JP2010516341A - 新規の生分解性骨プレートおよび結合システム - Google Patents
新規の生分解性骨プレートおよび結合システム Download PDFInfo
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- JP2010516341A JP2010516341A JP2009546474A JP2009546474A JP2010516341A JP 2010516341 A JP2010516341 A JP 2010516341A JP 2009546474 A JP2009546474 A JP 2009546474A JP 2009546474 A JP2009546474 A JP 2009546474A JP 2010516341 A JP2010516341 A JP 2010516341A
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Abstract
【選択図】なし
Description
本発明は、新規の生分解性生体インプラントを企図する。本発明のインプラントは、任意のタイプの医療用インプラントとすることができる。好ましい実施形態では、本発明のインプラントには、骨プレート、より好ましくは、再建手術中に頭蓋顎顔面骨格の骨のセグメントを固定して安定化させる頭蓋顎顔面プレートが含まれる。別の実施形態では、本発明のインプラントには、手の骨折の治療で使用する骨プレートが含まれる。さらなる実施形態では、骨切り術に伴って使用される骨プレートが企図される。
本発明はまた、上記した新規の生分解性インプラントを含めた様々な生分解性医療用インプラント(例えば、プレート)と併用できる新規の接着剤結合システムを企図している。新規の結合システムは、骨プレートの吸収特性を維持しながら、ねじ留め具を不要にし、ひいては骨セグメントの穴あけを不要にする。具体的には、本発明は、PLAまたはPLAベースのポリマーもしくはコポリマーを含む第1のポリマーと、ポリエステルベースのポリマーまたはコポリマーを含む第2のポリマーとを含む溶解接着システムを企図している。
本発明の結合システムは、従来の安定化システム(骨プレートおよびピン)の両方で結合剤として使用され、さらには本発明の新規の骨プレートと併用されるだけでなく、従来の安定化システムが使用できない様々な状況で役立つことができる。したがって、本発明は、本発明の接着剤ブレンドからなる、プレートのない結合システムを企図する。特に、本発明は、プレート、ピン、またはねじなどの他の固定手段を使用することなく、本発明の接着剤ブレンドを対象部位(通常は骨折部または骨切り部)に直接塗布することを企図する。
使用材料
a)ポリ乳酸(市販の生分解性脂肪族ポリエステル)
b)ビオノーレ(市販の脂肪族サクシネート−アジペートポリエステル)
c)エコフレックス(市販のBASF社製生分解性ポリエステル)
d)種々の厚さ(1mm、1.5mm、2mm)の圧縮成形用アルミニウムシート
e)市販の0.5mm厚鋼製金型
成形:ポリ乳酸ポリマーペレットを真空オーブン内で、24時間にわたって40℃で乾燥させた。金型内で、ガラスを25%充填した(表面を平滑にするための)テフロン(登録商標)コーティングシート間に、乾燥させたポリマーペレットを置いた。圧縮成形プレートを45分間、175℃で予熱した。確実に、金型が圧縮プレートと同じ温度を共有するようにした。金型を圧縮成形機のプレート間に置き、5分間予熱した。全圧力をかける前に、金型を2〜3回減圧して、パレット間の混入空気またはガスを除去した。5MPaの圧力を3分間加えた。このステップの後、成形プレートを取り出し、それらを空気中にて室温で冷却した。
新鮮なビーフの大腿部を特定の肉屋から調達した。用意された大腿部は、平均して、大きさが180mm×53mm×6mmであった。次いで、大腿部の皮をはがし、62mm×9mm×4mmの帯状片に切断した。この帯状片については、インストロン引張試験機への取り付けを容易にするために、非試験端部からばりをとった。鮮度を維持するために、帯状片を湿った環境に隔離した。
2種類の接着実験を行った。
a)液体接着剤を使用した接着
b)溶解接着剤を使用した接着
使用材料
i)シアノアクリレート
ii)ポリ酢酸ビニル
iii)シアノアクリレートとポリ酢酸ビニルとの混合物
キムワイプ(Kimwipes)(登録商標)を使用して骨標本を拭き、一滴のシアノアクリレートを骨の表面に塗布した。骨プレート標本を、シアノアクリレートを担持した骨部分と接触させた。骨と骨プレートとの間の接着部分に1分間にわたって親指で圧力をかけ続けた。次いで、引張試験を行った。
ポリ酢酸ビニル液体接着剤に対して同様の接着技術を行った。
シアノアクリレートおよびポリ酢酸ビニル混合物用の手順
キムワイプ(登録商標)を使用して骨標本を拭き、一滴のシアノアクリレートを骨の表面に塗布した。一滴のポリ酢酸ビニルを骨プレート標本に塗布した。骨プレート標本と骨標本両方の、接着剤を担持した部分を互いに接触させ、親指で圧力を1分間かけた。
使用材料
i)PLA溶解物
ii)エコフレックス溶解物
iii)PLAとエコフレックスからなる50:50ブレンド
キムワイプ(登録商標)を使用して骨標本を拭き、PLA溶解物を骨の表面に滴下した。骨プレート標本を(骨上の)溶解物と接触させ続け、最初の1分間に2〜3回加圧した。この後、接着したサンプルの引張試験を行った。サンプルの用意と試験の間の持続期間中に、室温と大気圧とでサンプルを物理エージングした。
