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WO2012075882A1 - 外科创面封闭式负压引流用创面填充敷料、制备方法及装置 - Google Patents

外科创面封闭式负压引流用创面填充敷料、制备方法及装置 Download PDF

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Publication number
WO2012075882A1
WO2012075882A1 PCT/CN2011/082578 CN2011082578W WO2012075882A1 WO 2012075882 A1 WO2012075882 A1 WO 2012075882A1 CN 2011082578 W CN2011082578 W CN 2011082578W WO 2012075882 A1 WO2012075882 A1 WO 2012075882A1
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Prior art keywords
wound
loofah
negative pressure
dressing
pressure drainage
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Ceased
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PCT/CN2011/082578
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English (en)
French (fr)
Inventor
陈德华
陈勇
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Individual
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Individual
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Publication date
Priority claimed from CN201010573765A external-priority patent/CN102038575B/zh
Priority claimed from CN 201110148013 external-priority patent/CN102284124A/zh
Application filed by Individual filed Critical Individual
Priority to DE212011100178U priority Critical patent/DE212011100178U1/de
Publication of WO2012075882A1 publication Critical patent/WO2012075882A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/24—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/30—Rubbers or their derivatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/40—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing ingredients of undetermined constitution or reaction products thereof, e.g. plant or animal extracts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/425—Porous materials, e.g. foams or sponges
    • 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
    • A61M1/915—Constructional details of the pressure distribution manifold

Definitions

  • the invention relates to a medical product description and preparation method, in particular to a wound filling dressing used in a surgical closed negative pressure drainage device, in particular to replace the costly porous sponge with a low cost loofah Wound-filled dressing and preparation method for surgical wound closed negative pressure drainage of wound surface suction head.
  • Vacuum-assisted Closure is a cutting-edge technology for wound healing in the 21st century. It has revolutionized wound treatment and is widely used in acute or chronic wounds and ulcers, large areas of soft tissue. Coverage and drainage of the wound under the condition of defect, tissue defect caused by war trauma or organ exposure.
  • This technology can accelerate the removal of necrotic tissue and exudate, eliminate bacterial breeding conditions, and reduce bacterial load; 2 eliminate inflammation and infection, and reduce wound edema; 3 improve local blood supply, reduce repair cell apoptosis, promote repair cell proliferation and migration, promote granulation; 4 bidirectional regulation of matrix metalloproteinases MMPs and hyaluronic acid HA levels, forming a wound microenvironment for healing, quickly advance Surgical treatment is ready for wound bed; 5 Reduce the number of dressing changes (5-7 days), save manpower, material resources, reduce the discomfort caused by routine dressing and dressing, and the area is refreshing, clean, without any odor, improve Casualty quality of life and wounds The quality of healing also reduces the economic burden.
  • the VAC can draw the wound tissue fluid out of the body by continuous vacuum suction, causing the tissue to swell. Under the action of negative pressure, the posterior load of small blood vessels is reduced after the tissue swelling subsides.
  • fresh blood flows to the wound, which leads to a significant increase in tissue blood and can improve local blood circulation.
  • closed vacuum suction devices can promote keratinocyte growth and protein synthesis through mechanical action. The decomposition of these transmembrane proteins can transmit extracellular signals into cells and promote cell proliferation. In an in vitro test of tissue proliferation, researchers have discovered that mechanical expansion of tissue can cause cell proliferation.
  • the inter-tissue pressure is reduced, the oxygen tension around the wound is reduced, the repair initiation signal is stimulated, the necrotic tissue is removed, the body secretes fibrinolytic activator and other enzymes, and autolysis is performed.
  • the expression of proto-oncogene C-fos and matrix metalloprotein decreased significantly after VAS treatment, which made the collagen component expressed by the wound protected, lost its tissue and effectively improved healing.
  • VAC The concept of VAC was first introduced by Fleischmann of ULM University of Germany. In 1996, the use of 25 patients with compartment syndrome was reported. The effect was good. Only one case developed necrosis. In 52 cases, only 5 cases of wound swab culture were detected. There is no infection in one case of bacteria, and it is believed that this technology can effectively clean and control wounds, promote granulation tissue proliferation, and accelerate healing. In 1997, Morykways and other studies found that the device can promote local blood circulation in wound wounds, promote the formation of post bud tissue, reduce the bacterial content of tissue, and improve the survival rate of flap or free skin graft. Later, Moues et al. confirmed that the negative pressure closed drainage technique significantly shortened the wound healing time compared with the traditional wet dressing.
  • VAC technology is a combination of traditional negative pressure drainage methods and closure dressings. It creates a negative pressure on the wound surface, producing mechanical and biological effects that promote wound healing. Therefore, it is necessary to use a special wound filling dressing.
  • the existing wound filling dressing consists of a porous sponge, a drainage tube and a film.
  • the porous sponge is a key technology, which requires the inside of the sponge to be kept unobstructed to ensure vacuum suction. The tissue can be sucked out normally.
  • the commonly used material is polyvinyl alcohol, and the diameter of the micropores is 0.2-1.0mm. The cost of polyvinyl alcohol is high and the manufacturing process is complicated. At present, it mainly relies on import and treatment for each patient. The large number required, resulting in high cost of such treatments, adds a heavy financial burden to patients. Therefore, it is imperative to develop a low-cost alternative.
  • the object of the present invention is to solve the problem of high cost of the filling dressing in contact with the wound surface used in the existing closed negative pressure drainage technology, and to invent a surgical wound closure based on pure natural material with low cost of loofah gluten.
  • the negative pressure drainage fills the dressing with the wound surface, and at the same time provides a preparation method of the wound filling dressing.
  • a wound filling dressing for surgical wound closed negative pressure drainage which is characterized in that it mainly consists of a formed loofah base, a microporous fabric or surface coating on the upper and lower surfaces of the loofah base or wrapped on the surface of the loofah rib base, covering The semi-permeable membrane which is closed and fixed on the microporous fabric on the upper surface of the loofah base and the negative pressure drainage tube inserted into the loofah matrix.
  • the microporous fabric is one or a combination of silk gauze, cotton gauze or perforated rubber.
  • a liquid replacement tube is also inserted into the base of the loofah.
  • the mature loofah ribs are seeded, washed, and dried for use; Secondly, the loofah rib is processed into a shape matching the shape of the wound by compression, cutting, etc., and the thickness thereof is controlled to not exceed 4 cm;
  • the micro-porous fabric is used to wrap the loofah or the surface of the loofah rib is coated with microporation; fifth, the formed loofah rib is sterilized by epoxy aceta or steam sterilization; The loofah obtained by the above preparation is placed in an aseptic packaging bag to fill the dressing based on the wound of the loofah rib.
  • the semi-permeable membrane for sealing and fixing on the surface of the microporous fabric and the attachment of the suction tube can be pre-filled with the wound filling dressing and can be added to the package or added during use.
