JP6163449B2 - 現場形成支持構造を備えたステントレス心臓弁 - Google Patents
現場形成支持構造を備えたステントレス心臓弁 Download PDFInfo
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- JP6163449B2 JP6163449B2 JP2014091393A JP2014091393A JP6163449B2 JP 6163449 B2 JP6163449 B2 JP 6163449B2 JP 2014091393 A JP2014091393 A JP 2014091393A JP 2014091393 A JP2014091393 A JP 2014091393A JP 6163449 B2 JP6163449 B2 JP 6163449B2
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- valve
- catheter
- implant
- tube
- inflation
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- CZHITHHCSDBMNR-UHFFFAOYSA-N CCC(C)[N+](C)(C)[O-] Chemical compound CCC(C)[N+](C)(C)[O-] CZHITHHCSDBMNR-UHFFFAOYSA-N 0.000 description 1
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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
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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
- A61F2230/008—Quadric-shaped paraboloidal
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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
- A61F2250/0003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having an inflatable pocket filled with fluid, e.g. liquid or gas
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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
- A61F2250/0021—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 coefficient of friction
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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
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0059—Additional features; Implant or prostheses properties not otherwise provided for temporary
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
- Y10S623/902—Method of implanting
- Y10S623/904—Heart
Description
本出願は、(1)2004年5月5日出願の米国仮出願60/568402号、(2)2004年5月19日出願の米国仮出願60/572561号、(3)2004年6月21日出願の米国仮出願60/581664号、(4)2004年7月7日出願の米国仮出願60/586054号、(5)2004年7月7日出願の米国仮出願60/586110号、(6)2004年7月7日出願の米国仮出願60/586005号、(7)2004年7月7日出願の米国仮出願60/586002号、(8)2004年7月7日出願の米国仮出願60/586055号、(9)2004年7月7日出願の米国仮出願60/586006号、(10)2004年7月15日出願の米国仮出願60/588106号、(11)2004年8月20日出願の米国仮出願60/603324号、(12)2004年8月27日出願の米国仮出願60/605204号、および(13)2004年9月16日出願の米国仮出願60/610269号の優先権の利益を主張し、これらの内容全体を参照により本明細書に組み込む。
