JP6525470B2 - 能動的に制御可能なステント、ステントグラフト、心臓弁、およびそれらを制御する方法 - Google Patents
能動的に制御可能なステント、ステントグラフト、心臓弁、およびそれらを制御する方法 Download PDFInfo
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- JP6525470B2 JP6525470B2 JP2016226773A JP2016226773A JP6525470B2 JP 6525470 B2 JP6525470 B2 JP 6525470B2 JP 2016226773 A JP2016226773 A JP 2016226773A JP 2016226773 A JP2016226773 A JP 2016226773A JP 6525470 B2 JP6525470 B2 JP 6525470B2
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- 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
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-
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- 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
- A61F2002/9534—Instruments specially adapted for placement or removal of stents or stent-grafts for repositioning of stents
-
- A—HUMAN NECESSITIES
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- 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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0008—Fixation appliances for connecting prostheses to the body
- A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
-
- A—HUMAN NECESSITIES
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- 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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
-
- A—HUMAN NECESSITIES
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- 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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0033—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
-
- A—HUMAN NECESSITIES
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- 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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0041—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using additional screws, bolts, dowels or rivets, e.g. connecting screws
-
- 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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0091—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
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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
- 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
- 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
- A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
- A61F2250/0006—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting angular orientation
-
- 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
- A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
- A61F2250/0007—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting length
-
- 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
- A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
- A61F2250/001—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting a diameter
-
- 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
- A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
Landscapes
- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Transplantation (AREA)
- Veterinary Medicine (AREA)
- Mechanical Engineering (AREA)
- Gastroenterology & Hepatology (AREA)
- Pulmonology (AREA)
- Prostheses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Surgical Instruments (AREA)
Description
。CAT走査による測定値に基づいたそのような事前のサイズ決定は、重大な問題である。これは、しばしば、誤ってサイズ決定されたグラフトにつながる。そのような状況では、より多くのグラフトセグメントを配置することが必要とされ、緊急の観血手術を必要とする可能性があり、また、不安定な封止および/または移動につながる可能性がある。現在、展開後に十分に再位置付けすることができる、いかなる体内グラフトも存在しない。
配置を可能にするようにサイズ決定および構成され、また、例えば大動脈弁輪、上行大動脈、大動脈弓、および胸部大動脈もしくは腹部大動脈の中への前進を可能にするのに適切な長さである。シースの動きは、手動作動および/または自動作動によって、新規な様式で提供される。
を提供するように配置され、次いで、従来の体内グラフトを含む、他の体内グラフトのためのレシピエント血管として機能する。
表現は、限定することを意図するものではなく、むしろ、理解できる本発明の説明を提供することを意図する。本仕様書は、新規であるとみなされる本発明の特徴を定義する特許請求の範囲で結論されるが、本発明は、同じ参照番号が持ち越される添付図面と併せて以下の説明を考慮することによってより良好に理解されるものと考えられる。
例えば、本願発明は以下の項目を提供する。
(項目1)
外科用移植片であって、
所与の形状に設定される形状記憶材料の自己拡張型ステントであって、壁厚を伴う壁を有する、自己拡張型ステントと、
前記自己拡張型ステントの選択的に調整可能なアセンブリであって、調整可能な要素を有し、前記自己拡張型ステントの少なくとも一部分において構成の変化を強制するように操作可能であり、前記調整可能な要素は、前記自己拡張型ステントの前記壁厚内に少なくとも部分的に位置する、選択的に調整可能なアセンブリと、を備える、外科用移植片。
(項目2)
前記調整可能な要素は、実質的に前記自己拡張型ステントの前記壁厚内に位置する、請求項1に記載の外科用移植片。
(項目3)
前記調整可能な要素は、前記壁厚内に位置する、項目1に記載の外科用移植片。
(項目4)
前記ステントは、外面および内面を有し、
前記ステントの前記外面および前記ステントの前記内面は、前記壁厚を画定し、
前記調整可能な要素は、前記外面と内面との間に位置する、項目1に記載の外科用移
植片。
(項目5)
前記壁厚は、半径方向範囲を有し、
