JP6100294B2 - 自己保持縫合糸を作製するための方法、レーザー加工システム、及び、安定化デバイス - Google Patents
自己保持縫合糸を作製するための方法、レーザー加工システム、及び、安定化デバイス Download PDFInfo
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Description
本出願は、米国特許法第119条(e)項の下で、2010年5月4日に出願された米国特許仮出願第61/331,294号、及び2010年5月4日に出願された同第61/331,302号の利益を主張するものであり、両出願ともに、参照によりそれらの全体が本明細書に組み込まれる。
本発明は、概して、自己保持縫合糸を作製するための方法、レーザー加工システム、及び、安定化デバイスに関する。
以下で使用され得るある特定の用語の定義は、以下を含む。
上述のように、本発明は、レーザー切断装置及び縫合スレッド上のリテーナを切断するための方法を提供する。図1Aは、レーザー切断自己保持縫合糸システム100を説明する。自己保持縫合糸システム100は、自己保持縫合スレッド102に取り付けられる針110、112を備える。自己保持縫合スレッド102は、フィラメント120の表面上に分布される複数のリテーナ130を含む。フィラメント120の導入区分140には、リテーナ130が存在しない。フィラメント120の区分142には、縫合糸を針110の方向に展開できるが、針112の方向への移動に抵抗するように配置された複数のリテーナ130が存在する。遷移区分144には、リテーナ130が存在しない。区分146には、縫合糸を針112の方向に展開できるが、針110の方向への移動に抵抗するように配置された複数のリテーナ130が存在する。フィラメント120の導入区分148には、リテーナ130が存在しない。各区分の長さを、縫合糸を使用することを目的とした適用に応じて変更及び選択してもよいことを示すために、中断が、区分140、142、144、146、及び148のそれぞれにおいて示される。例えば、所望の場合、遷移区分144を、針110又は針112により近づけて、非対称的に位置付けることができる。
本発明の実施形態において、縫合スレッドの表面上にリテーナを作製し、かつ/又は縫合スレッド上に可視的マーキングを提供するために、レーザー加工システムが提供かつ利用される。レーザー加工システムは、縫合スレッドから材料を選択的に切断及び/又は切除して、縫合スレッド上に所望の構成を有するリテーナを生成するために、コヒーレント光の集束光線を使用する。切断/切除プロセスは、非接触プロセスである。好適なレーザー加工システムは、リテーナ形成中に縫合スレッドへの損傷を阻止するように、非常に高い空間的閉じ込め及び制御、並びに縫合スレッドへの非常に低い熱蓄積を有する。
図8A〜8Bは、図2Aのレーザー切断システムで作製されたレーザー切断リテーナの実施例の画像である。その上に複数のレーザー切断リテーナを有する縫合スレッドを備える自己保持縫合糸を作製し、図2Aに従って、レーザー加工システムの能力を試験した。縫合スレッドは、いずれの場合も青色プロピレンフィラメントであった。
本明細書に記載の縫合スレッドを、制限なしに、射出成形、スタンピング、切断、レーザー、押出し等を含む任意の好適な方法によって生成してもよい。本明細書に記載の縫合スレッドは、例えば、金属及び金属合金、非分解性ポリマー及び生分解性ポリマーを含むポリマー、並びに天然材料を含む、縫合糸の製造に従来使用される任意の材料を使用してもよい。切断に関して、縫合糸本体にポリマー縫合スレッド/フィラメントを製造又は購入してもよく、その後、縫合糸本体にリテーナを切断してもよい。切断中、リテーナの寸法、形状、及び深度を制御するために、レーザー光線又は縫合スレッドのいずれかを他方に対して移動させてもよいか、又は両方ともに移動させてもよい。
