JP4636794B2 - 金属または擬似金属構造を有する弁状人工器官および製造方法 - Google Patents
金属または擬似金属構造を有する弁状人工器官および製造方法 Download PDFInfo
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- JP4636794B2 JP4636794B2 JP2003509959A JP2003509959A JP4636794B2 JP 4636794 B2 JP4636794 B2 JP 4636794B2 JP 2003509959 A JP2003509959 A JP 2003509959A JP 2003509959 A JP2003509959 A JP 2003509959A JP 4636794 B2 JP4636794 B2 JP 4636794B2
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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
- 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
- A61F2/2475—Venous valves
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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
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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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- 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
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/005—Rosette-shaped, e.g. star-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
- 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
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/0054—V-shaped
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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
- A61F2230/0073—Quadric-shaped
- A61F2230/0078—Quadric-shaped hyperboloidal
Description
先行技術には、経皮的人工弁に本質的に必要な、ある共通のデバイス、すなわち、拡張可能なステントセグメント、アンカー固定(anchoring)セグメント、および流量調節セグメントが開示されている。
本発明の心腔−血管間CV構成の特定の実施形態による、埋込み可能な人工器官または人工弁の全体を、図1〜図5に示す。心腔−血管間用の弁ステント10は、拡張可能なステント本体部材12とグラフト部材11とからなる。ステント本体部材12が、形状記憶および/または超弾性のニチノール材料、あるいは熱機械的に(thermomechanically)類似の材料から作製されることが好ましいが、ステンレス鋼、チタン、タンタルなど、塑性変形可能または弾性コンプライアンス材料で作製することもできる。グラフト部材11は、薄膜ステンレス鋼、ニッケルチタン合金、タンタル、チタン、炭素繊維など、生体適合性のある金属および/または擬似金属材料で製作される。ステント本体部材12は、3つの機能部、すなわち、近位アンカーフランジ22と、中間環状部20と、遠位アンカー部16とを有するように構成される。ステント本体部材12は、従来のステントと同様に複数のステントストラット13で形成されており、この複数のステントストラット13が、隣接するステントストラット13との間に隙間14を画定する。また、ステント本体部材が、中間環状部20と遠位アンカー部16とを相互連結させる移行部18を含むことが好ましく、これらが一体となって、埋込み後に解剖学的弁を締め出す本発明のステント弁10の弁締め出し領域を画定する。近位アンカーフランジ22、中間環状部20、および遠位アンカー部16は、それぞれ、ステント本体部材の形成中に形成され、ステント本体部材と同一の材料から形成され、ステントストラット13と、隣接したステントストラット13対の間に介在する隙間14とを含む。アンカーフランジ22は、例えば、複数のステントストラットと複数のステント隙間とからなり、これらはステント本体部材の中心長手軸から外側に放射状に突き出ている。したがって、ステント本体部材12の様々な部分は、ステント本体部材12の中心長手軸に対するステントストラットおよび隙間の位置的な配向によって画定される。
図7〜図11は、心腔−心腔間(CC)構成をした本発明のステント弁40を示す。CC弁ステント40は、CV弁ステント10の遠位アンカー部16がCC弁ステント40には存在せず、CCステント弁の遠位アンカーフランジ42で置き換えられていることを除いて、前述のCV弁ステント10と事実上同一の方式で構築される。したがって、前述のCV弁ステント10と同様に、CC弁ステント40は、ステント本体部材12とグラフト部材11とで形成されており、グラフト部材が管内部分11bおよび管外部分11aを有し、これらがそれぞれステント本体部材12の管内表面および管外表面の少なくとも一部分を覆っている。CC弁ステント40は、ステント本体部材12の一区分で形成された近位アンカーフランジ44と遠位アンカーフランジ42とを有しており、これらがステント本体部材12の両端で、CC弁ステント40の中心長手軸から径方向外側に向かって突き出ている。
ここで、図13〜図17を見ると、血管−血管間(VV)弁ステント構成をした本発明のステント弁50が示されている。VV弁ステント50は、CV弁ステント10の近位アンカーフランジ22がVV弁ステント50には存在せず、VVステント弁の近位アンカー部52で置き換えられていることを除いて、前述のCV弁ステント10と事実上同一の方式で構築される。したがって、前述のCV弁ステント10と同様に、VV弁ステント50は、ステント本体部材12とグラフト部材11とで形成されており、グラフト部材が管内部分11bおよび管外部分11aを有し、これらがそれぞれステント本体部材12の管内表面および管外表面の少なくとも一部分を覆っている。VV弁ステント50は、ステント本体部材12の一部で形成された近位アンカー部52と遠位アンカー部54とを有しており、これらは、VV弁ステント50の中間環状部20よりも直径が大きい。移行部56および58は、VV弁ステント50の中心長手軸から外側に向かってテーパしており、それぞれ、中間環状部20を遠位アンカー部54と近位アンカー部52とに相互連結させている。
