Self-driven deformation nerve pasting film

Abstract

The utility model belongs to the technical field of medical biological materials, and particularly relates to a self-driven deformation nerve pasting film. The self-driven deformation nerve pasting film comprises a self-driven layer (1) and an adhesion layer (2), the self-driven layer (1) comprises at least two nanofiber layers, and the porosity of the nanofiber layers is in gradient distribution from small to large in the direction from the upper surface to the lower surface of the self-driven layer (1); the adhesion layer (2) is arranged above the upper surface of the self-driven layer (1), and the adhesion layer (2) is used for adhering the whole self-driven deformation nerve pasting film to an outer nerve membrane. The self-driven deformation nerve pasting film provided by the utility model is self-driven and deformed in the presence of tissue fluid, so that dynamic adaptive wrapping is realized, and the complexity of a surgical operation is reduced.

Description

Technical Field

[0001] This utility model belongs to the field of medical biomaterials technology, specifically relating to a self-driven deformable nerve patch. Background Technology

[0002] Peripheral nerve injury is a major challenge in clinical medicine, especially the treatment of transection injuries. These injuries typically require connecting the proximal and distal nerves to allow the axons of the proximal nerve to regenerate and extend along the distal nerve, ultimately restoring nerve function. However, some clinical situations make direct connection between the proximal and distal nerves difficult, thus affecting repair outcomes. This is particularly true in patients with long gaps between the proximal and distal nerves (e.g., nerve defects) or the absence of the proximal nerve (e.g., brachial plexus root avulsion). In these cases, direct suturing of the proximal and distal nerves becomes extremely difficult, and the repair results are often unsatisfactory, with limited recovery of nerve function. For these patients, traditional nerve suturing methods are insufficient for repair needs and easily lead to a series of complications. Currently, traditional nerve repair methods typically involve appropriately retracting the epineurium of the proximal nerve and suturing it to the epineurium of the distal nerve. However, when there is a significant difference in diameter between the proximal and distal nerves, or when a suitable matching nerve conduit is unavailable, the epineurium at the suture point may peel off, increasing the risk of neuroma formation or even causing nerve suturing failure. Therefore, given the differences in nerve diameter among different patients, there is a large gap between the standard-sized nerve conduit and the nerve. Thus, developing an adaptable, seamless, and rapidly closure artificial nerve conduit scaffold as an alternative has significant clinical implications and application prospects.

[0003] Currently, various nerve conduit products are available on the market, designed to improve and promote nerve repair, especially for the repair of peripheral nerve injuries. Patent CN202210377724.2 discloses a double-layered tubular product with an outer tubular layer and an inner tubular layer tightly adhering to the inner wall. The weight ratio of the outer layer to the inner layer is 100:20 to 100, and the wall thickness is 50-500 μm. This design is primarily used to promote the regeneration of damaged nerves. Patent CN202110504965.4 describes a nerve conduit that utilizes reactive oxygen species (ROS) in response to hydrogen sulfide release technology. It leverages excess ROS in peripheral nerve injuries to activate hydrogen sulfide donors within the conduit. The release of hydrogen sulfide helps to reduce inflammation, provide antioxidant effects, and regulate macrophage polarization, thereby improving the nerve repair microenvironment and providing targeted drug delivery. Patent CN201820330275.5 discloses a nerve cannula for nerve transposition repair, designed with a small-diameter segment, a large-diameter segment, and a medium-diameter segment, connected by a row of channels and notches. It is suitable for tension-free suturing during nerve transposition repair, simplifying the surgical procedure and promoting nerve regeneration. Patent CN201510825106.X describes a double-layered fiber nerve repair cannula. The inner layer is an oriented polymer fiber layer, and the outer layer is a non-woven polymer fiber layer. The fiber orientation of the inner layer facilitates neuronal growth along the fibers, while the outer layer provides structural support, enhancing the cannula's strength and stability.