前記調整可能な要素は、前記壁厚の前記半径方向範囲を縦方向に通過する、項目1に
記載の外科用移植片。
(項目6)
前記調整可能な要素は、前記自己拡張型ステントの前記壁厚内に完全に位置する、請求項1に記載の外科用移植片。
(項目7)
前記選択的に調整可能なアセンブリは、前記自己拡張型ステントに取り付けられる、請求項1に記載の外科用移植片。
(項目8)
前記調整可能な要素は、前記自己拡張型ステントの少なくとも前記一部分で、直径、円周、および周辺の変化のうちの少なくとも1つを強制するように操作可能である、項目
1に記載の外科用移植片。
(項目9)
前記調整可能な要素は、前記自己拡張型ステントにおいて構成の変化を強制するように操作可能である、項目1に記載の外科用移植片。
(項目10)
前記自己拡張型ステントは、実質的に円筒として形成され、前記構成の変化は、前記円筒の直径、円周、および周辺のうちの少なくとも1つの拡張である、項目1に記載の外
科用移植片。
(項目11)
外科用移植片であって、
所与の形状に設定される形状記憶材料の自己拡張型ステントであって、壁厚および縦方向範囲を有する壁を有し、前記壁は、前記縦方向範囲に沿って、前記壁厚内で少なくとも1つの駆動ねじ管腔を画定する、自己拡張型ステントと、
前記自己拡張型ステントの選択的に調整可能なアセンブリであって、少なくとも1つの
駆動ねじを備える調整可能な要素を有し、前記自己拡張型ステントの少なくとも一部分において構成の変化を強制するように操作可能であり、前記調整可能な要素は、前記自己拡張型ステントの、前記調整可能な要素の、前記壁厚内で少なくとも部分的に位置する、前記少なくとも1つの駆動ねじ管腔は、前記少なくとも1つの駆動ねじをその中で受容するように成形され、前記少なくとも1つの駆動ねじは、前記少なくとも1つの駆動ねじ管腔内で回転可能に移動可能である、選択的に調整可能なアセンブリと、を備える、外科用移植片。
(項目12)
前記少なくとも1つの駆動ねじは、近位端部および縦軸を有し、
前記調整可能な要素は、前記近位端部に固定され、前記縦軸に沿ってそこから離れて延在する、少なくとも1つの駆動ねじカプラを備える、項目11に記載の外科用移植片。
(項目13)
前記少なくとも1つの駆動ねじカプラは、前記少なくとも1つの駆動ねじを回転させるためのツールを係合するように成形される、カップルを有する、項目11に記載の外科
用移植片。
(項目14)
前記少なくとも1つの駆動ねじ管腔は、実質的に前記自己拡張型ステントの前記壁厚内に位置する、項目11に記載の外科用移植片。
(項目15)
前記少なくとも1つの駆動ねじ管腔は、前記壁厚内に位置する、項目11に記載の外
科用移植片。
(項目16)
前記ステントは、外面および内面を有し、
前記ステントの前記外面および前記ステントの前記内面は、前記壁厚を画定し、
前記少なくとも1つの駆動ねじ管腔は、前記外面と内面との間に位置する、項目11
に記載の外科用移植片。
(項目17)
前記壁厚は、半径方向範囲を有し、
前記調整可能な要素は、前記壁厚の前記半径方向範囲を縦方向に通過する、項目11
に記載の外科用移植片。
(項目18)
前記少なくとも1つの駆動ねじ管腔は、前記自己拡張型ステントの前記壁厚内に完全に位置する、項目11に記載の外科用移植片。
(項目19)
前記少なくとも1つの駆動ねじ管腔は、雌ねじを有する部分を有し、
前記少なくとも1つの駆動ねじは、前記雌ねじに対応する雄ねじを有する、項目11
に記載の外科用移植片。
(項目20)
前記少なくとも1つの駆動ねじ管腔は、遠位管腔部分および近位管腔部分を含む、軸方向に位置合わせされ、縦方向に分離した1対の管腔部分であり、
前記少なくとも1つの駆動ねじは、前記2つの部分を、
互いに向かって、および
互いから離れて、のうちの少なくとも1つで移動させるように操作可能である、項目
11に記載の外科用移植片。
(項目21)
前記壁厚は、複数の前記駆動管腔を画定し、それぞれが、前記遠位管腔部分および前記近位管腔部分を含む、前記軸方向に位置合わせされ、縦方向に分離した1対の管腔部分を有し、
前記調整可能な要素は、前記複数の前記駆動ねじ管腔の中で回転可能に移動可能である複数の駆動ねじを備える、項目20に記載の外科用移植片。
(項目22)
前記少なくとも1つの駆動ねじは、トルクが前記少なくとも1つの駆動ねじに与えられるまで、前記少なくとも1つの駆動ねじを摩擦によって回転可能で静止状態に保持する、雄ねじを有する、項目11に記載の外科用移植片。
(項目23)
前記自己拡張型ステントの少なくとも前記一部分において構成の変化を強制した後に、前記調整可能な要素は、前記構成の変化を保持する、項目1に記載の外科用移植片。
(項目24)
前記自己拡張型ステントの少なくとも前記一部分において構成の変化を強制した後に、前記調整可能な要素は、前記構成の変化を保持する、項目11に記載の外科用移植片。
(項目25)
