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JP3007903B2 - 人工椎間板 - Google Patents

人工椎間板

Info

Publication number
JP3007903B2
JP3007903B2 JP3092699A JP9269991A JP3007903B2 JP 3007903 B2 JP3007903 B2 JP 3007903B2 JP 3092699 A JP3092699 A JP 3092699A JP 9269991 A JP9269991 A JP 9269991A JP 3007903 B2 JP3007903 B2 JP 3007903B2
Authority
JP
Japan
Prior art keywords
disc
pva
artificial
hydrogel
bone
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
JP3092699A
Other languages
English (en)
Other versions
JPH04303444A (ja
Inventor
正典 岡
義人 筏
丞烋 玄
英昭 興松
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Kyocera Corp
BMG Inc
Original Assignee
Kyocera Corp
BMG Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Kyocera Corp, BMG Inc filed Critical Kyocera Corp
Priority to JP3092699A priority Critical patent/JP3007903B2/ja
Priority to US07/692,202 priority patent/US5314478A/en
Priority to EP91303841A priority patent/EP0505634B1/en
Priority to DE69127354T priority patent/DE69127354T2/de
Publication of JPH04303444A publication Critical patent/JPH04303444A/ja
Priority to US08/189,603 priority patent/US5458643A/en
Application granted granted Critical
Publication of JP3007903B2 publication Critical patent/JP3007903B2/ja
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

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
    • A61F2/28—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
    • A61F2/30756—Cartilage endoprostheses
    • 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
    • A61F2/32—Joints for the hip
    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • A61F2/3601—Femoral heads ; Femoral endoprostheses for replacing only the epiphyseal or metaphyseal parts of the femur, e.g. endoprosthetic femoral heads or necks directly fixed to the natural femur by internal fixation devices
    • A61F2/3603—Femoral heads ; Femoral endoprostheses for replacing only the epiphyseal or metaphyseal parts of the femur, e.g. endoprosthetic femoral heads or necks directly fixed to the natural femur by internal fixation devices implanted without ablation of the whole natural femoral head
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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
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442—Intervertebral or spinal discs, e.g. resilient
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    • 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
    • A61L27/14—Macromolecular materials
    • A61L27/16—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
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    • 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
    • A61L27/52—Hydrogels or hydrocolloids
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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
    • A61F2/02—Prostheses implantable into the body
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    • A61F2002/30125—Rounded shapes, e.g. with rounded corners elliptical or oval
    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/3011—Cross-sections or two-dimensional shapes
    • A61F2002/30112—Rounded shapes, e.g. with rounded corners
    • A61F2002/30133—Rounded shapes, e.g. with rounded corners kidney-shaped or bean-shaped
    • 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
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    • A61F2002/30108—Shapes
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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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    • A61F2002/30108—Shapes
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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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    • A61F2/00—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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    • 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
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0008—Rounded shapes, e.g. with rounded corners elliptical or oval
    • 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
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0015—Kidney-shaped, e.g. bean-shaped
    • 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
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes
    • A61F2230/0019—Angular shapes rectangular
    • 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
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes
    • A61F2230/0021—Angular shapes square
    • 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
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes
    • A61F2230/0023—Angular shapes triangular
    • 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
    • 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
    • A61F2230/0069—Three-dimensional shapes cylindrical
    • 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
    • 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
    • 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
    • A61F2310/00179—Ceramics or ceramic-like structures
    • A61F2310/00185—Ceramics or ceramic-like structures based on metal oxides
    • A61F2310/00203—Ceramics or ceramic-like structures based on metal oxides containing alumina or aluminium oxide

