JP2011507562A - 吸収性ナノ強化止血構造体及び包帯材料 - Google Patents
吸収性ナノ強化止血構造体及び包帯材料 Download PDFInfo
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Abstract
【選択図】図22
Description
本発明の所定態様は医療用具、特に外傷、外科的処置、潰瘍形成に起因する失血を軽減/予防するため又は血液凝固を必要とする他の用途に使用される材料及び構造体(「止血材料」及び「止血構造体」)に関する。所定態様において、前記材料及び構造体はナノ構造及び/又は他の止血材料(例えばガラスビーズ、コア−シェル粒子等)を組込むことができる。このようなナノ構造及び/又は他の止血材料は更に止血特性を強化し、及び/又はベース材料及び構造に止血特性を提供する。実施態様としては、止血創傷包帯、止血栓、及び他の止血製剤(例えば液体、粉末、フォーム及びジェル)が挙げられる。ベース材料/構造(例えばマトリックス、基材等)は包帯フォーマット(例えばガーゼ等)、創傷(例えば出血部位)に絞り出すことができるジェルフォーマット、創傷に噴霧もしくは噴射することができる液体フォーマット、創傷に噴霧もしくは噴射することができる粉末フォーマット、又は創傷中/上に押出/噴射/注入することができるフォームとすることができる。ベース材料/構造とナノ構造の組合せにより形成される止血剤(例えばナノ構造で強化した材料/構造)は固体、液体、粉末、フォーム、又はジェル形態をとることができる。非固体形態の止血剤は特定態様に応じて、創傷と接触後も非固体フォーマットのままでもよいし、接触すると凝固してもよいし、分配直後に硬化してもよい。
1態様では、無機シリカナノファイバー等のナノ構造を包帯/包帯繊維の表面に添加する。このようなナノ構造(例えばナノファイバー、ナノ粒子等)は固有の(接触)凝固カスケードの活性化を助け、出血の抑制又は停止をもたらす。ナノ構造の寸法は接触経路の活性化に優れた表面を提供し、従って、凝固を強化する非生物学的手段を包帯表面に提供するように選択される。このようなナノ構造はナノワイヤー、ナノファイバー、ナノ粒子、及び/又は本明細書に記載する他の任意ナノ構造種とすることができる。このようなナノ構造はシリコン、酸化物薄層をもつシリコン、シリカ、カリウム(カリウムナノファイバー、ナノワイヤー又はナノ粒子を含む)、カリウムで機能化したシリコンナノ構造(例えばカリウムで機能化したシリコンナノファイバー)等から作製することができる。
内視鏡装置の入口/出口点が血管を貫通する内視鏡手術後の失血を防ぐために、伸縮性ポリマーが創傷閉鎖に使用されている。このような装置の1例はSt.Paul,MNに所在のSt.Jude Medicalから販売されているAngioseal(登録商標)血管閉鎖装置である。綿ガーゼやタンポン構造体等の吸収材も創傷閉鎖に使用されている。伸縮性材料を使用する装置では、血液及び/又は他の体液が前記材料に吸収され、材料は膨潤して物理的バリヤーとなる。静止血液を材料の細孔内に取り込むことができ、血液は静止により凝固する。膨張した材料内の血液をより迅速に凝固させることができるならば有利であろう。本発明の各種態様は伸縮性材料と非伸縮性材料(例えばガーゼ、タンポン等の綿材料、及び他のこのような非伸縮性材料)に基づく装置の凝固速度を増すことができる。
創傷の過度の出血を阻止し易くすると共に凝固速度を増すために各種材料が開発されている。このような材料は例えば外科的処置で及び/又は外傷イベントの最初の処置者が使用することができる。しかし、既存のバルク止血剤には欠点がある。例えば、既存のバルク止血剤がより迅速に機能し、吸収性であり、及び/又は血液と発熱反応を生じないならば、有利であろう。本発明の所定態様は従来のバルク止血剤のこれらの欠点を解決する。
