JP6093048B2 - Negative pressure closure therapy screen and film dressing and negative pressure closure therapy kit - Google Patents

Description

  The present invention relates to a screen and film dressing used for negative pressure closure therapy and a negative pressure closure therapy kit using the same, and more particularly, it is possible to avoid suction of granulation by suction means in negative pressure closure therapy and Prevents reversal, reduces the risk of bacterial growth on the wound surface, can be easily separated from granulation tissue when removed from the wound, and can be easily applied to various wound shapes The present invention relates to a negative pressure closure therapy screen and film dressing and a negative pressure closure therapy kit.

  In recent years, in the treatment of wounds, it has been found that a method for keeping a wound part in a moist environment by covering the wound part with a dressing material without drying is not performed. This treatment method is called wet therapy, closure therapy, etc. (hereinafter also simply referred to as closure therapy).

  As one type of the above-described closure therapy, negative pressure closure therapy is performed in which a suction means for sucking the inside of a closed region and maintaining negative pressure is combined (see, for example, Patent Documents 1 and 2). Wound healing requires that the epithelium and subcutaneous tissue move in the direction of closing the wound. The suction means is to introduce a drain pipe or the like connected to the suction device into the closed region and place the inside of the closed region under negative pressure, thereby removing excess exudate in the wound portion and tensioning the wound edge. Is generated. The application of negative pressure closure therapy has various effects such as promoting the movement of epithelium and subcutaneous tissue in the direction of closing the wound, promoting the formation of granulation tissue within the wound, and reducing bacterial density.

  In the negative pressure closure therapy, a screen means may be applied on the wound to prevent the granulation from being sucked in the wound part (see Patent Document 1). Conventionally, a sponge-like foam material has been used as the screen means.

However, since polyurethane foam has a function of absorbing and holding liquid, when used as a screen means, a part of the sucked exudate is held in its thickness. When pressure is applied to the polyurethane foam in this state, the absorbed exudate is reversed, and there is a risk that the bacteria may grow on the wound surface due to bacteria contained in the old exudate.
In addition, the polyurethane foam has a liquid permeation path formed between one surface and the other surface, and a part of the granulation tissue or the like of the wound portion is made transparent by the above suction or the like. May enter the fluid path. Since the liquid permeation path is formed in a fine and complicated path, the granulation tissue or the like that has entered the liquid permeation path is likely to be involved. As a result, this polyurethane foam cannot be easily separated from granulation tissue or the like, and there is a risk of damaging these tissues when removed from the wound part.

Special table hei 7-501958 JP 2006-116162 A

  The technical problem of the present invention is to solve the above-mentioned problems, avoid the suction of granulation by suction means in negative pressure closure therapy, and prevent the exudate from returning, reducing the risk of bacterial growth on the wound surface Negative pressure closure therapy screen and film dressing and negative pressure closure therapy that can be easily separated from granulation tissue, etc. when removed from the wound, and can be easily applied to various wound shapes Is to provide a kit.

  As a result of intensive studies to solve the above problems, the present inventor can prevent the growth of bacteria due to reversion of the exudate by providing a liquid permeable portion such as a mesh sheet as a screen means in the film dressing, and the wound portion The present inventors have found that it can be easily separated from granulation tissue and the like upon removal from the plant, and have further studied to complete the present invention.

That is, the present invention relates to a screen for negative pressure closure therapy, which is a screen for covering a wound (2) used for negative pressure closure therapy, and has a liquid permeable portion (A) made of a sheet member. The wound (2) can communicate with the suction means (5) through the liquid part (A), and the liquid-permeable part (A) is granulated tissue of the wound (2) when removed from the wound (2). It is easily separated from the above.
The present invention 2 also relates to a screen for negative pressure closure therapy, which is a screen for covering a wound (2) used for negative pressure closure therapy, and has a liquid permeable portion (A) made of a sheet member. The wound (2) can communicate with the suction means (5) through the liquid part (A), and the liquid permeable part (A) allows the liquid to permeate without being held in the wall thickness. And

The present invention 3 relates to a film dressing, and is a film-like dressing covering the wound (2) by bringing the peripheral edge into close contact with the skin surrounding the wound (2), and the negative pressure closure of the present invention 1 and / or the present invention 2 A therapeutic screen is provided.
The present invention 4 relates to a negative pressure closure therapy kit, and is arranged on one side of the film dressing (3) having the negative pressure closure therapy screen of the present invention 1 and / or the present invention 2, and the film dressing (3). A cover member (4) covering the liquid permeable part (A), and a suction means (5) capable of creating a negative pressure in the space between the liquid permeable part (A) and the cover member (4). Features.

  Here, the above-mentioned “wound” broadly means those in which the skin is damaged, and includes burns, pressure sores, cuts, surgical wounds and the like.

The above-mentioned “permeability easily separated from the granulation tissue of the wound” means that the granulation tissue or the like is difficult to enter the permeation passage formed in the permeation portion, or even if it enters, the permeation passage is easy. Say something that goes off.
In addition, the above-mentioned “liquid-permeable portion that does not hold the liquid” means a liquid-permeable portion that allows the liquid to pass therethrough but does not hold it in the wall thickness so that it can be returned to the wound side. The liquid does not return to the wound side even when pressed. More specifically, it may absorb and hold a small amount of liquid as well as a liquid that does not absorb and hold liquid at all. In addition, when the liquid-permeable part is hardly deformed by pressing, even when the liquid is stored in the liquid-permeable path formed in the liquid-permeable part or the outer surface of the sheet member, etc. Since these liquids do not return to the wound side, these liquid-permeable portions are also included.

In each of the negative pressure closure therapy screens of the present invention 1 and the present invention 2, since the suction means communicates with the wound through the liquid-permeable portion, exudate from the wound is sucked by the suction means. In this case, the liquid permeable portion acts as a screen body, and the suction of the granulation by the suction means is prevented.
And since the screen for negative pressure closure therapy of said invention 1 is easily isolate | separated from the granulation tissue of a wound, when removing from a wound, a granulation tissue etc. is caught in the permeation | transmission path for liquid permeation | damage, and is damaged. The fear is reduced.

