KR20030007959A - 인공 고관절 보철물을 위한 베어링 면 대체재 - Google Patents

인공 고관절 보철물을 위한 베어링 면 대체재 Download PDF

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Publication number
KR20030007959A
KR20030007959A KR1020027016911A KR20027016911A KR20030007959A KR 20030007959 A KR20030007959 A KR 20030007959A KR 1020027016911 A KR1020027016911 A KR 1020027016911A KR 20027016911 A KR20027016911 A KR 20027016911A KR 20030007959 A KR20030007959 A KR 20030007959A
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KR
South Korea
Prior art keywords
liner
shell
prosthesis
head
femoral head
Prior art date
Application number
KR1020027016911A
Other languages
English (en)
Inventor
고든윌리엄 블룬
사라캐트린 무어헤드-올-우드
Original Assignee
유니버시티 칼리지 런던
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Application filed by 유니버시티 칼리지 런던 filed Critical 유니버시티 칼리지 런던
Publication of KR20030007959A publication Critical patent/KR20030007959A/ko

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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
    • A61F2/32—Joints for the hip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
    • A61L27/30—Inorganic materials
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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
    • A61F2/30721—Accessories
    • A61F2/30724—Spacers for centering an implant in a bone cavity, e.g. in a cement-receiving cavity
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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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    • 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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    • A61F2/4637—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for connecting or disconnecting two parts of a prosthesis
    • 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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    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A61F2002/30205—Three-dimensional shapes conical
    • A61F2002/30217—Three-dimensional shapes conical hollow cones, e.g. tubular-like cones
    • 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
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    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30331—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
    • A61F2002/30332—Conically- or frustoconically-shaped protrusion and recess
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Abstract

고관절 대체 보철물을 복원시키는 방법이 기술되는데 있어서 이 보철물은 스템, 대퇴골 두 및 폴리에틸렌 라이더를 갖는 관골구 셸을 포함하는데, 이 라이너는 마모되거나 손상된다. 본 방법은 라이너를 이동시키고, 관골구 셸에 고정시키는 경질 라이너로 대체하는 것을 포함하는데, 이 경질 라이너는 대퇴골 두에 맞도록 만들어진다. 본 방법은 스템 및/또는 관골구 셸의 설치를 해제하지 않고 이루어진다.