Landscapes

  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Chemical & Material Sciences (AREA)
  • Cardiology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Neurology (AREA)
  • Dermatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Rheumatology (AREA)
  • Dispersion Chemistry (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (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
等の医療分野において使用される部材であって、椎間板
ヘルニア等の疾患、あるいは交通事故、災害等によって
高度な障害が生じた脊椎の椎間板の形態的、機能的修復
を可能とする人工椎間板に関するものである。
【０００２】
【従来の技術】椎間板は、個々の椎体の間に介在し、２
個の椎体とその間に介在する椎間板により、脊椎におけ
る一つの運動分節・機能的単位を構成しており、交互状
に配列するコラーゲン線維束を持つ線維軟骨より成る髄
核の外周をとりまく強靱な線維輪、内部にあって水を結
合したグリコサミノグリカンに富むコロイド性のゲルよ
り成る椎間板の緊張状態を保持する役割を果たす液状の
軟らかい髄核、及び硝子軟骨より成り椎体とこれらの構
成要素を分離させている軟骨終板から構成されている。
【０００３】日常生活においては、椎間板は通常圧縮、
曲げ、ねじりの組合せとして複雑に負荷を受け、脊椎の
屈曲、伸展そして側屈では、主として引張り及び圧縮応
力を生じ、一方回旋では剪断応力を生ずる。この際椎間
板内の髄核は、正常であれば、負荷を受けている間圧力
は均等に分布し、静水圧的に作用する。それゆえ椎間板
は、運動分節で静水圧的機能を備えており、椎体間でク
ッションとして作用し、エネルギーをたくわえ、負荷を
分散させるという負荷の緩衝作用に重要な役割を担って
いる他、靱帯とともに内的安定性にも大きく関与してい
る。
【０００４】このように機能的に重要な役割を持つ椎間
板において、椎間板ヘルニア等の障害が生じた患者に対
する現在の治療法としては、変性椎間板を摘出した後、
自家移植骨、骨セメントまたは人工椎体スペーサーを用
いた椎体間固定が主に行なわれている。
【０００５】しかしながら、自家移植骨を初め、これま
でに椎体間固定に使用されてきたステンレス鋼、アルミ
ナセラミック及びハイドロキシアパタイト製の人工椎体
スペーサー、またはポリメチルメタクリレート製骨セメ
ント、あるいはそれらの併用であっても、いずれの場合
も本来の椎間板が有する力学的特性を無視し椎体間の固
定のみを目的としており、患部椎間板が本来担っていた
柔軟性、負荷緩衝作用が犠牲になるため、特に上下隣接
椎間板に対し、生体力学的に何らかの悪影響が生じ、二
次的な隣接椎間板障害が生じる場合が多かった。
【０００６】これら実際に広く施行されている技術以外
のその他の従来技術としては、上下椎体との固定性、骨
に近い弾性率に着目した金属メッシュ単体の「人工椎体
スペーサ」（特開昭６４─７６８５１）、椎間板の運動
性を重視した「頸椎用人工椎間板」（特開昭６３─１６
４９４８）、椎間板の力学的特性の代替を目指した「人
工椎体」（特開昭６３─３００７５８）、「人工椎間板
カプセル及びその埋め込み方法」（特開昭６４─７００
４１）、「椎間円板プロテーゼ」（特開平２─２１５４
６１）等がある。
【０００７】
【従来技術の課題】これまでに考案されてきた各種人工
椎間板は、あくまで自家移植骨の代替としての人工椎体
スペーサーに過ぎず、椎間板本来の力学的特性は犠牲に
されていたり、運動性を重視しすぎて内的安定性が十分
でなかったりする。また、椎間板の力学的特性の代替を
目指し、主に内部に柔軟性を有する高分子材料を用い、
外部の骨と接する部分をセラミック粉粒体、不活性線維
等のより硬質な材料で構成した複合体の場合であって
も、生体椎間板の柔軟性、負荷緩衝作用を十分代行でき
ない、骨との結合、固定性が十分でない、複合体自体の
機械的接合強度が十分でない等、人工椎間板としての総
合的な役割を同時に満足できるものではなかった。
【０００８】
