JP5562829B2 - 外科的手技用自己保持システム - Google Patents
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Description
本願は、下記の米国特許出願の利益を主張し、これらの各々は、本明細書に参考として援用される:
米国仮特許出願第60/911,814号(名称「SELF−RETAINING SYSTEMS FOR SURGICAL PROCEDURES」、2007年4月13日出願、代理人整理番号ANGIO−01000US0);
米国実用出願第12/062,214号(名称「SELF−RETAINING SYSTEMS FOR SURGICAL PROCEDURES」、2008年4月3日出願、代理人整理番号ANGIO−010006US1);および
米国実用出願第12/062,256号(名称「SELF−RETAINING SYSTEMS FOR SURGICAL PROCEDURES」、2008年4月3日出願、代理人整理番号ANGIO−01000US6)。
本発明は、概して、外科的手技用の自己保持システム、外科的手技用の自己保持システムを製造する方法、およびそれらの使用に関する。
配備後に組織の中へ固着し、保持具が面する方向とは反対の方向で縫合糸の移動に抵抗する、多数の極めて小さな組織保持具(鉤等)を保有し、それにより、隣接する組織をともに固定するように結び目を作る必要性を排除する(「無結節閉鎖」)という点で、自己保持縫合糸(有鉤縫合糸を含む)は、従来の縫合糸とは異なる。糸結びを排除することによって、(i)突刺(縫合糸、通常は結び目が、皮下閉鎖後に皮膚に押し通る状態)、(ii)感染症(細菌がしばしば、結び目によって生成された空間に付着し、その中で成長することができる)、(iii)バルク/塊(創傷に残された有意量の縫合糸材料が、結び目を備える部分の中にある)、(iv)滑脱(結び目が滑脱するか、ほどける可能性がある)、および(v)刺激(結び目が創傷中でバルク状「異物」としての機能を果たす)を含むが、それらに限定されない、関連合併症が排除される。糸結びと関連する縫合糸ループは、外科創傷における、虚血(組織を括約し、領域への血流を制限し得る、張力点を生成する)および裂開または破裂の危険性の増加につながる場合がある。糸結びはまた、大きな労力を必要とし、外科創傷を閉鎖するのに費やされる、有意な割合の時間を備え得る。付加的な手術手技時間は、患者にとって悪いだけではなく(麻酔下で費やされる時間とともに合併症の発生率が上昇する)、手術の全体的な費用も増大させる(多くの外科的手技は、手術時間の1分につき$15から$30の間の費用がかかると推測される)。したがって、無結節縫合糸は、患者が改善した臨床転帰を経験することを可能にするだけでなく、長時間の手術および追従治療と関連する時間および費用も節約する。
配備後の自己保持縫合糸の固定は、周辺組織の中への保持具端の貫通を伴い、結果として、組織が保持具と縫合糸本体との間に捕捉される。本明細書では、「組織係合表面」または「内側保持具表面」と呼ばれる、保持具と縫合糸本体との間に捕捉される組織と実際に接触している保持具の内面は、より良好に組織に係合するように適合することができる。図1を参照すると、縫合糸100は、縫合糸本体102から突出する保持具104を含み、保持具104は、保持具本体106と、組織貫通端108と、組織係合表面110とを含む。図1に示されるように、保持具104の組織係合表面110には、不均一な構成を提供することができ、それにより、組織と接触している表面積を増加させ、配備方向以外の方向の移動に対する縫合糸100の抵抗を向上させる。本明細書で使用されるような「不均一な」という用語は、平坦ではなく、したがって均一な大きさの平面よりも広い表面積を備える、任意の表面構成を示すことを理解されたい。そのようなものとして、該用語は、限定するものではないが、波形、波状、粗面、くぼみ、鋸歯状、こぶ状、***、フィラメント状、凹面、凸面等である表面を包含してもよい。増加した表面積は、縫合糸材料と組織との間の相互作用を増加させるだけでなく、治癒を促進することができる細胞付着および内方成長のための支持基質も提供する。これは、縫合糸材料と組織との間の増加した接触面積により、自己保持縫合糸の保持力を急性的に(すなわち、配備の直後に)増加させると予期することができるだけでなく、治癒が進行するにつれて、組織係合表面上への治癒組織の付着および内方成長により、保持強度がさらに増加させられる。
