A method for preparing alloy eye implant

Abstract

The present invention relates to a method for preparing an alloy eye implant, comprising the following steps: S1: laser engraving; S2: pre-treating the surface of the eye implant by chemical polishing or electrolytic polishing; S3: detecting whether the surface roughness Ra of the eye implant after the treatment in step S2 satisfies Ra≤400nm; S4: ultrasonic cleaning one; S5: fluid polishing, placing the eye implant in a fluid polishing liquid, and polishing for 60 to 90 minutes under magnetic stirring conditions; S6: detecting whether the surface roughness Ra of the eye implant after the treatment in step S5 satisfies Ra≤50nm; S7: ultrasonic cleaning two. The present invention makes full use of the high removal efficiency of chemical polishing or electrolytic polishing and the good shape adaptability of fluid polishing and the ultra-smooth manufacturing capability, and combines the ultrasonic cleaning process to reduce the surface roughness while improving the processing efficiency, thereby realizing the nanometer precision surface manufacturing of the alloy eye implant.

Description

Technical Field

[0001] The invention relates to the technical field of implantable medical device processing, and in particular to a method for preparing an alloy eye implant. Background Art

[0002] Glaucoma is a difficult eye disease that develops rapidly, is highly harmful, and can lead to blindness in severe cases. Treatments include medication, laser, surgery, and other means, among which surgery is increasingly becoming the preferred treatment measure. Although traditional surgical treatments for glaucoma can effectively reduce intraocular pressure, common problems such as shallow anterior chamber and choroidal detachment are prone to occur in the early postoperative period, and complications are also prone to occur in the long term. Minimally invasive glaucoma surgery (MIGS) has developed rapidly in recent years. Compared with traditional surgery, MIGS has obvious advantages such as less trauma, definite efficacy, high safety, fast recovery, and low risk of complications. Ocular implants are the most commonly used medical products for MIGS.

[0003] CN115006103A discloses a metal eye implant tube with an arc-shaped bend, a hollow interior, and a hollow tube wall, the outer diameter of the implant tube is 0.25-0.4mm, and the tube wall thickness is 0.01-0.2mm. CN115212029A provides a thin-diameter thin-walled tube mesh eye drainage implant stent with a certain curvature, the outer diameter of the tube mesh stent is 0.25-0.35mm, the overall axial extension length of the stent is 6.5-9.5mm, and the bending arc is 65-105°.

[0004] The above-mentioned eye implants are generally made of medical metal materials, such as medical nickel-titanium alloys, which have poor wear resistance, many burrs on the surface of the implants formed by processing, and poor initial roughness. Poor surface roughness may induce infection risks and affect the speed of compatible healing with human tissues. The surface shape of the implant is complex and the size is small. Traditional polishing methods are difficult to meet the requirements of internal / external surface finish. The use scenario of eye implants requires high precision of the internal and external surface roughness of the implant, preferably better than 50nm, while the processing limit of electrochemical polishing, chemical polishing, etc. is about 400nm. The use requirements of eye implants make the preparation of high-precision alloy eye implants a major problem. Summary of the invention

[0005] The technical problem to be solved by the present invention is to provide a method for preparing an alloy eye implant, and the surface roughness of the obtained eye implant is better.

[0006] The technical solution adopted by the present invention to solve the above technical problem is: a method for preparing an alloy eye implant, comprising the following steps:

[0007] S1: Laser engraving, engraving an eye implant with a desired shape on an alloy substrate using a laser engraving method;

[0008] S2: Surface pretreatment of ocular implants by chemical polishing or electrolytic polishing to remove burrs generated by previous processing;

[0009] S3: Detect whether the surface roughness Ra of the ocular implant processed in step S2 satisfies Ra≤400nm, if so, execute step S4; if not, return to step S2;

[0010] S4: Ultrasonic cleaning 1: At room temperature, the ocular implant is ultrasonically cleaned to remove the residual polishing liquid on the surface, and then taken out and dried;

[0011] S5: Fluid polishing: Place the ocular implant in a fluid polishing solution at room temperature and polish for 60 to 90 minutes under magnetic stirring to further reduce surface roughness and improve brightness.

