CN103691010B - Multi-layer foam dressing for negative pressure sealing drainage and manufacturing method thereof - Google Patents

The invention provides a multilayer foam dressing for negative pressure closed drainage and a manufacturing method thereof, the multilayer foam dressing for negative pressure closed drainage comprises a negative pressure conducting layer, a drainage protective layer for contacting with a wound surface or a wound cavity is arranged at the lower part of the negative pressure conducting layer, and the negative pressure conducting layer and the drainage protective layer are both porous foam material layers; the negative pressure conducting layer is a hydrophobic porous foam material layer, the drainage protective layer is a hydrophilic porous foam material layer, and the two layers of materials are fixedly connected and communicated with each other in a penetrating manner. Two longitudinal broken seams are arranged on the multilayer foam dressing, the longitudinal broken seams are positioned at the installation position of the negative pressure drainage tube, and one end of the negative pressure drainage tube installed penetrates through the installation position of the pore of the negative pressure drainage tube and extends to the middle part of the multilayer foam dressing. The thickness a of the negative pressure conduction layer is 0.5-10 cm, the diameter of each pore is 1-2.5 mm, the thickness b of the drainage protection layer is 0.1-3.5 cm, and the diameter of each pore is 0.2-1 mm. Meanwhile, the invention also provides two methods for manufacturing the foam dressing by bonding and compounding. The invention adopts a multilayer structure, can effectively improve the negative pressure conduction performance of the material while ensuring the safety of the material, is not easy to block in the using process, has stable permeability and excellent treatment effect.

用于负压封闭引流的多层泡沫敷料及其制作方法Multi-layer foam dressing for negative pressure sealing drainage and manufacturing method thereof

技术领域technical field

本发明涉及医用创伤治疗器械领域，具体地说，是指一种用于负压封闭引流的多层泡沫敷料及其制作方法。The invention relates to the field of medical wound treatment equipment, in particular to a multi-layer foam dressing for negative pressure sealing drainage and a manufacturing method thereof.

背景技术Background technique

负压封闭引流技术（vacuum sealing drainage，简称VSD）是德国ULM大学WimFleischman博士于1992年首创，并形成理论雏形，用于四肢创面的引流；1994年中国裘华德教授首次将负压封闭引流技术应用于普外科，开创了负压封闭引流技术在普外科应用的先河，王彦峰、裘华德教授在中国于1997年3月17日得到授权的专利CN 2236350，为负压封闭引流技术的第一个专利。Vacuum sealing drainage technology (vacuum sealing drainage, referred to as VSD) was first created by Dr. Wim Fleischman of ULM University in Germany in 1992, and formed a theoretical prototype for the drainage of extremity wounds; in 1994, Professor Qiu Huade of China first applied the vacuum sealing drainage technology to General surgery pioneered the application of negative pressure sealing drainage technology in general surgery. The patent CN 2236350 authorized by Professor Wang Yanfeng and Qiu Huade in China on March 17, 1997 was the first patent of negative pressure sealing drainage technology.

现有的VSD技术基本配置包括负压源（包括医用吸引机、医院使用的中心负压装置或负压引流瓶等），引流管，亲水性泡沫材料或其它医用疏水性泡沫材料或海绵类敷料或纱布类敷料（以下对上述医用材料统称多孔泡沫材料）、可粘贴密封薄膜、引流容器组成。接通负压源引流，可以将人体组织内的渗血、渗液、液化坏死的组织碎片以及脓液等液化物质引流至引流容器内。上述技术可以将坏死组织和毒素、脓液等直接排出体外，避免毒素重吸收，快速清洁创面；同时，高负压吸引能够有效促进肉芽迅速生长，缩短创面愈合时间。使用该技术，病患者可以3-7天内不需换药，避免交叉感染，降低了医护人员工作量，减少了患者痛苦，降低了创伤的致死率、致残率。The basic configuration of the existing VSD technology includes negative pressure sources (including medical suction machines, central negative pressure devices used in hospitals, or negative pressure drainage bottles, etc.), drainage tubes, hydrophilic foam materials or other medical hydrophobic foam materials or sponges Dressing or gauze-like dressing (hereinafter referred to as porous foam material for the above-mentioned medical materials), adhesive sealing film, and drainage container. Connecting the negative pressure source for drainage can drain liquefied substances such as blood, exudate, liquefied necrotic tissue fragments and pus in human tissues into the drainage container. The above technology can directly excrete necrotic tissue, toxins, pus, etc., avoid reabsorption of toxins, and quickly clean the wound; at the same time, high negative pressure suction can effectively promote the rapid growth of granulation and shorten the wound healing time. Using this technology, patients do not need to change their dressings within 3-7 days, avoid cross-infection, reduce the workload of medical staff, reduce the pain of patients, and reduce the fatality rate and disability rate of trauma.

VSD技术主要是依靠多孔泡沫软垫这种医用高分子敷料来实现的。这种敷料既是负压传导介质，同时也是将坏死组织、脓液、渗液、其它毒性产物和毒素等物质引入引流管的引流介质。目前市场上用于负压封闭引流的泡沫敷料主要分为两种：疏水性敷料和亲水性敷料。疏水性敷料多为PU材料发泡而成，泡沫孔隙较大，通透率较高；由于其疏水的特性，泡沫内一般不会含水，因此负压传导性能极佳。亲水性敷料多为PVA材料发泡而成，泡沫孔隙比疏水性敷料小，材料通透率较低，但是也能满足负压引流治疗的需要；由于其亲水的特性，敷料表面会形成一层水分子薄膜，隔开了敷料与与肉芽组织的内皮细胞直接接触，能够阻止肉芽组织长入敷料内，避免牵拉出血，材料安全性极高。VSD technology mainly relies on the medical polymer dressing of porous foam cushion to realize. This dressing is not only a negative pressure transmission medium, but also a drainage medium for introducing necrotic tissue, pus, exudate, other toxic products and toxins into the drainage tube. Foam dressings currently on the market for negative pressure sealing drainage are mainly divided into two types: hydrophobic dressings and hydrophilic dressings. Hydrophobic dressings are mostly foamed from PU material, the foam has large pores and high permeability; due to its hydrophobic characteristics, the foam generally does not contain water, so the negative pressure conduction performance is excellent. Hydrophilic dressings are mostly foamed from PVA materials. The foam pores are smaller than hydrophobic dressings, and the material permeability is lower, but it can also meet the needs of negative pressure drainage treatment; due to its hydrophilic properties, the surface of the dressing will form A film of water molecules separates the dressing from the direct contact with the endothelial cells of the granulation tissue, which can prevent the granulation tissue from growing into the dressing and avoid traction bleeding. The material is extremely safe.

然而上述两种敷料在临床应用中均存在缺陷。疏水性敷料（PU）由于其疏水的特性，材料表面没有保护层，肉芽组织能够长入泡沫孔隙内，极易发生牵拉出血；也由于疏水性敷料（PU）抗拉力性较差，容易产生碎屑脱落，继而引起创面创腔的异物炎性反应（排斥反应）和继发性感染，因此材料安全性存在较大问题。美国FDA报告显示，使用PU 敷料，病人存在死亡和加重创伤的情况。使用PU敷料换药周期短（美国FDA报告及相关文献显示不能超过三天），成本高，医护人员的劳动强度大，病人也较痛苦。亲水性敷料（PVA）由于其亲水特性，材料本身是湿润的，虽然其通透率也较低，也能满足负压引流的治疗要求，但是由于材料含水，因此其负压传导性能较差，在大面积创面使用时容易产生负压传导衰弱区，其次PVA材料失水后易逐渐慢慢变干，导致通透率进一步下降，减弱治疗效果。Yet above-mentioned two kinds of dressings all have defects in clinical application. Hydrophobic dressing (PU) has no protective layer on the surface of the material due to its hydrophobic characteristics, and granulation tissue can grow into the foam pores, which is prone to traction bleeding; also due to the poor tensile resistance of hydrophobic dressing (PU), it is easy to Debris falls off, which in turn causes foreign body inflammatory reaction (rejection reaction) and secondary infection in the wound cavity, so there is a big problem in material safety. The US FDA report shows that the use of PU dressings has resulted in death and aggravated trauma in patients. The use of PU dressings has a short dressing change cycle (US FDA reports and related literature show that it should not exceed three days), high cost, high labor intensity for medical staff, and more pain for patients. Hydrophilic dressing (PVA) is wet due to its hydrophilic properties. Although its permeability is low, it can also meet the treatment requirements of negative pressure drainage. However, because the material contains water, its negative pressure conductivity is poor. Poor, when used on a large area of wounds, it is easy to produce a weak area of negative pressure conduction. Secondly, the PVA material tends to gradually dry out after dehydration, resulting in a further decrease in permeability and weakening the therapeutic effect.