  • the microporous fabric is one or a combination of silk gauze, cotton gauze or perforated rubber.
  • the above preparation method further comprises attaching a semipermeable membrane to the surface of the wound filling dressing and inserting a negative pressure drainage tube and/or a refilling tube into the wound filling dressing.
  • a wound filling dressing for surgical wound closed negative pressure drainage which is characterized in that it mainly consists of a loofah matrix which is matched with the shape of the wound surface, a microporous fabric on the upper and lower surfaces of the loofah rib base or a surface of the loofah rib base, covered in the loofah
  • the microporous fabric on the upper surface of the rib base body is composed of a semipermeable membrane and a negative pressure drainage tube or a vacuum suction tray, and a retractable window is disposed on the semipermeable membrane.
  • the uncovered window is a glue-free area, and is in a sealed state when uncovered.
  • the vacuum suction tube When the vacuum suction tube is used, the vacuum suction tube is inserted into the loofah matrix, and when the vacuum suction tray is used, the vacuum suction tray is used. Adsorbed on the substrate of the loofah through the semipermeable membrane.
  • a surgical wound closed negative pressure drainage device comprising a negative pressure source, a porous dressing matched to the shape of the wound surface, a semipermeable membrane required for a movable closed cavity on the porous dressing, and a negative pressure drainage inserted in the porous dressing
  • the tube is provided with a releasable window on the semipermeable membrane, and the releasable window is a glue-free area and is in a sealed state when not uncovered.
  • the releasable window is in the central region of the semipermeable membrane, and the releasable window is sealed by a removable sealing strip.
  • the peripheral edge region of the semipermeable membrane is a gas permeable, watertight, adhesive region.
  • the device further comprises a microporous fabric layer, a sterile transparent wear-resistant film paste, and a semi-permeable membrane disposed on the porous dressing, and the transparent transparent wear-resistant patch and the semi-permeable membrane are closely attached to form a transparent region.
  • the microporous fabric layer is one or more of silk gauze, cotton gauze, chemical fiber gauze or perforated rubber and plastic. Combination of species.
  • the device uses a mask instead of a negative pressure drainage tube, and the mask is connected to the uncoverable window of the semipermeable membrane.
  • the semi-permeable membrane can be uncovered with a window area of 1.5 to 2 times the area of the porous dressing.
  • the device also includes a fluid replacement tube that is inserted into the porous dressing.
  • the negative pressure drainage tube is externally connected to a portable mechanical negative pressure device.
  • the porous dressing is a polyvinyl alcohol foam, a porous foam, a sponge, or a loofah dressing having a surface covering microporous fabric.
  • the invention adopts the plant material which is originally useless or only used for household dish washing and bathing... - Loofah gluten (or loofah) as a medical material, making full use of the characteristics of its internal structure, is an all-natural biological material, Non-toxic and pollution-free.
  • Loofah gluten has a large pore size, which provides a more continuous and strong negative pressure than the polyvinyl alcohol foaming material. It will not block the drainage tube and keep the wound clean.
  • the silk protein and human skin keratin structure very similar characteristics, as the loofah surface coating material, increase the smoothness of the surface of the loofah and the microporation of the surface of the loofah (the diameter of the microfilament of the silk gauze is 0.2-1.0mm)
  • the granulation of the wound is uniform and the silk protein can promote the shrinkage of the inflammatory wound and promote the secretion of collagen.
  • the invention has the advantages of low cost, simple structure and convenient manufacture, and the raw material and manufacturing cost are only about one percent of similar products, which can greatly reduce the medical cost, and thus is beneficial to the promotion of the closed vacuum suction technology.
  • the wound targeted by the present invention is a skin incision, and a closed negative pressure drainage technique is used for the wound of the skin incision.
  • a closed negative pressure drainage technique is used for the wound of the skin incision.
  • the negative pressure of the present invention employs a portable negative pressure mechanical device that can be operated at any time.
  • the invention can also be used as a medical material, which is originally useless or only used as a household material for washing and bathing in the home - ... a loofah gluten (or loofah), which makes full use of the characteristics of its internal structure, is an all-natural organism. Material, non-toxic and pollution-free. 10, loofah ribs large pore size, compared with polyvinyl alcohol foam material, can provide more continuous and strong negative pressure, will not block the negative pressure drainage tube, can keep the wound clean.
  • the silk protein and human skin keratin structure very similar characteristics, as the surface covering or wrapping material of the loofah rib, increasing the surface finish of the loofah rib and microporing the surface of the loofah (the diameter of the microfilament of the silk gauze is 0.2-1.0mm)
  • the silk protein can promote the shrinkage of the inflammatory wound and promote the secretion of collagen.
  • the loofah rib base can be subjected to chitin coating and silver ion soaking antibacterial treatment, and will not be corroded during use.
  • the invention has the advantages of low cost, simple structure and convenient manufacture, and the raw material and manufacturing cost are only about one percent of similar products, which can greatly reduce the medical cost, and thus is beneficial to the promotion of the closed vacuum suction technology.
  • FIG. 1 is a schematic view showing the structure of a closed wound filling dressing of the present invention.
  • Figure 2 is a second schematic view of the structure of the closed wound dressing of the present invention.
  • Figure 3 is a plan view of Figure 2.
  • a wound filling dressing for surgical wound closed negative pressure drainage which is mainly composed of a loofah base 1, a microporous bottom layer 2, a microporous fabric surface layer 3, a semipermeable membrane 4 and a suction tube 5, and the loofah base 1
  • the thickness can be controlled within 4 cm, and it is located between the bottom layer 2 of the microporous fabric and the top layer 3.
  • the bottom layer 2 of the microporous fabric and the surface layer 3 can be connected to form a bag structure or not connected to each other.
  • 4 is a material that is permeable to gas but not permeable to water.
  • the liquid is passed through the bottom layer 2 of the microporous fabric into the loofah base 1 and then into the loofah
  • the suction tube 5 in the rib base 1 is sucked into the drainage bottle.
  • the supplemental tube 6 can also be inserted into the loofah base 1 to supplement the wound or the nutrient solution with the positive pressure system.
  • the semi-permeable membrane 4 for closure is used to seal the wound surface of the dressing. It is required to pass the gaseous molecules without passing through the liquid molecules, and has a certain negative barrier to the bacteria.
  • the currently used polyurethane semipermeable membrane can be used.
  • the drainage tube 5 can be used for filling the inside of the loofah rib base 1 according to the condition of the wound surface, and adopting a porous structure and requiring a certain hardness, and a silicone tube or a polymer plastic tube can be used.
  • a central vacuum suction device of the hospital, a surgical vacuum tube, and a commercially available vacuum assisted therapeutic device can be used, and a portable negative pressure generator disclosed in Chinese Patent No. 012469912 can also be used.
