JP2013150694A

JP2013150694A - Aneurysm treatment device and aneurysm treatment method

Info

Publication number: JP2013150694A
Application number: JP2012012789A
Authority: JP
Inventors: Katsuki Ebata; 勝紀江畑; Tetsuya Fukuoka; 徹也福岡
Original assignee: Terumo Corp
Current assignee: Terumo Corp
Priority date: 2012-01-25
Filing date: 2012-01-25
Publication date: 2013-08-08

Abstract

PROBLEM TO BE SOLVED: To provide an aneurysm treatment device which is configured in association with a method for treating an aneurysm via a blood vessel, which can effectively suppress an increase in internal pressure of an aneurysm and which can reduce an influence on surrounding tissue, and the aneurysm treatment method.SOLUTION: An aneurysm treatment device 10 includes: a linear shaft 12 with flexibility; an engagement part 14 which is connected to a tip part of the shaft 12 and which has at least one hook 24 capable of being engaged with an inner wall of an aneurysm and the vicinity of an opening thereof; and a disengagement mechanism 16 which disengageably connects the shaft 12 and the engagement part 14 together. The engagement part 14 has a spiral part 22 provided on the base end side of the hook 24. The hook 24 has a midway part bent, and has a sharp-pointed part 24a directed to the base end side of the engagement part 14.

Description

本発明は、生体器官に発生した瘤を治療するための瘤治療デバイス及び瘤治療方法に関する。 The present invention relates to an aneurysm treatment device and aneurysm treatment method for treating an aneurysm generated in a living organ.

血管の一部が膨らんで弱くなっている部分は瘤と呼ばれ、特に脳の動脈に生じるものは脳動脈瘤と呼ばれる。脳動脈瘤が破裂した場合、クモ膜下出血が起こる。このような破裂を予防するための治療方法としては、いくつかの方法がある。ひとつは、脳神経外科的に開頭し、脳動脈瘤と親動脈との間（動脈瘤の根元部分）をクリップで留める「ネッククリップ術」である。別の治療方法は、開頭することなく治療をするものであり、血管内を通してカテーテルを脳動脈瘤の中に入れ、当該カテーテルを通してプラチナ等の金属からなる柔軟なコイルを脳動脈瘤内に埋め込む「塞栓術」と呼ばれる方法である（下記特許文献１）。 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).

特表２００８−５１０５９４号公報Special table 2008-510594 gazette

本発明は、血管を介して（血管内インターベンション的な手技により）瘤を治療するための方法に関連してなされたものであり、瘤内圧の上昇を効果的に抑制することができ且つ周辺組織への影響を低減することが可能な瘤治療デバイス及び瘤治療方法を提供することを目的とする。 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 and an aneurysm treatment method capable of reducing the influence on a tissue.

上記の目的を達成するため、本発明の瘤治療デバイスは、可撓性を有する線状のシャフトと、前記シャフトの先端部に連結され、生体内に生じた瘤の内壁と、前記瘤の開口部近傍とに係合可能な少なくとも１つのフックを有する係合部と、前記シャフトと前記係合部とを離脱可能に連結する離脱機構とを備えることを特徴とする。 In order to achieve the above object, an aneurysm treatment device of the present invention includes a flexible linear shaft, an inner wall of an aneurysm that is connected to a distal end of the shaft, and an opening of the aneurysm. An engagement portion having at least one hook that can be engaged with the vicinity of the portion, and a release mechanism that releasably connects the shaft and the engagement portion.

上記の構成によれば、カテーテル内に瘤治療デバイスを挿通して血管に発生した瘤にアクセスし、先端に設けられた係合部を、瘤の内壁と瘤の開口部近傍の両方に順に係合させることにより、瘤の内壁の一部と開口部とを近づけた状態で保持し、その後、係合部をシャフトから離脱させる手技を実施することができる。瘤の内壁の一部と開口部とを近づけた状態で保持することにより、瘤の開口部が縮小又は閉塞するので、瘤内圧の上昇を効果的に抑制することができる。また、瘤の内容積が減少するので、瘤内圧の上昇を効果的に抑制するとともに周辺組織への影響を低減することができる。 According to the above configuration, the aneurysm treatment device is inserted into the catheter to access the aneurysm generated in the blood vessel, and the engaging portion provided at the distal end is sequentially engaged with both the inner wall of the aneurysm and the vicinity of the opening of the aneurysm. By combining, it is possible to carry out a procedure for holding a part of the inner wall of the knob and the opening in a close state, and then releasing the engaging portion from the shaft. By holding a part of the inner wall of the aneurysm and the opening in a close state, the opening of the aneurysm is reduced or closed, so that an increase in the internal pressure of the aneurysm can be effectively suppressed. Further, since the volume of the aneurysm is reduced, it is possible to effectively suppress the increase in the internal pressure of the aneurysm and reduce the influence on the surrounding tissue.

上記の瘤治療デバイスにおいて、前記係合部は、前記フックの基端側に螺旋部を有するとよい。 In the aneurysm treatment device, the engagement portion may have a spiral portion on a proximal end side of the hook.

上記の構成によれば、フックの基端側に螺旋部が設けられているので、係合部を回転させることによりフックを瘤の内壁又は開口部近傍に係合させる手技を行う際に、トルクをシャフト側からフックへ良好に伝達することができ、操作性に優れる。よって、手技を円滑に遂行することができる。 According to the above configuration, since the spiral portion is provided on the proximal end side of the hook, when performing the procedure of engaging the hook with the inner wall of the aneurysm or the vicinity of the opening by rotating the engaging portion, the torque Can be satisfactorily transmitted from the shaft side to the hook, and the operability is excellent. Therefore, the procedure can be performed smoothly.

上記の瘤治療デバイスにおいて、前記係合部の先端部に設けられた前記フックは、途中部位が屈曲し、先鋭部が前記係合部の基端側を向いているとよい。 In the aneurysm treatment device, the hook provided at the distal end portion of the engagement portion may be bent at a midpoint, and the sharpened portion may face the proximal end side of the engagement portion.

上記の構成によれば、フックの先鋭部を瘤の内壁から突出させる手技を容易且つ確実に行うことができる。このため、瘤の内壁に係合させた状態のフックを、瘤の開口部近傍に係合させる手技を容易に遂行するとともに瘤の内壁に一度係合させた後に係合が外れることを防ぐことができる。 According to said structure, the procedure which makes the sharp part of a hook protrude from the inner wall of a knob can be performed easily and reliably. For this reason, the hook engaged with the inner wall of the aneurysm can be easily engaged with the hook in the vicinity of the opening of the aneurysm and prevented from being disengaged after being once engaged with the inner wall of the aneurysm. Can do.

上記の瘤治療デバイスにおいて、前記係合部は、互いに異なる方向に設けられた複数の前記フックを有してもよい。 In the aneurysm treatment device, the engagement portion may include a plurality of the hooks provided in different directions.

上記の構成によれば、複数のフックの各々を、係合すべき各部位に対して確実且つ容易に係合させることができる。 According to said structure, each of several hook can be reliably and easily engaged with each site | part which should be engaged.

また、本発明の瘤治療方法は、可撓性を有する線状のシャフトと、前記シャフトの先端に設けられフックを有する係合部と、前記シャフトと前記係合部とを離脱可能に連結する離脱機構とを備えた瘤治療デバイスを、血管内に挿通されたカテーテル内を通して瘤がある位置まで送達するアクセスステップと、前記瘤内に前記係合部を挿入する挿入ステップと、前記係合部を前記瘤の内壁に係合させる第１係合ステップと、前記係合部を前記瘤の内壁に係合させた状態で、前記係合部を前記瘤の開口部側に引き寄せる引張ステップと、前記瘤の内壁に係合した状態の前記係合部を前記瘤の開口部近傍に係合させる第２係合ステップと、前記係合部を前記シャフトから離脱させる離脱ステップとを含むことを特徴とする。 In the aneurysm treatment method of the present invention, a flexible linear shaft, an engagement portion provided at a tip of the shaft and having a hook, and the shaft and the engagement portion are detachably connected. An access step for delivering an aneurysm treatment device comprising a disengagement mechanism through a catheter inserted into a blood vessel to a position where the aneurysm is located; an insertion step for inserting the engagement portion into the aneurysm; and the engagement portion A first engaging step that engages the inner wall of the knob, and a pulling step that draws the engaging portion toward the opening of the knob in a state where the engaging portion is engaged with the inner wall of the knob. A second engaging step for engaging the engaging portion engaged with the inner wall of the knob in the vicinity of the opening of the knob and a detaching step for releasing the engaging portion from the shaft. And

上記の瘤治療方法によれば、瘤の開口部を縮小又は閉塞させることにより、瘤内圧の上昇を効果的に抑制することができる。また、瘤の内容積が減少するので、瘤内圧の上昇を効果的に抑制するとともに周辺組織への影響を低減することができる。 According to the aneurysm treatment method described above, an increase in the internal pressure of the aneurysm can be effectively suppressed by reducing or closing the opening of the aneurysm. Further, since the volume of the aneurysm is reduced, it is possible to effectively suppress the increase in the internal pressure of the aneurysm and reduce the influence on the surrounding tissue.

上記の瘤治療方法において、前記係合部の先端部を構成する前記フックは、途中部位が屈曲し、先鋭部が前記係合部の基端側を向いており、前記第１係合ステップでは、前記係合部を回転させ、前記フックを前記瘤の内壁に刺した後、前記瘤の内壁から前記フックの先端を突出させ、前記第２係合ステップでは、前記瘤の内壁と係合した状態の前記フックを、前記瘤の開口部近傍に係合させてもよい。 In the above aneurysm treatment method, the hook constituting the distal end portion of the engagement portion is bent at a midpoint, and the sharpened portion faces the proximal end side of the engagement portion. In the first engagement step, The engaging portion is rotated, and the hook is inserted into the inner wall of the knob. Then, the tip of the hook protrudes from the inner wall of the knob, and in the second engaging step, the hook engages with the inner wall of the knob. The hook in a state may be engaged in the vicinity of the opening of the knob.

