JPH0640877B2 - 血管栓挿入組立体 - Google Patents

血管栓挿入組立体

Info

Publication number
JPH0640877B2
JPH0640877B2 JP3516798A JP51679891A JPH0640877B2 JP H0640877 B2 JPH0640877 B2 JP H0640877B2 JP 3516798 A JP3516798 A JP 3516798A JP 51679891 A JP51679891 A JP 51679891A JP H0640877 B2 JPH0640877 B2 JP H0640877B2
Authority
JP
Japan
Prior art keywords
incision
patient
distal end
plug
vascular plug
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 - Lifetime
Application number
JP3516798A
Other languages
English (en)
Other versions
JPH05508793A (ja
Inventor
フアウラ，ブラッドフォード・シー
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.)
Quinton Instrument Co
Original Assignee
Quinton Instrument Co
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Filing date
Publication date
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=24366118&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=JPH0640877(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Quinton Instrument Co filed Critical Quinton Instrument Co
Publication of JPH05508793A publication Critical patent/JPH05508793A/ja
Publication of JPH0640877B2 publication Critical patent/JPH0640877B2/ja
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00557—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00637—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for sealing trocar wounds through abdominal wall
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646—Type of implements
    • A61B2017/00654—Type of implements entirely comprised between the two sides of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • 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
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Cardiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Control And Other Processes For Unpacking Of Materials (AREA)
  • Amplifiers (AREA)
  • Prostheses (AREA)
