JP6316589B2 - レーザー切断リテーナを有する自己保持システム - Google Patents
レーザー切断リテーナを有する自己保持システム Download PDFInfo
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- A61B2017/0427—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from the anchor body
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- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
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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、外科処置のための自己保持システム、外科処置のための自己保持システムを製造する方法、及びその使用に関する。
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、外科処置において様々な制限を排除し、かつ強化された機能性及び/又は更なる機能性を提供する、レーザー切断リテーナを有する自己保持縫合糸、そのような縫合糸を製造する方法、並びにそのような縫合糸を使用する方法を提供する。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、レーザー加工システムは、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〜8Jは、図2Aによるレーザー加工システムの能力を試験するために作製された、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の例の画像である。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。
上述のように、縫合糸の異なる区分が双方向性自己保持縫合糸システムにおいて等の異なる特徴を有する自己保持縫合糸システムの一部分をマーキングかつ特定することが有用である。自己保持縫合糸システムにおいて、縫合糸の区分間の機能の相違点は、リテーナの存在、不在、及び/又は配向であり得る。一態様において、双方向性縫合糸の遷移区分をマーキングすることが望ましい場合がある。本発明の一実施形態では、図2Aのレーザー加工システム200を作動して、縫合糸が使用される状況下で医師によって容易に認識かつ区別される、レーザーでマーキングされたしるしを作製することもでき、それによって、外科医が自己保持縫合糸の遷移領域及び/又は他の区分を位置付けることを可能にする。
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、非分解性ポリマー、生分解性ポリマー、及び天然材料を含む、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。
複数の組織リテーナが、表面上に分布される、自己保持縫合スレッドであって、
複数の組織リテーナがそれぞれ、先端と、縫合スレッドの中心軸に対して鋭角に配向される少なくとも1つの組織係合面と、を有し、
少なくとも1つの組織係合面が、レーザー切断面であり、
複数の組織リテーナがそれぞれ、ある体積の材料が、リテーナの先端に隣接した縫合スレッドから除去された進入傾斜面を有し、進入傾斜面が、リテーナの組織係合面による組織の係合を促進するように適合された、自己保持縫合スレッド。
各スロットが、縫合スレッドの長手方向軸に対して鋭角に配向され、かつ外側及び内側を有し、
各スロットの外側が、組織リテーナの組織係合面を規定する、自己保持縫合糸。
(1) 自己保持縫合スレッド(self-retaining suture thread)であって、
前記縫合スレッドが、表面と、中心軸と、を有し、
複数の組織リテーナが、前記表面上に分布され、
前記複数の組織リテーナがそれぞれ、先端と、前記縫合スレッドの前記中心軸に対して鋭角に配向される少なくとも1つの組織係合面と、を有し、
前記少なくとも1つの組織係合面が、レーザー切断面であり、
前記複数の組織リテーナがそれぞれ、ある体積の材料が、前記リテーナの前記先端に隣接した前記縫合スレッドから除去された進入傾斜面を有し、前記進入傾斜面が、前記リテーナの前記組織係合面による組織の係合を促進するように適合された、自己保持縫合スレッド。
(2) 前記縫合スレッドが、前記組織リテーナを規定する複数のレーザー切断スロットを備え、
各スロットが、材料が除去された厚さを有し、
前記複数の組織リテーナのそれぞれの前記少なくとも1つの組織係合面が、レーザー切断スロットによって規定される、実施態様1に記載の自己保持縫合スレッド。
(3) 前記縫合スレッドが、USP 2−0の寸法を超えない、実施態様1に記載の自己保持縫合スレッド。
(4) 前記縫合スレッドが、USP 4−0の寸法を超えない、実施態様1に記載の自己保持縫合スレッド。
(5) 前記縫合スレッドが、USP 6−0の寸法を超えない、実施態様1に記載の自己保持縫合スレッド。
(6) 前記縫合スレッドが、USP 8−0の寸法を超えない、実施態様1に記載の自己保持縫合スレッド。
(7) 前記縫合スレッドが、USP 10−0の寸法を超えない、実施態様1に記載の自己保持縫合スレッド。
(8) ある体積の縫合スレッド材料が除去された、複数のスロットを有する縫合スレッドを備え、
各スロットが、前記縫合スレッドの長手方向軸に対して鋭角に配向され、かつ外側及び内側を有し、
各スロットの前記外側が、組織リテーナの組織係合面を規定する、自己保持縫合糸。
