JP2005034483A - Wound covering pad for decompression therapy and decompression therapy instrument - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a therapy instrument for a wounded part intended for enhancing a wound curing effect, facilitate therapy management and lessening a burden on a treater by continuously efficiently pouring a fluid having a high wound curing effect into an affected site of a wound having a lacuna and simultaneously continuously removing wound cure inhibiting substances such as a tissue exudate, pus, and tissue pieces. <P>SOLUTION: The decompression therapy instrument is made up of a decompression therapy wound covering pad (4) molded of a thermoplastic synthetic resin having a gas blocking property, having adhesiveness to the skin around a wound, and having a plurality of capillaries permitting the movement of a fluid inside and outside the wound, and a suction means (2) connected to one capillary of the pad and intended for decompressing the wound and removing body fluids and a medicine pouring means (5) connected to the other capillary of the pad. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  The present invention sucks and removes exudates, secretions, pus juice, fallen tissue fragments, etc. that occur locally when treating intractable wounds such as skin ulcers, superficial infection wounds, and burns, while washing as necessary. A wound dressing pad for reduced pressure treatment and a reduced pressure, which are preferably used when a fluid that induces an effect, a pharmacological effect, or a physiological activity, that is, a gas or a liquid is locally supplied to promote tissue regeneration and promote wound healing more efficiently than before. The present invention relates to a treatment device.

  Negative pressure wound closure (Vacuum Assisted Closure, hereinafter referred to as VAC) has recently attracted attention as one of the wound treatment techniques and as one of the most intractable wound treatments for exudative fluid such as pressure ulcers, skin ulcers, and infected wounds. Has been.

  The treatment method by VAC (for example, refer to Patent Document 1) has a suction function that allows fluid suction to the other end of a thin tube that is covered with a film-like thin film material and is previously inserted and placed in the affected area. A device having the device is attached, and the gas or liquid staying in the affected area is removed by suction, and the wound site is continuously maintained in a negative pressure state. The main purpose of the VAC technique is to keep the wound area to be treated under negative pressure constantly or intermittently, thereby aspirating and removing tissue secretions and pus that tend to accumulate in the affected area, thereby reducing local edema, The purpose is to improve blood circulation, promote the growth of healthy granulation tissue, and promote smooth tissue repair and wound healing. By applying this method to the affected area with significant tissue defects, it has been observed that wound healing is accelerated by granulation proliferation more quickly than conventional treatment methods.

  By applying VAC therapy, it has been reported that in many cases of wound healing, the wound has shrunk and a transition to treatment for milder symptoms than before treatment has been made possible. Furthermore, the introduction of the VAC treatment method reduces the troublesome labor required for the conventional wound treatment, and the secondary effects such as shortening the time required for treatment and lowering the economic burden associated therewith are also remarkable.

  Components required for effective VAC treatment include high viscosity such as instruments with suction function, tissue exudate, pus, tissue pieces, etc. that are necessary to maintain the inside of the wound in a negative pressure state for a long time. Tubes that can efficiently aspirate and remove the target fluid without causing blockage of the flow path by various wound healing inhibitors, including fluid secretions with consistency, and the epidermis around the wound area with high airtightness Examples thereof include a flexible thin film material having stable adhesion, and a flexible material for covering and protecting the wound cavity. Various proposals have been made individually for the materials, parts, and technologies that make up each of these members. For example, in Patent Document 2, a suction function and a container for collecting suction liquid are integrated, and the wound vacuum sealing device capable of maintaining a negative pressure state continuously is disclosed. There are drain catheters that are used in place and are not easily blocked by aspiration, and these members are individually applicable to the VAC method. In Patent Document 4 and Patent Document 5, a system for maintaining a negative pressure state during treatment with high accuracy, a suction fluid flow rate adjustment function, and the like are proposed. However, in order to fully demonstrate the healing effect of the VAC method and reduce the complexity, labor, time, and cost associated with the wound treatment, there are generally few attempts to integrate the components into an organic system. is there.