この方法によれば、係合部に設けるフックが１つだけで足り、係合部の構成を簡素化できる。また、フックが１つだけであるため、フックが周囲組織に触れて周囲組織を損傷する危険性も低い。 According to this method, only one hook is required for the engaging portion, and the configuration of the engaging portion can be simplified. Further, since there is only one hook, the risk of the hook touching the surrounding tissue and damaging the surrounding tissue is low.

上記の瘤治療方法において、前記係合部は、互いに異なる方向に設けられた複数の前記フックを有し、前記第１係合ステップでは、前記複数のフックのうち、前記係合部の先端部を構成するフックを前記瘤の内壁に係合させ、前記第２係合ステップでは、前記瘤の内壁に係合した前記フックとは別のフックを、前記瘤の開口部近傍に係合させてもよい。 In the aneurysm treatment method, the engagement portion includes a plurality of hooks provided in different directions, and in the first engagement step, of the plurality of hooks, a distal end portion of the engagement portion. In the second engagement step, a hook different from the hook engaged with the inner wall of the knob is engaged in the vicinity of the opening of the knob. Also good.

この方法によれば、複数の係合部の各々を、係合すべき各部位に対して確実且つ容易に係合させることができる。 According to this method, each of the plurality of engaging portions can be reliably and easily engaged with each portion to be engaged.

本発明の瘤治療デバイス及び瘤治療方法によれば、瘤内圧の上昇を効果的に抑制することができ且つ周辺組織への影響を低減することができる。 According to the aneurysm treatment device and the aneurysm treatment method of the present invention, it is possible to effectively suppress an increase in the internal pressure of the aneurysm and reduce the influence on the surrounding tissue.

本発明の第１実施形態に係る瘤治療デバイスの一部省略側面図である。It is a partially omitted side view of the aneurysm treatment device according to the first embodiment of the present invention. 図２Ａは、第１実施形態に係る瘤治療デバイスの係合部がカテーテルの先端部に位置した状態を示す側面断面図であり、図２Ｂは、第１実施形態に係る瘤治療デバイスの係合部がカテーテルの先端から押し出された状態を示す側面断面図であり、図２Ｃは、第１実施形態に係る瘤治療デバイスの係合部が弾性変形によって縮径した状態でカテーテルの先端内に位置した状態を示す側面断面図であり、図２Ｄは、第１実施形態に係る瘤治療デバイスがカテーテルの先端から押し出され、係合部が元の形状に復元した（拡径した）状態を示す側面断面図である。FIG. 2A is a side cross-sectional view showing a state in which the engagement portion of the aneurysm treatment device according to the first embodiment is located at the distal end portion of the catheter, and FIG. 2B is an engagement of the aneurysm treatment device according to the first embodiment. FIG. 2C is a side cross-sectional view showing a state in which the portion is pushed out from the distal end of the catheter, and FIG. 2C is a diagram showing a position within the distal end of the catheter in a state where the engaging portion of the aneurysm treatment device according to the first embodiment is reduced in diameter by elastic deformation. FIG. 2D is a side view showing a state in which the aneurysm treatment device according to the first embodiment is pushed out from the distal end of the catheter and the engaging portion is restored to its original shape (expanded diameter). It is sectional drawing. 図３Ａは、第１構成例に係る離脱機構の構成図であり、図３Ｂは、第２構成例に係る離脱機構の構成図であり、図３Ｃは、第３構成例に係る離脱機構の構成図であり、図３Ｄは、第４構成例に係る離脱機構の構成図であり、図３Ｅは、第５構成例に係る離脱機構の連結状態を示す構成図である。FIG. 3A is a configuration diagram of the detachment mechanism according to the first configuration example, FIG. 3B is a configuration diagram of the detachment mechanism according to the second configuration example, and FIG. 3C is a configuration of the detachment mechanism according to the third configuration example. FIG. 3D is a configuration diagram of the detachment mechanism according to the fourth configuration example, and FIG. 3E is a configuration diagram illustrating a connection state of the detachment mechanism according to the fifth configuration example. 図４Ａは、第１実施形態に係る瘤治療デバイスの使用方法を説明する第１の図であり、図４Ｂは、第１実施形態に係る瘤治療デバイスの使用方法を説明する第２の図であり、図４Ｃは、第１実施形態に係る瘤治療デバイスの使用方法を説明する第３の図である。FIG. 4A is a first diagram illustrating a method of using the aneurysm treatment device according to the first embodiment, and FIG. 4B is a second diagram illustrating a method of using the aneurysm treatment device according to the first embodiment. FIG. 4C is a third diagram for explaining a method of using the aneurysm treatment device according to the first embodiment. 図５Ａは、第１実施形態に係る瘤治療デバイスの使用方法を説明する第４の図であり、図５Ｂは、第１実施形態に係る瘤治療デバイスの使用方法を説明する第５の図であり、図５Ｃは、第１実施形態に係る瘤治療デバイスの使用方法を説明する第６の図である。FIG. 5A is a fourth diagram illustrating a method of using the aneurysm treatment device according to the first embodiment, and FIG. 5B is a fifth diagram illustrating a method of using the aneurysm treatment device according to the first embodiment. FIG. 5C is a sixth diagram illustrating a method for using the aneurysm treatment device according to the first embodiment. 本発明の第２実施形態に係る瘤治療デバイスの先端部を示す斜視図である。It is a perspective view which shows the front-end | tip part of the aneurysm treatment device which concerns on 2nd Embodiment of this invention. 図７Ａは、第２実施形態に係る瘤治療デバイスの使用方法を説明する第１の図であり、図７Ｂは、第２実施形態に係る瘤治療デバイスの使用方法を説明する第２の図であり、図７Ｃは、第２実施形態に係る瘤治療デバイスの使用方法を説明する第３の図であり、図７Ｄは、第２実施形態に係る瘤治療デバイスの使用方法を説明する第４の図である。FIG. 7A is a first diagram illustrating a method of using the aneurysm treatment device according to the second embodiment, and FIG. 7B is a second diagram illustrating a method of using the aneurysm treatment device according to the second embodiment. FIG. 7C is a third diagram for explaining how to use the aneurysm treatment device according to the second embodiment, and FIG. 7D is a fourth diagram for explaining the usage of the aneurysm treatment device according to the second embodiment. FIG. 図８Ａは、第２実施形態に係る瘤治療デバイスの使用方法を説明する第５の図であり、図８Ｂは、第２実施形態に係る瘤治療デバイスの使用方法を説明する第６の図であり、図８Ｃは、第２実施形態に係る瘤治療デバイスの使用方法を説明する第７の図である。FIG. 8A is a fifth diagram illustrating a method for using the aneurysm treatment device according to the second embodiment, and FIG. 8B is a sixth diagram illustrating a method for using the aneurysm treatment device according to the second embodiment. FIG. 8C is a seventh diagram illustrating a method of using the aneurysm treatment device according to the second embodiment. 本発明の第３実施形態に係る瘤治療デバイスの先端部を示す側面断面図である。It is side surface sectional drawing which shows the front-end | tip part of the aneurysm treatment device which concerns on 3rd Embodiment of this invention.

以下、本発明に係る瘤治療デバイス及び瘤治療方法について好適な実施形態を挙げ、添付の図面を参照しながら説明する。 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.

［第１実施形態］
図１は、本発明の一実施形態に係る瘤治療デバイス１０の構成を示す一部省略側面図である。この瘤治療デバイス１０は、カテーテル１１に挿通可能なシャフト１２と、シャフト１２に連結された係合部１４と、シャフト１２と係合部１４とを解除可能に連結する離脱機構１６とを備え、係合部１４を瘤の内壁とその開口部近傍とに係合させた後に、シャフト１２から係合部１４を離脱させることにより、瘤内部の血圧を下げて瘤の破裂を予防する治療をするためのデバイスである。以下、各構成要素の構成を説明する。 [First Embodiment]
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. The aneurysm treatment device 10 includes a shaft 12 that can be inserted into the catheter 11, an engagement portion 14 connected to the shaft 12, and a release mechanism 16 that releasably connects the shaft 12 and the engagement portion 14. After engaging the engaging portion 14 with the inner wall of the aneurysm and the vicinity of the opening, the engaging portion 14 is detached from the shaft 12 to reduce the blood pressure inside the aneurysm and prevent the aneurysm from rupturing. It is a device for. Hereinafter, the configuration of each component will be described.

図１に示すように、シャフト１２は、可撓性を有する長尺で線状（ワイヤー状）の部材であり、その基端部には、操作者が把持するための、シャフト１２よりも大径のグリップ部１８が設けられている。シャフト１２は、中空又は中実のいずれの構造でもよいが、生体内の管腔（血管等）に挿入されて管腔内を走行する際にカテーテル１１とともに管腔の湾曲に容易に追従できる程度の柔軟性を有するとともに、カテーテル１１から係合部１４を押し出すことができ且つ係合部１４にトルクを伝達できるような適度の剛性を有することが好ましい。 As shown in FIG. 1, the shaft 12 is a long and linear (wire-like) member having flexibility, and has a base end portion larger than the shaft 12 for an operator to hold. A grip portion 18 having a diameter is provided. The shaft 12 may be hollow or solid. However, when the shaft 12 is inserted into a lumen (blood vessel or the like) in a living body and travels in the lumen, the shaft 12 can easily follow the curvature of the lumen together with the catheter 11. It is preferable that the engagement portion 14 is pushed out from the catheter 11 and has an appropriate rigidity so that torque can be transmitted to the engagement portion 14.

