JP2013154052A - Device assembly for aneurysm treatment and aneurysm treatment method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To enable effective suppression of an increase in internal pressure of an aneurysm, and to reduce the influence on surrounding tissue.SOLUTION: A device assembly 10 for aneurysm treatment includes a puncture device 12 which comprises a storage lumen 14 and a puncture part 16, and an indwelling device 18 which comprises a shaft 20 housed in the puncture device 12 and an indwelling member 21. The indwelling member 21 comprises a first clip 22 which is locked to a first downstream-side blood vessel 104, a second clip 26 which is locked to a second downstream-side blood vessel 106, and an intermediate part 24a which connects the first and second clips 22 and 26 to each other. Thus, the indwelling member 21 brings the first and second downstream-side blood vessels 104 and 106 closer to each other, and contracts the aneurysm 102 by sandwiching it therebetween.

Description

  The present invention relates to an aneurysm treatment device assembly and an aneurysm treatment method for treating an aneurysm generated in a living organ.

  A portion where a part of a blood vessel is swollen and weakened is called an aneurysm, and particularly, a portion occurring in a cerebral artery is called a cerebral aneurysm. Subarachnoid hemorrhage occurs when a cerebral aneurysm ruptures. There are several methods for treating such rupture. One is a “neck clip technique” in which a neurosurgical craniotomy is performed, and a clip is attached between the cerebral aneurysm and the parent artery (the root portion of the aneurysm) with a clip. In another treatment method, treatment is performed without craniotomy. A catheter is inserted into the cerebral aneurysm through the blood vessel, and a flexible coil made of a metal such as platinum is implanted into the cerebral aneurysm through the catheter. This is a method called “embolization”.

  In recent years, as disclosed in Patent Document 1, a treatment method for performing a neck clip technique with a catheter has also been proposed. The aneurysm treatment device (instrument) disclosed in Patent Document 1 is configured to deliver two wires formed in advance in a predetermined shape by a catheter. And by arranging two wires on the outside of the neck of the aneurysm, the neck of the aneurysm is closed by the two wires.

JP 2008-532575 A

  The present invention has been made in connection with a method for treating an aneurysm via a blood vessel (by an intravascular interventional procedure), and can effectively suppress an increase in the intraluminal pressure and An object of the present invention is to provide an aneurysm treatment device assembly and an aneurysm treatment method capable of reducing an influence on a tissue.

  In order to achieve the above object, the present invention provides a puncture device having a lumen extending in the axial direction, a puncture device provided at the distal end portion and capable of penetrating a living body lumen, and capable of moving forward and backward within the puncture device. An indwelling device having a long shaft to be accommodated and an indwelling part that can be detached from the shaft, and the indwelling part is provided on a distal end side of the shaft and is locked to the biological lumen. A clip, a second clip that is provided between the first clip and the shaft and is locked to a biological lumen different from the biological lumen in which the first clip is locked; the first clip; An intermediate portion that is interposed between the second clips and connects the first clip and the second clip in a state where the indwelling portion is detached from the shaft.

  According to the above, the first clip provided in the indwelling device is locked to one biological lumen of the two adjacent biological lumens, and the other biological tube of the two adjacent biological lumens is engaged. It is possible to perform a procedure of placing the indwelling portion, which is locked in the cavity and the first clip and the second clip are connected by the intermediate portion, in the living body lumen. Accordingly, the aneurysm formed between the two adjacent living body lumens can be sandwiched between the one living body lumen locked by the first clip and the other living body lumen locked by the second clip. It becomes possible. By compressing the aneurysm through the living body lumen, the aneurysm is reduced or occluded, so it is possible to effectively suppress an increase in the internal pressure of the aneurysm and reduce the effect on the surrounding tissue by reducing the internal volume of the aneurysm can do.

  In this case, the first clip is inserted into the hole formed in the living body lumen by being punctured by the puncture part, and the first clip is connected to the engagement part and is engaged with the hole by a predetermined operation. A wall of the living body lumen between the locking portion and the deformed portion in the deformed state, and a deformable portion that is deformed so as to be surface contactable with the periphery, and a holding portion that holds the deformed state of the deformable portion It is preferable to be configured to be locked to the living body lumen by sandwiching the portion.

  In this way, by sandwiching the wall of the living body lumen between the locking part of the first clip and the deformed deformed part, the hole formed in the living body lumen becomes the locked part and the deformed deformed part. Thus, the first clip can be easily locked to the living body lumen while being blocked (hemostatic).

  Moreover, the said deformation | transformation part is good to be deform | transformed so that a surface contact may be carried out by pressing in the direction which adjoins the said latching | locking part.

  As described above, the deformed portion is deformed so as to be in surface contact by being pressed in the direction approaching the locking portion, and for example, the deformed portion can be easily pressed even in an intravascular interventional procedure. And can be in a deformed state.

  Here, a hollow portion extending in the axial direction is formed inside the shaft, and the intermediate portion is included in a wire member that can be inserted through the hollow portion, and the wire member includes the hollow portion. It is preferable that the part can be sent out from the opening part of the shaft with which the part communicates.

  Thus, since the wire member can be sent out from the opening of the shaft, the length of the intermediate portion interposed between the first clip and the second clip can be adjusted, and two biological tubes The aneurysm sandwiched between the cavities can be sandwiched with an appropriate force.

  In this case, it is preferable that the second clip is configured to be mounted and fixed at a desired position of the wire member delivered from the opening.

  Thus, the length of the intermediate portion between the first clip and the second clip can be easily adjusted by mounting and fixing the second clip at a desired position of the wire member.

  In addition, the second clip has a notch part through which the wire member can be inserted, and is configured to be elastically deformable in a direction in which the notch part is closed, and the shaft has the notch part opened. It is preferable that a fixing member for maintaining the direction and an operating means for moving the fixing member from the notch are provided.

  As described above, the second clip can be elastically deformed in the direction of closing the notch portion, whereby the wire member can be firmly sandwiched by the elastic force (blocking force). Moreover, the notch can be easily closed by removing the fixing member inserted into the notch from the notch.

  Furthermore, it is preferable that the shaft or the wire member is provided with a separation mechanism that separates the intermediate portion from the wire member and separates the indwelling portion.

  Thus, by providing the separation mechanism for separating the intermediate portion from the wire member, the indwelling portion including the first and second clips and the intermediate portion can be easily placed in the living body lumen.

  Further, the second clip has a diameter-expandable portion that can be expanded, and the diameter-expanded portion is placed along the wall portion of the living body lumen in a diameter-expanded state, thereby being punctured by the puncture portion. Thus, it is preferable to be caught around the hole formed in the living body lumen and locked to the living body lumen.

  In this way, the diameter-enlarged portion of the second clip is expanded and hooked around the hole of the biological lumen, so that the second clip can be more firmly locked to the biological lumen.

  In order to achieve the above object, the present invention provides a puncture device having a lumen extending in the axial direction, a puncture device provided at a distal end portion and penetrating a living body lumen, and advancing and retracting into the puncture device. An indwelling device comprising an elongate shaft that is freely accommodated and an indwelling device that can be detached from the shaft, and an aneurysm treatment device assembly disposed in one of the adjacent two living body lumens A delivery step to deliver, and after the delivery step, the puncture device is punctured from the inside of the one biological lumen to the outside, and moved outside the two adjacent biological lumens, and the other biological tube A puncturing step for puncturing from the outside to the inside of the cavity, and after the puncturing step, a first clip that constitutes a part of the indwelling portion and is provided on the distal end side of the shaft is locked to the other biological lumen First locking screw And after the first locking step, the indwelling device is operated to bring the one living body lumen and the other living body lumen close to each other between the two adjacent living body lumens. A pinching step for narrowing the aneurysm formed in the step, and after the pinching step, a second clip that constitutes a part of the indwelling portion and is connected to the first clip via an intermediate portion, A second locking step for locking to one living body lumen, and a detaching step for detaching the indwelling portion from the shaft after the second locking step.

  According to the above, the first locking step for locking the first clip to the other biological lumen of the two adjacent biological lumens, and the second clip connected to the first clip via the intermediate portion And a second locking step for locking the first clip to one living body lumen, so that the first clip locks the aneurysm formed between the two adjacent living body lumens. And it becomes possible to pinch | interpose with one biological lumen which a 2nd clip latches. By compressing the aneurysm through the body lumen, the opening of the aneurysm is reduced or occluded, so that an increase in the internal pressure of the aneurysm can be effectively suppressed, and a decrease in the internal volume of the aneurysm reduces the surrounding tissue. The influence can be reduced.

  According to the present invention, it is possible to effectively suppress an increase in the pressure inside the aneurysm and reduce the influence on the surrounding tissue.