一般的な創傷閉鎖及び軟組織修復用途に加えて、自己保持縫合糸を様々な他の適用において使用することができる。
(a)縫合スレッド上に組織リテーナの位置を特定する工程と、
(b)レーザー光線を、縫合スレッド上の組織リテーナの位置に指向する工程と、
(c)レーザー光線を使用して、前記縫合スレッドからスロットを規定する体積の材料を除去する工程であって、スロットが、組織リテーナの組織係合面を規定する、工程と、
(d)縫合スレッド上に複数の組織リテーナを生成するために、工程(a)、(b)、及び(c)を繰り返す工程と、を含む、方法。
(c1)レーザー光線を使用して、前記縫合スレッドからスロットを規定する体積の材料を除去する工程であって、スロットが、組織リテーナの組織係合面を規定する、工程と、
(c2)レーザー光線を使用して、前記組織係合面による組織の係合を促進する進入傾斜面を提供するために、スロットに隣接した前記縫合スレッドからくさび形体積の材料を除去する工程と、を含む、方法。
(e)工程(d)の終了後、前記複数のリテーナのそれぞれの先端を、前記縫合スレッドの表面より上に上昇させるために、縫合スレッドを処理する工程を更に含む、方法。
(e)工程(d)の終了後、前記複数のリテーナのそれぞれの先端を、前記縫合スレッドの表面より上に上昇させるために、縫合スレッドを加熱する工程を更に含む、方法。
(e)工程(d)の終了後、前記複数のリテーナのそれぞれの先端を、前記縫合スレッドの表面より上に上昇させるために、張力を縫合スレッドに印加する工程を更に含む、方法。
(e)工程(d)の終了後、前記複数のリテーナのそれぞれの先端を、前記縫合スレッドの表面より上に上昇させるために、熱及び張力を縫合スレッドに適用する工程を更に含む、方法。
(e)工程(d)の終了後、前記複数のリテーナのそれぞれの先端を、前記縫合スレッドの表面より上に上昇させるために、縫合スレッドを処理する工程と、
(f)前記複数のリテーナのそれぞれの先端を、前記縫合スレッドの表面より上に上昇させた状態に保つために、縫合スレッドをアニールする工程と、を更に含む、方法。
レーザー光線を提供するように適合されたレーザーサブシステムと、
レーザー光線を受信し、かつある体積の縫合スレッドに指向される集中レーザー光線を生成するように適合された光学システムと、
縫合スレッドを前記レーザー光線に対して移動させるように適合された輸送サブシステムと、
縫合スレッドを画像化し、かつ画像データを生成するように適合された画像化サブシステムと、
レーザーサブシステム及び輸送サブシステムから前記画像データを受信し、前記縫合スレッド上の選択された位置で、選択された構成の組織リテーナを作製するように適合された制御サブシステムと、を備える、レーザー加工システム。
レーザーサブシステムが、フェムト秒レーザーを備える、レーザー加工システム。
レーザーサブシステムが、紫外線レーザーを備える、レーザー加工システム。
レーザーサブシステムが、赤外線レーザーを備える、レーザー加工システム。
レーザーサブシステムが、赤外線及び紫外線波長を含むレーザー光線を提供するように適合される、レーザー加工システム。
制御サブシステムが、画像データに応答して、焦点制御信号を光学的サブシステムに提供し、
光学サブシステムが、焦点制御信号に応答して、レーザー光線の焦点深度を変化させるように適合された、レーザー加工システム。
光学サブシステムが、1つ又は2つ以上のアキシコンプリズムを含む、レーザー加工システム。
レーザー光線が、ガウスパワー密度分布を有する、レーザー加工システム。
レーザー光線が、選択可能なリング径のリング状のパワー密度分布を有する、レーザー加工システム。
加圧流体源と、
加圧流体源に接続され、かつ縫合スレッドの領域内の縫合スレッドに沿って、かつ縫合スレッドの周囲に、流体の層流を生成するように適合された、流体出口と、を備える、安定化デバイス。
流体出口が、ノズル形状である、安定化デバイス。
縫合スレッドが、流体出口を通過する、安定化デバイス。