  • the microporous fabric is one of silk gauze, cotton gauze or perforated rubber or other material coating capable of generating micropores, wherein silk gauze is the best, silk fibroin in silk gauze It has very similar characteristics to human skin keratin structure.
  • As a surface covering or wrapping material of loofah it can increase the surface smoothness of loofah and microporous surface of loofah (microfilament diameter of silk gauze is 0.2-1.0mm), making wound granulation
  • the growth is uniform, and silk fibroin can promote the shrinkage of inflammatory wounds and promote collagen secretion.
  • the manufacturing process of the wound filling dressing for the surgical wound closed negative pressure drainage of the present invention is as follows: First, the mature loofah ribs are seeded, washed and dried for use;
  • the loofah ribs are processed into a shape matching the shape of the wound by compression, cutting, etc., and the thickness is controlled to be no more than 4 cm; the shape can be cut into various shapes according to clinical needs, such as a long strip, a square, a circle, an ellipse. , triangles, etc.;
  • micro-porous fabric such as silk gauze, cotton gauze or perforated rubber
  • the micro-porous fabric is wrapped around the loofah or coated on the surface of the loofah;
  • the formed loofah ribs are sterilized by epoxy oxime or steam sterilization; finally, the loofah gluten obtained by the above preparation is placed in an aseptic packaging bag, and the wound dressing based on the loofah gluten is filled. Open the package, attach a semi-permeable membrane for sealing and fixing on the upper surface of the loofah including the microporous material, and connect one end of the suction tube to the negative pressure source to start working, negative pressure
  • the negative pressure of the source is preferably a controllable, adjustable negative pressure generator, and the operating voltage of the negative pressure generator is
  • Man-machine dialogue setting data liquid crystal display, there are two modes of operation, continuous and intermittent, and there are alarm systems such as tilting, draining bottle full, and leaking gas. It is also best to have a backup power supply so that the treatment is not interrupted in the event of a power outage and the injured person must leave.
  • the wound filling dressing of the invention has a smooth circulation, so the patient recovery period is shortened by an average of one and a half days, and the cost of the dressing is reduced. It is only less than 10% of imported dressings, which greatly reduces the economic burden of patients and has a good promotion value.
  • a wound filling dressing for surgical wound closed negative pressure drainage which mainly consists of a loofah rib base matched with the shape of the wound surface, a microporous fabric on the upper and lower surfaces of the loofah rib base or wrapped on the surface of the loofah rib base, and covered on the loofah rib base
  • the microporous fabric of the surface is composed of a semipermeable membrane and a negative pressure drainage tube or a vacuum suction tray, and a retractable window is disposed on the semipermeable membrane, and the releasable
  • the window is a rubber-free zone, and is in a sealed state when uncovered.
  • the vacuum suction pipe When a vacuum suction pipe is used, the vacuum suction pipe is inserted into the base of the loofah, and when the vacuum suction disk is used, the vacuum suction disk passes through the semi-transparent. The membrane is adsorbed on the loofah matrix.
  • a surgical wound closure type negative pressure drainage device mainly comprises a porous dressing 1, a semipermeable membrane 4 and a negative pressure drainage tube 5 inserted in the porous dressing 1, the porous dressing 1
  • the thickness can be controlled within 4 cm, covering the skin incision, and then the semipermeable membrane 4 required to form a closed cavity in which the porous dressing 1 is movable is disposed on the porous dressing 1, and the semipermeable membrane 4 is provided with an observable skin incision.
  • the uncoverable window 2 is provided for the negative pressure drainage tube 5 to pass through.
  • the uncoverable window 2 on the semipermeable membrane 4 is uncovered, and the porous porous dressing 1 is moved due to the uncovered window 2
  • the bottom is a glue-free area, so the movement of the porous dressing 1 can be performed.
  • a glue-free area can also be partially disposed.
  • a surgical wound closed negative pressure drainage device mainly comprises a porous dressing 1, a semipermeable membrane 4 and a negative pressure drainage tube 5 inserted in the porous dressing 1.
  • the porous dressing 1 is used.
  • the porous foam has a thickness controlled within 4 cm, covering the skin incision, and then a semipermeable membrane 4 required to form a movable cavity of the porous dressing 1 is disposed on the porous dressing 1, and the central portion of the semipermeable membrane 4 is releasable
  • the opened window 2, the uncoverable window 2 is a transparent area without glue, and the uncoverable window 2 has three sides as an opening, one side is in a closed state, and the opening is sealed by a detachable sealing paste, and the semipermeable membrane 4 is
  • the peripheral edge area is a permeable, watertight, adhesive area.
  • the uncoverable window 2 is provided for the passage of the negative pressure drainage tube 5.
  • the uncoverable window 2 on the semipermeable membrane 4 is uncovered, and the porous dressing 1 is moved; when the wound is observed, the half is closed.
  • the membrane 4 the three-sided opening of the releasable window 2 on the semipermeable membrane 4 is sealed by a sealing paste.
  • a surgical wound closed negative pressure drainage device is mainly composed of a porous dressing 1, a microporous fabric bottom layer 2, a microporous fabric surface layer 3, a semipermeable membrane 4, and a porous dressing 1
  • the sponge is used, and the thickness is controlled within 4 cm. It is located between the bottom layer 2 of the microporous fabric and the surface layer 3.
  • the bottom layer 2 of the microporous fabric and the surface layer 3 can be connected to form a bag structure, or can be disconnected from each other.
  • the central area of the membrane 4 is a releasable window 2
  • the uncoverable window 2 is a gel-free transparent area
  • the uncoverable window 2 is elliptical
  • one side is closed
  • the opening is detachably sealed.
  • the seal is sealed, and the peripheral edge region of the semipermeable membrane 4 is a gas permeable, watertight, adhesive region.
  • the uncoverable window 2 on the semipermeable membrane 4 is uncovered, and the porous dressing 1 is moved; when the wound is observed, the semipermeable membrane 4 is closed, and the semipermeable membrane 4 is uncoverable.
  • the opening of the window 2 is sealed by a sealing paste.
  • the releasable window 2 of the semipermeable membrane 4 is attached with a mask instead of the negative pressure drainage tube.
  • the semi-permeable membrane 4 can be uncovered by a window 2 having an area 1.5 times that of the porous dressing 1 area.
  • a surgical wound closure type negative pressure drainage device mainly comprises a porous dressing 1, a microporous bottom layer 2, a microporous fabric surface layer 3, and a movable cavity formed by the porous dressing 1.
  • the semi-permeable membrane 4 and the negative pressure drainage tube 5 are required.
  • the porous dressing 1 adopts a loofah matrix and the thickness can be controlled within 4 cm. It is located between the bottom layer and the surface layer of the microporous fabric, and the bottom layer and the surface layer of the microporous fabric.
