JP2013154088A - Knob treatment device and knob treatment method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a knob treatment device capable of effectively decreasing the risk of rupture of a knob by reducing the size of the knob and capable of reducing the influence on surrounding tissue, and a knob treatment method.SOLUTION: A knob treatment device 10 includes: a linear shaft 12 with flexibility; an elastically-deformable puncture body 14 which comprises a spiral body 22 and a sharp-pointed part 24 at a tip; a displacement mechanism 15 which can displace the sharp-pointed part 24 by pressing a tip part of the puncture body 14 from the inside of the puncture body 14; and a disengagement mechanism 16 which can disengage the puncture body 14 from the shaft 12. The displacement mechanism 15 comprises an elastically-deformable hold-down member 26, and a pull wire 27 which is connected to the hold-down member 26. When the pull wire 27 is displaced in a base end direction, the hold-down member 26 is elastically deformed to displace the sharp-pointed part 24 of the puncture body 14 outward.

Description

  The present invention relates to an aneurysm treatment device and 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” (Patent Document 1 below).

Special table 2008-510594 gazette

  The present invention has been made in connection with a method for treating an aneurysm via a blood vessel (by an intravascular interventional procedure), effectively reducing the risk of aneurysm rupture by reducing the aneurysm. An object of the present invention is to provide an aneurysm treatment device and an aneurysm treatment method capable of reducing the influence on surrounding tissues.

  In order to achieve the above object, an aneurysm treatment device according to the present invention comprises a flexible linear shaft, a helically configured body part, and a sharpened part provided at the tip of the body part. A puncture body that is elastically deformable and connected to the tip of the shaft; and is provided on the shaft and presses the tip of the puncture body from the inside of the puncture body to displace the sharpened portion. And a detachable mechanism capable of detaching the puncture body from the shaft.

  According to the above configuration, the aneurysm and its vicinity can be obtained by combining the operation of moving the sharpened portion of the puncture body and the operation of rotating the puncture body by accessing the aneurysm generated in the blood vessel by inserting the aneurysm treatment device into the catheter The puncture body can be punctured and engaged with the blood vessel wall, and then the puncture body can be detached from the shaft. By such a procedure, the aneurysm can be reduced and held in a state in which the aneurysm is reinforced with a puncture body, so that the risk of rupture of the aneurysm can be effectively reduced and the influence on the surrounding tissue can be reduced.

  In the aneurysm treatment device, the displacement mechanism includes a pressing member that is disposed in the hollow portion of the puncture body and is elastically deformable, and a driving member that is coupled to the pressing member and disposed along the shaft. It is preferable that when the drive member is displaced in the proximal direction, the pressing member is elastically deformed to displace the sharpened portion of the puncture body outward.

  Such a displacement mechanism does not require a complicated drive mechanism at the distal end portion of the aneurysm treatment device and can be configured compactly, which contributes to a reduction in the diameter of the aneurysm treatment device.

  In the aneurysm treatment device, the pressing member may be disposed at a position eccentric to the sharpened portion side in the hollow portion of the puncture body.

  According to said structure, the occupation area in the surface orthogonal to an axial direction of a pressing member can be made small, and a displacement mechanism can be comprised more compactly.

  In the aneurysm treatment device, the pressing member is provided at an arm extending from the tip of the shaft, an intermediate portion bent at the tip of the arm and approaching the sharpened portion, and an outer end of the intermediate portion. A pressing portion capable of pressing the distal end portion of the puncture body, and the distal end of the driving member may be coupled to the intermediate portion.

  According to said structure, by displacing a drive member to a base end direction, an arm curves by elastic deformation and a press part displaces outward. Therefore, the sharpened portion of the puncture body can be pressed from the inside thereof and the sharpened portion can be reliably pressed against the aneurysm or blood vessel wall.

  The aneurysm treatment method according to the present invention passes through an aneurysm treatment device comprising a flexible linear shaft and a helical puncture body connected to the tip of the shaft through a catheter inserted into a blood vessel. An access step for delivering the aneurysm to a position; an engaging step for engaging the puncture body with the aneurysm and the blood vessel wall in the vicinity thereof; and a state in which the puncture body is engaged with the blood vessel wall in the vicinity of the aneurysm And a detaching step for detaching the puncture body from the shaft, wherein the engaging step includes a pressing step for pressing a sharpened portion of the puncture body against the aneurysm or a blood vessel wall in the vicinity thereof, and the aneurysm or the vicinity thereof By rotating the puncture body in a state where the sharp portion is pressed against the blood vessel wall of the blood vessel, the sharp portion is punctured into the aneurysm or a blood vessel wall in the vicinity thereof and the sharp portion is exposed in the blood vessel. And a step, and repeating the puncture step and the pressing step.

  According to the aneurysm treatment method described above, since the aneurysm can be reduced and held in a state where the aneurysm is reinforced with a puncture body, the risk of aneurysm rupture can be effectively reduced and the influence on surrounding tissues can be reduced. it can.