  On the other hand, it is possible and well known to supply liquids including arbitrary gases, cleaning liquids and chemicals as working fluids to affected areas. The pharmacological effect exerted by the infusion fluid by performing such local administration of the fluid is of course suitable for tissue regeneration, such as maintaining the moist environment of the wound part, and further maintaining the temperature at a constant arbitrary temperature by the heating and cooling effect of the infusion fluid. A very significant effect can be expected in preparing the living environment.

  In order to enhance the healing effect on the affected area by the infused fluid, it is necessary that the fluid is stably infused and removed continuously for a certain period of time, and that an arbitrary amount of fresh fluid always stays in the affected area for a certain period of time. In order to effectively improve the cleaning power of the wound surface while demonstrating the wound healing effect due to negative pressure, a negative pressure is maintained while cleaning the wound part by providing a cleaning liquid inlet and drainage outlet on the wound surface cover An apparatus has been proposed (see, for example, Patent Document 6). In Patent Document 6, although the shape and material of the wound dressing are not particularly limited, it is desirable to have means for adhering to the surrounding tissue. This makes it possible to maintain a negative pressure in a region surrounded by the wound part and the wound dressing, but Patent Document 6 does not describe any specific means for the wound dressing to adhere to the surrounding tissue.

  In order to realize these, a system that realizes an integrated structure by adding a continuous decompression suction system to the continuous fluid infusion system as described above, and makes it possible to inject and discharge fluid at any time. Not proposed.

Moreover, in order to give and maintain such a negative pressure on a wound part, the member which coat | covers a wound part requires high airtightness. In general, as a wound dressing, an adhesive thin film resin film has been widely used for the purpose of maintaining the moist state of the wound, but VAC treatment is applied to areas where the body surface is not smooth, such as around the lower sacrum. In such a resin film, the resin film is inferior in the fit to the unevenness of the body surface, the negative pressure breaks down due to air leaks from around the insertion part of the suction tube, or the resin film breaks. There is a problem that it is difficult to maintain airtightness that guarantees a predetermined negative pressure state.
Japanese National Patent Publication No. 9-503923 Japanese National Patent Publication No. 11-504833 JP 2002-224222 A Special table 2000-59992 gazette JP-T-2002-521746 JP 2001-314479 A

  The present invention provides excellent wound healing and tissue regeneration promotion by continuously injecting a healing fluid into a wound site having a tissue defect or cavity, and discharging a healing inhibitor. It is an object of the present invention to provide a treatment wound covering pad and a reduced pressure treatment apparatus.

  The present inventors have focused on the technique of the VAC method, and are considering the use of the VAC method. In addition to the member having a continuous suction effect and the wound covering member constituting the VAC method, the present invention can inject any fluid. Focusing on each of the members responsible for the above, we will further develop the VAC method that has been recognized for its effect by functionally reconfiguring these, and find that a higher wound healing effect can be obtained, and conventional VAC treatment The present invention has been completed by paying attention to the shape and material of the wound covering pad, which has a great influence on the maintenance of hermeticity, which has been a chronic problem.

  That is, the first of the present invention is molded from a synthetic resin having gas barrier properties, can partition the space including the wound portion by closely contacting with the skin around the wound portion, and fluid inside and outside the partitioned space. A wound covering pad for reduced pressure treatment characterized by comprising a plurality of tubules that can move, preferably, the thermoplastic resin is an adhesive polyurethane, and The thermoplastic resin contains an antibacterial agent and / or an antibiotic.

  Further, the second of the present invention is the above-described reduced-pressure treatment wound covering pad, the suction means for reducing the space including the wound portion connected to one of the tubules of the pad and discharging the body fluid, and the other of the pad The decompression treatment apparatus is characterized by comprising a drug injection means for injecting a drug into a space including a wound part connected to a thin tube, and preferably the drug is physiological saline or disinfectant It is what is.

  According to the present invention, in addition to the VAC method whose high wound healing effect is becoming clear, in addition to actively washing and eliminating wound healing inhibitors that cannot be adequately handled by the VAC method, a fluid having a high wound healing effect is obtained. By combining sites that can be efficiently injected into the affected area, the wound healing effect can be further enhanced. In addition, fluids with a pharmacological effect on wounds can be continuously injected and removed, making it easier to manage treatments, reducing the burden on the operator and reducing labor and medical costs. . Therefore, it is suitably used for treatment of intractable wounds that require long-lasting treatment such as pressure ulcers, skin ulcers, infected wounds, and burns.

