Anti-fatigue nickel-titanium alloy rubber barrier clamp and manufacturing method thereof

Abstract

The invention relates to the technical field of oral medical instruments, and particularly discloses an anti-fatigue nickel-titanium alloy rubber barrier clamp and a manufacturing method thereof, and the manufacturing method of the rubber barrier clamp comprises the following steps: (1) preparing materials; (2) making a model; (3) investment casting; (4) heat treatment; and (5) post-treatment. Through synergistic improvement of materials and a process, stainless steel is replaced by nickel-titanium alloy to serve as a main body material; the manufacturing process is changed into precise investment casting from stainless steel stamping, and meanwhile, the super-hydrophobic treatment on the surface of the rubber barrier clip is combined, so that the obtained rubber barrier clip has the advantages that the comfort of a patient is improved, the service life is prolonged, and the precise adaptability and biocompatibility are excellent.

Description

Technical Field

[0001] The invention belongs to the technical field of oral medical devices, and particularly relates to a fatigue-resistant nickel-titanium alloy rubber dam clip and a manufacturing method thereof. Background Art

[0002] Oral rubber stamp clamps (rubber dam clamps) are commonly used auxiliary tools in dental treatment. They are mainly used to fix rubber dam cloth, isolate the treatment area, keep the surgical field dry and clear, and protect oral soft tissues and teeth. For example, the combined rubber dam clamp disclosed in patent CN117918969B adopts a clamping mechanism that can be detachably connected to each other, so that the rubber dam clamp can be flexibly switched between being adapted for a single tooth and being adapted for multiple adjacent teeth, thereby improving the matching degree for the dental treatment process. However, in clinical operation, the use of rubber dam clamps can cause pain to some patients. This is due to the principle of use of rubber dam clamps: rubber dam clamps mainly rely on two beaks to clamp the neck of the affected tooth to achieve fixation. Some rubber dam clamps have teeth on the beaks to increase the retention force. When using the rubber dam, the clamp must be pushed as far as possible towards the root direction, sometimes reaching the gingival edge or even below it. During this process, the hard metal of the two beaks of the rubber dam clamp may contact the patient's gums, the root surface, and directly contact and compress the oral mucosa, causing pain and discomfort, gingival bleeding, gingival attachment damage, or causing incisions in the cementum on the root surface.

[0003] In the existing technology, oral rubber stamp clips are mostly made of stainless steel through a stamping process, which has the following defects: 1. Excessive material rigidity: Stainless steel has a high elastic modulus, and excessive clamping force can easily cause discomfort to the patient's gums, and long-term use may cause the risk of tooth displacement; 2. Limited fatigue life: Metal fatigue fracture is prone to occur due to repeated opening and closing; 3. Process limitations: The stamping process is difficult to form complex curved surfaces, and the connection between the clamping end and the elastic arm needs to be welded, which poses a risk of stress concentration and fracture; 4. Insufficient biocompatibility: Long-term contact of stainless steel with oral tissue may cause allergic reactions in some patients. Summary of the Invention

[0004] In order to overcome the shortcomings of the above-mentioned prior art, the present invention adopts nickel-titanium alloy as the main material and changes the manufacturing process from stamping to precision investment casting. Through the synergistic improvement of this material and process, combined with the super-hydrophobic treatment of the surface of the rubber dam clip, it is made suitable for deformable nickel-titanium alloy, and finally a fatigue-resistant nickel-titanium alloy rubber dam clip is obtained.

[0005] In order to achieve the above object, the technical solution adopted by the present invention is:

[0006] In one aspect, the present invention provides a method for manufacturing a fatigue-resistant nickel-titanium alloy rubber dam clip, which specifically comprises the following steps:

[0007] (1) Material preparation: Select nickel-titanium alloy ingots; (2) Model making: Construct an individualized three-dimensional model based on CT data; (3) Investment casting: Melt and pour nickel-titanium alloy at 900-1200°C in an argon environment, and obtain a blank after cooling; (4) Heat treatment: First, subject the blank to solution treatment and then water quenching, and then to aging treatment to obtain a rough product; (5) Post-treatment: Electropolish the rough product, laser engrave the specification mark, and use a spray gun to spray the superhydrophobic mixed solution. After spraying, vacuum dry it for 10-40 minutes, take it out, and repeat the spraying operation until the thickness is 0.1-1 mm, thus obtaining a fatigue-resistant nickel-titanium alloy rubber dam clip.

[0008] In some embodiments, in step (1), the nickel content in the nickel-titanium alloy ingot is 50 to 60 at %.

