JP4469134B2 - 自己拡張式ステント配送装置 - Google Patents
自己拡張式ステント配送装置 Download PDFInfo
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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
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
- A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
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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
- A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M39/1011—Locking means for securing connection; Additional tamper safeties
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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)
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Description
このようなステント配送システムの早期開示を、ジアンツルコ(Gianturco)付与された米国特許第4,580,568号に見出すことができる。
第1の段階では、最初、包囲スリーブを近位方向に引寄せることによりステントの遠位端が放出され、これにより、ステントの長さ方向のこの部分が、手術部位を構成する体腔と接触し始める。この第1の段階は、ステントが、体腔ではなくステント配送システムに依然として結合されていることに特徴がある。しかしながら、第1の段階の終わる時、充分な長さのステントが拡張して体腔壁に接触し、ステントの位置が体腔壁に対して固定される。この時点で、ステントは配送システム及び体腔壁の両方に結合され、従って、体腔に対するステント配送システムの軸線方向移動は、体腔壁を傷付け易い。
ステント展開手順の第2の段階は、第1の段階に引き続く段階であり、すなわち、シースの残りの近位方向移動によって、ステントの残り長さ部分が体腔内に放出される。展開中、ステントの展開部分に作用するあらゆる軸線方向応力は、ステントと結合及び係合状態にある体腔の部分に作用する軸線方向応力となって伝達され、その結果、ステントによって支持された体腔壁は、ステントが完全に展開された後、張力及び応力を受けた状態に維持される。体組織中のこの好ましくない軸線方向応力は、患者にとって何らかの形で著しく有害であり、通常は除去すべきものである。
また、以前、ステントをその長さの中央部から最初に展開するために、ステントをその両端の中間に位置する開始箇所から近位方向及び遠位方向に同時に引いて、ステントの近位端及び遠位端の両方の展開で終了する拘束シースの組合せが提案された。このようなシステムでさえも、軸線方向応力に関する懸念が依然として当てはまる。従って、本願明細書における詳細な説明は、包囲スリーブを近位方向に引寄せる通常の仕方で構成されるステント配送システムのものであるけれども、本発明が包囲シースを遠位方向に引くことを含むステント配送システムにも適用できることを理解すべきである。
個々の医療実施者自身が、ステントを正確に展開するための好ましい技術を開発していることを本発明者は承知している。医療実施者がステント展開手術中に実際に取扱うアクチュエータを備えたステント配送システムの近位端部に注目すれば、当該技術状態は種々の形態を提案しており、個々の医療実施者は、彼らの手動操作技量に最も良く適合したアクチュエータを上記システムの性能から選択している。
自己拡張式ステントの制御された放出を行なう装置の他の方法は、米国特許第5,683,451号に見出すことができ、この方法は、ステントと包囲シースとの間に位置するいわゆるランナを使用するものである。ステント配送システムの近位端で、フォロワは包囲シースの近位端のハブを受入れ、ハンドルの回転によりねじシャフトが回転され、ねじシャフトに沿ってフォロワが前進し、シースの近位側ハブを近位側方向に移動させてステントを放出させる。
要するに、本願の発明者が見出したことは、全員が正確なステント展開について好ましい技術を有している一定範囲の個々の医療実施者医者が、彼らに最も適した仕方で彼らの熟練技術を実施すること、ステントの長さ方向の最初の部分を体腔内の正確な位置に配置すること、及び医療実施者がステントを配置すべき組織に許容できない軸線方向応力が作用することを満足いくように回避すべく正確且つ厳密に制御できる仕方でステントの全体長さ部分の展開を完了することを、ラチェット手段及びフルストロークアクチュエータの両方を具体化する放出装置により可能にすることである。
本発明の現在の好ましい実施形態は、トリガとスライダとの間の折り曲げ可能な連結体を特徴としており、この連結体により、ステント用シースを引寄せる間の任意の時点で、トリガを作動させる必要なしに、スライダが任意の位置からその摺動長さにわたってトリガに接近することを可能にする。ウインドラスのシャフトに連結された一端とシースに張力を加える他端とを備えた折り曲げ可能なラインを設け、ウインドラスリールはラインを巻上げ、リールの巻上げを、歯付きラチェットセグメントをウインドラス駆動ギヤの歯付き周囲に沿って連続的に通過させることによって達成し、ラチェットセグメントの各通過を、トリガを握ることによって達成することが便利である。ラインの端部がスライダに連結されることが便利である。もし医療実施者がスライダ自体を把持してそれをウインドラスシャフトに向って推し進めれば、スライダがウインドラスに接近するにつれて、ラインは折れ曲がる。
2つのハウジング半部は、組立てられた状態で、トラック14を形成し、このトラック14の中に、外側チューブ16を有する同軸ステント配送装置の近位端部が配置される。トラック14は、2つのハウジング半部の軸線方向凹部を合わせることによって形成され、その結果、図1のハウジングの上端部に開口する半円形チャネルが形成される。
