WO2017117761A1 - 一种贴覆结构 - Google Patents

一种贴覆结构 Download PDF

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Publication number
WO2017117761A1
WO2017117761A1 PCT/CN2016/070321 CN2016070321W WO2017117761A1 WO 2017117761 A1 WO2017117761 A1 WO 2017117761A1 CN 2016070321 W CN2016070321 W CN 2016070321W WO 2017117761 A1 WO2017117761 A1 WO 2017117761A1
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layer
hydrogel
melt
applicator
wound
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PCT/CN2016/070321
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English (en)
French (fr)
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林祖泰
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沃康生技股份有限公司
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Priority to EP16882906.7A priority Critical patent/EP3400916A4/en
Priority to PCT/CN2016/070321 priority patent/WO2017117761A1/zh
Publication of WO2017117761A1 publication Critical patent/WO2017117761A1/zh

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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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0203—Adhesive bandages or dressings with fluid retention members
    • A61F13/0213—Adhesive bandages or dressings with fluid retention members the fluid retention member being a layer of hydrocolloid, gel forming material
    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings

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  • the present invention relates to a covering structure, and more particularly to a covering structure which is excellent in air permeability, strong in stretchability, excellent in antibacterial property and high in water absorption.
  • the global trauma market is growing in demand, especially in surgical trauma, and its total number has exceeded 100 million person-times per year, and it is increasing year by year. Because of the trauma and laceration caused by accidents, about 20 million person-times per year, the number of burns and burns is about 10 million person-times per year; the ulcerative wounds caused by chronic diseases, diabetes and population aging have exceeded 3 Tens of thousands of people every year.
  • the traditional applicator structure is composed of natural plant fibers or animal hair materials, such as gauze, cotton pad, wool, various types of oil gauze, etc.
  • These applicator structures are only temporary covering materials, all of which need to be in a certain period of time. Replace it.
  • these wound covering structures are prone to sticking to the wounds when they are replaced, so that it is possible to tear apart the newly grown epithelial cells or the wounds that have gradually healed while tearing off the covering structure, causing pain to the user. Unbearable, and quite unfavorable for the natural recovery of the wound.
  • the research on the existing applicator structure has made people's understanding of the applicator structure more and more scientific.
  • the research shows that the better applicator structure can maintain the good cell growth healing environment at the wound site, and can control and absorb the exudate; It can prevent the invasion of bacteria; it can be applied to the individual closely; it can be loaded and released; in addition, it should have good tissue and blood compatibility, and it should not be adhered and desquamate when it is taken out from the individual; it should also be better.
  • the mechanical properties and tensile strength are easy to use.
  • the hydrogel applicator structure can provide better ventilation, moisture permeability, barrier of bacterial invasion and control and absorption of exudate, so that the wound is in a good cell growth healing environment.
  • the hydrogel overlay structure can be closely attached to the wound, and the wound does not stick to the wound to cause secondary damage when the patch structure is replaced. Therefore, the hydrogel patch structure is widely used in the field of biomedicine.
  • the support layer of the conventional laminated structure product is made of a material that is not easily stretched, such as polyethylene (PE), polypropylene (PP), or nylon (Nylon), and is combined with a hydrogel to form a covering structure.
  • PE polyethylene
  • PP polypropylene
  • Nylon nylon
  • the lack of compliance with the user's body generally causes the hydrogel-attached structure product to be absent. The comfort and service that the user wants.
  • the lack of compliance with the user's body generally results in the inability of the hydrogel-attached product to perform effective liquid absorption, distribution, and maintenance.
  • hydrogel-attached structure may be disintegrated into the material of each isolated area or mass, causing discomfort to the user and reducing hydrogel coverage. The efficiency of the structure.
  • a long-felt need in the art is to create a hydrogel overlay that excels in the performance characteristics of commonly known hydrogel overlay structures. More specifically, it is also desirable to produce a hydrogel overlay structure that is stretchable and conforms to the user's body, and that the hydrogel overlay structure can quickly absorb the liquid discharged from the user's body during normal use. And has the ability to continuously absorb liquids.
  • the present invention provides a affixing structure which is excellent in air permeability, strong in stretchability, excellent in antibacterial property and high in water absorption, and comprises: a melt-blown non-woven fabric layer on the upper side, having a multi-directional elastic tension; a layer of material located below the meltblown nonwoven layer; and a hydrogel layer positioned below the network of interlaced polymer layers, wherein the network of interlaced polymer layers is part of the meltblown nonwoven layer And forming a part of the hydrogel layer by copolymerization; and the melt-blown nonwoven layer in the pasting structure has a basis weight of 20-40 g/m 2 .
