JP3660931B2 - Thrombus embolus capture device - Google Patents

Thrombus embolus capture device

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JP3660931B2
JP3660931B2 JP2003330396A JP2003330396A JP3660931B2 JP 3660931 B2 JP3660931 B2 JP 3660931B2 JP 2003330396 A JP2003330396 A JP 2003330396A JP 2003330396 A JP2003330396 A JP 2003330396A JP 3660931 B2 JP3660931 B2 JP 3660931B2
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bag
stent
main body
capture device
filter
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JP2005095242A (en
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新 石丸
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新 石丸
北村 篤識
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Priority to JP2003330396A priority Critical patent/JP3660931B2/en
Priority to PCT/JP2004/008455 priority patent/WO2005027751A1/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01Filters implantable into blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2215Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having an open distal end
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01Filters implantable into blood vessels
    • A61F2002/016Filters implantable into blood vessels made from wire-like elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01Filters implantable into blood vessels
    • A61F2002/018Filters implantable into blood vessels made from tubes or sheets of material, e.g. by etching or laser-cutting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004Rounded shapes, e.g. with rounded corners
    • A61F2230/0006Rounded shapes, e.g. with rounded corners circular
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0067Three-dimensional shapes conical
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0073Quadric-shaped
    • A61F2230/008Quadric-shaped paraboloidal

Description

本発明は、ステント又はステントグラフトの留置術、経皮的血管形成術等の血管疾患の治療、或いは、外科手術において、脳、心臓、肺、肝臓、腎臓、四肢等の重篤な臓器を潅流する動脈又は静脈内が、浮遊する血栓や塞栓によって、閉塞されることを防止する血栓塞栓捕獲装置に関する。   The present invention perfuses severe organs such as brain, heart, lung, liver, kidney, and extremities in the treatment of vascular diseases such as placement of stents or stent grafts, percutaneous angioplasty, or surgery. The present invention relates to a thrombus embolus capturing device that prevents an artery or vein from being blocked by a floating thrombus or embolus.

高齢化社会を迎えて、動脈硬化に起因して発生する動脈閉塞や動脈瘤が著しく増加している。従来より、動脈閉塞や動脈瘤の治療は、外科手術を中心に行われてきたが、最近では、より侵襲の低いカテーテルを用いた血管内治療が注目されており、ステント又はステントグラフトの留置術、経皮的血管形成術等の血管疾患の治療において新技術の開発が急速に進められている。しかながら、外科的血行再建手術や血管内治療においては、手術手技やカテーテル操作によっては、しばしば血管内腔に血栓を形成したり、血管壁からアテローム(粥腫)を剥離させることがあるので、これらの血栓やアテロームによる塞栓が脳、心臓、肝臓、腎臓、四肢等の重篤な臓器を潅流する動脈又は静脈を閉塞させ、そのために、血栓やアテロームによる塞栓が血栓塞栓症を引き起こすという問題があった。また、通常の外科手術においても、同様に、血管内腔に血栓を形成したり、血管壁からアテローム(粥腫)を剥離させることがあるので、これらの血栓やアテロームによる塞栓が血管内を浮遊して血栓塞栓症を引き起こすという問題があった。特に、カテーテル手技を用いた血管内治療の際には、浮遊する血栓やアテロームによる塞栓を直接観察したり除去することができないので、浮遊する血栓やアテロームによる塞栓が心筋梗塞等の重篤な合併症を引き起こすという問題があった。   With the aging of society, arterial occlusions and aneurysms that occur due to arteriosclerosis have increased remarkably. Conventionally, treatment of arterial occlusion and aneurysm has been performed mainly in surgery, but recently, endovascular treatment using a less invasive catheter has attracted attention, and stent or stent graft placement, New technologies are being rapidly developed in the treatment of vascular diseases such as percutaneous angioplasty. However, in surgical revascularization and endovascular treatment, depending on the surgical technique and catheter operation, a blood clot often forms in the blood vessel lumen, and atheroma (atheroma) may be peeled off from the blood vessel wall. These thrombi and atherothromboembolism occlude arteries or veins that perfuse critical organs such as the brain, heart, liver, kidneys, and extremities. there were. Similarly, in normal surgical operations, blood clots may form in the lumen of the blood vessel, or atheroma may be detached from the blood vessel wall. There was a problem of causing thromboembolism. In particular, during endovascular treatment using a catheter technique, floating thrombi and atheroemboli cannot be observed or removed directly, so floating thrombi or emboli due to atherosclerosis are serious complications such as myocardial infarction. There was a problem of causing illness.

そこで、これらの問題を解決するために血管フィルタシステムに関する技術(以下、「従来技術1」という。)(特許文献1)、血管内の血液を濾過する装置に関する技術(以下、「従来技術2」という。)(特許文献2)、及び、血管内フィルタに関する技術(以下、「従来技術3」という。)(特許文献3)が提案された。
特開2003−220062号公報 特開2001−293084号公報 特開平5−76535号公報
In order to solve these problems, a technique relating to a blood vessel filter system (hereinafter referred to as “conventional technique 1”) (Patent Document 1) and a technique relating to a device for filtering blood in blood vessels (hereinafter referred to as “conventional technique 2”). (Patent Document 2) and a technique related to an intravascular filter (hereinafter referred to as “Prior Art 3”) (Patent Document 3) have been proposed.
Japanese Patent Laid-Open No. 2003-220062 JP 2001-293084 A Japanese Patent Laid-Open No. 5-76535

しかしながら、従来技術1〜3は、いずれも、管状のカテーテルから血管内に放出したフイルタを血管内壁に当接させるものであるので、血管内におけるフィルタの位置決めに熟練を要し、しかも、血栓、塞栓等の浮遊物を捕獲したフィルタをカテーテル内に回収する際に、フィルタあるいはステント部を充分に収縮させることができず、カテーテル内に収納できなかったり、血管内壁を損傷させるという問題があった。   However, since all of the prior arts 1 to 3 contact the inner wall of the blood vessel released from the tubular catheter into the blood vessel, skill is required for positioning the filter in the blood vessel, and thrombus, When collecting a filter that captured suspended matter such as an embolus into the catheter, there was a problem that the filter or the stent could not be sufficiently contracted and could not be stored in the catheter, or the inner wall of the blood vessel was damaged. .

本発明は、かかる問題を解決することを目的としている。   The present invention aims to solve this problem.

即ち、本発明は、カテーテルからの放出及び回収を滑らかに行って、血管中において袋状のフィルタを留置する場所の位置決めを容易に行うことができると共に、その場所に袋状のフィルタを血管内壁を損傷させずに安全且つ確実に留置することができ、しかも、血管中で血栓、塞栓等の浮遊物を捕獲した袋状のフィルタを血管内壁を損傷させずに安全且つ確実に体外に回収することができる血栓塞栓捕獲装置を低コストで提供することを目的としている。   That is, according to the present invention, discharge and collection from the catheter can be performed smoothly, and the position where the bag-like filter is placed in the blood vessel can be easily positioned, and the bag-like filter is placed at the inner wall of the blood vessel. It can be safely and reliably placed without damaging it, and the bag-like filter that captures suspended matter such as thrombus and embolus in the blood vessel can be safely and reliably recovered outside the body without damaging the inner wall of the blood vessel. An object of the present invention is to provide a thrombus embolus capturing device that can be manufactured at low cost.

