JP4783876B2 - ステントグラフト、ステントグラフトデリバリー(送入)システムおよびキット、およびステントグラフトを留置する方法 - Google Patents
ステントグラフト、ステントグラフトデリバリー(送入)システムおよびキット、およびステントグラフトを留置する方法 Download PDFInfo
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- JP4783876B2 JP4783876B2 JP2006525429A JP2006525429A JP4783876B2 JP 4783876 B2 JP4783876 B2 JP 4783876B2 JP 2006525429 A JP2006525429 A JP 2006525429A JP 2006525429 A JP2006525429 A JP 2006525429A JP 4783876 B2 JP4783876 B2 JP 4783876B2
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- stent
- repair device
- support member
- vascular repair
- curved
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- 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
-
- 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
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0067—Three-dimensional shapes conical
-
- 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
Landscapes
- 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)
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- Gastroenterology & Hepatology (AREA)
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- Physics & Mathematics (AREA)
- Optics & Photonics (AREA)
- Prostheses (AREA)
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Description
ステントグラフトは、管状の外科用グラフトカバー、および拡開式または自動拡開式のフレームからなる、留置型デバイスである。ステントグラフトは、例えば、血管の動脈瘤、破裂、または他の病変部を架橋し、これよって、血管の病変部から血流の血行力学的圧力を取り除くために、血管内に配置する。
図1,2および4に図示されているように、付属ステント32は、丸みを帯びている一方で比較的鋭く、そのため、血管を突き破る確率を増やしてしまう。
ハートリー特許の図1および2は、グラフト基端部(近位端)4から近位に伸長する、基端側(近位)頂点および末端側(遠位)頂点が両方とも尖端部に向かい細くなるような、基端側(近位)の第1ステント1を開示している。
本発明は、本明細書において前述した公知のデバイス、およびこの一般型の方法の欠点を解消するような、ステントグラフト、ステントグラフトデリバリー(送入)システムおよびキット、およびステントグラフトを留置する方法を提供し、そして、大動脈の自然な走行または病的な走行の中へより効率的に留置され、適合し、血管突き破る危険性を減らし、そして血液と密着した血管との連結を増し、血管の部位の内腔壁を保持し、より移動しにくくし、ステントグラフトを湾曲した血管へデリバリー(送入)する一方で、デリバリー(送入)の間にかかる内腔の力を最小限に抑え、ユーザーがステントグラフトを湾曲した血管へデリバリー(送入)するために必要な力を最小限に抑えるような、血管修復デバイスを提供する。
本明細書は、新規性があると考えられる本発明の特徴は特許請求の範囲で定義するが、以下同一部分には同一符号を付して示す図面につき本発明の好適な実施例を説明することによって、本発明をよりよく理解できるであろう。
本発明によるステントグラフトは、これまで当該技術では見られなかった様々な特徴を提供し、このことにより、大動脈の正常な経路または疾患経路内により効率的に留置/適合し、血管を突き破る危険性を減らし、そして血液漏れのない血管結合を増し、そしてグラフトが移動する確率を減らすような血管修復デバイスを提供する。
