JP5699126B2 - 非縫合弁人工弁並びに送達用の器具及び方法 - Google Patents
非縫合弁人工弁並びに送達用の器具及び方法 Download PDFInfo
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- JP5699126B2 JP5699126B2 JP2012503532A JP2012503532A JP5699126B2 JP 5699126 B2 JP5699126 B2 JP 5699126B2 JP 2012503532 A JP2012503532 A JP 2012503532A JP 2012503532 A JP2012503532 A JP 2012503532A JP 5699126 B2 JP5699126 B2 JP 5699126B2
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- valve
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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
- 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
- A61F2220/0066—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements stapled
-
- 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
- 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
- A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial 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)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
Description
この出願は、2009年3月30日に提出した米国仮出願第61/211430号、2009年3月30日に提出した第61/211431号、2009年3月30日に提出した第61/211432号、2009年3月30日に提出した第61/211433号、2009年7月24日に提出した第61/228423号の優先権の利益を主張する。これらのすべては、言及することによって全体が本明細書に組み込まれている。
第1態様においては、初めに図1Aを参照しながら、人工弁2を提供する。人工弁2は、好ましい実施形態において人工心臓弁である。この人工弁は、鼓動心臓経心尖的処置又は逆行性経大動脈的処置等のように最小限に侵襲性のアプローチを使用して、生来の狭窄大動脈、肺動脈弁又は左房室弁等のような対象の疾病した生来の弁の中に配置されるように構成されている。そのような処置は当業者に広く知られている。
第3の態様において、人工弁を送達するための埋め込み器具を提供する。一般的な一実施形態において、その埋め込み器具は、上述されている人工弁2のような人工弁と、以下に記載されている送達器具とを備える。
第4の態様において、大腿動脈を経由して人工大動脈弁装置を送達するための埋め込み器具300を提供する。埋め込み器具300は、図1Bに示されているような人工弁を備えていてもよく、各弁捕握部はU形部材を備える。
第5態様においては、図15Aを参照しながら、動かせるように人工弁とコントロールユニット410を備える送達器具とに接続された少なくとも1つの捕握部425を有する人工弁サポートフレーム440と、圧縮状態の人工弁サポートフレーム440を囲む第1被覆体410と、圧縮状態の弁捕握部を囲む第2被覆体430と、第1被覆体コントロールスイッチ445に固定された第1被覆体コントロールケーブル411と、第2被覆体コントロールスイッチ435に固定された第2被覆体コントロールケーブル412と、を備える埋め込み器具400を提供する。弁捕握部を有する人工弁の実施形態は上述されている。この埋め込み器具を人工大動脈弁装置の大腿送達に使用する方法は、図15A−図15Cに示されており、以下により詳細に検討されている。
