High-stability dental implant and manufacturing method thereof

Abstract

This invention discloses a highly stable dental implant and its manufacturing method, belonging to the field of biomedical device manufacturing technology. This invention employs a combined design of three components: an implant support sleeve, an implant core, and a fastening nut (abutment), a structure completely different from any other implant product, domestic or international. Implant and abutment placement can be completed in a single surgery, shortening treatment time. The implant core's main function is to transfer most of the implant's force to the jawbone implant socket during tooth occlusion, increasing the implant's stress area and reducing stress on the surrounding threads and jawbone, thus improving implant stability and firmness. The other end of the implant core's cylindrical shape is threaded; after connecting with the fastening nut (abutment), the exposed threaded portion serves as the crown support sleeve. The fastening nut, tightened with a special wrench, serves as the crown abutment.

Description

Technical Field

[0001] This invention belongs to the field of biomedical device manufacturing technology, and more specifically relates to a highly stable dental implant and its manufacturing method. Background Technology

[0002] In the biomedical field, titanium alloys are increasingly widely used in dental implants due to their excellent biocompatibility. With the accelerating aging of China's population, the demand for dental implants is growing. Currently, domestic dental implants are mainly imported from South Korea, Germany, and Switzerland, and are made of pure titanium. The main problems currently exist. First, there is the issue of implant material. Pure titanium implants have relatively low strength, generally between 400-500 MPa. While this is acceptable for incisors and nearby incisors, it is clearly insufficient for the first, second, and third molars, which primarily perform chewing. During chewing, this leads to micro-deformation of the implant, which is the most significant reason for its reduced lifespan. Secondly, there's the issue of implant shape and structure. Currently, all implants are conical with threads on the surface, with the apex either rounded or slightly flattened. This is primarily to minimize the surgical incision during implantation. However, due to the small contact area between the implant and the jawbone, relying solely on the threads on the implant surface for fusion with the jawbone limits bone strength, resulting in poor implant stability. In contrast, natural progenitor teeth, especially the first, second, and third molars, have two or three columellar bases that fuse with the jawbone, providing excellent stability during chewing. Thirdly, most existing implants require two surgeries. The first surgery involves drilling a hole in the jawbone, installing the implant, and observing the success rate for about three months. The second surgery involves cutting open the gingival tissue covering the implant to install the crown abutment. The connection between the crown abutment and implant is mostly threaded, with a few using a tapered static fit. Both methods present uncertainties in the positioning of the crown abutment and crown. Since the forces on teeth during chewing are random and uneven, the forces on the implant also vary randomly, affecting its lifespan.

[0003] Therefore, how to develop a highly stable dental implant that improves the lifespan and success rate of implants and its manufacturing method are technical problems that urgently need to be solved by those skilled in the art. Summary of the Invention

[0004] In view of this, the present invention provides a highly stable dental implant and a method for manufacturing the same.

[0005] To achieve the above objectives, the present invention adopts the following technical solution:

[0006] A highly stable dental implant includes an implant support sleeve, an implant core, and a fastening nut;

[0007] The above-mentioned implant support sleeve is shaped like a frustum. The side of the frustum is provided with a thread for connecting with the jawbone. The shaft of the frustum is provided with a through hole. Three through sutures are evenly arranged along the generatrix at the circumference of the small diameter end of the frustum.

[0008] The implant core column described above is shaped like a cylinder with one end being a frustum II, the smaller diameter end of frustum II being fixedly connected to the bottom end of the cylinder, and the maximum diameter of frustum II being the same as the minimum diameter of frustum I; the other end of the cylinder is provided with thread II.

[0009] The aforementioned implant support sleeve is fitted onto the outside of the cylinder through a through hole. The inner surface of the through hole at the small diameter end of the aforementioned frustum is machined into frustum three, and the side of frustum three matches the side of frustum two.

[0010] The aforementioned fastening nut is elliptical in shape, with the minor diameter of the ellipse being greater than the maximum diameter of the first truncated cone. The internal thread of the aforementioned fastening nut mates with the second thread.

