JP2012501391A - ヒアルロン酸および/またはその誘導体の糸、その作製方法、ならびにその使用 - Google Patents
ヒアルロン酸および/またはその誘導体の糸、その作製方法、ならびにその使用 Download PDFInfo
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Abstract
Description
本願は、米国特許法第119条(e)により、2008年9月2日に出願された米国特許仮出願第61/190,866号の恩典を主張する。
本発明は、概して、ヒアルロン酸および/またはその誘導体の糸、これを作製する方法、ならびにその使用、例えば、審美的用途(例えば、皮膚充填剤)、外科手術(例えば、縫合糸)、薬物送達、陰圧創傷療法、湿った創傷用包帯などにおける使用に関する。
ヒアルロン酸は、細胞外マトリックスの主成分である、β-D-N-アセチルグルコサミン(acetylglucoamine)とβ-D-グルクロン酸とが交互に結合した反復二糖単位(すなわち、(-4GlcUAβl-3GlcNAcβl-)n)からなる直鎖多糖(すなわち、非硫酸化グリコサミノグリカン)であり、例えば、結合組織、上皮組織、および神経組織に見出される。天然のヒアルロン酸(hylauronic acid)は、種特異性および臓器特異性が無いために生体適合性が高く、従って、組織工学において生体材料として、および様々な皮膚充填剤において一般的な成分として用いられることが多い。
本発明は、1つの局面において、ヒアルロン酸またはその塩、水和物、もしくは溶媒和化合物の糸、第2の局面において、架橋ヒアルロン酸またはその塩、水和物、もしくは溶媒和化合物の糸を提供することによって、これらのおよび他のニーズを満たす。一部の態様において、糸は、ヒアルロン酸またはその塩、水和物、もしくは溶媒和化合物の糸と、架橋ヒアルロン酸またはその塩、水和物、もしくは溶媒和化合物の糸の組み合わせである。
定義
「緩衝液」には、2-アミノ-2-メチル-1,3-プロパンジオール、2-アミノ-2-メチル-1-プロパノール、L-(+)-酒石酸、D-(-)-酒石酸、ACES、ADA、酢酸、酢酸アンモニウム、炭酸水素アンモニウム、クエン酸アンモニウム、ギ酸アンモニウム、シュウ酸アンモニウム、リン酸アンモニウム、リン酸アンモニウムナトリウム、硫酸アンモニウム、酒石酸アンモニウム、BES、BICINE、BIS-TRIS、炭酸水素塩、ホウ酸、CAPS、CHES、酢酸カルシウム、炭酸カルシウム、クエン酸カルシウム、クエン酸塩、クエン酸、ジエタノールアミン、EPP、エチレンジアミン四酢酸二ナトリウム塩、ギ酸溶液、Gly-Gly-Gly、Gly-Gly、グリシン、HEPES、イミダゾール、酢酸リチウム、クエン酸リチウム、MES、MOPS、酢酸マグネシウム、クエン酸マグネシウム、ギ酸マグネシウム、リン酸マグネシウム、シュウ酸、PIPES、リン酸緩衝食塩水、リン酸緩衝食塩水、ピペラジンD-酒石酸カリウム、酢酸カリウム、炭酸水素カリウム、炭酸カリウム、塩化カリウム、クエン酸カリウム、ギ酸カリウム、シュウ酸カリウム、リン酸カリウム、フタル酸カリウム、酒石酸カリウムナトリウム、四ホウ酸カリウム、四シュウ酸カリウム脱水和物、プロピオン酸溶液、STE緩衝溶液、5,5-ジエチルバルビツール酸ナトリウム、酢酸ナトリウム、炭酸水素ナトリウム、酒石酸水素ナトリウム一水和物、炭酸ナトリウム、クエン酸ナトリウム、ギ酸ナトリウム、シュウ酸ナトリウム、リン酸ナトリウム、ピロリン酸ナトリウム、酒石酸ナトリウム、四ホウ酸ナトリウム、TAPS、TES、TNT、TRIS-グリシン、TRIS-酢酸、TRIS緩衝食塩水、TRIS-HCl、TRISリン酸-EDTA、トリシン、トリエタノールアミン、トリエチルアミン、酢酸トリエチルアンモニウム、リン酸トリエチルアンモニウム、酢酸トリメチルアンモニウム、リン酸トリメチルアンモニウム、Trizma(登録商標)酢酸塩、Trizma(登録商標)塩基、Trizma(登録商標)炭酸塩、Trizma(登録商標)塩酸塩またはTrizma(登録商標)マレイン酸塩が含まれるが、これに限定されない。
