A wound repair material

Abstract

The present application provides a wound repair material, the side close to the wound is the inner side, the wound repair material comprises a film layer and a barrier layer from inside to outside; the barrier layer is a semi-permeable membrane layer allowing gas to permeate through; the film layer comprises an inner side surface for contacting the wound and an outer side surface combined with the barrier layer; an adhesion structure is arranged on the inner side surface of the film layer, and the adhesion structure is configured to be adhesively combined with the wound. The present application provides a wound repair material, which can solve the problem that the product is prone to falling off and displacement due to poor adhesion and insufficient adhesion of the wound repair material in the prior art.

Description

Technical Field

[0001] This invention relates to the field of medical technology, and in particular to a wound repair material. Background Technology

[0002] The skin is the largest organ in the human body, protecting it from harmful external substances and preventing the loss of water and electrolytes, thus maintaining the body's internal environment. It also participates in immune and metabolic processes. When skin tissue is severed or damaged due to external forces, it causes trauma. Minor skin injuries can heal through epithelial regeneration; however, severe injuries, such as deep second- or third-degree burns, wounds after scar excision, traumatic full-thickness skin defects, and chronic ulcers, cannot be healed by the skin itself and usually require artificial intervention for repair.

[0003] Wound repair materials generally include traditional wound dressings such as gauze and medical cotton, as well as artificially synthesized polymer scaffold materials, which are also commonly referred to as artificial dermis materials.

[0004] Traditional wound dressings such as gauze and medical cotton have a certain degree of breathability, but their mechanical strength is low, making them prone to wrinkles or damage. They also have poor adhesion to the wound and are prone to displacement due to movement or changes in body position, leading to leakage of tissue fluid and increasing the risk of secondary wound damage.

[0005] Artificial dermis is a biomaterial that guides tissue regeneration through a biomimetic dermal structure. It generally consists of two layers: an upper layer, typically a semi-permeable membrane acting like the epidermis to control moisture evaporation and prevent microbial invasion; and a lower layer, a biomimetic dermal scaffold with good biocompatibility and low immunogenicity, serving as a cell growth scaffold. This facilitates the invasion and growth of vascular endothelial cells and fibroblasts (Fb) at the wound site, forming a scaffold-new capillary-cell complex. After several weeks of full vascularization, autologous split-thickness skin can be transplanted. Subsequently, the dermal scaffold gradually degrades and is replaced by newly formed dermal tissue.

[0006] Artificial dermis can effectively guide the regeneration of new dermis, reduce and inhibit scar hyperplasia, thereby restoring the elasticity and flexibility of the wound and improving its appearance and function.

[0007] While existing artificial dermal materials possess a certain degree of mechanical strength, their planar underlying dermal support layer results in poor adhesion to the wound surface. This makes them ill-suited to irregular wound shapes, easily creating dead spaces and leading to tissue exudate accumulation. This can cause the product to detach or slip, causing secondary damage to the wound. Furthermore, during wound repair, existing artificial dermal structures often lack efficient tissue fluid absorption capabilities. Excessive tissue fluid accumulation can breed bacteria, delaying wound healing. Conversely, some artificial dermal materials using highly absorbent materials often suffer from poor breathability, leading to a hot and humid wound that hinders epithelial cell proliferation. Summary of the Invention

[0008] The purpose of this invention is to provide a wound repair material to solve the problem that existing wound repair materials have poor adhesion to the wound and are prone to falling off or shifting.

[0009] Another objective of this invention is to provide a wound repair material that can solve the problem that existing wound repair materials cannot simultaneously achieve good breathability and liquid absorption.

[0010] To address the aforementioned technical problems, this invention provides a wound repair material. Taking the side closest to the wound as the inner side, the wound repair material, from the inside out, comprises a thin film layer and a barrier layer. The barrier layer is a semi-permeable membrane layer that allows gas permeation. The thin film layer includes an inner surface for contact with the wound and an outer surface that bonds to the barrier layer. An adhesive structure is provided on the inner surface of the thin film layer, configured to adhere to and bond with the wound. The adhesive structure includes a plurality of fibrous hair-like structures disposed on the inner surface of the thin film layer, the fibrous hair-like structures being used for mechanically connecting with the wound.

[0011] Furthermore, the fibrous hair-like structure includes J-shaped, inverted Y-shaped, or suction cup-shaped structures.

[0012] Furthermore, multiple arrays of the aforementioned fibrous hair-like structures are distributed on the inner surface of the thin film layer. The length of the fibrous hair-like structures along the direction perpendicular to the thin film layer is 10-1000 μm, and the density of the fibrous hair-like structure array on the thin film layer is 10-100 structures / cm². 2 .

[0013] Furthermore, the fibrous hair-like structure is made of a hydrophilic biodegradable polymer selected from one or a mixture of chitosan, collagen, and silk fibroin.

[0014] Furthermore, the thin film layer is provided with multiple through holes, and antibacterial hydrogel microspheres are bonded to the inner wall of the through holes.