  • the meltblown type nonwoven fabric layer has a basis weight of 20-35 g/m 2 in the covering structure. In another preferred embodiment, the melt-blown nonwoven fabric layer has a basis weight of 20-30 g/m 2 in the covering structure, so that the covering structure is transparent.
  • the copolymerization includes, but is not limited to, chemical polymerization
  • the chemical polymerization includes, but is not limited to, formation using ultraviolet light irradiation, and the networked interlaced polymer
  • the medium meltblown type non-woven fabric is hydrophobic and some of the fibers are exposed.
  • the hydrogel layer can absorb excess moisture or wound tissue fluid to maintain proper skin moisture.
  • the hydrogel layer comprises: (a) a monomer; (b) a plasticizer; (c) a photoinitiator; (d) a crosslinking agent; and (e) a thickener.
  • the hydrogel layer stock weight ratio is:
  • the monomer comprises an acrylic amide monomer and an acrylic sulfonate monomer, and the acrylic sulfonate monomer imparts a bacteriostatic effect to the hydrogel layer;
  • the plasticizer and thickener are glycerin, which imparts softness to the hydrogel and increases hydrophilicity;
  • the photoinitiator generates active radicals under ultraviolet light irradiation for 1 to 50 seconds to complete the polymerization reaction, and does not have a reaction after the reaction. Cytotoxic;
  • the cross-linking agent is a bifunctional ester having an unsaturated double bond.
  • the applicator structure according to the present invention further comprises a bioactive nonwoven layer that is attached to the underside of the hydrogel layer.
  • the bioactive nonwoven layer is composed of collagen or chitin.
  • the covering structure of the present invention further comprises a polyurethane film layer which is a single direction permeable film and a pressure sensitive adhesive layer which is a hydrophobic material and is applied to the polyurethane film layer. The covering structure is sequentially from top to bottom: a polyurethane film layer, a pressure sensitive adhesive layer, a melt blown nonwoven layer, a mesh interlaced polymer layer and a hydrogel layer.
  • the water absorption rate is 10-40 g/g.
  • the term "water absorption rate” means the weight (gram) of water that can be absorbed by one gram of the covering structure of the present invention.
  • the meltblown nonwoven layer is composed of thermoplastic polyurethane (TPU).
  • the hydrogel layer of the applicator structure of the present invention acts as a conforming surface for contacting a wound wound that enables the wound wound to be in an appropriate state of humidity for accelerated healing.
  • the wet healing environment is conducive to wound healing. If the wound is dehydrated, the cells cannot survive. Although various wet gauze or bandages can provide a wet healing environment, the gauze or bandage-like covering structure needs to be replaced frequently to cause new formation. The cells are prone to damage, causing secondary damage to the wound and the risk of dehydration.
  • the hydrogel layer in the pasting structure of the invention has the characteristics of water absorption and desorption, and the damage of the wound is less than that of the generally wet gauze or bandage such as Vaseline gauze, and the water absorption rate is more in line with the requirement of wound healing.
  • the best moist state absorb excess water, maintain proper skin moisture, and more drug-loading.
  • the invention can be applied to various wound covering structures, attaching structures after annular foreskin cutting, electrode covering structures, medicine-containing adhesive tapes, facial masks or beauty patches, and other adhesive living articles (such as mosquito-proof stickers) , heel stickers, etc.).
  • the invention has the beneficial effects that the covering structure can prepare a wound covering structure with multi-directional elasticity conforming to various wound wounds, providing a better wound wound healing environment, shortening healing time, antibacterial and reducing the chance of infection.
  • Figure 1 is a schematic view of the attachment structure of the present invention.
  • 100 is a pasting structure
  • 101 is a melt-blown nonwoven layer
  • 102 is a network-interlaced polymer layer
  • 103 is a hydrogel layer
  • 104 is a bioactive nonwoven layer.
  • the affixing structure 100 of the present invention comprises: a melt-blown non-woven fabric layer 101 on the upper side, having a multi-directional elastic tension; and a mesh-like interlaced polymer layer 102 located at the melting a lower portion of the spray-type nonwoven fabric layer 101; and a hydrogel layer 103 located below the mesh-interlaced polymer layer 102, wherein the mesh-like interlaced polymer layer 102 is a part of the melt-blown nonwoven layer 101 and A portion of the hydrogel layer 103 is formed by copolymerization; and the melt-blown nonwoven layer 101 of the overlay structure 100 has a basis weight of 20-40 g/m 2 .
  • the overlay structure 100 further comprises a bioactive nonwoven layer 104 that is attached to the underside of the hydrogel layer 103.
  • the meltblown nonwoven fabric layer is composed of thermoplastic polyurethane (TPU)
  • the bioactive nonwoven fabric layer 104 is composed of collagen or chitin.
  • step (d) applying the mixture of step (c) to a meltblown nonwoven layer (such as a thermoplastic polyurethane), and after the mixture of step (c) is infiltrated into the meltblown nonwoven layer, it is irradiated with ultraviolet light.
  • the polymerization reaction is crosslinked to obtain the overlay structure 100 of the present invention.
  • the weight ratio of the above raw materials is:
  • the data of the meltblown type nonwoven fabric layer of the present invention are shown in the following table:
  • the covering structure according to the present invention has a water absorption ratio of 10 to 40 g/g, and the "water absorption rate" as used herein means the weight (gram) of water which can be absorbed by one gram of the covering structure of the present invention.