Description

인공 고관절 보철물을 위한 베어링 면 대체재{REPLACEMENT OF BEARING SURFACES FOR HIP PROSTHESIS}
많은 경우에, 인공 고관절 보철물은 얼마 후에 작동하지 않는다. 이것은 때때로 무균성 이완(aseptic loosening)으로 발생된다. 무균성 이완은 뼈와 보철물 사이의 계면에서 골손실(bone resorption)과 불안정한 고정에 부하를 거는 이차적인 연조직 형성을 발생시킨다. 무균성 이완은 관절로 연결된 면들의 움직임으로 발생된 마모 입자에 의해 야기될 수 있다. 이러한 마모 입자들은 폴리에틸렌 라이너에서 유도된 1 미크론보다 작은 크기의 소형 폴리에틸렌 입자들일 수 있다.
폴리에틸렌 라이너의 마모율은 어린이들을 포함해 체구가 작은 환자들에게 사용되는 소형 대퇴골 두의 경우에 더 큰 경향이 있다. 이것은 관절로 연결된 면들의 고부하와 폴리에틸렌 강안으로의 대퇴골 두의 높은 침투율로 일어난다. 그러한 환자들에게는 원본 보철물을 교체하는데 필요한 일회 또는 그 이상이 교정 수술을 이끄는 발병률이 높다.
무균성이완이 발생하지 않는 현재의 경험에 따르면, 교정수술은 관골구 라이너 및/또는 대퇴골 두 교체를 필요로 한다. 이것은 단기적로는 상태를 개선시키지만, 장기적으로는 재발을 방지하지 않는다.
본 발명은 고관절 대체 보철물을 복원시키는 방법과 그러한 보철물을 위한 개선된 요소들에 관계된다.
고관절염의 치료를 위해 가장 일반적으로 사용되는 방법은 고관절 전치환 수술(total hip replacement)이다. 이 절차는 강(natural socket) 대신에 골반골에 관골구(acetabular) 요소를 맞추는 것을 포함하고, 병에 걸린 대퇴골을 절제한 후에 대퇴골 두(femoral head)는 골수강내 스템(stem)을 이용해 대퇴골의 근단에 고정된다. 보통 보철물의 두 요소들은 아크릴 뼈 시멘트를 이용해 적소에 접합되거나, 특히 대퇴골 스템의 경우에는 뼈 부착물 또는 천연골(natural bone)로의 고정을 위한 내입(ingrowth)에 의존할 수 있다. 대퇴골 요소는 관골구 요소에 맞춰진 라이너에서 관절로 연결된 볼(ball)을 포함하는 대퇴골 두를 포함한다. 라이너는 종래에 초고분자량 폴리에틸렌 중합체(ultra-high molecular weight polyethylene polymer)로 만들어지고, 어떤 디자인에서는 이 대퇴골부가 외과의사가 특정 환자에게 적합한 크기를 고를 수 있도록 교환가능하다.
본 발명은 수반된 약식 도면들로 설명된다.:-
도 1은 마모된 관골구의 초고분자량 폴리에틸렌 라이너 내부에 관절로 연결된 대퇴골 스템의 사시도;
도 2는 관골구 셸에 맞춰진 대퇴골 스템과 금속 라이너의 대퇴골 두를 분해된 형태로 도시한 유사도;
도 3은 접합된 금속 라이너와 맞춰진 관골구 셸에 삽입되는 대퇴골 두를 도시한 도면.
* 부호설명 *
1 : 관골구 셸2 : 골반골
3 : 폴리에틸렌 라이너4 : 대퇴골 스템
5 : 대퇴골 두6 : 금속 라이너
7 : 아크릴 뼈 시멘트8 : 폴리에틸렌 층
9 : 대퇴 경부11 : 테이퍼
12 : 슬리브
본 발명의 한 관점에 따르면 스템, 대퇴골 두 및 마모되는 폴리에틸렌 라이너가 잇는 관골구 셸을 포함하는 고관절 대체 보철물을 복원시키는 방법을 제공하는데, 상기 방법은 라이너를 이동시키고 그것을 경질 라이너로 대체하는 것을 포함하며, 상기 라이너는 대퇴골 두에 맞도록 만들어지고 셸에 라이너를 고정시킨다. 이 라이너는 편리하도록 단단하고, 대퇴골 두와 접촉하기 위해 내마모성 면을 가진다. 적당한 재료로는 금속, 세라믹 또는 복합재료가 있다. 예를 들면, 경질성 라이너는 코발트 크롬 합금 또는 산화 알루미늄 및/또는 산화 지르코늄 또는 유리 재료와 같은 세라막 물질을 포함할 수 있다.
대퇴골 두는 또한 금속 라이너에 맞도록 만들어진 대체 헤드로 대체될 수 있다. 이것은 폴리에틸렌 라이너의 이동 후와 같이, 관골구 셸 내의 공간이 일반적으로 상이한 것이 바람직하다. 상이한 크기의 대퇴골 두의 대체재를 편리하게 적응시키기 위해, 대퇴골 요소는 에를 들면 테이퍼에 의한 것과 같이 스템에 맞춰진 규격 헤드를 포함할 수 있다. 대퇴골 두는 테이퍼 강(tapered socket)을 포함할 수 있고, 다양한 테이퍼의 강을 갖는 규격 헤드를 적응시키기 위해, 규격 슬리브는 대퇴골 스템과 규격 헤드 사이에 삽입될 수 있다.
금속 대체 라이너는 예를 들면 아크릴 뼈 시멘트와 같은 시멘트로 관골구 셸 안에 편리하게 고정된다.
상기 기술된 절차는 고관절 대체 보철물이 단(step)의 초기 고정물 및/또는 환자의 뼈속의 관골구 요소를 부수지 않고 치료하거나 복구시키도록 할 수 있다.
어떤 상황에서는, 예를 들어 폴리에틸렌과 같은 매개 스페이서를 넘어 셸로 금속 라이너를 접합시키는 것이 바람직할 수 있다. 이것은 예를 들어 셸 내부의 공간이 적합한 크기의 대퇴골 두를 선택함으로서 쉽게 적응될 수 없다면 바람직하다. 라이너는 특히 상당히 좋은 상태일 때, 현재의 폴리에틸렌 라이너를 넘어 직접 접합될 수 있다. 다른 상황에서, 새로운 매개 라이너는 금속 라이너를 고정시키기에 앞서 셸 내부에 놓일 수 있고, 또는 매개 라이너가 예를 들면 적층되거나 그렇지 않으면 관골구 셸에 접촉하려고 하는 표면에 고정되는 것과 같이 경질 라이너의 일부가 될 수 있다.
교환절차는 정형외과용 장비 제조업자에 의해 이미 제조된 현재의 상용 성분들을 활용하는 것이 선호되거나 본 발명의 목적을 위해 특별히 제작된 규격 장치들을 활용할 수 있다.
규격 대퇴골 두와 대퇴 경부의 접합에 대한 정형외과용 제품사에 의해 만들어진 다수의 상이한 테이퍼들이 있다. 몇몇 예에서, 이것은 헤드가 꼭 맞는 테이퍼를 적응시키는 것을 필요로 한다. 이는 대퇴골 스템의 테이퍼에 맞는 금속 슬리브를 이용해 이루어질 수 있고, 대체 대퇴골 두의 강에서 테이퍼를 맞추도록 적응될 것이다.
이러한 유형의 슬리브를 사용함으로서, 상이한 테이퍼가 있는 수많은 서로 다른 고관절 스템들이 상이한 대퇴골 두의 사용에 맞도록 적응될 수 있다. 많은 상이한 슬리브들은 서로 다른 정형외과용 장비 제조업자에 의해 사용된 상이한 테이퍼의 변화성에 맞추도록 제조되어야 할 것이다. 본 발명의 보철물의 한 가지 특별한 이점은 체구가 작은 환자에게 나타나는 폴리에틸렌 라이너의 마모를 방지한다는 것이다. 장기적으로, 이것은 비용 효율적인 절차인데 그것은 그러한 환자들이 필요로 하는 교정 절차들의 수를 줄일 것이기 때문이다.
도면들을 참조로, 관골구 셸(1)은 골성장이 셸(1)을 속박시켜 자극된 무시멘트 고정(cement-less fixing)으로 골반골(2)에 고정된다. 이것은 예를 들어 골반골에서 형에 맞추어진 강으로 셸을 밀접하게 끼워 맞추고 마이크로 압입(micro indentation) 및/또는 수산기 인회석 코팅(hydroxy apatite coating)하는 뼈와 접촉하는 표면을 형성함으로서 행해질 수 있다. 관골구 셸의 내면은 초고분자량 폴리에틸렌 라이너(3)를 지지한다. 대퇴골 스템(4)을 포함하는 대퇴골 요소는 관골구 셸 내부에 관절로 이어진 대퇴골 두(5)를 버틴다. 도면에 도시된 바와 같이, 폴리에틸렌 라이너는 불균일하게 마모되며 상이한 부분의 셸에서 두께가 서로 다르다.
도 2는 관골구 셸(1)이 골반골에서 강(2)에 단단히 고정되는 본 발명에 따른 개선점을 도시한다. 그러나 이 경우에는 불균일한 마모를 방지하기 위해 금속 라이너(6)가 아크릴 뼈 시멘트(7) 층으로 셸(1)에 접합된다. 셸 내부의 추가 공간을 조절하기 위해, 폴리에틸렌(8) 층은 시멘트 층과 금속 셸 사이에 매개 스페이서를 만든다.
금속 라이너의 경우에는, 대퇴골 두(5)가 단단히 고정되고, 금속 라이너(6)에 의해 형성된 반구형 강 내부에 제한된 공차를 갖는 것이 바람직하다. 따라서 본 발명의 범위 내에서 대퇴 경부(9)에 테이퍼로 부착된 대퇴골 스템(4)을 위한 규격 헤드(5)를 제공한다. 대퇴골 두의 강에서 서로 다른 정도의 테이퍼를 조절하고 대퇴골 스템에서 상이한 테이퍼(11)를 적합시키기 위해, 슬리브(12)는 외부 환형면에서 상이하게 테이퍼된 면들을 갖고 제공될 수 있다.
도 3은 도 2에 도시된 장치의 변형을 도시하며 금속 라이너(6)는 뼈 시멘트(7)를 거쳐 셸(1)에 직접 접합된다.