  In the aneurysm treatment method, the engagement step may further include an auxiliary engagement step of engaging the puncture body with a blood vessel wall facing the aneurysm.

  According to the above method, the aneurysm can be reliably reduced and the state can be maintained, so that a high therapeutic effect can be obtained.

  According to the aneurysm treatment device and the aneurysm treatment method of the present invention, by reducing the aneurysm, the risk of rupture of the aneurysm can be effectively reduced and the influence on the surrounding tissue can be reduced.

It is a partially omitted side view of an aneurysm treatment device according to an embodiment of the present invention. It is a perspective view of the front-end | tip part of an aneurysm treatment device. FIG. 3A is a side cross-sectional view of the puncture body of the aneurysm treatment device and its peripheral part, and FIG. 3B is a side cross-sectional view of the state where the tip (sharpened portion) of the puncture body of the aneurysm treatment device is displaced. FIG. 4A is a configuration diagram of the detachment mechanism according to the first configuration example, FIG. 4B is a configuration diagram of the detachment mechanism according to the second configuration example, and FIG. 4C is a configuration of the detachment mechanism according to the third configuration example. FIG. 4D is a configuration diagram of a separation mechanism according to a fourth configuration example, and FIG. 4E is a configuration diagram of a separation mechanism according to a fifth configuration example. FIG. 5A is a first diagram illustrating a method of using an aneurysm treatment device, FIG. 5B is a second diagram illustrating a method of using an aneurysm treatment device, and FIG. 5C is a method of using an aneurysm treatment device. FIG. 5D is a fourth diagram illustrating how to use the aneurysm treatment device. FIG. 6A is a fifth diagram for explaining how to use the aneurysm treatment device, FIG. 6B is a sixth diagram for explaining how to use the aneurysm treatment device, and FIG. 6C is a method for using the aneurysm treatment device. FIG. 6D is an eighth diagram illustrating a method of using the aneurysm treatment device. It is explanatory drawing which shows another example of the aneurysm treatment method.

  Preferred embodiments of an aneurysm treatment device and aneurysm treatment method according to the present invention will be described below with reference to the accompanying drawings.

  FIG. 1 is a partially omitted side view showing the configuration of an aneurysm treatment device 10 according to an embodiment of the present invention. In FIG. 1, for convenience of illustration, the distal end portion of the aneurysm treatment device 10 is shown larger than the other portions and the intermediate portion is omitted. This aneurysm treatment device 10 is a device for performing treatment to prevent the rupture of the aneurysm by reducing the aneurysm generated in the living body and maintaining the reduced state. In this embodiment, the aneurysm treatment device 10 can be inserted into the catheter 11. A shaft 12, a puncture body 14 connected to the tip of the shaft 12, a displacement mechanism 15 provided on the shaft 12, and a release mechanism 16 provided on the shaft 12 are provided. Hereinafter, the configuration of each component will be described.

  The shaft 12 is a long and linear member (wire shape) having flexibility. In the present embodiment, as shown in FIG. 2, a lumen 13 is formed in the axial direction. The lumen 13 extends in the axial direction of the shaft 12 and is open at the distal end surface and the proximal end surface of the shaft 12. A pull wire 27 (drive member), which will be described later, is inserted through the lumen 13.

  The shaft 12 is flexible to such an extent that it can easily follow the curvature of the lumen together with the catheter 11 when inserted into a lumen (blood vessel or the like) in a living body and travels in the lumen. It is preferable to have an appropriate rigidity that can be transmitted.

  Therefore, the shaft 12 may be a metal or a resin. 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 shaft 12 can be constituted by a multilayer tube or the like made of a composite formed from these metals and resins. An X-ray impermeable marker may be provided near the tip of the shaft 12 so as to be recognized under X-ray fluoroscopy.

  The dimensions of the shaft 12 are appropriately selected depending on the site to be treated. For example, when used for the treatment of a cerebral aneurysm, the overall length is set to 800 to 1500 mm and the outer diameter is set to about 0.6 to 3 mm. Is done. In addition to the lumen 13, the shaft 12 may be provided with a guide wire lumen for inserting the guide wire along the axial direction.

  As shown in FIG. 1, a grip portion 18 having a diameter larger than that of the shaft 12 is provided at the proximal end portion of the shaft 12 so as to be gripped by an operator. The grip portion 18 has an appropriate length and an outer diameter so that the operator can easily grip it, and an operation portion 28 for operating the displacement mechanism 15 is provided on the outer peripheral portion thereof. The form of the operation part 28 is not specifically limited, For example, the push-pull type which can move to the axial direction of the grip part 18, or the roller type which can rotate can be employ | adopted.