請求項1に記載された発明は、縮拡径自在とした常態時に拡径して円筒状となる本体部、該本体部に続いて設けられた縮拡径自在とした常態時に拡径してテーパー状となる尾部、及び、該尾部に続いて設けられた支柱部から構成されたステントと、該ステントの本体部内に保持された、開口部及び本体部から構成された、袋状のフィルタと、を有する血栓塞栓捕獲装置であって、
(イ)前記ステントの本体部及び尾部が1本又は複数本の線条によって螺旋状に撚り組まれて組み紐構造に形成され、且つ、
(ロ)前記袋状のフィルタが前記ステントの本体部に内挿されると共に、該袋状のフィルタの開口部が該ステントの本体部の先端に係合手段で係合されている
ことを特徴とする血栓塞栓捕獲装置である。
The invention described in claim 1 is a main body portion that is expanded to a cylindrical shape in a normal state where the diameter can be reduced and expanded, and is expanded in a normal state in which the diameter is expandable and is provided following the main body portion. A taper-shaped tail, and a stent composed of struts provided following the tail, and a bag-like filter composed of an opening and a body held in the main body of the stent; A thromboembolus capture device comprising:
(A) The main body and the tail of the stent are formed into a braid structure by being spirally twisted by one or a plurality of filaments, and
(B) The bag-shaped filter is inserted into the main body of the stent, and the opening of the bag-shaped filter is engaged with the distal end of the main body of the stent by engaging means. It is a thromboembolus capture device.

請求項2に記載された発明は、請求項1に記載された発明において、前記線条を形状記憶材料で構成して、ステントの本体部を常態時に拡径して円筒状となるように形状記憶させ、そして、ステントの尾部を常態時にテーパー状となるように形状記憶させたことを特徴とするものである。   The invention described in claim 2 is the invention described in claim 1, wherein the filament is made of a shape memory material, and the main body of the stent is expanded in a normal state to have a cylindrical shape. The shape is memorized, and the tail of the stent is memorized so as to be tapered in a normal state.

請求項3に記載された発明は、請求項1又は2に記載された発明において、前記支柱部が、1本又は複数本の線条を螺旋状に撚り組んで本体部及び尾部と一体的に形成した縮径自在の組み紐構造とされ、そして、常態時に縮径状にされて棒状体とされていることを特徴とするものである。 The invention described in claim 3 is the invention described in claim 1 or 2, wherein the strut portion is formed by twisting one or a plurality of filaments in a spiral manner so as to be integrated with the main body portion and the tail portion. is a form the reduced diameter capable of braid structure, and is characterized in that there is a rod-like body is in the normal state to the reduced径状.

請求項4に記載された発明は、請求項3に記載された発明において、前記線条が、形状記憶材料で構成されていることを特徴とするものである。   The invention described in claim 4 is the invention described in claim 3, wherein the filament is made of a shape memory material.

請求項5に記載された発明は、請求項1又は2に記載された発明において、前記支柱部が、ポリテトラフルオロエチレン、ポリオレフィン、ポリエステル、ポリウレタン、ポリシロキサン等の合成樹脂で構成される中空の棒状体であることを特徴とするものである。   According to a fifth aspect of the present invention, in the first or second aspect of the present invention, the support portion is a hollow formed of a synthetic resin such as polytetrafluoroethylene, polyolefin, polyester, polyurethane, or polysiloxane. It is a rod-shaped body.

請求項6に記載された発明は、請求項1〜5のいずれかに記載された発明において、前記ステントの先端に、線条の折り返し、2本の線条端の接合、線条の折り返し部分の捻り等によるループを等間隔に形成したことを特徴とするものである。   The invention described in claim 6 is the invention described in any one of claims 1 to 5, wherein at the distal end of the stent, the line is folded back, the two line ends are joined, and the line is folded back. It is characterized in that loops formed by twisting of the wire are formed at equal intervals.

請求項7に記載された発明は、請求項1〜6のいずれかに記載された発明において、前記袋状のフィルタが、口径10〜300μmの微細孔を多数有する編成布、織成布、不織布、網体又は孔あけされた高分子フィルムで構成されていることを特徴とするものである。   The invention described in claim 7 is the invention described in any one of claims 1 to 6, wherein the bag-like filter has a knitted fabric, a woven fabric, and a non-woven fabric having a large number of fine holes having a diameter of 10 to 300 μm. It is composed of a net or a perforated polymer film.

請求項8に記載された発明は、請求項7に記載された発明において、前記袋状のフィルタが、糸で袋状に編成された編成布、糸で袋状に織成された織成布、繊維ウエッブで袋状に成形された不織布、網体、又は、合成樹脂から直接に袋状に成形された後、孔あけされた高分子フィルムで構成されていることを特徴とするものである。   The invention described in claim 8 is the invention described in claim 7, wherein the bag-like filter is a knitted fabric knitted into a bag shape with yarn, and a woven fabric woven into a bag shape with yarn. , Characterized in that it is composed of a non-woven fabric formed in a bag shape with a fiber web, a net, or a polymer film that is directly formed into a bag shape from a synthetic resin and then perforated. .

請求項9に記載された発明は、請求項7に記載された発明において、前記袋状のフィルタが、接着又は縫着によって袋状に成形された編成布、織成布、不織布、網体又は孔あけされた高分子フィルムで構成されていることを特徴とするものである。 The invention described in claim 9 is the invention described in claim 7, wherein the bag-like filter is a knitted fabric, a woven fabric, a non-woven fabric, a net body, or a bag formed by bonding or sewing. It is composed of a perforated polymer film.

請求項10に記載された発明は、請求項7〜9のいずれかに記載された発明において、前記編成布及び織成布が、ポリエステル糸、ポリアミド糸、ポリプロピレン糸又は極細径金属線で構成されていることを特徴とするものである。   The invention described in claim 10 is the invention described in any one of claims 7 to 9, wherein the knitted fabric and the woven fabric are made of a polyester yarn, a polyamide yarn, a polypropylene yarn, or an ultrafine metal wire. It is characterized by that.

請求項11に記載された発明は、請求項7〜9のいずれかに記載された発明において、前記不織布、網体が、ポリエステル繊維、ポリアミド繊維、ポリプロピレン繊維、セルロース繊維又はそれらの混合繊維で構成されていることを特徴とするものである。   The invention described in claim 11 is the invention described in any one of claims 7 to 9, wherein the nonwoven fabric and the network are composed of polyester fiber, polyamide fiber, polypropylene fiber, cellulose fiber or a mixed fiber thereof. It is characterized by being.

請求項12に記載された発明は、請求項7〜9のいずれかに記載された発明において、前記高分子フィルムが、フッ素樹脂、ポリウレタン樹脂、ポリエステル樹脂、ポリアミド樹脂又はポリプロピレン樹脂で構成されていることを特徴とするものである。   The invention described in claim 12 is the invention described in any one of claims 7 to 9, wherein the polymer film is made of a fluororesin, a polyurethane resin, a polyester resin, a polyamide resin or a polypropylene resin. It is characterized by this.