本発明者はまた、ハウジングを透明材料で作り、レールおよびスライダ上にマーカを設けて、ステントの位置に対する外側チューブ16の近位方向引き長さを指示することを考えている。例えば、スライダ24上のマーカがレール22一方に設けられた最も近位側のマーカと整列していれば、ステントが完全に放出された状態にある旨の指示が医療実施者に与えられる。スライダ24は、図1のハウジング12の下端部のところでその外側に突出しており、人が、適当なときに、スライダ24をレール22の長さにわたって手で押すことを可能にする。スライダ24の突出長さは、スライダの最適な操作を行なうためにスライダ24を親指と人差し指で充分に掴むことができれば便利である。
ハウジング12には爪44が取付けられている。この爪44は、ラチェット要素38がその最初の位置に戻るときに巻上げリール32が反時計方向に戻る任意の移動を防止するするように、巻上げギヤ35の連続的な歯に係合している。
意図すべきことは、上記システムが種々のステント配送システムに広範囲に適用されるべきことであり、これは、それぞれのハブについて、容易に交換可能な係合構造をハウジングに設けることにより達成される。
トリガを、ラチェット要素38に対する幾つかの異なる位置でハウジングに取付けるために、トリガ34に種々の孔を設けることにより、トリガの各ストロークについて外側スリーブ16の所望の引寄せ長さを達成して、異なるストロークを選択することが可能になる。
ハブ18、28を受入れる形態は弾性クリップの形態に構成されるのが良く、その結果、種々の配送システムをトラック14内に配置することができる。
実際、装置は、一定範囲の配送装置および一定範囲の特徴のユーザへの使用を可能にする柔軟性に留意して設計される。ハウジングは、意図的に対称的に設計され、即ち、「利き手」に無関係に、左手による使用及び右手による使用に等しく適合している。
ステント配送装置の製造に使用される材料として、ポリオキシメチレン(POM)、ポリカーボネート(PC)及び医療装置の成形に従来から使用されているその他のポリマー組成物があるが、これらに限定されるものではない。レールおよび板ばね等の他の構成部品は、番手記号1.4310又は1.4301のステンレススチール等の医療器具に適した金属で作られる。当業者には、他の材料が分るであろうし、且つ容易に入手できるであろう。
ライン30はマルチフィラメントポリマーベース繊維であり、この繊維は、モノフィラメントラインにより得られる可撓性よりも大きい可撓性をライン30に付与する。この可撓性は、スライダを近位方向に移動させてラインの張力が解放され、次いで、ラインがハウジング内で曲りくねってしまうときに重要である。
Claims (10)
- 配送システムに取付けられ且つ拘束用配送器具の拘束体(16)によって保持された医療用プロテーゼを配送システムから身体内に放出する装置(1)であって、
前記配送システムのための第1の接合体(28)と、
前記装置とプロテーゼ拘束体とを連結する細長い要素(30)のための第2の接合体(18)と、
前記第2の接合体(18)が、プロテーゼを拘束する出発箇所からプロテーゼと拘束体(16)とを分離させる最終箇所まで前進する際に伝うトラック(14)と、
前記第2の接合体(18)を前記出発箇所から前記最終箇所まで複数の作動ストロークで徐々に前進させるラチェット手段(38)と、を有する装置(1)において、
ハウジング(12)と、
前記第2の接合体(18)を前記トラック上の中間箇所から前記最終箇所までの全体にわたって単一ストロークで前進させるフルストロークアクチュエータ(24)とを有し、
前記ラチェット手段(38)は、トリガ(34)を有し、
前記フルストロークアクチュエータ(24)は、手動操作のために、前記トリガ(34)よりも前記ハウジング(12)の遠位側で、当該フルストロークアクチュエータ(24)の移動方向と直交する方向に延びて前記ハウジング(12)から突出しており、
前記中間箇所は、前記トラック(14)の長さの少なくとも半分にわたって延びているトラックの部分の中においてユーザが選択できることを特徴とする装置。 - 前記ラチェット手段(38)は巻上げリール(32)を有する、請求項1に記載の装置。
- 前記巻上げリール(32)は逆方向移動を阻止する爪(44)を有する、請求項2に記載の装置。
- 前記トリガ(34)を休止位置に向かって付勢する付勢手段(46)を有する、請求項1〜3のいずれか1項記載の装置。
- 前記付勢手段(46)はラチェット手段(38)と巻上げリール(32)との接触を維持する、請求項1〜4のいずれか1項記載の装置。
- 前記付勢手段(46)は板ばね(46)である、請求項1〜5のいずれか1項記載の装置。
- 前記フルストロークアクチュエータはスライダ(24)である、請求項1〜6のいずれか1項記載の装置。
- 前記ラチェット手段(38)は、折り曲げ可能な要素(30)によって前記第2の接合体(18)に連結されている、請求項1〜7のいずれか1項記載の装置。
- 前記折り曲げ可能な要素(30)はラインである、請求項8記載の装置。
- 前記トラック(14)は1対の平行なレールにより形成される、請求項1〜9のいずれか1項記載の装置。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GBGB0110551.9A GB0110551D0 (en) | 2001-04-30 | 2001-04-30 | Self-expanding stent delivery service |
PCT/EP2002/004727 WO2002087470A1 (en) | 2001-04-30 | 2002-04-29 | Self-expanding stent delivery device |
Publications (2)
Publication Number | Publication Date |
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JP2004527316A JP2004527316A (ja) | 2004-09-09 |
JP4469134B2 true JP4469134B2 (ja) | 2010-05-26 |