[0004] While existing technologies offer various methods for nerve repair, several challenges remain, such as incompatibility with individual differences, the inability to achieve completely tension-free repair, difficulty in handling nerve injuries with large gaps, and a lack of adaptive and responsive repair materials. Therefore, there is an urgent need for a novel nerve repair material that can address the shortcomings of existing technologies, particularly in providing a more effective and flexible solution for problems such as nerve defects, nerve diameter mismatches, and long-gap repair. Utility Model Content

[0005] To address the aforementioned technical problems, this invention provides a self-driving deformable neural patch. This patch can self-deform under humid environmental stimuli, achieving dynamic adaptation and wrapping, thus reducing the complexity of surgical procedures.

[0006] This utility model is achieved through the following technical solution:

[0007] A self-driven deformable neural patch, the self-driven deformable neural patch comprising a self-driven layer (1) and an adhesive layer (2);

[0008] The self-driven layer (1) includes at least two nanofiber layers, and the porosity of the nanofiber layers exhibits a gradient distribution from small to large in the direction from the upper surface to the lower surface of the self-driven layer (1).

[0009] The adhesive layer (2) is disposed above the upper surface of the self-driven layer (1), and the adhesive layer (2) is used to adhere the entire self-driven deformable neural patch to the epineurium.

[0010] Furthermore, the thickness of the self-driving layer (1) is 1mm-5mm, and the thickness of the adhesive layer is 0.2mm-1mm; and the thickness ratio of the self-driving layer (1) to the adhesive layer (2) is in the range of 1:(0.1-1).

[0011] Furthermore, the self-driven layer (1) comprises 2-4 nanofiber layers.

[0012] Furthermore, the diameter of the nanofibers in the nanofiber layer ranges from 100 nm to 500 nm; the porosity of the nanofiber layer is 30% to 70%, and the porosity of two adjacent nanofiber layers differs by 5% to 30%.

[0013] Furthermore, the nanofiber layer in the self-driven layer (1) is prepared by electrospinning;

[0014] The electrospun materials used in each nanofiber layer include any one or more of the following: polycaprolactone, polyurethane, PLGA, polylactide, polyvinyl alcohol, polyvinylpyrrolidone, polyethylene glycol, chitosan, cellulose, silk fibroin, gelatin, polyacrylic acid, and polyamide.

[0015] Further, the adhesion layer includes a surface nanofiber layer and adhesion molecules; the surface adhesion nanofiber layer is located above the upper surface of the self-driven layer (1); the adhesion molecules are doped in the surface nanofiber layer; the adhesion layer is obtained by electrospinning after mixing the adhesion molecules with a spinning solution.

[0016] Furthermore, the adhesion molecules include any one or more of polydopamine, tannic acid, gallic acid, anthocyanins, and secretions from giant salamanders.

[0017] Furthermore, the surface nanofiber layer is prepared by electrospinning, and the electrospinning material used includes any one of polycaprolactone, polyurethane, PLGA, polylactide, polyvinyl alcohol, polyvinylpyrrolidone, polyethylene glycol, chitosan, cellulose, silk fibroin, gelatin, polyacrylic acid, and polyamide.

[0018] Furthermore, the shape of the self-driven deformable neural patch is circular, elliptical, or rectangular.

[0019] The beneficial technical effects of this utility model include:

[0020] (1) The self-driven deformable nerve patch provided by this utility model has responsive deformation. Through the self-driven deformation function, the patch can respond to external humidity stimulation, achieve dynamic adaptation and wrapping, and reduce the complexity of surgery.

[0021] (2) The self-driving deformable nerve patch provided by this utility model promotes nerve growth. The adhesion molecules in the adhesion layer are bioactive molecules that can bind to receptors on the surface of nerve cells, effectively promoting the adhesion, migration and growth of nerve cells and accelerating the nerve repair process.

[0022] (3) The self-driving deformable nerve patch provided by this utility model is biodegradable. Both the driving layer and the adhesive layer are made of biodegradable materials, which ensures that the patch gradually degrades after the repair process is completed, thus avoiding long-term burden on nerve tissue.

[0023] (4) The self-driven deformable nerve patch provided by this utility model has strong adaptability and can wrap nerves of different thicknesses, providing tension-free repair. Attached Figure Description

[0024] Figure 1 This is a schematic diagram of the self-driven deformable neural patch structure in an embodiment of the present invention.