請求項13に記載された発明は、請求項1〜12のいずれかに記載された発明において、前記係合手段が、(a)縫合糸による縫着、(b)接着剤による接着、又は、(c)溶着であることを特徴とするものである。   The invention described in claim 13 is the invention described in any one of claims 1 to 12, wherein the engaging means is (a) sewing with a suture, (b) adhesion with an adhesive, or (C) It is characterized by welding.

本発明は、以下に記載する効果を奏する。   The present invention has the following effects.

(1)請求項1,3〜5に記載された発明によれば、(イ)前記ステントの本体部及び尾部が1本又は複数本の線条によって螺旋状に撚り組まれて組み紐構造に形成され、且つ、(ロ)前記袋状のフィルタが前記ステントの本体部に内挿されると共に、該袋状のフィルタの開口部が該ステントの本体部の先端に係合手段で係合されたものであるので、カテーテルからの放出及び回収を滑らかに行って、血管中において袋状のフィルタを留置する場所の位置決めを容易に行うことができると共に、その場所に袋状のフィルタを血管内壁を損傷させずに安全且つ確実に留置することができ、しかも、血管中で血栓、塞栓等の浮遊物を捕獲した袋状のフィルタを血管内壁を損傷させずに安全且つ確実に体外に回収することができる血栓塞栓捕獲装置を低コストで提供することができる。   (1) According to the invention described in claims 1, 3 to 5, (a) the main body and the tail of the stent are spirally twisted by one or a plurality of filaments to form a braid structure And (b) the bag-shaped filter is inserted into the main body of the stent, and the opening of the bag-shaped filter is engaged with the distal end of the main body of the stent by the engaging means. Therefore, it is possible to smoothly release and collect from the catheter, and easily locate the place where the bag-like filter is placed in the blood vessel, and damage the inner wall of the blood vessel at the place. It is possible to safely and reliably indwell it, and to collect the bag-like filter that captures suspended matter such as thrombus and embolus in the blood vessel safely and reliably outside the blood vessel without damaging the inner wall of the blood vessel. Thrombus embolus capture device It can be provided at low cost.

(2)請求項2に記載された発明によれば、線条を形状記憶材料で構成して、ステントの本体部を常態時に拡径して円筒状となるように形状記憶させ、そして、ステントの尾部を常態時にテーパー状となるように形状記憶させたので、常態時に拡径した本体部及び常態時にテーパー状となる尾部を有するステントを容易に且つ低コストで製造することができる。   (2) According to the invention described in claim 2, the filament is made of a shape memory material, the shape of the main body of the stent is expanded so as to become a cylindrical shape in a normal state, and the stent Since the shape of the tail portion is memorized so as to be tapered in the normal state, it is possible to easily and inexpensively manufacture a stent having a main body portion having a diameter increased in the normal state and a tail portion that is tapered in the normal state.

(3)請求項6に記載された発明によれば、ステントの先端に、線条の折り返し、2本の線条端の接合、線条の折り返し部分の捻り等によるループを等間隔に形成したので、ステントの本体部に内挿した袋状のフィルタの開口部をステントの先端に係合手段で容易に係合させることができ、また、ステントの先端は、ループで形成されていると滑らかになるので、体内管状体の内壁損傷させることがない。   (3) According to the invention described in claim 6, loops are formed at equal intervals on the distal end of the stent by folding the filaments, joining the two filament ends, twisting the folded portions of the filaments, etc. Therefore, the opening of the bag-like filter inserted in the main body of the stent can be easily engaged with the distal end of the stent by the engaging means, and the distal end of the stent is smooth when formed with a loop. Therefore, the inner wall of the tubular body is not damaged.

(4)請求項7〜12に記載された発明によれば、袋状のフィルタが口径10〜300μmの微細孔を多数有する編成布、織成布、不織布、網体又は孔あけされた高分子フィルムで構成されているので、袋状のフィルタが、血液の流れを止めないで、血管中における血栓、塞栓等の浮遊物を確実に捕獲することができる。   (4) According to the invention described in claims 7 to 12, a knitted fabric, a woven fabric, a non-woven fabric, a net or a perforated polymer in which a bag-like filter has a large number of fine pores having a diameter of 10 to 300 μm. Since it is composed of a film, the bag-like filter can reliably capture suspended matters such as thrombus and embolus in the blood vessel without stopping the flow of blood.

(5)請求項13に記載された発明によれば、係合手段が、(a)縫合糸による縫着、(b)接着剤による接着、又は、(c)溶着であるので、係合手段によって、血管内壁を損傷させることはない。   (5) According to the invention described in claim 13, since the engaging means is (a) sewing with a suture, (b) adhesion with an adhesive, or (c) welding, the engaging means Does not damage the inner wall of the blood vessel.

以下、図面を参照しながら、本実施の形態を説明する。   Hereinafter, the present embodiment will be described with reference to the drawings.

図1は、本発明の一実施の形態を示す血栓塞栓捕獲装置の説明図であって、(a)は、ステントを示し、(b)は、袋状(円錐形状)のフィルタを示し、(c)は、(b)のフィルタのA−A断面を示し、(d)は、該袋状のフィルタが拡径状態のステントの本体部に内挿されていると共に、該袋状のフィルタの開口部が該ステントの本体部の先端に係合手段で係合されている状態を示し、そして、(e)は、該ステント及びその本体部に内挿され袋状のフィルタをカテーテル内に格納した状態を示す。図2は、本発明の他の一実施の形態を示す血栓塞栓捕獲装置の説明図であって、(a)は、ステントを示し、(b)は、袋状(縦断面U字形状)のフィルタを示し、(c)は、該袋状のフィルタが拡径状態のステントの本体部に内挿されると共に、該袋状のフィルタの開口部が該ステントの本体部の先端に係合手段で係合されている状態を示し、そして、(d)は、該ステント及びその本体部に内挿され袋状のフィルタをカテーテル内に格納した状態を示す。図3は、本発明の他の一実施の形態を示す血栓塞栓捕獲装置におけるステントの説明図である。図4は、カテーテル内に格納したステントの本体部及びそこに内挿した袋状のフィルタを、弓部大動脈から分岐した血管中に放出して、該袋状のフィルタで血液を濾過している状態を示す説明図であって、(a)は、全体説明図であり、そして、(b)は、その部分拡大説明図である。   FIG. 1 is an explanatory view of a thromboembolism capture device showing an embodiment of the present invention, in which (a) shows a stent, (b) shows a bag-like (conical shape) filter, (c) shows the AA cross section of the filter of (b), and (d) shows that the bag-shaped filter is inserted into the main body of the expanded diameter stent, The opening is shown in a state in which the opening is engaged with the distal end of the main body of the stent by the engaging means, and (e) is inserted into the stent and the main body and the bag-like filter is stored in the catheter. Shows the state. FIG. 2 is an explanatory view of a thromboembolism capture device showing another embodiment of the present invention, in which (a) shows a stent and (b) shows a bag shape (vertical section U-shaped). (C) shows the filter, wherein the bag-shaped filter is inserted into the main body portion of the expanded stent, and the opening of the bag-shaped filter is engaged with the distal end of the main body portion of the stent by the engaging means. The engaged state is shown, and (d) shows the state in which the bag-like filter is inserted into the stent and its main body and stored in the catheter. FIG. 3 is an explanatory view of a stent in a thromboembolism capture device showing another embodiment of the present invention. FIG. 4 shows the main body part of the stent stored in the catheter and the bag-like filter inserted therein, which is discharged into the blood vessel branched from the arch aorta, and the blood is filtered by the bag-like filter. It is explanatory drawing which shows a state, Comprising: (a) is a whole explanatory drawing, (b) is the elements on larger scale.