[0011] The beneficial effects of this invention: This invention adopts a combined design of three components: an implant support sleeve, an implant core, and a fastening nut (abutment), which is completely different from the structure of any implant product at home and abroad. Implant and abutment implantation can be completed in a single surgery, shortening treatment time.

[0012] The main function of the implant core is to transfer most of the force of the implant to the implant socket in the jawbone when the teeth bite food, thereby increasing the force-bearing area of ​​the implant, reducing the stress on the threads around the implant and the jawbone, and improving the stability and firmness of the implant.

[0013] The other end of the implant core cylinder is threaded, and after being connected to the fastening nut (abutment), the exposed threaded part serves as the crown support post.

[0014] After tightening the nut with a special wrench, it is used as the abutment for the crown.

[0015] Implant placement method and principle: Select a medical-grade drill bit of appropriate size to drill an implant socket in the jawbone, and then insert the assembled implant. Tighten the nut with a wrench to press the frustum at one end of the implant core into the implant support sleeve, causing the support sleeve to expand and deform, fitting very tightly against the wall of the jawbone implant socket. At this point, the shape of the implant support sleeve changes from a cone shape to a drum shape, significantly increasing the contact area and mechanical connection between the implant and the jawbone, which is beneficial for promoting bone tissue growth and increasing the success rate of implantation.

[0016] Furthermore, the maximum diameter of the first frustum is 6-8mm, the minimum diameter of the first frustum is 4-4.5mm, and the height of the first frustum is 10-20mm; the height of the second frustum is 2-3mm; the diameter of the cylinder is 2-4mm, and the height of the cylinder is 15-30mm; the height of the fastening nut is 2-4mm; the length of the second thread is 8-10mm; the minor diameter of the ellipse is 9-10mm, and the major diameter of the ellipse is 11-12mm.

[0017] The beneficial effects of adopting the above-mentioned further technical solutions are: facilitating the fastening operation during implantation surgery and improving the stability of the implant.

[0018] Furthermore, the height of the aforementioned through-slit accounts for one-fifth of the height of the first type of frustum.

[0019] The beneficial effects of adopting the above-mentioned further technical solutions are: ensuring that the through suture can be opened when the mandrel is tightened, so that the implant jawbone contact part expands and makes close contact with the implant socket wall.

[0020] Furthermore, the aforementioned implant support sleeve comprises the following components by weight percentage: O 0.28-0.32%, Fe 0.30-0.40%, and Ti balance.

[0021] The beneficial effects of adopting the above-mentioned further technical solutions are as follows: Since the implant support sleeve is in close contact with the jawbone, it is made of high-performance medical-grade pure titanium with good biocompatibility.

[0022] Furthermore, the materials of the implant core and fastening nut described above all contain the following components by weight percentage: Zr 13.00-17.00%, Ag 0.30-0.45%, Ti balance; impurity control range: O < 0.12%, N < 0.002%, H < 0.001%, C < 0.008%, Fe < 0.05%.

[0023] The beneficial effects of adopting the above-mentioned further technical solutions are as follows: Since the implant core and fastening nut are subjected to large forces and the composition of the medium in contact with the oral cavity is complex, they are made of high-strength and highly corrosion-resistant titanium-zirconium alloy.

[0024] This invention also provides a method for manufacturing the above-mentioned titanium-zirconium alloy dental implant, comprising the following steps:

[0025] (1) Design drawings;

[0026] (2) Digital modeling;

[0027] (3) Pure titanium rods are manufactured according to the above composition, and titanium alloy rods are manufactured according to the above composition;

[0028] (4) Laser cutting;

[0029] (5) High-precision CNC machining center processing;

[0030] (6) Precision grinding on CNC grinding machine;

[0031] (7) Polishing;

[0032] (8) Ultrasonic cleaning of implant support sleeve, implant core and fastening nut;

[0033] (9) Surface anodizing treatment;

[0034] (10) Testing, assembly, finished product.