I.身体活動の制限のない心疾患患者。通常の身体活動では過度の疲労、動悸、呼吸困難、または狭心痛を生じない。
II.身体活動が軽度に制限される心疾患患者。これらの患者は安静時には苦痛はない。通常の身体活動で、疲労、動悸、呼吸困難、または狭心痛を生じる。
III.身体活動が高度に制限される心疾患患者。これらの患者は安静時には苦痛はない。通常以下の身体活動で、疲労、動悸、呼吸困難、または狭心痛を生じる。
IV.つらさを伴わずにはいかなる身体活動も行うことができない心疾患患者。安静時であっても、心不全または狭心症の症状が起こる恐れがある。何らかの身体活動を行うと、症状が悪化する。
図2を引き続き参照すると、より詳細に後述するように部分的に取り除かれた、先天性異常のまたは病変した大動脈弁34を補う、本発明の一実施形態による人工大動脈弁移植片100が示される。移植片100およびその様々な変形実施形態は、以下に詳細に説明される。より詳細に後述するように、移植片100は、血管内送り出しカテーテル200、またはトロカールによる経尖的アプローチを用いて、低侵襲的に送り出されるのが好ましい。
図17A〜20Aは、異なる技術を使用して弁182を移植部位に固定する移植片180の他の実施形態を示す。この実施形態では、移植片180は、弁182に取り付けられた少なくとも1つの部材184を有し、体内に展開されると弁182形状を提供する。一般に、部材184は、作動され展開されると、リングまたは環状形状を形成する。しかし、送り出し中、部材184は可撓性であって、断面を小さくして概ね伸張され、それと同時に弁182のリーフレット183は送り出しカテーテルを貫通するように支持部材184(図20および20Aを参照)を包み込む。展開中、弁182のリーフレット183は広げられ、第2の形状をとって血管の封止を形成し、かつ血流の一方向のゲートとして機能する。心臓10内での弁180の展開を示す図21Aおよび21Bも参照のこと。
図1〜16Bの実施形態を再び参照すると、弁104は、寸法的に安定な、予め位置合わせされた組織リーフレットのサブアセンブリを含む、生体タイプの心臓弁であることが好ましい。この構成にしたがって、例示的な生体弁104は、寸法的に安定で、かつ寸法的に一定して接合しているリーフレットサブアセンブリを形成する、定型化され先端で互いに取り付けられた複数の組織リーフレットを含む。次に、単一のプロセスであり得るプロセスで、サブアセンブリの各リーフレットは、カフ102と位置合わせされ、1つの交連の先端からリーフレット尖頭の周囲を通り、隣接する交連の先端まで均一に、別個にカフ102に縫い合わされる。その結果、縫い合わされた縫合は、同様に位置合わせされたステープルのように働き、そのすべてが均等に、予め位置合わせされ接合しているリーフレットそれぞれの尖頭全体に沿って作用する負荷力を受ける。膨張すると、カフ102は、膨張媒体およびその個々の圧力で交連を支持し、それが固くなり、ステント構造に類似のシステムを作る。それによって形成された移植片100は、交連ごとにリーフレット尖頭全体にわたって均等に応力を分配することによって、リーフレットの縫合境界面での応力と潜在的な疲労とを減少させる。この、改善され、寸法的に安定し、応力が減少されたアセンブリは、予め準備された布被覆カフ102の頂部に操作可能に取り付けられて、布被覆カフの頂部によって形成された負荷を分配する布座部上で、リーフレットを変形させることなく、またはその相対的な位置合わせおよびその噛合縁部の結果的な接合を妨害することなく、組織リーフレット尖頭を挟持する。組織リーフレットは、操作中、より低くより均等な分配応力を受けるので、使用中に変形することが少ない。したがって、この付着力の均等な分配によって、より安定し、より寿命が長い、リーフレットの機能的閉止または接合が提供される。
膨張可能な構造107は、所望の性能によって、様々な膨張媒体122のいずれかを使用して膨張させることができる。一般に、膨張媒体は、水または水性ベース溶液などの液体、CO2などの気体、または、第1の比較的低粘性状態でカフ102に導入され、第2の比較的高粘性状態に変換させることができる、硬化可能な媒体を含むことができる。粘性の増大は、様々な既知のUV誘導または触媒誘導重合反応、あるいは当技術分野で既知の他の化学系のいずれかによって行われてもよい。粘性増大プロセスの終点は、所望の性能および耐久性によって、ゲルから剛性構造までの間のいずれかの硬度をもたらすことができる。
(1)約50から約55重量%の比率、特に約52重量%の比率で存在する、ポリエチレングリコールジアクリレート(PEGDA)、
(2)約22から約27重量%の比率、特に約24重量%の比率で存在する、ペンタエリトリトールテトラ3(メルカプトプロピオネート)(QT)、および
(3)約22から約27重量%の比率、特に約24重量%の比率で存在する、グリシルグリシンバッファ。
