WO2005027751A1 - Thrombus/embolus collecting device - Google Patents

Thrombus/embolus collecting device Download PDF

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Publication number
WO2005027751A1
WO2005027751A1 PCT/JP2004/008455 JP2004008455W WO2005027751A1 WO 2005027751 A1 WO2005027751 A1 WO 2005027751A1 JP 2004008455 W JP2004008455 W JP 2004008455W WO 2005027751 A1 WO2005027751 A1 WO 2005027751A1
Authority
WO
WIPO (PCT)
Prior art keywords
bag
stent
main body
thromboembolic
capture device
Prior art date
Application number
PCT/JP2004/008455
Other languages
French (fr)
Japanese (ja)
Inventor
Shin Ishimaru
Atsushi Kitamura
Original Assignee
Shin Ishimaru
Atsushi Kitamura
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shin Ishimaru, Atsushi Kitamura filed Critical Shin Ishimaru
Publication of WO2005027751A1 publication Critical patent/WO2005027751A1/en

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Classifications

    • 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

Definitions

  • the present invention relates to the treatment of vascular diseases such as stent or stent-graft placement, percutaneous angioplasty, or the like, or in the case of surgery, in which severe damage to the brain, heart, lung, liver, kidney, limb, etc.
  • the present invention relates to a thromboembolic capture device that prevents an artery or a vein perfusing an organ from being blocked by a floating thrombus or embolus.
  • thrombus emboli block arteries or veins that perfuse critical organs such as the brain, heart, liver, kidneys, and limbs, and therefore, thrombus atheroma causes thromboembolism.
  • a thrombus may be formed in a blood vessel lumen or an atheroma may be peeled off from a blood vessel wall.
  • embolism due to floating thrombus atheroma cannot be directly observed or removed, so embolus due to floating thrombus atheroma may cause serious infarction such as myocardial infarction. There was a problem when complications were caused.
  • Patent Document 1 a technique relating to a blood vessel filter system (hereinafter, referred to as “prior art 1”)
  • Patent Document 2 a technique relating to a device for filtering blood in a blood vessel
  • Patent Document 3 a technique relating to a device for filtering blood in a blood vessel
  • Patent Document 1 Japanese Patent Application Laid-Open No. 2003-220062
  • Patent Document 2 Japanese Patent Application Laid-Open No. 2001-293084
  • Patent Document 3 JP-A-5-76535
  • An object of the present invention is to solve a powerful problem.
  • the present invention can smoothly perform release and recovery from a catheter, easily position a place where a bag-shaped filter is to be placed in a blood vessel, and at the same time,
  • the bag-shaped filter can be safely and securely placed without damaging the inner wall of the blood vessel, and the bag-shaped filter capturing the suspended matter such as thrombus and embolus in the blood vessel without damaging the inner wall of the blood vessel. It is an object of the present invention to provide a low-cost thromboembolic capture device that can be safely and reliably collected outside the body.
  • the invention described in claim 1 is that, in a normal state in which the diameter can be freely reduced and expanded, the diameter of the main body portion becomes a cylindrical shape by expanding, and the diameter can be freely reduced and expanded provided following the main body portion.
  • a thrombus having a tapered tail that expands in a normal state, a stent formed of a strut provided subsequent to the tail, and a bag-shaped filter formed of an opening and a main body.
  • the main body portion and the tail portion of the stent are helically twisted by one or more filaments to form a braided structure
  • a thromboembolic capture device characterized in that:
  • the invention described in claim 2 is the invention described in claim 1, wherein the filament is formed of a shape memory material, and the main body of the stent is expanded in a normal state to have a cylindrical shape. Thus, the shape is memorized, and the shape of the tail of the stent is tapered in a normal state.
  • the invention described in claim 3 is the invention according to claim 1 or 2, wherein the pillar portion is formed by twisting one or a plurality of filaments in a helical shape and a main body portion and a tail portion. It is characterized in that it has a braided structure that can be reduced in diameter and that is formed integrally with it, and is in a rod-shaped body that is reduced in diameter to a normal state in a normal state.
  • the invention described in claim 4 is the invention described in claim 3, characterized in that the filaments are made of a shape memory material.
  • the invention described in claim 5 is the invention according to claim 1 or 2, wherein the support portion is made of a synthetic resin such as polytetrafluoroethylene, polyolefin, polyester, polyurethane, or polysiloxane. Characterized by a hollow rod-like body composed of:
  • the invention described in claim 6 is the invention according to any one of claims 15 to 15, wherein a fold of a striated wire, a joint of two striated ends, a wire, It is characterized in that loops are formed at equal intervals by twisting or the like of the folded portions of the strip.
  • the invention described in claim 7 is the invention according to any one of claims 16 to 19, wherein the bag-shaped filter has a large number of micropores having a diameter of 10-300 / im. , A woven fabric, a nonwoven fabric, a net, or a perforated polymer film.
  • the bag-shaped filter is woven in a bag-like knitted fabric and a bag-like knitted yarn. It is composed of a woven fabric, a nonwoven fabric formed into a bag shape with a fiber ep, a net, or a polymer film formed directly into a bag shape from synthetic resin and then perforated. It is assumed that.
  • the invention according to claim 9 is the invention according to claim 7, wherein the bag-shaped filter is a knitted fabric, woven fabric, non-woven fabric, formed into a bag shape by bonding or sewing. Mesh Alternatively, it is characterized by being constituted by a perforated polymer film.
  • the invention according to claim 10 is the invention 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. It is characterized by being constituted by a line.
  • the invention according to claim 11 is the invention according to any one of claims 79, wherein the nonwoven fabric and the mesh are made of polyester fiber, polyamide fiber, polypropylene fiber, cellulose fiber, or a mixture thereof. It is characterized by being composed of mixed fibers.
  • the invention described in claim 12 is the invention according to any one of claim 79, 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 comprising.
  • the invention according to claim 13 is the invention according to any one of claims 1-112, wherein the engaging means comprises: (a) sewing with a suture, and (b) an adhesive. Or (c) welding.
  • the present invention has the following effects.
  • the main body portion and the tail portion of the stent are helically twisted by one or a plurality of filaments and braided.
  • 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 tip of the main body of the stent 1 by engaging means. Since it is a combined filter, the release and collection from the catheter can be performed smoothly, and the location where the bag-shaped filter is to be placed in the blood vessel can be easily determined.
