JP2016112378A - Tool for wound and device for wound using tool for wound - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a tool for wound, which is used for negative-pressure wound therapy, and in which maceration of skin is avoided or reduced while keeping reduction of pressure to reduce damage on skin.SOLUTION: A tool for wound comprises at least one or more opening parts into which a wound part is inserted and a seal member having a bag shape or a sleeve shape for covering the wound in a closed state. The seal member is formed in a roll shape. The seal member is used in a condition that a communication port connected to a fluid absorption source is arranged at a desired position. The seal member has 10 to 100 μm in thickness. Extension force of the seal member is 0.1 to 15 N/25 mm at 10% extension, and 0.5 to 20 N/25 mm at 20% extension.SELECTED DRAWING: Figure 1

Description

  The present invention relates to a wound device used for protecting, treating, and cleaning wounds, and a wound device using the wound device. More specifically, a wound instrument used to treat and manage a wound by covering the wound in a hermetically sealed state, sucking exudate, drainage, blood, etc. from the wound surface, or performing washing or the like, And a wound device using the wound device.

Conventionally, in the treatment of wounds, burns, pressure ulcers, ulcers and the like (hereinafter sometimes referred to simply as “affected areas”), protection from the physical irritation to the affected areas, absorption of excessive exudate and maintenance of a moist environment, For the purpose of preventing contamination from the outside, a method of disposing a sterilized absorbent pad or the like on an affected area and fixing it to the surrounding skin with a bandage or an adhesive tape has been generally performed.
Currently, negative pressure closure therapy is used in combination as a method for further promoting healing. Here, negative pressure closure therapy means that the affected area is covered with a liquid and gas impermeable sealing member such as a film, and the affected area is placed under reduced pressure by applying a negative pressure to the affected area with a suction pump or the like. Thus, this is a treatment method for promoting healing (see Patent Document 1).

  In this negative pressure closure therapy, when the pressure is reduced, the sealing member is in close contact with the affected part or wound site, so the sealing member that is not sufficiently flexible may cause pain or damage to the affected part. It was. In particular, since this negative pressure closure therapy requires a relatively long treatment period of several days to several weeks, the skin may be softened or weakened by exudate or sweat from the wound. Yes, patient irritation can be more severe. Examples of damage and irritation include redness of the skin due to mechanical stimulation of the sealing member, damage to new tissue when removing the adhesive sealing member, and stimulation of peeling of the stratum corneum.

In addition, when this negative pressure closure therapy is applied to complicated shapes such as the hands and toes and a relatively wide range of affected areas, the sealing member is applied so that the affected areas are sealed. Since it is in the form of a film, it has been difficult to prevent air from leaking by, for example, laminating a plurality of tapes. On the other hand, when removing the sealing member, there are cases where it is difficult to handle such as carefully removing the tape so as not to damage the affected part.
In this way, the conventional sealing member used for negative pressure closure therapy has a strong adhesive force to prevent leakage, which not only strongly stimulates the patient's skin at the time of peeling, but also when medical personnel perform treatment However, there is also a need for shortening the working time in the medical field where the shortage of manpower is normal because it was difficult to reattach.

JP 2010-159 A

  The present invention has been made in view of the above points, and while maintaining the healing promotion effect of wounds by negative pressure closure therapy, stimulation to the affected area, reduction of damage, and improved handling It is a main object to provide a wound instrument and a wound device using the wound instrument.

In order to solve the above-mentioned problem, the present invention includes at least a sealing member in the form of a bag or a sleeve, which includes one or more openings for inserting an affected part having a wound and covers the wound in a sealed state, The sealing member is formed in a roll shape, and the sealing member is used by providing a communication port connected to a fluid suction source at an arbitrary position, and the thickness of the sealing member is 10 to 100 μm. The expansion force of the sealing member is 0.1 to 15 N / 25 mm at 10% elongation, 0.5 to 20 N / 25 mm at 20% elongation, and the flexible property of the sealing member is 1 to 25 mm. A wound device is provided.
In addition, the present invention includes at least one opening for inserting an affected part having a wound, and includes at least a bag-like or sleeve-like sealing member for covering the wound in a hermetically sealed state, The sealing member has a longitudinal direction and a transverse direction, and is formed continuously in the longitudinal direction. The sealing member is used by providing a communication port connected to a fluid suction source at an arbitrary position. The thickness of the member is 10 to 100 μm, and the extension force of the sealing member is 0.1 to 15 N / 25 mm at the time of 10% extension and 0.5 to 20 N / 25 mm at the time of 20% extension. A wound device is provided wherein the flexible properties of the member are from 1 to 25 mm.
In the present invention, it is preferable that in the wound instrument, the sealing member includes a resin bead.
Moreover, it is preferable that this invention is a wound instrument further provided with the fixing means for fixing the said sealing member to an affected part.
In the present invention, the moisture permeability of the sealing member is preferably 100 g / m ² · 24 hr or more.
In the present invention, the fixing means is an adhesive provided around the opening of the adhesive tape or the sealing member, and the adhesive force of the adhesive provided around the opening of the adhesive tape or the opening It is preferable that it is 0.2-4N. Under the present circumstances, it is preferable that the peeling energy of the adhesive provided in the said adhesive tape or the said opening part periphery shall be 0.05-5 N * sec.
Further, in the present invention, the fixing means is a stretchable strip-shaped article provided around the opening of the sealing member, and the stretching force of the strip-shaped member is 0.1 to 20 N / when stretched by 20%. 25 mm, and preferably 1 to 40 N / 25 mm when stretched 50%.
Furthermore, the present invention provides a wound pad disposed inside the wound instrument and at least one of a fluid suction source or a fluid supply source connected to the wound instrument together with the wound instrument described above, and a negative pressure closure therapy It can be set as the apparatus for wounds used for.

  According to the present invention, by adopting a sealing member that is bag-like or sleeve-like and has good adaptability to the affected area and less irritation, while maintaining the wound healing promotion effect by negative pressure closure therapy, It is possible to provide a wound device that is improved in handleability by reducing irritation and damage, and a wound device including the wound device.

It is a figure showing typically the device for wounds concerning the present invention. It is a schematic diagram which shows the one aspect | mode of the shape of the member for sealing. It is a schematic diagram which shows the one aspect | mode of the shape of the member for sealing. It is a schematic diagram which shows the one aspect | mode of the shape of the member for sealing. It is a schematic diagram which concerns on description of a flexible characteristic. It is a measurement figure of a maximum static friction coefficient or a dynamic friction coefficient. It is the graph which showed the relationship between the elongation rate and extension force in Examples 1-7 and a comparative example.

