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JPH0636807B2 - 体腔内への固定装置 - Google Patents

体腔内への固定装置

Info

Publication number
JPH0636807B2
JPH0636807B2 JP3509370A JP50937091A JPH0636807B2 JP H0636807 B2 JPH0636807 B2 JP H0636807B2 JP 3509370 A JP3509370 A JP 3509370A JP 50937091 A JP50937091 A JP 50937091A JP H0636807 B2 JPH0636807 B2 JP H0636807B2
Authority
JP
Japan
Prior art keywords
stent
axial length
diameter
axial
radially
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
JP3509370A
Other languages
English (en)
Other versions
JPH05507215A (ja
Inventor
ポーター，クリストファー・エイチ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Schneider USA Inc
Original Assignee
Schneider USA Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Schneider USA Inc filed Critical Schneider USA Inc
Publication of JPH05507215A publication Critical patent/JPH05507215A/ja
Publication of JPH0636807B2 publication Critical patent/JPH0636807B2/ja
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • 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
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • 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
    • A61F2/852—Two or more distinct overlapping stents
    • 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
    • A61F2002/826—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents more than one stent being applied sequentially
    • 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
    • A61F2/848—Devices 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
    • A61F2002/8486—Devices 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
    • 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
    • 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
    • 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
    • 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
    • A61F2250/0023—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 porosity
    • 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
    • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
    • A61F2250/0063—Nested prosthetic parts

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Materials For Medical Uses (AREA)

Description