図1において、10は、血栓塞栓捕獲装置である。血栓塞栓捕獲装置10は、縮拡径自在とした常態時に拡径して円筒状となる本体部1a、該本体部1aに続いて設けられた縮拡径自在とした常態時に拡径してテーパー状となる尾部1b、及び、該尾部1bに続いて設けられた支柱部1cから構成されたステント1と、該ステント1の本体部1a内に保持された、開口部2a及び本体部2bから構成された、袋状のフィルタ2と、開口部2a及び本体部2bから構成された袋状(円錐形状)のフィルタ2と、を有しており、そして、(イ)前記ステント1の本体部1a及び尾部1bが1本又は複数本の線条Wによって螺旋状に撚り組まれて組み紐構造に形成され、且つ、(ロ)前記袋状のフィルタ2が前記ステント1の本体部1aに内挿されると共に、該袋状のフィルタ2の開口部2aが該ステント1の本体部1aの先端1dに係合手段5で係合されている。図1において、2cは、ガイドワイヤーを通す穴であり、4は、カテーテルであり、そして、6は、ガイドワイヤーである。   In FIG. 1, 10 is a thromboembolism capture device. The thromboembolism capture device 10 has a main body 1a that is expanded and cylindrical in a normal state in which the diameter can be freely expanded, and is tapered in a normal state in which the diameter can be expanded and contracted, provided subsequently to the main body 1a. A stent 1 composed of a tail portion 1b and a strut portion 1c provided following the tail portion 1b, and an opening 2a and a body portion 2b held in the body portion 1a of the stent 1 A bag-like filter 2 and a bag-like (conical shape) filter 2 composed of an opening 2a and a main body 2b, and (a) a main body 1a of the stent 1. And the tail portion 1b are formed in a braided structure by being spirally twisted by one or a plurality of filaments W, and (b) the bag-like filter 2 is inserted into the main body portion 1a of the stent 1. In addition, the opening 2a of the bag-like filter 2 is It is engaged by the engaging means 5 to the tip 1d of the main body portion 1a of cement 1. In FIG. 1, 2c is a hole through which a guide wire passes, 4 is a catheter, and 6 is a guide wire.

図2において、20は、血栓塞栓捕獲装置である。血栓塞栓捕獲装置20は、縮拡径自在とした常態時に拡径して円筒状となる本体部1a、該本体部1aに続いて設けられた縮拡径自在とした常態時に拡径してテーパー状となる尾部1b、及び、該尾部1bに続いて設けられた支柱部1cから構成されたステント1と、該ステント1の本体部1a内に保持された、開口部3a及び本体部3bから構成された、袋状(縦断面U字形状)のフィルタ3と、開口部2a及び本体部2bから構成された、袋状のフィルタ3と、を有しており、そして、(イ)前記ステント1の本体部1a及び尾部1bが1本又は複数本の線条Wによって螺旋状に撚り組まれて組み紐構造に形成され、且つ、(ロ)前記袋状のフィルタ3が前記ステント1の本体部1aに内挿されると共に、該袋状のフィルタ3の開口部3aが該ステント1の本体部1aの先端1dに係合手段5で係合されている。図2において、4は、カテーテルであり、そして、6は、ガイドワイヤーである。   In FIG. 2, 20 is a thromboembolism capture device. The thromboembolism capturing device 20 has a main body portion 1a that is expanded and cylindrical in a normal state where the diameter can be reduced and expanded, and is expanded and tapered in a normal state that is provided following the main body portion 1a. A stent 1 composed of a tail portion 1b and a strut portion 1c provided following the tail portion 1b, and an opening 3a and a body portion 3b held in the body portion 1a of the stent 1 A bag-like (longitudinal U-shaped) filter 3 and a bag-like filter 3 composed of an opening 2a and a main body 2b, and (a) the stent 1 The main body portion 1a and the tail portion 1b are spirally twisted by one or a plurality of filaments W to form a braided structure, and (b) the bag-like filter 3 is the main body portion 1a of the stent 1. And the opening 3 of the bag-like filter 3. There has been engaged by the engaging means 5 to the tip 1d of the main body portion 1a of the stent 1. In FIG. 2, 4 is a catheter and 6 is a guide wire.

図1,2においては、円錐形状をした袋状のフィルタ2及び縦断面U字形状をした袋状のフィルタ3を示したが、本発明の目的に反しない限り、本発明の袋状のフィルタは、これらの形状以外の袋状をしたものであってもかまわない。   1 and 2 show the bag-shaped filter 2 having a conical shape and the bag-shaped filter 3 having a U-shaped longitudinal section, but the bag-shaped filter of the present invention is not deviated from the object of the present invention. May have a bag shape other than these shapes.

本発明は、縮拡径自在とした常態時に拡径して円筒状となる本体部1a、該本体部1aに続いて設けられた縮拡径自在とした常態時に拡径してテーパー状となる尾部1b、及び、該尾部1bに続いて設けられた支柱部1cから構成されたステント1と、該ステント1の本体部1a内に保持された、開口部2a,3a及び本体部2b,3bから構成された、袋状のフィルタ2,3と、を有する血栓塞栓捕獲装置10,20であって、(イ)前記ステント1の本体部1a及び尾部1bが1本又は複数本の線条Wによって螺旋状に撚り組まれて組み紐構造に形成され、且つ、(ロ)前記袋状のフィルタ2,3が前記ステント1の本体部1aに内挿されると共に、該袋状のフィルタ2,3の開口部2a,3aが該ステント1の本体部1aの先端1dに係合手段5で係合されたものであるので、カテーテル4からの放出及び回収を滑らかに行って、血管中において袋状のフィルタ2,3を留置する場所の位置決めを容易に行うことができると共に、その場所に袋状のフィルタ2,3を血管内壁を損傷させずに安全且つ確実に留置することができ、しかも、血管中で血栓、塞栓等の浮遊物を捕獲した袋状のフィルタを血管内壁を損傷させずに安全且つ確実に体外に回収することができる血栓塞栓捕獲装置を低コストで提供することができる。   The present invention has a main body portion 1a which is expanded and cylindrical in a normal state where the diameter can be reduced and expanded, and a diameter is increased and tapered in a normal state which is provided following the main body portion 1a. From the tail portion 1b and the stent 1 composed of the strut portion 1c provided following the tail portion 1b, and the openings 2a and 3a and the main body portions 2b and 3b held in the main body portion 1a of the stent 1 A thrombus embolus capturing device 10 or 20 having a bag-like filter 2 or 3, and (a) the main body 1 a and the tail 1 b of the stent 1 are formed by one or a plurality of filaments W. (B) the bag-like filters 2 and 3 are inserted into the main body 1a of the stent 1 and the openings of the bag-like filters 2 and 3 are formed. The portions 2a and 3a are attached to the tip 1d of the main body 1a of the stent Since it is engaged by the coupling means 5, the discharge and recovery from the catheter 4 can be performed smoothly, and the location where the bag-like filters 2 and 3 are placed in the blood vessel can be easily positioned. In addition, the bag-like filters 2 and 3 can be safely and surely placed without damaging the inner wall of the blood vessel, and the bag-like filter that captures floating substances such as thrombus and embolus in the blood vessel A thrombus embolus capture device that can be safely and reliably recovered outside the body without damaging the inner wall can be provided at a low cost.

