Transparent hydrogel dressing

Abstract

A dressing includes a top film, an adhesive layer positioned proximate the top film proximate the skin of a user when the bandage is used, a hydrogel layer positioned beneath the adhesive layer proximate the skin of the user when the bandage is used, including a support layer, and a lower perforation layer positioned beneath the hydrogel layer for adhering the bandage to the skin of the user. All layers may be transparent or at least partially translucent to allow a user to view the user's skin through the bandage. The hydrogel layer disperses the pressure to reduce the pressure on the skin of the user and reduce the possibility of pressure sores.

Description

Cross - Reference to Related Applications

[0001] This application claims the benefit and priority of a Chinese utility model patent application filed on September 23, 2022 (Application No.: CN202222528876.6).

[0002] This application claims the benefit and priority of a Chinese invention patent application filed on June 5, 2023 (Application No.: CN2023106537086).

[0003] This application claims the benefit and priority of a Chinese utility model patent application filed on June 5, 2023 (Application No.: CN2023214032638).

[0004] This application claims the benefit and priority of a US provisional patent application filed on June 9, 2023 (Application No.: 63 / 472,127).

[0005] This application claims the benefit and priority of a US provisional patent application filed on June 9, 2023 (Application No.: 63 / 472,091).

[0006] This application claims the benefit and priority of a US provisional patent application filed on June 9, 2023 (Application No.: 63 / 472,146).

[0007] This application claims the benefit and priority of a US provisional patent application filed on June 12, 2023 (Application No.: 63 / 472,496). Background Art Technical Field of the Present Disclosure

[0008] The present invention relates to a bandage that allows observation of a wound when placed on a user's skin. The bandage may include an antibacterial material to prevent infection. The bandage may include a hydrogel layer and may adhere to the skin around a wound on the user's skin through a silicone adhesive layer with micropores. Related Art

[0009] Existing medical dressings are usually opaque materials, so medical staff and patients cannot directly observe the skin condition under the bandage. Bandages are usually used to cover wounds to promote healing. In addition, bandages can also be used for patients with limited mobility and / or patients who are bedridden for a long time to prevent and treat pressure ulcers. Pressure ulcers can cause discomfort and lead to other serious health problems. The treatment of such pressure ulcers includes covering the bandage and closely monitoring to prevent infection. However, it is impossible to observe the wound or pressure ulcer condition with an opaque bandage, so the bandage needs to be removed frequently for observation. Frequent removal may cause skin irritation, increase the risk of infection, and affect the wound healing rate.

[0010] Currently, there are medical dressings or bandages made of transparent materials, but such bandages have various defects. Due to the materials used, the adhesive on the bandage may adhere to the patient's skin after use, causing discomfort. In addition, such dressings cannot effectively absorb wound exudate, thus affecting the adhesiveness of the dressing.

[0011] The exudate produced by the wound affects the adhesion performance of the dressing and may lead to poor absorption. Chinese Patent CN201922407013.1 discloses a dressing that improves the observation conditions, but its bandage structure is prone to forming bubbles on the surface, thus interfering with the observation effect, making its appearance incomplete, and affecting the long-term storage of such bandages, which may cause waste. In addition, the multi-layer structure of the transparent film adopted in this patent may further lead to the problem of liquid leakage.

[0012] Therefore, there is still a need to provide a bandage that can overcome the above problems and other defects. Summary

[0013] An object of the present disclosure is to provide a bandage that includes an absorbent hydrogel layer and allows the user's skin to be observed through the bandage.

[0014] Another object of the present disclosure is to provide a dressing or bandage that can absorb wound exudate while allowing the wound to be observed.

[0015] In some embodiments, the dressing may include an antibacterial agent, thereby effectively reducing the possibility of wound infection.

[0016] In some embodiments, the dressing includes a protective layer, a silicone gel layer, an absorbent hydrogel layer, an adhesive layer, and a transparent film. When the bandage is applied to the wound site, one side of the transparent film adheres to the side of the adhesive layer away from the wound area.

[0017] According to an embodiment of the present disclosure, a medical dressing includes: a silicone gel layer including a wound-facing surface configured to contact the user's skin; a hydrogel layer disposed above the silicone gel layer and connected to the silicone gel layer, the hydrogel layer including a support layer for supporting the hydrogel material; an adhesive layer located above the hydrogel layer and connected to the hydrogel layer; a top film located above the adhesive layer and including a wound-facing surface that adheres to the adhesive layer. The silicone gel layer, the hydrogel layer, the adhesive layer, and the top film are all made of transparent materials so as to observe the wound through the medical dressing.

[0018] In some embodiments, the medical dressing includes a protective layer that adheres to the skin-facing side of the silicone gel layer and is located on the opposite side of the hydrogel layer.

[0019] In some embodiments, the protective layer is made of the following materials: polyethylene (PE), polyvinyl chloride (PVC), polypropylene (PP), polyethylene terephthalate (PET) release film, or silicone-coated release paper.

[0020] In some embodiments, the support layer includes a textured surface that contacts the hydrogel material and has one or more grooves for accommodating the hydrogel when it swells.

[0021] In some embodiments, the support layer is a porous material.

[0022] In some embodiments, the support layer is a thin film polymer.

[0023] In some embodiments, the support layer is a woven fabric.

