KR20040101485A - 금속 임플란트 - Google Patents

금속 임플란트 Download PDF

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KR20040101485A
KR20040101485A KR10-2004-7016438A KR20047016438A KR20040101485A KR 20040101485 A KR20040101485 A KR 20040101485A KR 20047016438 A KR20047016438 A KR 20047016438A KR 20040101485 A KR20040101485 A KR 20040101485A
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South Korea
Prior art keywords
metal
implant
layer
surface layer
substrate
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KR10-2004-7016438A
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KR100985005B1 (ko
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피크포드마틴에드워드리
터너앤드류데릭
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액센투스 피엘씨
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    • 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
    • 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
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    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • 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
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
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    • 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
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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    • A—HUMAN NECESSITIES
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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    • A61L27/32—Phosphorus-containing materials, e.g. apatite
    • C—CHEMISTRY; METALLURGY
    • C25—ELECTROLYTIC OR ELECTROPHORETIC PROCESSES; APPARATUS THEREFOR
    • C25D—PROCESSES FOR THE ELECTROLYTIC OR ELECTROPHORETIC PRODUCTION OF COATINGS; ELECTROFORMING; APPARATUS THEREFOR
    • C25D11/00—Electrolytic coating by surface reaction, i.e. forming conversion layers
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    • C—CHEMISTRY; METALLURGY
    • C25—ELECTROLYTIC OR ELECTROPHORETIC PROCESSES; APPARATUS THEREFOR
    • C25D—PROCESSES FOR THE ELECTROLYTIC OR ELECTROPHORETIC PRODUCTION OF COATINGS; ELECTROFORMING; APPARATUS THEREFOR
    • C25D11/00—Electrolytic coating by surface reaction, i.e. forming conversion layers
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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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    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/30929—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having at least two superposed coatings
    • 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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    • A—HUMAN NECESSITIES
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    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A61F2310/00017—Iron- or Fe-based alloys, e.g. stainless steel
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
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    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
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    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
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    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
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  • Veterinary Medicine (AREA)
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  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Electrochemistry (AREA)
  • Materials Engineering (AREA)
  • Metallurgy (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)
  • Superconductors And Manufacturing Methods Therefor (AREA)
  • Electroplating Methods And Accessories (AREA)

Abstract

본 발명은 표면층과 금속 기재가 일체화되고, 살균 물질을 혼입시킨, 외과적 절차에 사용하기 위한 금속 임플란트에 관한 것이다. 표면층은 양극화에 의해 금속 기재로부터 성장시킬 수 있고, 살균 물질을 이온 교환에 의해 여기에 혼입시킨다. 또 다른 방법으로, 층을 전기도금한 후, 확산 접합시킴으로써 부착시켜 금속 기재와 일체화되도록 할 수 있다. 어느 경우나, 은이 적합한 살균 물질이고, 살균 물질의 방출 속도 및 양은 모두 체세포에 대한 독성 효과를 피할 정도로 낮아야 한다. 표면층을 형성하기 전에 표면을 전해연마시키는 것도 유리하며, 이는 전해연마에 의해 달성될 수 있다.