  • the surrounding areas can be connected into a bag-like structure, or they can be disconnected from each other.
  • the central area of the semi-permeable membrane 4 is a releasable window 2, and there is a transparent area with no glue and opening, which facilitates the movement of the loofah rib base to observe the wound, and the semi-permeable membrane.
  • the peripheral edge region of 4 is a gas-permeable and water-tight adhesive zone, and a transparent transparent wear-resistant film paste 2, a semi-permeable membrane 4 and a sterile transparent wear-resistant sticker are disposed between the microporous fabric layer and the semipermeable membrane 4 .
  • the negative pressure drainage tube and the rehydration tube are passed, or the mask of the negative pressure drainage tube and the rehydration tube is attached, and the opening is sealed by a detachable sealing paste.
  • Its main function is to form a closed environment around the wound so that a negative pressure can be formed by the negative pressure generator in a closed environment, thereby facilitating the wound exudate to pass through the bottom layer of the microporous fabric into the loofah matrix, and then The negative pressure drainage tube 5 extending into the loofah matrix is sucked into the drainage bottle.
  • the supplemental tube 6 can also be inserted into the loofah matrix to supplement the wound or the nutrient solution through the positive pressure system.
  • the semipermeable membrane 4 for sealing is used for sealing the wound surface of the dressing. It is required to pass the gaseous molecules and not the liquid molecules, and has certain barrier properties to the bacteria.
  • the currently used polyurethane semipermeable membrane can be used.
  • the negative pressure drainage tube 5 can use a single or multiple drainage according to the wound condition, and is buried in the inside of the loofah rib base. The porous structure and a certain hardness are required, and a silicone tube or a polymer plastic tube can be used. Replace the negative pressure drainage tube and the rehydration tube with a mask, and attach it to the opening in the transparent area window to become a mask type skin incision sticker.
  • the vacuum suction device uses a portable mechanical vacuum suction disk.
  • the microporous fabric is silk gauze
  • the silk fibroin in the silk gauze has very similar characteristics to the human skin keratin structure, and as the surface covering or wrapping material of the loofah rib can increase the surface smoothness of the loofah and the loofah
  • the surface is microporous (the diameter of the microfilament of the silk gauze is 0.2-1.0mm), so that the granulation growth of the wound is uniform, and the silk protein can promote the shrinkage of the inflammatory wound and promote the secretion of collagen.
