JP4667853B2 - 吸収性のコアを有する高強度縫合糸と縫合糸アンカーの組合せ体 - Google Patents
吸収性のコアを有する高強度縫合糸と縫合糸アンカーの組合せ体 Download PDFInfo
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- JP4667853B2 JP4667853B2 JP2004366444A JP2004366444A JP4667853B2 JP 4667853 B2 JP4667853 B2 JP 4667853B2 JP 2004366444 A JP2004366444 A JP 2004366444A JP 2004366444 A JP2004366444 A JP 2004366444A JP 4667853 B2 JP4667853 B2 JP 4667853B2
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Description
本発明の縫合糸は、以下に記載する方法で製造した。縫合糸は、メープル(中空)ブレーダ(maple (hollow) braider)を用いて製造した。この複合縫合糸は、超高分子ポリエチレンヤーンとポリジオキサノンヤーンからなるシースを含む。このシースは、45wt%の超高分子ポリエチレンと55wt%のポリジオキサノンを含む。この縫合糸のコアは、100wt%のポリジオキサノンヤーンからなる。全体として、縫合糸は、38wt%の超高分子ポリエチレンと62wt%のポリジオキサノンからなる。縫合糸構造の非吸収性部分は、反時計回り方向にブレーダに導入される8本の100デニール・ダイニーマ純度・超高分子ポリエチレン・マルチフィラメント・ヤーン(DSM社製)からなり、ポリジオキサノン部分は、ニュージャージー州ソマービル(Somerville)に所在のエシコン・インコーポレイテッド(Ethicon, Inc.)がポリジオキサノン縫合糸の製造に使用するような従来のマルチフィラメント・ポリジオキサノン・ヤーンである。ポリジオキサノン部分は、時計回り方向にブレーダに導入される8本のポリジオキサノン60×2デニール着色マルチフィラメントヤーンからなる。この編み縫合糸は、着色ポリジオキサノン60×2/3マルチフィラメントヤーンからなるコア構造を有する。ピックカウントは、約47〜48ppiに選択した。吸収性コアは、吸収された後の体内での縫合糸の大きさを最小にし、かつ縫合糸の切断が容易になるように選択した。この編み縫合糸の構造は、表1の通りである。
例1の縫合糸の抗張力は、定速度の伸長法を用いて米国薬局法(United States Pharmocopoeia)に従って試験した。加えて、ニュージャージー州ソマービル(Somerville)に所在のエシコン・インコーポレイテッド(Ethicon, Inc.)が製造するような芳香族ポリエステル(以降、PETと呼ぶ)や、フロリダ州ネイプルズ(Naples)に所在のアースレックス・インコーポレイテッド(Arthrex Inc.)が製造するファイバーワイヤー(FIBERWIRE)などの超高分子ポリエチレン/PETなどの市販の縫合糸も試験した。試験結果を表2に示した。
インビトロでの結節の破壊強さ維持(BSR)&時間経過による質量の減少
インビトロでの結節の安全性を調べるために、例1の縫合糸サンプルをpH7.27の緩衝液及び57℃の水槽で分解させた。5個の結び目からなる結節を緩衝液容器内に入れた。各ロットの5個の結び目からなる結節をそれぞれの時間に試験した。破壊強さを調べるために、ハルマンループ取付け具(Harmann's loop fixture)を利用するインストロン引張試験機(Instron Tensile Tester)を用いて、2インチ(5.08mm)/分のXH速度で分解の前後で縫合糸を試験した。この試験はループで行ったため、一般的なUSP結節強度試験の場合は結節強度が約2倍になることに留意されたい。緩衝液中でそれぞれの時間浸した後に縫合糸を乾燥させて、残存質量を測定した。
