JP6310416B2 - 脊椎安定化装置、ならびにその移植のための方法およびキット - Google Patents
脊椎安定化装置、ならびにその移植のための方法およびキット Download PDFInfo
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- JP6310416B2 JP6310416B2 JP2015094803A JP2015094803A JP6310416B2 JP 6310416 B2 JP6310416 B2 JP 6310416B2 JP 2015094803 A JP2015094803 A JP 2015094803A JP 2015094803 A JP2015094803 A JP 2015094803A JP 6310416 B2 JP6310416 B2 JP 6310416B2
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- tube element
- vertebral body
- interbody spacer
- anchor
- tube
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- 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
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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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00179—Ceramics or ceramic-like structures
-
- 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
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
- A61F2310/00796—Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
Description
本発明は、2つの脊椎骨を恒久に融合させるために、2つの隣接する椎体間の退化したまたは損傷した椎間板の代わりにスペーサとして、脊椎外科手術で用いられる脊椎安定化装置に関する。本発明はさらに、脊椎安定化装置を移植するための器具のキット、および装置を移植するための方法に関する。
先行技術において、融合させるべき隣接する椎体間のスペーサとして機能し、損傷または退化した椎間板の代わりとなる、このような着床システムが知られている。
本発明の目的は、従来の椎間板移植部の不利点を解消することである。
−上椎骨の椎体と下椎骨の椎体との間に挿入されるよう形作られる椎体間スペーサであって、上椎骨の椎体の下終板の方に配向される上面および下椎骨の椎体の上終板の方向に配向される底面を含み、椎体間スペーサは上面において前端部に達する少なくとも1つのチャネル状凹所と、底面において前端部に達する少なくとも1つのチャネル状凹所とを含み、さらに、これらの凹所の領域において、アンダーカットを含み、かつ構造に流れ込む再固化液体材とともに正嵌合接続をなすのに適する構造を含み;さらに
−各チャネル状凹所において固着装置であって、固着装置は近位端および遠位端と、第1の固定部と、第2の固定部と、第1および第2の固定部間のブリッジ部とを含み、第1および第2の固定部の各々は、ブリッジ部よりも遠位側に突出し、第1および第2の固定部は、熱エネルギ(たとえば機械的振動によってもたらされる摩擦熱、または好ましくは可視光線または赤外線周波数域の電磁波放射の吸収によってもたらされる吸収熱)によって液化可能である材料を含み、第1の固定部は、たとえば機械的振動または電磁波放射により、骨組織に固着されるようになっており、第2の固定部は構造において同じ態様で固着されるようになっている。
本発明の第3の局面に従い、脊椎安定化装置が提供され、以下を備える:
−上椎骨の椎体と下椎骨の椎体との間に挿入されるよう形作られる椎体間スペーサであって、上椎骨の椎体の下終板の方に配向される上面および下椎骨の椎体の上終板の方向に配向される底面を含み、さらに
