JP2771991B2 - 人工椎間板カプセル及びその埋め込み方法 - Google Patents

人工椎間板カプセル及びその埋め込み方法

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Publication number
JP2771991B2
JP2771991B2 JP63204922A JP20492288A JP2771991B2 JP 2771991 B2 JP2771991 B2 JP 2771991B2 JP 63204922 A JP63204922 A JP 63204922A JP 20492288 A JP20492288 A JP 20492288A JP 2771991 B2 JP2771991 B2 JP 2771991B2
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disc
artificial
artificial disc
nucleus pulposus
mantle
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JPS6470041A (en
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ディー．レイ チャールズ
ピー．コービン テリー
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レイメディカ，インコーポレイテッド
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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
    • 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
    • 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
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/441—Joints for the spine, e.g. vertebrae, spinal discs made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
    • 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
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4611—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of spinal prostheses
    • 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
    • A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L67/00—Compositions of polyesters obtained by reactions forming a carboxylic ester link in the main chain; Compositions of derivatives of such polymers
    • C08L67/04—Polyesters derived from hydroxycarboxylic acids, e.g. lactones
    • 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
    • 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
    • A61F2/44—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
    • 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
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
    • 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
    • A61F2002/30224—Three-dimensional shapes cylindrical
    • A61F2002/30235—Three-dimensional shapes cylindrical tubular, e.g. sleeves
    • 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
    • A61F2002/30667—Features concerning an interaction with the environment or a particular use of the prosthesis
    • A61F2002/30677—Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
    • 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
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2002/448—Joints for the spine, e.g. vertebrae, spinal discs comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
    • 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
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2002/4625—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use
    • A61F2002/4627—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • 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
    • 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
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/38—Materials or treatment for tissue regeneration for reconstruction of the spine, vertebrae or intervertebral discs
    • 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
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S128/00—Surgery
    • Y10S128/20—Inflatable splint
    • 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
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S424/00—Drug, bio-affecting and body treating compositions
    • Y10S424/07—Microporous membranes

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Transplantation (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Neurology (AREA)
  • Vascular Medicine (AREA)
  • Dermatology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Epidemiology (AREA)
  • Cardiology (AREA)
  • Composite Materials (AREA)
  • Polymers & Plastics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Materials Engineering (AREA)
  • Organic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Prostheses (AREA)
  • Medicinal Preparation (AREA)
  • Materials For Medical Uses (AREA)

