KR20140019764A - 임플란트 부품 및 방법 - Google Patents

임플란트 부품 및 방법 Download PDF

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Publication number
KR20140019764A
KR20140019764A KR1020137000339A KR20137000339A KR20140019764A KR 20140019764 A KR20140019764 A KR 20140019764A KR 1020137000339 A KR1020137000339 A KR 1020137000339A KR 20137000339 A KR20137000339 A KR 20137000339A KR 20140019764 A KR20140019764 A KR 20140019764A
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South Korea
Prior art keywords
reinforcement
protrusions
orthopedic
implant
bone
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KR1020137000339A
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English (en)
Inventor
나다니엘 퀸
제프리 조엘 셰어
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스미스 앤드 네퓨, 인크.
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Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=45098648&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=KR20140019764(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by 스미스 앤드 네퓨, 인크. filed Critical 스미스 앤드 네퓨, 인크.
Publication of KR20140019764A publication Critical patent/KR20140019764A/ko

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    • A61F2002/348—Additional features
    • A61F2002/3487—Partial acetabular cups, e.g. strips replacing only partially the natural acetabular cartilage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • 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
    • A61F2002/4615—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 of spacers
    • 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
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • 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
    • A61F2002/4619—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 for extraction
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
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Abstract

정형외과용 임플란트에 대해 시스템, 장치, 및 방법이 제공된다. 상기 임플란트는 기초 부재, 예를 들어 비구 쉘 또는 증강재를 포함할 수 있고, 기초 부재는 증강재, 플랜지 컵, 장착 부재, 또는 임의의 다른 적합한 정형외과용 부착물과 결합되도록 구성된다. 임플란트는, 2개 이상의 돌기부를 갖고 이 돌기부들 사이에 갭이 있는 기초 부재를 포함할 수 있다. 돌기부 사이의 갭은, 비구 쉘의 뼈 나사 주변과 같은 또다른 이식된 부품의 주변으로 임플란트가 이식될 수 있도록 한다. 임플란트는 이식된 비구 쉘과 임플란트를 결합시키는 나사 또는 접합홈 등의 고정 요소를 하나 이상의 돌기부 상에 포함할 수 있다. 또한, 임플란트는 또다른 이식된 부재상의 대응하는 마크와의 정렬을 용이하게 하기 위해 타이밍 마크(timing mark)를 포함할 수 있다.

Description

임플란트 부품 및 방법{IMPLANT COMPONENTS AND METHODS}
관련 출원의 상호-참조
본 출원은, 그 전문이 본원에 참조로 포함되는 2010년 6월 8일에 출원된 미국 가특허 출원 제61/352,705호, 2010년 6월 8일에 출원된 미국 가출원 제61/352,722호, 2010년 12월 14일에 출원된 미국 가출원 제61/422,903호, 및 2011년 3월 23일에 출원된 미국 가출원 제61/466,817호의 이익에 대한 권리를 주장한다.
관절은 흔히 다양한 이유로 인해 퇴행성 변화를 겪는다. 관절의 퇴행이 진행되거나 돌이킬 수 없게 되는 경우, 천연 관절을 인공보철 관절로 교체할 필요가 있다. 고관절, 어깨 관절, 및 무릎 관절을 비롯한 인공 임플란트가 정형외과 수술에서 광범위하게 이용된다. 특히, 고관절 인공보철물은 흔하다. 인간의 고관절은 구상 관절(ball and socket joint)로서 기계적으로 작용하며, 구 형상의 대퇴골두는 골반의 소켓 형상의 비구 내에 위치한다. 다양한 퇴행성 질환 및 부상으로 인해 고관절 전부 또는 일부를 합성 물질, 일반적으로 금속, 세라믹, 또는 플라스틱을 이용하여 교체해야할 필요가 있을 수 있다.
보다 특히, 천연 고관절이 흔히 퇴행성 변화를 겪게 되어, 고관절의 인공보철 관절로의 교체를 필요로 하게 된다. 흔히, 고관절은 대퇴골두와 비구 사이에서 2개의 지지 표면에 의해 교체된다. 제1 지지 표면은, 일반적으로 인공보철 쉘 또는 비구 컵이고, 금속, 세라믹 재료, 또는 다른 원하는 재료로 형성될 수 있다. 이어서, 라이너(통상적으로, 초고분자량 폴리에틸렌과 같은 폴리에틸렌 재료, 세라믹 재료, 또는 일부의 경우에는 심지어 금속 라이너로 형성됨)가, 관절을 형성하는 관계로 인공 대퇴골두를 수용하여 상호작용하는 내부 지지 표면을 제공하도록 쉘 내에 단단히 끼워맞춰져 대퇴골과 비구 사이의 상대적인 움직임을 따르고 수용한다.
