Metabolizable and isotropic tensile hernia patch and method of making same

Abstract

The application discloses a metabolizable and anisotropic tensile hernia patch and a preparation method thereof. The patch is prepared from the following raw material components in parts by weight: 10-15 parts of a polymer material, 80-180 parts of a solvent, 1-3 parts of a piezoelectric material, 0.05-0.15 parts of a decellularized dermal matrix and 8-12 parts of an acetic acid solution. The mechanical properties of the patch can be accurately controlled through high-speed electrospinning and angle layering design, and the anisotropy of the abdominal muscle layer is simulated. The multi-layer staggered structure is similar to the 'plywood' effect, can effectively disperse and bear multidirectional stress, avoids the wrinkling or swelling of the patch, and provides more stable and persistent mechanical support.

Description

Technical Field

[0001] This invention belongs to the field of biomedical materials and tissue engineering technology, specifically relating to a metabolizable and anisotropic tensile hernia patch and its preparation method. Background Technology

[0002] Abdominal wall hernia is a common disease in general surgery, and its repair relies on tension-free repair using mesh. An ideal mesh needs to possess good mechanical support, biocompatibility, and biodegradability, while actively promoting tissue regeneration and reducing complications such as adhesions. Poly-L-lactic acid (PLLA), as a biodegradable synthetic polymer, is widely used in tissue engineering scaffolds and absorbable medical devices due to its non-toxicity, good mechanical properties, and controllable degradation cycle. However, applying PLLA to the repair of abdominal walls under dynamic loads still faces multiple challenges. Existing technologies mainly optimize these repairs through material modification, structural design, and surface functionalization, but all have limitations.

[0003] Regarding material modification, existing patents primarily enhance PLLA performance through blending, copolymerization, or crosslinking. For example, patent CN103709386B discloses a method for blending linear high molecular weight polylactic acid with a biodegradable crosslinking agent, aiming to improve the material's processing performance and the mechanical strength of the final product. However, such chemical modification may introduce unknown degradation products, increasing the complexity of biosafety assessments. In terms of structural design, patent CN106147164A describes a patch material based on a three-dimensional network crosslinked biodegradable polymer, attempting to promote cell ingrowth through a porous structure. However, three-dimensional network structures prepared by traditional methods often exhibit a gap in matching mechanical isotropy with the anisotropy of abdominal wall muscles, and the preparation process is complex.

[0004] Electrospinning technology has attracted significant attention in the field of tissue repair patches due to its ability to prepare nanofiber structures that mimic the extracellular matrix (ECM). Existing patents explore the preparation of PLLA-based patches using electrospinning. For example, patent CN104096272A relates to a composite electrospinned nanofiber membrane hernia repair patch. However, these patents often focus on the formation or simple lamination of the fibers themselves, lacking precise design for fiber arrangement, particularly the angled layup structure mimicking the orientation of abdominal wall muscle fibers. Search results indicate that while patents exist such as "a method for preparing a poly-L-lactic acid electrospun film with a stable fiber orientation structure" (as mentioned), and specific Chinese invention patents that combine "high-speed electrospinning" with "specific angled layup" for abdominal wall hernia repair using electrospinning to prepare "double-layer, multi-layer, and ordered" structures have not been publicly reported. This leaves room for structural innovation in this invention.

[0005] A more advanced repair strategy utilizes bioelectric signals. Research shows that endogenous electric fields are crucial for tissue repair. Piezoelectric materials can convert mechanical motion (such as respiration and physical activity) into local electrical signals, thereby stimulating cellular behavior. Recent studies (such as the work of Binying Peng et al. in 2025) show that adding ZnO nanoparticles as piezoelectric fillers to PLLA can generate electrical stimulation through ultrasound activation, promoting the repair of abdominal wall defects. However, no Chinese invention patents with the subject matter of "adding ZnO nanoparticles to endow PLLA electrospun patches with piezoelectric properties for abdominal wall hernia repair" were found in the search results. This reveals a significant patent gap in combining piezoelectric effects with biodegradable PLLA patches, especially achieving structure-function integration through high-speed electrospinning.

[0006] In summary, the existing technology has the following shortcomings: (1) the traditional PLLA patch structure fails to effectively simulate the mechanical anisotropy of abdominal wall muscles; (2) most patches are passive repairs and lack the electrophysiological activity to actively promote tissue regeneration; (3) the preparation efficiency of complex multilayer or functionalized structures is low and it is difficult to realize industrialization. Summary of the Invention

[0007] The purpose of this invention is to provide a metabolizable and anisotropic tensile hernia patch and its preparation method.