上記のように、固有の(接触)凝固カスケードの活性化を助け、出血の抑制又は停止をもたらすように、ナノ構造を包帯に添加することができる。所定態様において、ナノ構造はシリコンナノ粒子等のナノ粒子とすることができる。包帯材料に凝固強化を提供するようにナノ粒子を包帯材料に分散させることができる。
上記のように、固有の(接触)凝固カスケードの活性化を助け、出血の抑制又は停止をもたらすように、ナノワイヤーを包帯に添加することができる。所定態様では、包帯の凝固及び組織接着特性を調整するように異なる長さのナノワイヤーを包帯に添加することができる。凝固及び組織接着特性を調整するように多数の異なる長さのナノワイヤーを添加することができる。
所定態様では、創傷を縫合するために使用される外科用ステープル及び縫合糸を止血ナノ材料で機能化し、凝固を改善することができる。例えば、図33は外科用ステープルの1例3300の斜視図を示す。図33に示すように、外科用ステープル3300は基部3304と第1の脚部3306と第2の脚部3308をもつ本体3302を含む。基部3304は相対向する第1の表面と第2の表面3310及び3312をもつ。第1の脚部3306は第1の表面3310の第1の端部3314から第1の角度(例えば図33では90°)で延びており、第2の脚部3306は第1の表面3308の第2の端部3316から第2の角度(例えば図33では90°)で延びている。第1及び第2の脚部3306及び3308は各々基部3304から延びる夫々の端部に夫々の先端部3318及び3320をもつ。図33には平坦部品を折り曲げ、成形又は他の方法で長方形状に形成したものとして外科用ステープル3300を示すが、外科用ステープル3300は湾曲状及び/又は円形等の他の形状でもよい。外科用ステープル3300は金属やポリマー等の非吸収性材料から作製してもよいし、吸収性材料から作製してもよい。
所定態様では、本明細書に記載するように止血剤を形成するように構造体/材料に組込んだナノ構造を付加材料で機能化することができる。このような付加材料はナノ構造の特性を改善及び/又は変更することができる。図39は本発明の1態様に従って材料3904で機能化したナノファイバー3900の一部の表面3902を示す。
以上、本発明の代表的態様について記載した。本発明はこれらの例に限定されない。これらの例は限定の目的ではなく、例証の目的で本明細書に記載する。本明細書に含まれる教示に基づいて代替態様(本明細書に記載する態様の等価態様、拡張態様、変形態様、誘導態様等)も当業者に認識されよう。このような代替態様も本発明の範囲と精神に含まれる。
Claims (88)
- 第1の材料を含むベース構造と;
ベース構造に組込んだ複数のナノ構造
を含む止血構造体であって;
ナノ構造が止血構造体を血液と接触させたときに止血を誘導するように構成されている前記止血構造体。 - ベース構造が第1の材料の織布又は不織布繊維を含む請求項1に記載の止血構造体。
- ナノ構造がベース構造を被覆している請求項1に記載の止血構造体。
- 第1の材料が吸収性である請求項1に記載の止血構造体。
- 第1の材料が綿を含む請求項1に記載の止血構造体。
- 第1の材料が天然繊維を含む請求項2に記載の止血構造体。
- 第1の材料が合成繊維を含む請求項2に記載の止血構造体。
- 第1の材料が酸化セルロースを含む請求項1に記載の止血構造体。
- 第1の材料がコラーゲンを含む請求項1に記載の止血構造体。
- 第1の材料が生体由来材料を含む請求項1に記載の止血構造体。
- 第1の材料が有機又は無機ポリマーを含む請求項1に記載の止血構造体。
- 繊維がガラスマイクロファイバーを含む請求項2に記載の止血構造体。
- 止血構造体が包帯である請求項1に記載の止血構造体。
- ベース構造が包帯である請求項1に記載の止血構造体。
- ナノ構造を第1の材料に組込み、止血構造体を形成する段階を含む止血構造体の形成方法。