컵(또는 컵 및 라이너 조립체)은, 일반적으로 컵 내부의 구멍을 통해 나사를 배치함으로써 또는 컵을 접합재(cement)로 고정시킴으로써 고정된다. 일부 경우에는, 환자에게서 불량한 골주(bone stock)로 인하여 단지 라이너만이 접합된다. 다른 경우에는, 다공 표면을 가진 컵이 확공된 비구 표면 내에 압입 끼워맞춤될 수 있다.
인공보철 관절을(흔히 더 큰) 교체 관절로 교체하기 위해 제2 또는 후속적인 수술을 수행할 필요가 있을 수 있다. 퇴행성 질환의 진행 또는 뼈의 추가적인 퇴행으로 인해 상기 수술이 흔히 필요하게 되고, 뼈를 추가적으로 제거하여 제거된 질환에 걸린 뼈를 큰 또는 개선된 인공보철 관절(흔히 교정 인공보철물로서 지칭됨)로 교체할 필요가 있다. 예를 들어, 뼈는 흔히 비구의 테두리 주변에서 손실되는데, 이로 인해 압입 끼워맞춤 컵을 고정 배치하기 위한 테두리 적용범위(coverage)가 더 적게 제공될 수 있다. 이와 같이, 이러한 수술을 교정 수술로 지칭할 수 있다.
비구 교정 수술에서, 비구 인공보철물에는, 일반적으로 추가의 장착 요소, 예를 들어 증강재(augment), 플랜지, 후크, 플레이트, 또는 일단 위치한 교체 인공보철물에 추가적인 지지 및/또는 안정성을 제공하는 임의의 다른 부착물 또는 장착 포인트 또는 부재가 포함된다. 손상된 영역(이 경우에는, 고관절)에서의 뼈의 퇴행, 뼈의 손실, 또는 뼈의 결함으로 인해, 이러한 추가의 장착 또는 부착 부재가 흔히 요구된다.
외과의사가 최적으로 고정시킬 수 있도록 도움을 주기 위해 다양한 유형의 상기 장착 부재(이 용어는 플랜지, 블레이드, 플레이트 및/또는 후크를 포함하나 이를 제한하고자 하는 것은 아님)가 인공보철 시스템과 함께 제공될 수 있고, 이들의 예로는 장골 플랜지(골반의 장골 부위 내부 및 외부에서의 고정 및 고착을 제공함), 좌골뼈(좌골 내부 및 외부에서의 고정 및 고착을 제공함), 및 폐쇄 후크(폐쇄공을 맞물리게 함으로써 내부 고정 및 고착을 제공함)가 포함되나 이에 제한되지는 않는다. 비록, 상기 장착 부착물에 모듈성을 제공하려는 시도가 있어왔으나, 일반적으로 지금까지의 해결방안들은 진정한 모듈성을 제공하기에 부족했다. 대신, 일반적으로 탑재될 부재가 위치할 수 있는 다수의 개별 위치를 제공하는데, 이것은 외과의사에게 폭넓은 의사결정 옵션을 제공하지는 않는다.
또한, 일부 일차 수술에서 및 보다 흔히 교정 수술에서, 비구는, 외과의사가 신규한 쉘을 삽입하기 전에 골이식편을 채워야 하는 뼈의 결함 또는 공동부를 가질 수 있다. 이것은 시간 소비적이고 고가일 수 있으며, 환자가 추가적인 건강상의 위험에 놓이게 될 수 있다. 일부 기술은 쉘의 외부 표면과 결합 또는 다른 방식으로 부착될 수 있는 증강재를 비구 쉘과 함께 이용한다.
현행 증강재의 경우, 외과의사는 증강재를 뼈에 부착한 다음, 컵을 이식할 수 있다. 그러나, 다수의 비구 쉘이 적절한 고정을 달성하는데 뼈 나사에 의존하고 있고, 증강재는 흔히 나사에 방해가 된다. 요약하자면, 외과의사는 최적의 위치에 자유롭게 나사를 배치할 필요가 있으나, 나사로 인해 증강재를 사용하는 외과의사의 능력이 방해된다. 또한, 현행 시스템의 경우, 부품 배향을 시도하고, 이어서 컵에 대한 양호한 뼈 고정부를 찾는데 수술 시간에서 더 많은 양의 시간이 소요된다. 증강재의 크기를 산정하는 것이 필요한 한, 외과의사는 흔히 뼈 제거량에 대해 재량권을 갖는다. 뼈가 자주 손실되는 경우, 외과의사는 필요한 것보다 임의로 더 많이 뼈를 제거하는 것을 주저하게 된다.