[0008] A metabolizable and anisotropic tensile hernia patch is made from the following raw material components in parts by weight: 10-15 parts of polymer material, 80-180 parts of solvent, 1-3 parts of piezoelectric material, 0.05-0.15 parts of decellularized dermal matrix, and 8-12 parts of acetic acid solution.

[0009] The polymer material is a mixture of poly-L-lactic acid and polypropylene glycol fumarate in a mass ratio of (1-5):1; the molecular weight of the poly-L-lactic acid is 200,000-400,000 Da, and the molecular weight of the polypropylene glycol fumarate is 3,000-6,000 Da.

[0010] The solvent is dichloromethane and / or N,N-dimethylformamide.

[0011] The piezoelectric material is a mixture of zinc oxide and diphenylalanine in a mass ratio of (1-3):1.

[0012] The acetic acid solution is a 2-4% acetic acid solution.

[0013] The preparation method of the metabolizable and anisotropic tensile hernia patch is carried out according to the following steps: (1) Dissolve 10-15g of polymer material in 100mL of solvent, add 1-3g of piezoelectric material, and stir magnetically for 3-5h to obtain spinning solution; (2) Dissolve 0.05-0.15g of decellularized dermal matrix in 8-12mL of 2-4% acetic acid solution, and shear and stir for 4-8h to obtain collagen gel; (3) Use two 5 ml syringes to draw 1 mL of spinning solution each; adjust the speed of the high-speed receiving roller to 2000-4000 rpm and the distance between the spinning needles to 10-20 cm, set the voltage to -1 kV and +18 kV, adjust the parameters and start spinning, and remove the whole fiber film and cut it into squares. (4) Rotate the cut square 45° clockwise around the membrane normal vector and rely on electrostatic adsorption to the surface of the spinning wheel for the next round of spinning. Repeat 3-5 times. (5) Take off the fiber membrane obtained in step (4) and immerse it in NaOH solution for 3-7 min, and wash it with water 2-4 times; add the washed fiber membrane to citric acid solution to restore the surface carboxyl groups, and then transfer it to the collagen gel prepared in step (2); (6) When the surface of the fiber membrane is completely covered with collagen gel, remove the excess collagen gel and transfer the fiber membrane with collagen gel attached to the PBS buffer system at pH 7.2-7.6 and incubate at 37°C for 3-5 hours; freeze-dry the obtained moist gel patch to obtain a metabolizable and anisotropic tensile hernia patch.

[0014] The concentration of the NaOH solution is 0.1-0.3 M.

[0015] The concentration of the citric acid solution is 0.03-0.07 g / L.

[0016] The beneficial effects of this invention are as follows: Through high-speed electrospinning and angled layup design, the mechanical properties of the patch can be precisely controlled, simulating the anisotropy of the abdominal wall muscle layer. The multi-layered interlaced structure, similar to a "plywood" effect, effectively disperses and withstands multi-directional stress, preventing patch shrinkage or bulging and providing more stable and durable mechanical support. Zinc oxide and diphenylalanine dispersed in the fibers endow the patch with piezoelectric properties. Under physiological mechanical stimulation such as abdominal wall respiration and physical activity, the patch can generate microcurrents (piezoelectric effect). This endogenous electrical signal has been proven to significantly promote fibroblast migration, collagen secretion, and angiogenesis, thereby actively accelerating tissue regeneration and repair at the hernia defect site, surpassing the passive isolation function of traditional patches. The combination of "high-speed electrospinning" and "repeated printing" technology achieves high-precision control over fiber diameter, orientation, layup angle, number of layers, and the content of zinc oxide and diphenylalanine. This allows the patch's porosity, degradation rate, mechanical strength, and piezoelectric output to be customized according to clinical needs, resulting in broad adaptability. The porous nanofiber structure of the patch facilitates cell infiltration, nutrient exchange, and tissue ingrowth. An optional collagen self-assembly surface coating further mimics the natural ECM, providing a superior interface for cell adhesion and growth. High-speed electrospinning technology significantly increases yield per unit time compared to traditional electrospinning. Combined with an automated, program-controlled "repeated printing" stacking process, integrated and continuous fabrication of single-layer to multi-layer biomimetic structures is possible, with stable processes and high repeatability, laying the foundation for large-scale production. Attached Figure Description

[0017] Figure 1 The process diagram for twisting fibers mainly includes three steps: high-speed electrospinning, fiber membrane splicing and twisting, and collagen fixation.

