KR960700025A - 피복 복합 스텐트(clad composite stent) - Google Patents

피복 복합 스텐트(clad composite stent) Download PDF

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KR960700025A
KR960700025A KR1019950702932A KR19950702932A KR960700025A KR 960700025 A KR960700025 A KR 960700025A KR 1019950702932 A KR1019950702932 A KR 1019950702932A KR 19950702932 A KR19950702932 A KR 19950702932A KR 960700025 A KR960700025 A KR 960700025A
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core
case
composite filament
strands
prosthesis
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데이비드 더블유 마이어
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알렌 제이.스피겔
슈나이더 (유에스에이) 인코포레이티드
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    • 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
    • A—HUMAN NECESSITIES
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    • 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
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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    • A61L31/18—Materials at least partially X-ray or laser opaque
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B21—MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
    • B21C—MANUFACTURE OF METAL SHEETS, WIRE, RODS, TUBES OR PROFILES, OTHERWISE THAN BY ROLLING; AUXILIARY OPERATIONS USED IN CONNECTION WITH METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL
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    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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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
    • 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
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0033—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
    • 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
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes
    • 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
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A61F2310/00029—Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • 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
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    • Y10S623/924—Material characteristic
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    • Y10T428/12771—Transition metal-base component
    • Y10T428/12806—Refractory [Group IVB, VB, or VIB] metal-base component
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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
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    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
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    • Y10T428/12861—Group VIII or IB metal-base component
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Abstract

인체 화합성 스텐트(16)은 꼬여진 배위로 서로 짜여진 대향 나선상으로 감긴 가닥 2개 세트로 배열된 다수 필라멘트(18,20)로 제조된다. 각 필라멘트(18,20)는 중심 코아(24) 및 코아(24)을 돌러싸고 있는 케이스(26)을 포함하는 복합체이다. 바람직한 상태에서, 코아(24)는 탄탈 또는 백금과 같은 비교적 연성이고 방사성 비투과성인 물질로 제조된다. 외부 케이스(26)은 예컨대 코발트/크롬 기재 합금과 같은 비교적 연성인 물질로 이루어 진ㄷ. 스텐트(16)의 바람직한 기계적 특성은 케이스(26)에 의하여 결정되며, 코아(24)는 스텐트(16)의 생체내 영상화를 가능하게 한다. 복합 필라멘트(18a)는 의도된 최종 필라멘트 직경보다 실질적으로 더 큰 직경의 관형 케이스(26)에 코아(24)가 삽입되는 인발 충진 튜빙 공정에 의하여 형성된다. 복합 필라멘트(18a)는 몇 단계로 냉각 처리되어 직경을 감소시키며 연속적인 냉각 처리 단계 사이에 어닐링된다. 최종 냉각 처리 단계후, 복합 필라멘트(18a)는 원하는 형태로 형성되고 숙성 경화된다. 다른 복합 필라멘트(18a)는 케이스(84)와 코아(82) 사이의 중간 차단층(86), 케이스(92)를 둘러싸고 있는 생화합성 덮개 층(94) 및 구조적 코아(90)을 둘러싸고 있는 방사선 비투과성 케이스(92)를 이용한다.

Description

피복 복합 스텐트(CLAD COMPOSITE STENT)
내용없음

Claims (43)

