KR20030066711A - 견고한 모듈식 시스템 - Google Patents

견고한 모듈식 시스템 Download PDF

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Publication number
KR20030066711A
KR20030066711A KR10-2003-7007985A KR20037007985A KR20030066711A KR 20030066711 A KR20030066711 A KR 20030066711A KR 20037007985 A KR20037007985 A KR 20037007985A KR 20030066711 A KR20030066711 A KR 20030066711A
Authority
KR
South Korea
Prior art keywords
prosthesis
bone
shaft
stem
taper
Prior art date
Application number
KR10-2003-7007985A
Other languages
English (en)
Other versions
KR100781021B1 (ko
Inventor
메스와니아제이
Original Assignee
스탠모어 임플란츠 월드와이드 리미티드.
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Publication of KR20030066711A publication Critical patent/KR20030066711A/ko
Application granted granted Critical
Publication of KR100781021B1 publication Critical patent/KR100781021B1/ko

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Classifications

    • 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
    • A61F2/30—Joints
    • A61F2/30721—Accessories
    • A61F2/30739—Devices connected to the proximal part of an endoprosthetic femoral shaft for reinforcing or replacing the trochanters, e.g. the greater trochanter
    • 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
    • A61F2/30721—Accessories
    • A61F2/30734—Modular inserts, sleeves or augments, e.g. placed on proximal part of stem for fixation purposes or wedges for bridging a bone defect
    • 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
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
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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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    • A61F2/3607—Femoral heads ; Femoral endoprostheses including proximal or total replacement of the femur
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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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    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166—Sutures
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    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
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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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    • A61F2/0811—Fixation devices for tendons or ligaments
    • 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
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    • 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
    • A61F2/32—Joints for the hip
    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • A61F2/3662—Femoral shafts
    • A61F2/367—Proximal or metaphyseal parts of shafts
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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
    • A61F2/32—Joints for the hip
    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • A61F2/3662—Femoral shafts
    • A61F2/3672—Intermediate parts of shafts
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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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    • A61F2310/00005—The prosthesis being constructed from a particular material
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    • A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
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Abstract

본 명세서는 인간 또는 동물의 긴 뼈를 교체할 수 있는 보철을 모듈식으로 형성할 수 있는 시스템에 관해 게재하고 있다. 상기 시스템은 인공 보철의 관절부 일 요소를 형성하는 선단부 또는 말단부를 포함하는 전자(trochanter)(1) 또는 콘딜라(condylar) 헤드와, 잘린 뼈 내의 스템(8)과의 결합과 말단부 또는 선단부 요소와의 조립용 축을 제공한다. 상기 시스템은 제한된 범위의 요소에서 전용 고정 인공 보철 조립체를 고려한 것이다.