[0015] Furthermore, the antibacterial hydrogel microspheres are hydrogel microspheres loaded with antibacterial materials, and the hydrogel microspheres are made of one or more of the following: collagen, chitosan, aloe polysaccharide, sodium hyaluronate, sodium alginate, stem cell extract and exosomes; the antibacterial materials include polyhexamethylene biguanide, silver ions and / or chlorhexidine.

[0016] Furthermore, the thin film layer is made of a biodegradable material selected from one or more of the following: polylactic acid, polylactic acid-glycolic acid copolymer, collagen, polycaprolactone, sodium hyaluronate, sodium alginate, silk fibroin, and chitosan.

[0017] Furthermore, the thin film layer has a plurality of first slits, and the barrier layer has second slits that correspond one-to-one with the first slits, so that the first slits and the second slits are connected.

[0018] Furthermore, the length of the first slit and the second slit is 2-4 mm, and the width of the first slit and the second slit is 50-100 μm.

[0019] Furthermore, taking the side closest to the wound as the inner side, the wound repair material, from the inside out, includes a thin film layer, a barrier layer, and a reservoir layer, wherein the reservoir layer is made of superabsorbent polymer.

[0020] In summary, compared with the prior art, the wound repair material provided by the present invention has the following advantages:

[0021] The present invention, through its adhesive structure, can significantly increase the adhesion between the wound repair material and the wound, effectively reducing the problem of the wound repair material sliding or falling off, and preventing secondary damage to the wound.

[0022] The wound repair material utilizes a fibrous, hair-like adhesive structure. Upon contact with wound tissue, it mechanically connects with irregular tissues on the wound surface (such as granulation tissue and fibrin membranes), firmly "grabbing" the wound through friction and interlocking, significantly enhancing the adhesion between the wound repair material and the wound. Simultaneously, the fibrous material itself possesses good flexibility, conforming to the uneven surface of the wound, resulting in a tighter fit between the wound repair material and the wound, reducing gaps, preventing the formation of "dead spaces," and minimizing the accumulation of tissue fluid.

[0023] On the other hand, the fibrous hair-like structure uses biocompatible materials such as hydrophilic biodegradable polymers. This allows the structure to degrade over time, creating space for new dermal tissue to grow and reducing material residue after wound healing. Furthermore, the chemical groups (such as hydroxyl, amino, and carboxyl groups) on the surface of these hydrophilic biodegradable polymers can interact weakly with the active components of the wound tissue (such as hydrogen bonds, van der Waals forces, and chemical bond forces). This further increases the bonding force between the fibrous hair-like structure and the wound tissue on the basis of mechanical connection, thereby improving the adhesion stability between the wound repair material and the wound.

[0024] This invention also incorporates multiple through-holes in the thin film layer. These through-holes serve as drainage channels for tissue fluid exudate from the wound, allowing the fluid to be drawn from the through-holes to the barrier layer via a siphon effect, thus rapidly capturing the exudate. Furthermore, antibacterial hydrogel microspheres can be attached to the inner walls of the through-holes. These microspheres absorb and swell after the tissue fluid enters the through-holes, exposing the antibacterial material within, achieving a long-lasting, controlled release of the antibacterial material and providing antibacterial and infection-preventing effects.

[0025] The thin film layer of this invention is made of biodegradable material, possessing good biocompatibility, reducing inflammatory responses, and promoting wound healing through the material itself or by loading additional growth factors. Furthermore, the degradation cycle of the thin film layer is approximately 1-10 months, with the degradation rate synchronized with the healing cycle (2-12 months), avoiding the need for secondary surgical removal. It also has a tensile modulus of 0.5-50 MPa and an elongation at break of 50-500%, exhibiting good matching with the mechanical properties of skin tissue, protecting the wound from external mechanical damage, and promoting wound tissue healing.

[0026] The present invention also creates an array of slits on the film layer and the barrier layer, using the siphon effect to allow the tissue fluid exuded from the wound to seep out rapidly from the slits, guiding the exudate to diffuse directionally from the wound to the outside of the barrier layer, thus preventing the exudate from accumulating at the wound.

[0027] This invention employs a three-layer scaffold model consisting of a thin film layer, a barrier layer, and a reservoir layer. When tissue fluid exudates from the wound, the slit array and through-holes in the thin film layer utilize a siphon effect to rapidly capture the exudate, transferring it through the barrier layer to the reservoir layer. Simultaneously, the antibacterial hydrogel microspheres on the inner wall of the through-holes in the thin film layer absorb the fluid and swell, releasing antibacterial materials to effectively prevent infection. The barrier layer also possesses excellent breathability, ensuring that external oxygen can enter the wound while promptly expelling carbon dioxide. The reservoir layer, with its excellent water absorption capacity, absorbs the exudate and maintains a moist environment at the wound site, accelerating wound healing. Thus, the three layers work synergistically to achieve efficient exudate absorption and management, long-lasting antibacterial effects, and maintenance of a moist environment, thereby accelerating wound healing, reducing the risk of infection, and providing a novel wound repair material that combines excellent adhesion, biocompatibility, antibacterial properties, breathability, and absorbency. Attached Figure Description

