JP2019517289A - 隔壁貫通孔閉鎖先端アセンブリを備えた経カテーテル弁送達システム - Google Patents
隔壁貫通孔閉鎖先端アセンブリを備えた経カテーテル弁送達システム Download PDFInfo
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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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/243—Deployment by mechanical expansion
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
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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
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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
- A61F2/2427—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
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3478—Endoscopic needles, e.g. for infusion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00238—Type of minimally invasive operation
- A61B2017/00243—Type of minimally invasive operation cardiac
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00238—Type of minimally invasive operation
- A61B2017/00243—Type of minimally invasive operation cardiac
- A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00579—Barbed implements
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00588—Rigid or stiff implements, e.g. made of several rigid parts linked by hinges
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/0061—Implements located only on one side of the opening
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00619—Locking means for locking the implement in expanded state
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00623—Introducing or retrieving devices therefor
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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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0008—Fixation appliances for connecting prostheses to the body
- A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
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- Heart & Thoracic Surgery (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Vascular Medicine (AREA)
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- Mechanical Engineering (AREA)
- Prostheses (AREA)
Abstract
Description
Claims (20)
- ステント付き人工心臓弁を埋め込むための送達デバイスであって、
遠位領域を有する支持シャフトと、
前記支持シャフトに連結されており、かつ前記ステント付き人工心臓弁を保持するように構成されている、保持アセンブリと、
前記保持アセンブリの遠位部の前記支持シャフトの前記遠位領域に取り外し可能に連結されている先端アセンブリと、を備え、
前記ステント付き人工心臓弁のインビボでの取り外しを可能にするように、及び個別の操作で、前記送達デバイスの残りから前記先端アセンブリのインビボでの取り外しを駆動するように構成されている、
送達デバイス。 - 前記先端アセンブリが送達状態から留置状態まで移行するように構成されており、更に、前記留置状態にある前記先端アセンブリの最大外径が、前記送達状態にある最大外径よりも大きい、請求項1に記載の送達デバイス。
- 前記先端アセンブリが、前記留置状態において、組織と係合するように構成されている、請求項2に記載の送達デバイス。
- 前記先端アセンブリが、前記留置状態にあり、前記送達デバイスの残りから取り外されると、心臓の隔壁の貫通孔の上から埋め込むように構成されている、請求項2に記載の送達デバイス。
- 前記先端アセンブリが、
近位側面、遠位側面及び空洞を画定する、ハウジングと、
前記ハウジングにスライド可能に接続されたアームアセンブリと、を含み、
前記先端アセンブリが、送達状態から留置状態まで移行するように構成されており、更に、前記送達状態が、前記空洞内に配設されている前記アームアセンブリの長さの少なくとも大部分を含み、前記留置状態が、前記空洞の外側側面の前記ハウジングから突き出た前記アームアセンブリの前記長さの少なくとも大部分を含む、
請求項1に記載の送達デバイス。 - 前記ハウジングが、前記送達状態における前記先端アセンブリの最大外径を画定し、前記アームアセンブリが、前記留置状態における前記先端アセンブリの最大外径を画定し、更に前記留置状態の前記先端アセンブリの前記最大外径が、前記送達状態の前記先端アセンブリの前記最大外径よりも大きい、請求項5に記載の送達デバイス。
- 前記アームアセンブリが、複数のアームを含み、更に前記アームが、前記送達状態では長手方向に配置されており、更に前記アームが、前記留置状態では横方向に配置されている、請求項5に記載の送達デバイス。
- 前記アームアセンブリが、複数のアーム及び複数の戻り部を含んでおり、更に前記戻り部の少なくとも1つが、前記アームの1つずつに取り付けられて、そこから延在している、請求項5に記載の送達デバイス。
- 前記送達状態が、前記空洞内に配設されている前記戻り部を含み、更に前記留置状態が、組織に係合するため、前記空洞の外側側面に配置されている前記戻り部を含む、請求項8に記載の送達デバイス。
- 前記アームアセンブリが、スカートを維持する複数のアームを含む、請求項5に記載の送達デバイス。
- 前記先端アセンブリが、前記ハウジングにより運搬されるシールを更に含む、請求項10に記載の送達デバイス。
- 前記先端アセンブリが、一般に、円錐形状しているハウジングを含む、請求項1に記載の送達デバイス。
- 経中隔アプローチにより欠陥心臓弁を処置するためのシステムであって、
前記システムが、
遠位領域を有する支持シャフトと、
前記支持シャフトに連結している保持アセンブリと、
前記支持シャフトの前記遠位領域に取り外し可能に連結されている先端アセンブリと、を含む、送達デバイスと、
前記支持シャフト上で圧縮され、前記送達デバイスの装填配置にある前記保持アセンブリによって保持されている、ステント付き人工心臓弁と、を含み、