  The wound dressing pad for reduced pressure treatment according to the present invention is molded from a synthetic resin having gas barrier properties, and can partition a space including a wound part by being in close contact with the skin around the wound part, and the inside and outside of the partitioned space. And a plurality of thin tubes capable of moving the fluid.

  When applying the present invention, it is necessary to seal the space including the wound surface with a covering material to maintain the wound site in a negative pressure state for a long time, and to maintain a moist environment of the affected area and prevent drying. Can enhance the therapeutic effect. That is, the wound covering pad for reduced pressure treatment according to the present invention uses a synthetic resin having a gas barrier property, so that the wet sealability of the wound part is further maintained, and the healing effect can be enhanced.

  Examples of such materials include synthetic resins or natural resins having a high gas barrier property. Specifically, polyurethane, polyvinyl alcohol, polyvinyl acetate, ethylene vinyl acetate copolymer, ethylene vinyl alcohol copolymer. And synthetic or natural polymer resins mainly composed of polyamide, polyester, polylactic acid, cellulose, polyvinylidene chloride copolymer and the like. These synthetic or natural polymer resins can be used as a single material or a combination of blend materials or copolymer materials. Among these, polyurethane is desirable because it is soft and sticky and can be easily applied to a wound.

  Such a polyurethane can be synthesized from a compound having an isocyanate group and a polyol. As the compound having an isocyanate group, 2,4-tolylene diisocyanate, 2,6-tolylene diisocyanate, 4,4′-diphenylmethane diisocyanate, 2,4′diphenylmethane diisocyanate, 1,6-hexamethylene diisocyanate and the like can be used. As the polyol, polyether polyol, polyester polyol, polycarbonate polyol, polycaprolactone polyol, and the like can be used. Furthermore, it is of course possible to use an antifoaming agent, a catalyst, etc. that are usually used for the synthesis of polyurethane.

  If the above-mentioned polyurethane is used, the adhesion to the skin around the wound part is sufficiently maintained, but it is desirable to impart appropriate flexibility and tackiness in order to further improve the adhesion. As a specific means for that purpose, it is important not to include a plasticizer in the component. It is desirable not to use a plasticizer from the viewpoints of safety to the environment and the human body.

  The shape of the wound covering pad for reduced pressure treatment according to the present invention may be any shape as long as it can cover the entire wound part and can maintain a certain space. For example, the shape as shown in FIGS. Therefore, it is possible to fit the wound part more preferably. FIG. 1 has a disk shape and can be applied to a wound part at any site. FIG. 2 shows a shape in which an incision is made on an arbitrary side, and is an optimal shape when used for a sacral region which is the most frequently occurring site of incurable wounds. FIG. 3 has a cup shape and is preferably used in the case of a wound of a convex portion such as a heel.

  Further, the wound covering pad for reduced pressure treatment of the present invention needs to have a thickness having an appropriate strength and flexibility, and a pad of 50 mm or less is preferably used. It is particularly preferable to use a pad of 30 mm or less. If the thickness exceeds 50 mm, it is not preferable because discomfort of the patient wearing the wound covering pad increases and it becomes difficult to change the body orientation (position change) required for a patient having a wound.

  The wound dressing pad for reduced pressure treatment according to the present invention is provided with two or more tubules for enabling fluid movement inside and outside the wound covered with the pad. Since the capillary of the present invention has one end placed in the wound part and the other end connected to the suction pump or the infusion pump and is installed around the wound part, it is preferably made of soft plastic, such as polyethylene, polyvinyl chloride, polyurethane. Various plastic products such as polyester, tubes and hoses such as natural rubber and synthetic rubber can be used.

  In addition, the shape of the tubule of the present invention is not particularly limited, but one end of the tubule is inserted and retained in the wound covering pad, so by using a double tubule that serves as both a suction tube and a drug injection tube It becomes possible to reduce the troublesomeness of a patient having a wound. A medical catheter such as an urotopic catheter (urinary catheter) can be used as an example of a double capillary that serves both as a suction tube and a drug injection tube.

