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JP4399585B2 - 多辺管内医療器具 - Google Patents

多辺管内医療器具 Download PDF

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JP4399585B2
JP4399585B2 JP2000551693A JP2000551693A JP4399585B2 JP 4399585 B2 JP4399585 B2 JP 4399585B2 JP 2000551693 A JP2000551693 A JP 2000551693A JP 2000551693 A JP2000551693 A JP 2000551693A JP 4399585 B2 JP4399585 B2 JP 4399585B2
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medical device
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JP2002516705A5 (ja
JP2002516705A (ja
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パブクニック、ドゥーサン
ケラー、フレデリック、エス.
ロッシュ、ジョセフ
トーマス エー. オズボーン
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Cook Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • AHUMAN NECESSITIES
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    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00Dilators with or without means for introducing media, e.g. remedies
    • AHUMAN NECESSITIES
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
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    • A61F2/00Filters 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
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    • A61F2/00Filters 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
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    • A61F2/89Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
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    • A61F2/00Filters 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
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    • A61F2002/075Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
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    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A61F2002/8483Barbs
    • AHUMAN NECESSITIES
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    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A61F2002/8486Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs provided on at least one of the ends
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008Fixation appliances for connecting prostheses to the body
    • AHUMAN NECESSITIES
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    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008Fixation appliances for connecting prostheses to the body
    • A61F2220/0016Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/005Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0058Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements soldered or brazed or welded
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075Connections 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
    • AHUMAN NECESSITIES
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    • A61FFILTERS 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
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    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004Rounded shapes, e.g. with rounded corners
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    • A61FFILTERS 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
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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Vascular Medicine (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Prostheses (AREA)

Description

【0001】
【発明の属する技術分野】
本発明は医療器具に関する。更に詳細には、本発明は管内器具に関する。
【0002】
【従来の技術】
管内器具を配置する最小侵襲性技術および機器が近年開発されるにつれ、治療器具の数およびタイプも急増している。ステント、ステント移植皮弁、閉鎖器具、人工弁、シャントなどが、これまで外科手術を必要とするか、適切な解決策が全くなかった幾つかの状況での治療に成功している。最小侵襲性管内器具は、特に1990年代初期の米国市場に冠状動脈ステントが導入されるとともに普及した。冠状動脈または辺縁用ステントは、血管の開通性を維持する優れた手段を提供することが証明されたが、その後、特に腹部大動脈瘤の修復として移植片と、閉塞器具として、および人工弁の管内支持体としてファイバまたは他の材料と組み合わせて使用されている。
【0003】
ステントおよび関連の器具を設計する際の主たる目標の幾つかは、血管に十分な力を供給し、器具の移動を防止するのに十分な半径方向の強度を提供することを含む。辺縁使用における追加の関心は、外部からの圧迫に対して抵抗するステントを有することである。自己拡張式ステントは、冠状動脈での使用により普及している拡張式ステントを膨張させる点で、優れている。難問は、可能な限り小さい形状で標的の血管に送出しながら、十分に膨張することができる器具を設計することである。自己拡張式ステントは、通常、バルーンで拡張可能なステントより大きい支柱を必要とし、したがって輪郭が大きくなる。送出カテーテルに織り込む必要がある布または他のカバー類とともに使用する場合、問題はさらに大きくなる。
【0004】
【発明が解決しようとする課題】
従って、本発明の目的は、小さい輪郭で送出できると共に、所望に応じて比較的大きい血管内に埋設できるのに十分な膨張率を有し、安定して、自動的に中心を合わせ、血管の形状に一致することができる、布製カバーを含む基本的ステントを提供することである。
【0005】
【課題を解決するための手段】