Description

【発明の詳細な説明】 産業上の利用分野 本発明は人工の椎間板に関し、脊椎骨の脊髄、特に人
間の脊髄における悪化した椎間板を修復するための人工
椎間板に関する。
従来の技術 正常な椎間板は環（アニユラスanulus）と称される外
側靭帯リングを有している。この外側靭帯リングは隣接
の脊椎骨同志を互いに結合している。又、外側靭帯リン
グはコラーゲン繊維で構成されており、これらのコラー
ゲン繊維は脊椎骨に取り付いていると共に互いにクロス
されていて、脊椎骨が何れかの方向へ回転されると各個
の繊維の半分が緊張され、これによつてツイスト即ち捩
れの動きに対抗するようになされている。脊椎骨間の捩
れの動きは、更に又フアセツトジヨイントによつて制限
されるようになつている。
アニユラスの内側深くには弛緩組織で構成されている
髄核（nucleus pulposis）があり、これはツルツル且つ
又ヌルヌルしている（約85％の水分を含有している）と
共に、前後もしくは左右の曲げに際して動き回るように
なつている。従つて、曲げによつ脊椎骨の向かい合う表
面同志が互いの間の平行関係状態に変化を生じると、椎
間板の両端側の空間に生じる間隔変化（ウエツジング）
を埋め合わせるように髄核組織が動くのである。曲げに
より、アニユラスは下向きのウエツジの側では膨らみ、
上向きのウエツジの側では緊張される。
古典的な椎間板ヘルニアは、環状繊維が弱化もしくは
引き裂かれたときに生じるのであり、内側の髄核組織が
正常な環状の状態から永久的に膨らみ、膨張し、もしく
は押し出されてしまう。このような状態に於ては、脊髄
管から脚へと外方へ通じている神経をこの髄核組織（即
ち、そのままの弱まつた膨らんでいるアニユラス）が圧
迫する結果として、脚の痛みが生じるのである。
動くことのできない絶え間のない背中の痛みの主なる
原因は、変質が進んでアニユラスが慢性的な炎症を引き
起こした場合に生じるのである。環状の外側を包囲する
神経ブランチから延びた小さな神経が僅かな距離（恐ら
く６〜8mm）だけアニユラス繊維内に侵入している。ア
ニユラスの繊維層間の結合力の欠如によつて生じる該繊
維層間の規則的な異常な動きが、小さな、患部の繊維内
神経を引つ張り、或いは擦りつけるのである。このよう
にして、患部はほんのちよつとした動きに対しても敏感
になつてしまうのである。このような場合には、痛みの
激しい脊椎骨に於る椎間板の動きを機械的に制限するた
めの何等かの対策が必要となる。極めて頑固な痛みのあ
る場合には、脊椎骨同志を永久的に固定して、痛みを生
じる動きを無くすように骨を結合することが行われる。
多くの場合、僅かながら小さな動き（痛みを生じない程
度の動き）を許容することが好ましい。或る程度の動き
を保持することは、近隣の脊椎骨に於る機械的な破壊を
防止することの助けとなるのである。現在に於ては、こ
のような柔りかい結合を形成し維持することは信頼性高
く実現できてはいない。
髄核組織がヘルニア化し、或いは外科処置によつて除
去された場合は常に、椎間板の空間は挟まり、その運動
性が殆ど失われてしまう。アニユラス及び髄核に対して
回転動作が潜在的に破壊的であると考えるならば、ヘル
ニアとなつた、即ち悪化した、除去せる椎間板を何れか
の人工補綴で置き換え、これによつて回転動作は制限す
るが、曲げ、特に前後の曲げは許容するようになすべき
である。横方向の曲げはそれ程重大ではない。
これ迄一般に使用されてきた装置の何れも椎間板の空
間高さを維持し且つ脊髄骨の間の重要な動きを確保する
ものとは考えられないが、数多くの特許は人工椎間板が
この目的に有用であると記載している。例えば、米国特
許第3,875,595号明細書（フローニング）は椎間板の髄
核全体を交換する形状の人工補綴を示している。フロー
ニングによれば、「人工補綴は中空で、柔軟な袋状の部
材であり、調整可能な圧力の下で流体及び／又はプラス
チツクを充填される。この圧力は、その人工補綴が或る
期間にわたつて所定位置に配置されている間に増減され
て、試行錯誤により最適圧力を決定されるようになさ
れ、しかる後人工補綴のステムが取り除かれる。椎間板
内に通常生じる圧力の下で膨張用材料が失われてしまう
のを十分に回避できるようにして、膨張用流体又は流
体、即ち水、を保持できる特性を有するプラスチツクを
与えることによつて、この最適圧力が永久的に維持され
るのであり、膨張用材料の特性は通常の椎間板の特徴に
