WO2015010445A1 - 一次性便携式负压创面疤痕治疗*** - Google Patents
一次性便携式负压创面疤痕治疗*** Download PDFInfo
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- WO2015010445A1 WO2015010445A1 PCT/CN2014/000698 CN2014000698W WO2015010445A1 WO 2015010445 A1 WO2015010445 A1 WO 2015010445A1 CN 2014000698 W CN2014000698 W CN 2014000698W WO 2015010445 A1 WO2015010445 A1 WO 2015010445A1
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- Prior art keywords
- negative pressure
- micro
- dressing
- layer
- negative
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Classifications
-
- 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
- A61F13/05—Bandages or dressings; Absorbent pads specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
- A61M1/96—Suction control thereof
- A61M1/962—Suction control thereof having pumping means on the suction site, e.g. miniature pump on dressing or dressing capable of exerting suction
Definitions
- the invention belongs to the technical field of medical instruments, and particularly relates to a disposable portable negative pressure wound scar treatment system suitable for use in wound patients. Background technique
- Negative Pressure Wound Therapy was initiated by Fleischmann of the Department of Trauma Surgery, ULM University, Germany.
- the report of Argenta and Morykwas in 1997 provided experimental and clinical evidence for NPWT, which greatly promoted Clinical application of basic research in NPWT. It is widely used in various types of acute and chronic wounds in departments such as trauma surgery, orthopedics, general surgery, and burns, and has achieved good results.
- NPWT technology has been included in the treatment guidelines for wounds in countries such as Germany and Austria.
- NPWT uses special medical dressing to seal the wound surface, significantly reducing cross-infection; through continuous vacuum suction, the wound will be The secretions are cleared in time, the drainage is smooth, and some necrotic tissues and bacteria remaining on the wound surface can be sucked out, the medium for reducing bacterial growth is automatically generated, and a wound debridement process is automatically generated; the closed environment and the continuous negative Pressure suction, so that the wound forms a continuous hypoxic or relatively hypoxic microenvironment, thereby inhibiting the growth of pathogenic microorganisms, and at the same time reducing the oxygen tension around the wound, triggering the activation of the repair signal, and promoting the body fibrinolytic activator And the release of other enzymes, forming an environment that accelerates fibrinolysis, fibrinolysis occurs in the wound surface, and autolytic debridement is performed to provide basic conditions for wound healing.
- NPWT is beneficial to maintain cell viability while facilitating wound blood perfusion and granulation tissue growth, keeping wounds moist. , initiates the expression of the repair gene and promotes the release of its products (eg, growth factors and functional enzymes).
- the basement membrane induces capillary endothelial cells to proliferate into the three-dimensional collagen matrix, forming a capillary lumen structure, promoting wound capillary rejuvenation, and providing good conditions for the growth of granulation tissue.
- the manufacturers of closed negative pressure drainage in the world mainly include the British Xerox Company.
- NPWT dressing is mainly medical foam, which is a foam-type synthetic material with polyvinyl alcohol (polyvinyl alcohol). PVA); Another foam similar to the polyethylene alcohol hydrated seaweed salt foam.
- the dressing has a white sponge shape, and is densely covered with a large number of voids having a diameter of 0.2 to 1 mm, which has excellent plasticity, water permeability and good biocompatibility; non-toxic, non-irritating to local tissues ; No immunological activity.
- Bio-permeable membrane A transparent film with unidirectional venting function produced by Smith & Nephew, UK. The main components are polyurethane and propylene, and a 3M transparent film produced by 3M Company of the United States. 3.
- Straight or three-way joint Connect between the drains. 4.
- Negative pressure drainage device The negative pressure source can use the NPWT special suction machine, the bed center negative pressure device or alternately use the ordinary electric suction machine. The negative pressure source needs to be connected to the liquid collection tank to collect the liquid leakage collected from the wound surface.
- NPWT has a wide range of applications and has achieved good results, there are still obvious shortcomings in the NPWT system on the market.
- the main disadvantages are as follows: 1.
- the NPWT dressing itself does not actively promote or regulate wound healing.
- the regulation of the wound surface mainly depends on the action of negative pressure and mechanical traction.
- the dressing itself does not have the component to regulate the growth of the wound; 2.
- the vacuum suction device of the NPWT system is large in volume, and the liquid collecting tank is required to collect the wound surface. Restrict patients to stay in bed for a long time, unable to move freely, unable to self-care in the family, affecting the normal work and life of high-end people; 3.
- the vacuum suction device of NPWT system needs external power supply, and can not provide negative pressure for a long time after leaving the power supply. Patients have to stay in bed for a long time, unable to freely move and internal self-care, an important limiting factor affecting quality of life.
- a large area of the skin caused by burns or trauma is often damaged, and scars often appear on the surface of the skin.
- the pain, itching, and burning sensation caused by scar hyperplasia plague the patient.
- Scar hyperplasia even affects the patient's appearance, causing pain to the patient in psychological and physiological aspects, and severely losing the confidence of returning to the family and society.
- pressure therapy and silicone therapy are the main adjuvant treatments for surgery, and they are also the main conservative treatments.
- the pressure therapy mainly adopts a elastic sleeve method to pressurize the site where the scar is located.
- Silica gel therapy is mainly to put a commercial self-adhesive silicone patch on the scar to achieve therapeutic effect.
- Silicone therapy and pressure therapy often play a better therapeutic role.
- the pressure therapy based on elastic sleeves has obvious defects, including the inability to precisely control the pressure, causing annular compression on the limbs, numbness of limb ischemia, long-term wear and loss of elasticity, and poor fixation of the trunk. Therefore, designing an NPWT dressing itself with NPWT system that promotes granulation growth and ultra-portability is the future direction of NPWT technology; further, designing a portable scar that can accurately control pressure and easily perform pressure treatment in any part of the body. A pressure therapy system is very necessary.
- the medium-sized negative pressure host is small and portable, which can reduce the cumbersome weight of the traditional NPWT system, requires a fixed power supply, and seriously affects the quality of life of the patient; it also reduces the patient's pain and the workload of the medical staff.
- Another object of the present invention is to provide the use of the above-described disposable portable negative pressure wound scar treatment system in the treatment of scars.