- 前記組込み段階がナノ構造を第1の材料の繊維織物に組込み、止血構造体を形成する段階を含む請求項15に記載の方法。
- 前記組込み段階が繊維織物をナノ構造で被覆し、止血構造体を形成する段階を含む請求項16に記載の方法。
- 前記被覆段階が、
ナノ構造で被覆したウェーハを液体中で音波処理する段階と;
音波処理したナノ構造を濾過する段階と;
濾過したナノ構造を液体に懸濁し、ナノ構造懸濁液を形成する段階と;
繊維織物をナノ構造懸濁液に浸漬する段階と;
浸漬した繊維織物を乾燥する段階を含む請求項17に記載の方法。 - 前記被覆段階が更に繊維織物を枠に装着する段階を含み;
前記浸漬段階が、枠に装着した繊維織物を浸漬する段階を含む請求項18に記載の方法。 - 前記被覆段階が電荷吸引を使用して繊維織物をナノ構造で被覆する段階を含む請求項17に記載の方法。
- 前記被覆段階が、
正荷電ポリマーを含有する溶液に繊維織物を浸漬し、繊維織物に正電荷を付与する段階と;
繊維織物を洗浄する段階と;
繊維織物を乾燥する段階と;
ナノ構造を含有する溶液を繊維織物に添加し、付与された正電荷によりナノ構造を繊維織物に吸引し、繊維織物を被覆する段階と;
被覆した繊維織物をインキュベートする段階と;
被覆した繊維織物を乾燥する段階を含む請求項20に記載の方法。 - 材料と;
複数のナノ構造を含む止血剤であって;
前記材料とナノ構造が混合物を形成する前記止血剤。 - 材料が止血性である請求項22に記載の止血剤。
- 止血材料が伸縮性である請求項23に記載の止血剤。
- 伸縮性止血材料がポリマーである請求項24に記載の止血剤。
- 止血材料が非伸縮性材料である請求項23に記載の止血剤。
- 材料が哺乳動物体内に吸収性である請求項22に記載の止血剤。
- 材料がキトサンを含む請求項22に記載の止血剤。
- 材料がキトサン微粒子を含む請求項28に記載の止血剤。
- 材料が生体適合性ポリマーを含む請求項22に記載の止血剤。
- ナノ構造がナノファイバーを含む請求項22に記載の止血剤。
- ナノファイバーが二酸化ケイ素で被覆されている請求項31に記載の止血剤。
- ナノファイバーがカリウムナノファイバーである請求項31に記載の止血剤。
- ナノファイバーがカリウムで機能化したシリコンナノファイバーである請求項31に記載の止血剤。
- 混合物が創傷に挿入され、創傷を塞栓するように構成されている請求項23に記載の止血剤。
- 材料が粉末である請求項22に記載の止血剤。
- 材料がジェルである請求項22に記載の止血剤。
- 材料がフォームである請求項22に記載の止血剤。
- 材料が液体である請求項22に記載の止血剤。
- ナノ構造が第2の材料で機能化されている請求項22に記載の止血剤。
- 第2の材料が止血材料である請求項40に記載の止血剤。
- 伸縮性止血材料を複数のナノ構造と混合する段階を含む止血剤の形成方法。
- 複数のガラスビーズと;
複数のナノ構造を含む止血剤であって;
ガラスビーズとナノ構造を混合して混合物を形成する前記止血剤。 - ガラスビーズの少なくとも一部が3〜10マイクロメーターの直径である請求項43に記載の止血剤。
- ナノ構造がナノワイヤーを含む請求項43に記載の止血剤。
- ナノワイヤーが無機物である請求項45に記載の止血剤。
- ナノワイヤーがシリコンを含む請求項43に記載の止血剤。
- ナノワイヤーがシリコンコアと、コアの周囲に配置され、二酸化ケイ素を含む少なくとも1層のシェル層を含む請求項47に記載の止血剤。
- 複数のガラスビーズを複数のナノ構造と混合する段階を含む止血剤の形成方法。
- 複数の止血粒子を含む止血剤であって;
各止血粒子が止血材料で被覆されたコア材料を含み;
コア材料の吸収速度が止血材料の吸収速度よりも大きい前記止血剤。 - コア材料がポリマーである請求項50に記載の止血剤。
- 止血材料が二酸化ケイ素を含む請求項50に記載の止血剤。