[0012] S6: Detect whether the surface roughness Ra of the ocular implant processed in step S5 satisfies Ra≤50nm. If so, execute step S7; if not, return to step S5;

[0013] S7: Ultrasonic cleaning 2: At room temperature, the ocular implant is ultrasonically cleaned to remove residual polishing liquid on the surface, and then taken out and dried.

[0014] Preferably, in step S1, the alloy substrate is a medical nickel-titanium alloy, and the formed eye implant is a thin-diameter, thin-walled tubular mesh stent with an arc-shaped bend, a hollow interior, and a hollow tube wall.

[0015] Preferably, the outer diameter of the formed ocular implant is not greater than 0.5 mm, the wall thickness of the ocular implant is not more than 0.2 mm, and the overall axial extension length of the ocular implant is not more than 10 mm.

[0016] Preferably, in step S2, the chemical polishing method is: placing the ocular implant in a chemical polishing solution at room temperature for 3 to 5 minutes to remove burrs.

[0017] Preferably, in step S4 and step S7, the medium of the ultrasonic cleaning method is deionized water or ethanol;

[0018] In step S4, the ultrasonic cleaning frequency is 40 to 270 kHz, and the cleaning time is 5 to 10 minutes;

[0019] In step S7, the ultrasonic cleaning frequency is 300-400 KHz, and the cleaning time is 5-10 minutes.

[0020] Preferably, in step S5, the rotation speed of the magnetic stirring is 500-1000 rpm.

[0021] Preferably, in step S5, during the fluid polishing process, the fluid polishing liquid forms a flexible polishing film under the action of the gradient magnetic field, and plastic shearing and removing the surface material of the ocular implant; different removal efficiencies are obtained by adjusting the pressing depth of the flexible polishing film.

[0022] The beneficial effects of the present invention are as follows: the preparation method of the alloy eye implant of the present invention fully utilizes the high removal efficiency of chemical polishing or electrolytic polishing and the good shape adaptability and ultra-smooth manufacturing capability of fluid polishing, and combines with the ultrasonic cleaning process to improve the processing efficiency while reducing the surface roughness. The surface roughness of the obtained eye implant is better, which has great advantages for the nano-precision surface manufacturing of thin-diameter thin-walled tube mesh alloy eye implants. The final surface roughness Ra of the eye implant is better than 50nm, and the nano-precision surface manufacturing of the alloy eye implant is finally realized. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 It is a schematic flow chart of the method for preparing the alloy eye implant of the present invention;

[0024] Figure 2 A schematic structural diagram of an embodiment of the alloy eye implant of the present invention;

[0025] Figure 3 The surface morphology of the alloy eye implant of the embodiment of the present invention after chemical polishing pretreatment;

[0026] Figure 4 This is a data table of surface roughness of alloy eye implants after chemical polishing pretreatment according to an embodiment of the present invention;

[0027] Figure 5 This is a data table of surface roughness of alloy eye implants according to embodiments of the present invention after fluid polishing. DETAILED DESCRIPTION

[0028] The present invention will now be described in further detail in conjunction with the accompanying drawings and preferred embodiments. These drawings are simplified schematic diagrams, which only illustrate the basic structure of the present invention in a schematic manner, and therefore only show the components related to the present invention.

[0029] like Figure 1 As shown, a method for preparing an alloy eye implant comprises the following steps:

[0030] S1: Laser engraving, using a laser engraving method to engrave an eye implant with a desired shape on an alloy substrate.

[0031] Specifically, in an optional embodiment, the eye implant is made of medical metal material. Specifically, in an optional embodiment, the alloy substrate is medical nickel-titanium alloy. Figure 2 As shown, the eye implant formed is a thin-diameter thin-walled tube mesh stent with an arc-shaped bend, a hollow interior, and a hollow tube wall. The eye implant has a certain curvature or arc.

[0032] Specifically, in an optional embodiment, the outer diameter of the formed ocular implant is not greater than 0.5 mm, the wall thickness of the ocular implant is not more than 0.2 mm, and the overall axial extension length of the ocular implant is not more than 10 mm.

