JP2012525930A - 出血コントロール機器および方法 - Google Patents
出血コントロール機器および方法 Download PDFInfo
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- JP2012525930A JP2012525930A JP2012509911A JP2012509911A JP2012525930A JP 2012525930 A JP2012525930 A JP 2012525930A JP 2012509911 A JP2012509911 A JP 2012509911A JP 2012509911 A JP2012509911 A JP 2012509911A JP 2012525930 A JP2012525930 A JP 2012525930A
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Abstract
Description
本願は、2009年5月4日出願の米国仮出願第61/215,377号、2009年9月18日出願の米国仮出願第61/277,117号および2010年3月3日出願の米国仮出願第61/310,075号の利点を請求するものであり、それらの内容は、全体として参照することにより本発明に援用される。
連邦支援の研究または開発
本発明は、アメリカ合衆国特殊作戦軍(United States Special Operatiosn Command)とのさまざまな契約にしたがって、アメリカ合衆国政府補助により行われた。アメリカ合衆国は、本発明に権利を有する。
技術分野
本発明の実施態様は、出血をコントロールし、創傷を治療する方法、組成物および機器に関する。
第1の態様において、本発明は、液体に接触して膨張することができる複数の液体膨張性アーティクル(liquid expandable articles)を含む止血組成物に関する。
以下の詳細な記載において、全体を通して同じ部品は同じ参照番号によって表されるところの図面を詳細に参照すると、本発明が実施されうる実施態様の説明が示される。他の実施態様が用いられてもよく、本発明の範囲から逸脱することなく、構造的または論理上の変化を行うことができる。したがって、以下の詳細な記載は、限定とみなされるべきではなく、本発明の実施態様の範囲は、請求の範囲およびその等価物によって定義される。
このような実施態様では、液体膨張性材料は、たとえば、型打ち機およびプレス機を用いて切断されてもよい。吸収材を、所望の形状および大きさに直接鋳型成型してもよい。
材料
組成物1:再生セルローススポンジブロック(3M、ミネアポリス、MN)(190 mm x 109 mm x 50 mm)を洗浄し、キトサン溶液(1%キトサン、2%酢酸)に浸し、圧縮し、凍結乾燥した。乾燥した圧縮ブロックを、直径9.52 mmの円柱にダイカットした。
組成物2:再生セルローススポンジブロック(3M、ミネアポリス、MN)(190 mm x 109 mm x 50 mm)を洗浄し、キトサン溶液(1%キトサン、2%酢酸)に浸し、加熱乾燥し、圧縮した。乾燥した圧縮ブロックを、直径9.52 mmの円柱にダイカットした。
組成物3:再生セルローススポンジブロック(3M、ミネアポリス、MN)(190 mm x 109 mm x 50 mm)を洗浄し、加熱乾燥し、圧縮した。乾燥した圧縮ブロックを、直径9.52 mmの円柱にダイカットした。
組成物4:再生セルローススポンジブロック(東レ・ファインケミカル、千葉、日本)(190 mm x 109 mm x 50 mm)を洗浄し、キトサン溶液(1%キトサン、2%酢酸)に浸し、加熱乾燥し、圧縮した。乾燥した圧縮ブロックを、直径9.52 mmの円柱にダイカットした。
テープで貼った定規を備えた大きい秤量皿を22 mLの生理食塩水で満たした。キャリパーを用いて各サンプルの厚さを測定した。次に、テストサンプルの頂面の中心に27ゲージ針を押し付けて刺した。タイマーをスタートさせ、定規の0 cmマークにサンプルを置く状態で、テストサンプルの付着した針を生理食塩水に入れた。5、20および60秒後の時点で、サンプルアーティクルの長さを測定した。
膨張の程度は、一定の時間間隔における完全膨張に対するパーセンテージとして定義される。詳しくは:
膨張の程度=ti/tf
(ここで、tiは、ある時間間隔における厚さであり、tfは、最終的厚さである)
である。最終的厚さは、生理食塩水の外側で実験の最後に測定される。
組成物1
致死性のブタ鎖骨下出血モデルにおいて、現在の特殊作戦部隊の重篤出血介護の標準品であるコンバットガーゼ(CG)のコントロールに対して、液体膨張性アーティクルを鋭敏にテストした。