[0024] In some embodiments, the support layer is a non-woven fabric.

[0025] In some embodiments, the hydrogel contains an antibacterial agent.

[0026] In some embodiments, the antibacterial agent is present on the hydrogel material in the form of a surface coating.

[0027] In some embodiments, the antibacterial agent is incorporated into the hydrogel material.

[0028] In some embodiments, the antibacterial agent includes one or more of the following components: chlorhexidine gluconate (CHG), polyhexamethylene biguanide hydrochloride (PHMB), benzalkonium chloride (BZK), povidone iodine, silver nanoparticles, silver microparticles, silver salts, and silver zeolite.

[0029] In some embodiments, the hydrogel material is an acrylamide hydrogel material.

[0030] In some embodiments, the hydrogel is a hydrophilic, water-swellable, water-insoluble three-dimensional crosslinked / polymerized polymer network and has a high water content.

[0031] In some embodiments, the hydrogel layer includes a second support layer that is located on the opposite side of the support layer.

[0032] In some embodiments, the silicone gel layer includes a plurality of openings that enable the hydrogel layer to be in fluid communication with the wound below the silicone gel layer.

[0033] In some embodiments, the plurality of openings include: a first set of large-sized openings that are disposed at the central position of the silicone gel layer and are located below the hydrogel layer; a second set of small-sized openings that are disposed in the edge region of the silicone gel layer.

[0034] In some embodiments, the adhesive layer is made of a biocompatible material and is used to adhere the antibacterial hydrogel layer and the transparent film.

[0035] In some embodiments, the adhesive layer is an acrylic adhesive, a pressure-sensitive adhesive, a hot-melt adhesive, or an adhesive having the same adhesion performance.

[0036] In some embodiments, the top film is made of a single-layer polyurethane material. Brief Description of the Drawings

[0037] The above and related objects, features, and advantages of the present disclosure will be more fully understood by describing in detail the following preferred (although illustrative) embodiments of the present invention in conjunction with the accompanying drawings, wherein:

[0038] Figure 1 FIG. is a schematic cross-sectional view of a dressing according to an embodiment of the present disclosure.

[0039] Figure 2 FIG. is a schematic cross-sectional view of a dressing structure according to an embodiment of the present disclosure.

[0040] Figure 3 FIG. is a schematic cross-sectional view of a dressing structure according to an embodiment of the present disclosure.

[0041] Figure 4 FIG. is a schematic cross-sectional view of a dressing structure according to an embodiment of the present disclosure.

[0042] Figure 5 FIG. is a schematic cross-sectional view of a dressing structure according to an embodiment of the present disclosure.

[0043] Figure 6 FIG. shows a cross-sectional view of a dressing structure according to an embodiment of the present disclosure.

[0044] Figure 7 FIG. shows a cross-sectional view of a dressing structure according to an embodiment of the present disclosure.

[0045] Figure 8 FIG. shows an exploded view of a dressing according to an embodiment of the present disclosure.

[0046] Figure 9 FIG. shows Figure 8 a perspective view of a dressing according to an embodiment of the present disclosure as shown.

[0047] Figure 10 FIG. shows a perspective view of a dressing having a circular structure according to an embodiment of the present disclosure. Detailed Description of the Preferred Embodiments

[0048] According to an embodiment of the present disclosure, the dressing 10 may include: a protective layer 1; a silicone gel layer 2, the wound contact surface of which is attached to the protective layer 1; an absorbent hydrogel layer 4, the wound contact surface of which is attached to the silicone gel layer 2; an adhesive layer 5, which is attached to the absorbent hydrogel layer 4; and a top film 6, the wound contact surface of which is attached to the adhesive layer 5. In some embodiments, the top film 6 adopts a single-layer structure, avoiding interlayer splicing, thereby preventing exudate leakage and bacterial penetration. In some embodiments, the protective layer 1 can be removed from the bottom or the wound-facing surface of the silicone gel layer 2 so as to apply the dressing 10 to the patient's skin. In some embodiments, the protective layer 1 may be a three-layer structure, including: a laminate film 1a disposed in the middle and outer film strips 1b, 1c disposed on both sides of the laminate film. In some embodiments, the protective layer 1 may include more or fewer layers.

[0049] In some embodiments, the silicone gel layer 2, the hydrogel layer 4, the adhesive layer 5, and the transparent film 6 are made of transparent materials. In some embodiments, the silicone gel layer 2 includes a plurality of openings or ventilation holes 3 that penetrate the entire silicone gel layer. In Figure 1 this case, all the ventilation holes 3 have the same size.

[0050] In Figure 1 this case, the length and width of the silicone gel layer 2 and the transparent top film 6 are both larger than those of the hydrogel layer 4, thereby increasing the fitting area of the dressing around the wound and making it easier to fit the wound during use.

[0051] In Figure 1 this case, the protective layer 1 may be made of polyethylene (PE) material; the top film 6 may be made of polyurethane (PU) material; the adhesive layer 5 may be made of acrylic adhesive. In some embodiments, the protective layer 1 can not only ensure the cleanliness and hygiene of the silicone gel layer 2 before use, but also be easily separated from the silicone gel layer so as to apply the silicone gel layer 2 to the user's skin.