发明内容Contents of the invention

本发明所要解决的技术问题就是提供一种用于负压封闭引流的多层泡沫敷料和其制作方法，能够克服现有负压封闭引流敷料的缺陷，在保证材料安全性的同时，能够有效提高其负压传导性能，并且在使用过程中不易堵塞，通透性稳定，治疗效果优异。The technical problem to be solved by the present invention is to provide a multi-layer foam dressing for negative pressure sealing drainage and its manufacturing method, which can overcome the defects of existing negative pressure sealing drainage dressings, and can effectively improve the safety of materials while ensuring the safety of materials. Its negative pressure conduction performance is not easy to block during use, its permeability is stable, and its therapeutic effect is excellent.

本发明的技术方案：本发明提供的一种用于负压封闭引流的多层泡沫敷料包括负压传导层，在负压传导层下部设用于与创面或创腔接触的引流保护层，所述负压传导层和引流保护层均为多孔泡沫材料层；所述负压传导层为疏水性多孔泡沫材料层，所述引流保护层为亲水性多孔泡沫材料层，两层材料之间固定连接且孔隙相互渗透联通。Technical solution of the present invention: a multi-layer foam dressing for negative pressure sealing drainage provided by the present invention includes a negative pressure conducting layer, and a drainage protective layer for contacting the wound surface or wound cavity is arranged at the lower part of the negative pressure conducting layer, so Both the negative pressure conduction layer and the drainage protection layer are porous foam material layers; the negative pressure conduction layer is a hydrophobic porous foam material layer, and the drainage protection layer is a hydrophilic porous foam material layer, and the two layers of materials are fixed connected and the pores communicate with each other.

所述负压传导层厚度a为0.5～10cm，孔隙直径为1～2.5mm，所述引流保护层厚度b为0.1～3.5cm，孔隙直径为0.2～1mm。The thickness a of the negative pressure conducting layer is 0.5-10 cm, and the pore diameter is 1-2.5 mm. The thickness b of the drainage protection layer is 0.1-3.5 cm, and the pore diameter is 0.2-1 mm.

优选地，所述负压传导层厚度a为1～3cm，孔隙直径为1～1.5mm。Preferably, the thickness a of the negative pressure conducting layer is 1-3 cm, and the pore diameter is 1-1.5 mm.

优选地，所述负压传导层厚度a为3～6cm，孔隙直径为1～2.0mm。Preferably, the thickness a of the negative pressure conducting layer is 3-6 cm, and the pore diameter is 1-2.0 mm.

优选地，所述负压传导层厚度a为6～9cm，孔隙直径为1～2.5mm。Preferably, the thickness a of the negative pressure conducting layer is 6-9 cm, and the pore diameter is 1-2.5 mm.

优选地，所述引流保护层厚度b为0.3～0.5cm，孔隙直径为0.2～0.5mm。Preferably, the thickness b of the drain protection layer is 0.3-0.5 cm, and the pore diameter is 0.2-0.5 mm.

优选地，所述引流保护层厚度b为0.5～1.5cm，孔隙直径为0.5～1.0mm。Preferably, the thickness b of the drain protection layer is 0.5-1.5 cm, and the pore diameter is 0.5-1.0 mm.

优选地，所述引流保护层厚度b为1.5～3.5cm，孔隙直径为0.8～1.0mm。Preferably, the thickness b of the drain protection layer is 1.5-3.5 cm, and the pore diameter is 0.8-1.0 mm.

优选地，所述负压传导层采用疏水性的PU泡沫、EVA泡沫或者复合壳聚糖的PU泡沫制成。Preferably, the negative pressure conducting layer is made of hydrophobic PU foam, EVA foam or PU foam compounded with chitosan.

优选地，所述引流保护层采用PVA泡沫、复合壳聚糖的PVA泡沫或者复合抗菌、抑菌药剂的PVA泡沫制成。Preferably, the drainage protective layer is made of PVA foam, PVA foam compounded with chitosan or PVA foam compounded with antibacterial and bacteriostatic agents.

所述的多层泡沫敷料用于负压引流管安装的产品上时，有两条纵向断缝，两条纵向断缝位于将安装负压引流管的位置，由负压引流管安装的一端开口，纵向断缝的长度只要穿过负压引流管管孔安装的位置即可。When the multi-layer foam dressing is used on a product with a negative pressure drainage tube installed, there are two longitudinal slits, the two longitudinal slits are located at the position where the negative pressure drainage tube will be installed, and one end of the negative pressure drainage tube is opened , the length of the longitudinal fracture only needs to pass through the position where the hole of the negative pressure drainage tube is installed.

在负压传导层上部，即远离创面的一侧设外表面层，外表面层固定连接有在负压传导层上部。An outer surface layer is arranged on the upper part of the negative pressure conduction layer, that is, on the side away from the wound surface, and the outer surface layer is fixedly connected to the upper part of the negative pressure conduction layer.

所述的外表面层是多孔泡沫外表面层，多孔泡沫外表面层为亲水性多孔泡沫材料层。The outer surface layer is a porous foam outer surface layer, and the porous foam outer surface layer is a hydrophilic porous foam material layer.

所述的多孔泡沫外表面层厚度c为0.1～0.5cm。The thickness c of the outer surface layer of the porous foam is 0.1-0.5 cm.

所述的外表面层是一层密封胶膜外表面层。The outer surface layer is an outer surface layer of a sealant film.

所述的密封胶膜外表面层厚度为0.1～0..5mm。The thickness of the outer surface layer of the sealant film is 0.1-0..5 mm.

本发明的一种制作所述用于负压封闭引流的多层泡沫敷料的制作方法之一，包括以下步骤：One of the manufacturing methods for making the multi-layer foam dressing for negative pressure sealing drainage of the present invention comprises the following steps:

第一步，切割裁剪制得负压传导层和引流保护层；The first step is to cut and cut the negative pressure conduction layer and the drainage protection layer;

第二步，将所述第一步制作的负压传导层泡沫材料和引流保护层泡沫材料之间采用点胶粘接的方式固定连接，两层多孔泡沫材料层接触面上设有点胶点，点胶点处由干、亲水性复合胶将相邻两层多孔泡沫材料层叠放粘接，形成复合层状结构；In the second step, the negative pressure conduction layer foam material and the drainage protective layer foam material produced in the first step are fixedly connected by dispensing and bonding, and glue dispensing points are arranged on the contact surface of the two porous foam material layers At the dispensing point, two adjacent layers of porous foam materials are laminated and bonded by dry and hydrophilic composite glue to form a composite layered structure;

本发明的一种制作所述用于负压封闭引流的多层泡沫敷料的制作方法之二，包括以下步骤：A second method of making the multi-layer foam dressing for negative pressure sealing drainage of the present invention comprises the following steps:

第一步，切割裁剪制得负压传导层和引流保护层；The first step is to cut and cut the negative pressure conduction layer and the drainage protection layer;

第二步，将负压传导层与引流保护层之间采用接触面刷胶粘接的方式固定连接叠放，制作出多层泡沫材料；In the second step, the negative pressure conductive layer and the drainage protective layer are fixedly connected and stacked by brushing the contact surface to make a multi-layer foam material;

第三步，将第二步制作的多层泡沫材料在针式穿孔设备上穿孔，孔径在1～4mm，且保证其针体穿透粘胶层，使两层泡沫材料之间连通，制得多层泡沫敷料。The third step is to perforate the multi-layer foam material produced in the second step on the needle-type perforation equipment, with a hole diameter of 1-4mm, and ensure that the needle body penetrates the adhesive layer, so that the two layers of foam materials are connected, and the obtained Multiple layers of foam dressing.