  Hereinafter, preferred embodiments for carrying out the present invention will be described. In addition, embodiment described below shows an example of typical embodiment of this invention, and, thereby, the range of this invention is not interpreted narrowly.

<Wound device>
FIG. 1 is a plan view schematically showing a wound device according to the present invention.
The wound device according to the present invention includes a wound device 1, a wound pad 30 disposed inside the wound device 1 between the wound device 1 and the wound, and a fluid suction source connected to the wound device 1. 50 and a communication port 40 for connecting the wound instrument 1 and the fluid suction source 50 to each other.
The wound instrument 1 according to the present invention includes a sealing member 10, a fixing means 11, and one or more openings 10a for inserting an affected part having a wound. Moreover, in another one aspect | mode of the wound instrument 1 which concerns on this invention, the sealing member 10 and the 1 or more opening part 10a for inserting the affected part which has a wound are provided. A fluid suction source 50 is connected to the wound instrument 1 through the connecting means 20 and the communication port 40. Moreover, the wound pad 30 may be provided in the inside of the sealing member 10 at the time of use as needed.
The communication port 40 is a sealing member for the purpose of communicating the inside and the outside of the sealing member 10 in order to suck the fluid from the inside of the sealing member 10 and / or supply the fluid to the inside of the sealing member 10. 10 is provided. The position of the communication port 40 is not particularly limited, and can be freely designed according to the purpose. For example, the surface of the sealing member 10 may be perforated and the hole may be used as the communication port 40, or the opening 10 a when the wound is covered with the sealing member 10 may be used as the communication port 40.
When the fluid is sucked from the inside of the sealing member 10, the inside of the sealing member 10 is decompressed by the negative pressure generated by the fluid suction source 50, and the therapeutic effect is exhibited. Moreover, the wound pad 30 of the magnitude | size which covers the wound site | part of a body may be arrange | positioned.
The wound appliance 1 according to the present invention includes a fixing means 11 around the opening 10 a of the sealing member 10. When the fixing means 11 is an adhesive tape to be described later, the sealing performance is improved by arranging the fixing means 11 from the opening 10a to the body surface. On the other hand, when the fixing means 11 is an elastic band-shaped article described later, sealing performance is improved if it is provided around the opening 10 a and on the sealing member 10.

<Wound device>
A wound instrument according to the present invention includes one or more openings for inserting an affected part having a wound, a bag-like or sleeve-like sealing member for covering the wound in a hermetically sealed state, and the sealing member. The fixing means for fixing to is provided.
In another aspect of the wound instrument according to the present invention, a bag-like or sleeve-like sealing member is provided that includes one or more openings for inserting an affected part having a wound and covers the wound in a sealed state. At least.
The sealing member is made of a base material having an appropriate extension force, flexibility, moisture permeability, and the like.

I. Sealing Member The sealing member according to the present invention covers an affected part having a wound and promotes healing of the wound under negative pressure. After covering the affected area with the sealing member, a communication port is created as necessary and connected to the fluid suction source via the connecting means.

1. The shape of the sealing member The sealing member according to the present invention can be formed by using a base material to be described later and fusing or bonding at least one place in the circumferential direction of the base material. Alternatively, it can be molded by other methods such as inflation molding as described later. Examples of the method of fusing include heat welding and ultrasonic welding, and adhesion may include adhesion with an adhesive. In this case, a portion that is not fused or bonded can be an opening. The shape of the sealing member can take various shapes such as a bag shape, and these may be appropriately selected depending on the position of the affected part to be applied. Here, the bag shape means not only a bag shape but also a sleeve shape.
The bag shape makes it easier for healthcare professionals to apply sealing members to patients in the medical field, reducing work time and reducing the chance of contact with the patient's body, unlike conventional tape shapes. , Medical staff and patients can work cleanly.

FIG. 2 is a schematic diagram showing an embodiment of the shape of the sealing member.
The shape of the sealing member 10 is not particularly limited, such as a polygon such as a triangle, a quadrangle, or a rhombus, a circle, an ellipse, or a shape obtained by appropriately combining these shapes. Is preferred. By making the shape square, it is easy to manufacture the sealing member, and the manufacturing efficiency is improved.
In addition, it is preferable that the shape of the sealing member is a shape that spreads from the opening 10a of the sealing member 10 to the side facing the opening (bottom 10b), which is suitable for storing a person's foot. .
Moreover, the shape of the member for sealing can also be made into the shape close | similar to a person's leg | foot, as shown in FIG. 3 in one aspect | mode. By making the shape close to the human foot, the work burden on the medical staff can be further reduced.

  In one embodiment, the sealing member can be formed in a roll shape as shown in FIG. As a method for forming a roll-shaped sealing member, for example, a resin used for a sealing substrate or a mixture of the resin and a filler is melted, and a cylindrical resin film is formed using an inflation molding apparatus. It is possible to take a method such as stacking two sized base materials, sealing both sides or one side of the sealing member along the longitudinal side edges, and making this into a roll shape. Of these, the inflation molding method is inexpensive and can form the sealing member at high speed, which is preferable from the viewpoint of productivity and cost. In addition, when making it into roll shape, it is preferable that the blocking prevention process mentioned later is made | formed.

  The roll-shaped sealing member has a vertical direction L and a horizontal direction S, and the sealing member is formed in a roll shape continuous in the vertical direction. The longitudinal direction in this aspect means a direction parallel to the manufacturing direction of the sealing member, which is a so-called longitudinal direction. On the other hand, the horizontal direction means a direction perpendicular to the vertical direction. In this embodiment, a long sealing member can be cut out with scissors or the like for use in a medical institution. Apply negative pressure closure therapy only to the tip of the limb and do not cover the hands and toes with a sealing member, or apply a sealing member to the patient's trunk, and seal the upper part from the limbs and shoulders. When not covered, the cut-out portion is not closed, and it is possible to use the sealing member with a cut if necessary. Further, it can be used with at least one side closed by heat sealing or the like. At this time, as a means for closing at least one side, in addition to the heat seal described above, a method of closely attaching the end of the sealing member with an adhesive tape, a method of folding the end so as not to spread, and a separate bag shape Any means can be used as long as the method can keep the airtightness of the sealing member to some extent, such as covering with a material. Supplying in such a form is economical because it can be used by cutting out the sealing for use only in medical institutions, and the manufacturer can reduce the product lineup and reduce costs, both from the viewpoint of economy preferable.

