JP2015515342A - 患者適合外科用ガイドおよびその使用方法 - Google Patents
患者適合外科用ガイドおよびその使用方法 Download PDFInfo
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- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
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- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
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- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
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- A61F2310/00011—Metals or alloys
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- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
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Abstract
Description
本出願は、2010年6月29日出願の米国仮特許出願第61/359,710号、および2010年10月15日出願の同第61/393,695号の優先権を主張する、2011年6月29日出願の米国特許出願第13/172,683号の一部継続出願である。本出願はまた、2012年4月17日出願の米国仮特許出願第61/625,559号の優先権を主張する。これらの出願は全て、それら全体を参照することにより本明細書に援用される。
患者の解剖学的構造に関連したデータを獲得するステップ;
獲得したデータを、3次元の1つまたは複数のデータセットに変換するステップ;
患者に実施する外科的処置を容易にするために、少なくとも1つの軌道または経路を決定するステップ;
患者の解剖学的構造に関連付けられた少なくとも1つの面を決定するステップ;
カスタマイズされた外科用デバイスまたは器具の3次元表示を生成するステップであって、この表示は、患者の解剖学的構造に関連付けられる少なくとも1つ面への経路の少なくとも1つ軌道および適合面を組み込んでいるステップ;および
3次元表示を使用して、カスタマイズされた外科用デバイスまたは器具を製作するステップ。
MRIまたはCTスキャンによって患者の解剖学的構造に関するデータを獲得するステップ;
MRIまたはCTスキャンデータを3次元の1つまたは複数のデータセットに変換するステップ
患者に実施する1つまたは複数の外科的処置を容易にするために使用されるように構成されるデバイスの向きの1つ以上の軸または平面を決定するステップ;
決定された軸を使用し、かつ変換された1つまたは複数のデータセットから導き出された任意の他の制約を考慮して、1つまたは複数の外科的処置を容易にするために使用されるデバイスをモデリングするステップ;
例えば、ラピッドプロトタイピング機を使用することによって、モデリングされたデバイスの原型を生成するステップ;および
1つまたは複数の外科的処置の最中に使用するための原型を準備するステップ。
患者特有の解剖学的構造に対応するデータを患者から収集するステップと;
収集したデータからテンプレートのモデルを作製するステップであって、モデルが、患者特有の解剖学的構造に対する複数の適合面を含むステップと;
モデルに関連したデータを、製作機械に提供するステップと;
複数の適合面を含むように、かつさらに、外科手術で使用される少なくとも1つ用具または器具に対応する少なくとも1つの追加的な適合面を含むようにテンプレートを迅速に生成するステップと;
外科手術で使用されるテンプレートに基づいて永久的なデバイスを生成するステップと
を含む。
患者からスキャンされたデータから決定された複数の面を含む外科用ガイドであって、これら複数の面は、患者の骨の解剖学的構造に適合するように構成され;
外科用ガイドが、さらに、外科的処置を容易にするために、患者の骨の解剖学的構造から決定された少なくとも1つの軌道または経路を含み;
外科用ガイドが、さらに、少なくとも1つのスリーブを含み、スリーブが導電性材料で構成され、かつ第1の端部および第2の端部を有する、外科用ガイドと;
導電性材料で構成された少なくとも第1の部分を含む器具であって、少なくとも第1の部分を少なくとも1つのスリーブの第1の端部に挿入することによって、少なくとも1つのスリーブ内に収容されかつ少なくとも1つのスリーブの導電性材料と接触するように適合され;
器具の少なくとも第1の部分は、少なくとも1つのスリーブを通過して少なくとも1つのスリーブの第2の端部から出るように適合されている、器具と
を含み、および
外科用ガイドは電流を受けて、外科用ガイドと患者の解剖学的構造とに接触している期間中、器具の術中監視(IOM)をもたらす。
A) MRIまたはCTスキャンによって患者の解剖学的構造に関するデータを獲得するステップ;
B) MRIまたはCTスキャンデータを3次元の1つまたは複数のデータセットに変換するステップ
C) 患者に実施される1つまたは複数の外科的処置を容易にするために使用されるように構成されたデバイスの1つ以上の軸の向きを決定するステップ;
D) 決定された軸を使用し、かつ変換された1つまたは複数のデータセットから導き出された任意の他の制約を考慮して、1つまたは複数の外科的処置を容易にするために使用されるデバイスをモデリングするステップ;
