JPH08509645A - Vertebral body implant - Google Patents

Vertebral body implant

Info

Publication number
JPH08509645A
JPH08509645A JP6524845A JP52484594A JPH08509645A JP H08509645 A JPH08509645 A JP H08509645A JP 6524845 A JP6524845 A JP 6524845A JP 52484594 A JP52484594 A JP 52484594A JP H08509645 A JPH08509645 A JP H08509645A
Authority
JP
Japan
Prior art keywords
embedding
shell
embedding member
cover plates
member according
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.)
Pending
Application number
JP6524845A
Other languages
Japanese (ja)
Inventor
ツィッペル,ハルトムート
ボブスト,フランツ
Original Assignee
プルス エンドプロテティク アーゲー
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 プルス エンドプロテティク アーゲー filed Critical プルス エンドプロテティク アーゲー
Publication of JPH08509645A publication Critical patent/JPH08509645A/en
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442Intervertebral or spinal discs, e.g. resilient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02Inorganic materials
    • A61L27/04Metals or alloys
    • A61L27/06Titanium or titanium alloys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28Materials for coating prostheses
    • A61L27/30Inorganic materials
    • A61L27/306Other specific inorganic materials not covered by A61L27/303 - A61L27/32
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
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    • A61F2/00Filters 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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    • A61F2/00Filters 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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    • A61F2002/30177W-shaped, M-shaped or sigma shaped
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30565Special structural features of bone or joint prostheses not otherwise provided for having spring elements
    • A61F2002/30571Leaf springs
    • AHUMAN NECESSITIES
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    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30841Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30878Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
    • A61F2002/30891Plurality of protrusions
    • A61F2002/30892Plurality of protrusions parallel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30878Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
    • A61F2002/30891Plurality of protrusions
    • A61F2002/30894Plurality of protrusions inclined obliquely with respect to each other
    • AHUMAN NECESSITIES
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    • A61FFILTERS 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004Rounded shapes, e.g. with rounded corners
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004Rounded shapes, e.g. with rounded corners
    • A61F2230/0013Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
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    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00011Metals or alloys
    • A61F2310/00017Iron- or Fe-based alloys, e.g. stainless steel
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    • A61F2310/00011Metals or alloys
    • A61F2310/00023Titanium or titanium-based alloys, e.g. Ti-Ni alloys
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    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/38Materials or treatment for tissue regeneration for reconstruction of the spine, vertebrae or intervertebral discs

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

Abstract

(57)【要約】 上部カバープレート(11)、下部カバープレート(12)、及び、これら両カバープレート間に配された弾性的な中間部材(13)を有し、隣接した椎体間に挿入され得るスペーサ部材(10)から成る椎体埋装部材。両カバープレート(11,12)の外表面には、アンカー部材(14,15,16)が設けられている。弾性を有した中間部材(13)は、生物学的適合性(biocompatible)を有した材料、特にチタンから成り略U字形、S字形、又はW字形に曲げられたプレート(17)により作成される。 (57) [Summary] An upper cover plate (11), a lower cover plate (12), and an elastic intermediate member (13) arranged between the both cover plates, which are inserted between adjacent vertebral bodies. A vertebral body implant comprising a spacer member (10) that can be applied. Anchor members (14, 15, 16) are provided on the outer surfaces of both cover plates (11, 12). The elastic intermediate member (13) is made of a plate (17) made of a biocompatible material, in particular titanium, and bent into a substantially U-shape, S-shape or W-shape. .