本発明におけるステント1を構成する線条Wは、好ましくは、形状記憶合金、即ち、Ni−Ti、Cu−Al−Ni、Cu−Zn−Al等の形状記憶合金で形成されるが、本発明の目的に反しないかぎり、ステンレス鋼、ニッケル、タンタル等の金属、及び、ポリエステル、ポリテトラフルオロエチレン、ポリオレフィン、ポリウレタン等の合成樹脂でも形成される。また、形状記憶合金、その他の金属で形成した金属線を前記したような合成樹脂で被覆してもかまわない。   The filament W constituting the stent 1 in the present invention is preferably formed of a shape memory alloy, that is, a shape memory alloy such as Ni—Ti, Cu—Al—Ni, or Cu—Zn—Al. Unless it is contrary to the above-mentioned purpose, it can be formed of metals such as stainless steel, nickel and tantalum, and synthetic resins such as polyester, polytetrafluoroethylene, polyolefin and polyurethane. Further, a metal wire formed of a shape memory alloy or other metal may be coated with the synthetic resin as described above.

前記線条Wを形状記憶材料で構成する場合には、ステント1の本体部1aを常態時に拡径して円筒状となるように形状記憶させ、そして、ステント1の尾部1bを常態時にテーパー状となるように形状記憶させる。このように、線条Wを形状記憶材料で構成して、ステント1の本体部1aを常態時に拡径して円筒状となるように形状記憶させ、そして、ステント1の尾部1bを常態時にテーパー状となるように形状記憶させると、常態時に拡径した本体部1a及び常態時にテーパー状となる尾部1bを有するステントを容易に且つ低コストで製造することができる。   In the case where the filament W is made of a shape memory material, the main body 1a of the stent 1 is expanded in diameter in a normal state so as to have a cylindrical shape, and the tail 1b of the stent 1 is tapered in a normal state. The shape is memorized so that In this way, the filament W is made of a shape memory material, the main body portion 1a of the stent 1 is expanded in diameter in a normal state so as to have a cylindrical shape, and the tail portion 1b of the stent 1 is tapered in a normal state. When the shape is memorized so as to have a shape, a stent having the main body portion 1a having a diameter expanded in a normal state and a tail portion 1b having a tapered shape in a normal state can be easily manufactured at a low cost.

前記ステント1における支柱部1cは、好ましくは、1本又は複数本の線条Wを螺旋状に撚り組んで本体部及び尾部と一体的に形成した縮径自在の組み紐構造とされ、そして、常態時に縮径状にされて棒状体とされているものであるが、前記線条Wは、好ましくは、形状記憶材料で構成されている。 The strut portion 1c in the stent 1 preferably has a braided structure having a reduced diameter, in which one or a plurality of filaments W are spirally twisted and formed integrally with the main body portion and the tail portion. Although the diameter is sometimes reduced to a rod-like body, the filament W is preferably made of a shape memory material.

図3に示すように、本発明においては、ステント11における支柱部11cは、ポリテトラフルオロエチレン、ポリオレフィン、ポリエステル、ポリウレタン、ポリシロキサン等の合成樹脂で構成される中空の棒状体(パイプ状体)であってもかまわない。図3において、11a、11b及び11dは、それぞれ、本体部、尾部及び先端である。   As shown in FIG. 3, in the present invention, the support 11c in the stent 11 is a hollow rod-shaped body (pipe-shaped body) made of a synthetic resin such as polytetrafluoroethylene, polyolefin, polyester, polyurethane, polysiloxane or the like. It doesn't matter. In FIG. 3, 11a, 11b, and 11d are a main-body part, a tail part, and a front-end | tip, respectively.

図1,3に示すように、本発明のステント1,11においては、そのステントの先端1d、11dに、線条の折り返し(図1(a)のステント1の先端部分1dの線条Wの折り返し参照。)、2本の線条端の接合、線条の折り返し部分の捻り等によるループが等間隔に形成されている。「線条の折り返しによるループ」は、ステント1の端部1dに線条Wの折り返しを形成するように線条Wを編み込んで組み紐構造を作りながら形成する。「2本の線条端の接合によるループ」は、線条Wを編み込んで形成した組み紐構造を横方向に切断して隣り合った2本の線条W、Wの端を溶接、ろう付け等により接合して形成する。「線条の捻りによるループ」は、線条Wの折り返しを捻って形成する。本発明によるループは、前記したような手段で形成されたループのみに限定されるものではなく、本発明の目的に反しない限り、その他の手段によって形成したものであってもかまわない。   As shown in FIGS. 1 and 3, in the stents 1 and 11 of the present invention, the filaments are folded back at the distal ends 1d and 11d of the stent (the filament W of the distal end portion 1d of the stent 1 in FIG. 1A). (Refer to Folding.) Loops formed by joining two wire ends, twisting the folded portion of the wire, and the like are formed at equal intervals. The “loop by the folding of the filament” is formed while creating the braid structure by weaving the filament W so as to form the folding of the filament W at the end 1d of the stent 1. “Loop by joining two wire ends” is a braided structure formed by weaving the wire W, cut in the horizontal direction and welded, brazed, etc. at the ends of the two adjacent wires W, W Are formed by bonding. The “loop by twisting of the wire” is formed by twisting the turn of the wire W. The loop according to the present invention is not limited to the loop formed by the above-described means, and may be formed by other means as long as the object of the present invention is not violated.

このように、ステント1,11の先端1d、11dに、線条の折り返し、2本の線条端の接合、線条の折り返し部分の捻り等によるループが等間隔に形成されていると、ステントの本体部に内挿した袋状のフィルタの開口部をステントの先端に係合手段で容易に係合させることができ、また、ステントの先端は、ループで形成されていると滑らかになるので、血管の内壁を損傷させることがない。   As described above, when the loops are formed at equal intervals on the distal ends 1d and 11d of the stents 1 and 11 by folding the filaments, joining the two filament ends, twisting the folded portions of the filaments, and the like. The opening of the bag-shaped filter inserted in the main body of the stent can be easily engaged with the distal end of the stent by the engaging means, and the distal end of the stent is smooth when formed with a loop. Does not damage the inner wall of the blood vessel.

