WO2021002729A1

WO2021002729A1 - Silicone gel sheet having wound pressing means

Info

Publication number: WO2021002729A1
Application number: PCT/KR2020/008745
Authority: WO
Inventors: 이민우; 이훈범
Original assignee: 주식회사 지엔 이노베이션; 이민우; 이훈범
Priority date: 2019-07-03
Filing date: 2020-07-03
Publication date: 2021-01-07
Also published as: KR102095229B1

Abstract

The present invention comprises: a silicone gel layer in contact with a wound area of the skin; an adhesive layer for fixing the silicone gel layer to the skin; and an expansion pressing layer interposed between the silicone gel layer and the adhesive layer, and prepared so as to enable pressing of the silicone gel layer onto the skin. Therefore, provided is a silicone gel sheet in which a pressing means can expand so as to stably perform pressing on the skin when the silicone gel layer attached to the skin is used in a wound healing process, the silicone gel layer and the expansion pressing layer can be combined and integrated so that a pressing effect is stably maintained even during use for a long time, and the density and the pressing force can be different over the whole area.

Description

Silicone gel sheet with wound compression means

The present invention relates to a silicone gel sheet having a wound compression means, and specifically, a wound compression means is integrally provided so that the wound can be effectively compressed in the process of healing a wound on the skin, and the pressure acting around the wound area is different. It relates to a silicon gel sheet having an improved structure to act to make it work.

Humans are made up of various tissues, and skin is one of them.

The skin protects the human body from external stimuli, prevents moisture loss, regulates body temperature, and has important life protection functions such as preventing bacterial invasion. When such skin defects occur due to burns or various traumas, its protective action is lost, resulting in functional impairment, and various side effects such as moisture loss and external bacterial infections are caused, making treatment of the affected area difficult or secondary. It leads to additional side effects such as dysfunction or impairment of phosphorus. In severe cases, it also affects life extension.

Therefore, it is desirable to promptly heal wounds and minimize secondary various side effects.

The wound healing or healing process generally consists of three types of inflammation (inflammation), granulation tissue formation, and matrix remodeling. Basically, scars are divided into two types: atrophic that looks dent and hypertrophic that looks like a bulge, and is determined by whether there was net gain or net loss of collagen during the recovery process. . 80-90% of patients develop atrophic scars due to collagen loss, and hypertrophic scars and keloids appear in a few.

After keloid tissue resection, continuous and even pressure compression therapy can be used to flatten keloids as well as hypertrophic scars. Compression tools are responsible for softening and flattening the wound. Recently, silicone gel sheets are widely used.

On the other hand, blood vessels, nerves, and lymphatic vessels are also present in the dermis, but most of the fibrils called collagen and fibroblasts that form them are present in the most. If there is damage to the dermis, collagen is formed in fibroblasts to fill and bond, and when the formed collagen fills the damage of the dermis, epidermal cells proliferate on it and regenerate the skin surface.

Scars occur because the regenerated collagen does not exist evenly in a certain direction like the original skin collagen, but is irregular and produced in several directions. In addition, the amount of collagen formed is also a problem. If too much collagen is formed, it becomes a protruding scar, and if only a small amount is formed, it becomes a hollow scar like an acne scar. In other words, such collagen works to bond wounds together and maintain tension. Once a lot of collagen is made, scars may occur, but afterwards, unnecessary collagen is absorbed, and the arrangement of collagen is not perfect depending on the skin tension gradually, but there is a time when it is ordered, and it is desirable to apply pressure to prevent scarring at this time. . When pressure is applied during the healing process of the wound, swelling, deposition and change of the matrix, scar nodules, etc. are reduced, it can induce realignment of collagen bundles parallel to the epithelium, and increase scar flexibility and flattening, and fiber The effect of gradual reduction of blast cells and reduction of itching and pain can be obtained.

However, in the case of using a silicone gel sheet of the prior art, the silicone gel sheet is attached to the skin, and a tape or band-aid is attached to the upper part, but the effect of compressing the silicone gel sheet is gradually reduced when it is attached for a long time, and the use is not simple. There is a problem that it is not convenient.

In addition, when using such a silicone gel sheet, it is more preferable to make the pressure acting around the wound area different.

