Production process of titanium stent reinforced polylactic acid oral barrier film

Abstract

The invention discloses a production process of a titanium stent reinforced polylactic acid oral barrier film. The production process comprises the following steps: S01, cleaning and pretreating the surface of a titanium-based material; s02, the titanium-based material is cut through laser cutting equipment, and a titanium support structure is formed; s03, carrying out surface treatment on the cut and formed titanium bracket; s04, selecting a polylactic acid raw material, adding an additive, and fully and uniformly mixing; s05, fully plasticizing the mixed raw materials through an extruder, and extruding into a uniform film shape to obtain a polylactic acid film; s06, stretching the extruded polylactic acid film through stretching equipment; s07, coating the surface of the titanium bracket with the stretched polylactic acid film in a hot pressing or extruding manner; s08, the coated composite film is subjected to annealing treatment through an annealing furnace; s09, the composite film is cut through cutting equipment; s10, performing quality detection on the cut oral cavity barrier film; and S11, packaging and sealing the barrier film which is detected to be qualified.

Description

Technical Field

[0001] The invention relates to the technical field of oral barrier membrane production, in particular to a production process of a titanium stent reinforced polylactic acid oral barrier membrane. Background Art

[0002] Oral implant restoration technology was a major revolution in oral medicine in the last century. Its excellent retention and realistic aesthetics have greatly improved the quality of life and mental well-being of patients with tooth loss. The long-term success of dental implants depends on many factors, including the selection of the implant site, the morphology of soft and hard tissues, the integrity of the surrounding bone, and the amount of bone powder implanted. Dental implant technology has become a common method for restoring missing teeth. Clinically, due to physiological bone resorption after edentulism and bone tissue defects caused by traumatic edentulism, there are often cases of low, narrow, or locally depressed alveolar ridges. 40% to 80% of patients have insufficient bone mass, and lateral perforation often occurs during the implantation process, leading to implant failure. Oral biofilms are used to protect and repair damaged soft and hard tissues and promote healing. Oral biofilms include non-absorbable biofilms, absorbable biofilms, magnesium-based biofilms, and animal-derived oral biofilms.

[0003] Non-absorbable biomembranes have drawbacks: Non-absorbable membranes include polytetrafluoroethylene (ePTFE) and titanium-reinforced PTFE. They require a secondary surgery to remove the membrane material, which can cause mechanical damage to the new tissue and hinder its healing process. Furthermore, the gingival flap may not fully cover the new tissue after membrane removal, further increasing patient pain and cost.

[0004] The drawback of absorbable biofilms is that they include natural collagen membranes and artificial polymer membranes (including commonly used polylactic acid membranes and polyglycolic acid membranes). If the membrane is exposed, it cannot be removed, allowing infection to spread to the new tissue beneath the membrane.

[0005] The disadvantages of magnesium-based biofilms are: magnesium-based materials have good mechanical properties and are degradable in the human body, and can be used as a new generation of biological barrier membrane materials. However, they are still in the research and exploration stage, and there is no detailed clinical conclusion on the current shortcomings. Further research is needed to clarify their shortcomings.

[0006] Animal-derived oral biofilms have the following disadvantages: (1) Triggering immune rejection: Animal-derived biofilms are foreign to the human body and may trigger an immune response. The human immune system will recognize foreign biofilms and attempt to remove them, thereby triggering an immune rejection reaction, affecting the effectiveness of the biofilm and even causing adverse reactions such as local inflammation. For example, immune rejection often occurs in some allogeneic tissue transplants.

[0007] (2) Impact on immune regulation: Animal-derived oral biofilms may interfere with the local immune regulation mechanism of the oral cavity. There is a complex immune balance in the oral cavity. Foreign biofilms may disrupt this balance, causing immune cells to be overactivated or suppressed, thereby affecting the normal immune function of the oral cavity and increasing the risk of infection or other diseases.

[0008] (3) Carrying pathogens: Animal-derived biofilms may carry pathogens in the animal body, such as bacteria, viruses, fungi, etc. When these biofilms are applied to the human oral cavity, pathogens may enter the human body and cause infection. For example, some animals may carry specific bacteria that may not cause disease in the animal body but may be pathogenic to humans.

[0009] (4) Transmission of drug-resistant bacteria: Bacteria in animals may be drug-resistant. When animal-derived biofilms are introduced into the human oral cavity, these drug-resistant bacteria may colonize and spread in the oral cavity, leading to the spread of drug-resistant bacteria in the oral cavity and increasing the difficulty of subsequent treatment. For example, some strains of the genus Fusobacterium are drug-resistant. If they enter the human body with animal-derived biofilms, they may cause adverse effects.