It is a schematic side view which shows the whole structure of the aneurysm treatment device assembly which concerns on this Embodiment. 2A is a perspective view showing the first clip of FIG. 1, FIG. 2B is a side view showing the first clip of FIG. 1, and FIG. 2C is a plan view showing the first clip of FIG. 3A is a first cross-sectional view illustrating a specific operation of the first clip of FIG. 2A, and FIG. 3B is a second cross-sectional view illustrating a specific operation of the first clip of FIG. 2A. 3C is a third cross-sectional view illustrating a specific operation of the first clip of FIG. 2A, and FIG. 3D is a fourth cross-section illustrating a specific operation of the first clip of FIG. 2A. FIG. 4A is a perspective view of the first clip according to the first configuration example, FIG. 4B is a side view of the first clip according to the second configuration example, and FIG. 4C is a first view according to the third configuration example. FIG. 4D is a perspective view of the first clip according to the fourth configuration example. 5A is a main part perspective view showing the second clip of FIG. 1 and the tip end portion of the shaft, and FIG. 5B is a main part perspective view showing a state where the second clip of FIG. 5A is attached to the wire member. . 6A is a first side cross-sectional view for explaining the operation of the second clip, the operation mechanism, and the release mechanism of FIG. 1, and FIG. 6B is a second side cross-sectional view showing the operation following FIG. 6A. FIG. 6C is a third side sectional view showing the operation following FIG. 6B, and FIG. 6D is a fourth side sectional view showing the operation following FIG. 6C. FIG. 7A is a configuration diagram of the detachment mechanism according to the first configuration example, FIG. 7B is a configuration diagram of the detachment mechanism according to the second configuration example, and FIG. 7C is a configuration of the detachment mechanism according to the third configuration example. FIG. 7D is a configuration diagram of the detachment mechanism according to the fourth configuration example, and FIG. 7E is a configuration diagram of the detachment mechanism according to the fifth configuration example. FIG. 8A is a first view for explaining how to use the aneurysm treatment device assembly, and FIG. 8B is a second view for explaining how to use the aneurysm treatment device assembly. FIG. 9A is a third diagram for explaining how to use the aneurysm treatment device assembly, and FIG. 9B is a fourth diagram for explaining how to use the aneurysm treatment device assembly. FIG. 10A is a fifth diagram for explaining how to use the aneurysm treatment device assembly, and FIG. 10B is a sixth diagram for explaining how to use the aneurysm treatment device assembly. FIG. 11A is a seventh view for explaining how to use the aneurysm treatment device assembly, and FIG. 11B is an eighth view for explaining how to use the aneurysm treatment device assembly. 12A is an explanatory view showing a treatment state of a blood vessel when the aneurysm treatment device assembly is used twice in the aneurysm treatment method, and FIG. 12B is a partial plan sectional view of the blood vessel of FIG. 12A. FIG. 13A is a side cross-sectional view of a main part showing a distal end portion of an indwelling device of an aneurysm treatment device assembly according to a modified example, and FIG. FIG.

  Hereinafter, preferred embodiments of an aneurysm treatment device assembly according to the present invention will be described in detail in relation to an aneurysm treatment method with reference to the accompanying drawings.

  The aneurysm treatment device assembly 10 is a device for treating an aneurysm 102 generated in a blood vessel 100 (biological lumen) by an intravascular interventional technique (a technique for delivering a device to an abnormal site through the blood vessel). In particular, as shown in FIG. 8A, the aneurysm treatment device assembly 10 according to the present exemplary embodiment can be suitably used for treating an aneurysm 102 formed in the vicinity of two adjacent biological lumens. The two adjacent living body lumens are, for example, an aneurysm 102 formed at a connection portion of the blood vessel 100 branched in a substantially Y shape (bifurcated).

  FIG. 1 is a schematic side view showing the overall configuration of an aneurysm treatment device assembly 10 according to the present embodiment. As shown in FIG. 1, the aneurysm treatment device assembly 10 has an accommodation lumen 14 extending in the axial direction, and a puncture device 12 in which a puncture portion 16 that can penetrate the blood vessel 100 is formed at the distal end portion. And an indwelling device 18 that is housed in the housing lumen 14 of the puncture device 12 so as to be able to advance and retreat. The indwelling device 18 includes a shaft 20 and an indwelling member 21 (an indwelling portion) that is detachably provided on the shaft 20. The indwelling member 21 includes a first clip 22, a wire member 24 (intermediate portion 24a), and The second clip 26 is used. The aneurysm treatment device assembly 10 is an assembly configured as described above.

  The surgeon (user of the aneurysm treatment device assembly 10) uses the catheter 28 (see FIG. 8A) to one blood vessel 100 (second downstream side) that branches the puncture device 12 and the indwelling device 18 in a substantially Y shape. Delivered to blood vessel 106: see FIG. 8A). After the puncture device 12 is advanced, the puncture device 12 punctures the wall portion 106a of the second downstream blood vessel 106 and the wall portion 104a of the other blood vessel (first downstream blood vessel 104: see FIG. 8A). (See FIG. 8B), the first clip 22 is locked to the wall 104a of the first downstream blood vessel 104 (see FIG. 9B). Further, after the first downstream blood vessel 104 and the second downstream blood vessel 106 are brought close to each other (see FIG. 10B), the second clip 26 is locked to the wall portion 106a of the second downstream blood vessel 106 (see FIG. 11A). ). Thereby, the aneurysm 102 formed in the connection part (branch part) of the substantially Y-shaped blood vessel 100 can be sandwiched and contracted (see FIG. 11B). Hereinafter, each configuration of the aneurysm treatment device assembly 10 will be specifically described.

  As shown in FIG. 1, the puncture device 12 is configured as an elongated tubular member (tubular body) having flexibility. Inside the puncture device 12, the accommodating lumen 14 is provided as described above, and openings (a distal end opening 14a and a proximal end opening 14b) are formed at both ends of the puncture device 12 so as to communicate with the accommodating lumen 14.

  The puncture device 12 preferably has flexibility (flexibility) that can easily follow the curvature of the catheter 28 inserted into the meandering blood vessel 100 and has rigidity capable of puncturing and penetrating the blood vessel 100. In this case, examples of the material constituting the puncture device 12 include metals and resins. Examples of the metal include pseudo-elastic alloys (including superelastic alloys) such as Ni-Ti alloys, shape memory alloys, stainless steel (for example, SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405, SUS430, SUS434, SUS444, SUS429, SUS430F, SUS302, etc.), cobalt-based alloys, noble metals such as gold and platinum, tungsten-based alloys, carbon-based materials (including piano wires), and the like. Examples of the resin include polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), polyvinyl chloride, polyamide, polyamide. Examples thereof include polymer materials such as elastomers, polyesters, polyester elastomers, polyurethanes, polyurethane elastomers, polyimides, fluororesins, mixtures thereof, and the above two or more polymer materials. The puncture device 12 may be a multilayer tube made of a composite formed from these metals and resins. An X-ray impermeable marker may be installed near the tip of the puncture device 12 so as to be recognized under X-ray fluoroscopy.

  The size of the puncture device 12 is appropriately selected according to the site to be treated (substantially Y-shaped blood vessel 100). For example, when the aneurysm treatment device assembly 10 is used for treatment of a cerebral aneurysm, the total length is The outer diameter is set to about 800 to 1500 mm.

  The puncture portion 16 on the distal end side is formed at an acute angle by projecting a part of the tubular body in the circumferential direction from the other portion. That is, the distal end surface of the puncture portion 16 forms an inclined surface 16a, and the distal end opening 14a of the housing lumen 14 is formed obliquely along the inclined surface 16a. Therefore, in the puncture device 12, the puncture portion 16 is formed by a simple method in which the distal end portion of the tubular body is cut obliquely. Needless to say, the shape of the puncture portion 16 is not limited to this.

  On the other hand, the indwelling device 18 includes the shaft 20 and the indwelling member 21 as described above. The indwelling member 21 has a first clip 22, an intermediate portion 24a, and a second clip 26 in order from the distal end side. The shaft 20 and the indwelling member 21 are both housed in the housing lumen 14 so as to be able to advance and retract. That is, in the aneurysm treatment device assembly 10, the first clip 22, the intermediate portion 24a, and the second clip 26 can be sequentially delivered from the distal end opening 14a of the puncture device 12.

  The shaft 20 of the indwelling device 18 is a long tubular member (tube body) extending in the axial direction, and a hub 30 is connected to a proximal end portion thereof. An insertion lumen 32 is formed inside the shaft 20 and the hub 30 so as to penetrate in the axial direction.

  The shaft 20 is formed so that the outer diameter thereof is smaller than the inner diameter of the housing lumen 14, and the mobility in the housing lumen 14 is ensured. The shaft 20 is preferably flexible enough to follow the deformation of the puncture device 12. The material which comprises the shaft 20 can apply what was mentioned by the material which comprises the puncture device 12. FIG. Further, the shaft 20 may be made of a material that is slightly higher in rigidity than the puncture device 12 so that a pressing operation of the first clip 22 described later can be easily performed.

