JP2008505726A - 接着剤含有創傷閉鎖デバイスおよび方法 - Google Patents
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- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
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- Y10T442/10—Scrim [e.g., open net or mesh, gauze, loose or open weave or knit, etc.]
- Y10T442/102—Woven scrim
- Y10T442/172—Coated or impregnated
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- Y10T442/00—Fabric [woven, knitted, or nonwoven textile or cloth, etc.]
- Y10T442/10—Scrim [e.g., open net or mesh, gauze, loose or open weave or knit, etc.]
- Y10T442/102—Woven scrim
- Y10T442/183—Synthetic polymeric fiber
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- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T442/00—Fabric [woven, knitted, or nonwoven textile or cloth, etc.]
- Y10T442/20—Coated or impregnated woven, knit, or nonwoven fabric which is not [a] associated with another preformed layer or fiber layer or, [b] with respect to woven and knit, characterized, respectively, by a particular or differential weave or knit, wherein the coating or impregnation is neither a foamed material nor a free metal or alloy layer
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Abstract
【解決手段】組織接着品などの製品は、軟質材料、軟質材料中もしくは軟質材料上に配置された重合開始剤または重合速度調整剤、および、軟質材料の少なくとも一部に亘って浸透された重合性接着組成物を含み、この場合、重合開始剤または重合速度調整剤は、重合性接着組成物用の重合開始剤または重合速度調整剤である。
【選択図】なし
Description
本発明は、内科および外科創傷閉鎖と管理、および当該デバイスの製造法および使用法に関する。特に、本発明は、内科および外科創傷閉鎖および管理デバイス、ならびに関連する方法に関するもので、組織接着性製品または創傷閉鎖デバイスは、開始剤負荷テキスタイル(織物)材料(initiator-loaded textile material)に適用される重合性接着材を組み入れる。本発明の材料および方法は、従来の包帯、縫合糸、およびステープルの改良品、ならびに、それらの代用物を提供し、創傷を接合させ、かつ覆い、および/または、閉鎖する改良法を提供し、よって、改善された創傷管理を提供する。
現在、手術切開または事故による裂傷から起こる創傷を閉鎖する主な使用法として、4種類の基本的方法がある。これらは、縫合糸、外科用ステープル、外科用皮膚テープ、および接着組成物である。縫合糸は、一般に、創傷治癒の期間に適した創傷支持を提供することが、認められている。しかし、縫合するということは、針および縫合糸が創傷の縁において組織を通過しなければならないので、この創傷に外傷を追加する。さらに、縫合は、審美的に美しくない創傷閉鎖痕を生じる可能性があり、時間がかかる可能性があり、また、使用される縫合糸の技術とタイプに応じて、除去を要する場合がある。当該除去は、さらなる治療を必要とし、特に、縫合糸が当該創傷内に埋まった場合、患者の痛み、および外傷を悪化させる。ある事例においては、縫合糸の除去は、麻酔薬を必要とする場合があり、かつ創傷部位に線路のような外観を生じる場合がある。