[0028] Figure 1 and Figure 2 This is a schematic diagram of the structure of a wound repair material according to one embodiment of the present invention;

[0029] Figure 3 This is a top view schematic diagram of a wound repair material according to one embodiment of the present invention;

[0030] Figure 4 A schematic diagram of a fibrous hair-like structure in a wound repair material according to one embodiment of the present invention;

[0031] Figure 5 A schematic diagram of another morphology of fibrous hair-like structure in a wound repair material according to one embodiment of the present invention;

[0032] Figure 6 A schematic diagram of another morphology of the fibrous hair-like structure in a wound repair material according to one embodiment of the present invention;

[0033] Figure 7 A schematic diagram of a wound repair material containing a fluid reservoir layer according to one embodiment of the present invention.

[0034] The reference numerals in the attached figures are as follows:

[0035] 10-Thin film layer; 20-Barrier layer; 30-Liquid reservoir layer; 11-Inner surface; 12-Outer surface; 13-Adhesion structure; 41-First slit; 42-Second slit. Detailed Implementation

[0036] The following detailed description, in conjunction with the accompanying drawings and specific embodiments, provides a further detailed explanation of the wound repair material proposed in this invention. The advantages and features of this invention will become clearer from the following description.

[0037] It should be noted that the accompanying drawings are in a very simplified form and use non-precise proportions, and are only used to facilitate and clearly illustrate the purpose of the embodiments of the present invention. Please refer to the accompanying drawings to make the objectives, features, and advantages of the present invention more apparent and understandable. It should be understood that the structures, proportions, sizes, etc., depicted in the accompanying drawings are only used to complement the content disclosed in the specification, for those skilled in the art to understand and read, and are not intended to limit the implementation conditions of the present invention. Therefore, they have no substantial technical significance. Any modifications to the structure, changes in proportions, or adjustments to the size, without affecting the effects and objectives achieved by the present invention, should still fall within the scope of the technical content disclosed in the present invention.

[0038] In the description of this invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "vertical", "horizontal", "top", "bottom", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing this invention and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this invention.

[0039] In this document, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0040] Example 1

[0041] like Figures 1 to 3 As shown, the present invention provides a wound repair material, with the side closest to the wound as the inner side. The wound repair material includes, from the inside out, a thin film layer 10 and a barrier layer 20. The barrier layer 20 is a semi-permeable membrane layer that allows gas to permeate through. The thin film layer 10 includes an inner surface 11 for contacting the wound and an outer surface 12 that is bonded to the barrier layer. An adhesion structure 13 is provided on the inner surface 11 of the thin film layer 10, and the adhesion structure 13 is configured to adhere to and bond with the wound.

[0042] In the present invention, the adhesion structure 13 can significantly increase the adhesion between the wound repair material and the wound, effectively reduce the problem of the wound repair material sliding or falling off, and prevent secondary damage to the wound.

[0043] In one implementation of the present invention, the adhesion structure 13 includes a plurality of fibrous hair-like structures disposed on the inner surface 11 of the thin film layer 10. These fibrous hair-like structures are used for mechanical adhesion to the wound surface. When in contact with wound tissue, the fibrous hair-like structures can form mechanical adhesion with irregular tissues (such as granulation tissue, fibrin membrane, etc.) on the wound surface, firmly "grabbing" the wound surface through friction and interlocking, significantly enhancing the adhesion between the wound repair material and the wound surface. Simultaneously, the fibrous material itself possesses good flexibility, conforming to the uneven morphology of the wound surface, resulting in a tighter fit between the wound repair material and the wound surface, reducing gaps, preventing the formation of "dead spaces," and reducing the accumulation of tissue fluid.

[0044] This invention does not limit the specific shape of the fibrous hair-like structure; any structure capable of achieving mechanical connection with wound tissue is acceptable. For example, the shape of the fibrous hair-like structure may include a J-shape, an inverted Y-shape, or a suction cup shape. Figures 4 to 6 As shown, the J-shaped fibrous hair structure can directly hook onto the wound tissue through the small hook at the tail; the inverted Y-shaped fibrous hair structure can tightly grip the unevenness of the wound tissue surface to form an interlocking structure; the suction cup-shaped fibrous hair structure, when the wound repair material is attached to the wound surface, can expel the air between the suction cup and the wound tissue by squeezing, so that the suction cup can be tightly attached to the wound tissue under atmospheric pressure, thus also achieving mechanical interlocking with the wound.

[0045] Preferably, a plurality of the fibrous hair-like structures are uniformly arrayed on the inner surface 11 of the thin film layer 10. The length of the fibrous hair-like structures along the direction perpendicular to the thin film layer can be set to 10-1000 μm, and the density of the fibrous hair-like structure array on the thin film layer 10 is 10-100 structures / cm². 2 The diameter of the fibrous hair structure can be 10-100 μm. It should be noted that the diameter of the fibrous hair structure here refers to the diameter of the main segment that makes up the structure. For example, the diameter of the J-shaped fibrous hair structure refers to the diameter of the entire fiber hair, the diameter of the inverted Y-shaped fibrous hair structure refers to the diameter of each straight segment in the three main segments that form the Y shape, and the diameter of the suction cup-shaped fibrous hair structure refers to the diameter of the suction cup.

