JP2018509948A - 体内人工組織及びその製造方法 - Google Patents
体内人工組織及びその製造方法 Download PDFInfo
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- JP2018509948A JP2018509948A JP2017538241A JP2017538241A JP2018509948A JP 2018509948 A JP2018509948 A JP 2018509948A JP 2017538241 A JP2017538241 A JP 2017538241A JP 2017538241 A JP2017538241 A JP 2017538241A JP 2018509948 A JP2018509948 A JP 2018509948A
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- support structure
- tissue
- synthetic material
- endoprosthesis
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Abstract
Description
開口を設けた表面を有する拡張可能な中空の支持構造体(ステント)と、
支持構造体の内側表面を少なくとも部分的に被覆する内側組織構造体と
を備える体内人工組織において、特筆すべきは、
可撓性血液適合性合成材料で構成され内側組織構造体に機械的に係留された外側被覆を備え、支持構造体が、外側被覆と内側組織構造体との間に少なくとも部分的に保持されることである。
実際、外側被覆は、支持構造体の表面に設けられた開口を介した内側組織構造体に接触でき、外側被覆の可撓性合成材料による内側構造体の侵入により機械的アンカー固定による内側構造体との結合を生み出し、支持構造体を保持して外側被覆及び内側構造体に対して固定する。これは、純粋に化学的な接着を生じる生物学的接着剤とは対照的に、非常に良好な機械的接着を得ることを可能にしている。
また、外側被覆は、内側被覆を膜から成形した結果生じた接合線を被覆する。接合線に対向する縁部同士を接着することによって接合線の密着度を確保する。
また、外側被覆は、本発明に係る体内人工器官のために、移植後、患者自体の壁部を、摩擦による摩耗から保護する可撓性外側補強部を形成する。
内側組織構造体を、支持構造体内に導入して、支持構造体の内側表面の少なくとも一部を、折れ曲がりも過剰な厚さもなく連続的に均一な形で被覆する工程と、
可撓性血液適合性合成材料の溶媒への分散体を用いて、支持構造体の表面および支持構造体の表面の開口を通じて接触可能な内側組織構造体の外側表面の部分を被覆することにより、内側被覆に機械的に固定された可撓性血液適合性合成材料の外側被覆を形成する工程と、
溶媒を、外側被覆から取り除く工程と
を特徴とする方法によって製造される。
形状記憶能力を有する合金(鋼鉄、ニチノール、金属、高分子等)からなるワイヤ2による格子から構成された支持構造体1(ステント)。そのメッシュ3により支持構造体の表面に開口が形成され、その支持構造体は長手方向軸線又は横方向軸線に対して対称又は非対称とすることが可能である。
例えば生物学的組織の膜(不図示)から切断され、その両端の縁部5A及び縁部5Bが接合線6に沿って接触するように丸められた内側組織構造体4。その生物学的組織は、動物由来(ブタ、ウマ、ウシ等)、またはヒト細胞の組織培養により作製することが可能である。良好な結果が動物の心膜で得られている。しかしながら、内側組織構造体4は、例えば延伸ポリテトラフルオロエチレン等の合成材料で構成してもよい。
脱水率は、少なくとも75%、好ましくは約78〜80%とすべきである。脱水率が低すぎると、ある程度の生物学的組織の再水和、ひいてはある程度の繊維の運動性を許容するため、保管段階後(たとえ短期間であっても)の可撓性の喪失及び弱い再水和が起こる可能性がある。逆に過度の脱水は、生物学的材料を変性させて大きな収縮に繋がりうる。実際、生物学的材料は、結合水で構成されており(心膜の場合、10%の乾燥物質及び10%の結合水)、これが材料の組成の一部であり、従ってそれを除去すべきではない。
Claims (17)
- 開口を設けた表面を有する拡張可能な中空の支持構造体(1)と、
前記支持構造体(1)の内側表面(7)を少なくとも部分的に被覆する内側組織構造体(4)と
を備える体内人工組織において、
前記体内人工組織が、可撓性血液適合性合成材料で構成された外側被覆(10)を備え、該外側被覆(10)は、前記内側組織構造体(4)に機械的に固定されており、
前記支持構造体(1)が、前記外側被覆(10)と前記内側組織構造体(4)との間に少なくとも部分的に保持されていることを特徴とする体内人工組織。 - 前記外側被覆(10)の前記可撓性血液適合性合成材料が、少なくとも部分的に前記内側組織構造体(4)に侵入していることを特徴とする、請求項1に記載された体内人工組織。
- 前記外側被覆(10)の前記可撓性血液適合性合成材料がエラストマーであることを特徴とする、請求項1又は請求項2に記載された体内人工組織。
- 前記エラストマーが、ポリウレタンエラストマー又はシリコーンエラストマーであることを特徴とする、請求項3に記載された体内人工組織。
- 前記外側被覆(10)の前記可撓性血液適合性合成材料が、純粋であるか又は添加されていることを特徴とする、請求項1から請求項4までのいずれか一項に記載された体内人工組織。
- 前記外側被覆(10)の厚さ(e)が、最小で0.1mm、最大で5mmであることを特徴とする、請求項1から請求項5までのいずれか一項に記載された体内人工組織。
- 前記外側被覆(10)の厚さ(e)が、前記体内人工器官の異なる位置において異なっていることを特徴とする、請求項1から請求項6までのいずれか一項に記載された体内人工組織。
- 前記内側組織構造体が、動物の心膜で構成されていることを特徴とする、請求項1から請求項7までのいずれか一項に記載された体内人工組織。
- 前記内側組織構造体が、延伸ポリテトラフルオロエチレンで構成されていることを特徴とする、請求項1から請求項7までのいずれか一項に記載された体内人工組織。
- 人工血管を形成することを特徴とする、請求項1から請求項9までのいずれか一項に記載された体内人工組織。
- 人工心臓弁を形成することを特徴とする、請求項1から請求項9までのいずれか一項に記載された体内人工組織。
- 開口を備えた表面を有する拡張可能な中空の支持構造体(1)と、
前記支持構造体(1)の内側表面(7)を少なくとも部分的に被覆する内側組織構造体(4)と
を備える体内人工組織の製造方法において、
前記内側組織構造体(4)を前記支持構造体(1)内に導入して、前記支持構造体(1)の前記内側表面(7)の少なくとも一部を、折れ曲がりも過剰な厚さもなく連続的に均一な形で被覆する工程と、
可撓性血液適合性合成材料の溶媒への分散体を用いて、前記支持構造体の表面、および前記支持構造体(1)の表面の前記開口(3)を通じて接触可能な前記内側組織構造体(4)の前記外側表面(8)の部分を被覆することにより、前記内側被覆(4)に機械的に固定された前記可撓性血液適合性合成材料の外側被覆(10)を形成する工程と、