Description

금속 임플란트{Metal implants}
본 발명은 외과적 절차, 특히 살균 물질을 이러한 임플란트로 도입하여 감염을 억제 또는 조절하는 데 사용하기 위한 금속 임플란트에 관한 것이다.
다양한 외과적 절차에 임플란트를 사용할 필요가 있다. 예를 들면, 보철술에서 암성 골을 제거하여 금속 임플란트로 대체시킬 수 있다. 이러한 임플란트는 예를 들면, 매우 강하고 상대적으로 가벼운 티탄 합금으로 된 것일 수 있다. 질긴 표면을 보장하기 위하여 질화티탄 피막을 제공할 것이 제안되었다. 추가로, 이러한 금속 임플란트를 이식하는 경우의 감염 도입 위험이 존재하여, 환자에 독성 효과를 발생시키지 않고 감염을 조절할 수 있는 살균 물질인, 금속성 은을 금속 임플란트에 도금할 것이 제안되었다. 그러나, 이러한 피막은 질화티탄이든 은이든, 체액으로부터의 부식으로 인하여 약화될 수 있어서, 피막이 임플란트로부터 박리될 수 있고, 이는 마모를 증가시키고 조직 손상을 일으킬 수 있다.
본 발명에 따라 금속 기재 및 당해 금속 기재와 일체화되며 용액으로부터 침착된 살균 금속이 혼입되어 있는 표면층을 포함하는, 외과적 절차에 사용하기 위한 임플란트가 제공된다.
또한, 본 발명은 이러한 임플란트의 제조방법을 제공한다.
이러한 일체화된 표면층은 금속 자체로부터 층을 성장시켜, 예를 들면, 양극화 공정에 의해; 또는 층을 예를 들면, 전기도금하여 부착시킨 다음, 확산 접합(diffusion bonding)시켜 층이 임플란트의 금속과 일체화되도록 하여 생성할 수 있다. 양극화는 부착성 산화물 층을 형성하지만, 인산 중에서 수행되는 경우, 인산염이 형성될 수 있다. 이러한 부착성 인산염 층은 또한 개질되어 하이드록시아파타이트 층을 형성할 수도 있으며, 이는 골 성장을 자극할 수 있다.
살균 물질은 수술 후 6주 이상 동안, 바람직하게는 6개월 이하 동안 유효한 것이 바람직하고, 방출 속도는 체세포에 대한 독성 효과를 피할 정도로 낮아야 한다. 추가로, 살균 물질의 총량은 바람직하게는 어떠한 독성 효과라도 최소화 시킬 정도로 제한된다.
표면이 표면층을 생성하기 전에 고도로 연마되는 경우 또한 바람직하다. 이는 예를 들면, 전해연마(electropolishing)에 의해 달성될 수 있다.
원칙적으로, 상이한 금속 범위가 살균 금속에 사용될 수 있다. 특히, 층이 전기도금에 의해 부착된 금속 층인 경우, 이는 명백히 부식에 안정해야 한다. 금, 백금, 이리듐 및 팔라듐이 잠재적으로 적합하지만 고가이고, 은이, 염화 이온의 존재 및 염화은의 낮은 용해도로 인하여 특히 체액에 용해성이 아니어서 바람직하다. 표면층이 이온 형태의 살균 금속을 함유하는 경우, 더 넓은 범위의 금속이 가능할 것이다. 이미 언급한 원소 외에도, 구리, 주석, 안티몬, 납, 비스무트 및 아연이 예를 들면, 금속 산화물 또는 금속 인산염의 불용성 매트릭스로 합쳐진 이온으로서 사용될 수 있다. 이러한 경우, 방출 속도는 주로 매트릭스 중의 금속 이온의 흡수 강도에 의해 조절될 것이다.
이러한 보철 임플란트를 제조하는 데 사용될 수 있는 금속은 통상적으로 스테인레스 강, 티탄 합금 또는 코발트/크롬 합금의 형태이지만, 지르코늄 또한 사용될 수 있다. 이러한 목적을 위한 표준 합금은 티탄 90%와, 알루미늄 6% 및 바나듐 4%(영국 표준 7252), 또는 크롬 26.5 내지 30%, 몰리브덴 4.5 내지 7% 및 잔여량의 코발트(영국 표준 7252 4부)이다.
바람직하게는, 임플란트는 우선 연마하여 매우 평활한 표면을 제공한다. 스테인레스 강(크롬/철/니켈) 및 코발트/크롬 합금 둘 다 인산과 글리세린의 혼합물 또는 인산과 황산의 혼합물을 전해질로서 사용하여 전해연마시킬 수 있다. 티탄 합금은 아세트산 또는 질산과 불화수소산의 혼합물을 사용하여 전해연마할 수 있다. 또 다른 방법으로, 임플란트는 일렉트로리니슁(electrolinishing)이라고 할 수 있는, 양극 패시베이션과 기계적 연마를 조합한 공정으로 처리하며, 이러한 공정은 표면 조도를 보호하는 산화물을 제거하고, 이 시점에서 표면을 이어서 전기화학적으로 다시 패시베이팅시켜, 거울 평활성 완성품을 제조한다. 질산과 혼합된 황산, 수산화나트륨, 인산나트륨 또는 수산화나트륨과 혼합된 질산나트륨을 포함하는, 다양한 전해질이 이러한 목적에 적합하다.
금속 표면을 연마 후, 은 침착 또는 표면 전환이 발생할 수 있다. 우선 표면 전환을 고려하면, 금속 산화물 또는 인산염 층이 적합한 전해질에서 양극화에 의해 형성될 수 있어서, 산화물 또는 인산염 층이 금속 표면으로부터 증축된다. 이어서, 살균 금속 이온, 예를 들면, Ag+또는 Cu++이온을 수성 염 용액으로부터산화물 또는 인산염 매트릭스로 흡수시킬 수 있다. 팔라듐, 백금 또는 루테늄의 양이온도 유사한 방식으로 흡수시킬 수 있을 것이다. 이어서, 필요한 경우, 산화물 또는 인산염 표면 피막 내에서, 침착된 은, 백금 또는 팔라듐 이온을 금속으로 전환시키거나, 침착된 루테늄 이온을 불용성 RuO2로 전환시키며, 이러한 반응은 화학적으로, 전기화학적으로 또는 광에 의해 수행된다.
이제 은 부착을 고려하면, 당해 피막은 독성 효과를 방지하도록 얇아야 한다. 우선 표면 산화물 층을 양극성 에칭으로 제거한 다음, 적합한 이온의 존재하에 극성을 짧게 반전시켜 표면을 은의 얇은 피막으로 피복함으로써, 하부 금속에 대한 고도의 부착성을 보장할 수 있다. 이러한 공정을 반복하여 핀 홀이 부재하도록 할 수 있다. 도금 전해질은 불화수소산을 포함할 수 있거나, 알칼리성 시아나이드 전기도금 전해질일 수 있다. 부착 후, 은 피막은 임플란트를 승온으로 가열함으로써 확산 접합되어 금속간 층을 형성하도록 해야 한다. 통상적으로, 이는 예를 들면, 아르곤의 불활성 대기 중에서 1 내지 6시간 동안 800℃ 초과, 바람직하게는 810 내지 950℃로 가열해야 한다. 이는 피막 박리 위험성을 실질적으로 제거한다. 그러나, 티탄계 임플란트를 사용하면 온도는 850℃를 초과하지 않아야 하는데, 이는 티탄이 이 온도를 초과하면 α 형태로부터 β 형태로 상변화가 발생하기 때문이다.
은 대신, 백금 또는 파라듐 등의 기타 금속을 전기부착시킨 다음, 유사한 방식으로 열처리할 수 있다.
이제, 본 발명을 추가로 보다 구체적으로 단지 예를 들어 설명할 것이다.
엉덩이 임플란트를 티탄 합금(Ti/Al/V)으로 제조한다. 임플란트를 액체 상으로서 제1 아세톤에 이어서 수산화나트륨 1M 수용액을 사용하여 초음파로 세정한 다음, 탈이온수로 헹군다. 이어서, 세정된 임플란트를 교반된 인산 12중량% 용액에 침지시키고, 최대 전압 10V 및 최대 전류 10㎃/㎠에서 2시간 동안 양극화시켜, 인산티탄의 표면 피막을 형성한다. 이어서, 이를 탈이온수로 다시 헹군다. 초기에 옅은 회색인 표면은 양극화의 결과 약간 황색을 띄는 어두운 비광택 회색으로 바뀐다.
이어서, 임플란트를 질산은 0.1M 수용액에 침지시키고, 2시간 동안 방치한다. 이온 교환의 결과, 인산티탄 피막에 일부 인산은이 결과적으로 존재한다. 이어서, 임플란트는 이식할 준비가 된다. 체액에 노출시키는 동안, 인산염 층으로부터 은 이온이 서서히 침출되어, 임플란트에 인접한 어떠한 균도 죽이도록 한다. 따라서, 임플란트로 인해 발생하는 감염이 억제된다.
이러한 티탄 함금의 실험적 샘플을 세정하고, 양극화시켜 인산티탄 층을 형성한 다음, 이온 교환시켜 인산은을 형한 후, 위에 기재한 공정을 수행하였다. 하나의 샘플을 110시간 동안 직사광에 위치시키면, 노출된 표면은 이러한 일광 노출의 결과 어둡게 되어, 광 환원에 의한 은 금속의 형성을 나타내었다. 다른 샘플을 4M 질산과 0.5M 불화나트륨(불화수소산과 동량)의 혼합물을 함유하는 용매에 침지시켜 피막을 용해시켰다. 암회색 표면 피막을 3분 이내에 완전히 제거하여 은회색 가공처리물을 수득했다. 수득한 용액을 원자 흡수 분광법으로 은의 존재에 대해분석하면, 은의 농도는 73㎍/㎠의 평균 표면 하중에 상당하다고 밝혀졌다.