  As shown in FIG. 2, the puncture body 14 includes a base portion 20 connected to the distal end portion of the shaft 12, a trunk portion 22 extending from the base portion 20 and configured in a spiral shape, and a distal end of the trunk portion 22. It is a member which has the sharpened part 24 provided in the, and is elastically deformable. The base portion 20 is connected to the distal end portion of the shaft 12 via the detachment mechanism 16 with a predetermined coupling force, and thereby the puncture body 14 is supported (fixed) to the distal end portion of the shaft 12. The puncture body 14 can be detached from the shaft 12 by the action of the separation mechanism 16.

  The body portion 22 is a portion formed in a loosely wound coil shape in the puncture body 14. The number of spiral turns of the body portion 22 can be appropriately selected according to the size of the aneurysm to be treated, and is, for example, about 2 to 30 turns. The sharpened portion 24 is a portion that constitutes the most distal portion of the helical shape of the body portion 22, and is formed so sharp as to be able to puncture a tissue (blood vessel and aneurysm) that constitutes a living body lumen.

  The puncture body 14 has a straight axis in the natural state. An X-ray impermeable marker may be provided on the entire puncture body 14 or the tip of the puncture body 14 (the sharpened portion 24 and its vicinity) so that it can be recognized under X-ray fluoroscopy. Like the shaft 12, the puncture body 14 is flexible enough to easily follow the curvature of the living body lumen when inserted into the living body lumen and travels through the lumen, and is pierced into the aneurysm and blood vessel. Therefore, it is preferable to have an appropriate rigidity so that the state in which the knob is reduced can be maintained.

  Therefore, the puncture body 14 is made of, for example, an elastic or superelastic metal material such as stainless steel, tantalum, cobalt alloy, titanium alloy, or a polyolefin such as polyethylene, polypropylene, ethylene-vinyl acetate copolymer, or polyvinyl chloride. , Polymethyl methacrylate, polycarbonate, polybutadiene, polyamide, polyester, and other various polymers.

  The dimensions of the puncture body 14 are appropriately selected depending on the site to be treated. For example, when used for the treatment of a cerebral aneurysm, the overall length is 2 to 50 mm, and the outer diameter (the outer diameter of the body portion 22). Is set to about 0.6 to 3 mm, and the wire diameter is set to about 0.01 to 1 mm. The outer diameter of the puncture body 14 is preferably set to be substantially the same as or smaller than the outer diameter of the shaft 12.

  The displacement mechanism 15 is configured to be able to displace the sharpened portion 24 by pressing the distal end portion (the sharpened portion 24 or its vicinity) of the punctured body 14 from the inside of the punctured body 14. In the present embodiment, the displacement mechanism 15 is disposed along the shaft 12 while being connected to the pressing member 26 that is elastically deformable with the distal end portion disposed in the vicinity of the distal end portion of the puncture body 14. And a pull wire 27 (drive member). The pull wire can be made of metal, resin, or the like, but preferably has a rigidity that hardly causes elongation due to elastic deformation so that the pressing member 26 can be reliably driven.

  The pressing member 26 extends from the tip of the shaft 12 and is disposed in the hollow portion of the puncture body 14. Specifically, the pressing member 26 includes a flat arm 29 whose base end is fixed to the distal end of the shaft 12 and extends in the distal direction along the axis of the shaft 12, and is bent and sharpened from the distal end of the arm 29. The intermediate part 30 which approaches the part 24 side, and the press part 31 bent in the front-end | tip direction from the outer end of this intermediate part 30 are included.

  In the present embodiment, the pressing member 26 is disposed at a position eccentric to the outside from the center of the shaft 12. In other words, the pressing member 26 is disposed at a position eccentric to the sharpened portion 24 side in the hollow portion of the puncture body 14. The holding member 26 is made of a material having an appropriate rigidity and elasticity that is bent by elastic deformation when pulled by the pull wire 27 when the pull wire 27 is displaced in the proximal direction. It may be composed of any of the materials exemplified as above.

  The distal end portion of the pull wire 27 is coupled to the intermediate portion 30 that is bent from the distal end of the arm 29 toward the inner peripheral portion of the puncture body 14. The pressing portion 31 is disposed on the inner side of the distal end portion of the puncture body 14 so as to be opposed to the distal end portion. When the pressing portion 31 is displaced radially outward of the puncture body 14, the distal end portion of the puncture body 14 is moved in the radial direction. It is comprised so that it may press from an inner side.

  The pull wire 27 is a linear member having flexibility, is inserted and arranged in the lumen 13 of the shaft 12, is pulled out from the distal end opening 13a of the lumen 13 in the distal direction, and is inserted into the hollow portion of the puncture body 14, The tip is connected to the intermediate portion 30. The base end of the pull wire 27 is connected to an operation unit 28 (see FIG. 1) provided in the grip unit 18, and the pull wire 27 is connected to the operation unit 28 according to a predetermined operation (push / pull operation, rotation operation, etc.). It moves forward and backward along the lumen 13 of the shaft 12.

