KR20030060910A - 비이식 척수 융합 장치 - Google Patents
비이식 척수 융합 장치 Download PDFInfo
- Publication number
- KR20030060910A KR20030060910A KR10-2003-7005156A KR20037005156A KR20030060910A KR 20030060910 A KR20030060910 A KR 20030060910A KR 20037005156 A KR20037005156 A KR 20037005156A KR 20030060910 A KR20030060910 A KR 20030060910A
- Authority
- KR
- South Korea
- Prior art keywords
- spinal cord
- implant
- implantable spinal
- implantable
- bioactive coating
- Prior art date
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Classifications
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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
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- 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
- A61F2/447—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 substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
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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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- 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
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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
- A61F2/02—Prostheses implantable into the body
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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
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- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/00976—Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Neurology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Cardiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Prostheses (AREA)
- Fertilizing (AREA)
- Superconductors And Manufacturing Methods Therefor (AREA)
- Transition And Organic Metals Composition Catalysts For Addition Polymerization (AREA)
- Materials For Medical Uses (AREA)
- Lining Or Joining Of Plastics Or The Like (AREA)
- Massaging Devices (AREA)
- Separation By Low-Temperature Treatments (AREA)
Abstract
2개의 인접한 척추를 기계적으로 부착하기 위한 비이식 척수 임플란트는 제1 및 제2 대향 표면들을 구비한 본체를 포함한다. 제1 및 제2 표면들은 인접한 척추에 본체를 고정하기 위한 적어도 하나의 돌기 부재를 포함하고, 그 본체의 외부면들과 제1 및 제2 돌기 부재들은 생체 활성 코팅을 포함한다. 생체 활성 코팅은 예컨대 하이드록시애퍼타이트와 같은 코팅들로부터 선택될 수 있다. 외부 생체 활성 코팅은 이식가능한 척수 융합 장치 및 인접한 척추 사이에 척추 뼈의 표면성장/내부성장을 용이하게 한다. 유리하게도, 이것은 뼈 이식제 및/또는 뼈 성장제의 사용을 피하게 한다.
Description
미국 특허 제6,241,769호("척수 융합용 임플란트") 및 미국 특허 제6,096,080호("임플란트 장치를 사용하는 척수 융합용 장치")는 척수 대체 장치를 개시한다. 2개의 특허들은 종래 기술의 장치들과 관련된 문제점들을 상세하게 설명한다.
참고문헌으로 본문에서 참조되는 미국 특허 제6,241,769호 및 6,096,080호에 개시된 장치들은 인접한 뼈 표면들에 장기간의 고정을 향상시키도록 중앙 이식 공간을 이용한다. 장치는 산호 또는 인산 칼슘과 같은 뼈 대체 재료의 인뼈 동종이식 재료로부터 제조될 수 있다. 이러한 특허들에 개시된 장치가 갖는 문제점들은 이러한 장치들은 뼈 이식을 요구하고 이러한 타입의 장치들의 파손율이 현격하게 높다는 점이다. 또한, 수용불가한 높은 이환율(예를 들어, 30%)을 가진다는 것이다.
따라서, 인접한 척추(vertebral) 뼈 표면들에 임플란트 장치의 고정을 용이하게 하기 위한 시도에서 뼈 이식을 이용하지 않는 척수 임플란트 장치가 필요하게 되어 척수 이동 분절을 안정화시킨다.
본 출원은 참고문헌으로 본문에 참조되는 2000년 10월 11일 출원된 가출원 지정 번호 60/239,368호("척수 융합 장치")로부터 우선권을 주장한다.
본 발명은 척수 임플란트(spinal implant)에 관한 것으로서, 특히 뼈 표면에 인접하게 임플란트의 고정을 향상시키도록 하이드록시애퍼타이트(hydroxyapatite)와 같은 생체 활성 코팅을 이용하는 비이식 척수 임플란트에 관한 것이다.
도1은 비이식 척수 임플란트의 제1 실시예의 사시도이다.
도2는 척수 내에 작동가능하게 임플란트된 비이식 척수 임플란트의 정면도이다.
도3은 도2에 도시된 비이식 척수 임플란트의 측면도이다.
도4는 비이식 척추 임플란트의 제2 실시예의 사시도이다.
도5 및 도6은 도4에 도시된 비이식 척수 임플란트(20)의 추가적 사시도이다.
도7은 비이식 척수 임플란트의 다른 실시예의 도면이다.
간략하게, 본 발명에 따르면 임플란트가능한 척수 융합 장치는 외향 생체 활성 코팅을 포함한다.
