WO2011035464A1 - 体表创面组织负压封闭引流装置 - Google Patents

体表创面组织负压封闭引流装置 Download PDF

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Publication number
WO2011035464A1
WO2011035464A1 PCT/CN2009/074088 CN2009074088W WO2011035464A1 WO 2011035464 A1 WO2011035464 A1 WO 2011035464A1 CN 2009074088 W CN2009074088 W CN 2009074088W WO 2011035464 A1 WO2011035464 A1 WO 2011035464A1
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WO
WIPO (PCT)
Prior art keywords
drainage
negative pressure
tube
body surface
wound tissue
Prior art date
Application number
PCT/CN2009/074088
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English (en)
French (fr)
Inventor
宋九宏
Original Assignee
武汉维斯第医用科技有限公司
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Filing date
Publication date
Application filed by 武汉维斯第医用科技有限公司 filed Critical 武汉维斯第医用科技有限公司
Priority to PCT/CN2009/074088 priority Critical patent/WO2011035464A1/zh
Priority to EP09849652.4A priority patent/EP2481442B1/en
Priority to US12/840,314 priority patent/US8597265B2/en
Publication of WO2011035464A1 publication Critical patent/WO2011035464A1/zh

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Classifications

    • 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
    • A61M1/71—Suction drainage systems
    • A61M1/78—Means for preventing overflow or contamination of the pumping systems
    • A61M1/784—Means for preventing overflow or contamination of the pumping systems by filtering, sterilising or disinfecting the exhaust air, e.g. swellable filter valves
    • 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
    • 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
    • A61M1/91—Suction aspects of the dressing
    • A61M1/918—Suction aspects of the dressing for multiple suction locations
    • 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
    • A61M1/966—Suction control thereof having a pressure sensor on or near the dressing
    • 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
    • A61F2013/00361—Plasters
    • A61F2013/00365—Plasters use
    • A61F2013/00536—Plasters use for draining or irrigating wounds
    • 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
    • A61M1/71—Suction drainage systems
    • A61M1/74—Suction control

Definitions

  • the invention relates to a negative pressure closed drainage device for a body surface wound tissue. It is designed for the treatment of various body surface ulceration areas for the cause of trauma, burns, infection, oppression, endocrine disorders, vascular occlusion, radioactive irradiation, surgery, surgical complications, snake bites
  • Vacuum sealing drainage/VSD was first initiated in 1992 by Dr. Wim Fleischman of ULM University in Germany, and formed a theoretical prototype for the drainage of limbs.
  • VSD technology is applied to general surgery, which pioneered the application of VSD technology in general surgery.
  • Wang Yanfeng and Professor Hua Huade were granted the patent CN 2276350 on March 18, 1998, which is the first patent of VSD technology. Since then, VSD technology has been greatly developed in China.
  • the basic configuration of the existing VSD technology includes a negative pressure source (including a medical suction machine, a central vacuum device used in a hospital or a negative pressure drainage bottle), a drainage tube, a polyvinyl alcohol foam or other medical porous foam, a sponge or a gauze (the following tube) It is called a porous foam cushion. It can be used for sealing a breathable film for sealing (hereinafter referred to as a sealing film), a joint (including a two-way joint, a three-way joint or a multi-joint), and a drainage container.
  • a negative pressure source including a medical suction machine, a central vacuum device used in a hospital or a negative pressure drainage bottle
  • a drainage tube a polyvinyl alcohol foam or other medical porous foam
  • a sponge or a gauze the following tube
  • a porous foam cushion It can be used for sealing a breathable film for sealing (hereinafter referred to as a sealing film), a joint (including a two-way joint
  • the structure is as follows: a drainage tube with a side hole at one end (generally two tubes placed in parallel, a small-sized porous foam cushion is a tube, a slightly larger size, generally three tubes or more are placed in parallel)
  • a drainage tube with a side hole at one end generally two tubes placed in parallel
  • a small-sized porous foam cushion is a tube, a slightly larger size, generally three tubes or more are placed in parallel
  • the outlet ends of the drainage tubes are merged into one outlet through a three-way joint, a two-way joint or a multi-way joint, and the negative pressure source drainage is turned on. , oozing blood, exudate, liquefied necrotic tissue fragments, and liquefied substances such as pus in human tissues are drained into the drainage container.
  • the porous foam cushion is wrapped in a multi-side hole drainage tube and placed on the wound surface or the wound cavity. Inside, the porous foam cushion and the outlet end of the drainage tube are tightly sealed by the sealing film to be insulated from the outside, and the drainage container is connected, and then the negative pressure source is connected (there is also a negative integration of the drainage container and the negative pressure source). Pressing the drain bottle) forms a highly efficient drainage system (VSD system). In this system, the negative pressure is transmitted to the porous foam cushion through the rigid conduction of the draft tube, and the negative pressure is distributed at each point on the porous foam cushion as the direction of the draft tube.
  • VSD system highly efficient drainage system
  • the negative pressure can reach every point of the target drainage zone to form a full-scale drainage.
  • Larger, less rigid block-like extracts are divided and shaped into granules under negative pressure. They enter the drainage tube through the pores of porous foam cushions or interpenetrating pores, and are quickly sucked into the drainage container.
  • the large extracts that may block the draft tube are blocked by the porous foam cushion and can only adhere to the surface of the porous foam cushion, leaving the body together with the porous foam cushion when removing or replacing the drain.
  • the sealing of the sealing film maintains the negative pressure as the guiding force, and also isolates the drained area from the outside, effectively preventing contamination and cross-infection.
  • the negative pressure is uniformly distributed on the surface of the drainage area through the soft porous foam cushion as an intermediary, it can effectively prevent the ischemia of the organ or tissue which may occur when the single drainage tube is under negative pressure drainage.
  • Complications such as necrosis and perforation ("Negative Pressure Closed Drainage Technology", 2nd Edition, P3-P4, published by Huade Song Jiuhong, editor of People's Health Publishing House).
  • the VSD technology can remove the exudate and necrotic tissue in the drainage area in a timely manner, and the "zero accumulation" state can be achieved in the drainage area, and the wound can be quickly cleaned.
  • the environment greatly reduces the body's reabsorption of toxins; even with larger cavities, the cavity is accelerated by the presence of negative pressure.
  • the sealing film and porous foam cushion also make local The environment is closer to the physiological moist state; the negative pressure stimulation on the soft tissue of the wound is beneficial to the improvement of the local microenvironment and the regression of tissue edema, accelerate the regeneration of granulation tissue in the wound, shorten the healing time of the wound; There is no need to change the medicine within 3-7 days, which reduces the workload of the medical staff, reduces the patient's pain, and reduces the comprehensive medical expenses.
  • VSD technology in China has been widely used in: trauma, orthopedics, general surgery, burns and other fields.
  • the existing VSD technology still has the following problems in the use of body surface drainage: 1.
  • the sealing is inconvenient. Good sealing is the key to ensure drainage effect, and it is also the most difficult part of the whole negative pressure closed drainage operation.