【課題を解決するための手段】上述課題を解決するた
め、本発明は金属製、あるいはセラミック製の多孔体の
間にポリビニールアルコールハイドロゲルから成るブロ
ック体が介在している構造を有することを特徴とする人
工椎間板を提供する。
【０００９】
【実施例】以下、図を用いて本発明の実施例を具体的に
説明する。重合度11,000、ケン化度99.9モル％のＰＶＡ
を５重量％の濃度になるよう、ジメチルスルホキシド
（ＤＭＳＯ）／水の混合溶媒（８／２重量比）に加え、
135℃で７時間、エチレングリコールの入った恒温油槽
中で電気攪拌器で攪拌しながら溶解してＰＶＡ溶液を調
製した。
【００１０】この場合用いるＰＶＡとしては、ケン化度
が95モル％以上、好ましくは97モル％以上、特に99モル
％以上のものが望ましい。これより低いケン化度のもの
はゲルの強度が軟弱になる傾向がある。平均重合度は粘
度平均で1700以上、特に5000以上のものが好ましく、そ
れ以下ではＰＶＡの重合度が低下するとともに得られる
ゲルの強度も低下する。また、低分子量ＰＶＡの溶出を
防止するためには、出発原料ＰＶＡを分子量分別して用
いるとよい。
【００１１】ＰＶＡ溶液を得るための溶媒としては、水
だけを用いてもよいが、水と親和性のある有機溶媒との
混合溶媒を用いるのが好ましく、水と親和性のある有機
溶媒としては、ジメチルスルホキシド（ＤＭＳＯ）、エ
チレングリコール（ＥＧ）、グリセリン（ＧＣ）、プロ
ピレンアルコール（ＰＯＨ）、エチレンアルコール（Ｅ
ＯＨ）、 1.3- ジメチル-2- イミダゾリジノン（ＤＭ
Ｉ）などを挙げることができる。また、これら溶媒は二
種以上の混合物であってもよい。本発明においては、上
記有機溶媒のなかでも特にＰＶＡに対する溶解性や水と
の混合割合と凝固点降下の関係などからＤＭＳＯを使用
するのが好ましい。
【００１２】上記有機溶媒と水との混合割合は任意であ
り、通常は水と有機溶媒との混合比は５：95〜95：５の
範囲で用いる。濃度は目的とする強度や含水率に応じて
２〜30重量％の範囲にするのが好ましい。このような調
製は一般にＰＶＡを加熱溶解させることにより行われる
が、単に攪拌下での加熱でもよいし、あるいはオートク
レーブや電子レンジを使用して溶解させてもよい。
【００１３】次に、あらかじめ作製した20×20×８mmの
直方体純チタン製ファイバーメッシュ（気孔率約50％）
各２個計４個の内各１個を、同様にあらかじめ作製して
おいた金属製金型の底に設置し、調製したＰＶＡ溶液を
注入し、その上から残りの各１個の純チタン製ファイバ
ーメッシュを被せ、プレス成形機にて圧迫後、直ちに瞬
間冷却スプレーを用いてＰＶＡ溶液の温度を下げ、上下
ファイバーメッシュ孔内の目的とする部分にだけＰＶＡ
を含浸させた。この場合、目的とする部分にだけＰＶＡ
ハイドロゲルを含浸、固定化させるため、予めシアノア
クリレートやゼラチンにより生体組織の増殖、侵入によ
る生物学的固定を望む部位に充填し、固化後にＰＶＡ溶
液を含浸させることもできる。
【００１４】その後、−20℃のフリーザーに入れて一昼
夜放置することにより、ＰＶＡ溶液をゲル化されて、上
下の純チタン製ファイバーメッシュに対しＰＶＡハイロ
ゲルを固定化させＰＶＡハイドロゲルのブロック体を得
た。その場合、温度が低ければ低いほど短時間でゲル化
が完了するので、−10℃以下、特に−20℃以下のフリー
ザーを使用した。
【００１５】次に、溶媒として用いたＤＭＳＯを除去す
るため、純チタン製ファイバーメッシュ／ＰＶＡハイド
ロゲルブロック体複合体２個をエチルアルコール中に浸
漬し、加熱化で攪拌しながら約１週間洗浄した。これを
室温で風乾後、さらに真空乾燥機にて約３日間乾燥し、
その後、この乾燥させた複合体に対し、温度140 ℃のシ
リコーンオイル中に入れて３時間熱処理を施した。この
熱処理は空気中でもよいが、酸化分解を防止するため、
真空中、窒素気流中あるいはシリコーンオイルなどの油
中にて行うのが好ましく、また、熱処理温度としてはＰ
ＶＡの結晶化が促進できる100 ℃以上であればよいが、
特に100 ℃〜180 ℃の温度範囲が好ましい。また、熱処
理時間は温度により異なり、通常1 時間〜72時間程度で
充分であるが、さらに長くしてもよい。
【００１６】こうして、最後に水中に浸漬して純チタン
製ファイバーメッシュとＰＶＡハイドロゲルから成るブ
ロック体から構成される図１と同形状の人工椎間板２個
を得た。図１、及び図2 はそれぞれ本発明による人工椎
