Process for manufacturing a single-piece medical oral implant abutment

Abstract

The application discloses a kind of single-section medical oral implant dental nail manufacturing process, comprising the following steps: incoming material preparation, select medical titanium alloy as raw material;Machining forming, titanium alloy raw material is integrated into single-section screw-shaped nail body, the surface of nail body is treated in machining process to improve friction, and nail body thread is processed into irregular honeycomb structure;Oxidation post-processing, vacuum high-temperature oxidation treatment is carried out to the dental nail of machining forming, and dense oxide film is formed on the surface;Sand blasting treatment, medical-grade inorganic particles are used to accurately sandblast the surface of dental nail, and micro rough topography is constructed.Using single-section integrated structure, one-time forming, one-time operation is realized to complete repair;Thread uses irregular honeycomb topography, improves mechanical locking;Surface uses three-level composite processing of rolling / etching, oxidation and sand blasting, micro-nano composite topography is constructed, and bone conduction is improved;It can be adapted to different diameter, length, bone density scene, and has strong versatility.

Description

Technical Field

[0001] This invention belongs to the field of dental implant restoration medical device manufacturing technology, specifically relating to a manufacturing process for a single-segment medical dental implant staple. Background Technology

[0002] Dental implant restoration has become the mainstream method for restoring missing teeth. Its core component is the implant, which achieves retention and functional support through osseointegration with the jawbone. With increasing clinical demands, the structural design, manufacturing process, and surface treatment of the implant directly determine the osseointegration efficiency, initial stability, and long-term success rate.

[0003] Most current mainstream clinical implants adopt a three-part structure, namely, the implant body, abutment, and crown are assembled separately. The relevant publicly available technologies are as follows: Chinese invention publication CN113729998B discloses a method for fabricating a dental implant. The method includes: generating a first dental implant using 3D printing; placing the first dental implant in a polishing solution and stirring for 30-80 seconds, followed by cleaning, to generate a second dental implant; roughening the surface of the second dental implant and cleaning it, to generate a third dental implant; anodizing the third dental implant and constructing a nanotube structure within it, to generate a fourth dental implant; depositing hydroxyapatite within the nanotubes of the fourth dental implant, to generate a fifth dental implant; and performing vacuum heat treatment on the fifth dental implant, to generate a sixth dental implant.

[0004] Existing technologies generally suffer from the following drawbacks: 1) Dental implants require multiple processing steps, multi-dimensional precision control, and multiple assembly processes, resulting in high processing costs and low yield rates; 2) The regular spiral pattern has a small bone contact area, a low coefficient of friction, insufficient initial stability, and a healing period of 3–6 months. 3) The surface treatment process is simple and lacks multi-level micro-morphology construction, resulting in weak osteoblast adhesion, proliferation and mineralization capabilities; 4) Clinically, two or even more surgeries are required, resulting in significant trauma, high risk of infection, and long treatment cycles for patients; 5) Micromovement of the implant can easily cause peri-implantitis, leading to failure of bone resorption and repair.

[0005] To address the aforementioned pain points, there is an urgent need in this field for an integrated, single-segment implant manufacturing process with a high-friction surface, honeycomb-shaped irregular threads, and multi-level surface modification, in order to achieve the comprehensive goals of simplified processing, efficient osseointegration, minimally invasive clinical procedures, and long-term stability. Summary of the Invention

[0006] The purpose of this invention is to provide a manufacturing process for a single-segment medical dental implant staple. Through integrated molding, irregular honeycomb threads, surface rolling reinforcement, high-temperature oxidation and precision sandblasting composite modification, it achieves the technical effects of simplified processing, improved osseointegration, enhanced stability and reduced clinical costs.

[0007] To solve the above-mentioned technical problems, the present invention is achieved through the following technical solution: A manufacturing process for a single-segment medical dental implant pin includes the following steps: (1) Material preparation: Medical titanium alloy is selected as raw material; (2) Machining: The titanium alloy raw material is integrated into a single-segment screw-shaped nail body. During the machining process, the surface of the nail body is strengthened to improve the friction, and the nail body thread is machined into an irregular honeycomb structure. (3) Post-oxidation treatment: Vacuum high-temperature oxidation treatment is performed on the machined dental studs to form a dense oxide film on the surface; (4) Sandblasting: Medical-grade inorganic particles are used to precisely sandblast the surface of the dental nail to create a micro-rough morphology.