本発明は、創傷の管理、接着(bonding)および接合(approximation)のための改良された材料および方法を提供することによって上記の技術上の需要に対応する。
実施態様では、本発明は、上記長所の一部または全部を提供する創傷閉鎖デバイスおよび方法を提供する。本発明は、創傷閉鎖デバイスとして、表面に適用され、重合性モノマー接着組成物を含浸することができる軟質材料を提供することによって、前記利益を提供するもので、固化または硬化時に、重合性モノマー接着組成物は、表面への粘着性構造体を提供する。重合性モノマー接着組成物の重合(固化または硬化)は、当該重合性モノマー接着組成物の重合開始剤または重合速度調整剤を負荷されるか、塗布されるかなどした軟質材料によって補助される。
R1およびR2は、それぞれ、H、直鎖、枝分れまたは環式アルキルであり、あるいは、結合されて環式アルキル基中に含まれており、R3は、直鎖、枝分れまたは環式アルキル基である。好ましくは、R1は、HまたはメチルもしくはエチルなどのC1、C2もしくはC3のアルキル基であり、R2は、HまたはメチルもしくはエチルなどのC1、C2もしくはC3のアルキル基であり、R3は、C1〜C16のアルキル基、さらに好ましくはC1〜C10のアルキル基で、メチル、エチル、プロピル、ブチル、ペンチル、ヘキシル、ヘプチル、オクチル、ノニルまたはデシル、はるかに好ましくはC2、C3もしくはC4のアルキル基である。当該アルキルエステルシアノアクリレートおよび他の適切なモノマーは、例えば、2001年8月2日出願の米国特許出願第09/919,877号および米国特許第6,620,846号に開示されており、全開示内容は、参照することによって本明細書に組み入れられている。
(butyl glycoloyl cyanoacrylate)(BGCA)、エチルラクトイルシアノアクリレート(ethyl lactoyl cyanoacrylate)(ELCA)およびエチルグリコロイルシアノアクリレート(ethyl glycoloyl cyanoacrylate)(EGCA)を含むが、それらに制約されない。BLCAは、上式で表されることができ、式中、R1はH、R2はメチル、および、R3はブチルである。BGCAは上式で表されることができ、式中、R1はH 、R2はH、R3はブチルである。ELCAは、上式で表されることができ、式中、R1はH、R2はメチル、R3はエチルである。EGCAは、上式で表されることができ、式中、R1はH、R2はH、R3はエチルである。
軟質テキスタイル材料およびシアノアクリレート重合性接着調合物を使った、本発明の複合デバイスの可使および固化時間(すなわち、セット時間)が、従来の市販シアノアクリレートデバイスの可使および固化時間と比較される。使用される従来の市販シアノアクリレートは、重合開始剤含有多孔質チップを有するアプリケーターから分散される重合性モノマーを含むDERMABOND(登録商標)局所皮膚接着品である。2種類のDERMABOND(登録商標)局所皮膚接着調合物が検討される。即ち、本明細書でDERMABOND LVと呼ばれる低粘度接着調合物、および、本明細書でDERMABOND HVと呼ばれる高粘度接着調合物である(両方とも、クローシュアメディカルコーポレーション(Closure Medical Corporation)で製造され、エチコン(Ethicon) から販売中)。本発明の複合デバイスは、DERMABOND LVおよびDERMABOND HV調合物のシアノアクリレート重合性接着組成物を使って調製されることもでき、当該シアノアクリレート重合性接着組成物は、当該組成物がアプリケーターチップ中に存在する重合開始剤と接触しないように、市販アプリケーターから搾り出される。これらの搾り出されたシアノアクリレート重合性接着組成物は、本明細書では、「複合接着調合物」と呼ばれる。
DERMABOND LV接着剤の薄膜サンプルの引張強さが、上記の実施例1に記述された複合材Aの引張強さと比較される。
(1) 複合製品において、
軟質材料と、
前記軟質材料中もしくは前記軟質材料上に配置された、重合開始剤または重合速度調整剤(polymerization initiator or rate modifier)と、
前記軟質材料の少なくとも一部に亘って浸透された重合性接着組成物と、
を含み、
前記重合開始剤または前記重合速度調整剤が、前記重合性接着組成物用の重合開始剤または重合速度調整剤である、
製品。
(2) 実施態様1に記載の製品において、
前記軟質材料が、メッシュである、
製品。
(3) 実施態様1に記載の製品において、
前記軟質材料が、柔軟かつ多孔質である、
製品。
(4) 実施態様1に記載の製品において、