  The hub 30 is formed larger in diameter than the shaft 20 so that the operator can easily grasp it. Further, a proximal end opening 32 b communicating with the insertion lumen 32 of the shaft 20 is formed on the proximal end surface of the hub 30. When the surgeon holds the hub 30 and performs an advance / retreat operation or a rotation operation, the indwelling device 18 transmits the operation force to the distal end side (the indwelling member 21) of the indwelling device 18 through the shaft 20.

  The insertion lumen 32 penetrating the shaft 20 and the hub 30 is formed to have an inner diameter larger than the outer diameter of the wire member 24, and the wire member 24 is accommodated so as to be able to advance and retract. Further, the insertion lumen 32 communicates with a distal end opening 32 a provided on the distal end surface of the shaft 20 in addition to the above-described proximal end opening 32 b.

  The wire member 24 has a length that can extend from the distal end opening 32 a and the proximal end opening 32 b of the insertion lumen 32. The distal end side of the wire member 24 constitutes an intermediate portion 24 a interposed between the first clip 22 and the second clip 26. The intermediate portion 24 a is placed in the living body as the placement member 21 together with the first and second clips 22 and 26.

  The wire member 24 is preferably made of a material that allows the intermediate portion 24a to continuously maintain the connected state of the first and second clips 22 and 26. In this case, for example, various synthetic resin materials such as polypropylene, polyester, nylon (polyamide), polyethylene, and rayon, various metal materials such as stainless wire, various natural materials such as silk, and the like can be used. The first clip 22 is connected to the distal end portion of the line member 24.

  2A is a perspective view showing the first clip 22 of FIG. 1, FIG. 2B is a side view showing the first clip 22 of FIG. 1, and FIG. 2C is a plan view showing the first clip 22 of FIG. FIG. 3A is a first cross-sectional view illustrating a specific operation of the first clip 22 in FIG. 2A, and FIG. 3B is a second cross-sectional view illustrating a specific operation of the first clip 22 in FIG. 2A. 3C is a third cross-sectional view illustrating a specific operation of the first clip 22 of FIG. 2A, and FIG. 3D is a specific operation of the first clip 22 of FIG. 2A. It is the 4th sectional view explaining.

  As shown in FIGS. 2A to 3D, the first clip 22 includes an engaging portion 34, a deformable portion 36 that can be deformed into a first form (see FIG. 3B) and a second form (see FIG. 3D). The holding portion 38 holds and fixes the deformation portion 36 in the second form (holds the deformation state of the deformation portion 36). The locking portion 34, the deforming portion 36, and the holding portion 38 are preferably integrally formed of the same material so as to have a predetermined elastic force. As a constituent material of the first clip 22, for example, a biocompatible material may be used among resin materials, metal materials, and the like.

  The locking part 34 is formed in a plate shape (substantially rectangular in plan view), and is a hole from the one surface (inner surface) side of the wall 100a of the blood vessel 100 (hole 100b by puncture of the puncture device 12: see FIG. 3A). A flat surface portion 40 that is in close contact with the periphery of the surface and covers the hole 100b. The locking portion 34 is preferably formed so that the dimension in the longitudinal direction is longer than the dimension of the outer diameter (diameter) of the puncture device 12 so as to be reliably caught around the hole 100b formed by the puncture device 12. . Further, the flat surface portion 40 (the upper surface in FIG. 2B) is formed in a substantially flat surface so as to easily come into surface contact with the periphery (wall portion 100a) of the hole 100b.

  The deforming portion 36 is configured as a so-called pantograph that can expand and contract in the vertical direction in FIG. 2B, and is connected to the approximate center of the plane portion 40. The deforming portion 36 includes a first form (see FIG. 3B) that can pass through the hole 100b from the basic form (basic shape) shown in FIG. 2A and the wall part of the blood vessel 100 from the other side (outer surface) side of the blood vessel 100. It can be transformed into a second form (see FIG. 3D) that abuts 100a in a planar manner.

  More specifically, the deformable portion 36 includes four linear frames 42 and four hinge portions 44a to 44d that connect the end portions of the four frames 42 so as to be bendable. Of the four hinge portions 44a to 44d, the hinge portion 44a (lower hinge portion in FIG. 2A) close to the locking portion 34 is connected to the flat surface portion 40 via the connecting portion 46, and is held by the locking portion 34 or the holding portion. The state is fixed to the portion 38.

  The hinge portion 44c facing the hinge portion 44a is displaced through the frame 42 and the two hinge portions 44b and 44d, so that the hinge portion 44c is displaced so as to approach or separate from the hinge portion 44a. Therefore, the deforming portion 36 expands and contracts in the orthogonal direction (vertical direction) of the locking portion 34 as a whole. In addition, the deformed portion 36 causes the frame 42 and the connecting portion 46 to be appropriately elastically deformed by the application of stress, so that the upper side (hinge portion 44c) of the engaging portion 34 is shifted from the vertical direction to the lateral direction. It can also be transformed into

  The upper surface of the hinge portion 44c is formed as a curved convex surface 47, and a substantially H-shaped slit 48 is formed as shown in FIGS. 2A and 2C. The pair of pieces 50 constituted by the slits 48 is configured to be elastically deformable with respect to the frame 42, and the intermediate portion 24 a (line member 24) and the like can be inserted through the slits 48.

  On the other hand, the holding portion 38 is formed in a rod shape whose base end portion is coupled to the hinge portion 44a and whose distal end portion extends toward the hinge portion 44c. The holding portion 38 extends into a frame surrounded by the frame 42 in the basic form of the deforming portion 36. A plurality (two in FIG. 2A) of claws 52 are arranged in parallel at predetermined intervals along the extending direction of the holding portion 38 on the side surface (right side surface in FIG. 2A) of the holding portion 38. Further, a connecting ring 54 that protrudes in the direction of the hinge portion 44 c is formed at the protruding side end portion of the holding portion 38. The connecting ring 54 is connected to the intermediate portion 24a (line member 24).

  Next, a specific operation of the first clip 22 configured as described above will be described.

  When the first clip 22 is accommodated in the accommodation lumen 14 of the puncture device 12, it is arranged so that the longitudinal direction of the flat locking portion 34 is along the axial direction of the puncture device 12 as shown in FIG. 3A. And the deformation | transformation part 36 and the connection part 46 are elastically deformed, and it inclines in the diagonal direction and accommodates. In this case, by extending the hinge portion 44c of the deformable portion 36 in a direction away from the hinge portion 44a, the shape of the side surface of the deformable portion 36 becomes thin as a whole, and is relatively easily bent and accommodated in the accommodating lumen 14. be able to. Further, in a state where the indwelling device 18 is accommodated in the puncture device 12, the wire member 24 is connected to the connection ring 54 (holding portion 38), and the wire member 24 is disposed on the proximal end side of the first clip 22. Connected to the second clip 26 and the shaft 20.

  When the puncture device 12 is punctured into the blood vessel 100 in the above state, a hole 100b is formed in the wall 100a of the blood vessel 100, and the distal end opening 14a of the housing lumen 14 is inserted into the blood vessel 100. As described above, when the shaft 20 is moved forward with the puncture device 12 inserted into the blood vessel 100, the first clip 22 existing on the distal end side is pushed by the shaft 20 and pushed into the blood vessel 100. In this case, since the wire member 24 is connected to the first clip 22, the first clip 22 is held near the position where the hole 100 b is formed without being pushed away by the blood in the blood vessel 100.

  After pushing the first clip 22 into the blood vessel 100, the puncture device 12 is moved backward, and the shaft 20 and the wire member 24 are moved backward integrally. Thereby, the 1st clip 22 is drawn near to the wall part 100a of the blood vessel 100, and the deformation | transformation part 36 contact | abuts to the hole 100b. As a result, the deforming portion 36 extends in a direction in which the hinge portion 44c is separated from the hinge portion 44a, and as shown in FIG. That is, the deforming portion 36 is deformed into the first form by the backward movement of the shaft 20 and the line member 24, so that the deforming portion 36 is easily exposed through the hole 100 b and exposed outside the blood vessel 100. In this case, the locking portion 34 is formed larger than the hole 100b formed by the puncture device 12, and the hole 100b is contracted by the elastic force of the blood vessel 100 as the puncture device 12 is removed. 40 is caught on the wall 100a (around the hole 100b) of the blood vessel 100. Therefore, the locking portion 34 is prevented from coming out of the blood vessel 100.

  Next, as shown in FIG. 3C, the distal end portion (second clip 26) of the shaft 20 is moved forward in the distal direction. As a result, the second clip 26 abuts on the hinge portion 44 c of the deformable portion 36 and the frame 42, and an operation (pressing operation) for pressing the deformable portion 36 in a direction approaching the locking portion 34 is performed. By this pressing operation, the deforming portion 36 is crushed so that the hinge portions 44b and 44d are bent at an acute angle, and the angle of the hinge portions 44a and 44c is deformed to an obtuse angle, and deformed into the second form (see FIG. 3D). ).

