JP6771315B2 - 編地および非多孔性フィルムを備える合成プロテーゼ、ならびにそれを形成する方法 - Google Patents
編地および非多孔性フィルムを備える合成プロテーゼ、ならびにそれを形成する方法 Download PDFInfo
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- JP6771315B2 JP6771315B2 JP2016108408A JP2016108408A JP6771315B2 JP 6771315 B2 JP6771315 B2 JP 6771315B2 JP 2016108408 A JP2016108408 A JP 2016108408A JP 2016108408 A JP2016108408 A JP 2016108408A JP 6771315 B2 JP6771315 B2 JP 6771315B2
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- 229920000747 poly(lactic acid) Polymers 0.000 description 1
- 229920001610 polycaprolactone Polymers 0.000 description 1
- 239000004632 polycaprolactone Substances 0.000 description 1
- 239000005020 polyethylene terephthalate Substances 0.000 description 1
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
-
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/146—Porous materials, e.g. foams or sponges
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- A—HUMAN NECESSITIES
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
- A61F2002/0068—Implantable repair or support meshes, e.g. hernia meshes having a special mesh pattern
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A—HUMAN NECESSITIES
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
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- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/34—Materials or treatment for tissue regeneration for soft tissue reconstruction
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Medicinal Chemistry (AREA)
- Dermatology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Surgery (AREA)
- Dispersion Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Cardiology (AREA)
- Materials For Medical Uses (AREA)
- Prostheses (AREA)
- Polymers & Plastics (AREA)
- Organic Chemistry (AREA)
- Laminated Bodies (AREA)
- Knitting Of Fabric (AREA)
Description
(項目1)
組織補強のための合成プロテーゼ(1)であって:
・合成生体適合性材料のモノフィラメント(3)から作製された多孔性編地(2)であって、該編地は、2つの反対側の面、すなわち、第一の面(4)および第二の面(5)を規定する、多孔性編地、
・少なくともε−カプロラクトンのコポリマーを少なくとも含む合成非多孔性生体分解性フィルム(8)であって、該フィルムは、該第一の面の少なくとも一部分を覆う合成非多孔性生体分解性フィルム、ならびに