[0033] S2: Chemical polishing or electrolytic polishing is used to pre-treat the surface of the ocular implant to remove burrs generated by the previous processing.

[0034] Specifically, in an optional embodiment, in step S2, the chemical polishing method is: placing the ocular implant in a chemical polishing solution at room temperature for 3 to 5 minutes to remove burrs. Preferably, the chemical polishing solution is cerium oxide particles with an average abrasive particle size of no more than 1 micron.

[0035] S3: Detect whether the surface roughness Ra of the ocular implant processed in step S2 satisfies Ra≤400nm. If so, execute step S4; if not, return to step S2.

[0036] On the one hand, the surface roughness limit of metal implants after chemical polishing pretreatment is about Ra400nm. On the other hand, the material removal efficiency of the fluid polishing method in the subsequent treatment is low. If the surface roughness value of the implant is large after chemical polishing pretreatment, the subsequent fluid polishing will require a large amount of material removal and a long processing time; therefore, the surface roughness Ra≤400nm is set as the threshold for the end of chemical polishing or electrolytic polishing pretreatment.

[0037] Figure 3 This is the surface morphology of the alloy eye implant of the embodiment of the present invention after chemical polishing pretreatment. Figure 4 This is a table showing the surface roughness of the alloy eye implants of the present invention after chemical polishing pretreatment. Figure 4 As shown, after one or more chemical polishing or electrolytic polishing, the average value of the surface roughness Ra of the ocular implant is 351 nm, and the surface roughness Ra is ≤ 400 nm.

[0038] S4: Ultrasonic cleaning 1: At room temperature, the ocular implant is ultrasonically cleaned to remove residual polishing liquid on the surface, and then taken out and dried.

[0039] Specifically, in an optional embodiment, in step S4, the medium of the ultrasonic cleaning method is deionized water or ethanol; in step S4, the ultrasonic cleaning frequency is 40 to 270 KHz, and the cleaning time is 5 to 10 minutes to fully remove the polishing liquid components that may remain on the polishing surface.

[0040] S5: Fluid polishing: at room temperature, the ocular implant is placed in a fluid polishing liquid and polished for 60 to 90 minutes under magnetic stirring conditions to further reduce the surface roughness and improve the brightness. Specifically, in an optional embodiment, the rotation speed of the magnetic stirring is 500 to 1000 rpm. Preferably, the fluid polishing liquid is a fluid polishing liquid containing soft iron powder and superhard abrasive micropowder.

[0041] S6: Check whether the surface roughness Ra of the ocular implant after the processing in step S5 satisfies Ra≤50nm, if so, execute step S7; if not, return to step S5. Specifically, in an optional embodiment, the surface of the ocular implant tested in this step includes the inner surface and the outer surface.

[0042] Figure 5 This is a table showing the surface roughness of the alloy eye implants of the embodiments of the present invention after being treated with fluid polishing. Figure 5 As shown, the average value of the surface roughness Ra of the ocular implant obtained by using the ASME B46.1 standard is 23.317 nm, and its surface roughness Ra≤50 nm. The average value of the surface roughness Ra of the ocular implant obtained by using the ISO 4287 Amplitude standard is 24.18 nm, and its surface roughness Ra≤50 nm.

[0043] S7: Ultrasonic cleaning 2: At room temperature, the ocular implant is ultrasonically cleaned to remove residual polishing liquid on the surface, and then taken out and dried.

[0044] Specifically, in an optional embodiment, in step S7, the medium of the ultrasonic cleaning method is deionized water or ethanol;

[0045] In step S7, the ultrasonic cleaning frequency is 300-400 KHz, and the cleaning time is 5-10 minutes to fully remove the polishing liquid components that may remain on the polishing surface. The ultrasonic cleaning frequency in step S7 is different from the ultrasonic cleaning frequency in step S4.