模したものとされる」（第１欄、第30〜43行目）。フロ
ーニングの人工補綴は、スタツド状の隆起部分を有して
おり、この隆起部分が隣の脊椎骨の骨端プレートを介し
て押し付けられたソケツト内に嵌め込まれて、人工補綴
がスリツプしないように固定されるのである。
米国特許第4,349,921号明細書（クンツ）は、高密度
ポリエチレン、ポリメタクリレート、ステンレススチー
ル、又は、クロム−コバルト合金のような生物学的に受
け入れることのできる何れかの材料で作られ、且つ又本
来の椎間板と置換される寸法形状となされた椎間板人工
補綴を示している。この人工補綴の長手方向の端部の一
方は、取り扱いを容易となすと共に、必要深さ以上に挿
入されるのを防止するように、隆起したフランジを有す
ることができる。これに対して他方の長手方向端部はウ
エツジ形状とされて挿入を容易に行えるようになされ
る。溝、皺、或いは突起のような表面の特徴を有して
「摩擦係合」を生じると共に、隣の脊椎骨の表面に応じ
た凸面を有する優劣面が備えられる。
米国特許第3,867,728号明細書（スタブスタツドその
他）は、様々な構造をした椎間板人工補綴を示してい
る。これらの人工補綴の各々は、弾性ポリマー、例えば
シリコンゴムやポリウレタンのようなエラストマーの強
化した弾性ブロツク、によって作られているコアーと、
組織が内部に侵入して成長できるような開口を有する材
料で作られた外側表面を形成するカバーと、を有してい
る。図示された殆ど全ての人工補綴は人間の椎間板の形
状とされた部材であるが、「その他の変形例として、複
数の柔軟な、弯曲した棒状の、並べて配置することによ
つて髄核を除去された本来の椎間板の内部空間を占拠で
きるような形状とされた部材、を含むことができる」
（アブストラクトに於る最後から二番目の文章）のであ
る。第23図および第24図を参照されたい。ヘルニアにな
つた椎間板を単体又は複数部材よりなる人工補綴と置き
換えるために、椎間板の空間は後方部分を露出され、そ
して、「椎間板切除術が実施されて、椎間板の空間に対
する一層良好なアクセスを得ると共に、髄核を除去し且
つ又人工補填を挿入するための開口を形成するようにな
されてる。脊髄の硬膜及び神経根が識別され、神経根は
自由状態に切り裂かれ、これらを一緒にして横方向へ引
つ込めてヘルニアを露出するようになすのである」（第
14欄、第17〜27行目）。ヘルニアになつた椎間板を完全
に切除して人工補綴を受け入れるための空間を形成した
後、「人工補綴の内方成長の表面に隣接される端部プレ
ートは弛緩組織を擦り落とされて出血面をそのままにさ
れ、内方成長する組織によつて人工補綴の固定を促進す
るようになされる」（第14欄、第35〜39行目）のであ
る。もし２部材よりなる人工補綴が使用されるならば、
「これらの２個のゼグメントをコード129で互いに縛り
付けるか、或いは隣接する一方の脊椎骨又は他方の利用
できる組織に対して縫合することができる」（第14欄、
第48〜50行目）。
脊椎骨の間に機械的に固定される椎間板の人工補綴
は、米国特許第4,554,914号（カツプその他）、第4,30
9,777号（ペーテイル）、第3,426,364号（ラム）、及
び、第4,636,217号（オギルビーその他）の明細書に示
されている。
発明の概要 本発明は、人間の椎間板の空間高さにほぼ等しい高さ
を有し、且つ又椎体のサジタル（sagittal）直径にほぼ
等しい長さを有する細長い円筒形の人工椎間板を提供す
る。その外側層すなわち外被は、組織を引き付けて内方
成長させ、ゲルコアー（gel core）を取り囲んでいる生
物学的に再吸収可能（又は、生物学的に吸収可能）な物
質を混ぜ合わされた強固で不活性な繊維で作られてい
る。ゲルコアーは、椎間板内方の髄核の本来のレオロジ
ーに似た粘性及び速度−剪断（velocity−sheer）の特
性を有する揺変性ゲルとされるのが好ましい。
この人工椎間板は対として埋込まれねばならない。こ
れらの埋込みに関する外科的処置方法は、１）損傷した
椎間板に隣接の脊椎骨をジヤツキによつて引き離し、
２）損傷した椎間板の横方向の各端部付近にサジタル穴
を間隔を隔てて形成し、そして３）各サジタル穴内に軸
線方向に細長い円筒形の人工椎間板を挿入する諸段階を
含むのである。２個のこれらの人工椎間板が損傷した椎
間板のアニユラスの髄核内に並べて挿入され、各人工椎
間板が椎間板の横方向の端部付近にそれぞれ配置される