일실시예에서, 2개의 인접한 척추를 기계적으로 부착하기 위한 비이식 척수 임플란트는 제1 및 제2 대향 표면들을 구비하는 본체를 포함한다. 제1 및 제2 표면들은 본체를 인접 척추에 고정시키기 위한 적어도 하나의 돌기 부재를 포함하고, 본체의 외향 표면들, 제1 및 제2 돌기 부재들은 생체 활성 코팅을 포함한다.
생체 활성 코팅은 예를 들어, 하이드록시애퍼타이트, 생체 유리(bioglass), 생체 복합제(biocomposites), 하이드록시애퍼타이트 트리칼슘 인산염(hydroxypatite tricalcium phosphate), 뼈 형태 형성 단백질(bone morphogenic protein) 또는 다른 뼈 생성 단백질과 같은 코팅으로부터 선택될 수 있다.
외부 생체 활성 코팅은 임플란트할 수 있는 척수 융합 장치와 인접한 척추 사이에 척추뼈의 표면 성장/ 내부 성장을 용이하게 한다. 장점으로서, 이것은 장치가 뼈 이식 및/또는 뼈 성장제의 사용을 방지하게 한다.
본 발명의 이러한 및 다른 목적, 특징 및 장점은 다음의 도면에 도시된 바와같이 양호한 실시예의 다음의 상세한 설명을 참조하여 명백해진다.
도1은 비이식 척수 전방 융합 장치(10)를 도시한다. 장치(10)는 본 실시예에서 실질적으로 직사각형의 형상을 한 본체(12)를 포함한다. 그러나, 보통의 기술자는 본체(12)가 직사각형 이외의 형상으로 형성될 수 있다는 것을 인지한다. 본체(12)는 또한 각각 제1 및 제2 대향 표면(14, 16)을 포함한다. 이러한 실시예에서, 제1 및 제2 표면(14, 16)은 실질적으로 평행하고 돌기 부재(18 내지 21)를 포함한다. 본체 및 돌기 부재는 바람직하게는 1 피스(즉, 단일) 구조이다. 장치(10)는 또한 완만한 커브/테이퍼질 수 있다.
도2는 척추(24) 내에 작동 가능하게 임플란트된 비이식 척수 전방 융합 장치(10)의 간략화된 도면이다. 척수는 척추(vertebrae, 26, 28) 및 천연 디스크(natural disks, 30, 32) 또한, 척수(24)는 부분적으로 제거되어 본 발명의비이식 척수 전방 융합 장치로 교체되는 병든/손상된 디스크(34)를 포함한다. 비이식 척수 전방 융합 장치(10)의 외과적인 삽입을 위한 준비 단계에서, 관련 돌기 부재(예컨대, 18 내지 21)를 견고하게 수용하도록 된 크기를 갖는 키웨이(36 내지 39, keyway)는 손상된/병든 디스크에 인접하여 위치된 각각의 척추(26, 28) 내에 형성된다.
도3은 도2에 도시된 비이식 척수 임플란트(10)의 측면을 도시한다. 특히, 연장 및 회전력은 돌기 부재에 의해 상쇄된다.
본 발명의 일 측면에 따르면, 장치(10)는 예컨대 하이드록시애퍼타이트(hydroxyapatite), 생체 유리(bioglass), 생체 복합재(biocomposites), 하이드록시퍼타이트 트리칼슘 인산염, 뼈 형태 형성 단백질 또는 다른 뼈 생성 단백질과 같은 생체 활성 코팅으로 코팅된다. 중요하게는, 생체 활성 코팅은 척추 뼈의 표면 성장/내부 성장을 촉진한다.
도4는 비이식 척수 임플란트(70)의 제2 실시예의 사시도를 도시한다. 이 실시예는 또한 실질적으로 직사각형형인 본체(72)와, 제1 및 제2 대향 표면(80, 82)의 각각으로부터 연장하는 적어도 하나의 돌기부(예컨대, 74 내지 77)를 포함한다. 특히, 돌기부(74 내지 77)는 실질적으로 원통형으로 형성된다. 물론, 인접 척추 내에 형성된 키웨이(keyway, 도시 생략)는 돌기부(74 내지 77)를 수용하도록 형성된다. 부가하여, 이 비이식 척수 임플란트(70)의 외부면은 직물의 짜임을 갖거나 거칠고, 임플란트의 표면 면적을 증가시키는 복수의 함몰부(79)를 포함한다. 즉, 바람직하게는 비이식 척수 임플란트(70)의 외부면은 임플란트와 인접 뼈의 융합을촉진하도록 복수의 얕은 함몰부(79)를 포함한다. 직물의 짜임을 갖는 표면은 비드(beads), 호형 퇴적물(arc deposits) 및/또는 합성 포움(systhetic foams)을 포함할 수 있다. 임플란트(70)의 외부면은, 예컨대 하이드록시애퍼타이트와 같은 생체 활성 코팅으로 코팅되어 있다. 이 코팅은 척추 뼈의 표면 성장/내부 성장을 촉진한다. 바람직한 실시예의 도1 내지 도4에 도시된 장치의 외부면은 바람직하게는 유사하게 거칠게 되어 있고 복수의 함몰부를 포함한다.