  In addition, since the size of the sealing member in the longitudinal direction can be adjusted by a medical institution, for example, not only in wounds but also in severely ill patients who have broken bones, the necessary and sufficient size is required. Since the sealing member can be cut out and used in a medical institution, it is preferable.

  In addition, the sealing member can be in a form that is continuous in the vertical direction other than the roll-like form that is continuous in the vertical direction as described above, a form that is alternately folded like a bellows structure, a predetermined shape It can be used in a form in which it is continuously wound around a core other than a shape frame or cylinder, or in a form in which it is housed in a dispenser and can be continuously pulled out.

  As a method of creating the sealing member, for example, a method of heat sealing (thermal welding) in the circumferential direction of the base material described later can be employed. Under the present circumstances, the sealing member with the support body can also be created by heat-sealing the circumferential direction with the support body mentioned later.

2. Base material used for sealing member (1) Material / thickness of base material For example, the following resin film base material can be used for the sealing member according to the present invention.
Specific resins include, for example, polyurethane; polyester such as polyethylene terephthalate and polybutylene terephthalate; polyamide such as nylon 6 and nylon 66; polyolefin such as polypropylene, polyethylene, low density polyethylene, high density polyethylene, and polypropylene; ethylene and acetic acid Vinyl copolymer (EVA), ethylene / ethyl acrylate copolymer (EEA), ethylene / methyl acrylate copolymer (EMA), ethylene / methyl methacrylate copolymer (EMMA), ethylene / methacrylic acid polymer (EMAA) Olefin copolymers such as ethylene / acrylic acid copolymer (EAA); polyvinyl alcohol; polyvinyl chloride, polyvinylidene chloride; one or more selected from silicone and the like It can gel. Among these, the film base material formed from polyurethane is preferable from the viewpoints of flexibility and moisture permeability. In addition, the base material of this invention may contain other than the said component.

  The thickness of the substrate is preferably in the range of 1 to 140 μm, more preferably in the range of 5 to 120 μm, ease of rehabilitation (hereinafter abbreviated as “rehabilitation”) while wearing the sealing member, and moisture content. From the viewpoint of permeability, the range of 10 to 100 μm is more preferable. When the thickness is less than 1 μm, the strength of the base material is not sufficient, and there is a possibility of tearing at the time of use, so 1 μm or more is preferable. On the other hand, if the thickness is greater than 500 μm, the film becomes bulky and uncomfortable when it comes into contact with the body. Furthermore, 100 μm or less is suitable for providing flexibility.

(2) Anti-blocking treatment It is preferable that the base material or the blown sealing member is subjected to anti-blocking treatment. Anti-blocking treatment is performed on the surface of the base material or sealing member by applying a surface modification treatment to prevent blocking, applying an anti-blocking agent, and applying physical force during base material creation to provide irregularities. Alternatively, there is a means of including a filler in the resin used for the sealing member.

Among these, it is preferable from the viewpoint of safety at the time of use that a means for containing a filler in the substrate or the resin can be used to create a sealing member without an antiblocking agent on the resin surface.
The filler can be applied in various forms such as a fibrous form, a plate form, and a particulate form. However, in order to avoid tearing of the film, a smooth form without corners is preferable, and a particulate form is preferred.
The material of the filler may be an inorganic material or an organic material.

  Inorganic materials include glass, silica, talc, mica, kaolin, sericite, muscovite, synthetic mica, phlogopite, saucite, biotite, lithia mica, vermiculite, magnesium carbonate, calcium carbonate, diatomaceous earth, magnesium silicate, silicic acid Calcium, aluminum silicate, barium silicate, strontium silicate, metal tungstate, hydroxyapatite, hydrous silicic acid, anhydrous silicic acid, magnesium oxide, bentonite, zeolite, ceramic powder, aluminum hydroxide, barium sulfate, titanium oxide, zinc oxide, zirconium oxide Inorganic powders commonly used in cosmetics such as iron oxide (Bengara), iron titanate, iron hydroxide, ocher, black iron oxide, carbon black, aluminum powder, stainless steel powder, and copper powder.

  Organic materials include nylon powder, polyethylene powder, polymethylbenzoguanamine powder, polymethyl methacrylate powder, ethylene tetrafluoride powder, microcrystalline cellulose, rice starch, lauroyl lysine, calcium stearate, zinc stearate, magnesium stearate, myristic Made of organic powders such as magnesium oxide, calcium cetyl phosphate, sodium cetyl phosphate, etc., and organic resin, polyvinyl chloride, polyethylene, polystyrene, polypropylene, polyamide, polyurethane, fluororesin, silicone resin, acrylic resin, etc. Examples thereof include beads.

Among these, considering the affinity with a resin or a resin film substrate, resin beads are preferable, and acrylic resin beads are preferably used from the viewpoint of transparency of the film.
The average particle diameter of the resin beads is preferably 0.01 to 90% of the thickness of the sealing substrate, and more preferably 1 to 85%.
More specifically, when the thickness of the substrate is 140 μm or less, the average particle size is preferably 1 μm to 30 μm.

In preparation of the base material, it can be prepared by laminating the base material on a support from the viewpoint of the handling property of the base material and the handling property of the sealing member. The material of the support is paper, polyurethane; polyester such as polyethylene terephthalate and polybutylene terephthalate; polyamide such as nylon 6 and nylon 66; one kind selected from polyolefin such as polypropylene, polyethylene, low density polyethylene, high density polyethylene and polypropylene Or 2 or more types can be mentioned.
When a sealing member is made using a base material that does not have an adhesive component with an adhesive strength enough to adhere to the skin, the irritation to the skin when peeling the sealing member during or after treatment is greatly reduced. Is preferable.

3. Characteristics of the sealing member The sealing member is preferably composed of a base material having the following predetermined range of extension force, softness characteristic, or moisture permeability, in particular, the following predetermined range of extension force, softness characteristic, And it is more preferable to comprise with the film base material provided with all the water vapor transmission rates.
Stretching force and flexibility characteristics relate to the flexibility of the sealing member, and when these are in the appropriate range, when the wounded area is at the end of the hand or foot, the wound device is worn and the degree of decompression is It is preferable because rehabilitation can be performed while maintaining the above. In the treatment of limb wounds such as hands, elbows, feet, and knees by negative pressure closure therapy, the wound may be fixed with a pad or cover for a long time. This is because the muscles and ligaments around the joints become stiff, and the functions of flexion / extension and rotation may be impaired, and early rehabilitation is required.

