JP4942031B2 - 特に大動脈弁狭窄症の治療における経動脈的デリバリに適した移植可能な人工補綴装置、及び同人工補綴装置を移植する方法 - Google Patents
特に大動脈弁狭窄症の治療における経動脈的デリバリに適した移植可能な人工補綴装置、及び同人工補綴装置を移植する方法Info
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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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/958—Inflatable balloons for placing stents or stent-grafts
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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
- A61F2/2418—Scaffolds therefor, e.g. support stents
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- A—HUMAN NECESSITIES
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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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
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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
- 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
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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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
- A61F2/97—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve the outer sleeve being splittable
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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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2002/068—Modifying the blood flow model, e.g. by diffuser or deflector
-
- 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
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/005—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
-
- 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
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0058—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements soldered or brazed or welded
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Description
本発明の他の特徴及び利点は、以下の説明から明らかとなるであろう。
上記図面及び以下の説明は、主として本発明の概念的態様及び現時点で好ましい実施形態であると考えられるものを含む本発明の様々な可能な実施形態の理解を容易にするために提供されているものであることは理解されるべきである。簡明化の利益にあたって、当業者が通常の技術及び設計を用いて記載された発明を理解し且つ実施することを可能とさせるのに必要である以上の詳細を提供しようとするものではない。さらに、記載される実施形態は例示のためのものに過ぎず、本発明が本願に記載されている以外の形態及び用途で具体化され得ることは理解されるべきである。
上述したように、本発明は、主として、大動脈狭窄症の利用において使用するための人工補綴装置を疾患大動脈弁へ移植することに向けたものである。この人工補綴装置は、左心室と大動脈との間の圧力勾配を減少させて心臓にかけられる仕事量を軽減するために、血液の圧力回復を助けるように設計されている。図2は、本発明による人工補綴装置の一つの構造を線図で示しており、図1a〜図1cは、深刻な大動脈狭窄症を患った大動脈弁によって心臓にかけられる仕事量を軽減させるためにこのような人工補綴装置が使用される様子を線図で示している。
前に指摘したように、本発明に従って構成された人工補綴装置は、また、発散錘状部分5の遠位端部DEに、人工補綴装置と共に移植される人工弁を備えていることが好ましい。しかしながら、用途によっては、人工補綴装置が人工弁なしで移植されてもよく、人工弁が続く第2の工程で人工補綴装置の大動脈下流側に移植されてもよいことは予期される。
このように、図5の断面図において特に示されているように、図示される人工補綴装置は、カテーテルを介して移植部位(この場合、大動脈閉塞によって影響を受ける大動脈弁輪又は大動脈弁口)に経動脈的に送達できるように、拡張可能な金属製ベース10(例えば、メッシュ構造のもの)を備える。図示される人工補綴装置は、さらに、例えば可撓性ポリマ材料又は他の生体適合性材料からなる内側エンベロープ(内包体)11を備え、内側エンベロープ11で金属製ベース10の全内側表面を覆っている。