  As shown in FIG. 3A, in a state where the pull wire 27 is not pulled, the arm 29 of the pressing member 26 maintains a substantially straight shape. Therefore, the puncture body 14 also maintains its natural shape. On the other hand, when the operation portion 28 is operated and the pull wire 27 is pulled in the proximal direction, the arm 29 is bent and deformed as the intermediate portion 30 is pulled in the proximal direction, as shown in FIG. The pressing part 31 is displaced radially outward of the puncture body 14. At the same time, the distal end portion of the puncture body 14 is pressed by the pressing portion 31 from the inside, and thus is displaced radially outward.

  The detachment mechanism 16 is configured to be able to detach the puncture body 14. The detachment mechanism 16 having such a function has a configuration in which two separately configured members are detachably connected by physical engagement (fitting, hooking, etc.), or a certain member is subjected to some physical action (thermal It is possible to adopt a configuration in which the parts are separated so as to be detachable by being separated by a chemical action, a chemical action, or the like. Hereinafter, some configuration examples of the separation mechanism 16 will be described, but it is needless to say that the separation mechanism 16 is not limited to these configuration examples.

  The detachment mechanism 16A according to the first configuration example shown in FIG. 4A is configured such that the base 20 of the puncture body 14 and the shaft 12 are fitted. The fitting force (bonding force) between the base 20 and the shaft 12 is fitted and maintained in a connected state until the force for detaching both is less than a predetermined value. The fitting force is set such that the base 20 and the shaft 12 are detached by disengaging the fitting. According to the detachment mechanism 16A configured as described above, the puncture body 14 can be automatically detached from the shaft 12 by moving the shaft 12 backward after the puncture body 14 is punctured into the aneurysm and blood vessel wall. . In FIG. 4A, the base 20 is inserted into the fitting hole 12a provided in the shaft 12 so that the two fit together. However, the relationship between the fitting male and female is reversed. Also good. That is, a fitting hole may be provided in the base 20 of the puncture body 14, and a fitting protrusion that can be fitted into the fitting hole may be provided at the tip of the shaft 12.

  The detachment mechanism 16B according to the second configuration example illustrated in FIG. 4B has a configuration in which the base 20 and the shaft 12 are screwed together. Specifically, a male screw 35 is formed on the outer peripheral portion of the base portion 20, and a female screw 36 is formed on the inner peripheral portion of the shaft 12. The male screw 35 and the female screw 36 are formed so as to be unscrewed in the rotational direction of the shaft 12 when performing a procedure for treating an aneurysm. Near the base end of the spiral body part 22, a hook-like locking part 32 is provided. The screwing force (coupling force) between the base 20 and the shaft 12 maintains the screwing until the torque acting between them is less than a predetermined value, but when the torque exceeding the predetermined value is applied, the screwing is released. The puncture body 14 and the shaft 12 are set to be detached.

  According to the detachment mechanism 16B configured in this way, after the puncture body 14 is engaged with the aneurysm and the blood vessel wall, when the shaft 12 is further rotated, the locking portion 32 comes into contact with the inner wall of the blood vessel so that the puncture body 14 rotation is blocked. When the torque becomes greater than or equal to a predetermined value by rotating the shaft 12, the puncture body 14 and the shaft 12 are disengaged, so that the puncture body 14 can be automatically detached from the shaft 12. In FIG. 4B, the male screw 35 provided on the base portion 20 is screwed into the female screw 36 provided on the shaft 12 so that they are connected. The configuration may be reversed. That is, a configuration in which a female screw is provided at the base 20 of the puncture body 14 and a male screw is provided at the tip of the shaft 12 may be employed.

  The disengaging mechanism 16C according to the third configuration example shown in FIG. 4C includes a connecting portion 38 that connects the base portion 20 and the tip of the shaft 12, a heater 40 that is wound around the outer periphery of the connecting portion 38 in a coil shape, and a heater 40. And first and second conductors 42 and 44 connected to each other. The connecting portion 38 is made of a material (for example, a resin, a low melting point metal, or the like) that can be melted and broken when heated. The first conducting wire 42 is connected to one end of the heater 40, the second conducting wire 44 is connected to the other end of the heater 40, and the first and second conducting wires 42 and 44 are inserted into the shaft 12 and connected to the heater 40. It is connected to the power source at the end opposite to the connected side. The power source may be either direct current or alternating current.

  According to the detachment mechanism 16C configured in this way, by puncturing the puncture body 14 into the aneurysm and blood vessel wall, the heater 40 is energized through the first and second conductive wires 42 and 44 to generate heat. The puncture body 14 can be detached from the shaft 12 by melting and breaking the connecting portion 38.