[0009] In some embodiments, in step (4), the temperature of the solution treatment is 800 to 1000° C., and the time is 30 to 90 minutes.

[0010] In some embodiments, in step (4), the aging treatment is performed at a temperature of 300 to 600° C. and for a time of 80 to 160 minutes.

[0011] This application first eliminates casting defects through solution treatment, dissolves brittle phases such as Ti2Ni, homogenizes the structure, and improves residual stress generated by processing, thereby avoiding failure caused by stress concentration during service. It also lays the structural foundation for subsequent aging treatment. During aging treatment, the fine, uniform Ni4Ti3 phase maintains a coherent relationship with the matrix, hindering dislocation movement and significantly improving yield strength. After solution-aging treatment, the rubber dam clip has good elasticity, and the strain generated automatically recovers after stress unloading, providing a constant corrective force for oral treatment and reducing discomfort during tooth movement.

[0012] In some embodiments, in step (5), the super-hydrophobic mixed solution is prepared as follows:

[0013] At room temperature, functionalized polydimethylsiloxane is dissolved in isooctane, and under nitrogen protection, azobisisobutyronitrile and N,N-methylenebisacrylamide are added, followed by 2-hydroxypropyl methacrylate. The mixture is stirred at 70-90°C for 4-6 hours and cooled to room temperature to obtain a reaction solution. A crosslinker and a catalyst are then added to the reaction solution, and the mixture is stirred evenly to obtain a superhydrophobic mixed solution.

[0014] In some embodiments, the functionalized polydimethylsiloxane contains carbon-carbon double bonds.

[0015] In some embodiments, the mass ratio of the polydimethylsiloxane to 2-hydroxypropyl methacrylate is 1:(0.7-1.1).

[0016] The oral environment is complex, with saliva, microorganisms, temperature changes, and mechanical friction. This application uses superhydrophobic treatment on rubber dam clips to reduce bacterial colonization and dirt accumulation, reduce the risk of infection, and extend the life of the device. At the same time, the low friction of the superhydrophobic surface improves patient comfort. In addition, during the synthesis of the superhydrophobic mixed solution, the propyl segment in the 2-hydroxypropyl methacrylate selected in this application provides good flexibility and ductility, which is suitable for nickel-titanium alloy surfaces that need to adapt to deformation.

[0017] In some embodiments, in step (5), the working pressure of the spray gun is 0.1-0.4 MPa, and the distance between the nozzle of the spray gun and the surface of the structure is 20-30 cm.

[0018] On the other hand, the present invention provides a fatigue-resistant nickel-titanium alloy rubber dam clip obtained by the above-mentioned manufacturing method. The rubber dam clip is integrally formed from a nickel-titanium alloy ingot through an investment casting process, and includes a clamping end, an elastic arm and a connecting part. The inner surface of the clamping end is provided with anti-slip micro-grooves directly formed by casting.

[0019] In some embodiments, the thickness of the elastic arm is gradually distributed from the connecting portion to the clamping end in a range of 0.1-1.5 mm.

[0020] Compared with the prior art, the present invention has the following beneficial effects:

[0021] The present invention provides a fatigue-resistant nickel-titanium alloy rubber dam clip through the coordinated improvement of materials and processes. The material improvement is to replace stainless steel with nickel-titanium alloy as the main material, and utilize the superelastic properties of nickel-titanium alloy to make the clamping force softer and the recoverable deformation amount increased, thereby reducing the pressure on the gums; the process improvement is to change the manufacturing process from stainless steel stamping to precision investment casting, thereby realizing personalized curved surface design, matching the anatomical morphology of different tooth positions, and eliminating welding points through integrated casting; on this basis, the surface of the formed rubber dam clip is super-hydrophobic treated to reduce bacterial colonization and dirt accumulation, thereby reducing the risk of infection, and the super-hydrophobic surface has good flexibility and ductility, which is suitable for nickel-titanium alloys with a large deformation range, so that the final rubber dam clip has improved patient comfort, extended service life, precise adaptability, and excellent biocompatibility. DETAILED DESCRIPTION

[0022] The present invention will be described below in conjunction with specific embodiments. It should be noted that the following examples are illustrative of the present invention and are intended only to illustrate the present invention and are not intended to limit the present invention. Other combinations and various modifications within the scope of the present invention may be made without departing from the spirit or scope of the present invention.

[0023] It is worth noting that the raw materials used in the following preparation examples and embodiments, unless otherwise specified, were obtained from any commercially available manufacturer:

[0024] Polydimethylsiloxane model is XIAMETER TM RBG-0614.

