Application of composite biological material in hernia repair operation
By using nanofiber scaffolds and gel layers in composite biomaterials, the biocompatibility and degradation issues of hernia repair materials have been solved, improving the biocompatibility and healing effect of the materials and reducing the risk of hernia recurrence.
Patent Information
- Application Number
- CN202511373538.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-09-25
- Publication Date
- 2025-12-12
AI Technical Summary
Existing hernia repair materials have problems such as poor biocompatibility, non-degradability, or improper degradation, leading to the risk of inflammation, infection, and hernia recurrence.
The composite biomaterials used include a nanofiber scaffold and a gel layer. The nanofiber scaffold is made of polylactic acid-glycolic acid and silk fibroin, with surface chemical modification, antibacterial coating and bioactive molecules, to provide mechanical support, promote cell attachment and control degradation.
It improves the biocompatibility of the material, reduces the risk of inflammation and infection, promotes tissue healing and angiogenesis, and reduces the likelihood of hernia recurrence.
Smart Images
Figure CN121102592A_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The present application relates to the technical field of biotechnology, in particular to application of a composite biomaterial in hernia repair surgery. BACKGROUND
[0002] Biocompatibility refers to the compatibility between the material and the organism, that is, the ability of the material to remain stable in the physiological environment without causing harmful reactions. In hernia repair surgery, biocompatibility issues mainly manifest in the following aspects:
[0003] Immune response: Some synthetic materials, such as polypropylene or polyester mesh, are recognized by the human body as foreign bodies, which easily trigger the response of the immune system. This leads to the infiltration of inflammatory cells, such as macrophages and lymphocytes, which release inflammatory mediators, such as cytokines and chemotactic factors, thereby causing inflammatory reactions.
[0004] Infection: The inflammatory environment provides a good growth condition for bacteria, increasing the risk of infection. Not only does it delay the healing process, but it can also lead to more serious complications.
[0005] The degradation performance of the material is also crucial for the success of hernia repair surgery, and there are problems of non-degradable or improper degradation, including:
[0006] Non-degradable materials: Some synthetic mesh materials are non-degradable in the body, meaning they will remain permanently in the body, which leads to long-term chronic inflammation. In addition, permanent mesh hardens over time, often causing discomfort for patients.
[0007] Improper degradation rate: Some degradable materials are designed to gradually be broken down and absorbed in the body, but when the degradation rate is too fast, the material loses its structural support before the newly formed tissue is strong enough, increasing the risk of hernia recurrence. Conversely, when the degradation rate is too slow, the material stays in the body for too long, causing chronic inflammation or other complications.
[0008] Therefore, we propose an application of a composite biomaterial in hernia repair surgery in order to solve the problems mentioned above.
[0009] The above information disclosed in the background section is only intended to increase the understanding of the background of the present application, and therefore, it can include prior art known to those skilled in the art. SUMMARY
[0010] The present application aims to at least solve one of the technical problems of poor biocompatibility, non-degradability or improper degradation in the prior art. To this end, one object of the present application is to propose an application of a composite biomaterial in hernia repair surgery.
[0011] To achieve the above object, the present application provides the following technical scheme:
[0012] The application of a composite biomaterial in hernia repair surgery, comprising:
[0013] A nanofiber scaffold, the scaffold is made of polylactic acid-glycolic acid and silk fibroin composite, wherein the weight ratio of polylactic acid-glycolic acid and silk fibroin is 70:30, the nanofiber scaffold is prepared by electrospinning technology, and is used for providing mechanical support and promoting cell adhesion and proliferation.
[0014] The fibers have a porous structure, and the pore size is 10-100 mu m, which is beneficial to cell penetration and nutrient exchange.
[0015] The nanofiber surface is chemically modified to enhance cell adhesion and biocompatibility.
[0016] As a further optimization scheme of the present application, the fiber diameter of the nanofiber scaffold is less than 500 nm.
[0017] As a further optimization scheme of the present application, a gel layer is further included, the gel layer is made of a temperature-sensitive hydrogel and a bioactive molecule, the thickness of the gel layer is 50-100 mu m, the gel layer is prepared by a solution phase separation method, and is used for providing a protective layer at the initial stage of the surgery and gradually degrading during the healing process to release growth factors to promote tissue regeneration.
[0018] As a further optimization scheme of the present application, the temperature-sensitive hydrogel is poly (N-isopropyl acrylamide) PNIPAM, and the bioactive molecule includes one of vascular endothelial growth factor or fibroblast growth factor.
[0019] As a further optimization scheme of the present application, an antibacterial coating is further included, the antibacterial coating is coated on the nanofiber scaffold, and the antibacterial coating internally contains zinc nanoparticles, the size of the zinc nanoparticles is 20-50 nm, and the antibacterial coating is used for reducing the risk of postoperative infection.