前記課題は、複数の辺および隣接する辺を相互接続する曲げ部を有する単一部片のワイヤまたは他の材料で構成された例示的多辺管内医療器具により解決される。曲げ部は、コイル、フィレット、または応力および疲労を減少させる他の形状でよい。単一部片のワイヤは、カニューレとはんだなどの取付機構で結合し、閉じた周枠を形成することが好ましい。器具は、辺と曲げ部とが概ね1つの平面にある第1形状を有する。4つの等しい辺を有する実施形態では、枠を、対向する曲げ部が器具の一方端に向かってともに近づき、他の対向する端部が器具の反対の端部に向かってともに近づく第2形状に折り畳む。第2の形状では、器具は自己拡張式ステントになる。第3の形状では、器具をカテーテルなどの送出器具に押し込み、したがって辺が相互に並ぶ。好ましい実施形態は4辺であるが、他の多角形も使用することができる。
【0006】
本発明の別の態様では、器具を血管の内腔に固定するため、1つまたは複数のかえしを枠に取り付けることができる、かえしは、単一部片のワイヤまたは枠を備える他の材料の拡張部か、または別個の取付機構によって枠に別個に取り付ける第2部片の材料でもよい。細長いかえしを使用して、同様の方法でかえしに取り付けた第2以降の枠を伴う追加の器具を接続することができる。
【0007】
本発明のさらに別の態様では、DACRON、PTFE、コラーゲンまたは他の軟質材料などのカバー類を、縫合または他の手段で器具に取り付けて、流体の流れを部分的に、完全に、または選択的に制限することができる。カバーが枠の口全体に広がる場合、第2形状に形成された枠は、いったん展開したら動脈をほぼ即座に閉塞することができる血管閉塞器具として機能する。下肢および脚部に使用して不全静脈を矯正するような人工弁は、枠の口の半分を三角形の材料部片で覆うことによって作成することができる。人工弁は、逆行する血液を捕捉して内腔を密封しながら、通常の血流は器具を通過できるようにする。関連の実施形態では、器具を使用して、損傷した血管または疾病のある血管を補修するステント移植皮弁を形成することができる。第1のステント移植皮弁の実施形態では、1対のカバー付き枠またはステント・アダプタを使用して、いずれかの端部で管状移植人工器官を固定し、血管を密封する。各ステント・アダプタは、配置する移植人工器官および両枠に取り付ける細長いかえしを通す開口を有する。別のステント移植片の実施形態では、第2形状の1つまたは複数の枠をスリーブの内側に使用して、器具を血管壁に固定する。
【0008】
【発明の実施の形態】
図1は、弾性材料、好ましくはステンレス鋼または超弾性材料(例えばニチノール)で作成した金属材料の枠11を備える本発明の医療器具10の1つの実施形態の上面図を示す。本明細書で示す各実施形態では丸いワイヤが描かれているが、例えば平坦、正方形、または三角形など、他のタイプを使用して枠を形成してもよい。例示的実施形態では、枠は、一連の曲げ部12によって相互接続された複数の辺13を有する器具10へと形成された単一部片59の材料の閉じた周62を備える。図示された実施形態は、ほぼ等しい長さの4本の辺13を含む。別の実施形態は、枠を例えば5辺形、6辺形、8辺形などの多角形に形成することである。1つの実施形態を図19に示し、これは2本の隣接する長辺66と2本の隣接する短辺67を伴う概ねたこ形を有する4辺の枠11を含む。図1の実施形態では、辺13を相互接続する曲げ部12は、ほぼ1−1/4巻のコイル14を備える。コイル曲げ部は、枠をステンレス鋼および他の大部分の標準的材料から形成した場合、図9で示すような単純な曲げ部40より優れた曲げ疲労特徴を生じる。しかし、枠をニチノール(NiTi)または他の超弾性合金から形成した場合には、図9の実施形態のほうが適切なことがある。というは、コイル14などの特定のタイプの曲げ部を形成すると、超弾性材料の器具の疲労寿命が実際に短縮することがあるからである。したがって、曲げ部12は曲げ疲労を最小にする構造であるとよい。曲げ部12の別の実施形態は、図10で示すように外側に突き出すフィレット41と、図11に示すように一連の湾曲63を備えて内側に突き出すフィレット42とを含む。フィレットは、ステントの技術では曲げ部の応力を減少させる手段としてよく知られている。フィレットを図11で示すように内側に延長させることにより、血管壁への外傷の可能性が低下する。
【0009】
ステンレス鋼ワイヤを使用する場合、ワイヤのサイズは器具のサイズおよび用途に応じて変化する。閉塞器具は、例えば100mmの正方形の枠には0.010インチのワイヤを使用することが好ましく、20mmおよび30mmの枠にはそれぞれ0.014インチおよび0.016インチのワイヤを使用する。堅すぎるワイヤは血管に損傷を与え、血管壁によく適合せず、器具の輪郭を大きくすることがある。
【0010】