所述第三步中，穿孔的孔径为2～3mm。In the third step, the diameter of the perforated holes is 2-3 mm.

本发明的一种制作所述用于负压封闭引流的多层泡沫敷料的制作方法之三，包括以下步骤：A third method of making the multi-layer foam dressing for negative pressure sealing drainage of the present invention comprises the following steps:

第一步，按照设计尺寸切割裁剪制得负压传导层及引流保护层；The first step is to cut and cut according to the design size to make the negative pressure conduction layer and the drainage protection layer;

第二步，将第一步中裁剪完成的引流保护层置于模具盒中，将适量亲水性泡沫材料发泡原料液注入其表面，静置10-30秒，待表面平整后将第一步中裁剪完成的负压传导层覆盖于原料液表面，使用工具对负压传导层均匀平整的施加压力，使负压传导层与原液面均匀充分接触；In the second step, place the drainage protection layer cut in the first step in the mold box, inject an appropriate amount of hydrophilic foam material foaming raw material solution into the surface, and let it stand for 10-30 seconds. After the surface is smooth, put the first The negative pressure conduction layer cut in the step is covered on the surface of the raw material liquid, and the negative pressure conduction layer is evenly and flatly applied with tools to make the negative pressure conduction layer evenly and fully contact with the raw liquid surface;

第三步，将第二步中注入原料液的模具盒加温，使发泡原料液反应固化成型，此时负压传导层与引流保护层会复合连接在一起，而后对中间新发泡的泡沫材料粘接层进行切割裁剪，制得双层泡沫敷料。The third step is to heat the mold box injected with the raw material liquid in the second step to make the foaming raw material liquid react and solidify into shape. The adhesive layer of the foam material is cut and trimmed to obtain a double-layer foam dressing.

所述用于负压封闭引流的多层泡沫敷料的制作方法制作方法之三，第三步中发泡反应过程为先加热至30～50℃，持续0.5～1小时，使之预合；而后升温至50～90℃，加热2～8小时。The manufacturing method of the multi-layer foam dressing for negative pressure sealing drainage is the third manufacturing method. In the third step, the foaming reaction process is to first heat to 30-50 °C for 0.5-1 hour to make it pre-combine; Raise the temperature to 50-90°C and heat for 2-8 hours.

优选地，预合温度为35～45℃，加热时间为0.5小时。Preferably, the precombination temperature is 35-45° C., and the heating time is 0.5 hour.

优选地，升温温度为55～75℃，加热时间为4～8小时。Preferably, the heating temperature is 55-75° C., and the heating time is 4-8 hours.

优选地，第三步中亲水性泡沫材料发泡原料液的组分和比例为：不同聚合度及醇解度的聚乙烯醇：强酸：多元醛：醇＝1：0.5～2：0.5～3：0.5～1。Preferably, in the third step, the components and ratios of the foaming raw material liquid of the hydrophilic foam material are: polyvinyl alcohol with different degrees of polymerization and alcoholysis: strong acid: polyaldehyde: alcohol=1:0.5～2:0.5～ 3: 0.5~1.

优选地，第三步中亲水性泡沫材料发泡原料液还包括所述原料液总质量0.5%～5%的抗菌剂、抑菌剂、增强剂。Preferably, in the third step, the raw material solution for foaming the hydrophilic foam material also includes 0.5% to 5% of the total mass of the raw material solution as an antibacterial agent, bacteriostatic agent, and enhancer.

一种所述用于负压封闭引流的多层泡沫敷料加设多孔泡沫外表面层的制作方法，包括以下步骤：A method for making a porous foam outer surface layer on the multi-layer foam dressing for negative pressure sealing drainage, comprising the following steps:

制得多层泡沫敷料上部加设多孔泡沫外表面层的方法是：将双层泡沫敷料的负压传导层朝下放置于方形模具盒内，重复方法三制得三层泡沫敷料。The method for adding a porous foam outer surface layer on the upper part of the multi-layer foam dressing is as follows: place the negative pressure conducting layer of the double-layer foam dressing downwards in a square mold box, and repeat method three to obtain a three-layer foam dressing.

第二种所述用于负压封闭引流的多层泡沫敷料加设多孔泡沫外表面层的制作方法，包括以下步骤：The second described method for making the multi-layer foam dressing for negative pressure sealing drainage and adding a porous foam outer surface layer comprises the following steps:

将制作的多层泡沫敷料上部刷胶，将密封胶膜外表面层粘接在上表面，制得三层泡沫敷料。Brush glue on the upper part of the prepared multi-layer foam dressing, and bond the outer surface layer of the sealant film on the upper surface to prepare a three-layer foam dressing.

在多层泡沫敷料上切割两条纵向断缝，纵向断缝位于负压引流管安装的位置，由多层泡沫敷料上负压引流管安装的一端穿过负压引流管管孔安装的位置伸至多层泡沫敷料中部。Cut two longitudinal slits on the multi-layer foam dressing, the longitudinal slits are located at the position where the negative pressure drainage tube is installed, and the end of the multi-layer foam dressing where the negative pressure drainage tube is installed passes through the position where the negative pressure drainage tube hole is installed. to the middle of the multilayer foam dressing.

与现有技术相比，本发明的有益效果在于：Compared with prior art, the beneficial effect of the present invention is:

1）在泡沫敷料下层设置了引流保护层，该层泡沫材料为亲水性泡沫材料，能够有效阻隔肉芽组织，避免肉芽组织与敷料之间发生黏连，造成牵拉出血，有效保证了治疗的安全性；1) A drainage protective layer is set on the lower layer of the foam dressing. The foam material of this layer is hydrophilic foam material, which can effectively block the granulation tissue, avoid the adhesion between the granulation tissue and the dressing, and cause traction bleeding, which effectively guarantees the effectiveness of the treatment. safety;

2）采用多层结构，中间设置负压传导层，专用于传导负压，有效提高了负压传导效率，在保证安全性的同时，能够有效提高敷料的负压传导性能，避免产生负压传导死角，保证了治疗效果；2) It adopts a multi-layer structure, and a negative pressure conduction layer is set in the middle, which is specially used to conduct negative pressure, which effectively improves the negative pressure conduction efficiency. While ensuring safety, it can effectively improve the negative pressure conduction performance of the dressing and avoid negative pressure conduction Dead angle ensures the therapeutic effect;

3）采用亲水性泡沫材料作为引流保护层，能够在创面表面区域形成湿润环境，有利于促进创面肉芽组织的生长，促进创面愈合，并且亲水性环境能够有效减少病人痛苦；3) The use of hydrophilic foam material as the drainage protection layer can form a moist environment in the surface area of the wound, which is conducive to promoting the growth of wound granulation tissue and promoting wound healing, and the hydrophilic environment can effectively reduce the pain of patients;