[0052] In some embodiments, the protective layer 1 is removable, and its top surface is attached to the bottom (wound contact surface) of the silicone gel layer 2. In some embodiments, the hydrogel layer 4 may contain an antibacterial agent. In some embodiments, the silicone gel layer 2, the absorbent hydrogel layer 4, the adhesive layer 5, and the top film 6 are all made of transparent or translucent materials so as to observe the wound, ulcer, or the user's skin through the dressing 10. In some embodiments, the antibacterial hydrogel layer 4 may be sandwiched between the top of the silicone gel layer 2 and the adhesive layer 5. In some embodiments, the silicone gel layer 2 includes a number of openings or pores 3 that completely penetrate it. In some embodiments, the absorbent hydrogel layer 4 may be in fluid communication with the protective layer 1 through the pores or openings 3 formed in the silicone gel layer 2, so that when the protective layer 1 is removed and the dressing 10 is applied to the wound or ulcer site, the absorbent hydrogel layer is in fluid communication with the wound area through the pores or openings in the silicone gel layer. In some embodiments, the absorbent hydrogel layer 4 absorbs wound exudate. In some embodiments, the hydrogel layer 4 may have an elastic structure and may deform under pressure, generating elasticity to disperse and relieve the pressure on the wound.

[0053] In some embodiments, the absorbent hydrogel layer 4 absorbs wound exudate while maintaining a moist environment for the wound. When the antibacterial hydrogel is used, the increased antibacterial agent can effectively inhibit the growth of microorganisms in the area in contact with the wound or ulcer, construct a microenvironment that promotes the growth of granulation tissue and wound healing, and enable real-time and direct observation of the wound. In some embodiments, the antibacterial hydrogel layer 4 can deform under pressure, generating elasticity to disperse and relieve the pressure on the wound or ulcer, thereby preventing or healing pressure ulcers.

[0054] In some embodiments, the adhesive layer 5 may be made of a biocompatible material and may be used to bond the absorbent hydrogel layer 4 to the transparent top film 6.

[0055] In Figure 1 some embodiments, the silicone gel layer 2 is made of silicone rubber material.

[0056] In some embodiments, the top film 6 is used to protect the dressing 10 and the wound surface to reduce the risk of infection.

[0057] In some embodiments, when the hydrogel layer 4 is antibacterial, it may be made of acrylamide hydrogel material, and the antibacterial agent therein is silver particles, silver nanoparticles, silver salts, or silver zeolite, and its antibacterial efficiency can exceed 99.9%. The specific test data related to this antibacterial hydrogel are listed in Table 1 below: Table 1: Bacterial strain Antibacterial efficiency (exposed for 7 days) Candida albicans >99.99％ Escherichia coli >99.99％ Staphylococcus aureus >99.99％ Enterococcus faecalis >99.99％ Bacillus pneumoniae >99.99％ Pseudomonas aeruginosa >99.99％ Staphylococcus epidermidis >99.99％ Staphylococcus pyogenes >99.99％

[0058] In Figure 1 some embodiments, the liquid absorption rate of the dressing can reach 20 g / 100 cm 2 .

[0059] In Figure 1 , the water vapor permeability of the dressing can reach 1,000 g / m 2 ·24 h.

[0060] In Figure 1 , the thickness of the antibacterial hydrogel layer is 2.5 mm and the water content is 30%.

[0061] In Figure 1 , the dressing 10 can reduce the contact pressure by more than 60%, thus effectively reducing the risk of pressure ulcers. Specific test data are shown in Table 2 below. Table 2: Sample Control (without any dressing) Using this example Average force 261.8 mmHg 141.3 mmHg Maximum 756.3 mmHg 286.2 mmHg Force-bearing area <![CDATA[0.88cm 2 > <![CDATA[8.8cm 2 > Contact pressure reduction ratio - 62.2％

[0062] Figure 2 Illustrated is an antibacterial medical dressing 20 according to another embodiment of the present disclosure, which allows observation of the wound. In this embodiment, the dressing 20 includes a protective layer 1, a silicone gel layer 2 (whose wound-facing surface is connected to the protective layer 1), a hydrogel layer 4 (whose wound-facing surface is connected to the opposite surface of the silicone gel layer), an adhesive layer 5 (connected to the opposite surface of the antibacterial hydrogel layer 4), and a transparent top film 6 (whose wound-facing surface is connected to the adhesive layer 5). In Figure 2 , the transparent film 6 has a single-layer (monomeric) structure, and the protective layer 1 is removable and has a two-layer film structure, including a left portion 1d and a right portion 1e.

[0063] In Figure 2 , the silicone gel layer 2, the antibacterial hydrogel layer 4, the adhesive layer 5, and the transparent film 6 are all made of transparent materials.

[0064] In Figure 2 , the pores formed in the silicone gel layer 2 can have different sizes, including larger pores 7 and smaller pores 3. In Figure 2 , the larger pores 7 are provided in the center of the silicone gel layer 2 that is in fluid communication with the hydrogel layer 4, while the smaller pores 3 are provided in the edge bonding region of the silicone gel layer 2.

[0065] In Figure 2 , the size of the antibacterial hydrogel layer 4 is smaller than that of the silicone gel layer 2 and the transparent film 6 to provide a larger bonding area at the edge of the dressing 20, making it easier to bond to the wound during use.