  • the filaments are formed of a shape memory material, and the main body of the stent is expanded in a normal state to have a shape memory so as to be cylindrical. And, the shape of the tail of the stent was made to be tapered during normal operation. It is possible to easily and inexpensively manufacture a stent having a body portion and a tail portion which is tapered in a normal state.
  • a loop formed by folding back a wire, joining two wire ends, twisting a folded portion of a wire, or the like is formed at the distal end of the stent at equal intervals.
  • the bag-shaped filter has a knitted cloth, a woven cloth, a nonwoven cloth, a mesh body, or a perforated cloth having a large number of micropores having a diameter of 10300 ⁇ m. Since it is made of a polymer film, it is possible to reliably capture floating substances such as thrombi and emboli in blood vessels without stopping the bag-like filter force S and blood flow.
  • FIG. 1 is an explanatory view of a thromboembolic capture device showing one embodiment of the present invention, wherein (a) shows a stent, and (b) shows a bag-shaped (conical) filter.
  • (C) is an A-A cross-sectional view of the filter of (b), and (d) shows that the bag-shaped filter is embedded in the main body of the stent in the expanded state,
  • (B) shows a state in which the opening of the bag-shaped filter is engaged with the distal end of the main body of the stent by engaging means, and (e) shows the bag contained in the stent and its main body.
  • 1 shows a state in which a filter having a shape of a letter is stored in a catheter.
  • FIG. 2 is an explanatory view of a thromboembolic capture device showing another embodiment of the present invention, wherein (a) shows a stent, and (b) shows a bag-like (U-shaped longitudinal section) shape. (C) shows a filter in which the bag-shaped filter is inserted into the main body of the stent in an expanded state, and the opening of the bag-shaped filter is engaged with the tip of the main body of the stent by engaging means. (D) shows a state in which the stent and a bag-shaped filter inserted in the main body thereof are stored in a catheter.
  • FIG. 3 Description of a stent in a thromboembolic capture device showing another embodiment of the present invention.
  • FIG. 4 The main body of the stent stored in the catheter and the bag-shaped filter inserted therein are released into the blood vessel branched from the aortic arch, and the blood is filtered by the bag-shaped filter.
  • FIG. 1 is an explanatory view of a thromboembolic capture device showing one embodiment of the present invention, wherein (a) shows a stent, and (b) shows a bag-shaped (conical) filter. (C) shows an A-A cross section of the filter of (b), and (d) shows that the bag-shaped filter is inserted into the main body of the expanded stent and the bag-shaped filter is inserted. (E) shows a state in which the opening of the filter is engaged with the distal end of the main body of the stent by engaging means, and (e) shows the bag-shaped filter inserted into the stent and the main body. 2 shows a state in which it is stored in a catheter. FIG. 2 shows another embodiment of the present invention.
  • FIG. 3 is an explanatory view of a stent in a thromboembolic capture device according to another embodiment of the present invention.
  • Figure 4 shows that the main body of the stent housed in the catheter and the bag-shaped filter inserted therein are released into the blood vessel branched from the aortic arch and blood is filtered by the bag-shaped filter.
  • reference numeral 10 denotes a thromboembolic device.
  • the thrombus embolus capture device 10 has a cylindrical body la that expands and expands in a normal state in which the diameter can be freely reduced and expanded, and a taper that expands and expands in a normal state in which the diameter can be freely expanded and contracted provided following the main body la.
  • a bag-shaped (conical) filter 2 composed of an opening 2a and a main body 2b.
  • reference numeral 20 denotes a thromboembolic capture device.
  • the thromboembolic capture device 20 has a main body la that expands in a normal state where the diameter can be freely reduced and expanded, and a taper that expands and expands in a normal state where the diameter can be freely expanded and contracted provided following the main body la. And a bag-shaped (U-shaped longitudinal section) composed of an opening 3a and a main body 3b.
  • a main body la and a tail lb of the stent 1 are helically twisted by one or a plurality of filaments W to form a braided structure
  • (B) The bag-shaped filter 3 is inserted into the main body la of the stent 1 and the opening 3a of the bag-shaped filter 3 is It is engaged with the tip Id of the body part la by the engagement means 5.
  • 4 is a catheter
  • 6 is a guide wire.
  • FIGS. 1 and 2 show a bag-shaped filter 2 having a conical shape and a bag-shaped filter 3 having a U-shaped vertical section, but the bag of the present invention is not contradicted by the object of the present invention.
  • the shape of the filter may be a bag-shaped filter other than these shapes.
  • the present invention provides a main body portion la that expands and becomes cylindrical in a normal state where the diameter can be freely reduced and expanded, and a taper that is provided following the main body portion la and expands in a normal state where the diameter can be freely expanded and contracted.
  • a stent 1 composed of a tail portion 1b in the shape of a pillar and a strut portion lc provided following the tail portion lb, and a bag-shaped filter 2 composed of the openings 2a and 3a and the body portions 2b and 3b.
  • the main body la and the tail lb of the stent 1 are helically twisted by one or a plurality of filaments W to form a braided structure.
  • a low-cost thromboembolic capture device that can safely and reliably recover a bag-like filter that captures suspended matter such as thrombus and embolus in a blood vessel without damaging the inner wall of the blood vessel is provided. can do.
  • the filament W constituting the stent 1 of the present invention is preferably formed of a shape memory alloy, that is, a shape memory alloy such as Ni—Ti, Cu—Al— ⁇ Cu—Zn—A1, As long as the purpose of the present invention is not violated, it is formed of a metal such as stainless steel, nickel, and tantalum, and a synthetic resin such as polyester, polytetrafluoroethylene, polyolefin, and polyurethane. Further, a metal wire formed of a shape memory alloy or another metal may be covered with the above-mentioned synthetic resin.
  • a shape memory alloy such as Ni—Ti, Cu—Al— ⁇ Cu—Zn—A1
  • a metal such as stainless steel, nickel, and tantalum
  • a synthetic resin such as polyester, polytetrafluoroethylene, polyolefin, and polyurethane.
  • a metal wire formed of a shape memory alloy or another metal may be covered with the above-mentioned synthetic resin.
  • the main body la of the stent 1 is expanded in a normal state so that the shape is memorized so as to be cylindrical, and the tail lb of the stent 1 is stored.
