KR20040038907A - 의학용 이식편 - Google Patents

의학용 이식편 Download PDF

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Publication number
KR20040038907A
KR20040038907A KR10-2003-7011294A KR20037011294A KR20040038907A KR 20040038907 A KR20040038907 A KR 20040038907A KR 20037011294 A KR20037011294 A KR 20037011294A KR 20040038907 A KR20040038907 A KR 20040038907A
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KR
South Korea
Prior art keywords
fibers
graft
cage
medical
oriented
Prior art date
Application number
KR10-2003-7011294A
Other languages
English (en)
Inventor
레인지로버트
Original Assignee
코-리그네 아게
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Filing date
Publication date
Application filed by 코-리그네 아게 filed Critical 코-리그네 아게
Publication of KR20040038907A publication Critical patent/KR20040038907A/ko

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    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • A61L27/443—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with carbon fillers
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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
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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
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    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30965—Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
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    • A61F2/446—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
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    • A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
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    • A61F2/02—Prostheses implantable into the body
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    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
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    • 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
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2002/30971—Laminates, i.e. layered products
    • 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
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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
    • A61F2230/00—Geometry 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
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    • A61F2230/00—Geometry 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
    • A61F2230/00—Geometry 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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    • A61F2230/0069—Three-dimensional shapes cylindrical
    • 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
    • A61F2230/0082—Three-dimensional shapes parallelepipedal
    • 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
    • A—HUMAN NECESSITIES
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    • 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
    • A61F2250/0028—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 fibre orientations

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Abstract

의학용 이식편은 섬유 강화 플라스틱으로 구성된다. 이러한 섬유(50a 및 50b)는 일반적으로 층(A 및 B)으로 정렬되며, 여기서 2개 이상의 상이한 층의 섬유는 상이하게 배향된다. 섬유(50a 및 50b)는 길며 생체역학적 요건에 따라 배향된다. 이식편은 다방향 힘에 대항할 수 있으며 적절한 길이 및 경도로 제조될 수 있다.

