JP6942652B2 - 心臓弁置換のためのシステム - Google Patents
心臓弁置換のためのシステム 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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- 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
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- 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
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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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
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- 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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/243—Deployment by mechanical expansion
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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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2436—Deployment by retracting a sheath
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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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
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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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
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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
- 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
- A61F2230/0069—Three-dimensional shapes cylindrical
-
- 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
- A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
-
- 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
-
- 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
- A61F2250/0063—Nested prosthetic parts
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- Heart & Thoracic Surgery (AREA)
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- Oral & Maxillofacial Surgery (AREA)
- Animal Behavior & Ethology (AREA)
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- Prostheses (AREA)
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Description
本願は、2013年8月14日に出願された(係属中)米国特許仮出願第61/865,657号、2014年2月20日に出願された(係属中)米国特許仮出願第61/942,300号、および2014年2月21日に出願された(係属中)米国特許仮出願第61/943,125号の優先権を主張するものである。これらの仮出願の開示は、ここに参照により本明細書に組み込まれる。
10a 遠位先端部
12 らせん状アンカー
12a 内部ワイヤコイル
12b 外部コーティング
12c 軟質先端部
14 交連
16 天然僧帽弁
18 天然弁葉、人工弁葉
20 天然弁葉、人工弁葉
22 巻線またはコイル
24 索、腱索
26 ワイヤ
30 らせん状送達ツール
31 コイル
32 外方チューブ
34 縫合糸
36 縫合糸
38 ループ
40 心臓
42 メス
44 鉗子
50 押し棒
52 カップ状端部
60 置換心臓弁
62 弁葉
64 弁葉
66 本体
70 ブレット形状ヘッド
72 スリット
80 緩衝体構造体
82 発泡体
84 封止層
86 開ステント構造体
90 生体組織シール
91 間隙
92 繊維層
100 送達シース