組成物1の液体膨張性アーティクルを実施例1に記載のように製造した。液体膨張性アーティクルの円柱の平均厚さは、4.54 mm(標準偏差0.84 mm)であった。使い捨て注射器を変更してアプリケーターを作製した。簡単に述べると、60 mlの注射器の先端を切り取り、ビニールの端部キャップを取り付けた。端部キャップにX型の切れ目を入れて、アーティクルが通過できるようにした。100個の液体膨張性アーティクルを各アプリケーターに装填した。
公開されている外科研究所(Institute of Surgical Research(ISR))のブタ大腿損傷モデル(Kheirabadi BSら、4009)の変更バージョンを、鎖骨下モデルの基礎とした。この実験では、16匹の交配種のヨークシャー去勢ブタを用いた。鎖骨下動脈および静脈を切断する前に、凝固障害を促進するために脾臓摘出を行った。創傷腔の体積および深さ、CO2、O2、平均動脈圧、ヘモグロビン濃度および血管直径を測定し、記録した。主要評価項目として、4分間での止血、60分間での止血および60分間における生存が挙げられる。先入観を最小化するために、マディガン陸軍病院の救急救命部門からの第三者の医者が無作為化した処置グループに適用された。
材料
組成物1の液体膨張性アーティクルを実施例1に記載のように製造した。組成物2のサンプルの平均厚さは、3.0 mm(標準偏差0.43 mm)であった。組成物3のサンプルの平均厚さは、2.7 mm(標準偏差0.30 mm)であった。組成物4のサンプルの平均厚さは、3.0 mm(標準偏差0.45 mm)であった。
公開されている外科研究所(Institute of Surgical Research(ISR))のブタ大腿損傷モデル(Kheirabadi BSら、4009)の変更バージョンを、鎖骨下モデルの基礎とした。この実験では、16匹の交配種のヨークシャー去勢ブタを用いた。鎖骨下動脈および静脈を切断する前に、凝固障害を促進するために脾臓摘出を行った。創傷腔の体積および深さ、CO2、O2、平均動脈圧、ヘモグロビン濃度および血管直径を測定し、記録した。主要評価項目として、4分間での止血、60分間での止血および60分間における生存が挙げられる。先入観を最小化するために、マディガン陸軍病院の救急救命部門からの第三者の医者が無作為化した処置グループに適用された。
Claims (24)
- 複数の液体膨張性アーティクルを含む止血組成物であって、
複数の液体膨張性アーティクルに含まれる個々の液体膨張性アーティクルが、5 mm3以上の体積を有し;および
複数の液体膨張性アーティクルが、液体に接触すると膨張して、膨張したアーティクルになることができる;止血組成物。 - 1種以上の治療薬をさらに含む、請求項1に記載の止血組成物。
- 液体膨張性アーティクルが、圧縮スポンジを含む、請求項1に記載の止血組成物
- 液体膨張性アーティクルが、セルロースを含む、請求項1に記載の止血組成物。
- 1種以上の治療薬が、止血剤を含む、請求項2に記載の止血組成物。
- 1種以上の治療薬が、キトサンを含む、請求項2に記載の止血組成物。
- 複数の液体膨張性アーティクルに含まれる個々の液体膨張性アーティクルが、マーカーを含む、請求項1に記載の止血組成物。
- マーカーが、放射線不透過性である、請求項7に記載の止血組成物。
- 液体膨張性アーティクルが、液体に浸した後、30秒以内にその最大膨張容量の90%以上に膨張することができる、請求項1に記載の止血組成物。
- 膨張したアーティクルに対する液体膨張性アーティクルの体積比が、少なくとも4倍である、請求項1に記載の止血組成物。
- アプリケーターおよび請求項1〜10のいずれか1つに記載の止血組成物を含む機器。
- アプリケーターが、出力端を含み、止血組成物が、容器内に位置する請求項11に記載の機器。
- 容器が管である、請求項12に記載の機器。
- 出力端を通って管から止血組成物を押し出すための、管内に位置するピストンをさらに含む、請求項13に記載の機器。
- 出力端に結合するバルブをさらに含む、請求項12に記載の機器。
- 複数の液体膨張性アーティクルを出血している創傷に適用することを含む、該創傷を有する個体を治療する方法であって、
個々の液体膨張性アーティクルが、5 mm3以上の体積を有し;および
複数の膨張性アーティクルが、創傷中の血液に曝されると膨張して、複数の膨張したアーティクルになり、集合的に止血を引き起こす;方法。 - 複数の液体膨張性アーティクルが、アプリケーターで創傷に適用される、請求項16に記載の方法。
- 創傷が、腔に通じる入り口開口を有する腔であって、血液が表面を通って腔内に流れる該表面によって境界される容積をもつ腔によって画定される、請求項16に記載の方法。
- 複数の液体膨張性アーティクルが、膨張し、創腔の少なくとも一部によって定義される形状に適合する、請求項18に記載の方法。
