JPH04357949A - 伸張性のある管腔内脈管移植片又はプロテーゼ - Google Patents
伸張性のある管腔内脈管移植片又はプロテーゼInfo
- Publication number
- JPH04357949A JPH04357949A JP3225376A JP22537691A JPH04357949A JP H04357949 A JPH04357949 A JP H04357949A JP 3225376 A JP3225376 A JP 3225376A JP 22537691 A JP22537691 A JP 22537691A JP H04357949 A JPH04357949 A JP H04357949A
- Authority
- JP
- Japan
- Prior art keywords
- prosthesis
- graft
- body passageway
- catheter
- extensible
- Prior art date
- Legal status (The legal status 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 status listed.)
- Granted
Links
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- 239000007943 implant Substances 0.000 claims abstract description 24
- 230000002792 vascular Effects 0.000 claims description 31
- 230000014759 maintenance of location Effects 0.000 claims description 4
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- 201000010099 disease Diseases 0.000 abstract description 2
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- 238000007796 conventional method Methods 0.000 description 2
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- 238000001356 surgical procedure Methods 0.000 description 2
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- 206010051268 Anastomotic stenosis Diseases 0.000 description 1
- 201000001320 Atherosclerosis Diseases 0.000 description 1
- 206010016717 Fistula Diseases 0.000 description 1
- 206010020772 Hypertension Diseases 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 208000001106 Takayasu Arteritis Diseases 0.000 description 1
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 1
- 238000004026 adhesive bonding Methods 0.000 description 1
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- 210000000013 bile duct Anatomy 0.000 description 1
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- 238000002224 dissection Methods 0.000 description 1
- 210000002615 epidermis Anatomy 0.000 description 1
- 229920006335 epoxy glue Polymers 0.000 description 1
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- 238000002474 experimental method Methods 0.000 description 1
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- 230000003890 fistula Effects 0.000 description 1
- 238000002594 fluoroscopy Methods 0.000 description 1
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 1
- 229910052737 gold Inorganic materials 0.000 description 1
- 239000010931 gold Substances 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/958—Inflatable balloons for placing stents or stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
- A61F2002/91533—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other characterised by the phase between adjacent bands
- A61F2002/91541—Adjacent bands are arranged out of phase
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
- A61F2002/9155—Adjacent bands being connected to each other
- A61F2002/91558—Adjacent bands being connected to each other connected peak to peak
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/0054—V-shaped
Abstract
(57)【要約】本公報は電子出願前の出願データであるた
め要約のデータは記録されません。
め要約のデータは記録されません。
Description
【0001】本発明は疾患により狭くなつた又は閉塞し
た血管を修復するための特に有用な伸張性のある管腔内
脈管移植片(expandable vascular
graft)又はプロテーゼを保持し、そして、該移
植片又はプロテーゼを身体通路内へ挿入するための装置
に関する。管腔内脈管内移植(intralumina
l endovascular grafting)は
慣用の脈管手術に替わることが可能であることが実験に
より示された。管腔内脈管内移植には管状プロテーゼ移
植片の血管への経皮挿入及びその脈管系内の所望の位置
にカテーテルを介してそれを送り込むことが含まれる。 慣用の脈管手術に対するこの方法の利点は欠陥のある血
管を外科的に露出させ、切開し、除去し、取り替え、又
はバイパスを付ける必要をなくすることを含む。
た血管を修復するための特に有用な伸張性のある管腔内
脈管移植片(expandable vascular
graft)又はプロテーゼを保持し、そして、該移
植片又はプロテーゼを身体通路内へ挿入するための装置
に関する。管腔内脈管内移植(intralumina
l endovascular grafting)は
慣用の脈管手術に替わることが可能であることが実験に
より示された。管腔内脈管内移植には管状プロテーゼ移
植片の血管への経皮挿入及びその脈管系内の所望の位置
にカテーテルを介してそれを送り込むことが含まれる。 慣用の脈管手術に対するこの方法の利点は欠陥のある血
管を外科的に露出させ、切開し、除去し、取り替え、又
はバイパスを付ける必要をなくすることを含む。
【0002】従来管腔内脈管移植片として使用されてき
