Topologically optimized alloy ocular prosthesis structure

Abstract

The invention provides a topologically optimized alloy ocular prosthesis structure, and relates to the technical field of ocular prosthesis structures, the topologically optimized alloy ocular prosthesis structure comprises an ocular prosthesis table body and a positioning hole, and the ocular prosthesis table body is made of a titanium alloy material through a 3D printing technology; the shape of the alloy prosthetic eye is matched with the shape of a human body muscular cone cavity, and the alloy prosthetic eye comprises a base which is used for being fixedly implanted into an eye socket; micropores are formed in the surface of the ocular prosthesis table body and used for promoting tissue fibrosis and new blood vessel generation. The surface of the ocular prosthesis table body is subjected to anodic oxidation and electrochemical polishing, and the surface of the ocular prosthesis table body is coated with a bioactive coating; the drug sustained-release through holes are formed in the artificial eye table body and used for slowly releasing anti-inflammatory or antibacterial drugs, a Ti-6Al-4V or similar titanium alloy material is adopted, anodic oxidation and electrochemical polishing treatment are combined, a uniform and stable titanium oxide layer is formed, the biocompatibility of the artificial eye table is effectively improved, and tissue rejection reaction is reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of artificial eye structures, and in particular to a topologically optimized alloy artificial eye structure. Background Art

[0002] Traditional artificial eye bases are mostly made of materials such as hydroxyapatite, which have problems such as poor biocompatibility, insufficient antibacterial properties, and easy infection. With the development of 3D printing technology, titanium alloy has gradually become an ideal material for manufacturing artificial eye bases due to its excellent mechanical properties and biocompatibility. However, the existing titanium alloy artificial eye base still has room for improvement in structural design, surface treatment, and drug release. There is an urgent need for an alloy artificial eye structure with better performance and wider application. Summary of the invention

[0003] Technical issues solved

[0004] In view of the deficiencies in the prior art, the present invention provides a topologically optimized alloy artificial eye structure.

[0005] Technical Solution

[0006] To achieve the above objectives, the present invention is implemented through the following technical solutions: a topologically optimized alloy artificial eye structure, including an artificial eye platform body and a positioning hole, wherein the artificial eye platform body is made of titanium alloy material through 3D printing technology;

[0007] The alloy artificial eye has an appearance that is compatible with the shape of the human body's myoconical cavity, and the alloy artificial eye includes a base, which is used to fix the implant into the eye socket;

[0008] The surface of the artificial eye platform is provided with micropores for promoting tissue fibrosis and the generation of new blood vessels;

[0009] The surface of the artificial eye platform body is anodized and electrochemically polished, and the surface of the artificial eye platform body is coated with a bioactive coating;

[0010] A drug sustained-release through hole is provided inside the artificial eye platform body for slowly releasing anti-inflammatory or antibacterial drugs.

[0011] Preferably, the pore size of the microporous or porous structure is in the range of 50-300 microns.

[0012] Preferably, the surface of the alloy artificial eye base is treated by anodizing, and a titanium oxide layer with a thickness of 10 to 50 nanometers is formed on the surface of the alloy artificial eye base.

[0013] Preferably, anti-inflammatory drugs, including ibuprofen or dexamethasone, are pre-installed in the drug sustained-release through hole to slowly release the drugs after surgery to reduce inflammatory response.

[0014] Preferably, the base portion is provided with a locking device, preferably a screw.

[0015] Preferably, the artificial eye is provided with micro vents to promote oxygen exchange and prevent tissue necrosis.

[0016] Preferably, the surface of the artificial eye platform is coated with antibacterial materials, including silver nanoparticles or copper ion coatings, to prevent bacterial infection.

[0017] Beneficial Effects

[0018] The present invention provides a topologically optimized alloy artificial eye structure, which has the following beneficial effects:

[0019] 1. The present invention adopts Ti-6A l-4V or similar titanium alloy materials, combined with anodizing and electrochemical polishing treatment, to form a uniform and stable titanium oxide layer, which effectively improves the biocompatibility of the artificial eye and reduces tissue rejection.

