JP2018515306A - 経カテーテル人工弁の送達、再配置及び回収のための装置及び方法 - Google Patents
経カテーテル人工弁の送達、再配置及び回収のための装置及び方法 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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/243—Deployment by mechanical expansion
- A61F2/2433—Deployment by mechanical expansion using balloon catheter
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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
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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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- 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
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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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- 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
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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
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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
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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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
- 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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Abstract
Description
[0001] 本出願は、開示が全体として参照により本明細書に組み入れられる、2015年4月16日に出願された表題「Apparatus and Methods for Delivery, Repositioning, and Retrieval of Transcatheter Prosthetic Valves」の米国特許仮出願第62/148,579号の優先権及び利益を主張するものである。本出願はまた、開示が全体として参照により本明細書に組み入れられる、2016年3月23日に出願された表題「Apparatus and Methods for Delivery, Repositioning, and Retrieval of Transcatheter Prosthetic Valves」の米国特許仮出願第62/312,136号の優先権及び利益を主張するものである。
Claims (38)
- 送達ルーメンを規定する細長いシースを含むカテーテルアセンブリと、
人工心臓弁を内部で受け入れるように構成された内部領域を規定し、前記カテーテルアセンブリのハブに着脱自在に連結されるように構成された先端部分を有する弁保持チューブと、
ハウジング及び送達ロッドを含むハンドルアセンブリであって、前記ハウジングの先端部分が前記弁保持チューブの基端部分に着脱自在に連結されるように構成されていることで、前記送達ロッドの先端が前記人工心臓弁の近位側で前記弁保持チューブの内部領域内で配置される、ハンドルアセンブリと、を備え、
前記送達ロッドが、前記ハウジングに対して遠位側に移動するように作動されて、前記弁保持チューブ内に配置された前記人工心臓弁を前記弁保持チューブから前記カテーテルアセンブリの前記細長いシース内で遠位側へ移動させるように構成され、
前記カテーテルアセンブリが、前記ハウジングに対して近位側に移動するように作動されて、前記人工弁が前記細長いシースのルーメンの外側に配置されるように構成される、装置。 - 前記弁保持チューブ内に配置された時及び前記細長いシース内に配置された時の縮小構成と、非制限で前記細長いシースの外側に配置された時の付勢された拡張性構成と、の間で移動可能である前記人工弁をさらに備える、請求項1に記載の装置。
- 前記ハンドルアセンブリが、前記ハンドルアセンブリの前記ハウジングに対して遠位側に前記送達ロッドを移動させるように作動されるように構成されたアクチュエータを含む、請求項1に記載の装置。