[0066] In Figure 2 , the protective layer 1 can be made of polyethylene material, the transparent top film 6 is made of polyurethane material, and the adhesive layer 5 is made of acrylic.

[0067] In Figure 2In [description], when the hydrogel layer 4 is an antibacterial hydrogel, it is mainly made of acrylamide hydrogel material, the added antibacterial agent is BZK, and its antibacterial efficiency can exceed 90%.

[0068] In Figure 2 [description], the liquid absorption rate of the dressing can reach 10 g / 100 cm 2 .

[0069] In Figure 2 [description], the water vapor permeability of the dressing can reach 1,000 g / m 2 ·24 h.

[0070] In Figure 2 [description], the thickness of the antibacterial hydrogel layer 4 is 2.5 mm and the water content is 20%. The dressing 20 can reduce the contact pressure by more than 50%, thus effectively reducing the risk of pressure ulcers.

[0071] Figure 3 Fig. [figure number] shows an antibacterial medical dressing 30 according to another embodiment of the present disclosure, which also allows observation of the wound. The dressing 30 includes a protective layer 1, a silicone gel layer 2 (whose wound-facing surface is connected to the protective layer 1), a hydrogel layer 4 (whose wound-facing surface is connected to the top surface of the silicone gel layer), an adhesive layer 5 (connected to the top surface of the hydrogel layer 4, i.e., the side away from the wound), and a top film 6 (whose bottom surface is connected to the wound-away surface of the adhesive layer 5).

[0072] In Figure 3 [description], the support layer 9 can be disposed on the surface of the hydrogel layer 4 away from the silicone gel layer 2. In some embodiments, the surface of the hydrogel layer 4 that is in contact with the silicone gel layer 2 can be coated with a high-absorbency resin coating 8. In Figure 3 [description], both the support layer 9 and the high-absorbency resin coating 8 are regarded as components of the antibacterial hydrogel layer 4.

[0073] In Figure 3 [description], the top film 6 has a single-layer structure. In Figure 3 [description], the protective layer 1 is removable and has a three-layer structure similar to the above.

[0074] In some embodiments, the silicone gel layer 2, the antibacterial hydrogel layer 4 including the support layer 9, the adhesive layer 5, and the transparent film 6 are all made of transparent materials. In some embodiments, the pores 3 formed in the silicone gel layer 2 have the same size. In some embodiments, a second support layer (not shown) can be connected to the other side or surface of the hydrogel layer 4.

[0075] In Figure 3 [description], the protective layer 1 can be made of coated release paper material, the transparent top film 6 is made of polyurethane material, and the adhesive layer 5 is made of hot melt adhesive.

[0076] In Figure 3 , when the hydrogel layer 4 is made of an antibacterial hydrogel, it is mainly made of an acrylamide hydrogel material, wherein the support layer 9 is a transparent polyurethane film, the added antibacterial agent is CHG, and its antibacterial efficiency can exceed 99%.

[0077] In Figure 3 , the liquid absorption rate of the dressing 30 can reach 40 g / 100 cm 2 .

[0078] In Figure 3 , the water vapor permeability of the dressing 30 can reach 500 g / m 2 ·24 h.

[0079] In Figure 3 , the thickness of the hydrogel layer 4 is 2.0 mm and the water content is 30%. Figure 3 The dressing 30 can reduce the contact pressure by more than 50%, thereby effectively reducing the risk of pressure ulcers.

[0080] Figure 4 shows an antibacterial medical dressing 40 according to another embodiment of the present disclosure, which allows observation of the wound. In Figure 4 , the dressing 40 includes a protective layer 1, a silicone gel layer 2 (whose wound-facing surface is connected to the protective layer 1), an antibacterial hydrogel layer 4 (whose wound-facing surface is connected to the opposite surface of the silicone gel layer), an adhesive layer 5 (connected to the opposite surface of the hydrogel layer 4), and a transparent top film 6 (whose wound-facing surface is connected to the adhesive layer 5). In Figure 4 , a support layer 9 is provided on the side of the hydrogel layer 4 away from the silicone gel layer 2, and this support layer 9 is regarded as a component of the hydrogel layer. In Figure 4 , the transparent top film 6 has a single-layer structure, and the protective layer 1 is removable and has a three-layer structure, including a laminated film 1a provided in the middle and outer films 1b and 1c provided on both sides of the laminated film.

[0081] In some embodiments, the hydrogel layer 4 can be disposed on the support layer 9. In some embodiments, the support layer 9 is responsible for supporting the hydrogel during the curing and formation process of the hydrogel layer 4. In some embodiments, during the preparation process, the support layer 9 may be coated with a layer of liquid hydrogel and can be cured and formed into a liquid hydrogel under the support of the support layer 9. In some embodiments, the support layer 9 is made of a transparent or semi-transparent material, such as a transparent polyurethane film, non-woven fabric, or a woven or knitted mesh film that can support the curing of the hydrogel and allow observation through a bandage or dressing.

[0082] The use of hydrogels in the absorbent layer of dressings has several advantages. For example, hydrogel dressings have the ability to absorb or release liquid according to the condition of the tissue beneath the wound to keep the wound environment moist, promoting cell migration and proliferation, thus accelerating the wound healing process and improving the therapeutic effect. In addition, hydrogel dressings promote autolytic debridement by allowing endogenous enzymes in the wound fluid secreted by white blood cells to digest and liquefy the necrotic tissue at the wound site. Moreover, hydrogels have a distinct cooling and soothing effect on the skin, which is valuable for burned and painful wounds.