前記調整可能な要素は、前記自己拡張型ステントの少なくとも前記一部分で、直径、円周、および周辺の変化のうちの少なくとも1つを強制するように操作可能である、項目
11に記載の外科用移植片。
(項目26)
前記形状記憶材料は、前記所与の形状に熱設定され、
圧縮され、解放された後に、自己拡張して前記所与の形状に戻るように操作可能である、および
拡張され、解放された後に、自己収縮して前記所与の形状に戻るように操作可能である、のうちの少なくとも1つである、項目1に記載の外科用移植片。
側ストラット112に接続される。より具体的には、内側ストラット114および外側ストラット112の各対は、各ストラット114、112の中心点で枢動可能に接続される。ある対の各内側ストラット114の端部は、隣接する外側ストラット112の端部に枢動可能に接続され、ある対の各外側ストラット112は、隣接する内側ストラット114の端部に枢動可能に接続される。図1〜図19のそれぞれで示される、複数のストラット対114、112が接続されて円を形成するような構成において、格子110を半径方向外向きに拡張させる傾向がある力は、各枢動点でストラット114、112を枢動させ、格子110全体を、閉じた状態(例えば、図3を参照されたい)から、任意の数の開いた状態(図4〜図13を参照されたい)まで均等かつ滑らかに拡張させる。同様に、ステント格子110が開いた状態であるとき、ステント格子110を半径方向内向きに収縮させる傾向がある力は、各枢動点でストラット114、112を枢動させ、ステント格子110全体を、閉じた状態に向かって均等かつ滑らかに収縮させる。したがって、この例示的な構成は、ステント格子110の円周の周りに、繰り返し組の1つの中間枢動点および2つの外側枢動点を画定する。単一の中間枢動点210は、図1〜図19で示される例示的な実施形態において、各ストラット112、114の中心点に位置する。単一の中間枢動点210の両側は、上下に対向する1対の外側枢動点220である。
ト格子110の少なくとも1組の上下に対向する上部および下部枢動点220への取り付けに基づく。図1〜図19で示される例示的な接続部716、726および枢動点210、220によって、一方の近位駆動ブロック720および遠位駆動ブロック710のもう一方に対する縦方向の上下運動は、本明細書で説明されるようにステント格子110を拡張または収縮させる。図20は、ステント格子110がその拡張した状態(例えば、図9)および収縮した状態(例えば、図2)との間で移動するにつれて、各中間枢動点210が横移動する半径方向の進行経路を、中実円筒2000で示す。進行経路が直線状であるので、ステント格子110は、その円周の全体にわたってスムースかつ均等に拡張および収縮する。
およびそれらが起こった後に、近位駆動ブロック720および接続解除器駆動ブロック730を互いに縦方向に接地させた状態に保つ。駆動ねじ740の回転は、遠位駆動ブロック710を近位駆動ブロック720に向かって移動させ、それによって、所望の移植直径までステント格子110を拡張させる。この運動は、図22と図23との間の移行で示される。この時点で、ステント格子110が移植部位内に適切に移植され、現在、ニードル2200を展開するときである。展開は、図24で示されるように、ニードルプッシャ2180を前進させることから始まる。ニードルプッシャ2810は、それ自体を、ニードル2200を前進および後退させるための制御ワイヤとすることができる。あるいは、および/または加えて、ニードル制御ワイヤ2182は、ニードルプッシャ2180が機能するための十分な支持を提供するために、ニードルプッシャ2180に取り付けるか、またはそれを囲うことができる。ニードルプッシャ2180の継続的な遠位運動は、ニードル2200を遠位上面612から外へ延長させ、形状記憶したニードル2200の予め設定された湾曲により、ニードル先端部は、外向きに移植部位の組織の中へ湾曲する。この湾曲は、図25の面から外に突出するので、該湾曲は、図25では示されない。
014には、駆動ねじ740の雄ねじに対応する雌ねじが構成され、駆動ねじ管腔3014の縦方向の上下長さは、ステント格子110の任意の拡張状態または収縮状態で、駆動ねじ740を、遠位駆動ブロック3010の遠位上面3011から外に突出させないように選択される。最後に、遠位駆動ブロック3010は、ニードルアセンブリ管腔を画定し、該ニードルアセンブリ管腔は、比較的より幅の広い近位ニードル管腔3016と、比較的より幅の狭い遠位ニードル管腔3018とで構成され、これらはどちらも下でさらに詳細に説明される。