た構造物には、ステンレス鋼コイルバネ;伸張性のある
感熱性材料から製造されたら旋状に巻かれたコイルバネ
;及びジグザグパターンにステンレス鋼ワイヤから形成
された伸張性ステンレス鋼ステント(stents)が
包含されていた。一般に、上記の構造は共通した1つの
欠点を有している。身体通路を通過するためには、これ
らの構造物はしぼんだ(collapsed)状態で所
定の身体通路内の所望の位置に送られなければならない
限り、各構造物の最終の伸張した形状にたいする有効な
制御ができなかつた。例えば、特定のコイルバネ型移植
片の伸張はコイルバネ構造物を製造するのに使用された
特定の材料のバネ定数及び弾性率により予め決定される
。これらの同じフアクターはステンレス鋼ワイヤからジ
グザグパターンに形成されたしぼんだステントの伸張量
を予め決定する。加熱すると伸張する感熱性材料から形
成された管腔内移植片又はプロテーゼの場合には、伸張
量は管腔内移植片の製造に使用された特定の合金の熱膨
張特性により同様に予め決定される。
た構造物には、ステンレス鋼コイルバネ;伸張性のある
感熱性材料から製造されたら旋状に巻かれたコイルバネ
;及びジグザグパターンにステンレス鋼ワイヤから形成
された伸張性ステンレス鋼ステント(stents)が
包含されていた。一般に、上記の構造は共通した1つの
欠点を有している。身体通路を通過するためには、これ
らの構造物はしぼんだ(collapsed)状態で所
定の身体通路内の所望の位置に送られなければならない
限り、各構造物の最終の伸張した形状にたいする有効な
制御ができなかつた。例えば、特定のコイルバネ型移植
片の伸張はコイルバネ構造物を製造するのに使用された
特定の材料のバネ定数及び弾性率により予め決定される
。これらの同じフアクターはステンレス鋼ワイヤからジ
グザグパターンに形成されたしぼんだステントの伸張量
を予め決定する。加熱すると伸張する感熱性材料から形
成された管腔内移植片又はプロテーゼの場合には、伸張
量は管腔内移植片の製造に使用された特定の合金の熱膨
張特性により同様に予め決定される。
【0003】故に、前記した型の管腔内移植片が身体通
路内の、例えば動脈又は静脈内の所望の位置で伸張させ
られると、移植片の伸張した寸法は変えることができな
い。所望の身体通路の直径を間違えて計算すると、寸法
が足りない移植片は身体通路の内側表面にしつかりと取
り付けられるように身体通路の内側表面に接触するのに
十分には伸張されないことがある。その場合にはそれは
身体通路内の所望の位置から移動して離れることがある
。同様に、寸法が大き過ぎる移植片は身体通路に対して
移植片により及ぼされるバネ力又は伸張力が身体通路の
破壊を引き起こす程に伸張することがある。
路内の、例えば動脈又は静脈内の所望の位置で伸張させ
られると、移植片の伸張した寸法は変えることができな
い。所望の身体通路の直径を間違えて計算すると、寸法
が足りない移植片は身体通路の内側表面にしつかりと取
り付けられるように身体通路の内側表面に接触するのに
十分には伸張されないことがある。その場合にはそれは
身体通路内の所望の位置から移動して離れることがある
。同様に、寸法が大き過ぎる移植片は身体通路に対して
移植片により及ぼされるバネ力又は伸張力が身体通路の
破壊を引き起こす程に伸張することがある。
【0004】慣用の血管手術に替わる他の方法としては
、カテーテルに取り付けられた血管形成術バルーンの弾
性脈管狭窄症(elastic vascular s
tenoses)又は遮断障害(blockages)
の経皮バルーン拡大(percutaneous ba
lloon dilation)であつた。この方法に
おいては、血管の壁成分に剪断力をかけてそれを砕いて
(disrupt)拡大された内腔を得るために、血管
形成術バルーンは狭窄血管又は身体通路内で膨らまされ
る。アテローム性動脈硬化症に関しては、身体通路のよ
り弾性の内側(medial)及び外膜(advent
itial)層はプレーク(plaque)の回りに伸
びるが、比較的圧縮不能なプレークは変化しないままで
ある。この方法は動脈又は身体通路の切り裂き(dis
section)又は裂け(splitting)及び
引き裂き(tearing)を生じ、動脈又は身体通路
の脈管内膜(intima)又は内側表面はき裂(fi
ssuring)を生じる。この切り裂きは下にある組
織の“フラツプ”(flap)を形成し、これは内腔を
通る血流を減少させたり内腔を閉塞することがある。典
型的には、身体通路内の拡張する(distendin
g)管腔内圧力が砕かれた層又はフラツプを所定の位置
に保持することができる。バルーン拡大過程により生じ
た脈管内膜フラツプが伸張された脈管内膜に対して所定
の位置に保持されていないならば、脈管内膜フラツプは
内腔内に折れそして内腔をふさぐことがあり又は離れた
り身体通路に入つたりすることすらある。脈管内膜フラ
ツプが身体通路をふさぐ場合には、この問題を直すため
に直ちに手術が必要である。
、カテーテルに取り付けられた血管形成術バルーンの弾
性脈管狭窄症(elastic vascular s
tenoses)又は遮断障害(blockages)
の経皮バルーン拡大(percutaneous ba
lloon dilation)であつた。この方法に
おいては、血管の壁成分に剪断力をかけてそれを砕いて
(disrupt)拡大された内腔を得るために、血管
形成術バルーンは狭窄血管又は身体通路内で膨らまされ
る。アテローム性動脈硬化症に関しては、身体通路のよ
り弾性の内側(medial)及び外膜(advent
itial)層はプレーク(plaque)の回りに伸
びるが、比較的圧縮不能なプレークは変化しないままで
ある。この方法は動脈又は身体通路の切り裂き(dis
section)又は裂け(splitting)及び
引き裂き(tearing)を生じ、動脈又は身体通路
の脈管内膜(intima)又は内側表面はき裂(fi
ssuring)を生じる。この切り裂きは下にある組
織の“フラツプ”(flap)を形成し、これは内腔を
通る血流を減少させたり内腔を閉塞することがある。典
型的には、身体通路内の拡張する(distendin
g)管腔内圧力が砕かれた層又はフラツプを所定の位置
に保持することができる。バルーン拡大過程により生じ
た脈管内膜フラツプが伸張された脈管内膜に対して所定
の位置に保持されていないならば、脈管内膜フラツプは
内腔内に折れそして内腔をふさぐことがあり又は離れた
り身体通路に入つたりすることすらある。脈管内膜フラ
ツプが身体通路をふさぐ場合には、この問題を直すため
に直ちに手術が必要である。
【0005】バルーン拡大法は典型的には病院のカテー
テル挿入室(catheterization lab
)で行なわれるけれども、前記の問題のため、脈管内膜
フラツプが血管又は身体通路をふさぐ場合に備えて外科
医を待機させることが常に必要である。更に、脈管内膜
フラツプが血管から引き裂けたり内腔をふさいだりする
可能性があるため、バルーン拡大は或る極めて重要な身
体通路、例えば心臓に通じている左主冠状動脈に対して
行うことはできない。バルーン拡大法により形成された
脈管内膜フラツプが急に左主冠状動脈の如き重要身体通
路に落ち込みそしてそれをふさぐならば患者は手術を行
う前に死亡することがある。
テル挿入室(catheterization lab
)で行なわれるけれども、前記の問題のため、脈管内膜
フラツプが血管又は身体通路をふさぐ場合に備えて外科
医を待機させることが常に必要である。更に、脈管内膜
フラツプが血管から引き裂けたり内腔をふさいだりする
可能性があるため、バルーン拡大は或る極めて重要な身
体通路、例えば心臓に通じている左主冠状動脈に対して
行うことはできない。バルーン拡大法により形成された
脈管内膜フラツプが急に左主冠状動脈の如き重要身体通
路に落ち込みそしてそれをふさぐならば患者は手術を行
う前に死亡することがある。
【0006】弾性脈管狭窄症のバルーン拡大に関連した
追加の欠点は狭窄性病変(stenoticlesio
n)の弾性跳ね返り(elastic recoil)
のために多くが失敗するということである。これは通常
病変における高いフイブロコラーゲン含有率により起こ
り、そして時には拡大されるべき区域の或る機械的特性
に起因する。故に、身体通路は最初はバルーン拡大法に
より都合良く伸張させられうるけれども、身体通路の以
前に伸張させられた内腔の寸法を減少させる身体通路の
跳ね返り(recoil)によりその後の早期の再発狭
窄症(restenosis)が起こることがある。例
えば、入り口(ostium)における腎臓動脈の狭窄
症は、前記拡大力が腎臓動脈自体にかかるよりはむしろ