[0046] In this invention, the fibrous hair-like structure can be made of a hydrophilic biodegradable polymer. For example, the hydrophilic biodegradable polymer is selected from one or a mixture of chitosan, collagen, and silk fibroin. Using biocompatible materials such as hydrophilic biodegradable polymers for the fibrous hair-like structure allows the structure to degrade over time, creating space for new dermal tissue to grow and reducing material residue after wound healing. Furthermore, the chemical groups (such as hydroxyl, amino, and carboxyl groups) on the surface of these hydrophilic biodegradable polymers can generate weak interactions (such as hydrogen bonds, van der Waals forces, and chemical bonding forces) with the active components of the wound tissue. This further increases the bonding force between the fibrous hair-like structure and the wound tissue, based on mechanical adhesion, thereby improving the adhesion stability between the wound repair material and the wound. For example, when fibrous structures made of collagen or chitosan adhere to a wound, the wound's own enzymes (such as transglutaminase) or exogenous enzymes can catalyze the reaction between the groups (such as hydroxyl, amino, and carboxyl groups) on the collagen or chitosan and the amino and carboxyl groups of the wound tissue proteins, forming additional chemical bonds for adhesion.

[0047] Preferably, in the present invention, multiple through-holes can be formed on the thin film layer 10. These through-holes can serve as drainage channels for tissue fluid exudate from the wound, conducting the tissue fluid from the through-holes to the barrier layer 20 via a siphon effect (when tiny pores (capillaries) come into contact with the tissue fluid, due to the surface tension of the tissue fluid and the adhesion of the solid pore walls to the liquid, the liquid is spontaneously drawn in and diffuses upwards along the pores), thus achieving the purpose of quickly capturing the tissue fluid exudate from the wound. Multiple through-holes can be evenly distributed in an array within the thin film layer 10, with a diameter of 70-400 μm, a spacing of 3-5 mm between the through-holes, and a porosity of 70%-95%. In the present invention, both the through-holes and the fibrous hair-like structure are disposed on the thin film layer 10. The positional relationship between them is not limited; they can be arranged adjacently or spaced far apart, as long as the fibrous hair-like structure does not block the through-holes.

[0048] Furthermore, antibacterial hydrogel microspheres can be bonded to the inner wall of the through-hole. These antibacterial hydrogel microspheres can absorb and swell the exudate after it seeps into the through-hole from the wound, exposing the antibacterial material within the microspheres. This achieves a controlled release of the antibacterial material, thus playing a role in antibacterial activity and preventing infection.

[0049] The antibacterial hydrogel microspheres can be hydrogel microspheres loaded with antibacterial materials. The hydrogel microspheres are made of one or more of the following: collagen, chitosan, aloe polysaccharide, sodium hyaluronate, sodium alginate, stem cell extracts, and exosomes. The antibacterial materials include polyhexamethylene biguanide (PHMB), silver ions, and / or chlorhexidine (CHG). Silver ions generally exist in the form of inorganic substances, such as nano silver, silver nitrate, silver zeolite, silver zirconium phosphate, silver sulfadiazine, etc.

[0050] Unlike surface-coated antibacterial coatings, which are prone to sudden release and lack a long-lasting sustained-release mechanism, the antibacterial hydrogel microspheres of this invention, which are set on the inner wall of the through-hole, have a long-lasting sustained-release mechanism. Taking PHMB antibacterial hydrogel microspheres as an example, after the microspheres come into contact with and absorb the tissue fluid of the wound, they will swell and release PHMB antibacterial material, which plays a role in inhibiting bacteria and preventing infection. The continuous release period of PHMB can reach more than 72 hours, which has a very good long-lasting and controlled release effect.

[0051] In preparation, sodium hyaluronate or sodium alginate, as the main material for the microspheres, can be dissolved in pure water (the pH can be adjusted to around 3 to accelerate dissolution). Then, an appropriate amount of antibacterial material is added, followed by 3% polyvinyl alcohol (PVA) solution as the aqueous phase. An emulsification crosslinking method is used to prepare antibacterial gel microspheres with a diameter of approximately 10-40 μm. The mass percentage of the antibacterial material in the antibacterial gel microspheres is approximately 0.05%-0.3%. The prepared antibacterial gel microspheres are then dispersed in an ethanol solution, and a thin film layer 10 is immersed in this solution, allowing the microspheres to adsorb onto the inner wall of the circular pore channels. The ethanol is then removed by freeze-drying. In this way, hydrogel microspheres loaded with antibacterial material are bound to the inner wall of the through-pores.

