JP2022548691A - 誘導骨再生および誘導組織再生に使用されるモデリングデバイス - Google Patents
誘導骨再生および誘導組織再生に使用されるモデリングデバイス Download PDFInfo
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- JP2022548691A JP2022548691A JP2022517377A JP2022517377A JP2022548691A JP 2022548691 A JP2022548691 A JP 2022548691A JP 2022517377 A JP2022517377 A JP 2022517377A JP 2022517377 A JP2022517377 A JP 2022517377A JP 2022548691 A JP2022548691 A JP 2022548691A
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Abstract
Description
本出願は、2020年9月18日に米国特許庁に出願された米国特許出願第17/026,151号、並びに、2019年9月19日に米国特許庁に出願された米国仮特許出願第62/902,898号の優先権および利益を主張するものであり、これらの出願の内容全体は、すべての適用可能な目的のために、その全体が以下に完全に記載されているかのように、引用により本明細書に援用されるものとする。
Claims (25)
- 骨および組織の再生を誘導するように構成されたデバイスを製造するための方法であって、
修復される解剖学的特徴を示す3次元デジタルモデルまたはスキャンを受け取るステップと、
前記3次元モデルまたはスキャンを使用して、シミュレートされた膜を生成するステップであって、シミュレートされた膜が、修復される解剖学的特徴を覆うように構成されている、ステップと、
シミュレートされた膜の物理的構造に一致するように前記デバイスを製造またはカスタマイズするステップと、
修復される解剖学的特徴に隣接する骨に前記デバイスを固定するために使用される、1または複数の穴を前記デバイスに開けるための穴開けテンプレートを生成するステップとを備え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、
前記デバイスを製造することが、
シミュレートされた膜に対応するテンプレートを作成するステップと、
テンプレートに従って、予め製造された膜を切断して、前記デバイスを得るステップとを備え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、
シミュレートされた膜のデジタル2次元平坦化バージョンを生成するステップと、
シミュレートされた膜の平坦化バージョンに対応する開口部を含む3D印刷またはフライス加工されたトリミングガイドを作成するステップと、
前記トリミングガイドを使用して、予め製造された膜をトリミングするステップとをさらに含むことを特徴とする方法。 - 請求項3に記載の方法において、
シミュレートされた膜の平坦化バージョンのサイズおよび形状に対する適合性に基づいて、膜のカタログの中から予め製造された膜を選択するステップと、
前記トリミングガイドにカットアウトを設けるステップであって、前記カットアウトが、予め製造された膜を保持するように構成される、ステップと、
予め製造された膜が前記カットアウトに保持されている間に、前記開口部を介して予め製造された膜をマーキングまたは切断するステップとをさらに含むことを特徴とする方法。 - 請求項3に記載の方法において、
前記デバイスを製造することが、
予め製造された膜がトリミングされた後に、予め製造された膜を前記修復される解剖学的特徴に適用することを含み、
予め製造された膜を前記修復される解剖学的特徴に適用することにより、予め製造された膜が、シミュレートされた膜に対応する3次元形状をと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、
前記デバイスを製造することが、
シミュレートされた膜から得られたテンプレート情報を使用して、材料の少なくとも1の層を印刷または切断するステップと、
前記材料の少なくとも1の層を材料の1または複数の他の層に接合して、前記デバイスを得るステップとを含むことを特徴とする方法。 - 請求項1に記載の方法において、
前記デバイスが、骨に接触するように構成された第1の層であって、延伸ポリテトラフルオロエチレン(ePTFE)を含む第1の層と、線維性結合組織が骨欠損に成長するのを実質的に防止するように構成された高密度の細胞閉塞性ポリテトラフルオロエチレン(PTFE)を含む第2の層とを備え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、
前記デバイスが、コラーゲン、生体吸収性ポリマー、動物組織またはヒト組織を有する少なくとも1の層を含むことを特徴とする方法。 - 請求項1に記載の方法において、
シミュレートされた膜によって規定されるサイズ、密度または間隔のうちの1または複数が、前記デバイスに含まれる材料の1または複数の特性、前記デバイスの厚さ、または前記デバイスのサイズに基づいて、モデリングシステムによって計算さ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、
補強バインダを使用して、修復される解剖学的特徴に隣接する骨に前記デバイスを取り付けるステップをさらに含むことを特徴とする方法。 - 請求項10に記載の方法において、
前記補強バインダが、
接合部から延びる複数の細長い部材であって、前記接合部から離れて延びる自由端を有する第1の細長い部材を含む、複数の細長い部材と、
前記第1の細長い部材に形成された穴であって、前記デバイスの第1の層および前記デバイスの第2の層を通って骨欠損で前記デバイスを定位置に保持する留め具を受け入れるように構成された穴とを備え、