  • the shape is memorized so as to be in a tapered shape under normal conditions.
  • the filament W is composed of the shape memory material.
  • the main body la of the stent 1 is expanded in a normal state and the shape is memorized so as to have a cylindrical shape
  • the tail lb of the stent 1 is memorized so as to be a taper shape in a normal state. It is possible to easily and inexpensively manufacture a stent having a body portion la which is sometimes expanded in diameter and a tail portion lb which is tapered in a normal state.
  • the strut portion lc in the stent 1 preferably has a diameter-reducible braided structure in which one or a plurality of filaments W are helically twisted and formed integrally with the main body portion and the tail portion, And, it is a rod-shaped body which is reduced in diameter to a normal state in a normal state.
  • the support 11c of the stent 11 is a hollow rod-shaped body (pipe-shaped body) made of a synthetic resin such as polytetrafluoroethylene, polyolefin, polyester, polyurethane, or polysiloxane. Body).
  • l la, l ib, and l id are the body, tail, and tip, respectively.
  • the ends ld and lid of the stents are folded back (the end portion Id of the stent 1 in Fig. 1 (a)). Loops are formed at equal intervals due to the joining of two filament ends and the twisting of the folded portions of the filaments.
  • the “loop due to the fold of the filament” is formed while braiding the filament W so as to form the fold of the filament W at the tip Id of the stent 1 while forming a braided structure.
  • Loop by joining the ends of two filaments '' is to cut the braided structure formed by weaving the filament W in the horizontal direction and weld and braze the ends of two filaments W and W adjacent to each other. It is formed by joining with the like.
  • the “loop due to the twist of the filament” is formed by twisting the turn of the filament 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 it does not contradict the object of the present invention.
  • loops are formed at the ends ld and lid of the stents 1 and 11 at equal intervals by folding of the filament, joining of the two filament ends, and twisting of the folded portion of the filament.
  • the opening of the bag-shaped filter inserted into 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 formed as a loop. It is smooth and does not damage the inner wall of blood vessels.
  • the bag-shaped filters 2 and 3 are composed of a knitted cloth, a woven cloth, a nonwoven cloth, a net, or a perforated polymer film having a large number of micropores having a diameter of 10-300 / im. I have.
  • the bag-shaped filters 2 and 3 are preferably a knitted fabric knitted in a bag shape with yarn, a woven fabric woven in a bag shape with yarn, a nonwoven fabric formed in a bag shape with a fiber web, and a mesh body Or a plastic film formed directly from synthetic resin into a bag shape and then perforated, but formed into a bag-like knitted fabric or woven fabric by bonding or sewing.
  • the perforation of the polymer film is preferably performed by a known perforation other than the laser processing, as long as the force performed by the laser cutter is not contrary to the object of the present invention.
  • the bag-shaped filter is formed of a knitted cloth, a woven cloth, a non-woven fabric, a net, or a perforated polymer film having a large number of micropores having a diameter of 10300 zm, It is possible to reliably capture suspended matter such as blood clots and emboli in the blood vessels without stopping the flow of Filteraka S.
  • 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 the mesh are preferably made of polyester fiber, It is composed of polyamide fiber, polypropylene fiber, cellulose fiber or a mixed fiber thereof, and the polymer film is preferably composed of fluororesin, polyurethane resin, polyester resin, polyamide resin or polypropylene resin. It is a thing.
  • the openings of the bag-shaped filters 2 and 3 inserted in the main body la of the stent 1 are
  • the engaging means 5 is preferably (a) sewn with a suture, (b) glued with an adhesive, or , (C) welding.
  • the engaging means 5 will not damage the inner wall of the blood vessel. Absent.
  • the engaging means 5 in the present invention is an engaging means other than (a) sewing with a suture, (b) bonding with an adhesive, and (c) welding, as long as the object of the present invention is not contravened. It can be something like a snap.
  • the thromboembolic capture devices 10, 20 of the present invention are pre-installed in a neat catheter 4. You can leave it. If the thromboembolic 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. Needless to say, the thromboembolic devices 10, 20 may be stored in the catheter 4 immediately before use.
  • the filter 2 in the shape of a tube is inserted therein, and the opening 2a in the filter 2 in the shape of a bag is fixed to the distal end Id of the stent 1 with a suture.
  • the thromboembolic capture device 10 re-stored in the catheter 4 is pulled out along the guide wire and taken out of the body.
  • the bag-shaped filter 2 can be expanded while the stent 1 is inserted into the main body la of the stent 1 to capture a floating substance such as a thrombus and an embolus, the floating substance such as a thrombus and an embolus can be captured.
  • the bag-shaped filter 2 can be safely and reliably collected outside the body without damaging the blood vessel inner wall.

Abstract

A thrombus/embolus collecting device (10), comprising a body part (1a) freely radially contracted and enlarged and normally radially enlarged in a cylindrical shape, a tail part (1b) formed continuously with the body part, freely radially contracted and enlarged, and normally radially enlarged in a tapered shape, a stent (1) formed continuously with the tail part and formed of a strut part (1c), and a bag-like (conical- shaped) filter (2) formed of an opening part (2a) and a body part (2b). The body part and the tail part of the stent are formed in a braided cord structure by spirally twisting one or a plurality of wires (W), the bag-like filter is inserted into the body part of the stent, and the opening part of the bag-like filter is engaged with the tip of the body part of the stent by an engagement means (5).

Description

明 細 書  Specification
血栓塞栓捕獲装置  Thromboembolic capture device
技術分野  Technical field
[0001] 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 臓器を灌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。  [0001] The present invention relates to the treatment of vascular diseases such as stent or stent-graft placement, percutaneous angioplasty, or the like, or in the case of surgery, in which severe damage to the brain, heart, lung, liver, kidney, limb, etc. The present invention relates to a thromboembolic capture device that prevents an artery or a vein perfusing an organ from being blocked by a floating thrombus or embolus.