  By using an antibacterial agent and / or an antibacterial substance, the infection-preventing property can be imparted to the wound dressing pad for reduced pressure treatment of the present invention. The antibacterial agent used is not particularly limited, and the components constituting the pad are affected by inorganic antibacterial agents using copper, silver, zinc, etc., organic antibacterial agents containing carbon, and photocatalytic antibacterial agents using titanium. It can be used if it has no nature. Antibiotics to be used are not particularly limited and can be used as long as they have penicillin, cephem, macrolide, and tetracycline properties that do not affect the components constituting the pad. . When using an antibacterial agent and / or antibiotic, it is preferable to make it 0.01% weight or more. When the content of the antibacterial agent is less than 0.01%, the antibacterial effect may be small.

  In addition, the wound covering pad for reduced pressure treatment has a deodorant, a fragrance, various inorganic powders, a foaming agent, a pigment, a dye, a hydrophilic short fiber, an adhesive, an interface as necessary as long as the effects of the present invention are not impaired. It is possible to add various functions by adding an activator, an oxidizing agent, a reducing agent, water, salts, and the like.

  Next, a reduced pressure treatment apparatus according to the second invention will be described.

  The reduced pressure treatment apparatus according to the present invention includes a wound covering pad for reduced pressure treatment as described above, a suction means connected to one of the tubules of the pad to decompress the space including the wound portion and drain the body fluid, and the other of the pad And a drug injection means for injecting a drug into a space including a wound part.

The member configuration of the present invention is illustrated in FIG. 4 or FIG.
Reference numeral 1 denotes a wound with a tissue defect and a cavity having a certain depth from the epidermis, which can be applied to the present invention. A suction means 2 is connected through a thin tube 3 different from the thin tube of the pad. 4 is a wound covering pad for reduced pressure treatment according to the first invention, which covers the entire affected area and seals the space including the wound area. Reference numeral 5 denotes a chemical solution injection means, which is connected through a thin tube 6 different from the thin tube of the pad.

  In the present invention, the wound is decompressed by the suction means and the body fluid is drained. In the present invention, suction of body fluid, exudate, and the like from the wound is performed by a suction device. As for the suction force, the necessary range varies depending on the state of body fluid, exudate, etc. coming out of the wound part and the medicine to be injected, but it is possible by sucking in the range of −1 to 100 kPa. In addition, the usage time of the present invention varies depending on the state of body fluids and exudates from the wound site and the drug to be injected, but considering the current state of wound treatment, this can be achieved by injecting and aspirating for 10 minutes or more per day. It is considered that the effect of the invention can be obtained.

  As the characteristics required for the thin tube 3, first, the diameter of the thin tube is narrow, and secondly, when the thin tube is used, the tube is blocked by an aspirated material containing a viscous semi-solid material including a tissue piece or the like. Thirdly, it is required that constant-pressure suction can be carried out continuously or intermittently for a long time. As a characteristic required for suction means, the viscosity of exudates, secretions, pus, and fallen tissue fragments from wounds varies depending on various conditions such as wound condition, environment, age of patients with wounds, sex and constitution. Therefore, it is desirable to be a constant pressure suction device capable of efficiently removing fluid and tissue secretion from the wound part and maintaining the environment in a wide pressure range of 1 to 100 kPa in order to enhance the healing effect.

  The suction means and the thin tube can be constituted by members using any shape and material as long as the above requirements are satisfied and the effects obtained by the present invention are not impaired. Are preferred. Further, it is preferable as a system that the suction means is provided with the suction device itself or separately aspirate. In addition, attaching a member that has a flow rate adjustment function such as a stopcock or a valve to any part of a thin tube, a device having a suction function, or a collection container corresponds to a change in the treatment status of the wound part and the suction state associated therewith. It is preferable to perform smooth suction removal of the fluid.

  The drug injection means is composed of a capillary 6 connected to the capillary of the pad and a device having fluid storage and injection functions at the other end. The characteristics required for the drug injection means are that the injected drug is stably supplied to the wound part, and the drug is supplied continuously or intermittently, and the flow rate can be adjusted in a wider range. There are no other restrictions. From this point of view, it is composed of a general-purpose injector and a fluid cylinder equipped with or equipped with a device having a suction function, or a narrow tube using a gastight and flexible material with a container connected to its end. Appropriate selection is possible depending on the situation.

