TW381007B - Catheter deliverable coiled wire thrombogenic apparatus and manufacturing method thereof - Google Patents

Catheter deliverable coiled wire thrombogenic apparatus and manufacturing method thereof Download PDF

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TW381007B
TW381007B TW087103870A TW87103870A TW381007B TW 381007 B TW381007 B TW 381007B TW 087103870 A TW087103870 A TW 087103870A TW 87103870 A TW87103870 A TW 87103870A TW 381007 B TW381007 B TW 381007B
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catheter
line
wire
coil
patent application
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TW087103870A
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Stephen C Jacobsen
Clark C Davis
John A Lippert
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Sarcos Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A61B17/12145—Coils or wires having a pre-set deployed three-dimensional shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • 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
    • A61F2/01—Filters implantable into blood vessels
    • 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
    • A61F2/01—Filters implantable into blood vessels
    • A61F2002/016—Filters implantable into blood vessels made from wire-like elements
    • 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
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0006—Rounded shapes, e.g. with rounded corners circular
    • 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
    • A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medical Informatics (AREA)
  • Reproductive Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Transplantation (AREA)
  • Surgical Instruments (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Materials For Medical Uses (AREA)
  • Endoscopes (AREA)

Description

經濟部中央標準局員工消費合作社印装 A7 B7 五、發明説明（1 ) 本發明背景 本發明有關用以阻滯身體血管網路或腔穴內血流之血 管閉塞性裝置〇 將血流閉塞及/或啓發凝血作用且可經由導管或其他 套管引進體內之裝置有用於停止出血或出血之威脅、'切斷 對患病器官之血液供應、減少血液流至器官、重建缺陷性 器官等等。通常所利用之裝置爲線圈或顆粒，係經由導管 部署於需要阻滯血流之標的部位〇此外，可經由該導管輸 送各種溶液供阻滯及加速凝血作用，或供處理醫學問題〇 過去使用之典型裝置包括鉑線圈，在挿入導管內之後 用習用之導管導線或其他稱爲''' 柱塞〃之裝置推動通過其 間到一標的部位〇線圈裝置係預先固定成所需之形狀，典 型爲簡單之螺旋線，俾其等在輸送至所需部位後回復原本 之形狀〇舊式鉑線圏裝置常不能有效將其等之位匱固定於 所輸送之部位，故而不能在該部位有效閉塞〇以往用於閉 塞血流之典型顆粒包括PVA或親水性顆粒，係在吸收血液 後膨脹成較大之尺寸〇當然，此種膨脹作用有助於停止血 液之流動，假設顆粒之位置維持不變0 舊法用於阻滯血流之手段頗爲原始，故僅部份成功獲 致所需之血流停止作用〇 本發明綜沭 本發明之一目的爲提供新潁且改良之血管閉塞性裝置 ，可輕易部署於人體內一標的部位，且有效誘發凝血或以 其他方式阻滯血流0 本紙張尺度逋用中國國家標準（CNS ) A4規格（210X297j^.f ) ----------裝------訂------銀 (請先閲请背面之注意事項再填寫本頁) 經濟部中央揉準局貝工消費合作社印策 A7 B7 五、發明説明（2 ) 本發明之又一目的爲提供易於製作，且尺寸及構形可 定製以適應標的部署位置之此等裝置0 本發明之進一步目的爲提供可迅速且輕易部署於身體 內一標的位置，並持留於定位之此等裝置0 本發明之以上及其他目的係以一種特定之例示性'血栓 形成裝置具體形式予以實現*包括一用以旋入身體血管網 路通道內到達一標的位置之導管、以及一在不受拘束時圈 捲並定形以佔據一定體積且在長向挿入並受該導管拘束時 伸直之用於最終自該導管排出以擴張而佔據該標靶位置之 線元件〇 依據本發明之一方面，該線元件係作成具有一朝遠端 逐漸變小之線圈直徑。