  • Making Paper Articles (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Electrotherapy Devices (AREA)
  • Table Devices Or Equipment (AREA)

Description

【発明の詳細な説明】 技術分野 本発明は一般に欝血装置、より詳細には、患者の体内に
形成された切開または穿刺内に挿入可能な挿入組立体及
び血管栓に関する。
背景技術 カテーテル法処置の間において、看護婦または医師は、
動脈または他の血管に従来のカテーテル導入器または拡
張器で開口を創作する。開口の寸法は処置の形式及び使
用されるカテーテルの寸法により異なる。例えば、標準
的血管造影処置において使用されるカテーテル及びカテ
ーテルシースの直径は、一般的に５乃至８フレンチ（そ
れぞれ１．６７mm乃至２．６７mm）の間である。血管形
成処置において使用されるカテーテル及びカテーテルシ
ースの直径は、８（２．６７mm）または９（３．３３m
m）フレンチであってもよい。大動脈内バルーンポンプ
処置において使用されるカテーテル及びカテーテルシー
スの直径は、一般的に１４乃至１６フレンチ（それぞれ
４．６７mm乃至５．３３）間であり、心肺支持装置と共
に使用されるカテーテル及びカテーテルシースの直径
は、一般に１８乃至２０フレンチ（それぞれ６．０mm乃
至６．６７mm）の間である。その上、カテーテルはしば
しば治療部位へ前進されるうちに、ねじれたりまたそう
でなければ操作されたりし、それが患者の体内の切開ま
たは穿刺の更なる拡大の原因となる。
医学的処置が完了し、カテーテルが動脈または他の血管
から除去される際、従来の方法は血塊が生じるまで差し
込み部位に外圧をかけるものであった。これらの処置を
受ける患者の多くはヘパリン等の抗凝血薬を投薬されて
いるので、看護婦は切開部位に長時間に渡って外圧をか
ける必要があることがある。切開における出血を止める
のに要する時間は、看護婦の時間を有効に使用するもの
ではなく、動脈は血塊が動脈内の開口を遮断するまで内
部で出血を続けるため、痛みを伴う血腫または見苦しい
挫傷が切開部位に未だ生じ得る。
カースの１９８９年３月１６日付にて許可された米国特
許第４、８２９、９９４号は、上記の問題を骨盤エプロ
ン及び鼠蹊部絆創膏からなるエプロン状の装置を提供
し、患者の大腿の血管に圧縮力をかけることにより解決
しようとしている。この装置は看護婦が切開部位に直接
圧力をかける必要を効果的に排除するが、この装置の使
用による大腿の動脈中の血液の流れの減少は、傷つけら
れた患者における血枢症形成の見込みを増加させること
がある。
上記の問題を解決する別の取組みがシモフスキーの１９
９０年５月２９日付にて許可された米国特許第４、９２
９、２４６号に開示される。本特許に開示される装置の
使用方法は、その遠位端に膨張可能なバルーンを有する
半硬質管を上行組織を通って穿刺された動脈の外側管腔
に隣接する位置まで前進させる工程を含む。バルーン
は、次いで膨張され、動脈の外側管腔に直接圧力をかけ
る。次にレーザーエネルギーが、半硬質管の中央に位置
される光ファイバーを経て、動脈の外側管腔に向けら
れ、該レーザーエネルギーは光ファイバー及び半硬質管
のバルーン内を通過し、動脈を熱によって溶着し、切開
を封鎖する。
上記の問題を解決する更なる取組みは、ケンジーの１９
８８年５月１７日付にて許可された米国特許第４、７４
４、３６４号及び関連するケンジーのそれぞれ１９８９
年８月１日付及び１９９０年１月２日付にて許可された
米国特許第４、８５２、５６８号及び４、８９０、６１
２号に開示される。ケンジーの最初の二件の特許は、血
管壁の開口を封鎖するための装置を開示し、該装置は、
内部に膨張可能な閉鎖部材を除去可能に配置した細長い
管状体からなる。管状体はまた、管状体から血管の内部
へ閉鎖部材を強制的に押し出すために管状体内に配置さ
れる排出装置を含む。引き戻しフィラメントが閉鎖部材
に固定され、それにより閉鎖部材の嵌合表面に、穿孔と
隣接する血管の内側表面を欝血するように嵌合する。最
後のケンジーの特許は、組織の穿刺された血管または器