本発明によれば、さらに、図19に示す単一カテーテル弁形成術および弁ステント送達システム200も提供される。単一カテーテル送達システム200の目的は、外科医またはインターベンション実施者(interventionalist)が、本発明の弁ステント10、40、または50を所望の解剖学的部位に経皮的に送達させて展開させ、単一カテーテルによる弁形成術を実施できるようにすることである。本発明の単一カテーテル送達システム200の好ましい実施形態によれば、二重の管腔212、216を有するカテーテル本体210が提供される。第1管腔212は、ガイドワイヤ管腔として設けられ、カテーテル本体210の長さを横切るガイドワイヤシャフト222によって画定される。第2管腔は、膨張用管腔216であり、外部の供給源からカテーテル210の操作者側端部にある膨張用ポート240を通じて、カテーテル本体210の遠位端またはその付近に位置する膨張可能バルーン214まで生理食塩水などの膨張用流体を通すためのものである。膨張用管腔216は、カテーテル本体210の管内表面と、ガイドワイヤシャフト222の管外表面との間の環状の空間によって画定される。カテーテル本体210の遠位端215には、バルーン214の遠位側に隣接して位置決めされた捕捉シース217が設けられている。捕捉シース217は、ガイドワイヤ管腔212および捕捉シース217の周りの環状の空間を画定しており、送達時にはその中にステント弁10、40、または50が位置決めされ、保持される。バルーン214の遠位側の膨張用管腔216内には、環状プラグ部材220があり、膨張用管腔216を流体密封式に終端させている。環状プラグ部材220は、中央の環状開口部221を有しており、その中をガイドワイヤシャフト222が通る。環状プラグ部材220は、ガイドワイヤシャフト222に結合しており、ガイドワイヤシャフト222を動かすことによって、カテーテル200の中心長手軸に沿って環状プラグ部材220を軸方向に動かすことができる。また、環状プラグ部材220は、ステント弁10、40、および50が捕捉シース217内に位置決めされているときに、ステント弁10、40、および50を支える働きをする。ガイドワイヤシャフト222は、捕捉シース217内を通り、送達時に遭遇する本来の組織を損傷させずに管腔内送達を容易にする非外傷性の先端218で終端している。この構成により、ガイドワイヤシャフト222を定位置に維持しながらカテーテル本体210を近位側に引き下げることによってステント弁が露出され、捕捉シース217がカテーテル本体210と共に近位側に引き下げられてステント弁が捕捉シース217によって覆われなくなると、環状プラグ部材220がステント弁の位置を保持することになる。
Claims (8)
- 放射状に伸長可能な本体によって特徴付けられ、及びグラフト部材によって少なくとも部分的に覆われたステント本体と、前記ステント本体からステント本体部材の中央の管腔内へと突き出た少なくとも1つの偏倚アームと、ステント本体の範囲内の閉じた位置に偏倚させた、前記偏倚アームに結合した少なくとも1つの弁フラップ部材とを有し、前記グラフト部材がステント本体の範囲内で前記弁フラップ部材を形成している埋込み可能な弁膜人工器官であって、前記グラフト部材及び前記少なくとも1つの弁フラップ部材が金属からなる群から選択される生体適合性材料の薄膜で作製されることを特徴とする埋込み可能な弁膜人工器官。
- 前記生体適合性材料は、真空蒸着された複数の層をさらに含むことを特徴とする請求項1に記載の埋込み可能な弁膜人工器官。
- 前記生体適合性材料は、チタン、バナジウム、アルミニウム、ニッケル、タンタル、ジルコニウム、クロム、銀、金、シリコン、マグネシウム、ニオブ、スカンジウム、白金、コバルト、パラジウム、マンガン、モリブデン、およびこれらの合金、例えば、ジルコニウム−チタン−タンタル合金、ニチノール、およびステンレス鋼からなる群から選択されることを特徴とする請求項1に記載の埋込み可能な弁膜人工器官。
- 前記グラフト部材は、生体適合性のある金属薄膜をさらに含むことを特徴とする請求項1に記載の埋込み可能な弁膜人工器官。
- 前記グラフト部材は、生体適合性のある金属薄膜をさらに含むことを特徴とする請求項2に記載の埋込み可能な弁膜人工器官。
- 前記グラフト部材の生体適合性のある金属薄膜は、チタン、バナジウム、アルミニウム、ニッケル、タンタル、ジルコニウム、クロム、銀、金、シリコン、マグネシウム、ニオブ、スカンジウム、白金、コバルト、パラジウム、マンガン、モリブデン、およびこれらの合金、例えば、ジルコニウム−チタン−タンタル合金、ニチノール、およびステンレス鋼からなる群から選択されることを特徴とする請求項4に記載の埋込み可能な弁膜人工器官。
- 放射状に伸長可能な本体によって特徴付けられ、及びグラフト部材によって少なくとも部分的に覆われたステント本体と、前記ステント本体からステント本体部材の中央の管腔内へと突き出た少なくとも1つの偏倚アームと、前記偏倚アームに結合した少なくとも1つの弁フラップ部材とを有し、前記グラフト部材がステント本体の範囲内で前記弁フラップ部材を形成しており、前記少なくとも1つの弁フラップ部材がステント本体内の閉じた位置に偏倚している埋込み可能な弁膜人工器官であって、前記グラフト部材および前記少なくとも1つの弁フラップ部材が金属から選択される材料で作製された、生体適合性のある自立性薄膜であることを特徴とする埋込可能な弁膜人工器官。
- 前記ステント本体は、近位アンカーフランジ、中間環状部、および遠位アンカー部を含み、少なくとも1つの弁フラップ部材が閉じた位置に偏倚され、前記中間環状部内に存在することを特徴とする請求項1に記載の埋込み可能な弁膜人工器官。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US30279701P | 2001-07-03 | 2001-07-03 | |
US10/120,728 US7195641B2 (en) | 1999-11-19 | 2002-04-11 | Valvular prostheses having metal or pseudometallic construction and methods of manufacture |
PCT/US2002/023239 WO2003003943A2 (en) | 2001-07-03 | 2002-07-03 | Valvular prostheses having metal or pseudometallic construction and methods of manufacture |
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JP2004531355A JP2004531355A (ja) | 2004-10-14 |