上述した実施形態では、カフ102にアンカー機構220を組み込むことが必要または望ましい場合がある。アンカー機構220は、腹部大動脈瘤治療用の移植片、心耳閉鎖装置およびフィルタなどの介入的装置で広範囲に使用されてきたものなど、様々なアンカーまたはかえしのいずれかを有することができる。経皮的に移植可能な弁に使用される従来の保持機構のほとんどは、移植片と血管との間の締まりばめによって、保持力の大部分を提供する、または保持手段を作動させるものである。しかし、僧帽弁または大動脈弁の置換の場合、一方の弁輪の過度の膨張が他方の弁の機能に不利益な作用を有するので、弁輪での半径方向の力を最小限に抑えるのが望ましいことがある。
図34〜37は、上述した弁100を送り出すのに使用することができる、送り出しカテーテル300の例示的な実施形態を示す。一般に、送り出しカテーテル300は、当該分野で周知の技術を用いて、押出し成形された管材料で構成することができる。いくつかの実施形態では、カテーテル300は、編まれたまたはコイルに巻かれたワイヤおよび/またはリボンを管材料に組み込んで、剛性および回転トルク能力を与えることができる。補強用のワイヤの数は1から64であってもよい。より好ましくは、8から32のワイヤまたはリボンを有する、編まれた構造が用いられる。ワイヤが使用された場合、直径は、約0.0005インチから約0.0070インチの範囲であることができる。リボンが使用された場合、厚さは好ましくは幅よりも小さく、また、リボンの厚さは約0.0005インチから約0.0070インチの範囲であると同時に、幅は約0.0010インチから約0.0100インチの範囲であってもよい。他の実施形態では、コイルは補強部材として使用される。コイルは、チューブの周面を包み、チューブ内に組み込まれた1〜8つのワイヤまたはリボンを有することができる。ワイヤは、チューブ表面の湾曲面において互いに平行であるように巻かれてもよく、または、複数のワイヤが、別個の層において反対方向に巻きつけられてもよい。コイルに使用されるワイヤまたはリボンの寸法は、編組に使用される寸法と同様とすることができる。
上述したように、多くの実施形態では、移植片100は、膨張チャネル120を規定する膨張可能な構造107を含む。これらの実施形態では、移植片100に構造を提供するために、膨張チャネル120は膨張媒体122によって膨張される。図34〜37に示すように、展開用カテーテル300は、少なくとも1つの膨張チューブ318を含み、図示される実施形態では、カテーテル300の近位端304から遠位端302まで延びる2つの膨張チューブ318を含む。膨張チューブは、膨張媒体122が膨張可能な構造107に供給されることができるように、膨張チャネル120と連通して配置される。膨張可能な構造107が膨張した後、移植片100から膨張チューブ318を分離または離脱させることが必要になることが理解されるであろう。膨張チューブ318から移植片100を離脱させるための様々な装置および方法を以下に記載する。
上述したように、本明細書に記載した多くの実施形態の1つの利点は、移植片100の展開を制御することができることである。一実施形態では、移植片の展開は、移植片に分離可能に連結することができる制御ワイヤ230を使用して制御される。移植片10に分離可能に制御ワイヤ230を連結するための様々な機構を以下に記載する。
現在の弁機構は、弁が支持構造に縫い合わされるステントに基づいた機構によって展開される場合が多い。本明細書に記載した膨張された実施形態では、膨張流体によって構造が二次的に移植片に付加される。これにより、固化するものを含む多数の媒体によって、ユーザが移植片を膨張または加圧することができるようになる。そのため、操作者が所望する場合、膨張媒体が固化されるか、または減圧によって身体内で移植片の移動が可能になる前に、移植片100を移動させることができる。カテーテルに基づいた装置は、直径が小さく、血管に対する外傷を低減し、かつ入口へのより容易なアクセスを可能にするので、ステントなどの装置が血管内で露出するかその中に導入された後に、それらを除去するのが困難な場合が多い。しかし、後述するように、本発明の装置により、経皮的に大動脈弁を身体から回収し、導入器に逆行させて再導入することが可能になる。
弁を移植する処置は、弁輪を拡大させることから始まるのが好ましい。これは、単純なバルーン弁形成術で実施することができる。しかし、多くの例ではこれは十分ではない。したがって、人工弁が外科的処置で置換される前に、外科医は、多くの場合、天然弁リーフレットを、特にその範囲内の石灰化または病的発生物を、修正または除去する。以下により詳細に記載するように、天然の大動脈弁が切除または減量される間、および人工弁が移植されるときに心臓からの流出を維持するため、一時弁520(図52Aを参照)を設置することができる。一時弁520は、動脈弓または下行大動脈もしくは上行大動脈内の大動脈36に配置することができる。これらのタイプの弁の例は、参照により本掲載書に組み込まれる米国特許第3671979号および米国特許第4056854号に記載されている。他の多くの一時弁構造が可能であるが、可撓性ポリマーまたは生体弁が、カテーテルを介して容易に送り出すことができるので好ましい弁タイプである。