Description

【発明の詳細な説明】 椎体埋装部材 本発明は、クレーム1の於て書き部による椎体埋装部材(vertebral body imp lant)に関する。この種の椎体埋装部材は周知である。これに関しては、再版 [Vertebral Column Surgcry II‐Surgical treatment of chronic sacral pain ],Symposium Augsburg 1991,editor Klaus A.Matzen,publishcd by Georgt hieme-Vcrlag Stuttgart,New York,1992”に述べられている。この再版は、 人工椎間円板の発展と現状について記載している。そこには、当該技術の現在の 状態として、クロム−コバルト合金から成り樋状凹所が形成された二つの金属カ バープレートと、それらプレート間に設けられたポリエチレン(Chirulen)製の レンズ状中央摺動コアとから構成された、三つに分かれた集台体円板によるプロ テーゼ(prosthcsis:人工補装具)が提示されている。前記土部及び下部のカバ ープレートは、リング状または列に配列された輔によって前記椎体における骨質 の両エンドプレートにアンカー固定されている。前記摺動コアは、セグメントの 伸展屈曲面内での動き、及び側方傾斜、回転を可能とするために、環状のリング 壁を有して両凸に形成されている。ただし、それと同時にこの構造は、10°か ら15°を超えての動き、及び極限位置での前記ポリエチレンレンズの脱臼を防 ぐものとなっている。この円板プロテーゼに関して記載しているものの一つに、 欧州特許文献EP-O 176 728-B1がある。周知であるこの構造の問題は、前記ポリ エチレンコアの弾性の限界、すなわちこの弾性が、低温流れ(cold flow)及び 脆弱化によって経時的に劣化するということである。実際問題としては、前記ポ リエチレン製のコア、特にそのエッジ部は、ダメージにより比較的早期に使用不 能となる。これがため、できることならば回避したい追加の手術が必要となる。 本発明の目的は、当該技術の現状に比較して実質的に単純な構造を有し、でき るだけ本来の(本物の)円板の機能に近似し、しかもその上で完全な耐摩耗性を 有し、以て寿命の長い、椎体埋装部材を提供することにある。本発明による椎体 埋装部材を用いることにより、摩耗及び破損に起因する再手術は不要となる。 上記の目的は、クレーム1に記載した特徴によって達成される。 クレーム記載のとおり本発明に係る椎体埋装部材は、実質的に単一の本質的構 成要素、すなわち特殊形状のバネ部材にまで単純化されている。極端なケース、 すなわちクレーム2によるものでは、該椎体埋装部材はほとんど、本発明により 構成されたバネ部材のみから構成したものとしている。このものでは摩耗は生じ 得ない。それは均質で生物学的適合性(biocompatiblc)を有する単一の材料の みから構成されている。従って本発明による構成は、極端に少ない構成部材の数 、極めて単純な構造並びに製造性、及び極めて容易な移植処置によって特徴付け られるものである。 外科的処置中におけるこの埋装部材の操作はさらに、クレーム8ないし10に 記載した手段により一層容易にできる。 驚くべきことに、本発明に係る椎体埋装部材は本来の椎間円板に近似する弾性 特性を有していることが実験により確かめられている。これは、前記伸展屈曲面 内での動き及び側方傾斜の何れについても言えることである。一方で、本発明に よる構成は回転は許容しない。しかし、かかる僅かな欠点は事実上は欠点となら ない。何故なら、完全な椎間円板でさえ許容できる回転偏位は非常に小さいもの であり、よって本発明によるこの埋装部材によって導かれる限定は問題とならな いからである。 本発明に係る椎体埋装部材のさらに有利となる構造の詳細については従属クレ ームに記載してある。それらの中ではクレー6による構造的解決、すなわち本発 明によるバネ部材の全側面がカプセルに包まれるということが強調されるべきで ある。従って、該埋装部材は外界より遮断された閉鎖系(closcd system)を提 供する。 また、本発明に係るこの埋装部材は、寸法的に、約12mm厚の円板を有した 個々のセグメントが約5°の範囲で変位できるように設定されている。より厚い 円板ではこのセグメントの変位はより大きくできる。 以下、本発明に係る椎体埋装部材の好ましい実施の形態を添付の図面を参照し て詳細に説明する。 図1は、本発明の第一の好ましい実施の形態による椎体埋装部材の斜視図; 図2は、図1に示した埋装部材を図1における矢印IIの方向から見た正面図; 図3は、図1に示した埋装部材を図1における矢印IIIの方向から見た側面図 ; 図4は、本発明の他の実施の形態による埋装部材の側面図; 図5は、図1ないし図3に示した埋装部材の、隣接した二つの椎体間に装着す る前の圧縮された状態を示す側面図; 図6は、図1ないし図3に示した埋装部材の、隣接した二つの椎体間に装着す る前の圧縮された状態を示す斜視図; 図7は、本発明の第三の実施の形態による椎体埋装部材を、点線で示した弾性 中間部材とともに、長手方向断面で示した概略図; 図8は、図7に示した埋装部材のためのカプセルを、該埋装部材カプセルの上 部及び下部シェルの相対可動性を示すために大きく拡大して示した図である。 図1ないし図3に示す椎体埋装部材は、図示しない隣接した椎体間に装着され るスペーサユニット10から成り、該スペーサユニットは、上部カバープレート 11と、下部カバープレート12と、それら二つのカバープレート間に設けられ た中間弾性部材13とを備えて成っている。前記カバープレート11,12の外 面、すなわち前記椎体に対面する面には、スパイク状のアンカー部材14,15 ,16が設けられている。これらの部材は、該椎体埋装部材が隣接する二つの椎 体間に装着された後にそれら椎体の骨に侵入し、該埋装部材をそれら隣接椎体間 にしっかりと固定する。前記中間弾性部材13は、特にチタン、チタン被覆され たコバルト−クロム−モリブデン,コバルト−クロム,又はステンレスバネ鋼等 の生物学的適合材料より成り、S字状に曲げられてバネを形成している。このプ レートの厚みは約0.2〜0.6mm、特には約0.35mmである。前記上部及 び下部プレート及び前記中間バネ部材13は平面視略楕円形のものである。ソラ マメ形(kidncy-shapcd)の外形を持ったものであってもよい。以下により詳細 に説明するこの図1ないし図3に示した実施の形態、及び図4ないし図6に示し た実施の形態では、上部及び下部カバー11,12は、S字形プレート17の部 分である前記中間弾性部材13によって結合されている。すなわち、上部及び下 部カバープレート11,12は、プレート17が曲げられて成るS字の外側の二 つのリム(枝状突出部)により形成されている。 あるいは図4に示すように、前記中間弾性部材13は、前記プレート17をW 字形に曲げることによって形成することもできる。最も単純な実施形態はU字形 に曲げたバネプレートである。 図2及び図3に示すように、前記各カバープレート11,12の外面は、長手 方向およびそれと直交する方向の双方に対して凸状にカーブしている。その結果 、それら両プレートは対応した椎体に対してより好適に埋め込まれあるいは固定 される。 図3及び図4に示すように中間弾性部材13にテンションが付与されていない 場合、二つのカバープレート11,12は、それらの長手範囲と直交する面内で 約3〜25°、特に約8°の角度αを囲んでいる。該埋装部材は、隣接した二つ の椎体間に、高い方の側面を前方にして装着される。そうして、伸展屈曲面の偏 位及び側方傾斜の双方に対して所望の弾性及び緩衝特性が保証される。 図7及び図8に示すように、他の実施の形態では、中間弾性部材を、例えば、 上部シェル18及び下部シェル19により形成されて図1ないし図3に従う前記 上部及び下部カバープレートがそれぞれそれら上部シェル18及び下部シェル1 9の一部となるカプセル20内に入れること、あるいは収納することができる。 この場合、上述のスパイク14,15,16は前記土部及び下部シェルの外面に 設けられるものとなる。 前記上部シェル18及び下部シェル19は生物学的適合性を有した材料、特に チタンのシートにより形成される。両者は互いに結合されており、特に、図7及 び図8に示すように互いの端部どうしが遊びなく中間弾性部材13の動きに追従 でるきようにフック状に係止されている。図8には、上部シェルと下部シェルと の間に生じ得る相対的な偏位を概略的に表している。ここで、セグメントの可動 性は、約12mmの高さを持った埋装部材に対応させて約5°としている。 図7に示すように、前記上部及び下部シェル18,19はそれぞれ凸状に形成 されている。この凸面は、各シェル18,19に本質的な安定性を付加的に供与 し、その結果前記シェルを、破断する恐れを伴うことなく薄い金属シートから作 ることができる。結局、本実施の形態では、各シェルの中央部を極端に肉薄とし 、その一方で、各シェルの周縁の壁厚(肉厚)を大きくすることが可能となる。 チタンのシートを用いた場合では、上部及び下部シェルの中央部における壁厚は 最大約0.05〜0.25mm、特には約0.10mmである。壁厚は周縁部に向 かって好ましくは連続的に約25〜30%増加する。 図8に示した実施の形態では、上部及び下部シェル18,19の壁厚は約0. 10−0.30mm、特には約0.15mmである。 図7及び図8に示した実施の形態は閉鎖系を提供するものである。前記カプセ ル20は図1ないし図3、図4に示したバネ部材以外のバネ部材を含むことが可 能である。