  1. a)코아 직경을 가지고 축방향 횡단면이 실질적으로 균일한 신장성 원통형 코아(24) 및 케이스 내경을 가지고 측방향 횡단면이 실질적으로 균일한 신장성 관형 케이스(26)를 제공하는 단계(상기 코아(24)와 케이스(26)중의 어느 하나는 방사선 비투과성 물질로 이루어지고 다른 하나는 150,000psi 이상(0.2% 오프셋)의 탄성 한계를 가지는 탄성 물질로 이루어 지고, 코아 직경을 케이스(26)의 내경보다 작고 케이스(26)과 코아(24)의 축방향 횡단면적은 코아(24)의 측방향 횡단면적의 10배 이하이다); b)코아(24)를 케이스(26)에 삽입하여 케이스가 코아를 둘러싸고 있는 신장성 복합 필라멘트(18a)를 형성하는 단계; c)복합 필라멘트(18a)를 냉각 처리하여 복합 필라멘트(18a)의 외경을 15%이상 감소시켜 선택한 직경을 형성하는 단계; d)복합 필라멘트(18a)를 어닐링하여 왜경화(strain hardening) 및 냉각 처리 단계에 의하여 유도된 기타 웅력을 실질적으로 제거하는 단계; e)어닐링되지 않은 복합 필라멘트(18a)를 최종 냉각 처리단계후 일정한 형태로 성형하는 단계; 및 f)냉각 처리된 복합 필라멘트(18a)를 일정한 형태로 유지하면서 숙성 경화시키는 단계를 포함하는 인체 삽입가능한 탄성 복합 필라멘트(18a)의 제조방법.
  2. 제1항에 있어서, 상기 방사선 비투과성 물질이 100KeV에서 20㎝-1이상의 선형 감쇄 계수를 가지고, 연성이며, 상기 코아(24)를 형성하는 방법.
  3. 제1항에 있어서, 냉각 처리 단계전에 복합 필라멘트(18a)의 외경이 약 6.35㎜(0.250 인치)이하인 방법.
  4. 제3항에 있어서, 상기 냉각 처리 단계가 복합 필라멘트(18a)를 탄성적으로 변형시켜 외경을 감소시키는 다수의 다이를 통하여 복합 필라멘트(18a)을 연속적으로 인발시킴을 포함하는 방법.
  5. 제4항에 있어서, 어닐링 단계가 복합 필라멘트(18a)를 하나의 다이를 통과한 후 약 1 내지 15초 동안 약 1900 내지 2300℉범위의 온도로 가열시킴을 포함하는 방법.
  6. 제2항에 있어서, 상기 신장성 코아(24) 및 케이스(26)을 제공하는 단계가 비슷한 열 팽창 계수 및 중첩된 어닐링 온도 범위를 가지는 코아(24) 및 케이스(26) 구성 물질로 선택함을 포함하는 방법.
  7. 제6항에 있어서, 상기 코아(24) 및 케이스(26)을 제공하는 단계가 또한 결정구조에 대한 관점에서 화합성을 가지는 코아(24) 및 케이스(26) 구성 물질을 선택함을 포함하는 방법.
  8. 제1항에 있어서, 상기 숙성 경화 단계가 약 1 내지 약 5시간동안 약 900 내지 1000℉범위의 온도로 복합 필라멘트(18a)을 가열함을 포함하는 방법.
  9. 제2항에 있어서, 복합 필라멘트(18a)을 형성한 후 냉각 처리 단계전에 복합 필라멘트(18a)을 탄성적으로 변형시키고 어닐링 온도에 적용시킴으로써 복합 필라멘트(18a)의 외경을 약 25㎜이상의 초기 수치에서 약 6.35㎜이하의 중간 수치로 실질적으로 감소시키는 단계를 또한 포함하는 방법.
  10. 제9항에 있어서, 상기 복합 필라멘트(18a)의 처리 단계가 복합 필라멘트 (18a)를 압축 또는 인발 성형시켜 연속적으로 조금씩 외경을 감소시키는 단계를 포함하는 방법.
  11. 제2항에 있어서, 복합 필라멘트(18a)를 형성하는 상기 단계 a)가 1)어닐링된 복합 필라멘트(18a)을 다수의 가닥으로 분리시키는 단계, 2) 가닥을 일정한 간격의 평행한 2개의 대향 가닥 세트로 원통형 주위를 나선상으로 감아 가닥이 서로에 대해 중첩되어 다수의 교차점을 형성하는 단계; 및 3)가닥을 약 900 내지 1000℉범위의 온도로 가열하여 나선상으로 감겨진 가닥을 숙성 경화시키면서 감겨진 상태로 일정한 장력하에 유지하는 단계를 포함하는 방법.
  12. 제11항에 있어서, 나선상 가닥의 2세트를 약 1 내지 5시간동안 가열하는 방법.
  13. 신장성 원통형 코아(24) 및 코아(24)를 둘러싸고 있는 신장성 관형 케이스 (26)를 포함하는, 전 길이에 걸쳐 측방향 횡단면이 실질적으로 균일한 신장성 필라멘트(18a)(상기 코아(24)와 케이스(26)중의 어느 하나는 150,000psi 이상(0.2% 오프셋)의 항복 강도를 가지는 제1물질로 이루어 지고, 다른 하나는 제1물질과 최소한 동일한 정도의 연성 및 더 큰 방사성 비투과성을 가지는 제2물질로 이루어지며, 상기 필라멘트(18a)는 숙성경화되어 탄성 모듈러스를 실질적으로 증가시킨다)를 포함하는 인체 화합성 장치.
  14. 제13항에 있어서, 상기 제2물질이 코아(24)를 형성하는 장치.
  15. 제14항에 있어서, 상기 제2물질이 100KeV에서 20㎝-1이상의 선형 감쇄 계수를 가지는 장치.