^景技術  ^ Scenic technology
[0002] 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 た力 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、血管壁からァテローム(粥腫)を剥離させることがあるので、これら の血栓ゃァ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灌 流する動脈又は静脈を閉塞させ、そのために、血栓ゃァ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、血管壁からァテローム(粥腫)を剥離させることがあ るので、これらの血栓ゃァ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 遊する血栓ゃァ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、 浮遊する血栓ゃァ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 レ、う問題があった。  [0002] In an aging society, arterial occlusion and aneurysms caused by arteriosclerosis have been significantly increased. Conventionally, the treatment of arterial occlusion and aneurysm has been performed mainly by surgery.Intravascular treatment using less invasive catheters has attracted attention recently. New technologies are being rapidly developed in the treatment of vascular diseases such as percutaneous angioplasty. However, in surgical revascularization surgery and endovascular treatment, thrombosis often forms in the blood vessel lumen and atheroma (atheroma) is detached from the blood vessel wall, depending on the surgical procedure and catheter operation. The problem is that these thrombus emboli block arteries or veins that perfuse critical organs such as the brain, heart, liver, kidneys, and limbs, and therefore, thrombus atheroma causes thromboembolism. was there. Similarly, in a normal surgical operation, a thrombus may be formed in a blood vessel lumen or an atheroma may be peeled off from a blood vessel wall. There was the problem of floating and causing thromboembolism. In particular, during endovascular treatment using the catheter technique, embolism due to floating thrombus atheroma cannot be directly observed or removed, so embolus due to floating thrombus atheroma may cause serious infarction such as myocardial infarction. There was a problem when complications were caused.
[0003] 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。 [0003] In order to solve these problems, a technique relating to a blood vessel filter system (hereinafter, referred to as "prior art 1") (Patent Document 1) and a technique relating to a device for filtering blood in a blood vessel (hereinafter, referred to as "prior art 1"). (Technique 2).) (Patent Document 2) Below, it is referred to as “Prior Art 3”. (Patent Document 3) has been proposed.
特許文献 1:特開 2003 - 220062号公報  Patent Document 1: Japanese Patent Application Laid-Open No. 2003-220062
特許文献 2:特開 2001 - 293084号公報  Patent Document 2: Japanese Patent Application Laid-Open No. 2001-293084
特許文献 3:特開平 5 - 76535号公報  Patent Document 3: JP-A-5-76535
発明の開示  Disclosure of the invention
発明が解決しょうとする課題  Problems to be solved by the invention
[0004] し力しながら、従来技術 1一 3は、いずれも、管状のカテーテルから血管内に放出し たフィ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、力 テーテル内に収納できなかたり、血管内壁を損傷させるという問題があった。  [0004] While the prior arts 13 through 13 are designed to make the filter released into the blood vessel from the tubular catheter abut against the inner wall of the blood vessel, all of the techniques are skilled in positioning the filter in the blood vessel. In addition, when a filter that has trapped suspended matter such as a thrombus or embolus is collected in a catheter, the filter or stent cannot be sufficiently contracted, and cannot be stored in the catheter. There was a problem of damaging the inner wall.
[0005] 本発明は、力かる問題を解決することを目的としている。  [0005] An object of the present invention is to solve a powerful problem.
[0006] 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 レ、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。  [0006] That is, the present invention can smoothly perform release and recovery from a catheter, easily position a place where a bag-shaped filter is to be placed in a blood vessel, and at the same time, In addition, the bag-shaped filter can be safely and securely placed without damaging the inner wall of the blood vessel, and the bag-shaped filter capturing the suspended matter such as thrombus and embolus in the blood vessel without damaging the inner wall of the blood vessel. It is an object of the present invention to provide a low-cost thromboembolic capture device that can be safely and reliably collected outside the body.
課題を解決するための手段  Means for solving the problem
[0007] 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、該本体部に続レ、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、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 つて、 [0007] The invention described in claim 1 is that, in a normal state in which the diameter can be freely reduced and expanded, the diameter of the main body portion becomes a cylindrical shape by expanding, and the diameter can be freely reduced and expanded provided following the main body portion. A thrombus having a tapered tail that expands in a normal state, a stent formed of a strut provided subsequent to the tail, and a bag-shaped filter formed of an opening and a main body. An embolic capture device,
(A)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、  (A) the main body portion and the tail portion of the stent are helically twisted by one or more filaments to form a braided structure, and
(B)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。 (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 tip of the main body of the stent by engaging means. A thromboembolic capture device characterized in that:
[0008] 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。  [0008] The invention described in claim 2 is the invention described in claim 1, wherein the filament is formed of a shape memory material, and the main body of the stent is expanded in a normal state to have a cylindrical shape. Thus, the shape is memorized, and the shape of the tail of the stent is tapered in a normal state.
[0009] 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、常態時に縮径常態にされて棒状体 とされていることを特徴とするものである。  [0009] The invention described in claim 3 is the invention according to claim 1 or 2, wherein the pillar portion is formed by twisting one or a plurality of filaments in a helical shape and a main body portion and a tail portion. It is characterized in that it has a braided structure that can be reduced in diameter and that is formed integrally with it, and is in a rod-shaped body that is reduced in diameter to a normal state in a normal state.
[0010] 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。  [0010] The invention described in claim 4 is the invention described in claim 3, characterized in that the filaments are made of a shape memory material.
[0011] 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、ポリテトラフルォロエチレン、ポリオレフイン、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。  [0011] The invention described in claim 5 is the invention according to claim 1 or 2, wherein the support portion is made of a synthetic resin such as polytetrafluoroethylene, polyolefin, polyester, polyurethane, or polysiloxane. Characterized by a hollow rod-like body composed of:
[0012] 請求項 6に記載された発明は、請求項 1一 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。  [0012] The invention described in claim 6 is the invention according to any one of claims 15 to 15, wherein a fold of a striated wire, a joint of two striated ends, a wire, It is characterized in that loops are formed at equal intervals by twisting or the like of the folded portions of the strip.
[0013] 請求項 7に記載された発明は、請求項 1一 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— 300 /i m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。  [0013] The invention described in claim 7 is the invention according to any one of claims 16 to 19, wherein the bag-shaped filter has a large number of micropores having a diameter of 10-300 / im. , A woven fabric, a nonwoven fabric, a net, or a perforated polymer film.
[0014] 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、繊維ゥ エップ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。  [0014] In the invention described in claim 8, in the invention described in claim 7, the bag-shaped filter is woven in a bag-like knitted fabric and a bag-like knitted yarn. It is composed of a woven fabric, a nonwoven fabric formed into a bag shape with a fiber ep, a net, or a polymer film formed directly into a bag shape from synthetic resin and then perforated. It is assumed that.