本発明は、概して、ヒアルロン酸またはその塩、水和物、もしくは溶媒和化合物の糸、架橋ヒアルロン酸またはその塩、水和物、もしくは溶媒和化合物の糸、およびその組み合わせを提供する。一部の態様において、ヒアルロン酸は動物供給源から単離される。他の態様において、ヒアルロン酸は細菌発酵物から単離される。
本発明はまた、前記のヒアルロン酸およびその誘導体の糸を作製するための方法を提供する。一部の態様において、ヒアルロン酸またはその塩、水和物、もしくは溶媒和化合物の糸を作製する方法が提供される。ヒアルロン酸またはその塩、水和物、もしくは溶媒和化合物を水または緩衝液と混合して、ゲルを形成する。次いで、ゲルを押出して、ゲルの糸を形成する。例えば、ゲルを、ノズルの付いた注射器に入れ、ゲルがノズルから押出されるように、注射器を加圧し、注射器を直線移動させることによって、ゲルを押出すことができる。ノズルの特徴、例えば、先細り、長さ、および直径、注射器の圧力、ならびに直線移動の速度は、異なるサイズおよび機械的強度の糸を作製するように調節することができる。ゲルの糸を作製する別の方法は、ゲルを回転させる、すなわち生地のように回転させることによる方法、またはゲルを型に入れることによる方法である。ゲルの糸を作製するさらに別の方法は、重力の影響下で、または遠心力を用いて、ゲルを伸ばして糸にする方法である。ゲルの糸を作製するさらに別の方法は、ゲルを、荷電した平行なガラス板の間に入れて剪断することによる方法である。ゲルの糸を作製するさらに別の方法は、エラストマー上に作られた溝にゲルを閉じ込め、次いで、エラストマーを伸ばすことによる方法である。ゲルの糸を作製するさらに別の方法は、ゲルを、糸の脱水が可能な透過性のある管状構造に閉じ込め、必要に応じて、環境パラメータ、例えば、温度、圧力、および気体組成を調節することによって、脱水の内容を制御することによる方法である。次いで、調製後に、ヒアルロン酸またはその塩、水和物、もしくは溶媒和化合物の糸を乾燥させる。
本明細書に記載の糸、ひも、コード、織物メッシュ、または三次元構造は、例えば、動脈瘤の充填、腫瘍への血流の閉塞(すなわち、腫瘍閉塞)、眼瞼手術、(例えば、拡大または感度低下、すなわち、早漏症の治療のための)陰茎増大、診断剤および/または治療剤の鼻腔内(血液脳関門)送達装置、薬物送達のための角膜移植、隆鼻または鼻の再建、口唇の増大または再建、顔の増大または再建、耳垂の増大または再建、脊髄移植(例えば、膨隆型椎間板ヘルニア(bulging disk)を支持するための脊髄移植)、根管充填材(治療剤が加えられる)、声門閉鎖不全、レーザーフォトリフラクティブ療法(例えば、クッションとして用いられるヒアルロン酸糸/織物)、臓器の再成長のための足場材料、パーキンソン病(定位送達)における脊髄治療(BDNFおよびNGF)、治療分子または診断分子の正確な送達、歯髄移植、交換歯髄根管治療(replacement pulp root canal treatment)、成形された根管系、陰圧創傷療法、癒着防止材および創傷用包帯において使用することができる。
5重量%ヒアルロン酸および0.4重量%BDDEの濃度を有し、残りが水からなるゲルを形成することによって、直径0.004インチ〜0.006インチの架橋糸を作製した。内径が0.02インチで先端が先細のノズル、20psiの注射器圧力、および注射器からのゲル射出の速度と釣り合った直線移動速度により、ゲルを押出して糸の形にした。しかしながら、望ましい太さの糸を作製することができる、押出しパラメータの非常に多くの組み合わせが存在する。糸を乾燥させ、次いで、糸を水和している水でリンスし、次いで、乾燥中に糸を伸ばした。リンスおよび乾燥の複数のサイクルを行っている間に、糸の全長が約25%〜約100%増えた。前記のように作製した糸は、おおよそ約0.25kg〜約1.50kgの張力で機能しなくなり、水和した時には直径が約25%〜約100%膨張する。これは、インビボでは1〜9ヶ月間、糸として存続し得る。