図1に戻ると、枠11を備える材料の単一部片59を、1片の金属カニューレなどの取付機構15で第1および第2端部60、61を固定することにより、閉じた周に形成する。次に、単一部片59の端部60、61をカニューレ15に挿入し、はんだ25、溶接、接着剤またはかしめによって固定し、閉じた枠11を形成する。単一部片59の端部60、61は、はんだ、溶接、または他の方法などによって、カニューレ15を追加せずに直接結合し、端部61と62を結合することができる。また、ワイヤを結合する以外に、別の薄板から(例えばレーザで)枠11を圧延または切断するか、型から作成するか、または一体わくの生産と同様の方法により、単一部片の材料59として枠を作成することができる。
【0011】
図1に示す器具10は、その第1形状35で図示され、4つの曲げ部20、21、22、23全部および各辺13が概ね1つの平面にある。器具を弾性変形させて図2に示す第2形状36にするには、図1の枠11を2回折り曲げる。最初は対角軸24に沿って対向する曲げ部20および21を近づけ、その後、対向する曲げ部22と23とをともに折り曲げて反対方向に近づける。図2に示す第2形状36は、器具10の第1端部68に向かう2つの対向曲げ部20、21を有し、他の対向曲げ部22、23は器具10の第2端部69に向かい、断面で見ると曲げ部20および21に対して約180°回転する。第2形状36の医療器具は、ステント44として使用して、静脈、動脈または管路などの血管33の開放内腔34を維持することができる。器具10を第2形状36に形成するために必要な第1および第2の折り畳みによって枠11に導入される曲げ応力は、血管壁70に対して半径方向の力を加え、器具10を所定の位置に保持し、血管の閉塞を防止する。折り畳みおよび展開中に重大な可塑変形が一切発生しないので、第2形状36の器具は、血管または他の制限手段から取り出すと、少なくとも部分的に第1形状25に復帰する。制限が除去されても開かないよう、器具10を可塑的に形成して第2形状36にすることが可能である。これは、器具をニチノールまたは超弾性合金から作成する場合に、特に望ましい。
【0012】
図6に示す血管33内で医療器具10を展開させる標準的方法は、枠11を弾性変形させて第3形状37にし、カテーテルなどの送出器具26に装填することを含む。第3形状37では、隣接する辺13が概ね近接して並ぶ。器具を送出カテーテル26の遠位端28から前進させて展開するため、押出し器27をカテーテル内腔29内に配置する。器具10が完全に展開すると、図2に示すように血管内で第2形状36をとる。枠の辺13は、弾性材料で作成され、血管壁70の形状に適合し、したがって端部から見ると、器具10は丸い血管内に展開時には円形の外観を有する。
【0013】
本発明の第2の実施形態を図3に示す。ここでは1つまたは複数のかえし16が含まれ、展開後に器具10を固定する。かえしはワイヤ、フック、または枠に取り付ける任意の構造で、器具10を内管内に固定できるよう構成される。図示された実施形態は、第1かえし16を含み、点線で示す最大3つの他のかえし17、71、72は別の実施形態を表す。詳細図Aで示すように、かえし17と18を備えるかえしの組合せ38で、各かえしは、枠11の材料の単一部片59が閉じた周59を越える延長部である。取付用カニューレ15が、前述したように単一部片59の材料を固定し、閉じて枠11にし、その第1および第2端部60、61はカニューレ15から延在して、延在する元となる枠11の辺13とほぼ平行に延び、それぞれが個々の曲げ部20、23の周囲で終了するか、それをわずかに越えることが好ましい。固定を容易にするため、図示された実施形態のかえし16の遠位端19は曲げ部またはフックを含む。
【0014】
所望により、遠位端19の先端は、組織によりよく貫通するよう、研磨して鋭利な先端にすることができる。図示のように第3および第4かえしを追加するにはかえし71および72を備える両端かえし39を、曲げ部21および22で画定される対向の辺13に取り付ける。かえしの組合せ38と異なり、詳細図Bで示すような両端かえし29は、1片のワイヤを備える。これは通常、主枠11を備える単一部片59とは別個のかえしの組合せ38の長さである。これは、図1で述べた方法を使用して、取付機構15によって枠に固定する。図4は、器具10が第2の展開形状36にある間、血管壁70と噛み合うかえし17(および18)を示す。この実施形態は最大4つのかえしシステムについて述べるが、5つ以上使用することもできる。
【0015】
図7は、直列に取り付けた複数の枠11を含む第1形状35にある、本発明の第3の実施形態の上面図を示す。図示された実施形態では、第1枠30および第2枠31は、個々の取付機構15によって各枠に固定されたかえし16によって取り付けられる。かえし16は、枠30および31を備える単一部片59とは別個の、図3に示すような両端かえし59でよいか、あるいはかえしは図3の詳細図Aに示すように、単一部片59のうち1つの長い延長端部でもよい。点線で示す第3枠32などのさらなる枠は、かえし16の長さを延長するだけで、追加することができる。図8は、血管33内で展開した状態の第2形状36にある、図7の実施形態の側面図を示す。