4）本发明率先提出了多层泡沫敷料的设想，克服了医学界多年来对临床上单纯、单一使用亲水性负压材料或疏水性负压材料的各自优劣性所造成的临床治疗的困扰和苦恼，利用简单的结构设计和制作方法，采用多层结构，综合了上述材料的优点，克服了其不足；4) The present invention is the first to propose the concept of multi-layer foam dressing, which overcomes the clinical treatment problems caused by the simple and single use of hydrophilic negative pressure materials or hydrophobic negative pressure materials in clinical practice for many years. Trouble and distress, using simple structural design and manufacturing methods, adopting a multi-layer structure, combining the advantages of the above materials and overcoming their shortcomings;

5）采用多层泡沫敷料结构，底层引流保护层由于其亲水性的特性，硬度和弹性都较高，而负压传导层能够保证高负压在传导过程中不会损失，在高负压作用下，底层引流保护层能够有效将大块坏死组织分割为小块，负压传导层能够有效将分割为小块的坏死组织引出，有效避免了负压传导层材料堵塞，同时能够更为有效地清洁创面，避免毒素产生，也避免毒素的吸收，降低感染发生率；5) The multi-layer foam dressing structure is adopted. Due to its hydrophilic characteristics, the bottom drainage protection layer has high hardness and elasticity, and the negative pressure conduction layer can ensure that the high negative pressure will not be lost during the conduction process. Under the action, the bottom drainage protection layer can effectively divide the large necrotic tissue into small pieces, and the negative pressure conduction layer can effectively lead out the necrotic tissue divided into small pieces, effectively avoiding the material blockage of the negative pressure conduction layer, and at the same time, it can be more effective Thoroughly clean the wound surface, avoid the production of toxins, avoid the absorption of toxins, and reduce the incidence of infection;

6）采用多层泡沫敷料结构后，由于引流通畅，并且材料安全性高、负压传导效率高，敷料使用时间能够有效延长，上述结构能够有效延长换药周期，进一步减缓病人痛苦，降低综合治疗费用；6) After adopting the multi-layer foam dressing structure, due to the smooth drainage, high material safety and high negative pressure conduction efficiency, the service life of the dressing can be effectively extended. The above structure can effectively prolong the dressing change cycle, further relieve the pain of patients, and reduce the risk of comprehensive treatment. cost;

7）采用亲水性泡沫材料作为引流保护层，由于亲水性泡沫抗拉强度高，不会产生碎屑，能够有效避免碎屑进入创面，造成创面愈合困难，进一步提高了泡沫敷料的治疗安全性。7) Hydrophilic foam material is used as the drainage protection layer. Due to the high tensile strength of the hydrophilic foam, no debris will be generated, which can effectively prevent debris from entering the wound surface, causing difficulty in wound healing, and further improving the treatment safety of the foam dressing sex.

附图说明Description of drawings

图1为本发明的基本结构－实施例1示意图；Fig. 1 is basic structure of the present invention-embodiment 1 schematic diagram;

图2为本发明实施例2－带多孔泡沫外表面层的结构示意图；Fig. 2 is the structural schematic diagram of embodiment 2 of the present invention-band outer surface layer of porous foam;

图3为本发明实施例3－带有密封胶膜外表面层的结构示意图；Fig. 3 is a schematic structural diagram of Embodiment 3 of the present invention-with an outer surface layer of a sealant film;

图4为图1的立体结构示意图；FIG. 4 is a schematic diagram of the three-dimensional structure of FIG. 1;

图5为图1、2、3与加引流管的俯视结构示意图；Fig. 5 is a top view structural schematic diagram of Fig. 1, 2, 3 and adding a drainage tube;

图6为加工本发明产品所用针式穿孔设备的结构示意图；Fig. 6 is the structural representation of the needle-type perforating equipment used for processing the product of the present invention;

图7是图6的俯视图；Figure 7 is a top view of Figure 6;

图中，1—负压传导层，2—引流保护层，3a－多孔泡沫外表面层，3b—密封胶膜外表面层，4—针式穿孔设备，5—针体，6－在多层泡沫敷料上切割的两条纵向断缝。In the figure, 1—negative pressure conduction layer, 2—drainage protective layer, 3a—outer surface layer of porous foam, 3b—outer surface layer of sealant film, 4—needle perforation device, 5—needle body, 6—in multi-layer Two longitudinal slits cut in the foam dressing.

具体实施方式detailed description

以下结合附图对本发明的具体实施例作进一步的详细描述：Below in conjunction with accompanying drawing, specific embodiment of the present invention is described in further detail:

如图1、图4、图5：本发明的一种用于负压封闭引流的多层泡沫敷料包括负压传导层1，在负压传导层1下部设用于与创面或创腔接触的引流保护层2，所述负压传导层1 和引流保护层2均为多孔泡沫材料层；所述负压传导层1为疏水性多孔泡沫材料层，所述引流保护层2为亲水性多孔泡沫材料层，两层材料之间固定连接且孔隙相互渗透联通。As shown in Fig. 1, Fig. 4, Fig. 5: a kind of multilayer foam dressing for negative pressure sealing drainage of the present invention comprises negative pressure conduction layer 1, is provided with in the lower part of negative pressure conduction layer 1 and is used for contacting with wound surface or wound cavity Drainage protection layer 2, described negative pressure conduction layer 1 and drainage protection layer 2 are porous foam material layer; Described negative pressure conduction layer 1 is hydrophobic porous foam material layer, and described drainage protection layer 2 is hydrophilic porous Foam material layer, the two layers of materials are fixedly connected and the pores are infiltrated and communicated with each other.

所述的多层泡沫敷料用于负压引流管安装的产品上时，有两条纵向断缝6，两条纵向断缝6位于将安装负压引流管的位置，由负压引流管安装的一端开口，纵向断缝6的长度只要穿过负压引流管管孔安装的位置即可。一般纵向断缝6的长度为多层泡沫敷料长度的1/10～1/2。When the multi-layer foam dressing is used on a product with a negative pressure drainage tube installed, there are two longitudinal fractures 6, and the two longitudinal fractures 6 are located at the position where the negative pressure drainage tube will be installed. One end is open, and the length of the longitudinal fracture 6 only needs to pass through the position where the negative pressure drainage tube hole is installed. Generally, the length of the longitudinal fracture 6 is 1/10 to 1/2 of the length of the multilayer foam dressing.

两条纵向断缝6的作用在于，对于已发生严重感染的创面，可以将胶膜、露出的引流管和冲洗管通过切割的缝隙翻转到引流保护层2，直接将负压传导层1与创面接触进行治疗。The function of the two longitudinal slits 6 is that for wounds that have been severely infected, the adhesive film, the exposed drainage tube and the irrigation tube can be turned over to the drainage protection layer 2 through the cut gap, and the negative pressure conduction layer 1 and the wound surface can be directly connected to each other. Contact for treatment.

所述负压传导层1厚度a为0.5～10cm，孔隙直径为1～2.5mm，所述引流保护层2厚度b为0.1～3.5cm，孔隙直径为0.2～1mm。The thickness a of the negative pressure conduction layer 1 is 0.5-10 cm, and the pore diameter is 1-2.5 mm. The thickness b of the drainage protection layer 2 is 0.1-3.5 cm, and the pore diameter is 0.2-1 mm.

所述负压传导层1厚度a为1～3cm，孔隙直径为1～1.5mm；引流保护层2厚度b为0.5～1.5cm，孔隙直径为0.5～1.0mm时，适用于各种形成瘘管、窦道的疾病的充分引流和负压传导。The thickness a of the negative pressure conducting layer 1 is 1-3 cm, and the pore diameter is 1-1.5 mm; the thickness b of the drainage protection layer 2 is 0.5-1.5 cm, and the pore diameter is 0.5-1.0 mm. Adequate drainage and negative pressure conduction for diseases of the sinus tract.