そこで、シャフト１２は、例えば、金属や樹脂が挙げられる。金属としては、例えば、Ｎｉ−Ｔｉ系合金のような擬弾性合金（超弾性合金を含む）、形状記憶合金、ステンレス鋼（例えば、ＳＵＳ３０４、ＳＵＳ３０３、ＳＵＳ３１６、ＳＵＳ３１６Ｌ、ＳＵＳ３１６Ｊ１、ＳＵＳ３１６Ｊ１Ｌ、ＳＵＳ４０５、ＳＵＳ４３０、ＳＵＳ４３４、ＳＵＳ４４４、ＳＵＳ４２９、ＳＵＳ４３０Ｆ、ＳＵＳ３０２等、ＳＵＳの全品種）、コバルト系合金、金、白金のような貴金属、タングステン系合金、炭素系材料（ピアノ線を含む）等が挙げられる。樹脂としては、ポリオレフィン（例えば、ポリエチレン、ポリプロピレン、ポリブテン、エチレン−プロピレン共重合体、エチレン−酢酸ビニル共重合体、アイオノマー、或いはこれら二種以上の混合物等）、ポリ塩化ビニル、ポリアミド、ポリアミドエラストマー、ポリエステル、ポリエステルエラストマー、ポリウレタン、ポリウレタンエラストマー、ポリイミド、フッ素樹脂等の高分子材料或いはこれらの混合物、或いは上記２種以上の高分子材料が挙げられる。シャフト１２はこれらの金属や樹脂から形成された複合物からなる多層チューブ等により構成され得る。シャフト１２の先端付近には、Ｘ線透視下で認識可能なようにＸ線非透過性マーカーが設置されていてもよい。 Therefore, examples of the shaft 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 elastomer, Examples thereof include polymer materials such as polyester, polyester elastomer, polyurethane, polyurethane elastomer, polyimide, fluororesin, or a mixture thereof, or two or more polymer materials described above. 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.

シャフト１２の寸法は、治療対象部位に応じて適宜選択されるが、例えば、脳動脈瘤の治療に使用される場合には、全長が８００〜１５００ｍｍ、外径が０．６〜１０ｍｍ程度、好ましくは０．９〜３ｍｍ程度に設定される。 The dimensions of the shaft 12 are appropriately selected according to the site to be treated. For example, when used for the treatment of a cerebral aneurysm, the overall length is about 800 to 1500 mm, and the outer diameter is about 0.6 to 10 mm, preferably Is set to about 0.9 to 3 mm.

係合部１４は、前記シャフト１２の先端部に連結された部材であり、生体内に生じた瘤の内壁と、当該瘤の開口部近傍とに係合可能な少なくとも１つのフック２４を有する。係合部１４は、図示の構成例では、先端側を構成する１つのフック２４と、シャフト１２に連結される基部２０と、このフック２４の基端側（フック２４と基部２０との間）に設けられ螺旋状に構成された螺旋部２２とを有する。フック２４は、螺旋部２２から先端側にさらに延出した部分であり、その先端は鋭利な先鋭部２４ａが形成されている。この先鋭部２４ａは、治療対象の生体組織（血管及び瘤）に貫通可能な程度に鋭利に形成されている。また、フック２４は、途中部分が屈曲し、先鋭部２４ａが係合部１４の基端側を向いている。先鋭部２４ａの基端側にはシャフト１２の長軸に対して略垂直な角度で形成された螺旋部２２が設けられていてもよい。螺旋部２２は、図示した構成では、２巻に形成されているが、１巻又は３巻以上に形成されてもよい。係合部１４全体又はフック２４にはＸ線透視下で認識可能なようにＸ線非透過性マーカーが設置されていてもよい。 The engaging portion 14 is a member connected to the tip end portion of the shaft 12 and has at least one hook 24 that can be engaged with the inner wall of the knob generated in the living body and the vicinity of the opening of the knob. In the illustrated configuration example, the engaging portion 14 includes one hook 24 constituting the distal end side, a base portion 20 connected to the shaft 12, and a proximal end side of the hook 24 (between the hook 24 and the base portion 20). And a spiral portion 22 formed in a spiral shape. The hook 24 is a portion further extending from the spiral portion 22 toward the distal end side, and a sharp pointed portion 24a is formed at the distal end. The sharpened portion 24a is formed so sharp that it can penetrate the biological tissue (blood vessel and aneurysm) to be treated. Further, the hook 24 is bent at an intermediate portion, and the sharpened portion 24 a faces the proximal end side of the engaging portion 14. A spiral portion 22 formed at an angle substantially perpendicular to the long axis of the shaft 12 may be provided on the proximal end side of the sharpened portion 24a. The spiral portion 22 is formed in two turns in the illustrated configuration, but may be formed in one turn or three turns or more. An X-ray impermeable marker may be provided on the entire engaging portion 14 or the hook 24 so as to be recognized under X-ray fluoroscopy.

係合部１４は、生体内の管腔に挿入されて管腔内を走行する際にカテーテル１１とともに管腔の湾曲に容易に追従できる程度の柔軟性を有するとともに、瘤の内壁又は開口部近傍にフック２４を当てて、回転又は進退させることにより当該箇所に係合させることが可能なように適度の剛性を有することが好ましい。 The engaging portion 14 is flexible enough to easily follow the curvature of the lumen together with the catheter 11 when inserted into the lumen in the living body and travels in the lumen, and near the inner wall or opening of the aneurysm It is preferable to have a suitable rigidity so that the hook 24 can be engaged with the portion by rotating or moving back and forth.

そこで、係合部１４は、例えば、ステンレス鋼、タンタル、コバルト合金、チタン合金等の弾性又は超弾性を有する金属材料、或いは、ポリエチレン、ポリプロピレン、エチレン−酢酸ビニル共重合体等のポリオレフィン、ポリ塩化ビニル、ポリメチルメタクリレート、ポリカーボネート、ポリブタジエン、ポリアミド、ポリエステル等の各種ポリマーにより形成され得る。 Therefore, the engaging portion 14 is made of, for example, a metal material having elasticity or superelasticity such as stainless steel, tantalum, cobalt alloy, or titanium alloy, or polyolefin such as polyethylene, polypropylene, or ethylene-vinyl acetate copolymer, or polychlorinated. It can be formed of various polymers such as vinyl, polymethyl methacrylate, polycarbonate, polybutadiene, polyamide, and polyester.

係合部１４の寸法は、治療対象部位に応じて適宜選択されるが、例えば、脳動脈瘤の治療に使用される場合には、全長が５〜３０ｍｍ、外径が２〜３０ｍｍ程度に設定される。 The dimensions of the engaging portion 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 set to 5 to 30 mm and the outer diameter is set to about 2 to 30 mm. Is done.

係合部１４の外径（シャフト１２の長軸を中心とした場合の外径）は、瘤治療デバイス１０が挿入されるカテーテル１１の内径と略同じかそれより小さくてもよく、或いは、当該カテーテル１１の内径より大きくてもよい。図２Ａに示す係合部１４は、自然状態でカテーテル１１の内径より小さく、自然状態での外径のままカテーテル１１内に位置している。図２Ａの係合部１４がカテーテル１１の先端から押し出されても、図２Ｂに示すように、係合部１４の外径はカテーテル１１内での外径と同じである。図２Ｃに示す係合部１４は、外径が自然状態でカテーテル１１の内径より大きく、カテーテル１１内で弾性変形して縮径している。図２Ｃの係合部１４がカテーテル１１の先端から押し出されると、図２Ｄに示すように、係合部１４は弾性復元力によりカテーテル１１の内径よりも大きく拡径する。 The outer diameter of the engaging portion 14 (the outer diameter when the major axis of the shaft 12 is the center) may be substantially the same as or smaller than the inner diameter of the catheter 11 into which the aneurysm treatment device 10 is inserted. It may be larger than the inner diameter of the catheter 11. The engaging portion 14 shown in FIG. 2A is smaller than the inner diameter of the catheter 11 in the natural state, and is located in the catheter 11 with the outer diameter in the natural state. Even when the engaging portion 14 of FIG. 2A is pushed out from the distal end of the catheter 11, the outer diameter of the engaging portion 14 is the same as the outer diameter in the catheter 11, as shown in FIG. 2B. The engaging portion 14 shown in FIG. 2C has an outer diameter that is larger than the inner diameter of the catheter 11 in a natural state, and is elastically deformed in the catheter 11 to be reduced in diameter. When the engaging portion 14 in FIG. 2C is pushed out from the distal end of the catheter 11, the engaging portion 14 expands larger than the inner diameter of the catheter 11 by elastic restoring force, as shown in FIG. 2D.

次に、図１に示した離脱機構１６について説明する。離脱機構１６は、シャフト１２と係合部１４とを離脱可能に連結し、シャフト１２と係合部１４とを連結した状態でシャフト１２から係合部１４側へトルクを伝達可能に構成されている。このような機能を有する離脱機構１６は、別々に構成された２つの部材を物理的な係合（嵌合、引っ掛かり等）により離脱可能に連結した構成や、ある部材を何らかの物理的作用（熱的作用、化学的作用等）により分断することにより離脱可能に連結した構成を採用し得る。以下、離脱機構１６について、いくつかの構成例を説明するが、離脱機構１６がこれらの構成例に限定されないことは勿論である。 Next, the separation mechanism 16 shown in FIG. 1 will be described. The detachment mechanism 16 is configured to connect the shaft 12 and the engagement portion 14 so as to be detachable, and to transmit torque from the shaft 12 to the engagement portion 14 side in a state where the shaft 12 and the engagement portion 14 are connected. Yes. 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.

図３Ａに示す第１構成例に係る離脱機構１６Ａは、係合部１４の基部２０とシャフト１２とが嵌合する構成となっている。基部２０とシャフト１２との嵌合力（結合力）は、両者を離脱させようとする力が所定未満までは嵌合して連結状態を維持するが、所定以上の力が作用した際には、嵌合が外れることで、係合部１４とシャフト１２とが離脱するような嵌合力に設定されている。このように構成された離脱機構１６Ａによれば、瘤の内壁及び開口部近傍に係合部１４を係合させた後、シャフト１２を後退移動させることで、自動的に係合部１４をシャフト１２から離脱させることができる。なお、図３Ａでは、基部２０がシャフト１２に設けられた嵌合孔１２ａに挿入され、両者が嵌合するように構成されているが、嵌合のオスメスの関係を逆にした構成であってもよい。すなわち、係合部１４の基部２０に嵌合孔を設け、シャフト１２の先端に当該嵌合孔に嵌合可能な嵌合突起を設けてもよい。 The detachment mechanism 16A according to the first configuration example shown in FIG. 3A is configured such that the base portion 20 of the engagement portion 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 engagement force is set such that the engagement portion 14 and the shaft 12 are detached by disengagement. According to the detaching mechanism 16A configured as described above, the engaging portion 14 is automatically moved to the shaft by moving the engaging portion 14 in the vicinity of the inner wall and the opening of the knob and then moving the shaft 12 backward. 12 can be detached. In FIG. 3A, the base 20 is inserted into the fitting hole 12a provided in the shaft 12 so that the two are fitted 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 portion 20 of the engaging portion 14, and a fitting protrusion that can be fitted into the fitting hole may be provided at the tip of the shaft 12.