【0016】
図12から図18は、布、コラーゲン(小さい腸粘膜下組織など)、または他の軟質材料を備えるカバー45を、縫合50、接着剤、熱融着、「製織」、架橋、または他の公知手段によって枠11に取り付ける本発明の実施形態を示す。図12は、第1形状35ではカバー45が部分的なカバー58であり、形状が三角形で、枠11の口56のほぼ半分に延在する本発明の第4の実施形態の上面図を示す。図13から図14に示すように第2形状36に形成すると、器具10は、弁閉鎖不全症の矯正に使用するタイプなどの人工弁43として作用することができる。図13は、開放形状48の弁43を示す。この状態で、部分的カバー58は、例えば通常の静脈血流46などの正の流体圧力のため、血管壁70に向かって変位し、これによって枠11および血管33の内腔34を通る通路65を開放する。図14に示すように、筋肉が弛緩して逆方向の血流47が生じるにつれ、部分的カバー58は、逆方向の血流を捕捉し、血管の内腔34を閉鎖することによって、通常の弁として作用する。通常の静脈弁は2つのリーフレットを有し、逆流中には相互に押しつけられるが、それとは異なり、人工弁43の場合、部分的カバー58は血管壁に押しつけられ、通路65を密封する。図示された実施形態と通常の静脈弁の人工弁43は両方とも、血液の捕捉およびその後の閉塞を容易にする湾曲した構造を有する。三角形のカバーに加えて、流体を1方向にすくって捕捉することになる部分的カバー58の他の可能な形状を使用することができる。
【0017】
血管に適切なサイズの弁を選択すると、部分的カバー58が血管壁70に適切に封止されることが保証される。血管の内腔34が器具10には大きすぎる場合、部分的カバー58の周囲に逆方向の漏出がある。
【0018】
図15は、枠11の口56全体を概ね覆う全カバー57がある、第1形状35における本発明の第5の実施形態の上面図を示す。図16に示すように、器具10を第2形状36に形成すると、管または血管を閉塞する、シャントを閉鎖する、欠陥を修復する、または完全な流れの防止が望ましい他の用途の閉塞器具51として有用になる。血管内器具として、ブタの研究により、動脈または大動脈内で展開するとほぼ即座に閉塞が生じることが判明し、剖検材料は血栓およびフィブリンが器具の周囲の空間を充填していることを示した。本発明の設計により、大動脈などの大きい血管内で正常に使用することができる。概して、閉塞器具は、埋設すべき血管の直径の少なくとも約50%以上である辺13の長さを有するとよい。
【0019】
図17から図18は、器具10がステント移植片75として機能し、動脈瘤の形成によるなどの損傷を受けた血管または疾病のある血管を補修する本発明の2つの実施形態を示す。図17は、ステント・アダプタ52、53として機能する1対の枠11によって保持される管状移植片人工器官54を有するステント移植片75を示す。管状移植片人工器官54上で、各ステント・アダプタ52、53は、枠の各辺13に取り付けたカバーを有し、これは中心の口55を含み、これを通して移植片人工器官54を所定の位置に配置して摩擦で保持するか、取り付けて移動を防止する。移動を防止する1つの方法は、本発明の小さい方の器具を各端に配置し、カバーに縫合することである。ステント・アダプタ52、53は、移植片人工器官を血管の中心に合わせながら、血流を密封する手段を提供する。長い両端かえし39が各ステント・アダプタ52、53を接続し、ステント移植片75のさらなる固定を補助する。図18に示す実施形態では、カバー45は外部スリーブ64を備え、これは第1および第2枠30、31によって所定の位置に保持され、これはステント44として機能し、スリーブ64を血管壁に対して保持して封止し、開放通路65を維持する。例示的実施形態では、任意選択で曲げ部12のコイル14に固定される縫合50によってステント44を移植片スリーブ64に固定する。図18の実施形態を比較的小さい血管に使用する場合は、ステント移植片74の各端に1つの枠11を使用することができる。
【0020】
【発明の効果】
以上説明したように、本発明のステントによれば、小さい輪郭で送出できると共に、所望に応じて比較的大きい血管内に埋設できるのに十分な膨張率を有し、安定して、自動的に中心を合わせ、血管の形状に一致することができる。
【図面の簡単な説明】
【図1】 本発明の1つの例示的実施形態の上面図を示す。
【図2】 図1の実施形態の絵画図法を示す。
【図3】 本発明の第2の例示的実施形態の上拡大部分断面図を示す。
【図4】 血管内で展開した図3の実施形態の側面図を示す。
【図5】 図1の実施形態の拡大部分図を示す。