(1) Extension force The extension force of the sealing member in the present invention (the base material constituting the sealing member) indicates the relationship between flexibility and mechanical stimulation with the body when used as a sealing member, The definition and measurement method will be described later. By adjusting the extension force to a predetermined range, even if the sealing member is in close contact with the body surface under reduced pressure, symptoms such as skin redness due to mechanical stimulation of the sealing member can occur. Can be suppressed and treated. Furthermore, because of its stretch characteristics, it stretches in conformity with the skin even under reduced pressure, so that wound treatment can be performed while moving the affected part and performing rehabilitation to prevent contracture.
The extension force is 0.1 to 15 N / 25 mm at 10% extension, preferably 0.5 to 20 N / 25 mm at 20% extension, 0.5 to 10 N / 25 mm at 10% extension, 20% It is more preferably 1 to 15 N / 25 mm at the time of elongation, and 1 to 8 N / 25 mm at the time of 10% elongation, and further preferably 2 to 10 N / 25 mm at the time of 20% elongation.

(2) Flexible property The flexible property of the sealing member (the base material constituting the sealing member) in the present invention indicates the flexibility during use. The definition and measurement method will be described later. The soft property is that the softness of the substrate is high when the numerical value is small. Higher flexibility is preferable when used as a sealing member because the followability of the sealing member to the body is improved.
On the other hand, if the flexibility is too high, the handleability at the time of use deteriorates and the strength decreases, so that it is preferably within a predetermined range.
The flexible property is preferably 1 to 25 mm, more preferably 3 to 20 mm, and still more preferably 5 to 15 mm.

(3) Moisture permeability The moisture permeability of the sealing member (base material constituting the sealing member) in the present invention is to seal water vapor and other moisture generated from the body during negative pressure closure therapy when used as a sealing member. It indicates the ability to drain out of the member, and a higher one is preferred because it can avoid skin maceration during treatment. The definition and measurement method of moisture permeability will be described later.
The moisture permeability is preferably 100 g / m ² · 24 hr or more, more preferably 150 g / m ² · 24 hr or more, and further preferably 200 g / m ² · 24 hr or more.
Further, the moisture permeability is preferably 5000 g / m ² · 24 hr or less, more preferably 3000 g / m ² · 24 hr or less, and still more preferably 2000 g / m ² · 24 hr.

(4) Air permeability The air permeability of the sealing member in the present invention (base material constituting the sealing member) is a barrier for oxygen and other gases flowing from outside the sealing member when used as the sealing member. It shows sex. When the sealing member is used in a wound device having a portable fluid suction source having a small suction capability, it is preferable that the air permeability is not too high in order to avoid a decrease in the degree of vacuum.
A method for measuring the air permeability will be described later.
Air permeability is preferably a ^{0cm 3 / m 2 · 24hr ·} atm or more ^{10000cm 3 / m 2 · 24hr ·} atm or ^{less, 0cm 3 / m 2 · 24hr} · atm or more ^{5000cm 3 / m 2 · 24hr ·} atm or less More preferably, it is more preferably 0 cm ³ / m ² · 24 hr · atm to 1000 cm ³ / m ² · 24 hr · atm.

(5) Oxygen permeability In the present invention, the oxygen permeability of the sealing member (the base material constituting the sealing member) is determined by the barrier property such as oxygen flowing from the outside of the sealing member when used as the sealing member. It is shown.
The oxygen permeability can be measured according to JIS K7126-1 and JIS K7126-2.
The oxygen permeability is preferably 100 cm ³ / m ² · 24 hr · atm or more, more preferably 10 cm ³ / m ² · 24 hr · atm or more, and 0 cm ³ / m ² · 24 hr · atm or more. Is more preferable. The oxygen permeability is preferably at most ^{50000cm 3 / m 2 · 24hr ·} atm, more preferably to less ^{10000cm 3 / m 2 · 24hr ·} atm.

II. Fixing means In one aspect of the wound instrument, in order to ensure the sealing property of the sealing member, a fixing means for the body is further provided around the opening of the sealing member. This is to seal the opening for inserting the affected part. Further, the fixing means is applied from above the sealing member, and also serves to prevent the sealing member applied to the affected part from being displaced from an appropriate position.

In one aspect of the fixing means in the present invention, the fixing means may be an adhesive or an adhesive tape.
Various adhesives such as rubber-based, acrylic-based, and silicone-based adhesives can be used when the adhesive is provided around the opening.
When an adhesive tape is provided around the opening, an adhesive tape provided with various adhesives such as rubber-based, acrylic-based, and silicone-based adhesives can be used.

In another aspect of the fixing means in the present invention, the fixing means can be easily attached and detached in order to adjust the position of the sealing member, or to appropriately treat the wound by opening the opening of the sealing member, Since it is desirable that the position can be adjusted, a belt-shaped article having stretchability can be used as the fixing means.
In the case where the fixing means does not contact the skin or is used in a mode in which the range of contact with the skin is small, when the strip-shaped article having elasticity that is used as the fixing means exhibits adhesiveness, the adhesive force to the sealing member is applied. If it is not sticking as much as possible, it is easy to change the placement of the fixing means to an appropriate location even if there is an error in the placement of the fixing means on the sealing member during medical treatment. As a result, the operation time can be shortened, which is preferable. This not only shortens the work time for the medical staff to fix the sealing member to the affected part, but also leads to cost reduction.
When a strip-shaped article having stretchability is provided around the opening, various articles such as a strip-shaped rubber, a stretchable bandage, and a fixed band provided with compressed urethane can be used. Among elastic bandages, using a bandage with self-adhesiveness between the bandages not only contributes to shortening the work time of medical personnel, but also when the fixing means is displaced from a predetermined position in rehabilitation and daily operations This is more preferable because the patient can make fine adjustments.

1. Adhesive or adhesive tape (1) Adhesive strength An adhesive or adhesive tape used as a fixing means has a predetermined adhesive strength. A lower adhesive strength can suppress the peeling stimulus at the time of peeling, but a higher adhesive strength improves the sealing performance. The definition and measurement method of adhesive strength will be described later.
The adhesive strength is preferably 0.2 to 4N, more preferably 0.3 to 3.5N, and still more preferably 0.5 to 3N.