다른 실시예에서, 임플란트(70)는 본 명세서에 참고로 포함된 상술한 미국 특허들에 개시된 바와 같이 뼈 성장제가 위치될 수 있는 개구(84)를 포함할 수 있다. 최종적인 장치는 개구 내에 위치되는 뼈 이식 재료의 포함으로 인하여 진정한 비이식 장치로서 더 이상 고려될 수 없을 수 있다. 중요하게는, 이 장치는 전술한 비이식 장치의 장점과 종래 기술의 이식 기술의 특징을 포함한다. 개구(84)는 본체(72)를 통해 연장될 수 있고(즉, 이는 관통 구멍), 또는 이는 본체(72)를 통해 부분적으로만 연장될 수 있다. 개구를 형성하는 표면은 감촉이 부드러운/거칠 수 있고, 얕은 만입부/구멍을 포함한다.
도5 및 도6은 비이식 척수 임플란트(7)의 부가적인 사시도이다.
도7은 비이식 척수 임플란트(100)의 다른 실시예의 사시도이다. 이러한 척수 임플란트는 상기 장치의 적어도 한 측에 테이퍼 엣지(102)를 포함하는 실시예를 제외하고는 도4 내지 도6에 도시된 임플란트와 동일하다. 테이퍼 엣지(102)는 임플란트를 척추에 절단된 키웨이(도시 생략)로 삽입하는 것을 용이하게 한다. 이러한 실시예에서, 임플란트(100)는 예로써 하이드록시애퍼타이트(hydroxyapatite)와같은 생체 활성 코팅으로 코팅된다.
상기 임플란트는 그 자체가 티타늄, 폴리페놀슐폰(polyphenolsulfone), 폴리아리레테르케톤(polyaryletherketone; PEEK), 폴리슐폰, 아세탈[acetal; 델린(delrin)], UHMW 폴리에틸렌과 같은 다양한 현재 입수가능한 생물학적으로 양립할 수 있는 재료와, 인장 강도 및 전단 강도를 부가하기 위한 고강도 탄소 섬유 또는 REM 유리 필라멘트와 관련된 이러한 재료의 혼합물을 포함할 수 있다. 상기 임플란트는 인간 뼈 타가 이식 재료, 자가 이식체 또는 산호 또는 인산 칼슘과 같은 뼈 대체 재료로 제조될 수 있다. 임플란트의 본체는 선택적으로 적절한 테이퍼를 가질 수 있다.
비록 상기 설명한 실시예에는 실질적으로 도브테일형 또는 원통형/편자형인 돌기 부재를 채용하였지만, 본질적으로 소정의 형상의 돌기 부재가 본 발명의 생체 활성 코팅식 임플란트에 사용될 수 있다는 것을 알 수 있다.
본 발명이 몇몇 양호한 실시예에 대해 도시하고 설명하였지만, 본 발명의 기술 사상 및 범위 내에서 그 형상 및 세밀한 점에 다양한 변경, 생략 및 추가가 가능하다는 것을 알아야 한다.
Claims (7)
- 2개의 인접한 척추를 기계적으로 부착하기 위한 비이식 척수 임플란트이며,제1 및 제2 대향 표면들을 구비한 본체와,제1 및 제2 표면들의 각각은 상기 본체를 인접한 척추에 고정하기 위한 적어도 하나의 돌기 부재를 포함하고, 상기 본체의 외부면들과 제1 및 제2 돌기 부재들은 생체 활성 코팅을 포함하는 것을 특징으로 하는 비이식 척수 임플란트.
- 제1항에 있어서, 상기 생체 활성 코팅은 하이드록시애퍼타이트를 포함하는 것을 특징으로 하는 비이식 척수 임플란트.