다양한 유형의 관절 임플란트를 이용하는 용도 및 응용을 목적으로 하는 수많은 추가의 특징 및 개선된 특징이 또한 본원에 기재되어 있고, 이들의 예로는 개선된 뼈 나사, 개선된 코팅, 및 각종 증강재 제거 및 삽입 옵션이 있다.
모듈식의 정형외과용 임플란트를 제공하기 위한 시스템, 장치 및 방법이 본원에 개시되어 있다. 상기 임플란트는 기초 부재, 예를 들어 비구 쉘 또는 증강재를 포함할 수 있으며, 기초 부재는 증강재, 플랜지 컵, 장착 부재, 임의의 다른 적합한 정형외과용 부착물, 또는 이들의 임의의 조합과 결합되도록 구성된다. 장착 부재에는, 예를 들어 플랜지, 블레이드, 후크, 및 플레이트가 포함된다. 일부 실시양태에서, 정형외과용 부착물은 기초 부재 또는 다른 부착물에 대해 조정가능하게 위치할 수 있고, 이에 의해 장치의 조립 및 이식에 모듈성을 제공한다. 각종 고정 및/또는 로킹(locking) 메카니즘이 임플란트의 부품들 간에 사용될 수 있다. 특정 실시양태에서는, 정형외과용 부착물이 기초 부재 또는 다른 부품에 제거가능하게 결합된다. 특정 실시양태에서, 정형외과용 부착물은 기초 부재 또는 다른 부품에 일체형으로 제공되나, 여전히 그에 대해 조정가능하게 위치할 수 있다. 일부 실시양태에서는, 팽창성 증강재, 기초 부재, 또는 다른 뼈 충전 장치가 제공된다. 일부 실시양태에서는, 마찰을 발생시키고 환자의 뼈와 임플란트의 경계에서 주위 뼈가 내성장하도록 하는 표면 특징부가 제공된다.
본원에 기재된 시스템, 장치, 및 방법은 복수의 돌기부 및 임의적인 고정 요소를 갖는 임플란트를 제공한다. 특정 실시양태에서, 정형외과용 증강재는 2개 이상의 돌기부가 결합된 기초 부재를 포함하며, 상기 2개 이상의 돌기부들 사이에는 갭이 있고, 상기 2개 이상의 돌기부 중 하나 이상에 고정 요소가 제공된다. 고정 요소는 접합홈일 수 있다. 특정 실시양태에서, 기초 부재는 임플란트와 결합하도록 성형된다. 예를 들어, 임플란트와 접촉하는 기초 부재의 제1 표면은 실질적으로 아치형일 수 있다. 2개 이상의 돌기부는 실질적으로 동일한 방향으로 배치될 수 있다. 2개 이상의 돌기부의 길이는 실질적으로 동일할 수 있거나, 2개 이상의 돌기부 중 하나의 길이는 2개 이상의 돌기부 중 또다른 하나의 길이와 각각 상이할 수 있다. 일부 실시양태에서, 기초 부재는 하나 이상의 고정 요소, 예를 들어 체결부를 수용하도록 구성된 나사 구멍을 포함한다. 일부 실시양태에서, 기초 부재는 정형외과용 증강재를 환자의 관절에 배치시키기 위한 드라이버 핸들을 수용하도록 구성된 연결 요소를 포함한다. 일부 실시양태에서, 상기 기초 부재는 임플란트상의 대응하는 타이밍 마크(timing mark)와 정렬되도록 구성된 타이밍 마크를 포함한다. 일부 실시양태에서, 증강재는 증강재에 부착되는 플랜지, 블레이드, 플레이트, 또는 후크를 추가로 포함할 수 있다.