【図6】 送出システム内にある図1の実施形態の部分断面側面図を示す。
【図7】 本発明の第3の実施形態の上面図を示す。
【図8】 血管内で展開した図7の実施形態の側面図を示す。
【図9】 本発明の他の実施形態の拡大部分図を示す。
【図10】 本発明の他の実施形態の拡大部分図を示す。
【図11】 本発明の他の実施形態の拡大部分図を示す。
【図12】 本発明の第4の実施形態の上面図を示す。
【図13】 図12の実施形態の側面図を示す。
【図14】 図12の実施形態の側面図を示す。
【図15】 本発明の第5の実施形態の上面図を示す。
【図16】 図15の実施形態の側面図を示す。
【図17】 本発明の第6の実施形態の側面図を示す。
【図18】 本発明の第7の実施形態の拡大絵画図法を示す。
【図19】 本発明の第8の実施形態の上面図を示す。
【符号の説明】
10 医療器具
11 枠
12 曲げ部
13 辺
14 コイル
16 かえし

Claims (36)

  1. 枠組みを形成する多辺を有する管内医療器具において、
    前記枠組みは、単一の(56)を規定する複数の辺(13)を有する閉じた周(62)を形成する枠(11)を含み、
    前記複数の辺(13)の内の隣接する辺は、曲げ部(20−23)で、相互に接続され、
    前記枠(11)は、複数の形状(35−37)を採るよう、構成され、
    前記複数の形状(35−37)の内の第1の形状(35)は、平面である、
    ことを特徴とする多辺を有する管内医療器具。
  2. 前記辺(13)と前記曲げ部(20−23)の少なくとも一方が、軟質材料で形成され、
    前記複数の形状(35−37)の内の第2形状(36)においては、隣接しない一対の曲げ部(20,21:22,23)の間の距離は、前記第1形状の場合より短い
    ことを特徴とする請求項1に記載の管内医療器具。
  3. 前記複数の形状(35−37)の内の第3形状(37)においは、隣接する辺(13)が近づく
    ことを特徴とする請求項2に記載の管内医療器具。
  4. 前記複数の辺(13)は、4つの辺である
    ことを特徴とする請求項1に記載の管内医療器具。
  5. 前記複数の辺(13)は、等しい長さの4つの辺である
    ことを特徴とする請求項1に記載の管内医療器具。
  6. 前記複数の辺(13)は、隣接する第一の対の辺と、隣接する第二の対の辺とを有し、
    前記第一の対の各辺は第1の長さを有し、
    前記第二の対の各辺は第2の長さを有し、
    前記記第1の長さと第2の長さとは、異なる
    ことを特徴とする請求項1に記載の管内医療器具。
  7. 前記第1の枠(30)に線形に連結する少なくとも第2の枠(31)を更に有する、
    ことを特徴とする請求項1に記載の管内医療器具。
  8. 前記曲げ部(20−23)の少なくとも1つが、コイル(14)を含む、
    ことを特徴とする請求項1に記載の管内医療器具。
  9. 前記曲げ部(20−23)の少なくとも1つが、フィレット(41)を含む、
    ことを特徴とする請求項1に記載の管内医療器具。
  10. 前記曲げ部(20−23)の少なくとも1つが、複数の曲線(63)を有する、
    ことを特徴とする請求項1に記載の管内医療器具。
  11. 前記複数の辺(13)の内の少なくとも2つの辺に取り付けられるカバー(45)を更に有する、
    ことを特徴とする請求項1に記載の管内医療器具。
  12. 前記複数の形状の内の第2形状(36)においては、隣接しない一対の曲げ部(20,21:22,23)の間の距離は、前記第1形状の場合より短い
    ことを特徴とする請求項11に記載の管内医療器具。
  13. 前記カバー(45)が、前記口(56)を覆う、
    ことを特徴とする請求項12に記載の管内医療器具。
  14. 前記カバー(45)が、開口(55)を更に有する、
    ことを特徴とする請求項13に記載の管内医療器具。
  15. 前記開口(55)内に配置される管状部材(54)を更に有する、
    ことを特徴とする請求項14に記載の管内医療器具。
  16. 前記カバーが部分的カバー(58)を含み、
    前記部分的カバー(58)は、前記枠が前記第1形状(35)にある時に、前記口(56)を覆うよう、部分的に延在する、
    ことを特徴とする請求項12に記載の管内医療器具。
  17. 前記複数の辺が、4つの辺からなり、
    前記部分的カバー(58)が、三角形の形状をしており、
    前記部分的カバー(58)が、前記口(56)の半分以上に延在する、
    ことを特徴とする請求項16に記載の管内医療器具。
  18. 前記カバーが、前記枠に取り付けられたスリーブ(64)を含み、
    これにより、前記第2形状(36)にある前記枠が、開放内腔(65)を有する、
