JP5161064B2 - フランジ付き椎体間癒合装置 - Google Patents
フランジ付き椎体間癒合装置 Download PDFInfo
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- JP5161064B2 JP5161064B2 JP2008501962A JP2008501962A JP5161064B2 JP 5161064 B2 JP5161064 B2 JP 5161064B2 JP 2008501962 A JP2008501962 A JP 2008501962A JP 2008501962 A JP2008501962 A JP 2008501962A JP 5161064 B2 JP5161064 B2 JP 5161064B2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
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- A61B17/8042—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates having indirect contact with screw heads, or having contact with screw heads maintained with the aid of additional components, e.g. nuts, wedges or head covers the additional component being a cover over the screw head
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Landscapes
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Description
Campbell’s Operative Orthopaerdics, 10th ed., edited by Canale et al., pp. 1569−1588
図1に示されるように、脊椎2は、身体上部を軸支し運動させる一連の交互の椎骨4および繊維性の円板6を備える。脊椎2は、一般的には、7個の頚椎(C1〜C7)、12個の胸椎(T1〜T12)、5個の腰椎(L1〜L5)、5個の癒合した仙椎、および4個の癒合した尾椎の、33個の椎骨4から成る。図2Aおよび2Bは一般的な胸椎を示す。脊椎はそれぞれ、後弓10を備えた腹側の本体8を含む。後弓10は、背側で接合されて骨棘16を形成する2つの茎12と2つの板14を備える。後弓10の各部位からは、横関節突起18、上関節突起20、および下関節突起22が突出している。上関節突起20および下関節突起22の小関節面24、26は、隣接した椎骨の関節突起とともに関節突起間関節28を形成する。
本発明の一実施形態では、椎体間椎骨移植片100が提供される。図5A〜5Cに示されるように、一実施形態では、移植片100は、上方部分104および下方部分106、骨に面する面108およびアクセス面110を有する安定化または固定プレート102を備える。使用中、一般的には、骨に面する面108は椎骨表面に実際に接触するが、他の実施形態では、他の構造または構成要素が、骨に面する面108と脊椎の骨表面との間にあってもよい。上方部分104および下方部分106はそれぞれ、移植片100を椎骨にしっかり固定するため、ねじおよび/または他のアタッチメント装置を受け入れるように構成された、骨に面する面108とアクセス面110の間に向けられた、1つ以上の空間または穴112を有する。1つ以上のスペーサまたはスペーシング構造114は、固定プレート102の骨に面する面108上に位置する。スペーサ114は、一般的に、骨に面する面108の周りで固定プレート102と一体化されている。
スペーサは、2つの隣接した椎体間の分離を維持し、かつそれらの間の圧縮に抵抗するように構成された任意の構造も備えてもよい。スペーサは、スペーシング構造内に1つ以上の内腔を有する、あるいは有さない、方形の箱形、台形の箱形、H字形、O字形、V字形などであるがそれらに限定されない、様々な全体形状のいずれかを有してもよい。図5Bおよび5Cに示されるように、スペーサ114は、基部116、上面118、および下面120、側面122、124、および背面126を有する。表面118、120、122、124、126はそれぞれ、平坦である必要はなく、湾曲しているか、波形であるか、またはそれらの任意の組合せであってもよい。