E) 例えば、ラピッドプロトタイピング機を使用することにより、モデリングされたデバイスの原型を生成するステップ;および
F) 1つまたは複数の外科的処置の最中に使用するために原型を準備するステップ。
Claims (20)
- カスタマイズされた外科用デバイスまたは器具を準備する方法であって、
患者の解剖学的構造に関連したデータを獲得するステップと;
前記獲得したデータを、3次元の1つまたは複数のデータセットに変換するステップと;
前記特定の患者に外科的処置を実施するのを容易にするための少なくとも1つの軌道または経路を決定するステップと;
前記患者の解剖学的構造に関連付けられた少なくとも1つの面を決定するステップと;
前記患者の解剖学的構造に関連付けられた前記少なくとも1つ面への前記少なくとも1つの軌道または経路および適合面を組み込む前記カスタマイズされた外科用デバイスまたは器具の3次元表示を生成するステップと;
少なくとも一部には前記生成した3次元表示に基づいてデバイスまたは器具の少なくとも1つのサイズおよびタイプを識別するステップと;
前記3次元表示を使用して前記カスタマイズされた外科用デバイスまたは器具を製作するステップと
を含むことを特徴とする、方法。 - 請求項1に記載の方法によって形成されることを特徴とする、カスタマイズされた外科用デバイスまたは器具。
- 請求項2に記載のカスタマイズされた外科用デバイスまたは器具において、前記外科用デバイスが、固定装置を配置するためのガイドであることを特徴とする、カスタマイズされた外科用デバイスまたは器具。
- 請求項2に記載のカスタマイズされた外科用デバイスまたは器具において、前記外科用デバイスが埋め込み型デバイスであることを特徴とする、カスタマイズされた外科用デバイスまたは器具。
- 請求項2に記載のカスタマイズされた外科用デバイスまたは器具において、前記外科用デバイスが切除ガイドを含み、前記切除ガイドが、骨の解剖学的構造に対する複数の切除平面を含み、切除器具が、前記複数の切除平面を通って切除するように向けられ、およびその後の骨の解剖学的構造の除去が、少なくとも1つの解剖学的変形の矯正をもたらすことを特徴とする、カスタマイズされた外科用デバイスまたは器具。
- 請求項1に記載の方法において、患者の解剖学的構造に関連したデータを獲得する前記ステップが、CT走査装置、MRI走査装置、超音波走査装置、放射線画像装置、X線透視装置または核医学走査装置からデータを獲得することによって成し遂げられることを特徴とする、方法。
- 請求項1に記載の方法において、さらに、
前記カスタマイズされた外科用デバイスまたは器具に関連付けられた監視デバイスからの電気信号に応答する患者の生体信号データを決定するステップと;
患者の前記生体信号データを、筋肉領域、神経領域、脈管領域および骨領域のうちの少なくとも1つに対応する予め決められた生体信号データと比較するステップと
を含むことを特徴とする、方法。 - 請求項7に記載の方法において、生体信号データを決定する前記ステップが、筋電図記録(EMG)データ、体性感覚誘発電位(SSEP)データおよび運動誘発電位(MEP)データからなる群のうちの1つを決定することを含むことを特徴とする、方法。
- 患者への外科的処置において使用するための外科用ガイドにおいて、
前記患者の解剖学的構造から決定されかつそれに相補的な少なくとも1つの面と;
前記外科的処置を容易にするために、前記患者の解剖学的構造から決定された少なくとも1つの軌道または経路と
を含み、
前記患者の解剖学的構造に相補的な前記少なくとも1つ面が、前記患者から少なくとも1つの第1の組の解剖学的データを獲得しかつ前記患者からの前記解剖学的データを前記少なくとも1つ面に組み込むことによって製作され、および前記外科的処置を容易にする前記少なくとも1つの軌道または経路は、獲得した少なくとも1つの他の組の解剖学的データから決定されることを特徴とする、外科用ガイド。 - 請求項9に記載の外科用ガイドにおいて、前記外科用ガイドがプレートで構成され、前記プレートが、前記患者の骨の解剖学的構造に対応する複数の輪郭または面特徴を含むことを特徴とする、外科用ガイド。
- 請求項10に記載の外科用ガイドにおいて、前記プレートが、前記患者の複数の椎骨にわたるように構成されていることを特徴とする、外科用ガイド。
- 請求項9に記載の外科用ガイドにおいて、前記ガイドが、少なくとも1つの外科切除器具を案内するための1つ以上の経路を含むことを特徴とする、外科用ガイド。
- 請求項12に記載の外科用ガイドにおいて、前記ガイドが、椎弓切除ガイド、椎体部分切除ガイド、PSOガイド、SPOガイド、脊柱切除ガイド、および非対称的骨切り術ガイドからなる群から選択されることを特徴とする、外科用ガイド。
- 請求項13に記載の外科用ガイドにおいて、前記ガイドが、順次の段階で複数の切除層または切除軌道を達成するために、互いに入れ子状になり得る複数のガイドで構成されることを特徴とする、外科用ガイド。
- 請求項13に記載の外科用ガイドにおいて、前記ガイドが、様々なレベルの患者の脊柱の間などで、モノリシックまたはマルチレベル構成に配置され得る複数のガイドで構成されることを特徴とする、外科用ガイド。
- 請求項9に記載の外科用ガイドにおいて、前記外科用ガイドが、ラピッドプロトタイピング機、ステレオリソグラフィ(SLA)機、選択的レーザ焼結(SLS)機、選択的加熱焼結(SHM)機、熱溶解積層(FDM)機、直接金属レーザ焼結(DMLS)機、粉体層印刷(PP)機、デジタル光処理(DLP)機、インクジェット式光樹脂機、および電子ビーム溶解(EBM)機からなる群から選択されるプロセスによって製造されることを特徴とする、外科用ガイド。
- 請求項16に記載の外科用ガイドにおいて、前記ガイドが、現場から離れた製造場所、現場での製造場所、診療所、手術センター、外科医の事務所、公立病院および私立病院からなる群から選択される場所で製造されることを特徴とする、外科用ガイド。
