JP4564006B2 - 脊椎安定化インプラントおよび適用するための方法 - Google Patents
脊椎安定化インプラントおよび適用するための方法 Download PDFInfo
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- JP4564006B2 JP4564006B2 JP2006518656A JP2006518656A JP4564006B2 JP 4564006 B2 JP4564006 B2 JP 4564006B2 JP 2006518656 A JP2006518656 A JP 2006518656A JP 2006518656 A JP2006518656 A JP 2006518656A JP 4564006 B2 JP4564006 B2 JP 4564006B2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- 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
- A61B17/7059—Cortical plates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
- A61B17/8023—Variable length plates adjustable in both directions
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- 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
- Y10S606/00—Surgery
- Y10S606/902—Cortical plate specifically adapted for a particular bone
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Description
これは、「SPINAL STABILIZATION IMPLANT AND METHOD OF APPLICATION」に対する2003年7月7日出願の米国特許出願番号10/615,196の部分継続出願である。
本発明は、全般的には脊椎の骨接合術用の固定システムに関し、特に脊椎インプラントシステムおよびこのインプラントを挿入し、適用するための手術法に関する。
腰部および胸部脊椎への脊椎外科手術は古典的には開放性手術であり、適切に可視化する必要性によって、器具取り付け対象の脊椎のすべて、ならびに器具取り付け対象の領域の上および下の脊椎の部分を露出する外科的創から使用器具が入れられるということを意味するものであった。この広範囲に及ぶ露出は、かなりの量の組織、特に露出するために脊椎骨から剥ぎ取る必要のある腰部傍脊椎筋系を分断する。この剥ぎ取りは、電気焼灼または手による切断により直接に生じるか、あるいは凝固による筋肉への血管供給の遮断または血管の切断により間接的に生じ、そして露出を維持するのに必要とされる筋肉上の開創器による圧縮による外科手術時の血管供給の困惑によっても生じる筋肉損傷をもたらす。加えて、脊椎インプラントは、脊椎の面関節、特に最上方のペディクルスクリュー対に影響を及ぼす可能性があり、関係する関節の痛みまたは機能障害を引き起こし得る。これは、一部には、このペディクルスクリューシステムが普通の解剖学を尊重せずに安定性を与えるように設計されているという事実によるものである。言い換えれば、脊椎に金属を合わせる代わりに、脊椎が金属に合わせられる。
本発明は、これまで想定に入れられなかった最少侵襲性脊椎外科手術と一緒に脊椎の骨融合および安定化の補助として使用される脊椎器具システムを提供する。本発明の装置またはシステムは、留置、体内での操作および脊椎の分節に種々の圧力または力を及ぼすためのインプラントの伸縮を最少侵襲性の方法により可能とせしめるという点で独自である。このことは、本発明の新規な脊椎インプラント組立て体、ならびにこのような最少侵襲性の方法を可能とする本発明のインプラント組立て体の挿入ツールおよびシステムにより可能とされる。
最初に図1から11まで参照すると、脊椎を安定化するための本発明のインプラントプレート組立て体10は、2つの別々の部分、すなわち図1から3に別々に図示されている第1の部分11と、図4から6に図示されている第2の部分12から構成されている。この組立て体のこれらの2つの部分は図10および11に合体した形で図示されている。
次に、図12から16を参照すると、本発明の細長挿入ガンあるいはツール40の第1の態様が図示されている。この態様はインライン経皮的バージョンと呼ばれる。図13および14に最もよく図示されているように、ツール40と細長プレート組立て体10がこれらの伸長の方向に端と端をくっつけて一緒に延びるように、挿入ツール40は、プレート組立て体10のアーム18の近位端41に解除可能なように固定可能である。細長挿入ツール40は、全体的にプレート組立て体10を操作するために、そしてこれらの要素の間の距離の調整にねじ受入れ要素13および21を遠隔操作するために構成されている。挿入ツール40の目的は、脊椎インプラントを保持し、制御するための便利なツールを外科医に提供し、このインプラントの最少侵襲性留置の機構を提供し、この脊椎インプラントが膨らみ、Kワイヤとして知られている予め配置されたペディクルワイヤーに嵌合することができる機構を提供し、骨固定あるいはペディクルスクリューの留置の後この脊椎インプラントが圧縮され得る機構を提供し、そしてこのインプラントが位置決めされ、適宜固定されたならば、このインプラントの容易な解除を更に可能とせしめることである。
本発明のシステムは蛍光透視法の援用により挿入するように設計され、それゆえ、全身麻酔の後、患者は蛍光透視適合したORテーブル上でうつぶせの位置でのせられる。ここで説明する方法はL4および5レベル用のものであるが、すべてのコメントはすべての脊椎レベルに一般に適用可能である。ここで説明する方法は、別の手術の一部として前出のPLIF無しで本発明の器具の挿入を行うことができるが、L4/5PLIFがMetr−xシステム(Danek Trademark)などのアクセス器具を使用して最少侵襲性の方法で既に行われ、あるいは挿入されるものであったということも前提とする。