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  • Engineering & Computer Science (AREA)
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Abstract

一种贴覆结构（100），包含：一熔喷型不织布层（101），位于上侧，具多向弹性张力；一网状交错聚合物层（102），位于熔喷型不织布层（101）的下方；及一水凝胶层（103），位于网状交错聚合物层（102）的下方，其中网状交错聚合物层（102）由熔喷型不织布层（101）的一部分及水凝胶层（103）的一部分共聚合而形成，该熔喷型不织布层（101）的基重为20-40g/m 2。这种贴覆结构（100）具有透气佳、拉伸延展性强、抗菌佳与吸水率高的特点。

Description

一种贴覆结构 技术领域
本发明是关于一种贴覆结构，尤其是关于一种透气佳、拉伸延展性强、抗菌佳与吸水率高的贴覆结构。
背景技术
根据近年来的科学和统计报导，全球创伤市场的需求越来越大，特别是外科手术类创伤，其总人数已经突破1亿人次每年，并且呈逐年增长的趋势。因为意外事故所造成的创伤与撕裂伤，约为2千万人次每年，烧烫伤数量约为1千万人次每年；因慢性疾病、糖尿病、人口老化所造成的溃疡性伤口则已经超过了3千万人次每年。
外科手术因为治疗的需求以及内窥镜手术的风行，已经大幅降低因为手术所造成的风险，但是随之而来的却是对于更好的伤口照护以及术后疤痕预防的需求，目前已经出现借助各种先进贴覆结构进行伤口照护的方法，藉以缩短伤口愈合时间同时消除疤痕。
传统的贴覆结构是由天然植物纤维或动物毛类物质构成，如纱布、棉垫、羊毛、各类油纱布等，这类贴覆结构只是暂时性的覆盖材料，均需在一定的时间内加以更换。然而，这些伤口贴覆结构在更换时容易发生与伤口相互沾黏的情况，因此在撕除贴覆结构的同时有可能一并撕开新生的上皮细胞或已逐渐愈合的伤口，导致使用者疼痛难耐，且相当不利于伤口的自然复原。
现有贴覆结构的研究让人们对于贴覆结构的认识日趋科学，研究表明：较佳的贴覆结构能够保持创伤处的良好细胞生长愈合环境，能够控制和吸收渗出物；透气、透湿，能阻止细菌侵入；能紧密贴敷于个体；可载设、释放药物；另外应具有良好的组织及血液兼容性，在从个体揭取时不发生黏连和脱屑；还应当具有较佳的机械性能和抗拉强度，使用方便。
相较于传统的贴覆结构，水凝胶贴覆结构能提供较佳的透气、透湿、阻隔细菌侵入以及控制和吸收渗出液等特性，使得伤口处于良好细胞生长愈合环境。此外，水凝胶贴覆结构能紧密贴覆于伤口处，且在更换贴覆结构时不会沾黏伤口造成二次伤害，因此水凝胶贴覆结构被广泛地应用于生医领域中。
一般，传统贴覆结构产品的支持层是由不易伸张的材质如聚乙烯(polyethylene，PE)、聚丙烯(Polypropylene，PP)或尼龙(Nylon)所制成，与水凝胶结合形成贴覆结构产品时，因支持层无法有效拉伸而容易造成贴覆结构断裂并使得此结构或产品无法顺应使用者身体，此对使用者身体所缺乏的顺应性一般会造成水凝胶贴覆结构产品没有用户所想要的舒适感与服贴度。此外，缺乏对使用者身体的顺应性一般会导致水凝胶贴覆结构产品无法进行有效的液体吸收、分布及维持能力。另一由水凝胶贴覆结构缺乏易于拉伸所衍生的问题为，水凝胶贴覆结构可能解体为各孤立区或团的材质，造成对使用者的不适性，降低水凝胶贴覆结构的效率。
本领域长期的需求为欲产生一种超越一般已知水凝胶贴覆结构表现特色的水凝胶贴覆结构。更特别的，亦希望能产生一种能拉伸，且顺应使用者身体的水凝胶贴覆结构，而该水凝胶贴覆结构在一般使用时能快速吸收使用者身体所排出的液体，并具有持续吸收液体的能力。
发明内容