  • Common sealing methods include: puncture method, "film” method, suture method and "dumpling” method (" Negative pressure closed drainage technology, the second edition of P20-P24, edited by Huade Song Jiuhong, published by People's Health Publishing House.
  • the above sealing method is very cumbersome in actual operation, and the surgeon needs to perform repeated operations and exercises to master.
  • the seal is not strong, and it is often the main cause of air leakage, which causes the treatment effect of VSD system to be weakened or even failed due to air leakage.
  • the outlet end of the drainage tube is used as the outlet for negative pressure conduction and drainage.
  • the outlet direction of negative pressure conduction and drainage is small, and there is often only negative pressure conduction and drainage in the longitudinal direction or lateral direction, which is prone to uneven and conduction of negative pressure conduction. Tube phenomenon, and when the pipe is blocked, flushing is not convenient.
  • the commonly used rinsing methods are as follows: 1.
  • a rubber tube is placed on the wound surface, but the "film-based method” is also required to seal the lead-out position of the rubber tube, which increases the possibility of "leakage” and the difficulty of sealing; Retrograde injection of irrigation fluid from the original drainage tube may re-inject the exuded fluid into the wound surface, causing "retrograde infection”; 3. Injecting the irrigation fluid from the porous foam cushion, but need to be on the porous foam cushion. Re-attach the sealing film at the hole to increase the difficulty of operation. 3, for large areas of irregular wounds, drainage is not convenient.
  • the leading end of the drainage tube is connected by a joint, and a large number of joints can finally merge the outlet end of the drainage tube into an outlet, forming a network structure which is criss-crossed like a "twig", and the patient's activity is very inconvenient.
  • the porous foam cushion is sealed with the healthy skin as a whole by a sealing film.
  • the hair of the healthy skin needs normal water permeability and permeability, and the larger the permeability of the sealing film, the better. Otherwise, Healthy skin can cause rash, edema, water immersion and whitening, causing the patient to scratch or rub the sealing film intentionally or unintentionally due to symptoms such as itching.
  • the porous foam cushion needs to be completely sealed, and the smaller the permeability of the sealing film is, the better. Otherwise, the porous foam cushion will cause moisture loss due to long time of minute air circulation, and the porous foam cushion will be dried, and finally Causes the porous foam cushion to lose its elasticity and wet environment, Delaying the healing time of the wound; thus, this creates a contradiction in the principle of two reactionary needs in one whole.
  • the existing sealing film can not meet the requirements of normal skin permeable, permeable, metabolic and porous foam cushions that need to be tightly sealed at the same time. 5
  • the drainage tube with side holes in the cushion is often pulled out, and the surgeon cuts more side holes on the drainage tube, and the side holes are extended.
  • the length of the drainage tube, followed by splicing, series or parallel porous foam cushions, is extremely cumbersome to operate.
  • the object of the present invention is to overcome the above-mentioned irrationality of the conventional vacuum sealing drainage device and to provide a body surface wound tissue negative pressure sealing drainage device.
  • a body surface wound tissue negative pressure sealing drainage device which comprises a porous foam cushion in contact with a body surface wound surface, a drainage tube with a side hole, a sealing film, a joint, a catheter, a drainage a container, a negative pressure source, characterized in that it further comprises a film and a take-up tube, the film being located above the porous foam cushion, the opening direction of the upper side hole of the draft tube being in contact with the porous foam cushion, the take-up tube
  • the drainage film is connected to the drainage film, and the sealing film is sealed on the adhesive film.
  • the extraction pipe is introduced into the drainage container through the conduit, and the drainage container is connected to the negative pressure source through the conduit.
  • the drainage tube is located between the porous foam cushion and the film.
  • the drainage tube is either circular or flat, and is located at the upper end of the film, and is integrated with the film.
  • a flow meter is connected to the conduit between the outlet pipe and the drainage container.
  • the drainage tube and the adhesive film are integrated.
  • the porous foam cushion has a pillar therein, and one end of the pillar is located in the porous foam cushion, and the other end of the pillar is fixed on the drainage tube and the adhesive film.
  • a pressure sensor is connected to the conduit, a pressure sensor is connected to the CPU, and the CPU is connected to a negative pressure source.
  • the periphery of the film is covered with a sealing film.
  • the drainage tube is a tube.
  • the drainage tube is two to five tubes placed in parallel.
  • the drainage tube is a one-piece structure with at least two cross-connections.
  • the pillar has a burr.
  • a connection between the drainage container and the source of negative pressure is provided with a bacteria filter and an odor filter.
  • the drainage tube is either a "well” type, or a "ten” type, or a “work” type, or a “meter” type structure.
  • the pillar is a hollow structure, and the pillar is connected to the drainage tube, and the pillar has a small opening.
  • one to five extraction tubes are connected to the drainage tube, and the extraction tube and the drainage tube are integrated.
  • the lower end surface of the pillar is a concave curved surface structure.
  • the outlet pipe has a sealing cover.
  • the outlet tube has a sealable sampling port.
  • the body surface wound tissue negative pressure sealing drainage device of the invention has the following advantages: 1.
  • the rubber film placed on the porous foam cushion (the gas permeability of the film is extremely low, and the air permeability of other materials can also be extremely low).
  • the membrane is used to seal the wound surface, which greatly prolongs the time that the porous foam cushion maintains an elastic and moist environment, which is beneficial to wound healing.
  • the sealing film only needs to be sealed around the film (it can also cover the film on the film and around the film), and does not need to seal the leading end of the drainage tube, which reduces the leakage of the VSD system.
  • Normal metabolism of healthy skin around. 3 can be in each
  • the outlet pipe is connected to the outlet pipe, so that the outlet direction is large, and the outlet of each outlet pipe can be used as a drainage port or as a flushing port when the pipe is blocked, and the drainage and flushing are very convenient.
  • a fixed lead-out tube is left for flushing during operation, and the possibility of retrograde infection when the same lead-out tube is drained and flushed is also avoided.
  • the side tube led by the drainage tube can also serve as a channel for sampling the drainage material. 4.
  • the upper drainage method whether it is conducting negative pressure or drainage, is more uniform and reasonable than the side drainage method, so it is not easy to block the pipe, especially when the outlet pipe is at the intersection of the drainage pipe. . 5.
  • the drainage is very convenient and does not form a "twig net" (as shown in Figure 14), which is convenient for the patient to be normal. activity. 6. Shorten the time of surgery, reduce the pain of the patient, and shorten the time of wound healing.
  • Embodiment 1 is a schematic structural view of Embodiment 1 of a negative pressure sealing drainage device for a body surface wound tissue of the present invention
  • Fig. 2 is a view showing the positional relationship of the porous foam cushion, the sealing film and the film in the present invention (the dotted line in the figure is an unvisible portion).
  • Fig. 3 is a schematic view showing a positional relationship structure of a lead pipe, a draft pipe, a film, and a strut in the present invention.
  • Fig. 4 is a schematic view showing the positional relationship of the take-up pipe, the draft pipe, the film, the pillar and the porous foam cushion in the present invention.