[0035] The beneficial effects of this invention are as follows: by using digital machining, the implant support sleeve, implant core column and fastening nut (base) are subjected to oxygen polarization treatment, which further improves their corrosion resistance and biocompatibility. Attached Figure Description

[0036] Figure 1 Exploded view of a high-stability dental implant assembly;

[0037] Figure 2 A cross-sectional view of a highly stable dental implant;

[0038] Figure 3 A three-dimensional structural diagram of a high-stability dental implant when the fastening nut is not tightened.

[0039] Figure 4 A three-dimensional structural diagram of a dental implant after the fastening nut has been tightened to ensure stability.

[0040] Among them, 1-implant support sleeve, 2-implant core column, 3-fastening nut, 4-frustum one, 5-thread one, 6-through hole, 7-through slit, 8-cylinder, 9-frustum two, 10-thread two, 11-frustum three. Detailed Implementation

[0041] 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.

[0042] like Figure 1-4 As shown, a high-stability dental implant includes an implant support sleeve 1, an implant core 2, and a fastening nut 3;

[0043] The implant support sleeve 1 is shaped like a frustum 4. The side of the frustum 4 is provided with a thread 5 for connecting with the jawbone. The axis of the frustum 4 is provided with a through hole 6. Three through slits 7 are evenly arranged along the generatrix direction on the circumference of the small diameter end of the frustum 4.

[0044] The implant core column 2 is shaped like a cylinder 8 with one end being a frustum 2 9. The small diameter end of the frustum 2 9 is fixedly connected to the bottom end of the cylinder 8. The maximum diameter of the frustum 2 9 is the same as the minimum diameter of the frustum 4. The other end of the cylinder 8 is provided with a thread 2 10.

[0045] The implant support sleeve 1 is fitted onto the outside of the cylinder 8 through the through hole 6. The inner surface of the through hole 6 at the small diameter end of the frustum 1 4 is machined into frustum 3 11. The side of frustum 3 11 matches the side of frustum 2 9.

[0046] The fastening nut 3 is elliptical in shape, with the minor diameter of the ellipse being greater than the maximum diameter of the frustum 4. The internal thread of the fastening nut 3 mates with thread 10.

[0047] In one embodiment, the maximum diameter of frustum 4 is 6-8 mm, the minimum diameter of frustum 4 is 4-4.5 mm, and the height of frustum 4 is 10-20 mm; the height of frustum 9 is 2-3 mm; the diameter of cylinder 8 is 2-4 mm, and the height of cylinder 8 is 15-30 mm; the height of fastening nut 3 is 2-4 mm; the length of thread 10 is 8-10 mm; the minor diameter of ellipse is 9-10 mm, and the major diameter of ellipse is 11-12 mm.

[0048] In one embodiment, the height of the through slit 7 is one-fifth of the height of the frustum 4.

[0049] In one embodiment, the implant support sleeve 1 comprises the following components by weight percentage: O 0.28-0.32%, Fe 0.30-0.40%, and Ti balance.

[0050] In one embodiment, the materials of the implant core 2 and the fastening nut 3 both comprise the following components by weight percentage: Zr 13.00-17.00%, Ag 0.30-0.45%, Ti balance; impurity control range: O < 0.12%, N < 0.002%, H < 0.001%, C < 0.008%, Fe < 0.05%.

[0051] A method for manufacturing titanium-zirconium alloy dental implants includes the following steps:

[0052] (1) Design drawings;

[0053] (2) Digital modeling;

[0054] (3) Manufacture pure titanium rods according to the composition, and manufacture titanium alloy rods according to the composition;

[0055] (4) Laser cutting;

[0056] (5) High-precision CNC machining center processing;

[0057] (6) Precision grinding on CNC grinding machine;

[0058] (7) Polishing;

[0059] (8) Ultrasonic cleaning of implant support sleeve 1, implant core column 2 and fastening nut 3;

[0060] (9) Surface anodizing treatment;

[0061] (10) Testing, assembly, finished product.

[0062] In this embodiment of the invention, medical pure titanium rods are manufactured through a process of forging → hot rolling → radial forging → cold drawing → heat treatment → polishing → finished product, using both hot and cold working techniques.