[0018] Figure 2 The image shows the macroscopic morphology of fibers at different twist levels, where the fiber length decreases with increasing twist after twisting.

[0019] Figure 3 This demonstrates how to splice a limited amount of fiber membrane. The first step is to remove the entire fiber membrane intact. The second step is to divide the fiber membrane into three equal strips and cut 45° notches at both ends, then connect the two strips at the halfway point, with the upper and lower layers separated by half a length. The third step involves twisting the strips after finishing.

[0020] Figure 4 This is a SEM image of the surface of the hernia patch.

[0021] Figure 5 This is a cross-sectional SEM image of the hernia patch.

[0022] Figure 6 A comparison chart of stress and strain applied to different processes. Detailed Implementation

[0023] To facilitate understanding of the present invention, a more comprehensive description will be given below. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to provide a thorough and complete understanding of the disclosure of the present invention. Example 1

[0024] A metabolizable and anisotropic tensile hernia patch is made from the following raw material components in parts by weight: 12.5g of polymeric material, 100mL of dichloromethane, 2g of piezoelectric material, 0.01g of decellularized dermal matrix, and 10mL of 3% acetic acid solution. The polymeric material is a mixture of poly-L-lactic acid and polypropylene glycol fumarate in a mass ratio of 4:1; the molecular weight of the poly-L-lactic acid is 300,000 Da, and the molecular weight of the polypropylene glycol fumarate is 4,500 Da. The piezoelectric material is a mixture of zinc oxide and diphenylalanine in a mass ratio of 1:1.

[0025] The method for preparing the metabolizable and anisotropic tensile hernia patch (refer to...) Figure 1-3 Follow these steps: (1) Dissolve 12.5g of polymer material in 100mL of dichloromethane, add 2g of piezoelectric material, and stir magnetically for 4h to obtain spinning solution; (2) Dissolve 0.01g of decellularized dermal matrix in 10mL of 3% acetic acid solution, and shear and stir for 6h to obtain collagen gel; (3) Use two 5 ml syringes to draw 1 mL of spinning solution each; adjust the speed of the high-speed receiving roller to 3000 rpm and the distance between the spinning needle to 15 cm, set the voltage to -1 kV and +18 kV, adjust the parameters and start spinning, and remove the whole fiber film and cut it into a square. (4) Rotate the cut square 45° clockwise around the membrane normal vector and rely on electrostatic adsorption to the surface of the spinning wheel for the next round of spinning. Repeat 4 times. (5) Take off the fiber membrane obtained in step (4) and immerse it in a 0.2 M NaOH solution for 5 min, and wash it with water 3 times; add the washed fiber membrane to a 0.05 g / L citric acid solution to restore the surface carboxyl groups, and then transfer it to the collagen gel prepared in step (2); (6) When the surface of the fiber membrane is completely covered with collagen gel, remove the excess collagen gel and transfer the fiber membrane with collagen gel attached to the PBS buffer system at pH 7.4 and incubate at 37°C for 4 hours; freeze-dry the obtained moist gel patch to obtain a metabolizable and anisotropic tensile hernia patch. Example 2

[0026] A metabolizable and anisotropic tensile hernia patch is made from the following raw material components in parts by weight: 10g of polymeric material, 100mL of N,N-dimethylformamide, 1.5 parts of piezoelectric material, 0.08g of decellularized dermal matrix, and 12mL of 2% acetic acid solution. The polymeric material is a mixture of poly-L-lactic acid and polypropylene glycol fumarate in a mass ratio of 3:1; the molecular weight of the poly-L-lactic acid is 250,000 Da, and the molecular weight of the polypropylene glycol fumarate is 3,500 Da. The piezoelectric material is a mixture of zinc oxide and diphenylalanine in a mass ratio of 2:1.