と、これらの人工椎間板は、その高さ寸法を維持し、
又、椎間板の空間にて前後方向への曲げを含む動きを確
保するが、回転、移動を制限し、そして横方向の曲げを
僅かな程度に制限するのである。
好ましい後方からのこの外科処置は、フアセツトジヨ
イントの各々を通して11mm穴をドリル加工して窓を形成
する段階を伴うのであり、これは上述した外科的処置方
法に於る１）の段階の前又は後の何れかに行われる。し
かる後アクセスするのにこの窓を使用し、外科医は外科
的処置の２）の段階を実施して、これらの穴から破片や
損傷した椎間板の髄核のその他の望ましくない物質を除
去する。次に、段階３）に於て、人工椎間板が各窓を通
して穴内に挿入される。或る場合には、埋め込んだ人工
椎間板は椎間板高さ寸法を再確立することができ、特に
大規模にヘルニアとなつた椎間板、或いは極めて初期の
ヘルニア化の後に萎縮し続けている椎間板のような対象
に関してこれが望まれるのである。
椎間板にドリル加工して形成された穴は、隣接する脊
椎骨の端部プレートを僅かながら剥ぎ取るのに十分な大
きさとされ、これにより人工椎間板が骨及び隣接組織に
対して取り付くのを促進するようになすことが好ましい
のである。
上述した後方からの処置に於て、これらの穴は互いに
向けて真のサジタル位置から約５〜10゜だけ角度を固有
に付されており、このことはドリルバイトが椎間板の裏
側へ突き抜けることのない状態で穴を一層深く形成でき
るという利点を与えているのである。このような角度は
非常に僅かであることから、埋め込んだ人工椎間板はそ
れらの軸線、即ち細長い方向、が真のサジタル方向に位
置されているように実質的に作用するのである。
フアセツトジヨイントをドリル加工することは、前方
からの処置によつて、或いは損傷した椎間板を後方から
フアセツトジヨイントの中間にてアクセスすることによ
つて、避けることは可能である。後者の方法によれば、
動く危険を伴い、従つて脊髄神経を損傷する可能性があ
る。更に、これは椎間板に形成される穴がサジタル方向
に延在されるか、僅かにサジタル方向からずれる程度と
されて、フアセツトの窓を通してドリル加工する場合に
比較して穴の長さが短くなされることが必要である。他
方に於て、フアセツトジヨイントに対する中間的な後方
からの処置は、経皮的技術によつて実行できるのであ
り、この技術に於ては人工椎間板は最小限の破砕で所定
位置へ移動させることが可能である。
人工椎間板が皮下注射針によつてパンクされるように
設計された離れたチヤンバーに連結される場合、このチ
ヤンバーはＸ線蛍光制御の下に長い針で容易に到達でき
る位置に置かれなければならない。埋め込んだ人工椎間
板が椎体骨の或る程度の再モールド作用を引き起こすな
らば、空間高さが傾斜してしまい、その高さを回復させ
るために恐らく数回にわたつて再充填されることにな
る。様々な患部に対して特性の異なる揺変性ゲルが必要
とされることになり、この人工椎間板が埋め込まれた後
に該ゲルを変質させることは、袋部に対して遠隔アクセ
スできるようになすチヤンバーによつて可能とされるの
である。
袋部がチユーブによつて離れた溜槽、即ちチヤンバ
ー、に接続され、このチヤンバーが針によつてパンクさ
せることのできる自己シールメンブレンを有している場
合、その袋部は損傷された椎間板内に挿入される後迄揺
変性ゲルを充填される必要はない。損傷した椎間板内に
新規な人工椎間板が挿入された後、揺変性ゲルをチヤン
バー内に注入するのに皮下注射針が使用でき、チユーブ
を通してゲルを袋部内に押し込めて袋部を膨らませる。
この袋部はこれによりそれ自体の挿入直後に完全に充填
され、或いは椎間板の空間高さを調整し、又は少しずつ
高めるために、一度に僅かずつ充填され得るのである。
ゆつくりした椎間板の高さ修復は自然の弾性回復を許容
するのであり、これに対して、急激な上昇は椎間板のア
ニユラスを一層傷める、即ち切り裂いてしまうのであ
る。チヤンバーは、充填し過ぎと判断された場合には或
る量のゲルを抜き出すために皮下注射針を使用され得
る。
チヤンバーが柔軟な浸透性メンブレンによつて２個の
隔室に隔離されているならば、そのチヤンバーは針によ
つてパンクされる必要はない。これらの隔室の一方は袋
部と連通され且つ又揺変性ゲルを収容し、又、他方の隔
室は吸湿性材料を収容し且つ水分が浸透可能な壁部で形
成され得る。椎体の水分は吸湿性材料を徐々に膨潤さ
せ、これにより揺変性材料が徐々に気袋を充填するよう