    ことを特徴とする請求項12に記載の管内医療器具。
  19. 前記枠から延在するかえし(16)を含み、
    前記かえし(16)は、患者の身体内の血管に係合し、前記管内医療器具を患者の身体内の血管に固定する
    ことを特徴とする請求項1に記載の管内医療器具。
  20. 複数のかえし(16)を含む
    ことを特徴とする請求項19に記載の管内医療器具。
  21. 前記枠が、第1端部(60)と第2端部(61)とを有する材料の単一部片(59)を含み、
    前記かえし(16)の少なくとも1つが、前記第1と第2端部の少なくとも一方を含む
    ことを特徴とする請求項20に記載の管内医療器具。
  22. 前記複数の形状(35−37)の内の第3形状(37)においは、隣接する辺(13)が近づき、
    前記枠(11)から延在する複数のかえし(16)を含み、
    前記枠(11)は、第1端部(60)と第2端部(61)とを有する単一部片(59)から構成され、
    前記かえし(16)の少なくとも1つが、前記第1と第2の端部の少なくとも一方を含み、
    カバー(45)を更に有し、
    前記カバーが、部分カバー(58)であり、
    前記部分的カバー(58)は、三角形の形状をしており、
    前記部分的カバー(58)は、前記枠が前記第1形状(35)にある場合、前記口(56)の半分以上に延在する、
    ことを特徴とする請求項12に記載の管内医療器具。
  23. 前記枠(11)は、以下の場合に、非平面形状を採り、
    前記場合とは、前記曲げ部(20−23)の内の対角線上にある対向する曲げ部(20,21:22,23)が、スプリング力に抗して互いの方向に近づくよう移動し、患者の血管治療部位への投薬のために、前記枠(11)が挿入されるカテーテルの内径と等しい距離だけ互いに近づいた前記曲げ部の関連する対を構成し、前記関連する対の曲げ部が、前記平面形状から非平面形状に変形する時であり、
    前記枠(11)が前記カテーテルから解放されると、前記枠の前記関連する曲げ部の対(20,21:22,23)は、互いに離間して、その結果前記枠が自己拡張し、血管の壁を押す
    ことを特徴とする請求項1に記載の管内医療器具。
  24. 前記枠は、4つの辺(13)を有し、前記4つの辺(13)の内の対向する辺(13)は、同じ長さを有する
    ことを特徴とする請求項23に記載の管内医療器具。
  25. 閉塞状態を生成させる移植可能な医療器具において、
    (A)閉じた周(62)を形成する1本の弾性ワイヤ製の枠(11)と、
    前記閉じた周で口(56)が形成され、
    前記枠(11)は、解放状態において平面状であり、脈管内に配置される際には、収縮形状(37)を採り、
    (B)前記枠(11)に固定され、前記口(56)を覆うカバー(57)と
    を有する
    ことを特徴とする移植可能な医療器具。
  26. 前記カバー(57)は、コラーゲンを含む
    ことを特徴とする請求項25記載の医療器具。
  27. 前記カバー(57)は、粘膜下組織のコラーゲンを含む
    ことを特徴とする請求項25記載の医療器具。
  28. 前記カバー(57)は、DACRON(登録商標)を含む
    ことを特徴とする請求項25記載の医療器具。
  29. 前記カバー(57)は、PTFEを含む
    ことを特徴とする請求項25記載の医療器具。
  30. 前記枠(11)は、複数の辺(13)を有する
    ことを特徴とする請求項25に記載の医療器具。
  31. 前記複数の辺(13)は、長さが等しい
    ことを特徴とする請求項30に記載の医療器具。
  32. 前記カバー(57)は、前記複数の辺(13)に取り付けられる
    ことを特徴とする請求項30記載の医療器具。
  33. 複数のかえし(16)を更に含み、
    前記かえし(16)は、患者の身体内の血管に係合し、前記医療器具を患者の身体内の血管に取り付ける
    ことを特徴とする請求項25に記載の医療器具。
  34. 前記複数のかえし(16)の内の少なくとも1つのかえし(16)は、前記枠(11)から延在する
    ことを特徴とする請求項33に記載の医療器具。
  35. 前記カバー(57)は、小腸粘膜下組織を含む
    ことを特徴とする請求項27記載の医療器具。
  36. 前記医療器具は、脈管を閉鎖する為、分岐血管を閉鎖する為、血管を治療する為のいずれかに利用される
    ことを特徴とする請求項25記載の医療器具。
JP2000551693A 1998-06-02 1999-06-02 多辺管内医療器具 Expired - Lifetime JP4399585B2 (ja)

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