  There is no restriction | limiting in particular regarding the kind of injection | pouring medicine in this invention. In the case of mainly expecting a cleaning effect on the wound part, a case where a physiological saline solution, a disinfectant solution or a solution containing a surfactant is continuously supplied in a relatively large amount is assumed. On the other hand, when the present method is implemented mainly for promoting tissue regeneration in the wound area and granulation tissue growth, by supplying a relatively small amount of any solution or gas having a pharmacological effect to the affected area for a long time. A case where the local concentration of the drug is adjusted to be constant is also assumed, but the method can also be applied to such a procedure. It is also possible to replenish any aqueous solution intermittently and locally when maintaining the moist environment of the wound or drying the wound.

  In addition to these members, in order to maintain the flow rate of the injected fluid arbitrarily and constant, a member having a flow rate adjusting function such as a stopcock and a valve is preferably attached to any part of the thin tube, the suction function and the collection container. . Further, in the treatment to which the present invention is applied, in order to make it possible to adjust the temperature of the infusion fluid in accordance with the situation, the provision of a heating / cooling function in the storage container for the supply fluid further enhances the effect of the present invention. preferable.

  An example of the operation method of the reduced pressure treatment apparatus of the present invention is as follows. In other words, a hole is made in the pad, a thin tube is passed, sterilized, and attached to the wound, and then an extension tube, an injection device, a suction device, etc. are connected to the thin tube, and then the drug is injected, and body fluid, exudate, etc. Aspirate. If there is a large amount of exudate from the wound, suction may be performed without injecting the drug.

  The reduced pressure treatment device and reduced pressure treatment wound covering pad of the present invention are preferably sterilized because they are mainly used as medical aids. For example, general methods such as ethylene oxide gas sterilization, gamma irradiation sterilization, and autoclave sterilization may be mentioned, but the method is not particularly limited.

  The present invention can be applied not only to the wound part but also to internal organs by adjusting the length of the tubule.

EXAMPLES Hereinafter, although an Example demonstrates this invention concretely, this invention is not limited to a present Example.
Example 1
(System preparation)
(1) Creation of pad A polyurethane pad was used as a wound covering pad for covering the entire wound part in the present invention. The preparation method is shown below.
100g polyurethane prepolymer "LP-0502" manufactured by Asahi Glass Urethane Co., Ltd., kept at 30 ° C, was measured in a 1000ml disposable cup, added with 586g polyol "LC-0205" manufactured by Asahi Glass Urethane Co., Ltd., and equipped with a general-purpose stirring blade The mixture was stirred for 60 min with a general-purpose agitator BLh300 manufactured by Shinto Kagaku Co., Ltd. Next, after defoaming by putting it in a vacuum dryer controlled at 30 ° C, a portable mini made by Sakai Plant Co., Ltd. equipped with a mold that was coated with a mold release agent and temperature controlled at 125 ° C. It was poured into the mold of the casting machine U caster mini and molded for 30 min. After demolding, put in a hot air dryer controlled at 100 ° C and cure for 13 hours, cure for 5d at room temperature to obtain an adhesive polyurethane pad with a diameter of 200mm and a thickness of 13mm (thickest part) It was.

(2) Combining the pads and capillaries and sterilizing treatment The unit made by Unitika Co., Ltd. as a narrow tube that serves as a capillary tube for the fluid suction means and a drug injection means. A Blood Access UK catheter (double axial type) was inserted and sterilized with a blend gas of 20% ethylene oxide and 80% carbon dioxide in an “EOG sterilizer” manufactured by Sakura Seiki Co., Ltd. Sterilization conditions were a gas concentration of 450 mg / L, a pressure of 1.2 kg / cm ² , a temperature of 50 ° C., a humidity of 60%, and a treatment time of 4.5 hours. In Fig. 5, a hole is made with a needle near the center of the adhesive polyurethane pad, and a Blood Access UK catheter (double axial type) manufactured by Unitika Co., Ltd. is inserted as a thin tube that serves both as a capillary tube for fluid suction and a capillary tube for drug injection. Shows the state.