本明細書に開示されている埋め込み器具と共に使用され得るような人工弁サポートフレームの他の代替的一実施形態において、図16Aは、遠位部分101と近位部分103とを備え、遠位部分101が近位部分103から独立して展開することができる単一のサポートフレーム95を作るための別々のユニットとして製造可能である人工弁サポートフレームを表す(図16A参照)。あるいは、図16Bに示されているように、単一のサポートフレーム97は、遠位部分105が近位部分107から独立して展開することができるような態様で、単一のユニットとして製造される。従って、図16Cに示されているように、人工弁サポートフレームの全体を露出及び伸張する前に人工弁95の一部分だけを露出させるために、第1被覆体112を近位方向に移動させる。同様に、人工弁サポートフレームの全体を露出及び伸張する前に人工弁97の一部分だけを露出させるために、第1被覆体を近位方向に移動させることができる。
弁捕握部の他の一実施形態が図17A−Bに示されている。これらの実施形態においては、捕握部複合ユニット800を形成するために、複数の弁捕握部のそれぞれが別の弁捕握部に固定されている。捕握部複合ユニット800は複数の脚部をさらに備える。複数の弁捕握部を有する捕握部複合ユニットを形成するために、2個、3個、4個又はそれ以上の脚部材に接続された2個、3個、4個又はそれ以上のU形部材が存在してもよいことがわかる。一例として、図17Aに図示されているように、U形部材802a及び802bは、各々頂点806b及び806cを経て脚部810aにそれぞれ接続されている。同様に、U形部材802b及び802cは、頂点806d及び806eを経て脚部810bにそれぞれ接続されている。いくつかの実施形態においては、図17Aの825a、b、cに示されているように、各脚部810a、b、cの近位端が孔を有していてもよい。他の実施形態においては、各脚部の近位端を通る孔が存在しない。
図19−図22は、弁捕握部に埋め込み器具を可逆的に取り付けるための代替的実施形態を図示している。図19−20は、弁埋め込み器具に対して捕握部複合ユニットを可逆的に取り付ける手段を提供するために、ロックアンドリリース部の軸方向の長さに沿って動くフレキシブル引張部を使用することを示している。図19Aに示されているように、捕握部複合ユニットの脚部に弁埋め込み器具を接続する前に、フレキシブル引張部902は、ロックアンドリリース部904に沿って、かつ、該部材904を越えて延在している。フレキシブル引張部902及びロックアンドリリース部904は、中空のトラックワイヤ906の中に少なくとも部分的に入っている。この例において、前記引張部及び前記ロックアンドリリース部は、複合捕握部ユニットの脚部908の近位端に取り付けられている。図19Bは、ロックアンドリリース部904及び引張部902の近位端を示しており、これら2つの部材のそれぞれの独立したコントロールを可能にする任意の手段によって埋め込み器具コントロールユニットに対してこれらを取り付けることができる。
第6の態様において、埋め込み器具100のような埋め込み器具を使用して、本明細書に記載されている圧縮形態又はコンパクト状態の人工弁を心臓に送達する方法を提供する。
第7の態様においては、埋め込み器具100を使用して、下大静脈を経由した送達によって、圧縮形態又はコンパクト状態にある人工弁を心臓に送達する方法を提供する。一実施形態において、人工弁は人工左房室弁である。
第8の態様においては、上大静脈を通した経皮的送達によって、埋め込み器具100を使用して、圧縮形態又はコンパクト状態にある本明細書に記載されている人工弁を心臓に送達する方法を提供する。この方法を図27に示す。この態様において、人工弁は、人工肺動脈弁である。
第9の態様においては、埋め込み器具300を使用して、本明細書に記載されている圧縮形態又はコンパクト状態の人工弁を心臓に送達する方法を提供する。一実施形態において、人工弁は、大腿動脈によって送達された人工大動脈弁である。
第10の態様においては、埋め込み器具400を使用して、大腿動脈を経由して本明細書に記載されている人工弁を大動脈弁に送達する方法を提供する。埋め込み器具400は、人工弁の長手軸に沿って弁捕握部を動かせるような又は弁捕握部が人工弁のサポートフレーム470に固定されているような、弁捕握部425を有するものとして本明細書に記載されている人工弁を含む多様な人工弁を送達するために使用することができる。
図30A−図30Cは、生来の弁の中にサポートフレームを配置するときに、被覆体から人工弁サポートフレーム715を切り離す代替的方法を表している。図30Aに示されているように、弁捕握部700は、被覆体705から解放される。一実施形態において、弁捕握部は、リリースボタン720a、720bを遠位方向に押すことによって、被覆体705から遠位方向に押される。
第11の態様において、医療用人工器官を患者に送達するための器具を提供する。一実施形態において、医療用人工器官を患者に送達するための装置は、該装置の遠位端から該装置の近位端まで延在する管状ステアリングワイヤと、該装置の近位端にあるコントロールユニットと、開いた管腔を備え、かつ、コントロールユニットに対して遠位に配置された第1被覆体と、少なくとも1つのトラックワイヤとを備える。少なくとも1つのトラックワイヤは、非中空の又は中空のワイヤ又はケーブルであってもよい。