[0083] The hydrogel layer 4 can be composed of a hydrophilic, water-swellable, water-insoluble three-dimensional network cross-linked / polymerized polymer network embedded with a high water content. In some embodiments, the hydrogel polymer network can include synthetic polymers (polyethylene oxide (PO), polyvinyl alcohol (PVA), polyacrylic acid (PAA), polyvinylpyrrolidone (PVP), polyethylene glycol (PEG), polyacrylamide, polypropylene glycol fumarate (P(PF-coEG), PEO-PEG-PEO, etc.), natural polymers (alginate, chitosan, collagen, gelatin, hyaluronic acid, gellan gum, polyhydroxybutyrate, cellulose, fibrin, pectin, agar, carboxymethyl cellulose, etc.), or a composite of the above polymers. In some embodiments, a plasticizer (poly(ethylene) glycol, poly(propylene) glycol, silicone oil, etc.) can be added to the hydrogel formulation to improve the flexibility of the material.

[0084] In some embodiments, the hydrogel polymer network is formed by depositing / casting an aqueous dispersion of the prepolymer component onto the support layer 9 and then cross-linking or polymerizing the hydrogel polymer component. There are several methods to cross-link or polymerize the hydrogel polymer mixture to form a hydrogel network. The most established and commonly used method for manufacturing hydrogels for wound dressings is to expose the hydrogel polymer mixture to ionizing (gamma or electron beam) or ultraviolet radiation.

[0085] In some embodiments, during the manufacture of the hydrogel layer 4, the aqueous dispersion of the prepolymer component typically uses the mechanical support layer 9 before the cross-linking or polymerization stage of the manufacturing process. The hydrogel is cross-linked in situ on the support layer 9, so the hydrogel can form a firm attachment to the support layer. In some embodiments, this structure improves the functional integrity and stability of the hydrogel material, especially when it is used in wound dressings. In some embodiments, the support layer 9 is typically a thin film polymer layer (such as polyurethane (PU)), a woven fabric (such as nylon mesh, acetate mesh, polyethylene terephthalate (PET) mesh, etc.) or a non-woven fabric (such as cellulose, CMC, polypropylene, etc.). In some embodiments, the support layer 9 is transparent to allow observation of the wound or ulcer through the dressings 10, 20, 30, 40, 50, 60, 70, and 80.

[0086] Key considerations in selecting the support layer 9 include determining a material with sufficient porosity such that the material is breathable (i.e., MVTR > 500 g / m2·day) to minimize the occurrence of skin maceration during treatment. Another key feature is to determine a support layer 9 made of a material with an appropriate surface tension such that the hydrogel in the pre-crosslinked or pre-polymerized state will not be absorbed into the support layer. Since hydrogels are typically transparent, a support layer 9 having a transparent material (such as a transparent PU film) can provide an additional advantage as the clinician or patient can monitor the wound site, ulcers or at-risk areas on the patient's skin without removing the dressing. This reduces the need for unnecessary dressing changes as dressing changes can cause trauma to the wound site and impede the wound healing process. It also reduces the time and cost for the clinician to unnecessarily treat healed wounds or non-ulcerated areas.

[0087] In some embodiments, the support layer 9 includes a "textured surface" facing the hydrogel (i.e., including embossed pockets or voids) which can improve the overall absorption capacity of the hydrogel material by allowing the hydrogel material to absorb liquid and expand or spread into the embossed voids when exposed to exudate. In some embodiments, a second support layer can be provided on the opposite side of the hydrogel layer 4.

[0088] In Figure 4 , the silicone gel layer 2, the antibacterial hydrogel layer 4 (including the support layer 9), the adhesive layer 5 and the transparent film 6 are all made of transparent materials, and the pores 3 formed in the silicone gel layer 2 are of the same size. However, in some embodiments, as described above, the pores may include larger pores 7 and smaller pores 3, as previously described.

[0089] In Figure 4 , the hydrogel layer 4 is mainly made of acrylamide hydrogel material, and the support layer 9 can be a translucent woven mesh. In Figure 4 , the antibacterial agent can be PHMB, which is coated on the side away from the adhesive layer 5 after the hydrogel is formed, and the antibacterial effect exhibited may exceed 99.9%.

[0090] In Figure 4 , the liquid absorption rate of the dressing 40 can reach 30 g / 100 cm 2 .

[0091] In Figure 4 , the water vapor permeability of the dressing 40 can reach 1,000 g / m 2 *24 h.

[0092] In Figure 4 , the thickness of the antibacterial hydrogel layer 4 is 5.0 mm and the moisture content is 10%. The dressing 40 can reduce the contact pressure by more than 50%, effectively reducing the risk of pressure ulcers.