[0020] 2. The present invention adopts a prosthetic eye base with micropores on its surface. Through the pore structure designed by topological optimization, it significantly promotes tissue fibrosis and the generation of new blood vessels, enhances the integration of the prosthetic eye base with surrounding biological tissues, and improves the stability and functionality of the implant. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 It is a schematic diagram of the structure of the artificial eye platform of the present invention;

[0022] Figure 2 This is the electron microscopic image of the experimental group one week after surgery of the present invention;

[0023] Figure 3 This is the electron microscopic image of the control group of the present invention one week after surgery;

[0024] Figure 4 This is the electron microscopic image of the experimental group 6 months after surgery;

[0025] Figure 5 This is an electron microscopic image of the control group of the present invention 6 months after surgery.

[0026] Legend:

[0027] 1. Prosthetic eye body; 2. Positioning hole; 3. Micropore; 4. Drug sustained release hole. DETAILED DESCRIPTION

[0028] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention. Specific embodiment one:

[0030] like Figure 1 As shown, a topologically optimized alloy artificial eye structure includes an artificial eye platform body 1 and a positioning hole 2, characterized in that: the artificial eye platform body 1 is made of titanium alloy material through 3D printing technology; the alloy artificial eye has an appearance that is adapted to the shape of the human myoconical cavity, and the alloy artificial eye includes a base, which is used to fix the implanted eye socket; the surface of the artificial eye platform body 1 is provided with micropores 3 for promoting tissue fibrosis and neovascularization; the surface of the artificial eye platform body 1 is anodized and electrochemically polished, and the surface of the artificial eye platform body 1 is coated with a bioactive coating; the artificial eye platform body 1 is provided with a drug sustained-release through hole 4 for slowly releasing anti-inflammatory or antibacterial drugs. The pore size range of the micropore 3 or the porous structure is 50-300 microns. The surface of the alloy artificial eye platform is treated by anodization, and a titanium oxide layer with a thickness of 10 to 50 nanometers is formed on the surface of the alloy artificial eye platform. Anti-inflammatory drugs, including ibuprofen or dexamethasone, are pre-placed in the drug sustained-release through hole 4 to slowly release drugs after surgery to reduce inflammatory reactions. The base portion is provided with a locking device, preferably a screw. There are micro-ventilations inside the artificial eye to promote oxygen exchange and prevent tissue necrosis. The surface of the artificial eye is coated with antibacterial materials, including silver nanoparticles or copper ion coatings, to prevent bacterial infection.

[0031] The alloy artificial eye is made of titanium alloy material through 3D printing technology, and the titanium alloy is Ti-6Al-4V or its similar alloy; the alloy artificial eye has an appearance that is adapted to the shape of the human body's myoconical cavity, and the alloy artificial eye includes a base, which is used to fix the implanted eye socket; the surface of the alloy artificial eye base is provided with micropores 3, which are used to promote tissue fibrosis and the formation of new blood vessels; the surface of the alloy artificial eye base is anodized and electrochemically polished, and the surface of the alloy artificial eye base is coated with a bioactive coating to improve its biocompatibility and antibacterial properties; the alloy artificial eye base is provided with a drug sustained-release through hole 4, which is used to slowly release anti-inflammatory or antibacterial drugs to reduce postoperative infection and inflammatory response. The pore size range of the micropore 3 or the porous structure is 50-300 microns. The surface of the alloy artificial eye base is treated with anodization, and a titanium oxide layer with a thickness of 10 to 50 nanometers is formed on the surface of the alloy artificial eye base. Anti-inflammatory drugs, including ibuprofen or dexamethasone, are pre-placed in the drug sustained-release through hole 4 to slowly release drugs after surgery to reduce inflammatory response. The base portion is provided with a locking device, preferably a screw. Micro-vents are provided in the artificial eye base to promote oxygen exchange and prevent tissue necrosis. The surface of the artificial eye base is coated with antibacterial materials, including silver nanoparticles or copper ion coatings, to prevent bacterial infection.