【発明の詳細な説明】 技術分野 本発明は、身体埋込み装置、特に、体腔内に長期間又は
恒久的に固定することを目的とする補綴具及び移植片に
関するものである。
従来の技術 種々の患者の治療及び診断方法は、患者の体内に挿入さ
れる装置を使用し、これら装置の一部を恒久的に埋め込
む段階を含んでいる。こうした装置として、例えば、米
国特許第4,655,771号（ウォルステン(Wallsten)）に開
示されたような経内腔埋込み型補綴具又は移植片があ
る。該ウォルステンの特許に記載された補綴具は、糸要
素をら旋状に巻き付けて形成した可撓性の管状編組み構
造体である。補綴具の両端の把持部材が補綴具を最初に
カテーテルに固着し、基端の把持部材が末梢方向に移動
し、補綴具をバルーンの形状にすることが出来る。展開
させるときは、把持部材及びカテーテルを除去し、補綴
具が僅かに膨張するとき、該補綴具が略円筒状の形状と
なり、血管壁又はその他の組織に略適合するようにす
る。別の補綴具が米国特許第4,681,110号（ウィクトウ
ル(Wiktor)）に開示されている。可撓性プラスチックか
ら成る編組みストランドにて形成される可撓性の管状ラ
イナーを大動脈内に挿入することが出来、その結果、該
ライナーが動脈溜に対して自然膨張し、血液を動脈溜を
経て流動させる。ウォルステン及びウィクトウルの編組
みステントは、半径方向に膨張するとき軸方向に収縮す
る。
別の弾性的なステントが、米国特許第4,830,003号（ウ
ォルフ(Wolff)等）に開示されている。該ステントは、
共に対に溶接した一連の略長手方向ワイヤーを備えてお
り、各対のワイヤーは「Ｖ字形」に曲げられている。編
組みステントと同様、このステントは半径方向に膨張す
るとき、軸方向の長さが短くなる。
又、可塑的に変形可能な材料にて形成された補綴具もあ
る。米国特許第4,733,665号（パルマス(Palmaz)）は血
管形成バルーンを使用して半径方向に膨張させた径内腔
血管移植片を開示している。これら移植片はワイヤーメ
ッシュ管であり、半径方向に膨張するとき軸方向長さが
短くなる。米国特許第4,800,882号（ギアンツルコ(Gian
turco)）は、対向するループを形成するように複数の蛇
行状の曲がり部分を有するワイヤーにて形成されたステ
ントを特徴としている。バルーンを膨張させ、軸方向に
著しく短くせずに、ステントを半径方向に膨張させる。
補綴具の設計の更に別のアプローチが米国特許第3,868,
956号（アルフィディ(Alfidi)等）に記載されている。
アルフィディ等の特許は、円筒状スリーブにより相互に
結束された複数の略長手方向ワイヤーを備えるストレー
ナ又はスクリーンを開示している。これらワイヤーは埋
め込みのため長手方向の直線状の形状に変形可能であ
る。埋め込んだならば、該装置を加熱する。ワイヤーを
形成する金属（例えばニチロール合金）の回復特性のた
め、加熱によりワイヤーの両端は半径方向外方に広が
り、これにより装置を所望の位置に固着する。半径方向
への膨張又は収縮に拘わらず、一定の軸方向長さを維持
する手段を備えるステントがヘリカルコイルばねの形態
の補綴具として米国特許第4,553,545号（マース(Maass)
等）に開示されている。一実施例において、ばねの一定
の軸方向長さが維持されており、ばねの両端は相互に関
して回転させ、ばねピッチ及び半径を変化させる。別の
アプローチは、バネ材料に対してばねのより圧縮された
部分からの「一定の長さ」部分を提供することにより、
ばねの所定の部分に亙り一定のピッチを維持することを
内容とするものである。各場合において、ばねは、弾性
的であり、半径方向に膨張した形態を提供する回復力を
備えることが望ましい。
自然膨張式ステント又は補綴具は、可塑的に変形させた
装置よりも望ましいことが多い。弾性的ステントは、拡
張バルーン又はその他のステント膨張手段を使用せずに
展開させることが出来る。自然膨張式ステントは、血管
又はその他の固定箇所の径に従って予め選択することが
出来る。展開には補綴具を位置決めする技術が必要であ
るが、バルーンを適正に拡張させ、補綴具を選択した径
に可塑的に膨張させる更なる技術は不要である。又、か
かる自然膨張装置は、固定後、少なくとも僅かに圧縮し
た状態を維持し、従って、急角度の固定を促進する回復
力を備えている。これに反し、可塑的に膨張させるステ
ントは、変形させた組織の回復力又はフック、引掛け部
（バーブ）又はその他の独立的な固定手段を利用しなけ
ればならない。
上述のウォルステンの特許におけるように、多数の編組
みしかつら旋状に巻いたストランド又は単繊維にて補綴
具を形成することにより、更に別の利点が得られる。単
繊維自体は回復力を備えており、この回復力により単繊
維は、ステントが固定される体腔の組織壁に圧接され、
これにより、該体腔を開放状態に維持する。これと同時
に、隣接する単繊維間には十分なスペースが得られ、ス
テントの組織内への埋め込みを促進し、長期間の固定を
容易にする繊維状の成長を促進する。この構造の更に別