Description

견고한 모듈식 시스템{Massive Modular System}
팔다리가 심각하게 손상되었거나 뼈의 상당량이 외과적으로 제거되어야 할 경우, 골암이 발생하여 치료하는 경우에, 원래 뼈의 상당 부분이 교체되고 다양한 조건을 충족하도록 외과의사에 의해 조립될 수 있는 인공 보철이 필요하다. 본 발명은 이러한 범위의 외과적 요구를 충족시키는 전용 인공 보철을 효율적으로 구성하기 위한 모듈식 시스템을 제공한다. 일반적인 요구는 예로써, 대퇴골의 선단 또는 말단을 교체하거나 대퇴부 전체를 교체하는 것일 수 있다.
본 발명은 인간 또는 동물 몸체의 긴 뼈를 부분 또는 전체적인 교체용 인공보철과 관련된 것이다.
도1은 대퇴부 인공 보철의 선단부의 조립 요소에 대한 측면도.
도2는 본 발명에 따른 대퇴부 인공 보철의 말단부의 대한 측면도.
도3a 및 도3b는 본 발명에 따른 전자 교체 요소의 다각도.
도4a 및 도4b는 본 발명에서 사용되는 모듈식 샤프트의 다각도.
도5는 본 발명에서 사용되는 대퇴부 스템의 다각도.
도6은 본 발명에 따른 인공 보철에서 사용되는 칼라의 다각도.
도7은 본 발명에 따른 모듈식 연장 샤프트의 다각도.
본 발명의 일 태양에 따라 인간 또는 동물의 긴 뼈를 일부 또는 전체적으로 교체하는 인공 보철이며, 상기 인공 보철은 보철 연결부의 일 요소를 형성하는 말단부 또는 선단부와, 상기 선단부 또는 말단부 및 잘려진 뼈의 결합용 스템과 조립되는 샤프트를 포함하며, 상기 샤프트, 스템, 선단부 및 말단부 요소는 암/수형 테이퍼에 의해 연결되며, 각각의 암형 테이퍼는 보철의 종방향으로 연장되나 축으로부터 옵셋되고 암형 테이퍼의 대응 리세스에 결합되는 돌출부를 갖고, 해체 공구에의해 수형 테이퍼의 단부 영역의 횡방향으로 접근하기 위해 구비된 교차 구멍을 더 포함하며, 상기 돌출부는 인접한 요소의 소정의 각도 관계를 유지하는 것을 특징으로 한다.
또한, 샤프트 또는 연장부에 조립되고, 뼈의 잘린 면에 접할 수 있는 치수를 가져 보철 그 안에 고정되고 잘린 면을 향해 테이퍼 형성되도록 구성된 부분을 갖고 칼라(collar)의 테이퍼 형성 면에 위에 뼈의 성장을 촉진하도록 설계된 표면 처리부를 갖는 칼라를 포함하는 것을 특징으로 한다.
대퇴부의 선단 교체 보철의 경우, 보철은 샤프트 및 스템과 조립된 전자(trochanter) 교체 요소를 포함하며, 상기 전자 교체 요소는 해부학적으로 전자 요소와 근접하게 대응되는, 대퇴부 볼(ball) 수용용 대퇴부 네크와 다른 뼈 또는 연성 조직에 연결하기 위한 대퇴부 네크에 대향한 일반적인 평평한 면을 포함한다.
본 발명에 따른 인공 보철의 상세한 특징은 참조도면에 의해 명확해질 것이다.
도1을 참조하면, 이 도면은 종래의 방식에 의해 대퇴부 볼을 수용할 수 있도록 테이퍼 형성된 대퇴부 네크(2)를 갖는 전자 요소(1)를 포함하는 조립된 대퇴부 선단 인공 보철을 개략적으로 도시한다. 전자 요소는 도3a 및 도3b에 다양한 각도에서 상세히 도시되었고 해부학적 형상이 대략 대응하며 다른 뼈 또는 연성 조직에 부착되기 위해 대체로 평평한 면(3)을 가짐을 알 수 있다. 도3a 및 도3b에 가장 잘 도시된 바와 같이, 전자 요소(1)는 내부에 암형 테이퍼를 갖고 샤프트(5)에 의해 지지된 수형 테이퍼에 조립된다. 샤프트(5)의 상세 구조는 도4a 및 도4b를 참조하면 명백히 알 수 있으며, 샤프트(5)가 전자 요소(1)의 암형 테이퍼로 결합되는 일단부에 수형 테이퍼를 갖고, 타단부는 스템(8)(도5에 상세 도시)의 일단부에 결합되는 암형 테이퍼를 가짐을 알 수 있다.
스템(8)은 압착식 끼움 또는 본 시멘트(bone cement)에 의한 잘려진 대퇴부에 끼워진다. 샤프트(5)의 말단부를 둘러싸는 것은 도6에 보다 상세히 도시된 칼라(10)이다. 칼라(10)는 잘려진 뼈(9)의 표면을 형성하는 해면 모양의 뼈에 인접한 말단 하단부(11)를 갖는다. 칼라(10)의 치수는 칼라(10)의 단부면이 뼈(9)의 외부 치수의 범위 내에서 종결하도록 선택된다. 칼라(10)는 그 외부 표면이 스티플(stipple)되거나 삼인산 칼슘(hydroxyapatite)과 같은 뼈 성장 활성 물질로 형성된다. 이러한 조치들은 해면 형상의 뼈를 칼라(10)의 표면 위로 성장하게 촉진하고 인공 보철물은 나머지 잘려진 뼈(9)에 보다 더욱 견고히 체결하는데 도움을 준다.
이것은 종종 전자의 잔류 부분(12)을 보유하기 위해 손상된 뼈 또는 종양을 제거할 때 가능하다. 이러한 잔류 뼈 조각은 그에 부착된 인대 또는 다른 연성 조직을 가질 수 있고 이것은 전자 교체 요소를 안정화시키는 것을 돕는데 유용하게 사용된다. 잔류 뼈(12)는 전자 요소의 면(3)에 판(13)을 클램핑하여 전자 교체 요소에 부착될 수 있다.