上面および下面118、120は、移植部位に隣接した上椎体および下椎体8または34に面するように構成される。上面118および下面120の相対的構成は、2つの隣接した椎骨間での所望の相対位置、椎骨の解剖学的形状、移植片の挿入の容易さ、および他の要因によって変わってもよい。例えば、2つの椎骨間で中立の垂直配置が望ましい場合、上面および下面118、120は、ほぼ平行の平坦な向きを有してもよい。例えば頚部部位における自然な脊柱弯曲を維持するため、非中立的な配置が望ましい場合、上面および下面118、120は、所望の非中立的位置で椎骨を固定できるようにするため、くさび様の関係を有してもよい。前後方向に対する非中立的な配置は、また、脊柱の他の部分における過度の前弯または後弯を補うために使用されてもよい。上面および下面118、120の間の任意の断面におけるスペーシング構造116の高さは、さらに、変性変化または解剖学的異常に適応して、所望の相対位置での固定を提供するように構成されてもよい。同様に、スペーシング構造114の側面122、124は、一般に、平行または斜めであってもよい。一実施形態では、移植片100の側面122、124は、移植片100の基部116から距離が増加するに従って先細になっている。先細のスペーシング構造は、椎間腔への移植片100の挿入を容易にすることがある。他の実施形態では、1つ以上の側面は、遠位側に向かってフレア状になっているか、またはテーバー状部分およびフレア状部分の両方を有してもよい。
固定プレートは、ほぼ平坦な形体、湾曲した形体、またはそれらの組合せを有してもよい。任意に、固定プレートの表面も、それぞれ、ほぼ平坦なもしくは湾曲した形体、またはそれらの組合せを有してもよい。固定プレートの表面はそれぞれ同じ形体を有する必要はない。固定プレートの縁部は、任意に、丸くされるか、滑らかにされるか、または磨かれてもよい。一実施形態では、フランジは、スペーサの基部の縁部を約2mm越えて延びるようにして寸法決めされる。本発明のいくつかの実施形態では、固定構成要素は、一般に、固定プレートとの境界面において、スペーサ構成要素の断面境界を約1mm〜約20mm越えて延びるように寸法決めされる。他の実施形態では、フランジは、スペーサ基部を3mm、4mm、またはそれ以上越えて延びてもよい。フランジは、スペーサ縁部に沿って均一に延びても延びなくてもよい。フランジの形状はスペーサ基部の形状と異なってもよい。
好ましい一実施形態では、フランジは、椎間腔の周りで、フランジの上方部分が上位椎骨に接触するように適合され、フランジの下方部分が下位椎骨に接触するように適合されるようにして、椎間腔を横切って位置付けられるように構成される。他の実施形態では、フランジは、椎間腔の周りの単一の椎骨、または3つ以上の椎骨に接触するように構成されてもよい。いくつかの実施形態では、フランジは、2つ以上の椎間腔にまたがってもよい。一般的には、移植片は、椎体の前面に沿って、椎骨の前面に対して位置付けられるように適合される。いくつかの例では、移植片のフランジはまた、茎、横突起、関節突起間関節、上下関節突起、および骨棘などの、他の椎骨構造に接触するように構成されてもよい。さらに他の実施形態では、移植片は、椎体に付着または接触することなくこれらの椎骨構造に付着するように構成される。
本発明の一実施形態では、患者は挿管され、全身麻酔が行われる。患者は、通常の殺菌方法で準備され布で覆われる。脊椎に対する前方進入路が、腹側の椎体を露出させるために使用される。脊柱に対する多くの前方進入路が、本明細書に参照により組み込まれる、非特許文献1などの様々な医学書に記載されている。一実施形態では、上部頚椎がアクセスされる。前方上部頚椎は、経口または喉頭後経路によって、あるいは部分的または拡大顎骨切開術を使用することによってアクセスされてもよい。他の実施形態では、下部頚椎、顎胸接合部、胸椎、胸腰接合部、腰部、腰仙接合部、仙骨、または上記部位の組合せがアクセスされる。
本発明の別の実施形態では、椎体間スペーサおよび固定プレートは、互いの間である程度相対的に動くように構成される。椎体間スペーサと固定プレート部分の間にある程度の相対的な動きを提供することにより、装置は、移植部位における既存の解剖学的形状に対する一致が改善されて、骨構造に対する固定が改善されてもよい。図26A〜26Dは、矢状面内で旋回できるように配向された蝶番関節308を備えるそのような一実施形態を示す。本発明の他の実施形態では、蝶番関節308は、横断面、前額面、または3つの平面の間の任意の平面などの、他の平面内で旋回できるように配向されてもよい。椎体間スペーサ114と固定プレート102の間に提供される関節は、さらに、提供される動きの範囲を制限するように構成されてもよい。