JP6679558B2 - 弁置換装置 - Google Patents
弁置換装置 Download PDFInfo
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- JP6679558B2 JP6679558B2 JP2017226655A JP2017226655A JP6679558B2 JP 6679558 B2 JP6679558 B2 JP 6679558B2 JP 2017226655 A JP2017226655 A JP 2017226655A JP 2017226655 A JP2017226655 A JP 2017226655A JP 6679558 B2 JP6679558 B2 JP 6679558B2
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- 238000006073 displacement reaction Methods 0.000 claims description 7
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- 238000003780 insertion Methods 0.000 description 8
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- HLXZNVUGXRDIFK-UHFFFAOYSA-N nickel titanium Chemical compound [Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni] HLXZNVUGXRDIFK-UHFFFAOYSA-N 0.000 description 2
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Classifications
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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
- A61F2/2412—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
-
- 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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- 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
- A61F2/2415—Manufacturing methods
-
- 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
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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
- A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
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- 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
- A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0004—Rounded shapes, e.g. with rounded corners
- A61F2230/001—Figure-8-shaped, e.g. hourglass-shaped
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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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0004—Rounded shapes, e.g. with rounded corners
- A61F2230/0013—Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
-
- 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
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
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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
- 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
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Vascular Medicine (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Manufacturing & Machinery (AREA)
- Prostheses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Surgical Instruments (AREA)
Description
大まかに言えば、本発明の1つの局面は、少なくとも2つの弁尖を有する弁構成要素(および/または生体弁)を含む心臓弁置換のための装置を提供する。ここで「弁構成要素」という用語は、弁尖が互いにしっかりと固定されて他の構成要素から独立した単一の弁構造を規定しているか否かに関わらず、弁尖を総称するために用いられる。
/または管状であり得る。弁尖は、ステント構成要素の内側で内部空間に及ぶように配置される。弁置換装置を患者の生来の弁の近くの目標位置に位置決めすると、ステント構成要素が機能状態へと拡張する。好ましくは、ステント構成要素は、ステント要素が拡張すると装置を心臓血管内にしっかりと取付けることを可能にするアンカー固定要素をさらに含み得る。