[0010] (5) Significantly affected by the environment: Similar to ordinary biofilms, the performance of animal-derived oral biofilms may be significantly affected by environmental factors. Factors such as oral temperature, pH, and saliva composition may affect the structure and function of the biofilm. If the environmental conditions are not suitable, the biofilm may degenerate, necrotize, or fall off, thereby reducing its ability to protect and repair damaged tissues.

[0011] (6) Quality differences: Due to differences between individual animals, biofilms from different animal sources may vary greatly in quality and performance. This difference may lead to unstable therapeutic effects and increase uncertainty in clinical applications.

[0012] (7) Potential allergic reactions: Some people may be allergic to certain components in animal-derived biofilms and may experience allergic symptoms after use, such as rash, itching, difficulty breathing, etc. Severe allergic reactions may even be life-threatening.

[0013] (8) Ethical and legal issues: The use of animal-derived biofilms may involve ethical and legal issues. For example, the source and acquisition process of animals must comply with relevant ethical and legal regulations. If handled improperly, it may cause social controversy. Summary of the Invention

[0014] The purpose of the present invention is to provide a production process for a titanium stent reinforced polylactic acid oral barrier membrane to solve the problems raised in the above background technology.

[0015] To achieve the above-mentioned object, the present invention provides the following technical solution: a production process of a titanium stent reinforced polylactic acid oral barrier membrane, comprising the following steps: S01: Select high-quality titanium-based materials with a thickness of 0.1-0.15mm, clean and pre-treat the surface of the material to remove impurities, oil stains, etc. on the surface to ensure the quality of subsequent processing; The structure of the titanium stent is designed according to the characteristics of the teeth in different parts of the oral cavity and the fixation requirements of the barrier membrane; S02: Use high-precision laser cutting equipment to cut the titanium-based material according to the designed structural diagram. During the cutting process, strictly control the laser power, cutting speed, pulse frequency and other parameters to ensure that the cut titanium stent is of high precision and the size meets the design requirements; S03: Surface treatment of the cut and formed titanium stents, including pickling and passivation. Pickling can further remove the oxide layer and impurities on the stent surface, while passivation can form a stable oxide film on the stent surface, improving the corrosion resistance and biocompatibility of the titanium stent. S04: Select polylactic acid (PLA) raw materials with good biocompatibility and biodegradability. Strictly test the raw material's molecular weight (between 300,000 and 700,000) and glass transition temperature (GST) to ensure its quality meets production requirements. Based on the performance requirements of the barrier membrane, appropriately add growth factors and plant extracts to the PLA raw material and thoroughly mix them to improve the flexibility, strength, and processing properties of the PLA membrane. S05: The mixed raw materials are fed into the extruder and melt-extruded under appropriate temperature and pressure conditions. By controlling the extruder's screw speed, temperature distribution and other parameters, the polylactic acid raw materials are fully plasticized and extruded into a uniform film. S06: Use stretching equipment to stretch the extruded film to improve the film's orientation and mechanical properties. Control the stretching speed, ratio and other parameters to obtain a polylactic acid film with appropriate thickness and properties. S07: The prepared polylactic acid film is coated on the surface of the titanium stent by hot pressing or extrusion. During the coating process, it is necessary to ensure that the film and the titanium stent are tightly fitted and free of defects such as bubbles and wrinkles. The surface of the coated composite film is then coated with a halogenated BODIPY photosensitizer. Halogenated BODIPY photosensitizers play an important role in photodynamic therapy (PDT), a treatment method that uses photosensitizers to generate reactive oxygen species (ROS) under light to kill cancer cells. S08: placing the coated composite film into an annealing furnace for annealing treatment to eliminate internal stress, improve the stability and crystallinity of the film, and control the annealing temperature and time to achieve the best performance of the composite film; S09: According to the design requirements, use cutting equipment to cut the composite film into a suitable size and shape so that it has a quadrilateral or approximately quadrilateral outline, and set a fixing point at or near each corner; S10: Conduct comprehensive quality inspection on the cut oral barrier membranes, including appearance inspection, dimensional accuracy inspection, mechanical property test, biocompatibility test, etc. to ensure that each barrier membrane meets the relevant quality standards and usage requirements; S11: Package the barrier membranes that pass the test and seal them with sterile packaging materials. Label the packaging with information such as the product name, specifications, production date, and expiration date. Finally, sterilize the packaged products. Common sterilization methods include ethylene oxide sterilization and irradiation.