[0025] Figure 2 This is a SEM image of the cross-section of the self-driving deformable neural patch in this embodiment of the present invention;

[0026] Figure 3 This is a SEM image of the high-porosity nanofiber layer in the self-driven deformable neural patch driving layer in this embodiment of the present invention.

[0027] Figure 4 This is a SEM image of the low-porosity nanofiber layer in the self-driven deformable neural patch driving layer in this embodiment of the present invention.

[0028] Figure 5 This is a diagram illustrating the automatic deformation and wrapping of the nerve by the self-driven deformable nerve patch in an embodiment of this utility model.

[0029] Reference numerals: 1. Self-driving layer; 2. Adhesion layer. Detailed Implementation

[0030] To make the objectives, technical solutions, and advantages of this utility model clearer, the present utility model will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only for explaining this utility model and are not intended to limit this utility model.

[0031] Conversely, this utility model encompasses any substitutions, modifications, equivalent methods, and solutions made within the spirit and scope of this utility model as defined in the claims. Furthermore, to provide the public with a better understanding of this utility model, certain specific details are described in detail in the following description. However, those skilled in the art will fully understand this utility model even without these detailed descriptions.

[0032] The self-driven nerve patch provided by this invention, through a combination of a self-driven layer and an adhesive layer, can adapt to nerve injuries of different types and sizes. The self-driven layer, composed of multiple layers of nanofibers, can self-deform in response to changes in external humidity, thus adapting to the repair needs of nerves of different diameters. The adhesive molecules in the adhesive layer promote the attachment and growth of nerve cells, further supporting nerve repair. Therefore, the self-driven deformable nerve patch provided by this invention not only solves the problems existing in the prior art but also significantly improves the repair effect of peripheral nerve injuries, showing broad clinical application prospects.

[0033] This utility model provides an embodiment of a self-driven deformable neural patch, wherein the self-driven deformable neural patch includes a self-driven layer and an adhesive layer;

[0034] The self-driven layer includes at least two nanofiber layers, and the porosity of the nanofiber layers exhibits a gradient distribution from small to large in the direction from the upper surface to the lower surface of the self-driven layer.

[0035] The adhesive layer is disposed above the upper surface of the self-driven layer, and the adhesive layer is used to adhere the entire self-driven deformable neural patch to the epineurium.

[0036] The thickness of the self-driving layer is 1mm-5mm, and the thickness of the adhesive layer is 0.2mm-1mm; and the thickness ratio of the self-driving layer to the adhesive layer is in the range of 1:(0.1-1); this thickness ratio can ensure a balance between the self-driving function and the adhesive performance.

[0037] The self-driving layer comprises 2-4 nanofiber layers, wherein the diameter of the nanofibers in the nanofiber layers ranges from 100nm to 500nm; the porosity of the nanofiber layers is 30%-70%, and the porosity of two adjacent nanofiber layers differs by 5% to 30%.

[0038] The nanofiber layer in the self-driven layer is prepared by electrospinning; the electrospinning material used for each nanofiber layer includes any one or more of polycaprolactone, polyurethane, PLGA, polylactide, polyvinyl alcohol, polyvinylpyrrolidone, polyethylene glycol, chitosan, cellulose, silk fibroin, gelatin, polyacrylic acid, and polyamide.

[0039] Specifically, the micropore size of the nanofiber layer is controlled by adjusting the electrospinning conditions, thereby achieving deformation. The electrospinning conditions are: spinning solution injection speed of 2-10 mL / min, voltage of 18-25 kV, airflow pressure of 0.2-2 MPa, receiving distance of 15-45 cm, temperature of 20-50℃, and humidity of 40%-80%. Controlling the micropore size of the nanofiber layer by adjusting the electrospinning conditions is a conventional technique and will not be elaborated upon here.

[0040] In one embodiment, the adhesion layer comprises a surface nanofiber layer and adhesion molecules; the surface adhesion nanofiber layer is located above the upper surface of the self-driven layer 1; the adhesion molecules are doped into the surface nanofiber layer; the adhesion layer is obtained by electrospinning after blending the adhesion molecules with a spinning solution.