It is an object of the present invention to provide a silicone gel sheet in which a pressing means can expand so that a silicone gel layer attached to the skin can be stably pressed toward the skin when a silicone gel layer attached to the skin is used during a wound healing process.

In addition, another object of the present invention is to provide a silicone gel sheet in which a silicone gel layer and an expansion compression layer are combined and integrated so that the compression effect can be stably maintained even when used for a long time.

In addition, another object of the present invention is to provide a silicone gel sheet that is simple and convenient to use since it does not need to be attached or detached separately during use, so that contamination can be prevented and can be used regardless of day and night.

In addition, another object of the present invention is to provide a silicone gel sheet that can be made thin and is easy to press and wear.

In addition, another object of the present invention is to provide a silicone gel sheet capable of more effectively healing a wound by causing the pressure to pressurize the wound to act differently from the center portion and the edge portion.

In addition, another object of the present invention is to provide a silicone gel sheet capable of differently applying pressure to pressurize the wound according to the location of the wound by making the thickness and density of the central portion and the edge portion different.

In addition, another object of the present invention is to provide a silicone gel sheet having a means for retaining moisture so that the introduced moisture does not evaporate when moisture is introduced into the expansion compression layer.

The object of the present invention. A silicone gel layer in contact with the wound area of the skin; An adhesion layer fixing the silicone gel layer to the skin; It is achieved by a silicone gel sheet comprising a; an expansion pressure layer interposed between the silicone gel layer and the adhesion layer provided to press the silicone gel layer to the skin.

In addition, it is preferable that the amount of expansion of the expansion pressure layer gradually decreases from the center region to the edge region.

In addition, it is preferable that the expansion pressure layer expands by a liquid containing moisture supplied from the outside of the adhesion layer while being fixed by the adhesion layer to press the silicone gel layer toward the skin against the adhesion layer.

In addition, the material of the expansion pressure layer is preferably selected from a hydrophilic colloid including polyvinyl alcohol (PVA), polyvinyl acetate (PVAc), and a cellulose sponge or pad.

In addition, it is preferable that the central portion including the central portion of the expansion compression layer comprises 60 to 70% of the total area, and the edge portion formed including the edge of the expansion compression layer occupies 30 to 40% of the total area.

In addition, the central portion including the central portion of the expansion pressure layer includes 55 to 65% of the total area, and the edge portion formed including the border of the expansion pressure layer is formed to 10 to 15% of the total area, and the central portion It is preferable that the middle portion between the and the rim portion occupies 20 to 25%.

In addition, it is preferable that the central portion has a density higher than that of the edge portion.

In addition, it is preferable that the material of the central portion has a higher expansion rate when absorbing moisture than the material of the edge portion.

In addition, the amount of expansion of the expansion compression layer gradually decreases from the central region to the rim region, or the expansion compression layer increases from the central region to the rim region, the compression pressure that compresses the wound after expansion of the expansion compression layer. It is desirable to be small.

In addition, the expansion compression layer includes a central portion including a central portion of the expansion compression layer, an edge portion formed including an edge of the expansion compression layer, and an intermediate portion between the edge portion, wherein the pressing pressure of the central portion It is preferable to include 15 to 30 mmHg, the pressure of the middle portion is 10 to 20 mmHg, the pressure of the edge portion includes a range of 3 to 10 mmHg.

In addition, it is preferable to include a foam repair unit provided between the expansion compression layer and the adhesion layer to hold the moisture supplied to the expansion compression layer.

In addition, it is preferable to provide a plurality of through holes penetrating the silicone gel layer, the expansion compression layer, and the attachment layer, or a plurality of through holes penetrating the expansion compression layer and the attachment layer.

In addition, it is preferable that the silicone gel layer includes a sheet in a solid shape, or is applied or coated on a region of the surface of the expansion pressure layer in contact with the skin with liquid silicone and silicone spray.

According to the present invention, it is possible to provide a silicone gel sheet in which the pressing means can expand so that when the silicone gel layer attached to the skin is used in the wound healing process, it can be stably pressed toward the skin.

In addition, it is possible to provide an integrated silicone gel sheet by combining a silicone gel layer and an expansion compression layer to stably maintain the pressing effect even when used for a long time.

In addition, since there is no need to attach and detach separately during use, contamination can be prevented, and since it can be used regardless of day and night, it is possible to provide a silicone gel sheet that is simple and convenient to use.