[0027] The preparation method of the metabolizable and anisotropic tensile hernia patch is carried out according to the following steps: (1) Dissolve 10g of polymer material in 100mL of N,N-dimethylformamide, add 1-3g of piezoelectric material, and stir magnetically for 3-5h to obtain spinning solution; (2) Dissolve 0.08g of decellularized dermal matrix in 12mL of 2% acetic acid solution, and shear and stir for 5h to obtain collagen gel; (3) Use two 5 ml syringes to draw 1 mL of spinning solution each; adjust the speed of the high-speed receiving roller to 2500 rpm and the distance between the spinning needle to 12 cm, set the voltage to -1 kV and +18 kV, adjust the parameters and start spinning, and remove the whole fiber film and cut it into a square. (4) Rotate the cut square 45° clockwise around the membrane normal vector and rely on electrostatic adsorption to the surface of the spinning wheel for the next round of spinning. Repeat 3 times. (5) Take off the fiber membrane obtained in step (4) and immerse it in a 0.15 M NaOH solution for 4 min, and wash it with water twice; add the washed fiber membrane to a 0.04 g / L citric acid solution to restore the surface carboxyl groups, and then transfer it to the collagen gel prepared in step (2); (6) When the surface of the fiber membrane is completely covered with collagen gel, remove the excess collagen gel, transfer the fiber membrane with attached collagen gel to a PBS buffer system at pH 7.3, and incubate at 37°C for 3 hours; freeze-dry the obtained moist gel patch to obtain a metabolizable and anisotropic tensile hernia patch. Example 3

[0028] A metabolizable and anisotropic tensile hernia patch is made from the following raw material components in parts by weight: 15g of polymer material, 100mL of dichloromethane, 3g of piezoelectric material, 0.15g of decellularized dermal matrix, and 8mL of 4% acetic acid solution. The polymer material is a mixture of poly-L-lactic acid and polypropylene glycol fumarate in a mass ratio of 2:1; the molecular weight of the poly-L-lactic acid is 350,000 Da, and the molecular weight of the polypropylene glycol fumarate is 5,000 Da. The piezoelectric material is a mixture of zinc oxide and diphenylalanine in a mass ratio of 2:1.

[0029] The preparation method of the metabolizable and anisotropic tensile hernia patch is carried out according to the following steps: (1) Dissolve 15g of polymer material in 100mL solvent, add 3g of piezoelectric material, and stir magnetically for 5h to obtain spinning solution; (2) Dissolve 0.15g of decellularized dermal matrix in 8mL of 4% acetic acid solution, and shear and stir for 8h to obtain collagen gel; (3) Use two 5 ml syringes to draw 1 mL of spinning solution each; adjust the speed of the high-speed receiving roller to 4000 rpm and the distance between the spinning needle to 20 cm, set the voltage to -1 kV and +18 kV, adjust the parameters and start spinning, and remove the whole fiber film and cut it into a square. (4) Rotate the cut square 45° clockwise around the membrane normal vector and rely on electrostatic adsorption to the surface of the spinning wheel for the next round of spinning. Repeat 5 times. (5) Take off the fiber membrane obtained in step (4) and immerse it in a 0.3 M NaOH solution for 4 min, and wash it with water 4 times; add the washed fiber membrane to a 0.07 g / L citric acid solution to restore the surface carboxyl groups, and then transfer it to the collagen gel prepared in step (2); (6) When the surface of the fiber membrane is completely covered with collagen gel, remove the excess collagen gel, transfer the fiber membrane with attached collagen gel to a PBS buffer system at pH 7.6, and incubate at 37°C for 5 hours; freeze-dry the obtained moist gel patch to obtain a metabolizable and anisotropic tensile hernia patch.

[0030] Comparative Example 1 A metabolizable and anisotropic tensile hernia patch is made from the following raw material components in parts by weight: 12.5 g poly-L-lactic acid, 100 mL dichloromethane, 2 g piezoelectric material, 0.01 g decellularized dermal matrix, and 10 mL 3% acetic acid solution. The poly-L-lactic acid has a molecular weight of 300,000 Da. The piezoelectric material is a mixture of zinc oxide and diphenylalanine in a 1:1 mass ratio.