所述负压传导层1厚度a为3～6cm，孔隙直径为1～2.0mm；引流保护层2厚度b为0.3～0.5cm，孔隙直径为0.2～0.5mm时，适用于各种慢性、急性、外伤性、亚急性及裂开伤口，烧伤，溃疡(例如糖尿病溃疡及压力性溃疡)，皮瓣和植皮前后等类型的伤口等的充分引流和负压传导）。The thickness a of the negative pressure conduction layer 1 is 3-6 cm, and the pore diameter is 1-2.0 mm; the thickness b of the drainage protection layer 2 is 0.3-0.5 cm, and the pore diameter is 0.2-0.5 mm, which is suitable for various chronic and acute Adequate drainage and negative pressure conduction of traumatic, subacute and dehiscing wounds, burns, ulcers (such as diabetic ulcers and pressure ulcers), skin flaps and wounds before and after skin grafting).

所述负压传导层1厚度a为6～9cm，孔隙直径为1～2.5mm；所述引流保护层2厚度b为1.5～3.5cm，孔隙直径为0.8～1.0mm时适用于各种开放性腹腔损伤的充分引流和负压传导。The thickness a of the negative pressure conduction layer 1 is 6-9 cm, and the pore diameter is 1-2.5 mm; the thickness b of the drainage protection layer 2 is 1.5-3.5 cm, and the pore diameter is 0.8-1.0 mm, which is suitable for various openings. Adequate drainage and negative pressure conduction for abdominal injuries.

经发明人长期临床研究分析，在高负压作用下，创面肉芽的直径一般在1mm以下。引流保护层2采用这种孔隙配置，一方面能够有利于负压的传导，另一方面能够有效避免肉芽组织生长入泡沫孔隙中，提高泡沫敷料的整体安全性和治疗效果。According to the inventor's long-term clinical research analysis, under the action of high negative pressure, the diameter of wound granulation is generally below 1mm. The drainage protection layer 2 adopts such a pore configuration, on the one hand, it can facilitate the conduction of negative pressure, on the other hand, it can effectively prevent the growth of granulation tissue into the foam pores, and improve the overall safety and therapeutic effect of the foam dressing.

采用较薄的引流保护层2，能够有效降低亲水性泡沫层对负压传导产生的负面影响，而一定的厚度又能有效对创面肉芽组织产生阻隔作用。采用较厚的负压传导层1，能够有效提高泡沫敷料的整体负压传导性能。上述数据是发明人经过大量临床实验研究所得出的。The use of a thinner drainage protection layer 2 can effectively reduce the negative impact of the hydrophilic foam layer on negative pressure conduction, and a certain thickness can effectively block the wound granulation tissue. Adopting a thicker negative pressure conduction layer 1 can effectively improve the overall negative pressure conduction performance of the foam dressing. The above data are obtained by the inventor through a large number of clinical experiments.

引流保护层2优选为亲水性多孔泡沫材料层。所述引流保护层2可以采用PVA泡沫、复合壳聚糖的PVA泡沫或者复合抗菌、抑菌药剂的PVA泡沫制成。The drainage protection layer 2 is preferably a hydrophilic porous foam material layer. The drainage protection layer 2 can be made of PVA foam, PVA foam compounded with chitosan or PVA foam compounded with antibacterial and bacteriostatic agents.

所述负压传导层1优选疏水性多孔泡沫材料层。可以采用疏水性的PU泡沫、EVA泡沫或者复合壳聚糖的PU泡沫制成。采用复合壳聚糖的PU泡沫更适于反过来使用的需要。The negative pressure conducting layer 1 is preferably a hydrophobic porous foam material layer. It can be made of hydrophobic PU foam, EVA foam or PU foam compounded with chitosan. The PU foam using complex chitosan is more suitable for the reverse use.

优选疏水性多孔泡沫材料泡沫孔隙较大，通透率较高，由于其疏水的特性，泡沫内一般不会含水，因此负压传导性能极佳，能够有效提高泡沫敷料的整体负压传导性能。The preferred hydrophobic porous foam material has larger foam pores and higher permeability. Due to its hydrophobic characteristics, the foam generally does not contain water, so the negative pressure conduction performance is excellent, which can effectively improve the overall negative pressure conduction performance of the foam dressing.

医学界多年来对临床上单纯、单一使用亲水性负压材料或疏水性负压材料的各自优劣性造成了临床治疗的很多困扰和苦恼。Over the years, the medical community has caused a lot of troubles and troubles in clinical treatment due to the advantages and disadvantages of using hydrophilic negative pressure materials or hydrophobic negative pressure materials alone in clinical practice.

在负压传导层1上部，即远离创面的一侧设外表面层3，外表面层3固定连接有在负压传导层1上部，用于阻止材料失水；同时，当用于腔内治疗时，外表面层3可以有效防止负压传导层1与创腔组织直接接触。An outer surface layer 3 is arranged on the upper part of the negative pressure conduction layer 1, that is, the side away from the wound surface, and the outer surface layer 3 is fixedly connected with the upper part of the negative pressure conduction layer 1 to prevent the material from dehydration; at the same time, when used for intracavitary treatment , the outer surface layer 3 can effectively prevent the direct contact between the negative pressure conduction layer 1 and the tissue of the wound cavity.

图2为本发明实施例2－带多孔泡沫外表面层的结构示意图；Fig. 2 is the structural schematic diagram of embodiment 2 of the present invention-band outer surface layer of porous foam;

外表面层3是多孔泡沫外表面层3a，多孔泡沫外表面层3a为亲水性多孔泡沫材料层。The outer surface layer 3 is a porous foam outer surface layer 3a, and the porous foam outer surface layer 3a is a hydrophilic porous foam material layer.

所述的多孔泡沫外表面层3a厚度c为0.1～0.5cm。The thickness c of the porous foam outer surface layer 3a is 0.1-0.5 cm.

图3为本发明实施例3－带有密封胶膜外表面层的结构示意图：Fig. 3 is a schematic structural diagram of Embodiment 3 of the present invention-with the outer surface layer of the sealant film:

外表面层3是一层密封胶膜外表面层3b。所述的密封胶膜外表面层3b厚度为0.1～0.5mm。The outer surface layer 3 is an outer surface layer 3b of a sealant film. The outer surface layer 3b of the sealant film has a thickness of 0.1-0.5 mm.

本发明的一种制作所述用于负压封闭引流的多层泡沫敷料的制作方法之一，包括以下步骤：One of the manufacturing methods for making the multi-layer foam dressing for negative pressure sealing drainage of the present invention comprises the following steps:

第一步，切割裁剪制得负压传导层1和引流保护层2；The first step is to cut and cut the negative pressure conduction layer 1 and the drainage protection layer 2;

第二步，将所述第一步制作的负压传导层1泡沫材料和引流保护层2泡沫材料之间采用点胶粘接的方式固定连接，两层多孔泡沫材料层接触面上设有点胶点，点胶点处由干、亲水性复合胶将相邻两层多孔泡沫材料层叠放粘接，形成复合层状结构。In the second step, the foam material of the negative pressure conduction layer 1 and the foam material of the drainage protection layer 2 made in the first step are fixedly connected by point glue, and points are arranged on the contact surface of the two layers of porous foam material layers. Glue point, at the point of glue point, the dry and hydrophilic composite glue will laminate and bond two adjacent layers of porous foam materials to form a composite layered structure.