[0041] The adhesion molecules bind to surface receptors on nerve cells, promoting nerve cell adhesion and growth. The adhesion molecules in the adhesion layer can be fixed to the upper surface of the self-driven layer through chemical bonding or physical adsorption.

[0042] The surface nanofiber layer is prepared by electrospinning, and the materials used for electrospinning include any one of polycaprolactone, polyurethane, PLGA, polylactide, polyvinyl alcohol, polyvinylpyrrolidone, polyethylene glycol, chitosan, cellulose, silk fibroin, gelatin, polyacrylic acid, and polyamide.

[0043] In this invention, the adhesive molecules include any one or more of the following: polydopamine, tannic acid, gallic acid, anthocyanins, and secretions from giant salamanders.

[0044] In this invention, the self-driven deformable neural patch is circular, elliptical, or rectangular in shape.

[0045] The following are specific examples:

[0046] Example 1: A self-driven deformable neural patch, such as Figure 1 As shown, it includes a self-driving layer 1 and an adhesive layer 2;

[0047] The self-driven layer 1 is a nanofiber layer prepared by electrospinning, and the porosity of the nanofibers in the self-driven layer exhibits a gradient distribution from small to large along the direction from the upper surface to the lower surface; the adhesion layer 2 is disposed on the upper surface of the self-driven layer 1, and the adhesion layer 2 is used to adhere the entire self-driven deformable neural patch to the epineurium.

[0048] In this embodiment, the self-driven layer comprises two nanofiber layers. The first nanofiber layer is prepared by electrospinning of polylactic acid (PLA), with a thickness of 2 mm, a nanofiber diameter ranging from 200 nm to 500 nm, and a porosity of 50%. The second nanofiber layer is prepared by electrospinning of polyvinyl alcohol (PVA), with a thickness of 3 mm, a nanofiber diameter ranging from 200 nm to 500 nm, and a porosity of 20%.

[0049] In this embodiment, the adhesion layer 2 is composed of a polyvinyl alcohol (PVA) and tannic acid composite material, prepared by electrospinning, with a thickness of 0.5 mm and a porosity of 35%. The adhesion layer and the second layer of nanofibers in the self-driven layer are physically adsorbed and fixed, ensuring a tight bond between the two layers. It can effectively adhere to the nerve epineurium, reducing secondary damage caused by suturing.

[0050] like Figures 2-4 The image shown is a SEM image of the self-driven deformable neural patch in this embodiment; Figure 2 It is evident that the porosity of the first layer of nanofibers is greater than that of the second layer of nanofibers.

[0051] like Figure 5 This is a diagram illustrating the automatic deformation and nerve wrapping process of the self-driven deformable nerve patch in this embodiment. The self-driven deformable nerve patch provided in this embodiment is elliptical in shape and has a size of 3mm x 6mm. The patch automatically deforms under tissue fluid, tightly wrapping the damaged nerve end and forming a tension-free repair environment.

[0052] Example 2: A self-driven deformable neural patch, basically the same as Example 1, except that in this example, the self-driven layer includes two nanofiber layers. The first nanofiber layer is prepared by electrospinning polyvinylpyrrolidone, with a thickness of 3 mm, a nanofiber diameter ranging from 100 nm to 300 nm, and a porosity of 70%. The second nanofiber layer is prepared by electrospinning polyvinyl alcohol (PVA), with a thickness of 3 mm, a nanofiber diameter ranging from 200 nm to 500 nm, and a porosity of 40%.

[0053] In this embodiment, the adhesion layer is composed of polyvinyl alcohol (PVA) and laminin, prepared by electrospinning, with a thickness of 1 mm and a porosity of 35%. The adhesion layer and the second layer of nanofibers in the self-driven layer are physically adsorbed and fixed, ensuring a tight bond between the two layers. This effectively adheres to the nerve epineurium, reducing secondary damage caused by suturing.

[0054] The patch provided in this embodiment is circular in shape and 5mm in size. In the presence of tissue fluid, the patch automatically deforms and tightly wraps around the damaged nerve endings, forming a tension-free repair environment.