- the present invention provides a disposable portable negative pressure wound scar treatment system, which is composed of a multilayer dressing, a negative pressure catheter, a negative pressure catheter suction cup and a micro negative pressure host, and the multilayer dressing is composed of a semipermeable membrane.
- the micro negative pressure main body is mainly a miniature negative pressure pump, and also includes a micro negative pressure pump control circuit board, a miniature negative pressure pump switch, and a miniature negative pressure
- the multi-layer dressing is connected to the negative pressure conduit through a negative pressure conduit suction cup, and the negative pressure conduit is connected to the negative pressure conduit joint of the micro negative pressure host.
- the miniature negative pressure host is composed of a casing, a miniature negative pressure pump in the casing and a micro negative pressure pump control circuit board.
- the miniature vacuum mainframe can provide a fixed 80-120mmHg negative pressure based on the pre-set of the control board.
- the miniature negative pressure pump switch is on the outer casing, preferably a circular switch button, which can be turned on or off by pressing the micro negative pressure pump.
- the micro negative pressure pump battery compartment can be located on the side wall of the outer casing, and the optimal built-in 2 section 5
- the battery or 2-6 button batteries provide 1-10 days of power for the miniature vacuum pump.
- the negative pressure conduit joint may be located on the side wall of the outer casing, preferably having an outer diameter of 0.5-0.8 cm, and one end is connected to a miniature negative pressure pump in the outer casing.
- the outer casing of the miniature negative pressure host is preferably a 1.5*6*6cm square casing.
- the multi-layer dressings can be designed into different sizes according to clinical needs, and preferably, according to the direction fixed on the body surface, from the outside to the inside:
- Semi-permeable membrane moisture permeability of more than 1000 (g / m 2 / 24h) ;
- the material is mesh hydrophobic gauze, the mesh diameter is 0.2-0.5mm ;
- An absorbent layer composed of fluff pulp and polymer composite absorbent paper containing superabsorbent resin (SAP). The function is that the wound exudate reaches a gelatinous solid after reaching the absorbent layer;
- Hydrophobic mesh foam layer This layer is made of medical polyethylene or other similar medical grade hydrophobic material. It has a thickness of 2-5mm. It has a sponge-like appearance and a certain elasticity. It is densely covered with a large number of 0.2 ⁇ 2 mm in diameter. The voids can maintain gap communication under the negative pressure of 120mmHg, have excellent water permeability and good biocompatibility; non-toxic, non-irritating to local tissues; no immunological activity; wounds through the passage of wound exudate The permeate is conducted to the absorbing layer.
- Film dressing A single-layer mesh silicone gel coated film dressing or a single-layer mesh carboxymethyl cellulose sodium film dressing can be used to directly contact the wound surface, and the function is to promote wound healing.
- the area of the film dressing is larger than the other layers to attach the multilayer dressing to the wound and wound.
- the central portion or one side of the multilayer dressing has a circular three-dimensional defect; the circular three-dimensional defect penetrates through the layers of the multilayer dressing, and the circular three-dimensional defect communicates with the suction tube of the negative pressure conduit to facilitate the passage of the negative pressure.
- Negative pressure conduit suction cup which is a single-hole suction-type drainage tube interface that can be connected to a negative pressure conduit.
- the negative pressure conduit has an inner diameter of 0.5-0.8 cm, and has a length of 0.2-1 m depending on the fixing portion, and the other end is connected to a negative pressure conduit joint on the miniature negative pressure host.
- the present invention is also provided with a clear silicone coated film tape for sealing the entire dressing to adhere the periphery of the multilayer dressing of the present invention to normal skin.
- the wound wound is debrided, the film dressing in the multilayer dressing is attached to the wound surface, and the negative pressure conduit is connected to the negative pressure pipe joint on the miniature negative pressure host, and the miniature vacuum pump switch is placed under the arm. , providing 80-120mmHg.
- the new dressing is sealed and fixed by using a transparent silicone coated film tape as a resealing fixing tool, which is convenient for the negative pressure wound treatment.
- the dressing can be vacuumed with a syringe and the negative pressure conduit sealed to maintain proper functioning of the system.
- the present invention revolutionizes the existing NPWT system, unidirectionally absorbs the wound exudate without the need for a reservoir, and the single layer mesh silicone gel coated film dressing or single layer mesh carboxymethyl cellulose of the film dressing
- the sodium film dressing is in direct contact with the wound, and at the same time has the effect of adhering to the skin and promoting wound healing.
- the negative pressure conduit material used in the present invention may be medical grade polyvinyl chloride (PVC) or polycarbonate (PC) to ensure that the conduit is flame retardant, acid and alkali resistant, antimicrobial, abrasion resistant and suitably resilient.
- PVC polyvinyl chloride
- PC polycarbonate
- the present invention provides the use of the above disposable disposable negative pressure wound scar treatment system in the treatment of scars.
- the invention relates to the application of the disposable portable negative pressure wound scar treatment system in the treatment of scars, wherein the multilayer dressing is a semipermeable membrane, a hydrophobic mesh foam layer and a film dressing, and the film dressing is a single layer self-adhesive silicon. Gel dressing.
- the single-layer self-adhesive silicone gel dressing may be selected from the self-adhesive silica gel sheet of Xerox Co., Ltd., and the multi-layer dressing is sealed with a transparent silicone coated film tape to make the invention more The layer dressing adheres completely and sealingly to the skin.
- the single-layer self-adhesive silicone gel dressing surface is in contact with the scar, and the semi-permeable film is closely adhered to the skin around the scar, and if necessary, the transparent silicone coated film tape is sealed around the semi-permeable membrane, and is guided by the negative pressure conduit. From the negative pressure of the micro-negative pressure host, the multi-layer dressing is fixed on the wound surface, and the pressure + silica gel is used to treat the scar.
- the invention is a disposable portable negative pressure wound scar treatment system suitable for wound patients, and the negative pressure wound treatment technology (NPWT) dressing in the treatment set itself has the function of promoting granulation growth, reducing wound damage, and the treatment set is
- the negative pressure host is small and portable, which can reduce the cumbersome weight of the traditional NPWT system, requires a fixed power supply, and seriously affects the quality of life of the patient; it also reduces the patient's pain and the workload of the medical staff.