  Further, as the pressing operation is performed on the deforming portion 36, the holding portion 38 acts through the slit 48 so as to protrude to the outside of the hinge portion 44c. When the deformable portion 36 is pressed by a predetermined amount by the second clip 26, the outer surface (piece 50) of the deformable portion 36 is locked to the claw 52 formed on the side surface of the holding portion 38. Thereby, the deformation | transformation state (2nd form) of the deformation | transformation part 36 is fixedly held. As described above, the deformable portion 36 is deformed so as to be capable of surface contact (second form) by an operation of pressing in the direction approaching the locking portion 34, and thus, for example, the deformable portion 36 is obtained by an intravascular interventional procedure. Can be easily deformed.

  In a state where the deforming portion 36 is held by the holding portion 38, as shown in FIG. 3D, the engaging portion 34 abuts on one surface (inner surface) of the wall portion of the blood vessel 100, and the deformed portion is deformed into the second form. 36 comes into contact with the opposite surface (outer surface) of the wall portion of the blood vessel 100. Accordingly, the hole 100b is closed by the locking portion 34 and the deformable portion 36 of the second form, and hemostasis is promoted. Further, the first clip 22 is firmly locked to the wall portion 100a when the locking portion 34 and the deforming portion 36 are hooked on the wall portion 100a of the blood vessel 100.

  When the shaft 20 that has pressed the deforming portion 36 is moved backward in the locked state of the first clip 22, the second clip 26 is moved from the first clip 22 to the intermediate portion 24a (line member 24). Spaced apart.

  3D shows a state in which the deforming portion 36 is locked to the lower claw 52 formed in the holding portion 38. For example, when the wall portion 100a of the blood vessel 100 is thick or the wall portion Of course, when 100a is hard, the pressing operation may be terminated in a state where the deformable portion 36 is locked to the upper claw 52.

Further, it is desirable that the deforming portion 36 of the first clip 22 has a physical property value excellent in hinge characteristics as a material physical property particularly required for a deforming function. Specifically, the tensile strength is 250 to 500 (Kg / cm ² ), the elongation is 150 to 800%, the tensile elastic modulus is 8 to 20 (× 103 Kg / cm ² ), and the bending strength is 300 to 700 (Kg / cm ² ). Things. By satisfying these physical property values, the deforming portion 36 is excellent in hinge characteristics and can be easily deformed in shape.

  Further, the first clip 22 may be subjected to a lubricity treatment for expressing lubricity on the surface of the locking portion 34 opposite to the flat surface portion 40. As a result, the running performance in the puncture device 12 and the blood vessel 100 is improved, the safety is improved, and the locking portion 34 can be positioned easily and reliably, and the hole 104b formed in the blood vessel 100 is obtained. Can be easily and reliably performed. Examples of the lubricity treatment include hydrophilic treatment, formation of a lubricity coating layer containing a lubricious material, and the like.

  4A is a configuration diagram of the first clip 22A according to the first configuration example, FIG. 4B is a configuration diagram of the first clip 22B according to the second configuration example, and FIG. 4C is related to the third configuration example. FIG. 4D is a configuration diagram of the first clip 22C, and FIG. 4D is a configuration diagram of the first clip 22D according to a fourth configuration example. As shown in FIGS. 4A to 4D, the first clip 22 may employ various configurations in addition to the above configuration.

  For example, in the first clip 22A according to the first configuration example shown in FIG. 4A, the holding portion 38a is formed in a flat plate shape, and the plane is arranged in a direction facing the frame 42 of the deformable portion 36. If the holding portion 38a is configured in this manner, the holding portion 38a can easily follow the deformation of the deformation portion 36 (particularly, the deformation in which the hinge portion 44c is shifted in the lateral direction), so that the first clip 22A into the puncture device 12 can be Accommodation becomes easy.

  Further, the claws 52 a of the holding portion 38 a are formed on both sides of the plane in the short direction, and the claws 52 a on both sides are engaged with the edge 48 a of the slit 48. Therefore, the holding part 38a (a pair of claws 52a) can firmly lock the upper surface of the deforming part 36, and can hold the second form more reliably.

  In the first clip 22B according to the second configuration example shown in FIG. 4B, the holding portion 38b formed in a rod shape penetrates the deformation portion 36 (slit 48) and extends to the outside of the deformation portion 36. Further, the connection ring 54 to which the wire member 24 is connected is formed at the protruding side end of the holding portion 38b. The first clip 22B according to the second configuration example has a guide function in which the holding portion 38b guides the deformation direction (stretching direction) of the deformation portion 36, and the deformation portion 36 has the first form and the second shape. The shape can be smoothly transformed.

  The first clip 22C according to the third configuration example shown in FIG. 4C is provided with only the locking portion 34 without the deformation portion 36 and the holding portion 38 being provided. Even in this case, the first clip 22C can be locked to the blood vessel 100 by hooking the locking portion 34 to the wall 100a of the blood vessel 100.

  In addition, a spherical body receiving portion 56 is provided at a substantially central portion of the flat surface portion 40 of the locking portion 34, and an end portion of the wire member 24 connected to the locking portion 34 is pivotally supported by the spherical body receiving portion 56. A spherical portion 57 is provided. Thereby, the direction of the latching | locking part 34 can be freely changed with respect to the edge part (spherical part 57) of the wire member 24, and accommodation in the puncture device 12, and sending out into the blood vessel 100 can be performed easily. it can.

  Similar to the first clip 22C according to the third configuration example, the first clip 22D according to the fourth configuration example illustrated in FIG. 4D includes a locking portion 34, and both side surfaces of the locking portion 34 are axially supported by the line member 24. It has become the composition. In this case, the wire member 24 is bifurcated at the distal end portion, and each branched end portion pivotally supports the middle portion in the longitudinal direction of the locking portion 34 so that the locking portion 34 has a center extending in the short direction. It becomes free to rotate around the line. Therefore, accommodation into the puncture device 12 and delivery into the blood vessel 100 can be easily performed.

  In addition to the configuration example described above, the first clip 22 may of course adopt a configuration that can be physically (hooked, narrowed, etc.) locked on the wall 100a of the blood vessel 100. .

  Returning to FIG. 1, the second clip 26 is detachably attached to the distal end portion of the shaft 20 on the proximal end side of the first clip 22. The second clip 26 has a structure that can be mounted and fixed at a desired position of the line member 24 delivered from the distal end opening 32 a of the insertion lumen 32, whereby an intermediate portion 24 a between the first clip 22 and the second clip 26. The length of can be adjusted. Hereinafter, the second clip 26 will be specifically described.

  FIG. 5A is a perspective view showing a main part of the second clip 26 and the distal end portion of the shaft 20 shown in FIG. 1, and FIG. 5B is a main part showing a state where the second clip 26 shown in FIG. It is a perspective view. 6A is a first side cross-sectional view for explaining the operations of the second clip 26, the operation mechanism 60, and the release mechanism 70 of FIG. 1, and FIG. 6B is a second view showing the operation following FIG. 6A. 6C is a third side sectional view showing the operation following FIG. 6B, and FIG. 6D is a fourth side sectional view showing the operation following FIG. 6C.

  The second clip 26 of the indwelling device 18 is formed as a disk-shaped member that substantially matches the outer diameter of the shaft 20, and has a notch 58 through which the wire member 24 can be inserted, as shown in FIG. 5A. . The second clip 26 is configured to be elastically deformable in a direction in which the notch 58 is closed.

  In this case, if the cutout portion 58 of the second clip 26 is formed in advance in a width (linear shape) as shown in FIG. 5B, the above configuration can be achieved. That is, the second clip 26 shown in FIG. 5A is expanded (elastically deformed) in the direction in which the notch 58 is opened, and the expanded state is maintained by interposing the fixing member 62 of the operation mechanism 60 described later. Thus, by removing the fixing member 62, the cutout portion 58 can be automatically reduced (restored) in the closing direction.

  Therefore, the material constituting the second clip 26 may be an elastic material such as various rubber materials such as natural rubber and silicone rubber, various thermoplastic elastomers such as polyurethane and styrene, or a mixture thereof. Of course, a resin material or a metal material may be applied in the same manner as the first clip 22.

  The notch 58 includes an engagement hole 58a that can be fitted to the wire member 24, and an opening / closing part 58b that is continuous with the engagement hole 58a and extends in the radial direction and can be opened and closed in the circumferential direction. The engagement hole portion 58a has a configuration in which the inner diameter (opening area) and the like thereof vary with the opening / closing operation of the opening / closing portion 58b. That is, as shown in FIG. 5A, when the opening / closing part 58b is opened, the inner diameter of the engagement hole part 58a is large, and the line member 24 inserted therein is movable. On the other hand, as shown in FIG. 5B, when the opening / closing portion 58 b is shifted to the closed state, the inner diameter of the engagement hole portion 58 a becomes smaller than the outer diameter of the wire member 24, and the engagement hole portion 58 a becomes the side surface of the wire member 24. Mates with. As a result, the second clip 26 is locked to the wire member 24.