[0016] Compared with the prior art, the present invention has the following beneficial effects: Advantages of combining polylactic acid with growth factors: 1. Although polylactic acid itself has a certain ability to promote tissue repair, the addition of growth factors can better enable osteoblasts to attach, proliferate, and express their functions, thereby promoting new bone formation. For example, in alveolar bone regeneration, it can accelerate the repair and reconstruction of alveolar bone, improve treatment efficacy, and promote the growth and functional expression of osteoblasts; 2. Polylactic acid, as the base material of the barrier membrane, provides a physical barrier to prevent the gingival epithelium and connective tissue from contacting the root surface, while growth factors promote cell growth and tissue regeneration under the membrane. The combination of the two can enhance the comprehensive performance of the barrier membrane in guiding periodontal tissue regeneration and improve periodontal attachment. It may have a better effect on the repair of dental lesions such as vertical bone defects and furcation lesions, thereby enhancing the overall performance of the barrier membrane. Effects of adding plant extracts to polylactic acid oral barrier film: 1. Improved safety: The polylactic acid oral barrier membrane is prepared by extracting raw materials from plants, which is safer than traditional animal-extracted raw materials, ensuring the safety of patients during use.

[0017] 2. Enhanced clinical operation and degradation controllability: Polylactic acid itself has good biodegradability, and the addition of plant extracts may further optimize its degradation conditions and process. By optimizing multiple influencing factors such as temperature, humidity, and pH, the degradation rate of the polylactic acid oral barrier film can be better controlled, making it more suitable for clinical needs in the oral environment, ensuring the optimal growth of oral bone tissue, and maintaining the stable and long-lasting use of the implant.

[0018] 3. Promotes tissue regeneration and repair: Polylactic acid itself has certain biological activities that can promote cell proliferation and differentiation, which is beneficial to tissue regeneration and repair. Plant extracts often contain a variety of ingredients that are beneficial to the human body. The plant extracts added to the oral barrier membrane work synergistically with polylactic acid to further enhance the polylactic acid oral barrier membrane's ability to promote tissue regeneration and repair, thereby improving the effectiveness of oral repair.

[0019] 4. Improved Product Performance: Polylactic acid (PLA) possesses high mechanical strength and toughness, capable of withstanding certain external forces and meeting the requirements of oral restorative materials. The addition of plant extracts may further optimize its mechanical properties through interaction with PLA, enabling it to better serve as a barrier in the complex oral environment. PLA also has excellent processability. Without compromising this performance, the addition of plant extracts may also impart new properties to the product, such as improved molding quality.

[0020] 5. Enhanced Material Functionality: Adding plant extracts to polylactic acid (PLA) may imbue this biomaterial with new functionalities. For example, plant extracts with antioxidant properties can enhance the antioxidant performance of PLA products, extending their service life. Furthermore, the antibacterial properties of plant extracts may enhance the antibacterial properties of PLA, giving it advantages in fields such as medical and food packaging.

[0021] 6. Optimizing barrier membrane performance: During guided bone regeneration, a barrier membrane is required to create a closed space for bone tissue to heal. The presence of a titanium scaffold enhances the barrier membrane's support, enabling it to better maintain space in the bone defect area, avoiding compression of surrounding tissue, and facilitating bone tissue repair and regeneration.

[0022] 7. Improved stability: Compared to a single polylactic acid barrier membrane, the titanium stent reinforced polylactic acid barrier membrane is more stable. It can function more stably in the body and is less likely to deform or shift due to external forces or the influence of surrounding tissues, ensuring the reliability of the treatment effect.

[0023] 8. Reduce the failure rate of surgery: Since the titanium stent reinforced polylactic acid barrier membrane has sufficient strength and stability, it can effectively support the growth space of bone tissue, reducing the possibility of treatment failure and reoperation due to insufficient strength of the barrier membrane, and improving the success rate of the surgery.

[0024] 9. Improved patient experience: The biodegradable nature of polylactic acid avoids secondary surgery, while the high strength of the titanium stent ensures therapeutic efficacy. This combination reduces patient pain and financial burden while improving the safety and effectiveness of treatment, providing patients with a better treatment experience. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1It is a schematic diagram of the disassembled structure of the polylactic acid membrane and titanium bracket of the present invention.