Claims (12)

  1. 고관절 대체 보철물을 복원하는 방법에 있어서, 스템, 대퇴골 두 및 마모되는 폴리에틸렌 라이너를 갖는 관골구 셸을 포함하며, 상기 방법이 라이너를 이동시키고 그것을 대퇴골 두에 맞도록 형성된 경질 라이너로 대체시키며 관골구 셸로 이 라이너를 고정시키는 것을 특징으로 하는 방법.
  2. 제 1항에 있어서, 대퇴골 두가 또한 경질 라이너에 맞도록 형성된 대체 헤드로 대체되는 것을 특징으로 하는 방법.
  3. 제 1항 또는 제 2항에 있어서, 경질 라이너가 셸로 접합되는 것을 특징으로 하는 방법.
  4. 전항들 중 어떠한 한 항에 있어서, 경질 라이너가 매게 스페이서를 넘어 관골구 셸로 접합되는 것을 특징으로 하는 방법.
  5. 전항들 중 어떠한 한 항에 있어서, 경질 라이너가 금속 또는 세라믹을 포함하는 것을 특징으로 하는 방법.
  6. 제 4항에 있어서, 매개 스페이서가 플라스틱 물질을 포함하는 것을 특징으로하는 방법.
  7. 스템, 대퇴골 두 및 관골구 셸을 포함하는데 있어서, 이 셸이 셸에 고정되는 경질 라이너를 갖는 것을 특징으로 하는 고관절 대체 보철물.
  8. 제 7항에 있어서, 헤드가 규격 헤드이며 대체 가능한 헤드인 것을 특징으로 하는 보철물.
  9. 제 7항 또는 제 8항에 있어서, 경질 금속 라이너가 매개 스페이서를 넘어 셸로 접합되는 것을 특징으로 하는 보철물.
  10. 제 9항에 있어서, 스페이서가 폴리에틸렌 스페이서인 것을 특징으로 하는 보철물.
  11. 본래 위치의 고관절 대체 보철물을 복원하고 개수하기 위한 한 벌의 요소들의 제조에 있어서, 보철물이 관골구 셸에 손상되거나 마모된 폴리에틸렌 라이너를 가지며, 한 벌의 요소들은 보철물의 대퇴골 두에 꼭 맞고 손상된 라이너를 제거한 후에 관골구 셸에 맞도록 만들어진 금속 라이너를 포함하는 것을 특징으로 하는 제조 방법.
  12. 제 11항에 있어서, 금속 라이너가 라이너와 셸 사이의 위치 선정을 위해 스페이서를 포함하는 것을 특징으로 하는 방법.
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