  The opening / closing part 58b has a pair of facing surfaces 59 by being cut out in a substantially linear shape, and the pair of facing surfaces 59 can be brought close to and separated from each other. As shown in FIG. 5A, the cutout portion 58 is formed in a keyhole shape as a whole by separating the facing surface 59 of the opening / closing portion 58b. Moreover, when the opposing surface 59 of the opening / closing part 58b comes close (contacts), the engaging hole part 58a is fitted into the line member 24, and the notch part 58 becomes inconspicuous.

  The open / close state of the notch 58 is operated by the operation mechanism 60. The operating mechanism 60 includes a fixing member 62 that can be inserted into the notch 58, a tension wire 64 that operates the backward movement of the fixing member 62, and a guide groove 66 that is provided on the shaft 20 and guides the backward movement of the fixing member 62. The operation lumen 68 is provided on the base end face of the guide groove 66 and can be inserted through the tension wire 64.

  The fixing member 62 is configured as a block body having a side surface portion 62 a that can abut on the opposing surface 59 of the notch portion 58. The fixing member 62 is formed to be sufficiently longer than the plate thickness of the second clip 26, and the other part extends into the guide groove 66 even when a part is inserted into the notch 58. Has been. As for the 2nd clip 26, this fixing member 62 is inserted in the notch part 58 (opening-and-closing part 58b), and the notch 58 is maintained in the expanded state. And it will be in the state attached to the front end surface of the shaft 20 via the fixing member 62. FIG. That is, the second clip 26 and the shaft 20 are integrally fixed by the notch 58 of the second clip 26 and the fixing member 62 inserted and extended in the guide groove 66 provided in the shaft 20 (see FIG. 5A and FIG. 5B).

  A tensile wire 64 is connected to the base end surface of the fixing member 62. The tensile wire 64 is inserted through the operation lumen 68 of the shaft 20, and the base end side thereof extends from the base end opening 32 b of the hub 30 (see also FIG. 1). The operator can move the fixing member 62 inserted into the notch 58 backward, that is, pull it out from the second clip 26 by grasping the proximal end side of the tension line 64 and moving it backward.

  The guide groove 66 is formed on the inner wall of the shaft 20 constituting the insertion lumen 32. The guide groove 66 is engraved sufficiently longer than the axial length of the fixing member 62, and can accommodate the fixing member 62 in a slidable manner. The base end surface of the guide groove 66 defines the movement limit of the backward movement of the fixing member 62, and an operation lumen 68 is formed in communication with the base end surface.

  Moreover, as shown to FIG. 6A, the removal mechanism 70 is provided in the position facing the operation mechanism 60 in the front end side inner surface of the shaft 20 (insertion lumen 32). The detachment mechanism 70 has a function of cutting the wire member 24 based on the operation of the operator. The detachment mechanism 70 includes an operating element 72 (see FIG. 1) operated by an operator, a driving mechanism 76 connected to the operating element 72 via an operating line 74, and a line member under the action of the driving mechanism 76. And a cutting blade 78 for cutting 24.

  The operation element 72 is provided so as to be exposed on the side peripheral surface of the hub 30 and is movable in the front-rear direction, and one end (base end) of the operation line 74 is connected thereto. That is, the operating force when the operator operates the operating element 72 is transmitted to the drive mechanism 76 via the operating line 74.

  The drive mechanism 76 is disposed on the inner wall of the insertion lumen 32, and a cutting blade 78 that can move in the insertion lumen 32 in the radial direction is accommodated therein. The drive mechanism 76 mechanically converts the operating force of the operating element 72 received via the operating line 74 to operate the cutting blade 78. The drive mechanism 76 is configured to return the cutting blade 78 to the original position based on the operation cancellation of the operation element 72.

  In addition, the drive mechanism 76 is not limited to such a configuration, and may adopt another mechanical mechanism or an electric mechanism. For example, as an electrical mechanism, a motor (not shown) may be provided inside the drive mechanism 76, and the cutting blade 78 may be driven by supplying electric power to the motor. In this case, the operator 72 may be a switch that switches on / off of power supply.

  The cutting blade 78 is provided in the drive mechanism 76 so as to be able to advance and retreat in the insertion lumen 32 under the drive action of the drive mechanism 76. When the operation element 72 is not operated normally, as shown in FIGS. 6A and 6B, the cutting blade 78 exists in the drive mechanism 76, and the movement (sending) of the wire member 24 in the axial direction is ensured. . When cutting the wire member 24, the operator 72 is operated, so that the cutting blade 78 moves forward toward the wire member 24 and cuts the line member 24 as shown in FIG. 6C.

  Hereinafter, based on FIG. 6A-FIG. 6D, the specific operation | movement of the 2nd clip 26 (operation mechanism 60) and the removal mechanism 70 is demonstrated. In the aneurysm treatment device assembly 10, at the position where the second clip 26 is in contact with the periphery (wall portion 100 a) of the hole 100 b of the blood vessel 100, the blood vessel 100 is locked by the second clip 26, that is, the second clip 26 is locked. Detention takes place.

  As shown in FIG. 6A, when the second clip 26 is positioned around the hole 100b, the fixing member 62 is inserted into the notch 58, and the fixing member 62 is expanded with the second clip 26 expanded. It is connected to the shaft 20 via. In this state, the wire member 24 is movable relative to the second clip 26.

  When the surgeon pulls the tension line 64, the fixing member 62 moves backward along the axial direction of the shaft 20, as shown in FIG. 6B. As a result, the second clip 26 is in a state in which the opening / closing part 58b is closed and the notch part 58 is closed. That is, the engagement hole 58 a is fitted into the wire member 24 and is firmly attached and fixed to the wire member 24. At this stage, the second clip 26 is detached from the shaft 20.

  After the second clip 26 is attached and fixed to the line member 24, the release member 70 is operated to cut the line member 24 with the cutting blade 78, as shown in FIG. 6C. As a result, the second clip 26 and the intermediate portion 24a are completely separated from the shaft 20. Then, as shown in FIG. 6D, by retracting the shaft 20, the second clip 26 is detached and placed in the blood vessel 100.

  The separation mechanism 70 can employ various configurations other than the above-described configuration. For example, the wire member 24 is composed of two members, and these are physically (fitted, hooked, etc.) engaged and detachably connected, or the wire member 24 has some physical action (thermal action, chemical action). Etc.) may be adopted so as to be detachable by dividing. Hereinafter, some configuration examples of the other separation mechanism 70 will be described.

  In the detachment mechanism 70A according to the first configuration example shown in FIG. 7A, the wire member 24 includes two members (a first wire member 24a and a second wire member 24b), and a base 80 and a hollow portion of the first wire member 24a. The tip of the second wire member 24b having 81 is fitted. The fitting force (coupling force) between the base portion 80 and the second wire member 24b is fitted and maintained in a connected state until the force for separating them is less than a predetermined value, but when a force exceeding a predetermined value is applied. Is set to such a fitting force that the first wire member 24a and the second wire member 24b are detached when the fitting is disengaged. According to the detachment mechanism 70A configured in this way, after the second clip 26 is locked to the blood vessel 100, the second line member 24b is moved backward to move the first line member 24a from the second line member 24b. It can be automatically detached. In FIG. 7A, the base portion 80 is inserted into the hollow portion 81 and is configured to fit together, but a configuration in which the relationship between the fitting male and female is reversed may be used.

  The detachment mechanism 70B according to the second configuration example shown in FIG. 7B is configured such that the base portion 80 of the first wire member 24a and the tip of the second wire member 24b are screwed together. Specifically, a male screw 82 is formed on the outer peripheral portion of the base portion 80, and a female screw 83 is formed on the inner peripheral portion of the second wire member 24b. The male screw 82 and the female screw 83 are formed so as to be unscrewed by rotating the second wire member 24b when performing a procedure for treating the aneurysm 102. According to the detachment mechanism 70B configured in this way, after the second clip 26 is locked to the blood vessel 100, the first line member 24a is automatically removed from the second line member 24b by rotating the second line member 24b. Can be removed. In FIG. 7B, the male screw 82 provided on the base 80 is connected to the female screw 83 provided on the second wire member 24b so that they are connected. The structure which reversed the relationship of male and female may be sufficient.

  The detachment mechanism 70 </ b> C according to the third configuration example illustrated in FIG. 7C is wound in a coil shape around the connection portion 84 that connects the base portion 80 of the first wire member 24 a and the tip of the second wire member 24 b, and the outer periphery of the connection portion 84. Heater 85 and first and second conductors 86a and 86b connected to the heater 85. The connecting portion 84 is made of a material (for example, resin, low melting point metal, or the like) that can be melted and broken when heated. The first conducting wire 86a is connected to one end of the heater 85, the second conducting wire 86b is connected to the other end of the heater 85, and the first and second conducting wires 86a and 86b are in the hollow portion 81 of the second wire member 24b. Is connected to the power source at the end opposite to the side connected to the heater 85. The power source may be either direct current or alternating current. According to the detachment mechanism 70C configured in this way, after the second clip 26 is locked to the blood vessel 100, the heater 85 is energized through the first and second conductive wires 86a and 86b to generate heat. By melting and breaking the connecting portion 84, the first wire member 24a can be detached from the second wire member 24b.