の利点は、展開中に補綴具が例えば、通常の径（即ち、
外力を受けないときの弛緩した状態の径）の約１／４程
度、顕著に半径方向に収縮することを許容する点であ
る。これにより、補綴具を固定箇所に向けて狭小な血管
又はその他の障害物を経て展開させることが容易とな
る。
これと同時に、半径方向に収縮するに伴い、顕著に軸方
向に延伸する。ステントはその半径方向への拘束状態か
ら自由になったならば、該ステントは自然膨張すると
き、軸方向に著しく収縮し又はその長さが短くなる。こ
のように、半径方向に膨張するステントの軸方向長さが
短くなるとき、組織に沿って軸方向長さが短くなると
き、組織に沿って軸方向に摩擦又は擦り動作が行われ
る。固定領域の組織が更に付勢して、補綴具をより長期
間、半径方向に膨張させる場合、かかる膨張により、更
に軸方向の長さが短くなりかつ拭き動作が行われ、組織
の損傷の虞れを更に大きくする。更に別の欠点は、ステ
ントがその固定中、予想以上に半径方向に膨張し、その
保持長さが所期の又は最小の必要な軸方向長さを下廻る
ことである。これと同様に、可塑的に変形可能なステン
トは、予想される以上の半径方向への膨張及び軸方向長
さの短縮を必要とする。
故に、本発明の一つの目的は、半径方向に自然膨張する
とき、その軸方向の長さを略維持し得る開放した織物状
のら旋状でかつ編組みした構造の補綴具を提供すること
である。
本発明の別の目的は、少なくとも２つのステント部分か
ら成り、断面の重なり合い領域の軸方向長さが可変であ
り、ステントの非重なり合い端部間の均一な軸方向の分
離状態を維持し得る半径方向に膨張する管状ステントを
提供することである。
本発明の更に別の目的は、ステントの両端に設けられ、
ステントを身体組織に固定する手段と組み合わせて、軸
方向長さが可変である中間部分を備えるステントであっ
て、該ステントが半径方向に膨張し又は収縮する間、身
体組織が２つの端部分の軸方向への分離状態を略一定に
維持し得るようにしたステントを提供することである。
発明の開示事項 上記及びその他の目的を達成するため、ステントを形成
し得るように摺動可能に係合した同軸状の第１及び第２
の開放した織物ステント部分を備える身体に埋込み可能
な装置が提供される。該ステント部分は、相互に重なり
合い、ステントの中間領域を形成するそれぞれの同心状
の第１及び第２の軸方向内方部分に沿って係合する。更
に、該ステント部分は、ステントのそれぞれの対向する
第１及び第２の端部を有し、第１及び第２の対向する軸
方向外方の非重なり合い部分を備えている。該ステント
部分は、少なくとも軸方向内方部分に沿って所定の第１
の径及び所定の第１の軸方向長さを備えている。ステン
ト部分は、半径方向に圧縮し、第１の径以下の第２の径
及び第１の軸方向長さより長い第２の軸方向長さとな
り、ステントを軸方向に体腔内に挿入し、体腔に沿った
所定の位置に供給し、その後、ステントを体腔を画成す
る空洞壁部分に固定することが出来る。ステントは、そ
の固定中に半径方向に膨張する。第１及び第２の軸方向
内方部分は、半径方向に膨張する間に相互に向けて摺動
し、中間領域の軸方向長さを短くする。このようにし
て、ステントは、半径方向に膨張する間、略一定の軸方
向長さを維持する。
好適なアプローチは、自然膨張型ステントの外端、例え
ば、該ステントの軸方向外方領域に沿ったそれぞれの第
１及び第２の広がった外端部分を固定する手段を使用す
る。これら第１及び第２の端部は、ステントが弛緩状態
にあるとき、第１の径より大きい径を備えており、圧縮
されたとき、ステントの他の部分に比べてキャビティ壁
部分に対しより大きい回復力を作用させる傾向となる。
端部径は、中間領域の径より５％以上大きくし、組織の
壁部分に沿った空洞の比較的一定の径に対して著しく異
なる回復力が作用するようにする必要がある。
これと別に、各ステント部分の外端部分は、中間領域と
同一径であるが、より大きい径の単繊維にて形成し、単
繊維を更に巻き付ける等の方法により、半径方向への収
縮に対する剛性又は抵抗力を中間領域におけるよりも増
大させることが出来る。更に別の実施例は、例えば、フ
ックのような固定要素をステントの両端に設けることで
ある。
ステントの両端を強固に固定することと相俟って、ステ
ント部分を半径方向に圧縮し又は供給形態にしたとき、
中間の略重なり合う領域が提供される。例えば、該重な
り合い領域は、圧縮したステントの軸方向長さの３／４
以上を占めることが出来る。次に、ステントの展開時、
両ステント部分は半径方向に膨張しかつ軸方向の長さが
短くなる。ステントの外端を固定した状態にて、軸方向
への長さの短縮は中間領域に沿ってのみ行われ、重なり
合い領域の長さを著しく短くするが、ステントの両端の
所望の軸方向への分離状態を維持する。
編組みし、ら旋状に巻き付けたストランド又は単繊維の
開放した織物が管状ステントの好適な構造体である。該
開放した織物構造体により、ステントは例えば供給中、
その径の少なくとも３倍の一定の径まで略自然に膨張す
ることが可能である。勿論、その結果、これに対応し