특정 실시양태에서, 환자의 관절 내에 정형외과용 장치를 이식하는 방법은, 환자의 관절 내에 고정 장치를 통해 관절에 고정되는 임플란트를 배치하고; 상기 임플란트와 고정 장치 근처의 환자의 뼈에 공간을 준비하고; 2개 이상의 돌기부를 포함하고 이 돌기부들 사이에 갭이 있는 증강재를 제공하고; 상기 증강재의 2개 이상의 돌기부 사이의 갭을 통해 고정 부재가 연장되도록 고정 부재 주위에 증강재를 위치시킴으로써 증강재를 준비된 상기 공간으로 삽입하는 것을 포함할 수 있다. 본 방법은 2개 이상의 돌기부 중 하나 이상에 접합홈을 형성하고, 접합재를 접합홈 내에 주입함으로써 증강재를 고정하는 것을 더 포함할 수 있다. 일부 실시양태에서, 본 방법은 나사를 이용하여 증강재를 고정하는 것을 포함한다. 상기 준비는 브로치(broach)에 의해 환자의 뼈를 다듬거나 확공하는 것을 포함할 수 있다. 상기 브로치는 증강재와 대략 동일한 단면 프로파일을 가질 수 있다. 일부 실시양태에서, 브로치상에 배치된 깊이조절장치(depth stop)를 이용하여 제거될 뼈의 양을 제한할 수 있다. 상기 삽입은 증강재를 준비된 공간 내에 위치시키기 위해 증강재를 드라이버 핸들에 부착시키는 것을 포함할 수 있다. 본 방법은 증강재상에 배치된 타이밍 마크와 임플란트상에 배치된 타이밍 마크를 정렬하는 것을 더 포함할 수 있다. 일부 실시양태에서, 증강재는 증강재에 부착되는 플랜지, 블레이드, 플레이트, 또는 후크를 추가로 포함한다. 일부 실시양태에서, 상기 배치는 환자의 비구 내에 케이지 또는 비구 쉘을 장착하는 것을 포함한다.
첨부 도면과 함께 하기 상세한 설명을 참조하여 상기 및 다른 목적과 장점들이 명백해질 것이며, 도면에서 동등한 참조 번호는 전체에서 동등한 부품을 지칭한다.
도 1 및 2는 각각 예시적인 증강재의 정면 투시도 및 후면도를 나타내고;
도 3은 비구 쉘에 예시적으로 설치된 증강재의 상부 평면도를 나타내고;
도 4 내지 7은 증강재를 환자의 관절 내에 설치하는 예시적인 방법을 예시하고;
도 8은 3개의 돌기부를 갖는 예시적인 증강재의 정면 투시도를 나타내고;
도 9는 예시적인 플랜지를 갖는 증강재의 상부 평면도를 나타내고; 및
도 10은 비구에 설치된 플랜지를 갖는 예시적인 증강재의 부분적인 단면 정면도를 나타낸다.
본원에 기재된 시스템, 장치, 및 방법의 전반적인 이해를 제공하기 위해, 특정한 예시적인 실시양태가 기재될 것이다. 본원에 기재된 실시양태 및 특징은 특히 비구 시스템과 관련된 용도를 기재하지만, 부품, 연결 메카니즘, 조정가능한 시스템, 고정 방법, 제조 방법, 코팅, 및 하기 요약된 다른 특징 모두는 임의의 적합한 방식으로 서로 조합될 수 있고, 다른 외과 절차(척추 관절성형술, 두개-악안면 수술 절차, 무릎 관절성형술, 어깨 관절성형술뿐만 아니라 발, 발목, 손, 및 다른 팔다리 수술 절차를 포함하나 이에 제한되지 않음)에 사용되는 임플란트 및 의료 장치에 채용되고, 적용될 수 있다.
이들의 다양한 실시양태에서 본원에 기재된 다수의 임플란트 및 다른 장치가 임의의 적합한 보강 재료와 함께 이용될 수 있고, 보강 재료의 예로는 뼈 접합재, 적합한 고분자, 재흡수가능한 폴리우레탄, 및/또는 폴리노보 바이오머티리얼 리미티드(PolyNovo Biomaterials Limited) 사에 의해 제공되는 임의의 물질, 또는 이들의 임의의 적합한 조합물이 포함되나 이에 제한되지 않는다. 사용될 수 있는 추가의 비제한적인 잠재적 물질의 예가 하기 참고문헌에 기재되어 있다: 미국 특허 출원 공보 제2006/0051394호 "Biodegradable Polyurethane and Polyurethane Ureas", 미국 특허 출원 공보 제2005/0197422호 "Biocompatible Polymer Compositions for Dual or Multi Staged Curing", 미국 특허 출원 공보 제2005/0238683호 "Biodegradable Polyurethane/Urea Compositions", 미국 특허 출원 공보 제2007/0225387호 "Polymer Compositions for Dual or Multi Staged Curing", 미국 특허 출원 공보 제2009/0324675호 "Biocompatible Polymer Compositions", 미국 특허 출원 공보 제2009/0175921호 "Chain Extenders", 및 미국 특허 출원 공보 제2009/0099600호 "High Modulus Polyurethane and Polyurethane/Urea Compositions." 상기 참고문헌 각각은 그 전문이 본원에 참조로 포함된다.