前記軟質材料が、実質的にエラスチンを含まない、
製品。
(5) 実施態様1に記載の製品において、
前記軟質材料は、弾力性を有する、
製品。
前記軟質材料の少なくとも一部の上に位置する圧力感受性接着剤、
をさらに含む、製品。
(7) 実施態様1に記載の製品において、
前記重合性接着組成物が、モノマー組成物である、
製品。
(8) 実施態様1に記載の製品において、
前記重合性接着組成物が、重合されている、
製品。
(9) 実施態様1に記載の製品において、
前記重合性接着組成物が、1,1-二置換モノマーを含む、
製品。
(10) 実施態様1に記載の製品において、
前記重合性接着組成物が、シアノアクリレートモノマーを含む、
製品。
前記重合性接着組成物が、重合後に、前記軟質材料の少なくとも底側および上側に位置する表面を実質的に覆う、
製品。
(12) 実施態様1に記載の製品において、
前記重合開始剤または前記重合速度調整剤が、前記軟質材料に固定化されている、
製品。
(13) 実施態様1に記載の製品において、
前記重合開始剤または前記重合速度調整剤が、前記軟質材料上に吸着または吸収されている、
製品。
(14) 実施態様1に記載の製品において、
前記重合開始剤または前記重合速度調整剤が、前記軟質材料に化学的に結合されている、
製品。
(15) 実施態様1に記載の製品において、
前記重合開始剤または前記重合速度調整剤が、前記重合性接着組成物中に可溶であるか、または分散可能である、
製品。
前記軟質材料中または前記軟質材料上に配置された生体活性材料、
をさらに含む、製品。
(17) 実施態様16に記載の製品において、
前記生体活性材料が、前記軟質材料に化学的に結合されている、
製品。
(18) 実施態様16に記載の製品において、
前記生体活性材料が、前記軟質材料に固定化されないが、前記重合性接着組成物中に可溶であるか、または分散可能である、
製品。
(19) 実施態様1に記載の製品において、
前記軟質材料中または前記軟質材料上に配置された非生体活性材料、
をさらに含む、製品。
(20) 実施態様19に記載の製品において、
前記非生体活性材料が、着色剤、香り、化学的に剥離しない保護コーティング剤、および、感温剤から成る群から選択される、
製品。
前記軟質材料が、生分解性である、
製品。
(22) 実施態様1に記載の製品において、
前記軟質材料が、生分解性でない、
製品。
(23) 実施態様1に記載の製品において、
前記軟質材料および前記重合性接着組成物が、共に生分解性である、
製品。
(24) 実施態様1に記載の製品において、
前記軟質材料および前記重合性接着組成物が、共に生分解性でない、
製品。
(25) 実施態様1に記載の製品において、
前記製品が、不透明である、
製品。
前記製品が、半透明である、
製品。
(27) 実施態様1に記載の製品において、
前記軟質基質が、使用中、下層の基質に浸透する特徴を含まない、
製品。
(28) 実施態様1に記載の製品において、
前記製品が、組織接着性製品である、
製品。
(29) 複合製品において、
軟質材料と、
前記軟質材料中もしくは前記軟質材料上に配置された、重合開始剤または重合速度調整剤と、
前記軟質材料の少なくとも一部に亘って浸透された、重合された接着組成物と、
を含み、
前記重合開始剤または前記重合速度調整剤が、前記重合性接着組成物用の重合開始剤または重合速度調整剤である、
製品。
(30) 接着する方法において、
基質上に軟質材料を設ける工程であって、前記軟質材料中もしくは前記軟質材料上に、重合開始剤または重合速度調整剤が配置される、工程と、
前記軟質材料の少なくとも一部の上に、前記少なくとも一部を実質的に覆う重合性接着組成物を適用する工程と、
前記重合性接着組成物を前記軟質材料の中、および前記軟質材料の下に浸透させ、前記重合性接着組成物を重合させて、前記基質に接着された複合構造体を形成する工程と、
を含む、方法。
前記重合開始剤または前記重合速度調整剤が、前記重合性接着組成物用の重合開始剤または重合速度調整剤である、
方法。
(32) 実施態様30に記載の方法において、
前記基質が、組織である、
方法。
(33) 実施態様30に記載の方法において、
前記組織が、骨、臓器表面、皮膚、および粘膜、から成る群から選択される、
方法。
(34) 実施態様30に記載の方法において、
前記基質が、内部組織である、
方法。
(35) 実施態様30に記載の方法において、
前記基質が、外部組織である、
方法。
前記基質が、閉鎖されるべき創傷を含む組織の部分である、
方法。
(37) 実施態様36に記載の方法において、
前記軟質材料が、前記創傷を完全に覆う、
方法。
(38) 実施態様30に記載の方法において、
前記適用する工程が、
