JP4865784B2 - 滑走嵌合伸延ピースを有する棘突起間インプラントおよび埋め込み法 - Google Patents
滑走嵌合伸延ピースを有する棘突起間インプラントおよび埋め込み法 Download PDFInfo
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- A—HUMAN NECESSITIES
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- 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
- A61B17/7062—Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
- A61B17/7068—Devices comprising separate rigid parts, assembled in situ, to bear on each side of spinous processes; Tools therefor
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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
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Description
2005年3月22日登録、James F. Zuckerman等による、名称「滑走嵌合伸延ピースを有する棘突起間インプラントおよび埋め込み法」なる米国特許仮出願第60/664,049号(代理人整理番号KLYC-01087US4)、
2005年3月22日登録、James F. Zuckerman等による、名称「滑走嵌合伸延ピースを有する棘突起間インプラントおよび埋め込み法」なる米国特許仮出願第60/664,311号(代理人整理番号KLYC-01087US5)、
2006年3月17日登録、James F. Zuckerman等による、名称「滑走嵌合伸延ピースを有する棘突起間インプラントおよび埋め込み法」なる米国特許出願第11/___,___号(代理人整理番号KLYC-01087US6)、および、
2006年3月17日登録、James F. Zuckerman等による、名称「滑走嵌合伸延ピースを有する棘突起間インプラントおよび埋め込み法」なる米国特許出願第11/___,___号(代理人整理番号KLYC-01087US7)。
図1および2は、本発明の実施態様によるインプラント100を示す。インプラント100は、ウィング130、スペーサ120、および、先導組織拡張器(本明細書では別に伸延ガイドとも呼ばれる)110を含む。この特定の実施態様における伸延ガイド110は楔型をしている。すなわち、インプラントは、インプラント100の遠位端から、ガイド110がスペーサ120に接続する領域104に向って拡大する断面を持つ(図に対する基準点は、隣接棘突起間に対するインプラントの挿入点に基づく)。上記構成を持つ伸延ガイドは、インプラント100が隣接棘突起間に外科的に挿入される際、軟部組織および棘突起の伸延を起動するように機能する。隣接頸椎の棘突起間へのインプラント100の挿入をやり易くするために、伸延ガイド110は尖端状等であってもよいことを理解しなければならない。手術部位への外傷を小さくし、早期の治癒を促進し、正常な解剖学の不安定化を阻止するためには、挿入技術が、骨および周辺組織または靭帯をできるだけ撹乱しないことが有利である。図1および図2の実施態様では、棘突起の骨を除去する必要、および、棘突起と直接関連する靭帯および組織を生体から摘出する必要は全くない。例えば、上部頸椎棘突起への衝撃を部分的に緩衝する項靭帯(棘上靭帯)を切る必要はない。
図18は、本発明によるインプラント700の別態様の斜視図である。インプラント700は、始動ピース704、および、始動ピース704と滑走性に結合するように適応した伸延ピース702を含んでもよい。始動ピース704および滑走嵌合伸延ピース702は、隣接棘突起の間に設置され、互いに結合されると、図1-17を参照しながら前述したインプラント100に近似する。例えば、図18のインプラント700は、インプラント700の遠位端に第1ウィング730、第1ウィング730から延びる固定スペーサ720、スペーサ720から延びる第2ウィング760を含む。従って、スペーサ720は、第1ウィング730と第2ウィング760との間に配され、伸延ガイド710は、インプラント700の近位端716に配される。
図23Aおよび23Bは、本発明によるインプラント800の別態様の、端面から見た斜視図である。インプラント800は、始動ピース804と、始動ピース804と滑走的に結合することが可能な滑走嵌合伸延ピース802を含む。始動ピース804および滑走嵌合伸延ピース802は、図23Bに示すように、隣接棘突起間に配され互いに結合されると、隣接棘突起の内の一方をまたぐ、第1ウィング830と第2ウィング860を含む、サドル型を有する。インプラント800は、図1-17において前述したインプラントと近似する。例えば、インプラント800は、インプラント800の遠位端において第1ウィング830、第1ウィング830から延びる固定スペーサ820、スペーサ820から延びる第2ウィング860、従ってスペーサ820は第1ウィング830と第2ウィング860の間に配される、および、インプラント800の近位端816における伸延ガイド810を含む。