도 1 및 2는 각각 특정 실시양태에 따른 증강재의 정면 투시도 및 후면도이다. 도 1 및 2에서, 증강재(910)는 스테이플 형태이고, 복수의 돌기부 및 임의적인 고정 요소가 제공된다. 예를 들어, 증강재(910)는 기초부 또는 기초 부재(970)로부터 연장된 2개의 돌기부(920)를 포함하며, 증강재(910)는 하기 기재된 바와 같이 기초 부재로부터 연장된 3개 이상의 돌기부를 가질 수 있는 것도 가능하다. 도시된 바대로, 돌기부(920)는 각 돌기부의 각각의 축에 의해 정해지는 증강재(910)로부터의 실질적으로 동일한 방향으로 2개의 돌기부(920) 사이에 갭(925)을 두고 배치될 수 있다. 특정 실시양태에서는, 돌기부(920)들이, 돌기부(920)가 증강재(910)로부터 동일한 방향으로 배치되지 않도록 경사지게 또는 다른 방식으로 어긋나게 놓이게 될 수 있지만, 바람직하게는 2개의 돌기부(920) 사이에 배치된 갭이 여전히 존재할 수 있다. 또한, 돌기부(920)의 길이는 실질적으로 동일한 것으로 도시되어 있지만, 돌기부(920) 중 하나의 길이가 다른 돌기부의 길이와 각각 상이할 수 있는 것으로 이해될 것이다. 기초 부재(970), 또는 돌기부(920), 또는 둘 다는, 예를 들어 비구 쉘 또는 다른 임플란트의 외부 만곡 표면에 대응되게 하기 위해 실질적으로 아치형인 표면을 가질 수 있다.
임의적인 고정 요소는 나사 구멍(930) 및 접합홈(960)을 포함한다. 고정 요소는 이식될 때 증강재(910)를 제 위치에 고정시킨다. 각 고정 요소는 증강재(910)를 환자의 뼈, 비구 쉘, 또는 둘 다에 연결할 수 있다. 증강재(910)는 또한 기초 부재(970) 상에, 예를 들어 증강재(910)의 중심 상부에 존재하는 연결 요소(940)를 포함할 수 있다. 특정 실시양태에서, 연결 요소(940)는 증강재(910)의 이식을 보조하기 위해 드라이버 핸들(예를 들어, 도 7의 드라이버 핸들(1060))의 말단부에 부착될 수 있는 나사 개구부이다. 그러나, 연결 요소(940)는 테이퍼형 연결, 퀵-컨넥트(quick-connect), 또는 임의의 다른 유형의 부품일 수 있다. 증강재(910)는 타이밍 마크(950)를 추가로 포함하여 증강재(910)가 엉덩이 뼈내에 적절하게 배치되도록 할 수 있다. 증강재(910)의 설치는 하기에 추가로 상세히 기재되어 있다.
도 3은 비구 쉘에 설치된 증강재의 평면도이다. 증강재(860)는 증강재(910)와 유사할 수 있다. 도시된 대로, 증강재(860)는 증강재(860) 상에 배치된 타이밍 마크(864)가 비구 쉘(862) 상에 배치된 타이밍 마크(866)와 정렬되도록 비구 쉘(862)에 근접 위치된다. 증강재(860)의 기초 부재는 비구 쉘(862)의 상보적인 만곡 외부 표면과 접촉하는 아치형 표면을 갖는다. 상기 기재된 대로, 증강재(860)와 같은 증강재는 나사 구멍 및 접합홈과 같은 임의적인 고정 요소를 통해 비구 쉘(862), 환자의 뼈, 또는 둘 다에 고정될 수 있다.
도 4 내지 7은 특정 실시양태에 따라 증강재(910)를 환자의 관절에 설치하는 예시적인 방법을 예시한다.