- 前記ハンドルアセンブリが、前記ハウジングに対して近位側に前記細長いシースを移動させるように構成されたアクチュエータを含む、請求項1に記載の装置。
- 前記弁保持チューブ内に配置された人工弁に連結されたテザーを、前記ハンドルアセンブリに対して固定された位置に固着させるように構成されたテザー留置メカニズムをさらに含む、請求項1に記載の装置。
- 前記ハウジングが、ウィンドウを含み、前記送達ロッドが、表面に配置された少なくとも1つのマーキングを含み、前記少なくとも1つのマーキングが、前記ウィンドウを通して観察可能であり、前記送達ロッドが前記人工心臓弁を前記細長いシース内で遠位側に移動するように作動されると、前記人工心臓弁の移動距離を示す、請求項1に記載の装置。
- 前記カテーテルアセンブリの前記ハブがポートを含み、
前記装置が、前記ポートから前記細長いシースのルーメンを通して受け入れられるように構成された拡大デバイスをさらに備え、そのため前記拡大デバイスの拡大部材が前記細長いシースの先端の外側に延在し、
前記拡大部材が、膨張されて前記装置に先細の先端を提供するように構成される、請求項1に記載の装置。 - 前記拡大部材が、先細の部分と、第1径を有する第1部分と、前記第1径よりも大きな第2径を有する第2部分と、を含み、前記第1部分が前記先細の部分と前記第2部分との間にある、請求項7に記載の装置。
- 前記先細の部分が、凹面の外面を有する、請求項8に記載の装置。
- 前記カテーテルアセンブリが作動された時に、前記弁保持チューブが、前記カテーテルアセンブリと共に近位側へ移動するように構成される、請求項1に記載の装置。
- 人工心臓弁を縮小構成で内部に受け入れるように構成された装填漏斗アセンブリと、
人工心臓弁を縮小構成で受け入れるように構成された内部領域を規定し、前記装填漏斗アセンブリに着脱自在に連結されるように構成された第1端部、及び第2端部を有する、弁保持チューブと、
ハンドル及び装填リードスクリューを含むハンドルアセンブリであって、前記装填リードスクリューが、前記弁保持チューブの前記第2端部に着脱自在に連結されるように構成される、ハンドルアセンブリと、を備え、
前記ハンドルアセンブリが、テザー留置メカニズム及びアクチュエータノブをさらに含み、前記テザー留置メカニズムが、前記漏斗アセンブリ内に配置された人工心臓弁から延在するテザーを前記ハンドルアセンブリに対して固定された位置に固着するように構成され、
前記アクチュエータノブが、前記装填リードスクリュー及び前記ハンドルに動作的に連結されることで、前記ハンドルと前記装填リードスクリューとの間の相対的移動で、前記人工弁が前記弁保持チューブ内に配置される、装置。 - 前記ハンドルアセンブリが、心出しロッドをさらに含み、前記心出しロットの端部が、前記漏斗アセンブリ内に配置されるように、そして内部に配置された人工心臓弁の一部の中に配置されるように構成される、請求項11に記載の装置。
- 前記アクチュエータノブが、前記装填リードスクリューを前記テザー留置メカニズムから離れる方向に移動させるように構成されることで、前記弁保持チューブ及び前記漏斗アセンブリが、前記心出しロットに対して移動し、前記人工心臓弁を前記テザー留置メカニズムから離れる方向に移動させるように構成されることで、前記人工心臓弁が前記弁保持チューブの内部領域内に配置される位置に、前記弁保持チューブが移動させられる、請求項11に記載の装置。
- 前記ハンドルが、前記装填リードスクリューに対して前記テザー留置メカニズムに向かう方向に移動させるように構成されることで、前記弁が前記漏斗アセンブリ内に配置される第1位置から、前記弁が前記弁保持チューブの内部領域内に配置される第2位置に、前記弁が前記テザー留置メカニズムに向かう方向に移動させられる、請求項11に記載の装置。
- 前記漏斗アセンブリが、外部漏斗及び内部漏斗を含み、前記人工心臓弁を付勢された拡張構成から縮小構成にするために、前記人工心臓弁が、前記外部漏斗と前記内部漏斗との間に配置可能である、請求項11に記載の装置。
- 前記心出しロッドが、前記漏斗アセンブリ内で前記人工心臓を心出しするように構成される、請求項11に記載の装置。
- 心臓内に留置された人工心臓弁を抜去又は再配置するように構成され、外部シースと、外部拡大器と、内部拡大器と、ハンドルアセンブリと、を含む再捕捉デバイス、を備え、
前記外部シースが第1ルーメンを規定し、
前記外部拡大器が、第2ルーメンを規定し、前記外部シースの前記第1ルーメン内に少なくとも一部が可動的に配置され、
前記内部拡大器が、第3ルーメンを規定し、前記外部拡大器の前記第2ルーメン内に少なくとも一部が可動的に配置され、遠位チップを含み、
前記ハンドルアセンブリが、前記内部拡大器に動作的に連結され、前記外部シースに動作的に連結され、テザー留置メカニズムを含み、前記テザー留置メカニズムが、前記人工心臓弁から延在するテザーを前記ハンドルアセンブリに固着するように構成され、
前記内部拡大器の前記遠位チップが、前記人工心臓弁の近位部分を係合するように構成され、前記人工心臓弁から延在するテザーが、前記テザー留置メカニズムに固着されると、前記内部拡大器が、前記内部拡大器及びテザー留置メカニズムを前記外部拡大器に対して近位側へ移動させるように作動されるように構成されることで、前記人工心臓弁の第1部分が、前記外部拡大器の前記第2ルーメン内に配置され、縮小構成になり、