図３Ｂに示す第２構成例に係る離脱機構１６Ｂは、係合部１４の基部２０とシャフト１２とが螺合する構成となっている。具体的には、基部２０の外周部に雄ネジ３５が形成され、シャフト１２の内周部に雌ネジ３６が形成されている。雄ネジ３５及び雌ネジ３６は、瘤を治療する手技を行う際におけるシャフト１２の回転方向に螺合が外れるように形成されている。基部２０とシャフト１２との螺合力（結合力）は、両者間に作用するトルクが所定未満までは螺合を維持するが、所定以上のトルクが作用した際には、螺合が外れることで、係合部１４とシャフト１２とが離脱するように設定されている。 The detachment mechanism 16B according to the second configuration example illustrated in FIG. 3B is configured such that the base portion 20 of the engagement portion 14 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. 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 engaging portion 14 and the shaft 12 are set to be detached.

このように構成された離脱機構１６Ｂによれば、瘤の内壁及び開口部近傍に係合した係合部１４をシャフト１２により回転させることに伴いトルクが所定以上になると、係合部１４とシャフト１２との螺合が外れるので、自動的に係合部１４をシャフト１２から離脱させることができる。なお、図３Ｂでは、基部２０に設けられた雄ネジ３５がシャフト１２に設けられた雌ネジ３６に螺合することで、両者が連結するように構成されているが、螺合のオスメスの関係を逆にした構成であってもよい。すなわち、係合部１４の基部２０に雌ネジを設け、シャフト１２の先端に雄ネジを設けた構成であってもよい。 According to the detachment mechanism 16B configured in this way, when the engagement portion 14 engaged with the inner wall of the knob and the vicinity of the opening is rotated by the shaft 12 and the torque exceeds a predetermined value, the engagement portion 14 and the shaft Therefore, the engagement portion 14 can be automatically detached from the shaft 12. In FIG. 3B, 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 portion 20 of the engaging portion 14 and a male screw is provided at the tip of the shaft 12 may be employed.

図３Ｃに示す第３構成例に係る離脱機構１６Ｃは、係合部１４の基部２０とシャフト１２の先端とを連結する連結部３８と、連結部３８の外周にコイル状に巻きつけられたヒータ４０と、ヒータ４０に接続された第１及び第２の導線４２、４４とを備える。連結部３８は、加熱されることにより溶融して破断することが可能な材料（例えば、樹脂、低融点金属等）からなる。第１の導線４２はヒータ４０の一端に接続され、第２の導線４４はヒータ４０の他端に接続され、第１及び第２の導線４２、４４はシャフト１２内に挿通されてヒータ４０に接続された側とは反対側の端部にて電源に接続されている。電源は直流又は交流のいずれでもよい。 The disengaging mechanism 16C according to the third configuration example shown in FIG. 3C includes a connecting portion 38 that connects the base portion 20 of the engaging portion 14 and the tip of the shaft 12, and a heater that is wound around the outer periphery of the connecting portion 38 in a coil shape. 40 and first and second conducting wires 42, 44 connected to the heater 40. 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.

このように構成された離脱機構１６Ｃによれば、瘤の内壁及び開口部近傍に係合部１４を係合させた後、第１及び第２の導線４２、４４を介してヒータ４０に通電して発熱させることで、連結部３８を溶融破断させることにより、係合部１４をシャフト１２から離脱させることができる。 According to the detachment mechanism 16 </ b> C configured in this manner, the heater 40 is energized via the first and second conductive wires 42, 44 after engaging the engaging portion 14 in the vicinity of the inner wall of the knob and the opening. By generating heat, the engaging portion 14 can be detached from the shaft 12 by melting and breaking the connecting portion 38.

図３Ｄに示す第４構成例に係る離脱機構１６Ｄは、係合部１４の基部２０に設けられたフック部４６と、シャフト１２の先端に設けられフック部４６に係合する係合部４８とを備える。離脱機構１６Ｄによれば、係合部１４が瘤内壁の所定部位に安定的に係合した状態でシャフト１２をやや先端側に押し出すことにより、フック部４６と係合部４８との係合が外れるので、係合部１４をシャフト１２から離脱させることができる。このときさらに瘤の内壁及び開口部近傍に係合部１４を係合させた状態でシャフト１２を回転させると、フック部４６と係合部４８との螺合が外れるので、自動的に係合部１４をシャフト１２から離脱させやすくすることができる。 The disengaging mechanism 16D according to the fourth configuration example shown in FIG. 3D includes a hook portion 46 provided at the base portion 20 of the engaging portion 14, and an engaging portion 48 provided at the distal end of the shaft 12 and engaged with the hook portion 46. Is provided. According to the detachment mechanism 16D, the hook portion 46 and the engagement portion 48 are engaged by pushing the shaft 12 slightly forward with the engagement portion 14 being stably engaged with a predetermined portion of the inner wall of the aneurysm. Since it comes off, the engaging portion 14 can be detached from the shaft 12. At this time, if the shaft 12 is further rotated with the engagement portion 14 engaged in the vicinity of the inner wall of the aneurysm and the opening, the hook portion 46 and the engagement portion 48 are disengaged, so that the engagement is automatically performed. The part 14 can be easily detached from the shaft 12.

図３Ｅに示す第５構成例に係る離脱機構１６Ｅは、基端にボール状部５０を有する介在部材５１と、介在部材５１を係合部１４の基部２０内に向けて引っ張る引張部材５２と、シャフト１２の先端部に設けられた保持リング５４と、シャフト１２内に挿通されたリリースワイヤ５６とを備える。リリースワイヤ５６は、例えば、グリップ部１８に設けた操作部（スライドノブ等）に連結され、操作部の操作により基端方向に引っ張られて後退する。図３Ｅに示すように、保持リング５４とボール状部５０との間にリリースワイヤ５６が挟まれた状態（ボール状部５０とリリースワイヤ５６が固定された状態）では、ボール状部５０は保持リング５４内を通過して基部２０内へ移動することが阻止されるため、係合部１４とシャフト１２との連結状態が維持される。一方、上記操作部を操作してリリースワイヤ５６を基端方向に引っ張ると、保持リング５４とボール状部５０との間からリリースワイヤ５６が外れることにより、ボール状部５０が保持リング５４内を通過可能となり、引張部材５２の引張作用下にボール状部５０が基部２０内へと移動する。これにより、係合部１４をシャフト１２から離脱させることができる。 The separation mechanism 16E according to the fifth configuration example shown in FIG. 3E includes an interposition member 51 having a ball-like portion 50 at the base end, a tension member 52 that pulls the interposition member 51 into the base portion 20 of the engagement portion 14, A holding ring 54 provided at the tip of the shaft 12 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) 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. 3E, 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 it is prevented from passing through the ring 54 and moving into the base portion 20, the coupling state between the engaging portion 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 engaging portion 14 can be detached from the shaft 12.

離脱機構１６の他の構成としては、係合部１４の基部２０とシャフト１２の先端とを金属製の連結部で連結し、当該連結部を電気分解することによりシャフト１２から係合部１４を離脱させる構成や、接続部分に流体圧をかけ、シャフト１２の基部２０とシャフト１２の連結部を切断して離脱させる構成を採用し得る。 As another configuration of the detachment mechanism 16, the base 20 of the engaging portion 14 and the tip of the shaft 12 are connected by a metal connecting portion, and the engaging portion 14 is detached from the shaft 12 by electrolyzing the connecting portion. It is possible to adopt a configuration in which the base portion 20 of the shaft 12 and the connecting portion of the shaft 12 are cut and released by applying fluid pressure to the connection portion and separating the connection portion.

本実施形態に係る瘤治療デバイス１０は、基本的には以上のように構成されるものであり、以下では、瘤治療デバイス１０の使用方法（瘤治療方法）との関係で、瘤治療デバイス１０の作用及び効果について説明する。瘤治療デバイス１０を用いた瘤治療方法は、以下の工程を有する。 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）アクセスステップ（第１ステップ）
図４Ａに示すように、カテーテル１１内を通して、瘤治療デバイス１０を治療対象部位である瘤６２の近傍に配置する。治療対象となる瘤６２は生体管腔(血管等)に発生する中空の袋状組織である。瘤６２は、管腔組織から一部が外側に向かって膨大するように外表面が突出した部分からなる。突出した部分は内部に空間を有し、この空間が管腔内に開口部６３を介して連通している。瘤６２は外部に突出した部分が袋状の構造を形成し、袋状の内部の空間は組織の一部により形成される膜状組織により外部と内部が隔てられている。瘤６２は管腔との開口部６３が狭くなり頸部を形成するものがあり、又は開口部６３が比較的大きく頸部を有さないものもある。瘤６２が発生する血管としては例えば、動脈、静脈、末梢血管がある。瘤６２の例としては、例えば、脳動脈瘤、腹部動脈瘤、胸部動脈瘤、冠状動脈瘤、膝窩動脈瘤、大腿動脈瘤、頸動脈瘤等である。 (1) Access step (first step)
As shown in FIG. 4A, 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 (blood vessel or the like). 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 protrusion 62 has a bag-like structure in which the protrusion 62 protrudes to the outside, and the inside of the bag-like space is separated from the outside by a film-like tissue formed by a part of the tissue. Some of the aneurysms 62 form a neck by narrowing the opening 63 with the lumen, or some have a relatively large opening 63 and no neck. 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, and a carotid aneurysm.

このアクセスステップでは、具体的には、ガイドワイヤを挿通したカテーテル１１を血管６０内に走行させ、カテーテル１１の先端が瘤６２の開口部６３近傍又は瘤６２内部まで到達させる。ガイドワイヤは先端がアングル付けされているものもあり、当該ガイドワイヤを押し引き操作することによりカテーテル１１先端の向きを調整することができる。このようにして、カテーテル１１の先端を瘤６２の開口部６３又は瘤６２内部に配置する。その後、カテーテル１１からガイドワイヤを抜去し、瘤治療デバイス１０をカテーテル１１に挿入する。 Specifically, in this access step, the catheter 11 with the guide wire inserted is moved into the blood vessel 60 so that the distal end of the catheter 11 reaches the vicinity of the opening 63 of the aneurysm 62 or the inside of the aneurysm 62. Some guide wires have an angled tip, and the direction of the tip of the catheter 11 can be adjusted by pushing and pulling the guide wire. In this way, the distal end of the catheter 11 is disposed inside the opening 63 of the aneurysm 62 or the inside 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.