他の実施形態では、椎体間スペーサ114および/または固定プレート102の形体は、2つの構成要素間の相対的な運動範囲を限定してもよい。固定プレート102が凹部を有し、または椎体間スペーサ構成要素114のサイズが可動関節(movement joint)308の周りで減少しているか、もしくは先細になっていることにより、より大きな動きが可能になってもよい。当業者であれば、可動関節308は、動きに対する摩擦抵抗またはラチェット式の抵抗など、可動関節の他の特性を変化させるように構成されてもよいことが理解されるであろう。図26A〜26Dの蝶番関節は、椎体間スペーサおよび固定プレート上で対称的な位置で示されているが、偏心的な位置が使用されてもよい。さらに、単一の椎体間スペーサ114、固定プレート102、可動関節308が示されているが、他の実施形態は、2つ以上の可動関節308を有し、その際、固定プレート102および/または椎体間スペーサ114のどちらかが分割された形体を有し、それにより、分割された構成要素がそれ自体の可動関節308を有し、既存の解剖学的形状にさらに一致するように独立して移動または旋回することができる。さらに他の実施形態では、固定プレート102および/または椎体間スペーサ114は、装置が既存の解剖学的形状にさらに良好に一致するように、構成要素内部の蝶番または可動関節を有して提供される、2つ以上のサブコンポーネントを備えて構成されてもよい。例えば、装置の固定プレート構成要素は、蝶番関節を間に有する左右のサブコンポーネントとして構成されてもよい。別の例では、椎体間スペーサの上面および下面が旋回できるようにするため、椎体間スペーサは、蝶番関節を間に有する上位および下位のサブコンポーネントを有してもよい。蝶番関節の向きによって、椎体間スペーサの上面および下面は、横方向に、前後方向に、またはそれらの間の任意の方向に旋回してもよい。
上述のねじ保持アセンブリの実施形態に加えて、他のねじ保持アセンブリも考慮され、上述の椎体間癒合装置とともに使用されてもよい。後述する他のねじ保持アセンブリも、他のタイプの整形および医療装置とともに、ならびに、建設、家の修繕、消費財、電子装置、および他の用途などであるがそれらに限定されない、医療以外の用途で使用されてもよい。
図27および28は、部分的に締結具内腔112の拡張溝312内にあり、かつ部分的に締結具内腔112自体の中にある拡張可能な締結具保持リング310を備える、本発明の代替実施形態を示す。保持リング310は縮小された形体および拡張された形体を有するが、縮小された形体に付勢されている。保持リング310は、保持セグメント314および旋回セグメント316を有する。図28を参照すると、保持セグメント314は、拡張溝312に嵌入するように適合された、拡大された外径を有する。保持リング310の拡張された形体では、保持セグメント314は拡張溝312内にさらに拡張し、それによって保持セグメント314の内径318が増加される。保持セグメント318の内径318は、保持リング310の近位側開口部322から狭くなる傾斜した内表面320を有する。傾斜した表面320により、締結具158が保持セグメント314に挿入されるとその拡張が容易になる。締結具頭部160が保持リング310の保持セグメント314を貫通すると、保持リング310の多軸セグメント316の内径324がより大きくなって、保持リング310に対して拡張力を働かせることなく締結具頭部160が保持リング310内に留まることが可能になる。これにより、保持リング310が、完全にではなくても少なくとも部分的に、その縮小された形体まで戻ることが可能になる。後退力が締結具頭部160に働いた場合、締結具頭部160は、リング310の保持セグメント314および多軸セグメント316の内径318、324からの移行部分に位置するほぼ垂直な保持面232に当接し、締結具頭部160の後退に抵抗する。
図29Aおよび29Bに示される本発明の別の実施形態では、締結具330は、締結具頭部336内の補助ねじ332およびねじ内腔334を備える。縮小された形体および拡張された形体を有する拡張可能なリング338またはディスクは、締結具頭部336の周りの溝340内に提供され、拡張可能なリングまたはディスクは縮小された形体に付勢される。溝340は、拡張可能なリング338またはディスクが縮小された形体のとき、拡張可能なリング338またはディスクの内面346の一部344が部分的にねじ内腔334内に突出するようにして、1つ以上の開口部342において締結具頭部336のねじ内腔334と連続している。締結具330の補助ねじ332は、一般的には補助ねじ332の頭部348である拡張部分を有し、それは、拡張リング338またはディスクがねじ内腔334内に突出するねじ内腔334内の距離352よりも大きい外径350を有する。