- the invention is also applicable to the treatment of negative pressure wounds in the home.
- FIG. 1 is a schematic structural view 1 of a miniature negative pressure host of the present invention
- Figure 2 is a schematic view of the structure of the miniature negative pressure host of the present invention 2;
- Figure 3 is a schematic view showing the structure of the multilayer dressing of the present invention connected to a vacuum conduit;
- Figure 4 is a schematic view showing the layered structure of the multilayer dressing of the present invention.
- Multi-layer dressing 1.1 semi-permeable membrane, 1.2 filter, 1.3 absorbent layer, 1.4 hydrophobic mesh foam layer, 1.5 film dressing; 1.6 round three-dimensional defect;
- the disposable portable negative pressure wound scar treatment system is composed of a multilayer dressing 1, a negative pressure catheter 2, a negative pressure catheter suction cup 3 and a micro negative pressure host 4, and the multilayer dressing is fixed according to In the direction of the body surface, from the outside to the inside are: semipermeable membrane 1.1, filter 1.2, absorbent layer 1.3, hydrophobic mesh foam layer 1.4, and film dressing 1.5; the micro negative pressure host is mainly miniature
- the negative pressure pump also includes a miniature negative pressure pump switch 4.1, a miniature negative pressure pump battery compartment 4.2 and a negative pressure conduit joint 4.3; the multilayer dressing is connected to the negative pressure conduit 2 through a negative pressure conduit suction cup 3, a negative pressure conduit and a miniature The negative pressure main pipe joint 4.3 of the negative pressure main is connected.
- the miniature negative pressure host is composed of a casing, a miniature negative pressure pump in the casing and a control circuit board.
- the miniature vacuum mainframe can provide a fixed 120mmHg negative pressure based on the pre-set of the control board.
- the miniature negative pressure pump can be purchased from the KPV08 series produced by Xiamen Keji Precision Equipment Co., Ltd.
- the micro-negative pump battery compartment 4.2 can be located on the side wall of the casing and has two No. 5 batteries, which provide a day-to-day power for the micro-negative pump.
- the negative pressure conduit joint 4.3 has an outer diameter of 0.5 cm, and the head is connected to a miniature negative pressure pump in the outer casing.
- the negative pressure conduit has an inner diameter of 0.5 cm and a length of 1 m, and one end and a negative pressure conduit joint Connected.
- the layers of the multilayer dressing have a size of 10 cm * 10 cm.
- Example 2 The layers of the multilayer dressing have a size of 10 cm * 10 cm.
- the disposable portable negative pressure wound scar treatment system can provide a fixed 120 mmHg negative pressure according to the preset of the control circuit board.
- the miniature negative pressure pump can be purchased from the MICRO BOXER model of the British BOXER company.
- the miniature negative pressure pump switch 4.1 is a circular switch button on the outer casing, and the micro negative pressure pump can be turned on or off by pressing.
- the micro-negative pump battery compartment 4.2 is located on the side wall of the casing, and the built-in 6 button battery provides 10 days of power for the micro-negative pump.
- the negative pressure conduit joint 4.3 is located on the side wall of the outer casing and has an outer diameter of 0.8 cm, and one end is connected to a miniature negative pressure pump in the outer casing.
- the central portion of the multilayer dressing has a circular three-dimensional defect 1.6; the circular three-dimensional defect runs through the layers of the 1.1-1.5 multilayer dressing, and the circular three-dimensional defect communicates with the negative pressure conduit suction cup 3; the negative pressure conduit suction cup 3 It is a single-hole suction-type drainage tube interface that can be connected to the negative pressure conduit 2.
- the negative pressure conduit has an inner diameter of 0.8 cm and a length of 0.8 m, and the other end is connected to a negative pressure conduit joint 4.3 on a miniature negative pressure host.
- the disposable portable negative pressure wound scar treatment system, and the other micro-pressure host described in the first embodiment, according to the preset of the control circuit board, can continuously provide a fixed negative pressure of 100 mmHg.
- the multilayer dressing 1 is in the direction of being fixed to the body surface, and is in the order from the outside to the inside: the semi-it film 1 has a moisture permeability of more than 1000 (g/m 2 /24h) and a size of 10 cm* 15 cm;
- Filter 1.2 The material is mesh hydrophobic gauze, the size is 10 cm * 15 cm, the mesh diameter is 0.5 mm;
- Absorbing layer 1.3 an absorbent layer composed of a fluff pulp containing high water-absorbent resin (SAP) and a polymer composite absorbent paper. The function is that the wound exudate reaches a gel-like solid after reaching the absorbent layer, and the size is 10 cm* 15 cm; SAP content is between 20% and 50% Hydrophobic mesh foam layer 1.4: Material is hydrophobic gauze, size 10 cm * 15 cm; film dressing 1.5: optional single-layer mesh silicone gel coated film dressing or single-layer mesh carboxymethyl cellulose sodium film dressing, Direct contact with wound wounds, the function is to promote wound healing, size 12 cm * 18 cm.
- SAP water-absorbent resin
- the multi-layered dressing has a circular three-dimensional defect 1.6 on the right side; the circular three-dimensional defect runs through
- the disposable portable negative pressure scar treatment system the remaining micro-negative pressure machine of the same embodiment 1, can provide a fixed negative pressure of 50-120 mmHg according to the preset of the control circuit board.
- the multi-layer dressing 1, according to the direction when fixed on the body surface, from the outside to the inside: semi-permeable membrane 1 ⁇ moisture permeability of more than 1000 (g / m 724h), size 20 cm * 15 cm;
- Hydrophobic mesh foam layer 1.4 Material is hydrophobic gauze, size 20 cm * 15 cm; film dressing 1.5: Single-layer self-adhesive silicone gel dressing, size 22 cm * 18 cm.
- the multilayered dressing has a circular three-dimensional defect 1.6 on the right side; the circular three-dimensional defect runs through the layers of the 1.1-1.5 multilayer dressing, and the circular three-dimensional defect communicates with the negative pressure conduit suction cup 3.