  The disengagement mechanism 70D according to the fourth configuration example shown in FIG. 7D includes a hook portion 88 provided at the base portion 80 of the first wire member 24a and a hook portion 88 provided at the distal end of the second wire member 24b. And a joint part 89. The engaging force (coupling force) between the hook portion 88 and the engaging portion 89 is obtained by pushing the second wire member 24b slightly forward with the second clip 26 detached and placed in the blood vessel 100. Since the engagement between the portion 88 and the engagement portion 89 is released, the first wire member 24a can be detached from the second wire member 24b. According to the detachment mechanism 70D configured as described above, when the second wire member 24b is rotated, the second clip 26 is locked to the blood vessel 100, and then the first wire member 24a and the second wire when the torque becomes a predetermined value or more. Since the engagement of the member 24b is released, the first wire member 24a can be easily detached from the second wire member 24b automatically.

  The disengagement mechanism 70E according to the fifth configuration example shown in FIG. 7E includes an interposition member 91 having a ball-shaped portion 90, a tension member 92 that pulls the interposition member 91 toward the base portion of the first wire member 24a, and a second line. The holding ring 94 provided in the front-end | tip part of the member 24b, and the release wire 95 penetrated by the 2nd wire member 24b are provided. For example, the release wire 95 is connected to an operation element 72 provided on the hub 30, and is pulled back in the proximal direction by the operation of the operation element 72. In a state where the release wire 95 is sandwiched between the holding ring 94 and the ball-shaped portion 90 (a state where the ball-shaped portion 90 and the release wire 95 are fixed), the ball-shaped portion 90 passes through the holding ring 94. Since the movement into the base is prevented, the connected state of the first wire member 24a and the second wire member 24b is maintained. On the other hand, when the operating element 72 is operated to pull the release wire 95 in the proximal direction, the release wire 95 is detached from between the holding ring 94 and the ball-shaped portion 90, so that the ball-shaped portion 90 moves inside the holding ring 94. The ball-shaped portion 90 moves into the base portion under the tension action of the tension member 92. Thereby, the 1st line member 24a can be made to detach | leave from the 2nd line member 24b.

  Other configurations of the detachment mechanism 70 include a configuration in which the wire member 24 is detached by electrolysis, or a configuration in which fluid pressure is applied to the wire member 24 to disconnect and disconnect the base portion of the wire member 24 and the shaft 20. Can be adopted.

  The aneurysm treatment device assembly 10 according to the present embodiment is basically configured as described above, and the operation and effect thereof will be described below. FIG. 8A is a first diagram illustrating a method of using the aneurysm treatment device assembly 10, FIG. 8B is a second diagram illustrating a method of using the aneurysm treatment device assembly 10, and FIG. FIG. 9B is a fourth diagram illustrating a method of using the aneurysm treatment device assembly 10, FIG. 9B is a fourth diagram illustrating a method of using the aneurysm treatment device assembly 10, and FIG. 10A is an aneurysm treatment device set. FIG. 10B is a sixth diagram illustrating how to use the aneurysm treatment device assembly 10, and FIG. 11A is a diagram illustrating how to use the aneurysm treatment device assembly 10. FIG. 11B is a seventh diagram illustrating the method, and FIG. 11B is an eighth diagram illustrating a method of using the aneurysm treatment device assembly 10. 8A to 11B are enlarged views of the aneurysm treatment device assembly 10 so that the operation within the blood vessel 100 can be easily understood. In actual use, the size of the blood vessel 100 and the aneurysm 102 is shown. Of course, an aneurysm treatment device assembly 10 that is appropriately sized (small enough) may be used.

  As shown in FIGS. 8A to 11B, the aneurysm treatment device assembly 10 according to this exemplary embodiment includes two adjacent biological lumens (a blood vessel 100 branched in a substantially Y shape (first and second downstream sides). It is used for the treatment of the aneurysm 102 formed in the connecting portion) of the blood vessels 104, 106). In such an aneurysm 102, the wall 100a (blood vessel wall) of the blood vessel 100 (artery) becomes weak due to causes such as arteriosclerosis, and blood flowing from the upstream blood vessel 108 (the lower blood vessel in FIG. 6A) is connected. It is formed by pressing the wall 100a of the partial blood vessel 100 and gradually inflating it. Examples of blood vessels in which the aneurysm 102 is generated include arteries, veins, and peripheral blood vessels. Examples of the aneurysm 102 include a cerebral aneurysm, an abdominal aneurysm, a thoracic aneurysm, a coronary aneurysm, a popliteal aneurysm, a femoral aneurysm, and a carotid aneurysm.

  Here, the aneurysm treatment method using the aneurysm treatment device assembly 10 will be schematically described. In the aneurysm treatment method, the puncture device 12 is substantially Y-shaped in a state where the indwelling device 18 is accommodated in the puncture device 12. A first step (delivery step) in which the puncture device 12 is punctured from the inside to the outside of the second downstream blood vessel 106, and inserted into the second downstream blood vessel 106. A second step (puncture step) for puncturing from the outside of the first downstream (peripheral) blood vessel 104 to the inside of the first downstream side (peripheral side), and locking the first clip 22 included in the indwelling device 18 to the first downstream side blood vessel 104 The third step (first locking step), the indwelling device 18 or the like is operated to bring the first downstream blood vessel 104 and the second downstream blood vessel 106 close to each other and formed therebetween A fourth step (squeezing step) for narrowing 102, a fifth step (second locking step) for locking the second clip 26 to the second downstream blood vessel 106, and a proximal side of the second clip 26. A sixth step (detachment step) for detaching the wire member 24 and a seventh step (retraction step) for retracting the puncture device 12 and the indwelling device 18 from the blood vessel 100 are sequentially performed. As a result, the aneurysm 102 can be sandwiched and contracted by the first and second downstream blood vessels 104 and 106. Please explain each step in detail below.

[Delivery step]
In the delivery step, the guiding catheter 96 is inserted into the blood vessel 100 percutaneously from a predetermined position (for example, a thigh). Then, the guiding catheter 96 is guided in accordance with a guide wire (not shown) inserted in advance, and as shown in FIG. 8A, the site where the aneurysm 102 is generated (through the substantially Y-shaped blood vessel) through the upstream blood vessel 108. The tip is delivered to the connecting part).

  Thereafter, the catheter 28 configured as a microcatheter is delivered from the distal end opening 96 a of the guiding catheter 96, and the catheter 28 is advanced to the second downstream blood vessel 106. Then, the distal end opening 28a of the catheter 28 is positioned at a desired location (for example, a position higher than the height of the aneurysm 102) of the second downstream blood vessel 106. The puncture device 12 is inserted into the lumen 98 of the catheter 28. For example, the catheter 28 is brazed in advance so that the distal end portion is bent approximately 90 ° with respect to the axial direction of the blood vessel 100. When the catheter 28 is delivered from the distal opening 96a of the guiding catheter 96, the distal opening 28a is 2 Deformed to face the wall 106a of the downstream blood vessel 106. Note that the distal end portion of the catheter 28 may be configured to bend with a wire or the like, for example.

[Puncture step]
After the delivery step, a puncture step is performed as shown in FIG. 8B. In the puncturing step, the puncturing device 12 is delivered from the distal end opening 28a of the catheter 28 positioned in the second downstream blood vessel 106. As a result, the puncture portion 16 is punctured into the wall portion 106 a of the second downstream blood vessel 106, and the puncture device 12 is exposed from the inside to the outside of the second downstream blood vessel 106.

  When the puncture device 12 is further delivered after passing through the second downstream blood vessel 106, the puncture portion 16 moves toward the first downstream blood vessel 104, and the wall portion 104a of the first downstream blood vessel 104 is moved by the puncture portion 16. Puncture. Thereby, the puncture unit 16 penetrates from the outside to the inside of the first downstream blood vessel 104, and the distal end opening 14 a of the puncture device 12 is inserted into the first downstream blood vessel 104.

  By puncturing with the puncture device 12, holes 104b and 106b are formed in the wall portions 104a and 106a of the first and second downstream blood vessels 104 and 106, respectively. An embolic agent may be applied to the side peripheral surface of the distal end portion (puncture portion 16) of the puncture device 12. Thereby, blood in the vicinity of the holes 104b and 106b formed by the puncture device 12 can be coagulated, and leakage of blood from the holes 104b and 106b can be reduced.