[0026] In the accompanying drawings: 1, titanium stent; 2, polylactic acid membrane. DETAILED DESCRIPTION

[0027] The present invention will be described in further detail below with reference to the accompanying drawings and embodiments. Identical components are denoted by the same reference numerals. It should be noted that the terms "front," "rear," "left," "right," "upper," and "lower" used in the following description refer to directions in the accompanying drawings, while the terms "bottom," "top," "inner," and "outer" refer to directions toward or away from the geometric center of a particular component, respectively.

[0028] Example: See Figure 1 The present invention provides a technical solution: a production process of a titanium stent reinforced polylactic acid oral barrier membrane, comprising the following steps: S01: Select high-quality titanium-based materials with a thickness of 0.1-0.15mm, clean and pre-treat the surface of the material to remove impurities, oil stains, etc. on the surface to ensure the quality of subsequent processing; The structure of titanium stent 1 is designed based on the specific tooth positions in different parts of the mouth and the requirements for barrier membrane fixation. Using professional design software, a main stent and a secondary stent connected to the main stent in a bifurcated structure are designed. The secondary stent consists of a first branch structure and a second branch structure at a certain angle (e.g., 20-30 degrees), with the ends of the bifurcated structure located at or near the fixation site. Cross-branch structures can be added as needed to ensure the titanium stent has good stability and plasticity, forming a suitable structure, such as a "M" shape. S02: Use high-precision laser cutting equipment to cut the titanium-based material according to the designed structural diagram. During the cutting process, strictly control the laser power, cutting speed, pulse frequency and other parameters to ensure that the cut titanium stent is of high precision and the size meets the design requirements; S03: Surface treatment of the cut and formed titanium stents, including pickling and passivation. Pickling can further remove the oxide layer and impurities on the stent surface, while passivation can form a stable oxide film on the stent surface, improving the corrosion resistance and biocompatibility of the titanium stent. S04: Select polylactic acid (PLA) raw materials with good biocompatibility and biodegradability. Strictly test the raw material's molecular weight (between 300,000 and 700,000) and glass transition temperature (GST) to ensure its quality meets production requirements. Based on the performance requirements of the barrier membrane, appropriately add growth factors and plant extracts to the PLA raw material and thoroughly mix them to improve the flexibility, strength, and processing properties of the PLA membrane. Polylactic acid has good biodegradability. After use, it can be completely degraded by microorganisms in nature under specific conditions, ultimately producing carbon dioxide and water, without polluting the environment. In oral barrier membrane applications, it can gradually degrade after completing its functions such as guiding periodontal tissue regeneration, eliminating the need for secondary surgical removal, reducing mechanical damage to new tissues, pain, and costs for patients. Polylactic acid has good biocompatibility, can reduce the body's immune response to the barrier membrane, and is beneficial to the growth and repair of surrounding tissues. In the oral environment, it can reduce the probability of inflammatory response and create a good local environment for periodontal tissue regeneration; Polylactic acid has good mechanical and physical properties. It is easy to process and has good tensile strength and ductility. It can be produced by various common processing methods and can be made into barrier membrane shapes suitable for different parts of the oral cavity and lesions. It also has good gloss and transparency, which makes it easier for doctors to observe the condition of the underlying tissue during surgery. Polylactic acid film has excellent air, oxygen, and carbon dioxide permeability, and also has odor-isolating properties. It is also the only biodegradable plastic with excellent antibacterial and antifungal properties. In the moist and bacterial-prone environment of the oral cavity, it can reduce the risk of bacterial growth and infection, helping to maintain oral hygiene and the health of new tissue. Growth factors are a class of bioactive substances that can stimulate cell growth and repair. Adding growth factors to the oral barrier membrane can directly act on cells, promoting cell proliferation and differentiation, and accelerating wound healing. For example, they can encourage periodontal ligament cells with the ability to form new attachments to preferentially occupy the root surface, accelerating the formation of new cementum and the embedding of periodontal ligament fibers, thereby accelerating the regeneration of periodontal tissue. The mixing ratio of polylactic acid raw material, growth factor and plant extract is 95%:2%:3%; S05: The mixed raw materials are fed into the extruder and melt-extruded under appropriate temperature and pressure conditions. By controlling the extruder's screw speed, temperature distribution and other parameters, the polylactic acid raw materials are fully plasticized and extruded into a uniform film. S06: Using a stretching device to stretch the extruded film to improve the film's orientation and mechanical properties. The stretching speed, ratio, and other parameters are controlled to obtain a polylactic acid film 2 with suitable thickness and properties. S07: The prepared polylactic acid film 2 is coated on the surface of the titanium stent 1 by hot pressing or extrusion. During the coating process, it is necessary to ensure that the film and the titanium stent 1 are tightly fitted and free of defects such as bubbles and wrinkles. The surface of the coated composite film is then coated with a halogenated BODIPY photosensitizer. Halogenated BODIPY photosensitizers play an important role in photodynamic therapy (PDT), which is a treatment method that uses photosensitizers to generate reactive oxygen species (ROS) under light to kill cancer cells. S08: placing the coated composite film into an annealing furnace for annealing treatment to eliminate internal stress, improve the stability and crystallinity of the film, and control the annealing temperature and time to achieve the best performance of the composite film; S09: According to the design requirements, use cutting equipment to cut the composite film into a suitable size and shape so that it has a quadrilateral or approximately quadrilateral outline, and set a fixing point at or near each corner; S10: Conduct comprehensive quality inspection on the cut oral barrier membranes, including appearance inspection, dimensional accuracy inspection, mechanical property test, biocompatibility test, etc. to ensure that each barrier membrane meets the relevant quality standards and usage requirements; S11: Package the barrier membranes that pass the test and seal them with sterile packaging materials. Label the packaging with information such as the product name, specifications, production date, and expiration date. Finally, sterilize the packaged products. Common sterilization methods include ethylene oxide sterilization and irradiation.