一方向性および二方向性の自己保持縫合糸の両方には、2つの端の間に拡張糸部を提供することができる。例えば、縫合糸は、糸の拡張部分の直径が、縫合糸の端の直径よりも大きくなるように、または縫合糸が、縫合糸の端よりも大きい直径を有する針による配備のために適合される場合は、針の直径よりも大きくなるように、糸の拡張部を含んでもよい。1つ以上の針による配備のために適合される縫合糸について、針付着部位から指定の距離(この距離は、臨床的適応によって変動する)を置いた糸の直径は、それに付着される針の直径よりも大きい。有鉤縫合用糸直径が最大である点から、糸の直径が、縫合糸を配備するために使用される針の直径(針の最大幅点における)に等しくなるか、またはそれより小さくなるまで、糸の直径は、針付着部位に接近するにつれて漸減する。糸の先細の割合、距離、程度、および長さは、臨床的適応によって調整することができる。
保持具上の不均一な張力分布もまた、特に、保持具が互いから過度に遠く離間し、保持具構成が配備後に「ねじれ」を可能にする場合、または十分な保持具(または固着点)が十分な保持強度を提供するように存在しない場合に、縫合不具合を引き起こす場合がある。自己保持縫合糸は、らせん状保持具(その連続的長さに沿って、張力が実質的に均一に分布される)、および鱗で覆われた保持具(最大の組織係合表面積を提供し、それにより張力分布を最適化する)等の、改良型保持具構成を含むことができる。例えば、図4aを参照すると、自己保持縫合糸400は、縫合糸本体402の少なくとも一部に沿って配置されるらせん状保持具404を含むことができ、らせん状保持具404は、保持具本体408と、組織貫通縁410とを含み、保持具404は、ある方向を向き、組織の中にあるときは、それが向く方向とは反対の方向に、縫合糸の移動に抵抗するために適合される。そのようならせん状自己保持縫合糸は、一方向性または二方向性であってもよく、後者は、縫合糸の一方の端から背く貫通縁410の少なくとも部分的に近位で、かつそれとともに配置されるらせん状保持具を有することができ、縫合糸の他方の端から背く貫通縁410の少なくとも部分的に近位で、かつそれとともに配置される、第2のらせん状保持具を含むことができ、縫合糸は、保持具を含まない中間部を含む。
不均一な張力分布または不充分な組織係合の問題が発生し、潜在的に縫合不具合に繋がることをさらに低減するために、自己保持縫合糸には、二次保持具構造、つまり、一次保持具上の二次保持具が提供されてもよい。二次保持具は、縫合糸の表面積をさらに増加させ、それにより、縫合糸と組織との間の相互作用の量を増加させる。また、一次保持具上に二次保持具を提供することにより、縫合糸本体に付加的な一次保持具をカットすることによって発生する場合がある縫合糸の引張強度の低減を伴わずに、縫合糸上の保持具の合計数(したがって組織貫通点の合計数)を増加させる。保持具の数の増加および縫合糸の組織係合表面積の増加は、縫合糸上の張力のより良好な分布および増加した組織保持をもたらす。図6から8は、一次保持具から突出する二次保持具を有する、自己保持縫合糸を示し、縫合糸は、一方向性または二方向性となり得る。これに関連して、自己保持縫合糸は、縫合糸本体から突出する一次保持具本体および組織貫通端を有する、少なくとも1つの一次保持具と、縫合糸本体に実質的に面する内面と、縫合糸本体から実質的に離れる方向に面する外面とを含むことができ、一次保持具は、ある方向に面して配備され、組織の中にあるときは、一次保持具が面する方向とは反対の方向で、縫合糸の移動に抵抗するように適合される。一次保持具はさらに、一次保持具から突出する少なくとも1つの二次保持具を含むことができる。そのような二次保持具は、一次保持具が面し、配備される方向から少なくとも約90°離れた方向に配向することができ、したがって、組織の「二重かぎ留め」を促進し、一次保持具の任意の表面上に配置されてもよい。一次保持具は、鉤、フラスト円錐形、らせん状等となり得る。二次保持具もまた、鉤、フラスト円錐形、らせん状、ならびにフィラメント状となり得る。