[0025] Preparation Example 1

[0026] The preparation steps of super-hydrophobic mixed solution A are as follows:

[0027] At room temperature, 10 g of polydimethylsiloxane was dissolved in 1.5 L of isooctane. Under nitrogen protection, 0.09 g of azobisisobutyronitrile and 0.135 g of N,N-methylenebisacrylamide were added, followed by 9 g of 2-hydroxypropyl methacrylate. The mixture was stirred at 80°C for 5 h and cooled to room temperature to obtain a reaction solution. 7.6 g of TEOS and 0.76 g of DEBTDL were then added to the reaction solution and stirred evenly to obtain a superhydrophobic mixed solution A.

[0028] Preparation Example 2

[0029] The preparation steps of superhydrophobic mixed solution B are different from those of Preparation Example 1 in that 2-hydroxypropyl methacrylate is replaced by an equal amount of 2-hydroxyethyl methacrylate.

[0030] Preparation Example 3

[0031] The preparation steps of super-hydrophobic mixed solution C are as follows:

[0032] At room temperature, 10 g of polydimethylsiloxane was dissolved in 1.5 L of isooctane, and then 7.6 g of TEOS and 0.76 g of DEBTDL were added. After stirring evenly, a superhydrophobic mixed solution C was obtained.

[0033] Example 1

[0034] A method for manufacturing a fatigue-resistant nickel-titanium alloy rubber dam clip specifically comprises the following steps:

[0035] (1) Material preparation: A nickel-titanium alloy ingot with a nickel content of 55 at% was selected;

[0036] (2) Model making: constructing a three-dimensional model of the maxillary premolar using a rubber stamp clip based on CT data;

[0037] (3) Investment casting: NiTi alloy is melted and poured at 1100°C in an argon atmosphere, and the embryo is obtained after cooling;

[0038] (4) Heat treatment: The embryo body is first subjected to solution treatment and then water quenching, the solution treatment temperature is 900°C and the time is 60 min, and then aging treatment is performed, the aging treatment temperature is 450°C and the time is 120 min to obtain a crude product;

[0039] (5) Post-processing: The rough product was electropolished, laser engraved with specification marks, and sprayed with superhydrophobic mixed solution A using a spray gun. The working pressure of the spray gun was 0.3 MPa, and the distance between the nozzle of the spray gun and the surface of the structure was 25 cm. After spraying, it was vacuum dried at 80 ° C for 30 minutes, taken out, and the spraying operation was repeated until the thickness was 0.5 mm, thus obtaining a fatigue-resistant nickel-titanium alloy rubber dam clip.

[0040] The fatigue-resistant nickel-titanium alloy rubber dam clip obtained in this embodiment is integrally formed from a nickel-titanium alloy ingot through an investment casting process, and includes a clamping end, an elastic arm and a connecting portion, wherein the inner surface of the clamping end is provided with anti-slip micro-grooves directly formed by casting, and the thickness of the elastic arm is gradually distributed in the direction of 1 mm from the connecting portion to the clamping end.

[0041] Example 2

[0042] A method for manufacturing a fatigue-resistant nickel-titanium alloy rubber dam clip specifically comprises the following steps:

[0043] (1) Material preparation: Select nickel-titanium alloy ingot with a nickel content of 50 at%;

[0044] (2) Model making: constructing a three-dimensional model of the maxillary premolar using a rubber stamp clip based on CT data;

[0045] (3) Investment casting: NiTi alloy is melted and poured at 900°C in an argon atmosphere, and the embryo is obtained after cooling;

[0046] (4) Heat treatment: The embryo body is first subjected to solution treatment and then water quenching, the solution treatment temperature is 800°C and the time is 90 min, and then aging treatment is performed, the aging treatment temperature is 300°C and the time is 160 min to obtain a crude product;

[0047] (5) Post-processing: The rough product was electropolished, laser engraved with specification marks, and sprayed with superhydrophobic mixed solution A using a spray gun. The working pressure of the spray gun was 0.4 MPa, and the distance between the nozzle of the spray gun and the surface of the structure was 30 cm. After spraying, it was vacuum dried at 80 ° C for 30 min, taken out, and the spraying operation was repeated until the thickness was 0.5 mm, thus obtaining a fatigue-resistant nickel-titanium alloy rubber dam clip.

[0048] The fatigue-resistant nickel-titanium alloy rubber dam clip obtained in this embodiment is integrally formed from a nickel-titanium alloy ingot through an investment casting process, and includes a clamping end, an elastic arm and a connecting portion, wherein the inner surface of the clamping end is provided with anti-slip micro-grooves directly formed by casting, and the thickness of the elastic arm is gradually distributed in the direction of 0.5 mm from the connecting portion to the clamping end.