(2) Release energy The release energy of the pressure-sensitive adhesive or pressure-sensitive adhesive tape used as a fixing means is an index representing a release stimulus, and it is preferable that the pressure-sensitive adhesive or the pressure-sensitive adhesive tape is within a range where the release stimulus at the time of release can be suppressed. The definition and measurement method of the peeling energy will be described later.
The peeling energy is preferably 0.05 to 5 N · sec, more preferably 0.1 to 3 N · sec, and further preferably 0.15 to 2 N · sec.

(3) Stretching force When using a stretchable strip-shaped article as the fixing means, the stretching force of the strip-shaped article is 0.01 to 10 N / 25 mm when stretched 10%, and 0.1 to 20 N when stretched 20%. / 25 mm, preferably 0.15 to 40 N / 25 mm at 50% elongation, 0.03 to 8.0 N / 25 mm at 10% elongation, and 0.12 to 15 N / 25 mm at 20% elongation. More preferably 0.20 to 25 N / 25 mm at 50% elongation, 0.05 to 4.0 N / 25 mm at 10% elongation, and 0.10 to 6.5 N / 25 mm at 20% elongation. Yes, and more preferably 0.30 to 8.0 N / 25 mm at 50% elongation.
In addition, as a raw material of a strip | belt-shaped article | item, the raw material which has the characteristic used for the base material used for the member for sealing can also be used.

  Since the extension force of the fixing means is within the above range, the fixing means is disposed on the sealing member with respect to the skin, and it is necessary to maintain the decompression degree at the affected part for a certain period of time and to compress the skin. It is possible to achieve both of them to the limit. Excessive skin pressure should be avoided as it can cause redness and congestion. Therefore, compared with the case where the above-mentioned pressure-sensitive adhesive or pressure-sensitive adhesive tape is used as the sealing member, it is possible to reduce the irritation to the skin and further reduce the burden on the patient, which is preferable.

2. Stretchable strip-shaped article (1) Coefficient of friction The coefficient of friction of a stretchable strip-shaped article used as a fixing means is an index that indicates how difficult the fixing means is when the sealing member is fixed by practical pressure. Specifically, the maximum friction coefficient and the dynamic friction coefficient between the fixing means are used as indexes. When pressure-sensitive adhesive or adhesive tape is not used as the fixing means, there is a concern that the degree of reduced pressure may be reduced due to a deviation of the fixing means, but the fixing means does not impair operability because the friction coefficient is in a certain range. Can be avoided, and as a result, a decrease in the degree of decompression can be avoided. The maximum static friction coefficient between the fixing means is preferably 0.5 to 8, and more preferably 0.8 to 5.
The coefficient of dynamic friction between the fixing means is preferably 0.3 to 5, and more preferably 0.5 to 4. A method for measuring the friction coefficient will be described later.

<Wound pad>
The wound pad is a known porous pad, and when it is placed on the affected area, it serves as an appropriate cushion to relieve physical stimulation from the wound device that occurs during decompression. In addition, the exudate can be efficiently absorbed and the pressure can be reduced uniformly by being porous. As the wound pad, fiber materials such as knitted fabrics, woven fabrics, and nonwoven fabrics, foam materials, and the like can be used.

<Fluid suction source or fluid supply source>
As the fluid suction source or the fluid supply source, any known device can be used as long as the fluid can be sucked or supplied. For example, an electric or manual pump, a syringe, a dropper, etc. are mentioned.

<Communication entrance>
The communication port is provided in the wound device for the purpose of communicating the inside and the outside of the wound device in order to suck fluid from the inside of the wound device and / or supply fluid to the inside of the wound device. The number of the communication ports is not particularly limited as long as one or more communication ports are provided in the wound device.
A plurality of communication ports may be provided in accordance with purposes such as a communication port for supplying a liquid such as a cleaning liquid or a sol-like body, a communication port for discharging or sucking a liquid such as a cleaning liquid or exudate from a wound, etc. Be free.
The position of the communication port provided in the wound instrument is not particularly limited, and can be freely designed according to the purpose. For example, the surface of the wound device may be perforated and the opening may be used as a communication port, or the opening through which the affected part is inserted when the wound is covered with the wound device may be used as the communication port.
The wound device of the present invention has been described so far. As one of the preferred embodiments of the present invention, at least a sealing member and a fixing means are provided, and the fixing means is an elastic band-shaped article. A wound device in which the stretchable band-shaped article is disposed on the sealing member so as not to directly touch the skin or the like in the vicinity of the opening of the sealing member can be mentioned.

  Hereinafter, although each characteristic of the sealing member which comprises the wound instrument of this invention and each fixing means is demonstrated in detail based on an Example, this invention is not limited to these.

<Moisture permeability>
Measured according to JIS K6404 and JIS L1099A-2 “Water Method”. 40 ml of water at a measurement environment temperature of 40 ° C. is put in a moisture permeable cup that has been adjusted to the measurement environment temperature (temperature 40 ° C., relative humidity 50%) in advance, and (1) the sealing member cut to an appropriate size in the moisture permeable cup. Place the test piece, (2) packing, and (3) ring in order, and fix with a wing nut. The total mass of the test specimen including the moisture permeable cup is measured and set as the initial mass C ₀ (g) of the specimen before the start of measurement. The total mass C ₂₄ (g) of the test piece after the moisture permeable cup was exposed to a test environment at a temperature of 40 ° C. and a relative humidity of 50% for 24 hours is measured, and the moisture permeability of the sealing member is calculated according to the following formula. In each of the examples, a moisture permeable cup having a diameter of 6 cm was used, and measurement was performed with S = 0.002826 m ² .
Moisture permeability (g / m ² · ₂₄ hr) = ((C ₂₄ −C ₀ ) / S)
C ₀ : Initial specimen mass (g) before starting measurement
C ₂₄ : total mass (g) of test specimen 24 hours after start of measurement
S: Moisture permeable area of cup (m ² )