前記留め具が、ピン、鋲、縫合糸またはネジを含むことを特徴とする方法。 - 請求項10に記載の方法において、
前記補強バインダがチタン製の補強バインダであり、前記デバイスの第1の層と前記デバイスの第2の層との間に配置されることを特徴とする方法。 - 骨欠損の修復のために構成されたデバイスであって、
骨に接触するように構成された第1の層であって、延伸ポリテトラフルオロエチレン(ePTFE)を含む第1の層と、
線維性結合組織が骨欠損に成長するのを実質的に防止するように構成された高密度の細胞閉塞性ポリテトラフルオロエチレン(PTFE)を含む第2の層と、
当該デバイスに開けられた1または複数の穴であって、修復される解剖学的特徴に隣接する骨に当該デバイスを固定するための留め具を受け入れるように構成された1または複数の穴とを備え、
当該デバイスは、修復される解剖学的特徴を示す3次元モデルから生成されたテンプレート情報を使用して製造またはカスタマイズされていることを特徴とするデバイス。 - 請求項13に記載のデバイスにおいて、
当該デバイスが、前記テンプレート情報に従って、予め製造された膜を切断することによって製造されたものであることを特徴とするデバイス。 - 請求項13に記載のデバイスにおいて、
当該デバイスが、前記テンプレート情報を使用して印刷された材料の1または複数の層から製造されたものであり、当該デバイスを得るために材料の1または複数の層が接合されていることを特徴とするデバイス。 - 請求項13に記載のデバイスにおいて、
当該デバイスが、コラーゲン、生体吸収性ポリマー、動物組織またはヒト組織を有する少なくとも1の層を含むことを特徴とするデバイス。 - 請求項13に記載のデバイスにおいて、
前記テンプレート情報によって規定されるサイズ、密度または間隔のうちの1または複数が、当該デバイスに含まれる材料の1または複数の特性、当該デバイスの厚さ、または当該デバイスのサイズに基づくものであることを特徴とするデバイス。 - 請求項13に記載のデバイスにおいて、
修復される解剖学的特徴に隣接する骨と当該デバイスを結合するように構成された補強バインダをさらに含み、この補強バインダが、接合部から延びる複数の細長い部材を有し、前記複数の細長い部材が、前記接合部から離れて延びる自由端を有する第1の細長い部材を含むことを特徴とするデバイス。 - 請求項18に記載のデバイスにおいて、
前記補強バインダが、当該デバイスの第1の層とデバイスの第2の層との間に展開されていることを特徴とするデバイス。 - コードを有するように構成されたプロセッサ可読記憶媒体であって、
前記コードは、プロセッサによって実行されると、前記プロセッサに、
修復される解剖学的特徴を示す3次元デジタルモデルまたはスキャンを受け取るステップと、
前記3次元モデルを使用して、シミュレートされた膜を生成するステップであって、シミュレートされた膜が、前記修復される解剖学的特徴を覆うように構成されている、ステップと、
シミュレートされた膜のデジタル2次元平坦化バージョンを生成するステップと、
3次元プリンタ(3Dプリンタ)またはフライス装置に、トリミングガイドを製造させるように構成されたコードまたは命令を生成するステップであって、前記トリミングガイドが、シミュレートされた膜の平坦化バージョンに対応する開口部を含み、さらに予め製造された膜を保持するように構成されたカットアウトを含む、ステップとを実行させるものであり、
前記トリミングガイドは、予め製造された膜が前記カットアウトに保持されている間に、前記開口部を介して予め製造された膜にマーキングまたは切断するためのガイドとして動作可能であることを特徴とするプロセッサ可読記憶媒体。 - 請求項20に記載のプロセッサ可読記憶媒体において、
前記プロセッサに、トリミング後に予め製造された膜に1または複数の穴を開けるための穴開けテンプレートを生成させるためのコードを備えるように構成され、前記穴が、修復される解剖学的特徴に隣接する骨にデバイスを固定するように構成されていることを特徴とするプロセッサ可読記憶媒体。 - 請求項20に記載のプロセッサ可読記憶媒体において、
前記プロセッサに、シミュレートされた膜の平坦化バージョンのサイズおよび形状に対する適合性に基づいて、膜のカタログの中から予め製造された膜を選択させるためのコードを備えるように構成されていることを特徴とするプロセッサ可読記憶媒体。 - 修復される解剖学的特徴を示す3次元デジタルモデルまたはスキャンを受け取るステップと、
前記3次元モデルを使用して、シミュレートされた膜を生成するステップであって、シミュレートされた膜が、前記修復される解剖学的特徴を覆うように構成されている、ステップと、
シミュレートされた膜のデジタル2次元平坦化バージョンを生成するステップと、
3次元プリンタ(3Dプリンタ)またはフライス装置に、トリミングガイドを製造させるように構成されたコードまたは命令を生成するステップであって、前記トリミングガイドが、シミュレートされた膜の平坦化バージョンに対応する開口部を含み、さらに予め製造された膜を保持するように構成されたカットアウトを含む、ステップとを備え、
前記トリミングガイドが、予め製造された膜が前記カットアウトに保持されている間に、前記開口部を介して予め製造された膜にマーキングまたは切断するためのガイドとして動作可能であることを特徴とする方法。 - 請求項23に記載の方法において、
トリミングの後に、予め製造された膜に1または複数の穴を開けるための穴開けテンプレートを生成するステップをさらに含み、前記穴が、修復される解剖学的特徴に隣接する骨にデバイスを固定するように構成されていることを特徴とする方法。 - 請求項23に記載の方法において、
シミュレートされた膜の平坦化バージョンのサイズおよび形状に対する適合性に基づいて、膜のカタログの中から予め製造された膜を選択するステップをさらに含むことを特徴とする方法。
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