도 4는 비구(990) 및 비구 쉘(1010)의 단면 입면도이다. 비구(990)는 확공, 다듬기 등에 의해 쉘(1010)을 수용하도록 준비된다. 또한, 뼈 나사(1020) 또는 다른 적합한 고정 장치가 쉘(1010)을 고정하기 위해 설치되었다. 또한, 뼈 손실 영역(1000)이 도시되어 있다. 이 영역(1000)은 비구 쉘(1010)의 외부 벽으로부터 비구(990)로 연장되는 빈 공간이다.
도 5에서는, 증강재(910)를 위해 브로치(1030)를 이용하여 비구(990)가 준비된다. 브로치(1030)는 뼈의 다듬기 또는 확공에 유용한 임의의 종류일 수 있다. 본원에 기재된 증강재에 이용하기 위해, 브로치(1030)에는 일반적으로 깊이조절장치(1040)가 제공된다. 깊이조절장치(1040)는 브로치(1030)가, 예를 들어 비구 쉘(1010)의 테두리에 대해 캐칭(catching)함으로써 너무 많은 뼈를 제거하는 것을 방지하도록 한다. 브로치(1030)는 증강재(910)와 대략 동일한 단면 프로파일 및 전체 형태를 가질 수 있고, 일반적으로 증강재(910)가 뼈 손실 영역(1000)에 쐐기-끼워맞춤되도록 크기 결정된다. 또한, 브로치(1030)는 그 내부에 제공된 슬롯을 가짐으로써 설치된 나사(1020)의 양측면에서 브로치(1030)가 슬라이딩되도록 하여 나사(1020)의 양측면에서 뼈를 잘라버릴 수 있다.
도 6에서는, 비구(990)가 증강재(910)를 위해 준비된다. 뼈 손실 영역(1000)은 비구(990)와 비구 쉘(1010) 사이에 존재하는 준비된 공간(1050)으로 교체되었고, 준비된 공간은 나사(1020)를 포함하고 있다.
절차상의 다음 단계가 도 7에 예시되어 있다. 증강재(910)가 드라이버 핸들(1060)에 부착되고, 준비된 공간(1050) 내로 삽입된다. 삽입되는 동안, 외과의사는 증강재(910)의 상부의 타이밍 마크(950)를 비구 쉘(1010)상의 타이밍 마크(예를 들어, 타이밍 마크(886))에 매치시켜 뼈 나사(1020)가 회피되지 않도록 보장한다. 증강재(910)를 나사(1020) (또는 임의의 다른 고정 부재) 주변에 위치시킴으로써, 나사(1020)가 증강재(910)의 돌기부(920) 사이에 있는 갭(925)을 통해 연장되도록 증강재(910)를 준비된 공간으로 삽입한다. 손으로 증강재(910)를 공간으로 밀어넣는 경우, 망치를 이용하여 최종 위치로 두들길 수 있다. 외과의사가 원하는 경우, 이어서 외과의사는 배치된 증강재 나사를 이용하여 나사 구명(930) 내로, 이어서 환자의 뼈 내로 증강재(910)를 더 고정시킬 수 있다. 다르게는 또는 추가적으로, 외과의사는 뼈 접합재를 도 1에 예시된 홈(960)으로 주입할 수 있다. 접합재는 증강재(910)를 비구 쉘(1010), 환자의 뼈, 또는 둘 다에 결합시킬 수 있다.
일부 실시양태에서는, 증강재(910)는 마찰 끼움에 의해 단독으로 제 위치에서 고정된다. 일부 실시양태에서, 뼈 나사 또는 접합재와 같은 고정 장치가, 예를 들어 나사 구멍(930) 또는 접합홈(960) 각각을 통해 제 위치에 증강재(910)를 고정시키기 위해 이용될 수 있다. 당업자에게 익숙한 임의의 종류의 뼈 나사 또는 접합재가 이용될 수 있다.
도 8은 특정 실시양태에 따라 상부 또는 기초 부재로부터 연장된 3개의 돌기부를 갖는 증강재의 정면 투시도를 나타낸다. 예를 들어, 증강재(910')는 도 1의 증강재(910)와 유사할 수 있으나, 증강재(910')는 상부 부재(970')로부터 연장된 3개의 돌기부(920')를 포함한다. 특정 실시양태에서, 증강재가 3개를 초과하는 돌기부를 포함할 수 있다는 것도 이해될 것이다.