理諭上はコイルスプリングパッケージを用いることも可能である。特 に円錐圧縮バネはバネ特性に関して有利である。 また、全ての実施の形態において、前記スパイクの長さは、該埋装部材が装着 された際に前方となる縁部近傍に配されたスパイク14,15の長さの方が、後 方に位置するスパイク16よりも大きいことに留意されたい。かかる特徴は、隣 接する二つの椎耐間の空間的関係に関連したものである。 複雑な装着器具を用いなくとも済むように、ここで説明した椎体埋装部材は、 該埋装部材を隣接する二つの椎体間に装着する前に、圧縮バンド21,圧縮ワイ ヤ,圧縮クランプ等、装着後に取り外すことの可能な手段によって前記中間弾性 部材の作動方向に圧縮しておくことが好ましい。これに関しては図5及び図6に 示してある。該埋装部材は、前記圧縮バンドによって、隣接する二つの椎体間に 装着する前に、最大高さの約1/4に前記アンカー部材(スパイク14,15, 16)の高さを加えた高さに圧縮される。従って該埋装部材は、拡張器具あるい は鉗子(forccps)を用いずに、隣接する二つの椎体間に装着可能である。前記 圧縮バンドは、埋装部材を所定位置に設置したときに開いて取り外せる。そして 該埋装部材は、前記中間弾性部材のバネテンションにより脊柱の軸方向に広がる 。これにより前記スパイク14,15,16が対応する椎体の骨内に進入する。 こうして、該埋装部材は自身を固定することになる。 好ましくは前記圧縮バンド21は、図6に示すように、該埋装部材10の周囲 、特に上部及び下部カバープレート11,12の外面に延在して形成された溝2 2内に設けられている。この溝22の深さ及び幅は、圧縮バンド21の厚み及び 幅に略対応したものである。圧縮バンドの代わりに圧縮ワイヤ等を用いることも 可能である。本実施形態の場合では、圧縮バンド21の二端が該埋装部材10の 前方において互いに取り付けられている(ハンダ付け等)。この接合は、埋装部 材装着後に例えばサイドカツタにより開かれて壊される。圧縮ワイヤを用いた場 合には、埋装部材10の前方において互いに捩ることができる。そして、そのワ イヤは、埋装部材装着後、埋装部材の周囲に沿って前方に引っ張ることにより解 いて取り外す。 理諭的には、該埋装部材を、隣接した二つの椎体間に装着する間圧縮しておく ために、該埋装部材の土部及び下部表面に、鉗子の先端を位置させるための凹部 あるいは開口を複数形成することも可能である。ただし、圧縮バンド等を利用し た上述の方法の方が、相対的に高い圧縮力を該埋装部材の製造過程において予め 付与することができる点で優れている。また、この圧縮力は、埋装部材装着後に 前記圧縮バンド等を開くことによって開放するだけでよい。言うまでもなく、こ の圧縮バンドも生物学的適合材料から成るものである。 図1ないし図3による実施の形態に示した如く凸状にカーブした前記上部及び 下部カバープレート11,12を設ける代わりに、前記バネ部材13の外側リム に、凸状のスパイク保持カバープレートを例えばネジ留め等によって取り付ける ことも可能である。この実施の形態による場合には、カバープレート11,12 の曲率を個々の患者に適合するように変更できる利点がある。 ここで説明した実施の形態では、埋装部材の横方向の可撓性は該埋装部材の長 寸方向と直交する平面内におけるものよりも幾分低いものとなっている。従って 、該埋装部材は、前記長寸方向と直交する面が患者の伸展屈曲面と平行に延在す るように装着される。この面内において該埋装部材は要望される高い柔軟性を示 す。該埋装部材は側方傾斜のために、横方向において屈曲に対しより高い抵抗を 示す。この点に関しては、この埋装部材は本来の椎体間円板の作動に近似してい る。すなわち、左右側方への可動性は大きくとも前後方向の可動性の約半分に見 積られている。ここにおける埋装部材はかかる要求を満たすものである。 個々の椎体の互いの回転のためのセグメントの偏位は2°から4°となってい る。従って一般に、埋装部材を構成する上でこれらの動きは無視できる。従って 、ここに説明した実施の形態によるものでは、回転しない埋装部材が提供されて いる。その結果として、該埋装部材の構成は非常に単純化されている。 本明細書で述べた特徴は、単一であるいは組み合わせることによって当該技術 の状態に照らして新規となる範囲まで、本発明の本質として全てクレームしてあ る。DETAILED DESCRIPTION OF THE INVENTION vertebral body UmaSo member present invention relates to vertebral bodies UmaSo member (vertebral body imp lant) by Te write portion at claim 1. Vertebral body implants of this kind are well known. Reprinted on this [Vertebral Column Surgcry II-Surgical treatment of chronic sacral pain], Symposium Augsburg 1991, editor Klaus A. Matzen, publishcd by Georgt hieme-Vcrlag Stuttgart, New York, 1992 ”. This reprint describes the development and current state of artificial intervertebral discs, where the current state of the art is. , Two metal cover plates made of chrome-cobalt alloy and having a trough-shaped recess, and a lens-shaped central sliding core made of polyethylene (Chirulen) provided between the plates, three, A prosthcsis (prosthcsis: prosthetic device) is presented, which is divided into two parts. Anchor-fixed to the end plate The sliding core has an annular ring wall and is formed in a biconvex shape so as to allow the segment to move in the extending and bending plane and to tilt and rotate laterally. However, at the same time, this structure prevents movement from 10 ° to more than 15 ° and dislocation of the polyethylene lens in extreme positions. One of these is the European patent document EP-O 176 728-B1.A well-known problem with this structure is the limit of elasticity of the polyethylene core, that is, this elasticity causes cold flow and weakening. As a practical matter, the polyethylene core, especially its edges, becomes unusable relatively quickly due to damage, which is why additional surgery that you might want to avoid should be avoided. The object of the present invention is to have a structure that is substantially simpler than the state of the art, and to be as close as possible to the function of the original (genuine) disc, and The object of the present invention is to provide a vertebral body implant having a complete wear resistance and a long service life by using the vertebral body implant according to the present invention. No surgery is required The above-mentioned object is achieved by the features stated in claim 1. As claimed, the vertebral body implant according to the invention is essentially a single essential component, namely a special component. In the extreme case, ie according to claim 2, it is assumed that