補助ねじ332の拡張部分348が、拡張可能なリング338またはディスクの内側突出部分344と接触していないとき、拡張可能なリング338またはディスクは縮小された形体のままであることができる。補助ねじ332の拡張部分348が、拡張可能なリング338またはディスクの突出部分344に完全に接して位置付けられているとき、それは、拡張可能なリング338あるいはディスクに対して作用し、拡張可能なリング338またはディスクをその拡張された形体に拡大させる。拡張された形体では、拡張可能なリング338またはディスクの外径354は、締結具330の残りの部分の中で最大外径よりも大きい。縮小された形体では、拡張可能なリングまたはディスクの外径は、溝から放射方向に延びても延びなくてもよい。
本発明の別の実施形態では、ねじ保持アセンブリは、締結具内腔の周りのアクセス空間にある付勢された遮断本体を備える。図30Aおよび30Bを参照すると、遮断本体368は、締結具158が通ることができるようにサイズ決めされた固定の開口部370を有する構造を備える。遮断本体368は、図30Aの非圧縮形体に付勢された1つ以上の付勢部材372をさらに備えるが、付勢は、付勢部材372を図30Bのような圧縮形体に動かすことによって克服されてもよい。図31は、非圧縮形体の締結具内腔112の周りに位置する、図30Aおよび30Bの遮断本体368を示す。図32A〜32Cでは、遮断本体368は、締結具本体162が遮断本体368の開口部370を通ることを可能にするアクセス空間374内の第1の位置を有する。遮断本体368の開口部370は、好ましくは、締結具頭部160が遮断本体368の開口部370に挿入されると、遮断本体368がその圧縮形体に変位するのを容易にするため、その近位面378からその遠位面380に向かって狭くなる傾斜した表面376を有する。図33A〜33Cは、締結具頭部160が遮断本体368を越えるのを防ぐ、またはそれに抵抗するアクセス空間374内の遮断本体368の第2の位置を示す。
本発明の別の実施形態では、フランジ付き椎体間癒合装置382のいくつかの実施形態は、1つ以上の骨ねじ158または締結具頭部160の少なくとも一部の上に重なって、後退を防ぐ、またはそれに抵抗するようにして固定プレート102に取り付けられてもよい、係止プレート384を備えてもよい。図34Aおよび34Bは、締結具386を使用して固定プレート102に取付け可能なX字形の係止プレート384を有する、本発明の一実施形態を示す。装置を骨に締結するのに使用される骨ねじの特定の配置および数に応じて、他の係止プレート形体も使用されてもよい。図34Bに示されるように、係止プレート384は、締結具386、一般的にはねじが回転されて係止プレート384を固定プレート102に係合したとき、係止プレート384が回転するのを防ぐ、1つ以上のアラインメント構造388を備えてもよい。アラインメント構造は、一般的に、固定プレート102上の補完的構造と接続するが、これは必須ではない。他の実施形態では、締結具のアラインメント構造または他の部分は固定プレート102とスナップ嵌合を形成してもよいので、締結具は不要であってもよい。
本発明を様々な代表的実施形態に関して記載してきたが、様々な追加の実施形態および記載された実施形態に対する変更が本発明の範囲内で検討される。したがって、上記の記載のいずれの部分も、特許請求の範囲において説明される本発明の範囲を限定するものと解釈されるべきでない。上述の実施形態のすべてについて、方法の段階を連続的に行う必要はない。
102 固定プレート
104 上方部分
106 下方部分
108 骨に面する面
110 アクセス面
112 穴
114 スペーサ
116 基部
118 上面
120 下面
122、124 側面
126 背面
Claims (19)
- 締結具頭部および締結具シャフトであって、前記締結具頭部が、ねじ内腔、外部溝、および前記ねじ内腔と前記外部溝との間の1つ以上の開口部を備える、締結具頭部および締結具シャフトと、
少なくとも部分的に前記外部溝内に位置し、前記1つ以上の開口部を通じて前記ねじ内腔内に突出する拡張可能な部材と、
前記ねじ内腔に嵌合するように構成されているとともに、前記1つ以上の開口部に対して前記拡張可能な部材を部分的に移動させるように構成されている補助ねじと、
を備える、締結具。 - 前記拡張可能な部材はリング状であることを特徴とする請求項1に記載の締結具。
- 締結具頭部およびねじ付き締結具本体を備える締結具であって、前記締結具頭部が、内腔開口部、該内腔開口部と連続する中央内部内腔、及び該中央内部内腔と連続する側部内腔とを備える締結具と、
少なくとも部分的に前記側部内腔内に位置し、拡張された形体および縮小された形体を有する拡張部材と、