に押し流すのである。
椎間板空間内で人工椎間板が横方向に膨らみを生じる
のを制限するために、強力な不活性繊維が外側層内に織
り込まれ、袋部を通して横方向に延在されることができ
る。このような横方向の繊維は、外側層の強力な不活性
繊維として識別されることができる。人工椎間板が離れ
たチヤンバーから更に一層充填されるならば、この横方
向繊維が先ず最初に椎間板高さの増大をもたらすのであ
る。
この新規な人工椎間板の両端は、内部圧力が脊椎骨の
荷重によつて増減する際に、裏返り、即ち捲れを生じ
て、周囲組織に圧力を伝えるように、嵌め込まれるので
ある。このことは、人工椎間板の柔軟性が構造体の弾性
的な引つ張り及び跳ね返りを必要としないようにできる
ことを意味するのである。
人工椎間板の一つがそれ自体動く傾向を示す可能性に
対抗してこれを抑制するために、各人工椎間板は挿入し
易くするが抜き出し困難、即ち自由に引き出せないよう
にするために形成されたカラー状の円周フランジを備え
ることができる。
挿入の間、もしくは埋め込んだ後に空間内で人工椎間
板が回転する可能性に対抗してこれを抑制するために、
人工椎間板は長手方向のフイン、即ちベーン、を備える
ことが好ましい。上述したような長手方向ベーン並びに
円周方向フランジの両方共、外被の繊維と同じとされ得
る強力な不活性繊維で作ることができる。
この新規な人工椎間板の外被の強力な不活性繊維、及
び該新規な人工椎間板のその他の機素の強力な不活性繊
維は、カーボン又はポリマーで作ることができるのであ
り、これらは冷間引きのポリ（エチレン テレフタレー
ト）ポリエステル繊維のような天然又は合成のポリマー
を含む。生物学的に再吸収可能な材料は、ポリ乳酸又は
ポリグリコール酸又はコラーゲン（例えば、半合成物）
とすることができるのであり、これらの各々は内方成長
組織によつて通常は置き換えられ、従つて周囲組織に対
して結合されるようになるのである。この生きている組
織による置き換えは、埋め込んだ人工補綴の永久的な柔
軟性を保証する。更に別の使用可能な生物学的に再吸収
可能な材料を記載している米国特許第4,643,734号（リ
ン）明細書を参照されたい。
生物学的に再吸収可能な材料はそれ自体が繊維質であ
り、不活性繊維と織り込まれる。他方に於て、外被、円
周フランジ、そして長手方向ベーンは、不活性繊維（生
物学的に再吸収可能な材料でコーティングされ、又は、
コーティングされない何れとすることもできる）によつ
て一緒に織ることができるのであり、しかる後に生物学
的に再吸収可能な材料を浸み込まされるのである。
埋め込んだ後、密接な繊維結合が人工椎間板の外側層
と椎体骨との間に展開される限り、椎体骨が外被に内方
成長する必要はない。外被の繊維はかなりの圧力を受け
入れできるようにするために織り上げられていることが
好ましい。
袋部は柔軟でなければならないが、弾性的である必要
はない。袋部のための好ましい材料には、方向付けされ
たポリ（エチレン テレフタレート）、高密度ポリプロ
ピレン、シリコーンゴム、そしてシリコーン及びカーボ
ンのコポリマーが含まれる。
この新規な人工椎間板が離れたチヤンバーを含む場合
には、袋部、チヤンバー及び接続チユーブは同じ材料
で、例えばブローモールド成形によつて、作られるのが
好ましい。袋部をチヤンバーと同じく自己シール材料で
作ることにより、袋部を通して横方向繊維を引つ張るた
めに、及び外被の繊維と織り合わせるために、針が使用
できるのであり、外被とその隆起部分及びフランジを同
時に織り込むのが好ましい。袋部が自己シール材料でな
い場合には、２個の半体部分に形成し、横方向繊維が所
定位置に取り付けられてこれらの横方向繊維の端部が外
被の繊維と互いに織り合わされた後、これらの半体部分
が互いにシールされるようになすのが好ましい。
揺変性ゲルは、無機質オイル（例えば、シリコーンや
フルオロカーボン）、及び、フエーム化されたシリカの
ようなゲル化剤（混合物の約３〜10重量％であり、6rpm
にて100〜10000cpsの間のブルツクフイールド粘度を与
えるのが好ましい）の混合物とされる。このゲルの粘度
は、制限された動きに際して、椎間板空間に於る曲げの
間に、特にゆつくりした姿勢の変化の間に、通常の迅速
性を有して運動できるように選定される。「Cab−Ｏ−S
ilの特性及び機能」と題されたカボツトコーポレーシヨ
ンによるブリテン（9/83の日付）は第10頁にて、「Cab