・該フィルムを該第一の面に結合する合成生体分解性結合剤(9)であって、該結合剤は、少なくともε−カプロラクトンのポリマーを含む、合成生体分解性結合剤
を備え、
該結合剤は、該フィルムと該第一の面との間に、不連続層の形態で存在し、そして
該多孔性編地の該第二の面は、細胞のコロニー形成のために覆われないままにされる、
合成プロテーゼ。
(項目2)
上記合成生体適合性材料はポリプロピレンである、上記項目に記載のプロテーゼ(1)。
(項目3)
上記編地は、1mmより大きい直径を有する複数の細孔を備える、上記項目のいずれかに記載のプロテーゼ(1)。
(項目4)
上記複数の細孔は、約35%〜約70%の範囲の、上記編地の有効多孔度を規定する、上記項目のいずれかに記載のプロテーゼ(1)。
(項目5)
上記合成非多孔性生体分解性フィルムは、グリコリドと、ε−カプロラクトンと、トリメチレンカーボネートと、ラクチドとのランダムコポリマーからなる組成物の押し出しによって得られるフィルムである、上記項目のいずれかに記載のプロテーゼ(1)。
(項目6)
上記合成非多孔性生体分解性フィルムは、約15μm〜約25μmの範囲の厚さを示す、上記項目のいずれかに記載のプロテーゼ(1)。
(項目7)
上記結合剤は、ε−カプロラクトンのポリマー、特に、約80,000g/molの分子量を有するε−カプロラクトンのポリマーからなる、上記項目のいずれかに記載のプロテーゼ(1)。
(項目8)
上記結合剤は、上記フィルムと上記第一の面に、約0.60mg/cm2〜約0.95mg/cm2の範囲、好ましくは約0.70mg/cm2〜約0.85mg/cm2の範囲、より好ましくは約0.83mg/cm2の量で存在する、上記項目のいずれか記載のプロテーゼ(1)。
(項目9)
上記結合剤は、上記プロテーゼの重量に対して、6重量%〜11重量%の範囲の量で存在する、上記項目のいずれかに記載のプロテーゼ(1)。
(項目10)
合成生体分解性材料から作製されたマーキング(10)を少なくともさらに備える、上記項目のいずれかに記載のプロテーゼ(1)。
(項目11)
上記マーキングを形成する上記合成生体分解性材料は、ε−カプロラクトンのポリマーおよび染料、例えばD&C Violet N°2からなる、上記項目のいずれかに記載のプロテーゼ(1)。
(項目12)
上記項目のいずれかのプロテーゼ(1)を形成する方法であって、以下の工程:
・a)合成生体適合性材料のモノフィラメント(3)から作製された多孔性編地(2)を提供する工程であって、該編地は、2つの反対側の面、すなわち、第一の面(4)および第二の面(5)を規定する、工程、
・b)少なくともε−カプロラクトンのコポリマーを少なくとも含む合成非多孔性生体分解性フィルム(8)を提供する工程、
・c)該編地の該第一の面を、ε−カプロラクトンのポリマーを少なくとも含む結合溶液で膠付けする工程であって、これによって、結合溶液の不連続層を、該編地の該第一の面上に形成する工程、ならびに
・d)工程b)の該フィルムを、該編地の該膠付けされた第一の面上に積層する工程
を包含する、方法。
(項目13)
上記結合溶液は、塩化メチレン中3%(w/v)のε−カプロラクトンのポリマーの溶液である、上記項目に記載の方法。
(項目14)
上記結合溶液は、上記編地の上記第一の面の表面に、約10mL/分の該溶液の送達速度で噴霧される、上記項目のいずれかに記載の方法。
(項目15)
工程d)の上記積層は、工程b)の上記フィルムを、工程c)で得られた上記編地の上記膠付けされた面と、約30秒間〜約7分間の範囲、好ましくは約5分間の時間にわたって、約105℃の温度で、約137,895Pa(20psi)〜約1,034,213Pa(150psi)の範囲、好ましくは約172,369Pa(25psi)の接触圧力で、接触させることにより行われる、上記項目のいずれかに記載の方法。
(項目16)
上記編地の上記第一の面に、1つまたはより多くのマーキング(10)を提供するための、印刷する工程をさらに包含し、該印刷する工程は、工程c)の前に行われる、上記項目のいずれかに記載の方法。
(項目17)
上記印刷する工程は、マスクを、上記編地の上記第一の面に配置すること、および染色溶液を、該マスクを提供された該編地の該第一の面に噴霧することを包含する、上記項目のいずれかに記載の方法。
(項目18)
上記染色溶液は、塩化メチレン中3%(w/v)のε−カプロラクトンのポリマー、およびε−カプロラクトンのポリマー中0.1%(w/w)のD&C Violet N°2の溶液である、上記項目のいずれかに記載の方法。
(項目19)
上記染色溶液は、上記マスクを提供された上記編地の上記第一の面の表面に、約10mL/分の該溶液の送達速度で噴霧される、上記項目のいずれかに記載の方法。