間板の模式図を示す。図中、1,11 はそれぞれ人工椎間
板の上下に位置する純チタン製ファイバーメッシュであ
り、2 はＰＶＡハイドロゲルのブロック体、3 ,33 は純
チタン製ファイバーメッシュへのＰＶＡハイドロゲルの
侵入部分、4 ,44 は不侵入部分である。純チタン製ファ
イバーメッシュ 1 ,11は、ＰＶＡハイドロゲルから成る
ブロック体22がその一部又は大部分に侵入した状態で強
固に接合固定されている。この場合、その接合をより強
固なものとするため、ＰＶＡハイドロゲルが侵入する3,
33 の端部にアンカリング効果を持たせるためのカラー
又は凸部を設けても良い。
【００１７】また図2 (a) の人工椎間板のように、ＰＶ
Ａハイドロゲルから成るブロック体22が左右または前後
方向に突出した翼部分を有することにより、上下隣接椎
体の終板との接触面積を大きくし、本来の椎間板により
近い負荷の分散が可能となる。さらにそれが終板の解剖
学的断面形状に近い方が望ましく、設置した際の人工椎
間板の内的安定性を高めることがてきる。また、本発明
の人工椎間板の形状は直方体に限られるわけではなく、
図２の(b) 、(c) 、(d) 、及び(e) の本発明の人工椎間
板の模式図に示すように三角柱状、楕円柱状、不規則形
状のもの、あるいは円柱状のものなどそれぞれ設置場所
の形状に適合したものが用いられる。尚、上記純チタン
製ファイバーメッシュ1,11の部分には生体骨と適合製の
良いセラミック製の多孔体または、他金属のメッシュ、
あるいは金属製ビーズなどの金属製の多孔体を使用して
も良い。この場合、本発明に用いるセラミックの多孔体
としては、アルミナ、ジルコニア、ハイドロキシアパタ
イトあるいは結晶化ガラスセラミックス製のものなど
を、また金属製の多孔体としてはチタン基合金、コバル
ト・クロム合金、ステンレス等の生体親和性を有する金
属から成るものを使用することができる。加えて、前記
純チタン製ファイバーメッシュ1,11の部分は上記のよう
なセラミック製の多孔体と金属製の多孔体の組合せであ
ってもよい。その有孔率はいずれにしても20〜90％の範
囲であることが望ましい。本発明実施例では２つの多孔
体を前述ブロック体の上下に有するものが使われている
が、例えば前後左右等にストッパーとしての多孔体が上
記ブロック体に合体させてあっても良く本発明の人工椎
間板が有する多孔体は２つに限られるわけではない。
【００１８】また、最終的に水を含浸させて製造される
多孔体／ＰＶＡハイドロゲルブロック体複合体のＰＶＡ
ハイドロゲルの含水率はその熱処理条件により10〜60重
量％と大幅に変えられ、目的とする力学的特性にあった
ものが調製できるが、この人工椎間板を37℃の水中にて
1 週間浸漬して平衡状態となったもののＰＶＡハイドロ
ゲルから成るブロック体の飽和含水率を測定したとこ
ろ、約14重量％であった。
【００１９】図3 は図2(a) と同形状の本発明の人工椎
間板を実際に装着した状態を示す。この場合、純チタン
製ファイバーメッシュ 1 ,11のＰＶＡハイドロゲルの未
含浸領域4 ,44 は、上下の椎体5 ,55 の骨と直接接し、
骨組織の多孔内部への骨の増成、侵入による生物学的な
固定が達成される。
【００２０】次に、上述の方法で作成される本発明の人
工椎間板の特性を調べる幾つかの実験を行った。
【００２１】実験1 上述の人工椎間板の作成方法を用いて４重量％のＰＶＡ
溶液を調製し、図4 のφ６×３mmの円柱状のＰＶＡハイ
ドロゲル６を作製したところ、その含水率は約16重量％
であった。図4 (a) に示す如く、これとφ６×６mmの円
柱状の純チタン製ファイバーメッシュ７（気孔率約50
％）及び豚膝関節より採取した海面骨をφ６×３mmに成
形した海面骨部８を上記ＰＶＡハイドロゲルのブロック
体６に積層したＰＶＡハイドロゲルモデルと、図4(b)に
示す如く超高分子量ポリエチレン９（φ６×５mm）、ポ
リメチルメタクリレート製の骨セメント１０（φ６×４
mm）及び海綿骨部８（φ６×３mm）を積層した超高分子
量ポリエチレンモデルの各試料を作製した。
【００２２】この試料に対し、生理食塩水中にて重さ2.
7 kgのおもりを50mmの高さから落下させて、各試料を経
て伝わる応力を試料下面に設置したロードセルを介して
経時的に測定した。その結果を図5 に示す。この曲線図
から、ＰＶＡハイドロゲルモデルの方が衝撃負荷がより
長時間に低く伝達され、負荷緩衝作用に優れていること
が認められた。