（２）挿入ステップ（第２ステップ）
次に、図４Ｂに示すように、カテーテル１１の位置を保持した状態で、カテーテル１１内でシャフト１２を先端方向に進めることにより、係合部１４をシャフト１２の先端から押し出し、係合部１４を瘤６２内に挿入する。図４Ｂに示す係合部１４は、図２Ａ及び図２Ｂに示した形態であり、自然状態での係合部１４の外径がカテーテル１１の内径と略同じかそれより小さいため、係合部１４がカテーテル１１から押し出されても、係合部１４の外径は変化しない。一方、図２Ｃ及び図２Ｄに示したように、自然状態での係合部１４の外径がカテーテル１１の内径よりも大きい場合、係合部１４がカテーテル１１から押し出されると、係合部１４が弾性復元力により拡径する。 (2) Insertion step (second step)
Next, as shown in FIG. 4B, in a state where the position of the catheter 11 is maintained, the shaft 12 is advanced in the distal direction within the catheter 11, thereby pushing out the engaging portion 14 from the distal end of the shaft 12. Is inserted into the aneurysm 62. The engaging portion 14 shown in FIG. 4B has the form shown in FIGS. 2A and 2B, and since the outer diameter of the engaging portion 14 in the natural state is substantially the same as or smaller than the inner diameter of the catheter 11, Even if 14 is pushed out of the catheter 11, the outer diameter of the engaging portion 14 does not change. On the other hand, as shown in FIGS. 2C and 2D, when the outer diameter of the engaging portion 14 in the natural state is larger than the inner diameter of the catheter 11, when the engaging portion 14 is pushed out of the catheter 11, the engaging portion 14. Expands due to elastic restoring force.

（３）第１係合ステップ（第３ステップ）
次に、図４Ｃに示すように、係合部１４を瘤６２の内壁に係合させる。具体的には、シャフト１２を周方向に回転させることにより当該シャフト１２に連結された係合部１４を回転させ、当該回転動作により、係合部１４のフック２４の先鋭部２４ａを、瘤６２の奥側（瘤６２の開口部６３から遠い側）の内壁に刺し、さらに回転させることでフック２４の先鋭部２４ａを瘤６２の内壁から突出させる。この場合、瘤６２の内壁表面に刺した先鋭部２４ａを瘤６２の壁部を貫通させて瘤６２の外部に露出させた後、先鋭部２４ａを瘤６２の外壁表面に刺して瘤６２の内側に再び戻して瘤６２の内部に露出させる。なお、瘤６２の内壁に刺した先鋭部２４ａを、瘤６２の外部に露出させることなく、瘤６２の壁部内を通して瘤６２の内側に再び戻して瘤６２の内部に露出させてもよい。本実施形態の場合、先鋭部２４ａが係合部１４の基端側を向くように係合部１４が屈曲しており、先鋭部２４ａの基端側にシャフト１２の長軸に対して略垂直な角度で形成された螺旋部２２が設けられているので、突き通した瘤６２の壁を前記略垂直な角度で形成された螺旋部２２に保持することができ、回転させた際に先鋭部２４ａを瘤６２の内側に戻し易い。 (3) First engagement step (third step)
Next, as shown in FIG. 4C, the engaging portion 14 is engaged with the inner wall of the knob 62. Specifically, the engaging portion 14 connected to the shaft 12 is rotated by rotating the shaft 12 in the circumferential direction, and the sharpened portion 24a of the hook 24 of the engaging portion 14 is moved to the knob 62 by the rotating operation. The sharpened portion 24a of the hook 24 is protruded from the inner wall of the knob 62 by piercing the inner wall on the back side (the side far from the opening 63 of the knob 62) and further rotating. In this case, the sharpened portion 24a pierced on the inner wall surface of the knob 62 passes through the wall portion of the knob 62 and is exposed to the outside of the knob 62, and then the sharpened portion 24a is inserted into the outer wall surface of the knob 62 to It is returned again to expose the inside of the knob 62. Note that the sharpened portion 24 a stabbed into the inner wall of the knob 62 may be returned to the inside of the knob 62 through the wall of the knob 62 and exposed to the inside of the knob 62 without being exposed to the outside of the knob 62. In the case of the present embodiment, the engaging portion 14 is bent so that the sharpened portion 24a faces the proximal end side of the engaging portion 14, and the proximal end side of the sharpened portion 24a is substantially perpendicular to the major axis of the shaft 12. Since the spiral portion 22 formed at a certain angle is provided, the wall of the protruding knob 62 can be held by the spiral portion 22 formed at the substantially vertical angle, and the sharpened portion when rotated. It is easy to return 24 a to the inside of the knob 62.

フック２４を刺す位置は、瘤６２内部の最奥部でもよいが、最奥部よりも若干外側にずれた位置にするとよい。瘤６２内部の最奥部は、血管からの瘤６２の突出方向に対して垂直であるため、その箇所でフック２４を回転させた際にフック２４の先鋭部２４ａを瘤６２の壁部に刺して再び瘤６２の内側に戻しにくい可能性がある。これに対し、瘤６２の最奥部より若干外側にずれた位置における瘤６２の内壁面は、血管からの瘤６２の突出方向に対して垂直ではなく傾斜している。このため、係合部１４を回転させた際に、先鋭部２４ａを瘤６２の内側に戻し易い。 The position where the hook 24 is stabbed may be the innermost part inside the knob 62, but may be a position slightly shifted outward from the innermost part. Since the innermost part of the aneurysm 62 is perpendicular to the protruding direction of the aneurysm 62 from the blood vessel, the sharp portion 24a of the hook 24 is pierced into the wall of the aneurysm 62 when the hook 24 is rotated at that position. Therefore, there is a possibility that it is difficult to return to the inside of the knob 62 again. On the other hand, the inner wall surface of the knob 62 at a position slightly shifted from the innermost part of the knob 62 is not perpendicular to the protruding direction of the knob 62 from the blood vessel but is inclined. For this reason, when the engaging portion 14 is rotated, the sharpened portion 24 a can be easily returned to the inside of the knob 62.

（４）引張ステップ（第４ステップ）
次に、図５Ａに示すように、係合部１４を瘤６２の内壁に係合させた状態で、係合部１４を瘤６２の開口部６３側に引き寄せる。具体的には、カテーテル１１の位置を保持した状態で、シャフト１２を基端方向に後退させることにより、シャフト１２に連結された係合部１４を開口部６３近傍まで移動させる。このとき、係合部１４のフック２４は瘤６２の内壁と係合したままなので、フック２４と瘤６２との係合箇所も瘤６２の開口部６３に向けて変位する。この過程で、瘤６２は、開口部６３に向かって内部に突出した形状（外表面からは窄んだ形状）へと変形していく。 (4) Tensile step (4th step)
Next, as shown in FIG. 5A, the engaging portion 14 is pulled toward the opening 63 side of the knob 62 with the engaging portion 14 engaged with the inner wall of the knob 62. Specifically, with the position of the catheter 11 held, the engaging portion 14 connected to the shaft 12 is moved to the vicinity of the opening 63 by retracting the shaft 12 in the proximal direction. At this time, since the hook 24 of the engaging portion 14 remains engaged with the inner wall of the knob 62, the engaging portion between the hook 24 and the knob 62 is also displaced toward the opening 63 of the knob 62. In this process, the knob 62 is deformed into a shape protruding inward toward the opening 63 (a shape narrowed from the outer surface).

（５）第２係合ステップ（第５ステップ）
係合部１４を瘤６２の開口部６３近傍まで移動させたら、次に、図５Ｂに示すように、瘤６２の内壁に係合した状態の係合部１４を瘤６２の開口部６３近傍に係合させる。具体的には、係合部１４を開口部６３近傍に位置させた状態で、シャフト１２を周方向に回転させることによって当該シャフト１２に連結された係合部１４を回転させ、これにより係合部１４のフック２４の先鋭部２４ａを開口部６３近傍に刺す。これにより、瘤６２の内壁に係合した状態の係合部１４をさらに開口部６３近傍にも係合させることができる。この場合、フック２４の先鋭部２４ａは、瘤６２の外側に突出していてもよく、或いは、開口部６３近傍で瘤６２の内側に突出していてもよい。なお、上記と同様の方法で、係合部１４のフック２４をさらに開口部６３近傍の別の箇所に係合させてもよい。 (5) Second engagement step (fifth step)
After the engaging portion 14 is moved to the vicinity of the opening 63 of the knob 62, the engaging portion 14 engaged with the inner wall of the knob 62 is next moved to the vicinity of the opening 63 of the knob 62 as shown in FIG. 5B. Engage. Specifically, with the engagement portion 14 positioned in the vicinity of the opening 63, the engagement portion 14 connected to the shaft 12 is rotated by rotating the shaft 12 in the circumferential direction, thereby engaging. The sharpened portion 24 a of the hook 24 of the portion 14 is stabbed near the opening 63. Thereby, the engaging portion 14 engaged with the inner wall of the knob 62 can be further engaged with the vicinity of the opening 63. In this case, the sharpened portion 24 a of the hook 24 may protrude outside the knob 62, or may protrude inside the knob 62 near the opening 63. Note that the hook 24 of the engaging portion 14 may be further engaged with another location near the opening 63 by the same method as described above.

このように、係合部１４を瘤６２の内壁と開口部６３近傍の両方に係合させることにより、開口部６３を縮小させ、或いは閉塞することができる。また、瘤６２の奥側の壁部の一部が開口部６３近傍まで引き寄せられ、係合部１４によりこの状態が保持される。これにより、瘤６２の内容積は、初期状態（図４Ａの状態）と比較して大幅に減少する。 Thus, by engaging the engaging portion 14 with both the inner wall of the knob 62 and the vicinity of the opening 63, the opening 63 can be reduced or closed. Further, a part of the wall portion on the back side of the knob 62 is drawn to the vicinity of the opening 63, and this state is held by the engaging portion 14. Thereby, the internal volume of the knob 62 is significantly reduced as compared with the initial state (the state of FIG. 4A).