本発明は、組織補強のための合成プロテーゼに関し、この合成プロテーゼは:
・合成生体適合性材料のモノフィラメントから作製された多孔性編地であって、この編地は、2つの反対側の面、すなわち、第一の面および第二の面を規定する、多孔性編地、
・少なくともε−カプロラクトンのコポリマーを少なくとも含む合成非多孔性生体分解性フィルムであって、このフィルムは、この第一の面の少なくとも一部分を覆う、合成非多孔性生体分解性フィルム、
・このフィルムをこの第一の面に結合する合成生体分解性結合剤であって、この結合剤は、ε−カプロラクトンのポリマーを少なくとも含む、合成生体分解性結合剤
を備え、
この多孔性編地の第二の面は、細胞のコロニー形成のために覆われないままにされる。
本発明はまた、このようなプロテーゼを形成する方法に関する。
・合成生体適合性材料モノフィラメントから作製された多孔性編地であって、この編地は、2つの反対側の面、すなわち、第一の面および第二の面を規定する、多孔性編地、
・少なくともε−カプロラクトンのコポリマーを少なくとも含む合成非多孔性生体分解性フィルムであって、このフィルムは、この第一の面の少なくとも一部分を覆う、合成非多孔性生体分解性フィルム
・このフィルムをこの第一の面に結合する合成生体分解性結合剤であって、この結合剤は、ε−カプロラクトンのポリマーを少なくとも含む、合成生体分解性結合剤
を備え、
この結合剤は、このフィルムとこの第一の面との間に、不連続層の形態で存在し、そして
この多孔性編地の第二の面は、細胞のコロニー形成のために覆われないままにされる。
バーB1:1.2/4.5/4.3/4.5/4.3/1.0/1.2/1.0//
バーB2:4.3/1.0/1.2/1.0/1.2/4.5/4.3/4.5//
ガイドバーB1およびB2は、1本おき(1 full 1 empty)に糸を通され得、対称的に動き得る。
・バーB1:5.4/4.3/2.1/0.1/1.2/3.4//
・バーB2:0.1/1.2/3.4/5.4/4.3/2.1//
ガイドバーB1およびB2は、1本おきに糸を通され、対称的に動く。
・a)合成生体適合性材料のモノフィラメントから作製された多孔性編地を提供する工程であって、この編地は、2つの反対側の面、すなわち、第一の面および第二の面を規定する、工程、
・b)少なくともε−カプロラクトンのコポリマーを少なくとも含む合成非多孔性生体分解性フィルムを提供する工程、
・c)この編地の第一の面を、ε−カプロラクトンのポリマーを少なくとも含む結合溶液で膠付けして、結合溶液の不連続層をこの編地の第一の面上に形成する工程、
・d)工程b)のフィルムをこの編地の膠付けされた第一の面に積層する工程。
この実施例は、本発明のプロテーゼのために適切な編地の製造を記載する。
編地Aを、2本のガイドバーB1、B2を有する縦編機またはラッシェル編機で、直径0.12mmのポリプロピレンのモノフィラメントを、このモノフィラメントの編成が従うパターンを以下のようにして、ISO 11676標準に従って、編成することにより製造する:
バーB1:1.2/4.5/4.3/4.5/4.3/1.0/1.2/1.0//
バーB2:4.3/1.0/1.2/1.0/1.2/4.5/4.3/4.5//
ガイドバーB1およびB2は、1本おきに糸を通され、対称的に動く。
編地Bを、直径0.10mmのポリプロピレンのモノフィラメントを、2本のガイドバーB1、B2を有する縦編機で、以下のパターンに従って、ISO 11676標準に従って、編成することにより得る:
・バーB1:5.4/4.3/2.1/0.1/1.2/3.4//
・バーB2:0.1/1.2/3.4/5.4/4.3/2.1//
ガイドバーB1およびB2は、1本おきに糸を通され、対称的に動く。
編地AおよびBの以下の特性を、以下のように決定した:
・単位面積あたりの質量(g/m2):ISO 3801:1977「Determination of mass per unit length and mass per unit area」に従って、5標本1dm2で測定する。
この実施例は、本発明のプロテーゼのために適切な、マークされた編地の調製を記載する。
a)染色溶液の調製:
塩化メチレン中0.1%(w/v)の染料の母溶液(mother solution)を、最初に以下のように調製する:200mgのD&C Violet N°2を撹拌しながら200mLの塩化メチレンに加える。
塩化メチレン中0.1%(w/v)の染料の、18mLの母溶液を、582mLの塩化メチレンに加える。18gのポリマーε−カプロラクトンを撹拌しながらこの溶液に加える。ε−カプロラクトンのポリマーの完全な可溶化まで、この撹拌を続ける。