- 患者に外科的処置を実施するためのシステムにおいて、
前記患者からスキャンされたデータから決定された複数の面を含む外科用ガイドであって、前記複数の面は、前記患者の骨の解剖学的構造に適合するように構成されており;
前記外科用ガイドは、さらに、前記外科的処置を容易にするために、前記患者の骨の解剖学的構造から決定された少なくとも1つの軌道または経路を含み;
前記外科用ガイドは、さらに、少なくとも1つのスリーブを含み、前記スリーブは、導電性材料で構成され、かつ第1の端部および第2の端部を有する、外科用ガイドと;
導電性材料で構成された少なくとも第1の部分を含む器具であって、前記少なくとも第1の部分を前記少なくとも1つのスリーブの前記第1の端部に挿入することによって、前記少なくとも1つのスリーブ内に収容されかつ前記少なくとも1つのスリーブの前記導電性材料と接触するように適合され、
前記器具の前記少なくとも第1の部分は、前記少なくとも1つのスリーブを通過して前記少なくとも1つのスリーブの前記第2の端部から出るように適合された、器具と
を含み;および
前記外科用ガイドが電流を受けて、前記外科用ガイドと前記患者の解剖学的構造とに接触している期間中、前記器具の術中監視(IOM)を提供し得ることを特徴とする、システム。 - 請求項18に記載のシステムにおいて、前記外科用ガイドが、前記外科用ガイドの前記導電性材料に少なくとも1つの電極を設けかつ前記少なくとも1つの電極に電流を流すことによって、電流を受けることを特徴とする、システム。
- 請求項19に記載のシステムにおいて、前記器具が、切除器具、ドリリング器具または経路指定器具であることを特徴とする、システム。
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US13/841,069 US8870889B2 (en) | 2010-06-29 | 2013-03-15 | Patient matching surgical guide and method for using the same |
US13/841,069 | 2013-03-15 | ||
PCT/US2013/036535 WO2013158521A1 (en) | 2012-04-17 | 2013-04-15 | Patient matching surgical guide and method for using the same |
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IN (1) | IN2014DN08401A (ja) |
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WO (1) | WO2013158521A1 (ja) |
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JP2019529024A (ja) * | 2016-09-23 | 2019-10-17 | メダクタ・インターナショナル・ソシエテ・アノニム | 患者に応じた誘導ガイド |
JP2020505192A (ja) * | 2017-01-09 | 2020-02-20 | ウォン,ヨガン | 脊椎固定装置 |
JP7041170B2 (ja) | 2017-01-09 | 2022-03-23 | ウォン,ヨガン | 脊椎固定装置 |
JP2021523792A (ja) * | 2018-05-16 | 2021-09-09 | メダクタ・インターナショナル・ソシエテ・アノニム | 脊椎手術用の特定の使い捨てガイド装置 |
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CN104363826B (zh) | 2017-07-28 |
RU2628464C2 (ru) | 2017-08-17 |
MX2014012513A (es) | 2015-05-11 |
CA2870696C (en) | 2019-02-19 |
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CA2870696A1 (en) | 2013-10-24 |
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IL235055A0 (en) | 2014-12-31 |
WO2013158521A1 (en) | 2013-10-24 |
US20130218163A1 (en) | 2013-08-22 |
KR20150003275A (ko) | 2015-01-08 |
JP6095139B2 (ja) | 2017-03-15 |
MX340689B (es) | 2016-07-21 |
IN2014DN08401A (ja) | 2015-05-08 |
AU2013249582B2 (en) | 2016-11-03 |
JP6348194B2 (ja) | 2018-06-27 |
JP2017131667A (ja) | 2017-08-03 |
US8870889B2 (en) | 2014-10-28 |
AU2013249582A1 (en) | 2014-10-23 |
RU2014143528A (ru) | 2016-06-10 |
HK1202791A1 (en) | 2015-10-09 |
KR101908764B1 (ko) | 2018-10-16 |
EP2838423A1 (en) | 2015-02-25 |
CN104363826A (zh) | 2015-02-18 |
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