本発明における袋状のフィルタ2,3は、口径10〜300μmの微細孔を多数有する編成布、織成布、不織布、網体又は孔あけされた高分子フィルムで構成されている。前記袋状のフィルタ2,3は、好ましくは、糸で袋状に編成された編成布、糸で袋状に織成された織成布、繊維ウエッブで袋状に成形された不織布、網体、又は、合成樹脂から直接に袋状に成形された後、孔あけされた高分子フィルムで構成さたものであるが、接着又は縫着によって袋状に成形された編成布、織成布、不織布、網体又は孔あけされた高分子フィルムで構成されたものであってもかまわない。前記高分子フィルムの孔あけは、好ましくは、レーザ加工によって行われるが、本発明の目的に反しない限り、レーザ加工以外の公知の孔あけ加工をしたものであってもかまわない。 The bag-like filters 2 and 3 in the present invention are composed of a knitted fabric, a woven fabric, a nonwoven fabric, a net, or a perforated polymer film having a large number of fine holes having a diameter of 10 to 300 μm. The bag-like filters 2 and 3 are preferably a knitted fabric knitted into a bag shape with yarn, a woven fabric woven into a bag shape with yarn, a nonwoven fabric formed into a bag shape with a fiber web, and a net Alternatively, a knitted fabric, a woven fabric, which is formed of a polymer film which is directly formed from a synthetic resin into a bag shape and then perforated, but which is formed into a bag shape by adhesion or sewing, It may be composed of a nonwoven fabric, a net, or a perforated polymer film. Preferably, the polymer film is perforated by laser processing. However, as long as the object of the present invention is not violated, known perforation processing other than laser processing may be performed.

このように、袋状のフィルタが口径10〜300μmの微細孔を多数有する編成布、織成布、不織布、網体又は孔あけされた高分子フィルムで構成されていると、袋状のフィルタが、血液の流れを止めないで、血管中における血栓、塞栓等の浮遊物を確実に捕獲することができる。   Thus, when the bag-shaped filter is composed of a knitted fabric, a woven fabric, a nonwoven fabric, a net, or a perforated polymer film having a large number of fine holes having a diameter of 10 to 300 μm, the bag-shaped filter is Without stopping the blood flow, it is possible to reliably capture suspended matters such as thrombus and embolus in the blood vessel.

前期編成布及び織成布は、好ましくは、ポリエステル糸、ポリアミド糸、ポリプロピレン糸又は極細径金属線で構成されたものであり、前記不織布、網体は、好ましくは、ポリエステル繊維、ポリアミド繊維、ポリプロピレン繊維、セルロース繊維又はそれらの混合繊維で構成されたものであり、そして、前記高分子フィルムは、好ましくは、フッ素樹脂、ポリウレタン樹脂、ポリエステル樹脂、ポリアミド樹脂又はポリプロピレン樹脂で構成されたものである。   The knitted fabric and the woven fabric are preferably made of polyester yarn, polyamide yarn, polypropylene yarn or ultrafine metal wire, and the nonwoven fabric and network are preferably polyester fiber, polyamide fiber, polypropylene. The polymer film is composed of fibers, cellulose fibers or mixed fibers thereof, and the polymer film is preferably composed of a fluororesin, a polyurethane resin, a polyester resin, a polyamide resin or a polypropylene resin.

本発明においては、ステント1の本体部1aに内挿した袋状のフィルタ2,3の開口部2a,3aをステント1の先端1dに係合手段5で係合するが、その係合手段5は、好ましくは、(a)縫合糸による縫着、(b)接着剤による接着、又は、(c)溶着である。このように、係合手段5が、(a)縫合糸による縫着、(b)接着剤による接着、又は、(c)溶着であると、係合手段5によって、血管内壁を損傷させることはない。本発明における係合手段5は、本発明の目的に反しない限り、(a)縫合糸による縫着、(b)接着剤による接着、及び、(c)溶着、以外の係合手段、例えば、スナップのようなものであってもかまわない。   In the present invention, the openings 2a and 3a of the bag-like filters 2 and 3 inserted in the main body 1a of the stent 1 are engaged with the distal end 1d of the stent 1 by the engaging means 5, and the engaging means 5 Is preferably (a) sewing with a suture, (b) adhesion with an adhesive, or (c) welding. As described above, when the engaging means 5 is (a) sewing with a suture thread, (b) adhesion with an adhesive, or (c) welding, the engaging means 5 does not damage the inner wall of the blood vessel. Absent. The engagement means 5 in the present invention is an engagement means other than (a) sewing with a suture, (b) adhesion with an adhesive, and (c) welding, as long as it is not contrary to the object of the present invention. It may be something like a snap.

本発明の血栓塞栓捕獲装置10,20は、パイプ状のカテーテル4内にあらかじめ格納しておいてもかまわない。血栓塞栓捕獲装置10,20は、パイプ状のカテーテル4内にあらかじめ滅菌した状態で格納しておくと、緊急時の使用に即対応することができる。もちろん、使用直前に、血栓塞栓捕獲装置10,20をカテーテル4内に格納しても良い。   The thrombus embolus capturing devices 10 and 20 of the present invention may be stored in the pipe-shaped catheter 4 in advance. If the thromboembolism capture devices 10 and 20 are stored in a sterilized state in the pipe-shaped catheter 4 in advance, they can be used immediately in an emergency. Of course, the thromboembolism capture devices 10 and 20 may be stored in the catheter 4 immediately before use.

次に、本発明の血栓塞栓捕獲装置の操作について説明する。   Next, the operation of the thromboembolism capture device of the present invention will be described.