In addition, it is possible to provide a silicone gel sheet that can be made thin and is easy to press and wear.

In addition, it is possible to provide a silicone gel sheet capable of more effectively healing the wound by causing the pressure to pressurize the wound to act differently from the center portion and the edge portion.

In addition, it is possible to provide a silicone gel sheet capable of having different thicknesses and densities of the central portion and the rim portion so that the pressure to press the wound may act differently depending on the location of the wound.

In addition, when moisture flows into the expansion pressure layer, a silicone gel sheet having a means for retaining moisture so that the introduced moisture does not evaporate may be provided.

1 is a cross-sectional view of a silicone gel sheet according to an embodiment of the present invention,

2 to 4 are cross-sectional views for explaining a use example of a silicone gel sheet,

5 is a plan view and a graph for explaining an expansion compression side according to another embodiment of the present invention;

6 is a plan view and a graph for explaining an expansion compression side according to another embodiment of the present invention,

7 is a plan view for explaining an expansion compression layer according to another embodiment of the present invention;

8 is a cross-sectional view of a silicone gel sheet according to another embodiment of the present invention.

The silicone gel sheet 100 (hereinafter referred to as'silicone gel sheet') having a wound pressing means according to embodiments of the present invention will be described in detail with reference to FIGS. 1 to 8.

1 is a cross-sectional view of a silicone gel sheet according to an embodiment of the present invention, FIGS. 2 to 4 are cross-sectional views for explaining a use example of the silicone gel sheet, and FIG. 5 is an expansion compression according to another embodiment of the present invention. It is a plan view and a graph for explaining the side, Figure 6 is a plan view and a graph for explaining an expansion compression side according to another embodiment of the present invention, Figure 7 is an expansion compression layer according to another embodiment of the present invention It is a plan view for explaining, and FIG. 8 is a cross-sectional view of a silicone gel sheet according to another embodiment of the present invention.

The silicone gel sheet 100 includes, as shown in FIG. 1, a silicone gel layer 110 in contact with a wound portion of the skin; An adhesion layer 130 fixing the silicone gel layer 110 to the skin; It is preferable to include an expansion pressure layer 150 interposed between the silicone gel layer 110 and the adhesion layer 130 to allow the silicone gel layer 110 to be pressed against the skin.

*Silicone gel layer 110 contains an adhesive so that it can be easily attached to the skin underneath by being in contact with the skin, and it is preferable that moisture and oxygen can pass through it, and the silicone gel sheet 100 has a hard yet soft and flexible property. Have.

When the silicone gel layer 110 is attached to the wound, new skin is formed and the less formed stratum corneum is improved, so that occlusion is generated, and the optimal water level is maintained so that the scar area can be normalized by supplying moisture from healthy skin. When the skin is properly hydrated, the risk of scar formation can be reduced because cells do not signal to produce collagen.

Since the silicone gel layer 110 can cover a large area at once, it is ideal for major abrasions such as large scars, burns, and rashes, and the silicone gel sheet 100 is provided in various shapes such as rectangles, squares, circles, ovals, etc. as needed. Can be. In a shape corresponding to the shape of the silicone gel layer 110, it is preferable that the shape of the expansion pressure layer 150 and the adhesion layer 130 to be described later are also provided.

The silicone gel layer 110 may include a solid sheet, or may be applied or coated with liquid silicone on the surface of the expansion compression layer 150 in contact with the skin, and in some cases, the expansion compression layer 150 with a spray. ) Can be applied or coated on the surface.

The adhesion layer 130 functions to fix or attach the silicone gel layer 110 and the expansion pressure layer 150 bonded to the silicone gel layer 110 to be in close contact with the skin, and moisture is supplied from the outside including a breathable material. In some cases, moisture inside may escape to the outside.

The adhesive layer 130 may include various types of tapes or band-aids that perform this function, and a bandage may be included depending on the wound area.

The expansion pressure layer 150 is bonded between the silicone gel layer 110 and the adhesion layer 130 to swell when moisture is supplied from the outside, and can press the silicone gel layer 110 toward the skin side due to this swelling expansion. It is preferable. The expansion compression layer 150 is provided with a porosity so as to easily absorb moisture supplied from the outside. For example, the material of the expansion compression layer 150 is made of polyvinyl alcohol (PVA) or polyvinyl acetate (PVAc). desirable. It is preferable that the expansion pressure layer 150 further includes a material capable of pressing the skin side by rapidly expanding the volume by moisture supplied from the outside, including a hydrophilic colloid such as a cellulose sponge or pad.