  The disengagement mechanism 16D according to the fourth configuration example shown in FIG. 4D includes a hook portion 46 provided at the base portion 20 of the puncture body 14 and an engagement portion 48 provided at the distal end of the shaft 12 and engaged with the hook portion 46. Prepare. Near the base end of the spiral body part 22, a hook-like locking part 32 is provided. According to the detachment mechanism 16D, the hook portion 46 and the engagement portion 48 are disengaged by pushing the shaft 12 slightly forward with the puncture body 14 punctured into the blood vessel wall. 20 can be detached from the tip of the shaft 12. According to the detachment mechanism 16D configured in this way, after the puncture body 14 is engaged with the aneurysm and the blood vessel wall, when the shaft 12 is further rotated, the locking portion 32 comes into contact with the inner wall of the blood vessel so that the puncture body 14 rotation is blocked. When the torque becomes greater than or equal to a predetermined value by rotating the shaft 12, the puncture body 14 and the shaft 12 are disengaged, so that the puncture body 14 can be automatically detached from the shaft 12.

  4E includes an interposition member 51 having a ball-like portion 50, a tension member 52 that pulls the interposition member 51 toward the base 20 of the puncture body 14, and the tip of the shaft 12. A holding ring 54 provided in the section and a release wire 56 inserted into the shaft 12 are provided. For example, the release wire 56 is connected to an operation unit (slide knob or the like) different from the operation unit 28 provided in the grip unit 18, and is pulled back in the proximal direction by the operation of the operation unit.

  As shown in FIG. 4E, when the release wire 56 is sandwiched between the holding ring 54 and the ball-shaped portion 50 (the ball-shaped portion 50 and the release wire 56 are fixed), the ball-shaped portion 50 is held. Since the movement through the ring 54 and the movement into the base 20 is prevented, the connection state between the puncture body 14 and the shaft 12 is maintained. On the other hand, when the operation portion is operated and the release wire 56 is pulled in the proximal direction, the release wire 56 is detached from between the holding ring 54 and the ball-shaped portion 50, so that the ball-shaped portion 50 moves inside the holding ring 54. The ball-shaped portion 50 moves into the base portion 20 under the tension action of the tension member 52. Thereby, the puncture body 14 can be detached from the shaft 12.

  Other configurations of the detachment mechanism 16 include a configuration in which the base 20 of the puncture body 14 and the tip of the shaft 12 are coupled by a metal coupling portion, and the coupling portion is electrolyzed to be detached from the shaft 12, A configuration may be employed in which fluid pressure is applied to the connecting portion, and the base portion 20 of the puncture body 14 and the connecting portion of the shaft 12 are cut and detached from the shaft 12.

  The aneurysm treatment device 10 according to the present embodiment is basically configured as described above. In the following, the aneurysm treatment device 10 is related to the method of using the aneurysm treatment device 10 (aneurysm treatment method). The operation and effect of will be described. The aneurysm treatment method using the aneurysm treatment device 10 includes the following steps.

(1) Access step (first step)
As shown in FIG. 5A, the aneurysm treatment device 10 is disposed in the vicinity of the aneurysm 62 that is a treatment target site through the catheter 11. The aneurysm 62 to be treated is a hollow bag-like tissue generated in a living body lumen. The aneurysm 62 consists of a portion whose outer surface protrudes so that a part thereof swells outward from the luminal tissue. The protruding portion has a space inside, and this space communicates with the inside of the lumen via the opening 63. The aneurysm treatment device 10 is intended for an aneurysm 62 in which the opening 63 is relatively large and does not have a neck. An aneurysm 62 having a relatively wide opening 63 and having no neck cannot be embedded with a coil or the like. However, according to the aneurysm treatment device 10, the aneurysm 62 having such a shape can be treated. Is possible. Examples of blood vessels in which the aneurysm 62 is generated include arteries, veins, and peripheral blood vessels. Examples of the aneurysm 62 include a cerebral aneurysm, an abdominal aneurysm, a thoracic aneurysm, a coronary aneurysm, a popliteal aneurysm, a femoral aneurysm, a carotid aneurysm, and a varicose vein.

  Specifically, in this access step, the catheter 11 through which the guide wire is inserted travels into the blood vessel 60, and the distal end of the catheter 11 reaches the vicinity of the opening 63 of the aneurysm 62. Thereafter, the guide wire is removed from the catheter 11, and the aneurysm treatment device 10 is inserted into the catheter 11. Once the guide wire is removed from the catheter 11, the aneurysm treatment device 10 is inserted into the catheter 11. In this case, as shown in FIG. 5A, the tip of the aneurysm treatment device 10 is disposed at a position slightly in front of the aneurysm 62. Specifically, when the shaft 12 is pushed and pulled and rotated, the sharpened portion 24 of the puncture body 14 faces the blood vessel wall in the vicinity of the aneurysm 62 (the blood vessel wall proximal to the shaft 12). The orientation and position of the puncture body 14 in the blood vessel 60 are adjusted so that

(2) Engagement step (second step)
Next, in a state where the position of the catheter 11 is maintained, an engaging step for engaging the puncture body 14 with the aneurysm 62 and the blood vessel wall in the vicinity thereof is performed. The engaging step includes a pressing step for pressing the sharpened portion 24 provided on the puncture body 14 against the blood vessel wall in or near the aneurysm 62, and a puncturing step for puncturing the sharpened portion 24 in the blood vessel wall near the aneurysm 62 or in the vicinity thereof. And repeating the pressing step and the puncturing step.