[0052] Preferably, an antibacterial coating may also be bonded to the inner surface 11 of the film layer 10. The material of this antibacterial coating may be the same as or different from the antibacterial hydrogel microspheres bonded to the inner wall of the through-hole mentioned above. The inner surface 11 of the film layer 10 is in direct contact with the wound, and the antibacterial coating bonded to this inner surface 11 can effectively inhibit bacteria and prevent infection.

[0053] Preferably, the antibacterial coating material can be a combination of a coating host material and an antibacterial material. The coating host material can be one or more combinations of collagen, chitosan, aloe polysaccharide, sodium hyaluronate, stem cell extract, and exosomes. The antibacterial material includes polyhexamethylene biguanide (PHMB), silver ions, and / or chlorhexidine (CHG). During preparation, the antibacterial coating can be formed by uniformly mixing the antibacterial material and the coating host material at a ratio of 1:10-50 and then spraying the mixture onto the inner surface 11 of the thin film layer 10.

[0054] In the wound repair material of the present invention, the thin film layer 10 can be made of a biodegradable material. The biodegradable material can be selected from one or more of the following: polylactic acid (PLA), polylactic-co-glycolic acid copolymer (PLGA), collagen, polycaprolactone (PCL), sodium hyaluronate, sodium alginate, silk fibroin, and chitosan. Thin film layers 10 prepared from such biodegradable materials exhibit good biocompatibility, reduce inflammatory responses, and promote wound healing through the material itself or by loading additional growth factors. Furthermore, the degradation cycle of the thin film layer 10 is approximately 1-10 months, with the degradation rate synchronized with the healing cycle (2-12 months), avoiding the need for secondary surgical removal. It also has a tensile modulus of 0.5-50 MPa and an elongation at break of 50-500%, which matches the mechanical properties of skin tissue well, protecting the wound from external mechanical damage and promoting wound tissue healing.

[0055] Preferably, in another embodiment of the present invention, the thin film layer 10 may also have a plurality of first slits 41, and the barrier layer 20 may have second slits 42 corresponding to the first slits 41, so that the first slits 41 and the second slits 42 are connected. The slits utilize a siphon effect to allow tissue fluid exudated from the wound to rapidly seep out through the slits, guiding the exudate to diffuse directionally from the wound to the outside of the barrier layer 20, thus preventing the exudate from accumulating at the wound site.

[0056] The lengths of the first slit 41 and the second slit 42 can be 2-4 mm, and the widths of the first slit 41 and the second slit 42 can be 50-100 μm. During fabrication, the first slit 41 and the second slit 42 can be formed separately in the thin film layer 10 and the barrier layer 20, respectively, or they can be formed after the thin film layer 10 and the barrier layer 20 are bonded together, thus forming a continuous array of first and second slits. The slits can be formed using photolithography and etching processes, or by laser cutting or plasma processing, etc., to form the slit array.

[0057] Preferably, the semi-permeable membrane layer used in the barrier layer 20 may include a porous silicone membrane or a polyurethane semi-permeable membrane. The semi-permeable membrane layer has good air permeability, allowing gases such as oxygen, carbon dioxide, and water vapor to diffuse through at a rate inversely proportional to the thickness of the membrane layer. This allows external oxygen to enter while preventing external bacteria or particles from passing through and contaminating the wound. Preferably, the thickness of the barrier layer 20 can be less than 0.5 mm. An ultra-thin barrier layer has good light transmittance, facilitating clinical observation of the wound, and also possesses good stretchability, ensuring a tight fit between the wound repair material and the wound surface.

[0058] Preferred, such as Figure 7As shown, with the side closest to the wound as the inner side, the wound repair material, from the inside out, includes a thin film layer 10, a barrier layer 20, and a reservoir layer 30. The reservoir layer 30 can be made of superabsorbent polymer (SAP), which has a strong water absorption capacity, capable of absorbing 50-100 times its own weight, with a water retention capacity of up to 90.0 g / g. Thus, exudate from the wound can be rapidly diffused and transferred to the outside of the barrier layer 20 through the pores of the thin film layer 10 and the array of slits on the thin film layer 10 and the barrier layer 20 under the influence of siphoning, and then absorbed by the reservoir layer 30, achieving management of the exudate from the wound and preventing the accumulation of tissue fluid. Simultaneously, the large amount of tissue fluid absorbed by the reservoir layer 30 can maintain a suitable moist environment at the wound site, which can accelerate wound healing, reduce scab formation, and lower the risk of infection at the wound site.

[0059] The liquid storage layer 30 can be prepared by mixing superabsorbent polymer (SAP) with plasticizer and crosslinking agent, and then hot-pressing it. The thickness of the liquid storage layer 30 is preferably 1-5 mm to provide sufficient water absorption capacity.

[0060] In the wound repair material of the present invention, the thicknesses of the film layer 10, the barrier layer 20, and the reservoir layer 30 can vary as needed. For example, the thickness of the film layer 10 can be 0.5-3 mm, the thickness of the barrier layer 20 is less than 0.5 mm, and the thickness of the reservoir layer is maintained at around 1-5 mm. However, the length and width of each layer can remain basically consistent. For example, the length of the film layer can be 5-70 cm and the width can be 5-50 cm. The length and width of the film layer can be adjusted as appropriate according to the actual wound condition.