[0032] In terms of specific applications, the topologically optimized alloy artificial eye structure is mainly suitable for patients with orbital loss or dysfunction caused by trauma, disease or congenital defects. Through personalized design and 3D printing technology, the artificial eye platform that is highly consistent with the patient's orbital muscle cone cavity can be implanted to ensure postoperative stability and comfort. In addition, the structure is also suitable for orbital reconstruction surgery and cosmetic plastic surgery to improve facial beauty and patient quality of life. In terms of manufacturing process, firstly, the patient's orbital CT or MRI data is used to perform three-dimensional modeling using computer-aided design (CAD) software, and the topological optimization algorithm is used to optimize the structural strength and material utilization. Subsequently, high-purity Ti-6Al-4V titanium alloy powder is selected and manufactured using selective laser melting (SLM) or electron beam melting (EBM) 3D printing technology to ensure the high precision and density of the artificial eye platform. After printing, anodization is performed to form a titanium oxide layer 10 to 50 nanometers thick to enhance the corrosion resistance and biocompatibility of the surface, and then electrochemical polishing is performed to improve the surface finish and reduce bacterial attachment. Next, a bioactive coating (such as hydroxyapatite) and an antibacterial coating (silver nanoparticles or copper ion coating) are applied to further enhance the antibacterial performance and tissue fusion ability. The internal drug sustained-release through hole 4 is pre-set with anti-inflammatory drugs (such as ibuprofen or dexamethasone) to reduce the risk of postoperative inflammation and infection by slowly releasing the drugs.

[0033] Process control requirements include ensuring that the purity of titanium alloy materials meets the standards for medical implants, and strictly controlling the temperature, laser power, and scanning speed during 3D printing to ensure the density and surface quality of the artificial eye. The process parameters of anodizing and electrochemical polishing need to be precisely controlled to ensure the uniformity and thickness of the titanium oxide layer, as well as the surface finish that meets the expected standards. The coating process needs to ensure uniform coverage of bioactive coatings and antibacterial materials to avoid infection risks caused by weak areas.

[0034] In terms of surgical requirements, a detailed orbital structure assessment is required before surgery, accurate orbital data is obtained through imaging examinations, and a personalized implant plan is developed. During the operation, general anesthesia or local anesthesia is used, and the appropriate anesthesia method is selected according to the patient's condition. An appropriate incision is designed to expose the myoconal cavity to ensure the surgical field of view and operating space. The alloy artificial eye base is fixed in the orbit through the screw locking device of the base to ensure stability and avoid displacement. Strict anti-infection management is required after surgery, relying on the design of the drug sustained-release system. The drug will be slowly released after surgery to further reduce the risk of infection and inflammation. Regularly review the implantation status, observe the tissue reaction and the stability of the artificial eye base, and promptly deal with any complications, such as abnormal secretions or signs of infection on the surface of the artificial eye base, to ensure patient safety and the long-term stability of the implant.

[0035] In addition, the alloy artificial eye structure promotes tissue fibrosis and angiogenesis through micropores 3 and micro vents, enhances the bonding between the artificial eye and surrounding tissues, and effectively prevents bacterial infection through antibacterial material coating, significantly improving the biocompatibility and antibacterial properties of the artificial eye. The integration of the drug sustained-release system effectively controls the risk of postoperative inflammation and infection, and improves the clinical application value of the implant and the patient's postoperative quality of life. Specific embodiment 2:

[0037] A topologically optimized alloy artificial eye structure, the alloy artificial eye is made of titanium alloy material through 3D printing technology, the titanium alloy is Ti-6Al-4V or its similar alloy; the alloy artificial eye has an appearance that is adapted to the shape of the human myoconical cavity, and the alloy artificial eye includes a base, which is used to fix the implanted eye socket; the surface of the alloy artificial eye base is provided with micropores 3 for promoting tissue fibrosis and the generation of new blood vessels; the surface of the alloy artificial eye base is anodized and electrochemically polished, and the surface of the alloy artificial eye base is coated with a bioactive coating to improve its biocompatibility and antibacterial properties; the alloy artificial eye base is provided with drug sustained-release through holes 4 for slowly releasing anti-inflammatory or antibacterial drugs to reduce postoperative infection and inflammatory response. The pore size range of the micropores 3 or the porous structure is 50-300 microns. The surface of the alloy artificial eye base is treated with anodization, and a titanium oxide layer with a thickness of 10 to 50 nanometers is formed on the surface of the alloy artificial eye base. Anti-inflammatory drugs, including ibuprofen or dexamethasone, are pre-placed in the drug sustained-release through holes 4 to slowly release drugs after surgery to reduce inflammatory response. The base portion is provided with a locking device, preferably a screw. Micro-vents are provided in the artificial eye base to promote oxygen exchange and prevent tissue necrosis. The surface of the artificial eye base is coated with antibacterial materials, including silver nanoparticles or copper ion coatings, to prevent bacterial infection.