−固定設備であって、固定設備は1つまたは2つの固定装置を含み、各固定装置は、支持部を含み、支持部は椎体間スペーサが上および下の椎骨の椎体の間から固定装置に向かう方向にずれないようにしっかりと留め、支持部は椎体間スペーサの表面の一部に対して静止するよう形作られ、固定設備は、固定装置を上部椎体にしっかりと留めるための2つの第1のファスナーと、固定装置を下部椎体にしっかりと留めるための2つの第2のファスナーとを含み、固定装置はそれぞれ、各ファスナーに対して、1つのファスナーを案内方向に案内するよう形作られるファスナー受け入れ開口を有し、第1のファスナーの案内方向と第2のファスナーの案内方向とは、互いに角度を持って、矢状面に対して投影をなし、案内方向およびファスナー受け入れ開口の位置は、第1および第2のファスナーが下部終板および上部終板とは異なる場所で、それぞれ上部椎体および下部椎体の皮質骨を縦断するようになっている。
本発明の第1および第3の局面の実施例に従い、脊椎安定化装置が提供され、この装置は以下を備える:
−上椎骨の椎体と下椎骨の椎体との間に挿入されるよう形作られる椎体間スペーサであって、上椎骨の椎体の下終板の方に配向される上面および下椎骨の椎体の上終板の方向に配向される底面を含み、さらに
−固定装置であって、椎体間スペーサが上および下の椎骨の椎体の間から固定装置に向かう方向にずれないようにしっかりと留める支持部を含み、支持部は椎体間スペーサの表面の一部に対して静止するよう形作られ、固定装置は、2つの第1のファスナー受け入れ開口を含み、各第1のファスナー受け入れ開口は、固定装置を上部椎体に固定するためのファスナーを受け入れ、さらに2つの第2のファスナー受け入れ開口を含み、各第2のファスナー受け入れ開口は、固定装置を下部椎体に固定するためのファスナーを受け入れ、第1のファスナー受け入れ開口は互いに第1の距離にあり、第2のファスナー受け入れ開口は互いに第2の距離にあり、第1の距離は第2の距離と異なる。
−自動挿入装置またはハンドピースであって、ハウジングと、機械的振動を発生するよう動作可能な超音波コンバータとを含み、コンバータはケース内に取付けられて、ハウジングに対して長手方向(近位側−遠位側の方向)に変位可能であり、さらにコンバータに結合可能(およびたとえば結合される)ソノトロードと、コンバータおよびソノトロードを遠位方向に押すための機構とを含み;
−ハウジングに結合することができる案内管(またはシャフト)であって、その中でソノトロードおよび/またはアンカー材エレメントが案内され、この配置と接触することになる組織は、コンバータによって生成され、かつソノトロードを介して伝えられる振動から守られ;さらに
−照準装置であって、移植に対して案内管方向を規定するよう案内管が結合され得る。
−剛性部および少なくとも1つの受け入れ開口を有する固定装置本体、
−受け入れ開口内に挿入するための少なくとも1つのファスナーであって、このファスナーはアンカー材部を有し、アンカー材部は液体状態で固定装置が固定されるべき骨組織内に挿入され、それにより骨組織に浸透し、後で硬化してファスナーを骨組織に固定し、
−少なくとも1つのファスナーは固定装置本体と協働して、ファスナーが骨組織に固定された場合に、固定装置本体を骨組織に保持する。
以下において、本発明の実施例は図面を参照して記載される。図面は概略的に示され、寸法通りではない。図面において、同じ参照符号は同じまたは同様のエレメントを示す。
図1はヒトの脊椎に挿入される脊椎安定化装置の実施例を示す。具体的には、図は上部脊椎骨1および下部脊椎骨2を示し、その間の椎間板は少なくとも部分的に除去されている。装置は上部脊椎骨と下部脊椎骨の椎体間に椎体間スペーサ3を含む。椎体間スペーサは、上部椎体および下部椎体間の距離保持装置として働く。椎体間で外科的に挿入された後の椎体間スペーサは、2つの固定装置4によって定位置に保持される。各固定装置4は、2つのアンカーを有し、それぞれ上部椎体および下部椎体に固着される。さらに、腹部方向への動きに対して、椎体間スペーサ3をしっかりと留める支持部6を含む。
−1個の中央に走る長手の通し開口12の代わりに、椎体間スペーサ3は中央ブリッジ(図面においては見えない)によって分離されている2つの横通し開口202を含む。
−管エレメント51用の受け入れ開口63は円形ではなく、それゆえ回転方向において対称ではない。さらに、管エレメントの部分の外形状はそれに対応して適合される。
図に示され、かつ上記の特徴に加えて、脊椎安定化装置は以下を備えることができる:
−頭蓋−仙骨方向における摺動相対運動に対して、椎体間スペーサ3および固定装置をしっかりと留める正嵌合構造。このような正嵌合構造は、たとえば椎体間スペーサの対応する窪みと協働する後部に突出するペグ、または固定装置の開口内で協働する椎体間スペーサのペグを含むことができる。
−傾いた、細い、自己リーミング構造の配置が可能となる。自己リーミング構造は、たとえば、突きぎりのような手段によって、椎体に穴を開ける外科的工程を避ける働きをなす。
