JP6470359B2 - 改良された縫合糸 - Google Patents
改良された縫合糸 Download PDFInfo
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- JP6470359B2 JP6470359B2 JP2017148672A JP2017148672A JP6470359B2 JP 6470359 B2 JP6470359 B2 JP 6470359B2 JP 2017148672 A JP2017148672 A JP 2017148672A JP 2017148672 A JP2017148672 A JP 2017148672A JP 6470359 B2 JP6470359 B2 JP 6470359B2
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Description
2012年2月23日に出願の米国仮特許出願番号第61/602,183号の優先権の利益をここに主張し、およびその全ての内容は、参照により本明細書に援用される。
本開示は、増加した表面領域および/または組織統合特性をもつ縫合糸、並びにその使用および製造の方法を提供する。特に、閉鎖を強化する、縫合糸断裂を防止する、および/または感染に抵抗する横断面プロフィールおよびその他の構造的な特徴をもつ縫合糸、並びにその使用方法が本明細書に提供される。
対照的に、本開示は、マクロポーラス構造を利用することによって縫合糸の周りの炎症および線維性組織形成のその「異物反応」を阻止するように設計された縫合糸に向けられる。マクロポーラス構造は、縫合糸に対する異物反応を最小限にすることを探求する。マイクロポーラス構造とは直接正反対に、マクロポーラス構造は、それ自体で縫合糸への新血管形成および局所的/正常な組織内部への成長を可能にすることによって最大の生体適合性を達成するように最適化される。
mm... 1cm)を有する。いくつかの態様において、切り開きを最小限にする、および/または最大荷重を提供する縫合糸寸法(たとえば、幅または深さ)が利用される。いくつかの態様において、最適な縫合糸寸法は、所与の組織および縫合糸材料について経験的に決定される。いくつかの態様において、縫合糸の1つまたは両方の断面寸法は、従来の縫合糸の断面寸法と同じである。いくつかの態様において、縫合糸は、異なる形状および/または寸法をもつ以外、従来の縫合糸と同じ断面積を含む。いくつかの態様において、縫合糸は、従来の縫合糸よりも大きな断面積を含む。いくつかの態様において、縫合糸横断面は、幅広い前縁を提供して、組織のより広い部分にわたって圧力を分配する。いくつかの態様において、縫合糸横断面は、単一の位置にてそれを焦めることよりもむしろ、組織のセグメントに沿って力を均一に分配する形づくられた前縁(たとえば、凸面)を提供する。いくつかの態様において、形づくられた縫合糸は、単一の位置にこれらを焦めるよりはむしろ、組織全体にわたって力を分配することによって切り開き防止する。いくつかの態様において、縫合糸は、組織を切り開くことがより困難であるより幅広い横断面を提供することによって、切り開き防止する。
実施例1
腹壁閉鎖を縫合させるための縫合糸/組織境界の有限要素解析
実験は、腹壁閉鎖を縫合させるための縫合糸/組織境界の有限要素解析を行うために、本開示の態様の開発の間に行った。理論的基礎は、照会のこのラインの設計における第1の工程として、直観的な概念および臨床的観察のために作製された(図1、2を参照されたい)。縫合糸/組織境界の有限要素解析を行った(図3)。実験は、仮定したように、縫合糸サイズ(すなわち、直径)を増加させると、縫合糸/組織境界における力を減少させることを証明した(図4)。また、縫合糸形状は、縫合糸による組織に対して適用される局所的力に影響を与えることを示した(図5)。
従来と本開示のマクロポーラス縫合糸との間の「同等性」を作製する。
生物組織および張力計を使用して急性縫合糸切り裂きモデルを作製し、確認する。
ラットヘルニアモデル
標準的縫合糸および我々の実験的なマクロポーラス縫合糸の切り開きを評価するために、本開示の態様の開発の間に、確立されたラットヘルニアモデルを繁殖して実験を行った。
縫合糸幅
縫合糸幅の効果を評価するために行った実験は、縫合糸幅の増大により、縫合糸の最大負荷の増大を生じ、縫合糸の切り開きの減少を生じることを示した。スズ引き銅平面編組線を、幅を変化させる縫合糸のための原型として使用した。組織と比較して、金属線は、本質的にコンプライアンスが悪く、組織に配置された縫合糸の引き裂きに対する可変幅のもの効果を単離するシステムを作製する。様々な幅のワイヤーを2つの異なる物質内:新鮮な動物組織(豚の腹壁)および合成発泡シートに置き、Instron 5942張力計を使用して正確にこのシステムの破壊強さを測定した。ワイヤーは、.36mm(O プロレン縫合糸に等しい)〜5mmの幅を試験した。これらの実験は、エキソビボと合成気質の間になんらかの相違があるかどうかを決定するために、動物組織および合成「組織」の両方において縫合糸幅を増加する効果を調べるためであった。