<Air permeability>
A bag 150 mm long and 150 mm wide is prepared using a test piece collected from the sealing member. Place a sponge-like foam of appropriate size in the bag. Cut the end of the bag, put a tube for air suction, and seal the insertion part. The bag internal pressure is reduced using a commercially available suction device through a tube. After confirming that the air has been completely removed, replace the tube with a simple aspirator (aspirator capable of reducing pressure from normal pressure to 75 mmHg). The test was started when it was confirmed that the scale of the simple aspirator did not move for 5 minutes and there was no air leak, and the amount of air that entered the bag by 12 hours and 24 hours (respectively,
V ₁₂ (cm ³ ) and V ₂₄ (cm ³ ). ) Is read from the scale. From V ₂₄ which is a value read after 24 hours, the air permeability of the sealing member is measured according to the following formula.
Air permeability _{^{(cm 3 / m 2 · 24hr}} · atm) = V 24 /(0.15m) 2/2

<Measurement of elongation rate and elongation force>
The elongation ratio and the elongation force are measured as follows.
(1) Sealing member For the sealing members of Examples 1 to 6, the elongation rate and the stretching force are measured under the following conditions.
A test piece having a length of 100 mm and a width of 25 mm is taken from the sealing member, and a tensile test is performed with a chuck width of 120 mm and a distance between chucks of 50 mm.
In the tensile test, after the test piece was allowed to stand for 3 hours in an environment of a temperature of 23 ° C. and a humidity of 65% RH, the tensile tester (trade name “INSTRON 5564” manufactured by Instron Co., Ltd.) was used in the environment of the same temperature and the same humidity. ) And the tensile speed is 100 mm / min.
A predetermined load for each predetermined elongation E (mm) of the test piece is measured, and the elongation percentage (%) of the sealing member is calculated from the following formula based on the result.
Elongation rate (%) = (E / L) × 100
E: Elongation (mm)
L: Distance between chucks 50 (mm)
Further, the stress (N / 25 mm) when the sealing member is extended to a predetermined elongation (elongation rate) is measured, and the value is taken as the extension force (N / 25 mm) of the sealing member.

For the sealing member of Example 7, the elongation rate and the elongation force are measured under the following conditions.
A test piece having a length of 100 mm and a width of 25 mm is taken from the sealing member, and a tensile test is performed at a chuck width of 65 mm and a distance between chucks of 50 mm.
In the tensile test, the test piece was allowed to stand for 3 hours in an environment of a temperature of 23 ° C. and a humidity of 65% RH, and then the tensile tester (made by SHIMADZU, trade name “AG-1” 20 kN "), and the tensile speed is tested at a tensile speed of 100 mm / min.
A predetermined load for each predetermined elongation E (mm) of the test piece is measured, and based on the result, the elongation ratio (%) of the fixing means is calculated from the following formula.
Elongation rate (%) = (E / L) × 100
E: Elongation (mm)
L: Distance between chucks 50 (mm)
Further, the stress (N / 25 mm) when the sealing member is extended to a predetermined elongation (elongation rate) is measured, and the value is taken as the extension force (N / 25 mm) of the sealing member.

(2) Fixing means A test piece having a length of 100 mm and a width of 25 mm is taken from the fixing means, and a tensile test is performed with a chuck width of 65 mm and a distance between chucks of 50 mm.
In the tensile test, the test piece was allowed to stand for 3 hours in an environment of a temperature of 23 ° C. and a humidity of 65% RH, and then the tensile tester (made by SHIMADZU, trade name “AG-1” 20 kN "), and the tensile speed is tested at a tensile speed of 100 mm / min.
A predetermined load for each predetermined elongation E (mm) of the test piece is measured, and based on the result, the elongation ratio (%) of the fixing means is calculated from the following formula.
Elongation rate (%) = (E / L) × 100
E: Elongation (mm)
L: Distance between chucks 50 (mm)
Further, the stress (N / 25 mm) when the fixing means is extended to a predetermined elongation (elongation rate) is measured, and the value is taken as the extension force (N / 25 mm) of the fixing means.

<Flexible properties>
The flexible property of the sealing member is measured as follows.
A test piece with a length of 250 mm or more and a width of 50 mm is collected from the sealing member, and the sample is allowed to stand for 3 hours in an environment of a temperature of 23 ° C. and a humidity of 65% RH, and then flat in the environment of the same temperature and the same humidity. And place a portion of 200 mm from one end in the longitudinal direction of the test piece (FIG. 5A). Next, the test piece is folded back from the one end toward the fixed portion, and after fixing the one end, the maximum height H (mm) of the formed folded portion is measured (FIG. 5 (b)), and H is flexible. Characteristic (mm).

<Adhesive strength and peeling energy>
When the sealing member and the fixing means are an adhesive tape and an adhesive, the adhesive force and the peeling energy are measured as follows.
A test piece having a length of 25 mm and a width of 25 mm is taken from the sealing member, and a probe tack test is performed.
In the probe tack, the sample was allowed to stand for 3 hours in an environment of a temperature of 23 ° C. and a humidity of 65% RH, and then in the environment of the same temperature and humidity, TAC-II "), the separation speed is 30 mm / min, the press pressure is 0.98 N, and the press time is 2 seconds.
The maximum tack force in the pulling process was defined as the adhesive strength.
Moreover, it was a time integral value of adhesive force, and what was displayed as an integral value in the probe tack tester was defined as peeling energy.

<Friction coefficient>
The coefficient of friction between the fixing means is measured as follows. An outline of an apparatus used for measurement is shown in FIG. In the text, numbers indicate the numbers shown in FIG.

1. Maximum static friction coefficient Using the precision universal testing machine 5 (Autograph AG-1 manufactured by Shimadzu Corporation), the stroke is within 150 mm, and measurement is performed with the test type “peel” set. On a horizontal plate 250 having a flat surface of 200 mm in length and 350 mm in width installed in the universal testing machine 5, a test piece 220 of 50 mm in length and 250 mm in width taken from the fixing means is fixed. On the other hand, a metal weight 300 having a smooth plane with a weight of 100 g and an area of 25 cm ² is prepared, and the surface is covered with another test piece 230 collected from the same type of fixing means, and the weight after coating of the test piece is measured. Measured as vertical load F1 (N).
The weight 300 and the tension means 280 of the universal testing machine are connected by the wire 270 through the pulley while the surface of the weight 300 covering the fixing means 230 is faced down and gently brought into contact with the fixing means 220 fixed to the horizontal plate. Pull the tension part 280 of the universal testing machine at a speed of 100 ± 0.2 mm / min, measure the load peak point that appears in the initial stage, and based on the average value F2 (N) of three repetitions, the static friction coefficient Is calculated.
Coefficient of static friction = F2 / F1

