KR20020009600A - 골조직 및/또는 결합조직의 내생 및 성장을 제공하기 위한물체 및 이러한 물체를 제조하는 방법 - Google Patents

골조직 및/또는 결합조직의 내생 및 성장을 제공하기 위한물체 및 이러한 물체를 제조하는 방법 Download PDF

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KR20020009600A
KR20020009600A KR1020017013733A KR20017013733A KR20020009600A KR 20020009600 A KR20020009600 A KR 20020009600A KR 1020017013733 A KR1020017013733 A KR 1020017013733A KR 20017013733 A KR20017013733 A KR 20017013733A KR 20020009600 A KR20020009600 A KR 20020009600A
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cavity
bone
bone tissue
growth
tissue
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KR100879424B1 (ko
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잉그리드 브루스
라르스 브루스
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브루스 메디칼 아베
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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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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/38—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells
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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
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Abstract

골조직 및/또는 결합조직의 내생 및 성장을 제공하기 위한, 입자와 같은 물체가 제공된다. 상기 물체는 플라스틱 또는 비필수적으로 탄성인 생체적합성 재료, 바람직하게는 금속 또는 금속 합금으로 구성된다. 물체는 또한 다공성이며, 하기의 다공성 특성을 가진다: (a) 다공성이 연속적이고, (b) 공동/만입/포켓의 구멍 및 공동/만입/포켓을 상호연결하는 관/통로의 구멍이 골조직에 대해서는 약 50㎛를 초과하고, 결합조직에 대해서는 약 10㎛를 초과하는 폭을 가진다. 이러한 물제를 제조하는 방법에 있어서, 물체는 금속의 용융물로 기체를 취입시켜 제조된다. 본 발명에 따른 물체의 유리한 용도는 이것을 구멍이 형성된 케이스내에 넣어 척추 이식편과 같은 이식편을 제조하는 것이다.

