KR20020068038A - 골 매스 대체물 또는 융합 증강 장치로서 사용되기 위한3차원 기하학적 다공성으로 설계된 구조물 - Google Patents

골 매스 대체물 또는 융합 증강 장치로서 사용되기 위한3차원 기하학적 다공성으로 설계된 구조물 Download PDF

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KR20020068038A
KR20020068038A KR1020027004948A KR20027004948A KR20020068038A KR 20020068038 A KR20020068038 A KR 20020068038A KR 1020027004948 A KR1020027004948 A KR 1020027004948A KR 20027004948 A KR20027004948 A KR 20027004948A KR 20020068038 A KR20020068038 A KR 20020068038A
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South Korea
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graft
repeating
bone
filament
shapes
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KR1020027004948A
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젠즈 피터 팀
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인터포어 크로스 인터내셔널
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Publication of KR20020068038A publication Critical patent/KR20020068038A/ko

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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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    • A61F2/4455—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
    • A61F2/4465—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 kidney shaped cross-section substantially perpendicular to the axis of the spine
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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurology (AREA)
  • Vascular Medicine (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Cardiology (AREA)
  • Prostheses (AREA)

Abstract

본 발명은 골 매스 대체물 또는 융합 증강 장치로서 사용되기 위한 3차원 기하학적 다공성으로 설계된 구조물을 제공한다. 구조물은 공간-충전성, 자체-지지성 구조물로 건조되거나 강성 필라멘트(12)로 서로 결합되어 규칙적이고 반복적인 기하학적 형상을 형성한다. 구조물은 회복 및/또는 골 융합 동안에 골격 구조뿐만 아니라 주위 조직을 지지한다. 게다가, 구조물은 많은 개방된 간극 영역(20)을 제공하고, 이것은 성장하는 골를 위해 적당한 형상 및 크기로 된다. 하나의 바람직한 기하학적 구조물은 5각형으로 구성된 반복되는 변형된 12면체에 기초한다. 수득된 구조물은 좌우 대칭의 2개의 횡단 평면을 갖는다. 기타 구체예는 자가 이식, 동종이계 이식 또는 인공 골 대체물의 가능성을 허용하는 개방된 내부 영역을 가진 디스크 형의 구조물(들)을 포함한다.