  • the negative pressure drainage tube 5 can use a single or multiple drainage according to the condition of the wound surface, and is buried in the inside of the loofah rib base.
  • the porous structure and a certain hardness are required, and a silicone tube or a polymer plastic tube can be used.
  • a portable mechanical vacuum suction tray is used.
  • the wound filling dressing of the invention has a better gas permeability, so the patient recovery cycle is shortened by an average of one and a half days, and the dressing is used.
  • the cost is only less than 10% of imported dressings, which greatly reduces the economic burden of patients and has a good promotion value.
  • porous dressing is a polyethylene alcohol hydrated seaweed salt foam dressing.

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Description

外科创面封闭式负压引流用创面填充敷料、制备方法及装置 技术领域
本发明涉及一种医疗用品说及制备方法， 尤其是一种外科封闭式负压引流 装置中使用的创面填充敷料， 具体地说一种用价格低廉的丝瓜筋代替成本很 高的多孔海棉作为创面过滤吸引头的外科创面封闭式负压引流用创面填充敷 料及制备方法。
背景技术 书
封闭负压引流技术 （Vacuum-assisted Closure, VAC) 是 21世纪创面治 疗的前沿技术， 使创面治疗发生了革命性变化， 被广泛应用于体表急性或慢 性各种伤口及溃疡面、 大面积软组织缺损、 战外伤所致组织缺损或脏器外露 等性况下创面的覆盖及引流。
传统的治疗方法对于那些损伤重， 污染重， 累及多种组织和多致伤因素 引起的复杂伤较为棘手， 感染、 坏疽和截肢率高， 并发症多， 各种原因形成 的慢性创面很难愈合， 卫生资源和人力消耗大， 即使能够愈合， 愈合质量也 不佳， 与现代人生活节奏和需要极不和谐。 创面难以愈合的原因是： ①顽固 性炎症、 感染和水肿； ②局部血运差， 难以形成健康创基； ③瘢痕形成或恶 性变； ④修复细胞增殖、 移行受阻， 不能形成有利于愈合的创面微环境。 相 比之下， VAC 技术显示了突出的优越性， 研究证明： 该技术能①加速坏死组 织和渗出物的清除， 消除细菌繁殖条件， 减轻细菌负荷； ②消除炎症和感染， 减轻创面水肿； ③改善局部血供， 减少修复细胞凋亡， 促进修复细胞增殖和 迁移，促进肉芽形成；④双向调节基质金属蛋白酶 MMPs和透明质酸 HA水平， 形成有利于愈合的创面微环境， 迅速为进一歩手术治疗准备好创面床； ⑤减 少换药次数 ( 5-7 天一次） ， 节约人力、 物力、 减少常规换药包扎给伤员带 来的不适， 而且创区清爽， 干净， 无任何异味， 提高了伤员生活质量和创面 愈合质量， 也减少了经济负担。 此外， 普通外科、 骨科、 心外科、 胸外科均 有广泛应用潜力， 还能显著促进各种组织瓣成活， 减轻深二度烧伤损伤， 减 少皮肤软组织爆炸伤创面细菌量和挽救间生态组织， 减少继发性坏死。
VAC 可以通过持续负压吸引将创面组织液吸出至体外， 使得组织肿胀消 退。 负压作用下组织肿胀消退后小血管后负荷降低， 对于外科创面， 新鲜血 液涌向创口， 导致组织血液明显增加， 可以改善局部血液循环情况。 目前研 究表明封闭负压吸引装置可以通过机械作用促进角质化细胞生长和蛋白质合 成，这些跨膜蛋白的分解可以传送细胞外信号到细胞内，促进细胞发生增殖。 在组织增殖的体外试管试验中， 学者们发现组织的机械膨胀可以使得细胞增 殖。 动物试验中也发现使用负压吸引可使得伤口肉芽组织形成迅速， 而普通 敷料无这种效果， 说明细胞复制不仅需要化学因素的刺激， 也依赖一定细胞 支架的张力作用， 这是伤口愈合的重要组织环境。 负压装置处理创面后其边 缘和底部在负压作用下发生组织移位， 创面的表面被吸到敷料的泡沬细孔引 起微小的局部微环境变化。 持续负压吸引的局部条件下， 细菌的生长系列受 到了明显的抑制， 从而促进伤口的愈合。 在创面的局部内环境中， 由于负压 作用， 降低了组织间压力， 伤口周围的氧张力下降， 刺激修复启动信号， 清 除坏死组织， 机体分泌纤溶蛋白激活物及其他酶释放， 进行自溶性清创， VAS 治疗后原癌基因 C-fos、 基质金属蛋白等表达均明显下降， 使得创面表达的 胶原成份得到保护， 组织其丧失， 有效改善愈合。
VAC的概念最早由德国 ULM大学 Fleischmann等介绍， 1996年报道了 25 例骨筋膜室综合征病人的使用情况， 效果良好， 仅 1例发生坏死， 52例术中 创面拭子培养仅 5例检出细菌无 1例出现感染， 据此认为该项技术能够有效 清理和控制创面， 促进肉芽组织增生， 加快愈合。 1997年， Morykways等研 究发现该装置可以促进伤口创面局部血液循环， 促进岗位芽组织生成， 减少 组织细菌含量， 提高皮瓣或游离植皮存活率。 后来 Moues等证实， 负压封闭 引流技术与传统的湿润敷料包扎相比， 显著缩短伤口愈合时间。 Fbaian通过 试验研究发现负压引流与高压氧治疗相比更能促进肉芽组织增生； Couttefangeas发现伤口充填的辅料上浸润的细胞主要为粒细胞成分， CD4 (+) 功能 T细胞可以促进创面内的清洁， 提供良好的微环境。 Labanaris等 2009 年研究发现 VSD可以促进创面周围组织淋巴管网的增生。 起来越多的学者通 过大量的研究和临床实践证实了 VSD技术的临床应用效果， 并将其理论研究 不断改进， 2003年德国、 奥地利等国将该技术纳入创口治疗指南。
VAC技术是将传统的负压引流方法与封闭性敷料相结合的产物，它通过 在创面形成负压， 产生机械和生物学效应， 促进创面愈合。 因此必须使用专 用的创面填充敷料， 现有的创面填充敷料方要由多孔海绵、 引流管和贴膜组 成， 其中的多孔海棉是关键技术， 它要求海棉内部要保持通畅， 以确保负压 吸引出的组织能被正常吸出， 常用材料为聚乙烯醇， 且要求泡沬微孔直径在 0.2-1.0mm, 而聚乙烯醇成本高， 制造工艺复杂， 目前主要依赖于进口， 同时 每个患者治疗所需的数量较多， 造成此类治疗方法成本很高， 给患者增加了 沉重的经济负担。 因此， 开发一种低成本的替代产品是当务之急。