JP4636794B2 true JP4636794B2 (ja) | 2011-02-23 |
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JP2003509959A Expired - Fee Related JP4636794B2 (ja) | 2001-07-03 | 2002-07-03 | 金属または擬似金属構造を有する弁状人工器官および製造方法 |
Country Status (8)
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US (1) | US7195641B2 (ja) |
EP (2) | EP1408895B1 (ja) |
JP (1) | JP4636794B2 (ja) |
AT (1) | ATE492242T1 (ja) |
AU (1) | AU2002319631B2 (ja) |
CA (1) | CA2452571C (ja) |
DE (1) | DE60238680D1 (ja) |
WO (1) | WO2003003943A2 (ja) |
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JP2010523234A (ja) * | 2007-04-13 | 2010-07-15 | イエナバルブ テクノロジー インク | 心臓弁の機能不全または狭窄症を治療するための医療用デバイス |
JP2011512922A (ja) * | 2008-02-26 | 2011-04-28 | イエナバルブ テクノロジー インク | 患者の心臓の移植部位で弁プロテーゼを位置決めし固定するためのステント |
JP2013052304A (ja) * | 2004-05-05 | 2013-03-21 | Direct Flow Medical Inc | 現場形成支持構造を備えたステントレス心臓弁 |
US10993805B2 (en) | 2008-02-26 | 2021-05-04 | Jenavalve Technology, Inc. | Stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient |
US11065138B2 (en) | 2016-05-13 | 2021-07-20 | Jenavalve Technology, Inc. | Heart valve prosthesis delivery system and method for delivery of heart valve prosthesis with introducer sheath and loading system |
US11185405B2 (en) | 2013-08-30 | 2021-11-30 | Jenavalve Technology, Inc. | Radially collapsible frame for a prosthetic valve and method for manufacturing such a frame |
US11337800B2 (en) | 2015-05-01 | 2022-05-24 | Jenavalve Technology, Inc. | Device and method with reduced pacemaker rate in heart valve replacement |
US11357624B2 (en) | 2007-04-13 | 2022-06-14 | Jenavalve Technology, Inc. | Medical device for treating a heart valve insufficiency |
US11517431B2 (en) | 2005-01-20 | 2022-12-06 | Jenavalve Technology, Inc. | Catheter system for implantation of prosthetic heart valves |
US11564794B2 (en) | 2008-02-26 | 2023-01-31 | Jenavalve Technology, Inc. | Stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient |
US11589981B2 (en) | 2010-05-25 | 2023-02-28 | Jenavalve Technology, Inc. | Prosthetic heart valve and transcatheter delivered endoprosthesis comprising a prosthetic heart valve and a stent |
Families Citing this family (560)
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US6006134A (en) * | 1998-04-30 | 1999-12-21 | Medtronic, Inc. | Method and device for electronically controlling the beating of a heart using venous electrical stimulation of nerve fibers |
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Also Published As
Publication number | Publication date |
---|---|
AU2002319631B2 (en) | 2007-12-06 |
JP2004531355A (ja) | 2004-10-14 |
ATE492242T1 (de) | 2011-01-15 |
CA2452571C (en) | 2010-12-14 |
EP1408895B1 (en) | 2010-12-22 |
WO2003003943A2 (en) | 2003-01-16 |
DE60238680D1 (de) | 2011-02-03 |
US7195641B2 (en) | 2007-03-27 |
CA2452571A1 (en) | 2003-01-16 |
WO2003003943A3 (en) | 2003-11-06 |
EP2298252A1 (en) | 2011-03-23 |
EP2298252B1 (en) | 2015-04-22 |
EP1408895A2 (en) | 2004-04-21 |
EP1408895A4 (en) | 2008-05-07 |
US20030023303A1 (en) | 2003-01-30 |
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