[0049] Example 3

[0050] A method for manufacturing a fatigue-resistant nickel-titanium alloy rubber dam clip specifically comprises the following steps:

[0051] (1) Material preparation: Select nickel-titanium alloy ingots with a nickel content of 60 at%;

[0052] (2) Model making: constructing a three-dimensional model of the maxillary premolar using a rubber stamp clip based on CT data;

[0053] (3) Investment casting: NiTi alloy is melted and poured at 1200°C in an argon atmosphere, and the embryo is obtained after cooling;

[0054] (4) Heat treatment: The embryo body is first subjected to solution treatment and then water quenching, the solution treatment temperature is 1000°C and the time is 30 minutes, and then aging treatment is performed, the aging treatment temperature is 600°C and the time is 80 minutes to obtain a crude product;

[0055] (5) Post-processing: The rough product was electrolytically polished, laser engraved with specification marks, and sprayed with superhydrophobic mixed solution A using a spray gun. The working pressure of the spray gun was 0.1 MPa, and the distance between the nozzle of the spray gun and the surface of the structure was 20 cm. After spraying, it was vacuum dried at 80 ° C for 30 minutes, taken out, and the spraying operation was repeated until the thickness was 0.5 mm, thus obtaining a fatigue-resistant nickel-titanium alloy rubber dam clip.

[0056] The fatigue-resistant nickel-titanium alloy rubber dam clip obtained in this embodiment is integrally formed from a nickel-titanium alloy ingot through an investment casting process, and includes a clamping end, an elastic arm and a connecting portion, wherein the inner surface of the clamping end is provided with anti-slip micro-grooves directly formed by casting, and the thickness of the elastic arm is gradually distributed in a 1.5 mm manner from the connecting portion to the clamping end.

[0057] Example 4

[0058] This embodiment provides a fatigue-resistant nickel-titanium alloy rubber dam clip and a manufacturing method thereof. The specific implementation method is the same as that of Example 1, except that the superhydrophobic mixed solution A is replaced by an equal amount of superhydrophobic mixed solution B.

[0059] Example 5

[0060] This embodiment provides a fatigue-resistant nickel-titanium alloy rubber dam clip and a manufacturing method thereof. The specific implementation method is the same as that of Example 1, except that the superhydrophobic mixed solution A is replaced by an equal amount of superhydrophobic mixed solution C.

[0061] Comparative Example 1

[0062] This comparative example provides a fatigue-resistant nickel-titanium alloy rubber dam clip and a manufacturing method thereof. The specific implementation method is the same as that of Example 1, except that:

[0063] (5) Post-processing: The rough product is electrolytically polished and laser engraved with specification marks to obtain a fatigue-resistant nickel-titanium alloy rubber dam clip.

[0064] Performance testing:

[0065] 1. Elastic modulus test: The rubber dam clamps obtained in Examples 1 to 5 and Comparative Example 1 were uniaxially compressed using an electronic universal testing machine until they broke. The loading process signals were collected and analyzed using Trapezium software to obtain the stress-strain curves of the specimens during the compression process and the elastic modulus of the rubber dam clamps.

[0066] 2. Tensile test: The rubber dam clamps obtained in Examples 1 to 5 were subjected to tensile testing at room temperature using a Shimadzu AG-IC vertical electronic universal testing machine. The tensile rate of the clamp was set to 1.0 mm / min, and the tensile length (mm) was recorded when cracks appeared on the surface.

[0067] 3. Hydrophobicity test: The contact angles of the rubber dam clamp surfaces of Examples 1 to 5 and Comparative Example 1 were measured using a contact angle meter.

[0068] The above results are shown in Table 1.

[0069] Table 1

[0070] Elastic modulus (GPa) Stretched length (mm) Contact angle (°) Example 1 5.22±0.14 2.17 153 Example 2 4.84±0.25 2.11 150 Example 3 5.18±0.21 2.08 151 Example 4 5.06±0.11 1.54 148 Example 5 4.96±0.18 1.37 131 Comparative Example 1 5.13±0.23 - 97

[0071] As can be seen from the data in Table 1, the rubber dam clips of Examples 1 to 5 all have good elastic moduli, among which Examples 1 to 3 have relatively excellent hydrophobicity. It can be seen from the tensile distance of cracks appearing on the hydrophobic surface that the flexibility and ductility of the hydrophobic surface are suitable for nickel-titanium alloys with a large deformation range in this application. Compared to Example 1, Example 4 replaces the 2-hydroxypropyl methacrylate in the super-hydrophobic mixed solution with an equal amount of 2-hydroxyethyl methacrylate, which has little effect on the hydrophobicity, but shortens the tensile distance of cracks appearing on the hydrophobic surface; further, it can be seen from Example 5 that no side chains are introduced into polydimethylsiloxane, which is not conducive to the improvement of hydrophobic properties. Compared to Example 1, the rubber dam clip of Comparative Example 1 has not undergone surface hydrophobic treatment, and its contact angle is significantly reduced, making it easy to colonize bacteria and accumulate dirt during use, resulting in a reduced life of the device.

