JP2015510817A - 自己展開アンカーを用いた椎体間脊椎補綴整形固定デバイス - Google Patents
自己展開アンカーを用いた椎体間脊椎補綴整形固定デバイス Download PDFInfo
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Abstract
Description
Claims (31)
- 間隔を空けて配置された第1および第2主要面と、主要面の間に延びる少なくとも一つの側壁と、を有する本体であって、前記第1主要面は脊椎の第1椎骨の端板と係合し、前記第2主要面は脊椎の隣接する第2椎骨の端板と係合し、前記第1および第2主要面は該主要面とほぼ垂直に延びる縦軸を画成する、第1および第2主要面と、
前記本体内から延び前記第1主要面で開口する少なくとも一つの開口部と、
前記開口部内に配置され、近位端および遠位端を有するシャフトを備える少なくとも一つの固定要素と、
前記少なくとも一つの固定要素の近位端と係合し、固定要素の主軸周りに前記少なくとも一つの固定要素を回転させることなく、該少なくとも一つの固定要素を前記少なくとも一つの開口部を通して前記第1椎骨内に押し込むように動作する駆動機構と、
を備える椎間補綴具。 - 前記少なくとも一つの固定要素は、前記少なくとも一つの開口部を通して前記本体の縦軸を横切る方向で前記第1椎骨内に展開するように、前記少なくとも一つの開口部と前記少なくとも一つの固定要素が配向されていることを特徴とする請求項1に記載の椎間補綴具。
- 前記本体の縦軸を横切る方向は、(i)脊椎の前方方向と、(ii)脊椎の後方方向と、のうち一つに第1の実質的な方向成分を有することを特徴とする請求項2に記載の椎間補綴具。
- 前記本体の縦軸を横切る方向は、脊椎の縦軸に平行な第2の実質的な方向成分を有することを特徴とする請求項3に記載の椎間補綴具。
- 前記少なくとも一つの固定要素はその遠位端に尖った先端を有することを特徴とする請求項1に記載の椎間補綴具。
- 前記少なくとも一つの固定要素のシャフトが円孤状であることを特徴とする請求項1に記載の椎間補綴具。
- 前記少なくとも一つの固定要素の円弧状のシャフトは、(i)約3mmから約30mmの間、(ii)約10mmから約15mmの間、(iii)約12mmのうち一つの曲率半径を有することを特徴とする請求項6に記載の椎間補綴具。
- 前記少なくとも一つの固定要素のシャフトは、円滑、部分的または完全な同心環状、うねり付き、とげ付き、多辺の断面、四辺の断面、三辺の断面、曲線の断面、円形の断面のうちの一つであることを特徴とする請求項1に記載の椎間補綴具。
- 前記駆動機構は、
近位端のヘッドと、近位端から延びるねじ付きシャフトと、を有し、縦軸を規定する駆動シャフトと、
(i)前記駆動シャフトのねじ付きシャフトとねじ係合するねじ付き穴と、(ii)前記少なくとも一つの固定要素の近位端と係合し関節接合を許容する少なくとも一つの結合要素と、を有する平行移動要素と、
を備え、
前記駆動シャフトは前記本体内に回転可能に縦軸方向で固定されており、前記駆動シャフトの回転力が、固定要素の主軸周りに前記少なくとも一つの固定要素を回転させることなく、前記駆動シャフトの縦軸に沿って前記平行移動要素を移動させて前記少なくとも一つの開口部を通して前記第1椎骨内に前記少なくとも一つの固定要素を押し込むことを特徴とする請求項1に記載の椎間補綴具。 - 前記平行移動要素の前記少なくとも一つの結合要素がソケットを備え、
前記少なくとも一つの固定要素の遠位端がボールを備え、
前記駆動シャフトの縦軸に沿った移動中に、前記平行移動要素が前記少なくとも一つの固定要素の近位端と係合して関節接合を許容するように、前記ボールが前記ソケット内に捕らわれることを特徴とする請求項9に記載の椎間補綴具。 - (i)前記駆動シャフトのねじ付きシャフトとねじ係合するねじ付き穴と、(ii)少なくとも一つの別の固定要素の近位端と係合し関節接合を許容する少なくとも一つの結合要素と、を有する別の平行移動要素をさらに備える請求項9に記載の椎間補綴具。