일부 실시양태에서, 상기 기재된 증강재에는 플랜지, 블레이드, 플레이트, 후크, 임의의 다른 적합한 장착 부재, 또는 이들의 임의의 조합이 제공될 수 있다. 예를 들어, 도 9는 플랜지(1090)를 갖는 증강재(1080)의 상부 평면도를 나타낸다. 플랜지(1090)는 비구(예를 들어, 도 10의 비구(1092))의 외측면에 대해 증강재(1080)를 위한 추가적인 지지를 제공할 수 있다. 도 10은 관통하여 제공되는 뼈 나사(1094)를 갖는 플랜지(1090)를 구비한, 비구(1092)에 설치된 증강재(1080)의 부분 단면 정면도를 예시한다.
본원에 기재된 증강재는 티타늄, 코발트-크롬, 산화지르코늄, 적합한 강도, 내마모성 등을 갖는 임의의 다른 생체적합성 물질 또는 합금, 또는 이들의 임의의 조합을 비롯한 수많은 물질로 제조될 수 있다. 또한, 증강재는, 예를 들어 전체적 다공성 또는 부분적 다공성으로 제조되어 뼈의 내성장을 더 향상시킬 수 있고, 증강재는 수산화인회석 또는 임의의 다른 뼈-성장촉진제 또는 이들의 조합물로 코팅될 수 있다.
상기 바람직하게 기재된 실시양태는 외과의사가 비구 쉘 또는 컵을 먼저 이식하고, 원하는 나사 고정을 하고, 이어서 원하는 증강재를 끼워맞추기 위해 뼈를 최소한으로 준비하도록 한다. 이것은 증강재를 사용하는 외과의사의 능력을 방해하지 않으면서 비구 쉘에 대해 원하는 고정을 가능하게 한다. 추가의 장점은, 외과의사가 필요한 것보다 더 많은 뼈를 제거하지 않는다는 것이다.
상기 내용은 본 발명의 원리를 단지 예시한 것이며, 본 발명의 시스템, 장치, 및 방법은, 예시의 목적으로 나타낸 것이지 제한하고자 하는 것은 아닌 상기 기재된 실시양태 이외의 것에 의해 수행될 수 있다. 본원에 개시된 시스템, 장치, 및 방법은 비구 시스템에서의 용도에 대해 나타냈으나, 척추 관절성형술, 두개-악안면 수술 절차, 무릎 관절성형술, 어깨 관절성형술뿐만 아니라 발, 발목, 손, 및 팔다리 수술 절차를 포함하나 이에 제한되지 않는 다른 수술 절차에서 사용되는 의료 장치에도 적용될 수 있음을 이해해야 한다.
본 개시내용을 참고한 후, 당업자에 의해 변형 및 개질이 일어날 것이다. 개시된 특징은 본원에 기재된 하나 이상의 다른 특징과 함께 임의의 조합 및 종속 조합(다수의 인용 조합 및 종속 조합을 포함함)하여 수행될 수 있다. 그의 임의의 부품을 비롯한, 상기 기재되거나 예시된 다수의 특징은 다른 시스템과 조합되거나 통합될 수 있다. 또한, 특정한 특징은 생략되거나 수행되지 않을 수도 있다.
교환, 치환, 및 변경의 예는 본원에 개시된 정보의 범주를 벗어나지 않으면서 당업자에 의해 확인되고, 수행될 수 있다. 본원에 인용된 모든 참고문헌은 그 전문이 참조로 포함되고, 본 출원의 일부를 구성한다.

Claims (23)

  1. 환자의 관절 내에 고정 장치를 통해 관절에 고정되는 임플란트를 배치하고;
    상기 임플란트와 고정 장치 근처의 환자의 뼈에 공간을 준비하고;
    2개 이상의 돌기부를 포함하고 이 돌기부들 사이에 갭이 있는 증강재를 제공하고;
    상기 증강재의 2개 이상의 돌기부 사이의 갭을 통해 고정 부재가 연장되도록고정 부재 주위에 증강재를 위치시킴으로써 증강재를 준비된 상기 공간 내로 삽입하는 것
    을 포함하는, 환자의 관절에 정형외과용 장치를 이식하는 방법.
  2. 제1항에 있어서, 2개 이상의 돌기부 중 하나 이상에 접합홈을 형성하는 것을 더 포함하는, 환자의 관절에 정형외과용 장치를 이식하는 방법.
  3. 제2항에 있어서, 접합재를 접합홈 내에 주입함으로써 증강재를 고정하는 것을 더 포함하는, 환자의 관절에 정형외과용 장치를 이식하는 방법.
  4. 제1항 내지 제3항 중 어느 한 항에 있어서, 나사를 이용하여 증강재를 고정하는 것을 더 포함하는, 환자의 관절에 정형외과용 장치를 이식하는 방법.