第二种所述用于负压封闭引流的多层泡沫敷料加设多孔泡沫外表面层的制作方法，包括以下步骤：The second described method for making the multi-layer foam dressing for negative pressure sealing drainage and adding a porous foam outer surface layer comprises the following steps:

第一步，切割裁剪制得负压传导层1和引流保护层2；The first step is to cut and cut the negative pressure conduction layer 1 and the drainage protection layer 2;

第二步，将负压传导层1与引流保护层2之间采用接触面刷胶粘接的方式固定连接叠放，制作出多层泡沫材料；In the second step, the negative pressure conduction layer 1 and the drainage protection layer 2 are fixedly connected and stacked by brushing and bonding the contact surface to produce a multi-layer foam material;

第三步，将第二步制作的多层泡沫材料在针式穿孔设备上穿孔，孔径在1～4mm，且保证其针体穿透粘胶层，使两层泡沫材料之间连通，制得多层泡沫敷料。The third step is to perforate the multi-layer foam material produced in the second step on the needle-type perforation equipment, with a hole diameter of 1-4mm, and ensure that the needle body penetrates the adhesive layer, so that the two layers of foam materials are connected, and the obtained Multiple layers of foam dressing.

图6、图7为加工本发明产品所用针式穿孔设备的结构示意图：Fig. 6, Fig. 7 are the structural representations of the needle type perforating equipment used for processing the product of the present invention:

所述第三步中，穿孔的孔径为2～3mm。In the third step, the diameter of the perforated holes is 2-3 mm.

本发明的一种制作所述用于负压封闭引流的多层泡沫敷料的制作方法之三，包括以下步骤：A third method of making the multi-layer foam dressing for negative pressure sealing drainage of the present invention comprises the following steps:

第一步，按照设计尺寸切割裁剪制得负压传导层1及引流保护层2；The first step is to cut and cut according to the design size to obtain the negative pressure conduction layer 1 and the drainage protection layer 2;

第二步，将第一步中裁剪完成的引流保护层2置于模具盒中，将适量亲水性泡沫材料发泡原料液注入其表面，静置10～30秒，待表面平整后将第一步中裁剪完成的负压传导层1覆盖于原料液表面，使用工具对负压传导层1均匀平整的施加压力，使负压传导层1与原液面均匀充分接触；In the second step, place the drainage protective layer 2 cut in the first step in the mold box, inject an appropriate amount of hydrophilic foam material foaming raw material solution into the surface, and let it stand for 10 to 30 seconds. The negative pressure conducting layer 1 cut in one step covers the surface of the raw material liquid, and the negative pressure conducting layer 1 is evenly and flatly applied pressure with a tool, so that the negative pressure conducting layer 1 is in uniform and full contact with the raw liquid surface;

第三步，将第二步中注入原料液的模具盒加温，使发泡原料液反应固化成型，此时负压传导层1与引流保护层2会复合连接在一起，而后对中间新发泡的泡沫材料粘接层进行切割裁剪，制得双层泡沫敷料。The third step is to heat the mold box injected with the raw material liquid in the second step to make the foaming raw material liquid react and solidify into shape. The foamed foam adhesive layer is cut and trimmed to obtain a double-layer foam dressing.

所述第三步中发泡反应过程为先加热至30～50℃，持续0.5～1小时，使之预合；而后升温至50～90℃，加热2～8小时。加热至30～50℃是为了更好地融合、预发泡，升温至50～90℃加热2～8是为了更好地固化。The foaming reaction process in the third step is to first heat to 30-50°C for 0.5-1 hour to precompose; then raise the temperature to 50-90°C and heat for 2-8 hours. Heating to 30-50°C is for better fusion and pre-foaming, and heating to 50-90°C for 2-8 is for better curing.

所述预合温度为35～45℃，加热时间为0.5小时。The precombination temperature is 35-45° C., and the heating time is 0.5 hour.

所述升温温度为55～75℃，加热时间为4～8小时。The heating temperature is 55-75° C., and the heating time is 4-8 hours.

所述第三步中亲水性泡沫材料发泡原料液的组分和比例为：不同聚合度及醇解度的聚乙烯醇：强酸：多元醛：醇＝1：0.5～2：0.5～3：0.5～1。In the third step, the components and ratios of the foaming raw material liquid of the hydrophilic foam material are: polyvinyl alcohol with different degrees of polymerization and alcoholysis: strong acid: polyaldehyde: alcohol=1:0.5～2:0.5～3 : 0.5~1.

强酸及多元醛的浓度越大，孔隙越小，产品的硬度越大，反之则强酸及多元醛的浓度越小，孔隙越大，产品的硬度越小；醇含量越高产品的亲水性越强，反之醇含量越低，产品的亲水性越弱。该处亲水性泡沫材料发泡原料液主要用于粘接，一般它的成份和比例与产品所采用的引流保护层2一致。The greater the concentration of strong acids and polyaldehydes, the smaller the pores, and the greater the hardness of the product. On the contrary, the smaller the concentration of strong acids and polyaldehydes, the larger the pores, and the smaller the hardness of the product; the higher the alcohol content, the more hydrophilic the product. Strong, on the contrary, the lower the alcohol content, the weaker the hydrophilicity of the product. The foaming raw material liquid of the hydrophilic foam material here is mainly used for bonding, and generally its composition and ratio are consistent with the drainage protection layer 2 adopted by the product.

所述第三步中亲水性泡沫材料发泡原料液还包括所述原料液总质量0.5%～5%的添加剂，包括但不限于抗菌剂、抑菌剂、增强剂等。The raw material liquid for foaming the hydrophilic foam material in the third step also includes additives in an amount of 0.5% to 5% of the total mass of the raw material liquid, including but not limited to antibacterial agents, bacteriostatic agents, enhancers, and the like.

采用亲水性泡沫材料发泡原料液将所述各层多孔泡沫材料层之间复合固定的方式连接，相邻两层泡沫材料相互渗透黏连，渗透性更好。The foaming raw material liquid of the hydrophilic foam material is used to connect the layers of the porous foam material in a composite and fixed manner, and the adjacent two layers of foam materials penetrate and adhere to each other, and the permeability is better.

将制得多层泡沫敷料上部加设多孔泡沫外表面层3a的方法是：将双层泡沫敷料的负压传导层1朝下放置于方形模具盒内，重复制作方法之三第二、第三步，制得三层泡 沫敷料。The method of adding a porous foam outer surface layer 3a to the upper part of the prepared multi-layer foam dressing is: place the negative pressure conduction layer 1 of the double-layer foam dressing downward in the square mold box, and repeat the third and third manufacturing methods step, a three-layer foam dressing is prepared.

制作多层泡沫敷料上部加设多孔泡沫外表面层3a的方法之二是：将多层泡沫敷料上部刷胶，将密封胶膜外表面层3b粘接在上表面，制得三层泡沫敷料。The second method of adding a porous foam outer surface layer 3a to the upper part of the multilayer foam dressing is: brush the upper part of the multilayer foam dressing with glue, and bond the outer surface layer 3b of the sealant film to the upper surface to obtain a three-layer foam dressing.

在多层泡沫敷料上切割两条纵向断缝，纵向断缝位于负压引流管安装的位置，由多层泡沫敷料上负压引流管安装的一端穿过负压引流管管孔安装的位置伸至多层泡沫敷料中部。Cut two longitudinal slits on the multi-layer foam dressing, the longitudinal slits are located at the position where the negative pressure drainage tube is installed, and the end of the multi-layer foam dressing where the negative pressure drainage tube is installed passes through the position where the negative pressure drainage tube hole is installed. to the middle of the multilayer foam dressing.

实施例1：Example 1:

复合型泡沫敷料composite foam dressing

该敷料为双层结构，由一层负压传导层1和一层引流保护层2复合而成。负压传导层1采用疏水性泡沫材料，引流保护层2采用亲水性泡沫材料。The dressing has a double-layer structure, which is compounded by a negative pressure conducting layer 1 and a drainage protection layer 2 . The negative pressure conducting layer 1 is made of hydrophobic foam material, and the drainage protection layer 2 is made of hydrophilic foam material.