(9) 前記複数のスロットが、レーザー切断される、実施態様8に記載の自己保持縫合糸。
(10) 各スロットの前記内側が、各スロットの前記外側に対して略平行である、実施態様8に記載の自己保持縫合糸。
(12) 各スロットの前記内側が、前記スロットに沿って各スロットの前記外側から10μm以下の略同一の距離だけ離間配置される、実施態様8に記載の自己保持縫合糸。
(13) 各スロットの前記内側が、前記スロットに沿って各スロットの前記外側から7μm以下の略同一の距離だけ離間配置される、実施態様8に記載の自己保持縫合糸。
(14) 各スロットの前記内側が、前記スロットに沿って各スロットの前記外側から5μm以下の略同一の距離だけ離間配置される、実施態様8に記載の自己保持縫合糸。
(15) 各スロットの前記内側が、前記スロットに沿って各スロットの前記外側から3μm以下の略同一の距離だけ離間配置される、実施態様8に記載の自己保持縫合糸。
(16) 前記縫合スレッドが、USP 4−0を超えない寸法である、実施態様8に記載の自己保持縫合糸。
(17) 前記縫合スレッドが、USP 6−0を超えない寸法である、実施態様8に記載の自己保持縫合糸。
Claims (17)
- 自己保持縫合スレッドであって、
前記縫合スレッドが、表面と、中心軸と、を有し、
複数の組織リテーナが、前記表面に分布され、
前記複数の組織リテーナがそれぞれ、先端と、平面でありかつ前記縫合スレッドの前記中心軸に対して鋭角に配向される少なくとも1つの組織係合面と、を有し、
前記少なくとも1つの組織係合面が、レーザー切断面であり、
前記縫合スレッドが、前記組織リテーナの前記先端に隣接した前記縫合スレッドの一部から、ある体積の材料を除去して形成された進入傾斜面を有し、前記進入傾斜面が、前記組織リテーナの前記組織係合面による組織の係合を促進するように適合されており、
前記組織リテーナの前記先端が、前記縫合スレッドの前記表面より突出しておらず、
前記進入傾斜面は、前記縫合スレッドの前記表面に近接した近位部分と、遠位部分と、を有し、
前記進入傾斜面の前記遠位部分は前記組織係合面と向かい合っており、
前記近位部分と前記中心軸との角度(θ2)は、前記遠位部分と前記中心軸との角度(θ)よりも小さい、
自己保持縫合スレッド。 - 前記縫合スレッドが、前記組織リテーナを規定する複数のレーザー切断スロットを備え、
各スロットが、材料が除去された厚さを有し、
前記複数の組織リテーナのそれぞれの前記少なくとも1つの組織係合面が、レーザー切断スロットによって規定される、請求項1に記載の自己保持縫合スレッド。 - 前記縫合スレッドが、USP 2−0の寸法を超えない、請求項1に記載の自己保持縫合スレッド。
- 前記縫合スレッドが、USP 4−0の寸法を超えない、請求項1に記載の自己保持縫合スレッド。
- 前記縫合スレッドが、USP 6−0の寸法を超えない、請求項1に記載の自己保持縫合スレッド。
- 前記縫合スレッドが、USP 8−0の寸法を超えない、請求項1に記載の自己保持縫合スレッド。
- 前記縫合スレッドが、USP 10−0の寸法を超えない、請求項1に記載の自己保持縫合スレッド。
- ある体積の縫合スレッド材料が除去された、複数のスロットを有する縫合スレッドであって、前記複数のスロットが複数の組織リテーナを形成する、縫合スレッドを備え、
各スロットが、前記縫合スレッドの長手方向軸に対して鋭角に配向され、かつ外側及び内側を有し、
各スロットの前記外側が、前記組織リテーナの組織係合面を規定しており、前記組織係合面は平面であり、
前記縫合スレッドが、前記組織リテーナの先端に隣接した前記縫合スレッドの一部から、ある体積の材料を除去して形成された進入傾斜面を有し、前記進入傾斜面が、前記組織リテーナの前記組織係合面による組織の係合を促進するように適合されており、
前記組織リテーナの前記先端が、前記縫合スレッドの表面より突出しておらず、
各スロットの前記内側が、前記進入傾斜面を規定しており、
前記進入傾斜面は、前記縫合スレッドの表面に近接した近位部分と、遠位部分と、を有し、
前記進入傾斜面の前記遠位部分は前記組織係合面と向かい合っており、
前記近位部分と前記長手方向軸との角度(θ2)は、前記遠位部分と前記長手方向軸との角度(θ)よりも小さい、
自己保持縫合糸。 - 前記複数のスロットが、レーザー切断される、請求項8に記載の自己保持縫合糸。
- 各スロットの前記内側の少なくとも一部が、各スロットの前記外側に対して略平行である、請求項8に記載の自己保持縫合糸。
- 各スロットの前記内側の少なくとも一部が、前記スロットに沿って各スロットの前記外側から略同一の距離だけ離間配置される、請求項8に記載の自己保持縫合糸。
- 各スロットの前記内側の少なくとも一部が、前記スロットに沿って各スロットの前記外側から10μm以下の略同一の距離だけ離間配置される、請求項8に記載の自己保持縫合糸。
- 各スロットの前記内側の少なくとも一部が、前記スロットに沿って各スロットの前記外側から7μm以下の略同一の距離だけ離間配置される、請求項8に記載の自己保持縫合糸。
- 各スロットの前記内側の少なくとも一部が、前記スロットに沿って各スロットの前記外側から5μm以下の略同一の距離だけ離間配置される、請求項8に記載の自己保持縫合糸。
- 各スロットの前記内側の少なくとも一部が、前記スロットに沿って各スロットの前記外側から3μm以下の略同一の距離だけ離間配置される、請求項8に記載の自己保持縫合糸。
- 前記縫合スレッドが、USP 4−0を超えない寸法である、請求項8に記載の自己保持縫合糸。
- 前記縫合スレッドが、USP 6−0を超えない寸法である、請求項8に記載の自己保持縫合糸。
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