- 止血材料がスピンオンガラスを含む請求項50に記載の止血剤。
- 複数の粒子と混合した複数のナノ構造を更に含む請求項50に記載の止血剤。
- ナノ構造がナノファイバーを含む請求項54に記載の止血剤。
- ナノファイバーが二酸化ケイ素で被覆されている請求項55に記載の止血剤。
- 吸収性コア材料の粒子を止血材料で被覆することにより複数の止血粒子を形成する段階を含み;
コア材料の吸収速度が止血材料の吸収速度よりも大きい止血剤の形成方法。 - 止血材料が二酸化ケイ素を含み、前記形成段階が、吸収性コア材料の粒子を二酸化ケイ素で被覆することにより複数の止血粒子を形成する段階を含む請求項57に記載の方法。
- 止血材料がスピンオンガラスを含み、前記形成段階が、吸収性コア材料の粒子をスピンオンガラスで被覆することにより複数の止血粒子を形成する段階を含む請求項57に記載の方法。
- 包帯材料と;
外側酸化物薄層をもつナノ粒子から形成されるナノ粉末を含む止血包帯であって;
ナノ粉末が包帯材料に分散されている前記止血包帯。 - ナノ粒子の酸化物薄層が天然酸化物層である請求項60に記載の止血包帯。
- 更に包帯材料の表面にナノワイヤーのコーティングを含む請求項60に記載の止血包帯。
- ナノワイヤーが二酸化ケイ素の外層を含む請求項62に記載の止血包帯。
- 外側酸化物薄層をもつナノ粒子から形成されるナノ粉末を包帯材料に分散させる段階を含む止血包帯の形成方法。
- ナノ粒子の酸化物薄層が天然酸化物層であり、前記分散段階が、天然酸化物層をもつナノ粒子を包帯材料に分散させる段階を含む請求項64に記載の方法。
- 更に包帯材料の表面をナノワイヤーで被覆する段階を含む請求項64に記載の方法。
- ナノワイヤーが二酸化ケイ素の外層を含み、前記被覆段階が、二酸化ケイ素の外層をもつナノワイヤーで包帯材料の表面を被覆する段階を含む請求項65に記載の方法。
- 更にシリコンウェーハを粉砕し、ナノ粉末を生成する段階を含む請求項64に記載の方法。
- 包帯材料と;
各々第1の長さをもつように形成された第1群のナノワイヤーと;
各々第2の長さをもつように形成された第2群のナノワイヤー
を含む止血包帯であって、第2の長さが第1の長さよりも長く;
第1群のナノワイヤーが包帯材料の第1の領域に分散されており、第2群のナノワイヤーが包帯材料の第2の領域に分散されている止血包帯。 - 第1の領域が内側領域であり、第2の領域が包帯材料の表面のコーティング層である請求項69に記載の止血包帯。
- 包帯材料が相対向する第1の表面と第2の表面をもち、第1の領域第1の表面がの中心領域であり、第2の領域が第1の表面の周辺領域である請求項69に記載の止血包帯。
- 包帯材料がゼラチン包帯材料又はコラーゲン包帯材料である請求項69に記載の止血包帯。
- 各々第1の長さをもつように形成された第1群のナノワイヤーを包帯材料の第1の領域に分散させる段階と;
各々第2の長さをもつように形成された第2群のナノワイヤーを包帯材料の第2の領域に分散させる段階
を含む止血包帯の形成方法。 - 各々第1の長さをもつように形成された第1群のナノワイヤーを包帯材料の第1の領域に分散させる前記段階が、第1群のナノワイヤーを包帯材料の内側領域に分散させる段階を含み;
各々第2の長さをもつように形成された第2群のナノワイヤーを包帯材料の第2の領域に分散させる段階が、第2群のナノワイヤーを包帯材料に添加し、包帯材料の表面にコーティングを形成する段階を含む請求項73に記載の方法。 - 包帯材料が相対向する第1の表面と第2の表面をもち、各々第1の長さをもつように形成された第1群のナノワイヤーを包帯材料の第1の領域に分散させる前記段階が、第1群のナノワイヤーを包帯材料の第1の表面の中心領域に添加する段階を含み;