て、各ステント部分の軸方向長さが著しく短縮するが、
ステントの重なり合う中間領域が存在するため、その全
体的な軸方向長さは実質的に一定である。
柔軟カテーテルは、ステントの供給及び展開に適した装
置である。特に、柔軟シースは、カテーテルの少なくと
も末端部分を囲繞し、末端先端を越えて伸長し、同様に
ステント部分を囲繞し、これらステント部分を半径方向
に圧縮された供給形態に維持する。カテーテルには、内
腔を設けることが出来、該内腔を通じてガイドワイヤを
挿入し、カテーテル及び圧縮したステントが血管又はそ
の他の体乎を経て固定領域に移動するのを容易にするこ
とが出来る。カテーテルを正確に挿入し、ステントを所
望の固定位置に位置決めしたならば、外側シースを基端
方向に引き出し、ステントがカテーテルに当接し、固着
されてシースと共に基端方向に移動しないように固着す
る。ステントの末端部分が最初に自然膨張し、組織に対
して膨張するとき、該末端部分はステント部分を基単方
向に移動しないように固着する。ステントの一端が組織
によって拘束され、その他端が静止カテーテルにより拘
束された状態のときのステントの軸方向長さは略一定で
ある。ステント部分の半径方向への膨張に伴ってステン
ト部分の軸方向への長さが短縮する結果、中間領域の長
さが短くなり、全体的な軸方向長さを一定に維持する傾
向が得られる。
固定後、組織部分が更に付勢される結果、ステントは更
に半径方向に膨張出来る。しかし、ステントの両端は固
着されており、ステント部分の軸方向への長さが短縮す
ることにより、中間の重なり合い領域のみが影響を受け
る。このように、ステントが半径方向に自然膨張すると
き、ステントの長さが短くなるという望ましくない欠点
を伴わずに、開放した織物構造体の利点が維持される。
図面の簡単な説明 上記及びその他の特徴及び利点を一層良く理解し得るよ
うにするため、添付図面を参照しつつ、未発明の実施例
について詳細に説明する。ここにおいて、 図１は本発明に従って構成された身体埋込み装置の側面
図である。
図２は埋め込み装置を半径方向に圧縮した状態に保持す
るカテーテル及びシースの側面図である。
図３は該身体埋込み装置、カテーテル及びシースの端面
図である。
図４は身体埋込み装置を体腔内に展開させる状態を示す
側断面図である。
図５は体腔内に固定された身体埋込み装置の側面図であ
る。
図６は弛緩し又は半径方向に完全に膨張状態にあるとき
の別の実施例の身体埋込み装置の側面図である。
図７は膨張し又は弛緩状態にある更に別の実施例の身体
埋込み装置の側面図である。
図８は半径方向に圧縮した状態にある更に別の実施例の
身体埋込み装置を示す側面図である。
図９は膨張した状態にある図８の身体埋込み装置の側面
図である。
図１０は半径方向に圧縮した状態にある更に別の実施例
の身体埋込み装置を示す側面図である。
図１１は半径方向に膨張した状態の図１０の身体埋込み
装置の側面図である。
発明を実施するための手法 図面を参照すると、図１には、身体埋込み型補綴具又は
ステント１６が図示してある。該ステント１６は、例え
ば身体適合可能なステンレス鋼、又は、例えばポリプロ
ピレン、ポリウレタン、ポリスルホン又はポリエステル
のようなエラストマーの如き弾性的材料から成るら旋状
に巻きかつ編組みしたストランド又は単繊維１８から形
成された開放したメッシュ又は織物構造体を備えてい
る。
ステント１６は、同軸状のステント基端部分２０及びス
テント末端部分２２を備えている。中間領域２４は、ス
テントの基端部分２０及び末端部分２２のそれぞれの軸
方向内方部分が重なり合うことにより形成される。これ
らステント基端部分及び末端部分の軸方向外方の非重な
り合い部分は、それぞれ符号３０、３２で示してある。
ステトンの両端には、各々、ステントの全長に亙って公
称半径より大きい半径の広がった端部３４、３６があ
る。後で説明するように、これら広がった端部３４、３
６は、ステントの基端部分２０及び端末部分２２が固定
中に半径方向に自然膨張しかつ軸方向に収縮する場合で
さえ、ステント１６の一定の全体的な軸方向長さを維持
するのに有用な固定機能を備えている。
図１にて、ステント１６は、該ステント１６を半径方向
に収縮させる外力が全く加えられていないその弛緩状態
で示してある。ステント１６は外力を受けないとき、図
２及び図３に示した径より遥かに大きい径となるという
意味で自然膨張型である。これら図面において、該ステ
ント１６は該ステント１６を囲繞する柔軟でかつ絶縁性
のシース３８により弾性的に変形されかつ半径方向に縮
小した形態に維持されている。
第２にその末端領域のみを示した細長くかつ柔軟なカテ
ーテル４０は、ステントの基端に当接する末端先端４２
を備えている。シース３８の基端部分は、カテーテルの
末端領域を囲繞する。カテーテル４０は先端４２に開口
し、カテーテルの全長に沿って伸長する中央内腔４４を
備えており、液体の形態の薬剤をカテーテル基端の供給
源からカテーテルの末端先端まで供給する。内腔４４は
ガイドワイヤー（図示せず）の使用を更に容易にし、該