发明内容
本发明的目的是针对现有的封闭式负压引流技术中使用的与创面相接触 的填充敷料成本很高的问题， 发明一种基于丝瓜筋的成本很低的纯天然材料 制备的外科创面封闭式负压引流用创面填充敷料， 同时提供这种创面填充敷 料的制备方法。
本发明的技术方案之一是：
一种外科创面封闭式负压引流用创面填充敷料， 其特征是它主要由加工 成形的丝瓜筋基体、 位于丝瓜筋基体上下表面或包裹在丝瓜筋基体表面的微 孔面料或表面涂层、 覆盖在丝瓜筋基体上表面的微孔面料上起封闭和固定作 用的半透膜以及插入丝瓜筋基体中的负压引流管组成。
所述的微孔面料为蚕丝纱布、 棉丝纱布或带孔橡胶中的一种或其组合。 所述的丝瓜筋基体中还插装有补液管。
本发明的技术方案之二是：
一种权利要求 1所述的创面填充敷料的制备方法， 其特征是它包括以下 歩骤：
首先， 将成熟的丝瓜筋去籽、 清洗、 干燥备用； 其次， 将丝瓜筋通过压缩、 切割等加工成与创面外形相配的形状， 控制 其厚度不超过 4厘米；
第三， 将引流管的一端插入丝瓜筋中。
第四， 用微孔面料包裹丝瓜筋或在丝瓜筋的表面进行涂层微孔化处理； 第五， 将成形的丝瓜筋进行灭菌， 可采用环氧乙垸或蒸汽灭菌； 最后， 将上述制备所得的丝瓜筋置于无菌包装袋中即得基于丝瓜筋的创 面填充敷料。 位于微孔面料表面的起密封和固定作用的半透膜以及吸引管等 附件可预先与创面填充敷料连接好一起装入包装袋中，也可在使用时再添加。
所述的微孔面料为蚕丝纱布、 棉丝纱布或带孔橡胶中的一种或其组合。 上述制备方法还包括在创面填充敷料表面帖装半透膜以及向创面填充敷 料中插装负压引流管和 /或补液管。
本发明的技术方案之三是：
一种外科创面封闭式负压引流用创面填充敷料， 其特征是它主要由与创 面外形相配的丝瓜筋基体、 位于丝瓜筋基体上下表面或包裹在丝瓜筋基体表 面的微孔面料、 覆盖在丝瓜筋基体上表面的微孔面料上起封闭和固定作用的 半透膜和负压引流管或负压吸引盘组成， 在所述的半透膜上设置有可揭开的 窗口， 所述的可揭开的窗口为无胶区， 且在未揭开时为密封状态， 采用负压 吸引管时， 所述的负压吸引管插入丝瓜筋基体中， 采用负压吸引盘时， 负压 吸引盘穿过半透膜吸附在丝瓜筋基体上。
本发明的技术方案之四是：
一种外科创面封闭式负压引流装置， 它包括负压源、与创面外形相配的多孔敷料， 在 多孔敷料上可移动的封闭腔所需的半透膜和插入在多孔敷料中的负压引流管，在所述的半 透膜上设置有可揭开的窗口， 所述的可揭开的窗口为无胶区， 且在未揭开时为密封状态。
所述可揭开的窗口在半透膜的中央区，可揭开的窗口通过可装可卸的密封贴密封，半 透膜的四周边缘区为透气不透水的有胶粘性区。
所述的装置还包括在多孔敷料上依次设置有微孔面料层、无菌透明耐磨膜贴、半透膜， 无菌透明耐磨贴和半透膜紧密贴附形成透明区。
所述的微孔面料层为蚕丝纱布、棉丝纱布、化纤纱布或带孔橡胶、塑料中的一种或几 种的组合。
所述的装置使用面罩代替负压引流管， 面罩与半透膜可揭开的窗口连接。
所述的半透膜可揭开的窗口面积为多孔敷料面积的 1.5 ~ 2倍。
所述的装置还包括插入多孔敷料中的补液管。
所述的负压引流管外接便携式机械负压装置。
所述的多孔敷料为聚乙烯醇泡沫、多孔泡沫、海绵、或者表面覆盖微孔面料的丝瓜筋 敷料。
本发明的有益效果：
1.本发明采用原本无用或仅作为家庭洗碗、 洗澡用的植物材料… -丝瓜筋 (或称丝瓜瓤） 作为医用材料， 充分利用其内部结构通畅的特点， 是一种全 天然生物材料， 无毒无公害。
2.丝瓜筋大孔径， 较聚乙烯醇泡沬材料， 能提供更为持续强力的负压， 不会堵塞引流管， 能持续保持伤口清洁。
3.利用蚕丝蛋白与人体皮肤角质朊结构极为相似特性， 作为丝瓜筋表面 包裹材料，增加丝瓜筋表面的光洁度及对丝瓜筋表面微孔化 (蚕丝纱布微孔直 径在 0.2-1.0mm)， 使创面肉芽生长均匀一致， 并且蚕丝蛋白能促进炎症伤口 缩小、 促进胶原蛋白分泌。
4.有利于促进农业发展， 发展低碳经济， 保护农业耕地， 保护自然环境。
5. 本发明成本低廉， 结构简单， 制造方便， 原材料及制造成本仅为同类 产品的百分之一左右， 可大大降低医疗成本， 因此有利于封闭负压吸引技术 的推广。
6. 本发明针对的伤口为皮肤切口， 采用皮肤切口创面使用封闭式负压引流技术， 在 使用这种装置时， 可进行伤口的愈合程度的观察， 方便医生的诊断；
7.观察皮肤切口的时候不需要整个更换封闭式负压引流的敷料、面料层， 节约成本。
8. 本发明的负压采用可携带的负压机械装置， 可随时进行操作。
9. 本发明也可采用原本无用或仅作为家庭洗碗、 洗澡用的植物材料-…丝瓜筋（或称 丝瓜瓤）作为医用材料， 充分利用其内部结构通畅的特点， 是一种全天然生物材料， 无毒 无公害。 10、 丝瓜筋大孔径， 较聚乙烯醇泡沫材料， 能提供更为持续强力的负压， 不会堵塞负 压引流管， 能持续保持伤口清洁。
11、利用蚕丝蛋白与人体皮肤角质朊结构极为相似特性，作为丝瓜筋表面覆盖或包裹 材料，增加丝瓜筋表面的光洁度及对丝瓜筋表面微孔化 (蚕丝纱布微孔直径在 0.2-1.0mm)， 使创面肉芽生长均匀一致， 并且蚕丝蛋白能促进炎症伤口缩小、 促进胶原蛋白分泌。
12、 丝瓜筋基体可以进行甲壳素涂层、 银离子浸泡抗菌处理， 在使用时不会被腐蚀。
13、 有利于促进农业发展， 发展低碳经济， 保护农业耕地， 保护自然环境。
14、本发明成本低廉， 结构简单， 制造方便， 原材料及制造成本仅为同类产品的百分 之一左右， 可大大降低医疗成本， 因此有利于封闭负压吸引技术的推广。 画髓
图 1是本发明的封闭式创面填充敷料的结构示意图之一。
图 2是本发明的封闭式创面填充敷料的结构示意图之二。
图 3是图 2的俯视图。
图 3 中： 1-多孔敷料； 2-可揭开的窗口； 3-无菌透明耐磨膜贴； 4-半透膜； 5-负压引 流管； 6-补流管。 具体实 式
下面结合附图和实施例对本发明作进一歩的说明。
实施例一。
如图 1所示。
一种外科创面封闭式负压引流用创面填充敷料， 它主要由丝瓜筋基体 1、 微孔面料底层 2、 微孔面料面层 3、 半透膜 4和吸引管 5组成， 丝瓜筋基 体 1的厚度可控制在 4厘米以内， 它位于微孔面料底层 2和面层 3之间， 微 孔面料底层 2和面层 3的四周可以相连成一个袋状结构， 也可互不相连， 半 透膜 4是一种能透过气体但不能透过水的材料， 它的主要作用是在创口表面 形成一个封闭的环境， 以便能在封闭的环境中通过负压发生器形成负压， 进 而便于创面渗出液透过微孔面料底层 2进入丝瓜筋基体 1中， 再从伸入丝瓜 筋基体 1中的吸引管 5吸入引流瓶中， 必要时， 丝瓜筋基体 1中还可插入补 流管 6， 以便通过正压系统为创面补充治疗液或营养液。 封闭用的半透膜 4 用于封闭敷料创面， 要求是可以通过气态分子而不通过液体分子， 对细菌有 一定的阴隔性， 可采用目前常用的聚氨脂半透膜。 引流管 5可根据创面情况 使用单根及多根引流，埋填于丝瓜筋基体 1内部 ，采用多孔结构并需要一定 的硬度， 可采用硅胶管或高分子塑料管。 对于负压吸引装置， 既可使用医院 的中心负压吸引装置、 外科真空管以及现有市售的真空辅助治疗仪， 也可采 用中国专利 012469912所公开的一种便于携带的负压发生器。