（６）離脱ステップ（第６ステップ）
次に、図５Ｃに示すように、離脱機構１６の作用下に、シャフト１２と係合部１４とを離脱させる。シャフト１２と係合部１４とを離脱させるための操作は、離脱機構１６の構成による。 (6) Separation step (6th step)
Next, as shown in FIG. 5C, the shaft 12 and the engaging portion 14 are detached under the action of the separation mechanism 16. The operation for separating the shaft 12 and the engagement portion 14 depends on the configuration of the separation mechanism 16.

図３Ａに示した離脱機構１６Ａの場合、係合部１４を瘤６２の内壁と開口部６３近傍に係合させた状態（図５Ｂの状態）からさらにシャフト１２を回転させることで、シャフト１２の先端と係合部１４の基部２０との嵌合力を超える力がかかると、嵌合が外れるので、係合部１４をシャフト１２から離脱させることができる。又は、シャフト１２を後退移動させることにより、シャフト１２の先端と係合部１４の基部２０との嵌合を外してもよい。図３Ｂに示した離脱機構１６Ｂの場合、係合部１４を瘤６２の内壁と開口部６３近傍に係合させた後、シャフト１２を回転させることで、シャフト１２の先端と係合部１４の基部２０との螺合が外れるので、係合部１４をシャフト１２から離脱させることができる。 In the case of the detaching mechanism 16A shown in FIG. 3A, the shaft 12 is further rotated from the state where the engaging portion 14 is engaged with the inner wall of the knob 62 and the vicinity of the opening 63 (the state shown in FIG. 5B). When a force exceeding the fitting force between the distal end and the base portion 20 of the engaging portion 14 is applied, the fitting is released, so that the engaging portion 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 engaging part 14 by moving the shaft 12 backward. In the case of the detachment mechanism 16B shown in FIG. 3B, the engagement portion 14 is engaged with the inner wall of the knob 62 and the vicinity of the opening 63, and then the shaft 12 is rotated, whereby the tip of the shaft 12 and the engagement portion 14 are rotated. Since the screwing with the base portion 20 is released, the engaging portion 14 can be detached from the shaft 12.

図３Ｃに示した離脱機構１６Ｃの場合、ヒータ４０に通電して連結部３８を溶融破断させることで、係合部１４をシャフト１２から離脱させることができる。図３Ｄに示した離脱機構１６Ｄの場合、係合部１４を瘤６２の内壁と開口部６３近傍に安定的に係合させた後、シャフト１２を先端側へやや押し戻すか回転させることで、係合部１４の基部２０に設けられたフック部４６とシャフト１２の先端に設けられた係合部４８との係合が外れるので、係合部１４をシャフト１２から離脱させることができる。図３Ｅに示した離脱機構１６Ｅの場合、係合部１４を瘤６２の内壁と開口部６３近傍に係合させた後、グリップ部１８に設けた操作部を操作して、リリースワイヤ５６をボール状部５０と保持リング５４との間から抜け出させ（リリースワイヤ５６をボール状部５０との結合から解除して）、ボール状部５０を基部２０内へと移動させる（リリースワイヤ５６を基端側に引き抜く）ことにより、係合部１４をシャフト１２から離脱させることができる。 In the case of the disengaging mechanism 16C shown in FIG. 3C, the engaging portion 14 can be disengaged from the shaft 12 by energizing the heater 40 to melt and break the connecting portion 38. In the case of the disengaging mechanism 16D shown in FIG. 3D, after the engaging portion 14 is stably engaged with the inner wall of the knob 62 and the vicinity of the opening 63, the shaft 12 is slightly pushed back or rotated toward the distal end side, Since the hook portion 46 provided at the base portion 20 of the joint portion 14 and the engagement portion 48 provided at the tip of the shaft 12 are disengaged, the engagement portion 14 can be detached from the shaft 12. In the case of the disengaging mechanism 16E shown in FIG. 3E, after engaging the engaging portion 14 with the inner wall of the knob 62 and the vicinity of the opening 63, the operating portion provided on the grip portion 18 is operated to release the release wire 56 into the ball. The release portion 56 is removed from between the holding portion 54 and the retaining ring 54 (release wire 56 is released from coupling with the ball-like portion 50), and the ball-like portion 50 is moved into the base portion 20 (the release wire 56 is moved to the proximal end). By pulling it out to the side, the engaging portion 14 can be detached from the shaft 12.

以上説明したように、本実施形態に係る瘤治療デバイス１０によれば、カテーテル１１内に瘤治療デバイス１０を挿通して血管に発生した瘤６２にアクセスし、カテーテル１１から係合部１４を出して瘤６２の内壁に係合させ、次に、係合部１４を開口部６３側へ引き寄せて係合部１４を開口部６３近傍に係合させることにより瘤６２の内容積を減少させ、その後、係合部１４をシャフト１２から離脱させる手技（瘤治療方法）を実施することができる。 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, and the engaging portion 14 is extended from the catheter 11. Engaging the inner wall of the knob 62 and then reducing the inner volume of the knob 62 by pulling the engaging portion 14 toward the opening 63 and engaging the engaging portion 14 near the opening 63. A procedure (aneurysm treatment method) for detaching the engaging portion 14 from the shaft 12 can be performed.

このように、瘤６２の壁部の一部が開口部６３近傍まで引き寄せられ、その状態が係合部１４により保持されるので、開口部が縮小するか或いは閉塞する。これにより、血管（親血管）を流れる血液の圧力の影響を受けにくくなり、瘤内圧を低減できる。特に、開口部６３を閉塞した場合、血管内と瘤６２内とが遮断されるため、瘤６２内圧の上昇を抑制又は防止する効果が大きく、瘤６２の破裂の危険性を効果的に除去することができる。 In this way, a part of the wall portion of the knob 62 is drawn to the vicinity of the opening 63 and the state is held by the engaging portion 14, so that the opening is reduced or closed. Thereby, it becomes difficult to receive the influence of the pressure of the blood which flows through the blood vessel (parent blood vessel), and the pressure inside the aneurysm can be reduced. In particular, when the opening 63 is blocked, the inside of the blood vessel and the inside of the aneurysm 62 are blocked, so that the effect of suppressing or preventing the increase in the internal pressure of the aneurysm 62 is great, and the risk of the rupture of the aneurysm 62 is effectively removed. be able to.

また、瘤６２の内容積が減少するので、瘤６２内圧の上昇を抑制又は防止することができ、そして周辺組織への影響を低減することができる。すなわち、例えば、脳動脈瘤の場合、脳動脈瘤の大きさが縮小することにより、脳動脈瘤の周囲にある脳組織への圧迫を軽減でき、治療効果を一層高めることができる。 Moreover, since the internal volume of the aneurysm 62 is reduced, an increase in the internal pressure of the aneurysm 62 can be suppressed or prevented, and 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.

本実施形態の場合、フック２４の基端側に螺旋部２２を有することにより、係合部１４を回転させることによりフック２４を瘤６２の内壁又は開口部６３近傍に係合させる手技を行う際に、トルクをシャフト１２側からフック２４側へ良好に伝達することができ、操作性に優れる。よって、手技を円滑に遂行することができる。 In the case of the present embodiment, by having the spiral portion 22 on the proximal end side of the hook 24, the engagement portion 14 is rotated to engage the hook 24 with the inner wall of the knob 62 or in the vicinity of the opening 63. In addition, torque can be satisfactorily transmitted from the shaft 12 side to the hook 24 side, and the operability is excellent. Therefore, the procedure can be performed smoothly.

本実施形態の場合、フック２４の途中部位が屈曲し、先鋭部２４ａが係合部１４の基端側を向いているので、瘤６２の内壁にフック２４を係合させる第１係合ステップの際に、フック２４の先鋭部２４ａを瘤６２の内壁から突出させる手技を容易且つ確実に行うことができる。また先鋭部２４ａを瘤６２の壁に貫通させて一度係合した後に先鋭部２４ａが壁から外れにくくなる。このため、第１係合ステップに引き続きいて行われる第２係合ステップにおいて、フック２４を瘤６２の開口部６３近傍に確実に係合させることができる。また、係合部１４に設けるフック２４が１つだけで足りることから、係合部１４の構成を簡素化できる。フック２４が１つだけであるため、フック２４が周囲組織に触れて周囲組織を損傷する危険性も低い。 In the case of the present embodiment, the intermediate portion of the hook 24 is bent and the sharpened portion 24a faces the proximal end side of the engaging portion 14, so that the hook 24 is engaged with the inner wall of the knob 62 in the first engaging step. At this time, the procedure of projecting the sharpened portion 24a of the hook 24 from the inner wall of the knob 62 can be easily and reliably performed. Further, after the sharpened portion 24a is passed through the wall of the knob 62 and once engaged, the sharpened portion 24a is difficult to come off the wall. For this reason, the hook 24 can be reliably engaged in the vicinity of the opening 63 of the knob 62 in the second engagement step performed following the first engagement step. Further, since only one hook 24 is provided on the engaging portion 14, the configuration of the engaging portion 14 can be simplified. Since there is only one hook 24, the risk of the hook 24 touching the surrounding tissue and damaging the surrounding tissue is low.

［第２実施形態］
図６は、本発明の第２実施形態に係る瘤治療デバイス７０の斜視図である。なお、第２実施形態に係る瘤治療デバイス７０において、第１実施形態に係る瘤治療デバイス１０と同一又は同様な機能及び効果を奏する要素には同一の参照符号を付し、詳細な説明を省略する。 [Second Embodiment]
FIG. 6 is a perspective view of an aneurysm treatment device 70 according to the second embodiment of the present invention. In the aneurysm treatment device 70 according to the second embodiment, elements having the same or similar functions and effects as those of the aneurysm treatment device 10 according to the first embodiment are denoted by the same reference numerals, and detailed description thereof is omitted. To do.