生体内での結節の破壊強さ維持(BSR)
生体内での破壊強さ維持は、例1の縫合糸を用いて以下の要領で実施した。
結節プロフィールの縮小(煮沸試験)
0.05N 水酸化ナトリウム溶液中での加速吸収試験(煮沸)を例1のコーティング縫合糸を用いて実施し、ポリジオキサノン部分が吸収された後の縫合糸の結節プロフィールの縮小を検証した。
この例では、抗菌薬トリクロサンをポリジオキサノンなどの生体分解性ポリマーの粉末に混合した。この混合は、ブラベンダー(Brabender)、ベーカー・パーキンス・ブレンダー(Baker Perkins blender)、またはVブレンダー(V-blender)を用いて、必ずしも必要ではないが加熱して行った。所望に応じて溶媒を添加して、混合を容易にすることができる。次いで、通常は分散溶媒を押出し工程の前に除去する。得られた組成物を一軸または二軸の押出機で押出しするか或いはペレット化する。混合したら、その材料を、モノフィラメント繊維またはマルチフィラメント繊維を形成できるダイを用いて従来の一軸または二軸のスクリュー押出機で再び押出しした。この繊維は、他の処理を行わないでスピナレットから直接収集する、或いはこの工程の後にアニーリングやドローイング(引抜き)を実施することもできる。樹脂のスループット、巻取り速度、及びドローイングの程度により、繊維の直径や向きが決まる。この繊維をヤーンに紡績する。
例6の吸収性マルチフィラメントヤーンを例1の生体吸収性ヤーンの代わりに用いて、例1の工程に従って本発明の複合縫合糸を製造した。
曲げ剛性試験
試験するために、長さが1.5インチ(38.1mm)の5本の縫合糸を各ロットから用意した。特殊な取付け具(後述)をインストロン引張試験機(モデル4201)と共に用いて、取付け具の開口に通された縫合糸を引張るために必要な抵抗力を測定した。この試験では、500gのロードセルを用いた。クロスヘッド速度は1インチ(25.4mm)/分とした。この試験の情報は電子的に収集した。
回旋腱板手術のために、患者の準備を従来の要領で行う。患者を従来の麻酔法で麻酔する。従来のトロカール及び従来の関節鏡を用いて病理を確認し診断する。外科医は、傷害部位に近接した肩にあるカニューレを介して挿入された従来の関節鏡を用いて障害部位を観察する。外科医は、あらゆる癒着を分離させ、回旋腱板の外側縁を除去し、腱を固定し、そして骨層の準備をする。外科医は、患者の上腕骨頭の大粗面の下側における最適な縫合糸アンカー配置部位を決定し、骨孔を穿孔して以下の要領でアンカーを配置する。ドリルガイドをトロカールから挿入する。ドリルガイドを介してドリルピットを配置し、縫合糸アンカー用の骨孔を穿孔する。本発明の縫合糸が取り付けられた図3に例示されている縫合糸アンカーなどの従来の縫合糸アンカーを、骨孔に挿入し、骨皮質の下側の海綿骨に係合するように配置する。縫合糸の端部に取り付けた外科用縫合針を用いて、軟組織(例えば、腱)が骨の表面に近接するように軟組織に刺入する。次いで、縫合糸を、従来の要領で従来の外科用結節を作って結節する。次いで、縫合針を縫合糸から切り離して処置を終了し、縫合または外科用テープや外科用接着剤を用いて従来の要領で患者の外筋膜と皮膚を近接させる。
(1)外科用縫合糸と縫合糸アンカーの組合せ体であって、
(a)アンカー本体を備え、縫合糸取付け孔が形成された縫合糸アンカーと、
(b)生体吸収性ポリマーを含む少なくとも1本の繊維からなる少なくとも1本の第1のヤーンを含む内側コアと、少なくとも1本の非吸収性繊維からなる第2のヤーン及び少なくとも1本の生体吸収性繊維を含む第3のヤーンを有する外側編みシースとを備えた、前記第2のヤーンと前記第3のヤーンが編み合わさって接触している外科用縫合糸とを含み、
前記縫合糸が前記縫合糸アンカーの前記縫合糸取付け孔に取り付けられていることを特徴とする外科用縫合糸と縫合糸アンカーの組合せ体。