に延在する半円形のボスである。近位駆動ねじカプラ部3054は、駆動ねじ740に向かって遠位方向に延在する、対応する半円形のボスを有する。これらは、具体的には、図37の拡大図で分かる。したがって、2つの半円形のボスが相互接続することを可能にするときに、近位駆動ねじカプラ部3054の任意の回転は、遠位駆動ねじカプラ部3052の対応する回転を生じさせる。接続解除器駆動ブロック3030は、その中で遠位駆動ねじカプラ部3052を保持するように成形される、ねじカプラ孔3031を有する。近位駆動ブロック3020でのように、ねじカプラ孔3031は、近位駆動ねじカプラ部3054を取り囲み、近位駆動ねじカプラ部3054が、実質的に摩擦を伴わずに、その中で自由に回転することを可能にするように成形される。ねじカプラ孔3031の近位部分は、図30〜図37で示されるように、近位駆動ねじカプラ部3054が駆動ワイヤ750に直接、または例えば中空のカプラを通して固定して接続された後に、その離脱を防止するために、より小さい直径にネッキングされる。
れている。上で説明されるように、支持ロッド管腔3012は、支持ロッド3080が、その中で上下に縦方向に摺動することを可能にするために、滑らかな円形断面の孔である。同様に、駆動ねじ管腔3014の遠位部分も、駆動ねじ740が回転され、そのねじ山が駆動ねじ管腔3014の近位ねじ付き部分に係合したときに、該駆動ねじが、その中で上下に縦方向に移動することを可能にするために、滑らかな円形断面の孔である。近位ニードル管腔3016は、対照的に、円筒形状のニードル3070、および側部同士が接続された円筒形状のニードル支持体3092に適応するために、非円形(例えば、長円形)である。図36の図で示されるように、少なくとも、ニードル支持体3092に対するニードル3070の接触部分は、コネクタスリーブ3071で覆われ、該コネクタスリーブは、ニードル3070に、また同時に、ニードル支持体3092に固定して接続されることを可能にする材料特性を有する。
る。第1の例示的な実施形態において、ステント格子は、ステントグラフト3800の近位ステント3810である。近位ステント3810は、グラフト3820に接続され、該グラフトによってその外周面が覆われる。図39の部分的な拡張状態の、および図40および図41の他の拡張状態の近位ステント3810によって、外側ストラット3812が、少なくとも1つの貫通孔3814、具体的には、外側ストラット3812を通って半径方向に延在する、一方の端部からもう一方の端部まで、一連の貫通孔を有することが分かる。これらの貫通孔は、グラフト3820を、外側ストラット3812に縫い付けることを可能にする。
、枢動軸を形成するストラットの特徴であり、リベット5110の特徴ではない。
ロック6432および近位駆動ブロック6434に自由に回転可能に接続され、よって、一方の方向に回転させると、遠位駆動ブロック6432および近位駆動ブロック6434が互いから離れて移動し、もう一方の方向に回転させると、遠位駆動ブロック6432および近位駆動ブロック6434が互いに向かって移動する。そのような構成において、前者の運動は、格子アセンブリ6410を半径方向に収縮させ、後者の運動は、格子アセンブリ6410を拡張させる。図64および図65で示される格子アセンブリ6410は、その拡張状態、すなわち移植する準備ができた状態であり、よって、移植部位の自然な幾何学形状に適応する。少なくとも3つのジャッキアセンブリ6430には、遠位駆動ブロック6432および近位駆動ブロック6434の1つまたは双方の内側で、3葉弁アセンブリ6440(例えば、大動脈弁アセンブリ)の例示的な実施形態が接続される。弁アセンブリ6440は、任意の所望の材料で作製することができ、例示的な構成では、ウシの心膜組織またはラテックスで作製される。
mm〜8mmの間、具体的には6mmの装填直径まで低減させることができる。大動脈弁アセンブリ6440が移植部位に到達すると、外科医は、送達システムの大動脈弁アセンブリ6440を均一かつ自動的に拡張させる。この移植位置の中への拡張は、ゆっくりで均一であるので、移植片部位での石灰化に優しい。同様に、送達システムが格子アセンブリ6410を拡張させる方法に起因するだけでなく、ストラット6412のそれぞれのヒンジ付き接続部が、各枢動ストラット6412に隣接する対応する組織壁に依存した移植の後に、格子アセンブリ6410が自然に屈曲し、撓曲することを可能にするので、均一な拡張は、移植部位の本来の非円形の周辺部を想定することを可能にする(本明細書で開示される代替のヒンジなしの実施形態によって、移植壁の自然な形状を想定することも起こる)。これらの事実のため、移植片のより良好な着座が起こり、明らかに、より良好な弁周囲の封止につながる。本発明の送達システムは、従来技術に存在する全体的な調整および取り付けの代わりに、人工器官を正確にサイズ決定する。従来技術の別の極めて不利な点は、弁を拡張させるためにバルーンが弁の中央開口内で使用され、したがって、大動脈を完全に閉塞し、心臓への相当な背圧を生じさせ、患者に危険であり得ることである。対照的に、本明細書で説明される弁は、展開中に開いた状態を維持し、それによって、初期展開中の連続的な血液の流れ、およびその後の手技中の再位置付けを可能にし、また、移植片が移植部位に完全に着座していないときであっても、弁として作用するプロセスを開始することを可能にする。