[0020] As a further optimization scheme of the present application, bone morphogenetic protein is coated on the gel layer, and is used for guiding cell behavior, promoting angiogenesis and bone regeneration, and the coating amount of the BMP is 10-20 mu g / cm 2 .
[0021] Compared with the prior art, the present application has the beneficial effects that:
[0022] The application is made of polylactic acid-glycolic acid and silk fibroin, simulates the mechanical properties of natural tissues, and provides a good growth scaffold for cells. The gel layer is prepared by a solution phase separation method, providing additional biological activity support and cell attachment surface for the nanofiber scaffold. By setting an antibacterial coating, the risk of postoperative infection is reduced, and the material and human tissue are protected.
[0023] The bone morphogenetic protein contained in the composite biomaterial in the application can guide cell behavior, promote angiogenesis and bone regeneration, accelerate the repair of hernia defects, and the nanofiber surface is chemically modified to enhance the biocompatibility of the material and promote cell attachment and proliferation.
[0024] The above summary is only for the purpose of the description and is not intended to limit in any way. In addition to the above described illustrative aspects, embodiments, and features, further aspects, embodiments, and features will be readily apparent from a study of the drawings and the following detailed description. BRIEF DESCRIPTION OF DRAWINGS
[0025] Figure 1 The structure of the composite biomaterial of the application is shown in the figure.
[0026] In the figure: 10, antibacterial coating; 20, gel layer; 30, nanofiber scaffold. DETAILED DESCRIPTION
[0027] The technical solutions in the embodiments of the application will be described clearly and completely below with reference to the drawings in the embodiments of the application. Obviously, the described embodiments are only a part of the embodiments of the application, rather than all the embodiments of the application. Based on the embodiments in the application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the application.
[0028] Example 1
[0029] Please refer to Figure 1 The application of a composite biomaterial in hernia repair surgery, the composite biomaterial is used in the surgery to strengthen the weak area of the abdominal wall and prevent the recurrence of hernia, comprising:
[0030] The nanofiber scaffold is made of polylactic acid-glycolic acid and silk fibroin, wherein the weight ratio of polylactic acid-glycolic acid to silk fibroin is 70:30, and the nanofiber scaffold is prepared by electrospinning technology to provide mechanical support and promote cell attachment and proliferation.
[0031] The specific steps for preparing the nanofiber scaffold by electrospinning technology are as follows:
[0032] 70:30 of polylactic acid-glycolic acid and silk fibroin;
[0033] PLGA and silk fibroin were dissolved in dichloromethane respectively to prepare the solution, and the concentration of the solution was 5-25%;
[0034] The PLGA solution was mixed uniformly with the silk fibroin solution;
[0035] An electrospinning device was prepared, and the flow rate of the syringe pump was set to 0.5-2.0 mL / h, and the voltage of the high-voltage power supply was set to 10-30 kV, so that the solution was ejected and stretched into fibers under the action of the electric field force, and the distance between the spinneret and the collector was 10-20 min;
[0036] The mixed solution was loaded into the syringe of the syringe pump, the high-voltage power supply and the syringe pump were turned on, and the solution was ejected from the spinneret and stretched into fibers under the action of the electric field force, and the solvent evaporated in the flight process, and finally deposited on the collector to form a nanofiber scaffold;
[0037] After spinning, the collected nanofiber scaffold was removed from the collector, and the nanofiber scaffold was heat treated to improve its mechanical properties and stability;
[0038] The morphology and diameter of the nanofiber were observed using a scanning electron microscope.
[0039] The fibers have a porous structure with a pore size of 10-100 μm, which is beneficial for cell penetration and nutrient exchange; the surface of the nanofiber is chemically modified to enhance cell adhesion and biocompatibility.
[0040] Specifically, the fiber diameter of the nanofiber scaffold is less than 500 nm.
[0041] Specifically, it further comprises a gel layer made of a temperature-sensitive hydrogel and a bioactive molecule, and the thickness of the gel layer is 50-100 μm, which is prepared by a solution phase separation method and used to provide a protective layer in the early stage of surgery and gradually degrade during the healing process to release growth factors to promote tissue regeneration.
