KR100788478B1 - 척추간 임플란트용 뼈 임플란트 - Google Patents

척추간 임플란트용 뼈 임플란트 Download PDF

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KR100788478B1
KR100788478B1 KR1020037008957A KR20037008957A KR100788478B1 KR 100788478 B1 KR100788478 B1 KR 100788478B1 KR 1020037008957 A KR1020037008957 A KR 1020037008957A KR 20037008957 A KR20037008957 A KR 20037008957A KR 100788478 B1 KR100788478 B1 KR 100788478B1
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bone
bone implant
implant
hollow body
implant according
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KR20030078880A (ko
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로버트쥬니어 마티스
레흐마니베아트
그라설베아트
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신세스 게엠바하
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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
    • 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
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • 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
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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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Abstract

본 발명의 척추간 임플란트용 뼈 임플란트는 방사선투과성 물질로 구성되고, 환형의 할로우바디(1) 형태로 제조된다. 상기 임플란트는 내부가 빈 실린더의 외주부(6)가 전면부(9), 후면부(10) 및 두 개의 측면부(11)로 구분된 형태로 형성되며 이러한 구분에 의하여 실린더축(7)이 정의된다. 할로우바디(1) 내부는 실린더축(7)에 실질적으로 평행하게 연장되어 있고 외주부(6)의 전면부(9) 및 후면부(10)를 서로 연결시키는 적어도 하나의 구획판(3)에 의하여 구획된다. 임프란트 표면은 적어도 2㎛ 이상의 표면 거칠기를 갖는다. 이로 인하여 새로 성장하는 뼈가 임플란트에 양호하게 접합되며, 뼈융합이 더욱 우수하게 된다.