次に、図26、27および28を参照すると、この挿入ツールの第2の態様が図示されている。この態様においては、例えば、米国特許出願公報2003/0208203に見られるように、脊柱におおむね垂直の姿勢で接近することにより患者の皮膚と組織を通しての最少侵襲性アクセスで挿入するために、プレート組立て体10は挿入ツール40’の遠位端において解除可能なように保持される。
図28から33に図示するインプラントシステムの外科的な適用に関しての説明は次の通りである。この外科的な開口は近位のペディクル領域の露出のみを必要とするが、近位および遠位の両方を露出してもよい。骨針と蛍光透視法を使用して、このペディクルを前述の本発明の経皮的バージョンまたはシステムの方法に同一の方法で突き刺す。両方のペディクルを露出する場合には、ガイドワイヤ71および72の両方が外科的創から突き出す。近位のペディクルのみを露出する場合には、遠位のペディクルを経皮的穿刺によりカニューレ挿入する。骨針を取り出して、ガイドワイヤ71および72を残す。図28に図示するように、挿入ツール40’を近位のガイドワイヤ71にかぶせて手術創のなかに進め、脊椎骨と接触させる。
Claims (10)
- 脊椎の安定化のためのインプラントプレート組立体であって:
該組立体の遠位端の第1のねじ受け入れ受口要素であって、骨固定ねじを用いて椎骨への取り付けのためにねじ軸部通路およびねじ頭座を備える形態である第1のねじ受け入れ受口要素;
該第1のねじ受け入れ受口要素から近位方向に延びる細長アームであって、該細長アームに沿った細長貫通スロットを有し、該スロットが縁、およびねじ頭を有する骨固定ねじの部分を選択的に着座するための一連の隣接するねじ頭座凹みを有する細長アーム;
ねじ軸部通路およびねじ頭座を備える形態である第2のねじ受け入れ受口要素であって、該アーム上にスライド可能に受け入れられ、該第2のねじ受け入れ受口要素の通路が椎骨への取り付けのために該第2のねじ受け入れ受口要素を通って骨固定ねじの軸部を受け入れるために該スロット上に整列される第2のねじ受け入れ受口要素;を備え、該第2のねじ受け入れ受口要素および該スロットが、該第2のねじ受け入れ受口要素に着座した骨固定ねじのねじ頭が該第2のねじ受け入れ受口要素の通路を通って突出し、そして該骨固定ねじが椎骨に完全に固定されるとき、該第2のねじ受け入れ受口要素を該アームにクランプするために該スロットの縁に係合する形態および寸法である、インプラントプレート組立体。 - 前記ねじ頭を係合するために、該ねじ頭上に、前記第2のねじ受け入れ受口要素にねじによって受け入れられるキャップのこ歯ナットをさらに備える、請求項1に記載のインプラントプレート組立体。
- 前記ナットが、前記ねじ頭を係合するために、底面隆起を有する、請求項2に記載のインプラントプレート組立体。
- 脊椎の安定化のためのインプラントであって:
遠位端および近位端を有する細長インプラントプレート組立体であって、遠位端および近位端が骨固定ねじを用いて間隔を置いた第1の椎骨および第2の椎骨に個々に取り付けるための形態であり、第1のねじ受け入れ要素および第2のねじ受け入れ要素を含み、該第1のねじ受け入れ要素および第2のねじ受け入れ要素間の距離を調節可能に変更するために互いに対してスライド可能に受け入れられる第1のねじ受け入れ要素および第2のねじ受け入れ要素を含む細長インプラントプレート組立体と;
該第1のねじ受け入れ要素および該第2のねじ受け入れ要素がそれらの間でさらに相対的に移動しないように選択的に固締めするための固締め組立体と;を備え、そして該第1のねじ受け入れ要素が第1の受口ボウルを有し、そして該第2のねじ受け入れ要素が第2の受口ボウルを有し、該第1の受口ボウルおよび該第2の受口ボウルの各々が、骨固定ねじの軸部の通過のために底部にある通路と緊密に嵌合して骨固定ねじの頭を受け入れるための形態であり、該第2のねじ受け入れ要素が該細長インプラントプレート組立体のアーム部分に沿ってスライド可能であり、該固締め組立体がスロットを含み、該スロットが、該スロットを通り、かつ該スロットに沿って骨固定ねじの軸部を所望の位置で受け入れるために第2の受口ボウルの通路の下にあるアーム部分にあり、該第2の受口ボウルおよび該スロットのための通路が、該第2の受口ボウルに受け入れられた該骨固定ねじの頭の部分が該第2の受口ボウルの通路を通って突出して該スロットの縁と係合し、そして該骨固定ねじが椎骨に完全に固定されるとき、該第2のねじ受け入れ要素を該細長インプラントプレート組立体にクランプする形態および寸法であり、該細長インプラントプレート組立体の遠位端が、該第1の受口ボウルと連通する開放端のガイドワイヤ捕捉スロットを有する、インプラント。 - 前記第1の受口ボウルおよび前記第2の受口ボウルに着座した前記骨固定ねじの頭で該第1の受口ボウルおよび該第2の受口ボウルを閉め切る形態および寸法である固締めキャップを含む、請求項4に記載のインプラント。
- 前記固締めキャップが前記第1の受口ボウルおよび前記第2の受口ボウル内にねじによって受け入れられ、そして前記骨固定ねじの頭を係合するための底面隆起を有する、請求項5に記載のインプラント。
- 前記遠位端が、先導するテーパー付けされた横方向の縁を有する、請求項4に記載のインプラント。
- 前記細長インプラントプレート組立体が、脊柱前湾の湾曲に勘合するために長手方向に湾曲している、請求項4に記載のインプラント。
- 前記スロットが、前記第2の受口ボウルから突出する骨固定ねじの頭の部分を着座するための寸法および輪郭である、請求項4に記載のインプラント。
- 前記スロットの縁が、前記スロットに沿った異なる位置で骨固定ねじの頭の部分を選択的に着座するために、整列された一連の隣接するねじ頭着座凹みを含む、請求項9に記載のインプラント。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/615,196 US6945974B2 (en) | 2003-07-07 | 2003-07-07 | Spinal stabilization implant and method of application |