大動脈壁にかかるため、バルーン拡大にたいして治療抵
抗性であることが知られている。新生内膜線維症(ne
ointimal fibrosis)により引き起こ
される脈管狭窄症、例えば、透析路フイステル(dia
lysis−access fistulas)におい
てみられる如きこれらは、高い拡大圧力及びより大きい
バルーン直径を必要とするので拡大するのが困難である
ことが証明された。同様な困難が移植動脈吻合狭窄症(
graft−artery anastomotic
strictures)及び動脈内膜切除後の再発狭窄
症(postendarterectomyrecur
rent stenoses)の血管形成術において観
察された。 高安動脈炎(Takayasu arteritis)
及び神経線維腫症動脈狭窄症(neurofibrom
atosis arterial stenoses)
の経皮血管形成術は不十分な初期応答及びこれらの症状
の線維症の性質(fibrotic nature)に
よると考えられる再発を示すことがある。
追加の欠点は狭窄性病変(stenoticlesio
n)の弾性跳ね返り(elastic recoil)
のために多くが失敗するということである。これは通常
病変における高いフイブロコラーゲン含有率により起こ
り、そして時には拡大されるべき区域の或る機械的特性
に起因する。故に、身体通路は最初はバルーン拡大法に
より都合良く伸張させられうるけれども、身体通路の以
前に伸張させられた内腔の寸法を減少させる身体通路の
跳ね返り(recoil)によりその後の早期の再発狭
窄症(restenosis)が起こることがある。例
えば、入り口(ostium)における腎臓動脈の狭窄
症は、前記拡大力が腎臓動脈自体にかかるよりはむしろ
大動脈壁にかかるため、バルーン拡大にたいして治療抵
抗性であることが知られている。新生内膜線維症(ne
ointimal fibrosis)により引き起こ
される脈管狭窄症、例えば、透析路フイステル(dia
lysis−access fistulas)におい
てみられる如きこれらは、高い拡大圧力及びより大きい
バルーン直径を必要とするので拡大するのが困難である
ことが証明された。同様な困難が移植動脈吻合狭窄症(
graft−artery anastomotic
strictures)及び動脈内膜切除後の再発狭窄
症(postendarterectomyrecur
rent stenoses)の血管形成術において観
察された。 高安動脈炎(Takayasu arteritis)
及び神経線維腫症動脈狭窄症(neurofibrom
atosis arterial stenoses)
の経皮血管形成術は不十分な初期応答及びこれらの症状
の線維症の性質(fibrotic nature)に
よると考えられる再発を示すことがある。
【0007】従つて、本発明の開発以前には、身体通路
における狭窄症の再発を防止し;患者の心臓の左主冠状
動脈の如き極めて重要な身体通路に使用することができ
;身体通路壁の跳ね返りを防止し;そして管腔内移植片
が可変寸法に伸張させられて移植片が所望の位置から離
れるように移動するのを防止することを可能としそして
伸張させられた移植片による身体通路の破壊を防止する
ことを可能とする、伸張性のある管腔内脈管移植片及び
身体通路内の内腔を伸張させるための方法及び装置はな
かつた。故に、当業界では、身体通路における狭窄症の
再発を防止し;心臓の左主冠状動脈の如き極めて重要な
身体通路に使用することができると考えられ;身体通路
の跳ね返りを防止し;身体通路内で可変寸法に伸張させ
られて移植片が所望の位置から離れるように移動するの
を防止しそして伸張させられた移植片による身体通路の
破壊を防止することができる、伸張性のある管腔内脈管
移植片及び身体通路の内腔を伸張させるための方法及び
装置が探し求められてきた。
における狭窄症の再発を防止し;患者の心臓の左主冠状
動脈の如き極めて重要な身体通路に使用することができ
;身体通路壁の跳ね返りを防止し;そして管腔内移植片
が可変寸法に伸張させられて移植片が所望の位置から離
れるように移動するのを防止することを可能としそして
伸張させられた移植片による身体通路の破壊を防止する
ことを可能とする、伸張性のある管腔内脈管移植片及び
身体通路内の内腔を伸張させるための方法及び装置はな
かつた。故に、当業界では、身体通路における狭窄症の
再発を防止し;心臓の左主冠状動脈の如き極めて重要な
身体通路に使用することができると考えられ;身体通路
の跳ね返りを防止し;身体通路内で可変寸法に伸張させ
られて移植片が所望の位置から離れるように移動するの
を防止しそして伸張させられた移植片による身体通路の
破壊を防止することができる、伸張性のある管腔内脈管
移植片及び身体通路の内腔を伸張させるための方法及び
装置が探し求められてきた。
【0008】前記利点は本発明の伸張性のある管腔内脈
管移植片又はプロテーゼを保持し、身体通路内へ挿入す
るための装置により達成される。該移植片又はプロテー
ゼ(「移植片」又は「プロテーゼ」は、本願発明を説明
する際に或る程度交換可能に使用される。)は、第1端
部及び第2端部と該第1端部と該第2端部との間に配置
されている壁表面とを有する管状部材を含み、該壁表面
は複数の交差する細長い部材によつて形成されており、
該細長い部材の少なくとも幾つかは該管状部材の第1端
部と第2端部との中間で相互に交差しており、該管状部
材は内腔を有する身体通路内への該管状部材の管腔内送
り込みを可能とする第1の直径を有しており、そして該
管状部材は該管状部材の内側から半径方向外方に伸び広
げる力をかけられるとき第2の伸張した直径を有し、該
第2の直径は可変であり且つ該管状部材に加えられた力
の量に依存しており、それにより、該管状部材は該身体
通路の内腔を伸張させるように伸張させることができる
ようになつている。
管移植片又はプロテーゼを保持し、身体通路内へ挿入す
るための装置により達成される。該移植片又はプロテー
ゼ(「移植片」又は「プロテーゼ」は、本願発明を説明
する際に或る程度交換可能に使用される。)は、第1端
部及び第2端部と該第1端部と該第2端部との間に配置
されている壁表面とを有する管状部材を含み、該壁表面
は複数の交差する細長い部材によつて形成されており、
該細長い部材の少なくとも幾つかは該管状部材の第1端
部と第2端部との中間で相互に交差しており、該管状部
材は内腔を有する身体通路内への該管状部材の管腔内送
り込みを可能とする第1の直径を有しており、そして該
管状部材は該管状部材の内側から半径方向外方に伸び広
げる力をかけられるとき第2の伸張した直径を有し、該
第2の直径は可変であり且つ該管状部材に加えられた力
の量に依存しており、それにより、該管状部材は該身体
通路の内腔を伸張させるように伸張させることができる
ようになつている。
【0009】本発明の装置に用いる移植片は、また、複
数の細長い部材が複数のワイヤであることができ、そし
て該ワイヤは該ワイヤが相互に交差するところで相互に
固定される(fixedly secured)ことが
できるということである。また追加の特徴は複数の細長
い部材が複数の薄いバーであることができ、該複数の細
長いバーは該バーが相互に交差しているところで相互に
固定されていることである。更なる特徴は管状部材が、
第7図及び第8図に示されているように、その壁表面に
生物学的に不活性なコーテイングを有することができ、
このコーテイングは管状部材を身体通路に固着させるた
めの手段を含むことができることである。
数の細長い部材が複数のワイヤであることができ、そし
て該ワイヤは該ワイヤが相互に交差するところで相互に
固定される(fixedly secured)ことが
できるということである。また追加の特徴は複数の細長
い部材が複数の薄いバーであることができ、該複数の細
長いバーは該バーが相互に交差しているところで相互に
固定されていることである。更なる特徴は管状部材が、
第7図及び第8図に示されているように、その壁表面に
生物学的に不活性なコーテイングを有することができ、
このコーテイングは管状部材を身体通路に固着させるた
めの手段を含むことができることである。
【0010】前記利点は身体通路の内腔を伸張させるた
めの方法によつても達成される。該方法は、カテーテル
上に配置された管腔内移植片を、それが該身体通路内の
所望の位置に隣接して配置されるまで、該身体通路内に
挿入することと、該身体通路の所望の位置における該身
体通路の内腔が伸張させられるまで、該カテーテルの部
分を伸張させて該管腔内移植片を半径方向外方に伸張さ
せて該身体通路と接触させ、それにより、該管腔内移植