In addition, the negative pressure closure therapy screen of the second aspect of the present invention does not hold the exudate from the wound excessively while the liquid permeation portion is thick. Reversal is prevented, and the problem caused by the growth of bacteria contained in the exudate is solved.
The negative pressure closure therapy screen of the second aspect of the present invention is more preferably provided with the configuration of the negative pressure closure therapy screen of the first aspect of the present invention.

  The thickness of the liquid permeation part is not particularly limited as long as the effect of the present invention is not hindered, but it is possible to avoid the suction of granulation when negative pressure is applied by the suction means, and the granulation tissue or the like is easily separated, And from the point which the return of an exudate does not occur, 1000 micrometers or less are preferable and 300 micrometers-500 micrometers are more preferable.

  The above-mentioned liquid permeable part retains moderate moisture between the wound part and keeps the wound part in a moist environment, but does not absorb and retain exudate during the wall thickness, and when the wound is removed It is more preferable that it is hydrophobic because it is easily separated from the granulation tissue. As the “hydrophobic”, for example, the dynamic contact angle with physiological saline (hereinafter also simply referred to as “contact angle”) is preferably 85 degrees or more, and the liquid-permeable part can be easily removed from the wound after use. This contact angle is more preferably 95 ° or more and particularly preferably 100 ° or more from the viewpoint that it can be peeled off. The liquid permeation part may be one in which the contact angle changes with time when it continuously contacts the liquid. However, the liquid permeable portion preferably has a contact angle of not less than the above value for at least 5 seconds after receiving the droplet, and more preferably not less than 10 seconds for the contact angle of not less than the above value.

  The “contact angle” used in the present invention means a value measured by the θ / 2 method, for example, measured according to JIS K 2396, and specifically, for example, measured as follows. A sample sheet material is cut into a square of 1.5 to 2 cm and placed at a measurement site of a contact angle measuring device (trade name: FTA-100, manufactured by First Ten Angstrom). The standard droplet reference sample 1.5 μL is brought into contact with the sample piece from the syringe installed in the apparatus, and each dynamic contact angle after 1, 3, 5 and 10 minutes has been measured by the droplet method (droplet droplets). (Supply speed: 0.5 μL / sec, drop amount: 1.5 μL), analysis is performed with the contact angle measuring device described above.

The sheet member constituting the liquid permeable portion is preferably made of a hydrophobic material having a large contact angle. For example, it is preferably formed of a polyolefin resin (for example, polyethylene, polypropylene, etc.), a polyurethane resin, a silicone resin, a polytetrafluoroethylene resin, etc., and a high density polyethylene resin (density range: 930 to 970 kg / m ³ ), More preferably, a low-density polyethylene resin (density range: 910 to 930 kg / m ³ ) is contained as a main component. Above all, if the above-mentioned liquid-permeable part is composed of a resin film or resin sheet containing a low-density polyethylene resin as a main component, a closed region can be formed flexibly according to the shape and undulation of the wound site, and a through-hole is formed. And water repellent treatment is easy, and a desired contact angle is easily obtained.

  The above-mentioned “hydrophobicity” does not need to be based only on the properties of the resin forming the sheet member. For example, even when a hydrophilic resin film is used, the surface thereof is treated with water repellent treatment such as fluorine coating or silicone coating. For example, the hydrophobicity may be exhibited by performing a water repellent treatment as necessary. For example, a polyolefin resin (polyethylene resin or the like) having a contact angle with physiological saline of less than 85 degrees, a polyamide resin such as 6-nylon or 6,6-nylon, or a polystyrene resin (contact angle with physiological saline: 84). Degree), the desired hydrophobicity can be exhibited by applying an appropriate water repellent treatment.

  The above water repellent treatment is not limited to a specific treatment method. For example, a water repellent containing a known water repellent substance is coated by a known method (for example, spin coating method, dip coating method, vapor deposition method, CVD method, etc.). And a method of treating the surface facing the wound with fluorine plasma, a method of forming a large number of fine irregularities and through holes on the surface, and the like. The water-repellent material is not particularly limited, but silicone, polyurethane, styrene-butadiene-styrene block copolymer, tetrafluoroethylene / hexafluoropropylene copolymer, tetrafluoroethylene / perfluoroalkyl vinyl ether copolymer, polytetrafluoroethylene, etc. Can be mentioned. These water repellent materials may be used alone or in combination of two or more.

  The shape of the liquid permeable portion is not particularly limited, and may be a rectangle, a square, a circle, an ellipse, or other shapes. The size of the liquid permeable portion can be appropriately selected according to the size of the wound and the size of the suction port of the suction means. Further, the surface shape of the sheet member constituting the liquid permeable portion is not limited to a specific shape, and a planar shape is usually used, but the surface may be uneven.

  The liquid permeable portion may be configured so as to allow liquid to pass therethrough, and the liquid permeable path formed in the liquid permeable portion is not limited to a specific shape or size. However, if this liquid-permeable part has a through-hole formed in a linear direction from one surface to the other surface, the above-mentioned screen may be wounded even if cell tissue such as granulation enters this through-hole. It is preferable because it can be easily detached from the granulation tissue of the wound when it is detached from the wound. In this case, since the through-hole has a simple shape, it is difficult for the liquid to be sucked and remain in the through-hole, and it is difficult to deform even when the liquid-permeable portion is pressed. This is preferable because it is possible to prevent reversal of the reverse.

  The above-mentioned through-hole is not limited to a specific size, but when the opening area on the wound side is 280 to 1400 μm corresponding to the diameter, the above screen is not used even if cellular tissue such as granulation enters the through-hole. It is preferable because it is easily removed when removed from the wound and the liquid does not easily remain in the through hole. The above “equivalent to diameter” means the diameter as it is when the opening shape is circular, and means the diameter of a circle equal to the opening area when the opening shape is not circular.