(2)前記第1の生体吸収性ヤーン及び前記第3の生体吸収性ヤーンが、p‐ジオキサノン、ε‐カプロラクトン、グリコリド(glycolide)、L(‐)‐ラクチド、D(+)‐ラクチド、Meso‐ラクチド、トリメチレンカーボネート、及びこれらの組合せからなる群から選択されるラクトンモノマーから製造されたポリマーを含むことを特徴とする実施態様(1)に記載の組合せ体。
(3)前記非吸収性繊維が超高分子ポリエチレンを含むことを特徴とする実施態様(1)に記載の組合せ体。
(4)前記縫合糸が約55wt%〜約70wt%の生体吸収性ポリマーを含むことを特徴とする実施態様(1)に記載の組合せ体。
(5)前記生体吸収性ヤーンがポリジオキサノンを含むことを特徴とする実施態様(2)に記載の組合せ体。
(7)前記第1の生体吸収性ヤーン及び前記第3の生体吸収性ヤーンが、鎮痛薬、抗生物質、抗炎症薬、及び痛み止めからなる群から選択される医薬組成物を含むことを特徴とする実施態様(6)に記載の組合せ体。
(8)前記ポリエチレンヤーンが、約500,000g/モル〜約5,000,000g/モルの平均分子量を有する超高分子ポリエチレンを含むことを特徴とする実施態様(1)に記載の組合せ体。
(9)更に縫合糸のコーティングを含むことを特徴とする実施態様(1)に記載の組合せ体。
(10)更に、前記縫合糸の一端に取り付けられた外科用縫合針を含むことを特徴とする実施態様(1)に記載の組合せ体。
(a)アンカー本体を備え、縫合糸取付け孔が形成された縫合糸アンカーと、(b)生体吸収性ポリマーを含む少なくとも1本の繊維からなる少なくとも1本の第1のヤーンを含む内側コアと、少なくとも1本の非吸収性繊維からなる第2のヤーン及び少なくとも1本の生体吸収性繊維を含む第3のヤーンを有する外側編みシースとを備えた、前記第2のヤーンと前記第3のヤーンが編み合わさって接触している外科用縫合糸とを含み、前記縫合糸が前記縫合糸アンカーの前記縫合糸取付け孔に取り付けられている、外科用縫合糸と縫合糸アンカーの組合せ体を用意するステップと、
外面を有する骨に前記アンカーを取り付けるステップと、
前記縫合糸を用いて軟組織を前記骨の外面に固定するステップと、
前記縫合糸を結んで結節を形成するステップとを含むことを特徴とする方法。
(12)前記第1の生体吸収性ヤーン及び前記第3の生体吸収性ヤーンが、p‐ジオキサノン、ε‐カプロラクトン、グリコリド(glycolide)、L(‐)‐ラクチド、D(+)‐ラクチド、Meso‐ラクチド、トリメチレンカーボネート、及びこれらの組合せからなる群から選択されるラクトンモノマーから製造されたポリマーを含むことを特徴とする実施態様(11)に記載の方法。
(13)前記非吸収性繊維が超高分子ポリエチレンを含むことを特徴とする実施態様(11)に記載の方法。
(14)前記縫合糸が約55wt%〜約70wt%の生体吸収性ポリマーを含むことを特徴とする実施態様(11)に記載の方法。
(15)前記ヤーンがポリジオキサノンを含むことを特徴とする実施態様(12)に記載の方法。
(17)前記第1の生体吸収性ヤーン及び前記第3の生体吸収性ヤーンが、鎮痛薬、抗生物質、抗炎症薬、及び痛み止めからなる群から選択される活性物質を含むことを特徴とする実施態様(16)に記載の方法。
(18)前記ポリエチレンヤーンが、約500,000g/モル〜約5,000,000g/モルの分子量を有する超高分子ポリエチレンを含むことを特徴とする実施態様(11)に記載の方法。
(19)更に、縫合糸のコーティングを含むことを特徴とする実施態様(11)に記載の方法。
(20)更に、前記縫合糸の一端に取り付けられた外科用縫合針を含むことを特徴とする実施態様(11)に記載の方法。
(22)前記第1のヤーン及び前記第3のヤーンが、リン酸三カルシウム及びヒドロキシアパタイトからなる群から選択される材料を含むことを特徴とする実施態様(1)に記載の組合せ体。