−Ｏ−Sil」のヒユーム化されたシリカは、製薬製品を
内服又は局部的に適用するために使用することが食品及
び薬品局（F.D.A.）によつて認知されたことを記載して
いる。
好ましい実施例の説明 第１図に示された細長い人工椎間板10は外被12を有し
ており、この外被12は、組織を引き付けて内方成長させ
る生物学的な再吸収可能な繊維と互いに織り合わされて
いる強力な不活性ポリマー繊維のネツト網として構成さ
れている。これらの繊維は又、２個の円周バンド、即ち
フランジ14、及び長手方向フイン、即ちベーン16、を形
成するように配置された強力な不活性ポリマー繊維が織
り合わされており、これらのフランジ及びベーンは外被
12の外面に突き出して形成されている。
外被12は袋部18を取り囲んでおり、この袋部は第２図
に示すように揺変性ゲル20を収容している。小さなチユ
ーブ22がこの袋部を小さな離れたチヤンバー24に接続し
ており、このチヤンバーは針でパンクさせることができ
る自己シールメンブレンによつて構成されている。人工
椎間板10が第４図及び第５図に示すように人間の脊髄内
に埋め込まれた後、チユーブ22はチヤンバー24が第４図
に示すように位置されることを可能にし、こにより揺変
性ゲルは皮下注射針を脊髄領域に差し込むことなく挿入
することでチヤンバーに追加又は抜き出しできるのであ
る。
埋め込む領域は、L4及びL5の脊椎骨の間の悪化した、
即ちヘルニアとなつた椎間板26の部分である。第３図に
見られるように、窓28及び28aがフアセツト30及び30aの
下部にドリル加工して形成されている。これらの窓を利
用して、一対の穴31及び31aの椎間板26内にドリル加工
されて形成されるのであり、各穴は損傷された椎間板26
の横方向の端部付近に形成され、且つ又、他方の穴に向
けてサジタル方向から約10゜だけ角度を付されている。
又これらの窓を使用して、ドリル加工による破片や、椎
間板の髄核の存在し得るその他の部分が除去される。こ
の除去の後、人工椎間板10及びこれと同じ人工椎間板10
aがそれぞれ穴31及び31a内に脊髄神経を乱すことなく軸
線方向に沿つて挿入される。
第４図に見られるように、人工椎間板10及び10aが穴3
1及び31a内に挿入されると、これらの人工椎間板は並ん
で且つ間隔を隔てて位置されるのであり、各人工椎間板
の細長い方向、即ち軸線、はサジタル方向に対して約10
゜の角度を付されて延在される。第５図は、人工椎間板
10及び10aが脊椎骨L4及びL5の間の高さ及び空間を修復
したことを示しており、椎間板26のアニユラスは緊密状
態とされている。これにより、椎間板空間の潰れ及び弱
つたアニユラスの膨れの組み合わせによつて生じた神経
に対する圧迫が解放されるのである。
再び第２図を参照すれば、多数のポリマー繊維又はそ
の他の強力な不活性繊維32が人工椎間板10の赤道を横方
向に横断して延在されており、これらの繊維は外被12の
繊維と織り合わされている。このような横方向の繊維32
の存在によつて、人工椎間板10は患部の脊髄の垂直方向
の圧力によつてフラツト形状となるのを防止され、これ
により患つている脊椎骨L4多びL5の間の空間を維持する
のである。この間隔内に人工椎間板10及び10aが埋め込
まれるのである。長手方向ベーン16及び16aは人工椎間
板が回転するのを防止するように作用する。一方、円周
フランジ14及び14aは人工椎間板を脊椎骨の間の空間内
に良好に固定するように作用するのである。
【図面の簡単な説明】
第１図は、人工椎間板を一層膨らませたりしぼめたりす
るための離れたチヤンバーを有している、本発明の好ま
しい細長い人工椎間板の斜視図。 第２図は、第１図の線２−２に沿う拡大した中央断面
図。 第３図は、第１図及び第２図に示した人工椎間板の対を
L4及びL5の脊椎骨の間の変質した椎間板内に埋め込むた
めに都合良いアクセスを得るように、フアセツトの下部
を通してドリル加工して形成された２個の窓を示す、人
間の脊髄の後方視図。 第４図は、L4の脊椎骨が省略された状態での第３図に与
えられた脊髄の横断面図。 第５図は、寸法を縮小した第４図の線５−５に沿う断面
図。 L4,L5……脊椎骨、10,10a……人工椎間板、12……外
被、14,14a……円周フランジ、16,16a……長手方向ベー
ン、18……袋部、20……揺変性ゲル、22……チユーブ、
24……チヤンバー、26……椎間板、32……不活性繊維。