上述したように、従来技術は、補綴物をルーメン(管腔)内送入する、とくに、ステントグラフトを血管内に送入する多くの異なったシステムがある。送入システムの多くは類似した部分を有し、典型的には、ほとんどは、送入システムを使用する前に患者の鼠径部の近くの大腿動脈に差し込み体を介して挿入したガイドワイヤに沿っ案内する。大動脈および大動脈につながる動脈の突き破りを防ぐために、送入システムはガイドワイヤと同軸状に連結し、大動脈に至るガイドワイヤの経路をたどる。したがって、ワイヤの経路をたどる送入システムの部品は患者の大腿動脈の内径よりも小さな外径を有する寸法にする。ガイドワイヤの経路をたどる送入システムの構成要素にはステントグラフトが含まれ、カテーテルおよびシースと称される、一連の同軸のルーメン(内腔)でできている。典型的には、ステントグラフトは外部カテーテルによって拘束されており、ステントグラフトが圧縮されて外部カテーテル内部に装入することを必要とする。そうすることによって、ステントグラフトを非常に強固に拘束する送入システムの部分ができ、その結果、この部位の柔軟性を減らし、特に大動脈弓のような湾曲したの血管に沿って送入システムがガイドワイヤの後をたどることを困難にする。加えて、ステントグラフトは、カテーテル内部に装入するために圧縮しなければならない量に起因して、拘束しているカテーテルに対して非常に大きな半径方向の力をかけるため、拘束しているカテーテルをステントグラフトからスライドさせて外すことによってステントグラフトを展開させる作業工程は、典型的には展開力と称される、非常に大きな力を必要とする。また、カテーテルはグラフトを拘束するために十分に強くなくてはならず、硬い材料で作られることを必要とする。この硬い材料が、例えば大動脈弓へと進むときに屈曲する場合、この硬い材料はねじれやすくなり、ねじれると、不可能ではないにしても、ステントグラフトを展開するのが難しくなる。
Claims (47)
- 血管修復デバイスであって、
管状グラフト本体と、
前記グラフト本体に連結した少なくとも2個のステントを有する構造フレームワークと、および、
前記グラフト本体に連結し、中心線を有する湾曲形状の長手方向支持部材であって、前記中心線に関してほぼ逆鏡像対称形をなすよう湾曲した、該長手方向支持部材と
を備え、
前記湾曲した長手方向支持部材を、前記構造フレームワークとは独立して前記グラフト本体に連結したことを特徴とする血管修復デバイス。 - 前記湾曲した長手方向支持部材を、ニチノール、ステンレス鋼、生体高分子、コバルト‐クロムおよびチタン合金よりなるグループから選択した材料により形成した請求項1に記載の血管修復デバイス。
- 前記湾曲した長手方向支持部材を平坦なS字形の形状とした請求項1に記載の血管修復デバイス。
- 前記湾曲した長手方向支持部材を部分的にらせん形の形状とした請求項1に記載の血管修復デバイス。
- 前記湾曲した長手方向支持部材を、端部が漸近線に収斂するよう湾曲させた請求項1に記載の血管修復デバイス。
- 前記湾曲した長手方向支持部材を、前記構造フレームワークの前記ステントのうち1個に連結した請求項1に記載の血管修復デバイス。
- 前記湾曲した長手方向支持部材を、前記1個のステントに連結した端部を有するものとした請求項6に記載の血管修復デバイス。
- 前記湾曲した長手方向支持部材は2個の端部を有し、端部を前記構造フレームワークの前記ステントのうち1方にそれぞれ連結するものとした請求項6に記載の血管修復デバイス。
- 前記湾曲した長手方向支持部材を、前記湾曲した形状に予め形成した請求項1に記載の血管修復デバイス。
- 前記湾曲した長手方向支持部材は丸い端部を有するものとした請求項1に記載の血管修復デバイス。
- 前記湾曲した長手方向支持部材は、長手方向終端部で湾曲させてループ状にした端部を有するものとした請求項1に記載の血管修復デバイス。
- 前記湾曲した長手方向支持部材は2個のループ状の端部を有するものとし、各端部は長手方向終端部で湾曲させてループ状にした請求項1に記載の血管修復デバイス。
- 前記湾曲した長手方向支持部材は前 記構造フレームワークよりも短いものとした請求項1に記載の血管修復デバイス。
- 血管修復デバイスであって、
管状グラフト本体と、
前記管状グラフト本体に連結した少なくとも2個のステントを有する構造フレームワークと、および、
前記構造フレームワークとは独立して前記グラフト本体に連結し、また2個の端部を有し、前記端部の少なくとも一方は長手方向の先端が湾曲形状である湾曲した長手方向支持部材であって、また中心線を有して前記中心線に関してほぼ逆鏡像対称形をなすよう湾曲した、該長手方向支持部材と
を備えたことを特徴とする血管修復デバイス。 - 血管修復デバイスであって、
基端部および末端部を有する管状グラフト本体と、
少なくとも2個のステントを有する構造フレームワークであって、ステントは前記基端部および前記末端部に隣接した前記管状グラフト本体にそれぞれ連結しており、その間の分離距離を定めている、該構造フレームワークと、および、