(23)前記第1のヤーン及び前記第3のヤーンが更に、バイオセラミックス材料を含むことを特徴とする実施態様(11)に記載の方法。
(24)前記第1のヤーン及び前記第3のヤーンが、リン酸三カルシウム及びヒドロキシアパタイトからなる群から選択される材料を含むことを特徴とする実施態様(11)に記載の方法。
(25)外科用縫合糸と縫合糸アンカーの組合せ体の結節の結節プロフィールを縮小させる方法であって、
アンカー本体及び縫合糸取付け孔を有する縫合糸アンカーを用意するステップと、
生体吸収性ポリマーを含む少なくとも1本の繊維からなる少なくとも1本の第1のヤーンを含む内側コアと、少なくとも1本の非吸収性繊維からなる第2のヤーン及び少なくとも1本の生体吸収性繊維を含む第3のヤーンを有する外側編みシースとを備えた、前記第2のヤーンと前記第3のヤーンが編み合わさって接触している縫合糸を用意するステップと、
外面を有する骨に前記アンカーを挿入するステップと、
前記縫合糸を組織に通して、前記縫合糸で前記骨の外面に組織を取り付けるステップと、
前記縫合糸を結んで結節プロフィールを有する結節を形成するステップと、
前記結節プロフィールが効果的に縮小するように十分な時間、前記縫合糸の前記結節を生体内に維持するステップとを含むことを特徴とする方法。
(27)前記ヤーンが、超高分子ポリエチレン/PETから製造された市販の縫合糸と比べて縫合糸の操作性及び剛性に実質的に悪影響がない、フィラメント当たり12デニールよりも大きいデニールを有するフィラメントを含むことを特徴とする実施態様(5)に記載の組合せ体。
(28)前記ヤーンが、フィラメント当たりのデニールが3未満のポリエチレンテレフタレートから製造された縫合糸に比べて縫合糸の操作性及び剛性に実質的に悪影響がない、フィラメント当たり12デニールよりも大きいデニールを有するフィラメントを含むことを特徴とする実施態様(5)に記載の組合せ体。
20 外側シース
30、35、70 ヤーン
60 内側コア
100 組織
110 創傷
115 創傷の縁
130 結節
140 結節プロフィール特性
200 縫合糸
250 縫合糸アンカー
255 縫合糸アンカー本体
260 縫合糸取付け孔
270 骨
280 海綿質部分
285 皮質
290 軟組織
310 結節
315 結節プロフィール特性
340 外科用縫合針
502 取付け具
505 ロードセル
506 ロッド
508 通路
510 縫合糸
512 ブラケット
514 ベース
516 開口
Claims (15)
- 外科用縫合糸と縫合糸アンカーの組合せ体において、
(a)アンカー本体を備え、縫合糸取付け孔が形成された縫合糸アンカーと、
(b)生体吸収性ポリマーを含む少なくとも1本の繊維からなる少なくとも1本の第1のヤーンを含む内側コアと、少なくとも1本の非吸収性繊維からなる第2のヤーン及び少なくとも1本の生体吸収性繊維を含む第3のヤーンを有する外側編みシースとを備えた、前記第2のヤーンと前記第3のヤーンが編み合わさって接触している外科用縫合糸とを含み、
前記縫合糸が前記縫合糸アンカーの前記縫合糸取付け孔に取り付けられていることを特徴とする、外科用縫合糸と縫合糸アンカーの組合せ体。 - 請求項1に記載の組合せ体において、前記第1のヤーン及び前記第3のヤーンが、p‐ジオキサノン、ε‐カプロラクトン、グリコリド(glycolide)、L(‐)‐ラクチド、D(+)‐ラクチド、Meso‐ラクチド、トリメチレンカーボネート、及びこれらの組合せからなる群から選択されるラクトンモノマーから製造されたポリマーを含むことを特徴とする、組合せ体。
- 請求項1または2に記載の組合せ体において、前記非吸収性繊維が超高分子ポリエチレンを含むことを特徴とする、組合せ体。
- 請求項1〜3のいずれか1項に記載の組合せ体において、前記縫合糸が55wt%〜70wt%の生体吸収性ポリマーを含むことを特徴とする、組合せ体。
- 請求項2〜4のいずれか1項に記載の組合せ体において、前記第1および第3のヤーンがポリジオキサノンを含むことを特徴とする、組合せ体。