[0061] The preparation process of the wound repair material proposed in this invention will be described below with specific examples, and the various properties of the wound repair material will be tested in specific test experiments to demonstrate the excellent performance of the wound repair material of this invention.

[0062] Example 2

[0063] This embodiment 2 describes the preparation process of wound repair material using a three-layer composite scaffold as an example. It should be noted that when the wound repair material only contains a thin film layer and a barrier layer, the following preparation method is also applicable, only the preparation process of the reservoir layer needs to be omitted.

[0064] S1: Thin film layer preparation:

[0065] 2g of silk fibroin and 1g of collagen were mixed in 100ml of pure water to obtain a solution. The solution was then poured into a pre-designed mold using a solution casting method. The substrate with the liquid film was then placed in a drying oven or fume hood. The water solvent was allowed to evaporate slowly by controlling the temperature (which must be below the solvent's boiling point, e.g., below 100℃ in this example to avoid boiling over and causing bubbles in the film), humidity, and ventilation speed. The drying process was gradual, first allowing the film to set at room temperature for 1-2 hours, then raising the temperature to 60-90℃ to dry until the solvent was completely removed, solidifying the liquid film into a solid sheet. After the drying process, a fibrous film sheet was produced. The film sheet could then be cut to a suitable size as needed. In this example, a film sheet with a thickness of 0.5 mm, a length of 50 cm, and a width of 10 cm was selected for use.

[0066] Using micro-nano fabrication technology, the fibers of the above-mentioned thin film were processed to prepare an inverted Y-shaped fiber-like structure array with a length of 100 μm and a diameter of 50 μm, wherein the density of the fiber-like structure was 30 fibers / cm. 2 .

[0067] Laser drilling technology was used to fabricate an array of circular holes with a diameter of 100 μm and a hole spacing of approximately 5 mm on the aforementioned thin film, resulting in a porosity of 80% on the thin film. Care should be taken during drilling to avoid covering the aforementioned fibrous structure with through-holes.

[0068] Sodium hyaluronate was dissolved in pure water, and the pH was adjusted to 3. Then, PHMB was added, and a 3% polyvinyl alcohol (PVA) solution was used as an emulsifying dispersant to obtain an aqueous phase. Cellulose acetate was dissolved in butyl acetate solvent to obtain an oil phase. The aqueous and oil phases were mixed, and glutaraldehyde was added as a crosslinking agent. Antibacterial hydrogel microspheres with a diameter of 30 μm were prepared using an emulsification crosslinking method. The preparation method of the antibacterial hydrogel microspheres is similar to common hydrogel microsphere preparation methods in the prior art, and a more detailed preparation process will not be described in this invention. The only difference in this invention is the addition of PHMB antibacterial material, with the PHMB mass percentage in the antibacterial hydrogel microspheres being approximately 0.1%.

[0069] Take an appropriate amount of antibacterial hydrogel microspheres and disperse them in anhydrous ethanol solution. Then immerse the perforated film sheet in the solution to allow the antibacterial hydrogel microspheres to adsorb onto the inner wall of the circular pore channel. Finally, remove the ethanol by freeze drying.

[0070] Preparation of antibacterial coating: Take 2g of collagen and add it to 100ml of pure water. Add 0.3g of the antibacterial hydrogel microspheres prepared above to the solution to obtain a mixed solution. Then, use a sprayer to spray the mixed solution onto the inner side of the film (the side in contact with the wound) to form an antibacterial coating.

[0071] Thus, after the above steps, a thin film layer is obtained.

[0072] S2: Barrier layer preparation

[0073] Silicone (silicone rubber) is heated and cured to form a silicone film. Then, it is perforated using a laser to obtain a porous silicone film with a porosity of 90% and a pore size of 2 μm. The porous silicone film has a thickness of approximately 0.3 mm, and its length and width are consistent with the film layer.

[0074] S3: Slit Array Machining

[0075] Before bonding the thin film layer and the barrier layer, photolithography and etching techniques are used to fabricate an array of slits at the corresponding positions of the thin film layer and the barrier layer. The slits are 3 mm long and 10 μm wide, and the edges of the slits are plasma-treated to make them smoother.

[0076] S4: Preparation of the reservoir layer

[0077] Superabsorbent polymer (SAP) is mixed with plasticizer and crosslinking agent, and a 2 mm thick sheet is prepared by hot pressing. The length and width of the sheet are then cut to match the thickness of the film layer.

[0078] S5: Support Composition

[0079] The reservoir layer is bonded to the barrier layer with bio-adhesive, and then the barrier layer and the film layer are bonded together by hot pressing, so that the three-layer membrane structure is tightly bonded, thereby obtaining the wound repair material of the present invention.

[0080] Example 3

[0081] The wound repair material obtained in Example 2 was tested in sequence according to the following test indicators to obtain the performance data of the wound repair material.