【００２３】実験２ 次に、実験1 と同様に４重量％のＰＶＡ溶液を調製後、
気孔率50％と70％のφ８×20mmの円柱状の純チタン製フ
ァイバーメッシュを各２個計４個に対し、あらかじめ長
さ約半分の部分にシアノアクリレートを含浸、固化させ
た後、注射用シリンジを用いてＰＶＡ溶液を圧迫、含浸
させた。その後の処理は、あらかじめ含浸、固化させた
シアノアクリレートを除去するため、エチルアルコール
洗浄の前にアセトン中での加熱、洗浄を追加した以外
は、実験１と同様に純チタン製ファイバーメッシュ／Ｐ
ＶＡハイドロゲルブロック体複合体を作製した。そのＰ
ＶＡハイドロゲルから成るブロック体の含水率は、実施
例２と同様約16重量％であった。
【００２４】この複合体のＰＶＡハイドロゲルのブロッ
ク体を約φ５〜６mmの大きさにトリミングし、島津製作
所製オートグラフ万能試験機を用いて剪断力を測定し
た。その結果を表１に示す。
【００２５】
【表１】
【００２６】気孔率50％の複合体で平均1.5MPa、70％の
もので平均2.0MPaの剪断応力が得られ、気孔率の高い方
が高い剪断応力を示した。人の胸椎及び腰椎にかかる剪
断力が最大で150Nと報告されているのであるから、実施
例１の複合体で純チタン製ファイバーメッシュとＰＶＡ
ハイドロゲルの接合面積（20×20＝400 mm2 )では、少
なくとも0.375MPaの最大剪断応力が作用すると考えられ
るが、本実施例の複合体はいずれもこの値を大きく上回
っていることが明らかとなった。したがって、本発明の
人工椎間板が、ＰＶＡハイドロゲルから成るブロック体
2 を挟むように位置する上下のセラミック製、あるいは
金属製の多孔体の孔内の一部あるいは大部分をＰＶＡハ
イドロゲル自体で含浸、固定化させることにより、両者
間の接合を強固にさせることが証明された。
【００２７】実験3 前述の本発明による人工椎間板の作成方法を用いて4 重
量％のＰＶＡ溶液を調整後、気孔率70％のφ5 x 10mmの
円柱状純チタン製ファイバーメッシュを用いて、純チタ
ン製ファイバーメッシュ／ＰＶＡハイドロゲルブロック
体複合体（含水率は約16重量％) を作成し、雑種犬の大
腿骨膝蓋窩に埋入後、経時的に屠殺して組織学的に検索
した。
【００２８】術後2 週で、組織学的には未熟な瘢痕組織
を生じ、一部では少数の炎症細胞が見受けられたがその
浸潤の程度は軽度であった。4 週後には試料周辺の炎症
反応は消退し瘢痕組織の成熟とともに純チタン製ファイ
バーメッシュ多孔内への新生骨侵入が認められた。その
後新生骨梁は経時的に成熟し、8 週後では、複合体は母
床にしっかりと固定されていた。したがって、人工椎間
板の上下端部に存在する多孔体のＰＶＡハイドロゲルの
不侵入部分への生体組織の増殖により生体組織との固定
を達成させ、長期にわたる力学的安定性と生体適合性に
優れたものとなることが証明された。
【００２９】最後に、気孔率70％のφ5 x 10mmのアルミ
ナから成る多孔体を用いて、実験３と同様な実験を行っ
た。その結果は上記実験の結果と同様にいたって良好で
あった。
【００３０】
【発明の効果】本発明の人工椎間板は、生体の椎間板の
持つ優れた力学的性質、即ち柔軟性、負荷緩衝作用に類
似した特性を有すると同時に生体骨との強固な結合、固
定が得られ、しかも実用に耐えうる複合体接合強度を有
している。従って脊柱の重要な構成要素である椎間板と
して用いることができることによって、生体本来の優れ
た椎間板機能を代行することとなり、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】本発明実施例において作成された人工椎間板の
模式図である。
【図２】(a) 〜(e) は、それぞれ本発明実施例の人工椎
間板の模式図である。
【図３】本発明の人工椎間板を人体内で装着した状態を
示す図である。
【図４】(a) は本発明実施例によるＰＶＡハイドロゲル
モデル、（b)は同超高分子量ポリエチレンモデルの各模
式図である。
【図５】本発明実施例の実験１における応力の経時変化
を示す曲線図である。る。
【符号の説明】
純チタン製ファイバーメッシュ 1, 11; 6 ブロック体 2, 22; 7 侵入部分 3, 33 不侵入部分 4, 44 椎体 5, 55 海面骨部 8 超高分子量ポリエチレン 9 骨セメント 10
フロントページの続き 審査官 中田 とし子 (58)調査した分野(Int.Cl.7，ＤＢ名) A61F 2/44 A61L 27/00