[0055] Example 3: A self-driven deformable neural patch, basically the same as Example 1, except that in this example, the self-driven layer includes two nanofiber layers. The first nanofiber layer is prepared by electrospinning of polyacrylic acid, with a thickness of 3 mm, a nanofiber diameter ranging from 100 nm to 300 nm, and a porosity of 60%. The second nanofiber layer is prepared by electrospinning of polyvinyl alcohol (PVA), with a thickness of 3 mm, a nanofiber diameter ranging from 200 nm to 500 nm, and a porosity of 35%.

[0056] In this embodiment, the adhesion layer 2 is composed of polylactic acid and fibrous adhesive, prepared by electrospinning, with a thickness of 1 mm and a porosity of 35%. The adhesion layer and the second layer of nanofibers in the self-driven layer are physically adsorbed and fixed, ensuring a tight bond between the two layers. It can effectively adhere to the nerve epineurium, reducing secondary damage caused by suturing.

[0057] In this embodiment, the patch is rectangular in shape and measures 5×7mm. The patch deforms in the presence of tissue fluid, tightly wrapping the damaged nerve endings and creating a tension-free repair environment.

[0058] Example 4: A self-driven deformable neural patch, basically the same as Example 1, except that in this example, the self-driven layer includes three nanofiber layers. The first nanofiber layer is prepared by electrospinning of polyacrylic acid, with a thickness of 2 mm, a nanofiber diameter range of 100 nm-200 nm, and a porosity of 70%. The second nanofiber layer is prepared by electrospinning of polyvinylpyrrolidone, with a thickness of 2 mm, a nanofiber diameter range of 250 nm-400 nm, and a porosity of 50%. The third nanofiber layer is prepared by electrospinning of polyvinyl alcohol (PVA), with a thickness of 2 mm, a nanofiber diameter range of 400 nm-500 nm, and a porosity of 30%.

[0059] In this embodiment, the adhesive layer is composed of polylactic acid and fibroin glue, prepared by electrospinning, with a thickness of 1 mm and a porosity of 35%. The adhesive layer and the third layer of nanofibers in the self-driven layer are physically adsorbed and fixed, ensuring a tight bond between the two layers. It can effectively adhere to the nerve epineurium, reducing secondary damage caused by suturing.

[0060] In this embodiment, the patch is rectangular in shape and measures 4×5mm. The patch deforms in the presence of tissue fluid, tightly wrapping the damaged nerve endings and creating a tension-free repair environment.

[0061] Example 5: A self-driven deformable neural patch, basically the same as Example 1, except that in this example, the self-driven layer includes three nanofiber layers. The first nanofiber layer is prepared by electrospinning of polylactide, with a thickness of 1.5 mm, a nanofiber diameter of approximately 250 nm, and a porosity of 75%. The second nanofiber layer is prepared by electrospinning of polyethylene glycol, with a thickness of 1.5 mm, a nanofiber diameter of approximately 300 nm, and a porosity of 60%. The third nanofiber layer is prepared by electrospinning of polylactic acid, with a thickness of 2 mm, a nanofiber diameter of approximately 400 nm, and a porosity of 50%.

[0062] In this embodiment, the adhesion layer 2 is composed of polylactic acid and tannic acid, prepared by electrospinning, with a thickness of 1 mm and a porosity of 45%. The adhesion layer and the third layer of nanofibers in the self-driven layer are physically adsorbed and fixed, ensuring a tight bond between the two layers. It can effectively adhere to the nerve epineurium, reducing secondary damage caused by suturing.

[0063] In this embodiment, the patch is rectangular in shape and measures 4×5mm. The patch deforms in the presence of tissue fluid, tightly wrapping the damaged nerve endings and creating a tension-free repair environment.

[0064] Compared with existing nerve conduits and nerve repair cannulas, the self-driven deformable nerve patch provided by this invention has the following unique advantages:

[0065] (1) Traditional nerve conduits or repair cannulas often need to be customized according to the patient's specific condition (such as nerve diameter, injury length, etc.) and usually cannot dynamically adapt to changes in the injury area. In contrast, the self-driving deformable nerve patch of this invention has a self-driving deformation function, which can spontaneously deform according to the presence of tissue fluid in the body, automatically adjusting its shape and size to precisely fit nerve injury areas of different sizes and shapes. This adaptive repair function significantly improves the effect of nerve repair and reduces repair failure or postoperative complications caused by size mismatch.