Description

척추간 임플란트용 뼈 임플란트{Bone implant, in particular, an inter-vertebral implant}
본 발명은 뼈 임플란트(implant), 특히 청구항 1의 전제부에서 청구되고 있는 바와 같은 척추간(intervertevral) 임플란트 및 청구항 16의 전제부에서 청구되고 있는 바와 같은 상기 뼈 임플란트의 제조방법에 관한 것이다.
뼈 임플란트의 예가 WO 00/66045 (MICHELSON)에 공지되어 있다. 공지된 뼈 임플란트는 다음과 같은 문제점을 안고 있다.
A) 임플란트 상면 및 저면에는 거대 치아질이 공급되고 인접하는 척추체(vertebral body)들의 종판과 접촉하게 되는데 임플란트 표면이 매끄럽기 때문에 새로운 골조직이 상기 표면에서 적절하게 성장하는 것을 방해한다. 또한,
B) 충진재가 임플란트 내부 빈 공간을 채우는 경우에 임플란트 내벽 표면의 매끄러움 때문에 충진재가 쉽게 빠져나가게 된다.
이와 같은 종래 기술에 관한 논의는 본 발명의 배경 기술을 설명하기 위한 것에 불과하며, 본 발명의 출원일 혹은 우선일 당시에 종래 기술의 상기와 같은 문제점들이 실제로 공개되었거나 공중에 알려졌다는 것을 의미하는 것은 아니다.
본 발명은 이러한 문제점들을 해결하기 위한 것이다. 따라서, 본 발명의 목적은 새로운 뼈가 임플란트 표면상에서 성장하도록 최적으로 설계된 표면 구조를 갖는 뼈 임플란트, 특히 척추간 임플란트를 제공하는데 있다.
본 발명에 따르면, 상기 목적은 청구항 1에 제시되어 있는 뼈 임플란트 및 청구항 16에 제시되어 있는 방법에 의해서 달성된다.
본 발명에 따르면, 적어도 2㎛ 이상의 표면 거칠기로 인하여 새로 성장하는 뼈가 임플란트에 양호하게 접합되고, 따라서 뼈융합(bone integration)이 더욱 우수하게 된다.
본 발명의 바람직한 실시예에 따르면, 할로우바디(hollow body)가 적어도 두 개의 구획판에 의하여 내부가 분할되어 있으며, 상기 구획판은 횡간 버팀대(transeverse brace)에 의하여 서로 보강되도록 하는 것이 바람직하다. 이 구획판들은 척추체들의 인접 종판(end plate)과의 접촉면을 증가시켜, 표면에서의 압력을 줄이고 상기 임플란트가 인접 척추체 안으로 함몰되는 것을 방지한다. 또한, 구획판 사이의 빈 공간들은 임플란트를 통하여 새로운 골조직이 성장할 수 있게 한다.
본 발명의 다른 바람직한 실시예에 따르면, 표면 거칠기는 10㎛ 미만이다. 과도한 표면 거칠기는 잔류점(remaining points)의 효율을 떨어뜨리게 되고, 이것은 오히려 골용해를 유발하고 따라서 관절고정(arthrodesis)에 악영향을 가져온다.
본 발명의 다른 실시예에 따르면, 상기 구획판에는 천공들이 형성되며, 이들은 최소 표면적 3.5mm2를 갖는 것이 바람직하다. 측벽상에 형성되는 천공들은 새로 성장하는 골조직을 단단히 고정시키는 역할을 하며, 또한 초기에 미리 삽입될 수도 있는 충진물질이 제자리에 위치되도록 한다.
본 발명의 다른 바람직한 실시예에 따르면, 상기 할로우바디 외주부의 측면부에는 천공들이 형성되며, 이들은 최소 표면적 3.5mm2를 갖는 것이 바람직하다. 상기 측부에 형성되는 천공들은 새로 성장하는 골조직을 고정시키고 제자리에 위치되도록 하며, 무엇보다 임플란트 삽입시 임프란트가 고정되도록 한다.
본 발명의 다른 바람직한 실시예에 따르면, 방사선투과성(radiolucent) 물질이 다음의 그룹에서 선택된다: 폴리아릴에테르케톤(PAEK), 폴리에테르이미드(PEI), 폴리옥시메틸렌(POM), 액정폴리머(LCP), 폴리에틸펜텐(PMP), 폴리술폰(PSU), 폴리에테르술폰(PESU or PES), 폴리에틸렌테레프탈레이트(PETP), 폴리메틸메타아크릴레이트(PMMA), 및 초고분자량폴리에틸렌(UHMWPE).
이러한 물질들은 모두 복원력을 갖고 있지만 탄성력(뻣뻣함)이나 저항력 같은 기계적 성질에 있어서 서로 다르다. 이들중 일부는 다른 고분자 물질과 비교할 때 우수한 크리프특성(creep property)을 가지거나 혹은 수분흡수가 매우 낮은 특징이 있다. 따라서, 응용 분야에 따라 최적의 물질을 선택할 수 있다.
본 발명의 다른 바람직한 실시예에 따르면, 상기 방사선투과성 물질은 섬유 강화된 것이며, 강화물질로는 탄소섬유나 PEEK 섬유가 바람직하다. 방사선투과성 물질을 섬유 강화하여 그 기계적 성질을 변화시키고 경도를 갖게 할 수 있으며, 이렇게 경도를 갖도록 하는 것은 상기 물질에 일반적인 혹은 특별한 효과를 미친다.
