JP7063875B2 - 人工心臓弁用の切頂型リーフレット - Google Patents
人工心臓弁用の切頂型リーフレット 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
- A61F2/02—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
- A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
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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
- A61F2/02—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
- A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
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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
- A61F2/02—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
-
- 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
- A61F2/02—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
- A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2415—Manufacturing methods
-
- 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
- A61F2/02—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
- A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
-
- 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
-
- 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
- A61F2230/0017—Angular shapes
- A61F2230/0023—Angular shapes triangular
-
- 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
- A61F2230/0017—Angular shapes
- A61F2230/0026—Angular shapes trapezoidal
-
- 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
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Cardiology (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)
- Manufacturing & Machinery (AREA)
- Prostheses (AREA)
Description
一実施形態によれば、リーフレットフレーム130は、図2A~2Dに示すように、概ね管状の部材で、開口部122の一般的な開放パターンを画定する。経カテーテルの実施形態では、リーフレットフレーム130は、異なる直径の間で圧縮と拡張ができるように作用できる。リーフレットフレーム130は、フレーム第1端部121aと、フレーム第1端部121aとは反対側のフレーム第2端部121bとを備える。図2Aに示すように、リーフレットフレーム130は、リーフレットフレーム外面126aと、リーフレットフレーム外面126aとは反対側のリーフレットフレーム内面126bとを備える。リーフレットフレーム130は、リーフレット自由縁142に連結する接合柱136を画定する。
フィルム160は、一般に、生体適合性がある任意のシート状材料であり、実施形態に従ってリーフレットをフレームに連結するように構成される。「フィルム」という語は、特定目的に適した1つ以上の生体適合性材料の総称として使用されるものと理解される。リーフレット140もフィルム160で構成される。
一実施形態によれば、植え込み時に左心室の索枝を覆わないことにより、大動脈弁置換術で起こり得るような心臓伝導系との干渉を防止するように人工弁100を構成できる。例えば、人工弁100の長さを約25mm未満又は約18mm未満にしてよい。また、人工弁100のアスペクト比(人工弁100の長さと拡張時の機能的直径との間の関係を表す比率)を1未満にしてよい。しかしながら、人工弁100は任意の長さで構成してよく、より一般的には所望の寸法で構成してよい。
図4Aを参照すると、一実施形態では、弁送達システム500は、上述のような折り畳み構成と拡張構成を有する人工弁100と、細長い可撓性カテーテル480(例えばバルーンカテーテル)とを備え、カテーテルを介して人工弁100を展開するように構成される。カテーテル480は、人工弁100を拡張させ、且つ/又は必要に応じて人工弁100を微調整して確実に配置させるためのバルーンを備えてよい。脈管構造を通じて送達するために、人工弁100をカテーテル480の遠位部に取り付けてよい。折り畳み構成時の弁をカテーテル480上に保持する目的で、弁送達システムは、経カテーテル人工弁100にぴったりとフィットする取り外し可能シース(図示せず)をさらに備えてよい。
上記実施形態の人工弁100を、経カテーテル手法を用いる代わりに外科的に植え込んでもよいと理解される。外科的に植え込まれる人工弁100の実施形態は、上記実施形態と実質的に同じであり得るが、一実施形態によれば、図4Aに示す通り、リーフレットフレーム外面126aに隣接して縫合カフ170が追加される。縫合カフ170は、当技術分野において周知であり、人工弁100を植え込み部位(例えば組織開口部150)に連結するための縫合糸を受け取る構造を提供するように作用できる。縫合カフ170は、任意の適切な材料(例えばダブルベロアポリエステルが挙げられるが、これに限定されない)を含んでよい。リーフレットフレーム130に応じて、リーフレットフレーム130の外周または弁周囲に縫合カフを配置してよい。