図9は、図4〜図8に関して上記で説明したものと類似の人工補綴装置であり、したがって理解を容易にするために、対応する部分は同じ参照番号によって識別されている。図9に示されている人工補綴装置の主たる相違点は複数の支え要素20が設けられていることであり、これら支え要素20は、金属製ベース10の遠位端部DEによって担持されており、人工補綴装置、特にその遠位端部を補強するために図10に示されているように大動脈内で大動脈の内側表面と係合可能である。
図12〜図14は、金属製ベースが大動脈弁輪に取り付けられた人工補綴装置の喉部分(図2の参照番号2)のみを占める点、すなわち図12〜図14において参照番号110によって示されている金属製ベースが人工補綴装置の発散錘状部分(図2の参照番号5)まで延びていない又は当該発散錘状部分の一部を構成していない点において、上述したものと大きく異なっている人工補綴装置を示している。人工補綴装置の発散錘状部分(図2の参照番号5)は、図12〜図14において参照番号111によって示されているエンベロープによってのみ占められており、このプラスチック製エンベロープが人工弁としても機能している。よって、心収縮期に、エンベロープ111が開き、エンベロープの遠位端部における圧力回復によって大動脈への非乱流血流を生じさせるように、発散していく錘状形態をとる。これに対して、心拡張期には、エンベロープ111が潰れて、中の流れを妨げる。
上記で指摘したように、本発明の人工補綴装置は、身体の通路壁に形成された開口に移植されることを意図されたものである。したがって、本発明の人工補綴装置は、身体通路を介して移植部位に送達するのに適した圧縮された状態を有し且つ移植部位で開口への移植に適した拡張された状態に拡張できるように構成されている。上述した本発明の好ましい実施形態は、患者の心臓の大動脈弁輪への移植を意図したものであるので、大動脈弁輪への経動脈デリバリ(経動脈送達)及び大動脈弁輪への移植のための大動脈弁輪での拡張に適するように構成されている。
図15a〜図15hは、単一のシース(鞘状体)を用いて例えば図2の人工補綴装置を展開する方法を図式的に示しているのに対して、図16a〜図16fは図11に示されている構成の人工補綴装置すなわち環状配列の支え要素40を備えている人工補綴装置を展開するために使用される方法を示している。
図17a〜図17hは、人工補綴装置の展開の2シース法を図解している。例示のため、この人工補綴装置は上述した図4〜図8に示されているものである。
Claims (24)
- 患者の心臓の大動脈閉塞症の治療のために使用する、人工補綴装置であって、
前記人工補綴装置は、拡張可能に構成されて、経動脈デリバリのための圧縮された状態と移植のための拡張された状態とを有し、
前記人工補綴装置は、
前記人工補綴装置の前記拡張された状態で大動脈弁輪に移植できるように構成された、拡張可能な支え要素と、
内側エンベローブであって、
前記支え要素の前記内側表面を覆う上流部分、及び、下流部分を有し、
前記下流部分が、前記人工補綴装置が前記拡張された状態にあるとき、大動脈内に延びて、かつ、上流端から下流端に向かって徐々に増加する直径を有する発散鐘状部分を規定し、前記発散鐘状部分は、心収縮期に発散鐘状部分の前記下流端で圧力回復を伴って前記大動脈の中へ非乱流血流を生成するように構成されている、内側エンベローブと、
前記発散鐘状部分の前記下流端で前記内側エンベロープの前記下流部に連結された人工弁と、
を備えた人工補綴装置。 - 前記支え要素は、弁口取付部材を含み、軸線方向に延び且つ前記弁口取付部材の近傍に取り付けられる互いに離間した複数のストラットをさらに備え、該ストラットは前記発散部材の少なくとも一部を覆って遠位方向に延びている、請求項1に記載の人工補綴装置。
- 前記ストラットは、該ストラットの遠位端部が該ストラットの近位端部よりも互いから遠くに配置されるように外方に拡がっている、請求項2に記載の人工補綴装置。
- 前記発散部材は、前記開いた位置のときに、錘状になっている、請求項1に記載の人工補綴装置。
- 前記発散部材は、心収縮期に、人工補綴装置内での流れの剥離及び圧力低下を抑止するように、発散していく形態に開くように構成されている、請求項1に記載の人工補綴装置。
- 前記発散部材は、心収縮期に、流れの剥離を抑止し且つ圧力回復をするように、発散していく形態に開くように構成されている、請求項1に記載の人工補綴装置。
- 前記発散部材は心拡張期に潰れて内部の流れを遮断する、請求項1に記載の人工補綴装置。
- 前記発散部材は、連続的なライナとして形成された漏斗形状の支持構造を含んでいる、請求項1に記載の人工補綴装置。
- 前記支え要素は、弁口取付部材を含み、前記弁口取付部材は、弁口の近傍に前記弁の両側を留めるように構成された留め具部材である、請求項1に記載の人工補綴装置。
- 前記支え要素は、弁口取付部材を含み、前記弁口取付部材は、前記弁を取り囲む大動脈弁輪の両側に係合するように構成された留め具部材である、請求項1に記載の人工補綴装置。
- 前記支え要素は、弁口取付部材を含み、前記弁口取付部材の一部が、前記弁よりも遠位側に配置され且つ大動脈洞と係合するように構成されている、請求項1に記載の人工補綴装置。
- 前記支え要素は、弁口取付部材を含み、前記弁口取付部材は、生来の弁小葉と係合するように構成された環状クランプ部である、請求項1に記載の人工補綴装置。
- 前記流入口は遠位側において非発散形態である、請求項1に記載の人工補綴装置。
- 前記発散部材に配置される人工弁をさらに備え、前記人工弁は、前記発散部材内を流れる流体の流れを制御するように構成されている、請求項1に記載の人工補綴装置。
- 前記発散部材の遠位端部に、血管の内側表面と係合可能な環状配列の支え要素をさらに備える、請求項1に記載の人工補綴装置。
- 内部に単一の血流場を有した血流要素を備える人工補綴装置を備える機器であって、
前記血流要素が、
流入口と、
前記流入口から下流方向に延びる喉部分であって、該喉部分の長手方向で最も狭い部位において、前記喉部分を通る血液の圧力の減少を引き起こす第1の断面積を有している喉部分と、
前記喉部分から下流方向に延びる発散部分であって、前記発散部分の下流端部の近傍において、前記喉部分において損失する圧力の少なくとも一部の回復を前記発散部分において生じさせ且つ前記第1の断面積よりも大きい第2の断面積を有し、かつ前記下流方向に向かって徐々に増加する直径を有して、前記発散部分の下流端で人工弁と連結された発散部分と、