the vertebral body implant member consists almost exclusively of the spring member according to the invention. No wear can occur in, it is composed of only a single material that is homogeneous and biocompatiblc. The construction according to the invention is therefore characterized by an extremely low number of components, a very simple construction and manufacturability, and a very easy implantation procedure. Manipulation of this implant during a surgical procedure is further facilitated by the means described in claims 8-10. Surprisingly, it has been experimentally confirmed that the vertebral body implant member according to the present invention has elastic characteristics similar to the original intervertebral disc. This is true both for the movement in the extension bending plane and the lateral inclination. On the other hand, the arrangement according to the invention does not allow rotation. However, such a slight defect does not actually become a defect. This is because the rotational excursion that is acceptable even for a perfect disc is so small that the limitation introduced by this implant according to the invention is not a problem. Further advantageous structural details of the vertebral body implant according to the invention are set out in the dependent claims. It should be emphasized among them that the structural solution with clay 6 is encapsulation on all sides of the spring element according to the invention. Therefore, the implantable member provides a closed system that is shielded from the outside world. Further, this embedding member according to the present invention is dimensionally set so that each segment having a disk with a thickness of about 12 mm can be displaced within a range of about 5 °. With thicker discs, the displacement of this segment can be larger. Hereinafter, a preferred embodiment of a vertebral body implant member according to the present invention will be described in detail with reference to the accompanying drawings. 1 is a perspective view of a vertebral body implant according to a first preferred embodiment of the present invention; FIG. 2 is a front view of the implant shown in FIG. 1 as viewed in the direction of arrow II in FIG. 1; 3 is a side view of the embedding member shown in FIG. 1 as seen from the direction of arrow III in FIG. 1; FIG. 4 is a side view of an embedding member according to another embodiment of the present invention; FIG. 6 is a side view of the implantation member shown in FIGS. 1 to 3 in a compressed state before being mounted between two adjacent vertebral bodies; FIG. 6 is a diagram showing the implantation member shown in FIGS. FIG. 7 is a perspective view showing a compressed state before being mounted between two adjacent vertebral bodies; FIG. 7 is an elastic intermediate member showing a vertebral body implant member according to a third embodiment of the present invention in a dotted line. And FIG. 8 is a schematic view in longitudinal section; FIG. 8 shows the capsule for the implantable member shown in FIG. It is a greatly enlarged with shows to indicate the relative mobility of the part shell. The vertebral body implanting member shown in FIGS. 1 to 3 includes a spacer unit 10 mounted between adjacent vertebral bodies (not shown). The spacer unit includes an upper cover plate 11, a lower cover plate 12, and a pair of them. And an intermediate elastic member 13 provided between two cover plates. Spike-shaped anchor members 14, 15, 16 are provided on the outer surface of the cover plates 11, 12, that is, the surface facing the vertebral body. These members penetrate the bones of the vertebral bodies after the vertebral body implants have been mounted between two adjacent vertebral bodies and secure the implant between the adjacent vertebral bodies. The intermediate elastic member 13 is made of a biocompatible material such as titanium, titanium-coated cobalt-chromium-molybdenum, cobalt-chrome, or stainless spring steel, and is bent into an S shape to form a spring. There is. The thickness of this plate is about 0.2-0.6 mm, especially about 0.35 mm. The upper and lower plates and the intermediate spring member 13 are substantially elliptical in plan view. It