  The through hole is not limited to a specific shape, and can be various shapes such as a columnar shape, a cone shape, a barrel shape, and a drum shape, and the cross-sectional shape is not limited to a circular shape. However, if the opening area of the through-hole decreases as it moves away from the wound side, even if cell tissue such as granulation enters the through-hole, it is easy to come off when the screen is removed from the wound, and the liquid passes through the through-hole. It is preferable because it hardly remains inside. Specifically, the opening area on the surface on the wound side is more preferably 1.1 to 1.8 times the opening area on the outer surface, and further preferably 1.2 to 1.5 times. .

  Moreover, when said liquid permeable part is provided with the through-hole penetrated and formed toward the other surface from one surface, the opening rate of this through-hole in the surface by the side of a wound is 42.1-88.6%. And the above-mentioned screen is preferable because it is difficult to adhere to the wound surface, and an opening ratio of 60.0 to 65.0% is more preferable because it is more difficult to adhere.

  The sheet member constituting the liquid permeable portion is not limited to a specific material, structure, and thickness, and can be manufactured by a known means, and a commercially available product may be used. Specifically, for example, a resin film, a resin sheet, a fabric, a nonwoven fabric, a net, and the like are included, and a sheet member having a large number of through holes penetrating in the thickness direction, such as a synthetic resin mesh sheet, is preferably used.

  Moreover, it is preferable that the sheet member constituting the liquid permeable portion is provided with stretchability so that it can be easily applied regardless of the shape and part of the wound by enhancing the fit. As the stretchable material, for example, a stretchable nonwoven fabric described in JP2007-1000027 may be used. As this stretchable nonwoven fabric, for example, a web obtained by a spunbond method using polyethylene or polyester (for example, polyethylene terephthalate, polybutylene terephthalate, etc.) is obtained by thermocompression bonding with an embossing roll.

  The film dressing of the present invention 3 may be provided with the screen for negative pressure closure therapy of the present invention 1 and / or the present invention 2, and the peripheral portion of this screen is attached to the skin surrounding the wound with an adhesive tape or the like. It may be adhered. However, this film dressing further has a close contact portion made of a sheet member, and when this close contact portion surrounds the liquid permeable portion and can be in close contact with the skin around the wound, the film dressing is easily attached to cover the wound. In addition, it is preferable because it can be easily applied to various wound shapes.

  The sheet member constituting the close contact portion can maintain the wound in a moist state, and when applying negative pressure to the wound by suction by the suction means, the sheet member can close the periphery of the wound and maintain the negative pressure. Any sheet member that does not allow gas to permeate may be used, and the sheet member is not limited to a specific material, structure, or thickness. However, specifically, a resin film or a resin formed of, for example, a polyurethane resin, a polyolefin resin (eg, polyethylene, polypropylene, etc.), a polyester resin (eg, polyethylene terephthalate, polybutylene terephthalate, etc.), a nylon resin, or the like. Sheets are preferable, and those having stretchability formed of polyurethane-based resins, polyolefin-based resins, and the like are more preferable.

  By using a stretchable resin film, the close contact portion can enhance the fit of the film dressing to the skin. Moreover, the thickness of this adhesion part is not specifically limited, Although it can set suitably considering intensity | strength, a softness | flexibility, etc., 1000 micrometers or less are preferable and 300 micrometers-500 micrometers are more preferable.

The method for producing the film dressing of the present invention is not particularly limited as long as the object of the present invention is not impaired, and a known method may be appropriately employed.
Specifically, for example, this film dressing includes a base sheet having an opening formed in an intermediate portion thereof, and the above contact portion is formed in the base sheet, and the above opening is the above shadow. It may be covered with a screen for pressure-closure therapy, and the peripheral portion of the screen may be fixed to the base sheet. In this case, it is only necessary to fix the screen for negative pressure closure therapy to the base material sheet so as to be laminated, and it is preferable because a film dressing can be easily produced.

  In the film dressing, the negative pressure closure therapy screen is composed of a base sheet having a large number of perforations formed in an intermediate portion, and the liquid permeation portion is formed by the intermediate portion where the perforations are formed. It is comprised and said contact part may be formed in the peripheral part of said base material sheet. In this case, it is only necessary to form a through-hole in the middle part of the base sheet, and it can be formed with only one sheet, so that it can be carried out at a low cost and the film dressing can be made thin.

In order for the suction means to keep the wound part at a negative pressure and suck the exudate from the wound, the suction port of the suction means that communicates with the liquid-permeable part is provided together with the liquid-permeable part. Need to be closed from outside space.
In the present invention 4 described above, since the cover member is provided on one side of the negative pressure closure therapy screen and covers the liquid permeable portion, the peripheral portion of the cover member is directly or liquid permeable. The space between the liquid-permeable part and the cover member and the space between the liquid-permeable part and the wound are closed from the external space by closely contacting the skin around the wound through the contact part around the part. Then, the wound portion is maintained at a negative pressure by the suction means, and exudate from the wound is sucked.

  The cover member may be provided separately from the film dressing provided with the negative pressure closure therapy screen, or the film dressing may be provided with the cover member. . That is, the film dressing has a cover member on the opposite side of the skin across the liquid-permeable portion, the cover member covers at least the liquid-permeable portion, and the peripheral portion of the cover member It may be in close contact with the close contact portion.

  Alternatively, the film dressing has a cover member on the opposite side of the skin across the negative pressure closure therapy screen, and the cover member covers at least the liquid-permeable portion. The contact portion may be formed at the peripheral portion. Specifically, the cover member can be formed wider than the negative pressure closure therapy screen, and the peripheral portion of the screen can be fixed to the intermediate portion of the cover member.

  The material of the cover film is not limited to a specific material as long as it is a material that can be in close contact with the skin around the wound and the close contact portion and can hold the wound at a negative pressure during suction. Specifically, for example, “Tegaderm (registered trademark) transparent dressing” (manufactured by Sumitomo 3M Limited) or the like, a commercially available film dressing having an adhesive on one side can be used.

  The film dressing may be provided with a suction path tip portion that can be connected to suction means and that opens a suction port facing the space between the cover member and the liquid-permeable portion. In this case, it is preferable that the wound can be made negative pressure by a simple operation of covering the wound portion with the film dressing and then connecting the suction means to the tip portion of the suction path.