본 발명의 다른 바람직한 실시예에 따르면, 뼈 임플란트의 전체 부피 V 에 대한 할로우바디의 부피 v 의 비율 V:v는 1.9 ~ 2.3의 범위에 있다. 실험에 따르면 이러한 범위의 부피비가 임플란트가 기계적인 안정성을 가지도록 하면서 또한 새로 성장하는 골조직이 최대 부피를 갖도록 하는 것으로 나타났다.
본 발명의 다른 바람직한 실시예에 따르면, 임플란트 표면에는 적어도 부분적으로 방사선투과성 코팅이 되거나 방사선투과성에 영향을 주지 않는 박막코팅이 되어 있다. 방사선투과성 코팅은 관절고정 과정중에 의사들이 관찰할 수 있는 가능성을 부여한다는 점에서 잇점이 있다. 순수한 PEEK는 그 자체가 생체친화적인 특징이 있지만, 적절한 물질을 부가적으로 코팅하여 기계적 특성 및 뼈와 임플란트 사이의 계면을 최적화할 수 있다. 적절한 코팅재로는 (임플란트의 방사선투과에 영향을 주지 않도록 두께가 매우 작은) 금속이 바람직하다. 특히, 티타늄, 금 또는 백금이 바람직하며 기타 다른 적절한 임플란트 금속이 포함된다.
본 발명의 다른 바람직한 실시예에 따르면, 상기 코팅재는 세라믹 물질, 바람직하게는 수산화아파타이트 또는 제3인산칼슘으로 구성된다. 수산화아파타이트와 제3인산칼슘은 모두 우수한 코팅재이며, 부가적인 잇점으로 뼈와 완전히 융합될 수 있고 심지어는 새로운 천연 골조직으로 대치되는 특징을 갖는다.
본 발명의 다른 바람직한 실시예에 따르면, 상기 할로우바디는 인산칼슘, 바람직하게는 수산화아파타이트 또는 제3인산칼슘으로 구성되는 충진재가 적어도 부분적으로 충진되어 있다. 이에 따라 관절고정 과정을 효과적으로 제어할 수 있다. 할로우바디는 또한 황산칼슘, 탈염된 뼈, 자가이식 뼈 또는 산호질 물질로 구성되는 충진재로 충진될 수 있다.
본 발명의 다른 바람직한 실시예에 따르면, 상기 할로우바디는 재흡수성(resorbable), 바람직하게는 다공성 폴리머로 구성되는 방사선불투과 충진재가 적어도 부분적으로 충진되어 있다. 상기 충진재가 방사선불투과성을 갖도록 하기 위해서, X선대조용물질(X-ray contrast media)이 상기 폴리머에 추가될 수 있다. PLA의 경우 지르코늄산화물과 같은 마커(marker)가 추가되며, 반면 PEEK의 경우에는 황산바륨이 추가될 수 있다.
본 발명의 다른 바람직한 실시예에 따르면, 임플란트에 형성된 천공들이 적어도 부분적으로 방사선불투과 충진재로 충진된다. 이렇게 하여 충진물질들이 임프란트로부터 빠져나오는 것을 방지할 수 있다.
본 발명에 따른 뼈 임플란트 제조방법에 따르면 사출성형, 열간성형 또는 열간가압성형에 의하여 환형의 할로우바디를 제조한다. 열간성형은 모든 구성 요소들에 있어서 폴리머의 치밀함을 가져옴으로써, 특히 피로저항성(fatigue resistance)을 향상시킨다.
도 1은 본 발명에 따른 척추 임플란트를 보여주는 사시도이다.
도 2는 도 1의 임플란트의 평면도이다.
도 3은 도 1의 임플란트의 정면도이다.
도 4는 도 1의 임플란트의 측면도이다.
이하에서 본 발명 및 실시예를 도식적인 묘사를 수반하여 자세하게 설명한 다.
도 1 내지 4에 도시된 척추 임플란트는 방사선투과성 물질 (PEEK, 선택적으로 탄소섬유 또는 유리섬유로 강화된) 로 구성되며, 사출성형에 의하여 환형의, 할로우바디(1) 형태로 제조된다. 상기 할로우바디는 외주부(6)가 전면부(9), 후면부(10) 및 두 개의 측면부(11)로 구분된 형태로 형성되며, 이러한 구분에 의하여 실린더축(7)이 정의된다.
할로우바디(1) 내부는 실린더축(7)에 실질적으로 평행하게 연장되어 있고 외주부(6)의 전면부(9) 및 후면부(10)를 서로 연결시키는 두 개의 구획판(3)에 의하여 개별적인 공동(cavity)으로 구획된다. 두 구획판(3)은 횡간 버팀대(4)에 의하여 서로 보강된다. 구획판(3)에는 약 10mm2 크기의 천공(5)이 형성된다. 외주부(6)의 측면부(11)에도 동일하게 약 10mm2 크기의 천공(8)이 형성된다.
뼈 임플란트의 표면(2)은 6㎛ 의 표면거칠기를 가지며, 방사선투과성 금 박막이 코팅되어 있다.
뼈 임플란트의 전체 부피 V 에 대한 할로우바디(1)의 부피 v 의 비율 V:v는 약 2.1 이다.
할로우바디(1)에는 방사선불투과 수산화아파타이트 충진재가 충진될 수 있으며, 또한 상기 천공들(5, 8)에도 상기 충진재가 충진되는 것이 바람직하다는 것을 상기할 필요가 있다.