ガイドワイヤーはその末端によりステント１６に対する
所望の固定箇所まで血管を通じて挿入することが出来
る。ガイドワイヤーが適所にあるとき、カテーテル４
０、ステント１６及びシース３８は、ガイドワイヤーが
内腔４４内に収容された状態でガイドワイヤーの基端を
囲繞するように位置決めされる。次いで、カテーテル、
シース及びステントはガイドワイヤーにより末端方向に
移動させ又は前進させて固定位置に進め、その後、ガイ
ドワイヤーを引き抜くことが出来る。
シース３８はシリコンゴム又はその他の適当な生物学的
に適合可能な材料にて形成することが望ましく、少なく
ともカテーテルの末端領域又は所望であれば、カテーテ
ルの全長に沿ってステント及びカテーテルを囲繞する。
シース３８はカテーテル、シース及びステントを血管を
通じて挿入するのを容易にするのに薄いが、ストランド
１８の回復力に抗してステント１６を縮小した半径、即
ち供給形態に維持するのに十分な厚さであることが望ま
しい。カテーテル、ステント及びシースを含む組立体の
外径は約２．３mmとする。
ステント１６は、血管又はその他の体腔内の補綴具又は
移植片として使用するのに特に適している。ステトンの
１つの有利な適用例は、経皮的冠状動脈形成（ＰＴＣ
Ａ）術に使用することである。かかる血管形成術は、冠
状動脈バイパス手術に比べてコスト及び危険性とも著し
く小さいが、バルーン血管形成法により開放した閉塞通
路の約３０％までが急激に閉塞し、狭窄部位が再発する
ことは非常な問題である。ステント１６を治療前の閉塞
領域に沿って血管内に固定することにより、この領域を
恒久的に開放した状態に維持することが可能となる。
組織壁部分４８を有する血管４６内にステント１６を固
定することは、ステント、カテーテル及びシースを図２
及び図３に示した供給形態にて血管を通じて挿入するこ
とから開始する。縮小した半径のため、ステント１６が
血管に沿った所定の固定位置に達するまで、この組立体
を血管４６を通じて挿入することが容易にである。例え
ば、ステント、シース又はカテーテルに１又は２以上の
放射線不透過性マーキングを使用することにより、ステ
ントの適正な位置決めを確認したならば、シース３８を
カテーテル４０に関して基端方向に動かす。
末端先端４２がステント１６に当接しているため、カテ
ーテルは、シース３８を引き抜くとき、ステントが該シ
ース３８と共に基端方向に移動するのを阻止する。この
ように、図４に示すように、ステント１６はその軸方向
長さの増大する末端部分の上方にてシース３８が存在し
なくなる。各テント部分２０、２２が自由になると、こ
れらステント部分２０、２２は組織の壁部分４８に接触
するまで半径方向に自然膨張し、次に、組織の壁部分に
より半径方向内方に付与される回復力により半径方向に
膨張する傾向が阻止されるまで、更に僅かに半径方向に
膨張する。図５に図示したこの平衡状態にて、ステント
は図１に示した弛緩形態まで完全に半径方向に膨張せ
ず、ステントを血管４６内の固定位置に維持する傾向と
なる回復力を作用させる。
本発明の顕著な特徴は、広がった端部３４、３６により
得られる固定状態と相俟って、ステント部分２０、２２
を同心状にかつ摺動可能に取り付け得ることである。シ
ース３８を最初に引き出す間、末端の広がった端部３６
は、組織の壁部分４８に遭遇する最初の部分である。そ
の大きい公称（弛緩形態の）径のため、広がった端部３
６は、この部分の軸方向外方部分３２の他の部分よりも
幾分より半径方向に膨張し、組織の壁部分に対して半径
方向外方に比較的より大きい復帰力を作用させる。従っ
て、ステントの末端部分２２が半径方向への膨張に伴っ
て、例えば、１００mmの長さから５０mmの固定長さまで
供給されたとき、軸方向への長さが短くなることは、軸
方向内方部分２８が図４に示すように末端方向又は右方
向に略完全に移動することにより生ずる。ステント部分
２０、２２が摺動可能に係合することにより、基端部分
２０がカテーテル４０に関して略固定されている間にか
かる基端方向への移動が可能となる。
シース３８を更に引き抜くと、基端部分２０は同様に、
半径方向に膨張しかつその軸方向長さが短くなる。図４
に図示するように、ステント部分２０の軸方向外方部分
３０の多くは、シース３８内に半径方向に圧縮されたま
まであり、カテーテルに関して固定されている。従っ
て、半径方向に膨張する間にステント基端部分２０が軸
方向に収縮することは、その軸方向内方部分が基端方向
に移動することにより略完全に行われる。これは、勿論
ステント部分を相互に対して更に摺動させることを含
み、中間の重なり合い領域２４の軸方向長さを更に短縮
させる。
図２及び図５から明らかであるように、符号「Ｌ」で表
示したステント１６の軸方向全長は、ステントが展開状
態にあるか、又は半径方向に膨張し、平衡又は固定状態
にあるか否かに関係なく略一定である。ステント基端部
分２０及びステント末端部分２２の長さは、各々平衡状
態にて著しく短い。しかし、軸方向長さが短くなる結
果、図２のステントの全長の３／４以上を占める中間の
