KR20170028975A - 다공질 내면을 지니는 전체 세라믹 표면치환 보철 - Google Patents

다공질 내면을 지니는 전체 세라믹 표면치환 보철 Download PDF

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KR20170028975A
KR20170028975A KR1020177003424A KR20177003424A KR20170028975A KR 20170028975 A KR20170028975 A KR 20170028975A KR 1020177003424 A KR1020177003424 A KR 1020177003424A KR 20177003424 A KR20177003424 A KR 20177003424A KR 20170028975 A KR20170028975 A KR 20170028975A
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porous
prosthesis
ceramic
sintering
molded article
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KR1020177003424A
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로만 프로쓰
마리타 라쉬케
페테르 스트로트겐
토비아스 바이쓰
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세람테크 게엠베하
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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
    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • 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
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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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    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
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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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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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    • 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
    • A61L27/56—Porous materials, e.g. foams or sponges
    • 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
    • A61F2/28—Bones
    • A61F2002/2825—Femur
    • A61F2002/2828—Femoral head
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30772—Apertures or holes, e.g. of circular cross section
    • A61F2002/30784—Plurality of holes
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/3092—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having an open-celled or open-pored structure
    • 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
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    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/3093—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth for promoting ingrowth of bone tissue
    • 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
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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
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Abstract

본 발명은 외부 구형 표면, 및 골과 마주하는 내부 측면 표면을 갖는 내부 수용 공간을 지니는 천연 대퇴골두를 위한 표면치환 보철에 관한 것이다. 금속을 사용하지 않으면서 표면치환 보철을 제조하고, 생체적합성 물질의 것으로의 골-보존 수술의 이점을 조합하고, 미끄럼 쌍의 마모를 낮게 유지하고, 골에서 탁월하고 장기간 적합한 방식으로 보철을 고정할 수 있게 하기 위해서, 표면치환 보철은 통합된 다공질 골유착성 내부 표면 및 표면치환 보철의 전체 세라믹 설계를 특징으로 한다.

Description

다공질 내면을 지니는 전체 세라믹 표면치환 보철{ENTIRELY CERAMIC RESURFACING PROSTHESIS HAVING A POROUS INNER FACE}
본 발명은 외부 구형 표면, 및 골과 마주하는 내부 측면 표면을 갖는 내부 수용 공간을 지니는 천연 대퇴골두를 위한 표면치환 보철(resurfacing prosthesis)에 관한 것이다.
대퇴골두 또는 고관절의 마모를 위한 현재 임상 종래 기술은 금속 또는 세라믹 물질로 제조된 표면치환 보철을 제공한다. 지금까지 세라믹 표면치환 보철은 주로 공지된 금속 설계를 기반으로 하며, 기본적으로 시멘트화된다. 내부 보철 표면에는 시멘트 포켓(cement pocket) 및 센터링 핀(centering pin)이 제공된다. 골 시멘트의 중합 동안 발생하는 발열 반응 때문에, 인접한 골 조직이 열에 의해 손상될 수 있는 위험이 있다. 추가로, 세라믹 물질과 골 시멘트 사이의 골은 장기간에 걸쳐 안정하지 않으며, 몇 년 후에는 보철의 해리로 이식물(implant)의 결함을 초래할 수 있다.
EP 0 542 815 B1호, EP1 268 364 A1호, 및 DE 10 2013 202 243 A1호는 종래 기술이다.
통합된 다공질 골유착성 내부 측면 표면을 갖는 본 발명에 따른 무시멘트인 전체 세라믹 표면치환 보철은 유리한 신규성인 것으로 여겨진다.
그러한 금속-비함유 표면치환 보철에는 생체적합성 물질의 것으로의 골-보존 작업, 미끄럼 쌍(sliding pair)의 낮은 마모, 및 장기간 안정성으로 골에서의 탁월한 고정(anchoring)의 이점이 조합된다.
외부 구형 표면 및 내부 측면 표면을 갖는 내부 수용 공간을 지니는 천연 대퇴골두를 위한 본 발명에 따른 표면치환 보철은 통합된 다공질 골유착성 표면 및 전체 세라믹 설계를 특징으로 한다. 이러한 표면치환 보철의 이점은 추가로 상기에 기재되어 있다.
청구항 제 1항에 따른 표면치환 보철의 통합된 다공질 골유착성 표면을 제작하기 위한 본 발명에 따른 방법은 표면치환 보철이 소결된 성형 물품(molded article)으로 제조되고, 다공질 골유착성 층이 표면에 적용됨을 특징으로 한다. 측면 표면은 이식 후에 골에 기대여 놓여지는 골과 마주하는 면인 것으로 이해된다.
본 발명에 따른 방법의 한 가지 구체예에서, 다공질 측면 표면은 미가공(green) 상태에서 세라믹 슬러리 및 플레이스-홀더(place-holder)(공극-형성제(pore-former))의 적용 및 소결 동안 플레이스-홀더의 소성에 의해 생성된다. 바람직하게는, 다공질 층은 미가공 상태에서 세라믹 슬러리의 발포 및 후속 소결에 의해 형성될 수 있다. 결합은 소결 과정에 의해 달성된다. 소결 동안 플레이스-홀더의 소성에 의해, 개방-공극형 구조가 골의 부착 및 내성장을 유리하게 지지하는 거친 표면으로 형성된다. 이와 관련하여 EP 1 268 364 A1호를 또한 참조하라.
다공질 측면 표면은 또한 소결된 상태에서 다공질 세라믹 성형 물품과 조밀한 성형 물품의 접합에 의해 형성될 수 있다. 다공질 측면 표면은 세라믹 슬러리의 발포 및 슬러리와의 다공질 기재 물질의 소결 또는 침윤 및 소결에 의해 형성될 수 있다. 접합은 바람직하게는 납땜(soldering) 또는 아교접착(gluing)에 의해 수행된다.
소결 방법에 의해서, 결합이 달성되고, 유리하게는 골의 부착 및 내성장을 유리하게 지지하는 거친 표면을 지니는 개방-공극형 구조가 형성된다. 세라믹 주요 몸체와 조합된 이러한 유형의 코팅은 유리하게는 알러지 반응과 관련된 금속-비함유이다.
본 발명에 따른 다공질 골유착성 측면 표면은 또한 2c-사출 성형(조밀 상(dense phase) 및 다공질 또는 공극-형성 상) 및 소결에 의해 생성될 수 있다. 세라믹 몸체와 조합된 이러한 유형의 코팅은 또한 금속-비함유이다.
본 발명에 따른 추가의 구체예에서, 통합된 다공질 골유착성 측면 표면은 이미 소결된 세라믹 주요 몸체와 다공질 금속의 생체적합성 층의 적용에 의해 형성된다(EP 1 052 949 B1호 참조).
추가의 코팅을 통해 골과 마주하는 다공질 측면 표면은 추가의 기능, 예컨대, 더 높은 통합 속도 또는 항균 효과를 얻을 수 있다. 통합 속도는 골로의 내성장 시간으로 이해된다. 바람직하게는, 이는 생체유리(bioglass), 수산인회석(hydroxylapatite), 기능성 단백질 또는 하이드로겔로 달성될 수 있다.
본 발명에 따른 표면치환 보철은 전체가 세라믹으로 구성되며, 다공질 측면 표면을 통해 직접적으로 이식될 수 있다. 골은 동작 후에 견고한 자리가 신속하게 보장되도록 다공질 측면 표면으로 신속하게 성장된다. 골 시멘트는 이식에 사용되지 않는다.