- 前記ねじ付きシャフトは、(i)第1方向にねじが切られた第1ねじ付き部と、(ii)第1方向と逆向きの第2方向にねじが切られた第2ねじ付き部と、を備え、
前記平行移動要素の前記ねじ付き穴は、前記駆動シャフトのねじ付きシャフトの第1部分とねじ係合し、
前記平行移動要素の前記ねじ付き穴は、前記駆動シャフトのねじ付きシャフトの第2部分と係合し、
前記駆動シャフト上の回転力が、(i)前記駆動シャフトの縦軸に沿って前記平行移動要素を第1方向に移動させ、同時に、(ii)前記駆動シャフトの縦軸に沿って前記別の平行移動要素を前記第1方向とは逆向きの第2方向に移動させ、固定要素の主軸周りに前記固定要素を回転させることなく、前記少なくとも一つの固定要素と前記少なくとも一つの別の固定要素を各開口部を通して押し込む
ことを特徴とする請求項9に記載の椎間補綴具。 - 前記駆動シャフトは前記本体内で前後方向を向いており、デバイスのオペレータによって前記ヘッドに回転力を与えられるように、前記本体の外部で少なくとも前記ヘッドにアクセス可能であることを特徴とする請求項9に記載の椎間補綴具。
- 前記駆動シャフトは前記本体内で側方を向いており、デバイスのオペレータによって前記ヘッドに回転力を与えられるように、前記本体の外部で少なくとも前記ヘッドにアクセス可能であることを特徴とする請求項9に記載の椎間補綴具。
- 前記駆動機構は、前記少なくとも一つの固定要素の近位端に係合し関節接合を許容する少なくとも一つの結合要素を有する平行移動要素を備え、
(i)前後方向、(ii)第1および第2側方方向のうちの一つで縦軸に沿った前記平行移動要素の移動が、固定要素の主軸周りに前記少なくとも一つの固定要素を回転させることなく、前記少なくとも一つの固定要素を前記少なくとも一つの開口部を通して前記第1椎骨内に押し引きするように、前記平行移動要素が移動可能であることを特徴とする請求項1に記載の椎間補綴具。 - 前記駆動機構は、
近位端および遠位端を持つ細長シャフトを有する展開ツールであって、前記遠位端は、前記平行移動要素への取り外し可能な接続を可能にするよう機能する係合構造を有する、展開ツールをさらに備え、
前記少なくとも一つの開口部を通して前記少なくとも一つの固定要素を前記第1椎骨内に押し引きするように前記展開ツールの細長シャフトを押し、引きまたは回転するのに応答して、前記平行移動要素が移動することを特徴とする請求項15に記載の椎間補綴具。 - 複数の前記開口部のうちの一つのそれぞれスライド強調する複数の固定要素をさらに備え、
前記複数の固定要素は前記駆動機構とその近位端で係合し、固定要素の各軸周りに前記固定要素のいずれも回転させることなく、前記複数の固定要素を前記開口部を通して前記第1および第2椎骨内に押すように機能することを特徴とする請求項1に記載の椎間補綴具。 - 前記駆動機構は、(i)本体の縦軸、(ii)脊椎、(iii)互いを横切る方向のいずれかで、前記本体から前記第1および第2椎骨の一方または他方へと前記複数の固定要素のいずれかを展開するように動作することを特徴とする請求項17に記載の椎間補綴具。
- 前記複数の固定要素のうち第1固定要素の第1展開方向は、(i)前記本体の前後方向のうちの一方における第1の実質的な方向成分と、(ii)前記本体の縦軸に平行な第2の実質的な方向成分と、を有し、
前記複数の固定要素のうち第2固定要素の第2展開方向は、(i)前記本体の前後方向のうちの一方における第1の実質的な方向成分と、(ii)前記本体の縦軸に平行かつ前記第1固定要素の第1展開方向の第2の実質的な方向成分とは逆向きである第2の実質的な方向成分と、を有する
ことを特徴とする請求項17に記載の椎間補綴具。 - 前記第1固定要素の第1展開方向は、(iii)前記本体の前後方向に対する側方方向における第3の実質的な方向成分を有し、
前記第2固定要素の第2展開方向は、(iii)前記本体の前後方向に対する側方方向であり前記第1固定要素の第1展開方向の第3の実質的な方向成分と平行である第3の実質的な方向成分と、を有する