加圧流体源に接続される流体マニホールドであって、流体出口が、流体マニホールドの1つの端に接続される、流体マニホールドと、
流体マニホールドに接続される縫合糸入口と、を備え、
縫合スレッドが、入口ポート及び流体出口に接触することなく、入口ポートを通って流体マニホールドに入り、かつ流体出口を通って流体マニホールドを出るように構成される、安定化デバイス。
レーザー光線を提供するように適合されたレーザーサブシステムと、
レーザー光線を受信し、かつある体積の縫合スレッドに指向される集中レーザー光線を生成するように適合された光学システムと、
縫合スレッドをレーザー光線に対して移動させるように適合された輸送サブシステムと、
縫合スレッドを画像化し、かつ画像データを生成するように適合された画像化サブシステムと、
縫合スレッドの領域で選択された構成の組織リテーナを作製するために、レーザーサブシステム及び輸送サブシステムを制御するように適合された制御サブシステムと、を備える、安定化デバイス。
(a)縫合スレッドの選択された領域を、縫合スレッドの選択された領域の位置を安定化するように適合された流体の層流内に配置する工程と、
(b)縫合スレッドの選択された領域内で、レーザー光線を選択された体積の縫合材料に指向する工程と、
(c)組織リテーナを作製するために、縫合スレッドの選択された領域の範囲から、選択された体積の縫合材料を除去する工程と、
(d)複数の組織リテーナを作製するために、縫合スレッドの複数の選択された領域において、工程(a)、(b)、及び(c)を繰り返す工程と、を含む、方法。
(e)縫合スレッドの選択されたマーキング領域を、流体の層流内に配置し、かつ選択されたマーキング領域内で、電磁放射線を縫合スレッドに指向する工程であって、電磁放射線が、縫合材料を切除することなく、縫合スレッドの選択されたマーキング領域の視覚的特徴を変化させるように適合された、工程を更に含む、方法。
レーザー光線を提供するように適合されたレーザーサブシステムと、
レーザー光線を受信し、かつある体積縫合スレッドに指向される集中レーザー光線を生成するように適合された光学システムと、
縫合スレッドを集中レーザー光線に対して移動させるように適合された輸送サブシステムと、
縫合材料を切除することなしに、縫合スレッドの選択された領域の視覚的特徴を変化させるように適合されたマーキングサブシステムと、
前記縫合スレッド上の選択された位置で選択された構成の組織リテーナを作製し、かつ前記縫合スレッド上の異なる選択された位置で縫合スレッド上に可視的マーカーを作製するために、レーザーサブシステム、マーキングサブシステム、及び輸送サブシステムを制御するように適合された制御サブシステムと、を備える、レーザー加工システム。
(a)縫合スレッド上に組織リテーナの位置を特定する工程と、
(b)レーザー光線を提供する工程と、
(b)レーザー光線を、縫合スレッド上の組織リテーナの位置の一部分に指向する工程と、
(c)レーザー光線を使用して、先端を有する組織リテーナを作製するために、縫合スレッド上の組織リテーナの位置からある体積の縫合材料を除去する工程と、
(d)縫合スレッド上に複数の組織リテーナを生成するために、工程(a)、(b)、及び(c)を繰り返す工程と、
(e)工程(d)の後に、複数の組織リテーナの先端を上昇させることによって、先端が縫合スレッドから突き出るように、自己保持縫合糸を処理する工程と、を含む、方法。
(f)工程(e)の後に、複数の組織リテーナの先端が縫合スレッドから突き出るように先端を維持するために、自己保持縫合糸をアニールする工程を更に含む、方法。
(a)表面を有する縫合スレッドを提供する工程と、
(b)スレッドの表面上の第1の体積の縫合材料を特定する工程と、
(c)第1の体積の縫合材料の範囲から、第2の体積の縫合材料を特定する工程と、
(d)第2の体積の縫合材料を除く、第1の体積の縫合材料内のすべての縫合材料を切除するために、レーザー光線を縫合スレッドに指向し、それによって、第2の体積の縫合材料が、縫合スレッドのレーザー切断面から突き出る組織リテーナを形成する工程と、