前記中央内部内腔内に位置し、近位位置および遠位位置を有する雌ねじと、
を備える整形外科的締結システムにおいて、
前記雌ねじは、前記近位位置にあるときには前記側部内腔の周囲に位置しているとともに前記拡張部材を前記側部内腔の外へ少なくとも部分的に移動させ、前記遠位位置にあるときには前記側部内腔より遠位にあることを特徴とする整形外科的締結システム。 - 前記雌ねじは、ねじを切られたねじ本体と、角度がついた端部を有するねじ頭部と、を備えることを特徴とする請求項3に記載の整形外科的締結システム。
- 前記雌ねじは、前記側部内腔の周りの位置近くへ移動するように構成され、前記雌ねじの前記角度がついた端部は、前記拡張部材の端部に作用することを特徴とする請求項4に記載の整形外科的締結システム。
- 前記雌ねじの前記近位位置は、前記拡張部材を前記拡張された形体に変位させることを特徴とする請求項4に記載の整形外科的締結システム。
- 前記雌ねじの前記近位位置は、前記拡張部材が前記縮小された形体になることを可能にすることを特徴とする請求項4に記載の整形外科的締結システム。
- 前記縮小された形体の前記拡張部材は、部分的に前記中央内部内腔内に位置することを特徴とする請求項4に記載の整形外科的締結システム。
- 前記雌ねじの前記近位位置は、前記拡張部材を少なくとも部分的に前記中央内部内腔の外に変位させることを特徴とする請求項8に記載の整形外科的締結システム。
- 前記拡張部材は、前記縮小された形体に付勢されることを特徴とする請求項3に記載の整形外科的締結システム。
- 前記締結具頭部は、前記側部内腔と連続する拡張溝をさらに備え、前記拡張部材は、前記拡張溝の周りに位置付けられた細長い本体を備えることを特徴とする請求項3に記載の整形外科的締結システム。
- 前記細長い本体は、弓状の細長い本体であることを特徴とする請求項11に記載の整形外科的締結システム。
- 前記拡張部材は、少なくとも部分的に前記側部内腔内に位置する放射方向の細長い本体をさらに備えることを特徴とする請求項11に記載の整形外科的締結システム。
- 前記締結具を保持するように適合された締結具内腔を備える整形装置をさらに備えることを特徴とする請求項3に記載の整形外科的締結システム。
- 前記締結具内腔は、近位側直径、中間部直径、および遠位側直径を備え、前記近位側直径は前記中間部直径よりも小さいことを特徴とする請求項14に記載の整形外科的締結システム。
- 前記締結具内腔の前記遠位側直径は、前記締結具内腔の前記近位側直径よりも小さいことを特徴とする請求項15に記載の整形外科的締結システム。
- 前記整形装置は、椎体間スペーサであることを特徴とする請求項14に記載の整形外科的締結システム。
- 前記椎体間スペーサは、フランジ付きの椎体間スペーサであることを特徴とする請求項17に記載の整形外科的締結システム。
- 前記整形装置は、固定プレートであることを特徴とする請求項14に記載の整形外科的締結システム。
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US60/708,918 | 2005-08-17 | ||
PCT/US2006/009120 WO2006101837A2 (en) | 2005-03-17 | 2006-03-14 | Flanged interbody fusion device |
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JP2011210533A Division JP5555680B2 (ja) | 2005-03-17 | 2011-09-27 | フランジ付き椎体間癒合装置 |
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JP2011210533A Expired - Fee Related JP5555680B2 (ja) | 2005-03-17 | 2011-09-27 | フランジ付き椎体間癒合装置 |
JP2013117602A Expired - Fee Related JP5707444B2 (ja) | 2005-03-17 | 2013-06-04 | フランジ付き椎体間癒合装置 |
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JP2013117602A Expired - Fee Related JP5707444B2 (ja) | 2005-03-17 | 2013-06-04 | フランジ付き椎体間癒合装置 |
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