JP4235554B2 - 左心室構造を成形するための僧帽弁の弁形成リング - Google Patents
左心室構造を成形するための僧帽弁の弁形成リング Download PDFInfo
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- JP4235554B2 JP4235554B2 JP2003543504A JP2003543504A JP4235554B2 JP 4235554 B2 JP4235554 B2 JP 4235554B2 JP 2003543504 A JP2003543504 A JP 2003543504A JP 2003543504 A JP2003543504 A JP 2003543504A JP 4235554 B2 JP4235554 B2 JP 4235554B2
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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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
- A61F2/2448—D-shaped rings
-
- 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
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- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
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- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
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- Prostheses (AREA)
Description
本願に対して、2001年11月13日に出願された、発明の名称「Mitral Valve Annuloplasty Ring for Molding Left Ventricle Geometry」の同時係属中の仮特許出願番号60/332,353から、米国特許法第119条第(e)項のもとで、優先権が主張される。この仮特許出願の開示は、その全体が本明細書中に参考として援用される。
本発明は、一般に、医療デバイスに関し、具体的には、弁形成リング、ならびに患者の心臓の僧帽弁輪を外科的に再構築および成形するための、関連する手順に関する。より具体的には、本発明は、僧帽弁修復デバイス、および左心室の幾何学的関係を再モデル化するように、僧帽弁輪における欠損の過剰補正を包含する対応する技術に関する。
うっ血性心不全(CHF)は、米国における主要な入院および死亡の原因であり、そしてその発生数は増加している。二次的な僧帽弁逆流(MR)(終末期心筋症の合併症)とは、僧帽弁の不完全に起因する、左心室から左心房への血液の逆流をいう。僧帽弁が、血液が左心房に逆流することを可能にする場合、左心室は、体中に血液を循環させるために、次第に激しくポンピングしなければならず、これは次に、CHFを促進する。心臓移植は、重篤なCHFおよび終末期心臓病に罹患している選ばれた患者に対する標準的な処置であると考えられるが、利用可能なドナー心臓の数が少ないこと、およびより弱い患者に対する手術が危険であることに起因して、患者の小割合に対して適用可能であるのみである。従って、このような状態を処置するための、代替の医療ストラテジーおよび外科ストラテジーが発展している。
本発明は、輪の補正と、うっ血性心不全の影響の緩和の補助との両方を行う、僧帽弁輪における移植のための、多数の弁形成リングを提供する。1つの局面において、本発明は、ほぼ卵円形状のリング本体を有する弁形成リングを提供し、このリング本体は、前部、この前部に対向する後部、前部と後部との間の右側部および左側部、ならびにこれらの側部と後部との間の移行セグメントを規定する。このリング本体は、中心軸の周りで、上向きの方向および下向きの方向を有して配向しており、この下向きの方向は、僧帽弁輪を通る血流の方向に対応する。このリングは、この中心軸に対して垂直な平面図において、短軸に沿った短い方の寸法より長い、長軸に沿った寸法を有し、そして後部は、前部の軸方向最高位置より高い軸方向位置まで、隣接する移行セグメントから上方に上昇している。
本出願人は、うっ血性心不全(CHF)および二次的な僧帽弁逆流(MR)が、新生代の僧帽弁形成リングを用いて取り組まれ得ることを決定した。このリングは、移植されると、既存の弁形成リングと同様に僧帽弁輪の周囲を改変するのみでなく、左心室の幾何学的形状を成形および再形成するように、僧帽弁輪の後部を上昇させ、そして/または再構築する。
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Claims (28)
- 僧帽弁輪に移植するための弁形成リングであって、該弁形成リングは、以下:
ほぼ卵円形状のリング本体であって、前部、該前部に対向する後部、該前部と後部との間の右側部および左側部、ならびに該側部と該後部との間の移行セグメントを有する、リング本体;