  • Fig. 5 is a schematic view showing another positional relationship of the take-up pipe, the draft pipe, the film, the pillar and the porous foam cushion in the present invention.
  • Figure 6 is a schematic view showing the structure of the take-out pipe and the sealing cover in the present invention.
  • Figure 7 is a schematic view showing the structure of a double parallel pipe in the present invention.
  • Fig. 8 is a structural schematic view of a "ten" type drainage tube in the present invention.
  • Figure 9 is a schematic view showing the structure of a "well” type drainage tube in the present invention.
  • Figure 10 is a schematic view showing the structure of a "work” type drainage tube in the present invention.
  • Figure 11 is a schematic view showing the structure of a "m" type drainage tube in the present invention.
  • Fig. 12 is a schematic view showing the structure of the second embodiment of the body surface wound tissue negative pressure sealing and drainage device of the present invention (the sealing film is not shown).
  • Figure 13 is a diagram showing the connection relationship between the filter and the drainage container and the negative pressure source in the present invention.
  • Fig. 14 is a structural schematic view showing the formation of a "twig net" by a conventional negative pressure closed drainage.
  • FIG. 1 Porous foam cushion, 2. Drainage tube, 3. Sealing membrane, 4. Joint, 5. Drainage vessel, 6. Negative pressure source, 7. Adhesive membrane, 8. Extraction tube, 9. Pillar, 10. Glitch, 11. Sealing cap, 12. Slotting, 13. Small opening, 14. Concave curved surface, 15. Sampling port, 16. Flow meter, 17. Catheter, 18. Bacterial filter, 19. Odour filtering , 20. Pressure sensor, 21. CPIL
  • the present invention relates to a body surface negative pressure sealing drainage device comprising a porous foam cushion 1 in contact with a body surface wound surface, a drainage tube 2 with a side hole, a sealing film 3, a joint 4, and a drainage container 5, a negative pressure source 6, which further comprises a film 7 and a take-up tube 8, wherein the film 7 is located above the porous foam pad 1, and the opening direction of the upper side hole of the draft tube 2 is in contact with the porous foam pad 1
  • the extraction tube 8 communicates with the drainage tube 2 and is located above the adhesive film 7, the sealing film 3 is sealed on the adhesive film 7, the extraction tube 8 is introduced into the drainage container 5, and the drainage container 5 is connected to the negative pressure source 6.
  • This type of upper drainage is used to make the drainage flow in all directions. Whether it is conducting negative pressure or draining, it is more uniform and reasonable than the side drainage method (the original drainage device is draining or conducting negative pressure at the leading end of the drainage tube), so it is not easy to block. Tube phenomenon, especially when the outlet tube is at the intersection of the drainage tube (as shown in Figure 1, Figure 2, Figure 3, Figure 4).
  • the drainage tube 2 is located between the porous foam pad 1 and the film 7 (as shown in FIG. 4), the drainage tube 2 It is integrated with the film 7 (the connection between the drainage tube and the film may also be unconnected).
  • This configuration can be slotted 12 in a porous foam pad and the drainage tube placed in the groove of the porous foam pad.
  • the drainage tube 2 is either circular or flat (or other structure) and is located at the upper end of the film 7 and is integral with the film 7 (as shown in Fig. 3).
  • the struts 9 are hollow structures, the struts 9 are in communication with the drainage tube 2, and the struts 9 have small openings 13 (with the effect of assisting drainage).
  • the lower end surface of the pillar 9 (the pillar is a malleable soft material) has a concave curved surface structure (relative to the lower end surface of the pillar is a plane, in the negative pressure state, the contact area with the wound surface is increased, and the contact area is reduced. The pressure on the wound tissue).
  • the porous foam cushion 1 has a pillar 9 therein, one end of which is located in the porous foam cushion 1, the other end of the pillar 9 is and/or fixed on the drainage tube 2 and the film 7; the pillar 9 has burrs 10 (as shown in Figure 2, Figure 3, Figure 4).
  • the structure has the following advantages.
  • the pillars enable the porous foam cushion to act as a support between the surface tissue wound surface and the sealing film, so that the pores in the porous foam cushion and the interpenetrating pores are maintained in a normal state or Only minor deformation occurs, so that oozing, exudate, liquefied and necrotic tissue fragments and pus liquefied substances in the surface tissue can be smoothly drained through the pores and interpenetrating pores into the drainage tube, reducing drainage Blocking the tube causes the possibility of drainage failure.
  • the support of the pillars maintains the elastic structure of the porous foam cushion to maintain the vacuum environment, and reduces the contact between the porous foam cushion and the body surface wound due to the negative pressure, so that the porous foam cushion and the body
  • the part of the surface of the wound cells forms the possibility of unnecessary adhesion, which is beneficial to the growth of the granulation of the surface tissue and reduces the healing time of the surface tissue.
  • the burr can riveen and fix the drainage tube, the pillar, the film and the porous foam cushion as a whole, and the pillar is not easily pulled out from the porous foam cushion.
  • a sealing film 3 is covered around the film 7. This filming method only needs to be filmed around the film, which is very simple. At the same time, when sealing the film, it is not necessary to seal the drainage tube at the leading end of the drainage tube to make the sealing more convenient.
  • the drainage tube 2 is a tube, and the drainage tube 2 is two to five tubes placed in parallel.
  • the drainage tube is a tube, this structure is suitable for small-area wounds.
  • the drainage tube 2 is two to five tubes placed in parallel (Generally used two tubes, three and three or more drainage tubes with larger area), this structure is suitable for regular wound use (as shown in Figure 7).
  • the drainage tube 2 is a one-piece structure with at least two cross-connections.
  • the drainage tube 2 may be a "well” type, or a "ten” type, or a "work” type structure, and may also be other cross-structure forms. This structure allows the drainage to extend in all directions, and also makes the negative pressure conduction more uniform, which is beneficial to negative pressure conduction and drainage (as shown in Figure 8, Figure 9, Figure 10, Figure 11).
  • the drainage tube 2 is connected with 1-5 extraction tubes 8, and the extraction tube 8 and the drainage tube 2 are integrated.
  • the outlet pipe 8 has a sealing cover 11 thereon. This configuration avoids the possibility of air pollution when the extraction tube is not drained or flushed (as shown in Figure 6).
  • a flow meter 16 (shown in Figure 12) is connected to the conduit 17 between the outlet tube 8 and the drainage container 5.
  • the flow meter has the following effects: First, monitor active bleeding of the wound to avoid hypovolemic shock. Second: Monitor the loss of large amounts of body fluids and avoid low proteinemia caused by large amounts of protein loss. Third: Provide data support for rehydration and supplementation of colloids. Fourth: Compared with the use of graduated drainage bottles to record the loss of body fluids, the flowmeter has the effect of recording the loss of body fluids per unit time, providing accurate real-time data support for clinical emergency treatment.