Description

골 매스 대체물 또는 융합 증강 장치로서 사용되기 위한 3차원 기하학적 다공성으로 설계된 구조물{THREE-DIMENSIONAL GEOMETRIC POROUS ENGINEERED STRUCTURE FOR USE AS A BONE MASS REPLACEMENT OR FUSION AUGMENTATION DEVICE}
본 발명은 일반적으로 골 매스 대체물 또는 융합 증강 장치로서 사용되기 위한 3차원 구조물에 관한 것이다. 특히, 이 구조물은 상호 연결성, 비-불규칙 금속 분절로 설계되어 공극에 대한 금속의 체적을 최소화하여 복원되는 골 성장을 위한 잠재 체적을 최대화하였다. 금속 분절 또는 필라멘트는 결합되어 규칙적으로 반복되는 기하학적 형상을 형성하여 최대 강도를 제공하고 구조물을 통한 잠재적 전단(shear) 평면을 최소화한다. 특히 바람직한 기하학적 형상은 5각형에 기초한 변형된 12면체이다. 수득된 구조물은 전체적으로 직사각형 블록 구성을 갖고, 보다 넓은 공극 영역을 포함할 수 있는 원통형 구성을 중심에 갖는다.
도 1은 본 발명의 제 1구체예의 측면도이다.
도 2는 도 1에 도시된 제 1구체예의 단면도이다.
도 3은 도 1에 도시된 구체예의 평면도이다.
도 4는 전면 요추 인체내 융합에 사용되기 위한 본 발명의 제 2구체예를 도시한 것이다.
도 5는 본 발명의 제 3의 환형 구체예를 도시한 것이다.
도 6은 제 3구체예의 상이한 도면이다.
도 7은 제 4구체예를 도시한 것이다.
도 8은 도 7의 구체예의 상이한 모습 및 크기를 도시한 것이다.
본 발명은 설계된 3차원 구조물을 제공하며, 이것은 융합 또는 복원 수술을 위해 골이 관통하여 성장하게 되는 구조물을 제공하는 것을 목적으로 한다. 추가로, 구조물은 골의 회복 동안, 즉 골의 복원이 있을 때의 치료 과정 동안에 골격 및 근육 구조를 지지할 수 있을 만큼 강해야 한다.
따라서, 본 발명의 목적은 복원 동안에 필수적인 지지 특성을 제공하기 위하여 어떠한 추가의 기질 또는 지지체도 필요 없는 자체 지지성인 구조물을 제공하는 것이다. 이것은 다공성 코팅을 가진 관골구 컵(acetabular cup)과 같은 이식편과 대조된다. 마찬가지로, 이러한 코팅물은 다공이 불규칙한 경향이 있고 실질적으로 본 발명의 다공에 비하여 (크기면에서 한 등급 또는 그 이상으로) 작기 때문에 명확히 구별될 수 있다.
추가로, 구조물은 반복하는 기하학적 형상인 부구성들(subcomponent)로 구성되고, 이들은 필라멘트 부재로 구성되어 골에 대하여 적당한 형상 및 크기의 규칙적인 간극 다공 및/또는 공극을 제공한다. 따라서, 필라멘트 분절이 구조적 지지를 제공하는 동안, 느린 성장이 공극 영역내로 발생할 수 있다. 이러한 성장은 골 이식 또는 골 대체물의 사용으로 촉진되고/거나 증강될 수 있다. "규칙적"이라는 것은 구성 부분이 균일하고, 또는 동일한 종류 또는 구조 또는 형상 또는 크기이고, 또는 동일한 크기 및/또는 각도의 반복 단위를 구비함을 의미한다. "기하학적"이라는 것은 일부 또는 전부의 구성 부분이 직선, 바(bar), 또는 교차이음으로 형성됨을 의미한다. "정렬된(ordered)"이라는 것은 형상이 불규칙이 아니고 대칭 및/또는 반복을 갖는 순서 또는 패턴으로 배열된 것을 의미한다. 추가의 구체예에서, 구조물은 골 이식편 또는 골 대체물을 수용하는 중앙 공극 영역을 갖는다.
본 발명의 추가의 측면은 "공간-충전성"인 구조물을 제공하는 것이고, 이것은 구조물이 임의의 크기로 팽창될 수 있고 반복 구조로서의 형상을 유지할 수 있다는 것을 의미한다. 따라서, 구조물은 정렬되고 불규칙이 아니다. 이것은 동질이고 다수의 대칭면을 제공한다.
이식편은 바람직하게는 생물 양립성 주조 금속 예를 들어, 티타늄 또는 티타늄 합금으로 구성되어, 강도를 최대화하고 단면 CT 촬영에서 나타나는 금속 인공물을 최소화한다. 구조물은 변형되어 다양한 적용에 있어서 원하는 이식편 강성도(stiffness)를 제공할 수 있다. 또한, 구조물은 변형되어 필요한 경우에 그 강도 및 피로에 대한 내성을 증가시킬 수 있다. 게다가, 일단 기본 구조물이 구성 반복 단위를 구성하여 수립되면, 개개의 필라멘트 부재가 변형되거나 제거되어 체결구에 부착되기 위한 수단 또는 골 성장 공극을 위한 예를 들어 공극을 포함하는 기능적 구조물을 제공한다.
잠재적인 응용분야로는 후면 요추 인체내 융합("PLIF": posterior lumbar inter-body fusion) 및 전면 요추 인체내 융합("ALIF": anterior lumbar inter-body fusion)과 같은 척추 융합, 인체내 융합 고리, 체액 또는 대퇴골 복원과 같은 긴-골 복원, 정강-평면(tibial-plateau) 복원, 믹슬로-안면(mixillo-facial) 복원과 같은 두개골 안면 복원, 및 골반-결함 복원을 포함한다. 따라서, 일반적으로, 본 발명의 구조물은 약한 골 조직을 보강하기 위한 많은 정형외과적 응용성을 갖는다.