[0082] Mechanical property testing: The wound repair material of this invention was tested according to GB / T 3923.1-2013 standard. The test results showed that the tensile speed of the wound repair material was 100 mm / min; the prepared wound repair material was subjected to tensile testing using a universal testing machine. The results showed that the breaking strength of the wound repair material was ≥500g, the elongation at break was ≥50%, the ductility was not greater than 4.0 N / cm, and the permanent deformation was not greater than 5%. These characteristics are consistent with the mechanical properties of human skin.

[0083] Liquid absorption performance test: The wound repair material was placed on a simulated exudate surface. Within 5 minutes, the material's thin film layer rapidly captured exudate at the pores and slits, conducting it to the barrier layer and reservoir layer via a siphon effect. After 1 hour, the uppermost reservoir layer absorbed 80 times its own weight in liquid, demonstrating the material's excellent liquid absorption capacity.

[0084] Antimicrobial performance test: Staphylococcus aureus and Escherichia coli were inoculated onto agar plates, and then wound repair material was applied to the plates. The growth of microorganisms on the plates was observed.

[0085] Generally, the antibacterial components in wound healing materials diffuse into the agar upon contact with the plate, thereby inhibiting bacterial growth and forming a transparent "inhibition zone." Typically, when the "inhibition zone" is greater than 7 mm, the material can be considered to have significant antibacterial activity.

[0086] In this embodiment, the wound repair material was applied to a plate and cultured for 24 hours. A "bacterial inhibition zone" of about 10-15 mm was clearly observed, which indicates that the wound repair material provided by the present invention has a good antibacterial effect.

[0087] Wound healing experiment: Ten SD rats were randomly divided into two groups of five each. The experimental group used the wound repair material obtained in Example 2 above, while the control group used commercially available Lando wound repair material. ® A double-layer artificial dermal repair material was developed. Circular wounds with a diameter of 1.5 cm were created on the backs of rats, and the corresponding material was applied for treatment. Wound healing was observed on days 3, 7, and 14 post-treatment. Results showed that the wound healing rate in the experimental group reached 50% on day 7, while the wound healing rate in the control group was 30%. By day 14, the wounds in the experimental group were essentially healed, with a healing rate of 95%, while the wound healing rate in the control group was 50%. This demonstrates that the wound repair material of this invention can effectively promote wound healing.

[0088] Biocompatibility: The wound repair material of the present invention was tested according to the test items in the biological evaluation regulations of GB / T 16886.1-2022 (including cytotoxicity, sensitization reaction, irritation or intradermal reaction, pyrogen, acute systemic toxicity, subacute toxicity, and implantation reaction). The test results showed that the wound repair material of the present invention has good biocompatibility.

[0089] Water vapor transmission rate: The wound repair material of the present invention was tested according to the method specified in 3.2 of YY / T 0471.2-2004, and the test result was 1459.2 g / (m²). 2*24h) indicates that the wound repair material of the present invention meets the requirements and has good breathability.

[0090] In summary, compared with the prior art, the wound repair material provided by the present invention has the following advantages:

[0091] The present invention, through its adhesive structure, can significantly increase the adhesion between the wound repair material and the wound, effectively reducing the problem of the wound repair material sliding or falling off, and preventing secondary damage to the wound.

[0092] The wound repair material utilizes a fibrous, hair-like adhesive structure. Upon contact with wound tissue, it mechanically connects with irregular tissues on the wound surface (such as granulation tissue and fibrin membranes), firmly "grabbing" the wound through friction and interlocking, significantly enhancing the adhesion between the wound repair material and the wound. Simultaneously, the fibrous material itself possesses good flexibility, conforming to the uneven surface of the wound, resulting in a tighter fit between the wound repair material and the wound, reducing gaps, preventing the formation of "dead spaces," and minimizing the accumulation of tissue fluid.

[0093] On the other hand, the fibrous hair-like structure uses biocompatible materials such as hydrophilic biodegradable polymers. This allows the structure to degrade over time, creating space for new dermal tissue to grow and reducing material residue after wound healing. Furthermore, the chemical groups (such as hydroxyl, amino, and carboxyl groups) on the surface of these hydrophilic biodegradable polymers can interact weakly with the active components of the wound tissue (such as hydrogen bonds, van der Waals forces, and chemical bond forces). This further increases the bonding force between the fibrous hair-like structure and the wound tissue on the basis of mechanical connection, thereby improving the adhesion stability between the wound repair material and the wound.

[0094] This invention also incorporates multiple through-holes in the thin film layer. These through-holes serve as drainage channels for tissue fluid exudate from the wound, allowing the fluid to be drawn from the through-holes to the barrier layer via a siphon effect, thus rapidly capturing the exudate. Furthermore, antibacterial hydrogel microspheres can be attached to the inner walls of the through-holes. These microspheres absorb and swell after the tissue fluid enters the through-holes, exposing the antibacterial material within, achieving a long-lasting, controlled release of the antibacterial material and providing antibacterial and infection-preventing effects.