本明細書に記載の実施形態は、本明細書に記載の実施形態の人工弁100を製作する方法にも関連する。円筒形のマンドレル710を使用して各種実施形態を製作できる。図5を参照すると、マンドレル710は、表面にリーフレットフレーム130を受け入れるように作用できる構造形態を含む。
Claims (18)
- 支持構造および複数のリーフレットを備える人工弁であって、
支持構造は、内側と外側を有する弁フレーム、および弁フレームの外側の覆いを含み、
複数のリーフレットの各リーフレットは、弁フレームの外側の覆いに連結され、第1のリーフレット側部と、該第1のリーフレット側部とは反対側の第2のリーフレット側部と、リーフレット基部と、該リーフレット基部とは反対側のリーフレット自由縁とを有し、
リーフレット基部は、弁フレームの外側の覆いに連結され、かつ平坦であり、断面において、各リーフレットがアルファ面において支持構造に対し連続的な取り付け線を形成するようになっており、
ここで、アルファ面は弁軸に対し垂直な平面であり、取り付け線に沿ってリーフレットと交差する平面である、人工弁。 - 前記支持構造は、前記複数のリーフレットに対応する複数のリーフレット窓を形成し、各リーフレット窓は、前記アルファ面において平坦なリーフレット窓基部を有する、請求項1に記載の人工弁。
- 前記支持構造は、前記複数のリーフレットに対応する複数の台形形状のリーフレット窓を形成する、請求項1に記載の人工弁。
- 前記複数のリーフレットの各々は、台形形状である、請求項1に記載の人工弁。
- 前記リーフレット基部は、前記人工弁の長手方向の軸に垂直な直線を形成する、請求項1に記載の人工弁。
- 前記リーフレット基部の全部が前記支持構造に連結している、請求項1に記載の人工弁。
- 前記支持構造は、拡張可能なリーフレットフレームを含む、請求項1に記載の人工弁。
- 前記リーフレットの各々は、ポリマーフィルム材料で形成される、請求項1に記載の人工弁。
- 人工心臓弁を製作する方法であって、
第1フィルムをリーフレットフレームの外側に連結し、リーフレット支持構造を形成すること;及び、
第2フィルムをリーフレットフレームの外側のリーフレット支持構造の第1フィルムに連結し、複数のリーフレットを形成することを含み、
ここで、各リーフレットは、第1のリーフレット側部と、該第1のリーフレット側部とは反対側の第2のリーフレット側部と、リーフレット基部と、該リーフレット基部とは反対側のリーフレット自由縁とを有し、
リーフレット基部は、支持構造に連結され、かつ平坦であり、断面において、各リーフレットがアルファ面において支持構造に対し連続的な取り付け線を形成するようになっており、
ここで、アルファ面は弁軸に対し垂直な平面であり、取り付け線に沿ってリーフレットと交差する平面である、前記方法。 - 前記第2フィルムを支持構造に連結することは、第2フィルムを第1フィルムに接合することを含む、請求項9に記載の方法。
- 前記第1フィルムをリーフレットフレームに連結し、リーフレット支持構造を形成することは、リーフレットフレーム及び第1フィルムで複数のリーフレット窓を形成することを含む、請求項9に記載の方法。
- 各リーフレット窓は、アルファ面において平坦なリーフレット窓基部を有する、請求項11に記載の方法。
- 各リーフレット窓は台形形状である、請求項11に記載の方法。
- 前記複数のリーフレットの各々は台形形状である、請求項9に記載の方法。
- 前記リーフレット基部が前記支持構造に連結され、前記人工心臓弁の長手方向の軸に垂直な直線を形成する、請求項9に記載の方法。
- 前記複数のリーフレットの各リーフレット基部の全部を前記支持構造に連結することを更に含む、請求項9に記載の方法。
- 前記支持構造は、拡張可能なリーフレットフレームを含む、請求項9に記載の方法。
- 前記第1および第2フィルムの各々は、生体適合性ポリマーフィルム材料を含む、請求項9に記載の方法。
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201261739721P | 2012-12-19 | 2012-12-19 | |
US61/739,721 | 2012-12-19 | ||
US13/843,196 US9144492B2 (en) | 2012-12-19 | 2013-03-15 | Truncated leaflet for prosthetic heart valves, preformed valve |
US13/843,196 | 2013-03-15 |
Related Parent Applications (1)
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JP2015549523A Division JP6639911B2 (ja) | 2012-12-19 | 2013-12-16 | 人工心臓弁用の切頂型リーフレット |
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JP2020049275A JP2020049275A (ja) | 2020-04-02 |
JP7063875B2 true JP7063875B2 (ja) | 2022-05-09 |
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JP2015549523A Active JP6639911B2 (ja) | 2012-12-19 | 2013-12-16 | 人工心臓弁用の切頂型リーフレット |
JP2019230319A Active JP7063875B2 (ja) | 2012-12-19 | 2019-12-20 | 人工心臓弁用の切頂型リーフレット |
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Country | Link |