因此发明人经由多方测试后发现调整水凝胶贴覆结构的支持层的材质与基重能够改善上述的问题，若支持层的基重过高，则因水凝胶与支持层疏水性的影响不易与水凝胶结合而导致有脱胶的情况，且支持层的基重过高所形成的贴覆结构为不透明，不利使用；若支持层的基重过低，则因支持层的抗张强度以及拉伸倍率不如预期，且水凝胶吸水后退黏导致与防水覆盖材脱离。因此本发明提供一种透气佳、拉伸延展性强、抗菌佳与吸水率高的贴覆结构，包含:一熔喷型不织布层，位于上侧，具多向弹性张力；一网状交错聚合物层，位于该熔喷型不织布层的下方；及一水凝胶层，位于该网状交错聚合物层的下方，其中该网状交错聚合物层由该熔喷型不织布层的一部份及该水凝胶层的一部份共聚 合而形成；且所述贴覆结构中该熔喷型不织布层的基重为20-40g/m2。于一较佳实施例中，所述贴覆结构中该熔喷型不织布层的基重为20-35g/m2。于另一较佳实施例中，所述贴覆结构中该熔喷型不织布层的基重为20-30g/m2，使所述贴覆结构为透明的。
依据本发明的贴覆结构，于一较佳实施例中，该共聚合包含但不限于化学性聚合，而该化学性聚合包含但不限于使用紫外光照射而形成，而该网状交错聚合物中熔喷型不织布为疏水性，部分纤维外露。于另一实施例中，该水凝胶层可吸收多余水分或伤口组织液，保持皮肤适当湿度。而该水凝胶层包含：(a)单体；(b)塑化剂；(c)光起始剂；(d)交联剂；及(e)增稠剂。
在较佳实施例中，该水凝胶层原料重量配比为：
Figure PCTCN2016070321-appb-000001
在较佳实施例中，该单体包含压克力系酰胺单体及压克力系磺酸盐类单体，该压克力系磺酸盐类单体赋予水凝胶层抑菌效果；该塑化剂及增稠剂为甘油，该甘油赋予水凝胶柔软度及增加亲水性；该光起始剂在1至50秒紫外光照射下产生活性自由基完成聚合反应，反应后不具细胞毒性；该交联剂为具不饱和双键的双官能基酯类。
依据本发明的贴覆结构，其另包含一生物活性不织布层，其是贴合于该水凝胶层的下方。于一较佳实施例中，该生物活性不织布层是由胶原蛋白或几丁质所组成。于另一实施例中，本发明的贴覆结构另包含一聚氨酯膜层，其为单一方向渗透膜与一感压胶层，其为疏水性材质，涂布于该聚氨酯膜层。该贴覆结构由上至下依序为：聚氨酯膜层、感压胶层、熔喷型不织布层、网状交错聚合物层与水凝胶层。
依据本发明的贴覆结构，于一较佳实施例中，其吸水率为10-40g/g，文中所 述的“吸水率”是指一克的本发明的贴覆结构所能吸收的水的重量(克)。而该熔喷型不织布层是由热塑性聚胺基甲酸酯(Thermoplastic Polyurethane，TPU)所组成。
本发明的贴覆结构中的水凝胶层，于一较佳实施例中，作为接触创伤伤口的贴合面，该水凝胶层能够使创伤伤口处于加速愈合的适当湿度状态。湿性愈合环境有利于伤口愈合，如果伤口脱水，细胞则不能存活，虽然各种湿润的纱布或绷带也能提供湿性的愈合环境，但是由于该纱布或绷带类贴覆结构需要经常更换而导致新形成的细胞易于损伤，造成伤口二次伤害，且有脱水的危险。本发明贴覆结构中的水凝胶层具吸水退黏特性，在换药时比起一般湿润的纱布或绷带例如凡士林纱布，对伤口的破坏较少，其吸水倍率更加符合伤口愈合所需求的最佳湿润状态，吸收多余水分，保持皮肤适当湿度，且更具载药性。
本发明可应用于各式创伤贴覆结构、环状***切割术后贴覆结构、电极贴覆结构、含药药胶布、面膜或美妆贴布、其他贴覆性生活用品(如防蚊贴、脚跟贴等)。本发明的有益效果在于，该贴覆结构能够制备具多向弹性符合多种创伤伤口使用的创伤贴覆结构，提供较佳创伤伤口愈合环境、缩短愈合时间、抗菌并减少感染机会。
附图说明
图1为本发明的贴覆结构示意图。
图中，100为贴覆结构、101为熔喷型不织布层、102为网状交错聚合物层、103为水凝胶层、104为生物活性不织布层。
具体实施方式