皮下針(22〜25Ga)に、太さが0.004インチ〜0.008インチのヒアルロン酸糸を1本または2本、付けた。非架橋糸およびBDDEを用いて架橋した糸を両方とも使用した。針は、50歳女性の死体頭部、例えば、鼻唇ヒダ、口周囲、眼窩周囲、前頭筋(額)、および眉間にある皺を横断することができた。針は、先に針が挿入された位置に糸があるように、糸を皮膚に通して引っ張ることができた。
急性イヌ試験および慢性イヌ試験を行った。皮下針(22〜25Ga)に、太さが0.004インチ〜0.008インチのヒアルロン酸糸を1本または2本、付けた。非架橋糸およびBDDEを用いて架橋した糸を両方とも使用した。全ての場合において、針は、取り付けられた糸を真皮に通して引っ張ることができた。数分以内に、ほとんどの糸は、線状の隆起の形で、動物の皮膚表面に対して目に見える影響を及ぼした。
自己架橋ヒアルロン酸糸の引張り強さを、実施例1の方法を用いて架橋した糸と比較した。ヒアルロン酸を自己架橋する方法(USPTO6,387,413を参照されたい)を再現して、非架橋ヒアルロン酸の糸をくりかえし凍結融解した。このような全ての試料は、前記と同じ押出しパラメータを用いて作製しBDDEを用いて架橋した糸よりも、破断張力が小さかった。
Claims (25)
- ヒアルロン酸またはその塩、水和物、もしくは溶媒和化合物からなる、糸。
- 架橋ヒアルロン酸またはその塩、水和物、もしくは溶媒和化合物からなる、糸。
- ヒアルロン酸またはその塩、水和物、もしくは溶媒和化合物からなる糸と、架橋ヒアルロン酸またはその塩、水和物、もしくは溶媒和化合物からなる糸との組み合わせからなる、糸。
- 請求項1〜3のいずれか一項記載の糸を含む、創傷用包帯。
- 糸がコラーゲンを含む、請求項4記載の創傷用包帯。
- 請求項1〜3のいずれか一項記載の糸からなる少なくとも1つの織物メッシュを含む、創傷用包帯。
- 2層〜約10層の織物メッシュを含む、請求項6記載の創傷用包帯。
- 織物メッシュが同一の糸を含む、請求項6記載の創傷用包帯。
- 織物メッシュが異なる糸を含む、請求項6記載の創傷用包帯。
- 請求項1〜3のいずれか一項記載の糸を含む、癒着防止材。
- 請求項1〜3のいずれか一項記載の糸からなる少なくとも1つの織物メッシュを含む、癒着防止材。
- 創傷位置に適合するパッド、パッドに着脱可能に接着された気密シール、パッドと流体連通している陰圧源、およびパッドの創傷接触面に取り付けられた請求項1〜3のいずれか一項記載の糸を含む、創傷用包帯。
- 糸からなる少なくとも1層の織物メッシュを含む、請求項12記載の創傷用包帯。
- 請求項4記載の創傷用包帯を、創傷治療を必要とする対象の創傷に取り付ける工程を含む、対象における創傷を治療する方法。
- 請求項12記載の創傷用包帯を、創傷治療を必要とする対象の創傷に取り付ける工程を含む、対象における創傷を治療する方法。
- 請求項1〜3のいずれか一項記載の糸からなる、皮膚充填剤。
- 美容用途において請求項16記載の皮膚充填剤を使用する方法。
- 請求項1〜3のいずれか一項記載の糸からなる、縫合糸。
- 外科手術用途において請求項18記載の縫合糸を使用する方法。
- 外科手術用途、眼科手術、創傷閉鎖、薬物送達、および関節内注射において請求項1〜3のいずれか一項記載の糸を使用する方法。
- 以下の工程を含む、対象における皺を治療する方法:
請求項1〜3のいずれか一項記載の糸を針に取り付ける工程;
針の末端を、対象の皮膚表面に通して、皺に隣接する対象の真皮に挿入する工程;
針を用いて、皺の下にある対象の真皮を横断する工程;
針を、対象の皮膚表面から押し出す工程;および
対象の皮膚表面で糸を針から切断する工程。 - ヒアルロン酸またはその塩、水和物、もしくは溶媒和化合物と、水または緩衝液とを混合して、ゲルを形成する工程;
ゲルを押し出して糸にする工程;
ヒアルロン酸の糸を乾燥させる工程を含む、請求項1記載の糸を作製する方法。 - 治療剤および/または診断剤と、ヒアルロン酸と、水または緩衝液とを混合して、ゲルを形成する工程をさらに含む、請求項22記載の方法。
- ヒアルロン酸またはその塩、水和物、もしくは溶媒和化合物と、水または緩衝液および架橋剤とを混合して、ゲルを形成する工程;
ゲルを押し出して糸にする工程;