図51は椎体間スペーサ3を組込むためのアセンブリを示す。ここに示される実施例において、スペーサテンプレートを保持するために用いられるハンドル装置241と異なるスペーサハンドル511が用いられる。さらに、スペーサハンドルは移植の最適な視野を得るよう角度がつけられている。スペーサハンドル511、椎体間スペーサ3、および固定装置本体21の間には、ねじ込み接続(したがって、中央穴205)があり、打抜き器521はねじ回しとして、かつ椎体間スペーサ3に打込むためのツールとして用いることができる。照準装置271は打抜き器が達する近位側−遠位側貫通孔を含むか、打抜き器521が取除かれた後のみスペーサハンドル511に固定される。
Claims (14)
- 脊椎安定化装置であって、
− 上椎骨の椎体と下椎骨の椎体との間に挿入されるよう形作られる椎体間スペーサを備え、椎体間スペーサは上椎骨の椎体の下終板の方に配向される上面および下椎骨の椎体の上終板の方向に配向される底面を含み、さらに
− 固定装置を備え、前記固定装置は、前記椎体間スペーサが上および下の椎骨の椎体の間から、固定装置に向かう方向にずれないようしっかりと留める支持部を含み、前記支持部は椎体間スペーサの表面の一部に静止するよう形作られ、前記支持部は複数のファスナー受け入れ開口を有し、
− 前記固定装置はさらに複数のファスナーを含み、前記ファスナーの各々は、近位側に向かって開口する空洞を規定する管エレメントを含み、近位端とは反対側の遠位端に向かって前記空洞を区切るベースと、骨側に向かって前記空洞が開口する少なくとも1つの横管エレメント開口とを含み、アンカー材部が前記空洞内に配置されるか、または前記近位側から前記空洞へと挿入するように形作られており、各ファスナーは受け入れ開口の1つの中へと挿入するのに適しており、
− 前記管エレメントは外面にねじ山を有しておらず、
− 前記アンカー材部は液体状態において、上椎骨の椎体および下椎骨の椎体の少なくとも一方の骨組織に、少なくとも1つの管エレメント開口を少なくとも部分的に通じて、挿入されるよう構成されており、それにより骨組織に浸透して、その後硬化して前記支持部を椎体に固定し、
− 前記管エレメントは、前記管エレメントの近接する部分より大きな最大直径を有するカラーを含み、前記カラーは、近位方向へと離脱しないように前記支持部を固定するために前記支持部と協働し、
− 前記管エレメントは、中央付け段差を前記カラーの近位に含み、前記中央付け段差は、前記アンカー材部を前記空洞に挿入するためのツールの遠位部分と協働することによって前記ツールをセンタリングするように適合される、脊椎安定化装置。 - 脊椎安定化装置であって、
− 上椎骨の椎体と下椎骨の椎体との間に挿入されるよう形作られる椎体間スペーサを備え、椎体間スペーサは上椎骨の椎体の下終板の方に配向される上面および下椎骨の椎体の上終板の方向に配向される底面を含み、さらに
− 固定装置を備え、前記固定装置は、前記椎体間スペーサが上および下の椎骨の椎体の間から、固定装置に向かう方向にずれないようしっかりと留める支持部を含み、前記支持部は椎体間スペーサの表面の一部に静止するよう形作られ、前記支持部は複数のファスナー受け入れ開口を有し、
− 前記固定装置はさらに複数のファスナーを含み、前記ファスナーの各々は、近位側に向かって開口する空洞を規定する管エレメントを含み、近位端とは反対側の遠位端に向かって前記空洞を区切るベースと、骨側に向かって前記空洞が開口する少なくとも1つの横管エレメント開口とを含み、アンカー材部が前記空洞内に配置されるか、または前記近位側から前記空洞へと挿入するように形作られており、各ファスナーは受け入れ開口の1つの中へと挿入するのに適しており、
− 前記管エレメントは外面にねじ山を有しておらず、
− 前記アンカー材部は液体状態において、上椎骨の椎体および下椎骨の椎体の少なくとも一方の骨組織に、少なくとも1つの管エレメント開口を少なくとも部分的に通じて、挿入されるよう構成されており、それにより骨組織に浸透して、その後硬化して前記支持部を椎体に固定し、
− 前記管エレメントは、前記管エレメントの近接する部分より大きな最大直径を有するカラーを含み、前記カラーは、近位方向へと離脱しないように前記支持部を固定するために前記支持部と協働し、
− 前記受け入れ開口は、前記支持部から遠位方向に突出し、前記椎体の骨組織内に突出するように構成されたカラー部を含む、脊椎安定化装置。 - 前記アンカー材は、液化可能である熱可塑性材料であり、押す力と機械的振動との共同作用により、液化の後少なくとも海綿質骨組織の構造の中に押込められ、その後硬化して、アンカーと骨組織との間に正嵌合接続を形成する、請求項1または2に記載の脊椎安定化装置。