管に隣接する組織部分と係合し、栓部材を保持するよう
に適合される保持部、及び穿刺された血管または器管内
へ延長し、該管に隣接する組織に係合し、穿孔を封鎖す
る気泡材料で形成される封鎖部を有する栓部材を含む装
置を開示する。
どの先行技術の装置も、患部の血管、管または管腔内に
延長することなしに血管壁、管壁または管腔壁の穿孔ま
たは切開の閉鎖を果たすための、簡素で比較的廉価な手
段の使用を教示しない。
発明の開示 従って、本発明の目的は、従来技術の不都合を克服する
装置及び使用方法を提供することにある。
本発明の別の目的は、動脈中の切開を封鎖するために要
する時間を削減し、切開からカテーテルが除去された後
に血腫が形成される見込みを減少させることにある。
本発明のこれら及びその他の目的は、以下に記載される
装置を使用することにより血管、管または管腔内の切開
を封鎖するための装置及び方法を提供することにより達
成される。
本発明の一態様は、好ましくは比較的小直径のバルーン
付きカテーテル及び多孔性の吸収可能な血管栓を含む。
血管栓は遠位端を含み、該端は血管栓の遠位端が血管、
管または管腔の外側表面に隣接して位置決めされ、切開
を通過する流体の流れを中断する原因となることのない
ような寸度とされ、形成される。本発明の好ましい形式
の使用方法は、先に挿入されたカテーテルシースを通し
てバルーン付きカテーテルを挿入し、次いで切開からカ
テーテルシースを除去する工程を含む。バルーンは次に
膨張され、血管、管または管腔の内壁に隣接して位置決
めされる。次に、血管栓は切開中に挿入され、血管栓の
遠位端はカテーテルの遠位端上のバルーンに隣接して位
置決めされる。バルーンはその後、収縮され、カテーテ
ルは切開から除去される。最後に、血管栓が周囲の組織
に一体化されるまで血管栓を切開中に維持するために、
切開部位上に包帯が位置されてもよい。
本発明の利点は、血管栓の遠位端が血管、管または管腔
内に延長しないので、血管内の流体の流れが血管栓によ
って遮断されず、血栓症が切開部位に形成される見込み
が減少されることにある。
本発明の更なる利点は、使用が比較的簡単であり、血腫
が切開部位に形成される見込みが最小化されることにあ
る。
図面の簡単な説明 図１は、患者に挿入された本発明のカテーテルシース及
びバルーン付きカテーテルを一部断面にて示す側面立面
図である。
図２は、膨張され、患者に位置されたバルーン付きカテ
ーテルのバルーンを一部断面にて示す側面立面図であ
る。
図３は、患者に挿入された血管栓及びバルーン付きカテ
ーテルを一部断面にて示す側面立面図である。
図４は、バルーン付きカテーテルを除去した状態で患者
に位置された血管栓を一部断面にて示す側面立面図であ
る。
図５は、本発明の血管栓の遠位端を示す部分側面図であ
る。
図６は、一旦まず患者に挿入された本発明の別の形式を
一部断面にて示す側面立面図である。
図７は、配置翼が延長された位置にある図６の導入器組
立体を一部断面にて示す側面立面図である。
図８は、延長された配置翼が患者の血管の内壁に隣接し
て位置される図６の導入器組立体を一部断面にて示す側
面立面図である。
図９は、プランジャーが血管栓の適切な配置を維持する
ために静止状態に維持される間、導入器組立体のプラン
ジャー部材と内側及び外側スリーブとが一部患者から除
去された後の図６の導入器組立体を一部断面にて示す側
面立面図である。
発明を実行する態様 本発明は、患者の大腿動脈１０等の血管の切開又は穿刺
を封鎖するための本発明の使用の詳細な参照を以って、
以下に記述される。本発明は、患者の切開又は穿刺を通
じての体液の損失を防ぐために該切開又は穿刺を封鎖す
ることが望ましい、ほとんどいかなるカテーテル法又は
他の医学的処置と共に使用され得ることが意図される。
ここで使用されるように、エレメントの遠位端は、エレ
メントの患者に最も近い端を示し、エレメントの近位端
は、エレメントの患者から最も遠いエレメントを示す。
本発明をより充分に理解し、認識するために、ここに従
来の患者の大腿動脈を通しての血管造影用カテーテル法
処置が記載される。このような処置において、血管造影
用針（図示せず）は、患者の皮膚１２の表皮層及び皮膚
層を通して約２５から４５度の好ましい角度で経皮挿入