依據本發明之另一方面，接近或在 該遠端之較小直徑線圈，當挿入血管內時予以捲緊以抑制 由其通過之血流〇 該線兀件有利爲一線配對，其一捲繞於另一上，於是 該複合配對形成較大之線圈〇 簡要圖說 本發明之以上及其他目的、特色及優點將因對以下與 所附圖式相關之詳述所作考量而變成明顯，圖中： 圖1 A爲一依據本發明各種原理所製血栓形成性捲線裝 置之分解橫剖面側視圖； 圖1B爲圖1A中捲線沿1B--1B線所取之前端視圖； 圖2爲一依據本發明各種原理所製捲線裝置之分解橫 剖面側視圖，所顯示爲部份置於導管內； 本紙張尺度適用中國國家標準（CNS ) A4規格（2丨〇X297f釐） ---------餐-----丨11------# (請先閲讀背面之注意事項再填寫本頁) 經濟部中央橾準局員工消費合作社印製 A7 ____B7_ 五、發明説明（3 ) 圖3A爲一依據本發明各種原理之可形成圖3B中所示捲 線裝置之線複合配對之一片段之分解側視圖〇 圖3U爲一可形成本發明捲線裝置之圖3B線複合配對之 分解側視圖〇 圖4爲一依據本發明所製另一捲線裝置具體形式之一 區段之分解側視圖〇 本發明詳述 請參考圖1 A及1 B ;所示分別爲一已製成線圈之彈性線 4之橫剖面分解側視圖及端視圖。在圖1A中，所顯示之線 4係置放於一血管8內〇線4包括一較大直徑區段4 a以及 —逐漸縮窄之區段4b。較大直徑區段“內之線圈擴張以接 觸血管8之壁，以將捲線4持於定位。較窄直徑區段4 b作 用如捲線4之引導或遠端，便利該裝置在血管中之定向， 且較佳爲更具撓性以於該捲線揷入時使對於血管壁之損壞 或創傷減爲最小（即將予以討論）〇 線4可能由例如高度彈性之鎳一鈦合金線製成〇較大 直徑區段4a之直徑有利約爲3至12毫米，而區段4b內最小 直徑線圈之直徑有利約爲〇 . 7 5至2毫米，二者均爲於捲線 4不受拘束時予以計算〇 如在區段4b中使捲線4之直徑漸小，即對血流提供較 大之障礙及密度，因而較大之閉塞能力，如於沿圖1 A之1 B --1B線所取圖1B視圖中所清楚看出〇 (控制線圈之漸小程 度及間隔，容許線圈之用作一種有限度洩漏閥或完全阻塊 0 ) 本紙張尺度逋用中國國家標準（CNS ) A4规格（210X297言釐） I.II — ^ — ^署 ·裝 H ——訂— 1· 殊 (請先閲讀背面之注意事項#填寫本頁) 經濟部中央樣準局貝工消費合作社印裂 A7 B7 _ 五、發明説明（4 ) 圖2顯示部份置放於一導管I2內之一捲線4之分解橫 斷面視圖〇爲將該捲線4部署於體內一血管網路通道或其 他腔穴中之一標的位置，可如圖2所示將該線4大體筆直 旋入該導管1 2內，然後藉另一引導線（未示出）或作用如 一種柱塞之類似裝置予以推動通過該導管，以將該捲'線迫 出該導管之遠端，然後在該處擴張以使其自身座定於該標 的位置〇當部署於體內一有血液流過之標的位置時，該捲 線4作用使血流緩慢以容許凝集或凝結，而最終阻滯進一 步之流動。爲輔助凝結程序，溶液形式之凝血劑可隨捲線 4之部署經由導管12輸送至標的部位〇此外，附接於各線 圈之纖維質材料將亦協助促進凝結作用〇 圖2中所示之捲線4具體形式包括一縮窄之遠端區段 4b，其中各線圈捲緊達各相鄰線圈觸接之程度。在各線圈 之此種高密度緊束下，血流實質上停止，甚至在凝集或凝 結發生前亦然〇 圖3 A及3 B顯示本發明之另一具體形式，包括一中心線 20以及一捲繞於該中心線之外周線24 (—次線圈）〇此一 線複合配對於是形成一示於圖3Β中之較大線圈（二次線圈 )，包括一大體圓柱形部份h及一漸小部份4b，類似於圖 1A中所示者。爲獲得該複合配對之遠端或漸小區段4b之較 大撓性，中心線2 0本身可漸細（或直徑逐漸減小）達區段 4b之較窄直徑，或可朝其末端漸細，但靠近該末端。當然 ，較窄之直徑將容許較大之撓性，而撓性程度可藉控制中 心線20之直徑予以控制〇 本紙張尺度適用中國國家標準（CNS ) A4規格（210X29』fjn — — — — — — —— •裝 —II I I 訂——I I · 蛛 (請先閲讀背面之注意事項再填寫本頁) 經濟部中央樣準局員工消費合作社印裝 A 7 ___B7_ 五、發明説明（5 ) 使中心線2ϋ漸細之一替代方法爲提供一製成具有適當 間隔及尺寸之切口之中心線（實心或管形），以獲得所需 之撓性〇 線圈24之直徑有利爲約ϋ .001吋至0 . 005吋。中心線 2 0可由鎳一汰合金、不銹鋼或其他合宜之合金或替代'品製 成0 圖4爲本發明另一血栓形成裝置具體形式之分解側視 圖。此具體形式涉及一緊捲之線28 (—次線圈），其本身 形成一類似圖3Β中所示但無中心線之較大線圈（二次線圈 )〇爲獲致該較大線圈之可變撓性，線28之直徑可予變化 ，以使該線之較小直徑區段具有大於各較大直徑區段之撓 性。在圖4中，線28之直徑朝一遠端28a逐漸變小。在圖 4之緊捲捲線28形成一例如圖3B中所示之較大線圈時，線 圈28具有較窄直徑之該一部份將位於該遠端或區段（圖3B 之 4b) 〇 當然，圖4之捲線28可配置以一類似圖3A具體形式之 中心線，可隨線2 8之漸小使其適當漸細，以控制沿該組合 物長度之撓性〇 一般均將了解，上述各種配置僅例示本發明各原理之 應用0業界熟練人士可設計出各種修改形式及替代之配置 ，而不背離本發明之精神及範疇，故後附之各申請專利範 圍項意在涵蓋此等修改形式及配置0 本紙張尺度適用中國國家揉準（CNS ) Λ4規格（210X2921# ) ---------妓-----—1T------g (請先閲讀背面之注意事項再填寫本頁)