[0063] 1. The production process of zirconium-silver master alloy is as follows:

[0064] Sponge zirconium (Zr > 99.9%) + silver powder (Ag > 99.90%) are mixed and placed into the vacuum electron beam furnace feed box. The vacuum electron beam furnace is then evacuated. The zirconium-silver alloy ingot is melted under high vacuum. The intermediate alloy ingot is cooled in the furnace under high vacuum. The intermediate alloy ingot is removed from the furnace at room temperature after the vacuum is broken. The composition of the intermediate alloy is analyzed. The intermediate alloy ingot is machined to particles (or shaved). The ingot is then tested, packaged, and ready for use.

[0065] 2. The production process of titanium alloy ingots is as follows:

[0066] Sponge titanium (GB0 grade or above) + sponge zirconium (1 grade or above) + zirconium-silver master alloy mixing — hydraulic press extrusion of titanium alloy consumable electrode blocks — vacuum welding box assembly of titanium alloy consumable electrodes — vacuum consumable furnace primary melting — ingot cooling and unloading from the furnace — machining of the head, tail and surface of the primary consumable ingot — assembly of secondary consumable electrodes — vacuum consumable furnace secondary melting — argon-assisted cooling of titanium alloy ingot — ingot room temperature vacuum breaking and unloading from the furnace — machining of the head and tail of the ingot and peeling of the ingot surface — alloy composition and impurity analysis by sampling five points at the top, middle and bottom of the ingot — testing and storage for future use;

[0067] 3. The manufacturing process of titanium alloy bars is as follows:

[0068] Titanium alloy ingot electric furnace heating — hydraulic high-speed forging machine free forging billet opening — billet grinding — sawing and blanking — three or more hydraulic high-speed forging machine uplift forging — rough billet grinding — radial forging machine precision forging of bar — grinding bar surface — hot rolling mill rolling of fine bar — peeling and grinding bar surface — proprietary patented technology warm drawing — bar straightening — bar polishing — mechanical property testing, microstructure testing — surface quality testing and flaw detection — dimensional specifications and tolerance testing — packaging and warehousing;

[0069] Opening temperature: 1100-1150℃;

[0070] Precision forging temperature: 930-980℃;

[0071] Hot rolling temperature: 950-980℃;

[0072] Wintrade temperature: 600-800℃;

[0073] Tissue control: The alloy is an α-structure titanium alloy, and the grain size is controlled at or above level 3 of the international medical titanium alloy standard.

[0074] 4. Antibacterial treatment process:

[0075] Mechanical processing of implants: cleaning of finished products – placement in a vacuum heat treatment furnace – vacuuming – heating to 450-650℃ – heat preservation for >8 hours – cooling and removal from the furnace – inspection and packaging.

[0076] 5. Corrosion resistance test of titanium alloy;

[0077] Sulfuric acid: Concentration 3-5%; Temperature: Room temperature; Time: 180 days; Corrosion rate: <0.01mm / year;

[0078] Hydrochloric acid: Concentration 1-5%; Temperature: Room temperature; Time: 180 days; Corrosion rate: <0.01mm / year;

[0079] Acetic acid: Concentration 7-9%; Temperature: Room temperature; Time: 180 days; Corrosion rate: <0.001mm / year;

[0080] Salt water concentration: 5-15%; Temperature: room temperature; Time: 180 days; Corrosion rate: <0.001mm / year;

[0081] Soda ash solution; concentration 3-5%; temperature: room temperature; time: 180 days; corrosion rate: <0.001mm / year;

[0082] 6. Antibacterial test;

[0083] An antibacterial test was commissioned to a hospital in Shenyang. The results showed that the inactivation rate of three common anaerobic bacteria in the gingival and periodontal tissues was >90%.

[0084] Example 1

[0085] A high-stability incisor implant, comprising an implant support sleeve 1, an implant core 2, and a fastening nut 3;

[0086] The implant support sleeve 1 is shaped like a frustum 4. The side of the frustum 4 is provided with a thread 5 for connecting with the jawbone. The axis of the frustum 4 is provided with a through hole 6. Three through slits 7 are evenly arranged along the generatrix direction on the circumference of the small diameter end of the frustum 4.