83で示される。例示的な実施形態は、大動脈弁について示されるが、本発明は、それに限定されない。この実施形態は、例えば、弁小葉に対する適切な変化によって、肺動脈弁、僧帽弁、および三尖弁にも同様に適用することができる。図71〜図75の種々の図で示される置換用心臓弁アセンブリ7100は、ステント格子7110と、グラフトエンクロージャ7120と、ジャッキアセンブリ3000と、グラフト材料7130と、弁小葉7140と、交連板7150とで構成される。置換用心臓弁アセンブリ7100の操作および構造は、その中のグラフト材料7130および/または弁小葉7140を取り外した種々の図によって、図76〜図83を参照して説明される。図75および図76において、置換用心臓弁アセンブリ7100は、拡張状態であり(本明細書で使用されるとき、「拡張状態」は、示される状態が、人工器官の最大拡張状態であることを意味せず、人工器官が、何らかの解剖学的部位に対してサイズ決定するのに十分に拡張されることを意味する)、よって、移植部位の自然な幾何学形状に適応する。グラフト材料を取り外すことによって(図76を参照されたい)、3つの弁小葉7140の周囲の構造が容易に観察される。近位駆動ブロック3020および遠位駆動ブロック3010は、内部構成、ならびにその中に配置される支持ロッド3080、駆動ねじ740、および遠位駆動ねじカプラ部3052を有する。
テント格子7110によって与えられる外向きの外力を補う。より具体的には、グラフトエンクロージャ7120は、ステント格子7110の外側ストラット7112の例示的な実施形態のように直線状ではない。その代わりに、グラフトエンクロージャには中央オフセット7622が形成され、該中心オフセットは、任意の形態をとることができ、これらの例示的な実施形態では、波形である。この中央オフセット7622は、最初に、グラフトエンクロージャ7120が、組織アンカー7114を妨害しないことを可能にする。中央オフセット7622はまた、例えば、図76および図77の右部ならびに、特に、図82および図83の図に見られるように、グラフトエンクロージャ7120の中央部をステント格子7110から離して持ち上げる。中央オフセット7622の半径方向外向きの突出部は、隣接する移植部位の組織の中へ挿入し、および/または突き刺し、それによって、置換用心臓弁アセンブリ7100の任意の移動または塞栓を阻止する。中央オフセット7622を適切に成形することによって、棚7624が形成され、該棚は、置換用心臓弁アセンブリ7100内の血液の流れに対して垂直な線と交差する、直線縁部を提供する。図76、図77、および図79〜図81に示される中央オフセット7622の例示的な実施形態において、棚7624は下流側に対面しており、したがって、収縮期圧を受けたときに、置換用心臓弁アセンブリ7100が下流方向に移動するのを実質的に阻止する。あるいは、中央オフセット7622は、上流側に対面している棚7624によって成形することができ、したがって、拡張期圧を受けたときに、置換用心臓弁アセンブリ7100が上流方向に移動するのを実質的に阻止する。グラフト材料は、末端の移植可能な直径の所望の範囲の全体にわたって、例えば密接に格子に取り付けることができる必要がある。これを達成するために、グラフト材料は、格子と同じような様式で移動する材料の構造で作製される。すなわち、その直径が増加するにつれて、その長さは減少する。この種の運動は、糸の編組によって、または最小スケールの繊維が編組と同様に配向されるグラフト材料の製作を通して達成することができ、該繊維が、格子に類似するハサミ作用を受けることを可能にする。材料の1つの例示的な実施形態は、ポリエステル糸によって作製される高エンド数の編組である(例えば、40〜120デニールの糸を使用した288エンド)。この編組は、次いで、全ての糸をともに接合することによって、安定性を生じさせ、浸透性を低減させるために、ポリウレタン、シリコーン、または類似する材料で被覆することができる。同様に、直径が約2〜10ミクロンの撚糸を形成する類似するポリマーで、紡糸繊維の管を作製することができる。これらの発明的なグラフト製作方法は、厚さが約0.005インチ〜0.0015インチ(0.127mm〜0.381mm)であり、また、必要な全ての物理的特性を有する材料を提供する。患者へのより簡単な導入のための圧縮直径を低減させるために、薄い材料が望ましい。この材料はまた、格子が広範囲の可能な末端直径にわたって封止することを必要とされる、ステントグラフト人工器官においても重要である。調整可能な材料は、上流側カフの最終的な末端直径からグラフトの本体への遷移を行うことができる。
