JP2017060777A - 人工弁 - Google Patents
人工弁 Download PDFInfo
- Publication number
- JP2017060777A JP2017060777A JP2016196818A JP2016196818A JP2017060777A JP 2017060777 A JP2017060777 A JP 2017060777A JP 2016196818 A JP2016196818 A JP 2016196818A JP 2016196818 A JP2016196818 A JP 2016196818A JP 2017060777 A JP2017060777 A JP 2017060777A
- Authority
- JP
- Japan
- Prior art keywords
- stent
- prosthetic valve
- valve
- catheter
- implantation site
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
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Classifications
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- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
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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
- 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
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in adsorbability or resorbability, i.e. in adsorption or resorption time
-
- 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
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in 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
- A61F2250/0069—Sealing means
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- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
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- Oral & Maxillofacial Surgery (AREA)
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- Animal Behavior & Ethology (AREA)
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- Prostheses (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
Description
以下の開示は、本開示の第1の一般的実施形態に関するもので、この第1の一般的実施形態は、進歩性のある人工弁と、損傷し若しくは病変のある弁を置換する方法とに関する。
以下の説明は、本開示の第2の一般的実施形態に関するもので、この第1の一般的実施形態は、進歩性のある人工弁と、損傷し若しくは病変のある弁を置換する方法と、人工弁を送達するシステムと、キットと、人工弁を送達する方法とに関する。
例示的な送達および移植処置は、人工弁を送達する本開示のシステムと、本開示に係る人工弁とを使って次のように行われる。
本発明に係る人工弁は、in situで、いくつかの異なる力を弁輪とその周囲の組織に及ぼす。そのような力は、移植部位で係止されて適切に配置された状態で保たれる当該人工弁独自の能力に寄与する。例えば、前記上方および下方フランジは、それぞれへ向かって反り曲がり、フランジと前記中間領域との間に介在する組織は、そのフランジと中間領域との間に把持される。また、前記ステントも弁輪壁に対して径方向外向きの力を及ぼす。そのような力を個別に測定することは難しいが、移植された人工弁を抜去する上で必要な力は、前記ステントが及ぼす各力の総計の一部を表す。
Claims (24)
- 人工弁であって、
少なくとも部分的に自己拡張するステントであって、
外面および内面を画成するワイヤーフレームワークと、中間領域により介設された上方および下方係止フランジとを有し、
前記ステントは、未拡張状態および拡張済み状態を有し、
前記下方係止フランジは、前記上方係止フランジの対応する寸法より大きい、少なくとも1つの幾何学的寸法を有するものである
前記ステントと、
前記ステントの前記内面に固着された少なくとも1つの弁尖を有する弁と
を有する人工弁。 - 請求項1記載の人工弁において、さらに、
前記ステントの外周面の少なくとも一部に沿って設けられた吸収性材料を有するカフを有し、前記吸収性材料は、液体の吸収により膨張して当該人工弁を移植部位に実質的に接着し、前記接着は、当該人工弁の前記移植部位への配置を可能にするために十分な時間だけ遅延されるものである人工弁。 - 請求項1記載の人工弁において、前記上方係止フランジおよび前記下方係止フランジは、それぞれ複数の突出したステント要素を有するものである人工弁。
- 請求項3記載の人工弁において、前記上方フランジおよび前記下方フランジは、前記ステントが未拡張状態の場合それぞれ実質的に直線形状を呈し、当該ステントが拡張済み状態の場合それぞれ当該ステントの前記中間領域へ向かって実質的に反り曲がるものである人工弁。