- the disposable portable negative pressure wound scar treatment system of the invention is used for debridement wound wounds in clinical use, and the film dressing 1.5 in the multilayer dressing 1 is attached to the wound surface, and the negative pressure conduit 2 is connected to the micro negative pressure host 4 On the negative pressure conduit connector 4.3, the underarm miniature vacuum pump switch 4.1 provides 80 mmHg - 120mmHg.
- Patient 1 1% TBSA deep second degree burn wound on the right forearm, debrided in the outpatient operating room, and installed the disposable portable negative pressure wound scar treatment system of Example 1 for 7 days. After the dressing was removed, the wound was clean and free of purulent Secretion, no redness and swelling in the wound, the wound is significantly reduced, for further treatment Lay a good foundation. During this treatment, the patient did not need to be hospitalized and did not significantly affect their life and work.
- Patient 2 left full leg skin defect left after a car accident in the left thigh, about 2% TBSA, after hospitalization in the operating room, the right thigh was taken after the left thigh was pulled and skin grafted, and the disposable portable negative pressure wound scar treatment system of Example 2 was installed.
- Patient 5 former torso burn patients, the front chest scar growth, higher than the skin, itching is obvious.
- the disposable portable negative pressure scar treatment system of Embodiment 4 is installed. When used, the scar is cleaned by warm water. After the surface of the scar is dried, a single layer of silicone of the new dressing is attached to the surface of the scar, and the negative pressure conduit is connected to the micro negative. On the pipe joint of the side wall of the pressure pump, the air under the semi-permeable membrane is removed, and the switch of the miniature negative pressure pump is provided to provide a negative pressure of 100 mmHg to fix the new silicone dressing on the surface of the scar.
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Abstract
一种一次性便携式负压创面疤痕治疗***，由多层敷料（1）、负压导管（2）、负压导管吸盘（3）和微型负压主机（4）组成，所述的多层敷料由半透膜（1.1）、过滤网（1.2）、吸收层（1.3）、疏水性网眼泡沫层（1.4）和薄膜敷料（1.5）组成；所述的微型负压主机（4）主要为微型负压泵，还包括微型负压泵控制电路板、微型负压泵开关（4.1）、微型负压泵电池仓（4.2）和负压导管接头（4.3）；所述的多层敷料（1）通过负压导管吸盘（3）连接负压导管（2）。所述***利于创面愈合，且负压主机（4）较小、便于携带，可随时随地进行负压创面治疗，减少了患者痛苦和医护人员的工作量。
Description
说 明 书 一次性便携式负压创面疤痕治疗*** 技术领域
本发明属于医疗器械技术领域， 具体涉及适用于伤口患者使用的一次 性便携式负压创面疤痕治疗***。 背景技术
负压创面治疗技术 (Negative Pressure Wound Therapy,简称 NPWT)技术 是由德国 ULM大学附属创伤外科医院的 Fleischmann等于 1992年首创， 1997年 Argenta和 Morykwas的报告为 NPWT提供了实验和临床依据， 大 大促进了 NPWT的基础研究的临床应用。 广泛应用于创伤外科、 骨科、 普 外科、 烧伤科等科室的各类急慢性创面， 并取得了良好的疗效。 早在 2003 年， NPWT技术就已经被德国和奥地利等国纳入创口治疗指南。