空隙ゾーンおよび充填ゾーンを備えるマスクを、編地Aの第一の面、すなわち、編地Aの、その後の工程で癒着障壁フィルムを付着させることが意図される面に、配置する。このマスクの充填ゾーンは、編地Aの第一の面の、マスクされることが意図されないゾーンを保護することが意図される。従って、このマスクの充填ゾーンは、編地Aの第一の面のこれらのゾーンが、染色溶液によって接触され、そして印刷されることを防止する。このマスクの空隙ゾーンは、染色溶液が、編地Aの第一の面の、マークされることが意図されるゾーンに達することを可能にすることが意図される。このマスクの空隙ゾーンには、編地Aの第一の面のマークされたゾーンが対応する。
・ノズル速度:100mm/s
・編地に対するノズルの高さ:40mm
・2個のノズル通路間の間隔:8mm
・溶液の送達速度:10mL/分
この噴霧は、噴霧ノズルの13回の通過の形態で行われる。この噴霧中に、塩化メチレンは完全に蒸発する。
この実施例は、本発明の方法による、本発明のプロテーゼのサンプルの製造を記載する。
上記実施例2で得られたような、マークされたゾーンを有する編地Aの第一の面を、結合溶液を用いて、以下の方法に従って膠付けする:
塩化メチレン中3%(w/v)のε−カプロラクトンのポリマーの溶液を、結合溶液として調製する。
・ノズル速度:100mm/s
・編地に対するノズルの高さ:40mm
・2個のノズル通路間の間隔:8mm
・溶液の送達速度:10mL/分
この噴霧は、噴霧ノズルの3回の通過の形態で行われる。この噴霧中に、塩化メチレンは完全に蒸発する。
上記マークされた編地Aの、10.5cm×20.5cmの寸法の矩形のサンプルを調製する。
フィルムの剥離強度を確認する目的、およびフィルムと編地Aの第一の面との間の結合の効率を確認する目的で、剥離試験を行った。その概念は、このフィルムを剥離するために必要なエネルギーを測定することである。必要なエネルギーが高いほど、このフィルムとこの編地との間の結合は、より効率的である。
・温度:20℃±2℃、
・相対湿度:65%±4%、
・試験速度:250mm/分、
・予圧:0.25N
・予圧速度:50mm/分
この試験中に、可動顎は、固定顎から離れる方向に動く。60mm〜150mmの変位でこのフィルムをこの編地から分離するために必要なエネルギー(mJ)を測定する。このサンプルを剥離するために必要な最大の力(N)もまた測定する。
・15サンプルについての平均エネルギー:429±37mJ、
・15サンプルについての平均の最大の力:6.4±0.6N
これらの結果は、フィルムと編地Aの第一の面との結合が効率的であることを確認する。従って、本発明のプロテーゼのフィルムは、剥離に対して非常に抵抗性である。
2つのプロテーゼ(プロテーゼP1およびプロテーゼP2)を、両方、上記実施例1の編地A、上記実施例3の結合溶液、および上記実施例3の非多孔性フィルムを用いて、製造した。
・プロテーゼP1において:結合剤は、非多孔性フィルムと編地Aの第一の面との間に、不連続層の形態で存在した。
Claims (18)
- 組織補強のための合成プロテーゼ(1)であって:
・合成生体適合性材料のモノフィラメント(3)から作製された多孔性編地(2)であって、該編地は、2つの反対側の面、すなわち、第一の面(4)および第二の面(5)を規定する、多孔性編地、
・少なくともε−カプロラクトンのコポリマーを少なくとも含む合成非多孔性生体分解性フィルム(8)であって、該フィルムは、該第一の面の少なくとも一部分を覆う合成非多孔性生体分解性フィルム、ならびに
・該フィルムを該第一の面に結合する合成生体分解性結合剤(9)であって、該結合剤は、少なくともε−カプロラクトンのポリマーを含む、合成生体分解性結合剤
を備え、
該結合剤は、該フィルムと該第一の面との間に、不連続層の形態で存在し、
該多孔性編地の該第二の面は、細胞のコロニー形成のために覆われないままにされ、
該プロテーゼは、合成生体分解性材料から作製されたマーキング(10)を少なくとも備え、そして
該マーキングを形成する該合成生体分解性材料は、少なくともε−カプロラクトンのポリマーを含む、合成プロテーゼ。 - 前記合成生体適合性材料はポリプロピレンである、請求項1に記載のプロテーゼ(1)。
- 前記編地は、1mmより大きい直径を有する複数の細孔を備える、請求項1または2に記載のプロテーゼ(1)。
- 前記複数の細孔は、約35%〜約70%の範囲の、前記編地の有効多孔度を規定する、請求項3に記載のプロテーゼ(1)。
- 前記合成非多孔性生体分解性フィルムは、グリコリドと、ε−カプロラクトンと、トリメチレンカーボネートと、ラクチドとのランダムコポリマーからなる組成物の押し出しによって得られるフィルムである、請求項1〜4のいずれか1項に記載のプロテーゼ(1)。