れている3つの小葉7140を図示する(材料は、代替として、1つまたは複数の交連板の周囲で挟持することができる)。弁小葉7140の上流側端部は、置換用心臓弁アセンブリ7100が機能するように固着されなければならない。したがって、例示的な実施形態において、グラフト材料7130の上流側端部は、図78で示されるように、弁小葉7140の上流側側部で、置換用心臓弁アセンブリ7100の周囲に巻き付けられ、それに固定して接続される。そのような構成において、弁小葉7140の上流側縁部は、ステント格子7110の円周の周囲で、グラフト材料7130に完全に固着される。縫い目は、グラフトの2つの層および小葉材料の上流側縁部を貫通して、縁縫いした縁部を形成することができる。
同じであり得るか、または支持バンド8410の遠位端部8614と同じであり得る。支持バンドを外側に予め付勢することによって、該支持バンドは、制御ワイヤを偏向させるのに必要とされる力を低減させる、または取り除くことを補助することができる。大動脈弁としての置換用心臓弁アセンブリ7100の実施形態は、図88で、患者の心臓の罹患した弁小葉内に移植されて示される。この図面から分かるように、自然の弁は、置換用心臓弁アセンブリ7100の中央線で、ある空間を占める。したがって、置換用心臓弁アセンブリ7100のステント格子は、ウエストライン、すなわちより狭い中央線を有するように、樽形状の代わりに砂時計形状にすることができる。そのような構成において、置換用心臓弁アセンブリ7100は、適所で自然に位置付けられ、保持される。
るジャッキアセンブリ700、2100、3000、6430を有する、ステントグラフトである。2つの追加的なジャッキアセンブリ700、2100、3000、6430の代わりに、この実施形態は、2つの対向する枢動接続解除器駆動ブロック9430を含む。これらの接続解除器駆動ブロック9430は、例えば図96の図で円周方向に90度回転させて示されるように、半径方向外向きに延在し、2つの交差するストラット9410のための中央枢動接合部を形成する、ボス9432を有する。2つの接続解除器駆動ブロック9430は、枢軸として作用して、人工器官9400が、2つの対向する組の制御ワイヤ750、770が対向する遠位方向および近位方向に移動するときに、斜板の様式で傾斜することを可能にする。図94は、近位に移動した近方の1組の制御ワイヤ750、770、および遠位に移動した遠方の組を示す。図95において、図96および図97の人工器官9400のように、人工器官9400の斜板は、傾斜しておらず、その後者は、単に、前者との比較として90度回転させたものに過ぎない。図98および図99は、管状グラフト9820の近位端部の内側にステント格子9810を有するステントグラフトの一部として、人工器官9400を表す。
合するようにサイズ決定され、該電力接点は、モータの全てを含む制御ハンドル10800上の全ての電子機器に電力を供給するために、少なくとも回路基板10812に電気的に接続される。ニードル運動サブアセンブリ11300は、送達シース11040が蛇行した解剖学的組織を通って屈曲させられ、異なる屈曲がニードルのそれぞれに与えられているときであっても、ニードルの展開を制御し、ニードル上の張力を継続的に均一に保つ。ニードルは、この例示的な実施形態において、合計3つである。最後に、ジャッキエンジン11600は、ジャッキアセンブリに関する全ての運動を制御する。
、これらの運動を補償するためにニードルロッド11302に縦方向に接続され、屈曲したニードル先端部3072を、遠位駆動ブロック3010のニードル先端溝3013内に保つ。
0のシースを外させる。ステップ11904で、蛍光透視法等の視覚化は、人工器官10730の遠位端部10732がどこに位置するのかを示すフィードバックをユーザに提供する。この位置において、ステント格子は、収縮状態である(図107の図では、拡張状態が示される)。人工器官10730上の放射線不透過性マーカーは、人工器官10730の最近位点を視覚的に確認することができる。ステップ11906で、別の手術スタッフは、一般的に、ペンまたはマーカーで、画面上の腎動脈の場所をマークしている(外科医がマーカーを見る)。ステップ11908で、外科医は、放射線不透過性マーカーを有する人工器官10730の格子を、腎動脈の下側の標的とされる場所に並進させる。ステップ11910で、医師は、右上のボタンを前方に押す(すなわち、前方=開く、および後方=閉じる)ことによって格子を拡張させ始める。外科医の要求に従って、または制御デバイス10700のプログラミングの設定として、格子は、漸増的に開くことができ(血液の流れの発生のため、所望される)、または流体的に外向きに拡張させることができる。ステップ11912で、移植が行われ、移植は、3つの段階を有する。移植の第1の段階で、医師は、腹部大動脈に着設するまで、人工器官10730の近位端部の全体的な配向を行う。