US10/832,928 US20050010221A1 (en) | 2003-07-07 | 2004-04-27 | Spinal stabilization implant and method of application |
PCT/US2004/019532 WO2005009259A1 (en) | 2003-07-07 | 2004-06-18 | Spinal stabilization implant and method of application |
Publications (2)
Publication Number | Publication Date |
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JP2007521087A JP2007521087A (ja) | 2007-08-02 |
JP4564006B2 true JP4564006B2 (ja) | 2010-10-20 |
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Application Number | Title | Priority Date | Filing Date |
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JP2006518656A Expired - Fee Related JP4564006B2 (ja) | 2003-07-07 | 2004-06-18 | 脊椎安定化インプラントおよび適用するための方法 |
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Country | Link |
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US (4) | US6945974B2 (ja) |
EP (2) | EP2305153B1 (ja) |
JP (1) | JP4564006B2 (ja) |
AT (1) | ATE541524T1 (ja) |
ES (2) | ES2434821T3 (ja) |
WO (1) | WO2005009259A1 (ja) |
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2003
- 2003-07-07 US US10/615,196 patent/US6945974B2/en not_active Expired - Lifetime
-
2004
- 2004-04-27 US US10/832,928 patent/US20050010221A1/en not_active Abandoned
- 2004-06-18 EP EP09171539.1A patent/EP2305153B1/en not_active Expired - Lifetime
- 2004-06-18 JP JP2006518656A patent/JP4564006B2/ja not_active Expired - Fee Related
- 2004-06-18 ES ES09171539T patent/ES2434821T3/es not_active Expired - Lifetime
- 2004-06-18 WO PCT/US2004/019532 patent/WO2005009259A1/en active Application Filing
- 2004-06-18 AT AT04776748T patent/ATE541524T1/de active
- 2004-06-18 EP EP04776748A patent/EP1641403B1/en not_active Expired - Lifetime
- 2004-06-18 ES ES04776748T patent/ES2386429T3/es not_active Expired - Lifetime
-
2005
- 2005-03-08 US US11/074,477 patent/US7419499B2/en not_active Expired - Fee Related
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2008
- 2008-01-07 US US11/970,310 patent/US8211145B2/en not_active Expired - Fee Related
Also Published As
Publication number | Publication date |
---|---|
EP2305153B1 (en) | 2013-08-21 |
WO2005009259A1 (en) | 2005-02-03 |
EP2305153A3 (en) | 2011-08-10 |
US20050010217A1 (en) | 2005-01-13 |
US6945974B2 (en) | 2005-09-20 |
ES2434821T3 (es) | 2013-12-17 |
US20050182407A1 (en) | 2005-08-18 |
JP2007521087A (ja) | 2007-08-02 |
EP2305153A2 (en) | 2011-04-06 |
US7419499B2 (en) | 2008-09-02 |
US20050010221A1 (en) | 2005-01-13 |
EP1641403A1 (en) | 2006-04-05 |
US8211145B2 (en) | 2012-07-03 |
ES2386429T3 (es) | 2012-08-21 |
ATE541524T1 (de) | 2012-02-15 |
EP1641403A4 (en) | 2008-10-22 |
EP1641403B1 (en) | 2012-01-18 |
US20080140129A1 (en) | 2008-06-12 |
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