- 前記合成非多孔性生体分解性フィルムは、約15μm〜約25μmの範囲の厚さを示す、請求項1〜5のいずれか1項に記載のプロテーゼ(1)。
- 前記結合剤は、ε−カプロラクトンのポリマー、特に、約80,000g/molの分子量を有するε−カプロラクトンのポリマーからなる、請求項1〜6のいずれか1項に記載のプロテーゼ(1)。
- 前記結合剤は、前記フィルムと前記第一の面に、約0.60mg/cm2〜約0.95mg/cm2の範囲、好ましくは約0.70mg/cm2〜約0.85mg/cm2の範囲、より好ましくは約0.83mg/cm2の量で存在する、請求項1〜7のいずれかに記載のプロテーゼ(1)。
- 前記結合剤は、前記プロテーゼの重量に対して、6重量%〜11重量%の範囲の量で存在する、請求項1〜8のいずれか1項に記載のプロテーゼ(1)。
- 前記マーキングを形成する前記合成生体分解性材料は、ε−カプロラクトンのポリマーおよび染料、例えばD&C Violet N°2からなる、請求項1〜9のいずれか1項に記載のプロテーゼ(1)。
- 請求項1のプロテーゼ(1)を形成する方法であって、以下の工程:
・a)合成生体適合性材料のモノフィラメント(3)から作製された多孔性編地(2)を提供する工程であって、該編地は、2つの反対側の面、すなわち、第一の面(4)および第二の面(5)を規定する、工程、
・b)少なくともε−カプロラクトンのコポリマーを少なくとも含む合成非多孔性生体分解性フィルム(8)を提供する工程、
・c)該編地の該第一の面を、ε−カプロラクトンのポリマーを少なくとも含む結合溶液で膠付けする工程であって、これによって、結合溶液の不連続層を、該編地の該第一の面上に形成する工程、ならびに
・d)工程b)の該フィルムを、該編地の該膠付けされた第一の面上に積層する工程
を包含する、方法。 - 前記結合溶液は、塩化メチレン中3%(w/v)のε−カプロラクトンのポリマーの溶液である、請求項11に記載の方法。
- 前記結合溶液は、前記編地の前記第一の面の表面に、約10mL/分の該溶液の送達速度で噴霧される、請求項11または12に記載の方法。
- 工程d)の前記積層は、工程b)の前記フィルムを、工程c)で得られた前記編地の前記膠付けされた面と、約30秒間〜約7分間の範囲、好ましくは約5分間の時間にわたって、約105℃の温度で、約137,895Pa(20psi)〜約1,034,213Pa(150psi)の範囲、好ましくは約172,369Pa(25psi)の接触圧力で、接触させることにより行われる、請求項11〜13のいずれか1項に記載の方法。
- 前記編地の前記第一の面に、1つまたはより多くのマーキング(10)を提供するための、印刷する工程をさらに包含し、該印刷する工程は、工程c)の前に行われる、請求項11〜14のいずれか1項に記載の方法。
- 前記印刷する工程は、マスクを、前記編地の前記第一の面に配置すること、および染色溶液を、該マスクを提供された該編地の該第一の面に噴霧することを包含する、請求項15に記載の方法。
- 前記染色溶液は、塩化メチレン中3%(w/v)のε−カプロラクトンのポリマー、およびε−カプロラクトンのポリマー中0.1%(w/w)のD&C Violet N°2の溶液である、請求項16に記載の方法。
- 前記染色溶液は、前記マスクを提供された前記編地の前記第一の面の表面に、約10mL/分の該溶液の送達速度で噴霧される、請求項17に記載の方法。
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US20200246124A1 (en) | 2020-08-06 |
JP2017006645A (ja) | 2017-01-12 |
CN117563042A (zh) | 2024-02-20 |
ES2676072T3 (es) | 2018-07-16 |
EP3106185B1 (en) | 2018-04-25 |
AU2016203147B2 (en) | 2020-09-10 |
US10743976B2 (en) | 2020-08-18 |
US20160367351A1 (en) | 2016-12-22 |
US11826242B2 (en) | 2023-11-28 |
EP3106185A1 (en) | 2016-12-21 |
AU2016203147A1 (en) | 2017-01-12 |
US20230263613A1 (en) | 2023-08-24 |
CA2931791A1 (en) | 2016-12-19 |
CN106256383A (zh) | 2016-12-28 |
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