される。針は、針が大腿動脈に穿刺するまで患者の皮膚
に６mmから７０mm経皮挿入される。針による動脈１０の
穿刺は、次に医師により確認され、小直径のガイドワイ
ヤ（図示せず）が、針を通して約１５から２０cm挿入さ
れる。針は次にガイドワイヤ上を引き抜かれ、一方切開
部位における出血を制限し、血栓の形成を防ぐために動
脈１０には圧力がかけられる。カテーテル（図示せず）
及び外部導入器又はカテーテルシース１４はガイドワイ
ヤ上を挿入され、ガイドワイヤは次にカテーテルの内部
から取り除かれる。次に、カテーテルは最終位置まで前
進させられ、処置が行なわれる。一旦処置が完了される
と、カテーテルは取り除かれ、カテーテルシースのみが
切開中に残され、本発明の血管栓２０が以下に記載され
るように切開中に挿入されるようにする。
図１から５に示されるように、本発明の好ましい形態
は、一般に比較的小直径のバルーン付きカテーテル２２
及び血管栓２０から成る。バルーン付きカテーテルは好
ましくは１mm又はそれ未満の外径を有し、その遠位端２
６に膨張式バルーン２４を含む。バルーン付きカテーテ
ル２２はポリエチレン又はポリ塩化ビニル等のほぼいか
なる半硬質材料によって構成されてもよい。バルーン付
きカテーテル２２は、近位端２８を含み、該端はその上
にシリンジアタッチメント３０を有する。シリンジアタ
ッチメント３０はシリンジ３１から流体または気体を受
理するように設計されており、該シリンジは該アタッチ
メントに取付け可能であり、以下により詳細に記述され
るようにバルーンが膨張できるようになっている。
図３−５に示されるように、本発明の血管栓２０は、好
ましくはヴィタカフの名称でヴィタフォー・コーポレー
ションにより販売されるコラーゲンカフ等の、多孔性
で、生物学的に崩壊可能であり、膨張可能な欝血コラー
ゲンスポンジから成る円筒形棒状部材、または重合ポリ
乳酸またはポリグリコール酸マトリックスである。血管
栓２０の遠位端３２は、好ましくは血管栓２０の縦方向
寸法に関して約２５から４５度の角度で向けられ、図５
に示されるように、血管栓２０の遠位端３２は、好まし
くは動脈１０の外側管腔に一致して輪郭づけられる。血
管栓２０の近位端３４は患者に配置された後、切除され
てもよく、以下により詳細に記述されるように患者の皮
膚の表皮層に、またはそのわずかに下に位置されてもよ
い。
一旦血管造影法または他の医学的処置がなされ、患者か
らカテーテルが除去されると、導入器すなわちカテーテ
ルシース１４は図１に示されるように切開内に残る。カ
テーテルシース１４は切開を開放状態に維持するように
機能し、一方バルーン付きカテーテル２２は該シースを
通して挿入される。一旦バルーン付きカテーテル２２が
切開内に適切に位置され、バルーン付きカテーテル２２
の遠位端２６が動脈１０内に延長すると、使用者はバル
ーン付きカテーテル２２の周囲から、及び切開内から外
へ、カテーテルシース１４を引き抜いてもよい。切開は
次いで、バルーン付きカテーテル２２のシャフトの周囲
で崩壊し、使用者は、バルーン２４を膨張させるため
に、バルーン付きカテーテル２２の遠位端２８上のシリ
ンジアタッチメント３０にシリンジを取付けてもよい。
代わりに、バルーン付きカテーテル２２は、その近位端
に予め取り付けられた膨張部材（図示せず）を含んでも
よく、該部材は一時的にバルーン２４を膨張させるため
に、しぼったりまたは別の方法で付勢されてもよい。一
旦バルーン２４が膨張されると、バルーン付きカテーテ
ル２２は切開から引き抜かれ、膨張したバルーン２４が
動脈１０の内側管腔に沿った切開部位に隣接して位置さ
れる。血管栓２０は次いでバルーン付きカテーテル２２
のシャフトに沿った切開内に挿入され、血管栓２０の遠
位端３２が、バルーン付きカテーテル２２の遠位端２６
において、膨張したバルーン２４に接触する。この位置
において、血管栓２０の遠位端３２は、動脈１０の外側
管腔と整列され、バルーン２４は血管栓２０が動脈１０
内に延長するのを防ぐ。一旦血管栓２０が切開内に適切
に位置されると、バルーン２４は収縮され、バルーン付
きカテーテル２２は切開から除去される。使用者は、バ
ルーン付きカテーテル２２が除去され、切開内の血管栓
２０を摩擦により保持する際に、切開に少量の圧力を適