Claims (16)

  1. 방사선투과성 물질로 구성되고, 형태는 환형의 할로우바디이며,
    상기 할로우바디(1)는 내부가 빈 실린더의 외주부(6)가 전면부(9), 후면부(10) 및 두 개의 측면부(11)로 구분된 형태로 형성되며 이러한 구분에 의하여 실린더축(7)이 정의되고, 할로우바디(1) 내부는 실린더축(7)에 실질적으로 평행하게 연장되어 있고 외주부(6)의 전면부(9) 및 후면부(10)를 서로 연결시키는 적어도 하나의 구획판(3)에 의하여 구획되는 뼈 임플란트로서,
    A) 상기 임플란트 표면(2)은 적어도 2㎛ 이상의 표면 거칠기를 가지며,
    B) 상기 구획판(3)에는 천공(5)이 형성되어 있는 것을 특징으로 하는
    척추간 임플란트용 뼈 임플란트.
  2. 제1항에 있어서, 상기 할로우바디(1)는 적어도 두 개의 구획판(3)에 의하여 구획되며, 두 구획판(3)은 횡간 버팀대(4)에 의하여 서로 보강되는 것을 특징으로 하는 뼈 임플란트.
  3. 제1항 또는 제2항에 있어서, 표면 거칠기는 10㎛ 미만인 것을 특징으로 하는 뼈 임플란트.
  4. 제1항에 있어서, 상기 구획판의 천공은 최소 표면적 3.5mm2를 갖는 것을 특징으로 하는 뼈 임플란트.
  5. 제1항에 있어서, 상기 외주부(6)의 측면부(11)에는 최소 표면적 3.5mm2를 갖는 천공들이 형성되는 것을 특징으로 하는 뼈 임플란트.
  6. 제1항 또는 제2항에 있어서, 상기 방사선투과성 물질은 다음의 그룹: 폴리아릴에테르케톤(PAEK), 폴리에테르이미드(PEI), 폴리옥시메틸렌(POM), 액정폴리머(LCP), 폴리에틸펜텐(PMP), 폴리술폰(PSU), 폴리에테르술폰(PESU or PES), 폴리에틸렌테레프탈레이트(PETP), 폴리메틸메타아크릴레이트(PMMA), 및 초고분자량폴리에틸렌(UHMWPE) 에서 선택되는 것을 특징으로 하는 뼈 임플란트.
  7. 제1항 또는 제2항에 있어서, 상기 방사선투과성 물질은 섬유 강화된 것이며, 강화물질로는 탄소섬유 또는 PEEK 섬유가 사용되는 것을 특징으로 하는 뼈 임플란트.
  8. 제1항 또는 제2항에 있어서, 뼈 임플란트의 전체 부피 V 에 대한 할로우바디의 부피 v 의 비율 V:v는 1.9 ~ 2.3의 범위인 것을 특징으로 하는 뼈 임플란트.
  9. 제1항에 있어서, 임플란트 표면에는 적어도 부분적으로 방사선투과에 영향을 주지 않도록 방사선투과성 코팅 또는 박막코팅이 되어 있는 것을 특징으로 하는 뼈 임플란트.
  10. 제9항에 있어서, 상기 코팅은 티타늄, 금 또는 백금 등의 금속으로 구성되는 것을 특징으로 하는 뼈 임플란트.
  11. 제9항에 있어서, 상기 코팅은 수산화아파타이트 또는 제3인산칼슘 등의 세라믹 물질로 구성되는 것을 특징으로 하는 뼈 임플란트.
  12. 제1항 또는 제2항에 있어서, 상기 할로우바디(1)는 수산화아파타이트 또는 제3인산칼슘 등의 인산칼슘으로 구성되는 충진재가 적어도 부분적으로 충진되어 있는 것을 특징으로 하는 뼈 임플란트.
  13. 제1항 또는 제2항에 있어서, 상기 할로우바디(1)는 황산칼슘, 탈염된 뼈, 자가이식 뼈 또는 산호질 물질로 구성되는 충진재가 충진되어 있는 것을 특징으로 하는 뼈 임플란트.
  14. 제1항 또는 제2항에 있어서, 상기 할로우바디(1)는 다공성 폴리머와 같은 재흡수성 폴리머로 구성되는 충진재가 충진되어 있는 것을 특징으로 하는 뼈 임플란트.
  15. 제4항 또는 제5항에 있어서, 임플란트에 형성되어 있는 상기 천공(5, 8)은 방사선불투과 충진재가 적어도 부분적으로 충진되어 있는 것을 특징으로 하는 뼈 임플란트.
  16. 상기 할로우바디(1)는 사출성형, 열간성형 또는 열간가압성형에 의하여 제조되는 것을 특징으로 하는 제1항 또는 제2항에 따른 뼈 임플란트 제조방법.
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