  The suction means is not particularly limited as long as it can apply a negative pressure to the wound. A. C. (Registered trademark) Therapy negative pressure maintenance management device (manufactured by Casey Co., Ltd.), wall surface suction device, low pressure continuous suction device, syringe and the like.

  The above-mentioned close contact part should just be in close contact with the skin. For example, a sheet member having an adhesive (for example, “Blenderm (registered trademark) Surgical Tape”, manufactured by Sumitomo 3M Co., Ltd.) or the like is used. It may be tightly fixed so as to seal the gap. However, it is preferable that the close contact portion has an adhesive layer on the surface facing the skin because the close contact portion can be easily attached and fixed to the skin simply by attaching the film dressing to a predetermined position.

  The pressure-sensitive adhesive constituting the above-mentioned pressure-sensitive adhesive layer is not limited to a specific material, but is preferably a pressure-sensitive adhesive that can adhere and fix the contact portion to the skin and can be easily peeled off. Specifically, hypoallergenic pressure-sensitive adhesives that are less likely to be irritated by contact with the skin, such as acrylic and silicone pressure-sensitive adhesives, are preferred, such as known emergency bandages (for example, “BandAid (registered trademark)”, Adhesives and the like used in Johnson & Johnson) can be employed.

  In addition, instead of applying the above-mentioned adhesive, a commercially available film dressing having an adhesive layer on one side (for example, “Tegaderm (registered trademark) transparent dressing”, manufactured by Sumitomo 3M Limited), etc. constitutes the above-mentioned adhesion portion It is also preferable to use it as a sheet member.

In addition, the film dressing may be one in which the surface of the liquid permeable portion, the close contact portion, the adhesive layer, or the like is exposed, but when having release paper on at least the side facing the skin, for example, In addition, the adhesive layer can be protected, and the thin film dressing can be easily handled.
This release paper may be disposed only on the surface side on which the adhesive layer facing the skin is formed, but may be disposed on the surface opposite to the skin (hereinafter also referred to as “outside”).

  The material of the release paper is not limited to a specific material, but polyamide, polyester, polyurethane, or the like may be used, and polyethylene-coated fine paper, polyolefin-coated glassine paper, or the like may be used. Examples of the polyamide include 6-nylon, 6,6-nylon, 6,10-nylon, 6,12-nylon, 4,6-nylon, 11-nylon, and 12-nylon. Examples of the polyester include polyethylene terephthalate (PET), polybutylene terephthalate (PBT), and polyethylene naphthalate (PEN). Examples of the polyurethane include thermoplastic polyurethanes such as polyesters and polyethers.

  The release paper may be added with an optional additive such as a release agent for imparting a function such as slipperiness to the surface, if necessary. The surface of the release paper may be treated by a known surface treatment method such as corona discharge treatment, plasma treatment, flame treatment, electron beam irradiation treatment, ultraviolet ray irradiation treatment. Further, the release paper may be colorless and transparent, or may be colored or printed.

The screen for negative pressure closure therapy according to the present invention can prevent the suction of granulation because the liquid-permeable portion made of a sheet member such as a mesh sheet acts as the screen body.
In addition, in the first aspect of the present invention, the negative pressure closure therapy screen is easily separated from the granulation tissue of the wound, and therefore, when removed from the wound, the granulation tissue or the like is caught and damaged in the liquid permeation passage. The fear can be reduced.
Moreover, in this invention 2, since the liquid permeable part does not hold | maintain a liquid in thickness, unlike what used the conventional polyurethane foam, it does not hold | maintain the exudate from a wound extra, and this liquid permeable Even if the portion is pressed, the exudate can be prevented from returning, and the problem of bacterial growth contained in the exudate can be solved.

It is the schematic which shows the usage condition of the negative pressure closure therapy kit of 1st Embodiment of this invention. It is a partially broken perspective view of film dressing of a 1st embodiment of the present invention. It is sectional drawing of the film dressing of 1st Embodiment of this invention. It is an expanded sectional view of the C section of FIG. It is sectional drawing of the film dressing of 2nd Embodiment of this invention. It is a partially broken perspective view of the film dressing of 3rd Embodiment of this invention. It is sectional drawing of the film dressing of 4th Embodiment of this invention. It is sectional drawing of the film dressing of 5th Embodiment of this invention. It is sectional drawing of the film dressing of 6th Embodiment of this invention.

  Hereinafter, the structure of the film dressing of this invention and the kit for negative pressure closure therapy which has this is demonstrated, referring drawings if necessary.

1 to 4 show a first embodiment of the present invention.
As shown in FIG. 1, the negative pressure closure therapy kit (1) of the first embodiment closes the wound (2) from the external space by bringing the peripheral edge into close contact with the skin surrounding the wound (2). A film dressing (3) to be covered, a cover member (4) disposed on one side of the film dressing (3), and a suction means (2) covered with the film dressing (3) to create a negative pressure ( 5).

  The film dressing (3) is a film-like dressing, and a negative pressure closure therapy screen (10) having a liquid permeable portion (A) made of a sheet member, and a wound surrounding the liquid permeable portion (A). (2) and a close contact portion (B) made of a sheet member that is firmly fixed to the surrounding skin. The liquid permeable part (A) allows the liquid to permeate without being held in the thickness, and can be easily separated from the granulation tissue of the wound (2) when removed from the wound (2). It is configured. On the other hand, the cover member (4) covers the liquid permeable part (A) so as to be closed from the external space. For example, a commercially available film dressing material is used, and a peripheral part is the film dressing ( 3).