[0031] The preparation method of the metabolizable and anisotropic tensile hernia patch is carried out according to the following steps: (1) Dissolve 12.5g of poly-L-lactic acid in 100mL of dichloromethane, add 2g of piezoelectric material, and stir magnetically for 4h to obtain spinning solution; (2) Dissolve 0.01g of decellularized dermal matrix in 10mL of 3% acetic acid solution, and shear and stir for 6h to obtain collagen gel; (3) Use two 5 ml syringes to draw 1 mL of spinning solution each; adjust the speed of the high-speed receiving roller to 3000 rpm and the distance between the spinning needle to 15 cm, set the voltage to -1 kV and +18 kV, adjust the parameters and start spinning, and remove the whole fiber film and cut it into a square. (4) Rotate the cut square 45° clockwise around the membrane normal vector and rely on electrostatic adsorption to the surface of the spinning wheel for the next round of spinning. Repeat 4 times. (5) Take off the fiber membrane obtained in step (4) and immerse it in a 0.2 M NaOH solution for 5 min, and wash it with water 3 times; add the washed fiber membrane to a 0.05 g / L citric acid solution to restore the surface carboxyl groups, and then transfer it to the collagen gel prepared in step (2); (6) When the surface of the fiber membrane is completely covered with collagen gel, remove the excess collagen gel and transfer the fiber membrane with collagen gel attached to the PBS buffer system at pH 7.4 and incubate at 37°C for 4 hours; freeze-dry the obtained moist gel patch to obtain a metabolizable and anisotropic tensile hernia patch.

[0032] Comparative Example 2 A metabolizable and anisotropic tensile hernia patch is made from the following raw material components in parts by weight: 12.5 g polypropylene fumarate, 100 mL dichloromethane, 2 g piezoelectric material, 0.01 g decellularized dermal matrix, and 10 mL 3% acetic acid solution. The polypropylene fumarate has a molecular weight of 4500 Da. The piezoelectric material is a mixture of zinc oxide and diphenylalanine in a 1:1 mass ratio.

[0033] The preparation method of the metabolizable and anisotropic tensile hernia patch is carried out according to the following steps: (1) Dissolve 12.5g of polyfuric acid propylene glycol ester in 100mL of dichloromethane, add 2g of piezoelectric material, and stir magnetically for 4h to obtain spinning solution; (2) Dissolve 0.01g of decellularized dermal matrix in 10mL of 3% acetic acid solution, and shear and stir for 6h to obtain collagen gel; (3) Use two 5 ml syringes to draw 1 mL of spinning solution each; adjust the speed of the high-speed receiving roller to 3000 rpm and the distance between the spinning needle to 15 cm, set the voltage to -1 kV and +18 kV, adjust the parameters and start spinning, and remove the whole fiber film and cut it into a square. (4) Rotate the cut square 45° clockwise around the membrane normal vector and rely on electrostatic adsorption to the surface of the spinning wheel for the next round of spinning. Repeat 4 times. (5) Take off the fiber membrane obtained in step (4) and immerse it in a 0.2 M NaOH solution for 5 min, and wash it with water 3 times; add the washed fiber membrane to a 0.05 g / L citric acid solution to restore the surface carboxyl groups, and then transfer it to the collagen gel prepared in step (2); (6) When the surface of the fiber membrane is completely covered with collagen gel, remove the excess collagen gel and transfer the fiber membrane with collagen gel attached to the PBS buffer system at pH 7.4 and incubate at 37°C for 4 hours; freeze-dry the obtained moist gel patch to obtain a metabolizable and anisotropic tensile hernia patch.

[0034] Comparative Example 3 A metabolizable and anisotropic tensile hernia patch is made from the following raw material components in parts by weight: 12.5g of polymeric material, 100mL of dichloromethane, 2g of zinc oxide, 0.01g of decellularized dermal matrix, and 10mL of 3% acetic acid solution. The polymeric material is a mixture of poly-L-lactic acid and polypropylene glycol fumarate in a mass ratio of 4:1; the molecular weight of the poly-L-lactic acid is 300,000 Da, and the molecular weight of the polypropylene glycol fumarate is 4,500 Da.