Claims (1)

    (57)【特許請求の範囲】
  1. 【請求項１】 金属製、あるいはセラミック製の多孔体
    の間にポリビニールアルコールハイドロゲルから成るブ
    ロック体を合体して成る人工椎間板。
JP3092699A 1991-03-29 1991-03-29 人工椎間板 Expired - Fee Related JP3007903B2 (ja)

Priority Applications (5)

Application Number Priority Date Filing Date Title
JP3092699A JP3007903B2 (ja) 1991-03-29 1991-03-29 人工椎間板
US07/692,202 US5314478A (en) 1991-03-29 1991-04-26 Artificial bone connection prosthesis
EP91303841A EP0505634B1 (en) 1991-03-29 1991-04-26 A prosthesis
DE69127354T DE69127354T2 (de) 1991-03-29 1991-04-26 Prothese
US08/189,603 US5458643A (en) 1991-03-29 1994-02-01 Artificial intervertebral disc

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP3092699A JP3007903B2 (ja) 1991-03-29 1991-03-29 人工椎間板

Publications (2)

Publication Number Publication Date
JPH04303444A JPH04303444A (ja) 1992-10-27
JP3007903B2 true JP3007903B2 (ja) 2000-02-14

Family

ID=14061745

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Application Number Title Priority Date Filing Date
JP3092699A Expired - Fee Related JP3007903B2 (ja) 1991-03-29 1991-03-29 人工椎間板

Country Status (4)

Country Link
US (2) US5314478A (ja)
EP (1) EP0505634B1 (ja)
JP (1) JP3007903B2 (ja)
DE (1) DE69127354T2 (ja)

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