Here, the expansion compression layer 150 has been exemplified that it expands by moisture supplied from the outside, but expands by force or air supplied from the outside, such as an air bag that expands by injecting air from the outside to expand the expansion of the present invention. It may include possible means consistent with the technical idea of the compression layer 150.

The release layer 170 is sealed, contaminated and sterilized, as shown in FIG. 2, and the silicone gel sheet 100 is packaged inside the package 180, and the silicone gel layer 110, the adhesive of the adhesive layer 130 Since it is bonded to the area including the back, the release layer 170 may be removed when the user uses it, and the silicone gel sheet 100 may be firmly adhered to the skin.

Meanwhile, a plurality of through holes (not shown) penetrating through the silicone gel layer 110, the expansion compression layer 150 and the attachment layer 130 are provided, or the expansion compression layer 150 and the attachment layer ( It is preferable to have a plurality of through holes passing through 130). It is preferable that the size of the through hole is composed of a plurality of fine holes such as to pass through the injection needle.

These through-holes serve as a passage for supplying moisture from the outside through the expansion compression layer 150, as well as a passage for discharging the exudate generated from the internal wound to the outside, thereby preventing the exudate from crumbling the wound or skin. In addition, it is preferable to provide a passage for injecting an injection solution or a required solution from the outside.

A method of using the silicone gel sheet 100 according to an embodiment of the present invention having the above-described configuration will be described in detail with reference to FIGS. 2 to 4.

First, as shown in FIG. 2, the release layer 170 is separated by tearing the silicone gel sheet 100 sterilized and sealed on the wrapping paper 180.

Next, as shown in FIG. 3, the silicone gel sheet 100 is attached to the wound area of the skin.

And, as shown in Fig. 4, water may be supplied from the outside to the expansion compression layer 150 using a syringe, etc., but the material of the adhesion layer 130 is breathable, so if water is wetted from the outside, the adhesion layer 130 is formed. When the passed water reaches the expansion compression layer 150, the expansion compression layer 150 absorbing water is swollen (the height of the expansion compression layer in FIG. 4 changes from'H1' to'H2'). It acts as a force that presses the silicon gel layer 110. As the expansion force of the expansion compression layer 150 is maintained, the silicone gel layer 110 is stably pressed, so that regeneration is more effectively performed during the healing process of the wound, and scars may hardly occur.

In addition, the silicone gel sheet 100 is simple and convenient to use because it is a single package or a module. It is manufactured for single use and can reduce cost.

Accordingly, according to the present invention, it is possible to provide a silicone gel sheet in which the pressing means can expand so that when the silicone gel layer attached to the skin is used during the wound healing process, it can be stably pressed toward the skin.

Meanwhile, a silicone gel sheet 100 according to another embodiment of the present invention is illustrated in FIGS. 5 to 7 and will be described in detail below. As described above, since the expansion compression layers 150, 250, 350, 450 may be provided in a rectangular, square, circular, oval, etc., the shapes of the expansion compression layers 150, 250, 350, 450 are shown in FIGS. 5 to 7 It is not limited to the shape shown in.

The expansion and

compression layers

150, 150 ′, 250, 350, and 450 of the silicone gel sheet 100 according to the present embodiment are bordered in the central region (refer to'O' in FIGS. 5 to 7). (Refer to'S or Sr, Sl, Sf, Sb' in 7), it is desirable that the amount of expansion gradually decreases. Alternatively, in the expansion compression layers 150, 150 ′, 250, 350, 450, it is preferable that the compression pressure for compressing the wound after the expansion compression layer expands becomes smaller and smaller from the central area to the edge area.

First, as shown in Figure 5, the expansion pressure layer 150, the edge area ('S or Sr, Sl, in Figures 5 to 7) in the central area (see'O' in Figures 5 to 7) Sf, Sb'), so that the amount of expansion gradually decreases, the border area ('S or Sr, Sl, Sf, Sb' of FIGS. 5 to 7) in the central area (see'O' of FIGS. 5 to 7). It is preferable that it is molded so that the density becomes smaller and smaller as it goes to the reference).