Description

의학용 이식편{Medical implant}
본 발명은 섬유 강화 플라스틱으로 구성되는 의학용 이식편에 관한 것이다. 의학용 이식편은 바람직하게는 척추 복구 수술시 사용하기 위한 추간 케이지(intervertebral cage)이다. 추간 케이지는 척추골 사이의 간격을 조절하고 고정하는 데 사용되며, 성장하여 궁극적으로 마치 단일 단위인 것처럼 함께 인접 척추골과 결합되는 골편을 수집할 수 있도록 공동화된다.
추간 케이지는 수 년 동안 이러한 목적으로 사용되어 왔다. 추간 케이지는 속이 비어 있으나 결코 함몰되지 않도록 충분히 강할 것이 필수적이다. 동시에, 중공 내부는 사이드 탑(side top)과 중공 개구부를 가져야 한다. 사용되는 골편이 많아지고 개구부가 커질수록 척추골이 보다 신속하게 함께 결합된다.
이러한 케이지에 사용되는 물질은 탄소 보강재의 존재 또는 부재하에 피복되거나 피복되지 않는 티탄 합금 또는 중합체이다. 탄소 복합체 중합체는 사용되는 티탄 및 기타 물질에 대해 두 가지 이점을 갖는다. 한편, 이의 방사선 투과성은 척추 복구가 표준 방사선 촬영법으로 모니터링되도록 한다. 다른 한편, 이의 탄성 모듈러스 및 구조는 이식편을 특수 골과 매우 가까운 경도를 갖도록 보강할 수 있게 한다. 이러한 기계적 특성은 골 이식편이 변성되는 것을 방지하고 부하하에서의 압박을 예방한다.
이식편은 효율성, 안정성 및 품질 기준을 충족시키는 것이 중요하다. 효율성은 당해 이식편이 사용하기에 적합하고 필수적인 생체역학적 작용에 적합함을 의미한다. 안정성은 환자에게 최소한의 건강상의 위험이 있음을 의미한다. 품질은 목적하는 특성이 예측 가능함을 의미한다.
본 발명의 목적은 장기간 이식하는 동안에 안정성이 우수하고 생체혼화성 기준도 충족시키는 향상된 의학용 이식편을 제공하는 것이다.
본 발명으로 연구용 이식편, 특히 강도가 증가된 추간 케이지를 제조할 수 있다. 다양한 구조상 부재내에서 섬유의 배향을 신중하게 선택함으로써, 강도가 증가된 이식편을 수득할 수 있다. 강도의 증가로 이식편, 특히 비교적 얇지만 함몰되지 않은 강한 벽을 갖는 케이지를 제조할 수 있다. 중량 부하 구조(weight bearing structure)는 다수의 다방향 힘을 받는다. 이러한 힘은 특정한 해부학적 구조에 따르는 적절한 강도 및 경도에 대항하여야 한다. 본 발명에 따르는 이식편은 층으로 정렬된 섬유를 가지며, 여기서, 2개 이상의 상이한 층의 섬유는 상이하게 배향된다. 이러한 섬유는 위에서 언급한 필수 조건에 따라, 특히 다방향 힘에 대비되도록 배향된다. 이러한 섬유는 장섬유이며, 이는 장섬유가 단섬유보다 튼튼하기 때문이다. 이러한 섬유는 일반적으로 이식편의 치수만큼 길다. 이러한 섬유는 무작위로 배향되지 않으며 촙섬유(chopped fiber)가 아니다. 이는, 골이, 적용되는 생리학적 부하에 따라 그 자체가 재생될 수 있음을 증명하는 것이다. 따라서, 특정 구조의 부하를 최소화할 수 있는 이식편은 골 재생을 돕는다.
언급한 본 발명의 또 다른 이점은, 금속 케이지와는 달리, 진단 x선을 거의간섭하지 않거나 전혀 간섭하지 않는다는 점이다. 따라서, 주치의는 금속 케이지를 사용하는 것보다 훨씬 정밀하게 수술 후 경과를 관찰할 수 있다. 언급한 발명의 중요한 이점은 이식편이 생체역학적 특성을 충족시키고 장기간 이식하는 동안에 이식편에 작용하는 특정 힘에 저항하도록 제조될 수 있다는 점이다. 이러한 생체역학적 힘은 회전력, 삼점 굽힘력(three point bending), 전단 압축력 및 수축력이다. 이는 복합력일 수도 있다. 섬유의 배향 및 길이를 변경시키면, 목적하는 유연성 및 저항 정도를 조절할 수 있다. 고령 환자들의 경우, 주치의는 일반적으로 유연성이 거의 없는 케이지를 선택하며, 젊은 환자들의 경우, 주치의는 해당 환자 골의 유연성과 보다 밀접하게 관련되도록 유연성을 허용하는 섬유 배향을 선택한다.
본 발명의 기타 이점 및 특징은 수반되는 도면을 참고하여 다음 기재 내용을 숙독한 후 당해 분야의 숙련가에게는 명백할 것이다.
도 1은 본 발명의 케이지의 투시도이다.
도 2는 측방 정면도이다.
도 3은 전방 부분이 파쇄된 본 발명의 케이지의 투시도이다.
도 4는 한 부분이 파쇄된, 본 발명의 이식편의 또 다른 양태의 측방 정면도이다.
도 5는 도 4에 따르는 이식편의 또 다른 측방 정면도이다.
도 6 내지 도 8은 추간 케이지에서 작용할 수 있는 힘의 개략도이다.
바람직한 양태의 설명:
도 1 내지 3에 도시된 케이지는 전방 벽(16), 후방 표면(18) 및 한쌍의 측방 표면(12 및 14)을 갖는다. 케이지는 상부(20) 및 하부(22)로써 완결한다.
한쌍의 내부 지주(24 및 26)는 측면(12) 및 (14) 사이에 연장되며 측면 개구부 사이의 벽의 고체 부분과 맞물린다. 측면(12)은 개구부(28, 30 및 32)를 가지며, 측면(14)은 개구부(34, 36 및 38)를 갖는다. 후방 벽(18)은 당해 분야의 숙련가에게 익히 공지되어 있는 유형의 고정화 공구가 도입되는 나사 개구부(39)를 갖는다. 파티션(partition) 또는 지주(24 및 26)는 도 2에 도시된 바와 같이 케이지(10)를 3개의 구획 또는 공동(40, 42 및 44)으로 분리시킨다. 평활한 전방 벽(16) 및 기타 측벽을 주목한다. 이러한 벽은 척추 부위 근처의 섬세한 신경 및 혈관을 인열하거나 베지 않는다.
케이지(10)는 섬유 복합체로 구성된다. 당해 복합체는 매트릭스(matrix)(51) 속으로 길고 정렬된 섬유(50a 및 50b)를 매봉시킴으로써 제조된다. 섬유는 바람직하게는 탄소 섬유이며 매트릭스(51)는 바람직하게는 PEEK(폴리에테르에테르케톤) 또는 PEKEKK(폴리에테르케톤에테르케톤케톤)이다. PEKEKK는 때로는 Ultra-Pek이라는 상표명하에 문헌에 인용되어 있다. 섬유(50a 및 50b)는 층(A 및 B)으로 정렬된다. 도 3에 명백하게 도시한 바와 같이, 섬유(50a)는 섬유(50b)와의 배향이 상이하다. 섬유(50a 및 50b)의 길이 및 배향은 케이지(10)의특정 생체역학적 요건을 충족시키도록 조절된다. 섬유(50a 및 50b)는 장섬유이고 바람직하게는 길이가 x 내지 ymm이다. 케이지가 저항해야 하는 힘은 특히 도 6, 도 7 및 도 8에 도시된 힘이다. 도 6은 케이지(10)에 작용하는 전단력을 나타낸다. 섬유 중 적어도 몇몇은 이러한 전단력에 저항하도록 배향된다. 도 7은 케이지(10)에 작용하는 삼점 굽힘력을 나타내고, 도 8은 케이지(10)에 작용하는 회전력을 나타낸다. 섬유(50a 및 50b)는 이러한 힘 중 적어도 하나에 저항하도록 배향된다. 일반적으로, 당해 섬유는 대항해야 하는 힘에 수직으로 배향된다. 섬유(50a 및 50b)는 배향이 상이하기 때문에, 상이한 힘에 대항할 수 있다.
도 4 및 도 5는 관 형태로서, 전방 표면(65), 후방 표면(62), 외표면(63) 및 내표면(64)을 갖는 이식편(60)을 나타낸다. 이식편(60)은 추간 케이지일 수 있고, 섬유 복합체로 제조되며, 바람직하게는 PEEK 또는 PEKEKK인 매트릭스(65) 속에 매봉된 탄소 섬유(66a 및 66b)를 갖는다. 섬유(66a 및 66b)는 외표면(60)에 평행하고 서로에 대해 평행한 층(C, D 및 E)으로 정렬된다. 섬유(66a 및 66b)는 코일 형태이며 도 4에 도시된 바와 같이 배향이 상이하다. 당해 명세서에 기재된 이식편은 케이지 형태이지만, 섬유가 이식편이 받는 압박에 저항하도록 배향된 평판, 봉 또는 레일 형태일 수 있다. 섬유의 길이는 이식편의 크기에 의존하며 바람직하게는 가능한 한 길다. 이식편이 레일이고 섬유가 길이 방향으로 평행하게 배향되는 경우, 이러한 섬유는 레일만큼 길다.