may have a broad bean (kidncy-shapcd) outer shape. In the embodiment shown in FIGS. 1 to 3 and in the embodiment shown in FIGS. 4 to 6, which will be described in more detail below, the upper and lower covers 11, 12 are part of an S-shaped plate 17. They are connected by the intermediate elastic member 13. That is, the upper and lower cover plates 11 and 12 are formed by two outer rims (branch-shaped protrusions) of the S shape formed by bending the plate 17. Alternatively, as shown in FIG. 4, the intermediate elastic member 13 may be formed by bending the plate 17 into a W shape. The simplest embodiment is a U-bent spring plate. As shown in FIGS. 2 and 3, the outer surface of each of the cover plates 11 and 12 is convexly curved in both the longitudinal direction and the direction orthogonal thereto. As a result, the two plates are better implanted or secured to the corresponding vertebral bodies. When tension is not applied to the intermediate elastic member 13 as shown in FIGS. 3 and 4, the two cover plates 11 and 12 are about 3 to 25 °, and particularly about 8 in a plane orthogonal to their longitudinal ranges. It encloses an angle α of °. The embedding member is mounted between two adjacent vertebral bodies with the upper side of the body facing forward. In this way, the desired elasticity and cushioning properties are assured against both deflection and lateral inclination of the extensional flexion surface. As shown in FIGS. 7 and 8, in another embodiment, an intermediate elastic member may be formed, for example, by the upper shell 18 and the lower shell 19 and the upper and lower cover plates according to FIGS. It can be placed or contained within a capsule 20 that is part of the upper shell 18 and the lower shell 19. In this case, the spikes 14, 15 and 16 described above are provided on the outer surface of the soil portion and the lower shell. The upper shell 18 and the lower shell 19 are formed of a sheet of biocompatible material, especially titanium. Both of them are connected to each other, and in particular, as shown in FIGS. 7 and 8, their ends are hooked so that they can follow the movement of the intermediate elastic member 13 without play. FIG. 8 schematically shows the possible relative deviation between the upper shell and the lower shell. Here, the mobility of the segment is set to about 5 ° corresponding to the embedding member having a height of about 12 mm. As shown in FIG. 7, the upper and lower shells 18 and 19 are each formed in a convex shape. This convex surface additionally imparts an intrinsic stability to each shell 18, 19 so that said shell can be made from a thin metal sheet without the risk of breaking. After all, in the present embodiment, the central portion of each shell can be made extremely thin, while the wall thickness (wall thickness) of the peripheral edge of each shell can be increased. With titanium sheets, the wall thickness in the middle of the upper and lower shells is up to about 0.05-0.25 mm, in particular about 0.10 mm. The wall thickness preferably increases continuously about 25-30% towards the periphery. In the embodiment shown in FIG. 8, the wall thickness of the upper and lower shells 18, 19 is about 0.10-0.30 mm, in particular about 0.15 mm. The embodiments shown in Figures 7 and 8 provide a closed system. The capsule 20 may include a spring member other than the spring members shown in FIGS. 1 to 3 and 4. In theory, it is possible to use a coil spring package. In particular, the conical compression spring is advantageous in terms of spring characteristics. In addition, in all the embodiments, the length of the spike is such that the length of the spikes 14 and 15 arranged near the edge that is the front when the embedding member is mounted is located rearward. Note that it is larger than spike 16 that does. Such features are related to the spatial relationship between two adjacent vertebrae. The vertebral body implant described herein is provided with a compression band 21, a compression wire, a compression clamp, and the like before the implant is mounted between two adjacent vertebral bodies so that a complicated attachment device is not required. It is preferable that the intermediate