NPWT治疗创面的主要机理包括： （1)自动清创， 有效控制感染， 提供 创面愈合基本条件： NPWT利用特殊医用敷料将创面封闭， 明显减少了交 叉感染； 通过持续的负压吸引， 将创面的分泌物及时清除， 引流的通畅， 可以将存留于创面上的一些坏死组织及细菌一并自创面吸出， 减少细菌生 长的培养基， 自动产生一个创面清创过程； 密闭的环境和持续的负压吸引， 使创面形成持续的低氧或相对缺氧的微环境， 从而抑制创面病原微生物的 生长， 同时能使创面周围的氧张力下降， 剌激修复信号的启动， 促使机体 纤溶蛋白激活物及其他酶的释放， 形成加快纤维蛋白溶解的环境， 创面内 发生纤维蛋白溶解， 进行自溶性清创 ， 提供创面愈合的基本条件。（2)促进 血流灌注和肉芽组织生长， 产生一个潮湿的愈合环境： NPWT治疗的初期 所形成的缺氧环境， 促进成纤维细胞的生长及刺激血管增生， 使肉芽组织 更快生长。 （3)刺激多种相关因子和酶类的基因表达、 增殖和释放， 促进创 面再上皮化： NPWT在有利于创面血流灌注和肉芽组织生长、 保持创面湿 润的同时，也有利于保持细胞活力，启动修复基因的表达，促进其产物 (如: 生长因子和功能酶类等)释放。促进碱性成纤维细胞生长因子（bFGF)通过 加速血管内皮细胞***、 生长， 剌激内皮细胞胶原酶和纤维蛋白酶降解基
底膜， 诱导毛细血管内皮细胞向三维胶原基质中增殖， 形成毛细血管腔状 结构， 促进创面毛细血管新生， 为肉芽组织的生长提供良好条件。
目前国际上生产封闭式负压引流的厂家主要包括英国施乐辉公司
(Smith & Nephew) 和美国 KCI公司为首的十余个厂家， 国内的武汉维斯 第及山东威高公司也分别有自己的系列产品。 所有的 NPWT***主要有四 部分构成： 1. 医用泡沫 (NPWT材料)与多侧孔引流管： NPWT敷料主要为 医用泡沬， 是一种泡沫型合成材料， 成分为聚乙烯醇 (polyvinyl alcohol, PVA); 另一种泡沫材料与其相似为聚乙烯酒***化海藻盐泡沫。 该敷料外 观呈白色海绵状， 其内密布大量彼此相通的、 直径 0.2〜1 mm的空隙， 有 极好的可塑性、透水性及良好的生物相容性； 无毒， 对局部组织无剌激性； 无免疫活性。 2. 生物半透性薄膜： 一种为英国 Smith & Nephew公司生产 的具有单方向透气功能的透明薄膜， 主要成份为聚氨酯和丙烯， 一种为美 国 3M公司生产的 3M透明薄膜。 3. 直通或三通接头： 在各引流管之间起 到连接作用。 4. 负压引流装置： 负压源可使用 NPWT专用吸引机、 床头 中心负压装置或交替使用普通电动吸引机， 该负压源需要连接集液罐收集 从创面收集的渗液。
尽管 NPWT有较广的应用领域， 也取得了不俗的治疗效果， 但是目前 市场上的 NPWT***仍有明显的缺点，'主要缺点如下： 1. NPWT敷料本 身没有主动促进或者调节创面愈合的作用， 对创面的调节作用主要依靠负 压作用及机械牵引力的作用， 敷料本身不具有的调节创面生长的成分； 2. NPWT***的负压吸引器体积较大， 且需要集液罐收集创面渗液， 限 制患者要长期卧床， 无法自由活动， 无法于家庭内自我护理， 影响高端人 群的正常工作和生活； 3. NPWT***的负压吸引器需要外接电源， 脱离电 源后无法长期提供负压， 也是患者要长期卧床， 无法自由活动及内自我护 理， 影响生活质量的重要限制因素。
烧伤或是外伤造成的皮肤较大的面积受损， 常常会在皮肤表面产生疤 痕。 疤痕增生所致的疼痛、 瘙痒、 灼热感困扰着患者， 疤痕增生甚至影响 患者容貌， 在心理及生理方面给患者带来痛苦， 重度患者甚至丧失重返家 庭和社会的信心。 目前国际上关于疤痕的治疗方法较多， 除手术治疗以外， 压力疗法和硅胶疗法是手术的主要辅助治疗方法， 也是主要的保守疗法。 目前压力疗法主要采取弹力套的方法， 对疤痕所在的部位进行加压治疗。
硅胶疗法主要是将商业化的自粘性硅胶贴片， 置于疤痕之上， 达到治疗作 用。 硅胶疗法与压力疗法合用常起到更好的治疗作用。 目前以弹力套为主 的压力疗法有明显缺陷， 包括无法精确控制压力， 对肢体造成环形压迫， 易造成肢体缺血麻木， 长期佩戴易失去弹性， 对躯干部位固定不良等。 因 此,设计一种 NPWT敷料本身具有促进肉芽生长及超便携性的 NPWT*** 是 NPWT技术未来的发展方向； 进一步地， 设计一种便携式、 能够精确控 制压力、 容易在身体任何部位实施压力治疗的疤痕压力治疗***是非常必 要的。
而目前国内外尚无文献报道具备以上功能的一次性便携式负压伤口 (疤痕） 治疗***。 发明内容
本发明的目的是提供一种适用于伤口患者使用的一次性便携式负压创 面疤痕治疗***， 该治疗套装中的负压创面治疗技术 （NPWT) 敷料本身 具有促进肉芽生长的功能， 而且该治疗套装中的负压主机较小、便于携带， 能够减少传统 NPWT***的笨重、 需要固定电源、 严重影响患者生活质量 的缺陷； 也减少了患者痛苦和医护人员的工作量。 本发明的另一目的在于 提供上述一次性便携式负压创面疤痕治疗***在疤痕治疗中的应用。
为解决上述技术问题， 本发明提供了一次性便携式负压创面疤痕治疗 ***， 由多层敷料、 负压导管、 负压导管吸盘和微型负压主机组成， 所述 的多层敷料由半透膜、 过滤网、 吸收层、 疏水性网眼泡沫层和薄膜敷料组 成； 所述的微型负压主机主要为微型负压泵， 还包括微型负压泵控制电路 板、 微型负压泵开关、 微型负压泵电池仓和负压导管接头； 所述的多层敷 料通过负压导管吸盘连接负压导管， 负压导管与微型负压主机的负压导管 接头相连。 ：
所述的微型负压主机由外壳、 外壳内的微型负压泵及微型负压泵控制 电路板组成。 该微型负压主机根据控制电路板的预设置， 可持续提供固定 的 80-120mmHg负压。
所述的微型负压泵开关在外壳上， 较优的为圆形开关按钮， 可以通过 按触打开或者关闭微型负压泵。
所述的微型负压泵电池仓可位于外壳侧壁上， 较优的可内置 2节 5号
电池或者 2-6个纽扣电池为微型负压泵提供 1-10天的电量。
所述的负压导管接头可位于外壳侧壁上， 较优的外直径 0.5-0.8cm， 一 头与外壳内的微型负压泵相连接。
所述的微型负压主机的外壳较优的为 1.5*6*6cm大小方形外壳。
所述的多层敷料可根据临床需要设计成不同的规格大小， 较优的， 按 照固定于体表时的方向， 由外向内依次为：