ことを特徴とする請求項19に記載の椎間補綴具。 - 前記複数の固定要素のうち第3固定要素の第3展開方向は、(i)前記本体の前後方向のうちの一方における第1の実質的な方向成分と、(ii)前記本体の縦軸に平行な第2の実質的な方向成分と、(iii)前記本体の前後方向に対する側方方向における第3の実質的な方向成分と、を有し、
前記第3展開方向の第1、第2、第3の実質的な方向成分のうち少なくとも二つは、前記第1および第2展開方向のうち少なくとも一つの第1、第2、第3の実質的な方向成分とほぼ逆向きである
ことを特徴とする請求項20に記載の椎間補綴具。 - 前記複数の固定要素のうち第4固定要素の第4展開方向は、(i)前記本体の前後方向のうちの一方における第1の実質的な方向成分と、(ii)前記本体の縦軸に平行な第2の実質的な方向成分と、(iii)前記本体の前後方向に対する側方方向における第3の実質的な方向成分と、を有し、
前記第4展開方向の第1、第2、第3の実質的な方向成分のうち少なくとも二つは、前記第1、第2および第3展開方向のうち少なくとも二つの第1、第2、第3の実質的な方向成分とほぼ逆向きである
ことを特徴とする請求項21に記載の椎間補綴具。 - 前記複数の固定要素のうち第1固定要素の第1展開方向は、(i)前記本体の第1側方方向と、前記本体の第2の逆向きの側方方向と、のうちの一方における第1の実質的な方向成分と、(ii)前記本体の縦軸に平行な第2の実質的な方向成分と、を有し、
前記複数の固定要素のうち第2固定要素の第2展開方向は、(i)前記本体の第1側方方向と、前記本体の第2の逆向きの側方方向と、のうちの一方における第1の実質的な方向成分と、(ii)前記本体の縦軸に平行かつ前記第1固定要素の第1展開方向の第2の実質的な方向成分とは逆向きである第2の実質的な方向成分と、を有する
ことを特徴とする請求項17に記載の椎間補綴具。 - 前記複数の固定要素のうち第3固定要素の第3展開方向は、(i)前記本体の第1側方方向と、前記本体の第2の逆向きの側方方向と、のうちの一方における第1の実質的な方向成分と、(ii)前記本体の縦軸に平行な第2の実質的な方向成分と、を有し、
前記第3展開方向の第1および第2の実質的な方向成分のうち少なくとも一つは、前記第1および第2展開方向のうち少なくとも一つの第1および第2の実質的な方向成分のそれぞれとほぼ逆向きである
ことを特徴とする請求項23に記載の椎間補綴具。 - 前記複数の固定要素のうち第4固定要素の第4展開方向は、(i)前記本体の第1側方方向と、前記本体の第2の逆向きの側方方向と、のうちの一方における第1の実質的な方向成分と、(ii)前記本体の縦軸に平行な第2の実質的な方向成分と、を有し、
前記第4展開方向の第1および第2の実質的な方向成分のうち少なくとも一つは、前記第1、第2、第3展開方向のうち少なくとも二つの第1および第2の実質的な方向成分のそれぞれとほぼ逆向きである
ことを特徴とする請求項24に記載の椎間補綴具。 - 前記本体の前記第1および第2主要面のうち少なくとも一つに配置される骨係合構造をさらに備え、
前記骨係合構造は、鋸歯状、突起、谷状、スパイク、ナーリング、キールのうち少なくとも一つを備えることを特徴とする請求項1に記載の椎間補綴具。 - 前記本体の前記第1および第2主要面のうち少なくとも一つの間にこれらを通って延びる少なくとも一つの開口部であって、当該補綴具の前記本体と一つ以上の椎骨との間の骨の成長を許容する開口部をさらに備えることを特徴とする請求項1に記載の椎間補綴具。
- 脊椎の隣接する第1および第2椎骨のそれぞれの端板間の椎間空間内に椎間補綴具を挿入する方法であって、
前記椎間空間内に前記椎間補綴具を配置するステップであって、前記椎間補綴具は、間隔を空けて配置された第1および第2主要面と、主要面の間に延びる少なくとも一つの側壁と、を有する本体を備え、前記第1主要面は前記第1椎骨の端板と係合し、前記第2主要面は前記第2椎骨の端板と係合し、前記第1および第2主要面は該主要面とほぼ垂直に延びる縦軸を画成する、ステップと、