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US (4) | US9144492B2 (ja) |
EP (3) | EP2934388B1 (ja) |
JP (2) | JP6639911B2 (ja) |
KR (1) | KR20150097758A (ja) |
CN (1) | CN105050541B (ja) |
AU (3) | AU2013363172C1 (ja) |
CA (2) | CA2893098C (ja) |
ES (3) | ES2715786T3 (ja) |
HK (2) | HK1215150A1 (ja) |
WO (1) | WO2014099722A1 (ja) |
Families Citing this family (68)
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PL3476368T4 (pl) * | 2008-06-06 | 2023-07-17 | Edwards Lifesciences Corporation | Niskoprofilowa przezcewnikowa zastawka serca |
US8579964B2 (en) | 2010-05-05 | 2013-11-12 | Neovasc Inc. | Transcatheter mitral valve prosthesis |
US20130197631A1 (en) | 2011-04-01 | 2013-08-01 | W. L. Gore & Associates, Inc. | Durable multi-layer high strength polymer composite suitable for implant and articles produced therefrom |
US8945212B2 (en) | 2011-04-01 | 2015-02-03 | W. L. Gore & Associates, Inc. | Durable multi-layer high strength polymer composite suitable for implant and articles produced therefrom |
US8961599B2 (en) | 2011-04-01 | 2015-02-24 | W. L. Gore & Associates, Inc. | Durable high strength polymer composite suitable for implant and articles produced therefrom |
US9554900B2 (en) * | 2011-04-01 | 2017-01-31 | W. L. Gore & Associates, Inc. | Durable high strength polymer composites suitable for implant and articles produced therefrom |
US9801712B2 (en) | 2011-04-01 | 2017-10-31 | W. L. Gore & Associates, Inc. | Coherent single layer high strength synthetic polymer composites for prosthetic valves |
US9744033B2 (en) | 2011-04-01 | 2017-08-29 | W.L. Gore & Associates, Inc. | Elastomeric leaflet for prosthetic heart valves |
US20140163673A1 (en) * | 2011-04-01 | 2014-06-12 | W. L. Gore & Associates, Inc. | Prosthetic heart valve leaflet adapted for external imaging |
US9554897B2 (en) | 2011-04-28 | 2017-01-31 | Neovasc Tiara Inc. | Methods and apparatus for engaging a valve prosthesis with tissue |
US9308087B2 (en) | 2011-04-28 | 2016-04-12 | Neovasc Tiara Inc. | Sequentially deployed transcatheter mitral valve prosthesis |
US9554806B2 (en) | 2011-09-16 | 2017-01-31 | W. L. Gore & Associates, Inc. | Occlusive devices |
US9345573B2 (en) | 2012-05-30 | 2016-05-24 | Neovasc Tiara Inc. | Methods and apparatus for loading a prosthesis onto a delivery system |
US9283072B2 (en) | 2012-07-25 | 2016-03-15 | W. L. Gore & Associates, Inc. | Everting transcatheter valve and methods |
US10376360B2 (en) | 2012-07-27 | 2019-08-13 | W. L. Gore & Associates, Inc. | Multi-frame prosthetic valve apparatus and methods |
US9968443B2 (en) | 2012-12-19 | 2018-05-15 | W. L. Gore & Associates, Inc. | Vertical coaptation zone in a planar portion of prosthetic heart valve leaflet |
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