[0015] 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。 [0015] The invention according to claim 9 is the invention according to claim 7, wherein the bag-shaped filter is a knitted fabric, woven fabric, non-woven fabric, formed into a bag shape by bonding or sewing. Mesh Alternatively, it is characterized by being constituted by a perforated polymer film.
[0016] 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。  [0016] The invention according to claim 10 is the invention 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. It is characterized by being constituted by a line.
[0017] 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。  [0017] The invention according to claim 11 is the invention according to any one of claims 79, wherein the nonwoven fabric and the mesh are made of polyester fiber, polyamide fiber, polypropylene fiber, cellulose fiber, or a mixture thereof. It is characterized by being composed of mixed fibers.
[0018] 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。  [0018] The invention described in claim 12 is the invention according to any one of claim 79, 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 comprising.
[0019] 請求項 13に記載された発明は、請求項 1一 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。  [0019] The invention according to claim 13 is the invention according to any one of claims 1-112, wherein the engaging means comprises: (a) sewing with a suture, and (b) an adhesive. Or (c) welding.
発明の効果  The invention's effect
[0020] 本発明は、以下に記載する効果を奏する。 [0020] The present invention has the following effects.
[0021] (1)請求項 1 , 3 5に記載された発明によれば、(A)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、(B)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 1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 供すること力 Sできる。  [0021] (1) According to the invention described in claims 1 and 35, (A) the main body portion and the tail portion of the stent are helically twisted by one or a plurality of filaments and braided. (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 tip of the main body of the stent 1 by engaging means. Since it is a combined filter, the release and collection from the catheter can be performed smoothly, and the location where the bag-shaped filter is to be placed in the blood vessel can be easily determined. Can be safely and reliably placed without damaging the inner wall of the blood vessel, and the bag-like filter that captures suspended matter such as thrombus and embolus in the blood vessel can be safely and reliably removed from the body without damaging the inner wall of the blood vessel. Low thromboembolic capture device Power to provide at cost S
[0022] (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 製造すること力 Sできる。 [0022] (2) According to the invention described in claim 2, the filaments are formed of a shape memory material, and the main body of the stent is expanded in a normal state to have a shape memory so as to be cylindrical. And, the shape of the tail of the stent was made to be tapered during normal operation. It is possible to easily and inexpensively manufacture a stent having a body portion and a tail portion which is tapered in a normal state.
[0023] (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、体内管状体の内壁を損傷させることがない。  [0023] (3) According to the invention described in claim 6, a loop formed by folding back a wire, joining two wire ends, twisting a folded portion of a wire, or the like is formed at the distal end of the stent at equal intervals. As a result, the opening of the bag-shaped filter inserted into the main body of the stent can be easily engaged with the distal end of the stent by engaging means, and the distal end of the stent is formed as a loop. The inner wall of the body tubular body will not be damaged because it is smooth when it is used.
[0024] (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 10 300 μ m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 イルムで構成されているので、袋状のフィルタ力 S、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, the bag-shaped filter has a knitted cloth, a woven cloth, a nonwoven cloth, a mesh body, or a perforated cloth having a large number of micropores having a diameter of 10300 μm. Since it is made of a polymer film, it is possible to reliably capture floating substances such as thrombi and emboli in blood vessels without stopping the bag-like filter force S and blood flow.
[0025] (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。  [0025] (5) According to the invention described in claim 13, since the engaging means is (a) sewing with a suture, (b) bonding with an adhesive, or (c) welding, The engaging means does not damage the inner wall of the blood vessel.
図面の簡単な説明  Brief Description of Drawings
[0026] [図 1]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 一 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揷さ 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揷さ れた袋状のフィルタをカテーテル内に格納した状態を示す。  FIG. 1 is an explanatory view of a thromboembolic capture device showing one embodiment of the present invention, wherein (a) shows a stent, and (b) shows a bag-shaped (conical) filter. (C) is an A-A cross-sectional view of the filter of (b), and (d) shows that the bag-shaped filter is embedded in the main body of the stent in the expanded state, (B) shows a state in which the opening of the bag-shaped filter is engaged with the distal end of the main body of the stent by engaging means, and (e) shows the bag contained in the stent and its main body. 1 shows a state in which a filter having a shape of a letter is stored in a catheter.
[図 2]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た袋状のフィルタをカテーテル内 に格納した状態を示す。  FIG. 2 is an explanatory view of a thromboembolic capture device showing another embodiment of the present invention, wherein (a) shows a stent, and (b) shows a bag-like (U-shaped longitudinal section) shape. (C) shows a filter in which the bag-shaped filter is inserted into the main body of the stent in an expanded state, and the opening of the bag-shaped filter is engaged with the tip of the main body of the stent by engaging means. (D) shows a state in which the stent and a bag-shaped filter inserted in the main body thereof are stored in a catheter.
[図 3]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。 [FIG. 3] Description of a stent in a thromboembolic capture device showing another embodiment of the present invention. FIG.
[図 4]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. 4] The main body of the stent stored in the catheter and the bag-shaped filter inserted therein are released into the blood vessel branched from the aortic arch, and the blood is filtered by the bag-shaped filter. It is explanatory drawing which shows a state, (a) is the whole explanatory drawing, and (b) is the partial enlarged explanatory drawing.
符号の説明  Explanation of symbols
[0027] 1 , 11 ステント [0027] 1 and 11 stents
la, 11a 本体部  la, 11a body
lb, l ib 尾部  lb, l ib tail
lc, 11c 支柱部  lc, 11c strut
Id, l id 先端  Id, l id tip
2, 3 袋状フィルタ  2, 3 Bag filter
2a, 3a 開口部  2a, 3a opening
2b, 3b 本体部  2b, 3b main unit
2c ガイドワイヤー通し穴  2c Guide wire through hole
4 カテーテル  4 catheter
5 係合手段  5 Engagement means
6 ガイドワイヤー  6 Guide wire
10、 20 血栓塞栓捕獲装置  10, 20 Thromboembolic device
W 線条  W streak
発明を実施するための最良の形態  BEST MODE FOR CARRYING OUT THE INVENTION
[0028] 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.