[0093] Figure 5 An embodiment of an antibacterial medical dressing 50 that allows wound observation according to an embodiment of the present disclosure is shown. The dressing 50 includes a protective layer 1, a silicone gel layer 2 (the wound contact surface is attached to the protective layer 1), a hydrogel layer 4 (the wound contact surface is attached to the silicone gel layer 2), an adhesive layer 5 (the wound contact surface is attached to the hydrogel layer 4), and a transparent top film 6 (the wound contact surface is attached to the opposite side of the adhesive layer 5). In Figure 5 , a support layer 9 may be located on one side of the antibacterial hydrogel layer 5, away from the silicone gel layer 2 and the support layer 9 is regarded as a part of the antibacterial hydrogel layer. In Figure 5 , the transparent film 6 is a single-layer structure. In Figure 5 , the protective layer 1 is removable and has a double-layer film structure.

[0094] In Figure 5 , the silicone gel layer 2, the antibacterial hydrogel layer 4, the adhesive layer 5, the transparent film 6, and the support layer 9 are all made of transparent materials.

[0095] In Figure 5 , the pores formed in the silicone gel layer 2 may include larger pores 7 and smaller pores 3, where the larger pores 7 are located in the central region in contact with the antibacterial hydrogel layer 4, and the smaller pores 3 are located in the edge region of the silicone gel layer 2. The larger pores 7 are located in the area in contact with the wound, ensuring that wound exudate enters the hydrogel through the pores 7 and is absorbed, while ensuring the breathability of the hydrogel layer 4. Figure 5 , the smaller pores 3 are located in the edge region of the silicone gel layer 2, aiming to improve the adhesion of the dressing 50 and prevent edge warping and adhesion difficulties during use.

[0096] In Figure 5 , the liquid absorption rate of the dressing 50 can reach 5 g / 100 cm 2 .

[0097] In Figure 5 , the water vapor permeability of the dressing 50 can reach 300 g / m 2 *24 h.

[0098] In Figure 5 , the thickness of the antibacterial hydrogel layer 4 is 0.8 mm and the moisture content is 90%. The dressing 50 can reduce the contact pressure by more than 40%, effectively reducing the risk of pressure ulcers.

[0099] In some embodiments, a medical dressing 60 according to an embodiment of the present disclosure (see Figure 6 ) allows observation of the patient's wound condition without removing the dressing. Figure 6In this case, the dressing 60 includes a protective film 1, a silicone gel layer 2 (the wound contact surface is attached to the protective film 1), a hydrogel layer 4 (the wound contact surface is attached to the silicone gel layer), and an acrylic adhesive layer 5 (the wound contact surface is attached to the hydrogel layer 4, and the other side is attached to the transparent top film 6). The transparent top film 6 is a single-layer structure. In some embodiments, the protective film 1 is tearable for removal and includes a left film 1b provided on the left side, a right film 1c provided on the right side, and an adhesive film 1a provided between the left film and the right film.

[0100] In some embodiments, the silicone gel layer 2, the hydrogel layer 4, the acrylic adhesive layer 5, and the transparent film 6 are all made of transparent materials. In some embodiments, the pores 3 formed in the silicone gel layer 2 penetrate the entire layer, while there are no pores in the acrylic adhesive layer 5.

[0101] In Figure 7 In this case, the dressing 70 is similar to the dressing 60, except that the silicone gel layer 2 includes larger pores 7 and smaller pores 3, where the larger pores 7 are located in the central region of the silicone gel layer 2, below the hydrogel layer 4, and the smaller pores 3 are located in the edge region of the silicone gel layer.

[0102] Figure 8 Figure 80 consistent with another embodiment of the present disclosure is shown. In some embodiments, the dressing 80 may include a top film 12 made of transparent polyurethane. However, like the film 1 discussed above, the film 12 is not limited to this material and can also be made of any suitable material. In some embodiments, the top film 12, like the film 1 discussed above, may be transparent or substantially transparent so that the skin under the bandage 80 can be seen. In some embodiments, the top film 12 may be translucent so that at least part of the skin under the bandage 80 can be seen.

[0103] In some embodiments, when the bandage 10 is placed on the user's body, an adhesive layer 14 may be provided near the top film 12 to be closer to the patient's skin. In some embodiments, the adhesive layer 14 fixes the top film 12 to the bandage 80 and prevents the bandage from wrinkling like the adhesive layer 5 discussed above. In some embodiments, the adhesive layer 14 may be an adhesive layer facing the body surface provided on the film 12 as a coating. In some embodiments, the adhesive layer 14 may be an independent material layer. In some embodiments, the adhesive layer 14 may be or use an acrylic adhesive. However, any suitable adhesive can also be used, including the adhesive for the adhesive layer 5. In some embodiments, the adhesive layer 14 may be transparent so that the wound covered by the bandage can be observed through the bandage 80. In some embodiments, the adhesive layer 14 may be transparent or translucent so that the skin under the bandage 10 can be observed.

[0104] In some embodiments, adhesive layer 14 connects top film 12 to absorbent layer 16. In some embodiments, absorbent layer 16 may be or include a hydrogel, similar to hydrogel layer 4 described above, and is used to absorb moisture from an ulcer or wound covered by bandage 80. In some embodiments, absorbent layer 16 has a thickness between 2 mm and 3 mm. In some embodiments, absorbent layer 16 (which may be hydrogel layer 4 described above) has sufficient absorptive capacity to absorb a large amount of ulcer or wound exudate without requiring replacement, as frequent removal of bandage 80 increases the risk of infection. In some embodiments, absorbent layer 16 has sufficient absorptive capacity to remain on the user for a long time.