[0095] The thin film layer of this invention is made of biodegradable material, possessing good biocompatibility, reducing inflammatory responses, and promoting wound healing through the material itself or by loading additional growth factors. Furthermore, the degradation cycle of the thin film layer is approximately 1-10 months, with the degradation rate synchronized with the healing cycle (2-12 months), avoiding the need for secondary surgical removal. It also has a tensile modulus of 0.5-50 MPa and an elongation at break of 50-500%, exhibiting good matching with the mechanical properties of skin tissue, protecting the wound from external mechanical damage, and promoting wound tissue healing.

[0096] The present invention also creates an array of slits on the film layer and the barrier layer, using the siphon effect to allow the tissue fluid exuded from the wound to seep out rapidly from the slits, guiding the exudate to diffuse directionally from the wound to the outside of the barrier layer, thus preventing the exudate from accumulating at the wound.

[0097] This invention employs a three-layer scaffold model consisting of a thin film layer, a barrier layer, and a reservoir layer. When tissue fluid exudates from the wound, the slit array and through-holes in the thin film layer utilize a siphon effect to rapidly capture the exudate, transferring it through the barrier layer to the reservoir layer. Simultaneously, the antibacterial hydrogel microspheres on the inner wall of the through-holes in the thin film layer absorb liquid and swell, releasing antibacterial materials. Furthermore, when an antibacterial coating is sprayed onto the inner surface of the thin film layer, antibacterial materials are also released. This effectively provides antibacterial and infection-preventing effects. The barrier layer also possesses excellent breathability, ensuring that external oxygen can enter the wound while promptly expelling carbon dioxide. The reservoir layer has excellent water absorption capacity, effectively absorbing the exudate and maintaining a moist environment at the wound site, thus accelerating wound healing. In this way, the three layers work synergistically to achieve efficient exudate absorption and management, long-lasting antibacterial effects, and maintenance of a moist environment, thereby accelerating wound healing, reducing the risk of infection, and providing a novel wound repair material that combines excellent adhesion, biocompatibility, antibacterial properties, breathability, and absorbency.

[0098] The above description is merely a description of preferred embodiments of the present invention and is not intended to limit the scope of the invention in any way. Any changes or modifications made by those skilled in the art based on the above disclosure are within the scope of the claims. Obviously, those skilled in the art can make various modifications and variations to the invention without departing from the spirit and scope of the invention. Therefore, if these modifications and variations of the invention fall within the scope of the claims and their equivalents, the invention also intends to include these modifications and variations.

Claims

1. A wound repair material, characterized in that, With the side closest to the wound as the inner side, the wound repair material, from the inside out, includes a thin film layer and a barrier layer in sequence. The barrier layer is a semi-permeable membrane layer that allows gas to permeate through; The film layer includes an inner surface for contact with the wound and an outer surface that is bonded to the barrier layer. An adhesive structure is provided on the inner surface of the film layer, and the adhesive structure is configured to adhere to and bond with the wound surface. The adhesion structure includes a plurality of fibrous hair-like structures disposed on the inner side of the film layer, the fibrous hair-like structures being used for mechanical connection with the wound surface; The fibrous hair-like structure includes J-shaped, inverted Y-shaped, or suction cup-shaped structures; The fibrous hair-like structure is made of a hydrophilic biodegradable polymer, which is selected from one or a mixture of chitosan, collagen and silk fibroin. Multiple arrays of the aforementioned fibrous hair-like structures are distributed on the inner surface of the thin film layer. The length of the fibrous hair-like structures along the direction perpendicular to the thin film layer is 10-100 μm, and the density of the fibrous hair-like structure arrays on the thin film layer is 10-100 structures / cm². 2 ; The thin film layer has a plurality of first slits, and the barrier layer has a second slit that corresponds one-to-one with the first slits, so that the first slits and the second slits are connected.

2. The wound repair material according to claim 1, characterized in that, The thin film layer also has multiple through holes, and antibacterial hydrogel microspheres are bonded to the inner wall of the through holes.

3. The wound repair material according to claim 2, characterized in that, The antibacterial hydrogel microspheres are hydrogel microspheres loaded with antibacterial materials. The hydrogel microspheres are made of one or more of the following: collagen, chitosan, aloe polysaccharide, sodium hyaluronate, sodium alginate, stem cell extract and exosomes. The antibacterial materials include polyhexamethylene biguanide, silver ions and / or chlorhexidine.

4. The wound repair material according to claim 1, characterized in that, The thin film layer is made of a biodegradable material selected from one or more of the following: polylactic acid, polylactic acid-glycolic acid copolymer, collagen, polycaprolactone, sodium hyaluronate, sodium alginate, silk fibroin, and chitosan.

5. The wound repair material according to claim 1, characterized in that, The length of the first slit and the second slit is 2-4 mm, and the width of the first slit and the second slit is 50-100 μm.

6. The wound repair material according to claim 1, characterized in that, With the side closest to the wound as the inner side, the wound repair material, from the inside out, includes a thin film layer, a barrier layer, and a reservoir layer, wherein the reservoir layer is made of superabsorbent polymer.

Images