Claims (1)

  1. 經濟部中央標隼局貝工消費合作社印簟 A8 B8 C8 D8 六、申請專利範園 1 . 一種血栓形成裝匱，包含： 一用以旋入身體血管網路通道內到達一標的位置之 導管，以及 一彈性線設置，在不受拘束時圈捲並定形以佔據一 定體積且在長向挿入並受該導管拘束時伸直，用於最終自 該導管排出以擴張而佔據該標靶位置，所述線設置進一步 包括： 一第一長度之線’及 一捲繞於該第一線上之第二長度之線，以形成一 複合配對，所述複合配對本身在不受拘束時圈捲並定形以 佔據一定體積，且在長向挿入並受該導管拘束時伸直0 2 .如申請專利範圍第1項之裝置，其中所述第一線漸 小而於一遠端處較窄，故而在該遠端更具撓性0 3 .如申請專利範圍第1或2項之裝置，其中所述第二 線漸小而於一遠端處較窄，故而在該遠端更具撓性〇 4 .如申請專利範圍第1項之裝置，.其中所述第一線延 伸至一靠近該第二捲線之一遠端之位置，以使該複合配對 之一遠端較該複合配對之其他部份更具撓性0 5 .如申請專利範圍第1項之裝置，其中所述第一線包 括多數在沿至少一部份長度之選定位置上之切口，以增加 其撓性〇 6 .如申請專利範圍第1項之裝置，其中所述複合配對 係作成具有一朝該遠端逐漸變小之線圈直徑0 7 .如申請專利範圍第（i項之裝置，其中接近或在該遠 本紙張尺度適用中國國家標準（CNS ) A4規格（210X297仓參J ---------裝-----訂------線 (請先閱讀背面之注^^項再填寫本頁) 經濟部中央橾準局更工消费合作社印製 A8 B8 C8 D8 六、申請專利範圍 端之較小直徑線圈在挿入血管內時予以捲緊，以抑制由其 通過之血流〇 8 .—種血栓形成裝置，包含： 一用以旋入身體血管網路通道內到達一標的位置之 導管，以及 —彈性線設置，在不受拘束時圈捲並定形以佔據一. 定體積且在長向挿入並受該導管拘束時仲直，用於最終自 該導管排出以擴張而佔據該標靶位置；所述線設置包含一 長度之緊捲線，其本身形成一較大之線圈並在不受拘束時 定形以佔據所述體積，且在長向挿入並受該導管拘束時伸 直，該線之直徑朝一遠端逐漸變小，故而更具撓性〇 9 .如申請專利範圍第8項之裝置，其中較大線圈之直 徑朝一遠端變小。 I ϋ .如申請專利範圍第8項之裝置，其中所述線設置係 由鎳與鈦之合金以及不銹鋼所組成集團中選出之材料製成 Ο II .如申請專利範圍第8項之裝置，其中所述線設置爲 實心〇 1 2 ,如申請專利範圍第8項之裝置，其中所述線設置爲 管形，具有多數環繞其中央空心之側壁。 1 3 .如申請專利範圔第8項之裝置，尙包括一心線，係 置放成在由該線設置所形成之線圈中心內延伸〇 1 4 .如申請專利範圍第1 3項之裝置，其中該心線之直徑 予選擇性改變，從而選擇性改變該線設置與心線組合之撓 本紙張尺度適用中國國家梂準（CNS ) Α4規格（210X297；!^|J --- ---- (請先閲讀背面之注意事項再填寫本頁) ί Τ A8 B8 C8 D8 六、申請專利範園 性0 1 5 .—種血栓形成裝置，包含： 一用以旋入身體血管網路通道內到達一標的位置之 導管，以及 —彈性線設置，包含一長度之經圈捲成一次線圈之 線，其本身圈捲成較大之二次線圈並在不受拘束時定形以 佔據一定體積，且在長向挿入並受該導管拘束時伸直，所 述線設置係製成在一末端較另一·末端更具撓性〇 --------.裝— (請先閱讀背面之注意事項再填寫本頁) τ訂- 抓 經濟部中央標芈局員工消费合作社印製 本紙張尺度適用中國國家標準（CNS )八4規格（2l〇X29；^g_)
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DE69833607D1 (de) 2006-04-27
KR19980080320A (ko) 1998-11-25
CA2232188C (en) 2005-11-29
ATE318552T1 (de) 2006-03-15
US5800454A (en) 1998-09-01
DE69833607T2 (de) 2007-02-08
JPH10328191A (ja) 1998-12-15
EP0865773A1 (en) 1998-09-23
EP0865773B1 (en) 2006-03-01
SG71767A1 (en) 2000-04-18
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ES2256916T3 (es) 2006-07-16
CA2232188A1 (en) 1998-09-17

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