[First locking step]
After the delivery step, the first locking step is performed as shown in FIGS. 9A to 10A. In the first locking step, an operation of locking the first clip 22 to the wall portion 104a of the first downstream blood vessel 104 is performed. That is, the first clip 22 is pushed out from the distal end opening 14a of the puncture device 12 by moving the shaft 20 forward (see FIG. 9A). Then, the shaft 20 and the wire member 24 are integrally moved backward to expose the deformable portion 36 outside the first downstream blood vessel 104, and the locking portion 34 is attached to the wall portion 104 a of the first downstream blood vessel 104. Hook (see FIG. 9B). At this time, it is preferable that the puncture device 12 is largely retracted and accommodated in the catheter 28. Thereby, the diameter of the holes 104b and 106b is positively reduced by the elastic force of the blood vessels, and the first and second clips 22 and 26 can be easily locked.

  Next, the shaft 20 is moved forward in the distal direction, and the deformable portion 36 is pressed in the direction approaching the locking portion 34 by the second clip 26. Thereby, the deformation | transformation part 36 deform | transforms into the 2nd form which can be surface-contacted to the periphery of the hole 104b (refer FIG. 10A). Note that, when the second clip 26 is pressed, the holding portion 38 (and the connection ring 54) exists at a position facing the notch portion 58 of the second clip 26. For this reason, when the holding part 38 protrudes outside the deforming part 36, the holding part 38 enters the notch part 58, and does not disturb the pressing operation of the second clip 26, and the pressing of the deforming part 36 is not performed. It can be done well.

  When the second clip 26 is pressed by a predetermined amount, the piece 50 of the deformation portion 36 is locked to the claw 52 of the holding portion 38, and the deformation state (second form) of the deformation portion 36 is fixed and held. As a result, the hole 104b is closed by the locking portion 34 and the deformable portion 36 of the second form, and hemostasis is promoted. Further, the first clip 22 is firmly locked to the wall portion 104a of the first downstream blood vessel 104 by the locking portion 34 and the deformed portion 36 in the deformed state.

(Pinch step)
After the first locking step, a pinching step is performed as shown in FIG. 10B. In the pinching step, an operation of moving the catheter 28 forward is performed while the indwelling device 18 is moved backward. That is, by moving the shaft 20 (including the second clip 26) and the wire member 24 in the backward direction, the first downstream blood vessel 104 is moved toward the second downstream blood vessel 106. In this case, the movement amount of the shaft 20 is made larger than the movement amount of the line member 24 so that the second clip 26 enters the second downstream blood vessel 106. Thereby, a state in which only the line member 24 is exposed from the hole 106b of the second downstream blood vessel 106 is formed.

  Further, the catheter 28 is moved forward to move the second downstream blood vessel 106 toward the first downstream blood vessel 104. As a result, the first and second downstream blood vessels 104 and 106 can be brought close to each other to sandwich the aneurysm 102 and contract.

  In this aneurysm treatment method, the first clip 22 engages in the vicinity of the upper portion of the aneurysm 102 and draws the first downstream blood vessel 104, so that the aneurysm 102 can be compressed from the upper side and flows into the aneurysm 102. While discharging blood, it can be crushed inward. Note that the proximity movement of the first downstream blood vessel 104 and the second downstream blood vessel 106 is not limited to the operation method described above. For example, the first clip 22 locked to the first downstream blood vessel 104 is used. Only the second blood vessel 106 may be brought close to the second blood vessel 106.

[Second locking step]
After the sandwiching step, a second locking step is performed as shown in FIG. 11A. In the second locking step, the second clip 26 is attached and fixed to the wire member 24 in a state where the first downstream blood vessel 104 and the second downstream blood vessel 106 are close to each other. Lock to the side blood vessel 106.

  Specifically, the operator pulls out the fixing member 62 from the cutout portion 58 of the second clip 26 by pulling the tensile wire 64 extending from the proximal end opening 32 b of the hub 30, and thereby the proximal end of the guide groove 66. Move backward (in the insertion lumen 32). Thus, the opening / closing part 58b is elastically closed, and the engagement hole part 58a (that is, the second clip 26) is reduced in diameter. As a result, the second clip 26 is fitted to the line member 24.

  Here, in the sandwiching step, by exposing only the line member 24 from the hole 106b of the second downstream blood vessel 106, the hole 106b is elastically reduced in diameter first, and the planar area of the second clip 26 is larger than that of the second clip 26. Is also getting smaller. For this reason, in a state where the second clip 26 is attached and fixed to the line member 24, the planar portion of the second clip 26 comes into surface contact with the periphery (wall portion 106a) of the hole 106b, and the second downstream blood vessel The second clip 26 can be easily locked inside the inner side 106.

  As described above, the second clip 26 is locked to the second downstream blood vessel 106 while the second clip 26 is attached and fixed to a desired portion of the wire member 24, so that the first and second downstream blood vessels 104, The aneurysm 102 can be contracted by an appropriate pinching force 106 and the contracted state can be continuously maintained.

[Leaving step]
After the second locking step, as shown in FIG. 11B, a detachment step is performed. In the detachment step, the detachment mechanism 70 is operated in a state where the second clip 26 is locked inside the second downstream blood vessel 106. That is, by operating the operating element 72 of the hub 30, the cutting blade 78 of the detachment mechanism 70 is moved forward into the insertion lumen 32, and the line member 24 is cut (see also FIG. 6C). Thereby, the front end side of the wire member 24, that is, the intermediate portion 24a is separated and separated from the proximal end side of the shaft 20 and the wire member 24 (see also FIG. 6D). In this manner, the indwelling member 21 is detached in a state in which the first downstream blood vessel 104 and the second downstream blood vessel 106 are brought close to each other, that is, in a state in which the aneurysm 102 is sandwiched between both blood vessels, by separating the wire member 24 by the separation mechanism 70. (First and second clips 22, 26, intermediate portion 24a) can be placed.

[Backward step]
After the separation step, the backward step is performed as shown in FIG. 11B. In the retracting step, the indwelling device 18 is retracted and accommodated in the catheter 28, and then the aneurysm treatment device assembly 10 (the puncture device 12 and the indwelling device 18) and the catheter 28 are integrally retracted to move into the blood vessel 100. Remove from. Thereby, only the indwelling member 21 is indwelled in the blood vessel 100.

  FIG. 12A is an explanatory view showing a treatment state of the blood vessel 100 when the aneurysm treatment device assembly 10 is used twice in the aneurysm treatment method, and FIG. 12B is a partial plan sectional view of the blood vessel 100 of FIG. 12A. .

  Here, in the aneurysm treatment method, the first and second downstream blood vessels 104 and 106 may be locked by the indwelling member 21 a plurality of times (twice in FIG. 12). That is, the first and second clips 22 and 26 of the two indwelling members 21 are locked to the first and second downstream blood vessels 104 and 106, respectively. Thereby, the pinching of the knob 102 can be further strengthened.

  In this case, as shown in FIG. 12A, one indwelling member (first indwelling member 21a) is disposed on the upper side of the aneurysm 102, and the other indwelling member (second indwelling member 21b) is disposed on the lower side (neck of the neck). In the vicinity of the portion). As a result, the first and second downstream blood vessels 104 and 106 are close to the top and bottom of the aneurysm 102, so that the vicinity of the opening of the aneurysm 102 is likely to be blocked, and the inflow of blood into the aneurysm 102 can be prevented more reliably. Can do.

  Also, as shown in FIG. 12B, the first and second indwelling members 21a and 21b are arranged so that the respective line members 24 wrap around one outer surface of the knob 102 and the outer surface on the opposite side. Is preferred. In this manner, by placing the first and second indwelling members 21a and 21b in the blood vessel 100, the first and second indwelling members 21a and 21b and the first and second downstream blood vessels 104 and 106 can The surroundings can be enclosed and can be contracted well.

  Further, when the first clip 22 of the first indwelling member 21a is locked to the first downstream blood vessel 104 and the second clip 26 is locked to the second downstream blood vessel 106, the first indwelling member 21b has a first clip. It is preferable that the clip 22 is locked to the second downstream blood vessel 106 and the second clip 26 is locked to the first downstream blood vessel 104. Thereby, it can prevent that each deformation | transformation part 36 of the 1st and 2nd indwelling members 21a and 21b contacts the same side surface direction of the knob 102, and presses the knob 102. FIG.

  As described above, according to the aneurysm treatment device assembly 10 and the aneurysm treatment method using the aneurysm treatment device assembly 10 according to the present exemplary embodiment, two adjacent blood vessels 100 (branched in two branches) are provided. The aneurysm 102 formed therebetween can be sandwiched between the first downstream blood vessel 104 locked by the first clip 22 and the second downstream blood vessel 106 locked by the second clip 26. As a result, by pressing the aneurysm 102 over the first and second downstream blood vessels 104 and 106, the opening of the aneurysm 102 is reduced or occluded, so that an increase in the internal pressure of the aneurysm 102 can be effectively suppressed. In addition, the influence on the surrounding tissue can be reduced by reducing the internal volume of the aneurysm 102.