本明細書で説明される縫合用糸は、限定するものではないが、射出成形、刻印、カット、レーザ、押出等を含む、任意の好適な方法によって生産されてもよい。カットに関して、ポリマー糸またはフィラメントが、縫合糸本体に対して製造または取得されてもよく、後に、保持具を縫合糸本体上でカットすることができ、それらは、手でカットされるか、レーザカットされるか、または、刃、カット車輪、粉砕輪等を使用して機械的に機械カットされてもよい。縫合糸は、任意の好適な生体適合性材料で作られてもよく、縫合糸の強度、弾力性、寿命、または他の質を向上させるためであろうと、または、組織をともに接合すること、組織を配置し直すこと、組織に異質要素を付着させることの他に付加的な機能を縫合糸が果たすことができるようにするためであろうと、任意の好適な生体適合性材料でさらに処理されてもよい。
先述の項で説明される一般的な創傷閉鎖および軟組織修復用途に加えて、自己保持縫合糸は、種々の他の適応で使用することができる。
Claims (18)
- 組織に挿入することができる自己保持縫合糸において、
縫合糸本体と、
該縫合糸本体において第1の方向に形成される、第1のらせん状斜面と、
該縫合糸本体において第2の方向に形成される、第2のらせん状斜面と
を備え、
該第1のらせん状斜面は、該縫合糸本体において複数の保持具を形成するために、該第2のらせん状斜面と交差し、各保持具は、該縫合糸本体から拡張される位置に配備可能であり、
前記第1の斜面および前記第2の斜面のうちの少なくとも一方は組織係合表面を含み、当該組織係合表面および当該組織係合表面に面する前記縫合糸本体の面の両方が不均一な表面である、
自己保持縫合糸。 - 請求項1に記載の縫合糸において、各保持具は、前記第1のらせん状斜面と前記第2のらせん状斜面との交差点において形成される斜面頂点を含む、縫合糸。
- 請求項1に記載の縫合糸において、
前記第1のらせん状斜面は、第1の組織貫通縁を含み、
前記第2のらせん状斜面は、第2の組織貫通縁を含む、
縫合糸。 - 請求項1に記載の縫合糸において、
前記第1のらせん状斜面は、第1の組織貫通縁を含み、
前記第2のらせん状斜面は、第2の組織貫通縁を含み、
該第1の組織貫通縁は、該第2の組織貫通縁と交差して組織を貫通するように適合される送り点を形成する、
縫合糸。 - 請求項1に記載の縫合糸において、前記保持具は、前記縫合糸本体の少なくとも一部の上に実質的に均一に分布している、縫合糸。
- 請求項2に記載の縫合糸において、前記各送り点は、丸みを帯びている、縫合糸。
- 請求項1に記載の縫合糸において、前記第1のらせん状斜面は、前記第2のらせん状斜面に対掌的に反対である、縫合糸。
- 請求項1に記載の縫合糸において、
前記縫合糸本体は、第1の端および第2の端を有し、
前記複数の保持具は各々、前記第1のらせん状斜面と前記第2のらせん状斜面との交差点において第1の斜面頂点を含み、
各第1の斜面頂点は、該第1の端の方を向き、
第3のらせん状斜面は、該縫合糸本体において第3の方向に形成され、
第4のらせん状斜面は、該縫合糸本体において第4の方向に形成され、
該第3のらせん状斜面は、該縫合糸本体において複数の別の保持具を形成するために、該第4のらせん状斜面と交差し、各別の保持具は、該縫合糸本体から拡張される位置に配備可能であり、
該複数の別の保持具は各々、該第3のらせん状斜面と該第4のらせん状斜面との交差点において第2の斜面頂点を含み、
各第2の斜面頂点は、該第2の端の方を向く、
縫合糸。 - 請求項8に記載の縫合糸において、前記縫合糸本体は、前記複数の保持具と前記複数の別の保持具との間に遷移区分を含む、縫合糸。
- 請求項9に記載の縫合糸において、前記遷移区分は、前記縫合糸本体の前記第1の端および該縫合糸本体の前記第2の端のどちらかの直径よりも大きい直径を有する、縫合糸。
- 請求項1に記載の縫合糸において、
前記縫合糸本体は、第1の端を有し、
各保持具は、前記第1のらせん状斜面と前記第2のらせん状斜面との交差点において形成される斜面頂点を含み、該斜面頂点は該第1の端から離れる方向に方向付けられ、
該縫合糸本体の該第1の端は、第1の直径を有し、
該縫合糸本体は、該第1の端から遠位に位置する第2の直径を有し、
該第2の直径は、該第1の直径よりも大きい、