2. Coefficient of dynamic friction Using a precision universal testing machine 5 (Autograph AG-1 manufactured by Shimadzu Corporation), the stroke is within 150 mm, and measurement is performed with the test type “peel” set. On a horizontal plate 250 having a flat surface of 200 mm in length and 350 mm in width installed in the universal testing machine 5, a test piece 220 of 50 mm in length and 250 mm in width taken from the fixing means is fixed. On the other hand, a metal weight 300 having a smooth plane with a weight of 100 g and an area of 25 cm ² is prepared, and the test piece 230 collected from the same type of fixing means is coated on the surface, and the weight after coating of the test piece is determined as a vertical load. Measure as F3 (N).
The weight 300 and the tension means 280 of the universal testing machine are connected by the wire 270 through the pulley while the surface of the weight 300 covering the fixing means 230 is faced down and gently brought into contact with the fixing means 220 fixed to the horizontal plate. The tensile unit 280 of the universal testing machine is pulled at a speed of 100 ± 0.2 mm / min, and the average frictional force from the time when the weight is moved 30 mm to the time when it is moved 120 mm is measured. Based on F4 (N), the dynamic friction coefficient is calculated from the following equation.
Coefficient of dynamic friction = F4 / F3

<Pressure pressure>
The compression pressure when the fixing means is applied so that the sealing member is not displaced is measured as follows. A sensor made by AIM Techno is affixed to the wrist, a sealing member is applied to the hand from above, and the wrist is fixed from above the sensor by a fixing means. In that case, it fixes so that it may become fixing force of the grade which does not slip | deviate to the sealing member in daily operation | movement. The measured compression pressure (mmHg) is measured for 100 to 200 seconds after fixing, and the average value is calculated. A fixing means that can be fixed so as not to be displaced with a small pressure is preferable from the viewpoint of making it difficult to cause blood flow disorder and redness.

<Easy to attach / detach>
After covering the hand with the sealing member and applying the fixing means around the wrist from above the sealing member, the operability when changing the position of the fixing means is evaluated according to the following criteria.
○: When the fixing means is removed, neither catching nor sticking occurs, and the sealing member is not displaced.
X: There is a catch or adhesion when the fixing means is removed, and the sealing member is displaced from an appropriate position.

<A feeling of wearing>
Covering the hand with a sealing member, applying a fixing means around the wrist from above the sealing member, then providing a communication port, connecting to a fluid suction source through the connecting means, and reducing the pressure inside the wound device The wearing feeling when worn for 3 hours is evaluated according to the following criteria.
○: There is no sense of discomfort to some extent, and there is no discomfort at the time of wearing.
Δ: There is no strong sense of incongruity, but skin pressure is felt.
X: The fixing means is hard, and it is worn and uncomfortable.

  A wound device comprising a sealing member and fixing means made of various materials was prepared, and various measurements were performed on the sealing member.

  As a sealing member, a wound device using a polyurethane film (support: polyethylene) having a thickness of 25 μm was prepared, and the moisture permeability, elongation force, elongation rate, and flexibility characteristics of the sealing member were measured.

  As a sealing member, a polyurethane film (support: paper) having a thickness of 50 μm was used, and moisture permeability, elongation force, elongation rate, and flexibility characteristics were measured.

  As a sealing member, a polyurethane film (support: paper) having a thickness of 50 μm was used, and moisture permeability, elongation force, elongation rate, and flexibility characteristics were measured.

  As a sealing member, a polyurethane film (support: polyethylene terephthalate) having a thickness of 50 μm was used, and moisture permeability, elongation force, elongation rate, and flexibility characteristics were measured.

  As a sealing member, a polyurethane film having a thickness of 100 μm was used, and moisture permeability, elongation force, elongation rate, and flexibility characteristics were measured.

  As a sealing member, a polyurethane film having a thickness of 50 μm was used, and moisture permeability, elongation force, elongation rate, and flexibility characteristics were measured.

  As a sealing member, a polyurethane film containing acrylic beads having a thickness of about 50 μm and a particle size of about 6 μm to 7 μm was used to measure moisture permeability, elongation force, elongation rate, and flexibility characteristics.

  Next, a wound instrument comprising a sealing member composed of various materials and fixing means was prepared, and various measurements were performed on the fixing means.

  As a pressure-sensitive adhesive tape as a fixing means, a commercially available pressure-sensitive adhesive tape obtained by applying a silicone gel to a polyester elastomer film was used, and the adhesive force and the peel energy were measured by probe tack.

  As a pressure-sensitive adhesive tape as a fixing means, a commercially available pressure-sensitive adhesive tape obtained by applying an acrylic pressure-sensitive adhesive to a nonwoven fabric was used, and the pressure-sensitive adhesive force and peeling energy were measured by probe tack.

  As a pressure-sensitive adhesive tape as a fixing means, a commercially available pressure-sensitive adhesive tape obtained by applying an acrylic pressure-sensitive adhesive to a polyethylene film was used, and the adhesive force and the peeling energy were measured by probe tack.

  As a pressure-sensitive adhesive tape as a fixing means, a commercially available pressure-sensitive adhesive tape obtained by applying a silicone gel to a base material obtained by laminating a nonwoven fabric on a polyurethane film was used to measure adhesive force and peeling energy by probe tack.

    As a pressure-sensitive adhesive tape as a fixing means, a commercially available pressure-sensitive adhesive tape obtained by applying an acrylic pressure-sensitive adhesive to a polyethylene film was used, and the adhesive force and the peeling energy were measured by probe tack.

  As a pressure-sensitive adhesive tape as a fixing means, a commercially available pressure-sensitive adhesive tape in which an acrylic pressure-sensitive adhesive was applied to a urethane film was used, and the adhesive strength and peeling energy were measured by probe tack.

  As the elastic band-shaped article as a fixing means, a knitted rubber band was used, and the elongation force and elongation ratio were measured.

  Moreover, using the sealing member used in Example 1, a wound device provided with a fixing means composed of various materials is prepared, and measurement relating to the fixing means, handleability of the wound device, wearing feeling, etc. are provided. evaluated.

  The elastic band-shaped article as a fixing means is a bandage made of cotton containing latex and polyurethane knitting, and the bandages are self-adhesive, and the elongation force, elongation rate, maximum static friction coefficient and dynamic friction coefficient are It was measured. In addition, the wound device was evaluated from the viewpoints of pressure when applying the fixing means so that the sealing member is not displaced, ease of attachment / detachment, and wearing feeling.