负压传导层1厚度为1cm，引流保护层2厚度为0.5cm。负压传导层1孔隙直径为2.5mm，引流保护层2孔隙直径为0.5mm。The negative pressure conduction layer 1 has a thickness of 1 cm, and the drain protection layer 2 has a thickness of 0.5 cm. The pore diameter of the negative pressure conducting layer 1 is 2.5mm, and the pore diameter of the drainage protection layer 2 is 0.5mm.

所述远离创面的一侧外层的多孔泡沫材料层外表面固定连接有一层密封胶膜外表面层3b。The outer surface of the porous foam material layer on the side away from the wound surface is fixedly connected with an outer surface layer 3b of a sealant film.

实施例2：Example 2:

复合型泡沫敷料composite foam dressing

该敷料为三层结构，负压传导层1居中。负压传导层1采用疏水性泡沫材料，引流保护层2采用亲水性泡沫材料。The dressing has a three-layer structure, and the negative pressure conducting layer 1 is centered. The negative pressure conducting layer 1 is made of hydrophobic foam material, and the drainage protection layer 2 is made of hydrophilic foam material.

负压传导层1厚度为1cm，引流保护层2厚度为0.5cm。负压传导层1孔隙直径为2.5mm，引流保护层2孔隙直径为0.5mm。加设多孔泡沫外表面层3a为0.5cm，孔隙直径为0.5mm。The negative pressure conduction layer 1 has a thickness of 1 cm, and the drain protection layer 2 has a thickness of 0.5 cm. The pore diameter of the negative pressure conducting layer 1 is 2.5mm, and the pore diameter of the drainage protection layer 2 is 0.5mm. The outer surface layer 3a of porous foam is added with a size of 0.5 cm and a pore diameter of 0.5 mm.

实施例3：Example 3:

粘接型泡沫敷料Adhesive Foam Dressing

该敷料为双层结构，由一层负压传导层1和一层引流保护层2粘接而成。负压传导层1采用疏水性泡沫材料，引流保护层2采用亲水性泡沫材料。The dressing has a double-layer structure, and is formed by bonding one layer of negative pressure conduction layer 1 and one layer of drainage protection layer 2 . The negative pressure conducting layer 1 is made of hydrophobic foam material, and the drainage protection layer 2 is made of hydrophilic foam material.

负压传导层1厚度为1cm，引流保护层2厚度为0.5cm。负压传导层1孔隙直径为2.5mm，引流保护层2孔隙直径为0.5mm。The negative pressure conduction layer 1 has a thickness of 1 cm, and the drain protection layer 2 has a thickness of 0.5 cm. The pore diameter of the negative pressure conducting layer 1 is 2.5mm, and the pore diameter of the drainage protective layer 2 is 0.5mm.

所述粘接方式为多点点胶粘接。所述远离创面的一侧外层的多孔泡沫材料层外表面固定连接有一层密封胶膜外表面层3b。The bonding method is multi-point glue bonding. The outer surface of the porous foam material layer on the side away from the wound surface is fixedly connected with an outer surface layer 3b of a sealant film.

实施例4：Example 4:

粘接型泡沫敷料Adhesive Foam Dressing

该敷料为双层结构，由一层负压传导层1和一层引流保护层2粘接而成。负压传导层1采用疏水性泡沫材料，引流保护层2采用亲水性泡沫材料。The dressing has a double-layer structure, and is formed by bonding one layer of negative pressure conduction layer 1 and one layer of drainage protection layer 2 . The negative pressure conducting layer 1 is made of hydrophobic foam material, and the drainage protection layer 2 is made of hydrophilic foam material.

负压传导层1厚度为1cm，引流保护层2厚度为0.5cm。负压传导层1孔隙直径为2.5mm，引流保护层2孔隙直径为0.5mm。The negative pressure conduction layer 1 has a thickness of 1 cm, and the drain protection layer 2 has a thickness of 0.5 cm. The pore diameter of the negative pressure conducting layer 1 is 2.5mm, and the pore diameter of the drainage protective layer 2 is 0.5mm.

所述粘接方式为面粘接，胶层上穿设有通孔，孔径为2mm。The bonding method is surface bonding, and the adhesive layer is pierced with through holes with a diameter of 2mm.

实施例5：Example 5:

复合型泡沫敷料composite foam dressing

该敷料为双层结构，由一层负压传导层1和一层引流保护层2复合而成。负压传导层1采用疏水性泡沫材料，引流保护层2采用亲水性泡沫材料。The dressing has a double-layer structure, which is compounded by a negative pressure conducting layer 1 and a drainage protection layer 2 . The negative pressure conducting layer 1 is made of hydrophobic foam material, and the drainage protection layer 2 is made of hydrophilic foam material.

负压传导层1厚度为3cm，引流保护层2厚度为1cm。负压传导层1孔隙直径为1.5mm，引流保护层2孔隙直径为1mm。The thickness of the negative pressure conducting layer 1 is 3 cm, and the thickness of the drainage protection layer 2 is 1 cm. The pore diameter of the negative pressure conducting layer 1 is 1.5mm, and the pore diameter of the drainage protective layer 2 is 1mm.

所述远离创面的一侧外层的多孔泡沫材料层外表面固定连接有一层密封胶膜外表面层3b。The outer surface of the porous foam material layer on the side away from the wound surface is fixedly connected with an outer surface layer 3b of a sealant film.

实施例6：Embodiment 6:

复合型泡沫敷料composite foam dressing

该敷料为双层结构，由一层负压传导层1和一层引流保护层2复合而成。负压传导层1采用疏水性泡沫材料，引流保护层2采用亲水性泡沫材料。The dressing has a double-layer structure, which is compounded by a negative pressure conducting layer 1 and a drainage protection layer 2 . The negative pressure conducting layer 1 is made of hydrophobic foam material, and the drainage protection layer 2 is made of hydrophilic foam material.

负压传导层1厚度为6cm，引流保护层2厚度为0.75cm。负压传导层1孔隙直径为1mm，引流保护层2孔隙直径为1mm。The negative pressure conduction layer 1 has a thickness of 6 cm, and the drainage protection layer 2 has a thickness of 0.75 cm. The pore diameter of the negative pressure conducting layer 1 is 1mm, and the pore diameter of the drainage protective layer 2 is 1mm.

所述远离创面的一侧外层的多孔泡沫材料层外表面固定连接有一层密封胶膜外表面层3b。The outer surface of the porous foam material layer on the side away from the wound surface is fixedly connected with an outer surface layer 3b of a sealant film.

实施例7：Embodiment 7:

复合型泡沫敷料composite foam dressing

该敷料为双层结构，由一层负压传导层1和一层引流保护层2复合而成。负压传导层1采用疏水性泡沫材料，引流保护层2采用亲水性泡沫材料。The dressing has a double-layer structure, which is compounded by a negative pressure conducting layer 1 and a drainage protection layer 2 . The negative pressure conducting layer 1 is made of hydrophobic foam material, and the drainage protection layer 2 is made of hydrophilic foam material.

负压传导层1厚度为8cm，引流保护层2厚度为1cm。负压传导层1孔隙直径为2.5mm，引流保护层2孔隙直径为0.5mm。The thickness of the negative pressure conducting layer 1 is 8 cm, and the thickness of the drainage protection layer 2 is 1 cm. The pore diameter of the negative pressure conducting layer 1 is 2.5mm, and the pore diameter of the drainage protective layer 2 is 0.5mm.

所述远离创面的一侧外层的多孔泡沫材料层外表面固定连接有一层密封胶膜外表面层3b。The outer surface of the porous foam material layer on the side away from the wound surface is fixedly connected with an outer surface layer 3b of a sealant film.