[0035] The preparation method of the metabolizable and anisotropic tensile hernia patch is carried out according to the following steps: (1) Dissolve 12.5g of polymer material in 100mL of dichloromethane, add 2g of zinc oxide, and stir magnetically for 4h to obtain spinning solution; (2) Dissolve 0.01g of decellularized dermal matrix in 10mL of 3% acetic acid solution, and shear and stir for 6h to obtain collagen gel; (3) Use two 5 ml syringes to draw 1 mL of spinning solution each; adjust the speed of the high-speed receiving roller to 3000 rpm and the distance between the spinning needle to 15 cm, set the voltage to -1 kV and +18 kV, adjust the parameters and start spinning, and remove the whole fiber film and cut it into a square. (4) Rotate the cut square 45° clockwise around the membrane normal vector and rely on electrostatic adsorption to the surface of the spinning wheel for the next round of spinning. Repeat 4 times. (5) Take off the fiber membrane obtained in step (4) and immerse it in a 0.2 M NaOH solution for 5 min, and wash it with water 3 times; add the washed fiber membrane to a 0.05 g / L citric acid solution to restore the surface carboxyl groups, and then transfer it to the collagen gel prepared in step (2); (6) When the surface of the fiber membrane is completely covered with collagen gel, remove the excess collagen gel and transfer the fiber membrane with collagen gel attached to the PBS buffer system at pH 7.4 and incubate at 37°C for 4 hours; freeze-dry the obtained moist gel patch to obtain a metabolizable and anisotropic tensile hernia patch.

[0036] Comparative Example 4 A metabolizable and anisotropic tensile hernia patch is made from the following raw material components in parts by weight: 12.5g of polymeric material, 100mL of dichloromethane, 2g of diphenylalanine, 0.01g of decellularized dermal matrix, and 10mL of 3% acetic acid solution. The polymeric material is a mixture of poly-L-lactic acid and polypropylene glycol fumarate in a mass ratio of 4:1; the molecular weight of the poly-L-lactic acid is 300,000 Da, and the molecular weight of the polypropylene glycol fumarate is 4,500 Da.

[0037] The preparation method of the metabolizable and anisotropic tensile hernia patch is carried out according to the following steps: (1) Dissolve 12.5g of polymer material in 100mL of dichloromethane, add 2g of diphenylalanine, and stir magnetically for 4h to obtain spinning solution; (2) Dissolve 0.01g of decellularized dermal matrix in 10mL of 3% acetic acid solution, and shear and stir for 6h to obtain collagen gel; (3) Use two 5 ml syringes to draw 1 mL of spinning solution each; adjust the speed of the high-speed receiving roller to 3000 rpm and the distance between the spinning needle to 15 cm, set the voltage to -1 kV and +18 kV, adjust the parameters and start spinning, and remove the whole fiber film and cut it into a square. (4) Rotate the cut square 45° clockwise around the membrane normal vector and rely on electrostatic adsorption to the surface of the spinning wheel for the next round of spinning. Repeat 4 times. (5) Take off the fiber membrane obtained in step (4) and immerse it in a 0.2 M NaOH solution for 5 min, and wash it with water 3 times; add the washed fiber membrane to a 0.05 g / L citric acid solution to restore the surface carboxyl groups, and then transfer it to the collagen gel prepared in step (2); (6) When the surface of the fiber membrane is completely covered with collagen gel, remove the excess collagen gel and transfer the fiber membrane with collagen gel attached to the PBS buffer system at pH 7.4 and incubate at 37°C for 4 hours; freeze-dry the obtained moist gel patch to obtain a metabolizable and anisotropic tensile hernia patch.

[0038] Experimental example: (1) The surface and cross-sectional layers of the hernia patch prepared in Example 1 were observed using a scanning electron microscope, such as... Figure 4-5 As shown.

[0039] (2) Mechanical properties: The distribution of mechanical properties of the hernia mesh is as follows Figure 6 As shown: Since the hernia patch is stretched along the vertical axis with almost no stress, there is almost no strain data when there is no angle less than 90° between the two sides of the stretch. The strength in the other axes will increase after adding new fiber layers. However, due to the increase in the overall cross-section, the tensile strength in other directions will decrease. But after the four-way stacking is completed, the fiber membrane as a whole has no mechanically weak axis.

[0040] (3) Cck8 method: First, cell seeding and co-culture are performed: cells in the logarithmic growth phase are digested with trypsin, resuspended, counted, and then seeded at a density of 5×10³ to 1×10³ cells per well. 4 Cells were seeded at a density of 100 μL of complete culture medium in each well of a 96-well plate. The plate was pre-cultured at 37°C in a 5% CO2 incubator for 24 hours until the cells were fully adherent. Then, a material extract (50 μL) was prepared for co-culture. Each group was divided into three replicates. The plate was returned to the incubator and cultured for another 48 hours. CCK-8 assay and incubation were then performed: 10 μL of CCK-8 reagent was added to each well, the plate was gently shaken to mix thoroughly, and the plate was returned to the incubator for 3 hours in the dark. Finally, the absorbance (OD value) at 450 nm was measured using a microplate reader. Cell-free wells containing only culture medium and CCK-8 reagent were used as blank controls to zero the readings. The relative cell survival rate (RGR) was calculated using the formula: RGR (%) = [(OD value of experimental group - OD value of blank group) / (OD value of negative control group - OD value of blank group)] × 100%.