  In the pressing step, first, the operating portion 28 is operated, and the pressing portion 31 of the pressing member 26 is displaced radially outward of the puncture body 14 by pulling the pull wire 27 in the proximal direction as shown in FIG. 5B. . If it does so, the press part 31 will press the front-end | tip part (the sharp part 24 or its vicinity part) of the puncture body 14, and will displace to radial direction outward. As a result, the sharpened portion 24 of the puncture body 14 is pressed against the blood vessel wall in the vicinity of the aneurysm 62.

  In the puncturing step, the puncture body 14 connected to the tip of the shaft 12 is rotated in the circumferential direction by rotating the shaft 12 in the circumferential direction while pressing the sharpened portion 24 against the blood vessel wall. Thereby, first, the sharpened portion 24 is punctured into the blood vessel wall. Then, by further rotating the puncture body 14 with the sharpened portion 24 pierced into the blood vessel wall, the sharpened portion 24 is exposed in the blood vessel 60 as shown in FIG. 5C. As a result, the puncture body 14 is engaged with the blood vessel wall in the vicinity of the aneurysm 62.

  When the puncture body 14 is rotated with the sharpened portion 24 pierced in the blood vessel wall, when the sharpened portion 24 begins to pierce the blood vessel wall, the pulling operation on the pull wire 27 is released. That is, the pull wire 27 is restored. Then, the pressing member 26 returns to its original shape by the elastic restoring force, and the pressing of the pressing portion 31 against the distal end portion of the puncture body 14 is released.

  Next, the puncture body 14 is moved further in the distal direction while rotating further, and the distal end portion of the puncture body 14 is disposed at a position facing the inner wall of the aneurysm 62. By rotating the puncture body 14 once in this way, the sharpened portion 24 of the puncture body 14 comes again to the aneurysm 62 side. Repeat the pressing step and the puncturing step. That is, by pulling the pull wire 27 in the proximal direction, the pressing portion 31 of the pressing member 26 is displaced radially outward of the puncture body 14 as shown in FIG. 5D. If it does so, the press part 31 will press the front-end | tip part of the puncture body 14, and will displace to radial direction outward. As a result, the sharpened portion 24 of the puncture body 14 is pressed against the inner wall of the knob 62. Next, the sharpened portion 24 is exposed in the blood vessel 60 by rotating the puncture body 14 in the circumferential direction while pressing the sharpened portion 24 against the inner wall of the knob 62, as in FIG. 5C.

  By repeatedly performing such a pressing step and puncturing step on the aneurysm 62, as shown in FIG. 6A, the wall portion of the aneurysm 62 is brought inward of the blood vessel 60, and the aneurysm 62 is reduced. That is, each time the puncture body 14 is rotated once, when the puncture body 14 is sequentially engaged with the aneurysm 62, the engagement position of the aneurysm 62 with the puncture body 14 is changed to the inside of the blood vessel 60 by the elastic force of the puncture body 14. Be drawn to. As shown in FIG. 6B, the pressing step and the puncturing step are repeated until the puncture body 14 is engaged with the blood vessel wall in the vicinity of the aneurysm 62 (the blood vessel wall distal to the shaft 12). As a result, the puncture body 14 is punctured and fixed to the aneurysm 62 and the blood vessel wall in the vicinity thereof.

  The length of the body portion 22 of the puncture body 14 is preferably larger than the size of the opening 63 (see FIG. 5A) of the aneurysm 62 (opening dimension along the longitudinal direction of the blood vessel 60), thereby reducing the aneurysm 62. The held state can be securely held. However, the length of the trunk portion 22 of the puncture body 14 may be smaller than the size of the opening 63 (see FIG. 5A) of the aneurysm 62 (opening dimension along the longitudinal direction of the blood vessel 60). In this case, the puncture body 14 can be punctured into only a part of the aneurysm 62 to reduce the aneurysm 62.

  If the aneurysm 62 is not sufficiently reduced only by the above-described procedure, the aneurysm 62 can be effectively reduced by adjusting the diameter or shape of the puncture body 14 by rotating or advancing and retracting the shaft 12. Can do.

(3) Removal step (third step)
Next, as shown in FIG. 6C, the puncture body 14 is detached from the shaft 12 (specifically, the tip of the shaft 12) under the action of the separation mechanism 16. The operation for detaching the puncture body 14 from the shaft 12 depends on the configuration of the detachment mechanism 16.

  In the case of the detachment mechanism 16A shown in FIG. 4A, when the shaft 12 is rotated while the puncture body 14 is punctured into the blood vessel and the aneurysm 62, a force exceeding the fitting force between the tip of the shaft 12 and the puncture body 14 is applied. Since the fitting is released, the puncture body 14 can be detached from the shaft 12. Or you may remove | fitting the front-end | tip of the shaft 12, and the base 20 of the puncture body 14 by moving the shaft 12 backward.