用してもよい。一旦血管栓２０が切開中に挿入される
と、血管栓２０は血管及び切開を取り囲む組織から血管
栓２０内に流体が引き込まれると膨張し、従って切開中
の血管栓２０の膨張と共に血管栓２０を取り囲む組織の
収縮は、血管栓２０を切開中の所定の位置に維持するの
を援助する。バルーン付きカテーテル２２は、バルーン
付きカテーテル２２が切開から除去されるまで、血管栓
２０のバルーン付きカテーテル２２に隣接する部分が、
軟化し周囲の組織から流体を吸収するのを防ぐので、切
開からのバルーン付きカテーテル２２の除去は、血管栓
２０の位置決めに不利に作用しない。血管栓２０の切開
への挿入の最終段階として、患者の皮膚１２を越えて延
長する血管栓２０の近位端３４は、血管栓２０の近位端
３４が皮膚１２の表皮層の下部近くに位置されるように
切除されてもよい。皮膚１２の開口は、次いで縫合して
閉じられるかまたは切開部上に包帯を適用してもよい。
上記に簡単に記述されたように、好ましい実施態様の血
管栓２０は、切開中に位置されるとまずふくらんで、切
開部における血腫の形成を防ぐ。加えて、血管栓２０の
気孔率は、より大きな切開が形成された場合、もしくは
血管栓２０がより急速に膨張する必要がある場合、周囲
の組織からの流体をより急速に吸収するように、切開の
予期される寸法によって異なってもよい。さらに、血管
栓２０の気孔率は、血管栓２０への結合組織細胞浸潤の
ための手段を提供し、患者の組織が最終的に血管栓２０
の気孔率に従って、種々の速度で経皮切開を充填する。
血管栓２０の遠位端３２を動脈１０の外側管腔にまたは
その近くに位置することにより、切開部における動脈１
０を通る流体の流れの中断はなく、動脈１０の内側管腔
に沿って位置される閉鎖または封鎖部材を含む従前の装
置と比較して、血栓症の危険性は最小化される。血管栓
２０が数週間から数か月の内に崩壊し、吸収されるの
で、後に切開から血管栓２０を除去する必要がないこと
が予知される。さらに、血管栓２０は組織トロンボプラ
スチン等の従来の凝血剤を含むように処方されてもよ
く、該凝血剤は膠原性材料中に混入され、局所的血液生
成を促進し、また医師が、処置の行なわれた後、患者を
ヘパリン等の抗凝血剤にて維持できるようにする。血管
栓２０は、その中に長手方向に組み込まれる放射線不透
過性物質を含むように処方され、血管栓２０の配置が従
来の肉眼的方法の使用により観察できるようにしてもよ
いことが、さらに予知される。
図６−１０は、挿入組立体と関連する血管栓５２を有す
る、予め負荷された挿入組立体５０から一般になる本発
明の別の形式を示す。本実施態様の挿入組立体５０は、
プランジャー５４を有するシリンジ様の装置、円筒形に
形成された外側スリーブ５６、及び円筒形に形成された
内側スリーブ５８からなる。プランジャー５４は、好ま
しくはその一部が円筒形内側スリーブ５８内に滑動可能
に嵌合するような寸度とされる。外側スリーブ５６及び
内側スリーブ５８は、角度をつけた遠位端６２及び６３
を含む。内側スリーブ５８は、内側スリーブ５８の遠位
端６３の近くに位置決めされた、外方に偏倚され延長す
る一対の配置翼６４を含む。これらの配置翼６４は外方
に偏倚され、内側スリーブ５８の遠位端の周囲から外側
スリーブ５６を引き抜くことにより開放され、内側スリ
ーブ５８の遠位端６３周囲の原位置に外側スリーブ５６
を戻すことにより閉鎖されてもよい。代わりに、本実施
態様は、スリーブの近位端の近くに位置する付勢部材を
有する一以上の円筒スリーブ部材で構成され、それによ
りレバー、回転ハンドル、またはスリーブの近位端付近
の他の付勢部材が、スリーブの遠位端上の配置翼の一つ
またはそれ以上をスリーブの遠位端から半径方向外方に
突出させ、血管栓５２が切開内において所望の位置に移
動される際に、一時的にスリーブの遠位端の径周囲を増
加させてもよいことが予知される。
本実施態様の血管栓５２は、好ましくは角度を付け輪郭
づけられた遠位端６８を有する比較的短い棒状部材とし
て形成される膠原性物質からなり、該端は血管７０の管
腔の外側輪郭に一致するよう形成される。血管栓５２の
近位端７２は、上述されたように、配置後に切除され、
患者の表皮層またはそのわずかに下に位置決めされても