[0029] 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 thromboembolic capture device showing one embodiment of the present invention, wherein (a) shows a stent, and (b) shows a bag-shaped (conical) filter. (C) shows an A-A cross section of the filter of (b), and (d) shows that the bag-shaped filter is inserted into the main body of the expanded stent and the bag-shaped filter is inserted. (E) shows a state in which the opening of the filter is engaged with the distal end of the main body of the stent by engaging means, and (e) shows the bag-shaped filter inserted into the stent and the main body. 2 shows a state in which it is stored in a catheter. FIG. 2 shows another embodiment of the present invention. It is explanatory drawing of the thromboembolic capture device which shows embodiment, (a) shows a stent, (b) shows the filter of bag shape (U-shaped longitudinal section), (c) shows the said filter. A state in which the bag-shaped filter is inserted into the main body of the stent in the expanded state, and the opening of the bag-shaped filter is engaged with the distal end of the main body of the stent by engaging means, and (D) shows a state in which a bag-shaped filter inserted into the stent and its main body is stored in the catheter. FIG. 3 is an explanatory view of a stent in a thromboembolic capture device according to another embodiment of the present invention. Figure 4 shows that the main body of the stent housed in the catheter and the bag-shaped filter inserted therein are released into the blood vessel branched from the aortic arch and blood is filtered by the bag-shaped filter. It is explanatory drawing which shows a state, (a) is the whole explanatory drawing, and (b) is the partial enlarged explanatory drawing.
[0030] 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 la、該本体部 la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 lb、及び、該尾部 lbに 続いて設けられた支柱部 lcから構成されたステント 1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、 (A)前記ステント 1の本体部 la及び尾部 lb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、(B)前記袋状のフィルタ 2が前記ステント 1の本体 部 la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 la の先端 Id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、力テーテノレであり、そして、 6は、ガイドワイヤーである。  In FIG. 1, reference numeral 10 denotes a thromboembolic device. The thrombus embolus capture device 10 has a cylindrical body la that expands and expands in a normal state in which the diameter can be freely reduced and expanded, and a taper that expands and expands in a normal state in which the diameter can be freely expanded and contracted provided following the main body la. And a bag-shaped (conical) filter 2 composed of an opening 2a and a main body 2b. And (A) the main body portion la and the tail portion lb of the stent 1 are helically twisted by one or more filaments W to form a braided structure, and (B) The bag-shaped filter 2 is inserted into the main body la of the stent 1, and the opening 2a of the bag-shaped filter 2 is engaged with the tip Id of the main body la of the stent 1 by the engaging means 5. Have been. In FIG. 1, 2c is a hole for passing a guide wire, 4 is a force wire, and 6 is a guide wire.
[0031] 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 la、該本体部 la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 lb、及び、該尾部 lbに 続いて設けられた支柱部 lcから構成されたステント 1と、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、を有しており、そして、(A)前記 ステント 1の本体部 la及び尾部 lb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、(B)前記袋状のフィルタ 3が前記ステント 1 の本体部 la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 laの先端 Id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, reference numeral 20 denotes a thromboembolic capture device. The thromboembolic capture device 20 has a main body la that expands in a normal state where the diameter can be freely reduced and expanded, and a taper that expands and expands in a normal state where the diameter can be freely expanded and contracted provided following the main body la. And a bag-shaped (U-shaped longitudinal section) composed of an opening 3a and a main body 3b. And (A) a main body la and a tail lb of the stent 1 are helically twisted by one or a plurality of filaments W to form a braided structure, and (B) The bag-shaped filter 3 is inserted into the main body la of the stent 1 and the opening 3a of the bag-shaped filter 3 is It is engaged with the tip Id of the body part la by the engagement means 5. In FIG. 2, 4 is a catheter, and 6 is a guide wire.
[0032] 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レ、。  FIGS. 1 and 2 show a bag-shaped filter 2 having a conical shape and a bag-shaped filter 3 having a U-shaped vertical section, but the bag of the present invention is not contradicted by the object of the present invention. The shape of the filter may be a bag-shaped filter other than these shapes.
[0033] 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 la、該本体部 la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 1 b、及び、該尾部 lbに続いて設けられた支柱部 lcから構成されたステント 1と、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、(A)前記ステント 1の本体部 la及び尾部 lb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、(B) 前記袋状のフィルタ 2, 3が前記ステント 1の本体部 la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 laの先端 Id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 provides a main body portion la that expands and becomes cylindrical in a normal state where the diameter can be freely reduced and expanded, and a taper that is provided following the main body portion la and expands in a normal state where the diameter can be freely expanded and contracted. A stent 1 composed of a tail portion 1b in the shape of a pillar and a strut portion lc provided following the tail portion lb, and a bag-shaped filter 2 composed of the openings 2a and 3a and the body portions 2b and 3b. (A) the main body la and the tail lb of the stent 1 are helically twisted by one or a plurality of filaments W to form a braided structure. And (B) the bag-shaped filters 2 and 3 are inserted into the main body la of the stent 1 and the openings 2a and 3a of the bag-shaped filters 2 and 3 are Since it is engaged with the tip Id of the main body part la by the engagement means 5, the release and collection from the catheter 4 can be performed smoothly, In this case, the location where the bag-shaped filters 2 and 3 are to be placed can be easily positioned, and the bag-shaped filters 2 and 3 can be placed safely and reliably at that location without damaging the inner wall of the blood vessel. In addition, a low-cost thromboembolic capture device that can safely and reliably recover a bag-like filter that captures suspended matter such as thrombus and embolus in a blood vessel without damaging the inner wall of the blood vessel is provided. can do.
[0034] 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-Νΰ Cu— Zn— A1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 、ポリテトラフルォロエチレン、ポリオレフイン、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 of the present invention is preferably formed of a shape memory alloy, that is, a shape memory alloy such as Ni—Ti, Cu—Al—ΝΰCu—Zn—A1, As long as the purpose of the present invention is not violated, it is formed of a metal such as stainless steel, nickel, and tantalum, and a synthetic resin such as polyester, polytetrafluoroethylene, polyolefin, and polyurethane. Further, a metal wire formed of a shape memory alloy or another metal may be covered with the above-mentioned synthetic resin.