Claims (8)

    (57)【特許請求の範囲】
  1. 【請求項１】損傷した椎間板の髄核内にサジタル方向に
    挿入されるようになされた細長い円筒形の人工椎間板で
    あって、特に、前記人工椎間板の空間高さにほぼ等しい
    高さを有すると共に、該椎間板の髄核のサジタル直径に
    ほぼ等しい長さを有しており、この人工椎間板が、組織
    を引き付けて内方成長させる生物学的な再吸収可能な材
    料と混合された強力な不活性繊維の外被と、ゲルコアー
    とを有して構成されていて、このような２個の人工椎間
    板が損傷した椎間板のアニュラス髄核内部に並べて挿入
    されて、各々が椎間板の横方向端部付近にそれぞれ位置
    され且つ又互いの人工椎間板から間隔を隔てて位置され
    たときに、これらの人工椎間板が、椎間板の空間に於
    て、高さ寸法を維持し且つ又前後の曲げを含む動きは確
    保するが、回転は制限するようになることを特徴とする
    人工椎間板。
  2. 【請求項２】前記ゲルコアーが、椎間板の髄核組織の本
    来のレオロジーを模した粘性及び速度−剪断の特性を有
    する揺変性ゲルとされたことを特徴とする特許請求の範
    囲第１項に記載の人工椎間板。
  3. 【請求項３】椎間板の空間内で人工椎間板が回転するの
    を防止するために、外被の外側部に外部隆起部分、即ち
    長手方向ベーンが取り付けられていることを特徴とする
    特許請求の範囲第１項に記載の人工椎間板。
  4. 【請求項４】外被が、前記不活性繊維と織り合わされて
    いる繊維を備える生物学的に再吸収可能な材料を含むこ
    とを特徴とする特許請求の範囲第１項に記載の人工椎間
    板。
  5. 【請求項５】生物学的に再吸収可能な材料が前記外被の
    上にコーティングされていることを特徴とする特許請求
    の範囲第１項に記載の人工椎間板。
  6. 【請求項６】前記生物学的に再吸収可能な材料がポリ乳
    酸、ポリグリコール酸及びコラーゲンから選定されてい
    ることを特徴とする特許請求の範囲第１項に記載の人工
    椎間板。
  7. 【請求項７】内部のゲルコアーと中空のチューブによっ
    て連通されている外部のチヤンバーが、針でパンクさせ
    ることができる自己シールメンブレンで作られているこ
    とを特徴とする特許請求の範囲第１項に記載の人工椎間
    板。
  8. 【請求項８】損傷した椎間板の髄核内にサジタル方向へ
    挿入されているようになされた細長い円筒形の人工椎間
    板であって、この人工椎間板が、椎間板の髄核組織の本
    来のレオロジーを模したゲルコアーと、該ゲルコアーを
    囲んだ外部層で、該椎間板の髄核のサジタル直径にほぼ
    等しい長さと、その長さより小さい幅と、その長さより
    小さい高さを備えた外部層とを含んでいることを特徴と
    する人工椎間板。
JP63204922A 1987-08-20 1988-08-19 人工椎間板カプセル及びその埋め込み方法 Expired - Fee Related JP2771991B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US07/087,424 US4772287A (en) 1987-08-20 1987-08-20 Prosthetic disc and method of implanting
US087424 1987-08-20
US07/223,400 US4904260A (en) 1987-08-20 1988-07-25 Prosthetic disc containing therapeutic material

Publications (2)

Publication Number Publication Date
JPS6470041A JPS6470041A (en) 1989-03-15
JP2771991B2 true JP2771991B2 (ja) 1998-07-02

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JP63204922A Expired - Fee Related JP2771991B2 (ja) 1987-08-20 1988-08-19 人工椎間板カプセル及びその埋め込み方法
JP1191230A Pending JPH02111359A (ja) 1987-08-20 1989-07-24 治療用物質を含むプロテーゼの円板

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JP1191230A Pending JPH02111359A (ja) 1987-08-20 1989-07-24 治療用物質を含むプロテーゼの円板

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US (2) US4772287A (ja)
EP (2) EP0304305B1 (ja)
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US4904260A (en) 1990-02-27
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JPS6470041A (en) 1989-03-15
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EP0353936B1 (en) 1992-11-19
US4772287A (en) 1988-09-20

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