れるように、および/または弁輪の心室側に延在するように構成される。
(i)各アイレット内に受け入れ可能な突出部を含み得、突出部は、ステント構成要素が折畳状態にあるときに、突出部がアイレット内に捕捉され、隣接する支柱同士の間を通過することができないように寸法決めされ得、および/または、
(ii)少なくともステント構成要素が折畳状態にあるときに、取付要素を実質的に内部に収容するための1つ以上の凹部または隙間
を含み得る。
るように選択される。好ましくは開口部は、たとえば2つの隣接する弁尖の2つのタブを挿入可能であるように適合される。代替的に、交連ポストは2つ以上のそのような開口部を含み得る。このように、各外縁に2つのタブなどのより多いタブを有する弁尖の取付が交連ポストに取付けられ得る。さらなる代替例では、交連ポストは、隣接する弁尖のタブの各々を別個の開口部に挿入可能であるように、互いに平行に配置された2つの開口部を含み得る。タブは好ましくは開口部に挿入され、交連ポスト上で弁尖に向けて折返され、弁尖に縫合される。
ましくは大腿動脈または鎖骨下動脈に沿って挿入することが可能になる。これによってさらに、小さな皮膚切開および/または心臓壁の切込を用いて弁置換装置を経心尖挿入することが可能になる。
(i)各アイレット内に受け入れ可能な突出部を含み得、突出部は、ステントが折畳状態にあるときに、突出部がアイレット内に捕捉され、隣接する支柱同士の間を通過することができないように寸法決めされ得、および/または、
(ii)少なくともステントが折畳状態にあるときに、取付要素を実質的に内部に収容するための1つ以上の凹部または隙間
を含み得る。
開放および/または自己解放取付を提供し得る。
に、内側スカートは、ステント構成要素の流出末端に向かって外側スカートが延在するよりも延在し得る。
ートは任意に、互いに同一材料からなり得る。
。下縁は自由縁よりも短い。好ましくは、下縁も湾曲しており、より好ましくは凸状湾曲である。「凸状」という用語は、弁尖の表面に対する弁尖の縁の湾曲を定義すると理解すべきである。したがって、凸状に湾曲した縁は弁尖から隆起する。
ってマンドレルは、管状スカートに特定の形を付加的に与え得る。特に好ましい実施例では、マンドレルはスカート上の円周方向の隆起を与える。少なくとも2つの弁尖を管状スカートに取付ける際、管状スカートはマンドレル上に存在し続け得る。
に、自身の近位端で直接的に取付けられる。近位端から開始して、アーチ21は自身の長さの一部にわたって半径方向外側に分岐し、自身の遠位端に向かって半径方向内側に集まる。以下、「遠位」および「近位」という用語は、心臓からより離れてまたはより近接して存在する弁置換装置15またはその構成要素の部分をそれぞれ指すために用いられる。遠位端は大動脈端とも称され、近位端は心室端とも称される。
押込むことになる方向において取付要素25が軸方向に変位しないようにさらに保護する。
Claims (14)
- 経カテーテル埋込のための弁置換装置であって、
流入末端を有する流入部と、中間部と、流出末端を有する流出部とを有するステント構成要素を備え、前記流入部の最大直径は前記流出部の最大直径よりも小さく、前記中間部は、前記流入部および前記流出部のいずれか一方の前記最大直径よりも小さい直径を有しており、前記ステント構成要素は、埋込部位への送達のための圧縮状態へと半径方向に圧縮可能であるとともに、機能状態へと半径方向に拡張可能であり、前記ステント構成要素は、送達装置と嵌合係合するための少なくとも1つの取付要素をさらに含み、前記弁置換装置はさらに、
前記ステント構成要素の内部に少なくとも部分的に装着された弁尖と、
ブタの心膜組織の内側スカートおよび外側スカートとを備え、前記内側スカートは前記弁尖に取付けられており、扇形の間隙によって間隔を空けられた交連部分を有しており、各間隙にはそれぞれの弁尖がまたがっており、前記内側スカートは前記流入末端に向かって前記ステント構成要素の内部に少なくとも部分的に延在しており、前記外側スカートは前記ステント構成要素の外部に少なくとも部分的に延在し、前記弁置換装置はさらに、
心臓において前記弁置換装置を挿入するための送達装置を備え、前記送達装置は、圧縮状態の前記弁置換装置を収容するための収容領域を有する遠位部を備え、前記送達装置は、前記弁置換装置が軸方向に動かないように前記弁置換装置を抑制するために、前記ステント構成要素の前記少なくとも1つの取付要素と嵌合係合するための前記収容領域に設けられたステントホルダをさらに備える、弁置換装置。 - 前記流入部は20mmから35mmの範囲内の最大直径を有しており、前記流出部は20mmから55mmの範囲内の最大直径を有している、請求項1に記載の装置。
- 前記ステント構成要素は自己拡張可能である、請求項1または2に記載の装置。
- 前記内側スカートおよび前記外側スカートは、軸方向において部分的に重なり合う、請求項1から3のいずれか1項に記載の装置。
- 前記軸方向におけるスカートの重なり合いの程度は、少なくとも8mmである、請求項4に記載の装置。
- 前記外側スカートは、前記ステント構成要素の前記流入末端に向かって前記内側スカートが延在するよりもさらに延在する、請求項1から5のいずれか1項に記載の装置。
- 前記内側スカートは、前記ステント構成要素の前記流出末端に向かって前記外側スカートが延在するよりもさらに延在する、請求項1から6のいずれか1項に記載の装置。
- 前記外側スカートは、前記弁尖のいずれの部分とも重なり合わない、請求項1から7のいずれか1項に記載の装置。
- 前記弁尖は前記内側スカートの内部に取付けられる、請求項1から8のいずれか1項に記載の装置。
- 前記内側スカートおよび前記外側スカートは同一材料からなる、請求項1から9のいずれか1項に記載の装置。
- 前記流入部は少なくとも部分的に円錐形の本体を含む、請求項1から10のいずれか1項に記載の装置。
- 取付要素の数はちょうど2つである、請求項1から11のいずれか1項に記載の装置。
- 前記弁尖の外縁および/または下縁が縫合によって前記内側スカートに取付けられる、請求項1から12のいずれか1項に記載の装置。
- 前記弁尖はブタの心膜組織からなる、請求項1から13のいずれか1項に記載の装置。
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