elastic member is compressed in the operating direction by a means that can be removed after mounting. This is shown in FIGS. 5 and 6. The embedding member added the height of the anchor member (spikes 14, 15, 16) to about 1/4 of the maximum height by the compression band before being mounted between two adjacent vertebral bodies. Compressed to height. Thus, the implantable member can be mounted between two adjacent vertebral bodies without the use of dilators or forceps. The compression band can be opened and removed when the embedding member is in place. Then, the embedding member expands in the axial direction of the spinal column by the spring tension of the intermediate elastic member. This causes the spikes 14, 15, 16 to enter the bone of the corresponding vertebral body. Thus, the embedded member fixes itself. Preferably, the compression band 21 is provided in a groove 22 formed around the embedding member 10, particularly on the outer surface of the upper and lower cover plates 11, 12 as shown in FIG. There is. The depth and width of the groove 22 substantially correspond to the thickness and width of the compression band 21. It is also possible to use a compression wire or the like instead of the compression band. In the case of this embodiment, the two ends of the compression band 21 are attached to each other in front of the embedding member 10 (soldering or the like). This joint is opened and broken by, for example, a side cutter after mounting the embedding member. When a compression wire is used, it can be twisted in front of the embedding member 10. After mounting the embedding member, the wire is removed by pulling it forward along the periphery of the embedding member. The rationale is to position the tip of the forceps on the soil and lower surface of the implant member in order to keep the implant member compressed during installation between two adjacent vertebral bodies. It is also possible to form a plurality of recesses or openings. However, the above method using a compression band or the like is superior in that a relatively high compression force can be applied in advance in the manufacturing process of the embedding member. Further, this compression force may be released only by opening the compression band or the like after mounting the embedding member. Needless to say, this compression band is also made of a biocompatible material. Instead of providing the convexly curved upper and lower cover plates 11, 12 as shown in the embodiment according to FIGS. 1 to 3, the outer rim of the spring member 13 is provided with a convex spike-holding cover plate, for example. It can also be attached by screwing or the like. According to this embodiment, there is an advantage that the curvatures of the cover plates 11 and 12 can be changed so as to suit each patient. In the embodiment described here, the lateral flexibility of the embedding member is somewhat lower than in the plane orthogonal to the longitudinal direction of the embedding member. Therefore, the embedding member is mounted so that the surface orthogonal to the longitudinal direction extends parallel to the extension and bending surface of the patient. In this plane, the embedding member exhibits the desired high flexibility. Due to the lateral inclination, the implant exhibits a higher resistance to bending in the lateral direction. In this regard, this implant mimics the operation of a natural interbody disc. That is, even if the lateral mobility is large, it is estimated to be about half of the longitudinal mobility. The embedding member here fulfills such a requirement. The deflection of the segments for rotation of the individual vertebral bodies with respect to each other is between 2 ° and 4 °. Therefore, these movements are generally negligible in constructing the implantable member. Therefore, according to the embodiments described herein, a non-rotating embedding member is provided. As a result, the construction of the embedding member is greatly simplified. The features described in this specification are all claimed as the essence of the present invention, to the extent they are novel in view of the state of the art, either alone or in combination.