本发明的较佳实施例将详细说明如下，其中所列举的实施例的图号与图式中所示号码相同，请同时参考图式及详细说明。下列实施例的目的非为限制本发明，而仅作为本发明的数种态样及特征的代表。
图1为本发明的贴覆结构示意图，本发明的贴覆结构100包含：一熔喷型不织布层101，位于上侧，具多向弹性张力；一网状交错聚合物层102，位于该 熔喷型不织布层101的下方；及一水凝胶层103，位于该网状交错聚合物层102的下方，其中该网状交错聚合物层102由该熔喷型不织布层101的一部份及该水凝胶层103的一部份共聚合而形成；且所述贴覆结构100中该熔喷型不织布层101的基重为20-40g/m2。
依据本发明的贴覆结构100，其另包含一生物活性不织布层104，其是贴合于该水凝胶层103的下方。于本实施例中，该熔喷型不织布层是由热塑性聚胺基甲酸酯(Thermoplastic Polyurethane，TPU)所组成，而该生物活性不织布层104是由胶原蛋白或几丁质所组成。
水凝胶层配方
(a)提供一混合物，包含：
(I)将光起始剂及压克力系酰胺单体搅拌混合至溶解；
(Ⅱ)进一步加入甘油混合至溶解；
(Ⅲ)进一步加入压克力系磺酸盐类单体混合至溶解；
(Ⅳ)进一步加入甘油搅拌混合。
(b)进一步提供一混合物，包含：
(I)将光起始剂及不饱和双键的双官能基酯类单体搅拌混合。
(c)搅拌混合步骤(a)及步骤(b)的混合物。
(d)将步骤(c)的混合物涂覆于一熔喷型不织布层上(如热塑性聚胺基甲酸酯)，待步骤(c)的混合物渗入熔喷型不织布层后以紫外灯照射进行交联聚合反应，以得到本发明的贴覆结构100。
上述原料重量配比为：
Figure PCTCN2016070321-appb-000002
本发明的熔喷型不织布层的各项数据如下表所示：
Figure PCTCN2016070321-appb-000003
依据本发明的贴覆结构，其吸水率为10-40g/g，文中所述的“吸水率”是指一克的本发明的贴覆结构所能吸收的水的重量(克)。吸水率的测定如下，将制备好的贴覆结构样品烘干，切样，称重并置于去离子水中，等贴覆结构达到吸水平衡后，取出静置后，使用滤纸去除表面水分，称取重量。贴覆结构的吸水率(g/g)按照下式计算：吸水率＝(w2-w1)/w1。式中，w1为贴覆结构烘干时的重量(单位：g)；w2为贴覆结构达到吸水平衡后的重量(单位：g)。
虽然本发明以前述的实施例揭露如上，然其并非用以限定本发明，任何熟习此技艺者，在不脱离本发明的精神和范围内，当可作些许更动与润饰，因此本发明的专利保护范围须视本说明书所附的申请专利范围所界定者为准。

Claims (6)

  1. 一种贴覆结构，包含:
    一熔喷型不织布层，位于上侧，具多向弹性张力；
    一网状交错聚合物层，位于该熔喷型不织布层的下方；及
    一水凝胶层，位于该网状交错聚合物层的下方，
    其中该网状交错聚合物层由该熔喷型不织布层的一部份及该水凝胶层的一部份共聚合而形成；
    且所述贴覆结构中该熔喷型不织布层的基重为20-40g/m2。
  2. 如权利要求1所述的贴覆结构，其另包含一生物活性不织布层，其贴合于该水凝胶层的下方。
  3. 如权利要求1所述的贴覆结构，其吸水率为10-40g/g。
  4. 如权利要求1所述的贴覆结构，其中该熔喷型不织布层是由热塑性聚胺基甲酸酯所组成。
  5. 如权利要求2所述的贴覆结构，其中该生物活性不织布层是由胶原蛋白或几丁质所组成。
  6. 如权利要求1所述的贴覆结构，其中该共聚合为化学性聚合。
PCT/CN2016/070321 2016-01-06 2016-01-06 一种贴覆结构 WO2017117761A1 (zh)

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