도 1은 골 매스 대체물 또는 융합 증강 장치로서 사용되기 위한 3차원적 기하학적 다공성으로 설계된 구조물을 도시하고 있다. 전체로 부재번호 "10"으로 도시된 구조물은 일련의 상호연결된 필라멘트(12)로부터 형성되고, 이것은 하나 이상의 종류의 반복되는 기하학적 형상을 형성한다. 도 1-3에 도시된 구조물에서, 제 1형상(15)은 오각형이고, 제 2 반복 형상은 변형된 12면체(17)이다. 형상들은 상호연결 됨으로써 간극 공극(20)의 다공 영역을 정의한다. 이들 영역은 골 복원 또는 융합 동안에 골이 성장되어 들어가는 공간을 제공한다. 따라서, 구조물은 궁극적으로 영역으로 성장되어 들어가는 골로 풍부해지고/거나 부이식(subplant)되게 된다.
도 1-3에 도시된 바와 같이, 구조물(10)은 전체적으로 규칙적인 전체 형상을 갖는다. 이 경우에, 구조물은 실질적으로 평면을 형성하는 상부(25), 바닥(27) 및 단부(31) 기하학적 구조를 가진 블록 구성을 갖는다. 그러나, 놀랍게도, 구조물은 전체적으로 "전단 평면"을 결핍하고 있고, 이것은 구조물내에 전단 손상을 초래하기 쉬운 평면이다. 본 발명의 이러한 측면은 골이 받게 되는 축방향 응력, 전단응력 및 비틀림 응력에 대한 특성을 포함하여 모든 방향으로 강도를 최대화하고, 금속성 비계(scaffolding) 또는 교각(substructure)을 최소화한다.
도 4는 척추 인체내 융합에 사용되기 위한 본 발명의 구체예를 도시한다. 특히, 이 디스크 또는 신장형 장치는 필라멘트 지주(44)에 의해 상호연결된 내부(41) 및 외부(40) 상부 고리 및 내부(43) 및 외부(42) 하부 고리를 구비하여 원하는 강도 특성을 제공한다. 게다가, 이 장치는 내부 고리에 의해 정의된 보다 넓은 공극(46)을 구비하여 골 이식, 또는 골 대체물이 구조물내로 이식될 수 있게 한다.
약한 골 조직을 보강하기 위한 유사한 고리 이식편이 도 5 및 도 6에 부재번호 "50"으로 도시되어 있다. 이 구조물은 다공(51)을 정의하는 개개의 필라메트(52)로 구성된 필라멘트 오각형 및 도 1-3에 도시된 제 1구체예에 도시된 것과 유사한 12면체 형상을 구비하는 것을 도시되었다. 그러나, 도 4에 도시된 구체예에 유사하게, 도 5 및 도 6의 이식편은 고리 형상이고, 그리하여 도 4에서와 동일한 목적을 위해 의도된 내부 공극(54)을 포함한다.
도 7 및 도 8은 규칙적인 반복 각도(63)로 결합된 필라멘트(62)로부터 구성되어 변형된 5각형 및 크게 변형된 12면체를 형성하는 블록형 구조물(60)을 도시하고 있다. "변형된"이라는 것은 기본 형상의 하나 이상의 각도 및 하나 이상의 필라멘트 분절 길이가 이 기하학적 형상에 대한 전체적인 이해로부터 변형되어 도면이 3차원 공간-충전성 구조물에 밀접하게 접근하게 한다. 오각형은 규칙적인 5변 형상이지만, 12면체는 결합되는 10개 오각형으로 형성된 구형 구조물이다. 또한,이 구조물은 인접한 8각형 내부 고리(66)에 의해 정의된 중심 공극(64)을 갖는다.
특정 응용을 위한 특이한 구조의 설계에서 고려될 특성은 의학적 시험인 ASTM 이식에 따라 시험된 압축, 전단 회전 및 비틀림을 포함한다. 일반적으로, 필라멘트는 약 0.25 내지 2 mm, 바람직하게는 0.5 내지 1.5mm, 가장 바람직하게는 0.5 내지 1mm의 두께를 갖는다. 5각형내에서의 이 필라멘트의 길이는 약 1 내지 10mm, 바람직하게는 1 내지 6mm, 가장 바람직하게는 1.5 내지 3mm이다. 12면체 형상은 20mm의 최대 크기를 갖는다. 주조 티타늄 또는 티타늄 합금이 바람직한 재료로서 상정되었더라도, 본 발명은 예를 들어 PEEK, 기타 금속을 포함하는 기타 생물 양립성 물질로 제조될 수 있으며, 세라믹 골 대체물이 상정될 수도 있다.
일반적으로, 본 발명에 사용되는 기하구조는 3차원 공간내에서 규칙적인 반복적 볼록 다면체, 예를 들어 사면체, 육면체, 규칙적인 팔면체, 규칙적인 12개의 오각형으로 결합된 오각형 12면체 및 규칙적인 20개의 삼각형으로 결합된 20면체를 상정할 수 있다. 따라서, 필라멘트 구조물이 서로 결합되어 기하학적 형상을 형성하고, 이것은 구조물의 전체적인 프로파일을 나타내는 보다 큰 구성을 형성하는 건조(building) 블록이다. 따라서, 본 발명은 또한 이러한 종류의 기하학적 형상에 기초하여 기타 구성 및 구조물을 상정할 수 있다.
특허법에 따라 최적 형태 및 바람직한 구체예가 개시되었으나, 본 발명의 범주는 이것에 한정되지 않으며, 첨부된 청구항의 범주에 의한다.