(3) Extension tube made of sterilized pad prepared in mounting 2 on wound wound with catheter, physiological saline as fluid having cleaning action or pharmacological effect on wound, and Izumi Kogaku Medical Industry as fluid suction means ( Connected to a low-pressure continuous suction device “MeraSacuum MS-008” manufactured by Co., Ltd. and attached to patients with stage III wounds classified by the National Pressure Surgery Advisory Committee (NPUAP) in the sacrum, wounds are intermittently cleaned and aspirated I saw changes in the department.

(4) Evaluation method A polyethylene film was applied to the wound, marking was performed along the outer edge of the wound, and the wound area and reduction ratio were calculated over time. Measurement was performed using a KS image analysis system and image analysis software KS400 manufactured by Carl Zeiss. In addition, the degree of granulation was determined with the naked eye. The evaluation criteria are shown below.
Reduction rate = area after treatment / area before treatment x 100 (%)
Granulation degree 0: Almost none
1: Some formation is observed
2: Formation is recognized
3: Many formations are recognized

(Application example)
150cm in height, 51.0kg in weight, age 77 years, female, applying the fluid injection and suction system of the present invention using polyurethane to a patient with a stage III wound on the classification of the National Pressure Ulcer Advisory Board (NPUAP) and the device thereof While injecting physiological saline at a flow rate of 1 ml / min, perform suction with -40 cmH ₂ O for 1 h and repeat the process for 5 h with the system attached, replacing the pad and catheter. Repeat the process for 1 h while injecting physiological saline at a flow rate of 1 ml / min and aspirating with a suction pressure of −40 cmH ₂ O for 1 h, and leave for 5 h with the system attached. The process of exchanging the catheter was repeated, and treatment was performed for a total of 4 weeks, and changes in the wound area were evaluated. The results are shown in Table 1. By using the fluid injection / suction system for a wound part and the apparatus of the present invention, it is possible to enhance the healing effect of the wound and facilitate treatment management. In addition, it has become possible to reduce the burden on the treatment person by proceeding with the treatment in a short period of time.

Comparative Example 1
Height: 153cm, weight: 50.5kg, age: 76, female, made by Smith & Nephew Co., Ltd. after cleaning wounds of patients with stage III wounds classified by the National Committee for Pressure Ulcers (NPUAP) with physiological saline It was covered with polyurethane foam wound dressing "Hydrosite AD" and replaced once a day to evaluate changes in the wound. The results are shown in Table 1. Even after 4 weeks of treatment, the degree of healing is small.

It is a general | schematic perspective view which shows an example of the wound covering pad for decompression treatment of this invention. It is a general-view perspective view which shows the other example of the wound-coating pad for decompression treatment of this invention. It is a general-view perspective view which shows another example of the wound-coating pad for decompression treatment of this invention. It is a block diagram which shows an example of the decompression treatment apparatus of this invention. It is a block diagram which shows another example of the decompression treatment apparatus of this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Wound part 2 Suction means 3 Capillary 4 Wound covering pad 5 for pressure reduction treatment Drug injection means 6

Claims (5)

A plurality of capillaries that are molded from a synthetic resin having gas barrier properties, can partition a space including a wound portion by being in close contact with the skin around the wound portion, and can move fluid inside and outside the partitioned space A wound dressing pad for reduced pressure treatment, comprising: 2. The wound dressing pad for reduced pressure treatment according to claim 1, wherein the synthetic resin is an adhesive polyurethane. The wound dressing pad for reduced pressure treatment according to claim 1 or 2, wherein the synthetic resin contains an antibacterial agent and / or an antibiotic. 4. A wound dressing pad for reduced pressure treatment according to any one of claims 1 to 3, a suction means for decompressing a space including a wound part connected to one of the tubules of the pad and draining a body fluid, and the other of the pad And a drug injection means for injecting the drug into a space including a wound part connected to the tubule of the above. The reduced pressure treatment apparatus according to claim 4, wherein the drug is physiological saline or a disinfectant.

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