(e)縫合スレッドから突き出る複数の組織リテーナを生成するために、工程(b)、(c)、及び(d)を繰り返す工程と、を含む、方法。
工程(c)が、ある体積の縫合材料の範囲から、円錐形副体積の縫合材料を特定する工程を含み、
工程(d)が、円錐形副体積の縫合材料を除く、選択された体積の縫合材料内のすべての縫合材料を切除するために、レーザー光線を縫合スレッドに指向する工程を含み、それによって、円錐形副体積の縫合材料が、縫合スレッドのレーザー切断面から突き出る組織リテーナを形成する、方法。
工程(a)が、表面と、複数の長手方向***部非円形断面とを有する縫合スレッドを提供する工程を含み、
工程(b)が、長手方向***部のうちの1つの範囲内のスレッドの表面上の第1の体積の縫合材料を特定する工程を含む、方法。
工程(a)が、表面と、複数の長手方向頂端部を有する多角形断面とを有する縫合スレッドを提供する工程を含み、
工程(b)が、長手方向頂端部のうちの1つを含むスレッドの表面上の第1の体積の縫合材料を特定する工程を含む、方法。
(1) 自己保持縫合糸を作製するための方法であって、
(a)表面を有する縫合スレッド(suture thread)を提供する工程と、
(b)前記スレッドの前記表面上の第1の体積の縫合材料を特定する工程と、
(c)前記第1の体積の縫合材料の範囲から、第2の体積の縫合材料を特定する工程と、
(d)前記第2の体積の縫合材料を除く、前記第1の体積の縫合材料内のすべての前記縫合材料を切除するために、レーザー光線を前記縫合スレッドに指向し、それによって、前記第2の体積の縫合材料が、前記縫合スレッドのレーザー切断面から突き出る組織リテーナを形成する工程と、
(e)前記縫合スレッドから突き出る複数の組織リテーナを生成するために、工程(b)、(c)、及び(d)を繰り返す工程と、
を含む、方法。
(2) 工程(c)が、前記第1の体積の縫合材料の範囲から、第2の体積の縫合材料を特定する工程を含み、前記第2の体積が、前記第1の体積の50%未満である、実施態様1に記載の方法。
(3) 工程(c)が、前記第1の体積の縫合材料の範囲から、第2の体積の縫合材料を特定する工程を含み、前記第2の体積が、前記第1の体積の25%未満である、実施態様1に記載の方法。
(4) 工程(c)が、前記体積の縫合材料の範囲から、円錐形副体積(conical subvolume)の縫合材料を特定する工程を含み、
工程(d)が、前記円錐形副体積の縫合材料を除く、前記選択された体積の縫合材料内のすべての縫合材料を切除するために、レーザー光線を前記縫合スレッドに指向する工程を含み、それによって、前記円錐形副体積の縫合材料が、前記縫合スレッドのレーザー切断面から突き出る組織リテーナを形成する、実施態様1に記載の方法。
(5) 工程(a)が、表面と、非円形断面とを有する縫合スレッドを提供する工程を含む、実施態様1に記載の方法。
(6) 工程(a)が、表面と、複数の長手方向***部非円形断面とを有する縫合スレッドを提供する工程を含み、
工程(b)が、前記長手方向***部のうちの1つの範囲内の前記スレッドの前記表面上の第1の体積の縫合材料を特定する工程を含む、実施態様1に記載の方法。
(7) 工程(a)が、表面と、複数の長手方向頂端部を有する多角形断面とを有する縫合スレッドを提供する工程を含み、
工程(b)が、前記長手方向頂端部のうちの1つを含む前記スレッドの前記表面上の第1の体積の縫合材料を特定する工程を含む、実施態様1に記載の方法。
(8) 自己保持縫合糸を作製するための方法であって、
(a)前記縫合スレッド上に組織リテーナの位置を特定する工程と、
(b)レーザー光線を、前記縫合スレッド上の前記組織リテーナの位置に指向する工程と、
(c)前記レーザー光線を使用して、前記縫合スレッドからスロットを規定する体積の材料を除去する工程であって、前記スロットが、組織リテーナの組織係合面を規定する、工程と、