よい。本実施態様において、血管栓５２は、挿入組立体
５０内に、最初の予め負荷された状態で位置決めされ、
図６及び７に示されるように、血管栓５２の遠位端６８
が、外側及び内側スリーブ５６及び５８内で配置翼６４
に隣接した所定位置に位置される。
本実施態様のプランジャー部材５４は、好ましくは内側
スリーブ５８の内径内に滑動可能に嵌合するような寸度
とされる円筒形に形成された部材である。最初の予め負
荷された状態において、プランジャー部材５４の近位端
は外側スリーブ５６及び内側スリーブ５８の近位端を越
えて近位に延長する。プランジャー部材５４の近位端
は、その上の近位端部材７４を含み、該近位端部材は、
内側及び外側スリーブ５６及び５８が、以下により詳細
に記載されるように切開から引き抜かれる際、使用者が
プランジャー部材５４及び血管栓５２の切開内における
好ましい位置を維持できるよう設計される。
図１−５に示される好ましい実施態様と同様に、図６−
１０に示される別の実施態様は医学的処置がなされた後
に用いられる。本実施態様において、先に挿入されたカ
テーテルシース（図示せず）は、まず血損失を防ぐため
に切開に外圧が適用される間に除去される。予め負荷さ
れた挿入組立体５０は、次いで図６に示されるように切
開及び血管内へ挿入される。また、カテーテル組立体の
この交換は、カテーテルシース内に切開からのその除去
に先立って配置されたガイドワイヤ（図示せず）の使用
により容易にされてもよい。挿入組立体５０は、次いで
ガイドワイヤに沿ってすなわちそれを被うように、続い
て切開内に挿入されてもよい。一旦使用者が、図６に示
されるように、挿入組立体５０が切開及び血管７０内に
完全に挿入されたことを確認したなら、使用者は、外側
スリーブ５６を内側スリーブ５８に関して少し引き抜
き、配置翼６４を内側スリーブ５８の遠位端６３から横
方向外方に延長してもよい。使用者は、図８に示される
ように、配置翼６４が血管７０の内側管腔の所定位置に
接触するまで、次いで切開から挿入組立体５０を引き抜
いてもよい。血管栓５２の遠位端６８は、特に外側及び
内側スリーブ５６及び５８内で配置翼６４に隣接して位
置決めされ、それにより、配置翼６４が血管７０の内側
管腔に接触した際、血管栓５２の遠位端６８が切開内に
おいて適切に整列される。次に、患者に関して固定され
た位置にプランジャー部材５４を保つ間、使用者は外側
スリーブ５６を内側スリーブの周囲の原位置に戻し、内
側スリーブ５８の遠位端６３上の配置翼６４を後退させ
る。切開に対して固定位置にプランジャー５４を保持
し、血管栓５２を所望の深度に維持し続ける間、挿入組
立体５０の外側及び内側スリーブ５６及び５８は、図９
及び１０に示されるように、切開及び血管栓５２の周囲
から引き抜かれる。プランジャー部材５４及び血管栓５
２の全長は、内側スリーブ５４の近位端がプランジャー
部材５４上の近位端部材７４に到達する際に、血管栓５
２の充分な量が挿入組立体５０を越えて末梢的に延長す
るように選択され、挿入組立体５０は、次いで切開から
引き抜かれ、一方血管栓５２の遠位端６８は、切開中の
所望位置に摩擦により保持されてもよい。
本実施態様の配置翼６４は、挿入組立体５０が血管７０
の内側管腔に沿って所望の位置に移動される際に、最小
限の抵抗を提供する役割を果たす。配置翼６４が後退可
能であり、血管７０の内側管腔において充分な抵抗を提
供し、挿入組立体５０が血管栓５２の切開への挿入に適
切な位置にあることを使用者に知らせる限り、配置翼６
４は、ほぼいかなる付勢機構によって付勢されてもよい
ことが予知される。
前実施態様において、血管栓５２の遠位端６８は、血管
７０の外側管腔の、またはそこに隣接する切開内に位置
決めされ、その結果どの血管栓５２も、血管７０内に延
長して該管内の血液の流れを中断させることがない。血
管栓５２の気孔率は、血管栓５２が周囲の組織から流体
を吸収して膨張し、また血管栓５２が数週間から数か月
で崩壊するように選択される。血管栓５２は血管７０の
管腔内へ延長しないので、本実態様の血管栓５２は、該
栓中に混入された凝血剤を含み、血管７０内における血
栓症の形成の見込みを増加させることなしに、切開中の
限局化された欝血を促進してもよい。