重なり合い領域２４の長さは著しく短くなり、図５のス
テントの全長の約１／５程度の長さとなる。
最終的に、ストランド１８を組織の壁部分４８内に埋め
込み、ストランド間及びストランドの周囲にて組織を繊
維状に成長させ、ステントを固着することにより、ステ
ント１６は恒久的に固定される。この固定方法は、数週
間の間行われ、その間、組織の壁部分４８は屈曲してス
テントを更に半径方向に膨張させ、ステント部分２０、
２２の軸方向長さを更に短くさせることが出来る。しか
し、この更に軸方向への収縮の結果、同様、中間の重な
り合い領域が更に短くなるため、軸方向長さ「Ｌ」は略
一定である。広がった端部３４、３６が組織に対して比
較的大きい回復力を作用させ、これにより、ステントの
中央部分に比べて端部をより確実に固着するため、軸方
向への収縮は中間領域に沿って生じる。このように、ス
テントの全長は、固定中及び固定直後のみならず、繊維
がステントを恒久的に固着するときまでの中間の間も維
持される。
図６には、別の実施例のステント５２が図示されてお
り、同様に、同心状でかつ摺動可能に接続されたステン
トの基端部分及び端末部分は５４、５６で示してある。
これらステント部分の軸方向内方部分は重なり合って、
中間領域５８を形成する。ステント５２はら旋状に巻き
かつ編組みした単繊維６０から成る開放メッシュ又は織
物構造体を備えている。
その弛緩した状態、即ち、非応力状態で示したステント
５２は、その両端に半径方向外方への広がり部分を備え
ていない。広がった端部に代えて、ステント部分５
４、、５６の各々は、その軸方向外端に編組みした単繊
維６０に接続された複数の強化ストランド６２を備えて
おり、それぞれの基端及び末端の強化端部領域６４、６
６を形成する。強化ストランド６２は、基部の単繊維と
同一構造とすることが出来るが、必ずしもそうする必要
はない。何れの場合でも、強化ストランド６２は半径方
向圧縮力に対して更に弾性的抵抗力を付与し、その結
果、ステント５２を所定の弾性力で半径方向に圧縮する
ためには、強化端部領域６４、６６には、これら領域の
中間に付与することを要する力よりも大きい力を付与す
ることを必要とする。
ステント５２はステント１６に関して上述した方法にて
展開させることが出来る。ステント５２を血管又はその
他の体腔内に適正に位置決めした後、シース３８と同様
の囲繞シースをそのステント５２との囲繞関係から基端
方向に引き出し、ステント５２が半径方向に自然膨張
し、空洞を形成する組織と接触するのを許容する。同様
に、ステント５２は体腔の径より大きい公称径（弛緩状
態にて）を備えるものを選択し、その結果、基部単繊維
６０及び強化ストランド６２が完全に膨張する前に組織
に係合し、身体組織により完全に膨張する手前の状態に
拘束され、ステントの回復力と身体組織の反対方向に作
用する回復力とを平衡状態にさせる。ステントがかかる
平衡状態にあるとき（ステント１６に関して図５に図示
するように）、強化端部領域６４、６６はステントの他
の部分から僅かに半径方向外方に広がるようにすること
が出来るが、広がらないようにしてもよい。何れの場合
でも、強化端部領域における回復力は、ステントの全長
の他の部分の長さに沿った回復力を上廻る。従って、ス
テント５２の両端は、身体組織に関してその軸方向位置
決め状態を確実に保持し、軸方向への収縮は中間領域５
８の長さの著しい短縮として行われる。
図７には、ステントの軸方向長さを維持する更に別のア
プローチが図示されており、この場合、摺動可能に相互
接続されかつ同軸状のステントの基端部分７４及び末端
部分７６を有するステント７２の両端に複数の固定フッ
ク７０が設けられている。該固定フック７０は、幾分か
の損傷の虞れを生じ、上述の別の固定手段よりもその適
用分野は狭い。しかし、固定フック７０は、ステント７
２の両端を体腔内に確実にかつ迅速に固定する。その
後、ステント部分７４、７６が半径方向に膨張しかつ軸
方向に収縮することは、中間領域７８の長さを短くし、
ステントの全長を維持する働きをする。
図８及び図９には、基端部分８２と、末端部分８４と、
該基端部分８２及び該末端部分８４に摺動可能に係合す
る中心部分８６とを有する更に別の実施例のステント、
即ち補綴具８０が図示されている。これら補綴具８０の
３つの部分は、全て編組み単繊維から成る上述の開放し
たメッシュ又は織物構造体を備えている。このように、
ステント８０は、その基端８８と末端９０との中間に２
つの重なり合い領域、即ち、基端寄りの中間領域９２及
び末端寄りの中間領域９４を備えている。中央部分８６
は、便宜上その他の部分よりも小さい半径で示してある
が、これら全ての部分の半径は略同一であることが望ま
しい。
図９には、弛緩し又は半径方向に膨張した状態のステン
ト８０が示してある。これら部分８２、８４、８６の各
々は、縮小した軸方向寸法及びより大きい半径を備えて
いる。しかし、基端８８と末端９０との間の軸方向距離
は略等しく、実質的に全ての軸方向収縮の結果、中間の