PLA溶解物に対するのと同様の溶解結合手順をエコフレックスおよびブレンド溶解物を使用して行った。
グリップ間隔とグリップ分離速度からサンプル長を修正して、ASTM D 882準拠の引張試験を行った。
すべての試験で使用した骨プレートは、80:20のPLA/エコフレックスブレンドで作った。引張試験中に、純粋なPLAで作った骨プレートが非常に脆く、接着ボンドと比較して機械特性に劣ることが観察され、結果として、接着ボンドが機能しなくなる前にプレートが割れた。重量で20%のエコフレックスにより、骨プレートの機械特性が向上し、試験中にその機械特性が接着ボンドより高くなった。
Claims (33)
- PLAを含む第1のポリマーと、ポリエステルベースのポリマーを含む第2のポリマーとを含む、ポリマーブレンドからなる内固定具。
- 前記第2のポリマーは脂肪族ポリエステルである、請求項1に記載の内固定具。
- 前記内固定具が生分解性骨プレートである、請求項1に記載の内固定具。
- 前記ポリマーブレンドにはPLAが少なくとも約10%ある、請求項1に記載の内固定具。
- 前記ポリマーブレンドは、PLAが約80%および脂肪族ポリエステルが約20%である、請求項4に記載の内固定具。
- 前記内固定具が単一ユニットとして製造される、請求項1に記載の内固定具。
- 前記内固定具が、第1の部品と、少なくとも1つの追加の部品とを含み、両部品は別々に製造されて、その後結合される、請求項1に記載の内固定具。
- 前記内固定具が、第1の部品と、少なくとも1つの追加の部品とを含み、両部品は別々に製造されて、その後結合される、請求項3に記載の内固定具。
- 外科用の請求項1に記載の内固定具を処理する方法であって、以下を含む:
a)請求項1に記載の内固定具を調達すること;
b)前記内固定具を消毒すること;
c)前記内固定具を無菌容器に保管すること。 - 内固定具を人体組織に結合する方法であって、以下を含む:
エコフレックスおよびPLAからなるポリマーブレンドを人体組織か、または内固定具のいずれかに塗布すること;
前記ポリマーブレンドを加熱すること;
前記内固定具を前記人体組織に貼り付けること。 - 前記ポリマーブレンドにはPLAが少なくとも約10%ある、請求項10に記載の方法。
- 前記ポリマーブレンドにはPLAが少なくとも約20%ある、請求項11に記載の方法。
- 前記ポリマーブレンドは、PLAが約50%および脂肪族ポリエステルが約50%である、請求項12に記載の方法。
- 第1の内固定具と第2の内固定具とを結合する方法であって、以下を含む:
エコフレックスおよびPLAからなるポリマーブレンドを前記第1の内固定具に塗布すること;
前記ポリマーブレンドを加熱すること;
前記第2の内固定具を前記第1の内固定具に貼り付けること。 - 前記ポリマーブレンドにはPLAが少なくとも約10%ある、請求項14に記載の方法。
- 前記ポリマーブレンドにはPLAが少なくとも約20%ある、請求項15に記載の方法。
- 前記ポリマーブレンドは、PLAが約50%および脂肪族ポリエステルが約50%である、請求項16に記載の方法。
- ポリマーベースの新規の接着剤ブレンドであって、以下を含む:
PLAを含む第1のポリマー、およびポリエステルベースのポリマーを含む第2のポリマー。 - 前記接着剤は熱溶解接着剤である、請求項18に記載のポリマーベースの新規の接着剤ブレンド。
- 前記第1のポリマーはPLAであり、前記第2のポリマーは脂肪族ポリエステルである、請求項18に記載のポリマーベースの新規の接着剤ブレンド。
- 前記接着剤ブレンドにはPLAが少なくとも約10%ある、請求項18に記載の接着剤ブレンド。
- 前記接着剤ブレンドにはPLAが少なくとも約20%ある、請求項21に記載の接着剤ブレンド。
- 前記接着剤ブレンドは、PLAが約50%およびポリエステルベースのポリマーが約50%である、請求項22に記載の接着剤ブレンド。
- 前記ポリエステルベースのポリマーは脂肪族ポリエステルである、請求項23に記載の接着剤ブレンド。
- 請求項1に記載の内固定具を結合する方法であって、シアノアクリレート、ポリ酢酸ビニル、ポリ酢酸ビニルおよびシアノアクリレートの混合物からなる群から選択される接着剤を使用して前記内固定具を貼り付けることを含む。
- 前記内固定具が吸収性の骨プレートである、請求項1に記載の内固定具。
- 対象部位の損傷や骨折を安定化させる方法であって、以下を含む:
(a)外固定具を使用することなく、請求項18に記載の接着剤ブレンドを対象部位に直接塗布すること;および
(b)前記接着剤が硬化するか、または相変化を受けて、骨折部または損傷部に確実に固着するのを可能にすること。 - 前記接着剤ブレンドは熱溶解接着剤である、請求項27に記載の方法。
- 第1の接着剤はPLAであり、第2の接着剤は脂肪族ポリエステルである、請求項27に記載の方法。
- 前記接着剤ブレンドにはPLAが少なくとも約10%ある、請求項27に記載の方法。
- 前記接着剤ブレンドにはPLAが少なくとも約20%ある、請求項27に記載の方法。
- 前記接着剤ブレンドは、PLAが約50%およびポリエステルベースのポリマーが約50%である、請求項27に記載の方法。
- 前記ポリエステルベースのポリマーは脂肪族ポリエステルである、請求項32に記載の方法。
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