated by the phantom line is circular. Therefore, the diameter of the shaft 18 can be reduced, and the burden on the patient can be reduced.

  In addition, in the case of the pair of arms 26 having the shape shown by the solid line, the cross section shown by the phantom line is more advantageous than the arm 26 having the circular cross section shown by the following points. That is, since the contact area between the arm 26 and the blood vessel can be increased, it is difficult to form a hole in the blood vessel, the blood vessel is difficult to be damaged, and the arm 26 is difficult to enter the side branch. Moreover, since the cross-sectional area of the arm 26 can be gained, the strength of the arm 26 can be improved.

  In addition, each treatment device 10A-10N, 10P-10R mentioned above can be comprised as a device for various treatments which need obstruction | occlusion of a biological lumen besides the treatment of a varicose vein. Therefore, it can be applied to the treatment of various body lumens such as arteries, lymphatic vessels, bile ducts, trachea, esophagus, urethra, and nasal cavity.

  In the above description, the present invention has been described with reference to preferred embodiments. However, the present invention is not limited to the above-described embodiments, and various modifications can be made without departing from the scope of the present invention. Yes.

10A to 10N, 10P to 10R ... treatment devices 16, 36, 38a, 38b, 40, 46, 56, 60, 68, 70, 80 ... electrode 18 ... shaft 22 ... flat forming part 24 ... support 26 ... arm 42 , 48, 58, 62 ... element member 104 ... balloon (first balloon)
110 ... second balloon M ... curing agent

Claims (7)

A therapeutic device for occluding a biological lumen,
An elongated body insertable into the living body lumen;
A flat forming portion that is supported by the elongate body and is expandable in the width direction, and forms a flat portion in the living body lumen as it expands in the living body lumen;
A curing agent supply unit that supplies a curing agent toward the flat portion of the biological lumen;
Supported by the flat forming portion, is expandable, and includes a closing portion capable of temporarily closing the lumen of the flat portion as it expands.
A treatment device characterized by that. The treatment device according to claim 1.
The flat forming portion is expandable in the width direction on the distal end side than the elongated body, and forms a flat portion in the biological lumen at the distal end portion with expansion in the biological lumen,
The blocking part is supported at the tip of the flat forming part,
A treatment device characterized by that. The treatment device according to claim 2, wherein
The elongate body is a hollow shaft through which the flat forming portion is inserted so as to be displaceable in the longitudinal direction,
The flat forming portion has a pair of arms that can be extended and retracted from the tip opening of the shaft and can be expanded in the width direction,
The distance between the outer ends of the pair of arms is maximized at the distal ends of the pair of arms in the expanded state,
The closing portion is disposed between the tip portions of the pair of arms.
A treatment device characterized by that. The treatment device according to claim 3.
Each of the pair of arms is configured to be elastically deformable,
The pair of arms expands in the width direction by an elastic restoring force as it protrudes from the tip opening of the shaft,
The occlusion portion is disposed inside the flat portion of the living body lumen as the pair of arms are expanded.
A treatment device characterized by that. The treatment device according to any one of claims 1 to 4,
A second occlusion that can temporarily occlude between the elongate body and the living body lumen as it expands on the outer periphery of the elongate body separately from the occlusion part as the first occlusion part. Part is provided,
The curing agent supply unit supplies the curing agent to a region between the first closing part and the second closing part;
A treatment device characterized by that. The treatment device according to any one of claims 1 to 5,
The occlusion is a balloon that can be expanded and contracted,
A treatment device characterized by that. The treatment device according to claim 5, wherein
The second occlusion is a balloon that can be expanded and contracted.
A treatment device characterized by that.

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