  • the outlet tube 8 has a sealable sampling port 15. It overcomes the shortcomings of the existing VSD device without sampling port. When sampling in the original VSD device, the connection position of the drainage tube needs to be opened to take samples. This sampling process creates the possibility of new contaminated wounds.
  • the dedicated sampling port avoids these problems.
  • the sampling port has the following functions: First, qualitative analysis of the liquid component that is drained out provides a basis for clinical treatment. Second: Drug susceptibility testing of the drain samples to provide the best antibiotic and anti-bacterial infection treatment (Figure 1, Figure 12).
  • the connection between the drainage container 5 and the negative pressure source 6 is a bacterial filter 18 and an odor filter 19.
  • Bacterial filters reduce bacteria, especially anaerobic bacteria, into the next drainage channel, such as entering a central source of negative pressure, to avoid the possibility of causing contamination of the central negative pressure system in the hospital.
  • the odor filter reduces the odor generated on the wound surface from the system (as shown in Figure 13).
  • a pressure sensor 20 is connected to the conduit 22, and the pressure sensor 20 is connected to the CPU 21,
  • the CPU 21 is connected to the negative pressure source 6.
  • the pressure sensor measures the pressure transmitted from the porous foam cushion in the conduit, and the pressure signal is processed by the CPU, and controls the opening and closing of the negative pressure source through the command of the CPU, or adjusts the negative pressure of the negative pressure source output.
  • the negative pressure is then passed through the drainage volume and conducted through the drainage tube to the porous foam cushion to adjust the pressure between the pores and the pores in the porous foam cushion.
  • the pillar is inserted into the porous foam cushion, the film and the drainage tube are placed on the porous foam cushion, the periphery of the film is sealed with a sealing film, the catheter is inserted into the extraction tube on the film, and the drainage container is turned on. And a negative pressure source, ready to use.
  • the multi-connector can be used for one-time connection on the outlet tube. If there are four outlet tubes, a five-way joint can be used to connect to the drainage container through the catheter at one time, or only two extraction tubes can be used for drainage. For export use, other outlet tubes are used for flushing.
  • VSD device of the present invention The advantages of the VSD device of the present invention will now be described by comparing the clinical medical case of the VSD device of the present invention with the clinical medical case of the existing VSD device.
  • the existing VSD device is a double parallel drainage tube placed in a porous foam cushion, sealed by a sealing film, connected to the drainage container through a joint and a conduit, and then connected to a negative pressure source.
  • the VSD device of the present invention means: a flat "well-shaped" drainage tube is placed at the upper end of the film, the pillar is located at the lower end of the film, the pillar has a burr, the pillar is inserted into the porous gun cushion, and the drainage tube has a lead-out tube
  • the extraction tube has a sampling port, and the drainage container is connected through a conduit, and then connected to a negative pressure source. Between the drainage container and the negative pressure source, there is a bacteria filter and an odor filter.
  • a multi-way joint is used to pass through the connecting conduit to the drainage container at one time, and a lead-out tube is reserved as a flushing port.
  • the comparison items are: The area of the wound is approximately 450 cm 2 .
  • the time to produce a single product refers to the time of insertion of the drainage tube into the porous foam cushion for an existing VSD device.
  • the integrated film, the drainage tube, the extraction tube and the porous foam cushion are combined for a period of time.
  • the following is a clinical comparative analysis of the postoperative effects of the VSD device of the present invention and the existing VSD device:
  • the inventors treated 30 cases of soft tissue defect infection with the existing VSD device and the VSD device of the present invention. All cases began to be treated more than two weeks after the injury, which was post-treatment; the wound area was above 100 cm 2 and deep into the muscular layer; both were associated with tissue necrosis. The two groups were excluded: facial, hand, foot and perineal wounds, chronic soft tissue infections, patients with osteomyelitis, those over 50 years of age, and those with diabetes. There are 17 males and 13 females with an average age of 27.8 years and an average wound area of 182.3 cm 2 .
  • the VSD device of the present invention is 16 males and 14 females, aged 7-49 years old. 28.3 years old, the average wound area was 169.8 cm 2 .
  • the systemic conditions and wounds of the two groups were basically similar and comparable. The t test was used for statistical analysis.
  • the injury, injury and repair methods of the two groups are shown in Table 2-1 and 2-2.
  • the wound cleaning time for the two groups of cases is listed in Table 2-3.
  • Wound cleansing time refers to the time required for a wound with a soft tissue defect to be infected from the start of treatment to the condition of the wound.
  • the standard for wound cleansing and allowing closure is: The wound surface is smooth and clean, no necrotic tissue and exudate; the wound edema subsides; the wound granulation tissue is fresh, pink granular, easy to hemorrhage; the wound can guarantee the second stage suture, skin graft or skin The flap was successfully transposed. Time to clinically detect signs of wound infection or debridement, remove necrotic tissue to repair wounds (second-stage suture, Skin graft or flap indexing) Calculated the number of days before the day.
  • the wound cleaning time was 5 to 15 days, the wound surface was reduced to varying degrees, 22 cases were skin grafted, and 3 cases were flapped and repaired.
  • the wound cleaning time of the VSD group of the present invention was 3 to 10 days, which was significantly shorter than that of the existing VSD group (P ⁇ 0.01, and the difference between the two groups was extremely significant).
  • the wound reduction of the VSD group of the present invention is more obvious, 25 cases of skin grafting, and 1 case of flap flap repair.

