JP3012095B2 - 多孔質生体補綴部材とそれに弾性付与するための処理方法 - Google Patents

多孔質生体補綴部材とそれに弾性付与するための処理方法

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Publication number
JP3012095B2
JP3012095B2 JP4270371A JP27037192A JP3012095B2 JP 3012095 B2 JP3012095 B2 JP 3012095B2 JP 4270371 A JP4270371 A JP 4270371A JP 27037192 A JP27037192 A JP 27037192A JP 3012095 B2 JP3012095 B2 JP 3012095B2
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Prior art keywords
porous
compressive
stress
compression
elasticity
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JP4270371A
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JPH06121827A (ja
Inventor
英昭 興松
保典 田村
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Kyocera Corp
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Kyocera Corp
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Priority to JP4270371A priority Critical patent/JP3012095B2/ja
Priority to DE69328226T priority patent/DE69328226T2/de
Priority to US08/133,655 priority patent/US5437834A/en
Priority to EP93116261A priority patent/EP0591976B1/en
Publication of JPH06121827A publication Critical patent/JPH06121827A/ja
Priority to US08/426,035 priority patent/US5492768A/en
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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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02—Inorganic materials
    • A61L31/022—Metals or alloys
    • 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
    • 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
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30965—Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
    • 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
    • A61L27/02—Inorganic materials
    • A61L27/04—Metals or alloys
    • 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
    • A61L27/02—Inorganic materials
    • A61L27/04—Metals or alloys
    • A61L27/06—Titanium or titanium alloys
    • 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
    • A61L27/56—Porous materials, e.g. foams or sponges
    • 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/146—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
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30907—Nets or sleeves applied to surface of prostheses or in cement
    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A61F2002/30261—Three-dimensional shapes parallelepipedal
    • A61F2002/30263—Three-dimensional shapes parallelepipedal cubical
    • 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
    • A61F2/3094—Designing or manufacturing processes
    • A61F2002/30968—Sintering
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0082—Three-dimensional shapes parallelepipedal
    • A61F2230/0084—Three-dimensional shapes parallelepipedal cubical
    • 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
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/12—All metal or with adjacent metals
    • Y10T428/12014—All metal or with adjacent metals having metal particles
    • Y10T428/12028—Composite; i.e., plural, adjacent, spatially distinct metal components [e.g., layers, etc.]
    • Y10T428/12035—Fiber, asbestos, or cellulose in or next to particulate component

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Transplantation (AREA)
  • Epidemiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medicinal Chemistry (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Surgery (AREA)
  • Dispersion Chemistry (AREA)
  • Manufacturing & Machinery (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)
  • Dental Prosthetics (AREA)

