CN201996967U - Negative pressure drainage trauma care device - Google Patents

Abstract

The utility model discloses a negative pressure drainage trauma care device. The device comprises a medical foam 1 and a draft tube 2, wherein one end of draft tube 2 is inserted into the medical foam 1, small holes 3 are arranged on the tube wall of the draft tube inside the medical foam, and the medical foam is made of the composite foam material of PVA (Poly Vinyl Alcohol) and chitosan. The negative pressure drainage trauma care device adopts the composite foam material of PVA and chitosan, not only has the original functions and properties, but also has various biological effects of chitosan and the derivants of the chitosan such as inhibiting microbial growth, promoting wound healing, hemostasis, relieving pain etc.

Description

Translated fromChinese

负压引流护创装置Negative pressure drainage device

技术领域technical field

本实用新型涉及一种负压引流护创装置，属于医疗器械领域。The utility model relates to a negative pressure drainage and wound protection device, which belongs to the field of medical equipment.

技术背景technical background

本实用新型的负压引流护创装置适用于负压封闭引流技术。负压封闭引流技术是在引流管外用医用泡沫包裹，使泡沫材料成为引流管和被引流腔隙或创面之间的中介，再利用具有生物阀功能的半透性粘贴薄膜封闭被引流区，使之与外界隔绝，接通高负压源（125～450mmHg），形成一个高效引流系统，及时地清除被引流区的渗出物。该技术是外科引流技术的革命性创新，能够彻底去除腔隙或创面的分泌物和坏死组织，促进伤口愈合，该技术操作简单，效果甚佳，易于推广。该技术减少了患者的痛苦，免去了平时更换敷料给病人带来的疼痛；减少创面愈合时间；在病人监护和管理方面，检查创面时，减少了开放换药致使外界环境污染的危险性，减少院内交叉感染的机会；减少医护人员的工作量，无需每天换药，只要检查负压是否有效；总体上降低了患者的医疗费用。该技术由德国Ulm大学附属创伤外科医院的WimFleischmann博士在1992年所发明，主要用于四肢创面的引流，后经欧洲、北美等地区多家医院广泛应用到临床，将其应用范围扩展到矫形外科、创伤外科、显微外科、烧伤科、溃疡中心等多个学科。裘华德于1994年引进国内，先后在武汉大学中南医院、华中科技大学同济医学院附属同济医院、华中科技大学同济医学院附属协和医院、第四军医大学附属唐都医院、第三军医大学附属大坪医院、北京大学附属深圳医院等多家医院开展，均取得了很好的疗效，并有大量文章在各种权威杂志中发表，在临床的有效性上已经得到了很好的验证。2005年发明人所在项目组成功研制出国产聚乙烯醇复合泡沫材料，并获产品注册证。在该技术投入使用取得成功和发展之时，泡沫材料本身无明显生物活性、炎性创面容易堵管等弊端也逐渐显露出来。The negative pressure drainage and wound protection device of the utility model is suitable for the negative pressure sealing drainage technology. Negative pressure sealing drainage technology is to wrap the drainage tube with medical foam, so that the foam material becomes the intermediary between the drainage tube and the drained cavity or wound surface, and then use the semi-permeable adhesive film with the function of biological valve to seal the drained area, so that It is isolated from the outside world and connected to a high negative pressure source (125-450mmHg) to form an efficient drainage system to promptly remove the exudate from the drainage area. This technology is a revolutionary innovation in surgical drainage technology, which can completely remove the secretions and necrotic tissue in the cavity or wound surface, and promote wound healing. This technology is simple to operate, has excellent results, and is easy to promote. This technology reduces the pain of patients and eliminates the pain caused by changing dressings; it reduces the wound healing time; in terms of patient monitoring and management, when checking wounds, it reduces the risk of external environmental pollution caused by open dressing changes. Reduce the chance of cross-infection in the hospital; reduce the workload of medical staff, no need to change the dressing every day, just check whether the negative pressure is effective; generally reduce the medical expenses of patients. This technology was invented by Dr. Wim Fleischmann of Trauma Surgery Hospital Affiliated to Ulm University in Germany in 1992. It is mainly used for the drainage of extremity wounds. It has been widely used clinically by many hospitals in Europe, North America and other regions, and its application scope has been extended to orthopedic surgery. , Trauma Surgery, Microsurgery, Burns, Ulcer Center and many other disciplines. Qiu Huade was introduced into China in 1994, and successively worked in Zhongnan Hospital of Wuhan University, Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Tangdu Hospital Affiliated to Fourth Military Medical University, and Daping Hospital Affiliated to Third Military Medical University , Shenzhen Hospital Affiliated to Peking University and many other hospitals have achieved good curative effect, and a large number of articles have been published in various authoritative journals, and the clinical effectiveness has been well verified. In 2005, the inventor's project team successfully developed the domestic polyvinyl alcohol composite foam material and obtained the product registration certificate. When the technology was successfully put into use and developed, the disadvantages of the foam material itself, such as no obvious biological activity and easy blockage of inflammatory wounds, were gradually revealed.