As an example of this method of varying the density, the material is stacked thinner from the center area to the border area, and then pressed to form the same thickness. The material is compressed in the center area. It is a structure that has the lowest density in which materials are stacked. In such a structure, when moisture is supplied to the expansion compression layer 150, more moisture is absorbed toward a higher density and thus more expands. This property decreases toward the edge area, and thus, in the center area as shown in FIG. The pressure to press the wound area is the highest, and the pressure to press the wound area becomes the lowest as it goes toward the edge area.

As an example of another method, the material selected in the center area selects a material capable of absorbing more moisture than the material selected in the border area. By selecting such a material, it expands more in the central region and expands less toward the rim region, so that the pressure to press the wound in the central region is highest and becomes smaller and smaller toward the rim region. For example, when the same moisture is absorbed, the expansion coefficient of PVA or PVAc is greater than that of methylcellulose, and in this case, the central area contains almost 100% of the PVA or PVAc material, and the edge area contains almost 100% of the methylcellulose material, and the center It is preferable to form the expansion pressure layer 150 by gradually decreasing the content of the PVA or PVAc material from the region to the edge region and increasing the material of methylcellulose.

Here, there is no need to have a difference in thickness between the central region and the edge region of the expansion compression layer 150, and may have a thicker structure toward the center, and whether or not such thickness is the same in the embodiments to be described later unless otherwise specified. A detailed description is omitted from.

In addition, the expansion compression layer 150 ′ according to another embodiment of the present invention is divided into a plurality of regions, and as an example, the central portion 153 divided into 3 regions, the middle It consists of a portion 155 and an edge portion 157. These divisions can be divided into various forms including two parts and four parts.

The central portion 153 is a central area partitioned including a central point (see'O' in FIG. 6, the same hereinafter), which is the center of the central area, and the border portion 157 is a border ('Sr (right border) in FIG. 6). , Sl (left border), Sf (front border), Sb (refer to Sb (rear border)) is a divided border area, and the middle part 155 is an area that divides between the center part 153 and the border part 157 to be.

It is preferable to have a structure in which the density decreases toward the central portion 153, the middle portion 155, and the rim portion 157 in the divided area, and when moisture flows in, the pressure to press the wound portion gradually decreases.

Here, as an example, the pressure of the wound area or the skin in the central part 153 is 15 to 30 mmHg, the pressure in the middle part 155 is 10 to 20 mmHg, and the pressure of the edge part 157 has a range of 3 to 10 mmHg. It is desirable. If the compression pressure is higher than this, the pressure received by the patient using the silicone gel sheet 100 is high and uncomfortable, and if it is lower than this, the effect of compressing the wound area sharply decreases, which is undesirable.

In addition, here, the central portion 153 including the central portion of the expansion compression layer 150 includes 55 to 65% of the total area, and the edge portion 157 formed including the border is 10 to 15% of the total area It is formed of, and the middle portion 155 is preferably occupied 20 to 25%.

Since the central part 153 occupies a large part, the central part is the scar caused by the wound, and the most pressure is applied thereto, thereby suppressing the rearrangement of collagen and the swelling of the scar, thereby minimizing the occurrence of the scar.

Although not shown here, if the expansion compression layer 150 is divided into two regions, the central portion 153 includes 60 to 70% of the total area, and the rim portion 157 formed including the rim is 30 to 30 of the total area. It is desirable to account for 40%.

In addition, in this embodiment, unlike FIG. 5, as shown in FIG. 6, it is preferable that the pressure for pressing the wound area in each region of the central portion 153, the middle portion 155, and the rim portion 157 is the same, and the central portion It is preferable that the density in each region of the 153, the middle portion 155, and the rim portion 157 are the same.

And, the shape of the central portion (253, 353, 453), the middle portion (255, 355, 455) and the edge portion (257, 357, 457) of the expansion compression layer (250, 350, 450) as shown in FIG. Likewise, it can be provided in various shapes.

That is, the

central portions

253 and 453 and the

intermediate portions

255 and 455 may also be partitioned to include a part of the edge area.

Accordingly, according to another embodiment of the present invention, it is possible to provide a silicone gel sheet capable of more effectively healing a wound by causing the pressure to pressurize the wound to act differently from the center portion and the edge portion.