本発明の好ましい形式は本明細書中に記載、説明される
けれども、以下の特許請求の範囲に規定される本発明の
範囲から離れることなく、様々な変更及び改変がなされ
てもよいことは、当業者にとって自明である。

Claims (5)

    【特許請求の範囲】
  1. 【請求項１】患者の体内に形成された切開を封鎖するた
    めの閉鎖装置であって、該切開は患者の皮膚から患者の
    標的器官または血管に延長し、該閉鎖装置は栓手段を含
    む該閉鎖装置であって、 細長い生物学的に分解可能な血管栓を含み、該血管栓は
    遠位端及び近位端を有し、前記血管栓は切開中に受理さ
    れるように形成され、それにより前記遠位端は、患者の
    標的器官または血管の外側表面に隣接する切開内の第一
    の所定位置に位置され、前記近位端は患者の皮膚の表皮
    層に隣接して位置決めされることからなる閉鎖装置。
  2. 【請求項２】患者の体内に形成された切開を封鎖するた
    めの閉鎖装置であって、該切開は患者の皮膚または他の
    表面から患者の標的器官または血管に延長する該閉鎖装
    置であって、 遠位端及び近位端を有する細長い生物学的に分解可能な
    棒状の血管栓手段であって、前記栓手段は切開中に受理
    されるように形成され、それにより前記遠位端は、挿入
    後患者の標的器官または血管の外側表面に隣接する切開
    内の第一の所定位置に位置決めされる前記血管栓手段
    と、 前記第一の所定位置に前記栓手段の遠位端を位置決めす
    るために、前記栓手段と操作的に関連される位置決め手
    段とからなる閉鎖装置。
  3. 【請求項３】患者の体内に形成された切開を封鎖するた
    めの挿入組立体であって、該切開は一般に患者の皮膚か
    ら患者の血管へ延長し、該挿入組立体は、 遠位端及び近位端を有し、患者の体内に吸収可能な材料
    から形成される血管栓であって、前記血管栓は患者の切
    開内に挿入されるような寸度とされ、それにより、前記
    血管栓の前記遠位端は、患者の血管の外側表面に沿った
    切開内に位置決めされ、前記近位端は切開内にその近位
    に位置決めされる前記血管栓と、 近位端及び遠位端を有する除去可能な挿入部材であっ
    て、前記遠位端は、切開に隣接する血管の管腔に位置す
    るような寸度とされ、前記血管栓の遠位端の、血管の外
    側表面に沿った配置を容易にする該挿入部材 との結合を含む挿入組立体。
  4. 【請求項４】患者の体内に形成された切開を封鎖するた
    めの挿入組立体であって、該切開は患者の皮膚から選択
    された患者の血管へ延長し、該挿入組立体は、 遠位端及び近位端を有し、患者の体内に吸収可能な材料
    から形成される血管栓であって、前記血管栓は、切開内
    に受理されるような寸度とされる細長い部材であって、
    それにより、前記遠位端は、患者の血管の近位の切開内
    の所定位置に位置されるような寸度とされ、前記血管栓
    の残りは挿入後、切開内においてそこから近位に延長す
    る前記血管栓と、 前記血管栓の遠位端の前記所定位置における位置決めを
    補助するために、前記血管栓と操作的に関連される除去
    可能な位置決め手段 との結合を含む挿入組立体。
  5. 【請求項５】患者の体内に形成された切開を封鎖するた
    めの挿入組立体であって、該切開は患者の皮膚から選択
    された患者の血管へ延長し、該挿入組立体は、 ａ． 遠位端及び近位端を有し、切開内に受理されるよ
    うな寸度とされ、それにより、スリーブが切開内の所定
    位置に位置されるスリーブと、 ｂ． 患者の体内に吸収可能である材料から構成され、
    遠位端及び近位端を有する血管栓であって、該血管栓は
    スリーブを通って切開内に受理されるような寸度とされ
    る細長い部材であって、それにより前記血管栓の遠位端
    は、切開内の血管の近位の所定位置に位置され、前記血
    管柱の残りは挿入後、切開内においてそこから近位に延
    長する前記血管栓と、 ｃ． スリーブ内に滑動可能に嵌合し、前記血管栓の遠
    位端を所定位置に位置するような寸度とされるプランジ