可撓性ポリマー弁のいくつかの種類、例えば、「ダックビル」式、三葉式、二葉式の弁を使用することができる。あるいは、傘型弁または吹流し型弁を使用することができる。一時弁520は、自己拡張ステントまたは膨張可能なバルーン状の構造など、様々な方法によって、弁の基部で大動脈36の壁を封止し、一時的にそれに係合することができる。さらに、一時弁520は、全体的に膨張可能であるか、または、ナイロン、テフロン(登録商標)、ダクロン、またはポリプロピレンなどのポリマーを、ニチノール、ステンレス鋼、または医療装置で使用するのに一般に受容可能な他の材料などを含む金属元素と組み合わせて使用することができる。適切な配置のため、一時弁に放射線不透過性マーカーを取り付けてもよく、また、一時弁から展開可能なまたは受動的に取り付けられたアンカーが、装置の固定を補助することがある。
大動脈の位置の中で移植片100を展開するための様々な手順および方法を以下に記載する。一実施形態では、方法は、概ね、多くの場合は大腿動脈を通して、大動脈にアクセスすることを含む。バルーン弁形成術が、大動脈弁狭窄症の場合に任意に実施されてもよく、または、上述のように天然弁を除去または減量する他の方法が使用されてもよい。送り出しシースまたはカテーテルが、大動脈弓上で、大動脈弁を越えて前進される。カテーテルの外側シースは後退されて弁およびカフを露出させる。弁を膨張させるために流体が使用され、第2の膨張流体が部分的に移植片を形成するために使用されてもよい。これにより、移植片の遠位部分がその全径まで開くことが可能になる。移植片の近位部分は、展開制御機構によってわずかに制限されてもよい。一般に、展開制御機構が装置の近位端の直径を制限する量は、外側シースを越えて延びるワイヤの長さによって決まり、それは操作者が調節することができる。あるいは、いくつかの実施形態では、移植片は、操作者が移植片の特定範囲を異なる量で膨張させることを可能にするため、複数の膨張ポートを含む。他の実施形態では、破裂ディスクまたはフロー制限器が、移植片100の近位部分の膨張を制御するために使用される。その後、移植片は適所に引き戻される。遠位リングは、大動脈輪の心室側に収まる。バルーンが、必要であれば装置を拡張または再拡張するために使用されてもよい。このとき、展開制御ワイヤは、切断バルーンが繊維状または石灰化した病変を破壊することができるのと同じ機構によって、融合した交連を分離するのを助けるように作用してもよい。追加の鋳込み材料が付加されて、移植片を完全に膨張させてもよい。その後、膨張管腔は分断され、展開制御ワイヤが次に分断され、カテーテルは装置を後に残して引き抜かれる。変形実施形態では、所望であれば、これらのステップは逆にされても、またその順序が変更されてもよい。
部位において装置をワンステップで展開することによって、新たな弁を配置しながら天然弁を排除することができる。装置は、展開中に新たな構造下で古い弁を捕捉することによってそれを排除するため、管状の双曲線に類似した形状を有してもよいと考えられる。これは、バルーンで展開されるステントシステムによる移植中に血管が閉塞されない場合、患者の快適さを助けることができる。シースに収められた装置が、血管を通ってカテーテルによって大動脈弁を越えて送り出されると、それは、シースを部分的または完全に除去し、また天然弁のところもしくはその下での適切な配置を可能にすることによって、開かれるか露出される。血管に入ると、装置を近位側または遠位側に移動させることができ、また、流体がカフに導入されて、形状および構造的一体性を提供することができる。適切な配置または除去のため、流体を追加または回収することが必要な場合がある。カフが適切に配置され、流体が追加されて構造を作り、装置が血管壁を封止すると、送り出しカテーテルは、機能するようになった弁装置を恒久的な移植片として残して、分断され除去されてもよい。分断方法は、取付部を切断し、ねじを回転させ、ピンを引き抜きまたはせん断し、連結された要素を機械的に切り離し、溶融接合部を電気的に分離し、捕捉されたシリンダをチューブから除去し、加工領域を壊し、収集機構を除去して機械的接合部を露出させること、または当業界で既知の他の多くの技術を含んでもよい。
2ステップで弁構造を移植することが望ましい場合がある。安全にかつ漏れなしで弁を天然の組織に取り付けることが望ましい。また、長期間血流を阻害することを回避するのが望ましい。これらの理由から、最初に保持・封止装置を第1ステップとして移植し、次に、第2ステップとして、取り付けられた弁とともにカフを移植することが望ましい場合がある。保持・封止装置は、適所で拡張されるステント様構造、または弁が二次的に取り付けられるリング状の支持構造であることができる。リング状構造は、上述したような流体膨張方法を利用することができ、また別個のシステムおよびカテーテルであることができる。それは、固定のためのかえしを含むことができる。さらに、血液が弁の周りで漏れるのを防ぐ助けとなる封止材料を含むこともできる。装置は、支持構造を取り付ける機構を含むことができる。保持機構は、支持体が受け入れる肩部またはチャネルであることができる。適所に置かれると、弁の展開は、上述したワンステップ移植で言及したように行われることができる。