On the other hand, a silicone gel sheet 600 according to another embodiment of the present invention is shown in FIG. 8.

The silicone gel sheet 600 as shown in FIG. 8 is applied to all the silicone gel sheets 100 including FIGS. 1 to 7 as described above.

The silicone gel sheet 600 according to this embodiment is a foam provided to hold the moisture supplied to the expansion compression layer 650 between the adhesion layer 630 and the expansion compression layer 650 as shown in FIG. It characterized in that it is provided with a maintenance unit 690.

The foam repair unit 690 has a somewhat elasticity and has many pores, so that the moisture supplied to the expansion compression layer 650 does not evaporate to the outside. I can. That is, it is possible to prevent the supplied moisture from evaporating to the outside and the silicone gel sheet 600, in particular, the expansion pressure layer 650 to become hard.

Accordingly, according to another embodiment of the present invention, when moisture is introduced into the expansion compression layer, a silicone gel sheet having a means for retaining moisture so that the introduced moisture does not evaporate may be provided.

Herein, although various embodiments of the present invention have been shown and described, those skilled in the art with ordinary knowledge in the technical field to which the present invention pertains will recognize that the present embodiments can be modified without departing from the principles or spirit of the present invention. The scope of the invention will be determined by the appended claims and their equivalents.

Claims

A silicone gel layer in contact with the wound area of the skin;

An adhesion layer fixing the silicone gel layer to the skin;

Including; an expansion pressure layer interposed between the silicone gel layer and the adhesion layer provided to press the silicone gel layer to the skin;

The material of the expansion compression layer is selected from polyvinyl alcohol (PVA), polyvinyl acetate (PVAc), and a hydrophilic colloid including a cellulose sponge or pad, and the expansion compression layer gradually expands from the central region to the edge region. The amount to do is less,

The content of the material of PVA or PVAc in the central region is higher than that of cellulose, and the content of the cellulose material in the edge region is higher than that of PVA or PVAc.
The method of claim 1,

The expansion pressure layer is a silicone gel sheet, characterized in that in a state fixed by the adhesion layer, it expands by a liquid containing moisture supplied from the outside of the adhesion layer to press the silicone gel layer toward the skin against the adhesion layer. .
The method of claim 1,

The central portion including the central portion of the expansion compression layer includes 60 to 70% of the total area,

Silicon gel sheet, characterized in that the edge portion formed including the edge of the expansion pressure layer occupies 30 to 40% of the total area.
The method of claim 1,

The central portion including the central portion of the expansion compression layer includes 55 to 65% of the total area,

The edge portion formed including the edge of the expansion pressure layer is formed to be 10 to 15% of the total area,

Silicon gel sheet, characterized in that the middle portion between the central portion and the edge portion occupies 20 ~ 25%.
The method of claim 3,

Silicon gel sheet, characterized in that the density of the central portion is formed higher than the density of the edge portion.
The method of claim 3,

When the material of the central part absorbs moisture than the material of the edge part, the silicone gel sheet has a higher expansion rate.
The method of claim 1,

The expansion pressure layer gradually expands from the central region to the border region, and the amount of expansion decreases.

The expansion compression layer is a silicone gel sheet, characterized in that the compression pressure for pressing the wound after the expansion of the expansion compression layer gradually decreases from the center region to the edge region.
The method of claim 7,

The expansion compression layer includes a central portion including a central portion of the expansion compression layer, an edge portion formed including an edge of the expansion compression layer, and an intermediate portion between the edge portion,

The pressure of the central portion is 15 ~ 30mmHg, the pressure of the middle portion is 10 ~ 20mmHg, the pressure of the edge portion is a silicone gel sheet, characterized in that the range of 3 ~ 10mmHg.
The method of claim 1,

A silicone gel sheet comprising a foam repair unit provided between the expansion compression layer and the adhesion layer to hold moisture supplied to the expansion compression layer.
The method of claim 1,

Having a plurality of through-holes penetrating through the silicone gel layer, the expansion pressure layer, and the adhesion layer,

A silicone gel sheet comprising a plurality of through holes penetrating the expansion pressure layer and the adhesion layer.
The method of claim 1,

The silicone gel layer comprises a sheet in a solid shape, or is applied or coated on an area of the surface of the expansion pressure layer in contact with the skin with liquid silicone and silicone spray.