[0087] The implant core column 2 is shaped like a cylinder 8 with one end being a frustum 2 9. The small diameter end of the frustum 2 9 is fixedly connected to the bottom end of the cylinder 8. The maximum diameter of the frustum 2 9 is the same as the minimum diameter of the frustum 4. The other end of the cylinder 8 is provided with a thread 2 10.

[0088] The implant support sleeve 1 is fitted onto the outside of the cylinder 8 through the through hole 6. The inner surface of the through hole 6 at the small diameter end of the frustum 1 4 is machined into frustum 3 11. The side of frustum 3 11 matches the side of frustum 2 9.

[0089] The fastening nut 3 is elliptical in shape, with the minor diameter of the ellipse being greater than the maximum diameter of the frustum 4. The internal thread of the fastening nut 3 mates with thread 10.

[0090] The height of the through seam 7 is one-fifth of the height of the frustum 4.

[0091] The implant core 2 and the fastening nut 3 are both made of the following composition by weight percentage: Zr 15.02%, Ag 0.31%, and Ti balance.

[0092] Mechanical properties: σb 980MPa, δ 20%.

[0093] Mechanical properties of processed materials

[0094] σb1050-1200MPa

[0095] σ 0.2990-1030MPa

[0096] δ18-22%

[0097] Ψ21-28%

[0098] The implant support sleeve 1 comprises the following components by weight percentage: O 0.28%, Fe 0.30%, Ti balance. Mechanical properties: σb 550MPa, δ 30%.

[0099] Example 2

[0100] A highly stable dental implant, comprising an implant support sleeve 1, an implant core 2, and a fastening nut 3;

[0101] The implant support sleeve 1 is shaped like a frustum 4. The side of the frustum 4 is provided with a thread 5 for connecting with the jawbone. The axis of the frustum 4 is provided with a through hole 6. Three through slits 7 are evenly arranged along the generatrix direction on the circumference of the small diameter end of the frustum 4.

[0102] The implant core column 2 is shaped like a cylinder 8 with one end being a frustum 2 9. The small diameter end of the frustum 2 9 is fixedly connected to the bottom end of the cylinder 8. The maximum diameter of the frustum 2 9 is the same as the minimum diameter of the frustum 4. The other end of the cylinder 8 is provided with a thread 2 10.

[0103] The implant support sleeve 1 is fitted onto the outside of the cylinder 8 through the through hole 6. The inner surface of the through hole 6 at the small diameter end of the frustum 1 4 is machined into frustum 3 11. The side of frustum 3 11 matches the side of frustum 2 9.

[0104] The fastening nut 3 is elliptical in shape, with the minor diameter of the ellipse being greater than the maximum diameter of the frustum 4. The internal thread of the fastening nut 3 mates with thread 10.

[0105] The height of the through seam 7 is one-fifth of the height of the frustum 4.

[0106] The implant core 2 and the fastening nut 3 are both made of the following composition by weight percentage: Zr 16.10%, Ag 0.30%, Ti balance.

[0107] Mechanical properties: σb 990 MPa, δ 18%.

[0108] Mechanical properties of processed materials

[0109] σb1050-1200MPa

[0110] σ 0.2990-1030MPa

[0111] δ18-22%

[0112] Ψ21-28%

[0113] The implant support sleeve 1 comprises the following components by weight percentage: O 0.30%, Fe 0.35%, and Ti balance.

[0114] Mechanical properties: σb 588 MPa, δ 32%.

[0115] Example 3

[0116] A highly stable dental implant, comprising an implant support sleeve 1, an implant core 2, and a fastening nut 3;

[0117] The implant support sleeve 1 is shaped like a frustum 4. The side of the frustum 4 is provided with a thread 5 for connecting with the jawbone. The axis of the frustum 4 is provided with a through hole 6. Three through slits 7 are evenly arranged along the generatrix direction on the circumference of the small diameter end of the frustum 4.