도2는 도1의 전자 요소(1)가 샤프트(5)에 연결되는 방식과 유사한 방식으로 샤프트(5)에 연결된 무릅 관절의 일부를 형성하는 콘딜라(condylar) 헤드 요소(21)를 포함하는 조립된 말단부 인공 보철을 도시한다. 도1에서 전술한 방법과 유사하게 샤프트(5)는 스템(8)에 연결되고, 칼라(10)는 도1과 관련지어 상기에 설명한 바와 같이 샤프트 부재(5)의 테이퍼 형성된 하부 위로 활주하고 대퇴부(9)의 잘려진 뼈의 면에 인접한 테이퍼 형성된 말단부(11)를 갖는다. 유사한 방식으로 이것은 칼라(10)의 표면에 위로 뼈의 성장을 촉진한다.
전자 요소(1)는 도3a 및 도3b에 상세히 도시된다. 전자 요소(1)의 평면(3)은 스파이크(30) 패턴으로 형성된 것을 알 수 있다. 스파이크의 이런 패턴은 잔류 뼈(12)(도1 참조)와의 견고한 연결을 보장하고 인공 보철을 더욱 안정화시키는데 기여한다. 전자 요소가 옵셋 리세스(31)를 가지고 내부에 종결하는 암형 테이퍼를 갖는 것을 알 수 있다. 리세스(31)는 샤프트(5)의 수형 테이퍼(33) 상에 형성된 돌출부(32)에 결합될 수 있는 형상이다(도4a 및 도4b 참조). 전자 요소는 해체가요구되는 곳에서 전자 요소를 가압하도록 해체 공구가 삽입될 수 있는 횡방향 구멍(34)과 샤프트가 구비된다. 또한, 도4a 및 도4b에 도시된 바와 같이, 샤프트(5)는 암형 테이퍼(7)를 갖고 상기 전자 요소의 리세스(31)와 유사한 리세스(35)를 형성된다. 또한, 샤프트(5)는 해체 공구가 테이퍼(7)에 끼워지도록 설계된 스템 요소와 샤프트를 분리식으로 가압하도록 삽입될 수 있는 횡방향 구멍(36)을 구비한다.
또한, 도3a 및 도3b를 더욱 참조하면, 구멍(36)을 합체하는 전자 요소를 볼 수 있다. 이것은 건(tendon)이 부착될 그리고, 스티플 면에 클램핑될 잔류된 뼈가 없는 경우에, 연성 조직에 전자 요소를 봉합하기 위한 것이다.
상기 전자 요소는 좌, 우의 구조가 있기는 하지만 모듈형 시스템의 표준 요소로서 제공된다. 또한, 대퇴부 네크의 옵셋 각이 특정 환자마다 달라지는 상이한 전자 요소일 수 있다.
도4a 및 도4b에 도시된 바와 같이, 고려되는 테이퍼를 표준화시킬 수 있음에도 불구하고, 대퇴부 샤프트는 15mm의 간격의 길이로 공급될 수 있다. 또한, 대퇴부 샤프트에는 칼라(10)와 일체로 된 대응 이어(ear)(38)에 결합되도록 설계된 노치(37)가 제공된다. 도6에 도시된 바와 같이, 칼라(10)는 샤프트(5)의 일단부에서 대응 테이퍼(40)에 끼워지도록 구성된 내부 테이퍼(39)를 갖는다. 샤프트(5) 상에 칼라와 노치(37) 안의 이어(38)를 결합시킴으로써 칼라는 샤프트에 확실하게 고정된다. 도6에 도시된 것처럼, 상기 칼라는 D1 및 D2의 직경으로 공급된다.
도5는 스템(8) 요소의 다각도를 도시한다. 단면도에서 볼 수 있는 바와 같이, 상기 스템에는 피질층(cortical)의 뼈와 결합하기 위한 플루트(flute)가 형성되며 뼈의 도관의 임의의 곡률을 수용할 수 있도록 곡선 또는 직선일 수 있다. 샤프트의 선단부는 샤프트 요소의 내부 테이퍼(7)에 대응하는 테이퍼(42)를 갖는다. 또한, 상기 샤프트는 샤프트 요소의 리세스(35)에 대응되는 돌출부(43)를 구비한다. 상기 샤프트 요소(5)는 결합 해제를 위한 횡방향 구멍(36)을 구비하여, 이 구 멍을 통해 삽입된 공구는 스템과 샤프트가 다음 단부로 지탱되는 것을 분리식으로 가압한다. 도5에 도시된 바와 같이, 스템은 다양한 직경과 길이로 유용가능하고, 외과적인 문제에서 이러한 보철을 끼울 수 있도록 곡선 또는 직선일 수 있다.
도7은 도1 및 도2에 도시된 것처럼 모든 조립품들이 연장될 수 있는 모듈식 연장 샤프트를 도시한다. 모듈식 연장 샤프트(50)는 각각 모듈식 스템의 테이퍼와(42)와 모듈식 샤프트(42)의 테이퍼(7)에 대응되는 암/수형 테이퍼를 갖는다. 물론, 모듈식 연장 샤프트(50)는 표준 샤프트와의 결합 또는 전자 요소(1)로의 단독 연결 또는 스템(8)을 갖는 콘듈라(condular) 요소(21)와의 결합에 사용될 수 있다.
상세히 도시하진 않았지만, 도1 및 도2에 도시된 인공 보철은 완전한 대퇴부 교체 보철을 형성하기 위해 샤프트(8)와 칼라(10)를 생략한 채로 결합될 수 있다. 또한, 유사하게 형성된 요소들은 상박골과 같은 또 다른 긴 뼈를 교체하는데 사용될 수 있다.
상기와 같이, 보철의 요소들은 교정 작업 중 또는 시험 조립 후 각각 테이퍼 형성된 결합부에 있어 요소 내의 횡방향 벽에 삽입된 해체 공구를 사용함으로써 용이하게 분리할 수 있다.
사용되는 재료는 세라믹 헤드 또는 코발트 크로미늄이 우선적으로 사용되는 대퇴부 헤드를 제외하고는 티타늄 합금이 사용된다.