ある量の前記重合性接着組成物を前記軟質材料の露出面上に設ける工程と、
前記軟質材料を実質的に覆うように、前記ある量の前記重合性接着組成物を塗り広げる工程と、
を含む、方法。
(39) 実施態様30に記載の方法において、
前記基質上に前記軟質材料を設ける前に、重合性接着組成物を前記基質へ適用する工程、
をさらに含む、方法。
Claims (39)
- 複合製品において、
軟質材料と、
前記軟質材料中もしくは前記軟質材料上に配置された、重合開始剤または重合速度調整剤と、
前記軟質材料の少なくとも一部に亘って浸透された重合性接着組成物と、
を含み、
前記重合開始剤または前記重合速度調整剤が、前記重合性接着組成物用の重合開始剤または重合速度調整剤である、
製品。 - 請求項1に記載の製品において、
前記軟質材料が、メッシュである、
製品。 - 請求項1に記載の製品において、
前記軟質材料が、柔軟かつ多孔質である、
製品。 - 請求項1に記載の製品において、
前記軟質材料が、実質的にエラスチンを含まない、
製品。 - 請求項1に記載の製品において、
前記軟質材料は、弾力性を有する、
製品。 - 請求項1に記載の製品において、
前記軟質材料の少なくとも一部の上に位置する圧力感受性接着剤、
をさらに含む、製品。 - 請求項1に記載の製品において、
前記重合性接着組成物が、モノマー組成物である、
製品。 - 請求項1に記載の製品において、
前記重合性接着組成物が、重合されている、
製品。 - 請求項1に記載の製品において、
前記重合性接着組成物が、1,1-二置換モノマーを含む、
製品。 - 請求項1に記載の製品において、
前記重合性接着組成物が、シアノアクリレートモノマーを含む、
製品。 - 請求項1に記載の製品において、
前記重合性接着組成物が、重合後に、前記軟質材料の少なくとも底側および上側に位置する表面を実質的に覆う、
製品。 - 請求項1に記載の製品において、
前記重合開始剤または前記重合速度調整剤が、前記軟質材料に固定化されている、
製品。 - 請求項1に記載の製品において、
前記重合開始剤または前記重合速度調整剤が、前記軟質材料上に吸着または吸収されている、
製品。 - 請求項1に記載の製品において、
前記重合開始剤または前記重合速度調整剤が、前記軟質材料に化学的に結合されている、
製品。 - 請求項1に記載の製品において、
前記重合開始剤または前記重合速度調整剤が、前記重合性接着組成物中に可溶であるか、または分散可能である、
製品。 - 請求項1に記載の製品において、
前記軟質材料中または前記軟質材料上に配置された生体活性材料、
をさらに含む、製品。 - 請求項16に記載の製品において、
前記生体活性材料が、前記軟質材料に化学的に結合されている、
製品。 - 請求項16に記載の製品において、
前記生体活性材料が、前記軟質材料に固定化されないが、前記重合性接着組成物中に可溶であるか、または分散可能である、
製品。 - 請求項1に記載の製品において、
前記軟質材料中または前記軟質材料上に配置された非生体活性材料、
をさらに含む、製品。 - 請求項19に記載の製品において、
前記非生体活性材料が、着色剤、香り、化学的に剥離しない保護コーティング剤、および、感温剤から成る群から選択される、
製品。 - 請求項1に記載の製品において、
前記軟質材料が、生分解性である、
製品。 - 請求項1に記載の製品において、
前記軟質材料が、生分解性でない、
製品。 - 請求項1に記載の製品において、
前記軟質材料および前記重合性接着組成物が、共に生分解性である、
製品。 - 請求項1に記載の製品において、
前記軟質材料および前記重合性接着組成物が、共に生分解性でない、
製品。 - 請求項1に記載の製品において、
前記製品が、不透明である、
製品。 - 請求項1に記載の製品において、
前記製品が、半透明である、
製品。 - 請求項1に記載の製品において、
前記軟質基質が、使用中、下層の基質に浸透する特徴を含まない、
製品。 - 請求項1に記載の製品において、
前記製品が、組織接着性製品である、
製品。 - 複合製品において、
軟質材料と、
前記軟質材料中もしくは前記軟質材料上に配置された、重合開始剤または重合速度調整剤と、
前記軟質材料の少なくとも一部に亘って浸透された、重合された接着組成物と、
を含み、
前記重合開始剤または前記重合速度調整剤が、前記重合性接着組成物用の重合開始剤または重合速度調整剤である、
製品。 - 接着する方法において、
基質上に軟質材料を設ける工程であって、前記軟質材料中もしくは前記軟質材料上に、重合開始剤または重合速度調整剤が配置される、工程と、
前記軟質材料の少なくとも一部の上に、前記少なくとも一部を実質的に覆う重合性接着組成物を適用する工程と、