Claims (20)
- 圧縮状態と展開状態との間において放射状に伸張可能なサポートフレームであって、外側面を有し、かつ、流入・流出方向の軸の周囲に中央開口部を定義するサポートフレームと、
前記サポートフレームが展開状態にあるときに前記開口部の中に一方向弁を提供するために前記サポートフレームに取り付けられた複数のフレキシブル弁尖と、
前記サポートフレームの外側面との組込位置と係合位置との間において前記軸に沿って前記サポートフレームに対して相対的に動くことができるように、前記サポートフレームに対して可逆的に接続された少なくとも1つの弁捕握部とを備え、
前記少なくとも1つの弁捕握部が前記サポートフレームから物理的に分離されていることを特徴とする人工弁。 - 前記少なくとも1つの弁捕握部が、第1脚部、第2脚部及びU形部材からなることを特徴とする請求項1に記載の人工弁。
- 前記少なくとも1つの弁捕握部がU形部材からなることを特徴とする請求項1に記載の人工弁。
- 前記サポートフレームの長さがLであり、前記第1脚部及び前記第2脚部の長さが少なくともLであることを特徴とする請求項2に記載の人工弁。
- 前記少なくとも1つの弁捕握部が3つの弁捕握部からなることを特徴とする請求項1〜4のいずれか1項に記載の人工弁。
- 前記少なくとも1つの弁捕握部の自由端が戻り止めにおいて終端することを特徴とする請求項1〜5のいずれか1項に記載の人工弁。
- 前記サポートフレームが被覆材によって少なくとも部分的に覆われていることを特徴とする請求項1〜6のいずれか1項に記載の人工弁。
- 前記少なくとも1つの弁捕握部の少なくとも一部分が前記被覆材と前記サポートフレームとの間に配置されていることを特徴とする請求項7に記載の人工弁。
- 請求項1〜8のいずれか1項に記載の人工弁と、
コントロールユニットを備える送達器具と、
前記コントロールユニットに取り付けられた近位端、及び、前記少なくとも1つの弁捕握部との接触のための遠位端とを有する少なくとも1つのトラックワイヤと、
圧縮状態にある前記人工弁の少なくとも一部分を囲むための第1被覆体と、を備えることを特徴とする埋め込み器具。 - 第2被覆体をさらに備え、前記第2被覆体は、第1被覆体と連続的に配置され、前記連続的に配置される位置は、第1被覆体に対して近位にまたは遠位に配置される位置であることを特徴とする請求項9に記載の埋め込み器具。
- 前記第2被覆体が、前記第1被覆体と連続的に、かつ、前記第1被覆体から遠位方向に配置されていることを特徴とする請求項9又は10に記載の埋め込み器具。
- 前記第2被覆体は、前記コントロールユニットの中に配置された第2被覆体コントローラによって動かせるようになっており、
第2被覆体コントローラは、前記第2被覆体から前記第2被覆体コントローラまで延在する第2被覆体コントロールケーブルからなることを特徴とする請求項9〜11のいずれか1項に記載の埋め込み器具。 - 前記コントロールユニットに固定された近位端と、前記人工弁との接触のための遠位端とを有する人工弁プッシャワイヤをさらに備えることを特徴とする請求項9〜12のいずれか1項に記載の埋め込み器具。
- 前記少なくとも1つのトラックワイヤが中空のトラックワイヤであり、
ロックワイヤが前記中空のトラックワイヤの内部に配置されており、
前記ロックワイヤは、前記少なくとも1つの弁捕握部を前記少なくとも1つのトラックワイヤに分離できるように固定するためのロック部材を近位端に有していることを特徴とする請求項9〜13のいずれか1項に記載の埋め込み器具。 - 前記コントロールユニットがトラックワイヤコントローラを備えることを特徴とする請求項9〜11のいずれか1項に記載の埋め込み器具。
- 前記人工弁は、請求項1、2又は4〜8のいずれか1項に記載のものであり、
前記第1被覆体が前記サポートフレームを囲んでおり、前記第2被覆体が前記少なくとも1つの弁捕握部を囲んでいることを特徴とする請求項10〜15のいずれか1項に記載の埋め込み器具。 - 前記人工弁は、請求項3〜8又は10〜15のいずれか1項に記載のものであり、
前記第1被覆体が少なくとも1つの弁捕握部を囲んでおり、前記第2被覆体が前記サポートフレームを囲んでいることを特徴とする請求項10〜15のうちのいずれか1項に記載の埋め込み器具。 - 人工弁を患者の体内に埋め込むために用いられることを特徴とする請求項9〜17のいずれか1項に記載の埋め込み器具。
- 請求項16に記載の埋め込み器具であって、前記人工弁が肺動脈弁、大動脈弁又は左房室弁であることを特徴とする埋め込み器具。
- 請求項17に記載の埋め込み器具であって、前記人工弁が大動脈弁又は左房室弁であるであることを特徴とする埋め込み器具。
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