[0008] Furthermore, the machining process is completed in one go using a five-axis CNC milling and turning center, resulting in a single-segment structure without splicing, assembly, or separate connecting parts. This single-segment integrated structure eliminates components such as the base and central screw, reducing the machining process from the traditional 12-18 steps to 6-8 steps, increasing machining efficiency by 50%, improving raw material utilization by 25%, and reducing production costs by 30%-50%. From a mechanical perspective, the overall structure has no stress concentration points, increasing fatigue strength by more than 20%.

[0009] Furthermore, the surface strengthening treatment is performed by roller burnishing or laser etching, with the cutting depth controlled at 0.2–0.3 mm and the feed rate controlled at 0.3–0.7 mm / r. During the machining process, the friction of the nail surface is intentionally increased by adjusting the tool processing parameters and the surface roller burnishing process, thereby enhancing the mechanical interlocking force with the bone tissue.

[0010] Furthermore, the irregular honeycomb-shaped thread is an asymmetric, discontinuous three-dimensional concave-convex structure with a pitch of 0.65–0.7 mm and a thread depth of 0.5–0.6 mm. The irregular honeycomb-shaped thread forms a three-dimensional interlaced microstructure, allowing bone tissue to grow into the gaps and create a mechanical fit. Compared to regular threads, the BIC value is increased by 50%–85%, the initial implantation torque is increased by 30%–50%, and the anti-rotation and anti-pull-out capabilities are significantly enhanced. Simultaneously, the honeycomb structure increases the specific surface area, providing more adhesion sites for osteoblasts and promoting bone matrix deposition and mineralization.

[0011] Furthermore, the vacuum oxidation treatment is performed at a temperature of 550–600℃ for 1.5–2 hours, resulting in an oxide film thickness of 1.5–2.5 μm. The machined dental studs are then placed in a vacuum oxidation furnace and held at 600℃ for 2 hours, forming a dense oxide film approximately 2 μm thick. This film exhibits high density, increases the corrosion resistance potential to above 0.4V, reduces metal ion release, and prevents tissue inflammation.

[0012] Furthermore, the sandblasting treatment uses alumina or zirconium oxide particles with a particle size of 30–50 μm, a sandblasting pressure of 0.25–0.3 MPa, and a sandblasting time of 20–30 seconds. By sandblasting the dental screw surface under a pressure of 0.25–0.3 MPa and optimizing the sandblasting time, the surface roughness is ultimately optimized to below Ra1.6, meeting the optimal growth morphology requirements for osteoblasts. This results in a cell adhesion rate increase of over 60%, a doubling of the bone integration rate, and improved surface biocompatibility.

[0013] Specifically, the surface roughness Ra of the dental studs produced by the aforementioned process is controlled within 1.2–1.6 μm, and the surface friction coefficient is not less than 0.65.

[0014] Specifically, the dental nails produced by the aforementioned process have an osseointegration rate of no less than 75% in animal implantation models after 4 weeks and a pull-out force of no less than 110N after 6 weeks.

[0015] Specifically, the medical titanium alloy is TC4, TC4ELI, or TA4 titanium alloy. The selection of medical titanium alloy as a raw material ensures that its biocompatibility and mechanical strength meet the standards for medical implant materials.

[0016] The present invention has the following beneficial effects: Employing a single-segment, integrated structure, eliminating the need for separate assembly, this implant achieves one-time molding and single-operative repair. The irregular honeycomb-like thread shape significantly increases the bone-implant contact area (BIC), enhancing mechanical locking. The surface undergoes a three-stage composite treatment of rolling / etching, oxidation, and sandblasting to create a micro-nano composite morphology, improving osteoconductivity. Precise and controllable process parameters allow for adaptation to different diameters, lengths, and bone densities, offering strong versatility. The single-segment structure eliminates the need for secondary surgery for implant retrieval and abutment installation, reducing surgical time by 40%. Patients experience less trauma and pain, a 70% reduction in infection risk, and a healing period shortened from 3–6 months to 6–8 weeks, enabling early weight-bearing and immediate implantation.