(d)前記縫合スレッド上に複数の組織リテーナを生成するために、工程(a)、(b)、及び(c)を繰り返す工程と、
を含む、方法。
(9) 工程(c)が、
(c1)前記レーザー光線を使用して、前記縫合スレッドからスロットを規定する体積の材料を除去する工程であって、前記スロットが、組織リテーナの組織係合面を規定する、工程と、
(c2)前記レーザー光線を使用して、前記組織係合面による組織の係合を促進する進入傾斜面を提供するために、前記スロットに隣接した前記縫合スレッドからくさび形体積の材料を除去する工程と、
を含む、実施態様8に記載の方法。
(10) 工程(b)が、レーザー光線を前記縫合スレッド上の前記組織リテーナの位置に指向する工程と、前記レーザー光線の焦点を5μm以下の直径に合わせる工程と、を含む、実施態様8に記載の方法。
(12) (e)工程(d)の終了後、前記複数のリテーナのそれぞれの先端を、前記縫合スレッドの表面より上に上昇させるために、前記縫合スレッドを処理する工程を更に含む、実施態様8に記載の方法。
(13) (e)工程(d)の終了後、前記複数のリテーナのそれぞれの先端を、前記縫合スレッドの表面より上に上昇させるために、前記縫合スレッドを処理する工程と、
(f)前記複数のリテーナのそれぞれの先端を、前記縫合スレッドの前記表面より上に上昇させた状態に保つために、前記縫合スレッドをアニールする工程と、
を更に含む、実施態様8に記載の方法。
(14) 縫合スレッド上に組織リテーナを作製するように適合されたレーザー加工システムであって、
レーザー光線を提供するように適合されたレーザーサブシステムと、
前記レーザー光線を受信し、かつある体積の前記縫合スレッドに指向される集中レーザー光線を生成するように適合された光学システムと、
前記縫合スレッドを前記レーザー光線に対して移動させるように適合された輸送サブシステムと、
前記縫合スレッドを画像化し、かつ画像データを生成するように適合された画像化サブシステムと、
前記レーザーサブシステム及び輸送サブシステムから前記画像データを受信し、前記縫合スレッド上の選択された位置で、選択された構成の組織リテーナを作製するように適合された制御サブシステムと、
を備える、レーザー加工システム。
(15) 前記レーザーサブシステムが、フェムト秒レーザーを備える、実施態様14に記載のレーザー加工システム。
(16) 前記制御サブシステムが、前記画像データに応答して、焦点制御信号を前記光学的サブシステムに提供し、
前記光学サブシステムが、前記焦点制御信号に応答して、前記レーザー光線の焦点深度を変化させるように適合された、実施態様14に記載のレーザー加工システム。
(17) 前記選択された位置で、前記縫合スレッドに沿って、かつ前記縫合スレッドの周囲に、高速の流体の層流を提供するエアベアリングデバイスを更に備える、実施態様14に記載のレーザー加工システム。
(18) 前記光学サブシステムが、1つ又は2つ以上のアキシコンプリズムを含む、実施態様14に記載のレーザー加工システム。
(19) 前記レーザー光線が、選択可能なリング径のリング状のパワー密度分布を有する、実施態様14に記載のレーザー加工システム。
(20) 縫合スレッドの領域内の前記縫合スレッドの非接触安定化のための安定化デバイスであって、
加圧流体源と、
前記加圧流体源に接続され、かつ前記縫合スレッドの前記領域内の前記縫合スレッドに沿って、かつ前記縫合スレッドの周囲に、流体の層流を生成するように適合された、流体出口と、
を備える、安定化デバイス。
前記加圧流体源に接続される流体マニホールドであって、前記流体出口が、前記流体マニホールドの1つの端に接続される、流体マニホールドと、
前記流体マニホールドに接続される縫合糸入口と、
を備え、
縫合スレッドが、入口ポート及び流体出口に接触することなく、前記入口ポートを通って前記流体マニホールドに入り、かつ前記流体出口を通って前記流体マニホールドを出るように構成される、安定化デバイス。