を備え、
該リング本体は、中心軸の周りで、上向きの方向および下向きの方向を有して配向しており、該下向きの方向は、該僧帽弁輪を通る血流の方向に対応し、該リングは、該中心軸に対して垂直な平面図において、長軸に沿って、短軸に沿ったより短い寸法より長い寸法を有し;そして
該後部の中央セクションは、該前部の軸方向最高位置より高い軸方向位置まで、隣接する該移行セグメントから上方に上昇している、
弁形成リング。 - 前記後部が、前記隣接する移行セグメントから、前記短軸に沿った半径方向位置へと、半径方向内向きに延びており、該半径方向位置は、平面図において、互いの方に向く側部の想像の後方投影より前記中心軸に近い、請求項1に記載の弁形成リング。
- 前記後部が、前記隣接する移行セグメントから、半径方向位置へと半径方向内向きに延び、該半径方向位置は、平面図において、互いの方に向く側部の想像の後方投影より前記中心軸に約30〜50%近い、請求項2に記載の弁形成リング。
- 前記リングが、実質的に鞍形状であり、前記側部が、前記前部と隣接する移行セグメントとの間で上方に湾曲している、請求項1に記載の弁形成リング。
- 前記右側部および左側部の各々が、前記隣接する移行セグメントから上向きに、前記前部の軸方向最高位置より上の軸方向位置まで上昇している、請求項4に記載の弁形成リング。
- 前記後部が、前記隣接する移行セグメントから上向きに、前記右側部または左側部のいずれかの軸方向最高位置より上の軸方向位置まで上昇している、請求項4に記載の弁形成リング。
- 前記右側部および左側部の各々が、前記隣接する移行セグメントから上向きに、前記後部の軸方向最高位置より上の軸方向位置まで上昇している、請求項4に記載の弁形成リング。
- 前記リングが、前記後部を除いてほぼ平坦である、請求項1に記載の弁形成リング。
- 前記側部および移行セグメントが、ほぼ曲線であり、そして隣接する側部と移行セグメントとの間の連結が、ほぼ円形である、請求項1に記載の弁形成リング。
- 前記後部が、前記隣接する側部から、前記短軸に沿った半径方向位置へと半径方向内向きに延びており、該半径方向位置は、平面図において、互いの方に向く前記側部の想像の後方投影より前記中心軸に近い、請求項1に記載の弁形成リング。
- 前記後部が、前記隣接する側部から、前記短軸に沿った半径方向位置へと半径方向内向きに延びており、該半径方向位置は、平面図において、互いの方に向く該側部の想像の後方投影より前記中心軸に約30〜50%近い、請求項10に記載の弁形成リング。
- 前記リング本体が、高い弾性率を有する材料から構成され、該材料は、該リングが、作動しているヒトの心臓の僧帽弁輪に移植される場合に該材料に付与される応力に供される場合に、ひずみに実質的に抵抗する、請求項1に記載の弁形成リング。
- 前記リングが、セラミック材料から構成される、請求項12に記載の弁形成リング。
- 前記リングが、ステライトから構成される、請求項13に記載の弁形成リング。
- 前記リング本体を囲む外側縫合シースをさらに備え、該縫合シースは、該縫合シースを通しての縫合糸の通過を可能にする材料から形成されている、請求項1に記載の弁形成リング。
- 僧帽弁形成リングであって、以下:
高い弾性率を有する材料から作製されたリング本体であって、該材料は、該リングが作動中のヒト心臓の僧帽弁輪に移植される場合に該材料に付与される応力に供される場合に、ひずみに実質的に抵抗し、該リング本体は、中心軸の周りで、上向きの方向および下向きの方向を有して配向しており、該下向きの方向は、該僧帽弁輪を通る血流の方向に対応しており、該リング本体は、半径方向内向きかつ軸方向上向きの両方に延びる後部弓型を有する、僧帽弁形成リング。 - 前記リング本体が、前部、該前部に対向する後部、該前部と後部との間の右側部および左側部、ならびに該側部と該後部との間の移行セグメントを有し、該リング本体が、実質的に鞍形状であり、該側部が、該前部と隣接する該移行セグメントとの間で上向きに湾曲している、請求項16に記載の僧帽弁形成リング。
- 前記後部の中央セクションが、前記隣接する移行セグメントから上向きに、前記右側部または左側部のいずれかの軸方向最高位置より高い軸方向位置まで弓形になっている、請求項17に記載の僧帽弁形成リング。
- 前記右側部および左側部の各々が、前記隣接する移行セグメントから上向きに、前記後部の軸方向最高位置より上の軸方向位置まで上昇している、請求項17に記載の僧帽弁形成リング。
- 前記リング本体が、前記後部の弓形部分を除いて実質的に平坦である、請求項16に記載の僧帽弁形成リング。
- 前記リング本体が、前部、該前部に対向する後部、該前部と後部との間の右側部および左側部、ならびに該側部と該後部との間の移行セグメントを有し、該後部が、隣接する該移行セグメントから、短軸に沿った半径方向位置へと半径方向内向きに延びており、該半径方向位置は、平面図において、互いの方に向く該側部の想像の後方投影より前記中心軸に近い、請求項16に記載の僧帽弁形成リング。
- 前記後部が、前記隣接する移行セグメントから、半径方向位置へと半径方向内向きに延びており、該半径方向位置は、平面図において、互いの方に向く該側部の想像の後方投影より、前記中心軸に約30〜50%近い、請求項21に記載の僧帽弁形成リング。
