JP4903049B2 - カテーテル装置 - Google Patents
カテーテル装置 Download PDFInfo
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- JP4903049B2 JP4903049B2 JP2006540368A JP2006540368A JP4903049B2 JP 4903049 B2 JP4903049 B2 JP 4903049B2 JP 2006540368 A JP2006540368 A JP 2006540368A JP 2006540368 A JP2006540368 A JP 2006540368A JP 4903049 B2 JP4903049 B2 JP 4903049B2
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- 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
-
- 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
- A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Description
図1、図2、および、図3を参照すると、自己拡張型ステント10またはステント移植片が鞘部材の遠位端領域12の内側に載置されており、この遠位端領域には先細り先端部16と熱成形された近位端18が設けられており、この近位端がガイドワイヤ22を通すための近位ガイドワイヤ出口ポートの開口部20を定めている。自己拡張型であるために、ステント10は、少なくとも体温では、遠位端領域12のスリーブ14の管腔表面に圧迫応力を加えている。ステント10より近位で、スリーブ14の管腔側から遠い表面24では、スエージ加工された放射線不透過性の金属製素材のマーカー帯26が設けられており、帯26はその内側の鞘部材14の素材を放射方向内向きに押圧している。この地点における鞘部材の放射方向内側には、段差を設けた金属環体28が配置されており、この環体自体が、マーカー帯26の内側で鞘部材14の素材30による放射方向内向きの圧迫応力を受ける。従って、鞘部材の素材30は鞘部材14の内側の金属帯(28)と外側の金属帯(26)の間で圧迫される。引張りワイヤ32が環体28に硬鑞付けされているが、該ワイヤは環体28からカテーテル装置の近位端までずっと逆行して延びており、そのため、引張りワイヤ32の近位端に加えられる手前方向引張り応力が環体28を近位方向に引張ることで、環体28より遠位の鞘部材14の各部に手前方向引張り応力を加え、ステントに関して近位方向に鞘部材14を引張ることでステントを放出する。これと同時に、環体28より近位の鞘部材14の各部が近位方向に押されることになる。
図5は本発明の第2の要素の側面から見た概略図であり、自己拡張型ステント201の搬送システム200には、ガイドワイヤ204を伝って前進する遠位端202が設けられ、ガイドワイヤ近位端はガイドワイヤ管腔203に沿って近位方向に前進し、システムのカテーテル212のシャフトの近位端210より遠位にある2個の交互のガイドワイヤ出口ポート206、208のうちの選択された一方と同程度の距離に至る。ハンドユニット214には第1のアクチュエータ216と第2のアクチュエータ218が設けられており、これらを交互に使用して、または、連続的に使用して、システムの遠位端で自己拡張型ステントに放射方向に重畳している鞘部材220を近位方向に引張ることができる。近位ハブ224のポート222では、洗浄液が導入され、システムから気泡を洗い流す。回りナット226がカテーテルシャフト212をハンドユニット214に接続し、シャフトの長軸の周囲でハンドユニットを自由に回転させることができるようにしている。
i)ステント配備の間、周囲の体組織に関して配備システムのシャフトの外表面が軸線方向に移動することがない、
ii)ステント放出システムの同軸部分の両方について、各構成要素が完全に金属から成り、長く薄い荷重耐性のある構成要素であるため、ステント鞘部材が近位方向に引張られてステントから離れる際にシャフトに加えられる端部応力をシャフト長尺部が受けた場合の長さの変動を最小限に抑えることができる、
iii)本質的に規格寸法である設計から生じるステント長さやステント径の違いを許容する、
iv)ガイドワイヤ管腔の2種類の異なる長さから選択できる、
v)ステント管腔内に入るシステムの先端部の各表面が凹入面ではないため、ステント管腔を通して先端部を近位方向に引出す際に、ステント配備後のシステムの引き出しによってステント設置部位から体組織を転位させたり、***させてしまうという危険が無い(本件出願人の国際公開WO 2001/034061号(特許文献5)を参照)、といった利点がある。
Claims (18)