[0042] The specific steps for preparing the gel layer by the solution phase separation method are as follows:
[0043] PVA with a molecular weight of about 150,000 daltons and an alcoholysis degree of about 95% was weighed, and the PVA was added to deionized water, the ratio of PVA to water was 5-20% by weight / volume, the mixture was heated to 80-95℃, and the stirring was continued until the PVA was completely dissolved to form a clear solution;
[0044] The dissolved PVA solution was cooled to room temperature, and the stirring was kept uniform during the process;
[0045] The cooled PVA solution is left at room temperature for 24 h to promote the maturation of the solution, reducing the bubbles and impurities in the solution;
[0046] The mold is preheated to 30 °C to prevent premature gelation of the solution when pouring into the mold. The matured PVA solution is slowly poured into the mold to avoid the formation of bubbles. The mold is placed in a cold room to initiate the phase separation and gelation of the solution;
[0047] The mold is kept in a low-temperature environment until the solution is completely gelled;
[0048] After the gel is formed, the gel layer is removed from the mold. The solvent in the gel is removed by freeze-drying to increase the porosity and mechanical strength of the gel. The gel layer is sterilized before use.
[0049] Specifically, the temperature-sensitive hydrogel is poly(N-isopropylacrylamide) PNIPAM, and the bioactive molecules include one of vascular endothelial growth factor or fibroblast growth factor.
[0050] Specifically, it also includes an antibacterial coating coated on the nanofiber scaffold, which contains zinc nanoparticles inside, with a size of 20-50 nm, to reduce the risk of postoperative infection.
[0051] Specifically, the gel layer is coated with bone morphogenetic protein to guide cell behavior and promote angiogenesis and bone regeneration. The coating amount of BMP is 10-20 μg / cm 2 .
[0052] Among them, bone morphogenetic protein is a kind of protein belonging to transforming growth factor-β (TGF-β) superfamily. BMPs can induce undifferentiated mesenchymal stem cells to differentiate into osteocytes and chondrocytes, thereby initiating and guiding the process of bone formation.
[0053] The specific steps of chemical modification of the nanofiber surface are as follows:
[0054] First, a nanofiber scaffold composed of polylactic acid-glycolic acid (PLGA) and silk fibroin is prepared by electrospinning technology. The nanofiber is washed with anhydrous ethanol to remove surface impurities and unreacted molecules;
[0055] The cleaned nanofiber is placed in a plasma treatment device for plasma activation treatment;
[0056] The activated nanofiber is immersed in acrylic acid, and the molecules are grafted onto the surface of the fiber through free radical polymerization;
[0057] Glutaraldehyde is used to further crosslink the grafted molecules to enhance their bonding force with the fiber surface;
[0058] The nanofibers are immersed in RGD peptides to coat the fiber surface by physical adsorption;
[0059] After the coating process, the nanofibers are washed with deionized water to remove unbound molecules and residual solvents.
[0060] The implantation steps of the composite biomaterial in a hernia repair surgery:
[0061] The composite biomaterial is sterilized and in sterile packaging, ready for use in surgery;
[0062] Make an incision of appropriate size on the patient's abdominal wall to expose the hernia defect area, assess the size and shape of the hernia defect, determine the area that needs to be implanted with the material, and deploy the composite biomaterial on the operating table, cut the appropriate shape and size according to the size of the defect;
[0063] Place the cut composite biomaterial at the hernia defect site using sterile forceps, and the antibacterial coating fits the hernia defect, so that the material fits the tissue without wrinkles or folds;
[0064] Use external anchoring structures and corresponding tools to fix the composite biomaterial to the surrounding healthy tissue, confirm that the material is in the correct position without displacement, and covers the entire defect area, and close the skin incision according to the routine surgical procedure.
[0065] Experimental Example One
[0066] Purpose of the experiment: To evaluate the mechanical properties of nanofiber scaffolds made of polylactic acid-glycolic acid and silk fibroin composite;
[0067] Experimental materials: PLGA and silk fibroin composite nanofiber scaffolds as the experimental group, pure PLGA nanofiber scaffolds as the control group, and pure silk fibroin nanofiber scaffolds as the control group.
[0068] Tensile test: Prepare nanofiber scaffolds of three different materials, with at least five samples for each material.
[0069] Use a universal testing machine to perform tensile testing on the samples, set the tensile speed to 5 mm / min, record the maximum force at the time of sample fracture and the original width and thickness of the sample, and calculate the tensile strength (MPa) = maximum force (N) / (original width (mm) * thickness (mm)).
[0070] Experimental results: The tensile strength of the experimental group nanofiber scaffold is 20 MPa, which is significantly higher than that of the pure PLGA control group (15 MPa) and the pure silk fibroin control group (10 MPa).
[0071] Elastic Modulus Test: In the tensile test, the ratio of stress to strain of the sample before the yield point is recorded.
[0072] Experimental Results: The elastic modulus of the experimental group of nanofiber scaffolds is 500 MPa, which is better than the 300 MPa of the pure PLGA control group and the 200 MPa of the pure silk fibroin control group.
[0073] Tear Strength Test: The tear test is performed on the sample using a tear tester, and the force required to tear the sample is recorded.