  The suction means (5) arranged on the opposite side of the wound (2) across the film dressing (3), that is, on the outside, has a suction port (7) formed in the tip portion (6) of the suction path. The space between the liquid permeable portion (A) and the cover member (4) is opened, and the space between the liquid permeable portion (A) and the cover member (4) is set to a negative pressure. Can do. Since the liquid permeable portion (A) can transmit liquid, the suction means (5) can communicate with the surface of the wound (2) through the liquid permeable portion (A). Therefore, by sucking with this suction means (5), negative pressure can be applied to the wound (2) via the liquid-permeable part (A), and the exudate from the wound (2) is sucked into the suction means (5). Can be aspirated. Moreover, even if the film dressing (3) is kept fixed to the patient's skin, the exudate from the wound (2) is not retained in the thickness of the permeable part (A). There is no risk of bacterial growth due to reversion.

  As shown in FIG. 2 and FIG. 3, the film dressing (3) is arranged so as to cover the base sheet (9) having the opening (8) formed in the intermediate portion and the opening (8). And a negative pressure closure therapy screen (10) made of a mesh sheet or the like, and the peripheral portion of the screen (10) is fixed to the peripheral edge of the opening (8) of the base material sheet (9). It is. And said adhesion part (B) is formed in said base material sheet (9).

  Said base material sheet (9) is formed, for example with a polyurethane-type resin, a polyolefin-type resin, etc., has the property which does not permeate | transmit a liquid and air, Preferably it has a stretching property. An adhesive layer (11) is formed on one side of the base sheet (9) facing the patient's skin. A release paper (12) is affixed to the adhesive layer (11), and the release paper (12) protects the adhesive surface of the adhesive layer (11) from sticking to other objects. The release paper (12) is divided by a dividing line (13) provided in the middle portion. When the film dressing (3) is mounted, the release paper (12) divided by the dividing line (13) The half part and the remaining part are peeled off in order, and the contact part (B) is tightly fixed to the patient's skin by the adhesive layer (11).

  A second release paper (14) is adhered to the surface of the base sheet (9) opposite to the patient's skin. Even if the base sheet (9) is thin, for example, about 300 μm to 500 μm, it is integrated with the second release paper (14), so that the film dressing (3) can be easily handled. . Since this second release paper (14) is simply brought into close contact with the outer surface of the base sheet (9), the close contact portion (B) made of the base sheet (9) is tightly fixed to the patient's skin. After that, the substrate sheet (9) is easily peeled off and removed. After that, the suction path tip portion (6) of the suction means (5) is arranged outside the film dressing (3), and the suction port (7) formed in the suction path tip portion (6) and the above-mentioned The peripheral portion of the cover member (4) is adhered to the outer surface of the base sheet (9) so that the liquid-permeable portion (A) is closed from the external space.

  The screen (10) is a non-woven fabric made of a hydrophobic material such as polyethylene resin, and is formed into a thin wall of, for example, about 300 μm to 500 μm, and preferably has stretchability. As shown in FIG. 4, the screen (10) has a number of fine through holes (15) formed over the entire surface. This screen (10) has a dynamic contact angle with the physiological saline set to about 110 degrees, for example, and has a property of allowing liquid to permeate without being substantially retained in the thickness. As a result, the screen (10) retains moderate moisture between the wound (2) and keeps the wound (2) in a moist environment. Even if the exudate is not absorbed, even if it is absorbed, the amount of absorption is very small. Even if this screen (10) is pressed, the absorbed exudate or the like is returned to the wound (2) side. Never do. Moreover, since the screen (10) has hydrophobicity, it is possible to prevent the granulation tissue or the like of the wound (2) from entering the through-hole (15).

The through hole (15) can apply a negative pressure to the wound (2) via the negative pressure closure therapy screen (10) by the suction means (5), and the wound (2) The exudate may be allowed to pass through, and the number is not limited to a specific value. For example, the number is set to about 50 to 400 per 1 cm ² , and more preferably about 60 to 350. .

  The through hole (15) can have various shapes such as a columnar shape, a cone shape, a barrel shape, and a drum shape, but is formed so as to penetrate in a linear direction in the thickness direction of the screen (10). It is preferable that it is a so-called inclined hole in which the opening area decreases as the distance from the wound side surface increases. Specifically, the opening area on the surface on the wound side is more preferably 1.1 to 1.8 times the opening area on the outer surface, and further preferably 1.2 to 1.5 times. .

  The opening area of the through-hole (15) is preferably 280 to 1400 μm, more preferably 500 to 1000 μm, in terms of the diameter of the opening area on the wound side surface of the screen (10). If it is less than 280 μm, it tends to inhibit the exudate from passing toward the suction means. On the other hand, if it exceeds 1400 μm, the granulation may be sucked by the suction means, which is not preferable.

Moreover, since the said screen (10) is hard to adhere to a wound surface as said aperture ratio of said through-hole (15) in the surface by the side of wound is 42.1-88.6%, the aperture ratio is preferable. More preferably, it is 60.0 to 65.0%.
Specifically, for example, a screen (10) is used in which about 200 through holes (15) having an opening area of about 615 μm corresponding to the diameter are provided, for example, about 200 per cm ² and the opening ratio is about 60%.

  The negative pressure closure therapy screen (10) is formed of the hydrophobic material described above and includes the above-mentioned through holes, so that exudate from the wound (2) is excessively added to the thickness of the screen (10). Even if liquid passes through the through-hole (15) without being held and liquid remains in the through-hole (15) or the like, it is well prevented from returning to the wound (2) side. When removing the film dressing (3) from the wound (2), the granulation tissue of the wound (2) is easily removed even if it enters the through-hole (15). (10) is easily separated without involving its granulation tissue or the like.

  The negative pressure occlusion therapy screen (10) is used as long as the peripheral edge is at least partially fixed to the base sheet (9) and no external force is applied to force it to peel off. What is necessary is just to maintain the state which is not isolate | separated from a base material sheet (9) in a state. The fixing means for fixing the screen (10) is not particularly limited.For example, in addition to bonding with an adhesive such as a hot-melt adhesive, fusion by heat sealing, etc., or crimping by embossing Etc.

  Said film dressing (3) should just be equipped with said base material sheet (9) and said negative pressure closure therapy screen (10), and can be manufactured by arbitrary methods. For example, the area of the negative pressure closure therapy screen (10) is set smaller than the area of the base sheet (9), and an area slightly smaller than the area of the screen (10) is cut out from the base sheet (9). The opening (8) is formed. Then, the screen (10) is laminated so as to cover the opening (8) of the base sheet (9), and the periphery of the screen (10) is placed around the opening (8). It can be obtained by fixing to 9).