(22) 自己保持縫合糸を作製するための方法であって、
(a)前記縫合スレッドの選択された領域を、前記縫合スレッドの前記選択された領域の位置を安定化するように適合された流体の層流内に配置する工程と、
(b)前記縫合スレッドの前記選択された領域内で、レーザー光線を選択された体積の縫合材料に指向する工程と、
(c)組織リテーナを作製するために、前記縫合スレッドの前記選択された領域の範囲から、前記選択された体積の前記縫合材料を除去する工程と、
(d)複数の組織リテーナを作製するために、前記縫合スレッドの複数の選択された領域において、工程(a)、(b)、及び(c)を繰り返す工程と、
を含む、方法。
(23) (e)前記縫合スレッドの選択されたマーキング領域を、前記流体の層流内に配置し、かつ前記選択されたマーキング領域内で、電磁放射線を前記縫合スレッドに指向する工程であって、前記電磁放射線が、縫合材料を切除することなく、前記縫合スレッドの前記選択されたマーキング領域の視覚的特徴を変化させるように適合された、工程を更に含む、実施態様22に記載の方法。
(24) 自己保持縫合糸を作製するための方法であって、
(a)前記縫合スレッド上に組織リテーナの位置を特定する工程と、
(b)レーザー光線を提供する工程と、
(b)レーザー光線を、前記縫合スレッド上の前記組織リテーナの位置の一部分に指向する工程と、
(c)前記レーザー光線を使用して、先端を有する組織リテーナを作製するために、前記縫合スレッド上の前記組織リテーナの位置からある体積の縫合材料を除去する工程と、
(d)前記縫合スレッド上に複数の組織リテーナを生成するために、工程(a)、(b)、及び(c)を繰り返す工程と、
(e)工程(d)の後に、前記複数の組織リテーナの前記先端を上昇させることによって、前記先端が前記縫合スレッドから突き出るように、前記自己保持縫合糸を処理する工程と、
を含む、方法。
(25) (f)工程(e)の後に、前記複数の組織リテーナの前記先端が前記縫合スレッドから突き出るように前記先端を維持するために、前記自己保持縫合糸をアニールする工程を更に含む、実施態様24に記載の方法。
Claims (6)
- 縫合スレッド上に組織リテーナを作製するように適合されたレーザー加工システムであって、
レーザー光線を提供するように適合されたレーザーサブシステムと、
前記レーザー光線を受信し、かつある体積の前記縫合スレッドに指向される集中レーザー光線を生成するように適合された光学システムと、
前記縫合スレッドを前記レーザー光線に対して移動させるように適合された輸送サブシステムと、
前記縫合スレッドを画像化し、かつ画像データを生成するように適合された画像化サブシステムと、
前記画像化サブシステムから前記画像データを受信し、前記レーザーサブシステム及び輸送サブシステムを制御して、前記縫合スレッド上の選択された位置で、選択された構成の組織リテーナを作製するように適合された制御サブシステムと、
を備える、レーザー加工システム。 - 前記レーザーサブシステムが、フェムト秒レーザーを備える、請求項1に記載のレーザー加工システム。
- 前記制御サブシステムが、前記画像データに応答して、焦点制御信号を前記光学システムに提供し、
前記光学システムが、前記焦点制御信号に応答して、前記レーザー光線の焦点深度を変化させるように適合された、請求項1に記載のレーザー加工システム。 - 前記選択された位置で、前記縫合スレッドに沿って、かつ前記縫合スレッドの周囲に、高速の流体の層流を提供するエアベアリングデバイスを更に備える、請求項1に記載のレーザー加工システム。
- 前記光学システムが、1つ又は2つ以上のアキシコンプリズムを含む、請求項1に記載のレーザー加工システム。
- 前記レーザー光線が、選択可能なリング径のリング状のパワー密度分布を有する、請求項1に記載のレーザー加工システム。
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