[0038] In terms of topological optimization, the alloy artificial eye structure adopts advanced computer-aided design (CAD) and finite element analysis (FEA) technology, and optimizes the internal structure of the artificial eye platform through the topological optimization algorithm. The main purpose of topological optimization is to minimize the use of materials while meeting the requirements of mechanical strength and biomechanics, thereby reducing the weight of the artificial eye platform and improving its compatibility and comfort with surrounding tissues. In the specific implementation process, firstly, according to the patient's orbital CT or MRI imaging data, an accurate three-dimensional model is generated, and the topological optimization software is input to set the boundary conditions and load conditions, the pressure distribution in the orbit and the mechanical stress that the artificial eye platform needs to bear. The topological optimization algorithm removes unnecessary material areas through iterative calculations, while retaining sufficient structural strength at key stress-bearing parts, and finally generates a lightweight and structurally reasonable artificial eye platform design. The optimized structure usually presents complex internal pores and support beams, which not only helps to reduce weight, but also enhances the rigidity and durability of the artificial eye platform. In addition, the pore structure in the topological optimization design is combined with the surface micropores 3, which further promotes tissue fibrosis and neovascularization, and improves the integration of implants with tissues in the body. Through topological optimization, the alloy artificial eye structure can achieve efficient material utilization and reduce material costs, while improving its mechanical properties and bioadaptability to ensure stability and safety during long-term implantation. Topological optimization also allows for personalized design, and customized shapes and internal structures of artificial eye bases can be customized according to the specific anatomical structures and needs of different patients to meet the requirements of personalized medicine. The entire topological optimization process requires strict control of design parameters and optimization goals to ensure that the generated structure is not only lightweight and strong, but also has good biocompatibility and antibacterial properties. Combined with the high-precision manufacturing capabilities of 3D printing technology, topological optimization design can be accurately implemented to ensure that each artificial eye base meets the design requirements, has excellent clinical application value and broad market prospects.

[0039] In terms of drug use, in addition to ibuprofen and dexamethasone, the drug sustained-release through hole 4 can also preset other drugs approved by the FDA (U.S. Food and Drug Administration) or NMPA (National Medical Products Administration) for human use, antibiotics (gentamicin, vancomycin), antifungal drugs (fluconazole), and growth factors (vascular endothelial growth factor VEGF) to target the postoperative needs and potential infection risks of different patients. The choice of drugs needs to be personalized according to the specific clinical situation and the patient's allergy history to ensure the best anti-infection and anti-inflammatory effects during postoperative recovery.

[0040] The arrangement of through holes can be varied and customized according to specific design requirements and topology optimization results. Through holes can be arranged in a regular grid, radially or randomly to optimize the uniformity and efficiency of drug release. Regular grid arrangement helps to achieve uniform drug distribution, radial arrangement can provide balanced drug release in different directions, and random distribution helps to prevent local excess or insufficient drug release. The size, depth and spacing of the through holes can also be adjusted according to the requirements of the drug release rate and the implantation site to achieve the best drug sustained release effect. In addition, the geometry of the through holes (circular, elliptical or polygonal) can also be optimized according to the requirements of drug release kinetics to further enhance the controllability and effect of drug release.