各々第2の長さをもつように形成された第2群のナノワイヤーを包帯材料の第2の領域に分散させる段階が、第2群のナノワイヤーを包帯材料の第1の表面の周辺領域に添加する段階を含む請求項73に記載の方法。 - 包帯材料がゼラチン包帯材料である請求項73に記載の方法。
- 基部と、基部の第1の表面の第1の端部から第1の角度で延びる第1の脚部と、基部の第1の表面の第2の端部から第2の角度で延びる第2の脚部をもつ本体と;
本体の少なくとも一部を被覆するナノ構造層
を含む外科用ステープル。 - ナノ構造層が基部の第1の表面を被覆する請求項77に記載の外科用ステープル。
- 基部が第1の端部と第2の端部を結ぶ第1の軸をもち、基部の第1の表面が第1の軸に垂直な第1の幅をもち、第1及び第2の脚部が各々基部と夫々の先端部の間に位置する第1の幅に平行な第2の幅をもち、第1の幅が第2の幅よりも大きい請求項78に記載の外科用ステープル。
- ナノ構造がナノファイバーを含む請求項77に記載の外科用ステープル。
- ナノファイバーが二酸化ケイ素の外層をもつ請求項80に記載の外科用ステープル。
- 基部と、基部の第1の表面の第1の端部から第1の角度で延びる第1の脚部と、基部の第1の表面の第2の端部から第2の角度で延びる第2の脚部をもつ外科用ステープルを仕込む段階と;
外科用ステープルの少なくとも一部をナノ構造層で被覆する段階
を含む外科用止血ステープルの形成方法。 - 前記被覆段階が、基部の第1の表面をナノ構造層で被覆する段階を含む請求項82に記載の方法。
- 基部が第1の端部と第2の端部を結ぶ第1の軸をもち、基部の第1の表面が第1の軸に垂直な第1の幅をもち、第1及び第2の脚部が各々基部と夫々の先端部の間に位置する第1の幅に平行な第2の幅をもち、方法が更に、第1の幅が第2の幅よりも大きくなるように外科用ステープルを形成する段階を含む請求項83に記載の方法。
- ナノ構造がナノファイバーを含み、前記被覆段階が、外科用ステープルの少なくとも一部をナノファイバーで被覆する段階を含む請求項82に記載の方法。
- ナノファイバーが二酸化ケイ素の外層をもち、前記被覆段階が、二酸化ケイ素を被覆したナノファイバーで外科用ステープルの少なくとも一部に被覆する段階を含む請求項85に記載の方法。
- 糸と;
糸の少なくとも一部を被覆するナノ構造層
を含む外科用縫合糸。 - 糸の少なくとも一部をナノ構造層で被覆する段階を含む外科用止血縫合糸の形成方法。
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- 2008-12-05 WO PCT/US2008/085719 patent/WO2009073854A1/en active Application Filing
- 2008-12-05 CN CN200880118915.5A patent/CN101883545B/zh not_active Expired - Fee Related
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Also Published As
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US20090192429A1 (en) | 2009-07-30 |
WO2009073854A1 (en) | 2009-06-11 |
US8304595B2 (en) | 2012-11-06 |
EP2219572A1 (en) | 2010-08-25 |
CN101883545A (zh) | 2010-11-10 |
JP5519524B2 (ja) | 2014-06-11 |
EP2219572A4 (en) | 2014-05-28 |
CN101883545B (zh) | 2013-08-07 |
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