- 제2항에 있어서, 상기 돌기 부재들은 도버테일형의 설부 돌기로 형성된 것을 특징으로 하는 비이식 척수 임플란트.
- 제2항에 있어서, 상기 본체는 실질적으로 직사각형인 것을 특징으로 하는 비이식 척수 임플란트.
- 제2항에 있어서, 상기 돌기 부재들은 편자 형상의 설부 돌기로 형성된 것을 특징으로 하는 비이식 척수 임플란트.
- 비이식 척수 임플란트를 형성하는 방법이며,척수 임플란트를 제공하는 단계와,상기 척수 임플란트의 외부면을 생체 활성 코팅으로 코팅하는 단계를 포함하는 것을 특징으로 하는 비이식 척수 임플란트 형성 방법.
- 제6항에 있어서, 상기 생체 활성 코팅은 하이드록시애퍼타이트를 포함하는 것을 특징으로 하는 비이식 척수 임플란트 형성 방법.
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US23936800P | 2000-10-11 | 2000-10-11 | |
US60/239,368 | 2000-10-11 | ||
PCT/US2001/031821 WO2002030337A2 (en) | 2000-10-11 | 2001-10-11 | Graftless spinal fusion device |
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KR20030060910A true KR20030060910A (ko) | 2003-07-16 |
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US (2) | US6743256B2 (ko) |
EP (2) | EP1576938B1 (ko) |
JP (1) | JP4472925B2 (ko) |
KR (1) | KR20030060910A (ko) |
AT (2) | ATE296073T1 (ko) |
AU (2) | AU2002213124B2 (ko) |
CA (1) | CA2425500C (ko) |
DE (2) | DE60111069D1 (ko) |
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-
2001
- 2001-10-11 CA CA2425500A patent/CA2425500C/en not_active Expired - Fee Related
- 2001-10-11 AU AU2002213124A patent/AU2002213124B2/en not_active Ceased
- 2001-10-11 AT AT01981487T patent/ATE296073T1/de active
- 2001-10-11 EP EP05076116A patent/EP1576938B1/en not_active Expired - Lifetime
- 2001-10-11 EP EP01981487A patent/EP1326560B1/en not_active Expired - Lifetime
- 2001-10-11 KR KR10-2003-7005156A patent/KR20030060910A/ko not_active Application Discontinuation
- 2001-10-11 AT AT05076116T patent/ATE334644T1/de not_active IP Right Cessation
- 2001-10-11 WO PCT/US2001/031821 patent/WO2002030337A2/en not_active Application Discontinuation
- 2001-10-11 US US09/976,685 patent/US6743256B2/en not_active Expired - Lifetime
- 2001-10-11 NZ NZ525798A patent/NZ525798A/en not_active IP Right Cessation
- 2001-10-11 DE DE60111069T patent/DE60111069D1/de not_active Expired - Lifetime
- 2001-10-11 DE DE60122027T patent/DE60122027T2/de not_active Expired - Lifetime
- 2001-10-11 AU AU1312402A patent/AU1312402A/xx active Pending
- 2001-10-11 JP JP2002533785A patent/JP4472925B2/ja not_active Expired - Fee Related
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2004
- 2004-01-29 US US10/767,637 patent/US7163560B2/en not_active Expired - Fee Related
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JP2004516866A (ja) | 2004-06-10 |
EP1576938B1 (en) | 2006-08-02 |
EP1576938A1 (en) | 2005-09-21 |
ATE334644T1 (de) | 2006-08-15 |
ATE296073T1 (de) | 2005-06-15 |
US20040186578A1 (en) | 2004-09-23 |
WO2002030337A2 (en) | 2002-04-18 |
JP4472925B2 (ja) | 2010-06-02 |
DE60111069D1 (de) | 2005-06-30 |
DE60122027D1 (de) | 2006-09-14 |
NZ525798A (en) | 2004-10-29 |
AU1312402A (en) | 2002-04-22 |
US20020049497A1 (en) | 2002-04-25 |
WO2002030337A3 (en) | 2002-07-25 |
AU2002213124A2 (en) | 2002-04-22 |
DE60122027T2 (de) | 2007-03-01 |
EP1326560A2 (en) | 2003-07-16 |
CA2425500C (en) | 2010-08-03 |
AU2002213124B2 (en) | 2006-02-23 |
CA2425500A1 (en) | 2002-04-18 |
EP1326560B1 (en) | 2005-05-25 |
US6743256B2 (en) | 2004-06-01 |
US7163560B2 (en) | 2007-01-16 |
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