(一)自己拡張が可能な組み紐構造に形成されたステント1の本体部1aの内側に、ポリエステル糸、ポリアミド糸、ポリプロピレン糸又は極細径金属線を袋状に編成して得た袋状のフィルタ2を内挿し、その袋状のフィルタ2における開口部2a及び後端2cをそれぞれステント1の先端1d及び尾部1bの後端に縫合糸で縫合固定して血栓塞栓捕獲装置10とする。[図1(d)]
(二)この血栓塞栓捕獲装置10におけるステント1の本体部1aに内挿した袋状(円錐形状)のフィルタ2をステントの本体部と共に折り畳んだまま細いカテーテル4の中に格納する。[図1(e)]
(三)このカテーテル4中に格納したステント1の本体部1aに内挿したフィルタ2を有する血栓塞栓捕獲装置10を、予め血管内に配設しておいたガイドワイヤー6に沿って、血管内の留置場所に到達させた後、支柱部1cを固定しつつカテーテル4を引くことによって、血管内に押し出してステント1の本体部1aに内挿したフィルタ2を拡張させる。[図4]
(四)心臓疾患や動静脈疾患に対する心臓血管外科治療、経カテーテル的血管内治療等の治療を実施している間は、血液フィルターを拡張させたままにしておき、治療が終了した後に、ステント1の尾部1bに連続する支柱部1cを保持したままカテーテル4を押し戻すことによって、ステント1の本体部1a及びその内側に内挿した袋状のフィルタ2を含めた血栓塞栓捕獲装置10を収縮させつつカテーテル4の中に再格納する。[図1(e)]
(五)カテーテル4の中に再格納した血栓塞栓捕獲装置10をガイドワイヤーに沿って引いて体外に取り出す。
(1) A bag-like filter obtained by knitting polyester yarn, polyamide yarn, polypropylene yarn, or ultrafine metal wire into a bag shape inside the main body 1a of the stent 1 formed in a braid structure capable of self-expansion. 2 is inserted, and the opening 2a and the rear end 2c of the bag-like filter 2 are secured to the rear end of the distal end 1d and the tail 1b of the stent 1 with a suture to form the thromboembolus capture device 10. [FIG. 1 (d)]
(2) The bag-like (conical) filter 2 inserted in the main body 1a of the stent 1 in the thrombus embolus capturing device 10 is stored in the thin catheter 4 while being folded together with the main body of the stent. [FIG. 1 (e)]
(3) A thromboembolism capture device 10 having a filter 2 inserted in the main body 1a of the stent 1 housed in the catheter 4 is placed in the blood vessel along the guide wire 6 previously disposed in the blood vessel. Then, by pulling the catheter 4 while fixing the column portion 1c, the filter 2 pushed out into the blood vessel and inserted in the main body portion 1a of the stent 1 is expanded. [Fig. 4]
(4) While performing cardiovascular surgical treatment for heart disease and arteriovenous disease, transcatheter endovascular treatment, etc., leave the blood filter expanded, and after the treatment is finished, stent The thromboembolus capture device 10 including the main body 1a of the stent 1 and the bag-like filter 2 inserted inside the stent 1 is contracted by pushing back the catheter 4 while holding the strut 1c continuous with the tail 1b. Re-store in the catheter 4. [FIG. 1 (e)]
(5) Pull the thromboembolism capture device 10 re-stored in the catheter 4 along the guide wire and remove it from the body.

このように、ステント1の本体部1a及びその内側に内挿した袋状のフィルタ2を含めた血栓塞栓捕獲装置10を収縮させつつカテーテル4の中に再格納すると、袋状のフィルタ2は、ステント1の開口部に縫合固定されているので、カテーテル4を押し戻すことによって、尾部1bのテーパが収束するのに伴って収縮しつつカテーテル4の中に格納される際に、袋状のフィルタ2によって捕獲された血栓、塞栓等の浮遊物は、袋状のフィルタ2と共にカテーテル内に回収される。本発明によれば、ステント1の本体部1aに内挿したまま袋状のフィルタ2を拡張させて血栓、塞栓等の浮遊物を捕獲できるので、かかる血栓、塞栓等の浮遊物を捕獲した袋状のフィルタ2を血管内壁を損傷させずに安全且つ確実に体外に回収することができる。   As described above, when the thromboembolism capturing device 10 including the main body 1a of the stent 1 and the bag-like filter 2 inserted inside the stent 1 is retracted into the catheter 4 while being contracted, the bag-like filter 2 is Since it is sutured and fixed to the opening of the stent 1, when the catheter 4 is pushed back and retracted as the taper of the tail 1 b converges, the bag-like filter 2 is retracted. Floats such as thrombi and emboli captured by the are collected in the catheter together with the bag-like filter 2. According to the present invention, the bag-like filter 2 can be expanded while being inserted into the main body 1a of the stent 1 to capture floating substances such as thrombi and emboli. The filter 2 can be safely and reliably recovered outside the body without damaging the inner wall of the blood vessel.

本発明の一実施の形態を示す血栓塞栓捕獲装置の説明図であって、(a)は、ステントを示し、(b)は、袋状(円錐形状)のフィルタを示し、(c)は、(b)のフィルタのA−A断面図であり、(d)は、該袋状のフィルタが拡径状態のステントの本体部に内挿されていると共に、該袋状のフィルタの開口部が該ステントの本体部の先端に係合手段で係合されている状態を示し、そして、(e)は、該ステント及びその本体部に内挿され袋状のフィルタをカテーテル内に格納した状態を示す。It is explanatory drawing of the thromboembolism capture device which shows one embodiment of this invention, (a) shows a stent, (b) shows a bag-like (conical shape) filter, (c), It is AA sectional drawing of the filter of (b), (d) is that the bag-shaped filter is inserted in the main-body part of the stent of a diameter-expanded state, and the opening part of the bag-shaped filter is FIG. 2 shows a state in which the distal end of the main body portion of the stent is engaged by engagement means, and FIG. 4E shows a state in which the stent and the bag-like filter are inserted in the main body portion and stored in the catheter. Show. 本発明の他の一実施の形態を示す血栓塞栓捕獲装置の説明図であって、(a)は、ステントを示し、(b)は、袋状(縦断面U字形状)のフィルタを示し、(c)は、該袋状のフィルタが拡径状態のステントの本体部に内挿されると共に、該袋状のフィルタの開口部が該ステントの本体部の先端に係合手段で係合されている状態を示し、そして、(d)は、該ステント及びその本体部に内挿され袋状のフィルタをカテーテル内に格納した状態を示す。It is explanatory drawing of the thromboembolism capture device which shows other one Embodiment of this invention, (a) shows a stent, (b) shows a bag-like (vertical-section U-shaped) filter, (C) The bag-shaped filter is inserted into the main body portion of the expanded stent, and the opening of the bag-shaped filter is engaged with the distal end of the main body portion of the stent by the engaging means. (D) shows a state in which a bag-like filter inserted in the stent and its main body is stored in the catheter. 本発明の他の一実施の形態を示す血栓塞栓捕獲装置におけるステントの説明図である。It is explanatory drawing of the stent in the thromboembolism capture device which shows other one Embodiment of this invention. カテーテル内に格納したステントの本体部及びそこに内挿した袋状のフィルタを、弓部大動脈から分岐した血管中に放出して、該袋状のフィルタで血液を濾過している状態を示す説明図であって、(a)は、全体説明図であり、そして、(b)は、その部分拡大説明図である。Description of a state in which a main body of a stent stored in a catheter and a bag-like filter inserted therein are discharged into a blood vessel branched from the arch aorta and blood is filtered by the bag-like filter It is a figure, (a) is a whole explanatory drawing, and (b) is the elements on larger scale.