Description

体表创面组织负压封闭引流装置
技术领域
本发明涉及体表创面组织负压封闭引流装置。它是专为对各种体表组织 破溃区治疗而设计的一种用于对因由创伤、烧伤、感染、压迫、 内分泌失调、 血管闭塞、 放射性照射、 手术、 手术并发症、 虫蛇咬噬、 低温冷冻伤等原因 而发生的创面进行负压封闭弓 )流治疗的装置。 背景技术
负压封闭引流技术（ vacuum sealing drainage/VSD, 筒称 VSD技术）是 德国 ULM大学 Wim Fleischman博士于 1992年首创， 并形成理论雏形， 用于四肢创面的引流； 1994年中国袭华德教授首次将 VSD技术应用于普外 科， 开创了 VSD技术在普外科应用的先河， 王彦峰、 袭华德教授在中国于 1998年 3月 18日得到授权的专利 CN 2276350,为 VSD技术的第一个专利。 从此， VSD技术在我国得到了较大的发展。
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）， 引流管， 聚乙烯醇泡沫或其它医用多孔泡沫、 海绵或纱布 （以下筒称多孔泡沫软垫）、 可粘贴密封用的透气薄膜（以下筒 称密封薄膜）、接头（包括二通接头、三通接头或多通接头 )、 引流容器组成。 其结构形式为： 一端带侧孔的引流管（一般为平行放置的二根管， 小规格的 多孔泡沫软垫为一根管， 稍大规格的， 一般平行放置三根管或以上）通入已 钻好孔的多孔泡沫软垫内， 使用多块多孔泡沫软垫时， 再通过三通接头、 二 通接头或多通接头将引流管的出口端合并为一个出口，接通负压源引流， 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。
实际应用中，将多孔泡沫软垫包裹多侧孔引流管，放置在创面上或创腔 内，再用密封薄膜将多孔泡沫软垫和引流管出口端严密封闭，使之与外界隔 绝， 连接引流容器， 再接通负压源（现也有将引流容器和负压源做成一体的 负压引流瓶）， 就形成了一个高效引流系统（VSD 系统）。 在这个系统中， 负压经过引流管的刚性传导传递到多孔泡沫软垫，并可随着引流管的走向将 负压分布在多孔泡沫软垫上的每一个点。由于多孔泡沫软垫内的孔泡互相连 通且富有弹性，负压可以到达目标引流区的每一点，形成一个全方位的引流。 较大的、 质地不太硬的块状引出物在负压作用下会被分割和塑型成颗粒状， 经过多孔泡沫软垫的孔隙或相互贯通的孔泡进入引流管，再被迅速吸入引流 容器内； 而可能堵塞引流管的大块引出物则被多孔泡沫软垫阻挡， 只能附着 在多孔泡沫软垫表面， 在去除或更换引流物时与多孔泡沫软垫一起离开机 体。 密封薄膜的封闭使作为引流动力的负压得以维持， 同时也使被引流区与 外界隔绝，有效地防止了污染和交叉感染。 由于负压经过作为中介的柔软多 孔泡沫软垫均匀分布于被引流区的表面，可以有效地防止单根引流管负压引 流时可能发生的脏器或组织被吸出或受压而致的缺血、坏死、 穿孔等并发症 (《负压封闭引流技术》第 2版 P3- P4, 袭华德 宋九宏主编 人民卫生出版 社出版)。
与现有的普通换药治疗相比， VSD技术能将被引流区内的渗出物和坏 死组织非常及时地清除， 被引流区内可达到"零积聚"状态， 创面能够很快地 获得清洁的环境， 大大降低机体对毒素的重吸收； 即使有较大的腔隙存在， 腔隙也因负压的存在而加速缩小，对浅表创面而言， 密封薄膜和多孔泡沫软 垫也使局部环境更接近生理性的湿润状态； 作用于创面软组织上的负压刺 激，有利于局部微环境的改善和组织水肿的消退，加速了创面中肉芽组织的 新生,缩短创面愈合时间；在 VSD治疗的 3-7天内均不需要再换药， 降低了医 护人员工作量， 减少了患者痛苦， 降低了综合医疗费用。
在我国 VSD技术已广泛适用于： 创伤科、 骨科、 普外科、 烧伤科等领 域。 但是现有的 VSD技术在体表创面引流的使用过程中 ,仍存在以下问题： ①、 密封不方便。 良好的密封是保证引流效果的关键， 也是整个负压封闭引 流操作中最困难之处， 常用的密封方法包括： 戳孔法、 "系膜 "法、 缝合法及 "包饺子"法等（《负压封闭引流技术》第 2版 P20-P24, 袭华德 宋九宏主编, 人民卫生出版社出版）。 但上述的密封方法在实际的操作中均非常繁瑣， 手 术医生均需要进行反复的操作和练习才能掌握。 而密封不牢固，往往是漏气 最主要的原因， 从而造成因漏气而导致的 VSD系统治疗效果的削弱甚至失 败。 ②、 采用引流管的引出端作为负压传导和引流的出口， 负压传导和引流 的出口方向少，往往只有纵向或横向单一方向的负压传导和引流， 容易发生 负压传导不均匀和堵管现象， 且发生堵管时， 沖洗也不方便。 现常用的沖洗 方法为： 1、 在创面上另置一根橡胶管， 但也需要用"系膜法"密封橡胶管的 引出位置， 增加了 "漏气 "的可能性和密封的难度； 2、 从原引流管逆行注入 沖洗液， 可能会将引流出的渗液重新注入创面上， 造成"逆行感染"； 3、 从 多孔泡沫软垫上戳孔注入沖洗液，但需要在多孔泡沫软垫上的破孔处重新粘 贴密封薄膜， 增加了操作的难度。 ③、 对大面积不规则创面， 引流不方便。 引流管的引出端通过接头进行连接，通过大量的接头才能在最后将引流管的 出口端合并为一个出口， 形成了一个纵横交错如同"树枝"的网状结构， 患者 的活动非常不方便。 ④、 在临床实际使用中， 是用密封薄膜将多孔泡沫软垫 与健康皮肤整体密封在一起， 健康皮肤中的毛嚢需要正常的透水透气代谢， 就要求密封薄膜通透率越大越好， 否则健康皮肤会出现皮疹、 毛嚢炎、 水分 浸渍发白等现象，导致患者因发痒等不适症状而有意或无意地抓挠、磨擦密 封薄膜。也可能导致皮肤与密封薄膜之间由于水分浸渍，密封薄膜粘性消失， 从皮肤表面脱开， 继而使空气进入密封区最终导致负压封闭引流效果下降， 甚至完全失效。 而多孔泡沫软垫需要完全密封， 又要求密封薄膜通透率越小 越好，否则将引起多孔泡沫软垫由于经过长时间的微小空气流通而造成水分 丟失， 使多孔泡沫软垫变干， 最终导致多孔泡沫软垫失去弹性和湿润环境， 延緩了创面愈合时间；于是这就形成了在一个整体中存在两个反作用需求原 理的矛盾。 而现有的密封薄膜不能同时满足健康皮肤正常的透水、 透气、 代 谢和多孔泡沫软垫需要严密密封的要求。⑤对较大面积创面， 需要两张以上 的多孔泡沫软垫时，往往是将软垫内的带侧孔的引流管抽出， 手术医生在引 流管上剪出更多侧孔， 延伸带侧孔的引流管的长度， 然后拼接、 串联或并联 多孔泡沫软垫， 操作极其烦瑣。
因此， 对现有的 VSD技术在体表创面组织愈合中的使用进行改进已成 为非常迫切的一项重要工作。 发明内容
本发明的目的在于克服现有负压封闭引流装置的上述不合理之处， 而提 供了一种体表创面组织负压封闭引流装置。