- 請求項1記載の人工弁において、前記ワイヤーフレームワークはニチノールを有するものである人工弁。
- 請求項1記載の人工弁において、前記ワイヤーフレームワークは、0.005インチ〜0.030インチの太さを有するワイヤーを使って形成されるものである人工弁。
- 請求項1記載の人工弁において、前記ワイヤーフレームワークはワイヤー織りを有するものである人工弁。
- 請求項1記載の人工弁において、前記ワイヤーフレームワークは、2〜10ステップを使って形成されるワイヤー織りを有するものである人工弁。
- 請求項1記載の人工弁において、前記ステントは、当該ステントが拡張済み状態のとき、約25mm〜約50mmの直径を有するものである人工弁。
- 請求項1記載の人工弁において、当該弁は3つの弁尖を有するものである人工弁。
- 請求項1記載の人工弁において、当該人工弁は、経心房的に、経心尖的に、または経皮的に送達されるよう構成されるものである人工弁。
- 請求項1記載の人工弁において、当該人工弁は、僧帽弁を置換するように構成されるものである人工弁。
- 損傷し若しくは病変のある弁を対象体内で置換する方法であって、
前記対象の移植部位に人工弁を送達する工程であって、前記人工弁は、
少なくとも部分的に自己拡張するステントであって、
外面および内面を画成するワイヤーフレームワークと、中間領域により介設された上方および下方係止フランジとを有し、
前記ステントは、未拡張状態および拡張済み状態を有し、
前記上方係止フランジは、前記下方係止フランジの対応する寸法より大きい、少なくとも1つの幾何学的寸法を有するものである
前記ステントと、
前記ステントの前記内面に固着された少なくとも2つの弁尖を有する弁と
を有するものである、前記送達する工程と、
前記ステントを拡張して前記人工弁を前記移植部位に実質的に接着させる工程と
を有する方法。 - 請求項13記載の人工弁において、当該人工弁は、経心房的に、経心尖的に、または経皮的に前記移植部位に送達されるものである人工弁。
- 請求項13記載の方法において、さらに、
前記人工弁を前記移植部位に配置する工程を有するものである方法。 - 請求項15記載の方法において、さらに、
前記人工弁を前記移植部位に再配置する工程を有するものである方法。 - 請求項13記載の方法において、前記移植部位は僧帽弁輪である人工弁。
- 少なくとも部分的に自己拡張するステントを有する人工弁を移植部位に送達するシステムであって、
カテーテルであって、
遠端部および近端部と、
ガイドワイヤーに沿って前記カテーテルを平行移動させるガイドワイヤールーメンと、
前記カテーテルを操作する張力ケーブルを収容する操作用ルーメンと、
前記遠端部にあり、前記ステントを装填するドックと
を有するものである、前記カテーテルと、
前記ステントが前記ドックに装填されている間、当該ステントの少なくとも一部を圧縮する後退自在な圧縮スリーブと、
前記ドックの遠位に配置され、送達中に前記カテーテルを先導する先行端部と、
前記張力ケーブルと動作可能に連結され、少なくとも1つの方向平面内で前記先行端部の方向を変える操作機構と
を有するシステム。 - 請求項18記載のシステムにおいて、前記ドックは前記ステントを拡張させる膨張自在なバルーンを有するものであるシステム。
- 請求項18記載のシステムにおいて、前記カテーテルは、前記ステントが前記ドックに装填されている間、当該ステントの別の一部を圧縮する後退自在な圧縮スリーブを有するものであるシステム。
- 請求項18記載のシステムと少なくとも1つの人工弁とを有するキットであって、
少なくとも部分的に自己拡張するステントであって、
外面および内面を画成するワイヤーフレームワークと、中間領域により介設された上方および下方係止フランジとを有し、
前記ステントは、未拡張状態および拡張済み状態を有し、
前記上方係止フランジは、前記下方係止フランジの対応する寸法より大きい、少なくとも1つの幾何学的寸法を有するものである
前記ステントと、
前記ステントの前記内面に固着された少なくとも2つの弁尖を有する弁と
を有するキット。 - 請求項21記載のキットにおいて、このキットは、
複数の前記人工弁を有し、拡張済み状態の前記人工弁の少なくとも1つの直径は、拡張済み状態の前記人工弁の少なくとも他の1つの直径より大きいものであるキット。 - 少なくとも部分的に自己拡張するステントを有する人工弁を移植部位に送達する方法であって、
(i)システムを提供する工程であって、前記システムは、
カテーテルであって、
遠端部および近端部と、
ガイドワイヤーに沿って前記カテーテルを平行移動させるガイドワイヤールーメンと、
前記カテーテルを操作する張力ケーブルを収容する操作用ルーメンと、
前記遠端部にあり、前記ステントを装填するドックと
を有するものである、前記カテーテルと、
前記ステントが前記ドックに装填されている間、当該ステントの少なくとも一部を圧縮する後退自在な圧縮スリーブと、
前記ドックの遠位に配置され、送達中に前記カテーテルを先導する先行端部と、
張力ケーブルと動作可能に連結され、少なくとも1つの方向平面内で前記先行端部の方向を変える操作機構と
を有するものである、前記システムを提供する工程と、
(ii)前記人工弁を前記ドックに装填する工程と、
(iii)前記ガイドワイヤーを前記移植部位に送達する工程と、
(iv)前記カテーテルを前記ガイドワイヤー上で平行移動させ、前記装填された人工弁を前記移植部位に配置する工程と、
(v)前記後退自在な圧縮スリーブを後退させて前記ステントを前記移植部位で拡張させ、前記カテーテルから離脱する工程と、
(vi)前記移植部位から前記カテーテルおよび前記ガイドワイヤーを抜去する工程と
を有する方法。 - 請求項23記載の方法において、前記ドックは膨張自在なバルーンを有し、前記後退自在な圧縮スリーブを後退させる工程後、前記バルーンを少なくとも部分的に膨張させて前記ステントをさらに拡張させる工程を有するものである方法。
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