Description

골조직 및/또는 결합조직의 내생 및 성장을 제공하기 위한 물체 및 이러한 물체를 제조하는 방법 {BODY FOR PROVIDING INGROWTH AND GROWTH OF BONE TISSUE AND/OR CONNECTIVE TISSUE AND METHOD OF MAKING SUCH A BODY}
SE-B-462,638호에는 긴 보형물, 예를 들어 대퇴골 보형물의 스템을, 특정 길이의 보형물이 공동(cavity)의 경계에 있는 틈(gap)으로 수용되는 공동과 경계를 이루는 생체 조직에 고정시키는 수단이 기재되어 있다. 본질적으로 전체 틈은 생체적합성 재료로 된 느슨하나 꽉찬 입자들(grains)로 충전되어 있으며, 상기 입자들은 연결되어 있다. 입자상 재료의 예로서 티탄이 언급되어 있고, 입자들은 불규칙적이고, 본질적으로 비탄성이며 바람직하게는 다공성인 것으로 언급되고 있으며, 후자의 다공성은 골벽으로부터 성장한 골조직의 성장물을 결합시키는 것으로 알려져 있다. 다공성은 입자상 재료의 용융물을 통해 기체를 취입시킴으로써 얻어져 왔다.
US-A-5,217,496호에는 생체 골조직에 사용하기에 적합하고 다공성의 외부 표면을 가진 티탄 지지체 및 분해된 생체 골조직과 티탄 분말로 구성된 혼합물로 된 부착층을 포함하는 이식편이 기재되어 있다. 상기 혼합물에 분해된 골조직을 성장시키는 영양물이 공급되어 분해된 골조직과 티탄 분말을 상호 연결시키고 지지체와 연결시키는 조직을 형성한다.
US-A-5,676,700호에는 골조직의 회복, 보강 및 교체를 위한 생체적합성 구조 엘리먼트가 기재되어 있고, 상기 엘리먼트는 골조직 공동에서 골전도성 또는 골유도성 매트릭스를 형성하는 것으로 나타난다. 엘리먼트의 재료는 티탄일 수 있고 엘리먼트는 천연 골의 내생(ingrowth)을 위해 미다공성인 것이 유리한 것으로 언급되어 있다.
상기 모든 문헌에서는 생체적합성 재료로서 티탄에 부가하여, 특히 히드록실아파타이트, 바이오세라믹스(bioceramics), 및 바이오글라스(bioglass)가 언급되어 있다.
상기 문헌에서, 생체적합성 재료의 다공성은 골조직의 결합에 유리한 것을 초래하는 것으로 지적되어 있다.
본 발명에 따르면, 놀랍게도 생체적합성 재료의 소정 한도의 다공성이 사실상 골조직의 성장율에 관한 중요한 인자인 것으로 밝혀졌다. 표면 다공성은 획실히 골조직을 결합시키는 한편, 현저하게 증가된 골조직 성장율 및 보다 대량의 골이 얻어져,
- 생체적합성 재료의 물체, 예를 들어 입자가 연속적으로 다공성인 경우,
- 물체의 다공성이 최소 한계값을 갖는 경우
생체적합성 재료상에서 골조직의 고정 및 강도가 현저하게 개선된다는 것이 밝혀졌다.
본 발명의 추가의 장점은 내생 골조직을 가진 다공성 입자의 강도가 골이 내부로 성장되도록 하지 않는 경우 보다 크다는 점에 의해 달성된다. 골의 내생에의하여, 강도는 주로 골조직에 보유될 것이며, 이것은 생체역학적 관점에서 유리한 것이다.
"연속적인 다공성"은 본원에서는 골조직을 다공성 물체, 예를 들어 생체적합성 재료의 입자를 통해 성장시키는 다공성을 의미한다. 본 발명에 따르면, 이러한 다공성은 물체내의 공동들이 관, 통로에 의해 연결되도록 하여, 물체의 외부 표면의 한 부분상에서 골조직의 성장물이 물체를 통해 나와 물체의 외부 표면의 다른 부분을 통해 성장을 계속하도록 한다. 공동은 임의의 형태의 만입(indentation), 핏(pit), 포켓(pocket)을 의미하며 이들 공동을 연결하는 관, 통로는 임의의 형태를 가질 수 있고 공동의 일부를 구성할 수 있다. 이러한 구조의 예는 자연계에 산호 또는 종유석 동굴에서 발견할 수 있다.
최소 한계값은 본원에서는 폭이 약 50㎛를 초과하는, 만입, 핏, 포켓의 구멍 및 관의 구멍을 의미한다. 보다 작은 구멍 칫수는 골조직의 성장을 제한 또는 억제하는데, 이는 아마도 영양물의 공급이 억제되고 골이 함유 엘리먼트를 갖는 정상적인 구조로 발달하는 것이 억제되기 때문일 것이다. 사실상 물체의 다공성에 상한은 없다. 상한은 오히려 물체의 강성에 의해 결정된다.
본 발명에 따르면, 공동은 서로 이웃하여 위치하고 개방된 표면 공극을 가진 물체에서 표면 공극을 형성하도록 될 수 있어, 한 물체의 표면 공극은 다른 물체의 표면 공극과 함께 공동 또는 관/통로를 형성한다.
본 발명에 따르면, 또한 히드록실아파타이트와 같은 취성의 생체적합성 재료가, 이러한 재료를 천연 골의 회복, 보강, 및 교체에 사용하는 경우 본 발명의 목적에 최적이 아닌 것으로 밝혀졌다. 이러한 재료는 불가피하게 일어나는 하중을 받는 경우, 예를 들어 상기 입자와 같은 생체적합성 물체가 위치한 사람의 신체 또는 신체의 일부가 예를 들어 사지를 움직일 때 하중을 받는 경우 용이하게 분해된다. 생체적합성 재료로 된 물체의 분해된 부분은 골형성을 억제하고 종종 골흡수를 초래하는 불리한 염증 반응을 일으킨다.