[0035] 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 la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 lb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 la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 lb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 la及び常態時にテーパー状となる尾部 lb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。 [0035] When the filament W is formed of a shape memory material, the main body la of the stent 1 is expanded in a normal state so that the shape is memorized so as to be cylindrical, and the tail lb of the stent 1 is stored. The shape is memorized so as to be in a tapered shape under normal conditions. Thus, the filament W is composed of the shape memory material. Then, when the main body la of the stent 1 is expanded in a normal state and the shape is memorized so as to have a cylindrical shape, and the tail lb of the stent 1 is memorized so as to be a taper shape in a normal state. It is possible to easily and inexpensively manufacture a stent having a body portion la which is sometimes expanded in diameter and a tail portion lb which is tapered in a normal state.
[0036] 前記ステント 1における支柱部 lc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、常態時に縮径常態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[0036] The strut portion lc in the stent 1 preferably has a diameter-reducible braided structure in which one or a plurality of filaments W are helically twisted and formed integrally with the main body portion and the tail portion, And, it is a rod-shaped body which is reduced in diameter to a normal state in a normal state.
、好ましくは、形状記憶材料で構成されている。 , Preferably made of a shape memory material.
[0037] 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 フルォロエチレン、ポリオレフイン、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、 l la、 l ib及び l id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 of the stent 11 is a hollow rod-shaped body (pipe-shaped body) made of a synthetic resin such as polytetrafluoroethylene, polyolefin, polyester, polyurethane, or polysiloxane. Body). In FIG. 3, l la, l ib, and l id are the body, tail, and tip, respectively.
[0038] 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 ld、 l idに、線条の折り返し(図 1 (a)のステント 1の先端部分 Id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の先端 Id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 なぐ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。 [0038] As shown in Figs. 1 and 3, in the stents 1 and 11 of the present invention, the ends ld and lid of the stents are folded back (the end portion Id of the stent 1 in Fig. 1 (a)). Loops are formed at equal intervals due to the joining of two filament ends and the twisting of the folded portions of the filaments. The “loop due to the fold of the filament” is formed while braiding the filament W so as to form the fold of the filament W at the tip Id of the stent 1 while forming a braided structure. `` Loop by joining the ends of two filaments '' is to cut the braided structure formed by weaving the filament W in the horizontal direction and weld and braze the ends of two filaments W and W adjacent to each other. It is formed by joining with the like. The “loop due to the twist of the filament” is formed by twisting the turn of the filament 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 it does not contradict the object of the present invention.
[0039] このように、ステント 1, 11の先端 ld、 l id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。 [0040] 本発明における袋状のフィルタ 2, 3は、 口径 10— 300 /i m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力、まわなレ、。前記高分子フ イルムの孔あけは、好ましくは、レーザカ卩ェによって行われる力 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。 As described above, loops are formed at the ends ld and lid of the stents 1 and 11 at equal intervals by folding of the filament, joining of the two filament ends, and twisting of the folded portion of the filament. In this case, the opening of the bag-shaped filter inserted into 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 formed as a loop. It is smooth and does not damage the inner wall of blood vessels. [0040] The bag-shaped filters 2 and 3 according to the present invention are composed of a knitted cloth, a woven cloth, a nonwoven cloth, a net, or a perforated polymer film having a large number of micropores having a diameter of 10-300 / im. I have. The bag-shaped filters 2 and 3 are preferably a knitted fabric knitted in a bag shape with yarn, a woven fabric woven in a bag shape with yarn, a nonwoven fabric formed in a bag shape with a fiber web, and a mesh body Or a plastic film formed directly from synthetic resin into a bag shape and then perforated, but formed into a bag-like knitted fabric or woven fabric by bonding or sewing. Even if it is made of cloth, non-woven fabric, mesh, or perforated polymer film, it can be used for power and control. The perforation of the polymer film is preferably performed by a known perforation other than the laser processing, as long as the force performed by the laser cutter is not contrary to the object of the present invention.
[0041] このように、袋状のフィルタが口径 10 300 z m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 ィルタカ S、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。  As described above, when the bag-shaped filter is formed of a knitted cloth, a woven cloth, a non-woven fabric, a net, or a perforated polymer film having a large number of micropores having a diameter of 10300 zm, It is possible to reliably capture suspended matter such as blood clots and emboli in the blood vessels without stopping the flow of Filteraka S.
[0042] 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。  [0042] 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 the mesh are preferably made of polyester fiber, It is composed of polyamide fiber, polypropylene fiber, cellulose fiber or a mixed fiber thereof, and the polymer film is preferably composed of fluororesin, polyurethane resin, polyester resin, polyamide resin or polypropylene resin. It is a thing.
[0043] 本発明においては、ステント 1の本体部 laに内挿した袋状のフィルタ 2, 3の開口部  In the present invention, the openings of the bag-shaped filters 2 and 3 inserted in the main body la of the stent 1 are
2a, 3aをステント 1の先端 I dに係合手段 5で係合する力 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。 Force for engaging 2a, 3a with the distal end Id of the stent 1 by the engaging means 5 The engaging means 5 is preferably (a) sewn with a suture, (b) glued with an adhesive, or , (C) welding. Thus, if the engaging means 5 is (a) sewing with a suture, (b) bonding with an adhesive, or (c) welding, the engaging means 5 will not damage the inner wall of the blood vessel. Absent. The engaging means 5 in the present invention is an engaging means other than (a) sewing with a suture, (b) bonding with an adhesive, and (c) welding, as long as the object of the present invention is not contravened. It can be something like a snap.
[0044] 本発明の血栓塞栓捕獲装置 10, 20は、ノ イブ状のカテーテル 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。 [0044] The thromboembolic capture devices 10, 20 of the present invention are pre-installed in a neat catheter 4. You can leave it. If the thromboembolic 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. Needless to say, the thromboembolic devices 10, 20 may be stored in the catheter 4 immediately before use.
[0045] 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 thromboembolic capture device of the present invention will be described.