Claims (16)
- 外科用針と、
前記外科用針に付着された第1の末端及び前記外科用針から離れて位置した第2の末端を有する細長いメッシュの縫合糸とを備え、
細長いメッシュの縫合糸は、管状壁と、前記管状壁内部の中空コアと、前記管状壁を貫通する複数の孔とを含み、
前記細長いメッシュの縫合糸は、ほぼ20センチメートル以上の長さを有し、前記孔の少なくともいくつかはほぼ200ミクロン以上の孔径を有し、前記孔は、体内に導入された場合に、前記メッシュの縫合糸の前記管状壁を通じての組織組込みを容易にするように適合される医療装置。 - 前記縫合糸の管状壁は、前記第1及び第2の末端間に前記縫合糸の全体に沿って伸長する請求項1に記載の医療装置。
- 前記孔径は、(a)ほぼ200ミクロン〜ほぼ5ミリメートルの範囲、(b)ほぼ200ミクロン〜ほぼ3ミリメートルの範囲、(c)ほぼ1ミリメートル〜ほぼ3ミリメートルの範囲、又は、(d)ほぼ2.5ミリメートルである請求項1に記載の医療装置。
- 前記複数の孔は孔径が異なる請求項1に記載の医療装置。
- 前記縫合糸は、ほぼ1mm〜ほぼ10mmの範囲の直径を有する請求項1に記載の医療装置。
- 前記縫合糸は、その全体に沿って直径が均一である請求項1に記載の医療装置。
- 前記縫合糸は、ポリエチレンテレフタラート、ナイロン、ポリオレフィン、ポリプロピレン、絹、重合体p-ジオキサノン、p-ジオキサノンの共重合体、ε-カプロラクトン、グリコリド、L(-)-ラクチド、D(+)-ラクチド、メゾ-ラクチド、トリメチレンカルボナート、ポリジオキサノンホモポリマー、及びこれらの組み合わせからなる群から選択される材料で構成される請求項1に記載の医療装置。
- 前記縫合糸は、横方向の応力の非存在下で第1の断面プロフィールを、横方向の応力の存在下で第2の断面プロフィールを採るように、前記縫合糸は半径方向に変形可能である
請求項1に記載の医療装置。 - 前記第1の断面プロフィールは半径方向対称を示す請求項8に記載の医療装置。
- 前記第2の断面プロフィールは、部分的に又は完全に潰れた形状を示す請求項9に記載の医療装置。
- 前記縫合糸は、非応力状態にある場合に、実質的に円形の断面プロフィール又は非円形の断面プロフィールを有する請求項1に記載の医療装置。
- 使用時における前記縫合糸の断裂を防止するために前記縫合糸の第2の末端に付着されたアンカーをさらに含み、前記アンカーは、前記縫合糸の直径より大きい直径を有する請求項1に記載の医療装置。
- 前記アンカーは、ループ、ボール、ディスク、シリンダー、棘及び/又はフックを含む請求項12に記載の医療装置。
- 前記管状壁は、織られた又は編まれたメッシュ材を含む請求項1に記載の医療装置。
- 前記中空コアは、実質的に中空の円筒状または非円筒状のスペースである請求項1に記載の医療装置。
- 前記中空コアは、ハニカム構造、3次元格子構造、又は1つ以上の内部空隙を定義する他の適切なマトリックスを含む請求項1に記載の医療装置。
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CN202051754U (zh) * | 2011-03-30 | 2011-11-30 | 上海索康医用材料有限公司 | 一种医用缝合线 |
KR101155817B1 (ko) * | 2011-10-31 | 2012-06-12 | 김종우 | 조직거상용 이식물 |
US10278694B2 (en) | 2012-02-23 | 2019-05-07 | Northwestern University | Indirect attachment of a needle to a mesh suture |
EP3305211B1 (en) | 2012-02-23 | 2021-09-22 | Northwestern University | Improved suture |
AU2016233740A1 (en) | 2015-03-17 | 2017-09-07 | Advanced Suture, Inc. | Mesh suture with anti-roping characteristics |
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