Claims (11)

  1. 섬유가 일반적으로 층으로 정렬되고 2개 이상의 상이한 층의 섬유가 상이하게 배향됨을 특징으로 하는, 섬유 강화 플라스틱으로 구성된 의학용 이식편.
  2. 제1항에 있어서, 섬유가 생체역학적 요건에 따라 배향됨을 특징으로 하는 의학용 이식편.
  3. 제1항 또는 제2항에 있어서, 섬유가 매트릭스 속에 매봉됨을 특징으로 하는 의학용 이식편.
  4. 제3항에 있어서, 매트릭스가 PEEK(폴리에테르에테르케톤) 또는 PEKEKK(폴리에테르케톤에테르케톤케톤)인 의학용 이식편.
  5. 제1항 내지 제4항 중의 어느 한 항에 있어서, 층의 섬유의 길이가 대체로 동일함을 특징으로 하는 의학용 이식편.
  6. 제4항 또는 제5항에 있어서, 추간 케이지인 의학용 이식편.
  7. 제6항에 있어서, 케이지가 일반적으로 연장된 중공 쉘을 포함하는 의학용 이식편.
  8. 제6항 또는 제7항에 있어서, 케이지가 제1 및 제2 측면 부재를 가지며 당해 측면 부재가 존재하는 섬유들 사이와 당해 섬유 중 적어도 몇몇 사이에 지주를 가짐을 특징으로 하는 의학용 이식편.
  9. 제1항 내지 제8항 중의 어느 한 항에 있어서, 섬유가 탄소 섬유임을 특징으로 하는 의학용 이식편.
  10. 일반적으로 전방 표면과, 일반적으로 사이가 연장되어 있는 제1 및 제2 측벽에 평행한 후방 표면을 갖는 직사각형 외벽을 포함하는 의학용 케이지 이식편으로서,
    외벽이 상부 표면과 하부 표면을 갖고, 다수의 지주가 제1 측벽과 제2 측벽 사이에 연장되어 있고 전방 표면과 후방 표면에 평행하며 이식편을 다수의 공동으로 분할하며, 측벽이 공동과 통하는 개구부를 가지며, 전방 벽, 후방 벽 및 지주에서 섬유가 배향되고 당해 섬유가 최소한 상이하게 배향되는 의학용 케이지 이식편.
  11. 제10항에 있어서, 하나 이상의 층의 섬유가 수평으로 배향되고 하나 이상의 기타 층의 섬유가 수직으로 배향되는 의학용 케이지.
KR10-2003-7011294A 2001-02-27 2002-02-26 의학용 이식편 KR20040038907A (ko)

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