- シャフト(14;220)を設けたカテーテル装置であって、シャフトは、カテーテル装置の近位端から遠位端まで延びて自らの遠位端に自己拡張型移植片(10)を保持し、前記カテーテル装置内の前記移植片の放射方向外側に存在する鞘部材(14;220)を近位方向に引出すことにより、ガイドワイヤ(22;204)を伝って前記移植片に管腔内を前進させるとともに、前記移植片をステント設置部位に搬送し、前記カテーテル装置には、鞘部材を近位方向に引張る第1シャフト部材と、移植片を遠位方向に押す第2シャフト部材が設けられて、鞘部材が近位方向に引っ張られた際に、鞘部材と一緒に移植片が近位方向に移動するのを阻止するようにしており、
i)前記シャフトは洗浄管腔を定めており、
ii)前記シャフト(14;220)は、その近位端より遠位に設けられた近位ガイドワイヤ出口ポート(20;206)を定めて、ガイドワイヤに関してカテーテルを迅速に交換できるように図っており、
iii)前記第1シャフト部材は引張りワイヤ(32)であり、
iv)前記第2シャフト部材は、前記鞘部材(14;220)が前記引張りワイヤ(32)によって近位方向に引張られた際に、前記移植片(10)が前記鞘部材とともに近位端側に移動することを防止するように前記移植片を遠位方向に押すための押し部材チューブ(52;246)であり、
前記押し部材チューブ(52;246)には遠位端が設けられており、該遠位端には、前記ガイドワイヤ用管腔を定める押し部材−案内部材チューブ(42;254)の近位端が横並びに固着される、ことを特徴とするカテーテル装置。 - 前記鞘部材(14;220)には先細り状の遠位先端部(16;238)が設けられることを特徴とする、請求項1に記載のカテーテル装置。
- 前記引張りワイヤ(32)は、前記鞘部材の内側で放射方向に配置されている内側引張りリング(28;235)によって前記鞘部材(14;220)に接続されており、引張りワイヤと引張りリングは両方が金属製であり、引張りワイヤと引張りリングの間に金属帯を設けていることを特徴とする、請求項1または請求項2に記載のカテーテル装置。
- 前記鞘部材(14)と前記内側引張りリング(28)の放射方向外側に外側引張りリング(26)を設け、内側引張りリングと外側引張りリングの間で鞘部材が圧縮されるように構成されることを特徴とする、請求項3に記載のカテーテル装置。
- 前記鞘部材(14;220)はポリマー製であり、その壁厚部の内部に編組状の金属線条を保持することを特徴とする、請求項1から請求項4のいずれか1項に記載のカテーテル装置。
- 前記押し部材−案内部材チューブ(42;254)は螺旋状の金属線条で形成され、かつ、ストッパリング(40;260)を保持しており、前記押し部材チューブ(52;246)、前記押し部材・案内部材チューブ(42;254)、および、ストッパリング(40;260)が前記第2シャフト部材として作用するように構成されることを特徴とする、請求項1から請求項5のいずれか1項に記載のカテーテル装置。
- 前記押し部材・案内部材チューブ(42;254)は前記ストッパリング(40;260)より遠位に延び、前記カテーテル装置の遠位先端部まで延びることを特徴とする、請求項6に記載のカテーテル装置。
- 前記押し部材チューブ(246)と前記押し部材・案内部材チューブ(254)とを接続するアダプタブロック(248)が設けられ、該アダプタブロックは2本の管腔を横並びに形成しており、その一方は押し部材チューブの管腔(250)であり、他方は押し部材・案内部材チューブの管腔(252)であることを特徴とする、請求項1から請求項7のいずれか1項に記載のカテーテル装置。
- 前記鞘部材(220)と切れ目無く連続しているとともに、前記押し部材チューブ(246)を保有する管腔を定める洗浄スリーブ(228)が設けられることを特徴とする、請求項1から請求項8のいずれか1項に記載のカテーテル装置。
- 前記シャフトは、円筒状外表面が設けられて前記洗浄スリーブ(228)を受け入れるようになっている案内部材ブロック(230)と、ガイドワイヤ管腔(203)と、該ガイドワイヤ管腔と横並びに配置されて前記押し部材チューブ(246)を受け入れるように構成された管腔(262)とを備えることを特徴とする、請求項9に記載のカテーテル。
- 前記案内部材ブロック(230)より遠位にある前記洗浄スリーブ(228)に、蛇腹状チューブ(232)が設けられることを特徴とする、請求項10に記載のカテーテル装置。
- 前記案内部材ブロック(230)より遠位にある前記洗浄スリーブ(228)に、入れ子式チューブ(240)が設けられることを特徴とする、請求項10または請求項11に記載のカテーテル装置。
- 前記案内部材ブロック(230)は、前記押し部材チューブ(246)に関する軸線方向の移動と、前記案内部材ブロックの円筒状表面上の洗浄スリーブ(228)に関する軸線方向の移動とに抵抗するように固着されることを特徴とする、請求項10から請求項12のいずれか1項に記載のカテーテル装置。