半透膜： 潮气通透率达到 1000以上 (g/m2/24h);
过滤网： 材质为网眼疏水性纱布， 网眼直径 0.2-0.5mm;
吸收层. · 为含有高吸水性树脂 (SAP)的绒毛浆、 高分子复合吸水纸构成 的吸收层， 功能是伤口渗液到达该吸收层后被变成胶冻状固体；
疏水性网眼泡沫层： 该层材质为医用聚乙烯或其他类似医疗级疏水材 料， 厚度为 2-5mm， 外观呈海绵状， 有一定弹性， 其内密布大量彼此相通 的、 直径 0.2〜2 mm的空隙， 在 120mmHg负压下仍能保持空隙相通， 有 极好的透水性及良好的生物相容性； 无毒， 对局部组织无刺激性； 无免疫 活性； 作为伤口渗液的通过通道将创面渗液传导至吸收层。
薄膜敷料： 可选用单层网眼硅凝胶涂层薄膜敷料或单层网眼羧甲基纤 维素钠薄膜敷料， 直接与伤口创面接触， 功能是促进伤口愈合作用。
最优的， 其中薄膜敷料的面积较其他几层都大， 以便将多层敷料贴附 于伤口和创面。
所述的多层敷料中央部分或者一侧有圆形立体缺损； 该圆形立体缺损 贯穿多层敷料的各层， 该圆形立体缺损与负压导管吸盘相通， 便于负压通 过。 负压导管吸盘， 该负压导管吸盘为单孔的吸盘式引流管接口， 可与负 压导管连接。 所述的负压导管内直径为 0.5-0.8cm， 依据固定部位不同， 长 度为 0.2-1米， 另一端连接于微型负压主机上的负压导管接头。
另外， 本发明还配备用于密封整个敷料的透明硅胶涂层薄膜胶带， 以 便将本发明的多层敷料周围粘附与正常皮肤上。
本发明在临床使用时， 伤口创面清创， 将多层敷料中的薄膜敷料贴附 创面， 将其负压导管连接于微型负压主机上的负压导管接头上， 摁下微型 负压泵开关， 提供 80-120mmHg。 另外， 当将多层敷料固定于创面同时， 使用透明硅胶涂层薄膜胶带作为再次密封固定工具对新型敷料进行密封及 固定， 这样便于行负压创面治疗术。
在负压泵无电时， 可以用注射器将敷料抽成真空， 并将负压导管密封， 保持该***正常功能。
本发明革命性地更改了现存的 NPWT***， 不需要储液罐即可将创面 渗液单向吸收， 并且薄膜敷料的单层网眼硅凝胶涂层薄膜敷料或单层网眼 羧甲基纤维素钠薄膜敷料与创面直接接触， 同时具有粘附皮肤及促进创面 愈合作用。
本发明所采用的负压导管材料可以为医用级聚氯乙烯 （PVC) 或聚碳 酸酯（PC), 以保证该导管难燃、 耐酸碱、抗微生物、 耐磨并具有适当的弹 性。
进一步地， 本发明提供了上述一次性便携式负压创面疤痕治疗***在 疤痕治疗中的应用。
本发明的一次性便携式负压创面疤痕治疗***在疤痕治疗中的应用， 所述的多层敷料为半透膜、 疏水性网眼泡沫层和薄膜敷料， 所述的薄膜敷 料为单层自粘性硅凝胶敷料。
所述的单层自粘性硅凝胶敷料， 可选自施乐辉公司的自粘性硅胶片产 较优的， 所述的多层敷料外周密封有透明硅胶涂层薄膜胶带， 以便将 本发明的多层敷料全部地、 密封地粘附在皮肤上。
本发明在使用时， 将单层自粘性硅凝胶敷料面与疤痕接触， 半透膜与 疤痕周围皮肤紧贴， 必要时透明硅胶涂层薄膜胶带密封半透膜周围， 依靠 负压导管传导的来自于微型负压主机的负压， 将多层敷料固定于创面， 起 到压力 +硅胶治疗疤痕的目的。
本发明是适用于伤口患者使用的一次性便携式负压创面疤痕治疗系 统， 该治疗套装中的负压创面治疗技术 （NPWT) 敷料本身真有促进肉芽 生长的功能， 减少创面损伤， 而且该治疗套装中的负压主机较小、 便于携 带， 能够减少传统 NPWT***的笨重、 需要固定电源、 严重影响患者生活 质量的缺陷； 也减少了患者痛苦和医护人员的工作量。 本发明也可用于家 庭负压创面治疗。 附图说明
图 1是本发明的微型负压主机的结构示意图 1 ;
图 2是本发明的微型负压主机的结构示意图 2;
图 3是本发明的多层敷料与负压导管相连的结构示意图；
图 4是本发明的多层敷料的分层结构示意图；
附图标记说明：
1 多层敷料： 1.1半透膜， 1.2过滤网， 1.3吸收层， 1.4疏水性网眼泡 沫层， 1.5薄膜敷料； 1.6圆形立体缺损；
2负压导管；
3负压导管吸盘；
4微型负压主机： 4.1微型负压泵开关； 42微型负压泵电池仓； 4.3负 压导管接头。 具体实施方式
下面结合附图和实施例对本发明作进一步详细说明， 但本发明的实施 不仅限于此。
实施例 1 :
如图 1-4所示， 一次性便携式负压创面疤痕治疗***， 由多层敷料 1、 负压导管 2、 负压导管吸盘 3和微型负压主机 4组成， 所述的多层敷料按 照固定于体表时的方向， 由外向内依次为： 半透膜 1.1、 过滤网 1.2、 吸收 层 1.3、 疏水性网眼泡沬层 1.4、 和薄膜敷料 1.5组成； 所述的微型负压主 机主要为微型负压泵， 还包括微型负压泵开关 4.1、 微型负压泵电池仓 4.2 和负压导管接头 4.3 ;所述的多层敷料通过负压导管吸盘 3连接负压导管 2， 负压导管与微型负压主^ I的负压导管接头 4.3相连。
所述的微型负压主机由外壳、外壳内的微型负压泵及控制电路板组成。 该微型负压主机根据控制电路板的预设置， 可持续提供固定的 120mmHg 负压。
所述微型负压泵可购自厦门科际精密器材有限公司生产的 KPV08 系 列。
所述的微型负压泵电池仓 4.2可位于外壳侧壁上， 内置 2节 5号电池， 为微型负压泵提供 Ί天的电量。
所述的负压导管接头 4.3外直径 0.5cm, —头与外壳内的微型负压泵相 连接。所述的负压导管内直径为 0.5cm， 长度为 1米， 一端与负压导管接头
相连。
所述的多层敷料各层的大小为 10厘米 * 10厘米。 实施例 2:
一次性便携式负压创面疤痕治疗***，其余同实施例 1，所述的微型负 压主机根据控制电路板的预设置， 可持续提供固定的 120mmHg负压。
所述的微型负压泵可购买自英国 BOXER公司的 MICRO BOXER型 号。
所述的微型负压泵开关 4.1在外壳上，为圆形开关按钮，可以通过按触 打开或者关闭微型负压泵。
所述的微型负压泵电池仓 4.2位于外壳侧壁上，内置 6个纽扣电池为微 型负压泵提供 10天的电量。
所述的负压导管接头 4.3位于外壳侧壁上， 外直径 0.8cm， 一头与外壳 内的微型负压泵相连接。
所述的多层敷料中央部分有一个圆形立体缺损 1.6;该圆形立体缺损贯 穿 1.1-1.5多层敷料的各层， 该圆形立体缺损与负压导管吸盘 3相通； 负压 导管吸盘 3为单孔的吸盘式引流管接口， 可与负压导管 2连接。 所述的负 压导管内直径为 0.8cm， 长度为 0.8米， 另一端连接于微型负压主机上的负 压导管接头 4.3。 实施例 3:
一次性便携式负压创面疤痕治疗***，其余同实施例 1，所述的微型负 压主机根据控制电路板的预设置， 可持续提供固定的 lOOmmHg负压。
所述的多层敷料 1， 按照固定于体表时的方向， 由外向内依次为： 半 it膜 1丄 潮气通透率达到 1000以上 (g/m2/24h)， 尺寸为 10厘米 * 15 厘米；
过滤网 1.2: 材质为网眼疏水性纱布，尺寸为 10厘米 * 15厘米， 网眼直 径 0.5mm;
吸收层 1.3 : 为含有高吸水性树脂 (SAP)的绒毛浆、 高分子复合吸水纸 构成的吸收层， 功能是伤口渗液到达该吸收层后被变成胶冻状固体， 尺寸 为 10厘米 *15厘米； SAP的含量在 20%-50%之间
疏水性网眼泡沫层 1.4: 材质为疏水性纱布， 尺寸为 10厘米 *15厘米； 薄膜敷料 1.5:可选用单层网眼硅凝胶涂层薄膜敷料或单层网眼羧甲基 纤维素钠薄膜敷料， 直接与伤口创面接触， 功能是促进伤口愈合作用， 尺 寸为 12厘米 * 18厘米。
所述的多层敷料靠右侧有一个圆形立体缺损 1.6;该圆形立体缺损贯穿
1.1-1.5多层敷料的各层， 该圆形立体缺损与负压导管吸盘 3相通。 实施例 4:
一次性便携式负压疤痕治疗***，其余同实施例 1，所述的微型负压主 机根据控制电路板的预设置， 可持续提供固定的 50-120mmHg负压。
所述的多层敷料 1， 按照固定于体表时的方向， 由外向内依次为： 半透膜 1丄 潮气通透率达到 1000以上 (g/m724h)， 尺寸为 20厘米 * 15 厘米；
疏水性网眼泡沬层 1.4: 材质为疏水性纱布， 尺寸为 20厘米 * 15厘米； 薄膜敷料 1.5: 为单层自粘性硅凝胶敷料， 尺寸为 22厘米 *18厘米。 所述的多层敷料靠右侧有一个圆形立体缺损 1.6;该圆形立体缺损贯穿 1.1-1.5多层敷料的各层， 该圆形立体缺损与负压导管吸盘 3相通。 实施例 5:
本发明的一次性便携式负压创面疤痕治疗***， 临床使用时， 伤口创 面清创，将多层敷料 1中的薄膜敷料 1.5贴附创面，将其负压导管 2连接于 微型负压主机 4上的负压导管接头 4.3上， 摁下微型负压泵开关 4.1， 提供 80 mmHg— 120mmHg。
另外， 当将多层敷料 1固定于创面同时， 使用透明硅胶涂层薄膜胶带 作为再次密封固定工具对新型敷料进行密封及固定， 这样便于行负压创面 治疗术。 实施例 6:
本发明的临床使用实施：
患者 1， 右前臂 1% TBSA深二度烫伤创面， 经在门诊手术室清创、 安 装实施例 1的一次性便携式负压创面疤痕治疗***， 治疗 7天， 清除套装 后， 创面清洁无脓性分泌物， 创周无红肿， 创面明显缩小， 为进一步治疗
打下良好基础。 在此治疗期间患者不需住院， 未明显影响生活和工作。 患者 2， 左大腿车祸后遗留全层皮肤缺损， 约 2%TBSA， 经住院在手 术室行右大腿取皮左大腿拉网植皮术后， 安装实施例 2的一次性便携式负 压创面疤痕治疗***， 3天后出院，术后 7天清除套装后，创面清洁无脓性 分泌物， 创周无红肿， 左大腿网状皮成活良好。 在此治疗期间患者早期出 院， 在家休养， 并可以适当处理工作， 减少了住院费用， 未明显影响工作。
患者 3， 右手背外伤致全层皮肤缺损， 约 0.5%TBSA， 经门诊在手术室 行清创术后， 安装实施例 3的一次性便携式负压创面疤痕治疗***， 无需 住院， 术后 7天清除套装后， 创面清洁无脓性分泌物， 创周无红肿， 右手 背创面基本愈合。 在此治疗期间患者不需住院， 减少了医疗费用， 未明显 影响生活和工作。
患者 4， 臀部刀伤后遗留全层皮肤缺损， 约 2%TBSA， 经久不愈， 经 住院在手术室行右大腿取皮臀部邮票植皮术后， 安装实施例 3的一次性便 携式负压创面疤痕治疗***， 3天后出院， 术后 7天清除套装后， 创面清洁 无脓性分泌物， 创周无红肿， 臀部邮票皮成活良好。 在此治疗期间患者早 期出院， 在家休养， 并可以适当处理工作， 减少了住院费用， 未明显影响 工作。
患者 5， 前躯干烧伤病人， 前胸部疤痕生长， 高出皮面， 痛痒明显。 安 装实施例 4的一次性便携式负压疤痕治疗***， 使用时， 温水清洁疤痕， 待疤痕表面晾干后， 将新型敷料的单层硅酮贴附疤痕表面， 将其负压导管 连接于微型负压泵侧壁的导管接头上， 排除半透膜下空气， 摁下微型负压 泵的开关， 提供 lOOmmHg负压， 将新型硅酮敷料固定于疤痕表面。
以上已对本发明创造的较佳实施例进行了具体说明， 但本发明创造并 不限于所述实施例， 熟悉本领域的技术人员在不违背本发明创造精神的前 提下还可作出种种的等同的变型或替换， 这些等同的变型或替换均包含在 本申请权利要求所限定的范围内。
Claims
1、 一次性便携式负压创面疤痕治疗***， 其特征在于， 该套装是由多层敷 料 （1 )、 负压导管 （2)、 负压导管吸盘 （3 ) 和微型负压主机 （4 ) 组成， 所述的多层敷料由半透膜 （1.1 )、 过滤网 （1.2)、 吸收层 （1.3 )、 疏水性网 眼泡沬层（1.4)和薄膜敷料（1.5 )组成； 所述的微型负压主机主要为微型 负压泵， 还包括微型负压泵控制电路板、 微型负压泵开关 （4.1 )、 微型负 压泵电池仓（4.2)和负压导管接头（4.3 ) ; 所述的多层敷料（1 )通过负压 导管吸盘（3 )连接负压导管（2)， 负压导管与微型负压主机的负压导管接 头 （4.3 )相连。
2、根据权利要求 1所述的一次性便携式负压创面疤痕治疗***， 其特征在 于， 所述的微型负压主机（4) 由外壳、 外壳内的微型负压泵及微型负压泵 控制电路板组成； 该微型负压主机根据微型负压泵控制电路板的预设置， 可持续提供固定的 80-120mmHg负压。
3、根据权利要求 2所述的一次性便携式负压创面疤痕治疗***， 其特征在 于， 所述的微型负压泵开关 （4.1 ) 在外壳上， 为圆形开关按钮。
4、根据权利要求 2所述的一次性便携式负压创面疤痕治疗***， 其特征在 于， 所述的微型负压泵电池仓 （4.2) 位于外壳侧壁上， 内置 2节 5号电池 或者 2-6个纽扣电池。