본 발명에 따르면, 금속성 재료 또는 비취성 복합물이 선택되는데, 천연 재료, 예를 들어 히드록실아파타이트, 바이로세라믹스 등은 다공성 물체 재료에서 한 성분으로서 포함될 수 있고, 플라스틱과 같은 다른 성분은 가소성을 보장한다. 본 발명에 따른 물체 재료는 사실상 플라스틱 또는 본질적으로 비탄성이어야 한다. 과도한 탄성은 골조직상에 압력을 유발하여 후속하여 골조직의 파괴를 가져온다.
티탄(이산화티탄)은 금속성 재료로서 유리하게 선택된다. 티탄 물체의 다공성은 티탄 용융물을 통해 기체를 취입시킴으로써 유리하게 달성된다. 이것은 SE-B-462,638호에서 기재된 바와 같이 티탄 입자의 생성을 가능케 한다.
그러나, 상기 언급된 다공성에 관한 요건은 금속 용융물을 통해 기체를 취입시키는 것에 의해 자동적으로 충족되지 않는다. 본 발명에 따르면, 이러한 방식으로 수득된 물체/입자/입자들의 다공성을 검사하여 요건에 충족하는지를 확인한다. 상기 검사는, 예를 들어 적합한 파장에서 형광투시법 및 TV 수상기 및 상기 요건을 충족하지 않는 입자의 자동 분리(예를 들어, 컨베이어 벨트로부터)에 의해 수행될 수 있다.
약 50㎛ 초과의 상기 한계값은 골조직과 관련이 있다. 골조직 대신 또는 골조직을 희생시킨 결합조직의 내생이 요망되는 경우, 한계값은 약 50 내지 10㎛ 초과이다.
본 발명에 따른 입자와 같은 다공성 물체는 파괴된 사지의 골의 공동을 생체내 골조직의 성장후 교체물로서 충전시키거나, SE-B-462,638호에 따른 보형물을 고정시키기 위해 생체, 예를 들어 사람의 신체에 이식될 수 있다. 본 발명에 따른 다공성 물체는 시험관내에서 골조직의 예비배양을 위한 기재로서 작용하거나 시험관내에서 특히 성장 인자를 함유한 영양물 용액으로 충전되어 생체 조직내에 후속하여 이식될 수 있다. 골 공동을 충전하는 경우, 다수의/많은 입자들이 골의 공동을 최적으로 충전하도록, 물체가 입상이고 불규칙적이며 크기가 10mm 미만인 것이 바람직하다.
다공성 물체는 분해가능한 재료, 예를 들어 소위 천연 재료의 매트릭스로 충전될 수 있다. 이러한 천연 재료의 예는 콜라겐, 피브린, 전분 및 히알루론산의 겔이다. 본 발명에 따르면, 이 매트릭스는 분해되어 내생 골조직으로 교체된다. 골조직의 내생은 성장 촉진 물질, 특히 TGF 베타(전환 성장 인자 베타) 또는 BGF(골 성장 인자)가 분해가능한 재료에 첨가되는 경우 더욱 촉진될 수 있다. 본 발명에 따른 물체내의 공극은 재료가 미리 겔화되기 전에 겔 재료와 함께, 예를 들어 흡인에 의해 이동될 수 있다.
본 발명에 따른 보다 작은 물체인 입자들은 이식편을 제조하기 위하여 가요성 또는 강성의 케이스에 넣어질 수 있다. 예를 들어 본 발명에 따른 입자들은 강성 슬리브(sleeve)에 넣어져 슬리브와 함께 척추 이식편을 형성할 수 있다[참조:US-A-5,015,247호의 슬리브]. 케이스내에 넣는 다른 가능성들은 SE 9803078-6호에 기재되어 있다. 케이스는 케이스를 통해 생체 세포 물질의 입자내로의 내생 및 입자로부터의 성장을 허용하는 구멍을 가진다. 본 발명에 따른 입자들은 분해된 생체 조직과 혼합될 수 있다.
본 발명의 구현예는 전자 현미경 이미지인 첨부 도면에 예시되어 있고, 도 1은 본 발명에 따른 다공성 구조를 나타내며 도 2는 티탄 입자의 외부 표면을 가진 본 발명에 따른 다른 다공성 구조를 나타낸다. 도 3은 본 발명에 따른 다공성을 가진 티탄 입자 박편의 이미지이다. 모든 이미지는 SE-B-462,638호에 보다 상세히 기술되어 있는 진동 기술을 사용하여 이식된 후에 사람 신체의 대퇴골로부터 제거된 불규칙한 입자 또는 입상물로 이루어져 있다.
도 1은 돌더미 형태의 구조를 나타내고 도 2는 산호형 구조를 나타낸다. 구조들은 티탄 용융물을 통해 기체를 취입시키고 상기 품질 검사를 적용함으로써 제공되었다. 두 이미지 모두 골조직의 전단계인 생체 물질의 회백색 막을 나타내며, 상기 막은 입자의 외부 표면을 덮고 공동 및 티탄 입자의 공극중의 틈으로 침투한다. 또한, 도 1은 구조의 공동/틈을 가교하는 골세포 성장을 나타낸다.
도 3은 본 발명에 따른 입자를 가로질러 침투하는 골조직을 예시한다.
임상적 분석 결과 도 1 내지 3에 따른 입자중의 골조직이 95 내지 98% 골, 2% 골수 및 0 내지 3%의 결합조직의 조성을 가지는 것으로 입증되었고, 이 조성은 근접한 입자들 외부에 있는 골의 조성과 실질적으로 일치한다.