[0105] In some embodiments, the hydrogel material of absorbent layer 16 can provide pressure distribution, which can reduce the likelihood of pressure sores forming. In some embodiments, absorbent layer 16 (including hydrogel material) can be transparent so that the wound covered by the bandage can be viewed through bandage 80. In some embodiments, absorbent layer 16 can be translucent, allowing at least partial viewing of the skin under bandage 80.

[0106] In some embodiments, when the bandage 80 is applied to the user's skin, a lower layer 18 is provided below the absorbent layer 16. In some embodiments, the lower layer 18 is the silicone gel layer 2 described above. In some embodiments, the lower layer 18 may have perforations to allow wound exudate to pass through the layer and into the hydrogel in the absorbent layer 16. In some embodiments, the lower layer 18 may be or contain silicone gel. In some embodiments, the adhesive lower layer 18 may be a layer of polyurethane film with a silicone-based adhesive on its surface to fix the bandage 80 on the user's skin. In some embodiments, the upper surface of the lower layer 18 may have an acrylic-based adhesive to fix it to the absorbent layer 16, although other adhesives may also be used. In some embodiments, the adhesive or material that contacts the user's skin is silicone-based. In some embodiments, the bottom surface of the adhesive lower layer 18 is coated with a silicone-based adhesive that adheres to the wound area around the user's skin while avoiding strong adhesion to the wound. In some embodiments, the lower layer 18 may also be made of other materials as long as the adhesive facing the user's skin is silicone-based.

[0107] In some embodiments, the lower layer 18 has perforations 18a extending through its structure to allow liquid to pass from the patient's skin into the absorbent layer 16. In some embodiments, the perforations 18a may be similar to the openings 3, 7 discussed above. In some embodiments, the lower layer 18 may provide a secure adhesion to the user's skin while allowing for relatively easy removal without damaging wounds or ulcers.

[0108] In some embodiments, the lower layer 18 can be transparent such that the wound covered by the bandage 10 can be observed through the dressing 80. In some embodiments, the lower layer 18 can be translucent to allow at least partial observation of the skin under the bandage 10.

[0109] In some embodiments, the bandage 80 can be made in a series of shapes. Figure 9 A heart-shaped dressing is shown, with exemplary dimensions as follows.

[0110] Figure 10 An embodiment of a generally circular bandage 80 is shown. Figures 9 - 10 The dimensions shown are in millimeters and are exemplary dimensions, and smaller or larger bandages can be provided as needed.

[0111] In some embodiments, one or more protective liners 20 may cover the silicone adhesive on the lower layer 18 that contacts the patient until the bandage 80 is applied to the user's skin as discussed above for the protective film 1. In some embodiments, the liner 20 can be made of polyethylene, but any other suitable material can be used provided that the liners can be removed from the lower layer 18 without damaging the adhesive.

[0112] In some embodiments, one or more packaging elements (not shown) can be provided to store the bandage 80 prior to use.

[0113] An advantage of the dressing 80 is that using transparent or at least substantially translucent materials for all layers allows the wound or the user's skin under the bandage to be visible without removing the bandage. This allows monitoring of wound healing without removing the bandage. Similarly, when the dressing 80 is used to prevent the formation of pressure ulcers, the patient's skin can be monitored through the visibility of the bandage without removing the bandage to ensure that ulcers do not form. Additionally, using a hydrogel material in the absorbent layer 16 provides pressure distribution to minimize the pressure transmitted to the user's skin and reduce the likelihood of pressure ulcer formation.

[0114] In some embodiments, the dressings 10, 20, 30, 40, 50, 60, 70, and 80 can be provided in different shapes and sizes depending on the end-use wound or ulcer location. In some embodiments, the dressing can be heart-shaped (see Figure 9 )、circular (see Figure 10 )、oval, triangular, or rectangular to fit different wound or ulcer locations or shapes. For example, a heart-shaped dressing can be used when the dressing is for a wound at the coccyx.

[0115] In some embodiments, the antimicrobial agent can be one or more of chlorhexidine gluconate (CHG), polyhexamethylene biguanide hydrochloride (PHMB), benzalkonium chloride (BZK), povidone iodine, silver nanoparticles, silver microparticles, silver salts, or silver zeolites, to name a few.

[0116] In some embodiments, the antimicrobial agent can be added by means of a surface coating after the hydrogel is formed, or directly added during the hydrogel formation process. In some embodiments, the antimicrobial hydrogel is absorbable. In some embodiments, the antimicrobial hydrogel may include absorbent or superabsorbent polymers.

[0117] In some embodiments, the thickness of the hydrogel layer can be 0.8–5 millimeters, and the water content rate of the antimicrobial hydrogel layer is 10–90%. Such thickness and water content rate can effectively disperse and relieve the pressure applied to the wound, thereby reducing the pressure on the user's skin.

[0118] In some embodiments, the protective layer 1 can be made of materials such as polyethylene, polyvinyl chloride, polypropylene, polyethylene terephthalate release film, silicone-coated release paper, etc.

[0119] In some embodiments, the adhesive layer 5 can be an acrylic adhesive, a pressure-sensitive adhesive, a hot-melt adhesive, or other adhesives with the same viscosity.