[0029] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above and that the invention can be embodied in other specific forms without departing from the spirit or essential characteristics of the invention. Therefore, the embodiments should be considered in all respects as illustrative and non-restrictive, and the scope of the invention is defined by the appended claims, not the foregoing description, and all variations within the meaning and range of equivalents of the claims are intended to be included therein. Any reference sign in a claim should not be construed as limiting the claim to which it relates.

[0030] In the description of the present invention, unless otherwise specified, "plurality" means two or more; terms such as "upper," "lower," "left," "right," "inner," "outer," "front end," "rear end," "head," and "tail" indicate positions or relationships based on those shown in the accompanying drawings. These terms are intended solely to facilitate the description of the present invention and simplify the description. They do not indicate or imply that the devices or components referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limiting the present invention. Furthermore, terms such as "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0031] In the description of the present invention, it should be noted that, unless otherwise specified or limited, the terms "connected" and "connection" should be understood in a broad sense. For example, they can refer to fixed or detachable connections, mechanical or electrical connections, and direct or indirect connections through an intermediary. Those skilled in the art will understand the specific meanings of the above terms in the present invention.

Claims

1. The production process of titanium stent reinforced polylactic acid oral barrier membrane is characterized by: The following steps are involved: S01: Clean and pretreat the surface of titanium-based materials; S02: cutting the titanium-based material by laser cutting equipment to form the structure of the titanium stent (1); S03: performing surface treatment on the titanium stent (1) after cutting and forming; S04: Select polylactic acid raw material and add additives, and mix thoroughly; S05: fully plasticizing the mixed raw materials through an extruder and extruding them into a uniform film to obtain a polylactic acid film; S06: stretching the extruded polylactic acid film (2) using a stretching device; S07: coating the stretched polylactic acid film (2) on the surface of the titanium stent (1) by hot pressing or extrusion; S08: annealing the coated composite film in an annealing furnace; S09: cutting the composite film by a cutting device; S10: Perform quality inspection on the cut oral barrier film; S11: Package and seal the barrier films that have passed the inspection.

2. The production process of the titanium stent reinforced polylactic acid oral barrier membrane according to claim 1, characterized in that: The thickness of the titanium-based material is 0.1-0.15 mm.

3. The production process of the titanium stent reinforced polylactic acid oral barrier membrane according to claim 1, characterized in that: After the S07 process, a halogenated BODIPY photosensitizer is coated on the surface of the coated composite film.

4. The production process of the titanium stent reinforced polylactic acid oral barrier membrane according to claim 1, characterized in that: The molecular weight of the polylactic acid raw material is between 300,000 and 700,000.

5. The production process of the titanium stent reinforced polylactic acid oral barrier membrane according to claim 1, characterized in that: The additives are growth factors and plant extracts.

6. The production process of the titanium stent reinforced polylactic acid oral barrier membrane according to claim 5, characterized in that: The mixing ratio of the polylactic acid raw material, the growth factor and the plant extract is 95%:2%:3%.

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