实用新型内容Utility model content

本实用新型所要解决的技术问题在于提供一种具有生物活性的负压引流护创装置。The technical problem to be solved by the utility model is to provide a biologically active negative pressure drainage and wound protection device.

本发明人继2005年研制出国产聚乙烯醇泡沫材料后，进一步研究出具有生物活性的负压封闭吸引材料--聚乙烯醇/壳聚糖复合泡沫材料。此复合材料及其制备方法已于《中华显微外科杂志》2010，33：482-484公开。Following the development of the domestic polyvinyl alcohol foam material in 2005, the inventor further developed a negative pressure sealing suction material with biological activity-polyvinyl alcohol/chitosan composite foam material. The composite material and its preparation method have been published in "Chinese Journal of Microsurgery" 2010, 33: 482-484.

聚乙烯醇/壳聚糖复合泡沫材料的制作方法如下：将壳聚糖溶于3%稀醋酸中配成质量分数3%的壳聚糖溶液。称取10g聚乙烯醇，量取80ml蒸馏水, 加入到配备搅拌器、温控调节装置的器皿中，在60～80R/min的低速搅拌下升温至95℃待聚乙烯醇完全溶解。加入40ml的壳聚糖溶液，继续低速搅拌均匀。降温至50℃，加入1.5 ml发泡剂，在800～1000R/min的速度下高速搅拌70min使溶液自由发泡至原始体积的2.0～2.5倍。加入8ml质量分数为50%的硫酸，继续高速搅拌20min。再加入10 ml质量分数为36%的甲醛，高速搅拌20 min。降温至4℃，加入5ml0.25%戊二醛溶液，高速搅拌10min，立即将泡沫体注入模具中，放入烘箱，在55～60℃下恒温6 h固化,取出成型泡沫体，洗去未反应的甲醛、戊二醛和硫酸，在水中洗至中性和漂洗时不再产生泡沫，将泡沫体冷冻干燥24h，得到聚乙烯醇/壳聚糖复合泡沫材料（PVA-CS泡沫）。The preparation method of the polyvinyl alcohol/chitosan composite foam material is as follows: dissolve chitosan in 3% dilute acetic acid to form a chitosan solution with a mass fraction of 3%. Weigh 10g of polyvinyl alcohol and 80ml of distilled water, add it to a vessel equipped with a stirrer and a temperature control device, and raise the temperature to 95°C under stirring at a low speed of 60-80R/min until the polyvinyl alcohol is completely dissolved. Add the chitosan solution of 40ml, continue to stir at a low speed evenly. Cool down to 50°C, add 1.5 ml foaming agent, and stir at a high speed of 800-1000 R/min for 70 minutes to make the solution foam freely to 2.0-2.5 times the original volume. Add 8ml of sulfuric acid with a mass fraction of 50%, and continue stirring at high speed for 20min. Then add 10 ml of formaldehyde with a mass fraction of 36%, and stir at high speed for 20 min. Cool down to 4°C, add 5ml of 0.25% glutaraldehyde solution, stir at high speed for 10 minutes, immediately inject the foam into the mold, put it in an oven, and cure it at a constant temperature of 55-60°C for 6 hours, take out the molded foam, and wash off the untreated foam. The reacted formaldehyde, glutaraldehyde and sulfuric acid were washed in water until neutral and no foam was produced during rinsing, and the foam was freeze-dried for 24 hours to obtain polyvinyl alcohol/chitosan composite foam (PVA-CS foam).

基于上述科研成果，本实用新型的技术方案是：Based on above-mentioned scientific research achievement, the technical scheme of the utility model is:

一种负压引流护创装置，包括医用泡沫和导流管，导流管的一端插入医用泡沫中，并且插在医用泡沫的管壁上布有小孔，所述的医用泡沫采用聚乙烯醇/壳聚糖复合泡沫材料。A negative pressure drainage and wound protection device, including medical foam and a guide tube, one end of the guide tube is inserted into the medical foam, and small holes are inserted on the tube wall of the medical foam, and the medical foam is made of polyvinyl alcohol / Chitosan composite foam.

进一步地优选，Further preferably,

所述医用泡沫的孔隙率为70%～85%，孔径为0.2～1.0mm。The porosity of the medical foam is 70%-85%, and the pore diameter is 0.2-1.0mm.

所述管壁上的小孔孔径为0.7～2.0mm。The diameter of the small holes on the tube wall is 0.7-2.0 mm.

所述的引流管采用较好强度的硬塑胶管。The drainage tube adopts a hard plastic tube with good strength.

所述医用泡沫的厚度为8.0～14.0mm。The thickness of the medical foam is 8.0-14.0mm.

所述导流管的管径为3.0～7.0mm。The diameter of the guide tube is 3.0-7.0 mm.