- 前記リング本体が、前部、該前部に対向する後部、該前部と後部との間の右側部および左側部、ならびに該側部と該後部との間の移行セグメントを有し、該後部が、隣接する該側部から半径方向内向きに、短軸に沿った半径方向位置へと延びており、該半径方向位置が、平面図において、互いの方に向く該側部の想像の後方投影より前記中心軸に近い、請求項16に記載の僧帽弁形成リング。
- 前記後部が、短軸に沿った半径方向位置へと、前記隣接する側部から半径方向内向きに延びており、該半径方向位置は、平面図において、互いの方に向く該側部の想像の後方投影より、前記中心軸に約30〜50%近い、請求項23に記載の僧帽弁形成リング。
- 前記リング本体が、セラミック材料から構成されている、請求項16に記載の僧帽弁形成リング。
- 前記リング本体が、ステライトから構成されている、請求項25に記載の僧帽弁形成リング。
- 前記後部の中央セクションの上方への上昇が、3〜5ミリメートルであり、該後部の上方への湾曲が、僧帽弁輪の後面を引っ張るように構成されている、請求項1に記載の僧帽弁形成リング。
- 前記後部弓形の上方への上昇が、3〜5ミリメートルであり、該後部弓形の該上方への湾曲が、僧帽弁輪の後面を引っ張るように構成されている、僧帽弁輪に移植するための請求項16に記載の僧帽弁形成リング。
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US33235301P | 2001-11-13 | 2001-11-13 | |
US10/267,272 US6805710B2 (en) | 2001-11-13 | 2002-10-09 | Mitral valve annuloplasty ring for molding left ventricle geometry |
PCT/US2002/036242 WO2003041617A1 (en) | 2001-11-13 | 2002-11-12 | Mitral valve annuloplasty ring for molding left ventricle geometry |
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JP2005508702A JP2005508702A (ja) | 2005-04-07 |
JP4235554B2 true JP4235554B2 (ja) | 2009-03-11 |
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US (3) | US6805710B2 (ja) |
EP (1) | EP1443877B1 (ja) |
JP (1) | JP4235554B2 (ja) |
AT (1) | ATE539704T1 (ja) |
AU (1) | AU2002340469B2 (ja) |
CA (1) | CA2467766C (ja) |
WO (1) | WO2003041617A1 (ja) |
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2002
- 2002-10-09 US US10/267,272 patent/US6805710B2/en not_active Expired - Lifetime
- 2002-11-12 CA CA2467766A patent/CA2467766C/en not_active Expired - Lifetime
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- 2002-11-12 EP EP02778834A patent/EP1443877B1/en not_active Expired - Lifetime
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- 2002-11-12 JP JP2003543504A patent/JP4235554B2/ja not_active Expired - Lifetime
- 2002-11-12 AT AT02778834T patent/ATE539704T1/de active
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CA2467766A1 (en) | 2003-05-22 |
US6805710B2 (en) | 2004-10-19 |
EP1443877A1 (en) | 2004-08-11 |
ATE539704T1 (de) | 2012-01-15 |
EP1443877B1 (en) | 2012-01-04 |
US8236050B2 (en) | 2012-08-07 |
AU2002340469B2 (en) | 2007-08-30 |
CA2467766C (en) | 2012-02-07 |
US20080097593A1 (en) | 2008-04-24 |
JP2005508702A (ja) | 2005-04-07 |
US20030093148A1 (en) | 2003-05-15 |
US20050049698A1 (en) | 2005-03-03 |
US7329280B2 (en) | 2008-02-12 |
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