前記分離距離よりも短く、前記少なくとも2個のステントの間で前記グラフト本体に連結して前記グラフト本体の基端部および末端部のうち少なくとも一方においてジンバルを構成する、湾曲した長手方向支持部材であって、また中心線を有して前記中心線に関してほぼ逆鏡像対称形をなすよう湾曲した、該長手方向支持部材と
を備えたことを特徴とする血管修復デバイス。 - 血管修復デバイスであって、
基端部および末端部を有する管状グラフト本体と、
少なくとも2組のステントを有する構造フレームワークであって、ステントは前記基端部および前記末端部に隣接した前記グラフト本体にそれぞれ連結しており、前記2組のステントの各々の前記ステントは前記グラフト本体において互いに分離して、各々の外側ステントおよび各々の内側ステントを定めている、該構造フレームワークと、および、
前記グラフト本体に連結し湾曲した長手方向支持部材であって、前記2組のステントのうちの第1ステントにおける少なくとも前記内側ステントと前記2組のステントのうちの第2ステントにおける少なくとも前記外側ステントとの間に延在し、また中心線を有して前記中心線に関してほぼ逆鏡像対称形をなすよう湾曲した、該長手方向支持部材と
を備えたことを特徴とする血管修復デバイス。 - 前記湾曲した長手方向支持部材が、前記2組のステントの前記内側ステントの双方の間で前記グラフト本体に連結する、請求項16に記載の血管修復デバイス。
- 前記湾曲した長手方向支持部材を、前記2組のステントの各々の前記内側ステントに各々連結する端部を有するものとした、請求項16に記載の血管修復デバイス。
- 請求項16に記載のデバイスであって、
前記湾曲した長手方向支持部材は端部を有し、
前記端部のうちの少なくとも1個は、前記2組のステントのうち一方の前記内側ステントに連結する、
血管修復デバイス。 - 血管修復デバイスであって、
基端部および末端部を有する管状グラフト本体と、
少なくとも2組のステント有する構造フレームワークであって、ステントは前記基端部および前記末端部に隣接した前記グラフト本体にそれぞれ連結し、前記2組のステントの各々の前記ステントは、前記グラフト本体においてお互いに分離しており、各々の外側ステントおよび各々の内側ステントを定めている該構造フレームワークと、および、
前記構造フレームワークとは独立しており、また2個の端部を有し、前記2組のステントの前記内側ステントの双方の間で前記グラフト本体に連結する、湾曲形状の長手方向支持部材であって、中心線を有して前記中心線に関してほぼ逆鏡像対称形をなすよう湾曲した、該長手方向支持部材と
を備えたことを特徴とする血管修復デバイス。 - 前記湾曲した長手方向支持部材を、前記内側ステントに接触することなく、前記グラフト本体に連結した、請求項20に記載の血管修復デバイス。
- 前記湾曲した長手方向支持部材を、前記内側ステントの少なくとも一方に接触するように前記グラフト本体に連結した、請求項20に記載の血管修復デバイス。
- 血管修復デバイスであって、
第1端部および第2端部を有する管状グラフト本体と、
少なくとも3つのステントを有する構造フレームワークであって、前記ステントのうち2個は前記第1端部に隣接した前記管状グラフト本体に連結し、前記2個のステントは、前記グラフト本体上でお互いに分離して外側ステントおよび内側ステントを定め、前記ステントの3番目は前記第2端部に隣接した前記管状グラフト本体に連結した、該構造フレームワークと、および、
2個の端部を有し、前記内側ステントおよび前記第3ステントの間で、前記内側ステントおよび前記第3ステントに接触することなく、前記グラフト本体に連結した、湾曲した長手方向支持部材であって、中心線を有して前記中心線に関してほぼ逆鏡像対称形をなすよう湾曲した、該長手方向支持部材と
を備えたことを特徴とする血管修復デバイス。 - 血管修復デバイスであって、
管状グラフト本体と、
少なくとも2個のステントを有する構造フレームワークと、
前記グラフト本体に連結し、中心線を有する湾曲形状の長手方向支持部材であって、前記中心線に関してほぼ逆鏡像対称形をなすよう湾曲した、該長手方向支持部材と、
前記第1ステントの全体にわたって、前記管状グラフト本体に連結した前記第1ステントと、
一定の曲率半径を有する基端側頂点、および前記一定の曲率半径よりも小さな曲率半径を有する末端側頂点を定めるような、周期的に変化する形状を有する、第2ステントであって、前記末端側頂点で前記管状本体に連結した、該第2ステントと
を備えたことを特徴とする血管修復デバイス。 - 前記第2ステントを、前記末端側頂点のみで前記管状本体に連結した、請求項24に記載の血管修復デバイス。
- 前記第1ステントを、ほぼ等しい曲率半径の基端側頂点および末端側頂点を交互に有するものとした、請求項24に記載の血管修復デバイス。
- 前記曲率半径を0.1mm〜3.0mmとした、請求項26に記載の血管修復デバイス。
- 前記曲率半径を0.5mmとした、請求項26に記載の血管修復デバイス。