  In the case of the detachment mechanism 16B shown in FIG. 4B, when the puncture body 14 is engaged with the aneurysm 62 and the blood vessel wall in the vicinity thereof, when the shaft 12 is further rotated, the locking portion 32 comes into contact with the inner wall of the blood vessel. Thus, the rotation of the puncture body 14 is prevented, whereby the distal end of the shaft 12 and the base 20 of the puncture body 14 are disengaged, so that the puncture body 14 can be detached from the shaft 12.

  In the case of the detaching mechanism 16C shown in FIG. 4C, after the puncture body 14 is punctured into the blood vessel and the aneurysm 62, the heater 40 is energized to melt and break the connecting portion 38, thereby detaching the puncture body 14 from the shaft 12. Can do.

  In the case of the detachment mechanism 16D shown in FIG. 4D, when the puncture body 14 is engaged with the aneurysm 62 and the blood vessel wall in the vicinity thereof, when the shaft 12 is further pushed to the distal end side and then rotated, the locking portion 32 becomes the blood vessel. The rotation of the puncture body 14 is prevented by abutting against the inner wall of the 60, whereby the engagement between the hook portion 46 provided on the base 20 of the puncture body 14 and the engagement portion 48 provided on the tip of the shaft 12 is prevented. Since it comes off, the puncture body 14 can be detached from the shaft 12.

  In the case of the detachment mechanism 16E shown in FIG. 4E, the puncture body 14 is punctured into the blood vessel and the aneurysm 62, and then the operation portion 28 (not shown) provided on the grip portion 18 is operated to hold the release wire 56 with the ball-shaped portion 50. The puncture body 14 can be detached from the shaft 12 by being pulled out from between the ring 54 and moving the ball-shaped portion 50 into the base portion 20.

  By performing the above steps (1) to (3), as shown in FIG. 6D, only the puncture body 14 is placed in the body while being fixed to the aneurysm 62, and this state is maintained. The aneurysm 62 is reduced and no longer bulges outward from the blood vessel 60 as it was before the procedure, but becomes a wave shape to form part of the vessel wall. In addition, although the trunk | drum 22 comprised in the helical form has the one end side fixed to the blood vessel wall (aneurysm 62) and the other end side of the trunk | drum 22 is not in contact with the blood vessel wall, the other end side Alternatively, it may be placed so as to be in contact with the blood vessel wall on the opposite side opposite to the aneurysm 62 (state of contact without engagement).

  As described above, according to the aneurysm treatment device 10 according to the present embodiment, the aneurysm treatment device 10 is inserted into the catheter 11 to access the aneurysm 62 generated in the blood vessel 60, and the sharpened portion 24 of the puncture body 14 is removed. By combining the operation of moving and the operation of rotating the puncture body 14, the puncture body 14 is punctured and engaged with the aneurysm 62 and the blood vessel wall in the vicinity thereof, and then the puncture body 14 is detached from the shaft 12. be able to.

  By such a procedure, the aneurysm 62 can be reduced and held in a state reinforced by the puncture body 14. Since the wall portion of the lumbar 62 is punctured by the puncture body 14 and held in a wave shape, the wall portion thereof is reinforced, so that the risk of the rupture of the lumbar 62 can be effectively reduced. Further, since the bulge 62 does not bulge from the blood vessel 60, the influence on the surrounding tissue can be reduced. That is, for example, in the case of a cerebral aneurysm, by reducing the size of the cerebral aneurysm, the pressure on the brain tissue around the cerebral aneurysm can be reduced, and the therapeutic effect can be further enhanced.

  In the case of the present embodiment, as described above, the displacement mechanism 15 is disposed in the hollow portion of the puncture body 14 and is elastically deformable with the pressing member 26 and is connected to the pressing member 26 and disposed along the shaft 12. And a pull wire 27. When the pull wire 27 is displaced in the proximal direction, the pressing member 26 is elastically deformed to displace the sharpened portion 24 of the puncture body 14 outward. Such a displacement mechanism 15 does not need to provide a complicated drive mechanism at the distal end portion of the aneurysm treatment device 10 and can be configured compactly, which contributes to a reduction in the diameter of the aneurysm treatment device 10.

  In the case of this embodiment, since the pressing member 26 is disposed at a position eccentric to the sharpened portion 24 side in the hollow portion of the puncture body 14, the area occupied by the pressing member 26 in the plane orthogonal to the axial direction is reduced. The displacement mechanism 15 can be configured more compactly.

  In the case of this embodiment, the pressing member 26 includes an arm 29 extending from the tip of the shaft 12, an intermediate portion 30 bent at the tip of the arm 29 and approaching the sharpened portion 24, and an outer end of the intermediate portion 30. And the pressing portion 31 that can press the distal end portion (the sharpened portion 24 or its vicinity) of the puncture body 14, and the distal end of the pull wire 27 is connected to the intermediate portion 30. By displacing in the direction, the arm 29 is bent by elastic deformation, and the pressing portion 31 is displaced outward. Therefore, the sharpened portion 24 of the puncture body 14 can be pressed from the inside thereof, and the sharpened portion 24 can be reliably pressed against the aneurysm 62 or the blood vessel wall.