    ャー とからなる挿入組立体。
JP3516798A 1990-10-01 1991-09-26 血管栓挿入組立体 Expired - Lifetime JPH0640877B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US591,342 1990-10-01
US07/591,342 US5108421A (en) 1990-10-01 1990-10-01 Insertion assembly and method of inserting a vessel plug into the body of a patient
PCT/US1991/007119 WO1992005740A1 (en) 1990-10-01 1991-09-26 Vessel plug insertion assembly and method

Publications (2)

Publication Number Publication Date
JPH05508793A JPH05508793A (ja) 1993-12-09
JPH0640877B2 true JPH0640877B2 (ja) 1994-06-01

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Country Link
US (6) US5108421A (ja)
EP (2) EP0655223B1 (ja)
JP (1) JPH0640877B2 (ja)
AT (2) ATE217173T1 (ja)
AU (1) AU650688B2 (ja)
BR (1) BR9106916A (ja)
CA (1) CA2091890C (ja)
DE (2) DE69133007D1 (ja)
FI (1) FI931465A (ja)
IE (1) IE70454B1 (ja)
IL (1) IL99572A (ja)
MX (1) MX9101334A (ja)
WO (1) WO1992005740A1 (ja)

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EP0655223B1 (en) 2002-05-08
CA2091890C (en) 1998-12-29
US5478352A (en) 1995-12-26
ATE130743T1 (de) 1995-12-15
ATE217173T1 (de) 2002-05-15
AU8664591A (en) 1992-04-28
US5591205A (en) 1997-01-07
JPH05508793A (ja) 1993-12-09
US5716375A (en) 1998-02-10
US5275616A (en) 1994-01-04
CA2091890A1 (en) 1992-04-02
IL99572A (en) 1996-08-04
FI931465A0 (fi) 1993-04-01
US5108421A (en) 1992-04-28
DE69133007D1 (de) 2002-06-13
US5601602A (en) 1997-02-11
WO1992005740A1 (en) 1992-04-16
US5275616B1 (en) 1996-01-23
EP0655223A3 (en) 1995-08-30
EP0551425A1 (en) 1993-07-21
EP0655223A2 (en) 1995-05-31
FI931465A (fi) 1993-04-01
DE69115052T2 (de) 1996-04-18
DE69115052D1 (de) 1996-01-11
IE70454B1 (en) 1996-11-27
AU650688B2 (en) 1994-06-30
IL99572A0 (en) 1992-08-18
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EP0551425B1 (en) 1995-11-29

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