  5. 제1항 내지 제4항 중 어느 한 항에 있어서, 상기 준비는 브로치(broach)에 의해 환자의 뼈를 다듬거나 확공하는 것을 포함하는, 환자의 관절에 정형외과용 장치를 이식하는 방법.
  6. 제5항에 있어서, 브로치상에 배치된 깊이조절장치(depth stop)를 이용하여 제거될 뼈의 양을 제한하는 것을 더 포함하는, 환자의 관절에 정형외과용 장치를 이식하는 방법.
  7. 제5항 또는 제6항에 있어서, 상기 브로치는 증강재와 대략 동일한 단면 프로파일을 갖는 것인, 환자의 관절에 정형외과용 장치를 이식하는 방법.
  8. 제1항 내지 제7항 중 어느 한 항에 있어서, 상기 삽입은 증강재를 준비된 공간 내로 위치시키기 위해 증강재를 드라이버 핸들에 부착시키는 것을 포함하는, 환자의 관절에 정형외과용 장치를 이식하는 방법.
  9. 제1항 내지 제8 중 어느 한 항에 있어서, 증강재상에 배치된 타이밍 마크(timing mark)와 임플란트상에 배치된 타이밍 마크를 정렬하는 것을 더 포함하는, 환자의 관절에 정형외과용 장치를 이식하는 방법.
  10. 제1항 내지 제9항 중 어느 한 항에 있어서, 상기 증강재는 증강재에 부착되는 플랜지, 블레이드, 플레이트, 또는 후크를 추가로 포함하는, 환자의 관절에 정형외과용 장치를 이식하는 방법.
  11. 제1항 내지 제10항 중 어느 한 항에 있어서, 상기 배치는 환자의 비구 내에 케이지 또는 비구 쉘을 장착하는 것을 포함하는, 환자의 관절에 정형외과용 장치를 이식하는 방법.
  12. 2개 이상의 돌기부가 결합되어 있고 2개 이상의 돌기부 사이에 갭이 있는 기초 부재; 및
    2개 이상의 돌기부 중 하나 이상에 제공된 고정 요소
    를 포함하는 정형외과용 증강재.
  13. 제12항에 있어서, 상기 고정 요소는 접합홈을 포함하는, 정형외과용 증강재.
  14. 제12항 또는 제13항에 있어서, 상기 기초 부재는 임플란트와 결합되도록 성형되는, 정형외과용 증강재.
  15. 제14항에 있어서, 상기 기초 부재의 임플란트와 접촉하는 제1 표면은 실질적으로 아치형인 정형외과용 증강재.
  16. 제12항 내지 제15항 중 어느 한 항에 있어서, 상기 2개 이상의 돌기부가 실질적으로 동일한 방향으로 배치되는, 정형외과용 증강재.
  17. 제12항 내지 제16항 중 어느 한 항에 있어서, 상기 기초 부재가 체결부를 수용하도록 구성된 하나 이상의 고정 요소를 포함하는, 정형외과용 증강재.
  18. 제17항에 있어서, 상기 하나 이상의 고정 요소는 나사 구멍을 포함하는, 정형외과용 증강재.
  19. 제12항 내지 제18항 중 어느 한 항에 있어서, 상기 기초 부재는 정형외과용 증강재를 환자의 관절 내에 배치시키기 위한 드라이버 핸들을 수용하도록 구성된 연결 요소를 포함하는, 정형외과용 증강재.
  20. 제12항 내지 제19항 중 어느 한 항에 있어서, 상기 기초 부재는 임플란트상의 대응하는 타이밍 마크와 정렬되도록 구성된 타이밍 마크를 포함하는, 정형외과용 증강재.
  21. 제12항 내지 제20항 중 어느 한 항에 있어서, 상기 2개 이상의 돌기부의 길이가 실질적으로 동일한 정형외과용 증강재.
  22. 제12항 내지 제20항 중 어느 한 항에 있어서, 상기 2개 이상의 돌기부 중 하나의 길이가 2개 이상의 돌기부 중 또다른 하나의 길이와 각각 상이한 정형외과용 증강재.
  23. 제12항 내지 제22항 중 어느 한 항에 있어서, 플랜지, 블레이드, 플레이트, 또는 후크를 추가로 포함하는 정형외과용 증강재.
KR1020137000339A 2010-06-08 2011-06-08 임플란트 부품 및 방법 KR20140019764A (ko)

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