片は該身体通路がしぼんだり該伸張した内腔の寸法が減
少するのを防止することを含む。
めの方法によつても達成される。該方法は、カテーテル
上に配置された管腔内移植片を、それが該身体通路内の
所望の位置に隣接して配置されるまで、該身体通路内に
挿入することと、該身体通路の所望の位置における該身
体通路の内腔が伸張させられるまで、該カテーテルの部
分を伸張させて該管腔内移植片を半径方向外方に伸張さ
せて該身体通路と接触させ、それにより、該管腔内移植
片は該身体通路がしぼんだり該伸張した内腔の寸法が減
少するのを防止することを含む。
【0011】該方法の更なる特徴は管腔内移植片と接触
している該カテーテルの部分をしぼませそして該カテー
テルを該身体通路から除去することができることである
。該方法の更なる特徴はそれと関連した伸張性のある膨
張可能な部分を有するカテーテルを使用することができ
、そして該管腔内移植片及び該カテーテルの部分の伸張
は該カテーテルの伸張性のある膨張可能な部分を膨らま
すことにより達成されることである。
している該カテーテルの部分をしぼませそして該カテー
テルを該身体通路から除去することができることである
。該方法の更なる特徴はそれと関連した伸張性のある膨
張可能な部分を有するカテーテルを使用することができ
、そして該管腔内移植片及び該カテーテルの部分の伸張
は該カテーテルの伸張性のある膨張可能な部分を膨らま
すことにより達成されることである。
【0012】本発明に用いる管腔内移植片として金網管
(wire meshtube)を使用することができ
、この金網管は、該管が所望の位置で身体通路内に挿入
されそして所望の位置に送り込まれることを可能とする
第1の所定のしぼんだ直径を有することである。本発明
の他の特徴は、金網管を該身体通路内で第2の直径に伸
張させることができ;該第2の伸張した直径は可変であ
りそして、該身体通路の所望の伸張された内径により決
定され、それにより、該伸張した金網管は該身体通路内
で所望の位置から移動せず且つ該管腔内移植片の伸張は
該身体通路の破壊を引き起こさないことである。
(wire meshtube)を使用することができ
、この金網管は、該管が所望の位置で身体通路内に挿入
されそして所望の位置に送り込まれることを可能とする
第1の所定のしぼんだ直径を有することである。本発明
の他の特徴は、金網管を該身体通路内で第2の直径に伸
張させることができ;該第2の伸張した直径は可変であ
りそして、該身体通路の所望の伸張された内径により決
定され、それにより、該伸張した金網管は該身体通路内
で所望の位置から移動せず且つ該管腔内移植片の伸張は
該身体通路の破壊を引き起こさないことである。
【0013】本発明の装置は、第1端部及び第2端部と
該第1端部と該第2端部との間に配置されている壁表面
とを有する伸張性のある管状プロテーゼとカテーテルを
具備し、該壁表面は複数の交差する細長い部材によつて
形成されており;該カテーテルはプロテーゼに関連した
伸張性のある膨張可能な部分を有しそして該伸張性のあ
る膨張可能な部分に前記伸張性のある管状プロテーゼを
取り付け且つ保持するための手段を含み、それにより該
カテーテルの伸張性のある膨張可能な部分が膨らまされ
ると、該プロテーゼは半径方向外方に強制されて該身体
通路と接触するようになつている。本発明の更なる特徴
は上記取り付け及び保持手段が該伸張性のある膨張可能
な部分に隣接して且つ該伸張性のある管状プロテーゼの
各端部に隣接して該カテーテル上に配置されている保持
器リング部材を具備することができることである。
該第1端部と該第2端部との間に配置されている壁表面
とを有する伸張性のある管状プロテーゼとカテーテルを
具備し、該壁表面は複数の交差する細長い部材によつて
形成されており;該カテーテルはプロテーゼに関連した
伸張性のある膨張可能な部分を有しそして該伸張性のあ
る膨張可能な部分に前記伸張性のある管状プロテーゼを
取り付け且つ保持するための手段を含み、それにより該
カテーテルの伸張性のある膨張可能な部分が膨らまされ
ると、該プロテーゼは半径方向外方に強制されて該身体
通路と接触するようになつている。本発明の更なる特徴
は上記取り付け及び保持手段が該伸張性のある膨張可能
な部分に隣接して且つ該伸張性のある管状プロテーゼの
各端部に隣接して該カテーテル上に配置されている保持
器リング部材を具備することができることである。
【0014】上記の伸張性のある管腔内脈管移植片、身
体通路の内腔を伸張させる方法及び移植片又はプロテー
ゼを保持し、身体通路内へ挿入する本発明の装置を、こ
れまでに提唱された先行技術の管腔内移植片、それらを
移植する方法及びバルーン拡大法と比較したとき、狭窄
症の再発を防止する;心臓の左主冠状動脈における如き
極めて重要な身体通路における移植片の移植を可能とす
ると考えられる;身体通路の跳ね返りを防止する;身体
通路内の条件に依存して変動可能な寸法に移植片を伸張
させることを可能とする:という利点を有している。
体通路の内腔を伸張させる方法及び移植片又はプロテー
ゼを保持し、身体通路内へ挿入する本発明の装置を、こ
れまでに提唱された先行技術の管腔内移植片、それらを
移植する方法及びバルーン拡大法と比較したとき、狭窄
症の再発を防止する;心臓の左主冠状動脈における如き
極めて重要な身体通路における移植片の移植を可能とす
ると考えられる;身体通路の跳ね返りを防止する;身体
通路内の条件に依存して変動可能な寸法に移植片を伸張
させることを可能とする:という利点を有している。
【0015】本発明を好ましい態様に関して説明するが
、これは本発明をその態様に限定することを意図するも
のではないことを理解されたい。反対に、特許請求の範
囲に記載された本発明の精神及び範囲内に包含されうる
ようなすべての代替、修正及び均等物及び均等手段を包
含することを意図する。
、これは本発明をその態様に限定することを意図するも
のではないことを理解されたい。反対に、特許請求の範
囲に記載された本発明の精神及び範囲内に包含されうる
ようなすべての代替、修正及び均等物及び均等手段を包
含することを意図する。
【0016】第1図及び第3図において、伸張性のある
管腔内脈管移植片又は身体通路のための伸張性のあるプ
ロテーゼ70が例示されている。用語“伸張性のある管
腔内脈管移植片”及び伸張性のあるプロテーゼとは、方
法、装置及び構造が血管又は身体通路の部分的に閉塞さ
れたセグメントを伸張させるための伸張性のある管腔内
脈管移植片に関連してのみならず、他の多くの型の身体
通路のための伸張性のあるプロテーゼとして多くの他の
目的にも使用することが出来る限りにおいて、本発明を
説明する際に或る程度交換可能に使用されることは理解
されるべきである。例えば、伸張性のあるプロテーゼ7
0は(1)トランスルミナル再疎通(translum
inal recanalization)により開か
れているがしかし内部支持体の不存在下ではつぶれそう
な閉塞された動脈内の支持移植片配置、(2)手術不能
のガンにより閉塞された縦隔静脈(mediastin
al vein)及び他の静脈を通るカテーテル通路に
従う同様な使用;(3)門脈高圧症(portal h
ypertension)にかかつている患者の門脈と
肝臓静脈間のカテーテルで作られた肝内の連通の強化;
(4)食道、腸、尿管、尿道の狭窄化の支持移植片配置
(supportive graft placeme
nt);及び(5)再開された及び以前に閉塞された胆
管の支持移植片強化;の如き目的にも使用することが出
来る。従つて、用語“プロテーゼ”の使用は種々のタイ
プの身体通路内の使用法を包含しそして用語“管腔内脈
管移植片”の使用は身体通路の内腔を伸張させるための
使用を包含する。更に、この点について、用語“身体通
路”は前記した如き人間の身体内の管及び人間の脈管系
(vascular system)内の静脈、動脈又
は血管を包含する。
管腔内脈管移植片又は身体通路のための伸張性のあるプ
ロテーゼ70が例示されている。用語“伸張性のある管
腔内脈管移植片”及び伸張性のあるプロテーゼとは、方
法、装置及び構造が血管又は身体通路の部分的に閉塞さ
れたセグメントを伸張させるための伸張性のある管腔内
脈管移植片に関連してのみならず、他の多くの型の身体
通路のための伸張性のあるプロテーゼとして多くの他の
目的にも使用することが出来る限りにおいて、本発明を
説明する際に或る程度交換可能に使用されることは理解
されるべきである。例えば、伸張性のあるプロテーゼ7
0は(1)トランスルミナル再疎通(translum
inal recanalization)により開か
れているがしかし内部支持体の不存在下ではつぶれそう
な閉塞された動脈内の支持移植片配置、(2)手術不能