[0041] The experimental results were statistically analyzed using SPSS 24.0 software. Quantitative data were expressed as mean ± standard deviation (x ± √2). The Kolmogorov-Smirnov test was used to test the normality of the data. For normally distributed data, the t-test was used to compare the differences in means between two groups, with P < 0.05 considered statistically significant. The measurement results are shown in Table 1. Table 1

[0042] Note: * indicates that compared with Example 1 group, P<0.05.

[0043] (4) The piezoelectric constant of the hernia patches prepared in Examples 1-3 and Comparative Examples 3-4 was measured using a piezoelectric constant tester (ZJ-3A). Each measurement was repeated three times and the average value was taken. Statistical analysis was performed using SPSS 24.0 software. The results of the measurement data were expressed as x̅±s (mean ± standard deviation). The Kolmogorov-Smirnov test was used to test the normality of the data. For data that conformed to a normal distribution, the difference between the means of the two groups was compared using a t-test, and P<0.05 was considered statistically significant. The measurement results are shown in Table 2: Table 2

[0044] Note: * indicates that compared with Example 1 group, P<0.05.

[0045] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A metabolizable and anisotropic tensile hernia patch, characterized in that, It is made from the following raw material components in parts by weight: 10-15 parts of polymer material, 80-180 parts of solvent, 1-3 parts of piezoelectric material, 0.05-0.15 parts of decellularized dermal matrix, and 8-12 parts of acetic acid solution; wherein the polymer material is a mixture of poly-L-lactic acid and polypropylene fumarate in a mass ratio of (1-5):1; wherein the molecular weight of poly-L-lactic acid is 200,000-400,000 Da, and the molecular weight of polypropylene fumarate is 3,000-6,000 Da; wherein the piezoelectric material is a mixture of zinc oxide and diphenylalanine in a mass ratio of (1-3):

1. The preparation method of the metabolizable and anisotropic tensile hernia patch is carried out according to the following steps: (1) Dissolve 10-15g of polymer material in 100mL of solvent, add 1-3g of piezoelectric material, and stir magnetically for 3-5h to obtain spinning solution; (2) Dissolve 0.05-0.15g of decellularized dermal matrix in 8-12mL of 2-4% acetic acid solution, and shear and stir for 4-8h to obtain collagen gel; (3) Use two 5 ml syringes to draw 1 mL of spinning solution each; adjust the speed of the high-speed receiving roller to 2000-4000 rpm and the distance between the spinning needles to 10-20 cm, set the voltage to -1 kV and +18 kV, adjust the parameters and start spinning, and remove the whole fiber film and cut it into squares. (4) Rotate the cut square 45° clockwise around the membrane normal vector and rely on electrostatic adsorption to the surface of the spinning wheel for the next round of spinning. Repeat 3-5 times. (5) Take off the fiber membrane obtained in step (4) and immerse it in NaOH solution for 3-7 min, and wash it with water 2-4 times; add the washed fiber membrane to citric acid solution to restore the surface carboxyl groups, and then transfer it to the collagen gel prepared in step (2); (6) When the surface of the fiber membrane is completely covered with collagen gel, remove the excess collagen gel and transfer the fiber membrane with collagen gel attached to the PBS buffer system at pH 7.2-7.6 and incubate at 37°C for 3-5 hours; freeze-dry the obtained moist gel patch to obtain a metabolizable and anisotropic tensile hernia patch.

2. The metabolizable and anisotropic tensile hernia patch according to claim 1, characterized in that, The solvent is dichloromethane and / or N,N-dimethylformamide.

3. The metabolizable and anisotropic tensile hernia patch according to claim 1, characterized in that, The acetic acid solution is a 2-4% acetic acid solution.

4. The metabolizable and anisotropic tensile hernia patch according to claim 1, characterized in that, The concentration of the NaOH solution is 0.1-0.3 M.

5. The metabolizable and anisotropic tensile hernia patch according to claim 1, characterized in that, The concentration of the citric acid solution is 0.03-0.07 g / L.

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