- 前記アンカー材は、機械的エネルギ、放射エネルギおよび電気エネルギの少なくとも1つがアンカー材エレメントに結び付けられる間、ベースに対して押されると部分的に液化するようになっているアンカー材エレメントにより、与えられる、請求項1から3のいずれか1項に記載の脊椎安定化装置。
- 前記受け入れ開口は、正中面に対してゼロでない角度で管エレメントを案内するよう適合され、上椎体に挿入されるファスナーおよび下椎体に挿入される管エレメントは、互いに対して平行ではない、請求項1から4のいずれか1項に記載の脊椎安定化装置。
- 前記管エレメントは、前記空洞の長手方向の軸に対して角度をなして構成される指向構造を備え、液化可能材の複数の互いに異なる部分を、前記横管エレメント開口の複数の互いに異なるものにそれぞれ方向づけ、前記指向構造は、空洞を遠位側に終端させる指向構造体と、前記指向構造体から近位に突出する少なくとも1つの壁を有する分離部とを含む、請求項1から5のいずれか1項に記載の脊椎安定化装置。
- 前記管エレメントは前記横管エレメント開口の遠位に自己リーミング構造を有する、請求項1から6のいずれか1項に記載の脊椎安定化装置。
- 前記管エレメントのうち少なくとも1つは、前記管エレメントが前記受け入れ開口に挿入されたときに、前記受け入れ開口の遠位側に位置することで、前記固定装置に対して前記管エレメントを留めるように構成されるロッキング特徴部を前記カラーの遠位に含む、請求項1から7のいずれか1項に記載の脊椎安定化装置。
- 前記ロッキング部はランプ状特徴部である、請求項8に記載の脊椎安定化装置。
- 2つの椎体間の空間内に脊椎安定化装置を移植するためのパーツのキットであって、前記キットは、
− 脊椎安定化装置を備え、前記脊椎安定化装置は、
○ 上椎骨の椎体と下椎骨の椎体との間に挿入されるよう形作られる椎体間スペーサを含み、椎体間スペーサは上椎骨の椎体の下終板の方に配向される上面および下椎骨の椎体の上終板の方向に配向される底面を有し、さらに
○ 固定装置を含み、前記固定装置は、前記椎体間スペーサが上および下の椎骨の椎体の間から、固定装置に向かう方向にずれないようしっかりと留める支持部を含み、前記支持部は椎体間スペーサの表面の一部に静止するよう形作られ、前記支持部は複数のファスナー受け入れ開口を有し、
○ 前記固定装置はさらに複数のファスナーを含み、前記ファスナーの各々は、近位側に向かって開口する空洞を規定する管エレメントを含み、近位端とは反対側の遠位端に向かって前記空洞を区切るベースと、骨側に向かって前記空洞が開口する少なくとも1つの横管エレメント開口とを含み、アンカー材部が前記空洞内に配置されるか、または前記近位側から前記空洞へと挿入するように形作られており、各ファスナーは受け入れ開口の1つの中へと挿入するのに適しており、
○ 前記アンカー材部は液体状態において、上椎骨の椎体および下椎骨の椎体の少なくとも一方の骨組織に、少なくとも1つの管エレメント開口を少なくとも部分的に通じて、挿入されるよう構成されており、それにより骨組織に浸透して、その後硬化して前記支持部を椎体に固定し、
前記キットはさらに、
− 前記脊椎固定装置に接続するよう機能するハンドル装置を備え、前記キットは前記椎体間スペーサからある距離でもって前記ハンドル装置に固定するよう機能する照準装置をさらに備え、前記照準装置は複数の照準開口を含み、各照準開口は、前記受け入れ開口の1つに対応し、さらに、
− 案内管を備え、前記案内管は、前記照準開口の1つを通って前記対応する受け入れ開口に到達し、横断面および正中矢状面を横断するように配置されるように構成され、これによって前記照準開口および対応する受け入れ開口は、交差した構成において前記照準開口が受け入れ開口に対応するように互いに適合される、キット。 - 前記管エレメントは、前記管エレメントの隣接部分より大きな最大直径を有するカラーを含む、請求項10に記載のキット。
- 前記管エレメントは、中央付け段差を前記カラーの近位に含み、前記中央付け段差は、前記案内管の遠位部分と協働するように適合される、請求項11に記載のキット。
- 前記アンカー材は、液化可能である熱可塑性材料であり、押す力と機械的振動との共同作用により、液化の後少なくとも海綿質骨組織の構造の中に押込められ、その後硬化して、アンカーと骨組織との間に正嵌合接続を形成する、請求項10から12のいずれか1項に記載のキット。
- 機械的振動をアンカー材に結び付けるためのソノトロードをさらに備え、前記ソノトロードは、前記案内管を通って挿入され、前記案内管内において挿入されながら前記管エレメント内の前記アンカー材を遠位側へ向けて押すように適合される、請求項13に記載のキット。
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