のガンにより閉塞された縦隔静脈(mediastin
al vein)及び他の静脈を通るカテーテル通路に
従う同様な使用;(3)門脈高圧症(portal h
ypertension)にかかつている患者の門脈と
肝臓静脈間のカテーテルで作られた肝内の連通の強化;
(4)食道、腸、尿管、尿道の狭窄化の支持移植片配置
(supportive graft placeme
nt);及び(5)再開された及び以前に閉塞された胆
管の支持移植片強化;の如き目的にも使用することが出
来る。従つて、用語“プロテーゼ”の使用は種々のタイ
プの身体通路内の使用法を包含しそして用語“管腔内脈
管移植片”の使用は身体通路の内腔を伸張させるための
使用を包含する。更に、この点について、用語“身体通
路”は前記した如き人間の身体内の管及び人間の脈管系
(vascular system)内の静脈、動脈又
は血管を包含する。
【0017】更に第1図を参照すると、伸張性のある管
腔内脈管移植片又はプロテーゼ70は、第1端部72及
び第2端部73と該第1端部72と該第2端部73の間
に配置された壁表面74を有する管状部材71を具備す
る。好ましくは、壁表面74は複数の交差する細長い部
材75,76により形成され、細長い部材75,76の
少なくとも幾つかは交差点77で示された如き管状部材
71の第1及び第2端部72,73の中間で相互に交差
している。管状部材71は、後に詳細に説明する如く、
内腔81を有する身体通路80への管状部材71の管腔
内送り込みを可能とする第1直径dを有する。第2図を
参照すると、後に更に詳細に説明する如く、半径方向外
方に伸び広げる力が管状部材71の内側から加えられる
と管状部材71は第2の伸張した直径d′を有し、該第
2直径d′は寸法が可変でありそして管状部材71に加
えられた力の量に依存する。
腔内脈管移植片又はプロテーゼ70は、第1端部72及
び第2端部73と該第1端部72と該第2端部73の間
に配置された壁表面74を有する管状部材71を具備す
る。好ましくは、壁表面74は複数の交差する細長い部
材75,76により形成され、細長い部材75,76の
少なくとも幾つかは交差点77で示された如き管状部材
71の第1及び第2端部72,73の中間で相互に交差
している。管状部材71は、後に詳細に説明する如く、
内腔81を有する身体通路80への管状部材71の管腔
内送り込みを可能とする第1直径dを有する。第2図を
参照すると、後に更に詳細に説明する如く、半径方向外
方に伸び広げる力が管状部材71の内側から加えられる
と管状部材71は第2の伸張した直径d′を有し、該第
2直径d′は寸法が可変でありそして管状部材71に加
えられた力の量に依存する。
【0018】第1図及び第2図を参照すると、管状部材
71の壁表面74を形成する細長い部材75,76は人
間の身体及び脈管移植片又はプロテーゼ70が接触しう
る体液(示されていない)と適合性であるいかなる適当
な材料であつてもよい。細長い部材75,76は又、管
状部材71が第1図に示された形状から第2図に示され
た形状に伸張させられることを許容するとともに更に管
状部材71を第2図に示された拡大された直径d′を有
するその伸張された形状を保持することを許容するのに
必要な強度及び弾性特性を有する材料から作られなけれ
ばならない。管状部材71を製造するのに適当な材料に
は銀、タンタル、ステンレス鋼、金、チタン又は前記し
た必要な特性を有する適当なプラスチツク材料が包含さ
れる。好ましくは、細長い部材75,76はステンレス
鋼から作られる。好ましくは、第1図及び第2図に示さ
れた細長い部材75,76はシリンダ状断面を有する小
さな直径のステンレス鋼ワイヤである。各細長い部材7
5,76は三角形、四角形、長方形、六角形等の如き他
の断面形状を有することもできることはもちろん理解さ
れるべきである。更に、複数の細長い部材75,76は
、該細長い部材75,76が例えば交差点77における
如き、相互に交差するところで相互に固定して取り付け
られる(fixedly secured)ことが好ま
しい。細長い部材75,76は慣用の方法で、例えば、
溶接、はんだ付け又は接着(gluing)、例えば適
当なエポキシ接着材(epoxy glue)による接
着によつて相互に固定的に取り付けることができる。し
かしながら、交差点77は銀ではんだ付けされているこ
とが好ましい。細長い部材75,76を相互に固定的に
取り付けることによつて、管状部材71は半径方向押し
つぶしに対する比較的高い抵抗を与えられ、そして管状
部材71は第2図に示された如きその拡大された直径d
′を保持する能力を有する。 好ましくは、管状部材71は、一般に金網管(wire
mesh tube)として示すことができるものを
形成するように、十字形管状パターンで織られた連続的
なステンレス鋼ワイヤで作られる。
71の壁表面74を形成する細長い部材75,76は人
間の身体及び脈管移植片又はプロテーゼ70が接触しう
る体液(示されていない)と適合性であるいかなる適当
な材料であつてもよい。細長い部材75,76は又、管
状部材71が第1図に示された形状から第2図に示され
た形状に伸張させられることを許容するとともに更に管
状部材71を第2図に示された拡大された直径d′を有
するその伸張された形状を保持することを許容するのに
必要な強度及び弾性特性を有する材料から作られなけれ
ばならない。管状部材71を製造するのに適当な材料に
は銀、タンタル、ステンレス鋼、金、チタン又は前記し
た必要な特性を有する適当なプラスチツク材料が包含さ
れる。好ましくは、細長い部材75,76はステンレス
鋼から作られる。好ましくは、第1図及び第2図に示さ
れた細長い部材75,76はシリンダ状断面を有する小
さな直径のステンレス鋼ワイヤである。各細長い部材7
5,76は三角形、四角形、長方形、六角形等の如き他
の断面形状を有することもできることはもちろん理解さ
れるべきである。更に、複数の細長い部材75,76は
、該細長い部材75,76が例えば交差点77における
如き、相互に交差するところで相互に固定して取り付け
られる(fixedly secured)ことが好ま
しい。細長い部材75,76は慣用の方法で、例えば、
溶接、はんだ付け又は接着(gluing)、例えば適
当なエポキシ接着材(epoxy glue)による接
着によつて相互に固定的に取り付けることができる。し
かしながら、交差点77は銀ではんだ付けされているこ
とが好ましい。細長い部材75,76を相互に固定的に
取り付けることによつて、管状部材71は半径方向押し
つぶしに対する比較的高い抵抗を与えられ、そして管状
部材71は第2図に示された如きその拡大された直径d
′を保持する能力を有する。 好ましくは、管状部材71は、一般に金網管(wire
mesh tube)として示すことができるものを
形成するように、十字形管状パターンで織られた連続的
なステンレス鋼ワイヤで作られる。
【0019】管状部材又は金網管71を製造する場合に
、それは第1図に示された直径dを有する形状に最初作
ることができる。あるいは、それは最初の直径dより大
きい直径に作り、作つた後第1図に示された直径dを有
するように注意深くしぼませることができる。管状部材
又は金網管71をしぼませる期間中隣接した細長い部材
75,76の重なりが回避されるように注意しなければ
ならない。管状部材又は金網管71が第2図に示された
形状に伸張されると第1及び第2端部72及び73間の
距離はもちろん減少することは理解されるべきである。
、それは第1図に示された直径dを有する形状に最初作
ることができる。あるいは、それは最初の直径dより大
きい直径に作り、作つた後第1図に示された直径dを有
するように注意深くしぼませることができる。管状部材
又は金網管71をしぼませる期間中隣接した細長い部材
75,76の重なりが回避されるように注意しなければ
ならない。管状部材又は金網管71が第2図に示された
形状に伸張されると第1及び第2端部72及び73間の
距離はもちろん減少することは理解されるべきである。
【0020】第3図及び第4図を参照すると、伸張性の
ある管腔内脈管移植片又はプロテーゼ70の他の態様が
示される。同じ参照番号が使用されそして第1図及び第
2図に前記した要素に適用可能である。第3図及び第4
図の管腔内脈管移植片又はプロテーゼ70は、複数の細
長い部材75,76が複数の薄いバー78,79であり
、これらのバーはバー78,79が相互に交差するとこ
ろで好ましくは相互に固定的に取り付けられているとい
う点で、第1図及び第3図に関連して前記したそれとは
異なる。バ−78,79は好ましくは薄い長方形断面形
状を有しており、そして例えば、溶接、ろう付け、はん