ある実施態様では、インプラントは、医用級金属、例えば、チタン、ステンレススチール、コバルトクロム、およびそれらの合金、あるいは、同様に高い強度および生体適合性を持つ、好適なインプラント材料から製造される。さらに、インプラントは、少なくとも部分的に、形状記憶金属、例えば、チタンとニッケルの合金であるNitinolから製造されてもよい。このような材料は、通常、X線不透過であり、X線画像法および他のタイプの画像法で目に見える。本発明によるインプラント、および/または、その部分もまた、やや屈曲性および/または変位性の高い材料から製造することが可能である。これらの実施態様では、インプラントおよび/またはその部分は、全体としてまたは部分的に、医用級生体適合性ポリマー、コポリマー、ポリマー混合物、およびポリマー組成物から製造することが可能である。コポリマーとは、1種を超えるモノマーから得られるポリマーである。ポリマー組成物は、二つ以上の物質から成る異種混合物であって、成分同士が混じり合わず、従って、相互の間に界面を形成する混合物である。ポリマー混合物は、異なる2種以上のポリマーから成る、巨視的には均一な混合物である。多くのポリマー、コポリマー、ポリマー混合物、およびポリマー組成物は、X線透過性であり、X線またはその他のタイプの画像法では目に見えない。このような材料を含むインプラントは、医師に対し、完全にX線不透過材料から成るインプラントと比べると、視像化される脊柱について比較的妨げられない目視を可能とする。しかしながら、インプラントは、X線透過材料を含むことを要しない。
性質 値
密度 1.3 g/cc
ロックウェルM 99
ロックウェルR 126
引っ張り強度 97 MPa
弾性係数 3.5 GPa
曲げ強度係数 4.1 GPa
PEEK 450Gは、適切な物理的・力学的性質を持つので、隣接棘突起間の物理的負荷を担持し、分散させるのに好適である。インプラント、および/またはその部分は、押し出し成形、射出成形、圧縮成形、および/または機械加工技術によって形成することが可能である。選択された材料には充填剤を添加することも可能であることに注意しなければならない。ポリマー材料を補強するために、充填剤を、ポリマー、コポリマー、ポリマー混合物、またはポリマー組成物に添加することが可能である。充填剤は、力学的、光学的、および熱的性質のような性質を修飾するために添加される。例えば、カーボン線維は、ある用途、例えば、負荷担持装置用として強度を機械的に強化するためポリマー補強用として添加される。ある実施態様では、他の等級のPEEKも利用が可能であり、本発明によるインプラントへの使用が考えられる。例えば、30%ガラス充填、または30%カーボン線維充填等級PEEKも、それらの材料の体内埋め込み装置用使用が、FDA、またはその他の統制機関によって承認される限り、考慮の対象になる。ガラス充填PEEKは、充填されないPEEKに比べて、膨張率を下げ、PEEKの曲げ強度係数を上げる。その結果得られる製品は、強度、剛性、または安定性の強化にとって理想的であることが知られる。カーボン充填PEEKは、充填されないPEEKと比べて、圧縮強度および剛性が強化され、膨張率が下がることが知られる。カーボン充填PEEKも、磨耗耐性および負荷担持能を提供する。
頸椎において、インプラント400を埋め込むための、最小侵襲手術法が、本明細書に開示され、教示される。この方法では、図25Aに示すように、好ましくは、ガイドワイヤー80が、設置ネットワークまたはガイド90を貫いて、インプラントレシピエントの頸部に挿入される。ガイドワイヤー80は、棘突起を含む頸椎に対してインプラントをどこに置くべきなのかその位置を特定するために使用される。ガイドワイヤー80が、画像技術の助けを借りて位置づけられたならば、切開創を頸部側面に設ける。これによって、本発明の実施態様によるインプラントが、切開創を通じて、ガイドワイヤー80に対してほぼ直角な線にそって、かつ、ガイドワイヤー80の先端に向かって頸部に位置づけられる。一つの実施態様では、インプラントは、図1-17で前述したものと同じ大きさのインプラント400(すなわち、伸延性ではない本体を持つ)で、伸延ガイド110、スペーサ120、および第1ウィング130を有するインプラントであってもよい。このインプラント400が患者の頸部に挿入される。挿入時、伸延ガイド110は、組織を切り離さず、組織を貫通し、または分離することが好ましい。
Claims (10)
- 棘突起間に配置されるように適応した棘間インプラントであって、
始動ピース;および、
伸延ピースであって、始動ピース上を第1の方向に滑走させられることにより始動ピースに滑走的に連結されて、始動ピースに隣接して配される伸延ピースを含み、
始動ピースは、伸延ピースが始動ピースの上に配される前に、棘突起間に前記第1の方向と同一直線上の方向に挿入されることにより棘突起間に配置されるように適応することを特徴とする、前記インプラント。 - 棘間インプラントは、棘間インプラントの遠位端に第1ウィング、第2ウィング、第1ウィングと第2ウィングの間に配されるスペーサ、および、棘間インプラントの近位端に組織拡張器を有する、請求項1に記載のインプラント。
- 始動ピースは下方滑走面と下方接触面を含み、
伸延ピースは上方滑走面と上方接触面を含み、上方滑走面は下方滑走面にそって滑走し、それによって伸延ピースが始動ピースの上に配置されるように適応し、
棘突起に対するインプラントの動きが、下方接触面によって制限される、
ことを特徴とする、請求項1に記載のインプラント。 - 始動ピースは第1ウィングと第2ウィング、および伸延要素を有し、
伸延ピースは、始動ピースの上に配されてスペーサを定め、
始動ピースは、棘突起の間に配されるように適応し、そのために、棘突起の内の一方が、少なくとも部分的に、第1ウィングと第2ウィングの間に配される、
ことを特徴とする、請求項1に記載のインプラント。 - 始動ピースの少なくとも一部の内部に配される空洞;
伸延ピースの少なくとも一部から延びる突起をさらに含み、
伸延ピースが始動ピースに滑走的に連結する時、突起は空洞に受容されることを特徴とする、請求項1から4のいずれか一項に記載のインプラント。 - 第1ウィングおよび第2ウィングの内の一方、または両方が、棘突起に対するインプラントの相対的移動を制限するように適応することを特徴とする、請求項2、4、5のいずれか一項に記載のインプラント。
- 始動ピースは、棘突起の内の一方に接触するように適応した下方接触面、および、下方接触面に対し非ゼロ角度で配される下方滑走面を含み;かつ、
伸延ピースは、棘突起の内の他方に接触するように適応した上方接触面、および、それに対して下方滑走面が滑走するように適応する上方滑走面を含み;かつ、
棘突起の間に配された時、上方滑走面は、下方滑走面に対し実質的に平行に配されるように適応し;かつ、
伸延ピースが始動ピースの上に配された時、スペーサが、下方接触面と上方接触面の間に定められる、
ことを特徴とする、請求項1に記載のインプラント。 - 始動ピースは、スペーサの下方部分に対し非ゼロ角度で配置される下方滑走面を含み;かつ、