Claims (20)

  1. 일련의 반복적 정렬된 개구 형상을 집합적으로 정의하는 상호 연결된 강성 필라멘트를 포함하는, 골격 복원을 위한 자체지지성 생물양립성 다공성 3차원 구조물.
  2. 제 1항에 있어서, 필라멘트가 연결되어 반복적 기하학적 형상을 정의함을 특징으로 하는 구조물.
  3. 제 2항에 있어서, 하나 이상의 반복 형상이 5변형(five-sided)임을 특징으로 하는 구조물.
  4. 제 3항에 있어서, 하나 이상의 반복 형상이 5각형(pentagon)임을 특징으로 하는 구조물.
  5. 제 2항에 있어서, 하나 이상의 반복 형상이 10변형임을 특징으로 하는 구조물.
  6. 제 5항에 있어서, 형상이 변형된 12면체임을 특징으로 하는 구조물.
  7. 제 1항에 있어서, 필라멘트가 금속임을 특징으로 하는 구조물.
  8. 제 7항에 있어서, 필라멘트가 티타늄임을 특징으로 하는 구조물.
  9. 제 8항에 있어서, 구조물이 골 이식편임을 특징으로 하는 구조물.
  10. 제 9항에 있어서, 구조물이, 반복적 개방 구조물을 정의하는 상호 연결된 견조한 구성요소를 구비하고 전단 평면을 구비하지 않은 3차원, 자체-지지성, 공간-충전성 구조물임을 특징으로 하는 구조물.
  11. 다공을 정의하는 비-불규칙성 상호연결성 생물양립성 필라멘트로 형성되고, 전단 손상을 초래하는 평면이 실질적으로 존재하지 않는 구조물을 포함하는 정형외과적 이식편.
  12. 제 11항에 있어서, 골 이식편 또는 골 대체물을 위한 구조물내의 다공을 추가로 포함함을 특징으로 하는 이식편.
  13. 제 11항에 있어서, 구조물이 실질적으로 평탄한 제 1표면을 정의하는 상부, 및 제 1표면에 실질적으로 평행한 실질적으로 평탄한 표면을 정의하는 하부를 구비함을 특징으로 하는 이식편.
  14. 제 13항에 있어서, 필라멘트가 연결되어 반복하는 기하학적 형상을 정의함을 특징으로 하는 이식편.
  15. 제 14항에 있어서, 하나 이상의 반복적 형상이 5변형(five-sided)임을 특징으로 하는 이식편.
  16. 제 15항에 있어서, 하나 이상의 반복적 형상이 5각형(pentagon)임을 특징으로 하는 이식편.
  17. 제 16항에 있어서, 하나 이상의 반복적 형상이 10변형임을 특징으로 하는 이식편.
  18. 제 17항에 있어서, 형상이 변형된 12면체임을 특징으로 하는 이식편.
  19. 제 11항에 있어서, 필라멘트가 금속임을 특징으로 하는 이식편.
  20. 제 19항에 있어서, 필라멘트가 티타늄임을 특징으로 하는 이식편.
KR1020027004948A 1999-10-20 2000-10-10 골 매스 대체물 또는 융합 증강 장치로서 사용되기 위한3차원 기하학적 다공성으로 설계된 구조물 KR20020068038A (ko)

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US09/421,723 US6206924B1 (en) 1999-10-20 1999-10-20 Three-dimensional geometric bio-compatible porous engineered structure for use as a bone mass replacement or fusion augmentation device
US09/421,723 1999-10-20
PCT/US2000/027884 WO2001028460A1 (en) 1999-10-20 2000-10-10 Three-dimensional geometric porous engineered structure for use as a bone mass replacement or fusion augmentation device

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US6206924B1 (en) 2001-03-27
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