だ付けの如き慣用の方法によって相互に接合されていて
もよく、又は相互に一体的に形成されていてもよい。 好ましくは、管状部材71は最初肉薄の(thin−w
alled)ステンレス鋼管であり、そして交差するバ
ー78と79間の開口82は慣用のエツチングプロセス
、例えば電気機械的又はレーザーエツチングにより形成
され、その際得られる構造は複数の交差する細長い部材
78,79を有する管状部材71である。第3図の移植
片又はプロテーゼ70の態様は半径方向外方に伸び広げ
る力が管状部材71の内側から加えられると、第4図に
示されそして第2図に関連して前記した如き伸張された
形状を同様にとることができる。更に第3図及び第4図
の脈管移植片又はプロテーゼ70の態様は一般に金網管
として示すこともできることは理解されるべきである。
ある管腔内脈管移植片又はプロテーゼ70の他の態様が
示される。同じ参照番号が使用されそして第1図及び第
2図に前記した要素に適用可能である。第3図及び第4
図の管腔内脈管移植片又はプロテーゼ70は、複数の細
長い部材75,76が複数の薄いバー78,79であり
、これらのバーはバー78,79が相互に交差するとこ
ろで好ましくは相互に固定的に取り付けられているとい
う点で、第1図及び第3図に関連して前記したそれとは
異なる。バ−78,79は好ましくは薄い長方形断面形
状を有しており、そして例えば、溶接、ろう付け、はん
だ付けの如き慣用の方法によって相互に接合されていて
もよく、又は相互に一体的に形成されていてもよい。 好ましくは、管状部材71は最初肉薄の(thin−w
alled)ステンレス鋼管であり、そして交差するバ
ー78と79間の開口82は慣用のエツチングプロセス
、例えば電気機械的又はレーザーエツチングにより形成
され、その際得られる構造は複数の交差する細長い部材
78,79を有する管状部材71である。第3図の移植
片又はプロテーゼ70の態様は半径方向外方に伸び広げ
る力が管状部材71の内側から加えられると、第4図に
示されそして第2図に関連して前記した如き伸張された
形状を同様にとることができる。更に第3図及び第4図
の脈管移植片又はプロテーゼ70の態様は一般に金網管
として示すこともできることは理解されるべきである。
【0021】本発明の装置を、主として、第5図及び第
6図により詳細に説明する。再び、本発明の装置は人間
の脈管系の動脈、静脈又は血管の如き身体通路の内腔を
伸張させるためのみならず、前記した如き他の身体通路
又は管を管腔内で強化する(intraluminal
ly reinforce)のにも有用であることが理
解されるべきである。第1図又は第3図に関して前記し
た型のものであつてもよい伸張性のある管腔内脈管移植
片又はプロテーゼ70はカテーテル83上に配置され又
は取り付けられる。カテーテル83はそれに関連した伸
張性のある膨張可能な部分84を有している。カテーテ
ル83は伸張性のある管腔内脈管移植片又はプロテーゼ
をカテーテル83の伸張性のある膨張可能な部分84に
取り付け及び保持するための手段85を含む。好ましく
は、取り付け及び保持手段85はカテーテル83の伸張
性のある膨張可能な部分84に隣接してカテーテル83
上に配置された保持器リング部材86を具備し、そして
保持器リング部材86は伸張性のある管腔内脈管移植片
又はプロテーゼ70の各端部72,73に隣接して配置
されている。保持器リング部材はカテーテル83と一体
的に形成されるが、後に詳細に説明する如く、移植片又
はプロテーゼ70が身体通路80の内腔81に挿入され
るときそれを保護及び保持するために、カテーテル83
の先導チツプ87に隣接した保持器リング部材86はカ
テーテルチツプ87から遠ざかる方向に登りこう配を持
つていることが好ましい。残りの保持器リング部材86
は身体通路80からのカテーテル83の容易な除去を確
実にするためにカテーテル83のチツプ87から遠ざか
る方向に下りこう配を持つている。伸張性のある管腔内
脈管移植片又はプロテーゼ70が前記した如くカテーテ
ル83上に配置された後、移植片又はプロテーゼ70及
びカテーテル83は慣用の方法で身体通路80のカテー
テル挿入(catheterization)により身
体通路80内に挿入される。
6図により詳細に説明する。再び、本発明の装置は人間
の脈管系の動脈、静脈又は血管の如き身体通路の内腔を
伸張させるためのみならず、前記した如き他の身体通路
又は管を管腔内で強化する(intraluminal
ly reinforce)のにも有用であることが理
解されるべきである。第1図又は第3図に関して前記し
た型のものであつてもよい伸張性のある管腔内脈管移植
片又はプロテーゼ70はカテーテル83上に配置され又
は取り付けられる。カテーテル83はそれに関連した伸
張性のある膨張可能な部分84を有している。カテーテ
ル83は伸張性のある管腔内脈管移植片又はプロテーゼ
をカテーテル83の伸張性のある膨張可能な部分84に
取り付け及び保持するための手段85を含む。好ましく
は、取り付け及び保持手段85はカテーテル83の伸張
性のある膨張可能な部分84に隣接してカテーテル83
上に配置された保持器リング部材86を具備し、そして
保持器リング部材86は伸張性のある管腔内脈管移植片
又はプロテーゼ70の各端部72,73に隣接して配置
されている。保持器リング部材はカテーテル83と一体
的に形成されるが、後に詳細に説明する如く、移植片又
はプロテーゼ70が身体通路80の内腔81に挿入され
るときそれを保護及び保持するために、カテーテル83
の先導チツプ87に隣接した保持器リング部材86はカ
テーテルチツプ87から遠ざかる方向に登りこう配を持
つていることが好ましい。残りの保持器リング部材86
は身体通路80からのカテーテル83の容易な除去を確
実にするためにカテーテル83のチツプ87から遠ざか
る方向に下りこう配を持つている。伸張性のある管腔内
脈管移植片又はプロテーゼ70が前記した如くカテーテ
ル83上に配置された後、移植片又はプロテーゼ70及
びカテーテル83は慣用の方法で身体通路80のカテー
テル挿入(catheterization)により身
体通路80内に挿入される。
【0022】慣用の方法においては、カテーテル83及
び移植片又はプロテーゼ70は身体通路80内の所望の
位置に送り込まれ、そこで管腔内移植片70を経由して
身体通路80の内腔81を伸張させることが望まれ又は
そこでプロテーゼ70を移植することが望まれる。カテ
ーテル83及び移植片又はプロテーゼ70が身体通路内
の所望の位置に送り込まれることを確実にするために、
X線透視検査(fluoroscopy)及び/又は他
の慣用の方法を使用することが出来る。次いでプロテー
ゼ又は移植片70はカテーテル83の伸張性のある膨張
可能な部分84を伸張させることにより伸張せしめられ
、それによりプロテーゼ又は移植片70は身体通路80
と接触するように半径方向外方に強制される。この点に
ついて、カテーテル83の伸張性のある膨張可能な部分
は慣用の血管形成術バルーン88であることが出来る。 プロテーゼ又は移植片70の所望の伸張が終了した後、
血管形成術バルーン88はしぼまされ、又は収縮させら
れ、そしてカテーテル83は慣用の方法で身体通路80
から除去することができる。所望により、それに移植片
又はプロテーゼ70が配置されているカテーテル83は
最初慣用のテフロンさや89に包まれていてもよく、さ
や89はプロテーゼ又は移植片70の伸張の前にプロテ
ーゼ又は移植片70から引っ張り離される。
び移植片又はプロテーゼ70は身体通路80内の所望の
位置に送り込まれ、そこで管腔内移植片70を経由して
身体通路80の内腔81を伸張させることが望まれ又は
そこでプロテーゼ70を移植することが望まれる。カテ
ーテル83及び移植片又はプロテーゼ70が身体通路内
の所望の位置に送り込まれることを確実にするために、
X線透視検査(fluoroscopy)及び/又は他
の慣用の方法を使用することが出来る。次いでプロテー
ゼ又は移植片70はカテーテル83の伸張性のある膨張
可能な部分84を伸張させることにより伸張せしめられ
、それによりプロテーゼ又は移植片70は身体通路80
と接触するように半径方向外方に強制される。この点に
ついて、カテーテル83の伸張性のある膨張可能な部分
は慣用の血管形成術バルーン88であることが出来る。 プロテーゼ又は移植片70の所望の伸張が終了した後、
血管形成術バルーン88はしぼまされ、又は収縮させら
れ、そしてカテーテル83は慣用の方法で身体通路80
から除去することができる。所望により、それに移植片
又はプロテーゼ70が配置されているカテーテル83は
最初慣用のテフロンさや89に包まれていてもよく、さ