他の実施形態では、バルーン膨張ステップが用いられて装置が使用可能にされ、支持構造およびアンカー装置は後のステップで送り出される。一実施形態では、支持構造はバルーン拡張可能なステントである。そのステントは膨張したカフの内部に配置される。ステントはまた、カフから近位方向または遠位方向に拡張してもよい。1つ以上のステントを使用することができる。好ましくは、ステントは、移植片の弁部分よりも近位側に配置され、ステントは、移植片の弁部分よりも遠位側に配置され、またはステントの一部は弁を越えて延びる。一実施形態では、バルーンは移植片の一部として収縮された状態で残される。バルーンは、封止機構が不要な場合を除いて、本願に記載した機構によってカテーテルから分断される。他の分離機構も可能である。他の実施形態では、バルーンは、収縮された後、装置から除去される。バルーンは、カフの中でチャネル内に配置され、単に収縮後に後退されてもよい。あるいは、バルーンは、バルーンが膨張すると壊れるように設計された縫合で移植片に取り付けられてもよい。バルーンが膨張され、および収縮された後、バルーンを後退させることができる。
カフに取り付けられた弁を第1ステップとして送り出し、第2ステップとして拡張可能な構造を送り出す方法。その構造は、カフの内部において同軸でかみ合った、ステントまたは広げることが可能なバンドであってもよい。カフは、膨張可能なカフを使用して配置されてもよく、装置がカテーテルから分断された後、カフは膨張したままである。この場合、膨張は、一時的な固定および恒久的な封止の機能を果たす。あるいは、カフは取外し可能なバルーンを含んでもよい。この実施形態では、恒久的な支持構造が展開されるまで、膨張は一時的な支持手段を提供する。しかし、他の代替例は、膨張を提供しない、弁とカフのアセンブリを含む。カフは、ある程度人工器官の拡張を引き起こすように形成された展開制御ワイヤを使用して、適所に保持される。その後、ステントまたは拡張可能な支持構造は、カフ内における同軸の配置まで送り出される。その後、ステントが展開されて装置を固定する。
本発明は、患者の体内で支持構造を作製する方法を含む。好ましい実施形態は、鋳造み方法によって支持構造を製造することを含む。この方法では、流体が、弁に取り付けられて経皮的に送り出された型すなわちカフに注入される。その後、液体は、ゲル化、硬化、または凝固して支持構造を形成する。
本発明では、弁は非構造要素にのみ取り付けられる。好ましい実施形態では、非構造要素は縫い合わせカフまたは型である。支持構造は後に型内で製造される。非構造要素のみに恒久的に取り付けられた弁の他の例が可能である。弁は、布の支持されていない管状部分に取り付けることができる。布移植片および弁を患者の中で配置した後、ステントまたは他の支持構造を移植片とともに展開して、移植片を適所に固定することができる。ステントは、移植片を穿刺し、装置をしっかり天然の組織に固定する、かえしまたは牙を利用することができる。ステントはまた、部分的にのみ移植片に重なるように配置することもできる。このように、かえしまたは牙が移植片を穿刺しないように配置されることができる。他の実施形態では、交連支持ポストまたはかえし、もしくはアンカーなどの剛性のある構造要素がカフに取り付けられ、非構造要素によって送り出される。
102 カフ(本体)
104 弁
107 膨張可能な構造
108、108a、108b リング
114 ストラット
120 膨張チャネル
122 膨張媒体
126 近位端
128 遠位端
200 送り出しカテーテル
300 展開システム
Claims (6)
- 第1の端および第2の端を有し、前記第1の端から前記第2の端へ延びる通路を備える管状ステントと、
前記通路内に配置された弁と、
前記管状ステントの第1の端で前記管状ステントの外側の部分に配置された環状封止構造と、
を有し、
前記環状封止構造は、織布のチューブからなるカフを有し、
前記織布のチューブは、一端または両端が裏返しにされて前記チューブの長手方向の端部に前記チューブの二層の部分を形成し、前記チューブの二層の部分が縫い合わされて、膨張媒体によって膨張されるリング形状の膨張チャネルを形成している心血管人工弁。 - 前記環状封止構造は低デュロメータ材料を有する請求項1に記載の心血管人工弁。
- 前記ステントは自己拡張性である請求項1に記載の心血管人工弁。
- 前記管状ステントの外側の部分に1つ以上の環状封止構造をさらに有する請求項1に記載の心血管人工弁。
- 前記心血管人工弁はウシの心膜から作られたリーフレットを有する請求項1から4のいずれかに記載の心血管人工弁。
- 前記環状封止構造は弁周囲の漏れを最小限にするかまたは排除するように構成される請求項1から5のいずれかに記載の心血管人工弁。
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