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JP2002584824A Expired - Fee Related JP4469134B2 (ja) | 2001-04-30 | 2002-04-29 | 自己拡張式ステント配送装置 |
Country Status (9)
Country | Link |
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US (1) | US7550001B2 (ja) |
EP (2) | EP1637092B1 (ja) |
JP (1) | JP4469134B2 (ja) |
AT (1) | ATE308286T1 (ja) |
CA (1) | CA2445850A1 (ja) |
DE (1) | DE60207065T2 (ja) |
ES (1) | ES2251588T3 (ja) |
GB (1) | GB0110551D0 (ja) |
WO (1) | WO2002087470A1 (ja) |
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GB0121980D0 (en) * | 2001-09-11 | 2001-10-31 | Cathnet Science Holding As | Expandable stent |
GB0123633D0 (en) | 2001-10-02 | 2001-11-21 | Angiomed Ag | Stent delivery system |
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US7351255B2 (en) | 2001-12-03 | 2008-04-01 | Xtent, Inc. | Stent delivery apparatus and method |
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US7147656B2 (en) | 2001-12-03 | 2006-12-12 | Xtent, Inc. | Apparatus and methods for delivery of braided prostheses |
CA2513082C (en) | 2003-01-15 | 2010-11-02 | Angiomed Gmbh & Co. Medizintechnik Kg | Trans-luminal surgical device |
GB0327306D0 (en) * | 2003-11-24 | 2003-12-24 | Angiomed Gmbh & Co | Catheter device |
US7758625B2 (en) * | 2003-09-12 | 2010-07-20 | Abbott Vascular Solutions Inc. | Delivery system for medical devices |
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-
2001
- 2001-04-30 GB GBGB0110551.9A patent/GB0110551D0/en not_active Ceased
-
2002
- 2002-04-29 EP EP05020913.9A patent/EP1637092B1/en not_active Expired - Lifetime
- 2002-04-29 JP JP2002584824A patent/JP4469134B2/ja not_active Expired - Fee Related
- 2002-04-29 WO PCT/EP2002/004727 patent/WO2002087470A1/en active IP Right Grant
- 2002-04-29 ES ES02727583T patent/ES2251588T3/es not_active Expired - Lifetime
- 2002-04-29 EP EP02727583A patent/EP1383446B1/en not_active Expired - Lifetime
- 2002-04-29 CA CA002445850A patent/CA2445850A1/en not_active Abandoned
- 2002-04-29 AT AT02727583T patent/ATE308286T1/de not_active IP Right Cessation
- 2002-04-29 DE DE60207065T patent/DE60207065T2/de not_active Expired - Lifetime
- 2002-04-29 US US10/476,351 patent/US7550001B2/en active Active
Also Published As
Publication number | Publication date |
---|---|
EP1383446B1 (en) | 2005-11-02 |
ES2251588T3 (es) | 2006-05-01 |
US7550001B2 (en) | 2009-06-23 |
ATE308286T1 (de) | 2005-11-15 |
GB0110551D0 (en) | 2001-06-20 |
EP1637092A3 (en) | 2014-07-23 |
DE60207065T2 (de) | 2006-07-13 |
WO2002087470A1 (en) | 2002-11-07 |
JP2004527316A (ja) | 2004-09-09 |
US20040181239A1 (en) | 2004-09-16 |
DE60207065D1 (de) | 2005-12-08 |
CA2445850A1 (en) | 2002-11-07 |
EP1637092B1 (en) | 2016-06-29 |
EP1383446A1 (en) | 2004-01-28 |
EP1637092A2 (en) | 2006-03-22 |
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