Skin patch and its medical devices and use in the prevention and treatment of scars

Abstract

A skin patch is composed of a plurality of functional layers provided by a plurality of materials. The moisturizing layer is provided with through holes with a diameter of 1mm-5mm and a hole spacing of 1mm-5mm. The adsorbing layer is made of hydrocolloid material and is attached to the moisturizing layer. The water vapor and oil produced by skin metabolism enter the through holes and are captured by the adsorbing layer. The medical device made of the skin patch is used by removing the protective layer and attaching the moisturizing layer to the skin after injury. The skin epidermis is hydrated, the skin metabolism is promoted, and the skin is autolyzed. Finally, the effect of preventing scar hyperplasia and promoting the flattening of hyperplastic scars is achieved.

Description

TECHNICAL FIELD

[0001] The present application relates to a product for the prevention and treatment of scars, in particular to a skin patch as a medical device for the skin surface after trauma, preventing the formation of scars, or facilitating the early treatment of scars. BACKGROUND

[0002] Silicone is an organic silicon compound widely used in medical and cosmetic fields, with good biocompatibility and chemical stability. It is usually in the form of silicone gel or silicone patch for skin care and scar prevention. Silicone is colorless, odorless, non-toxic, mild to the skin, and less likely to cause allergic reactions, so it has become a commonly used material in dermatology and plastic surgery.

[0003] Silicone (silicone gel or silicone patch) has a significant effect in the prevention and treatment of scars. Its main principle is to form a protective film to regulate the water content and oxygen supply of the scar area. Silicone film can keep the skin moist and reduce water loss, thereby softening the scar tissue and reducing itching and discomfort. At the same time, the silicone film can also inhibit the abnormal proliferation of scar tissue through moderate pressure, promoting the flattening and color fading of the scar. In addition, silicone has good biocompatibility and safety, and is suitable for various types of pathological scars, including hypertrophic scars and keloids. It is easy to use, usually applied for several hours a day, and can see effects in a few months, making it an effective non-invasive method for scar prevention and treatment.

[0004] Compared with silicone gel, silicone patch has the advantages of continuity and stability, which can continuously cover the scar and provide constant therapeutic effect, and is not easy to be rubbed off or washed off. At the same time, silicone patch is easy to use, only needs to be replaced once or twice a day, provides moderate pressure, helps to flatten the scar, and protects the scar from friction and contamination. However, silicone patch is prone to fall off in the joints and areas with frequent activities. In addition, skin irritation or allergic reactions caused by long-term use of silicone patch sometimes occur. The main reason is that the skin not only secretes oil, but also continuously sheds keratinocytes during the normal physiological process. The long-term use of existing silicone patch causes the accumulation of these skin metabolic products in the local area, causing skin irritation symptoms. Moreover, some patients experience increased itching and scar proliferation after using silicone patch. SUMMARY

[0005] One object of the present application is to provide a skin patch composed of multiple material layers, which enhances the bonding force between the patch and the skin, prevents the patch from falling off, and prevents the formation of scars.

[0006] Another object of the present application is to provide a skin patch composed of multiple material layers, which reduces the occurrence of skin irritation and allergic reactions, and is suitable for long-term use.

[0007] Still another object of the present application is to provide a skin patch made into a medical device for use on skin after trauma, to promote normal metabolism of the skin, to prevent the formation of scars, or to facilitate early treatment of scars.

[0008] The skin patch of the present application, with proper adhesion and hypoallergenic properties, ensures long-term use on the skin, and ultimately prevents the formation of scars, to improve the defects of current silicone products, such as easy allergy, inability to absorb oil, and strong moisturizing and low permeability.

[0009] A hydrocolloid dressing is an innovative dressing for wound care, mainly composed of hydrophilic particles (such as gelatin, pectin, and carboxymethyl cellulose) and hydrophobic matrix (such as polyurethane). The hydrocolloid dressing can absorb excess water and oil and other exudates from the skin to form a gel, maintain a moist environment, promote healing and reduce scarring. At the same time, the hydrocolloid dressing also promotes autolytic debridement of the local skin, i.e. using its own enzymes and a moist environment to soften and remove necrotic and exfoliated tissue, and promotes normal skin metabolism.

[0010] A skin patch is composed of a functional layer provided by a plurality of materials, including

[0011] A moisturizing layer made of polysiloxane, which is in contact with the skin after trauma (closed, non-wound surface), has a plurality of through pores, and

[0012] An adsorption layer made of hydrocolloid material, with adhesion, and combined with the moisturizing layer;

[0013] Water vapor and oil produced by skin metabolism enter the through pores and are captured by the adsorption layer.

[0014] A specific embodiment of a moisturizing layer, with a thickness of 0.2mm to 1mm.