101 送達シース、送達カテーテル
102 右心房
104 心房中隔
106 左心房
108 左心室
110 アーム
120 ループ
126 天然僧帽弁輪
140 らせん状アンカー送達チューブ、チューブ状アーム
152 面
160 繊維カバー
162 発泡層、発泡体
170 組織束ねデバイス
172 一時的リングまたはループ
180 上方らせん状アンカー部分、心房らせん状アンカー部分
182 下方らせん状アンカー部分、心室らせん状アンカー部分
184 圧着接合部
200 間隙
202 弁輪シール
210 バルーンカテーテル
Claims (21)
- 天然心臓弁(16)に移植されるように構成されたらせん状アンカー(12)であって、当該らせん状アンカー(12)のコイル部分が心臓弁輪の上方および/または下方に配置されるように調整された状態で心臓弁プロテーゼ(60)を支持するように構成された複数の巻線(22)を備えるように形成されたらせん状アンカー(12)と、
可撓性を有する外方チューブ(32)であって、前記らせん状アンカー(12)の複数の前記巻線(22)を当該外方チューブ(32)内に保持し、アセンブリを形成するように構成され、前端部と後端部とを備えた外方チューブ(32)と、
前記アセンブリを搬送し、前記アセンブリを前記心臓弁輪の上方および/または下方に位置決めすることができるらせん状送達ツール(30)であって、該らせん状送達ツール(30)が複数の巻線と遠位端とを備え、該らせん状送達ツール(30)の遠位端が、縫合糸により前記外方チューブ(32)の前端部に結合され、前記アセンブリの複数の前記巻線(22)が、該らせん状送達ツール(30)の複数の巻線上の所定位置に保持されている、らせん状送達ツール(30)と、
カップ状端部を有する押し棒(50)と、
を含んでなるシステムであって、
前記アセンブリが前記心臓弁輪の上方および/または下方に位置決めされた後に、前記押し棒(50)を用いて、前記カップ状端部を前記外方チューブ(32)の後端部内に挿入し、前記外方チューブ(32)を前記らせん状アンカー(12)から引き抜くことによって、前記らせん状アンカー(12)を所定位置に保持しながら、前記外方チューブ(32)が、前記らせん状アンカー(12)の複数の前記巻線(22)から取り除かれるように構成されていることを特徴とするシステム。 - 前記天然心臓弁に送達され得る拡張可能心臓弁プロテーゼ(60)であって、前記天然心臓弁において複数の前記巻線(22)の内部で拡張され得る拡張可能心臓弁プロテーゼ(60)をさらに含むことを特徴とする請求項1に記載のシステム。
- 前記心臓弁プロテーゼ(60)が、前記心臓弁プロテーゼ(60)の流出端部のエッジをカバーするシールを備えていることを特徴とする請求項2に記載のシステム。
- 複数の前記巻線(22)と前記心臓弁プロテーゼ(60)とが、前記天然心臓弁に移植された時、複数の前記巻線(22)と前記心臓弁プロテーゼ(60)との間で、前記天然心臓弁の弁葉を捕獲するように構成されていることを特徴とする請求項2に記載のシステム。
- 前記らせん状送達ツール(30)が、前記縫合糸の固定のための座を提供するための溝を備えていることを特徴とする請求項1に記載のシステム。
- 前記らせん状送達ツール(30)が遠位端でループ(38)を備え、前記らせん状送達ツール(30)の前記遠位端が、前記ループ(38)を通った縫合糸で、前記外方チューブの前端部に結合されていることを特徴とする請求項1に記載のシステム。
- 天然心臓弁(16)に移植されるように構成されたらせん状アンカー(12)であって、当該らせん状アンカー(12)のコイル部分が心臓弁輪の上方および/または下方に配置されるように調整された状態で心臓弁プロテーゼ(60)を支持するように構成された複数の巻線(22)を備えるように形成されたらせん状アンカー(12)と、
可撓性を有する外方チューブ(32)であって、前記らせん状アンカー(12)の複数の前記巻線(22)を当該外方チューブ(32)内に保持し、アセンブリを形成するように構成され、前端部と後端部とを備えた外方チューブ(32)と、
前記アセンブリを搬送し、前記アセンブリを前記心臓弁輪の上方および/または下方に位置決めすることができるらせん状送達ツール(30)であって、該らせん状送達ツール(30)が複数の巻線と遠位端とを備え、該らせん状送達ツール(30)が前記遠位端で弾丸形状のヘッド(70)を備え、前記弾丸形状のヘッド(70)が、前記弾丸形状のヘッド(70)に隣接する、複数の前記巻線(22)の一つと平行に延在するスリット(72)を備え、前記外方チューブ(32)の前端部が、前記スリット(72)において前記弾丸形状のヘッド(70)内に挿入されている、らせん状送達ツール(30)と、
カップ状端部を有する押し棒(50)と、
を含んでなるシステムであって、
前記アセンブリが前記心臓弁輪の上方および/または下方に位置決めされた後に、前記押し棒(50)を用いて、前記カップ状端部を前記外方チューブ(32)の後端部内に挿入し、前記外方チューブ(32)を前記らせん状アンカー(12)から引き抜くことによって、前記らせん状アンカー(12)を所定位置に保持しながら、前記外方チューブ(32)が、前記らせん状アンカー(12)の複数の前記巻線(22)から取り除かれるように構成されていることを特徴とするシステム。 - 前記弾丸形状のヘッド(70)が、弾性ポリマーを含むことを特徴とする請求項7に記載のシステム。
- 前記らせん状送達ツール(30)は、前記天然心臓弁の交連を貫通する前記アセンブリを、前記心臓弁輪の上方および/または下方に位置決めされた前記アセンブリの位置内に送達するように適用されていることを特徴とする請求項1に記載のシステム。
- 複数の前記巻線(22)が少なくとも3つの巻線を含むことを特徴とする請求項1に記載のシステム。
- 複数の前記巻線(22)が少なくとも4つの巻線を含むことを特徴とする請求項1に記載のシステム。