や89はプロテーゼ又は移植片70の伸張の前にプロテ
ーゼ又は移植片70から引っ張り離される。
【0023】プロテーゼ又は移植片70の管状部材71
は、金網管又は管状部材71が前記した如く身体通路8
0内に挿入されるのを可能とするために、最初は、第1
図及び第3図に関連して記載された如き第1の所定のし
ぼまされた直径dを有することに留意するべきである。 前記した目的でプロテーゼ70を身体通路80内に移植
することを望む場合には、金網管又はプロテーゼ70は
第2直径d′に伸張させられ、そして第2直径d′は可
変でありそして身体通路80の内径により決定される。 従つて、伸張させられたプロテーゼ70は血管形成術バ
ルーン88が収縮させられると身体通路80内の所望の
位置から移動することが出来ず、プロテーゼ70の伸張
は多分身体通路80の破断(rupture)を引き起
こさないであろう。
は、金網管又は管状部材71が前記した如く身体通路8
0内に挿入されるのを可能とするために、最初は、第1
図及び第3図に関連して記載された如き第1の所定のし
ぼまされた直径dを有することに留意するべきである。 前記した目的でプロテーゼ70を身体通路80内に移植
することを望む場合には、金網管又はプロテーゼ70は
第2直径d′に伸張させられ、そして第2直径d′は可
変でありそして身体通路80の内径により決定される。 従つて、伸張させられたプロテーゼ70は血管形成術バ
ルーン88が収縮させられると身体通路80内の所望の
位置から移動することが出来ず、プロテーゼ70の伸張
は多分身体通路80の破断(rupture)を引き起
こさないであろう。
【0024】狭窄症の区域を有する身体通路80の内腔
81を伸張するのに伸張性のある管腔内移植片70を使
用することが所望される場合には、血管形成術バルーン
88による管腔内脈管移植片の伸張は狭窄症区域の制御
された拡大を可能とし、同時に、脈管移植片70の制御
された伸張を可能とし、それにより脈管移植片70は身
体通路80がしぼんだり、先に伸張させられた内腔81
の寸法が減少したりするのを防止する。この場合も、管
腔内脈管移植片70の第2の伸張させられた直径d′は
可変であり、そして身体通路80の所望の伸張させられ
た内径により決定される。かくして、伸張性のある管腔
内移植片70は血管形成術バルーン88が収縮しても身
体通路80内の所望の位置から離れるように移動せず、
管腔内移植片70の伸張は身体通路80の破断を引き起
こさないようである。内膜フラツプ又は裂溝(fiss
ure)が身体通路80内で移植片70の位置に形成さ
れているならば、移植片70はこのような内膜フラツプ
が身体通路80へと内方に折り込まれ得ないこと及びゆ
るく引き裂けたり身体通路80を通つて流れたりしない
ことを確実にする。左主動脈の部分の内腔を伸張させる
ために前記した方法で移植片70を使用する情況におい
ては、内膜フラツプは心臓にはいることができずそして
患者の死を引き起こすことはできないと考えられる。
81を伸張するのに伸張性のある管腔内移植片70を使
用することが所望される場合には、血管形成術バルーン
88による管腔内脈管移植片の伸張は狭窄症区域の制御
された拡大を可能とし、同時に、脈管移植片70の制御
された伸張を可能とし、それにより脈管移植片70は身
体通路80がしぼんだり、先に伸張させられた内腔81
の寸法が減少したりするのを防止する。この場合も、管
腔内脈管移植片70の第2の伸張させられた直径d′は
可変であり、そして身体通路80の所望の伸張させられ
た内径により決定される。かくして、伸張性のある管腔
内移植片70は血管形成術バルーン88が収縮しても身
体通路80内の所望の位置から離れるように移動せず、
管腔内移植片70の伸張は身体通路80の破断を引き起
こさないようである。内膜フラツプ又は裂溝(fiss
ure)が身体通路80内で移植片70の位置に形成さ
れているならば、移植片70はこのような内膜フラツプ
が身体通路80へと内方に折り込まれ得ないこと及びゆ
るく引き裂けたり身体通路80を通つて流れたりしない
ことを確実にする。左主動脈の部分の内腔を伸張させる
ために前記した方法で移植片70を使用する情況におい
ては、内膜フラツプは心臓にはいることができずそして
患者の死を引き起こすことはできないと考えられる。
【0025】移植片70を伸張させるために血管形成術
バルーン88を1回しか膨らます必要はないので、トラ
ンスルミナル血管形成術(transluminal
angioplasty)期間中内皮の表皮はく落(e
ndothelial denudation)の程度
がバルーン膨らまし時間に比例している限りは、より多
くの量の内皮、又は内膜の内側層又は身体通路の内側表
面が保存されると考えられる。更に、理論上は、移植片
70の伸張させられた形状においては可能性として内皮
の80%が移植片70の開口82をとおして露出される
ので、保存される内皮(preserved endo
thelium)の量は大きいであろう。更に、移植片
70の細長い部材75,76,78,79間の内皮の損
なわれていないパツチが実験的研究により示された如く
迅速な多中心内皮化パターン(multicentri
c endothelialization patt
ern)をもたらしうると考えられる。
バルーン88を1回しか膨らます必要はないので、トラ
ンスルミナル血管形成術(transluminal
angioplasty)期間中内皮の表皮はく落(e
ndothelial denudation)の程度
がバルーン膨らまし時間に比例している限りは、より多
くの量の内皮、又は内膜の内側層又は身体通路の内側表
面が保存されると考えられる。更に、理論上は、移植片
70の伸張させられた形状においては可能性として内皮
の80%が移植片70の開口82をとおして露出される
ので、保存される内皮(preserved endo
thelium)の量は大きいであろう。更に、移植片
70の細長い部材75,76,78,79間の内皮の損
なわれていないパツチが実験的研究により示された如く
迅速な多中心内皮化パターン(multicentri
c endothelialization patt
ern)をもたらしうると考えられる。
【0026】本発明は例示されそして説明された構造、
操作の詳細そのもの、材料そのもの又は態様に限定され
るものではなく、修正及び均等物又は均等手段が当業者
には明らかであることは理解されるべきである。例えば
、プロテーゼ又は移植片を伸張させるための手段はカテ
ーテル上に配置された複数の流体圧作動式硬質部材であ
ることができ、又は複数の血管形成術バルーンはプロテ
ーゼ又は移植片を伸張させるのに使用されうる。従つて
、本発明は特許請求の範囲のみによつて限定されるべき
である。
操作の詳細そのもの、材料そのもの又は態様に限定され
るものではなく、修正及び均等物又は均等手段が当業者
には明らかであることは理解されるべきである。例えば
、プロテーゼ又は移植片を伸張させるための手段はカテ
ーテル上に配置された複数の流体圧作動式硬質部材であ
ることができ、又は複数の血管形成術バルーンはプロテ
ーゼ又は移植片を伸張させるのに使用されうる。従つて
、本発明は特許請求の範囲のみによつて限定されるべき
である。
【図1】図1は身体通路内への移植片又はプロテーゼの
送り込みを可能とする第1の直径を有する身体通路のた
めの伸張性のある管腔内脈管移植片又はプロテーゼの斜
視図である。
送り込みを可能とする第1の直径を有する身体通路のた
めの伸張性のある管腔内脈管移植片又はプロテーゼの斜
視図である。
【図2】図2は身体通路内に配置されたときその伸張さ
れた形状にある第1図の移植片又はプロテーゼの斜視図
である。
れた形状にある第1図の移植片又はプロテーゼの斜視図
である。
【図3】図3は身体通路内への移植片又はプロテーゼの
管腔内送り込みを可能とする第1の直径を有する、身体
通路のための伸張性のある管腔内脈管移植片又はプロテ
ーゼの他の態様の斜視図である。
管腔内送り込みを可能とする第1の直径を有する、身体
通路のための伸張性のある管腔内脈管移植片又はプロテ
ーゼの他の態様の斜視図である。
【図4】図4は身体通路内に配置されたときその伸張さ
れた形状において示された第3図の移植片又はプロテー
ゼの斜視図である。
れた形状において示された第3図の移植片又はプロテー
ゼの斜視図である。
【図5】図5は図1及び図3に示された形状にある移植
片又はプロテーゼを保持し、身体通路内へ挿入するため
の装置の断面図である。
片又はプロテーゼを保持し、身体通路内へ挿入するため
の装置の断面図である。
【図6】図6は図2及び図4に示された形状にある移植
片又はプロテーゼを保持している上記装置の断面図であ
る。