[0015] Another specific embodiment of a moisturizing layer, with a plurality of through pores with a pore size of 1mm to 5mm distributed thereon, and a pore spacing of 1mm to 5mm.

[0016] A specific embodiment of an adsorption layer, with a thickness of 0.5mm to 5mm.

[0017] Another specific embodiment of an adsorption layer, in which the hydrocolloid mainly includes 10wt% to 15wt% of a colloidal matrix, 40wt% to 80wt% of a hydrophilic polymer, 5wt% to 10wt% of a filler, and 5wt% to 10wt% of a functional additive.

[0018] The colloidal matrix, such as but not limited to polyisobutylene, rubber, and cyanoacrylate, is used alone or in combination in the present application.

[0019] Hydrophilic polymers such as but not limited to sodium carboxymethylcellulose, chitosan, sodium alginate, pectin and gelatin, etc. These polymers are used alone or in combination in the present invention.

[0020] Fillers such as but not limited to colloidal silica, content 5wt%.

[0021] Functional additives such as but not limited to glycerol, zinc oxide and propylene glycol, etc. These compounds are used alone or in combination in the present invention, content such as 8wt%.

[0022] Another embodiment of the adsorption layer, the hydrocolloid includes 31.5wt% sodium carboxymethylcellulose or 36.5wt% sodium carboxymethylcellulose, and the same hydrophilic polymer.

[0023] Another embodiment of the adsorption layer, the hydrocolloid includes 10wt% polyisobutylene, 5wt% cyanoacrylate, 31.5wt% sodium carboxymethylcellulose, 10wt% chitosan, 10wt% sodium alginate, 10wt% pectin, 10wt% gelatin, 5wt% colloidal silica, 5wt% glycerol, 3wt% propylene glycol and 0.5wt% zinc oxide.

[0024] Another embodiment of the adsorption layer, the hydrocolloid includes 10wt% polyisobutylene, 36.5wt% sodium carboxymethylcellulose, 10wt% chitosan, 10wt% sodium alginate, 10wt% pectin, 10wt% gelatin, 5wt% colloidal silica, 5wt% glycerol, 3wt% propylene glycol and 0.5wt% zinc oxide.

[0025] Another embodiment of the adsorption layer, the hydrocolloid includes 5wt% polyisobutylene, 5wt% cyanoacrylate, 36.5wt% sodium carboxymethylcellulose, 10wt% chitosan, 10wt% sodium alginate, 10wt% pectin, 10wt% gelatin, 5wt% colloidal silica, 5wt% glycerol, 3wt% propylene glycol and 0.5wt% zinc oxide.

[0026] According to the area of the skin injury, the adjuvant is cut to reduce the contact of the skin patch with healthy skin, or multiple skin patches are covered to completely cover the injured skin with the skin patch.

[0027] In order to prevent contact with external liquids such as water, soup and beverages, etc. splashing during use, affecting the normal function of the adsorption layer, a waterproof layer is also covered on the adsorption layer, such as transparent plastic film, material such as polyurethane.

[0028] The skin patch of the present application further comprises a protective layer, which is coated on the moisturizing layer to protect the moisturizing layer from damage by external force or contamination by external microorganisms.

[0029] Another medical device comprises

[0030] a moisturizing layer made of polysiloxane, which is in contact with the skin after injury, has a plurality of through pores, and

[0031] an adsorption layer made of hydrocolloid material, which has adhesion and is combined with the moisturizing layer;

[0032] a waterproof layer made of polyurethane, which is coated on the adsorption layer;

[0033] Water vapor and oil produced by skin metabolism enter the through pores and are captured by the adsorption layer.

[0034] It has been verified that the skin patch provided by the present application is easy to apply to the skin surface, has strong adhesion to the skin, and is not easy to slip off the skin due to joint movement. The ability of the skin patch to absorb water and moisturize the skin after injury is improved, and the skin patch has the ability to absorb oil produced by skin metabolism and promote autolysis of metabolic tissues.

[0035] The medical device made of the skin patch of the present application promotes the recovery of normal metabolism of the skin, prevents the generation of scars, or is beneficial to the early treatment of scars.

[0036] Another medical device comprises

[0037] a moisturizing layer made of polysiloxane, which is in contact with the skin after injury, has a plurality of through pores, and

[0038] an adsorption layer made of hydrocolloid material, which has adhesion and is combined with the moisturizing layer;

[0039] a waterproof layer made of polyurethane, which is coated on the adsorption layer;

[0040] a protective layer, which is release paper, coated on the moisturizing layer;

[0041] Water vapor and oil produced by skin metabolism enter the through pores and are captured by the adsorption layer.

[0042] Compared with the prior art, the present application has the following advantages and beneficial effects:

[0043] The skin patch provided by the present application comprises a moisturizing layer made of silicone material and an adsorption layer made of hydrocolloid material, which can increase the ability of the patch to absorb water and moisturize.