[0118] The implant core column 2 is shaped like a cylinder 8 with one end being a frustum 2 9. The small diameter end of the frustum 2 9 is fixedly connected to the bottom end of the cylinder 8. The maximum diameter of the frustum 2 9 is the same as the minimum diameter of the frustum 4. The other end of the cylinder 8 is provided with a thread 2 10.

[0119] The implant support sleeve 1 is fitted onto the outside of the cylinder 8 through the through hole 6. The inner surface of the through hole 6 at the small diameter end of the frustum 1 4 is machined into frustum 3 11. The side of frustum 3 11 matches the side of frustum 2 9.

[0120] The fastening nut 3 is elliptical in shape, with the minor diameter of the ellipse being greater than the maximum diameter of the frustum 4. The internal thread of the fastening nut 3 mates with thread 10.

[0121] The height of the through seam 7 is one-fifth of the height of the frustum 4.

[0122] The implant core 2 and the fastening nut 3 are both made of the following composition by weight percentage: Zr 16.30%, Ag 0.33%, Ti balance.

[0123] Mechanical properties: σb 1020 MPa, δ 19%.

[0124] Mechanical properties of processed materials

[0125] σb1050-1200MPa

[0126] σ0.2 990-1030MPa

[0127] δ18-22%

[0128] Ψ21-28%

[0129] The implant support sleeve 1 comprises the following components by weight percentage: O 0.29%, Fe 0.36%, and Ti balance.

[0130] Mechanical properties: σb 590MPa, δ 32%.

[0131] The description of the disclosed embodiments enables those skilled in the art to make or use the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A dental implant, characterized in that Includes implant support sleeve, implant core, and fastening nut; The implant support sleeve is shaped like a frustum. The side of the frustum is provided with a thread for bonding with the jawbone. A through hole is provided at the axis of the frustum. Three through slits are evenly arranged along the generatrix at the circumference of the small diameter end of the frustum. The implant core column is shaped like a cylinder with one end being a frustum II, the smaller diameter end of frustum II being fixedly connected to the bottom end of the cylinder, and the maximum diameter of frustum II being the same as the minimum diameter of frustum I; the other end of the cylinder is provided with thread II. The implant support sleeve is fitted onto the outside of the cylinder through a through hole. The inner surface of the through hole at the small diameter end of the frustum is machined into frustum three, and the side of frustum three matches the side of frustum two. The fastening nut is elliptical in shape, with the minor diameter of the ellipse being greater than the maximum diameter of the first frustum. The internal thread of the fastening nut mates with the second thread. After being tightened with a special wrench, the fastening nut is used as the base of a dental crown. The first frustum has a maximum diameter of 6-8 mm, a minimum diameter of 4-4.5 mm, and a height of 10-20 mm; the second frustum has a height of 2-3 mm; the cylinder has a diameter of 2-4 mm and a height of 15-30 mm; the fastening nut has a height of 2-4 mm; the second thread has a length of 8-10 mm; the ellipse has a minor diameter of 9-10 mm and a major diameter of 11-12 mm. The implant support sleeve comprises the following components by weight percentage: O 0.28-0.32%, Fe 0.30-0.40%, and Ti balance; The implant core and fastening nut are both made of the following components by weight percentage: Zr 13.00-17.00%, Ag 0.30-0.45%, Ti balance; impurity control range: O < 0.12%, N < 0.002%, H < 0.001%, C < 0.008%, Fe < 0.05%.

2. The dental implant of claim 1, wherein The height of the through seam is one-fifth of the height of the frustum.

3. A method of manufacturing a dental implant according to any one of claims 1-2, characterized in that, Includes the following steps: (1) Design drawings; (2) Digital modeling; (3) Titanium alloy rods are manufactured according to the composition described in claim 1; (4) Laser cutting; (5) High-precision CNC machining center processing; (6) Precision grinding on a CNC grinding machine; (7) Polishing; (8) Ultrasonic cleaning of implant support sleeve, implant core and fastening nut; (9) Surface anodizing treatment; (10) Testing, assembly, finished product.

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