片又はプロテーゼを保持している上記装置の断面図であ
る。
【図7】図7は移植片又はプロテーゼがその上にコーテ
イングを有している、身体通路のための移植片又はプロ
テーゼの斜視図である。
イングを有している、身体通路のための移植片又はプロ
テーゼの斜視図である。
【図8】図8は、移植片又はプロテーゼがその上にコー
テイングを有している、身体通路のための他の態様の移
植片又はプロテーゼの斜視図である。
テイングを有している、身体通路のための他の態様の移
植片又はプロテーゼの斜視図である。
70 伸張性のある管腔内脈管移植片又はプロテーゼ
71 管状部材 72 第1端部 73 第2端部 74 壁表面 75,76 交差している細長い部材77 交差点 78,79 バー 80 身体通路 81 内腔 82 開口 83 カテーテル 84 伸張性のある膨張可能な部分 85 取り付け及び保持手段 86 保持器リング部材 87 先導チツプ 88 慣用の血管形成術バルーン 89 慣用のテフロンさや
71 管状部材 72 第1端部 73 第2端部 74 壁表面 75,76 交差している細長い部材77 交差点 78,79 バー 80 身体通路 81 内腔 82 開口 83 カテーテル 84 伸張性のある膨張可能な部分 85 取り付け及び保持手段 86 保持器リング部材 87 先導チツプ 88 慣用の血管形成術バルーン 89 慣用のテフロンさや
Claims (2)
- 【請求項1】 第1端部及び第2端部と該第1端部と
該第2端部との間に配置されている壁表面とを有する伸
張性のある管腔内脈管移植片又はプロテーゼとカテーテ
ルを具備し、該壁表面は複数の交差する細長い部材によ
つて形成されており、該交差している細長い部材は複数
の薄いバーであり、各バーは均一な薄い長方形の断面形
状を有しており;該カテーテルは該移植片又はプロテー
ゼに関連した伸張性のある膨張可能な部分を有しそして
該伸張性のある膨張可能な部分に前記伸張性のある管腔
内脈管移植片又はプロテーゼを取り付け且つ保持するた
めの手段を含むことを特徴とする該移植片又はプロテー
ゼを保持し、身体通路内へ挿入するための装置。 - 【請求項2】 該取り付け及び保持手段が該伸張性の
ある膨張可能な部分に隣接して且つ該伸張性のある管腔
内脈管移植片又はプロテーゼの各端部に隣接して該カテ
ーテル上に配置されている保持器リング部材を具備する
特許請求の範囲第1項記載の装置。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US796009 | 1985-11-07 | ||
US90/002493 US4733665C2 (en) | 1985-11-07 | 1985-11-07 | Expandable intraluminal graft and method and apparatus for implanting an expandable intraluminal graft |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP61265419A Division JPS62231657A (ja) | 1985-11-07 | 1986-11-07 | 伸張性のある管腔内脈管移植片又はプロテーゼ |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP34646396A Division JP2999731B2 (ja) | 1985-11-07 | 1996-12-11 | 移植片又はプロテーゼとカテーテルとを具備する装置 |
Publications (2)
Publication Number | Publication Date |
---|---|
JPH04357949A true JPH04357949A (ja) | 1992-12-10 |
JP2731642B2 JP2731642B2 (ja) | 1998-03-25 |
Family
ID=25167022
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP61265419A Granted JPS62231657A (ja) | 1985-11-07 | 1986-11-07 | 伸張性のある管腔内脈管移植片又はプロテーゼ |
JP3225376A Expired - Lifetime JP2731642B2 (ja) | 1985-11-07 | 1991-08-12 | 伸張性のある管腔内脈管移植片又はプロテーゼ |
JP34646396A Expired - Lifetime JP2999731B2 (ja) | 1985-11-07 | 1996-12-11 | 移植片又はプロテーゼとカテーテルとを具備する装置 |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP61265419A Granted JPS62231657A (ja) | 1985-11-07 | 1986-11-07 | 伸張性のある管腔内脈管移植片又はプロテーゼ |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP34646396A Expired - Lifetime JP2999731B2 (ja) | 1985-11-07 | 1996-12-11 | 移植片又はプロテーゼとカテーテルとを具備する装置 |
Country Status (10)
Country | Link |
---|---|
US (3) | US4733665C2 (ja) |
EP (1) | EP0221570B2 (ja) |
JP (3) | JPS62231657A (ja) |
AT (1) | ATE60500T1 (ja) |
BR (1) | BR8605658A (ja) |
CA (2) | CA1338303E (ja) |
DE (2) | DE3677321D1 (ja) |
ES (1) | ES2020502T5 (ja) |
GR (2) | GR3001410T3 (ja) |
ZA (1) | ZA868414B (ja) |
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Also Published As
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EP0221570B1 (en) | 1991-01-30 |
JP2999731B2 (ja) | 2000-01-17 |
CA1338303E (en) | 1996-05-07 |
CA1281504C (en) | 1991-03-19 |
GR3035143T3 (en) | 2001-04-30 |
US4776337A (en) | 1988-10-11 |
AU591942B2 (en) | 1989-12-21 |
ES2020502B3 (es) | 1991-08-16 |
JP2731642B2 (ja) | 1998-03-25 |
US4733665C2 (en) | 2002-01-29 |
US4739762B1 (en) | 1998-10-27 |
US4733665A (en) | 1988-03-29 |
ATE60500T1 (de) | 1991-02-15 |
EP0221570A3 (en) | 1987-12-23 |
AU6488286A (en) | 1987-05-14 |
JPH046377B2 (ja) | 1992-02-05 |
JPS62231657A (ja) | 1987-10-12 |
DE3677321D1 (de) | 1991-03-07 |
US4739762A (en) | 1988-04-26 |
US4733665B1 (en) | 1994-01-11 |
ES2020502T5 (es) | 2001-03-16 |
BR8605658A (pt) | 1987-12-15 |
DE221570T1 (de) | 1987-12-17 |
US4776337B1 (en) | 2000-12-05 |
EP0221570B2 (en) | 2000-10-04 |
ZA868414B (en) | 1987-09-30 |
GR3001410T3 (en) | 1992-09-25 |
EP0221570A2 (en) | 1987-05-13 |
JPH09276302A (ja) | 1997-10-28 |
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