- 吸収材を複液体膨張性アーティクルにすること;および液体膨張性アーティクを合わせて複数の液体膨張性アーティクルにすることを含む、医療機器を製造する方法。
- 吸収剤を複液体膨張性アーティクルにすることが、吸収材を圧縮することを含む、請求項20に記載の方法。
- 液体膨張性アーティクルにする前、最中または後に、吸収材に治療薬を適用することをさらに含む、請求項20に記載の方法。
- 複数の液体膨張性アーティクルをアプリケーターに装填することをさらに含む、請求項20に記載の方法。
- (a)腔に通じる入り口開口を有する腔であって、血液が表面を通って腔内に流れる該表面によって境界される容積をもつ腔によって画定される創傷がある身体を有する生物;
(b)およびそれぞれ出発体積および出発体積より大きい第2体積を有する複数の膨張性アーティクルであって、該入り口開口を通って腔内にデリバリー可能な、該腔内の液体に曝されて第2体積に膨張する出発体積を有し、腔内で第2体積に膨張して集団で止血を引き起こす複数の膨張性アーティクル;の組み合わせ。
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US21537709P | 2009-05-04 | 2009-05-04 | |
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US27711709P | 2009-09-18 | 2009-09-18 | |
US61/277,117 | 2009-09-18 | ||
US31007510P | 2010-03-03 | 2010-03-03 | |
US61/310,075 | 2010-03-03 | ||
PCT/US2010/033596 WO2010129587A1 (en) | 2009-05-04 | 2010-05-04 | Hemorrhage control devices and methods |
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EP (1) | EP2427157B1 (ja) |
JP (1) | JP2012525930A (ja) |
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US8932560B2 (en) | 2007-09-04 | 2015-01-13 | University of Maryland, College Parke | Advanced functional biocompatible polymeric matrix used as a hemostatic agent and system for damaged tissues and cells |
WO2010129587A1 (en) | 2009-05-04 | 2010-11-11 | Oregon Biomedical Engineering Institute, Inc. | Hemorrhage control devices and methods |
US8668899B2 (en) | 2009-11-13 | 2014-03-11 | University Of Maryland, College Park | Advanced functional biocompatible foam used as a hemostatic agent for compressible and non-compressible acute wounds |
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US8828050B2 (en) | 2014-09-09 |
US9656050B2 (en) | 2017-05-23 |
WO2010129587A1 (en) | 2010-11-11 |
US20110077682A1 (en) | 2011-03-31 |
US20150057696A1 (en) | 2015-02-26 |
AU2010246025B2 (en) | 2015-11-12 |
CA2760201C (en) | 2019-11-19 |
EP2427157B1 (en) | 2019-03-13 |
EP2427157A4 (en) | 2012-10-24 |
EP2427157A1 (en) | 2012-03-14 |
CA2760201A1 (en) | 2010-11-11 |
AU2010246025A1 (en) | 2011-11-17 |
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