实施例8：Embodiment 8:

复合型泡沫敷料composite foam dressing

该敷料为双层结构，由一层负压传导层1和一层引流保护层2复合而成。负压传导层1采用疏水性泡沫材料，引流保护层2采用亲水性泡沫材料。The dressing has a double-layer structure, which is compounded by a negative pressure conducting layer 1 and a drainage protection layer 2 . The negative pressure conducting layer 1 is made of hydrophobic foam material, and the drainage protection layer 2 is made of hydrophilic foam material.

负压传导层1厚度为10cm，引流保护层2厚度为3.5cm。负压传导层1孔隙直径为2.5mm，引流保护层2孔隙直径为0.5mm。The thickness of the negative pressure conducting layer 1 is 10 cm, and the thickness of the drainage protection layer 2 is 3.5 cm. The pore diameter of the negative pressure conducting layer 1 is 2.5mm, and the pore diameter of the drainage protective layer 2 is 0.5mm.

所述远离创面的一侧外层的多孔泡沫材料层外表面固定连接有一层密封胶膜外表面层3b。The outer surface of the porous foam material layer on the side away from the wound surface is fixedly connected with an outer surface layer 3b of a sealant film.

实施例9：Embodiment 9:

复合型泡沫敷料composite foam dressing

该敷料为双层结构，由一层负压传导层1和一层引流保护层2复合而成。负压传导层1采用疏水性泡沫材料，引流保护层2采用亲水性泡沫材料。The dressing has a double-layer structure, which is compounded by a negative pressure conducting layer 1 and a drainage protection layer 2 . The negative pressure conducting layer 1 is made of hydrophobic foam material, and the drainage protection layer 2 is made of hydrophilic foam material.

负压传导层1厚度为6cm，引流保护层2厚度为2.5cm。负压传导层1孔隙直径为2.5mm，引流保护层2孔隙直径为0.5mm。The thickness of the negative pressure conducting layer 1 is 6 cm, and the thickness of the drainage protection layer 2 is 2.5 cm. The pore diameter of the negative pressure conducting layer 1 is 2.5mm, and the pore diameter of the drainage protection layer 2 is 0.5mm.

所述远离创面的一侧外层的多孔泡沫材料层外表面固定连接有一层密封胶膜外表面层3b。The outer surface of the porous foam material layer on the side away from the wound surface is fixedly connected with an outer surface layer 3b of a sealant film.

实施例10：Example 10:

复合型泡沫敷料composite foam dressing

该敷料为双层结构，由一层负压传导层1和一层引流保护层2复合而成。负压传导层1采用疏水性泡沫材料，引流保护层2采用亲水性泡沫材料。The dressing has a double-layer structure, which is compounded by a negative pressure conducting layer 1 and a drainage protection layer 2 . The negative pressure conducting layer 1 is made of hydrophobic foam material, and the drainage protection layer 2 is made of hydrophilic foam material.

负压传导层1厚度为6cm，引流保护层2厚度为2cm。负压传导层1孔隙直径为2.5mm，引流保护层2孔隙直径为0.5mm。The thickness of the negative pressure conducting layer 1 is 6 cm, and the thickness of the drainage protection layer 2 is 2 cm. The pore diameter of the negative pressure conducting layer 1 is 2.5mm, and the pore diameter of the drainage protective layer 2 is 0.5mm.

所述远离创面的一侧外层的多孔泡沫材料层外表面固定连接有一层密封胶膜外表面层3b。The outer surface of the porous foam material layer on the side away from the wound surface is fixedly connected with an outer surface layer 3b of a sealant film.

加热温度与时间与产品的机械强度和硬度直接相关。温度越高，加热时间越长，机械强度和硬度越大；温度越低，加热时间越短，则产品的机械强度和硬度越小。The heating temperature and time are directly related to the mechanical strength and hardness of the product. The higher the temperature, the longer the heating time, the greater the mechanical strength and hardness; the lower the temperature, the shorter the heating time, the smaller the mechanical strength and hardness of the product.

双层复合PVA与现有PVA敷料和PU敷料进行实验对比，具体结果如下表：The experimental comparison between the double-layer composite PVA and the existing PVA dressing and PU dressing is shown in the following table:

*A：一期治疗转归时间是指创面、创腔经负压封闭引流技术治疗后形成可以做二期直接缝合或植皮或组织瓣转移的创面床修复时间。*A: The outcome time of the first-stage treatment refers to the time when the wound and the wound cavity can be repaired after the negative pressure sealing and drainage technology can be used for the second-stage direct suture or skin grafting or tissue flap transfer.

*C：上皮化率。上皮化过程包括角质形成细胞的迁移、增殖和分化三个阶段，是组织修复过程的重要标志；上皮化率是上皮化修复过程的显著指标。*C: Epithelialization rate. The epithelialization process includes three stages of keratinocyte migration, proliferation and differentiation, and is an important symbol of the tissue repair process; the epithelialization rate is a significant indicator of the epithelialization repair process.

*D：创面、创腔血流灌注量，是指每100g血液每分钟内能流入每平方厘米的创面或者创腔腔壁的血液量（ml）；创面、创腔血流灌注量越大，单位面积内毛细血管的生成越活跃，肉芽组织的生长速率越快。PU=ml·100g-1·min-1*D: wound surface and wound cavity blood perfusion, refers to the amount of blood (ml) that can flow into each square centimeter of wound surface or wound cavity wall per 100g of blood per minute; the greater the wound surface and wound cavity blood perfusion, The more active the formation of capillaries per unit area, the faster the growth rate of granulation tissue. PU=ml·100g-1·min-1

*F：肉芽组织填充率，是指创面、创腔中肉芽组织填充的比例；肉芽组织填充率越大，表示创面、创腔被新生肉芽填充的越多，伤口愈合情况*F: The filling rate of granulation tissue refers to the filling ratio of granulation tissue in the wound surface and wound cavity; the higher the filling rate of granulation tissue, the more the wound surface and the wound cavity are filled with new granulation, and the wound healing status is higher.

*G：细菌计数，是指单位体积中的活菌个数；细菌计数越大，表示感染可能性越大。*G: Bacteria count, which refers to the number of viable bacteria per unit volume; the greater the bacterial count, the greater the possibility of infection.

*K：综合费用，包括住院期间材料费用、抗生素等药品费用、手术费、治疗费、床位费、营养费等。*K: Comprehensive expenses, including material expenses during hospitalization, antibiotics and other medicine expenses, operation expenses, treatment expenses, bed expenses, nutrition expenses, etc.

根据上述对比实验可知，本发明产品在治疗效果，综合治疗费用等多方面均优于现有产品。According to above-mentioned comparative experiment, product of the present invention is all better than existing product in many aspects such as therapeutic effect, comprehensive treatment cost.

综上所述，本发明的核心是利用外侧为引流保护层的多层复合的泡沫敷料，巧妙地解决了现有负压封闭引流泡沫敷料疏水性敷料材料安全性能差，亲水性敷料负压传导性能差的问题。在单个泡沫敷料中，可以根据需要使用双层或多层结构，极其灵活。因此，在不改变本发明原理的前提下，所作出的任何改变或变形，均属于本发明的保护范围。In summary, the core of the present invention is to utilize the multi-layer composite foam dressing whose outer side is the drainage protective layer, which skillfully solves the poor safety performance of the existing negative pressure sealing drainage foam dressing hydrophobic dressing material and the negative pressure of the hydrophilic dressing. The problem of poor conductivity. In a single foam dressing, two or more layers can be used according to the needs, which is extremely flexible. Therefore, on the premise of not changing the principles of the present invention, any change or deformation made falls within the protection scope of the present invention.