具体实施时， 所述的微孔面料为蚕丝纱布、 棉丝纱布或带孔橡胶中的一 种或其他能产生微孔的材料涂层， 其中以蚕丝纱布为最佳， 蚕丝纱布中的蚕 丝蛋白与人体皮肤角质朊结构极为相似特性， 作为丝瓜筋表面覆盖或包裹材 料，能增加丝瓜筋表面的光洁度及对丝瓜筋表面微孔化 (蚕丝纱布微孔直径在 0.2-1.0mm), 使创面肉芽生长均匀一致， 并且蚕丝蛋白能促进炎症伤口缩小、 促进胶原蛋白分泌。
实施例二。
本发明外科创面封闭式负压引流用创面填充敷料的制造歩骤如下： 首先， 将成熟的丝瓜筋去籽、 清洗、 干燥备用；
其次， 将丝瓜筋通过压缩、 切割等加工成与创面外形相配的形状， 控制 其厚度不超过 4厘米； 形状可根据临床需要切成各种形状， 如长条形、方形、 圆形、 椭圆形、 三角形等；
第三， 将引流管的一端插入丝瓜筋中 （也可在临床使用时插装）， 必要 时还应插装一根补液管。
第四， 用微孔面料 （如蚕丝纱布、 棉丝纱布或带孔橡胶） 包裹丝瓜筋或 在丝瓜筋的表面进行涂层微孔化处理；
第五， 将成形的丝瓜筋进行灭菌， 可采用环氧乙垸或蒸汽灭菌； 最后， 将上述制备所得的丝瓜筋置于无菌包装袋中即得基于丝瓜筋的创 面填充敷料， 现场打开包装， 在包括有微孔材料的丝瓜筋的上表面贴上起密 封和固定作用的半透膜， 将吸引管的一端与负压源相连即可开始工作， 负压 源的负压最好是采用可控、 可调的负压发生器， 负压发生器的工作电压为
220V电源， 负压工作范围 -50〜- 400mmHg， 压力间隔 -10mmHg。 工作时间设置 默认值 20小时（间隔 5小时）， 间断时间设置默认值 2分钟（间隔 1分钟）。 人机对话设置数据， 液晶显示， 有持续和间歇两种工作方式， 并设有倾斜、 引流瓶满、 漏气等告警系统。 最好是还带有备用电源， 以便在停电和伤员必 须离开时不中断治疗。
通过将本发明的丝瓜筋制造的创面填充敷料与进口创面填充敷料的一 百组对比试验发现， 本发明的创面填充敷料由于引流通畅， 因此患者痊愈周 期平均缩短一天半， 而敷料所使用的费用仅为进口敷料的 10%不到， 大大降 低了患者了经济负担， 具有很好的推广价值。
实施例三。
一种外科创面封闭式负压引流用创面填充敷料， 它主要由与创面外形相 配的丝瓜筋基体、 位于丝瓜筋基体上下表面或包裹在丝瓜筋基体表面的微孔 面料、 覆盖在丝瓜筋基体上表面的微孔面料上起封闭和固定作用的半透膜和 负压引流管或负压吸引盘组成， 在所述的半透膜上设置有可揭开的窗口， 所 述的可揭开的窗口为无胶区，且在未揭开时为密封状态，采用负压吸引管时， 所述的负压吸引管插入丝瓜筋基体中， 采用负压吸引盘时， 负压吸引盘穿过 半透膜吸附在丝瓜筋基体上。
实施例四。
如图 2和图 3所示， 一种外科创面封闭式负压引流用装置， 它主要由多孔敷料 1、 半 透膜 4和插入在多孔敷料 1的负压引流管 5组成，多孔敷料 1的厚度可控制在 4厘米以内， 它覆盖皮肤切口，然后在多孔敷料 1的上面设置有形成多孔敷料 1可移动的封闭腔所需半 透膜 4， 半透膜 4上设置有可观察皮肤切口的可揭开的窗口 2， 可供负压引流管 5通过， 当需要观察伤口的愈合情况时， 揭开半透膜 4上可揭开的窗口 2， 移动多孔敷料 1由于在 揭开的窗口 2下方是无胶区域，所以可以进行多孔敷料 1的移动，在半透膜 4的四周边缘 区也可以部分设置有无胶区域， 当观察完伤口， 关闭半透膜 4， 把半透膜 4上可揭开的窗 口 2密封。
实施例五。 如图 2和图 3所示， 一种外科创面封闭式负压引流用装置， 它主要由多孔敷料 1、 半 透膜 4和插入在多孔敷料 1的负压引流管 5组成，多孔敷料 1采用多孔泡沫，厚度控制在 4厘米以内， 它覆盖皮肤切口， 然后在多孔敷料 1的上面设置有形成多孔敷料 1可移动的 封闭腔所需半透膜 4， 半透膜 4的中央区为可揭开的窗口 2， 可揭开的窗口 2为无胶透明 区，可揭开的窗口 2有三边为开口，一边为封闭状态，开口处通过可装可卸的密封贴密封， 半透膜 4的四周边缘区为透气不透水的有胶粘性区。 可揭开的窗口 2可供负压引流管 5 通过， 当需要观察伤口的愈合情况时， 揭开半透膜 4上可揭开的窗口 2， 移动多孔敷料 1 ; 当观察完伤口， 关闭半透膜 4， 把半透膜 4上的可揭开的窗口 2的三边开口处通过密封贴 进行密封。
实施例六
如图 2和图 3所示， 一种外科创面封闭式负压引流用装置， 它主要由多孔敷料 1、 微 孔面料底层 2、 微孔面料面层 3、 半透膜 4组成， 多孔敷料 1采用海绵， 厚度控制在 4厘 米以内，它位于微孔面料底层 2和面层 3之间，微孔面料底层 2和面层 3的四周可以相连 成一个袋状结构， 也可互不相连， 半透膜 4的中央区为可揭开的窗口 2， 可揭开的窗口 2 为无胶透明区， 可揭开的窗口 2为椭圆形， 一边为封闭状态， 开口处通过可装可卸的密封 贴密封， 半透膜 4的四周边缘区为透气不透水的有胶粘性区。
当需要观察伤口的愈合情况时， 揭开半透膜 4上可揭开的窗口 2， 移动多孔敷料 1 ; 当观察完伤口， 关闭半透膜 4， 把半透膜 4上的可揭开的窗口 2的开口处通过密封贴进行 密封。半透膜 4的可揭开的窗口 2用面罩贴附， 代替负压引流管。半透膜 4可揭开的窗口 2面积为多孔敷料 1面积的 1.5倍。
实施例七。
如图 2和图 3所示， 一种外科创面封闭式负压引流用装置， 它主要由多孔敷料 1、 微 孔面料底层 2、 微孔面料面层 3、 形成多孔敷料 1可移动的封闭腔所需半透膜 4和负压引 流管 5组成， 多孔敷料 1采用丝瓜筋基体， 厚度可控制在 4厘米以内， 它位于微孔面料底 层和面层之间， 微孔面料底层和面层的四周可以相连成一个袋状结构， 也可互不相连， 半 透膜 4的中央区为可揭开的窗口 2， 无胶且有开口的透明区， 便于丝瓜筋基体移动观察伤 口，半透膜 4的四周边缘区为透气不透水的有胶粘性区，在微孔面料层和半透膜 4之间设 置有无菌透明耐磨膜贴 2，半透膜 4和无菌透明耐磨贴 2紧密贴附形成透明区，上有开口， 供负压引流管、补液管通过， 或者代替负压引流管、补液管的面罩贴附， 开口处通过可装 可卸的密封贴密封。它的主要作用是在创口周围形成一个封闭的环境， 以便能在封闭的环 境中通过负压发生器形成负压， 进而便于创面渗出液透过微孔面料底层进入丝瓜筋基体 中， 再从伸入丝瓜筋基体中的负压引流管 5吸入引流瓶中， 必要时， 丝瓜筋基体中还可插 入补流管 6， 以便通过正压系统为创面补充治疗液或营养液。封闭用的半透膜 4用于封闭 敷料创面， 要求是可以通过气态分子而不通过液体分子， 对细菌有一定的阻隔性， 可采用 目前常用的聚氨脂半透膜。负压引流管 5可根据创面情况使用单根及多根引流，埋填于丝 瓜筋基体内部 ， 采用多孔结构并需要一定的硬度， 可采用硅胶管或高分子塑料管。 用面 罩替代负压引流管和补液管， 贴附于透明区窗口中开口， 即变成面罩型皮肤切口贴。负压 吸引装置， 采用便携式机械负压吸引盘。