- 請求項24に記載のデバイスであって、
前記グラフト本体は基端部を有し、
前記第2ステントは前記基端部に連結し、および、
前記基端側頂点は、前記基端部から突出する、
血管修復デバイス。 - 請求項29に記載のデバイスであって、
前記第1ステントは、ほぼ等しい曲率半径の基端側頂点および末端側頂点を交互に有し、
前記第2ステントの前記末端側頂点は、前記第1ステントの前記基端側頂点および末端側頂点の前記曲率半径にほぼ等しい曲率半径を有する、
血管修復デバイス。 - 前記第2ステントの前記基端側頂点は1.5mmにほぼ等しい曲率半径を有し、前記第2ステントの前記末端側頂点は0.5mmにほぼ等しい曲率半径を有する、請求項30に記載の血管修復デバイス。
- 請求項24に記載のデバイスであって、
前記第1ステントは一定の振幅を有し、
前記第2ステントは、前記一定の振幅よりも大きい振幅を有する、
血管修復デバイス。 - 血管修復デバイスであって、
管状グラフト本体と、
少なくとも2個のステントを有する構造フレームワークと、
前記グラフト本体に連結し、中心線を有する湾曲形状の長手方向支持部材であって、前記中心線に関してほぼ逆鏡像対称形をなすよう湾曲した、該長手方向支持部材と、
前記第1ステントであって、第1曲率半径を有する第1基端側頂点、および前記第1曲率半径にほぼ等しい曲率半径を有する第1末端側頂点を定めるような、周期的に変化する形状を有し、また前記第1ステントの全体にわたって前記管状グラフト本体に連結した、該第1ステントと、および、
前記第2ステントであって、前記第1曲率半径よりも大きな第2曲率半径を有する第2基端側頂点、および前記第1曲率半径とほぼ等しい曲率半径を有する第2末端側頂点を定めるような、周期的に変化する形状を有し、前記第2末端側頂点のみで前記管状本体に連結した、該第2ステントと、
を備えたことを特徴とする血管修復デバイス。 - 前記グラフト本体を、前記グラフト本体を配置する血管の直径と少なくとも同じ大きさの直径を有するものとした、請求項1に記載の血管修復デバイス。
- 請求項1に記載のデバイスであって、
前記少なくとも2個のステントは各々頂点を有し、
前記構造フレームワークは、最も末端側のステントを有し、および、
前記最も末端側のステントは、前記少なくとも2個のステントのもう一方よりも、少なくとも1個多くの頂点を有する、
血管修復デバイス。 - 前記グラフト本体を、前記グラフト本体を配置する血管の直径と少なくとも同じ大きさの直径を有するものとした、請求項14に記載の血管修復デバイス。
- 請求項14に記載のデバイスであって、
前記少なくとも2個のステントは、各々頂点を有し、
前記構造フレームワークは、最も末端側のステントを有し、および、
前記最も末端側のステントは、前記少なくとも2個のステントのもう一方よりも、少なくとも1個多くの頂点を有する、
血管修復デバイス。 - 前記第1ステントを、前記第2ステントよりも少なくとも1個多くの頂点を有するものとした、請求項33に記載の血管修復デバイス。
- 請求項1に記載のデバイスであって、
前記グラフト本体は、長手方向を定義するような長手方向の広がりを有し、前記ステントは、前記長手方向にほぼ直線的に延在する外側輪郭を有する、
血管修復デバイス。 - 前記ステントを、円形断面の形状を有するものとした、請求項39に記載の血管修復デバイス。
- 前記ステントを、非円形断面の形状を有するものとした、請求項39に記載の血管修復デバイス。
- 前記非円形断面の形状を、10面体形状から12面体形状よりなるグループから選択した、請求項41に記載の血管修復デバイス。
- 請求項1,14,15,16,20,23,24または33のうちいずれか一項に記載の血管修復デバイスにおいて、前記湾曲した長手方向支持部材の基端部分が前記管状グラフト本体の長手方向軸線に対して比較的平行であるが第1段階の角度をなし、前記湾曲した長手方向支持部材の末端部分が前記管状グラフト本体の長手方向軸線に対して比較的平行であるが、前記第1段階の角度とは異なる第2段階の角度をなすようにした、血管修復デバイス。
- 請求項43記載の血管修復デバイスにおいて、前記湾曲した長手方向支持部材の基端部分および末端部分は、それぞれ前記第1段階の角度および第2段階の角度に漸近するよう延在させた、血管修復デバイス。
- 請求項44記載の血管修復デバイスにおいて、前記管状グラフト本体は、20cmの長さを有し、前記第1段階および第2段階の角度は、互いに80゜〜110゜離れる、血管修復デバイス。
- 請求項45記載の血管修復デバイスにおいて、前記管状グラフト本体は、9cmの長さを有し、前記第1段階および第2段階の角度は、互いに30゜〜60゜離れる、血管修復デバイス。
- 請求項46記載の血管修復デバイスにおいて前記第1段階および第2段階の角度は、互いに45゜離れる、血管修復デバイス。
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