- 請求項1〜5のいずれか1項に記載の組合せ体において、前記第1のヤーン及び前記第3のヤーンが医薬組成物を含むことを特徴とする、組合せ体。
- 請求項6に記載の組合せ体において、前記第1のヤーン及び前記第3のヤーンが、鎮痛薬、抗生物質、抗炎症薬、及び痛み止めからなる群から選択される医薬組成物を含むことを特徴とする、組合せ体。
- 請求項1〜7のいずれか1項に記載の組合せ体において、前記非吸収性の繊維が、500,000g/モル〜5,000,000g/モルの重量平均分子量を有する超高分子ポリエチレンを含むことを特徴とする、組合せ体。
- 請求項1〜8のいずれか1項に記載の組合せ体において、更に縫合糸のコーティングを含むことを特徴とする、組合せ体。
- 請求項1〜9のいずれか1項に記載の組合せ体において、更に、前記縫合糸の一端に取り付けられた外科用縫合針を含むことを特徴とする、組合せ体。
- 請求項1〜10のいずれか1項に記載の組合せ体において、前記第1のヤーン及び前記第3のヤーンが、更に、バイオセラミックス材料を含むことを特徴とする、組合せ体。
- 請求項1〜11のいずれか1項に記載の組合せ体において、前記第1のヤーン及び前記第3のヤーンが、リン酸三カルシウム及びヒドロキシアパタイトからなる群から選択される材料を含むことを特徴とする、組合せ体。
- 請求項5〜12のいずれか1項に記載の組合せ体において、前記第1のヤーンと前記第3ヤーンのそれぞれが、フィラメント当たり3デニールよりも大きいデニールを有するフィラメントを含むことを特徴とする、組合せ体。
- 請求項5〜13のいずれか1項に記載の組合せ体において、前記第1のヤーンと前記第3ヤーンのそれぞれが、超高分子ポリエチレン/PETから製造された市販の縫合糸と比べて縫合糸の操作性及び剛性に実質的に悪影響がない、フィラメント当たり12デニールよりも大きいデニールを有するフィラメントを含むことを特徴とする、組合せ体。
- 請求項5〜14のいずれか1項に記載の組合せ体において、前記第1のヤーンと前記第3ヤーンのそれぞれが、フィラメント当たりのデニールが3未満のポリエチレンテレフタレートから製造された縫合糸に比べて縫合糸の操作性及び剛性に実質的に悪影響がない、フィラメント当たり12デニールよりも大きいデニールを有するフィラメントを含むことを特徴とする、組合せ体。
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US8632566B2 (en) | 2009-04-27 | 2014-01-21 | Teleflex Medical Incorporated | Colored suture construction |
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CA2490175A1 (en) | 2005-06-18 |
US9642930B2 (en) | 2017-05-09 |
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US8568449B2 (en) | 2013-10-29 |
AU2004235664B2 (en) | 2011-08-04 |
JP2005177500A (ja) | 2005-07-07 |
US20050149118A1 (en) | 2005-07-07 |
EP1543848B1 (en) | 2011-09-28 |
US20150133868A1 (en) | 2015-05-14 |
EP1543848A1 (en) | 2005-06-22 |
US7357810B2 (en) | 2008-04-15 |
US10624632B2 (en) | 2020-04-21 |
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