架橋ヒアルロン酸の糸を乾燥させる工程を含む、請求項2記載の糸を作製する方法。 - 治療剤および/または診断剤と、ヒアルロン酸またはその塩、水和物、もしくは溶媒和化合物と、水または緩衝液および架橋剤とを混合して、ゲルを形成する工程をさらに含む、請求項24記載の方法。
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JP2018531123A (ja) * | 2015-09-03 | 2018-10-25 | ジンウ バイオ カンパニー リミテッドJinwoo Bio Co.,Ltd. | ヒアルロン酸塩がコーティングされた高機能性縫合糸の製造方法及びこれにより製造された高機能性縫合糸 |
US10695459B2 (en) | 2015-09-03 | 2020-06-30 | Jinwoo Bio Co., Ltd. | Method for preparing high-functional suture yarn coated with hyaluronate and high-functional suture yarn prepared therefrom |
US10994048B2 (en) | 2015-09-03 | 2021-05-04 | Jinwoo Bio Co., Ltd. | Method for manufacturing hyaluronate fibers by using melt spinning and hyaluronate fibers manufactured thereby |
US11617813B2 (en) | 2015-09-03 | 2023-04-04 | Jinwoo Bio Co., Ltd. | Method for preparing high-functional suture yarn coated with hyaluronate and high-functional suture yarn prepared therefrom |
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ES2658609T3 (es) | 2018-03-12 |
US11154484B2 (en) | 2021-10-26 |
JP2017038939A (ja) | 2017-02-23 |
EP2324064A4 (en) | 2013-07-03 |
EP2324064A1 (en) | 2011-05-25 |
US20160074307A1 (en) | 2016-03-17 |
WO2010028025A1 (en) | 2010-03-11 |
EP3184552B1 (en) | 2020-08-12 |
US10463595B2 (en) | 2019-11-05 |
US9228027B2 (en) | 2016-01-05 |
JP2015144848A (ja) | 2015-08-13 |
JP6063981B2 (ja) | 2017-01-18 |
CA2735173C (en) | 2017-01-10 |
ES2829971T3 (es) | 2021-06-02 |
US9861570B2 (en) | 2018-01-09 |
CA2735173A1 (en) | 2010-03-11 |
JP5722217B2 (ja) | 2015-05-20 |
AU2009288118A1 (en) | 2010-03-11 |
EP2324064B1 (en) | 2017-11-08 |
AU2009288118B2 (en) | 2014-12-11 |
JP6334635B2 (ja) | 2018-05-30 |
US20180344610A1 (en) | 2018-12-06 |
EP3184552A1 (en) | 2017-06-28 |
US20200009038A1 (en) | 2020-01-09 |
US20110263724A1 (en) | 2011-10-27 |
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