前記送達デバイスが、前記ステント付き人工心臓弁、及び前記送達デバイスの残りから前記先端アセンブリをインビボで取り外すことが可能になるように構成されている、システム。 - 前記送達デバイスが外側シースを含み、更に、前記送達デバイスが、前記外側シースの遠位端部が前記先端アセンブリの近位かつ前記ステント付き人工心臓弁の上にある装填配置から、前記外側シースの遠位端部が、前記ステント付き人工心臓弁の近位にある弁留置配置まで移行して、前記送達デバイスから前記人工心臓弁の留置を可能にする、請求項13に記載のシステム。
- 前記先端アセンブリが、送達状態から留置状態まで移行するように構成されている、請求項14に記載のシステムであって、前記留置状態にある前記先端アセンブリの最大外径が、前記送達状態にある前記最大外径よりも大きく、更に前記先端アセンブリが、前記装填配置と前記弁留置配置の両方において、前記送達状態にある、システム。
- 前記先端アセンブリが、前記留置状態にあり、前記送達デバイスの残りから取り外されると、心臓の隔壁の貫通孔を埋め込むように構成されている、請求項15に記載のシステム。
- 前記先端アセンブリが、
近位側面、遠位側面及び空洞を画定する、ハウジングと、
前記ハウジングにスライド可能に接続されたアームアセンブリと、を含み、
前記先端アセンブリが、送達状態から留置状態まで移行するように構成されており、更に、前記送達状態が、前記空洞内に配設されている前記アームアセンブリの長さの少なくとも大部分を含み、前記留置状態が、前記空洞の外側側面の前記ハウジングから突き出た前記アームアセンブリの長さの少なくとも大部分を含む、請求項13に記載のシステム。 - 患者の欠陥心臓弁を処置する方法であって、
ステント付き人工心臓弁を維持し、かつ前記人工心臓弁に隣接して遠位にある先端アセンブリを有する支持シャフトを含む、送達デバイスを用意することと、
前記患者の心臓の隔壁に貫通孔を形成することと、
前記貫通孔から、前記先端アセンブリ及び前記ステント付き人工心臓弁を向かわせることと、
前記送達デバイスから前記人工心臓弁を留置して、前記欠陥心臓弁に前記人工心臓弁を埋め込むことと、
前記隔壁の前記貫通孔に前記先端アセンブリを埋め込むことと、
を含む、方法。 - 前記先端アセンブリを埋め込むことが、前記先端アセンブリを送達状態から留置状態に移行させることを含み、前記送達状態における前記先端アセンブリの最大外径が、前記貫通孔の直径より小さく、前記留置状態における前記先端アセンブリの最大外径が、前記貫通孔の前記直径よりも大きい、請求項18に記載の方法。
- 前記先端アセンブリを埋め込んだ後に、前記支持シャフトから前記先端アセンブリを取り外すことを更に含む、請求項18に記載の方法。
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US201662344869P | 2016-06-02 | 2016-06-02 | |
US62/344,869 | 2016-06-02 | ||
PCT/US2017/035304 WO2017210356A1 (en) | 2016-06-02 | 2017-05-31 | Transcatheter valve delivery system with septum hole closure tip assembly |
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JP2019517289A true JP2019517289A (ja) | 2019-06-24 |
JP2019517289A5 JP2019517289A5 (ja) | 2020-04-16 |
JP6987790B2 JP6987790B2 (ja) | 2022-01-05 |
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US (2) | US10449044B2 (ja) |
EP (2) | EP3791828B1 (ja) |
JP (1) | JP6987790B2 (ja) |
CN (2) | CN111759368B (ja) |
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CA3050938C (en) | 2004-10-02 | 2021-10-19 | Edwards Lifesciences Cardiaq Llc | Methods and devices for repair or replacement of heart valves or adjacent tissue without the need for full cardiopulmonary support |
EP1951352B1 (en) | 2005-11-10 | 2017-01-11 | Edwards Lifesciences CardiAQ LLC | Balloon-expandable, self-expanding, vascular prosthesis connecting stent |
WO2008013915A2 (en) | 2006-07-28 | 2008-01-31 | Arshad Quadri | Percutaneous valve prosthesis and system and method for implanting same |
EP2367505B1 (en) | 2008-09-29 | 2020-08-12 | Edwards Lifesciences CardiAQ LLC | Heart valve |
EP2810620B1 (en) | 2009-04-15 | 2022-09-14 | Edwards Lifesciences CardiAQ LLC | Vascular implant and delivery system |
US8579964B2 (en) | 2010-05-05 | 2013-11-12 | Neovasc Inc. | Transcatheter mitral valve prosthesis |
EP3061422B1 (en) | 2010-06-21 | 2021-11-03 | Edwards Lifesciences CardiAQ LLC | Replacement heart valve |
WO2012040655A2 (en) | 2010-09-23 | 2012-03-29 | Cardiaq Valve Technologies, Inc. | Replacement heart valves, delivery devices and methods |
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 |
US9730791B2 (en) | 2013-03-14 | 2017-08-15 | Edwards Lifesciences Cardiaq Llc | Prosthesis for atraumatically grasping intralumenal tissue and methods of delivery |
US20140277427A1 (en) | 2013-03-14 | 2014-09-18 | Cardiaq Valve Technologies, Inc. | Prosthesis for atraumatically grasping intralumenal tissue and methods of delivery |
US9572665B2 (en) | 2013-04-04 | 2017-02-21 | Neovasc Tiara Inc. | Methods and apparatus for delivering a prosthetic valve to a beating heart |
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US10449044B2 (en) | 2019-10-22 |
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WO2017210356A1 (en) | 2017-12-07 |
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EP3463192A1 (en) | 2019-04-10 |
US11273035B2 (en) | 2022-03-15 |
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