[0074] Experimental Results: The tear strength of the experimental group of nanofiber scaffolds is 30 N, which is higher than the 25 N of the pure PLGA control group and the 20 N of the pure silk fibroin control group.
[0075] Fatigue Test: The sample is subjected to cyclic loading test using a fatigue testing machine, with a loading frequency of 5 Hz and a maximum stress of 50% of the material yield strength. The number of fractures of the sample under cyclic loading is recorded.
[0076] Experimental Results: The experimental group of nanofiber scaffolds did not fracture after 100,000 cycles of loading, while the control group began to fracture around 50,000 cycles.
[0077] From the above experimental examples, it can be seen that the nanofiber scaffold made of PLGA and silk fibroin composite is superior to the control group of single material in terms of tensile strength, elastic modulus, tear strength and fatigue durability, which proves that the composite biomaterial in the present application can withstand the stress of abdominal wall in hernia repair surgery and reduce the risk of hernia recurrence.
[0078] Experimental Example Two
[0079] Experimental Purpose: To evaluate the degradation behavior of the composite biomaterial in the present application in vivo and its effect on the surrounding tissue.
[0080] Experimental Preparation: Adult male Sprague-Dawley rats are selected as experimental models, and the composite biomaterial is implanted into the rat abdominal wall defect model. Sample collection is performed at four time points of 1, 3, 6 and 12 months after implantation.
[0081] Experimental Steps:
[0082] The abdominal wall defect surgery is performed on the rats, and the composite biomaterial is implanted into the defect, and then the wound is closed;
[0083] At each predetermined time point, the abdominal wall tissue sample containing the material is removed;
[0084] The collected sample is fixed, dehydrated, embedded and paraffin sectioned;
[0085] H&E staining was performed on the sections to observe inflammation, neovascularization, and collagen deposition;
[0086] Masson's trichrome staining was used to evaluate the distribution and maturity of collagen fibers;
[0087] Scanning electron microscopy was used to observe the microstructure changes on the material surface, and micro-computed tomography was used to evaluate the three-dimensional structural changes of the material in vivo.
[0088]
[0089]
[0090] Table 1 Sample collection table
[0091] In Table 1, the time point represents the time of sample collection, i.e. different months after implantation of the material; the observation index includes inflammation, material degradation rate, and concentration of inflammatory factors; the experimental group results record the observation results of the experimental group; the control group results record the observation results of the control group; the remarks provide a brief explanation of the results and the observed trends.
[0092] Experimental results: At 1 month after implantation, mild inflammation and neovascularization were observed, and at 3 months, the inflammation decreased and collagen fibers began to deposit. At 6 and 12 months, mature collagen fibers and vascular networks were observed, indicating good tissue healing.
[0093] The parts not involved in the present application are the same as or can be implemented using the prior art. Although embodiments of the present application have been shown and described, it is understood that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principles and spirit of the present application, and the scope of the present application is defined by the appended claims and their equivalents.
Claims
1. Use of a composite biomaterial in hernia repair surgery, characterized in that, Comprise: A nanofiber scaffold made of polylactic acid-glycolic acid and silk fibroin composite, wherein the weight ratio of polylactic acid-glycolic acid and silk fibroin is 70:30, the nanofiber scaffold is prepared by electrospinning technology, for providing mechanical support and promoting cell adhesion and proliferation; The fibers have a porous structure with a pore size of 10-100 μm; The nanofiber surface is chemically modified to enhance cell adhesion and biocompatibility.
2. Use of a composite biomaterial according to claim 1 in hernia repair surgery, characterized in that: The fiber diameter of the nanofiber scaffold is less than 500 nm.
3. Use of a composite biomaterial according to claim 1 in hernia repair surgery, characterized in that, Also comprising a gel layer made of a temperature-sensitive hydrogel and bioactive molecules, the thickness of the gel layer is 50-100 μm, prepared by solution phase separation method, for providing a protective layer at the early stage of surgery and gradually degrading during the healing process to release growth factors to promote tissue regeneration.
4. Use of a composite biomaterial according to claim 3 in hernia repair surgery, characterized in that: The temperature-sensitive hydrogel is poly(N-isopropylacrylamide) PNIPAM, and the bioactive molecules include one of vascular endothelial growth factor or fibroblast growth factor.
5. Use of a composite biomaterial according to claim 1 in hernia repair surgery, characterized in that, Also comprising an antibacterial coating coated on the nanofiber scaffold, which contains zinc nanoparticles inside, the size of the zinc nanoparticles is 20-50 nm, for reducing the risk of postoperative infection.
6. Use of a composite biomaterial according to claim 3 in hernia repair surgery, characterized in that, The gel layer is coated with bone morphogenetic protein for guiding cell behavior, promoting angiogenesis and bone regeneration, and the coating amount of the BMP is 10-20 μg / cm 2 .