Description

【発明の詳細な説明】
【０００１】
【産業上の利用分野】本発明は、整形外科、脳神経外
科、口腔外科、歯科等の医療分野において使用される多
孔質生体補綴部材及びそれに弾性付与するための処理方
法に関するものである。
【０００２】
【従来の技術】従来、骨に近い圧縮弾性率を有する多孔
質の生体補綴部材として、特開昭６３１０９８６７号公
報に記載される多孔質補綴部材の如く、金属線材を圧
縮、集積する圧縮成形後に真空焼結して作製される多孔
質生体補綴部材があった。このような多孔質生体補綴部
材は骨に近い弾性率を有し、ある期間後、骨の表面と直
接接する多孔質表面における骨の内方成長による骨との
生物学的固定が達成されるとともに、ポリメチルメタク
リレート製骨セメント等の骨接合剤と共に移植された場
合は、この骨接合剤が多孔質内へ侵入することによって
骨との機械的な固定が得られものであった。
【０００３】
【発明が解決しようとする課題】上述のような多孔質生
体補綴部材は、それ以前の生体補綴部材に比べ圧縮弾性
率、強度の面での改善が認められたものの、これを生体
内の脊椎、股関節等の高圧縮荷重部位で使用した場合、
圧縮応力除荷後の歪みの発生、すなわち永久塑性変形が
発生していた。
【０００４】これは、上記の多孔質生体補綴部材が、一
般に信じられているように圧縮降伏応力以下の圧縮荷重
下で弾性を示すものではなく、実際には粘弾性に近い挙
動を示すものであって、ある大きさ以上の圧縮応力を付
与した後それを除荷しても、歪みが残ってしまうためで
ある。
【０００５】そして、上記の多孔質生体補綴部材を生体
内に移植した後この変形が生じた場合、骨の多孔質内へ
の内方成長による生物学的固定が崩壊し、生体補綴部材
の「ゆるみ」が発生し、多孔質生体補綴部材の脱落等、
重大な問題を引き起こすことがあった。
【０００６】本発明の目的は、上記従来技術の問題点を
解決すべく、骨に近い圧縮弾性率を保持したまま、その
永久変形の発生を防止するべく圧縮降伏応力以下の荷重
に対してほぼ完全な弾性を有した多孔質生体補綴部材と
該多孔質生体補綴部材にほぼ完全な弾性を付与するため
の処理方法を提供することである。
【０００７】
【課題を解決するための手段】上記課題を解決するた
め、本発明においては金属線材を所望形状に圧縮成形し
た集積体に圧縮応力を付与し、これを多孔質生体補綴部
材とする。このような処理を受けてなる多孔質生体補綴
部材の圧縮降伏応力は上記の圧縮応力とほぼ等しくな
り、さらにこの圧縮降伏応力以下の圧縮応力に対して
は、永久変形率0.1 ％以下のほぼ完全な弾性を示すよう
になる。したがって、人の腰椎等の高圧縮荷重部位に使
用しても、永久変形がほとんど発生しない。また、上記
圧縮応力の大きさとしては本発明の多孔質補綴部材が受
ける最大圧縮応力以下であれば良く、上記圧縮応力が小
さいほどその圧縮弾性率が小さくなる。
【０００８】また本発明の多孔質生体補綴部材は、上記
圧縮応力を0.4 MP以下とすることで圧縮弾性率を2100MP
a 以下とすることができる。ただし、上記圧縮応力が0.
04より小さい時は、圧縮降伏応力が小さくなりすぎて生
体内のいかなる部位に用いても実用性がない。
【０００９】例えばチタン単体及びアルミナセラミック
の弾性率、110000MPa 及び390000MPa に比し、本発明の
多孔質生体補綴部材はその圧縮弾性率は2100MPa 以下と
著しく低く、人の海綿骨の圧縮弾性率、60〜130MPa に
比較的近いことから、生体内に移植された際、骨への応
力の伝達が良く、多孔質に対する骨の内方成長に有利に
働くとともに、高圧縮弾性率を有する生体補綴材でみら
れるような応力遮断により惹起される生体補綴部材周囲
の骨吸収が発生することがない。
【００１０】
【実施例】以下、本発明の実施例を図を用いて説明す
る。
【００１１】(実施例１)線径 250μｍのチタン線材を金
網状に編み上げた後、丸めて15×15mmの正方形断面を有
する金型に充填し、約1.5 MPa の圧力で加圧成形した。
これを約1300℃で真空焼結することにより、図１に示す
ような気孔率約50％の立方体の集積体１を得た。
【００１２】これらの集積体１にそれぞれ0.2 MPa 、0.
4 MPa の圧縮応力を付与し、本発明の多孔質生体補綴部
材を構成する試験体を得た。
【００１３】次に、これらの試験体を用いそれぞれの永
久変形率を測定し、さらに、これらの試験体を用いそれ
ぞれの圧縮弾性率を測定した。その結果を表１に示す。
【００１４】
【表１】
【００１５】また、比較例として上記の立方体の集積体
１を作製し、真空焼結後の上記圧縮応力の付与を行わ
ず、比較例の試験体を得た。この試験体を用いて測定し
た圧縮弾性率を表１に示す。
【００１６】表１から明らかなように、比較例の試験体
では永久変形率が1 ％近くもあるのに対し本発明を構成
する試験体は永久変形率が0.1 ％以下で、さらに圧縮弾
性率はＭＰａ２１００以下であった。
【００１７】（実施例２）実施例１の方法で集積体１を
作製し、これを金型加圧方向と垂直方向に表２に示す圧
縮応力を加えてこれを試験体となし、さらにこれらの試
験体に再度圧縮応力を加えて、各試験体の(a) 圧縮降伏
応力、及び該圧縮降伏応力以下の圧縮応力下での(b) 圧
縮弾性率、(c) 除荷後の永久変形率（図２参照）を測定
した。その結果を表２に示す。
【００１８】
【表２】
【００１９】表２から明らかなように、圧縮降伏応力は
集積体１に付与した圧縮応力にほぼ等しく、除荷後の永
久変形率は１％以下となり、さらに0.4 MPa までの範囲
内で圧縮応力を付与するのであれば、圧縮弾性率は2100
MPa以下に保つことが可能であった。また、金型加圧方
向と同じ方向に段階的圧縮荷重を加えた場合でも、同様
の結果が得られた。
【００２０】なお、上記圧縮応力の付与は真空焼結の工
程で同時に行ってもよいが、装置が大がかりになる等の
設備面の問題がある。
【００２１】
【効果】本発明においては、金属線材を所望形状に圧縮
成形した集積体に圧縮応力を付与して多孔質生体補綴部
材を得る。このような処理を受けてなる多孔質補綴部材
の圧縮降伏応力は上記の圧縮応力とほぼ等しくなり、さ
らにこの圧縮降伏応力以下の圧縮応力に対しては、永久
変形率0.1 ％以下のほぼ完全な弾性を示すようになるた
め、人の腰椎等の高圧縮荷重部位で使用しても永久変形
がほとんど発生しない。また、上記圧縮応力を0.4 MP以
下とすることで圧縮弾性率を2000MPa 以下とすることが
でき、生体内に移植された際、骨への応力の伝達が良
く、孔内への骨の内方成長に有利に働くとともに、高弾
性率を有する生体補綴材でみられるような応力遮断によ
り惹起される補綴物周囲の骨吸収が発生することがな
い。
【００２２】さらに、以上のようにな効果が、上述のよ
うに圧縮応力の付与という簡便な方法で達成されるた
め、生体補綴部材として臨床上極めて有効であり、人類
福祉に寄与するところ大である。
【図面の簡単な説明】
【図１】実施例１に説明される集積体の斜視図である。
【図２】圧縮応力と歪みの関係を現すグラフである。
【符号の説明】
１ 集積体