  In the first embodiment, the base sheet (9) and the negative pressure closure therapy screen (10) are used one by one. However, the film dressing (3) of the present invention can be provided between the base sheets (9, 9) using two base sheets (9) and one negative pressure closure therapy screen (10) if desired. The screen (10) may be sandwiched, or the base sheet (9) and two negative pressure closure therapy screens (10) may be used to sandwich the base sheet (9). You may arrange a screen (10 * 10).

The liquid permeable part (A) and the close contact part (B) are not limited to a specific size or shape, and are appropriately set according to the size of the wound (2), the suction port (7) of the suction means (5), and the like. The For example, the area of the liquid permeation part (A) is such that the suction means (5) can communicate with the wound (2) via the liquid permeation part (A) and the exudate from the wound (2) can be removed. What is necessary is just to be able to suck through the liquid-permeable part (A), and it may be smaller than the wound (2). For example, the area of the close contact portion (B) is set to about 30 to 100 cm ² and the liquid permeable portion (A) is set to about 6 cm ² .

  The thickness of the film dressing (3) as a whole depends on the number of base sheets (9) and negative pressure closure therapy screen (10) used and the thickness of each sheet, and is limited to specific dimensions. Not. In the first embodiment, since one base sheet (9) and one negative pressure closure therapy screen (10) are used, the total thickness is preferably 2000 μm or less, preferably 600 μm to 1000 μm is more preferable.

  In the first embodiment, the film dressing (3) and the cover member (4) are separately supplied, and the negative pressure closure therapy kit (1) is provided with the film dressing (3). The case where the cover member (4) is provided has been described. However, in the present invention, the film dressing (3) may be provided with either one or both of the cover member (4) and the suction path tip portion (6).

  For example, in the second embodiment of the present invention shown in FIG. 5, the film dressing (3) includes the cover member (4) and a suction path tip portion (6) to which suction means can be connected. The suction port (7) formed in the suction path tip portion (6) is opened so as to face the space between the cover member (4) and the liquid-permeable portion (A). A connection portion (16) is formed at the outer end portion of the suction path tip portion (6), and can be detachably connected to a suction means (not shown).

In this case, the negative pressure closure therapy kit is configured to include the film dressing (3) and suction means (not shown). Then, after the film dressing (3) is attached to the wound part, the suction means is connected to and applied to the suction path tip part (6), thereby making the wound negative pressure, Exudate from the wound is aspirated. The other configuration is the same as that of the first embodiment described above, and functions in the same manner, so that the description is omitted.
In addition, in this 2nd Embodiment, although the case where the film dressing was provided with the cover member and the suction path front-end | tip part was demonstrated, the film dressing of this invention is equipped with only one and the other is a kit for negative pressure closure therapy. It may be a separate part.

  In the first embodiment, an opening (8) is provided in a base sheet (9) separate from the negative pressure closure therapy screen (10), and the opening (8) is formed in the screen ( 10) covered. However, in the present invention, for example, as in the third embodiment shown in FIG. 6, the negative pressure closure therapy screen (10) is constituted by the base sheet (9), and an intermediate portion of the base sheet (9) is formed. The liquid-permeable part (A) may be formed in the above.

  That is, in this 3rd Embodiment, as shown in FIG. 6, many through-holes (15) are formed in the intermediate part of the base material sheet (9). The through-hole (15) is formed by an arbitrary through-hole means, for example, by pressing the through-hole means provided with a number of protrusions against the base sheet (9). The liquid permeable part (A) is constituted by an intermediate part in which a large number of the through holes (15) are formed. The base sheet (9) is formed of a hydrophobic material such as polyethylene resin and has a large dynamic contact angle with physiological saline. Therefore, the liquid permeable portion (A) is the first embodiment. Like the form, the granulation tissue of the wound (2) is prevented from entering the above-mentioned through-hole (15), and the liquid can permeate without substantially retaining the thickness. Yes.

  An adhesive layer (11) is formed around the liquid-permeable part (A) on one side of the base sheet (9) facing the patient's skin. ) Constitutes a close contact portion (B). A release paper (12) is attached to the surface of the adhesive layer (11), and a second release paper (14) is attached to the surface of the base sheet (9) opposite to the patient's skin. In addition, other configurations such as the shape and size of the through hole (15), the number of formed holes, and the like are the same as those in the first embodiment.

In this 3rd Embodiment, the base material sheet (9) comprises the screen for negative pressure closure therapy, The opening part is shape | molded in this base material sheet (9), or the separate body which covers this opening part There is no need to provide a sheet member, and the liquid-permeable part (A) and the contact part (B) are formed on the base sheet (9). Moreover, since the film dressing (3) is composed of one sheet member, there is an advantage that the thickness of the entire film dressing (3) can be reduced.
As in the first embodiment, the film dressing (3) of the third embodiment forms a negative pressure closure therapy kit by combining a cover member (not shown) and suction means.

  The film dressing (3) described in the third embodiment is similar to the second embodiment, for example, as in the fourth embodiment shown in FIG. ) May be provided. The other configuration of the fourth embodiment is the same as that of the second embodiment described above, and functions similarly.

  In said 2nd Embodiment, the contact part was formed in said base material sheet, and the case where a cover member different from this contact part was provided was demonstrated. However, in the present invention, it is possible to form a close contact portion at the peripheral edge of the cover member.

  That is, in the fifth embodiment shown in FIG. 8, the film dressing (3) has the same negative pressure closure therapy screen (10) as that used in the first embodiment and the screen (10). And a cover member (4) made of a sheet member disposed on the side opposite to the skin. The cover member (4) is formed wider than the screen (10), and the peripheral portion of the screen (10) is fixed to the intermediate portion of the cover member (4). This negative pressure closure therapy screen (10) has a liquid permeable part (A), and therefore the liquid permeable part (A) is covered with the cover member (4). A close contact portion (B) is formed at the peripheral portion of the cover member (4) at the portion protruding from the screen (10).