[0041] The fixed structure design of the artificial eye base is diverse. In addition to the screw locking device of the base part, other fixing methods can also be used, such as snap-on fixation, adhesive fixation or magnetic locking device. The snap-on fixation provides a stable fixation effect by interlocking the artificial eye base with the structure in the orbit; the adhesive fixation uses biocompatible adhesives to fix the artificial eye base in a predetermined position, which is suitable for occasions where mechanical fixation is not required; the magnetic locking device uses magnetic materials to achieve a seamless connection between the artificial eye base and the fixed structure, which is convenient for daily disassembly and replacement. In addition, the locking device of the base part can also be designed as a multi-point fixation to further enhance the stability of the implant and prevent displacement or loosening during daily activities. The choice of the fixing structure should be customized according to the patient's specific anatomical structure, living habits and surgical needs to ensure the stability and adaptability of the artificial eye base in different application scenarios.

[0042] In terms of manufacturing process, the realization of topological optimization design relies on high-precision 3D printing technology, selective laser melting (SLM) and electron beam melting (EBM), which can accurately control the deposition and melting process of materials to ensure that complex topological optimization structures can be accurately manufactured. In addition, post-processing processes such as heat treatment, surface roughening or coating application also need to be strictly controlled to maintain the mechanical properties and surface characteristics of the artificial eye. The heat treatment process needs to be controlled at a specific temperature and time to optimize the grain structure and mechanical properties of the titanium alloy; surface roughening treatment sandblasting or chemical corrosion can further increase the microporous structure of the surface and enhance the adhesion of the tissue; the coating application process needs to ensure the uniformity and adhesion of the coating to prevent the coating from falling off or wearing after implantation. Aseptic operation should be used in the manufacturing process to ensure the biosafety of the implant, and through strict quality control processes, X-ray detection, scanning electron microscope (SEM) analysis and mechanical strength testing, ensure that each artificial eye meets the design and performance standards.

[0043] In terms of surgical requirements, a detailed orbital structure assessment is required before surgery, accurate orbital data is obtained through imaging examinations (CT or MRI), and a personalized implant plan is developed. During the operation, general anesthesia or local anesthesia is used, and the appropriate anesthesia method is selected according to the patient's condition. An appropriate incision is designed to expose the myoconal cavity to ensure the surgical field of view and operating space. The alloy artificial eye base is fixed in the orbit through the screw locking device of the base to ensure stability and avoid displacement. During the operation, attention should be paid to protecting the surrounding tissues, avoiding excessive damage, and promoting postoperative recovery. Strict anti-infection management is required after surgery, relying on the design of the drug sustained-release system. The drug will be slowly released after surgery, further reducing the risk of infection and inflammation. Regularly review the implantation situation, observe the tissue reaction and the stability of the artificial eye base, and promptly deal with any complications. There are abnormal secretions or signs of infection on the surface of the artificial eye base to ensure patient safety and the long-term stability of the implant.

[0044] In addition, in order to further improve the functionality and adaptability of the artificial eye, an intelligent monitoring system can be introduced into the design. A micro sensor module is integrated inside the artificial eye to monitor the physiological parameters, temperature, pH value and concentration of inflammatory markers at the implant site in real time. These sensor data can be transmitted to medical devices through wireless transmission technology to achieve real-time postoperative monitoring, timely detection and treatment of potential complications, and further improve the safety of the implant and the quality of life of the patient. The sensor module should be made of biocompatible materials and have a miniaturized design to ensure that it will not affect the overall structure and function of the artificial eye.

[0045] In summary, the topologically optimized 3D printed titanium alloy artificial eye structure significantly improves the biocompatibility, antibacterial properties, mechanical properties and clinical adaptability of the artificial eye platform through optimized design, advanced manufacturing process, diversified drug use, flexible through-hole arrangement and diversified fixed structure design. Its personalized design and efficient material utilization not only meet the individual needs of different patients, but also have good market prospects and extensive clinical application value. The selection of all drugs meets the standards for human use, ensuring the safety and effectiveness of the implant, and further improving its reliability in clinical applications and the quality of life of patients after surgery.