  Further, the wall 100a of the blood vessel 100 is sandwiched between the locking portion 34 of the first clip 22 and the deformable portion 36 of the second form, so that the hole 100b formed in the blood vessel 100 is deformed by the locking portion 34 and the deformation. The first clip 22 can be easily locked to the blood vessel 100 while being blocked by the portion 36.

  Furthermore, before the second clip 22 is attached, the wire member 24 can be fed out from the tip opening 32a of the shaft 20, so that the length of the wire member 24 connecting the first clip 22 and the second clip 26 can be increased. The aneurysm 102 sandwiched between the first and second downstream blood vessels 104 and 106 can be sandwiched with an appropriate pressing force.

  Furthermore, by configuring the second clip 26 so as to be elastically deformable in the direction of closing the notch 58, the wire member 24 can be firmly sandwiched by the elastic force (blocking force) of the second clip 26. In addition, the notch 58 can be easily closed by an operation of removing the fixing member 62 inserted into the notch 58 from the notch 58.

  Furthermore, by providing the shaft 20 or the wire member 24 with the detaching mechanisms 70, 70 </ b> A to 70 </ b> E, the distal end side of the wire member 24 to which the first and second clips 22, 26 are connected is the proximal end side of the line member 24. Can be easily detached from the blood vessel 100 and placed in the blood vessel 100.

[Modification]
FIG. 13A is a side sectional view of a main part showing a distal end portion of an indwelling device 200 of an aneurysm treatment device assembly 10A according to a modification, and FIG. 13B is a main view showing an example of use of the aneurysm treatment device assembly 10A of FIG. 13A. FIG. In addition, in the aneurysm treatment device assembly 10A according to the modified example, elements having the same or similar functions and effects as those of the aneurysm treatment device assembly 10 according to the present embodiment are denoted by the same reference numerals and are described in detail. Is omitted.

  In the aneurysm treatment device assembly 10A according to the modification, the indwelling device 200 includes a second clip 202 different from the second clip 26 according to the present embodiment. The second clip 202 includes a clip main body 204 that is detachably attached to the distal end portion of the shaft 20, and a locking leg 206 that is accommodated in the clip main body 204 and that can advance and retreat in the radial direction.

  The clip main body 204 is made of a disk-shaped member having a thickness that can accommodate the locking leg 206 and has a flat distal end surface 204 a that abuts against the wall portion 106 a of the second downstream blood vessel 106. A wire member 24 (intermediate portion) connected to the first clip 22 is connected to the distal end surface 204a. In the clip body 204, a valve 208 through which the holding portion 38 of the first clip 22 can pass is provided in the central portion, and the deformed portion 36 is pressed by the distal end surface 204a in the same manner as the first clip 22 according to the present embodiment. It has the function to do.

  The locking legs 206 are bar-like members that can project from the side of the clip body 204, and a plurality of the locking legs 206 are arranged along the circumferential direction of the clip body 204. The locking leg 206 is accommodated while being urged toward the outer side of the clip body 204 by an elastic member (for example, a spring) (not shown), and its proximal end is locked by the fastener 210. A tension wire 212 is connected to the fastener 210, and the tension wire 212 extends from the proximal end opening 32b of the hub 30 so that the operator can perform a grasping operation. Therefore, when the operator pulls the pull line 212, the fastener 210 is detached from the clip body 204, and the locking leg 206 protrudes to the outside of the clip body 204.

  When the locking leg 206 protrudes in a state where the second clip 202 is in contact with the wall 106a of the second downstream blood vessel 106, the locking leg 206 comes into contact with and is caught by the periphery (wall 106a) of the hole 106b. Thereby, the locking of the second clip 202 with respect to the second downstream blood vessel 106 is further ensured. Therefore, the aneurysm treatment device assembly 10A can more firmly lock the first and second downstream blood vessels 104 and 106 by the first clip 22 and the second clip 202, and the first and second downstream sides can be locked. It is possible to satisfactorily sandwich the aneurysm 102 with the blood vessels 104 and 106.

  Note that the mechanism for projecting the locking leg 206 is not limited to the above-described fastener 210 and the tension wire 212, and can take various configurations. For example, it is good also as a structure which gives the rotation torque to the 2nd clip 202, and makes the latching leg 206 protrude. In addition, in the aneurysm treatment device assembly 10A (indwelling device 200) according to the modified example, the same or similar functions and effects can be obtained with respect to each component common to the aneurysm treatment device assembly 10 according to the present embodiment. Of course.

  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.

DESCRIPTION OF SYMBOLS 10, 10A ... Aneurysm treatment device assembly 12 ... Puncture device 14 ... Accommodating lumen 16 ... Puncture part 18, 200 ... Indwelling device 20 ... Shaft 21, 21a, 21b ... Indwelling member 22, 22A-22D ... First clip 24 ... Line Member 26, 202 ... 2nd clip 28 ... Catheter 30 ... Hub 32 ... Insertion lumen 34 ... Locking part 36 ... Deformation part 38 ... Holding part 58 ... Notch part 62 ... Fixing member 64 ... Tensile wire 70 ... Release mechanism 100 ... Blood vessel 102 ... aneurysm 104 ... first downstream blood vessel 106 ... second downstream blood vessel

Claims (9)

A puncture device having a lumen extending in the axial direction, and a puncture device provided at a distal end portion and capable of penetrating a biological lumen;
An elongate shaft accommodated in the puncture device so as to be able to advance and retreat, and an indwelling device having an indwelling portion detachable from the shaft,
The indwelling portion is provided on the distal end side of the shaft and is locked to the living body lumen; and
A second clip that is provided between the first clip and the shaft and is locked to a biological lumen different from the biological lumen to which the first clip is locked;
An intermediate portion that is interposed between the first clip and the second clip and connects the first clip and the second clip in a state where the indwelling portion is detached from the shaft. An aneurysm treatment device assembly. The aneurysm treatment device assembly according to claim 1.
The first clip is inserted into the living body lumen by being punctured by the puncturing section, and the first clip is connected to the locking section and is connected to the locking section to face the periphery of the hole by a predetermined operation. A deformable portion that is deformed to be contactable, and a holding portion that holds a deformed state of the deformable portion,
An aneurysm treatment device assembly that is locked to a living body lumen by sandwiching a wall portion of the living body lumen between the locking portion and the deformed portion in a deformed state. The aneurysm treatment device assembly according to claim 2.
The aneurysm treatment device assembly, wherein the deformable portion is deformed so as to be surface contactable by being pressed in a direction close to the locking portion. The aneurysm treatment device assembly according to any one of claims 1 to 3,
A hollow portion extending in the axial direction is formed inside the shaft,
The intermediate portion is configured to be included in a wire member that can be inserted through the hollow portion,
The aneurysm treatment device assembly, wherein the wire member can be sent out from an opening of the shaft through which the hollow portion communicates. The aneurysm treatment device assembly according to claim 4.
The aneurysm treatment device assembly, wherein the second clip is mounted and fixed at a desired position of the wire member delivered from the opening. An aneurysm treatment device assembly according to claim 5,
The second clip has a notch part through which the wire member can be inserted, and is configured to be elastically deformable in a direction to close the notch part,
An aneurysm treatment device assembly, wherein the shaft is provided with a fixing member for maintaining the cutout portion in an opening direction, and an operating means for moving the fixing member from the cutout portion. The aneurysm treatment device assembly according to any one of claims 4 to 6,
An aneurysm treatment device assembly, wherein the shaft or the wire member is provided with a detaching mechanism for separating the intermediate portion from the wire member and detaching the indwelling portion. The aneurysm treatment device assembly according to any one of claims 1 to 7,
The second clip has a diameter-expandable portion, and the diameter-expanded portion is disposed along the wall portion of the living body lumen in a diameter-expanded state so that the second clip is punctured by the puncture portion and An aneurysm treatment device assembly characterized by being caught around a hole formed in a living body lumen and locked to the living body lumen. A puncture device having a lumen extending in the axial direction, a puncture device provided at the distal end and penetrating the living body lumen, a long shaft accommodated in the puncture device so as to be able to advance and retreat, and a detachment from the shaft A delivery step of delivering an aneurysm treatment device assembly comprising an indwelling device having a possible indwelling portion to one biological lumen of two adjacent biological lumens;
After the delivery step, the puncture device is punctured from the inside of the one living body lumen to the outside, moved outside the two adjacent living body lumens, and moved from the outside of the other living body lumen to the inside. A puncturing step for puncturing;
After the puncturing step, a first locking step of locking a first clip that constitutes a part of the indwelling portion and is provided on the distal end side of the shaft to the other biological lumen;
After the first locking step, the indwelling device is operated so that the one living body lumen and the other living body lumen are brought close to each other and formed between the two adjacent living body lumens. A pinching step to narrow the aneurysm,
A second locking step of locking a second clip constituting a part of the indwelling portion and connected to the first clip via an intermediate portion after the sandwiching step to the one biological lumen; ,
A detachment step of detaching the indwelling portion from the shaft after the second locking step. An aneurysm treatment method comprising:

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