[0017] Of course, any product implementing this invention does not necessarily need to achieve all of the advantages described above at the same time. Detailed Implementation

[0018] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0019] Example 1 The selected material is TC4 titanium alloy rod with a diameter of φ4.0mm and a length of 15mm. Its chemical composition and mechanical properties meet the requirements of GB / T13810-2017 "Titanium and Titanium Alloy Processed Materials for Surgical Implants". It is free from cracks, inclusions and oxidation defects.

[0020] Machining Using a five-axis CNC milling and turning machining center, a single-segment nail body is formed in one go, with a total length of 13.5mm and a head with an internal hexagonal drive structure (2.5mm).

[0021] (1) Surface strengthening treatment: Surface is machined using a roller burnishing tool with a cutting depth of 0.25 mm and a feed rate of 0.3 mm / r to improve the surface friction coefficient; (2) Thread processing: Irregular honeycomb threads are processed using special forming tools with a pitch of 0.7 mm and a thread depth of 0.6 mm, forming a three-dimensional concave-convex micro-morphology.

[0022] Post-oxidation treatment The dental nail was placed in a vacuum oxidation furnace, evacuated to 5×10⁻³Pa, heated to 600℃, held at that temperature for 2 hours, and then cooled to room temperature with the furnace to form a dense TiO2 oxide film with a thickness of about 2.0μm on the surface.

[0023] Sandblasting Using medical-grade 50μm alumina particles, the sandblasting pressure was 0.3MPa, the sandblasting time was 30 seconds, and the distance was 10mm. After treatment, the surface roughness Ra was controlled at 1.4–1.6μm.

[0024] Example 2 It is made using a narrow-diameter, single-segment implant (TA4 titanium alloy). Material preparation The selected material is a medical-grade TA4 titanium alloy rod with a diameter of φ2.4mm and a length of 12mm, which meets the medical implantation standards.

[0025] Machining It is integrally formed by high-precision CNC lathe, with a total nail length of 10mm and a cross-slot drive structure at the head.

[0026] (1) Surface strengthening: Laser etching process is used to construct a micro-rough surface to improve friction; (2) Thread machining: Electrical discharge machining of irregular honeycomb threads with a pitch of 0.65 mm and a thread depth of 0.5 mm.

[0027] Post-oxidation treatment Vacuum oxidation temperature 550℃, holding time 1.5 hours, oxide film thickness approximately 1.5μm.

[0028] Sandblasting Using 30μm zirconium oxide particles, a pressure of 0.25MPa, and a time of 20 seconds, the surface roughness Ra≈1.2–1.4μm.

[0029] Example 3 The implant was fabricated using an immediate load-bearing, high-stability implant (TC4ELI). Material preparation It uses medical-grade TC4ELI ultra-low gap titanium alloy with a diameter of φ5.0mm, which has higher purity and better biocompatibility.

[0030] Machining The integrated single-section structure has a total length of 14mm. The thread adopts a double-lead irregular honeycomb structure and is reinforced by rolling and spiral groove composite treatment.

[0031] Post-oxidation treatment After holding at 580℃ for 1.8 hours, the oxide film thickness is approximately 2.2μm.

[0032] Sandblasting 40μm composite ceramic microspheres, 0.28MPa, 25 seconds, Ra≈1.3–1.5μm.

[0033] Comparative Example 1 Traditional three-section polished implant: It adopts a three-section structure with regular trapezoidal threads, and the surface is only polished, without oxidation or sandblasting.

[0034] Comparative Example 2 Single-segment regular thread with no surface reinforcement: It has a single-segment structure but the thread is a regular continuous thread, without rolling, oxidation, or sandblasting.

[0035] Summary table of test data (Table 1) Table 1

[0036] Experimental methods and conclusions Surface friction coefficient: tested using a friction and wear testing machine with a load of 5N and a speed of 1mm / s.