[0046] During the technical research process, the following experiments were further conducted. The experimental data are shown in the attached figure. Figure 2-Figure 5 :

[0047] Samples: 18 adult New Zealand white rabbits of either sex were selected, with the left eye as the experimental group and the right eye as the control group. Enucleation of the left eye was performed, and the 3D-printed titanium alloy artificial eye socket was implanted in the myoconal cavity. The 18 rabbits were randomly divided into 6 groups, with 3 rabbits in each group. They were killed 1 week, 2 weeks, 1 month, 2 months, 3 months, and 6 months after surgery, respectively. Before killing, the implanted eye was observed for exposure of the artificial eye socket, purulent and abnormal secretions, and conjunctival and scleral tissues were obtained after killing, embedded in paraffin, and stored in electron microscope solution. HE staining and scanning electron microscopy were performed to observe whether there were residual metal particles, infiltration of inflammatory cells, fibrosis of the tissue surface in contact with the implant, and whether new blood vessels were formed.

[0048] Results: One week after surgery, the conjunctiva was red and swollen, and the rabbits had no abnormal behavior, no artificial orbit was exposed, and no abnormal secretions were found. One month after surgery, the redness and swelling improved compared with before. Six months after surgery, the conjunctiva was not red and swollen, and the artificial orbit was not exposed in the rabbits, and no acute toxic reaction occurred. HE staining showed that a large number of inflammatory cells and spindle-shaped fibroblasts were infiltrated in the conjunctiva and sclera on the side contacting the implant one week after surgery. Inflammatory cell infiltration and new blood vessels were seen one month after surgery, and no inflammatory cell infiltration was seen six months after surgery. Scanning electron microscopy showed that a large number of spiral fibers were formed one week after surgery, some inflammatory cells were seen, and no metal particles were left. Six months after surgery, bundles of collagen fibers were seen, no obvious inflammatory cells were seen, and no metal particles were left.

[0049] Conclusion: The 3D printed titanium alloy artificial eye socket is safe and stable in vivo, and can be used as a substitute for hydroxyapatite in clinical practice.

[0050] It should be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, the elements defined by the statement "comprising a reference structure" do not exclude the existence of other identical elements in the process, method, article or device including the elements.

[0051] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A topologically optimized alloy artificial eye structure, comprising an artificial eye platform body (1) and a positioning hole (2), characterized in that: The artificial eye platform body (1) is made of titanium alloy material by 3D printing technology; The alloy artificial eye has an appearance that is compatible with the shape of the human body's myoconical cavity, and the alloy artificial eye includes a base, which is used to fix the implant into the eye socket; The surface of the artificial eye socket body (1) is provided with micropores (3) for promoting tissue fibrosis and the generation of new blood vessels; The surface of the artificial eye socket body (1) is anodized and electrochemically polished, and the surface of the artificial eye socket body (1) is coated with a bioactive coating; The artificial eye platform body (1) is provided with a drug slow-release through hole (4) for slowly releasing anti-inflammatory or antibacterial drugs.

2. The topologically optimized alloy artificial eye structure according to claim 1, characterized in that: The pore size of the micropores (3) or porous structure is in the range of 50-300 microns.

3. The topologically optimized alloy artificial eye structure according to claim 1, characterized in that: The alloy artificial eye base is subjected to anodizing treatment to form a titanium oxide layer with a thickness of 10 to 50 nanometers on the surface of the alloy artificial eye base.

4. The topologically optimized alloy artificial eye structure according to claim 1, characterized in that: The drug sustained-release through hole (4) is pre-installed with an anti-inflammatory drug for slowly releasing the drug after surgery to reduce inflammatory reactions.

5. The topologically optimized alloy artificial eye structure according to claim 1, characterized in that: The base portion is provided with locking means, preferably screws.

6. The topologically optimized alloy artificial eye structure according to claim 1, characterized in that: The artificial eye base is provided with micro-ventilation holes for promoting oxygen exchange and preventing tissue necrosis.

7. The topologically optimized alloy artificial eye structure according to claim 1, characterized in that: The surface of the artificial eye platform is coated with antibacterial materials, including silver nanoparticles or copper ion coatings, to prevent bacterial infection.

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