- 前記近位ガイドワイヤ出口ポート(206)は、前記案内部材ブロック(230)の直ぐ近位に設けられることを特徴とする、請求項13に記載のカテーテル装置。
- 前記案内部材ブロック(230)は、前記カテーテル装置の遠位先端部から約75cm付近に配置されることを特徴とする、請求項10から請求項14のいずれか1項に記載のカテーテル装置。
- 前記近位の出口ポート(206)から突出するとともに、前記カテーテルから外に引張りだすことができる追加のチューブ(272)であり、ガイドワイヤを前記鞘部材の遠位端ポート(58)から前記近位の出口ポート(206)まで先導するための追加のチューブ(272)が設けられ、
前記ガイドワイヤ管腔(203)は、前記近位の出口ポート(206)から、該近位の出口ポートより近位にある第2のより近位の出口ポート(208)まで、近位方向に切れ目無く続き、
前記追加のチューブ(272)は前記カテーテル装置から外へ引張りだされて、ガイドワイヤが近位方向に前進して前記追加のチューブ(272)の位置を越えて、前記第2のより近位の出口ポート(208)付近まで進むことができるように構成されることを特徴とする、請求項14または請求項15に記載のカテーテル装置。 - 前記第2のより近位の出口ポートはハブ(224)に定められており、該ハブも洗浄ポート(222)を定めることで、前記洗浄管腔に洗浄液を導入できるように構成されることを特徴とする、請求項16に記載のカテーテル装置。
- 自己拡張型ステントを設けていることを特徴とする、請求項1から請求項17のいずれか1項に記載のカテーテル装置。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GBGB0327306.7A GB0327306D0 (en) | 2003-11-24 | 2003-11-24 | Catheter device |
GB0327306.7 | 2003-11-24 | ||
PCT/EP2004/013339 WO2005053574A2 (en) | 2003-11-24 | 2004-11-24 | Catheter device |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2007512061A JP2007512061A (ja) | 2007-05-17 |
JP4903049B2 true JP4903049B2 (ja) | 2012-03-21 |
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Application Number | Title | Priority Date | Filing Date |
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JP2006540368A Expired - Fee Related JP4903049B2 (ja) | 2003-11-24 | 2004-11-24 | カテーテル装置 |
Country Status (8)
Country | Link |
---|---|
US (1) | US20070191925A1 (ja) |
EP (1) | EP1689327B1 (ja) |
JP (1) | JP4903049B2 (ja) |
CA (1) | CA2546766C (ja) |
EA (1) | EA008407B1 (ja) |
GB (1) | GB0327306D0 (ja) |
MX (1) | MXPA06005907A (ja) |
WO (1) | WO2005053574A2 (ja) |
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MXPA06005907A (es) | 2006-08-23 |
CA2546766C (en) | 2013-05-14 |
GB0327306D0 (en) | 2003-12-24 |
EP1689327B1 (en) | 2016-09-14 |
CA2546766A1 (en) | 2005-06-16 |
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WO2005053574A2 (en) | 2005-06-16 |
US20070191925A1 (en) | 2007-08-16 |
JP2007512061A (ja) | 2007-05-17 |
EA200601038A1 (ru) | 2006-10-27 |
EP1689327A2 (en) | 2006-08-16 |
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