[0037] Bone-implant contact area (BIC): Analyzed using Micro-CT scanning and 3D reconstruction.

[0038] Implantation torque: A digital torque tester was used to implant the artificial bone model.

[0039] Bone integration rate: Quantitative analysis of hard tissue sections after 4 weeks of rabbit tibial implantation with staining.

[0040] Pull-out force: Universal testing machine, tensile speed 5mm / min.

[0041] Corrosion potential: Electrochemical workstation, ASTM F2129 standard.

[0042] Cellular assay: CCK-8 assay for osteoblast proliferation.

[0043] Experimental conclusion: This invention utilizes a composite process of single-segment integration, honeycomb threading, rolling reinforcement, oxidation, and sandblasting. It significantly outperforms traditional three-segment implants and conventional single-segment implants in terms of bone integration area, initial stability, bone integration rate, biocompatibility, and long-term reliability, demonstrating outstanding substantive features and significant progress.

[0044] The preferred embodiments of the present invention disclosed above are merely illustrative of the invention. These preferred embodiments do not exhaustively describe all details, nor do they limit the invention to the specific implementations described. Clearly, many modifications and variations can be made based on the content of this specification. This specification selects and specifically describes these embodiments to better explain the principles and practical applications of the invention, thereby enabling those skilled in the art to better understand and utilize the invention. The invention is limited only by the claims and their full scope and equivalents.

Claims

1. A manufacturing process for a single-segment medical dental implant staple, characterized in that, Includes the following steps: (1) Material preparation: Medical titanium alloy is selected as raw material; (2) Machining: The titanium alloy raw material is integrated into a single-segment screw-shaped nail body. During the machining process, the surface of the nail body is strengthened to improve the friction, and the nail body thread is machined into an irregular honeycomb structure. (3) Post-oxidation treatment: Vacuum high-temperature oxidation treatment is performed on the machined dental studs to form a dense oxide film on the surface; (4) Sandblasting: Medical-grade inorganic particles are used to precisely sandblast the surface of the dental nail to create a micro-rough morphology.

2. The manufacturing process of the single-segment medical dental implant screw according to claim 1, characterized in that, The medical titanium alloy is TC4, TC4ELI, or TA4 titanium alloy.

3. The manufacturing process of the single-segment medical dental implant screw according to claim 1, characterized in that, The machining process is completed in one go using a five-axis CNC milling and turning center. The nail body is a single-section structure without splicing, assembly, or separate connecting parts.

4. The manufacturing process of the single-segment medical dental implant screw according to claim 1, characterized in that, The surface strengthening treatment is performed by roller rolling or laser etching, with the cutting depth controlled at 0.2–0.3 mm and the feed rate controlled at 0.3–0.7 mm / r.

5. The manufacturing process of the single-segment medical dental implant screw according to claim 1, characterized in that, The irregular honeycomb thread is an asymmetrical, discontinuous three-dimensional concave-convex structure with a pitch of 0.65–0.7 mm and a thread depth of 0.5–0.6 mm.

6. The manufacturing process of the single-segment medical dental implant screw according to claim 1, characterized in that, The vacuum oxidation process is performed at a temperature of 550–600℃ for 1.5–2 hours, resulting in an oxide film thickness of 1.5–2.5 μm.

7. The manufacturing process of the single-segment medical dental implant screw according to claim 1, characterized in that, The sandblasting process uses alumina or zirconium oxide particles with a particle size of 30–50 μm, a sandblasting pressure of 0.25–0.3 MPa, and a sandblasting time of 20–30 seconds.

8. The manufacturing process of the single-segment medical dental implant screw according to claim 1, characterized in that, The surface roughness Ra of the dental studs produced by the above process is controlled at 1.2–1.6 μm, and the surface friction coefficient is not less than 0.

65.

9. The manufacturing process of the single-segment medical dental implant screw according to claim 1, characterized in that, The dental nails produced by the aforementioned process have an osseointegration rate of no less than 75% after 4 weeks and a pull-out force of no less than 110N after 6 weeks in animal implantation models.

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