本发明的目的是通过如下措施来达到的：体表创面组织负压封闭引流装 置， 它包括与体表创面接触的多孔泡沫软垫， 带侧孔的引流管， 密封薄膜， 接头， 导管， 引流容器， 负压源， 其特征在于它还包括胶膜和引出管， 所述 的胶膜位于多孔泡沫软垫的上方，引流管上侧孔的开口方向与多孔泡沫软垫 接触，所述引出管与引流管相通并位于胶膜的上方，密封薄膜密封在胶膜上， 引出管通过导管通入引流容器内， 引流容器通过导管连接负压源。
在上述技术方案中， 所述引流管位于多孔泡沫软垫和胶膜之间。
在上述技术方案中， 所述引流管或为圓形， 或为扁形， 并位于胶膜的 上端， 且与胶膜为一体结构。
在上述技术方案中， 在所述引出管和引流容器之间的导管上连接有流 量计。
在上述技术方案中， 所述引流管与胶膜为一体结构。
在上述技术方案中， 所述多孔泡沫软垫内有支柱， 所述支柱的一端位 于多孔泡沫软垫内 , 所述支柱的另一端和 /或固定在引流管和胶膜上。 在上述技术方案中， 在所述导管上连接有压力传感器， 压力传感器连 接 CPU, 所述的 CPU与负压源连接。
在上述技术方案中， 所述胶膜的四周覆盖有密封薄膜。
在上述技术方案中， 所述引流管为一根管。
在上述技术方案中， 所述引流管为平行放置的二至五根管。
在上述技术方案中， 所述引流管为至少二根交叉连接的一体式结构。 在上述技术方案中， 所述支柱上有毛刺。
在上述技术方案中，在所述引流容器和负压源之间的连接有细菌过滤器 和气味过滤器。
在上述技术方案中，所述引流管或为"井"字型，或为"十"字型，或为"工" 字型， 或为"米"字型结构。
在上述技术方案中， 所述支柱为中空结构， 支柱与引流管相通， 支柱上 有小开孔。
在上述技术方案中， 所述引流管上连接有一至五个引出管，且引出管与 引流管为一体结构。
在上述技术方案中， 所述支柱的下端面为内凹的弧面结构。
在上述技术方案中， 所述引出管上有密封盖。
在上述技术方案中， 所述引出管上有可密封的取样口。
本发明体表创面组织负压封闭引流装置具有如下优点： ①、通过放置在 多孔泡沫软垫上的胶膜 (这种胶膜的透气率极低，也可以是其它材料制成的 透气率极低的膜 )来密封创面， 大大延长了多孔泡沫软垫保持弹性和湿润环 境的时间， 有利于创面愈合。 ②、 密封薄膜只需要密封胶膜的四周即可（也 可以将密封薄膜全部覆盖在胶膜上及胶膜的四周 ), 并且不需要密封引流管 的引出端， 降低了 VSD系统发生"漏气"的可能性， 使负压封闭引流的密封 变得更加筒单、 可靠， 同时密封薄膜是通透性能很高的膜， 也具有很好的皮 肤相容性， 致敏率低， 有利于创面周围健康皮肤的正常代谢。 ③、 可在每根 引流管上连接引出管， 因此引出出口方向多，每根引出管的出口既可以作为 引流口， 又可以作为发生堵管时的沖洗口， 引流和沖洗都非常方便。 同时， 操作时留出固定的引出管作沖洗用，也避免了同一引出管既引流又沖洗时发 生逆行感染的可能。 引流管引出的侧管， 还可作为引流物取样的通道。 ④、 上引流方式，无论是传导负压，还是引流，都比侧引流方式更加均勾和合理， 因此不容易发生堵管现象，特别是当引出管位于引流管的交叉处时， 更是如 此。 ⑤、 对大面积不规则创面时， 只需要在引出管上采用多通接头即可导入 引流容器， 引流非常方便， 不会形成"树枝网"（如图 14所示） 的情况， 方 便患者正常的活动。 ⑥.缩短了手术的时间， 并减轻了病人的痛苦， 缩短了 患者创面愈合的时间。 附图说明
图 1 为本发明体表创面组织负压封闭引流装置实施例 1 的结构示意图
(其中的密封薄膜未画出）。
图 2为本发明中多孔泡沫软垫、 密封薄膜和胶膜的位置关系图（图中的 虚线部分为未可见部分）。
图 3为本发明中引出管、 引流管、胶膜及支柱的一种位置关系结构示意 图。
图 4为本发明中引出管、 引流管、 胶膜、 支柱和多孔泡沫软垫的一种 位置关系结构示意图。
图 5 为本发明中引出管、 引流管、 胶膜、 支柱和多孔泡沫软垫的另一 种位置关系结构示意图。
图 6为本发明中引出管与密封盖的结构示意图。
图 7为本发明中双平行管的结构示意图。
图 8为本发明中 "十"字型引流管的结构示意图。
图 9为本发明中 "井"字型引流管的结构示意图。 图 10为本发明中"工"字型引流管的结构示意图。
图 11为本发明中"米"字型引流管的结构示意图。
图 12为本发明体表创面组织负压封闭引流装置实施例 2的结构示意图 (其中的密封薄膜未画出）。
图 13为本发明中过滤器与引流容器及负压源的连接关系图。
图 14为现有负压封闭引流形成"树枝网 "的结构示意图。
图中 1.多孔泡沫软垫， 2.引流管， 3.密封薄膜， 4.接头， 5.引流容器， 6. 负压源， 7.胶膜， 8.引出管， 9.支柱， 10.毛刺， 11.密封盖， 12.开槽， 13.小 开孔， 14.内凹的弧面， 15.取样口， 16.流量计， 17.导管， 18.细菌过滤器， 19.气味过滤器， 20.压力传感器， 21. CPIL 具体实施方式
下面结合附图详细说明本发明的实施情况，但它们并不构成对本发明的 限定， 仅作举例而已。 同时通过说明， 本发明的优点将变得更加清楚和容易 理解。
参阅附图可知： 本发明体表创面组织负压封闭引流装置， 它包括与体表 创面接触的多孔泡沫软垫 1 , 带侧孔的引流管 2, 密封薄膜 3, 接头 4, 引流 容器 5, 负压源 6, 它还包括胶膜 7和引出管 8, 所述的胶膜 7位于多孔泡 沫软垫 1的上方， 引流管 2上侧孔的开口方向与多孔泡沫软垫 1接触， 所述 引出管 8与引流管 2相通并位于胶膜 7的上方， 密封薄膜 3密封在胶膜 7 上， 引出管 8通入引流容器 5内， 引流容器 5连接负压源 6。
采用这种上引流方式使引流四通八达， 无论是传导负压， 还是引流， 都 比侧引流方式（原引流装置在引流管的引出端引流或传导负压）更加均匀和 合理， 因此不容易发生堵管现象， 特别是当引出管位于引流管的交叉处时， 更是如此（如图 1、 图 2、 图 3、 图 4所示）。
引流管 2位于多孔泡沫软垫 1和胶膜 7之间 （如图 4所示；)， 引流管 2 与胶膜 7为一体结构 （引流管和胶膜之间也可以没有连接关系）。 这种结构 可在多孔泡沫软垫上开槽 12, 将引流管置于多孔泡沫软垫的槽内。
引流管 2或为圓形， 或为扁形（或为其它的结构）， 并位于胶膜 7的上 端， 且与胶膜 7为一体结构 （如图 3所示）。
支柱 9为中空结构，支柱 9与引流管 2相通，支柱 9上有小开孔 13(有 辅助引流的作用）。 支柱 9 (支柱为可延展的软性材料） 的下端面为内凹的 弧面结构（相对于支柱的下端面为平面来说， 在负压状态下， 增大了与创面 的接触面积， 减少了对创面组织的压强）。