  The adhesive part (B) has an adhesive layer (11) formed on one side facing the skin, and a release paper (12) is adhered to the surface of the adhesive layer (11). Moreover, the 2nd release paper (14) is stuck on the outer surface of the cover member (4). Further, a suction path tip portion (6) is disposed between the cover member (4) and the negative pressure closure therapy screen (10), and the cover member (4) and the negative pressure closure therapy screen ( A suction port (7) is opened to face the space between 10). The other end of the suction path tip (6) is the same as that of the second embodiment, such as a connection (16) to which suction means (not shown) can be connected. Since it acts similarly, description is abbreviate | omitted.

  In each of the above embodiments, the case has been described in which the suction port (7) is opened facing the space between the liquid-permeable portion (A) and the cover member (4). At this time, if the liquid-permeable part (A) is wide, the suction force is high at the site close to the suction port (7), and exudate from the wound (2) is sucked well, but the suction port (7 ), The suction force is low at the part separated from the), and the exudate may be difficult to be sucked.

  In order to solve this problem, for example, in the sixth embodiment shown in FIG. 9, a pressure equalizing means (17) is disposed between the liquid permeable portion (A) and the suction port (7) of the film dressing (3). is there. The pressure equalizing means (17) is a means for dispersing / differing along the wound surface the pressure difference between the high suction pressure portion generated in the vicinity of the suction port (7) and the low suction pressure portion generated at a site separated from the suction port (7). For example, a non-woven fabric, cotton-like pulp, air-laid non-woven fabric, foam material, etc., which has liquid permeability and air permeability, but has a larger ventilation resistance than the above-mentioned liquid permeable portion (A) If it is. As a result, when the space between the liquid permeation part (A) and the cover member (4) is sucked by the suction means (not shown) through the suction port (7), the space is uniform. The exudate from the wound (2) is satisfactorily aspirated at the site where the pressure is reduced and the site away from the suction port (7) is the same as the site near the suction port (7).

  The pressure equalizing means (17) may be arranged so as to cover the entire liquid permeable part (A) as in the sixth embodiment, but in the present invention, it is close to the suction port (7). You may arrange | position in the state which covers a liquid-permeable part (A) only in a site | part. The other configuration is the same as that of the fifth embodiment described above and functions in the same manner, so that the description thereof is omitted.

  The negative pressure closure therapy screen, film dressing, and negative pressure closure therapy kit described in each of the above-described embodiments are examples for embodying the technical idea of the present invention, and the shape and dimensions of each member. The structure, material, and the like are not limited to those of this embodiment, and various modifications can be made within the scope of the claims of the present invention.

For example, in each of the above-described embodiments, the liquid-permeable portion includes a configuration in which the liquid-permeable portion is easily separated from the granulation tissue of the wound when removed from the wound, and a configuration in which the liquid is permeated without being held in the thickness. Explained the case. However, in the present invention, the liquid permeable portion may have only one of the configurations.
In each of the above embodiments, the case where an adhesive layer is formed on one side of the contact portion has been described. However, the film dressing of the present invention omits the adhesive layer and hermetically fixes the periphery of the contact portion with an adhesive tape. It may be a thing to do.
Moreover, the film dressing of each said embodiment demonstrated the case where a release paper was each provided on both surfaces. However, in the present invention, one or both of the release papers may be omitted.

The film dressing may be provided with the negative pressure closure therapy screen, and the negative pressure closure therapy kit may be configured in combination with a base sheet or cover member separate from the film dressing. Also good. For example, in the fifth embodiment, the case where the film dressing includes the negative pressure closure therapy screen and the cover member has been described. However, in the present invention, the negative pressure closure therapy screen may constitute a film dressing, and the negative pressure closure therapy kit may comprise the cover member and the suction path tip portion.
Needless to say, the suction means included in the negative pressure closure therapy kit is not limited to a specific suction device or instrument.

  The negative pressure closure therapy screen and film dressing and negative pressure closure therapy kit of the present invention can prevent granulation inhalation, prevent the exudate from returning, and reduce the risk of bacterial growth on the wound surface. Moreover, since it can be easily separated from the granulation tissue when removed from the wound part, and can be easily applied to various wound part shapes, it is suitably used for negative pressure closure therapy.

DESCRIPTION OF SYMBOLS 1 ... Negative pressure closure therapy kit 2 ... Wound 3 ... Film dressing 4 ... Cover member 5 ... Suction means 6 ... Suction channel tip part 7 ... Suction port 8 ... Opening 9 ... Base material sheet
10 ... Negative pressure closure therapy screen
11… Adhesive layer
12 ... Release paper
13 ... Dividing line
14 ... Second release paper
15 ... Through hole
16 ... Connection
17 ... Pressure equalizing means A ... Liquid permeation part B ... Adhesion part

Claims (23)