伸延ピースは、棘突起の間に配されると、下方滑走面に対し実質的に平行に配置される上方滑走面を含むことを特徴とする、請求項2に記載のインプラント。 - 始動ピースが、棘突起の内の一方に接触するように適応した第1接触面を含み;
伸延ピースは、棘突起の内の他方に接触するように適応した第2接触面を含み;および、
伸延ピースが始動ピースの上に配されると、第1接触面と第2接触面の間にスペーサが定められることを特徴とする、請求項1から4のいずれか一項に記載のインプラント。 - 始動ピースが、下方伸延要素、第1ウィング、スペーサの下方部分、および第2ウィングを含み、かつ、
伸延ピースは、上方伸延要素、およびスペーサの上方部分を含む、
ことを特徴とする、請求項1に記載のインプラント。
Applications Claiming Priority (9)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US66431105P | 2005-03-22 | 2005-03-22 | |
US66404905P | 2005-03-22 | 2005-03-22 | |
US60/664,311 | 2005-03-22 | ||
US60/664,049 | 2005-03-22 | ||
US11/378,893 | 2006-03-17 | ||
US11/378,893 US8070778B2 (en) | 2003-05-22 | 2006-03-17 | Interspinous process implant with slide-in distraction piece and method of implantation |
US11/384,055 | 2006-03-17 | ||
US11/384,055 US20060264939A1 (en) | 2003-05-22 | 2006-03-17 | Interspinous process implant with slide-in distraction piece and method of implantation |
PCT/US2006/010521 WO2006102485A2 (en) | 2005-03-22 | 2006-03-22 | Interspinous process implant with slide-in distraction piece and method of implantation |
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Publication Number | Publication Date |
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JP2008534066A JP2008534066A (ja) | 2008-08-28 |
JP4865784B2 true JP4865784B2 (ja) | 2012-02-01 |
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JP2008503171A Expired - Fee Related JP4865784B2 (ja) | 2005-03-22 | 2006-03-22 | 滑走嵌合伸延ピースを有する棘突起間インプラントおよび埋め込み法 |
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US (1) | US8070778B2 (ja) |
EP (1) | EP1861025A4 (ja) |
JP (1) | JP4865784B2 (ja) |
KR (1) | KR101221274B1 (ja) |
WO (1) | WO2006102485A2 (ja) |
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- 2006-03-17 US US11/378,893 patent/US8070778B2/en not_active Expired - Fee Related
- 2006-03-22 EP EP06739348A patent/EP1861025A4/en not_active Withdrawn
- 2006-03-22 JP JP2008503171A patent/JP4865784B2/ja not_active Expired - Fee Related
- 2006-03-22 KR KR1020077024297A patent/KR101221274B1/ko not_active IP Right Cessation
- 2006-03-22 WO PCT/US2006/010521 patent/WO2006102485A2/en active Application Filing
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JP2003523214A (ja) * | 1997-10-27 | 2003-08-05 | セント フランシス メディカル テクノロジーズ インコーポレイテッド | 背骨用伸延インプラント |
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Also Published As
Publication number | Publication date |
---|---|
US8070778B2 (en) | 2011-12-06 |
US20060265067A1 (en) | 2006-11-23 |
EP1861025A4 (en) | 2009-07-15 |
WO2006102485A2 (en) | 2006-09-28 |
EP1861025A2 (en) | 2007-12-05 |
KR20080040620A (ko) | 2008-05-08 |
WO2006102485A3 (en) | 2007-03-01 |
KR101221274B1 (ko) | 2013-01-11 |
JP2008534066A (ja) | 2008-08-28 |
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