多孔泡沫软垫 1内有支柱 9,所述支柱 9的一端位于多孔泡沫软垫 1内， 所述支柱 9的另一端和 /或固定在引流管 2和胶膜 7上； 支柱 9上有毛刺 10 (如图 2、 图 3、 图 4所示）。 这种结构具有如下优点， 第一： 支柱使多孔泡 沫软垫在体表组织创面与密封薄膜之间起立撑的作用，使多孔泡沫软垫内的 孔隙和相互贯通的孔泡均保持正常状态或仅发生较小的变形，使体表组织创 面内的渗血、渗液、液化坏死的组织碎片以及脓液等液化物质能顺利通过孔 隙和相互贯通的孔泡引流至引流管内，减少了由于引流物堵管造成引流失败 的可能。第二： 支柱的支撑作用使多孔泡沫软垫维持真空环境的弹性结构保 持正常状态，减少了由于负压的作用使多孔泡沫软垫与体表创面形成紧密的 接触，使多孔泡沫软垫与体表创面细胞生长的部分形成不必要的粘连的可能 性， 有利于体表组织创面肉芽的生长， 减少了体表组织创面愈合的时间。 同 时毛刺可将引流管、 支柱、 胶膜与多孔泡沫软垫之间铆合固定为一个整体， 且支柱不易从多孔泡沫软垫中拨出。
在胶膜 7的四周覆盖有密封薄膜 3。 这种贴膜方式， 仅需在胶膜的四周 贴膜， 非常筒单， 同时这种方式， 密封贴膜时不需要在引流管的引出端采用 "系膜 "法密封引流管， 使密封更加方便。
引流管 2为一根管， 引流管 2为平行放置的二至五根管。 引流管为一根 管时， 这种结构适用于小面积创面使用。 引流管 2为平行放置的二至五根管 (一般常用的为二根管， 面积较大的使用三根及三根以上的引流管）， 这种 结构适用于规则创面使用 （如图 7所示）。
引流管 2为至少二根交叉连接的一体式结构。如引流管 2或为"井"字型， 或为"十"字型， 或为"工"字型结构， 也可以为其它的交叉结构形式。 这种结 构使引流四通八达， 而且使负压传导时， 也更加均勾， 有利于负压传导和引 流（如图 8、 图 9、 图 10、 图 11所示）。
引流管 2上连接有 1-5个引出管 8,且引出管 8与引流管 2为一体结构。 引出管 8上有密封盖 11。 这种结构避免了引出管不引流或沖洗时， 发 生空气污染的可能（如图 6所示）。
在引出管 8和引流容器 5之间的导管 17上连接有流量计 16 (如图 12 所示）。 流量计具有如下作用， 第一： 监控创面活动性出血， 以避免低血容 量性休克。 第二： 监控大量体液的丟失， 避免大量蛋白丟失导致的低蛋白血 症。 第三： 为补液、 补充胶体提供数据支持。 第四： 与用带刻度引流瓶来记 录体液丟失量相比较， 流量计更具有单位时间内记录体液的丟失量的作用， 为临床的急诊治疗提供准确的即时数据支持。
引出管 8上有可密封的取样口 15。 克服了现有的 VSD装置中无取样口 的缺点。 原有的 VSD装置中取样时， 需要将引流管的连接位置打开才能取 样， 这种取样的过程造成了新的污染创面的可能性。 而专用的取样口， 则避 免了这些问题的发生。 取样口具有如下作用， 第一： 对引流出的液体成份进 行定性分析， 为临床治疗提供依据。 第二： 对引流物样品进行药敏试验， 以 提供最佳的抗生素和抗细菌感染治疗 （如图 1、 图 12所示）。
引流容器 5和负压源 6之间的连接有细菌过滤器 18和气味过滤器 19。 细菌过滤器可减少细菌，尤其是厌氧菌进入下一步引流通道，如进入中心负 压源， 以避免造成造成医院内中心负压系统污染的可能性。 气味过滤器可减 少创面上产生的恶臭气味从本系统中溢出 （如图 13所示）。
导管 22上连接有压力传感器 20, 压力传感器 20连接 CPU21 , 所述的 CPU21与负压源 6连接。 压力传感器可通过测量导管内从多孔泡沫软垫内 传导的压力， 并将压力信号通过 CPU处理， 并通过 CPU的命令来控制负压 源的开、 闭， 或调节负压源输出负压的大小， 负压再通过引流容量， 并通过 引流管传导给多孔泡沫软垫，从而调节多孔泡沫软垫内孔泡和孔隙之间的压 力。
使用时，将支柱插入多孔泡沫软垫内，胶膜和引流管置于多孔泡沫软垫 上， 将胶膜的四周用密封薄膜封闭， 将导管接入胶膜上的引出管中， 接通引 流容器和负压源， 即可使用。 使用时， 可在引出管上使用多通接头一次性连 接， 如若有四个引出管时， 采用一个五通接头， 即可一次性通过导管连接至 引流容器，或仅使用二个引出管作为引流出口使用，其它的引出管作为沖洗 时使用。
下面通过采用本发明 VSD装置的临床医疗病例与现有的 VSD装置的临 床医疗病例的对比情况来说明本发明 VSD装置的优点。
其中现有的 VSD装置为置于多孔泡沫软垫内的双平行引流管， 采用密 封薄膜密封， 通过接头、 导管连接引流容器， 再接入负压源。
本发明 VSD装置是指： 扁形的 "井字型"引流管置于胶膜的上端， 支柱 位于胶膜的下端， 支柱上有毛刺， 支柱插入多孔炮沫软垫内， 引流管上有引 出管， 引出管上有取样口， 通过导管连接引流容器， 再接入负压源， 在引流 容器和负压源之间， 有细菌过滤器和气味过滤器。 采用多通接头， 一次性地 通过连接导管通入引流容器， 预留一个引出管作为沖洗口。 在胶膜的四周， 通过密封胶膜密封。
软组织撕脱伤、开放性骨折并软组织缺损等共 180例， 病程均为 3个月 内， 按入医院治疗的先后顺序分为奇数组和偶数组。 其中奇数组 90例用现 有的 VSD装置治疗（ A组）， 偶数组 90例用本发明 VSD装置治疗（ B组）， 观察时间均为一个 VSD治疗疗程， 即 5-7天时间。 在上述治疗疗程内， 对 以上手术中密封操作时间、 堵管率、 多孔泡沫软垫变干率、 创面上出现压痕 比例各个项目进行比较， 此外对生产单个产品的时间比较也列入以下表格： 表 1: 本发明 VSD装置与现有的 VSD装置的在临床操作与术后效果的比较表。
Figure imgf000013_0001
比较项目为： 创面的面积约为 450c m2。 生产单个产品时间对于现有的 VSD装置 而言是指： 引流管插入多孔泡沫软垫内的时间。 对本发明而言是指： 一体化的胶膜、 引 流管、 引出管与多孔泡沫软垫复合在一起的时间。 以下为本发明 VSD装置与现有的 VSD装置的在术后效果的临床比较 分析：
2009年 1月至 2009年 9月， 本发明人对照现有的 VSD装置和本发明 的 VSD装置治疗软组织缺损合并感染各 30例。所有病例均在伤后两周以上 开始接受治疗， 属于后期处理； 创面面积均在 100 c m2以上且深达肌层； 均 合并有组织坏死。 两组病例都排除了： 面部、 手、 足和会阴部创面者， 慢性 软组织感染者， 合并骨髓炎者， 年龄超过 50岁者， 合并糖尿病者。 现有的 VSD装置男 17例，女 13例，年龄 6-48岁，平均 27.8岁,平均创面面积 182.3 c m2; 本发明的 VSD装置男 16例， 女 14例， 年龄 7-49岁， 平均 28.3岁, 平均创面面积 169.8 c m2.两组病例全身条件和创面基本相似,具有可比性.采 用 t检验作统计学处理.