第2の段階で、医師は、3つ全ての次元で接合する前に、断続的な拡張を使用して、移植を微調整し、第3の段階で、移植片10730の近位端部は、十分に共適合されるか、または医師がその接合に満足しない場合、医師は、ステント格子の直径を低減させて、再度第2の段階から始める。制御デバイス10700は、右上のボタンの最初のタッチで、特定の開口直径まで進むようにプログラムすることができることに留意されたい。例えば、移植部位が20mmである場合は、制御デバイス10700が15mmまで直接拡張し、その後に、右上ボタンがどれだけ長い間前方に押されても、右上のボタンにタッチする度に、拡張の増加が1mmずつだけしか起こらないようにプログラムすることができる。ステップ11912中に、医師は、人工器官のリアルタイムの直径、その角度形成、着設点の予め定められた大動脈直径との比較、壁への近接度を評価する血管内超音波診断、およびいつ壁への接触が起こったのか等の、種々のフィードバックデバイスの全てを制御ハンドル上で見ることができる。本発明のデジタルディスプレイ10711で、医師は、上記の特徴の全てを示す、拡張格子の実際の描写を視認することもできる。種々の移植段階中に、医師は、移植片の位置を変えるために、任意のときに一時中断することができる。ステント格子の角度形成は、能動的に、または一時中断の間に行うことができる。外側グラフト材料が壁に接近するにつれて、全ての送達デバイスの調整を、人工器官10730の完全な接合まで継続し、ここで、適切な角度形成とともに、腎動脈に対する場所が良好であることを確実にする。ステントグラフトが大動脈壁に接触するときに、医師は、移植フィードバックデバイスの全てを分析して、移植を変更することができる。医師が移植を疑う場合はいつでも、第2の段階に戻るとともに、ステント格子の再調整を再開する。さらに、接合が生じると、任意の他の固定デバイス、例えば受動的なタイン/鉤、(例えば、グラフトを通して)保持デバイスを大動脈壁の中へ押す、外向きに移動する屈曲性バンド、組織アンカー7114、およびグラフトエンクロージャ7120を利用することができる。そのようなデバイスの場合、係合されたタインを係合解除/後退させるために、いかなる副アクションも必要とされない。ステップ11914で、医師は、血管造影を行って移植の位置付けを決定し(血管造影は、送達システム10700と別体、またはそれと一体とすることができる)、位置決めが所望された通りではなかった場合、医師は、ステント格子を後退させ、シース10720を使用して、格子の上に送達シース1020が戻るのを容易にするグラフト材料を使用したステント格子を再度折り畳むことができる。しかしながら、医師が、良好な位置決めであると判断した場合、医師は、少なくとも対側のゲートが露出するまで左上のボタンを後方に押すことによって、送達シース10720を後退させる。しかしながら、医師が、良好な位置決めであると判断した場合、医師は、少なくとも対側のゲートが露出するまで左上のボタンを後方に押すことによって、送達シース10720を後退させる。送達システム10700による同側のグラフト材料の安定化は、副人工器官のための対側のゲートのより良好なカニューレ挿入を可能にすることに留意されたい。
あるときに、ジャッキねじ12020は、遠位駆動ねじカプラ部12052が近位ジャッキストラット12014の近位端部に当たるまで、遠位ジャッキストラット12014の孔の中へ移動する。故に、ジャッキねじ12020がステント拡張方向に回転することによって、遠位駆動ねじカプラ部12052が近位ジャッキストラット12012の近位端部に当たった後に、さらなる駆動ねじ12020の格子拡張運動が、近位ジャッキストラット12014を遠位ジャッキストラット12013に向かって移動させ始め、ステントアセンブリ12000を拡張させる。
カプラ部12752、12754の近位部材は、格子接続解除管12630の中央孔の中へ部分的に後退される。
センブリ13500の格子を示す。
Claims (1)
- 外科用移植片であって、
移植片本体であって、該移植片本体は、形状記憶材料の部分片から一体的に形成されている複数の格子セグメントを含み、該複数の格子セグメントは、複数の第1のストラットと、複数の第2のストラットと、複数の横方向に延びているアームとを含み、該複数の第1のストラットおよび該複数の第2のストラットは、該複数の横方向に延びているアームによって接続されており、該複数の横方向に延びているアームは、互いに接続されていない、移植片本体と、
該移植片本体に取り付けられる選択的に調整可能なアセンブリと
を含み、該アセンブリは、調整可能な要素を有し、かつ、該移植片本体の一部分において構成の変化を生じさせ、それによって、解剖学的オリフィス内の該移植片本体の移植が、その中で封止を達成することを可能にするように操作可能である、外科用移植片。
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