Claims (2)

    (57)【特許請求の範囲】
  1. 【請求項１】 金属線材を所望形状に圧縮成形した集積
    体からなる多孔質生体補綴部材であって、圧縮弾性率が
    2000MPa 以下で、圧縮降伏応力以下の応力下で生ずる永
    久変形が0.1 ％以下であることを特徴とする多孔質生体
    補綴部材。
  2. 【請求項２】 金属線材を所望形状に圧縮成形した集積
    体を真空中での焼結時；もしくは焼結完了後に、0.04〜
    0.4 MPの圧縮荷重でもって圧縮応力を付与する工程を含
    む多孔質生体補綴部材に弾性付与するための処理方法。
JP4270371A 1992-10-08 1992-10-08 多孔質生体補綴部材とそれに弾性付与するための処理方法 Expired - Fee Related JP3012095B2 (ja)

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JP4270371A JP3012095B2 (ja) 1992-10-08 1992-10-08 多孔質生体補綴部材とそれに弾性付与するための処理方法
DE69328226T DE69328226T2 (de) 1992-10-08 1993-10-07 Poröses Reparaturteil für einen lebenden Körper und Verfahren zum Elastischmachen desselben
US08/133,655 US5437834A (en) 1992-10-08 1993-10-07 Porous living body repairing member, and a method of imparting elasticity to it
EP93116261A EP0591976B1 (en) 1992-10-08 1993-10-07 Porous living body repairing member, and a method of imparting elasticity to it
US08/426,035 US5492768A (en) 1992-10-08 1995-04-21 Porous living body repairing member, and a method of imparting elasticity to it

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US5492768A (en) 1996-02-20
DE69328226D1 (de) 2000-05-04
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DE69328226T2 (de) 2001-01-25
EP0591976B1 (en) 2000-03-29
US5437834A (en) 1995-08-01
EP0591976A1 (en) 1994-04-13

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