前記外部シースが、前記外部シースを前記内部拡大器に対して、そして前記外部拡大器に対して遠位側へ移動させるように作動されるように構成されることで、前記人工心臓弁の第1部分の遠位にある前記人工心臓弁の第2部分が、前記外部シースの第1ルーメン内に配置され、縮小構成になる、装置。 - 前記人工心臓弁の第1部分及び前記人工心臓弁の第2部分が、集合的に前記人工心臓弁全体を含むことで、前記人工心臓弁全体が前記外部シース内に配置される、請求項17に記載の装置。
- 前記ハンドルアセンブリが、前記内部拡大器に動作的に連結された第1アクチュエータと、前記外部シースに動作的に連結された第2アクチュエータと、をさらに含み、前記第1アクチュエータが、前記内部拡大器を前記外部拡大器に対して移動させるように構成され、前記第2アクチュエータが、前記外部シースを前記内部拡大器に対して、そして前記外部拡大器に対して移動させるように構成される、請求項17に記載の装置。
- 心臓内に留置された人工心臓弁を抜去又は再配置するように構成され、外部シースと、外部拡大器と、内部拡大器と、ハンドルアセンブリと、を含む再捕捉デバイスを備える装置であって、
前記外部シースが第1ルーメンを規定し、
前記外部拡大器が、第2ルーメンを規定し、前記外部シースの前記第1ルーメン内に少なくとも一部が可動的に配置され、
前記内部拡大器が、前記外部拡大器の前記第2ルーメン内に少なくとも一部が可動的に配置され、遠位チップを含み、
前記ハンドルアセンブリが、前記内部拡大器に動作的に連結され、前記外部拡大器に動作的に連結された、アクチュエータを含み、前記ハンドルアセンブリが、テザー留置メカニズムをさらに含み、前記テザー留置メカニズムが、前記人工心臓弁から延在するテザーを前記ハンドルアセンブリに固着するように構成され、
前記アクチュエータが、前記内部拡大器に連結された第1ばねと、前記外部拡大器に連結された第2ばねと、に動作的に連結された駆動メカニズムを含み、
前記アクチュエータが、作動されると、前記内部拡大器の遠位チップが、前記人工心臓弁の近位部分に係合するように構成され、前記人工心臓弁から延在するテザーが、前記テザー留置メカニズムに固着されると、前記内部拡大器が、前記外部拡大器に対して近位側に移動するように構成されることで、前記人工心臓弁の第1部分が、前記外部拡大器の第2ルーメン内に引込まれ、縮小構成になり、前記外部拡大器が内部拡大器の後に作動されて、前記外部拡大器を前記外部シースに対して近位側へ移動させることで、前記人工心臓弁の第1部分の遠位にある前記人工心臓弁の第2部分が、前記外部シースの第1ルーメン内に引込まれ、縮小構成になる、装置。 - 前記人工心臓弁の前記第1部分及び前記人工心臓弁の前記第2部分が、集合的に前記人工心臓弁全体を含む、請求項20に記載の装置。
- 前記アクチュエータが、さらに前記テザー留置メカニズムに動作的に連結されることで、前記内部拡大器及び前記テザー留置メカニズムが互いに移動するように作動され得る、請求項20に記載の装置。
- 前記アクチュエータが、さらに前記テザー留置メカニズムに動作的に連結され、前記内部拡大器及び前記外部拡大器が作動されると、前記テザーを巻取りハウジング内に巻き取るように構成された駆動シャフトを前記テザー留置メカニズムが含む、請求項20に記載の装置。
- 前記第2ばねが、前記第1ばねと異なるばね定数を有する、請求項20に記載の装置。
- 前記第1ばねがコイルばねを含み、前記第2ばねがテープばねを含む、請求項20に記載の装置。
- 前記第1ばねがコイルばねを含み、前記第2ばねがコイルばねを含む、請求項20に記載の装置。
- 縮小構成で内部に配置された人工心臓弁を有する弁保持チューブを、弁送達デバイスのハンドルアセンブリの先端部分に連結することと、
前記弁保持チューブを前記弁送達デバイスのカテーテルアセンブリのハブに連結することで、前記弁保持チューブが、前記カテーテルアセンブリと前記ハンドルアセンブリとの間に配置されることと、
前記カテーテルアセンブリの先端部分を心臓内へ挿入して、心臓の左心房内へ延設することと、
第1アクチュエータを作動させて、前記カテーテルアセンブリのシースにより規定されるルーメンの先端部分の中へ遠位側へ前記人工心臓弁を移動させることと、
前記第1アクチュエータを作動させた後、第2アクチュエータを作動させて、前記シースを前記ハンドルアセンブリに対して近位側へ移動させることで、前記人工心臓弁が、前記シースの先端の外側及び前記心臓の左心房内に配置されることと、を含む方法。 - 前記人工心臓弁が、前記シースの先端の外側に配置されると、前記人工心臓弁が、付勢された拡張構成をとる、請求項27に記載の方法。
- 前記ハンドルアセンブリが、送達ロッドを含み、前記第1アクチュエータが、前記送達ロッドに動作的に連結され、前記第1アクチュエータを作動させることが、前記送達ロッドを遠位側へ移動させることで、前記送達ロッドが、前記人工心臓弁を前記シースのルーメン内で遠位側へ移動させる、請求項27に記載の方法。
- 前記ハンドルアセンブリが、テザー留置メカニズムを含み、前記方法が、
前記第1アクチュエータを作動させる前に、前記人工心臓弁から延在するテザーを前記テザー留置メカニズムに連結することをさらに含む、請求項27に記載の方法。 - 前記弁保持チューブが、第1端部及び第2端部を含み、前記弁保持チューブを前記ハンドルアセンブリの前記先端部分に前記連結することが、前記弁保持チューブの前記第1端部を前記ハンドルアセンブリの前記先端部分に着脱自在に連結することを含み、