  As a stretchable band-like article as a fixing means, a bandage made of rayon or spandex was used, and the stretching force, elongation ratio, maximum static friction coefficient and dynamic friction coefficient were measured. In addition, the wound device was evaluated from the viewpoints of pressure when applying the fixing means so that the sealing member is not displaced, ease of attachment / detachment, and wearing feeling.

  As a stretchable band-shaped article as a fixing means, a fixing band obtained by laminating compressed urethane and a raised material on a jersey material was used to measure elongation force, elongation rate, maximum static friction coefficient, and dynamic friction coefficient. In addition, the wound device was evaluated from the viewpoints of pressure when applying the fixing means so that the sealing member is not displaced, ease of attachment / detachment, and wearing feeling.

<Reference Example 1>
As a sealing member, a polyurethane film having a thickness of 65 μm was used, and the air permeability was measured.

<Comparative Example 1>
As a sealing member of Comparative Example 1, a film made of polypropylene / polyethylvinyl alcohol / polyethylene having a thickness of 150 μm was used, and moisture permeability, elongation force, elongation rate, and flexibility characteristics were measured.

<Comparative Example 2>
As a pressure-sensitive adhesive tape as a fixing means, a commercially available pressure-sensitive adhesive tape obtained by applying a silicone gel to a mesh was used, and the adhesive force and peeling energy were measured by probe tack.

<Comparative Example 3>
As a pressure-sensitive adhesive tape as a fixing means, a commercially available pressure-sensitive adhesive tape in which an acrylic pressure-sensitive adhesive was applied to a urethane film was used, and the adhesive strength and peeling energy were measured by probe tack.

<Creation of sealing member>
The base material with a support was cut into an appropriate size and shape, the base-side surfaces were overlapped, and the circumferential direction was heat-sealed to obtain a sealing member.

Table 1 is a table showing the relationship between the elongation rate and the elongation force, moisture permeability, and flexibility characteristics in Examples 1 to 7 and Comparative Example 1.
Table 2 is a table showing the adhesive strength and peeling energy in Examples 8 to 13 and Comparative Examples 2 and 3.
Table 3 is a table showing the relationship between the elongation rate and the elongation force in Example 14.
Table 4 is a table showing the relationship between the elongation rate and the elongation force in Examples 15 to 17.
Table 5 shows the maximum static friction coefficient, dynamic friction coefficient, compression pressure, displacement of the fixing means, ease of attachment / detachment, and wearing feeling in Examples 15 to 17.
Table 6 is a table showing the air permeability of Reference Example 1.
FIG. 7 is a graph showing the relationship between the elongation rate and the elongation force in Examples 1 to 7 and Comparative Example 1.
As can be seen from the results in Tables 1 to 5, the wound device of the present invention falls within the preferable characteristics of the above-described sealing member or fixing means, and constitutes the wound device having the configuration as described above. By doing so, it is possible to provide a wound device that has good adaptability to the affected area, less irritation, can reduce irritation and damage to the affected area, and can improve handling.
It is believed that human capillary pressure is an important value in wound healing. Healing wounds in patients with very low capillary pressure is said to be extremely difficult, as is the application of negative pressure closure therapy. Therefore, it is preferable that the compression pressure by the strip-shaped article having elasticity is low. Therefore, the stretchable strip-shaped article used in one embodiment of the present invention is excellent as a wound treatment device for negative pressure closure therapy.
As can be seen from the results in Table 6, the wound device of Reference Example 1 satisfies the preferable air permeability of the sealing member described above, and constitutes the wound device configured as described above. Therefore, it is excellent as a portable wound treatment device for negative pressure closure therapy.

DESCRIPTION OF SYMBOLS 1 Wound instrument 10 Sealing member 10a Opening part 10b Bottom part 11 Fixing means 20 Connection means 30 Wound pad 40 Communication port 50 Fluid suction source 90 Fixing part 95 One end

Claims (9)

A bag-like or sleeve-like sealing member provided with one or more openings for inserting an affected part having a wound, and covering the wound in a sealed state;
Comprising at least
The sealing member is formed in a roll shape,
The sealing member is used by providing a communication port connected to a fluid suction source at an arbitrary place,
The sealing member has a thickness of 10 to 100 μm,
The expansion force of the sealing member is 0.1 to 15 N / 25 mm at 10% elongation, and 0.5 to 20 N / 25 mm at 20% elongation,
A wound device, wherein the sealing member has a softness characteristic of 1 to 25 mm. A bag-like or sleeve-like sealing member provided with one or more openings for inserting an affected part having a wound, and covering the wound in a sealed state;
Comprising at least
The sealing member has a vertical direction and a horizontal direction, and is formed continuously in the vertical direction,
The sealing member is used by providing a communication port connected to a fluid suction source at an arbitrary place,
The sealing member has a thickness of 10 to 100 μm,
The expansion force of the sealing member is 0.1 to 15 N / 25 mm at 10% elongation, and 0.5 to 20 N / 25 mm at 20% elongation,
A wound device, wherein the sealing member has a softness characteristic of 1 to 25 mm.   The wound device according to claim 1, wherein the sealing member includes a resin bead.   The wound device according to any one of claims 1 to 3, wherein the wound device further includes a fixing means for fixing the sealing member to an affected part. The wound device according to any one of claims 1 to 4, wherein a moisture permeability of the sealing member is 100 g / m2 · 24 hr or more.   The fixing means is an adhesive provided around the opening of the adhesive tape or the sealing member, and the adhesive force of the adhesive provided around the opening of the adhesive tape or the opening is 0.2 to 4N. The wound device according to any one of claims 4 and 5.   The wound device according to claim 6, wherein the adhesive tape or the adhesive provided around the opening has a peel energy of 0.05 to 5 N · sec. The fixing means is a stretchable strip-shaped article provided around the opening of the sealing member, and the stretching force of the strip-shaped member is 0.1 to 20 N / 25 mm when stretched by 20%, and 50%. The wound device according to any one of claims 4 and 5, which is 1 to 40 N / 25 mm when stretched. A wound instrument according to any one of claims 1 to 8,
A wound pad disposed within the wound instrument between the wound instrument and a wound;
At least one of a fluid suction source or a fluid source connected to the wound device;
Wound device comprising at least.

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