前記溶媒を、前記外側被覆(10)から取り除く工程と
を含むこと特徴とする製造方法。 - 前記外側被覆(10)の前記可撓性血液適合性合成材料がポリウレタンエラストマー又はシリコーンエラストマーであることを特徴とする、請求項12に記載された製造方法。
- 前記分散体における前記可撓性血液適合性合成材料の重量濃度が10〜30%であることを特徴とする、請求項12又は請求項13に記載された製造方法。
- 前記分散体における前記可撓性血液適合性合成材料の重量濃度が20〜22%であることを特徴とする、請求項14に記載された製造方法。
- 前記分散体の粘度が500〜1000cPであることを特徴とする、請求項12から請求項15までのいずれか一項に記載された製造方法。
- 前記内側組織構造体(4)が、化学的に固定された生物学的組織により形成され、
前記内側組織構造体(4)が、
化学的に固定された後、前記支持構造体(1)に導入する前に、部分的脱水を施され、
前記溶媒を前記外側被覆(10)から取り除く間又はその後、再水和する
ことを特徴とする請求項12から請求項16までのいずれか一項に記載された製造方法製造方法。
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FR1500457A FR3033494B1 (fr) | 2015-03-10 | 2015-03-10 | Endoprothese tissulaire et procede pour sa realisation |
FR1500457 | 2015-03-10 | ||
PCT/FR2016/050525 WO2016142617A1 (fr) | 2015-03-10 | 2016-03-07 | Endoprothèse tissulaire et procédé pour sa réalisation |
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US8579964B2 (en) | 2010-05-05 | 2013-11-12 | Neovasc Inc. | Transcatheter mitral valve prosthesis |
US9308087B2 (en) | 2011-04-28 | 2016-04-12 | Neovasc Tiara Inc. | Sequentially deployed transcatheter mitral valve prosthesis |
US9554897B2 (en) | 2011-04-28 | 2017-01-31 | Neovasc Tiara Inc. | Methods and apparatus for engaging a valve prosthesis with tissue |
US9345573B2 (en) | 2012-05-30 | 2016-05-24 | Neovasc Tiara Inc. | Methods and apparatus for loading a prosthesis onto a delivery system |
US9572665B2 (en) | 2013-04-04 | 2017-02-21 | Neovasc Tiara Inc. | Methods and apparatus for delivering a prosthetic valve to a beating heart |
JP7006940B2 (ja) | 2016-01-29 | 2022-01-24 | ニオバスク ティアラ インコーポレイテッド | 流出の閉塞を回避するための人工弁 |
CN113893064A (zh) | 2016-11-21 | 2022-01-07 | 内奥瓦斯克迪亚拉公司 | 用于快速收回经导管心脏瓣膜递送系统的方法和系统 |
WO2019036810A1 (en) | 2017-08-25 | 2019-02-28 | Neovasc Tiara Inc. | TRANSCATHETER MITRAL VALVULE PROSTHESIS WITH SEQUENTIAL DEPLOYMENT |
JP7260930B2 (ja) | 2018-11-08 | 2023-04-19 | ニオバスク ティアラ インコーポレイテッド | 経カテーテル僧帽弁人工補綴物の心室展開 |
US11998447B2 (en) | 2019-03-08 | 2024-06-04 | Neovasc Tiara Inc. | Retrievable prosthesis delivery system |
CN113811265A (zh) | 2019-04-01 | 2021-12-17 | 内奥瓦斯克迪亚拉公司 | 能够以可控的方式部署的假体瓣膜 |
US11491006B2 (en) | 2019-04-10 | 2022-11-08 | Neovasc Tiara Inc. | Prosthetic valve with natural blood flow |
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US5411552A (en) | 1990-05-18 | 1995-05-02 | Andersen; Henning R. | Valve prothesis for implantation in the body and a catheter for implanting such valve prothesis |
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ATE287679T1 (de) * | 1997-03-05 | 2005-02-15 | Boston Scient Ltd | Konformanliegende, mehrschichtige stentvorrichtung |
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US6579307B2 (en) * | 2001-07-19 | 2003-06-17 | The Cleveland Clinic Foundation | Endovascular prosthesis having a layer of biological tissue |
US20070083258A1 (en) * | 2005-10-06 | 2007-04-12 | Robert Falotico | Intraluminal device and therapeutic agent combination for treating aneurysmal disease |
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US20060025848A1 (en) * | 2004-07-29 | 2006-02-02 | Jan Weber | Medical device having a coating layer with structural elements therein and method of making the same |
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