  In the above-described embodiment, the puncture body 14 is engaged only with the aneurysm 62 and the blood vessel wall in the vicinity thereof, but the puncture body 14 is also engaged with the blood vessel wall facing the aneurysm 62 as shown in FIG. You may let them. The step of engaging the puncture body 14 with the blood vessel wall facing the aneurysm 62 (hereinafter referred to as “auxiliary engagement step”) is performed after the puncture body 14 is engaged with the blood vessel wall proximal to the shaft 12. The shaft 12 until the puncture body 14 is engaged with the aneurysm 62, during each engagement operation when the puncture body 14 is engaged with the aneurysm 62 a plurality of times, or after the puncture body 14 is engaged with the aneurysm 62. Can be performed at any timing until the puncture body 14 is engaged with the blood vessel wall on the distal side.

  Specifically, in the auxiliary engagement step, first, the puncture body 14 is rotated to place the sharpened portion 24 on the blood vessel wall facing the aneurysm 62. Then, by pulling the pull wire 27 and displacing the pressing portion 31 of the pressing member 26 radially outward of the puncture body 14, the sharpened portion 24 is punctured into the blood vessel wall facing the aneurysm 62. Next, the sharpened portion 24 is exposed in the blood vessel by rotating the puncture body 14 in the circumferential direction. The place where the puncture body 14 is engaged with the blood vessel wall facing the aneurysm 62 may be one place or a plurality of places in the longitudinal direction of the blood vessel 60.

  Thus, by engaging the puncture body 14 not only with the aneurysm 62 and the blood vessel wall in the vicinity thereof, but also with the blood vessel wall facing the aneurysm 62, the reduced state of the aneurysm 62 can be reliably maintained, and high treatment is achieved. An effect is obtained.

  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 ... Aneurysm treatment device 11 ... Catheter 12 ... Shaft 14 ... Puncture 15 ... Displacement mechanism 16, 16A-16E ... Detachment mechanism 24 ... Sharp part 26 ... Pressing member 27 ... Pull wire (drive member) 29 ... Arm 30 ... Middle part 31 ... Pressing part

Claims (6)

A linear shaft having flexibility;
A puncture body having a helically configured body portion and a sharpened portion provided at the tip of the body portion, elastically deformable, and connected to the tip of the shaft;
A displacement mechanism provided on the shaft and capable of displacing the sharpened portion by pressing the tip of the puncture body from the inside of the puncture body;
A detachment mechanism capable of detaching the puncture body from the shaft,
An aneurysm treatment device characterized by that. The aneurysm treatment device according to claim 1, wherein
The displacement mechanism includes a pressing member that is disposed in the hollow portion of the puncture body and is elastically deformable, and a driving member that is coupled to the pressing member and disposed along the shaft. When displaced in the end direction, the pressing member is elastically deformed to displace the sharpened portion of the puncture body outwardly,
An aneurysm treatment device characterized by that. The aneurysm treatment device according to claim 2,
The pressing member is disposed at a position eccentric to the sharpened portion side in the hollow portion of the puncture body,
An aneurysm treatment device characterized by that. The aneurysm treatment device according to claim 2 or 3,
The pressing member includes an arm extending from the tip of the shaft, an intermediate portion bent at the tip of the arm and approaching the sharpened portion side, and a tip portion of the puncture body provided at an outer end of the intermediate portion. A pressing part that can be pressed,
The front end of the drive member is connected to the intermediate part,
An aneurysm treatment device characterized by that. Access for delivering an aneurysm treatment device including a linear shaft having flexibility and a spiral puncture body connected to a tip of the shaft to a position where the aneurysm is located through a catheter inserted into a blood vessel Steps,
An engagement step of engaging the puncture body with the aneurysm and the blood vessel wall in the vicinity thereof;
A detachment step of detaching the puncture body from the shaft in a state in which the puncture body is engaged with the aneurysm and a blood vessel wall in the vicinity thereof,
The engaging step includes a pressing step of pressing the sharpened portion of the puncture body against the blood vessel wall in the vicinity of the aneurysm or the vicinity thereof, and the puncture body in a state where the sharpened portion is pressed against the blood vessel wall of the aneurysm or the vicinity thereof. Puncturing the sharpened portion into the aneurysm or the blood vessel wall in the vicinity thereof by rotating and puncturing the sharpened portion into the blood vessel, and repeating the pressing step and the puncturing step.
An aneurysm treatment method characterized by the above. The aneurysm treatment method according to claim 5,
The engagement step further includes an auxiliary engagement step of engaging the puncture body with a blood vessel wall facing the aneurysm.
An aneurysm treatment method characterized by the above.

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