Claims (11)

  1. 외부 구형 표면, 및 골과 마주하는 내부 측면 표면을 갖는 내부 수용 공간을 지니는 천연 대퇴골두를 위한 표면치환 보철(resurfacing prosthesis)로서, 통합된 다공질 골유착성 측면 표면 및 전체 세라믹 표면치환 보철을 특징으로 하는, 표면치환 보철.
  2. 제 1항에 따른 표면치환 보철의 통합된 다공질 골유착성 측면 표면을 제작하기 위한 방법으로서, 표면치환 보철이 소결된 성형 물품(molded article)으로부터 생성되고, 다공질 골유착성 층이 측면 표면에 적용됨을 특징으로 하는 방법.
  3. 제 2항에 있어서, 다공질 측면 표면이 미가공(green) 상태에서 세라믹 슬러리 및 플레이스-홀더(place-holder)(공극-형성제(pore-former))의 적용 및 소결 동안 플레이스-홀더의 소성에 의해 생성됨을 특징으로 하는 방법.
  4. 제 2항에 있어서, 다공질 측면 표면이 미가공 상태에서 세라믹 슬러리의 발포 및 후속 소결에 의해 생성됨을 특징으로 하는 방법.
  5. 제 2항에 있어서, 다공질 측면 표면이 소결된 상태에서 다공질 세라믹 성형 물품과 조밀한 성형 물품의 접합에 의해 형성됨을 특징으로 하는 방법.
  6. 제 5항에 있어서, 다공질 성형 물품이 세라믹 슬러리의 발포 및 슬러리와의 다공질 기재 물질의 소결 또는 침윤 및 소결에 의해 생성됨을 특징으로 하는 방법.
  7. 제 5항 또는 제 6항에 있어서, 접합이 납땜(soldering) 또는 아교접착(gluing)에 의해 수행됨을 특징으로 하는 방법.
  8. 제 2항에 있어서, 다공질 측면 표면이 2c-사출 성형(조밀 상(dense phase) 및 다공질 또는 공극-형성 상) 및 소결에 의해 생성됨을 특징으로 하는 방법.
  9. 제 2항에 있어서, 다공질 측면 표면이 이미 소결된 세라믹 표면치환 보철 상에 다공질 금속의 생체적합성 층의 적용에 의해 형성됨을 특징으로 하는 방법.
  10. 제 2항 내지 제 9항 중 어느 한 항에 있어서, 추가 코팅을 통해 다공질 측면 표면이 추가의 기능, 예컨대, 더 높은 통합 속도 또는 항균 효과를 얻음을 특징으로 하는 방법.
  11. 제 10항에 있어서, 다공질 후면이 생체유리(bioglass), 수산인회석(hydroxylapatite), 기능성 단백질 또는 하이드로겔로 코팅됨을 특징으로 하는 방법.
KR1020177003424A 2014-07-09 2015-07-01 다공질 내면을 지니는 전체 세라믹 표면치환 보철 KR20170028975A (ko)

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