JPH04303444A - 人工椎間板 - Google Patents

人工椎間板

Info

Publication number
JPH04303444A
JPH04303444A JP3092699A JP9269991A JPH04303444A JP H04303444 A JPH04303444 A JP H04303444A JP 3092699 A JP3092699 A JP 3092699A JP 9269991 A JP9269991 A JP 9269991A JP H04303444 A JPH04303444 A JP H04303444A
Authority
JP
Japan
Prior art keywords
pva
intervertebral disc
pure titanium
pva solution
hydrogel
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.)
Granted
Application number
JP3092699A
Other languages
English (en)
Other versions
JP3007903B2 (ja
Inventor
Masanori Oka
正典 岡
Yoshito Ikada
義人 筏
Jiyoukiyuu Gen
丞烋 玄
Hideaki Okimatsu
興松　英昭
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.)
BIOMATERIAL UNIVERSE KK
Kyocera Corp
Original Assignee
BIOMATERIAL UNIVERSE KK
Kyocera Corp
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 BIOMATERIAL UNIVERSE KK, Kyocera Corp filed Critical BIOMATERIAL UNIVERSE KK
Priority to JP3092699A priority Critical patent/JP3007903B2/ja
Priority to EP91303841A priority patent/EP0505634B1/en
Priority to DE69127354T priority patent/DE69127354T2/de
Priority to US07/692,202 priority patent/US5314478A/en
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
    • 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
    • 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
    • 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
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442—Intervertebral or spinal discs, e.g. resilient
    • 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
    • A61L27/14—Macromolecular materials
    • A61L27/16—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • A61L27/52—Hydrogels or hydrocolloids
    • 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
    • A61F2/02—Prostheses implantable into the body
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    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30965—Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
    • 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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    • A61F2002/30112—Rounded shapes, e.g. with rounded corners
    • A61F2002/30113—Rounded shapes, e.g. with rounded corners circular
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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
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    • A61F2002/30125—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
    • 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
    • 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
    • A61F2002/3011—Cross-sections or two-dimensional shapes
    • A61F2002/30138—Convex polygonal shapes
    • A61F2002/30153—Convex polygonal shapes rectangular
    • 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
    • A61F2/02—Prostheses implantable into the body
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    • A61F2002/30108—Shapes
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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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    • 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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    • 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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    • A61F2/00—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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    • A61F2/00—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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    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30563—Special structural features of bone or joint prostheses not otherwise provided for having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
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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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    • 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
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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
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    • 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
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    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
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    • 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
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    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
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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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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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
    • 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
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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
    • A61F2310/00179—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

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Abstract

(57)【要約】本公報は電子出願前の出願データであるた
め要約のデータは記録されません。

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ＰＶ
Ａ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９
９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（ＤＭＩ）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ＤＭＳ
Ｏ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２０×２０×８
ｍｍ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ＰＶ
Ａ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ＰＶＡ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、Ｐ
ＶＡ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
、ＰＶＡ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１，１
１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１０〜６
０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φ
６×６ｍｍ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（φ６×４ｍｍ）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／ＰＶＡハイドロゲルブロック体複合体を作製した
。そのＰＶＡ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０．３７５
ＭＰａ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　１０ｍ
ｍ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】

Claims (1)

    【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
EP91303841A EP0505634B1 (en) 1991-03-29 1991-04-26 A prosthesis
DE69127354T DE69127354T2 (de) 1991-03-29 1991-04-26 Prothese
US07/692,202 US5314478A (en) 1991-03-29 1991-04-26 Artificial bone connection prosthesis
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 true JPH04303444A (ja) 1992-10-27
JP3007903B2 JP3007903B2 (ja) 2000-02-14

Family

ID=14061745

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Application Number Title Priority Date Filing Date
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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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