  16. 제14항에 있어서, 상기 제2물질이 50이상의 직접적이거나 또는 등가적인 원자 번호 및 입방 인치당 0.5파운드 이상의 밀도를 가지는 장치.
  17. 제14항에 있어서, 제2물질이 탄탈, 백금, 금, 이리듐, 레늄, 텅스텐, 루테늄 및 고갈된 우라늄으로 구성되는 군으로 부터 선택되는 하나 이상의 물질로 필수적으로 구성되는 장치.
  18. 제14항에 있어서, 케이스(26)이 코어와 실질적으로 동심원인 장치.
  19. 제18항에 있어서, 케이스(26)을 형성하는 물질이 인체 화합성인 장치.
  20. 제18항에 있어서, 케이스(26)이 코발트, 크롬, 티탄, 알루미늄, 바나듐, 크톰, 니켈, 몰리브덴 및 철로 구성되는 군으로부터 선택되는 하나 이상의 물질로 필수적으로 구성되는 케이스 물질로 제조되는 장치.
  21. 제18항에 있어서, 케이스(26)을 형성하는 물질이 코발트 기재 합금으로 필수적으로 구성되는 장치.
  22. 제18항에 있어서, 상기 합금이 코발트, 크롬, 철 니켈 및 몰리브덴으로 필수적으로 구성되는 장치.
  23. 제14항에 있어서, 코아(24)의 측방향 횡단면적인 복합 필라멘트의 축방향 횡단면적의 10 내지 46%범위인 장치.
  24. 제13항에 있어서, 코아(82)와 케이스(84) 사이에 차단층을 형성하는 중간층(86)을 또한 포함하는 장치.
  25. 제24항에 있어서, 상기 중간층(86)이 탄탈, 니오븀 및 백금으로 구성되는 군으로 부터 선택되는 하나 이상의 물질로 필수적으로 구성되는 장치.
  26. 제13항에 있어서, 케이스(92)를 둘러싸고 덮고 있는 인체 화합성 덮개 층(94)을 또한 포함하는 장치.
  27. 제26항에 있어서, 상기 덮개 층(94)가 탄탈, 백금, 이리듐, 스테인레스 스틸, 니오븀 및 티탄으로 구성되는 군으로 부터 선택되는 하나 이상의 물질로 필수적으로 구성되는 장치.
  28. 제13항에 있어서, 제1물질이 코아(24)을 형성하는 장치.
  29. 일정 간격의 최소한 2개의 대향 가닥 세트(가닥 세트는 꼬여진 배위로 서로 짜여진다)로 나선상으로 감겨진 다수의 신장성 탄성 가닥을 포함하고; 각각의 가닥은 신장성 코아(24) 및 코아(24)를 둘러싸는 신장성 관형 케이스(26)를 포함하고, 코아(24)의 측방향 횡단면적은 가닥(18,20)의 측방향 횡단면적의 10%이상이고; 코아(24)와 케이스(26)중의 하나는 100KeV에서 20㎝-1의 선형 감쇄 계수를 가지는 제1물질로 이루어지고, 다른 하나는 탄성 제2물질이고, 제1물질은 제2물질보다 연성 및 방사선 비투과성이 더 높은, 인체 이식가능한 탄성 인공삽입물.
  30. 제29항에 있어서, 제1물질이 코아(24)을 형성하는 인공삽입물.
  31. 제30항에 있어서, 제1물질이 50이상의 직접적이거나 또는 동가적인 원자 번호 및 입방 인치당 0.5이상의 밀도를 가지는 인공삽입물.
  32. 제31항에 있어서, 제1물질이 탄탈, 백금, 금, 이리듐, 레늄, 텅스텐, 루테늄 및 고갈된 우라늄으로 구성되는 군으로 부터 선택되는 하나 이상의 물질로 필수적으로 구성되는 인공삽입물.
  33. 제30항에 있어서, 케이스(26)이 코아(24)와 실질적으로 동심원인 인공삽입물.
  34. 제33항에 있어서, 제2물질이 인체 화합성인 인공삽입물.
  35. 제34항에 있어서, 제2물질이 150,000psi의 항복 강도(0.2% 오프셋)를 가지는 인공삽입물.
  36. 제33항에 있어서, 제2물질이 코발트, 크롬, 티탄, 바나듐, 크롬, 니켈, 몰리브덴 및 철로 구성되는 군으로 부터 선택되는 하나 이상의 물질로 필수적으로 구성되는 인공삽입물.
  37. 제36항에 있어서, 제1물질이 코발트-기재 합금으로 필수적으로 구성되는 인공삽입물.
  38. 제37항에 있어서, 코발트-기재 합금이 코발트, 크롬, 철, 니켈 및 몰리브덴으로 필수적으로 구성되는 인공삽입물.
  39. 제30항에 있어서, 가닥(18,20) 각각의 코아(24)의 축방향횡단면적이 가닥의 측방향 횡단면적의 10 내지 46%범위인 인공삽입물.
  40. 제29항에 있어서, 가닥(18,20) 각각의 코아(82)의 케이스(84) 사이에 차단층을 형성하는 중간층(86)을 또한 포함하는 인공삽입물.
  41. 제29항에 있어서, 가닥(18,20) 각각의 케이스(92)을 둘러싸고 덮고 있는 인체 화합성 덮개 층(94)을 또한 포함하는 인공삽입물.
  42. 제29항에 있어서, 세트 각각의 가닥(18,20)이 서로 평행하고, 가닥 세트가 공조하여 원통형 스텐트를 형성하는 인공삽입물.
  43. 제29항에 있어서, 상기 제2물질이 코아(24)를 형성하는 인공삽입물.
    ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
KR1019950702932A 1993-01-19 1993-11-23 피복 복합 스텐트(clad composite stent) KR960700025A (ko)