Claims (1)

【特許請求の範囲】 1.隣接した椎体間に装着可能とされ、上部カバープレート(11),下部カ バープレート(12),及びこれら二つのカバープレー卜間に配された中間弾性 部材(13)を備えたスペーサ部材(10)から成り、前記両カバープレートの 外面すなわち椎体に対向する面に設けられたアンカー部材(14,15,16) を備えた椎体埋装部材において、 前記中間弾性部材(13)が生物学的適台材料、特にチタン、チタン被覆され たコバルト−クロム−モリブデン合金,コパルト−クロム合金,又はステンレス 鋼等から成るプレート(17)から構成され、該プレートが略U字形,S字形, またはW字形に曲げられて成ることを特徴とする椎体埋装部材。 2.請求項1記載の埋装部材において、前記上部及び下部カバープレート(1 1,12)は前記U字,S字,又はW字形とされたバネプレート(17)との一 体部材とされるか、あるいは該上部及び下部カバープレートは前記U字,S字, 又はW字形とされたバネプレート(17)の外側の二つのリムによって形成され ていることを特徴とする埋装部材。 3.請求項1又は2記載の埋装部材において、前記上部及び下部カバープレー ト(11,12)はそれぞれ平面視において楕円形又はソラマメ形を呈している ことを特徴とする埋装部材。 4.請求項1ないし3の何れかに記載の埋装部材において、前記二つのカバー プレート(11,12)はそれぞれ凸状に形成されるか、あるいはその外面が曲 面に形成されていることを特徴とする埋装部材。 5.請求項1ないし4の何れかに記載の埋装部材において、前記二つのカバー プレート(11,12)は、前記中間弾性部材(13)にテンションが付与され ていない状態で、これらカバープレートの長手方向と直交する面すなわち伸展屈 曲面内において約3〜25°、特に約8°の角度(α)を囲むことを特徴とする 埋装部材。 6.請求項1,3ないし5の何れかに記載の埋装部材において、前記中間弾性 部材が、上部シェル(18)及び下部シェル(19)より形成されたカプセル( 20)内に収納されており、前記上部及び下部カバープレートが前記上部シェル (18)及び前記下部シェル(19)の一部を形成していることを特徴とする埋 装部材。 7.請求項6記載の埋装部材において、前記土部シェル(18)及び下部シェ ル(19)が生物学的適合材料、特にシート状チタンから成り、かつ両者が互い に接合されていること、特に互いの縁部どうしが前記中間弾性部材(13)の動 きに遊びなく追従でるきようフック状に係止されていることを特徴とする埋装部 材。 8.請求項1ないし7の何れかに記載の埋装部材において、該埋装部材は、隣 接する二つの椎体間に装着する前に、圧縮バンド(21),圧縮ワイヤ,圧縮ク ランプ等、装着後に取り外すことの可能な手段によって前記中間弾性部材(13 )の作動方向に圧縮されていることを特徴とする埋装部材。 9.請求項8記載の埋装部材において、該埋装部材は、隣接する二つの椎体間 に装着する前に、最大高さの約1/4に前記アンカー部材(14,15,16) の高さを加えた高さに圧縮することが可能であることを特徴とする埋装部材。 10.請求項8又は9記載の埋装部材において、前記圧縮バンド(21)等は 、該埋装部材(10)の周囲、特に少なくとも前記上部及び下部カバープレート (11,12)の外面に延在して形成された溝(22)内に設けられ、該溝の深 さ及び幅が前記圧縮バンド(21)等の厚み及び幅に略対応していることを特徴 とする埋装部材。 11.請求項6記載の埋装部材において、前記上部シェル(18)及び下部シ ェル(19)の壁厚が約0.10〜0.30mm、特には約0.15mmであるこ とを特徴とする埋装部材。 12.請求項6又は11記載の埋装部材において、上部シェル(18)及び下 部シェル(19)の周縁域における前記シェルの壁厚は中央域よりも大きく、該 中央域の厚みが最大約0.05〜0.25mm、特には0.10mmであることを 特徴とする埋装部材。[Claims]   1. It can be installed between the adjacent vertebral bodies, and the upper cover plate (11) and lower cover Bar plate (12) and intermediate elasticity arranged between these two cover plates A spacer member (10) with a member (13), Anchor members (14, 15, 16) provided on the outer surface, that is, the surface facing the vertebral body In a vertebral body implant member having   Said intermediate elastic member (13) is coated with a biologically suitable base material, especially titanium, titanium Cobalt-chromium-molybdenum alloy, copalto-chromium alloy, or stainless steel It is composed of a plate (17) made of steel or the like, and the plate is substantially U-shaped, S-shaped, Alternatively, the vertebral body implant member is characterized by being bent into a W shape.   2. The embedded member according to claim 1, wherein the upper and lower cover plates (1 1, 12) is one of the U-shaped, S-shaped, or W-shaped spring plate (17) Body member, or the upper and lower cover plates are U-shaped, S-shaped, Or formed by two outer rims of a W-shaped spring plate (17) Embedded member characterized by being.   3. The embedding member according to claim 1 or 2, wherein the upper and lower cover plates To (11, 12) each have an oval shape or broad bean shape in a plan view. An embedding member characterized by the above.   4. The embedded member according to claim 1, wherein the two covers are provided. The plates (11, 12) are each formed in a convex shape, or their outer surfaces are curved. An embedding member formed on the surface.   