[0046] Specifically, in an optional embodiment, in step S5, during the fluid polishing process, the fluid polishing liquid forms a flexible polishing film under the action of a gradient magnetic field, and plastic shearing and removing the surface material of the ocular implant; different removal efficiencies are obtained by adjusting the pressing depth of the flexible polishing film, and nanometer precision surface polishing is achieved. The flexibility of the flexible polishing film is adjusted by changing the strength or size of the magnetic field, electric field, and flow field, and nanometer-level material removal is achieved.

[0047] The preparation method of the alloy eye implant of the present invention fully utilizes the high removal efficiency of chemical polishing or electrolytic polishing and the good shape adaptability and ultra-smooth manufacturing capability of fluid polishing, and combines the ultrasonic cleaning process to improve the processing efficiency while reducing the surface roughness. The surface roughness of the obtained eye implant is better, which has great advantages for the nanometer precision surface manufacturing of thin-diameter thin-walled tube mesh alloy eye implants. The final surface roughness Ra of the eye implant is better than 50nm, and the nanometer precision surface manufacturing of the alloy eye implant is finally realized.

[0048] The above description only describes the specific implementation mode of the present invention. Various examples do not limit the essential content of the present invention. After reading the description, ordinary technicians in the relevant technical field can modify or deform the specific implementation modes described above without departing from the essence and scope of the invention.

Claims

1. A method for preparing an alloy eye implant, characterized in that: The steps include: S1: laser engraving, engraving an eye implant having a desired shape on an alloy substrate by a laser engraving method, wherein the alloy substrate is a medical nickel-titanium alloy; S2: Surface pretreatment of ocular implants by chemical polishing or electrolytic polishing to remove burrs generated by previous processing; S3: Detect whether the surface roughness Ra of the ocular implant processed in step S2 satisfies Ra≤400nm, if so, execute step S4; if not, return to step S2; S4: Ultrasonic cleaning 1: At room temperature, the ocular implant is ultrasonically cleaned to remove the residual polishing liquid on the surface, and then taken out and dried; S5: Fluid polishing: at room temperature, the ocular implant is placed in a fluid polishing liquid and polished for 60 to 90 minutes under magnetic stirring conditions at a speed of 500 to 1000 rpm to further reduce surface roughness and improve brightness; the fluid polishing liquid is a fluid polishing liquid containing soft iron powder and superhard abrasive micropowder; In the step S5, during the fluid polishing process, the fluid polishing liquid forms a flexible polishing film under the action of the gradient magnetic field, and plastic shears and removes the surface material of the ocular implant; different removal efficiencies are obtained by adjusting the pressing depth of the flexible polishing film; S6: Detect whether the surface roughness Ra of the ocular implant processed in step S5 satisfies Ra≤50nm. If so, execute step S7; if not, return to step S5; S7: Ultrasonic cleaning 2: At room temperature, the ocular implant is ultrasonically cleaned to remove residual polishing liquid on the surface, and then taken out and dried.

2. The method for preparing an alloy eye implant according to claim 1, characterized in that: In the step S1, the eye implant formed is a thin-diameter, thin-walled tube mesh stent that is curved in an arc shape, hollow inside, and has a hollow tube wall.

3. The method for preparing an alloy eye implant according to claim 1 or 2, characterized in that: The outer diameter of the formed eye implant is not greater than 0.5 mm, the wall thickness of the eye implant is not more than 0.2 mm, and the overall axial extension length of the eye implant is not more than 10 mm.

4. The method for preparing an alloy eye implant according to claim 1, characterized in that: In step S2, the chemical polishing method is: at room temperature, the ocular implant is placed in a chemical polishing solution for 3 to 5 minutes to remove burrs, and the chemical polishing solution is cerium oxide particles with an average abrasive particle size of no more than 1 micron.

5. The method for preparing an alloy eye implant according to claim 1, characterized in that: In step S4 and step S7, the medium of the ultrasonic cleaning method is deionized water or ethanol; In step S4, the ultrasonic cleaning frequency is 40 to 270 kHz, and the cleaning time is 5 to 10 minutes; In step S7, the ultrasonic cleaning frequency is 300-400 KHz, and the cleaning time is 5-10 minutes.

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