前記重合性接着組成物を前記軟質材料の中、および前記軟質材料の下に浸透させ、前記重合性接着組成物を重合させて、前記基質に接着された複合構造体を形成する工程と、
を含む、方法。 - 請求項30に記載の方法において、
前記重合開始剤または前記重合速度調整剤が、前記重合性接着組成物用の重合開始剤または重合速度調整剤である、
方法。 - 請求項30に記載の方法において、
前記基質が、組織である、
方法。 - 請求項30に記載の方法において、
前記組織が、骨、臓器表面、皮膚、および粘膜、から成る群から選択される、
方法。 - 請求項30に記載の方法において、
前記基質が、内部組織である、
方法。 - 請求項30に記載の方法において、
前記基質が、外部組織である、
方法。 - 請求項30に記載の方法において、
前記基質が、閉鎖されるべき創傷を含む組織の部分である、
方法。 - 請求項36に記載の方法において、
前記軟質材料が、前記創傷を完全に覆う、
方法。 - 請求項30に記載の方法において、
前記適用する工程が、
ある量の前記重合性接着組成物を前記軟質材料の露出面上に設ける工程と、
前記軟質材料を実質的に覆うように、前記ある量の前記重合性接着組成物を塗り広げる工程と、
を含む、方法。 - 請求項30に記載の方法において、
前記基質上に前記軟質材料を設ける前に、重合性接着組成物を前記基質へ適用する工程、
をさらに含む、方法。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US10/887,884 US20060009099A1 (en) | 2004-07-12 | 2004-07-12 | Adhesive-containing wound closure device and method |
PCT/US2005/024042 WO2006017109A2 (en) | 2004-07-12 | 2005-07-07 | Adhesive containing wound closure device and method |
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JP2008505726A true JP2008505726A (ja) | 2008-02-28 |
Family
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Country Status (8)
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US (4) | US20060009099A1 (ja) |
EP (1) | EP1766117A4 (ja) |
JP (1) | JP2008505726A (ja) |
CN (1) | CN100594863C (ja) |
AU (1) | AU2005272008A1 (ja) |
BR (1) | BRPI0513322A8 (ja) |
CA (1) | CA2573686A1 (ja) |
WO (1) | WO2006017109A2 (ja) |
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US20080255610A1 (en) | 2008-10-16 |
US11446407B2 (en) | 2022-09-20 |
AU2005272008A1 (en) | 2006-02-16 |
CA2573686A1 (en) | 2006-02-16 |
EP1766117A4 (en) | 2009-08-12 |
CN100594863C (zh) | 2010-03-24 |
CN101018519A (zh) | 2007-08-15 |
US9623142B2 (en) | 2017-04-18 |
US10398800B2 (en) | 2019-09-03 |
WO2006017109A2 (en) | 2006-02-16 |
US20190381206A1 (en) | 2019-12-19 |
BRPI0513322A8 (pt) | 2018-08-14 |
US20170173208A1 (en) | 2017-06-22 |
US20060009099A1 (en) | 2006-01-12 |
BRPI0513322A (pt) | 2008-05-06 |
WO2006017109A3 (en) | 2006-07-06 |
EP1766117A2 (en) | 2007-03-28 |
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