5、根据权利要求 2所述的一次性便携式负压创面疤痕治疗***， 其特征在 于， 所述的负压导管接头（4.3 )位于外壳侧壁上， 外直径为 0.5-0.8cm， 一 端与外壳内的微型负压泵相连接。
6、根据权利要求 1或 2 ^lf述的一次性便携式负压创面疤痕治疗***， 其特 征在于，所述的多层敷料（1 )按照固定于体表时的方向， 由外向内依次为: 半透膜 （1.1 )、 过滤网 （1.2)、 吸收层 （1.3 )、 疏水性网眼泡沬层 （1.4)、 薄膜敷料（1.5 ); 且薄膜敷料（1.5 ) 的面积较其他几层都大。
7、根据权利要求 1或 2所述的一次性便携式负压创面疤痕治疗***， 其特 征在于， 所述的多层敷料（1 )的中央部分或者一侧有圆形立体缺损（1.6); 该圆形立体缺损贯穿多层敷料的各层，该圆形立体缺损与负压导管吸盘（3 ) 相通。
8、根据权利要求 7所述的一次性便携式负压创面疤痕治疗***， 其特征在
于， 所述的半透膜 （1.1 ) 潮气通透率达到每 24小时 1000g/m2以上； 所述的过滤网 （1.2) 材质为网眼疏水性纱布， 网眼直径 0.2-0.5mm;
所述的吸收层 （1.3 ) 由含有高吸水性树脂的绒毛浆和高分子复合吸水纸构 成；
所述的疏水性网眼泡沫层 （1.4) 由医疗级疏水材料构成， 厚度为 2-5mm， 外观呈海绵状， 内布大量彼此相通的直径为 0.2〜2 mm的空隙；
所述的薄膜敷料 （1.5 ) 为单层网眼硅凝胶涂层薄膜敷料或单层网眼羧甲基 纤维素钠薄膜敷料。
9、根据权利要求 7所述的一次性便携式负压创面疤痕治疗***， 其特征在 于， 所述的负压导管吸盘（3 )为单孔的吸盘式引流管接口， 可与负压导管
(2)连接； 所述的负压导管（2) 的内直径为 0.5-0.8cm， 长度为 0.2-1米。
10、 一种如权利要求 1至 9任一所述的一次性便携式负压创面疤痕治疗系 统在疤痕治疗中的应用。
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| CN201310314870.1A CN103394155B (zh) | 2013-07-24 | 2013-07-24 | 一次性便携式负压创面治疗*** |
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| CN104623795B (zh) * | 2015-02-03 | 2017-08-25 | 山东省立医院 | 一种创伤骨科用的外敷袋 |
| CN105497993A (zh) * | 2015-07-21 | 2016-04-20 | 龙丹 | 药线引流治疗及负压辅助愈合治疗仪 |
| CN109350174A (zh) * | 2018-12-12 | 2019-02-19 | 吴闽 | 一种检验科用止血装置 |
| CN110229752B (zh) * | 2019-06-24 | 2024-03-19 | 上海长海医院 | 一种微负压细胞培养装置 |
| CN113712735A (zh) * | 2021-11-03 | 2021-11-30 | 上海大博医疗科技有限公司 | 一种便携式创面管理敷料 |
| CN115363860A (zh) * | 2022-07-11 | 2022-11-22 | 广州华一生物科技有限公司 | 一种高吸水负压护创装置 |
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| CN201481968U (zh) * | 2009-09-03 | 2010-05-26 | 邱燕萍 | 创伤负压引流装置 |
| US20110195105A1 (en) * | 2010-02-08 | 2011-08-11 | Nanos John I | Foam Cellular Matrix Impregnated With Anti-Microbial Active Agent For Use In Negative Pressure Wound Therapy Applications And Process For Producing The Same |
| CN201664463U (zh) * | 2010-04-08 | 2010-12-08 | 上海理工大学 | 一种手持式的低功耗创面负压治疗仪 |
| CN102908719A (zh) * | 2012-09-20 | 2013-02-06 | ***广州总医院 | 一种医用可控便携式持续负压吸引装置 |
| CN103394155A (zh) * | 2013-07-24 | 2013-11-20 | 中国人民解放军第二军医大学 | 一次性便携式负压创面治疗*** |
| CN203408345U (zh) * | 2013-07-24 | 2014-01-29 | 中国人民解放军第二军医大学 | 一次性便携式负压伤口治疗套装 |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB2555584A (en) * | 2016-10-28 | 2018-05-09 | Smith & Nephew | Multi-layered wound dressing and method of manufacture |
| GB2555584B (en) * | 2016-10-28 | 2020-05-27 | Smith & Nephew | Multi-layered wound dressing and method of manufacture |
| EP3689305A1 (en) * | 2019-02-01 | 2020-08-05 | Evophancie Biotech Ltd. | Negative pressure wound dressing and negative pressure wound treatment device |
Also Published As
| Publication number | Publication date |
|---|---|
| CN103394155B (zh) | 2016-04-06 |
| CN103394155A (zh) | 2013-11-20 |
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