縫合糸。 - 請求項8に記載の縫合糸において、前記第3のらせん状斜面と前記第4のらせん状斜面とは、対掌的に反対である、縫合糸。
- 請求項8に記載の縫合糸において、前記複数の保持具および前記複数の別の保持具は、実質的に均一に分布している、縫合糸。
- 請求項1に記載の縫合糸において、前記複数の保持具は、鱗形状物を画定する、縫合糸。
- 請求項1に記載の縫合糸において、抗増殖剤、抗血管新生剤、抗感染剤、線維化誘発剤、抗瘢痕化剤、潤滑剤、エコー発生剤、抗炎症剤、細胞周期阻害剤、鎮痛剤、および抗微小管剤から成る部類から選択される、少なくとも1つから成る被覆を含む、縫合糸。
- 請求項1に記載の縫合糸において、前記第1の斜面および前記第2の斜面のうちの少なくとも一方は、カット刃、粉砕輪、研磨表面のうちの1つによって形成される、縫合糸。
- 請求項1に記載の縫合糸において、前記第1の斜面および前記第2の斜面のうちの少なくとも一方は、研磨剤、重合剤、およびエッチャントから成る部類より選択される、薬剤で処理される、縫合糸。
- 組織に挿入することができる自己保持縫合糸において、
縫合糸本体と、
該縫合糸本体において第1の方向に形成される第1のらせん状斜面であって、該第1のらせん状斜面は第1の組織貫通縁を含む、第1のらせん状斜面と、
該縫合糸本体において第2の方向に形成される第2のらせん状斜面であって、該第2のらせん状斜面は第2の組織貫通縁を含む、第2のらせん状斜面と
を備え、
該第1のらせん状斜面は、該縫合糸本体において複数の保持具を形成するために、該第2のらせん状斜面と交差し、各保持具は、該縫合糸本体から拡張される位置に配備可能であり、
各保持具は、該第1の組織貫通縁の一部分および該第2の組織貫通縁の一部分を含み、
前記第1の斜面および前記第2の斜面のうちの少なくとも一方は組織係合表面を含み、当該組織係合表面および当該組織係合表面に面する前記縫合糸本体の面の両方が不均一な表面である、
自己保持縫合糸。
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- 2008-04-11 US US12/101,885 patent/US8793863B2/en active Active
- 2008-04-11 CA CA2683819A patent/CA2683819C/en not_active Expired - Fee Related
- 2008-04-11 JP JP2010503254A patent/JP5562829B2/ja not_active Expired - Fee Related
- 2008-04-11 KR KR1020097023593A patent/KR101485327B1/ko active IP Right Grant
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Also Published As
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EP3409214A2 (en) | 2018-12-05 |
EP3409214A3 (en) | 2018-12-19 |
US20080255611A1 (en) | 2008-10-16 |
KR20100016471A (ko) | 2010-02-12 |
US20090012560A1 (en) | 2009-01-08 |
US8915943B2 (en) | 2014-12-23 |
US20080255612A1 (en) | 2008-10-16 |
EP2146646B1 (en) | 2018-07-04 |
CA2683819A1 (en) | 2008-10-23 |
WO2008128113A1 (en) | 2008-10-23 |
JP2010523288A (ja) | 2010-07-15 |
KR101485327B1 (ko) | 2015-01-22 |
US8793863B2 (en) | 2014-08-05 |
EP2146646A1 (en) | 2010-01-27 |
CA2683819C (en) | 2016-02-23 |
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