具体实施时，所述的微孔面料为蚕丝纱布，蚕丝纱布中的蚕丝蛋白与人体皮肤角质朊 结构极为相似特性，作为丝瓜筋表面覆盖或包裹材料，能增加丝瓜筋表面的光洁度及对丝 瓜筋表面微孔化 (蚕丝纱布微孔直径在 0.2-1.0mm)， 使创面肉芽生长均匀一致， 并且蚕丝 蛋白能促进炎症伤口缩小、 促进胶原蛋白分泌。
负压引流管 5可根据创面情况使用单根及多根引流，埋填于丝瓜筋基体内部 ，采用 多孔结构并需要一定的硬度，可采用硅胶管或高分子塑料管。采用便携式机械负压吸引盘。
通过将本发明的丝瓜筋制造的创面填充敷料与进口创面填充敷料的一百组对比试验 发现， 本发明的创面填充敷料由于透气性更好， 因此患者痊愈周期平均缩短一天半， 而敷 料所使用的费用仅为进口敷料的 10%不到， 大大降低了患者了经济负担， 具有很好的推 广价值。
实施例八。
本实施例与实施例七相同， 所不同的是多孔敷料采用聚乙烯酒精水化海藻盐泡沫敷 料。
本发明未涉及部分均与现有技术相同或可采用现有技术加以实现。

Claims

利 要 求 书
1、 一种外科创面封闭式负压引流用创面填充敷料， 其特征是它主要由与创面外 形相配的丝瓜筋基体、位于丝瓜筋基体上下表面或包裹在丝瓜筋基体表面的微孔 面料、覆盖在丝瓜筋基体上表面的微孔面料上起封闭和固定作用的半透膜以及插 入丝瓜筋基体中的负压引流管组成。
2、 根据权利要求 1所述的外科创面封闭式负压引流用创面填充敷料， 其特征是 所述的微孔面料为蚕丝纱布、 棉丝纱布或带孔橡胶中的一种或其组合。
3、 根据权利要求 1所述的外科创面封闭式负压引流装置用创面填充敷料， 其特 征是所述的丝瓜筋基体中还插装有补液管。
4、一种权利要求 1所述的创面填充敷料的制备方法，其特征是它包括以下步骤: 首先， 将成熟的丝瓜筋去籽、 清洗、 干燥备用；
其次， 将丝瓜筋通过压缩、切割加工与创面外形相配的形状， 控制其厚度不 超过 4厘米；
第三， 将引流管的一端插入丝瓜筋中。
第四， 用微孔面料包裹丝瓜筋或在丝瓜筋的表面进行涂层微孔化处理； 第五， 将成形的丝瓜筋进行灭菌， 可采用环氧乙烷或蒸汽灭菌； 最后，将上述制备所得的丝瓜筋置于无菌包装袋中即得基于丝瓜筋的创面填 充敷料。
5、 根据权利要求 4所述的创面填充敷料的制备方法， 其特征是所述的微孔面料 为蚕丝纱布、 棉丝纱布或带孔橡胶中的一种或其组合。
6、 根据权利要求 4所述的创面填充敷料的制备方法， 其特征是它还包括在创面 填充敷料表面帖装半透膜以及向创面填充敷料中插装负压引流管和 /或补液管。
7、 一种外科创面封闭式负压引流用创面填充敷料， 其特征是它主要由与创面外 形相配的丝瓜筋基体、位于丝瓜筋基体上下表面或包裹在丝瓜筋基体表面的微孔 面料、覆盖在丝瓜筋基体上表面的微孔面料上起封闭和固定作用的半透膜和负压 引流管或负压吸引盘组成，在所述的半透膜上设置有可揭开的窗口，所述的可揭 开的窗口为无胶区， 且在未揭开时为密封状态， 采用负压吸引管时， 所述的负压 吸引管插入丝瓜筋基体中，采用负压吸引盘时， 负压吸引盘穿过半透膜吸附在丝 瓜筋基体上。
8、 一种外科创面封闭式负压引流装置， 它包括负压源、 与创面外形相配的多孔 敷料（1 )， 在多孔敷料（1 )上可移动的封闭腔所需的半透膜（4)和插入在多孔 敷料（1 ) 中的负压引流管 （5 )， 其特征在于： 在所述的半透膜（4)上设置有可 揭开的窗口 （2)， 所述的可揭开的窗口 （2) 为无胶区， 且在未揭开时为密封状 态。
9、 根据权利要求 8所述的外科创面封闭式负压引流装置， 其特征在于： 所述可 揭开的窗口 （2) 在半透膜 （4) 的中央区， 可揭开的窗口 （2) 通过可装可卸的 密封贴密封， 半透膜 （4) 的四周边缘区为透气不透水的有胶粘性区。
10、根据权利要求 8所述的外科创面封闭式负压引流装置， 其特征在于： 所述的 装置还包括在多孔敷料（1 )上依次设置有微孔面料层、 无菌透明耐磨膜贴（3 )、 半透膜 （4)， 无菌透明耐磨贴 （3 ) 和半透膜 （4) 紧密贴附形成透明区。
11、 根据权利要求 10所述的外科创面封闭式负压引流装置， 其特征在于： 所述 的微孔面料层为蚕丝纱布、棉丝纱布、化纤纱布或带孔橡胶、塑料中的一种或几 种的组合。
12、 根据权利要求 8至 10任意一项所述的外科创面封闭式负压引流装置， 其特 征在于： 所述的装置使用面罩代替负压引流管 （5 )， 面罩与半透膜 （4) 可揭开 的窗口 （2) 连接。
13、 根据权利要求 8至 10任意一项所述的外科创面封闭式负压引流装置， 其特 征在于：所述的半透膜（4)可揭开的窗口（2)面积为多孔敷料（ 1 )面积的 1.5 ~ 2倍。
14、 根据权利要求 8至 10任意一项所述的外科创面封闭式负压引流装置， 其特 征在于： 所述的装置还包括插入多孔敷料 （1 ) 中的补液管 （6)。
15、根据权利要求 8所述的外科创面封闭式负压引流装置， 其特征在于： 所述的 负压引流管 （5 ) 外接便携式机械负压装置。
16、根据权利要求 8所述的外科创面封闭式负压引流装置， 其特征在于： 所述的 多孔敷料 （1) 为聚乙烯醇泡沫、 多孔泡沫、 海绵、 或者表面覆盖微孔面料的丝 瓜筋敷料。
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CN102038575A (zh) * 2010-12-06 2011-05-04 陈德华 外科创面封闭式负压引流用创面填充敷料及制备方法
CN201880186U (zh) * 2010-12-06 2011-06-29 陈德华 外科创面封闭式负压引流用创面填充敷料
CN102274574A (zh) * 2011-06-02 2011-12-14 陈德华 一种外科创面封闭式负压引流装置
CN202113475U (zh) * 2011-06-02 2012-01-18 陈德华 一种外科创面封闭式负压引流装置

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TWI894600B (zh) * 2023-08-15 2025-08-21 中鎮醫療產品科技股份有限公司 醫療器件固定裝置、固定醫療管件的方法及醫療器件固定裝置的製造方法
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