を備える機器。 - 前記発散部分の最も下流側の部分は、大動脈洞内に配置されるように構成されている、請求項16に記載の機器。
- 前記人工補綴装置は、前記発散部分が患者の大動脈内に収容されるように、血流要素を患者の大動脈弁に結合するように構成された取付部材を備える、請求項16に記載の機器。
- 前記流入口は、その上流端部において、内部の血流に関して、第3の断面積を有し、該第3の断面積は、前記喉部分の前記第1の断面積よりも大きい、請求項16に記載の機器。
- 前記人工補綴装置は、前記喉部分が開いている間に圧力の回復が起こるように構成されている、請求項16に記載の機器。
- 前記人工補綴装置は、前記発散部分の少なくとも一部に沿って軸線方向に延びる複数のストラットを備えている、請求項16に記載の機器。
- 前記発散部分の少なくとも一部は、心収縮期に開くように構成されている、請求項16に記載の機器。
- 前記発散部分の少なくとも一部は、順流れの際に開き且つ逆流を抑制するように閉じるように構成されている、請求項16に記載の機器。
- 前記人工補綴装置は、複数の前記支え要素を備え、前記複数の前記支え要素は、前記発散部分の下流端部に結合され且つ患者の大動脈の内側表面に係合する、請求項16に記載の機器。
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US48515603P | 2003-07-08 | 2003-07-08 | |
US60/485,156 | 2003-07-08 | ||
PCT/IL2004/000601 WO2005002466A2 (en) | 2003-07-08 | 2004-07-06 | Implantable prosthetic devices particularly for transarterial delivery in the treatment of aortic stenosis, and methods of implanting such devices |
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JP4942031B2 true JP4942031B2 (ja) | 2012-05-30 |
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US (1) | US7429269B2 (ja) |
EP (1) | EP1648339B2 (ja) |
JP (1) | JP4942031B2 (ja) |
KR (1) | KR20060112705A (ja) |
CN (1) | CN1849102B (ja) |
AU (1) | AU2004253375B2 (ja) |
BR (1) | BRPI0412362A (ja) |
CA (1) | CA2531528C (ja) |
NO (1) | NO20060588L (ja) |
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- 2004-07-06 JP JP2006518487A patent/JP4942031B2/ja not_active Expired - Fee Related
- 2004-07-06 RU RU2006103367/14A patent/RU2006103367A/ru not_active Application Discontinuation
- 2004-07-06 KR KR1020067000423A patent/KR20060112705A/ko not_active Application Discontinuation
- 2004-07-06 BR BRPI0412362-0A patent/BRPI0412362A/pt not_active Application Discontinuation
- 2004-07-06 EP EP04744941.8A patent/EP1648339B2/en not_active Expired - Lifetime
- 2004-07-06 CN CN2004800256667A patent/CN1849102B/zh not_active Expired - Fee Related
- 2004-07-06 CA CA2531528A patent/CA2531528C/en not_active Expired - Fee Related
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Also Published As
Publication number | Publication date |
---|---|
KR20060112705A (ko) | 2006-11-01 |
CA2531528A1 (en) | 2005-01-13 |
AU2004253375A2 (en) | 2005-01-13 |
WO2005002466A2 (en) | 2005-01-13 |
EP1648339A2 (en) | 2006-04-26 |
US20060259134A1 (en) | 2006-11-16 |
CN1849102B (zh) | 2011-01-19 |
EP1648339A4 (en) | 2011-03-16 |
EP1648339B1 (en) | 2013-02-20 |
NO20060588L (no) | 2006-04-10 |
AU2004253375A1 (en) | 2005-01-13 |
JP2007526789A (ja) | 2007-09-20 |
RU2006103367A (ru) | 2006-06-27 |
US7429269B2 (en) | 2008-09-30 |
WO2005002466A3 (en) | 2005-03-03 |
CA2531528C (en) | 2013-09-03 |
CN1849102A (zh) | 2006-10-18 |
EP1648339B2 (en) | 2020-06-17 |
AU2004253375B2 (en) | 2011-07-14 |
BRPI0412362A (pt) | 2006-09-05 |
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