5. The embedded member according to claim 1, wherein the two covers are provided. The plates (11, 12) are tensioned to the intermediate elastic member (13). Surface, that is, the plane perpendicular to the longitudinal direction of these cover plates Characterized by enclosing an angle (α) of about 3-25 °, especially about 8 ° in a curved surface Embedded member.   6. The embedding member according to claim 1, wherein the intermediate elasticity is provided. The member is a capsule formed by an upper shell (18) and a lower shell (19) ( 20) and the upper and lower cover plates are housed in the upper shell. (18) and a part of the lower shell (19), characterized in that Mounting member.   7. The embedding member according to claim 6, wherein the earth shell (18) and the lower shell. (19) consists of a biocompatible material, in particular sheet titanium, and both Are joined to each other, in particular, the edges of the intermediate elastic member (13) move relative to each other. An embedded part characterized by being hooked so that it can follow without play. Material.   8. The embedding member according to any one of claims 1 to 7, wherein the embedding member is adjacent to the embedding member. Before fitting between the two vertebral bodies in contact, the compression band (21), compression wire, compression The intermediate elastic member (13) can be removed by means such as a lamp that can be removed after mounting. ) The embedding member characterized in that it is compressed in the operating direction.   9. The implantable member according to claim 8, wherein the implantable member is between two adjacent vertebral bodies. Before mounting on the anchor member (14, 15, 16) to about 1/4 of the maximum height An embedding member, which is capable of being compressed to a height including the height of the embedding member.   10. The embedding member according to claim 8 or 9, wherein the compression band (21) and the like are Around the embedding member (10), in particular at least said upper and lower cover plates It is provided in a groove (22) formed on the outer surface of (11, 12), and the depth of the groove is increased. The width and the width of the compression band (21) substantially correspond to those of the compression band (21). Embedded member to be.   11. The embedding member according to claim 6, wherein the upper shell (18) and the lower shell (18). The wall thickness of the shell (19) is about 0.10 to 0.30 mm, especially about 0.15 mm. An embedding member characterized by:   12. Embedding member according to claim 6 or 11, wherein the upper shell (18) and the lower shell The wall thickness of the shell in the peripheral region of the partial shell (19) is larger than that in the central region, The maximum thickness of the central area is about 0.05 to 0.25 mm, especially 0.10 mm. Characterized embedded member.
JP6524845A 1993-05-11 1994-03-09 Vertebral body implant Pending JPH08509645A (en)

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DE4315757.2 1993-05-11
DE4315757A DE4315757C1 (en) 1993-05-11 1993-05-11 Vertebral implant
PCT/EP1994/000728 WO1994026213A1 (en) 1993-05-11 1994-03-09 Vertebral body implant

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