[0072] The embodiments and comparative examples described above do not impose any form of limitation on the present invention. Although the present invention has been disclosed as a preferred embodiment as above, it is not intended to limit the present invention. Any technician familiar with the present profession can make some changes or modifications to equivalent embodiments of equivalent changes using the technical content disclosed above without departing from the scope of the technical solution of the present invention. However, any simple modifications, equivalent changes and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the technical solution of the present invention still fall within the scope of the technical solution of the present invention.

Claims

1. A method for manufacturing a fatigue-resistant nickel-titanium alloy rubber dam clip, characterized in that: The specific steps include: (1) Material preparation: Select nickel-titanium alloy ingots; (2) Model making: Construct an individualized three-dimensional model based on CT data; (3) Investment casting: Melt and pour nickel-titanium alloy at 900-1200°C in an argon environment, and obtain a blank after cooling; (4) Heat treatment: First, subject the blank to solution treatment and then water quenching, and then to aging treatment to obtain a rough product; (5) Post-treatment: Electropolish the rough product, laser engrave the specification mark, and use a spray gun to spray the superhydrophobic mixed solution. After spraying, vacuum dry it for 10-40 minutes, take it out, and repeat the spraying operation until the thickness is 0.1-1 mm, thus obtaining a fatigue-resistant nickel-titanium alloy rubber dam clip.

2. The method for manufacturing the fatigue-resistant nickel-titanium alloy rubber dam clip according to claim 1, characterized in that: In step (1), the nickel content in the nickel-titanium alloy ingot is 50 to 60 at%.

3. The method for manufacturing the fatigue-resistant nickel-titanium alloy rubber dam clip according to claim 1, characterized in that: In step (4), the temperature of the solution treatment is 800-1000° C., and the time is 30-90 minutes.

4. The method for manufacturing the fatigue-resistant nickel-titanium alloy rubber dam clip according to claim 1, characterized in that: In step (4), the aging treatment is performed at a temperature of 300 to 600° C. and for a time of 80 to 160 minutes.

5. The method for manufacturing the fatigue-resistant nickel-titanium alloy rubber dam clip according to claim 1, characterized in that: In step (5), the preparation steps of the super-hydrophobic mixed solution are as follows: at room temperature, functionalized polydimethylsiloxane is dissolved in isooctane, under nitrogen protection, azobisisobutyronitrile and N,N-methylenebisacrylamide are added, and then 2-hydroxypropyl methacrylate is added, and stirred at 70-90° C. for 4-6 hours, and cooled to room temperature to obtain a reaction solution; then a cross-linking agent and a catalyst are added to the reaction solution, and the super-hydrophobic mixed solution is obtained after stirring evenly.

6. The method for manufacturing the fatigue-resistant nickel-titanium alloy rubber dam clip according to claim 5, characterized in that: The functionalized polydimethylsiloxane contains carbon-carbon double bonds.

7. The method for manufacturing the fatigue-resistant nickel-titanium alloy rubber dam clip according to claim 5, characterized in that: The mass ratio of the polydimethylsiloxane to 2-hydroxypropyl methacrylate is 1:(0.7-1.1).

8. The method for manufacturing the fatigue-resistant nickel-titanium alloy rubber dam clip according to claim 1, characterized in that: In step (5), the working pressure of the spray gun is 0.1-0.4 MPa, and the distance between the nozzle of the spray gun and the surface of the structure is 20-30 cm.

9. A fatigue-resistant nickel-titanium alloy rubber dam clip obtained according to the manufacturing method according to any one of claims 1 to 8, characterized in that: The rubber dam clamp is integrally formed from a nickel-titanium alloy ingot through an investment casting process, and comprises a clamping end, an elastic arm and a connecting portion. The inner surface of the clamping end is provided with anti-slip micro-grooves formed directly by casting.

10. The fatigue-resistant nickel-titanium alloy rubber dam clip according to claim 9, characterized in that: The thickness of the elastic arm is gradually distributed from the connecting portion to the clamping end in a range of 0.1 to 1.5 mm.