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KR0147482B1 (ko) 1998-08-01
ES2166370T3 (es) 2002-04-16
EP0773751A1 (en) 1997-05-21
EP0773751B1 (en) 2001-10-31
ZA94334B (en) 1995-07-18
CA2152594C (en) 1998-12-01
IL108325A (en) 2000-02-17
AU689739B2 (en) 1998-04-02
NO952852L (no) 1995-07-18
TW234689B (ko) 1994-11-21
CA2152594A1 (en) 1994-08-04
DE69331069T2 (de) 2002-07-04
JP2746755B2 (ja) 1998-05-06
NO952852D0 (no) 1995-07-18
DE69331069D1 (de) 2001-12-06
US20030009215A1 (en) 2003-01-09
AU5672694A (en) 1994-08-15
IL108325A0 (en) 1994-04-12
US5679470A (en) 1997-10-21
ATE207728T1 (de) 2001-11-15
AU673878B2 (en) 1996-11-28
US5800511A (en) 1998-09-01
AU1501497A (en) 1997-05-29
FI953472A0 (fi) 1995-07-18
US5824077A (en) 1998-10-20
US5628787A (en) 1997-05-13
WO1994016646A1 (en) 1994-08-04
IL127418A0 (en) 1999-10-28
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JPH08502436A (ja) 1996-03-19

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