[0066] (2) Existing nerve repair methods often face situations where there are gaps between nerves of different diameters, or where the damaged area cannot be directly sutured. This can lead to epineurial sheath detachment, neuroma formation, or even repair failure. The self-driven deformable nerve patch of this invention can automatically adjust its size during nerve repair, reducing or eliminating tension at the suture site, achieving a more stable and tension-free nerve repair. Through its self-driven function, the patch can adhere closely to the nerve tissue, thereby reducing tension and stress during the repair process and improving the success rate of nerve regeneration.

[0067] (3) Existing nerve conduits and repair materials typically lack the ability to directly promote nerve cell growth. Although some repair materials use bioactive molecules, they usually cannot effectively bind to nerve cell surface receptors, thus affecting the repair effect. The adhesion layer in this invention contains adhesion molecules that can bind to nerve cell receptors. These molecules not only promote nerve cell adhesion but also stimulate their proliferation and differentiation, thereby accelerating the nerve repair process. This function greatly improves the efficiency of nerve regeneration, especially in cases of severe nerve damage, effectively promoting the recovery of nerve function.

[0068] (4) Traditional nerve repair surgery typically requires meticulous manipulation to ensure the correct installation and docking of nerve conduits or cannulas, and involves repeated adjustments and suturing during the procedure, making it highly complex. This invention's self-driven deformable nerve patch, through its self-adaptive properties, can automatically adjust its shape and size at the injury site, reducing the difficulty for surgeons during the operation. This not only reduces surgical time but also lowers the complexity of intraoperative procedures, improving the safety and success rate of the surgery.

[0069] (5) Traditional nerve repair materials (such as metals or non-degradable materials) often need to remain in the body for a long time after the repair is completed, which may cause chronic inflammation or other adverse reactions, affecting the patient's long-term health. In contrast, the self-driven deformable nerve patch of this invention uses biodegradable materials that can gradually degrade after nerve repair, without causing long-term burden on nerve tissue or other biological tissues. Biodegradable materials not only improve the biocompatibility of the material and avoid immune rejection caused by long-term implants, but also ensure that patients do not need to remove external materials after nerve repair is completed.

[0070] (6) Most nerve conduits are standardized designs, often only suitable for certain fixed-specification nerve injuries, and cannot be used for personalized treatment. The self-driven deformable nerve patch of this invention can be dynamically adjusted according to the actual situation of the nerve injury (such as nerve diameter, injury length, etc.). This flexibility allows this invention to adapt to the needs of different patients, further improving the repair effect and clinical applicability.

[0071] The above description is only a preferred embodiment of the present utility model and is not intended to limit the present utility model. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present utility model should be included within the protection scope of the present utility model.

Claims

1. A self-driven deformable neural patch, characterized in that, The self-driven deformable neural patch includes a self-driven layer (1) and an adhesive layer (2). The self-driven layer (1) includes at least two nanofiber layers, and the porosity of the nanofiber layers exhibits a gradient distribution from small to large in the direction from the upper surface to the lower surface of the self-driven layer (1). The adhesive layer (2) is disposed above the upper surface of the self-driven layer (1), and the adhesive layer (2) is used to adhere the entire self-driven deformable neural patch to the epineurium.

2. The self-driven deformable neural patch according to claim 1, characterized in that, The thickness of the self-driving layer (1) is 1mm-5mm, and the thickness of the adhesive layer is 0.2mm-1mm; and the thickness ratio of the self-driving layer (1) to the adhesive layer (2) is in the range of 1:(0.1-1).

3. The self-driven deformable neural patch according to claim 1, characterized in that, The self-driven layer (1) comprises 2-4 nanofiber layers.

4. The self-driven deformable neural patch according to claim 3, characterized in that, The diameter of the nanofibers in the nanofiber layer ranges from 100 nm to 500 nm; the porosity of the nanofiber layer is 30% to 70%, and the porosity of two adjacent nanofiber layers differs by 5% to 30%.

5. The self-driven deformable neural patch according to claim 1, characterized in that, The self-driven deformable neural patch is circular, elliptical, or rectangular in shape.

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