[0046] (1)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 la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をステント 1 の先端 Id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) ] (1) A bag obtained by knitting a polyester thread, a polyamide thread, a polypropylene thread, or an ultrafine metal wire into a bag inside the main body la of the stent 1 formed into a self-expandable braided structure. The filter 2 in the shape of a tube is inserted therein, and the opening 2a in the filter 2 in the shape of a bag is fixed to the distal end Id of the stent 1 with a suture. [Fig. 1 (d)]
[0047] (2)この血栓塞栓捕獲装置 10におけるステント 1の本体部 l a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) ] (2) The bag-shaped (conical) filter 2 inserted into the main body la of the stent 1 in the thromboembolic capture device 10 is stored in a thin catheter 4 while being folded together with the main body of the stent. [Fig. 1 (e)]
[0048] (3)このカテーテル 4中に格納したステント 1の本体部 la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に沿つ て、血管内の留置場所に到達させた後、支柱部 lc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 laに内挿したフィルタ 2を拡張 させる。 [図 4]  (3) The thrombus embolus capturing device 10 having the filter 2 inserted in the main body la of the stent 1 stored in the catheter 4 is moved along the guide wire 6 previously arranged in the blood vessel. Then, after reaching the indwelling place in the blood vessel, by pulling the catheter 4 while fixing the support portion lc, the filter 2 pushed out into the blood vessel and expanded into the main body la of the stent 1 is expanded. [Figure 4]
[0049] (4)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 lbに連続する支柱部 lcを保持したまま力テーテ ル 4を押し戻すことによって、ステント 1の本体部 l a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) ]  [0049] (4) While performing treatments such as cardiovascular surgical treatment for heart disease and arteriovenous disease, and transcatheter endovascular treatment, the blood filter is kept expanded, and the treatment is completed. Then, by pushing back the force table 4 while holding the strut lc continuous to the tail lb of the stent 1, thromboembolism including the main body la of the stent 1 and the bag-shaped filter 2 inserted inside the main body la The capture device 10 is retracted and retracted into the catheter 4 while contracting. [Fig. 1 (e)]
[0050] (5)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。  (5) The thromboembolic capture device 10 re-stored in the catheter 4 is pulled out along the guide wire and taken out of the body.
[0051] このように、ステント 1の本体部 la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 イノレタ 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 lb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 la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 thrombus embolus capturing device 10 including the main body portion la of the stent 1 and the bag-shaped filter 2 inserted therein is contracted and re-stored in the catheter 4, the bag-shaped fiber Since Inoreta 2 is sutured and fixed to the opening of stent 1, push back catheter 4 As a result, when stored in the catheter 4 while contracting as the taper of the tail lb converges, the suspended matter such as thrombus and emboli captured by the bag-shaped filter 2 is removed by the bag-shaped filter. Collected together with 2 in the catheter. According to the present invention, since the bag-shaped filter 2 can be expanded while the stent 1 is inserted into the main body la of the stent 1 to capture a floating substance such as a thrombus and an embolus, the floating substance such as a thrombus and an embolus can be captured. The bag-shaped filter 2 can be safely and reliably collected outside the body without damaging the blood vessel inner wall.

Claims

請求の範囲 The scope of the claims
[1] 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、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、  [1] A main body portion which expands in a normal state in which the diameter can be freely reduced and expanded to be cylindrical, a tail portion which is provided subsequent to the main body portion and which is expanded in a normal state in which the diameter can be freely expanded and contracted, and A thrombus embolus capturing device comprising: a stent configured by a strut provided subsequent to the tail; and a bag-shaped filter configured by an opening and a main body.
(A)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、  (A) the main body portion and the tail portion of the stent are helically twisted by one or more filaments to form a braided structure, and
(B)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  (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 tip of the main body of the stent by engaging means.
ことを特徴とする血栓塞栓捕獲装置。  A thromboembolic capture device, comprising:
[2] 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。  [2] The filament is formed of a shape memory material so that the main body of the stent expands in diameter in a normal state and has a shape memory so as to have a cylindrical shape, and the tail of the stent is tapered in a normal state. 2. The thromboembolism capturing device according to claim 1, wherein the shape is stored.
[3] 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、常態時に縮径常態にされて 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。  [3] The support portion has a diameter-reducible braided structure in which one or a plurality of filaments are helically twisted and formed integrally with the main body portion and the tail portion. 3. The thromboembolism capturing device according to claim 1, wherein the thrombus embolus capturing device is a rod-shaped body.
[4] 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  [4] The blood according to claim 3, wherein the filament is formed of a shape memory material.
[5] 前記支柱部が、ポリテトラフルォロエチレン、ポリオレフイン、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。 [5] The method according to claim 1 or 2, wherein the support portion is a hollow rod made of a synthetic resin such as polytetrafluoroethylene, polyolefin, polyester, polyurethane, or polysiloxane. The thromboembolic capture device according to claim.
[6] 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 1一 5のいずれ かに記載の血栓塞栓捕獲装置。  [6] The stent according to claim 15, characterized in that loops are formed at equal intervals on the distal end of the stent by folding of the filament, joining of two filament ends, and twisting of the folded portion of the filament. The thromboembolic capture device according to any one of the above.
[7] 前記袋状のフィルタが、 口径 10— 300 /i m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 1一 6のいずれかに記載の血栓塞栓捕獲装置。  [7] The bag-shaped filter is formed of a knitted fabric, a woven fabric, a nonwoven fabric, a net, or a perforated polymer film having a large number of micropores having a diameter of 10-300 / im. The thromboembolic capture device according to any one of claims 11 to 16.
[8] 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。 [8] The knitted cloth in which the bag-shaped filter is knitted in a bag shape with yarn, or a knitted fabric woven in a bag shape with yarn. It is characterized by being composed of a nonwoven fabric, a net formed in a bag shape with a synthetic fabric or a fiber web, or a polymer film formed in a bag shape directly from a synthetic resin and then perforated. The thromboembolic capture device according to claim 7.
[9] 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。  [9] The bag-shaped filter is characterized by being constituted by a knitted fabric, a woven fabric, a nonwoven fabric, a net, or a perforated polymer film formed into a bag shape by bonding or sewing. The thromboembolic capture device according to claim 7.
[10] 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  10. The blood according to claim 79, 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.
[11] 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。 [11] The thromboembolism according to any one of claims 7 to 9, wherein the nonwoven fabric and the mesh are made of polyester fiber, polyamide fiber, polypropylene fiber, cellulose fiber or a mixed fiber thereof. Capture device.
[12] 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。  12. The thromboembolic capture device according to claim 7, wherein the polymer film is made of a fluororesin, a polyurethane resin, a polyester resin, a polyamide resin, or a polypropylene resin. .
[13] 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 1一 12のいずれかに記載の血栓塞栓捕獲装置。  13. The method according to claim 11, wherein the engagement means is (a) sewing with a suture, (b) bonding with an adhesive, or (c) welding. Thromboembolic device.
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