固定要素の主軸周りに少なくとも一つの固定要素を回転させることなく、前記椎間補綴具の本体内から前記本体内の少なくとも一つの開口部を通して前記第1椎骨内に少なくとも一つの固定要素を展開するステップと、
を含む方法。 - 前記少なくとも一つの固定要素の展開方向は、前記本体の縦軸を横切ることを特徴とする請求項28に記載の方法。
- 前記本体の縦軸を横切る展開方向は、(i)脊椎の前方方向と、(ii)脊椎の後方方向と、のうち一つに第1の実質的な方向成分を有することを特徴とする請求項29に記載の方法。
- 前記本体の縦軸を横切る展開方向は、脊椎の縦軸に平行な第2の実質的な方向成分を有することを特徴とする請求項30に記載の方法。
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US11147686B2 (en) | 2015-05-21 | 2021-10-19 | Globus Medical Inc. | Device and method for deployment of an anchoring device for intervertebral spinal fusion |
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US11896496B2 (en) | 2015-05-21 | 2024-02-13 | Globus Medical, Inc. | Device and method for deployment of an anchoring device for intervertebral spinal fusion |
US11903844B2 (en) | 2015-05-21 | 2024-02-20 | Globus Medical, Inc. | Device and method for deployment of an anchoring device for intervertebral spinal fusion |
JP2018530394A (ja) * | 2015-10-13 | 2018-10-18 | グローバス メディカル インコーポレイティッド | 椎間脊椎融合用固定デバイスの展開用デバイス及び方法 |
JP2018531052A (ja) * | 2015-11-20 | 2018-10-25 | アミカス デザイン グループ、エルエルシー | 自己展開固定要素を備える椎間人工器官及び整形外科用融合デバイス |
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US9283087B2 (en) | 2016-03-15 |
WO2013141990A1 (en) | 2013-09-26 |
US20150305886A1 (en) | 2015-10-29 |
US9107761B2 (en) | 2015-08-18 |
US20150066147A1 (en) | 2015-03-05 |
JP5913727B2 (ja) | 2016-04-27 |
US8906101B2 (en) | 2014-12-09 |
EP2827807B1 (en) | 2019-12-11 |
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ES2770824T3 (es) | 2020-07-03 |
US8685104B2 (en) | 2014-04-01 |
EP2827807A4 (en) | 2015-11-25 |
US20140156010A1 (en) | 2014-06-05 |
US20130245767A1 (en) | 2013-09-19 |
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