重なり合い領域９２、９４の軸方向寸法は、著しく縮小
する。
補綴具８０は、その他の実施例に関して上述した方法に
て展開させることが出来る。補綴具を血管又はその他の
体腔内に所望通りに位置決めした後、囲繞するシースを
補綴具に対する囲繞関係から摺動可能に引き出し又は折
り畳み、該シースが半径方向に自然膨張し、空洞を形成
する組織壁部分（図示せず）に接触するのを許容する。
勿論、体腔の径は、補綴具の公称径又は半径方向に膨張
した径より小さいはずである。補綴具８０は、上述のフ
ック、強化端部又は広がり端部のような特別な端部固定
構造体を一切利用しない。該補綴具は、上述の部分の自
然膨張及び復帰力により位置決めされ、特に、その展開
中及びシース等から開放されるときである固定後に、そ
の相対的位置を維持する。ある型式の端部固定手段を使
用すれば、ステントの一定の軸方向長さを維持するのが
容易になるが、このアプローチは、上述の２つの部分か
ら成るステントに適したものであることに留意すべきで
ある。所望であれば、端部８８、９０に固定構造体を設
けることも可能である。
図１０及び図１１には、中間領域１０２に沿って摺動可
能に係合しかつ重なり合う基端部分９８及び末端部分１
００を有する更に別の実施例のステント９６が示してあ
る。ストランド又はワイヤー１０４がステント９６に対
して平行に伸長し、それぞれ基端１１０及び末端１１２
付近にて箇所１０６、１０８に固着される。ワイヤー１
０４は、ステントを固定箇所に供給する間、ステント部
分９８、１００と共に屈曲するのに十分可撓性である。
しかし、該ワイヤー１０４は軸方向に剛性で、略延伸不
能である。従って、ステント部分９８、１００が図１０
に図示するように半径方向に拘束され、又は図１１に図
示するように半径方向に膨張するか否かを問わず、ワイ
ヤー１０４は基端１１０及び末端１１２を一定の軸方向
に分離した状態に維持する。ワイヤー１０４がステント
９６の全長が確実に決定されるが、ステント部分９８、
１００が軸方向に収縮する結果、中間の重なり合い領域
１０２が縮小する。１又は２以上のワイヤー１０４を設
けかつ固着することにより、その他の実施例に比べてス
テント９６のコストは増大するが、該ワイヤー１０４に
より、固定中の半径方向への膨張程度に関係なく、ステ
ントの長さは一定に維持される。
上述の実施例は、全て自然膨張型ステント、即ち補綴具
用の弾性的な単繊維から成る織物又は編組み構造体を特
徴とする。これとは別に、ステントは可塑的に変形可能
なストランドにて形成することも出来る。かかるステン
トは、縮小した半径の形態にて供給し、位置決め後、例
えば、上述のパルメッツの特許におけるようにカテーテ
ルバルーン等を拡張させ、半径方向に膨張させる。更
に、上述の実施例は血管に採用されるが、これらステン
トの設計は、例えば尿道、胆管又は気管のようなその他
の体腔にも適したものであることを理解すべきである。
フック、強化ストランド又は外方に広がった端部分を使
用して外端を固定するか否かに関係なく、係合したステ
ント部分の半径方向への拡張及びそれに伴う軸方向への
収縮による影響を受けることなく、ステントの軸方向へ
の全長は略一定に維持される。従って、展開させ、固定
したその後の数週間、軸方向へ長さの短縮に伴う欠点を
生ずることなく、ら旋状に巻き、編組みした単繊維の機
能上の利点が達成される。

Claims (10)

    【特許請求の範囲】
  1. 【請求項１】体腔内への固定装置にして、 相互に重なり合い、ステント（１６）の中間領域（２
    ４）を形成するそれぞれの第１及び第２の軸方向内方部
    分に沿って摺動可能に係合した略管状でかつ同軸状の第
    １及び第２の開放したステント織物部分（２０、２２）
    を有するステント（１６）を備え、 前記ステント織物部分（２０、２２）が、前記ステント
    （１６）のそれぞれの対向する第１及び第２の端部（３
    ４、３６）を有するそれぞれの非重なり合い第１及び第
    ２の軸方向外方領域（３０、３２）を更に備え、 前記ステント織物部分（２０、２２）が、少なくとも前
    記軸方向内方部分に沿って、所定の第１の径及び所定の
    第１の軸方向長さを備え、前記ステント織物部分（２
    ０、２２）が、前記第１の径より小さい第２の径に、及
    び前記第１の軸方向長さより長い第２の軸方向長さに半
    径方向に圧縮可能であり、前記ステント（１６）を体腔
    内に軸方向に挿入し、該体腔に沿った選択された位置に
    供給し、その後、前記ステント織物部分（２０、２２）
    を前記体腔を画成する組織壁部分と係合させることによ
    り、前記ステント（１６）を体腔内に固定し、 前記ステント織物部分（２０、２２）が半径方向に膨張
    し、前記係合状態となるとき、前記第１及び第２の軸方
    向内方部分が相互に関して摺動し、前記中間領域（２
    ４）の軸方向長さを短くし、これにより、前記半径方向
    への膨張中、前記ステント（１６）の略一定の軸方向長