Claims (6)

  1. 인간 또는 동물의 긴 뼈를 일부 또는 전체적으로 교체하는 인공 보철이며,
    상기 인공 보철은 보철 연결부의 일 요소를 형성하는 말단부 또는 선단부와, 상기 선단부 또는 말단부 및 잘려진 뼈의 결합용 스템과 조립되는 샤프트를 포함하며,
    상기 샤프트, 스템, 선단부 및 말단부 요소는 암/수형 테이퍼에 의해 연결되며, 각각의 암형 테이퍼는 보철의 종방향으로 연장되나 축으로부터 옵셋되고 암형 테이퍼의 대응 리세스에 결합되는 돌출부를 갖고,
    해체 공구에 의해 수형 테이퍼의 단부 영역의 횡방향으로 접근하기 위해 구비된 교차 구멍을 더 포함하며,
    상기 돌출부는 인접한 요소의 소정 각도 관계를 유지하는 것을 특징으로 하는 인공 보철.
  2. 제1항에 있어서, 샤프트 또는 연장부에 조립되고, 뼈의 잘린 면에 접할 수 있는 치수를 가져 보철이 그 안에 고정되고 잘린 면을 향해 테이퍼 형성되도록 구성된 부분을 갖고 칼라의 테이퍼 형성 면에 위에 뼈의 성장을 촉진하도록 설계된 표면 처리부를 갖는 칼라를 포함하는 것을 특징으로 하는 인공 보철.
  3. 제2항에 있어서, 상기 칼라에는 외부 스티플 면이 형성되거나 또는 삼인산칼슘 또는 다른 종류의 뼈 성장 촉진 물질로 코팅된 것을 특징으로 하는 인공 보철.
  4. 상기 항 중 어느 한 항에 있어서, 대퇴부 교체 보철의 선단부이며, 샤프트 또는 스템에 조립된 전자 교체 요소를 구비하는 것을 특징으로 하는 인공 보철.
  5. 제4항에 있어서, 상기 전자 교체 요소는 해부학적 전자와 근접하게 대응되는 형상이며, 대퇴부 볼을 수용하기 위한 대퇴부 네크와, 연성조직 또는 잔류 뼈 연결용 대퇴부 네크에 대향한 일반적인 평평한 면을 구비하는 것을 특징으로 하는 인공 보철.
  6. 제5항에 있어서, 상기 일반적인 평평한 면은 잔류 뼈와의 결합을 위한 스티플들을 지지하는 것을 특징으로 하는 인공 보철.
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