两组病例受伤情况、 受伤部位和修复方式见表 2-1、 2-2。 表 2-3 中列 出两组病例的创面清洁时间。创面清洁时间指软组织缺损合并感染的创面从 开始治疗至创面情况允许闭合所需时间。 创面清洁、 允许闭合的标准是： 创 面平整清洁， 无坏死组织及渗液； 创面水肿消退； 创面肉芽组织新鲜， 呈粉 红色颗粒状， 触之易出血； 创面能保证二期缝合、 植皮或皮瓣转位成功。 时 间上以临床发现创面感染征象或清创、清除坏死组织至修复创面（二期缝合、 植皮或皮瓣转位）前一日的天数计算。
表 2-1 受伤原因和并发症
Figure imgf000014_0001
表 2-2创面部位和修复方式
Figure imgf000014_0002
表 2-3创面清洁的时间分布
Figure imgf000014_0003
现有的 VSD组创面清洁时间为 5~15天， 创面有不同程度的缩小， 22例植皮， 3 例皮瓣转位修复。 经本发明的 VSD组创面清洁时间为 3~10天， 较现有的 VSD组明显 缩短（P<0.01,两组间差异有极显著意义）。 本发明的 VSD组创面缩小更为明显， 25例 植皮， 1例皮瓣转位修复。
对照结果证实： 应用本发明的 VSD装置处理合并感染的软组织缺损的治疗效果明 显优于现有的 VSD装置。
从表 1、 表 2-1、 表 2-2、 表 2-3可知： 本发明 VSD装置比较在国内、 国外的现有的产品与各种与本专业相关的技术资料和文献，在临床实际的操 作方便性，对原理的充分理解和实施， 结构的科学合理安排等等方面都产生 了质的飞跃， 其优点或积极效果超出了本专业技术人员的想象。 需要说明的是： 对于所属领域的技术人员来说，在不改变本发明原理的 前提下还可以对本发明做出若干的改变或变形，这同样属于本发明的保护范

Claims

权 利 要 求 书
1、体表创面组织负压封闭引流装置， 它包括与体表创面接触的多孔泡 沫软垫 (1), 带侧孔的引流管 (2), 密封薄膜 (3), 接头 (4), 导管 (17)， 引流容 器 (5), 负压源 (6), 其特征在于它还包括胶膜 (7)和引出管 （8 ), 所述的胶膜 (7)位于多孔泡沫软垫 (1)的上方， 引流管 (2)上侧孔的开口方向与多孔泡沫软 垫 (1)接触， 所述引出管（8 )与引流管 (2)相通并位于胶膜 (7)的上方， 密封薄 膜 (3)密封在胶膜 (7)上， 引出管 (8)通过导管 (17)通入引流容器 (5)内， 引流容 器 (5)通过导管 (17)连接负压源 (6)。
2、根据权利要求 1所述的体表创面组织负压封闭引流装置，其特征在 于所述引流管 (2)位于多孔泡沫软垫 (1)和胶膜 (7)之间。
3、根据权利要求 1所述的体表创面组织负压封闭引流装置，其特征在 于所述引流管 (2)或为圓形， 或为扁形， 并位于胶膜 (7)的上端， 且与胶膜 (7) 为一体结构。
4、根据权利要求 1所述的体表创面组织负压封闭引流装置，其特征在 于在所述引出管（ 8 )和引流容器（ 5 )之间的导管（ 17)上连接有流量计（ 16)。
5、根据权利要求 2所述的体表创面组织负压封闭引流装置， 其特征在 于所述引流管 (2)与胶膜 (7)为一体结构。
6、根据权利要求 1或 2所述的体表创面组织负压封闭引流装置， 其特 征在于所述多孔泡沫软垫 (1)内有支柱（9 ), 所述支柱（9 ) 的一端位于多孔 泡沫软垫 (1)内， 所述支柱（9 )的另一端和 /或固定在引流管 (2)和胶膜 (7)上。
7、根据权利要求 4所述的体表创面组织负压封闭引流装置，其特征在 于在所述导管 (22)上连接有压力传感器 (20), 压力传感器 (20)连接 CPU(21), 所述的 CPU(21)与负压源 (6)连接。
8、根据权利要求 6所述的体表创面组织负压封闭引流装置， 其特征在 于所述在胶膜 (7)的四周覆盖有密封薄膜 (3)。
9、根据权利要求 6所述的体表创面组织负压封闭引流装置， 其特征在 于所述引流管 (2)为一根管。
10、 根据权利要求 6所述的体表创面组织负压封闭引流装置， 其特征 在于所述引流管 (2)为平行放置的二至五根管。
11、 根据权利要求 6所述的体表创面组织负压封闭引流装置， 其特征 在于所述引流管 (2)为至少二根交叉连接的一体式结构。
12、 根据权利要求 6所述的体表创面组织负压封闭引流装置， 其特征 在于所述支柱（9 )上有毛刺 （10 )。
13、 根据权利要求 7所述的体表创面组织负压封闭引流装置， 其特征 在于在所述引流容器 (5)和负压源 (6)之间的连接有细菌过滤器 (18)和气味过 滤器 (19)。
14、根据权利要求 11所述的体表创面组织负压封闭引流装置， 其特征 在于所述引流管 (2)或为"井"字型， 或为"十"字型， 或为"工"字型， 或为"米" 字型结构。
15、根据权利要求 12所述的体表创面组织负压封闭引流装置， 其特征 在于所述支柱（9 ) 为中空结构， 支柱（9 )与引流管 (2)相通， 支柱（9 )上 有小开孔（13 )。
16、根据权利要求 14所述的体表创面组织负压封闭引流装置， 其特征 在于所述引流管 (2)上连接有一至五个引出管 （8 ), 且引出管 （8 )与引流管 (2)为一体结构。
17、根据权利要求 15所述的体表创面组织负压封闭引流装置， 其特征 在于所述支柱（9 ) 的下端面为内凹的弧面（14)结构。
18、根据权利要求 16所述的体表创面组织负压封闭引流装置， 其特征 在于所述引出管 （8 )上有密封盖（11 )。
19、根据权利要求 18所述的体表创面组织负压封闭引流装置， 其特征 在于所述引出管 （8 )上有可密封的取样口（15)。
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