    さを維持することを特徴とする装置。
  2. 【請求項２】請求項１に記載の装置にして、 前記ステント織物部分（２０、２２）の各々が、弾性的
    で身体適合可能な材料の単繊維（１８）をら旋状に巻い
    て形成した開放織物構造体であることを特徴とする装
    置。
  3. 【請求項３】請求項に２記載の装置にして、 前記第１の端部（３４）及び第２の端部（３６）を前記
    組織壁部分に固定する手段を更に備えることを特徴とす
    る装置。
  4. 【請求項４】請求項３に記載の装置にして、 前記ステント織物部分（２０、２２）が可撓性であり、
    外力を受けないとき、前記所定の第１の径及び第１の軸
    方向長さを備え、前記第２の径に弾性的に圧縮可能であ
    ることを特徴とする装置。
  5. 【請求項５】請求項４に記載の装置にして、 前記固定手段が前記第１及び第２の軸方向外方領域（３
    ０、３２）のそれぞれの第１及び第２の広がった外端部
    分を備え、これにより、前記第１の端部（３４）及び第
    ２の端部（３６）が、ステント（１６）が弛緩状態にあ
    るとき、前記第１の径より大きい径を有することを特徴
    とする装置。
  6. 【請求項６】請求項５に記載の装置にして、 前記第１の端部（３４）及び第２の端部（３６）の径が
    前記第１の径より少なくとも５％だけ大きいことを特徴
    とする装置。
  7. 【請求項７】請求項６に記載の装置にして、 前記広がった外端部分の各々の軸方向長さが前記ステン
    ト織物部分（２０、２２）の関係する１つの部分の軸方
    向長さの１／３以下であることを特徴とする装置。
  8. 【請求項８】請求項４に記載の装置にして、 前記固定手段が、それぞれ前記第１の端部（３４）及び
    第２の端部（３６）を有する第１及び第２の外端部分に
    沿って前記単繊維に接続された弾性的な強化ストランド
    を備えることを特徴とする装置。
  9. 【請求項９】請求項３に記載の装置にして、 前記固定手段がそれぞれ前記第１の端部（３４）及び第
    ２の端部（３６）にてステント（１６）に取り付けられ
    た第１及び第２の複数の固定フックを備えることを特徴
    とする装置。
  10. 【請求項１０】請求項１に記載の装置にして、 前記第１の端部（３４）及び第２の端部（３６）寄りの
    前記第１のステント織物部分（２０）及び第２のステン
    ト織物部分（２２）に接続されかつ軸方向に伸長し、前
    記半径方向への膨張中、前記ステント（１６）の軸方向
    長さを一定に維持する細長くかつ可撓性でしかつ略延伸
    不能な部材を更に備えることを特徴とする装置。
JP3509370A 1990-06-28 1991-04-25 体腔内への固定装置 Expired - Fee Related JPH0636807B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US544923 1983-10-24
US07/544,923 US5064435A (en) 1990-06-28 1990-06-28 Self-expanding prosthesis having stable axial length
PCT/US1991/002854 WO1992000043A1 (en) 1990-06-28 1991-04-25 Self-expanding prosthesis having stable axial length

Publications (2)

Publication Number Publication Date
JPH05507215A JPH05507215A (ja) 1993-10-21
JPH0636807B2 true JPH0636807B2 (ja) 1994-05-18

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Country Link
US (1) US5064435A (ja)
EP (1) EP0536164B1 (ja)
JP (1) JPH0636807B2 (ja)
AT (1) ATE102466T1 (ja)
CA (1) CA2086333C (ja)
DE (2) DE9190098U1 (ja)
DK (1) DK0536164T3 (ja)
ES (1) ES2050054T3 (ja)
WO (1) WO1992000043A1 (ja)

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US5064435A (en) 1991-11-12
EP0536164B1 (en) 1994-03-09
WO1992000043A1 (en) 1992-01-09
CA2086333A1 (en) 1991-12-29
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