前記弁保持チューブを前記カテーテルアセンブリの前記ハブに前記連結することが、前記弁保持チューブの前記第2端部を前記カテーテルアセンブリの前記ハブに着脱自在に連結することを含む、請求項27に記載の方法。 - 前記カテーテルアセンブリを前記心臓内に挿入する前に、前記カテーテルの前記シースのルーメン内に拡大デバイスを挿入することと、
前記シースの前記先端に外側に配置された前記拡大デバイスの拡大部材を拡張構成に拡張して、前記カテーテルアセンブリが前記心臓内に挿入されると滑らかな移行部を提供することと、をさらに含む、請求項27に記載の方法。 - 前記第2アクチュエータを前記作動させた後、前記第1アクチュエータを作動させて、前記送達ロッドを遠位側へ移動させて、前記送達ロッドのルーメン内で前記人工弁の一部を再捕捉することをさらに含む、請求項29に記載の方法。
- 前記第2アクチュエータを作動させた後、前記第2アクチュエータを反対方向に作動させて、前記シースを前記ハンドルアセンブリに対して遠位側へ移動させ、前記シースのルーメン内で前記人工弁の一部を再捕捉することをさらに含む、請求項27に記載の方法。
- 人工心臓弁を弁装填デバイスの漏斗アセンブリ内に配置することと、
前記人工心臓弁を前記漏斗アセンブリ内で付勢された拡張構成から圧縮構成に移行することと、
弁保持チューブを前記漏斗アセンブリに連結することと、
前記弁保持チューブを前記弁装填デバイスのハンドルアセンブリに連結することと、
前記人工心臓弁に連結されたテザーを、前記弁装填デバイスの前記ハンドルアセンブリに着脱自在に連結することと、
前記ハンドルアセンブリに連結されたアクチュエータを作動させて、前記弁保持チューブを前記ハンドルアセンブリに対して移動させることで、前記人工心臓弁が、もはや前記漏斗アセンブリ内に配置されなくなり、前記人工心臓弁を前記圧縮構成に維持しながら、前記弁保持チューブの内部領域内に配置されることと、を含む方法。 - 前記作動させた後、前記弁保持チューブを前記漏斗アセンブリから切り離して、前記弁保持チューブを、前記弁保持チューブの内部領域内に前記圧縮構成で配置された前記人工心臓弁と共に、前記ハンドルアセンブリから切り離すことをさらに含む、請求項35に記載の方法。
- 前記作動させることが、前記弁保持チューブ及び前記漏斗アセンブリを、前記ハンドルアセンブリに対して、そして前記人工心臓弁に対して移動させることを含むことで、前記人工心臓弁が、前記弁保持チューブの前記内部領域内に配置される、請求項35に記載の方法。
- 回収デバイスを心臓内に挿入し、前記回収デバイスの遠位チップを前記心臓内に植込まれた人工心臓弁の近位側に配置することであって、前記回収デバイスが、外部拡大器のルーメン内に可動的に配置された内部拡大器を含み、前記外部拡大器が外部シースのルーメン内に少なくとも一部が配置されることと、
前記回収デバイスの第1アクチュエータを作動させて、前記内部拡大器を近位側へ移動させることで、前記人工心臓弁の第1部分が、前記外部拡大器のルーメン内に縮小構成で配置されることと、
前記回収デバイスの第2アクチュエータを作動させて、前記外部シースを前記外部拡大器及び前記内部拡大器に対して遠位側へ移動させることで、前記人工心臓弁の第2部分が、前記外部シースのルーメン内に縮小構成で配置され、前記第2部分が、前記人工心臓弁の前記第1部分の遠位になることと、
前記回収デバイスを前記外部シースのルーメン内に配置された前記人工心臓弁と共に前記心臓から抜去することと、を含む方法。
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Also Published As
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AU2016248314A1 (en) | 2017-11-02 |
JP6694948B2 (ja) | 2020-05-20 |
WO2016168609A1 (en) | 2016-10-20 |
CN107750150A (zh) | 2018-03-02 |
CN107750150B (zh) | 2021-03-05 |
JP2020078584A (ja) | 2020-05-28 |
JP6853905B2 (ja) | 2021-03-31 |
ES2818128T3 (es) | 2021-04-09 |
CA2983002A1 (en) | 2016-10-20 |
AU2016248314B2 (en) | 2020-05-21 |
EP3695810B1 (en) | 2022-05-18 |
US10667905B2 (en) | 2020-06-02 |
US20180028314A1 (en) | 2018-02-01 |
EP4070763A1 (en) | 2022-10-12 |
US11523902B2 (en) | 2022-12-13 |
CA2983002C (en) | 2023-07-04 |
EP3283010B1 (en) | 2020-06-17 |
EP3695810A1 (en) | 2020-08-19 |
US20200246143A1 (en) | 2020-08-06 |
EP3283010A1 (en) | 2018-02-21 |
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