[0044] By creating a porous structure in the moisturizing layer, it can provide powerful hydration while allowing skin metabolites to be absorbed by the adsorption layer through the pores. This further enhances the skin patch's oil adsorption capacity and promotes the autolysis of metabolic tissues.

[0045] The adsorption layer provided by this invention is made of hydrocolloid and has low viscosity, which reduces the use of adhesives, making it easy to clean while reducing skin irritation. Attached Figure Description

[0046] Figure 1 This is a schematic diagram of an embodiment of the skin patch of the present invention;

[0047] Figure 2 for Figure 1 A cross-sectional view of the skin patch shown at one angle;

[0048] Figure 3 Bright field photographs of various groups of experimental animals with hypertrophic scars after trauma, showing the application of the skin patch of the present invention to the skin.

[0049] Figure 4 The skin patch of the present invention is used to treat hypertrophic scars in various groups of experimental animals after trauma, and the pathological staining and statistical graphs are shown.

[0050] Figure 5 This is a diagram showing the results of an experimental animal skin sensitivity test of the skin patch of the present invention. Detailed Implementation

[0051] The technical solution of the present invention will be described in detail below with reference to the accompanying drawings. The embodiments of the present invention are only used to illustrate the technical solution of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solution of the invention without departing from the spirit and scope of the technical solution of the present invention, and all such modifications and substitutions should be covered within the scope of the claims of the present invention.

[0052] Example 1

[0053] like Figure 1 and Figure 2 As shown, the skin patch of the present invention includes an absorbent layer (2) and a moisturizing layer (3), a waterproof layer (1) is applied to the absorbent layer (2), and a protective layer (4) is applied to the moisturizing layer (3). The absorbent layer (2) is 0.5mm-5mm thick and is a hydrocolloid material. It can directly contact the skin through the pores of the moisturizing layer (2). It is a pale yellow semi-transparent material with adhesive properties. It can absorb skin moisture or exudate and then turn into a white opaque material. It can absorb skin metabolic secretions, promote local epidermal renewal and autolysis, reduce skin irritation, and can also serve as an indicator to remind the patch to be replaced.

[0054] The substrate of the adsorption layer (2) is a hydrocolloid material, mainly composed of 10wt% to 15wt% colloidal matrix, 40wt% to 80wt% hydrophilic polymer, 5wt% to 10wt% filler, and 5wt% to 10wt% functional additives. It directly contacts the skin through the pores in the middle of the moisturizing layer, and can absorb the water vapor released by the skin, forming a local moist environment to reduce skin irritation. The outermost waterproof layer is made of polyurethane film substrate, which has both strong adhesion and breathability, and is less irritating to the skin. It is a commonly used medical dressing.

[0055] The adsorbent layer consists of the following components: 10 wt% polyisobutylene, 5 wt% cyanoacrylate, 31.5 wt% sodium carboxymethyl cellulose, 10 wt% chitosan, 10 wt% sodium alginate, 10 wt% pectin, 10 wt% gelatin, 5 wt% colloidal silica, 5 wt% glycerol, 3 wt% propylene glycol, and 0.5 wt% zinc oxide. (Referred to as: Scheme 1)

[0056] Another example: 10 wt% polyisobutylene, 36.5 wt% sodium carboxymethyl cellulose, 10 wt% chitosan, 10 wt% sodium alginate, 10 wt% pectin, 10 wt% gelatin, 5 wt% colloidal silica, 5 wt% glycerol, 3 wt% propylene glycol, and 0.5 wt% zinc oxide. (Referred to as: Scheme Two)

[0057] For example: 5 wt% polyisobutylene, 5 wt% cyanoacrylate, 36.5 wt% sodium carboxymethyl cellulose, 10 wt% chitosan, 10 wt% sodium alginate, 10 wt% pectin, 10 wt% gelatin, 5 wt% colloidal silica, 5 wt% glycerol, 3 wt% propylene glycol, and 0.5 wt% zinc oxide. (Referred to as: Scheme Three)

[0058] The moisturizing layer (3) has a thickness of 0.2mm to 1mm, a pore size of 1mm to 5mm, and a pore spacing of 1mm to 5mm. It is made of polysiloxane material and comes into direct contact with the skin to provide moisturizing effects. This helps to increase the water content of scarred skin. The pores in the middle of the moisturizing layer allow the hydrocolloid to come into direct contact with the skin. On the one hand, this avoids the accumulation of local skin metabolic secretions due to long-term contact, which can cause irritation. On the other hand, the adsorption layer promotes the renewal and recovery of local scarred skin.