Claims (12)

  1. 금속 기재 및 당해 금속 기재와 일체화되며 용액으로부터 침착된 살균 금속이 혼입되어 있는 표면층을 포함하는, 외과적 절차에 사용하기 위한 임플란트.
  2. 제1항에 있어서, 일체화된 표면층이 금속으로부터 층을 성장시킴으로써 생성되는 임플란트.
  3. 제2항에 있어서, 표면층이 양극화 공정(anodising process)에 의해 생성되는 임플란트.
  4. 제3항에 있어서, 표면층이 금속 인산염을 포함하는 임플란트.
  5. 제2항 내지 제4항 중의 어느 한 항에 있어서, 살균 금속이 표면층 내에 흡수된 금속 이온을 포함하는 임플란트.
  6. 제5항에 있어서, 살균 금속이 은을 포함하는 임플란트.
  7. 제1항에 있어서, 일체화된 표면층이, 우선 층을 부착시키고, 이어서 층과 기재를 확산 접합시켜, 층이 기재의 금속과 일체화되도록 함으로써 생성된 것인 임플란트.
  8. 제1항 내지 제7항 중의 어느 한 항에 있어서, 표면이 표면층을 제공하기 전에 고도로 연마되는 임플란트.
  9. 금속 기재와 일체화되는 기재 위에 표면층을 형성시키고, 살균 금속을 용액으로부터 침착시켜 층에 혼입시킴을 포함하는, 외과적 절차에 사용하기 위한, 금속 기재를 포함하는 임플란트의 제조방법.
  10. 제9항에 있어서, 기재의 표면을 양극화시켜 일체화된 표면층을 형성하는 방법.
  11. 제10항에 있어서, 은 이온이 은 이온을 함유하는 용액과 접촉시킴으로써 표면층에 혼입되는 방법.
  12. 제9항에 있어서, 표면층이 전기도금에 의해 부착된 금속 층이고, 후속적으로 열처리에 의해 기재와 일체화되어 확산 접합을 유발시키는 방법.
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