A screen covering the wound (2) used for negative pressure closure therapy,
A liquid-permeable part (A) comprising a sheet member, and the wound (2) can communicate with the suction means (5) through the liquid-permeable part (A);
The liquid permeation part (A) permeates the liquid without returning to the wound (2) side, and the liquid permeation part (A) is removed from the granulation tissue of the wound (2) when removed from the wound (2). The liquid-permeable part (A) has a thickness of 300 μm to 500 μm so that the liquid-permeable part (A) can be easily separated, and the liquid-permeable part (A) penetrates in a linear direction from one surface to the other surface. A screen for negative pressure closure therapy comprising a hole (15), wherein the opening area of the through hole (15) decreases as the distance from the wound (2) side increases . The negative pressure closure therapy screen according to claim 1 , wherein the liquid permeable portion (A) is made of a hydrophobic material. The negative pressure closure therapy screen according to claim 2 , wherein the hydrophobic material contains a polyethylene resin as a main component. The negative pressure according to any one of claims 1 to 3 , wherein the liquid permeation part (A) has a contact angle of 85 degrees or more with physiological saline at least on a surface facing the wound (2). Closure therapy screen. The negative pressure closure therapy screen according to any one of claims 1 to 4 , wherein the through hole (15) has an opening area on the wound (2) side corresponding to a diameter of 280 to 1400 µm. The liquid permeable portion (A) includes a through hole (15) formed so as to penetrate from one surface to the other surface, and the opening ratio of the through hole (15) on the surface on the wound (2) side is The negative pressure closure therapy screen according to any one of claims 1 to 5 , wherein the screen is 42.1 to 88.6%. The screen for negative pressure closure therapy according to any one of claims 1 to 6 , wherein the liquid permeable part (A) has elasticity. The screen for negative pressure closure therapy according to any one of claims 1 to 7 , wherein the liquid permeable portion (A) is formed of a synthetic resin mesh sheet. A film-like dressing covering the wound (2) by bringing the peripheral edge into close contact with the skin surrounding the wound (2),
9. A film dressing comprising the negative pressure closure therapy screen (10) according to any one of claims 1 to 8 . The film according to claim 9 , further comprising a close contact portion (B) made of a sheet member, wherein the close contact portion (B) surrounds the liquid permeable portion (A) and is in close contact with the skin around the wound (2). dressing. A base sheet (9) having an opening (8) formed in an intermediate portion is provided, and the contact portion (B) is formed on the base sheet (9), and the opening (8) is The film dressing according to claim 10 , wherein the film dressing is covered with the negative pressure closure therapy screen (10), and a peripheral portion of the screen (10) is fixed to the base sheet (9). A base sheet (9) having a number of through holes (15) formed in an intermediate portion is provided, and the base sheet (9) constitutes the negative pressure closure therapy screen (10). (15) the above liquid-section (a) is formed by an intermediate portion is formed, are above contact portion to the peripheral portion of the substrate sheet (9) (B) is formed, according to claim 10 Film dressing as described in 1. A film-like dressing covering the wound (2) by bringing the peripheral edge into close contact with the skin surrounding the wound (2),
A screen (10) used for negative pressure closure therapy, covering the wound (2) and having a liquid-permeable part (A) made of a sheet member;
An adhesive part (B) made of a sheet member that surrounds the liquid-permeable part (A) and adheres closely to the skin around the wound (2);
The liquid permeable part (A) permeates the liquid without returning to the wound (2) side, and the wound (2) is connected to the suction means (5) through the liquid permeable part (A). Communication is possible,
A cover member (4) is provided on the opposite side of the skin across the liquid-permeable portion (A), and the cover member (4) covers at least the liquid-permeable portion (A). The peripheral portion of (4) is in close contact with the contact portion (B), and the liquid permeation can be made without interposing another member between the liquid permeation portion (A) and the cover member (4). The film dressing characterized in that the part (A) faces the cover member (4) . A film-like dressing covering the wound (2) by bringing the peripheral edge into close contact with the skin surrounding the wound (2),
A screen (10) used for negative pressure closure therapy, covering the wound (2) and having a liquid-permeable part (A) made of a sheet member;
An adhesive part (B) made of a sheet member that surrounds the liquid-permeable part (A) and adheres closely to the skin around the wound (2);
The liquid permeable part (A) permeates the liquid without returning to the wound (2) side, and the wound (2) is connected to the suction means (5) through the liquid permeable part (A). Communication is possible,
A cover member (4) is provided on the opposite side of the skin across the negative pressure closure therapy screen (10), and the cover member (4) covers at least the liquid-permeable part (A), The contact portion (B) is formed at the peripheral portion of the cover member (4), and no other member is interposed between the liquid permeable portion (A) and the cover member (4). The film dressing is characterized in that the liquid-permeable part (A) faces the cover member (4) . The cover member (4) is formed wider than the negative pressure closure therapy screen (10), and the peripheral portion of the negative pressure closure therapy screen (10) is fixed to the intermediate portion of the cover member (4). The film dressing according to claim 13 or 14 . A suction passage tip portion (6) connectable to the suction means (5) is provided, and a suction port (7) formed in the suction passage tip portion (6) is connected to the cover member (4) and the liquid-permeable portion. The film dressing according to any one of claims 13 to 15 , wherein the film dressing is opened facing the space between (A). The film dressing according to any one of claims 13 to 16 , wherein the contact portion (B) has an adhesive layer (11) on a surface facing the skin. The film dressing according to any one of claims 13 to 17, comprising a release paper (12) on at least the side facing the skin. The film dressing according to any one of claims 13 to 18, wherein the negative pressure closure therapy screen (10) is the negative pressure closure therapy screen according to any one of claims 1 to 8 . A negative pressure closure therapy screen (10) used for negative pressure closure therapy, covering the wound (2) and having a liquid permeable portion (A) made of a sheet member;
A cover member (4) that is disposed on one side of the negative pressure closure therapy screen (10) and covers the liquid permeable portion (A), and between the liquid permeable portion (A) and the cover member (4). Suction means (5) for making the space negative pressure,
The wound (2) can communicate with the suction means (5) through the liquid permeable part (A),
The liquid permeable part (A) permeates the liquid without returning to the wound (2) side, and another member is interposed between the liquid permeable part (A) and the cover member (4). Without doing so, the liquid permeation part (A) is facing the cover member (4), The kit for negative pressure closure therapy characterized by the above-mentioned . The film dressing (3) having the negative pressure closure therapy screen (10) includes the cover member (4), and the suction means (5) is the transparent member of the film dressing (3). 21. The kit for negative pressure closure therapy according to claim 20, wherein a space between the liquid part (A) and the cover member (4) is set to a negative pressure . The film dressing (3) provided with the negative pressure closure therapy screen (10) includes a suction path tip portion (6) connectable to the suction means (5), and the suction path tip portion ( The suction port (7) formed in 6) is opened to face the space between the cover member (4) and the liquid-permeable part (A). Negative pressure closure therapy kit . The negative pressure closure therapy kit according to any one of claims 20 to 22, wherein the negative pressure closure therapy screen (10) is the negative pressure closure therapy screen according to any one of claims 1 to 8. .

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