Claims (10)

  1. 골조직 및/또는 결합조직의 내생 및 성장을 제공하기 위한, 플라스틱 또는 본질적으로 비탄성인 생체적합성 재료, 바람직하게는 금속 또는 금속 합금으로 제조된 입자와 같은 물체에 있어서, 물체가 다공성이며,
    - 다공성이 연속적이고,
    - 공동/만입/포켓의 구멍 및 공동/만입/포켓을 상호연결하는 관/통로의 구멍이 골조직에 대해서는 약 50㎛를 초과하고, 결합조직에 대해서는 약 10㎛를 초과하는 폭을 가지는 다공성 특성을 가진 것을 특징으로 하는 물체.
  2. 제 1항에 있어서, 물체가 티탄으로 제조된 것을 특징으로 하는 물체.
  3. 제 1항 또는 제 2항에 있어서, 물체의 공동이 분해가능한 재료, 예를 들어 콜라겐, 피브린, 전분, 히알루론산의 겔과 같은 천연 재료의 매트릭스로 충전된 것을 특징으로 하는 물체.
  4. 제 1항 내지 제 3항중 어느 한 항에 있어서, 분해가능한 재료가 성장 촉진 물질을 함유하는 것을 특징으로 하는 물체.
  5. 제 1항 내지 제 4항중 어느 한 항에 있어서, 물체가 산호형 구조인 것을 특징으로 하는 물체.
  6. 제 1항 내지 제 5항중 어느 한 항에 있어서, 물체가 10mm 미만인 것을 특징으로 하는 물체.
  7. 제 1항 내지 제 6항중 어느 한 항에 있어서, 물체가 유사한 물체들의 집합체중 일원으로 이루어져 있는 것을 특징으로 하는 물체.
  8. 제 1항 내지 제 7항중 어느 한 항의 물체를 제조하는 방법에 있어서, 금속, 예를 들어 티탄으로 구성된 물체를 제조하고, 금속의 용융물을 통해 기체를 취입시키며 공동/만입/포켓의 구멍 및 공동/만입/포켓을 연결시키는 관/통로의 구멍이 50㎛ 미만인 물체들을 분리하여 제조하는 것을 특징으로 하는 방법.
  9. 구멍/공극을 가진 케이스에 들어있는 제 7항에 따른 물체의 이식편 제조용 용도.
  10. 제 9항에 있어서, 케이스가 척추 이식편을 제조하기 위한 강성의 실린더형 슬리브인 것을 특징으로 하는 용도.
KR1020017013733A 1999-04-28 2000-04-28 골조직 및/또는 결합조직의 내생 및 성장을 제공하기 위한 입자 및 이러한 입자를 제조하는 방법 Expired - Fee Related KR100879424B1 (ko)

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PCT/SE2000/000802 WO2000064504A2 (en) 1999-04-28 2000-04-28 Body for providing ingrowth and growth of bone tissue and/or connective tissue and method of making such a body

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US7553539B2 (en) 2009-06-30
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DE60039871D1 (de) 2008-09-25
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