本実施形態に係る瘤治療デバイス７０は、係合部７２の構成において、第１実施形態に係る瘤治療デバイス１０と異なる。係合部７２は、シャフト１２の先端部に連結された部材であり、生体内に生じた瘤の内壁と、当該瘤の開口部近傍とに係合可能な複数（図示例では３つ）の湾曲したフック７４、７６、７８を有する。これらのフック７４、７６、７８は互いに異なる方向に設けられている。具体的には、各フック７４、７６、７８は、互いに異なる方向の複数の平面Ｐ１、Ｐ２、Ｐ３上に存在するように形成されている。 The aneurysm treatment device 70 according to the present embodiment is different from the aneurysm treatment device 10 according to the first embodiment in the configuration of the engaging portion 72. The engaging portion 72 is a member connected to the distal end portion of the shaft 12, and a plurality of (three in the illustrated example) engageable with the inner wall of the knob generated in the living body and the vicinity of the opening of the knob. It has curved hooks 74, 76, 78. These hooks 74, 76 and 78 are provided in different directions. Specifically, the hooks 74, 76, and 78 are formed so as to exist on a plurality of planes P1, P2, and P3 in different directions.

最も先端側に設けられたフック７４（以下、「第１フック７４」という）は、瘤の奥側の内壁に係合可能に構成されている。第１フック７４よりも基端側に設けられたフック７６（以下、「第２フック７６」という）及びフック７８（以下、「第３フック７８」という）は、それぞれ、先鋭部７６ａ、７８ａを有し、瘤の開口部近傍に係合可能である。係合部７２は、上述した第１実施形態における係合部１４と同じ材料により構成され得る。 A hook 74 (hereinafter referred to as “first hook 74”) provided on the most distal end side is configured to be able to engage with an inner wall on the back side of the knob. The hooks 76 (hereinafter referred to as “second hooks 76”) and the hooks 78 (hereinafter referred to as “third hooks 78”) provided on the proximal end side with respect to the first hooks 74 have sharpened portions 76a and 78a, respectively. And can be engaged in the vicinity of the opening of the knob. The engaging part 72 can be made of the same material as the engaging part 14 in the first embodiment described above.

係合部７２の寸法は、治療対象部位に応じて適宜選択されるが、例えば、脳動脈瘤の治療に使用される場合には、全長が５〜３０ｍｍ、幅が２〜３０ｍｍ程度に設定される。 Although the dimension of the engaging part 72 is suitably selected according to a treatment object site | part, for example, when using for the treatment of a cerebral aneurysm, the full length is set to about 5-30 mm and the width | variety is set to about 2-30 mm. The

以上のように構成された瘤治療デバイス７０を用いた瘤治療方法は、以下の工程を有する。 The aneurysm treatment method using the aneurysm treatment device 70 configured as described above includes the following steps.

（１）アクセスステップ（第１ステップ）
図７Ａに示すように、カテーテル１１内を通して、瘤治療デバイス７０を瘤６２の近傍に配置する。ここでのアクセスステップは、第１実施形態に係る瘤治療デバイス１０を用いた瘤治療方法のアクセスステップと同じである。 (1) Access step (first step)
As shown in FIG. 7A, the aneurysm treatment device 70 is disposed in the vicinity of the aneurysm 62 through the catheter 11. The access step here is the same as the access step of the aneurysm treatment method using the aneurysm treatment device 10 according to the first embodiment.

（２）挿入ステップ（第２ステップ）
次に、図７Ｂに示すように、カテーテル１１の位置を保持した状態で、シャフト１２を先端方向に進めることにより、係合部７２をシャフト１２の先端から押し出し、係合部７２を瘤６２内に挿入する。図７Ｂに示す係合部７２は、自然状態での係合部７２の外径がカテーテル１１の内径と略同じかそれより小さいため、係合部７２がカテーテル１１から押し出されても、係合部７２の外径は変化しない。係合部７２は、自然状態での外径がカテーテル１１の内径よりも大きく設定され、係合部７２がカテーテル１１から押し出されたときに弾性復元力により拡径するように構成されてもよい。 (2) Insertion step (second step)
Next, as shown in FIG. 7B, with the position of the catheter 11 held, the shaft 12 is advanced in the distal direction, thereby pushing out the engaging portion 72 from the distal end of the shaft 12. Insert into. The engaging portion 72 shown in FIG. 7B is engaged even when the engaging portion 72 is pushed out from the catheter 11 because the outer diameter of the engaging portion 72 in the natural state is substantially the same as or smaller than the inner diameter of the catheter 11. The outer diameter of the portion 72 does not change. The engaging portion 72 may be configured such that the outer diameter in a natural state is set larger than the inner diameter of the catheter 11 and the diameter is expanded by an elastic restoring force when the engaging portion 72 is pushed out of the catheter 11. .

（３）第１係合ステップ（第３ステップ）
次に、図７Ｃに示すように、係合部７２を瘤６２の内壁に係合させる。具体的には、シャフト１２を周方向に回転させ又は進退させることにより、当該シャフト１２に連結された係合部７２を回転又は進退させ、当該動作により、係合部７２の第１フック７４の先鋭部７４ａを、瘤６２の奥側（瘤６２の開口部６３から遠い側）の内壁に刺す。この場合、可能であれば、瘤６２の内壁に刺した先鋭部７４ａを瘤６２の壁部を貫通させて瘤６２の外部に露出させた後、先鋭部７４ａを瘤６２の外壁に刺して瘤６２の内側に露出するよう再び戻してもよい。 (3) First engagement step (third step)
Next, as shown in FIG. 7C, the engaging portion 72 is engaged with the inner wall of the knob 62. Specifically, by rotating or advancing and retracting the shaft 12 in the circumferential direction, the engaging portion 72 connected to the shaft 12 is rotated or advanced and retracted, and the operation causes the first hook 74 of the engaging portion 72 to move. The sharpened portion 74a is pierced into the inner wall on the back side of the knob 62 (the side far from the opening 63 of the knob 62). In this case, if possible, after the sharpened portion 74a pierced on the inner wall of the knob 62 penetrates the wall of the knob 62 and is exposed to the outside of the knob 62, the sharpened portion 74a is pierced on the outer wall of the knob 62. You may return again so that it may be exposed inside 62.

（４）引張ステップ（第４ステップ）
次に、図７Ｄに示すように、係合部７２を瘤６２の内壁に係合させた状態で、係合部７２を瘤６２の開口部６３側に引き寄せる。具体的には、カテーテル１１の位置を保持した状態で、シャフト１２を基端方向に後退させることにより、シャフト１２に連結された係合部７２を開口部６３近傍まで移動させる。このとき、係合部７２の第１フック７４は瘤６２の内壁と係合したままなので、第１フック７４と瘤６２との係合箇所も瘤６２の開口部６３に向けて変位する。この過程で、瘤６２は、開口部６３に向かって突出した形状へと変形していく。 (4) Tensile step (4th step)
Next, as shown in FIG. 7D, the engaging part 72 is pulled toward the opening 63 side of the knob 62 in a state where the engaging part 72 is engaged with the inner wall of the knob 62. Specifically, the engagement portion 72 connected to the shaft 12 is moved to the vicinity of the opening 63 by retracting the shaft 12 in the proximal direction while maintaining the position of the catheter 11. At this time, since the first hook 74 of the engaging portion 72 remains engaged with the inner wall of the knob 62, the engaging portion of the first hook 74 and the knob 62 is also displaced toward the opening 63 of the knob 62. In this process, the knob 62 is deformed into a shape protruding toward the opening 63.

（５）第２係合ステップ（第５ステップ）
係合部７２を瘤６２の開口部６３近傍まで移動させたら、次に、図８Ａ及び図８Ｂに示すように、第１フック７４が瘤６２の内壁に係合した状態を維持したまま、係合部７２の第２フック７６と第３フック７８を順に瘤６２の開口部６３近傍に係合させる。具体的には、係合部７２を開口部６３近傍に位置させた状態で、シャフト１２を周方向に回転させ又は進退させることによって、図８Ａに示すように、第２フック７６の先鋭部７６ａを開口部６３近傍に刺して係合させる。次に、図８Ｂに示すように、第３フック７８の先鋭部７８ａを、第２フック７６が係合した箇所とは別の開口部６３近傍に刺して係合させる。これにより、瘤６２の内壁に係合した状態の係合部７２をさらに開口部６３近傍にも係合させることができる。 (5) Second engagement step (fifth step)
After the engaging portion 72 is moved to the vicinity of the opening 63 of the knob 62, next, as shown in FIGS. 8A and 8B, the first hook 74 is kept engaged with the inner wall of the knob 62, and the engaging portion 72 is maintained. The second hook 76 and the third hook 78 of the joint portion 72 are sequentially engaged with the vicinity of the opening 63 of the knob 62. Specifically, when the engagement portion 72 is positioned in the vicinity of the opening 63, the shaft 12 is rotated in the circumferential direction or advanced and retracted, thereby, as shown in FIG. 8A, the sharpened portion 76a of the second hook 76. Is inserted into the vicinity of the opening 63 and engaged. Next, as shown in FIG. 8B, the sharpened portion 78a of the third hook 78 is pierced and engaged in the vicinity of the opening 63 different from the portion where the second hook 76 is engaged. Thereby, the engaging part 72 in the state engaged with the inner wall of the knob 62 can be further engaged with the vicinity of the opening 63.

このように、係合部７２を瘤６２の内壁と開口部６３近傍の両方に係合させることにより、開口部６３を縮小させ、或いは閉塞することができる。また、瘤６２の奥側の壁部の一部が開口部６３近傍まで引き寄せられ、係合部７２によりこの状態が保持される。これにより、瘤６２の内容積は、初期状態（図７Ａの状態）と比較して大幅に減少する。 Thus, by engaging the engaging portion 72 with both the inner wall of the knob 62 and the vicinity of the opening 63, the opening 63 can be reduced or closed. Further, a part of the wall portion on the back side of the knob 62 is drawn to the vicinity of the opening 63, and this state is maintained by the engaging portion 72. Thereby, the internal volume of the knob 62 is significantly reduced as compared with the initial state (the state of FIG. 7A).