[0059] In this embodiment, the waterproof layer (1) is a transparent plastic film made of polyurethane film, which serves to waterproof, prevent sticking, and protect the hydrocolloid layer.

[0060] Example 2 Hypertrophic Scar Inhibition Experiment

[0061] The hypertrophic scar model was constructed using a rabbit ear hypertrophic model. Female New Zealand white rabbits aged 3-6 months were used. Four circular incisions were made on the ventral side of each rabbit's ear using a 10mm / 15mm diameter trephine. The scabs were repeatedly removed to construct the hypertrophic scar model of the wound.

[0062] The experiment tested the inhibitory effect of the patented scar patch made with the absorbent layer of Example 1 (e.g., Scheme 1) and the control scar patch on hypertrophic scars on the skin of four rabbit ear hypertrophic scar animal models after continuous use for one month (see details). Figure 3 ).

[0063] Experimental results showed that the patented scar patch had a more significant effect in inhibiting scar hyperplasia compared with the control scar patch. Histopathological examination showed that both the silicone patch and the patented scar patch significantly reduced scar thickness compared with the control group, with the patented scar patch showing a more pronounced effect in reducing thickness (see Figure 4 for details).

[0064] Example 3 Skin Allergy Test

[0065] According to the national standard GB / T 16886.23 Biological evaluation of medical devices: Methods for irritation and skin sensitization tests, the skin irritation of the skin patch of the present invention, made with the adsorption layer of Example 1 (e.g., Scheme 1), and the control group saline patch were compared.

[0066] The experiment tested the skin irritation of the skin patch of the present invention, made using the absorbent layer of Example 1 (e.g., Scheme 1), with physiological saline on the skin of four rabbit animal models. Details of the results are available in the original text. Figure 5 The repeated exposure experiment involved a single exposure time of 4 hours, followed by an observation period of 24 hours, and a final exposure observation period of 72 hours, for a total of 6 exposures.

[0067] The experimental results show that, compared with physiological saline, the patented scar patch made using the absorbent layer of Example 1 (e.g., Scheme 1) showed no obvious skin reaction after a single stimulation, as shown in Table 1 below. Repeated stimulation resulted in very slight skin reactions (0-0.4), mainly manifested as very slight erythema (barely visible), with no obvious skin erythema or swelling. The highest-scoring skin irritation reaction observed during the experiment was very slight erythema, occasionally seen in repeated contact experiments.

[0068] Table 1

[0069]

[0070]

[0071] When using the medical device made from the skin patch of this invention, the protective layer (4) is peeled off, and the moisturizing layer (3) is applied to the skin after injury. This provides hydration to the skin epidermis and promotes skin metabolism and autolysis, ultimately achieving the effect of preventing scar hyperplasia and promoting the smoothing of hyperplastic scars. If the absorbent layer (2) changes from pale yellow and transparent to white and cloudy, a new skin patch can be replaced.

Claims

1. A skin patch, composed of functional layers made of multiple materials, for inhibiting scar hyperplasia, characterized in that... include: The moisturizing layer, made of polysiloxane, comes into direct contact with the skin to provide hydration, increasing the moisture content of scarred skin, and The adsorption layer, made of hydrocolloid material, is sticky and combined with the moisturizing layer. It directly contacts the skin through the pores in the moisturizing layer, absorbing the moisture released by the skin and creating a localized moist environment to reduce skin irritation. The moisturizing layer has through pores with a diameter of 1mm to 5mm and a spacing of 1mm to 5mm. The hydrocolloid mainly comprises 10wt% to 15wt% colloidal matrix, 40wt% to 80wt% hydrophilic polymer, 5wt% to 10wt% filler, and 5wt% to 10wt% functional additives. The hydrophilic polymer comprises 31.5 wt% or 36.5 wt% carboxymethyl cellulose, 10 wt% chitosan, 10 wt% sodium alginate, 10 wt% pectin and 10 wt% gelatin; Water vapor and oil produced by skin metabolism enter the permeable pores and are captured by the adsorption layer.

2. The skin patch according to claim 1, characterized in that... The colloidal matrix is ​​selected from one or more of polyisobutylene, rubber and polyacrylate adhesives.

3. The skin patch according to claim 1, characterized in that... The colloidal matrix is ​​selected from one of the following: 10 wt% polyisobutylene; 5% polyisobutylene and 5% polyacrylate adhesive, or 10% polyisobutylene and 5% polyacrylate adhesives.

4. The skin patch according to claim 1, characterized in that... The filler is colloidal silica, with a content of 5 wt%.

5. The skin patch according to claim 1, characterized in that... A waterproof layer is applied over the adsorption layer.

6. The use of the skin patch according to claim 1 in the preparation of a medical device for preventing scarring of the skin after trauma.

7. A medical device, characterized in that... Including the skin patch as described in claim 1.

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