- 天然心臓弁(16)に移植されるように構成されたらせん状アンカー(12)であって、当該らせん状アンカー(12)のコイル部分が心臓弁輪の上方および/または下方に配置されるように調整された状態で心臓弁プロテーゼ(60)を支持するように構成された少なくとも3つの巻線(22)を備えるように形成されたらせん状アンカー(12)と、
可撓性を有する外方チューブ(32)であって、前記らせん状アンカー(12)の少なくとも3つの前記巻線(22)を当該外方チューブ(32)内に保持し、アセンブリを形成するように構成され、前端部と後端部とを備えた外方チューブ(32)と、
前記アセンブリを搬送し、前記アセンブリを前記心臓弁輪の上方および/または下方に位置決めすることができるらせん状送達ツール(30)であって、該らせん状送達ツール(30)が複数の巻線と遠位端とを備え、該らせん状送達ツール(30)の遠位端が、縫合糸により前記外方チューブ(32)の前端部に結合され、前記アセンブリの複数の前記巻線(22)が、該らせん状送達ツール(30)の複数の巻線上の所定位置に保持されている、らせん状送達ツール(30)と、
を含んでなるシステムであって、
前記アセンブリが前記心臓弁輪の上方および/または下方に位置決めされた後に、前記外方チューブ(32)が、前記らせん状アンカー(12)の少なくとも3つの前記巻線(22)から取り除かれるように構成され、
カップ状端部を有する押し棒(50)をさらに含み、前記アセンブリが前記心臓弁輪に位置決めされた後に、前記押し棒(50)を用いて、前記カップ状端部を前記外方チューブ(32)の後端部内に挿入し、前記外方チューブ(32)を前記らせん状アンカー(12)から引き抜くことによって、前記らせん状アンカー(12)を所定位置に保持しながら、前記外方チューブ(32)が、前記らせん状アンカー(12)の少なくとも3つの前記巻線(22)から取り除かれるように構成されていることを特徴とするシステム。 - 前記天然心臓弁に送達され得る拡張可能心臓弁プロテーゼ(60)であって、前記天然心臓弁において少なくとも3つの前記巻線(22)の内部で拡張され得る拡張可能心臓弁プロテーゼ(60)をさらに含むことを特徴とする請求項12に記載のシステム。
- 前記心臓弁プロテーゼ(60)が、前記心臓弁プロテーゼ(60)の流出端部のエッジをカバーするシールを備えていることを特徴とする請求項12に記載のシステム。
- 少なくとも3つの前記巻線(22)と前記心臓弁プロテーゼ(60)とが、前記天然心臓弁に移植された時、複数の前記巻線(22)と前記心臓弁プロテーゼ(60)との間で、前記天然心臓弁の弁葉を捕獲するように構成されていることを特徴とする請求項13に記載のシステム。
- 前記らせん状送達ツール(30)が、前記縫合糸の固定のための座を提供するための溝を備えていることを特徴とする請求項12に記載のシステム。
- 前記らせん状送達ツール(30)が遠位端でループ(38)を備え、前記らせん状送達ツール(30)の前記遠位端が、前記ループ(38)を通った縫合糸で、前記外方チューブの前端部に結合されていることを特徴とする請求項12に記載のシステム。
- 少なくとも3つの前記巻線(22)が少なくとも4つの巻線を含むことを特徴とする請求項12に記載のシステム。
- 前記らせん状送達ツール(30)は、前記天然心臓弁の交連を貫通する前記アセンブリを、前記心臓弁輪の上方および/または下方に位置決めされた前記アセンブリの位置内に送達するように適用されていることを特徴とする請求項12に記載のシステム。
- 天然心臓弁(16)に移植されるように構成されたらせん状アンカー(12)であって、当該らせん状アンカー(12)のコイル部分が心臓弁輪の上方および/または下方に配置されるように調整された状態で心臓弁プロテーゼ(60)を支持するように構成された少なくとも3つの巻線(22)を備えるように形成されたらせん状アンカー(12)と、
可撓性を有する外方チューブ(32)であって、前記らせん状アンカー(12)の少なくとも3つの前記巻線(22)を当該外方チューブ(32)内に保持し、アセンブリを形成するように構成され、前端部と後端部とを備えた外方チューブ(32)と、
前記アセンブリを搬送し、前記アセンブリを前記心臓弁輪の上方および/または下方に位置決めすることができるらせん状送達ツール(30)であって、該らせん状送達ツール(30)が複数の巻線と遠位端とを備え、該らせん状送達ツール(30)が前記遠位端で弾丸形状のヘッド(70)を備え、前記弾丸形状のヘッド(70)が、前記弾丸形状のヘッド(70)に隣接する、複数の前記巻線(22)の一つと平行に延在するスリット(72)を備え、前記外方チューブ(32)の前端部が、前記スリット(72)において前記弾丸形状のヘッド(70)内に挿入されている、らせん状送達ツール(30)と、
を含んでなるシステムであって、
前記アセンブリが前記心臓弁輪の上方および/または下方に位置決めされた後に、前記外方チューブ(32)が、前記らせん状アンカー(12)の少なくとも3つの前記巻線(22)から取り除かれるように構成され、
カップ状端部を有する押し棒(50)をさらに含み、前記アセンブリが前記心臓弁輪に位置決めされた後に、前記押し棒(50)を用いて、前記カップ状端部を前記外方チューブ(32)の後端部内に挿入し、前記外方チューブ(32)を前記らせん状アンカー(12)から引き抜くことによって、前記らせん状アンカー(12)を所定位置に保持しながら、前記外方チューブ(32)が、前記らせん状アンカー(12)の少なくとも3つの前記巻線(22)から取り除かれるように構成されていることを特徴とするシステム。 - 前記弾丸形状のヘッド(70)が、弾性ポリマーを含むことを特徴とする請求項20に記載のシステム。
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