（６）離脱ステップ（第６ステップ）
次に、図８Ｃに示すように、離脱機構１６の作用下に、シャフト１２と係合部７２とを離脱させる。シャフト１２と係合部７２とを離脱させるための操作は、第１実施形態に係る瘤治療デバイス１０を用いた瘤治療方法の離脱ステップと同様に、離脱機構１６の構成による。 (6) Separation step (6th step)
Next, as shown in FIG. 8C, the shaft 12 and the engaging portion 72 are separated under the action of the separation mechanism 16. The operation for detaching the shaft 12 and the engaging portion 72 depends on the configuration of the detachment mechanism 16 as in the detachment step of the aneurysm treatment method using the aneurysm treatment device 10 according to the first embodiment.

本実施形態に係る瘤治療デバイス７０によれば、カテーテル１１内に瘤治療デバイス７０を挿通して血管に発生した瘤６２にアクセスし、カテーテル１１から係合部７２を出して瘤６２の内壁に係合させ、次に、係合部７２を開口部６３側へ引き寄せて係合部７２を開口部６３近傍に係合させることにより瘤６２の内容積を減少させ、その後、係合部７２をシャフト１２から離脱させる手技（瘤治療方法）を実施することができる。 According to the aneurysm treatment device 70 according to the present embodiment, the aneurysm treatment device 70 is inserted into the catheter 11 to access the aneurysm 62 generated in the blood vessel, and the engagement portion 72 is extracted from the catheter 11 to the inner wall of the aneurysm 62. Next, the internal volume of the knob 62 is reduced by pulling the engaging portion 72 toward the opening 63 and engaging the engaging portion 72 near the opening 63, and then the engaging portion 72 is A procedure (aneurysm treatment method) for detaching from the shaft 12 can be performed.

従って、第１実施形態に係る瘤治療デバイス１０と同様に、瘤６２の内容積を減少させることで周辺組織への影響を低減することができるとともに、開口部６３を縮小又は閉塞させることで瘤６２内圧の上昇を抑制又は防止し、瘤６２の破裂の危険性を効果的に除去することができる。 Accordingly, similarly to the aneurysm treatment device 10 according to the first embodiment, the influence on the surrounding tissue can be reduced by reducing the internal volume of the aneurysm 62, and the aneurysm can be reduced by closing or closing the opening 63. The increase in the internal pressure of 62 can be suppressed or prevented, and the risk of rupture of the knob 62 can be effectively removed.

特に、本実施形態によれば、係合部７２が複数のフック（第１〜第３フック７４、７６、７８）を有することから、係合部７２を、係合すべき各部位に対して確実且つ容易に係合させることができる。また、本実施形態の場合、係合部７２は、瘤６２の開口部６３近傍に係合可能なフック（第２及び第３フック７６、７８）を複数有することから、開口部６３近傍の複数箇所に係合させることが可能である。係合部７２を開口部６３近傍の複数箇所に係合させることにより、開口部６３を縮小或いは閉塞させ易い。従って、瘤６２内圧を一層効果的に低減することができる。 In particular, according to this embodiment, since the engaging part 72 has a plurality of hooks (first to third hooks 74, 76, 78), the engaging part 72 is connected to each part to be engaged. Engage reliably and easily. In the case of the present embodiment, the engaging portion 72 has a plurality of hooks (second and third hooks 76, 78) that can be engaged in the vicinity of the opening 63 of the knob 62. It is possible to engage with the location. By engaging the engaging portion 72 with a plurality of locations near the opening 63, the opening 63 can be easily reduced or closed. Therefore, the internal pressure of the knob 62 can be further effectively reduced.

なお、第２実施形態において、第１実施形態と共通する各構成部分については、第１実施形態における当該共通の各構成部分がもたらす作用及び効果と同一又は同様の作用及び効果が得られることは勿論である。 In addition, in the second embodiment, for each component common to the first embodiment, it is possible to obtain the same or similar operation and effect as the operation and effect brought about by the common component in the first embodiment. Of course.

［第３実施形態］
図９は、本発明の第３実施形態に係る瘤治療デバイス８０の側面断面図である。なお、第３実施形態に係る瘤治療デバイス８０において、第１実施形態に係る瘤治療デバイス１０と同一又は同様な機能及び効果を奏する要素には同一の参照符号を付し、詳細な説明を省略する。 [Third Embodiment]
FIG. 9 is a side sectional view of an aneurysm treatment device 80 according to a third embodiment of the present invention. In the aneurysm treatment device 80 according to the third embodiment, elements having the same or similar functions and effects as those of the aneurysm treatment device 10 according to the first embodiment are denoted by the same reference numerals, and detailed description thereof is omitted. To do.

本実施形態に係る瘤治療デバイス８０は、上述した第１実施形態に係る瘤治療デバイス１０と同様に構成されたメインデバイス８２と、当該メインデバイス８２及びガイドワイヤ９０が挿通可能なアウタシャフト８４とを備える。アウタシャフト８４は、軸線方向に貫通したデバイス用ルーメン８６と、当該デバイス用ルーメン８６に平行に形成されたガイドワイヤ用ルーメン８８とを有する。デバイス用ルーメン８６とガイドワイヤ用ルーメン８８は、メインデバイス８２の先端にて開口している。係合部１４に代えて、図６に示した係合部７２を採用してもよい。 The aneurysm treatment device 80 according to the present embodiment includes a main device 82 configured in the same manner as the aneurysm treatment device 10 according to the first embodiment described above, and an outer shaft 84 through which the main device 82 and the guide wire 90 can be inserted. Is provided. The outer shaft 84 includes a device lumen 86 penetrating in the axial direction, and a guide wire lumen 88 formed in parallel to the device lumen 86. The device lumen 86 and the guide wire lumen 88 are opened at the tip of the main device 82. Instead of the engaging portion 14, the engaging portion 72 shown in FIG.

このように構成された瘤治療デバイス８０によれば、図９に示すように、メインデバイス８２をアウタシャフト８４に挿通させた状態の瘤治療デバイス８０と、この瘤治療デバイス８０を挿通させたカテーテル１１とを、ガイドワイヤ用ルーメン８８に挿通されたガイドワイヤ９０を先行させた状態で、血管内に走行させることができる。従って、瘤治療デバイス８０をそれが挿通されるカテーテル１１とともに瘤がある場所まで迅速に送達することができる。 According to the aneurysm treatment device 80 configured as described above, as shown in FIG. 9, the aneurysm treatment device 80 in a state where the main device 82 is inserted through the outer shaft 84 and the catheter through which the aneurysm treatment device 80 is inserted. 11 can be caused to travel into the blood vessel with the guide wire 90 inserted through the guide wire lumen 88 being advanced. Accordingly, the aneurysm treatment device 80 can be quickly delivered to the place where the aneurysm is located together with the catheter 11 through which it is inserted.

なお、第３実施形態において、第１実施形態と共通する各構成部分については、第１実施形態における当該共通の各構成部分がもたらす作用及び効果と同一又は同様の作用及び効果が得られることは勿論である。 In addition, in the third embodiment, with respect to each component common to the first embodiment, the same or similar operation and effect as the operation and effect brought about by each common component in the first embodiment can be obtained. Of course.

上記において、本発明について好適な実施形態を挙げて説明したが、本発明は前記実施形態に限定されるものではなく、本発明の要旨を逸脱しない範囲において、種々の改変が可能なことは言うまでもない。 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.

１０、７０、８０…瘤治療デバイス１１…カテーテル
１２…シャフト１４、７２…係合部
１６、１６Ａ〜１６Ｅ…離脱機構２４、７４、７６、７８…フック
２４ａ、７４ａ、７６ａ、７８ａ…先鋭部 10, 70, 80 ... aneurysm treatment device 11 ... catheter 12 ... shaft 14, 72 ... engagement portion 16, 16A-16E ... disengagement mechanism 24, 74, 76, 78 ... hook 24a, 74a, 76a, 78a ... sharp point

Claims

A linear shaft having flexibility;
An engagement portion having at least one hook that is coupled to the distal end portion of the shaft and can be engaged with an inner wall of an aneurysm formed in a living body and an opening vicinity of the aneurysm;
A disengagement mechanism for releasably connecting the shaft and the engagement portion;
An aneurysm treatment device characterized by that.

The aneurysm treatment device according to claim 1, wherein
The engaging portion has a spiral portion on the proximal end side of the hook,
An aneurysm treatment device characterized by that.

The aneurysm treatment device according to claim 1 or 2,
The hook provided at the distal end portion of the engaging portion is bent in the middle, and the sharpened portion faces the proximal end side of the engaging portion.
An aneurysm treatment device characterized by that.

The aneurysm treatment device according to claim 1, wherein
The engaging portion has a plurality of hooks provided in different directions.
An aneurysm treatment device characterized by that.

An aneurysm treatment device comprising: a flexible linear shaft; an engagement portion provided at a tip of the shaft and having a hook; and a release mechanism that releasably connects the shaft and the engagement portion. An access step for delivering to a position where an aneurysm is located through a catheter inserted into the blood vessel;
An insertion step of inserting the engaging portion into the aneurysm;
A first engaging step for engaging the engaging portion with an inner wall of the knob;
In a state where the engaging portion is engaged with the inner wall of the knob, a pulling step for pulling the engaging portion toward the opening side of the knob;
A second engagement step for engaging the engagement portion in a state of being engaged with the inner wall of the knob in the vicinity of the opening of the knob;
A detaching step of detaching the engaging portion from the shaft,
An aneurysm treatment method characterized by the above.

The aneurysm treatment method according to claim 5,
The hook constituting the distal end portion of the engaging portion has a bent portion in the middle, and the sharpened portion faces the proximal end side of the engaging portion,
In the first engaging step, the engaging portion is rotated, and after the hook is pierced into the inner wall of the knob, the tip of the hook protrudes from the inner wall of the knob.
In the second engagement step, the hook engaged with the inner wall of the knob is engaged in the vicinity of the opening of the knob.
An aneurysm treatment method characterized by the above.

The aneurysm treatment method according to claim 5,
The engaging portion has a plurality of hooks provided in different directions,
In the first engagement step, of the plurality of hooks, a hook constituting a tip portion of the engagement portion is engaged with an inner wall of the knob.
In the second engagement step, a hook different from the hook engaged with the inner wall of the knob is engaged in the vicinity of the opening of the knob.
An aneurysm treatment method characterized by the above.