符号の説明Explanation of symbols

1 ステント
1a 本体部
1b 尾部
1c 支柱部
1d 先端
2,3 袋状フィルタ
2a,3a 開口部
2b,3b 本体部
2c ガイドワイヤー通し穴
4 カテーテル
5 係合手段
6 ガイドワイヤー
10、20 血栓塞栓捕獲装置
W 線条
DESCRIPTION OF SYMBOLS 1 Stent 1a Main body part 1b Tail part 1c Support | pillar part 1d Tip 2, 3 Bag-like filter 2a, 3a Opening part 2b, 3b Main body part 2c Guide wire through hole 4 Catheter 5 Engaging means 6 Guide wire 10, 20 Thrombus embolus capture device W Filament

Claims (13)

縮拡径自在とした常態時に拡径して円筒状となる本体部、該本体部に続いて設けられた縮拡径自在とした常態時に拡径してテーパー状となる尾部、及び、該尾部に続いて設けられた支柱部から構成されたステントと、該ステントの本体部内に保持された、開口部及び本体部から構成された、袋状のフィルタと、を有する血栓塞栓捕獲装置であって、
(イ)前記ステントの本体部及び尾部が1本又は複数本の線条によって螺旋状に撚り組まれて組み紐構造に形成され、且つ、
(ロ)前記袋状のフィルタが前記ステントの本体部に内挿されると共に、該袋状のフィルタの開口部が該ステントの本体部の先端に係合手段で係合されている
ことを特徴とする血栓塞栓捕獲装置。
Main body part that expands in diameter and becomes cylindrical in a normal state that can be expanded and contracted, a tail part that expands in a normal state that can be expanded and contracted in a normal state that can be expanded and contracted, and a tail part, and the tail part A thromboembolus capture device comprising: a stent composed of struts provided subsequently to the body; and a bag-like filter composed of an opening and a body part, which is held in the body part of the stent. ,
(A) The main body and the tail of the stent are formed into a braid structure by being spirally twisted by one or a plurality of filaments, and
(B) The bag-shaped filter is inserted into the main body of the stent, and the opening of the bag-shaped filter is engaged with the distal end of the main body of the stent by engaging means. Thromboembolus capture device.
前記線条を形状記憶材料で構成して、ステントの本体部を常態時に拡径して円筒状となるように形状記憶させ、そして、ステントの尾部を常態時にテーパー状となるように形状記憶させたことを特徴とする請求項1に記載の血栓塞栓捕獲装置。   The filament is made of a shape memory material, the shape of the main body of the stent is expanded so as to become a cylindrical shape in a normal state, and the shape of the tail of the stent is changed to a tapered shape in a normal state. The thrombus embolus capture device according to claim 1, wherein 前記支柱部が、1本又は複数本の線条を螺旋状に撚り組んで本体部及び尾部と一体的に形成した縮径自在の組み紐構造とされ、そして、常態時に縮径状にされて棒状体とされていることを特徴とする請求項1又は2に記載の血栓塞栓捕獲装置。 The strut is set to one or the body portion and the tail portion of the plurality of filament teamed twisted spirally and integrally formed with a reduced diameter capable of braid structure, and is the normal state to the reduced径状 rod-like The thrombus embolus capturing device according to claim 1 or 2, wherein the device is a body. 前記線条が、形状記憶材料で構成されていることを特徴とする請求項3に記載の血栓塞栓捕獲装置。   The thrombus embolus capture device according to claim 3, wherein the filament is made of a shape memory material. 前記支柱部が、ポリテトラフルオロエチレン、ポリオレフィン、ポリエステル、ポリウレタン、ポリシロキサン等の合成樹脂で構成される中空の棒状体であることを特徴とする請求項1又は2に記載の血栓塞栓捕獲装置。   The thrombus embolus capture device according to claim 1 or 2, wherein the support portion is a hollow rod-shaped body made of a synthetic resin such as polytetrafluoroethylene, polyolefin, polyester, polyurethane, or polysiloxane. 前記ステントの先端に、線条の折り返し、2本の線条端の接合、線条の折り返し部分の捻り等によるループを等間隔に形成したことを特徴とする請求項1〜5のいずれかに記載の血栓塞栓捕獲装置。   6. The loop according to any one of claims 1 to 5, wherein loops are formed at equal intervals on the distal end of the stent by folding the filaments, joining the two filament ends, twisting the folded portions of the filaments, and the like. The thromboembolism capture device described. 前記袋状のフィルタが、口径10〜300μmの微細孔を多数有する編成布、織成布、不織布、網体又は孔あけされた高分子フィルムで構成されていることを特徴とする請求項1〜6のいずれかに記載の血栓塞栓捕獲装置。   The said bag-shaped filter is comprised with the knitted fabric which has many fine holes with a diameter of 10-300 micrometers, a woven fabric, a nonwoven fabric, a net | network body, or the perforated polymer film, It is characterized by the above-mentioned. The thromboembolism capture device according to any one of 6. 前記袋状のフィルタが、糸で袋状に編成された編成布、糸で袋状に織成された織成布、繊維ウエッブで袋状に成形された不織布、網体、又は、合成樹脂から直接に袋状に成形された後、孔あけされた高分子フィルムで構成されていることを特徴とする請求項7に記載の血栓塞栓捕獲装置。   The bag-shaped filter is formed of a knitted fabric knitted into a bag shape with yarn, a woven fabric woven into a bag shape with yarn, a non-woven fabric formed into a bag shape with a fiber web, a net, or a synthetic resin. 8. The thromboembolism capture device according to claim 7, wherein the thromboembolus capture device is formed of a polymer film which is directly formed into a bag shape and then perforated. 前記袋状のフィルタが、接着又は縫着によって袋状に成形された編成布、織成布、不織布、網体又は孔あけされた高分子フィルムで構成されていることを特徴とする請求項7に記載の血栓塞栓捕獲装置。 8. The bag-like filter is composed of a knitted fabric, a woven fabric, a non-woven fabric, a net or a perforated polymer film formed into a bag shape by adhesion or sewing. The thromboembolism capture device according to 1. 前記編成布及び織成布が、ポリエステル糸、ポリアミド糸、ポリプロピレン糸又は極細径金属線で構成されていることを特徴とする請求項7〜9のいずれかに記載の血栓塞栓捕獲装置。   The thromboembolism capturing device according to any one of claims 7 to 9, wherein the knitted fabric and the woven fabric are made of polyester yarn, polyamide yarn, polypropylene yarn, or ultrafine metal wire. 前記不織布、網体が、ポリエステル繊維、ポリアミド繊維、ポリプロピレン繊維、セルロース繊維又はそれらの混合繊維で構成されていることを特徴とする請求項7〜9のいずれかに記載の血栓塞栓捕獲装置。   The thromboembolism capturing device according to any one of claims 7 to 9, wherein the nonwoven fabric and the net are made of polyester fiber, polyamide fiber, polypropylene fiber, cellulose fiber, or a mixed fiber thereof. 前記高分子フィルムが、フッ素樹脂、ポリウレタン樹脂、ポリエステル樹脂、ポリアミド樹脂又はポリプロピレン樹脂で構成されていることを特徴とする請求項7〜9のいずれかに記載の血栓塞栓捕獲装置。   The thrombus embolus capturing device according to any one of claims 7 to 9, wherein the polymer film is made of a fluororesin, a polyurethane resin, a polyester resin, a polyamide resin, or a polypropylene resin. 前記係合手段が、(a)縫合糸による縫着、(b)接着剤による接着、又は、(c)溶着であることを特徴とする請求項1〜12のいずれかに記載の血栓塞栓捕獲装置。   The thromboembolus capture according to any one of claims 1 to 12, wherein the engaging means is (a) sewing with a suture, (b) adhesion with an adhesive, or (c) welding. apparatus.
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