[0120] In some embodiments, the acrylic adhesive layer 5 may have no air holes, and the transparent film 6 is a single-layer structure to eliminate the air bubbles on the dressing surface, which will affect the appearance of the dressing and long-term storage.

[0121] In some embodiments, providing improved adhesion at the edge of the silicone gel layer 2 can prevent edge warping and adhesion difficulties during use, thereby improving the comfort of the patient. In some embodiments, the larger air holes may be 0.5–5.0 millimeters, and the smaller air holes may be 0.1–2.0 millimeters.

[0122] In some embodiments, the silicone gel layer 2 and the hydrogel used in the absorbent hydrogel layer 4 provide a moist environment, protect the wound surface, and provide pain relief. As described above, using the hydrogel can also reduce the pressure applied to the wound, thereby contributing to the treatment and prevention of pressure ulcers.

[0123] Providing an acrylic adhesive layer 5 without openings or air holes and using a single (single-layer) transparent top film 6 can improve the appearance, solve the long-term storage problem, and reduce the risk of liquid exudate leakage and bacterial entry caused by the splicing of multiple transparent films.

[0124] In some embodiments, the dressings 10, 20, 30, 40, 50, 60, 70 and 80 of the present disclosure provide several advantages: (1) The main structure thereof is made of a transparent or see-through material, allowing medical staff and patients to observe the wound, ulcer or the user's skin without removing the dressing; (2) By adding an antibacterial agent to the hydrogel layer, the probability of wound infection is effectively reduced; (3) The multi-layer structure and the absorbency of the hydrogel (whether or not coated with a superabsorbent resin layer) greatly improve the absorbency of the dressing to wound exudate; (4) The contact pressure on the wound, ulcer or the user's skin can be dispersed and reduced, effectively reducing the risk of pressure ulcers; (5) There is no residual adhesive, preventing adhesion between the wound tissue and the dressing.

[0125] Although the invention has been described in terms of its specific embodiments, many other variations and modifications and other uses will become apparent to those skilled in the art. Therefore, preferably, the invention is not limited to the specific disclosure herein.

Claims

1. A medical dressing, comprising: A silicone gel layer, including a surface facing the wound and configured to contact the user's skin; A hydrogel layer, disposed above the silicone gel layer and attached thereto, wherein the hydrogel layer includes a support layer for supporting the hydrogel material; An adhesive layer, located above the hydrogel layer and attached thereto; and A top film, located above the adhesive layer and including a wound-facing surface attached to the adhesive layer, Wherein the silicone gel layer, the hydrogel layer, the adhesive layer and the top film are all transparent to allow observation of the wound through the medical dressing.

2. The medical dressing according to claim 1, further comprising a protective layer attached to the skin-facing surface of the silicone gel layer, located opposite to the hydrogel layer.

3. The medical dressing according to claim 2, wherein the protective layer is made of polyethylene, polyvinyl chloride, polypropylene, polyethylene terephthalate release film or silicone-coated release paper.

4. The medical dressing according to claim 1, wherein the support layer includes a textured surface that contacts the hydrogel material and has one or more grooves for accommodating the hydrogel when it swells.

5. The medical dressing according to claim 1, wherein the support layer is a porous material.

6. The medical dressing according to claim 1, wherein the support layer is a thin film polymer.

7. The medical dressing according to claim 1, wherein the support layer is a woven fabric.

8. The medical dressing according to claim 1, wherein the support layer is a non-woven fabric.

9. The medical dressing according to claim 1, wherein the hydrogel includes an antibacterial agent.

10. The medical dressing according to claim 9, wherein the antibacterial agent is a surface coating of the hydrogel material.

11. The medical dressing according to claim 9, wherein the antibacterial agent is mixed into the hydrogel material.

12. The medical dressing according to claim 1, wherein the antibacterial agent includes one or more of the following: chlorhexidine gluconate (CHG), polyhexamethylene biguanide hydrochloride (PHMB), benzalkonium chloride (BZK), povidone iodine, silver nanoparticles, silver microparticles, silver salts and silver zeolite.

13. The medical dressing according to claim 1, wherein the hydrogel material is an acrylamide hydrogel material.

14. The medical dressing according to claim 1, wherein the hydrogel is a hydrophilic, water-swellable, water-insoluble three-dimensional crosslinked / polymerized polymer network with a high water content.

15. The medical dressing according to claim 1, wherein the hydrogel layer includes a second support layer located opposite to the support layer.

16. The medical dressing according to claim 1, wherein the silicone gel layer includes a plurality of openings formed therein, such that the hydrogel layer is in fluid connection with the wound under the silicone gel layer.

17. The medical dressing according to claim 16, wherein the plurality of openings include a first group of large openings located below the hydrogel layer and in the central region of the silicone gel layer and a second group of small openings formed around the edge of the silicone gel layer.

18. The medical dressing according to claim 1, wherein the adhesive layer is made of a biocompatible material for adhering the antibacterial hydrogel layer and the transparent film together.

19. The medical dressing according to claim 1, wherein the adhesive layer is an acrylic adhesive, a pressure-sensitive adhesive, a hot-melt adhesive, or an adhesive having the same viscosity.

20. The medical dressing according to claim 1, wherein the top film is a single-layer polyurethane material.

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