为弥补现有负压引流护创装置无明显生物活性、炎性创面容易堵管等不足，本实用新型采用聚乙烯醇/壳聚糖复合泡沫材料。在材料中复合生物活性物质壳聚糖，除具备原有的功能特性外，还同时具有壳聚糖及其衍生物的抑制微生物生长、促进创面愈合、止血、止痛等多种生物功效。In order to make up for the lack of obvious biological activity of existing negative pressure drainage and wound protection devices, and the easy blockage of inflammatory wounds, the utility model adopts polyvinyl alcohol/chitosan composite foam material. The bioactive substance chitosan is compounded in the material. In addition to the original functional properties, it also has various biological functions such as inhibiting microbial growth, promoting wound healing, hemostasis, and pain relief of chitosan and its derivatives.

附图说明Description of drawings

图1 负压引流护创装置的结构示意图Figure 1 Schematic diagram of the structure of the negative pressure drainage wound protection device

其中1-聚乙烯醇/壳聚糖复合泡沫，2-导流管，3-小孔Among them 1-polyvinyl alcohol/chitosan composite foam, 2-drain tube, 3-small hole

具体实施方式Detailed ways

本实用新型公开了一种负压引流护创装置，包括医用泡沫1和导流管2，导流管2的一端插入医用泡沫1中，并且插在医用泡沫的管壁上布有小孔3，所述的医用泡沫采用聚乙烯醇/壳聚糖复合泡沫材料。The utility model discloses a negative pressure drainage and wound protection device, which comprises amedical foam 1 and adiversion tube 2, one end of thediversion tube 2 is inserted into themedical foam 1, andsmall holes 3 are arranged on the tube wall of the medical foam , the medical foam adopts polyvinyl alcohol/chitosan composite foam material.

临床使用时，将本实用新型的负压引流护创装置贴于创面之上，使泡沫材料1成为引流管2和被引流腔隙或创面之间的中介，再用具有生物阀功能的半透性粘贴薄膜封闭被引流区，使之与外界隔绝。导流管2接通外部负压源，外部负压源可以采用中央负压源或电动吸引器，形成一个高效引流系统，及时地清除被引流区的渗出物。所述医用泡沫的厚度为8.0～14.0mm。所述导流管的管径为3.0～7.0mm。In clinical use, the negative pressure drainage wound protection device of the present utility model is pasted on the wound surface, so that thefoam material 1 becomes an intermediary between thedrainage tube 2 and the drained cavity or the wound surface, and then the semi-permeable device with the function of a biological valve is used to The adhesive film seals the drained area and isolates it from the outside world. Thediversion tube 2 is connected to an external negative pressure source, and the external negative pressure source can use a central negative pressure source or an electric suction device to form an efficient drainage system to timely remove the exudate in the drained area. The thickness of the medical foam is 8.0-14.0mm. The diameter of the guide tube is 3.0-7.0 mm.

为了得到好的引流效果，所述医用泡沫的孔隙率为70%～85%，孔径为0.2～1.0mm。所述插在医用泡沫的管壁上的小孔孔径为0.7～2.0mm。In order to obtain a good drainage effect, the porosity of the medical foam is 70%-85%, and the pore diameter is 0.2-1.0 mm. The diameter of the small hole inserted on the pipe wall of the medical foam is 0.7-2.0mm.

为了便于和外部负压源连接，所述引流管应具有可弯曲性。为了在负压过程中，保持管道通畅，导流管还要有一定的强度。所述的引流管可采用较好强度的硬塑胶管。In order to facilitate connection with an external negative pressure source, the drainage tube should be bendable. In order to keep the pipeline unobstructed during the negative pressure process, the draft tube must have a certain strength. The drainage tube can adopt a hard plastic tube with better strength.

本实用新型主要应用于临床治疗皮肤软组织缺损、体表脓肿和感染、开放性骨折可能合并感染者、烧伤或化学烧伤或电击伤创面、糖尿病性褥疮、压迫性溃疡、骨筋膜室综合征等。The utility model is mainly used in the clinical treatment of skin and soft tissue defects, body surface abscess and infection, open fractures that may be co-infected, burns or chemical burns or electric trauma wounds, diabetic bedsores, compressive ulcers, osteofascial compartment syndrome, etc. .

Claims (5)

1. a negative pressure drainage protects the wound device, comprise medical foam (1) and mozzle (2), one end of mozzle (2) inserts in the medical foam (1), and be inserted on the tube wall of medical foam (1) and be furnished with aperture (3), it is characterized in that: described medical foam adopts polyvinyl alcohol/chitosan composite foam material.

2. negative pressure drainage as claimed in claim 1 protects the wound device, it is characterized in that, the porosity of described medical foam is 70%～85%, and the aperture is 0.2～1.0mm.

3. negative pressure drainage as claimed in claim 1 or 2 protects the wound device, it is characterized in that, the aperture on the described tube wall (3) aperture is 0.7～2.0mm.

4. negative pressure drainage as claimed in claim 1 or 2 protects the wound device, it is characterized in that, the thickness of described medical foam is 8.0～14.0mm.

5. negative pressure drainage as claimed in claim 1 or 2 protects the wound device, it is characterized in that, the caliber of described mozzle is 3.0～7.0mm.

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