CN-121023608-B - Preparation method and application of medical implant

Abstract

The invention provides a preparation method and application of a medical implant, relating to the technical field of preparation of medical implants, the medical implant is prepared by forming a strontium-doped TiO 2 coating on the surface of a substrate by adopting a micro-arc oxidation method, and then forming a TiO 2 mesoporous array layer with a honeycomb structure on the surface by adopting an anodic oxidation method. According to the technical scheme, the specific surface area of the medical implant is increased by introducing the micro-holes and the mesoporous arrays into the medical implant, the cell differentiation and the cell activity of the medical implant in the in-vivo application process can be improved, and the obtained medical implant has excellent biocompatibility and great application potential in the loading of macromolecular proteins or medicines.

Inventors

• XI WEIHONG
• Yue Ketong
• Wang Tiebiao
• ZHANG XUEE
• ZHOU WUCHAO
• ZHANG XU

Assignees

• 南昌大学附属口腔医院(江西省口腔医院)

Dates

Publication Date

20260512

Application Date

20250813

Claims (6)

1. 1. A method for preparing a medical implant, comprising the steps of: S1, surface pretreatment of a base material; s2, preparing a strontium-doped TiO 2 coating on the surface of the pretreated substrate obtained in the step S1 by adopting a micro-arc oxidation method, and then preparing a pure Ti transition layer on the surface of the strontium-doped TiO 2 coating by adopting an electron beam evaporation method; Taking a strontium acetate aqueous solution as electrolyte, taking a pretreated substrate as an anode, taking a platinum plate as a cathode, and carrying out electrolytic oxidation to obtain the strontium-doped TiO 2 coating on the surface of the substrate, wherein the concentration of the strontium acetate aqueous solution is 3mol/L, the technological parameters of electrolytic oxidation are that the forward current is 3A, the reverse current is 1A, the pulse frequency is 1000Hz, the total duty ratio is 30%, the positive and negative duty ratios are 50%, and the treatment time is 3min; The method for preparing the pure Ti transition layer by adopting the electron beam evaporation method comprises the steps of placing a substrate in a cavity of a high-vacuum electron beam evaporation coating machine, vacuumizing until the system vacuum degree reaches 5X 10 -4 Pa, starting an evaporation procedure, taking Ti as a target material for deposition, and continuously performing the evaporation process until the film thickness reaches 100nm, and completing the deposition to obtain a required device; and S3, carrying out surface treatment on the pure Ti transition layer by adopting an anodic oxidation method to form a TiO 2 mesoporous array layer on the surface of the pure Ti transition layer, thus obtaining the medical implant.
2. 2. The preparation method of the TiO 2 mesoporous array layer according to the claim 1, wherein in the step S3, the step of preparing the TiO 2 mesoporous array layer by adopting an anodic oxidation method is characterized in that an anodic oxidation power supply is placed in a mixed electrolyte, and the pure Ti transition layer is subjected to anodic oxidation treatment, wherein the technological parameters of the anodic oxidation treatment are as follows, the treatment voltage is 20V, and the treatment time is 55min.
3. 3. The preparation method of claim 2, wherein the mixed electrolyte comprises 94.75-99.70wt% of ethylene glycol, 0.20-0.30wt% of ammonium fluoride and 0.1-5.05wt% of water, and the sum of the mass percentages of the three is 100%.
4. 4. The method according to claim 1, wherein in step S1, the substrate is at least one of titanium, titanium alloy, tantalum alloy, and stainless steel, and the pretreatment is performed by sanding.
5. 5. A medical implant produced by the production method according to any one of claims 1 to 4, comprising: A base material: The composite coating comprises a strontium-doped TiO 2 coating and a TiO 2 mesoporous array layer covering the surface of the strontium-doped TiO 2 coating, wherein the TiO 2 mesoporous array layer is formed by oxidizing a pure Ti transition layer, and the strontium-doped TiO 2 coating is close to the substrate; The TiO 2 mesoporous array layer has a honeycomb structure, the thickness of the mesoporous array layer is 80-120nm, the surface roughness average value is Ra4.63nm, and Rq is 6.11nm.
6. 6. The medical implant according to claim 5, wherein the holes of the honeycomb structure in the TiO 2 mesoporous array layer have a diameter of 10-14nm, and the holes are round or oval.

Description

Preparation method and application of medical implant Technical Field The invention relates to the technical field of medical implant preparation, in particular to a preparation method and application of a medical implant. Background Titanium and titanium alloys are commonly used materials for hard tissue implants in the medical field, which find wide application in artificial joints, artificial bones, spinal rods, intramedullary nails, dental implants, cranium, and the like. Titanium and titanium alloy have advantages of small density, high specific strength, low elastic modulus, good corrosion resistance, etc., but there are many problems such as low strength of bonding with bone, poor bioactivity, long healing time, etc. when the titanium and titanium alloy are directly implanted into human body. In order to overcome the problems, the biological modification of the surface of titanium and titanium alloy is of great significance. Titanium dioxide has low inherent toxicity, low solubility in water, low reactivity with biological molecules, nearly chemical inertness and obvious anti-inflammatory effect, so that the surface modification treatment of titanium and titanium alloy by adopting an oxidation method can be used as an effective mode. The micro-arc oxidation method is a common metal surface oxidation mode, an oxidation layer is formed on the metal surface through electrolytic oxidation, and a coating generated by oxidation can be embedded into microelements in electrolyte and form micron-sized holes, but the specific surface area of the coating is small, so that the loading capacity is insufficient when the drug protein is directly loaded, and the requirements of in-vivo application are difficult to meet. In view of the foregoing, there is a need for an improved method of manufacturing medical implants and applications thereof that address the above-mentioned issues. Disclosure of Invention The invention aims to provide a preparation method and application of a medical implant. In order to achieve the above object, according to a first aspect, the present invention provides a method for preparing a medical implant, comprising the steps of: S1, surface pretreatment of a base material; s2, preparing a strontium-doped TiO 2 coating on the surface of the pretreated substrate obtained in the step S1 by adopting a micro-arc oxidation method, and then preparing a pure Ti transition layer on the surface of the strontium-doped TiO 2 coating by adopting an electron beam evaporation method; and S3, carrying out surface treatment on the pure Ti transition layer by adopting an anodic oxidation method to form a TiO 2 mesoporous array layer on the surface of the pure Ti transition layer, thus obtaining the medical implant. Preferably, in the step S3, the step of preparing the TiO 2 mesoporous array layer by adopting an anodic oxidation method comprises the steps of placing an anodic oxidation power supply in mixed electrolyte, and carrying out anodic oxidation treatment on the pure Ti transition layer, wherein the technological parameters of the anodic oxidation treatment are as follows, the treatment voltage is 20V, and the treatment time is 55min. Preferably, the mixed electrolyte consists of 94.75-99.70wt% of ethylene glycol, 0.20-0.30wt% of ammonium fluoride and 0.1-5.05wt% of water, wherein the total mass percentage of the ethylene glycol, the ammonium fluoride and the water is 100%. Preferably, in the step S2, the strontium-doped TiO 2 coating is prepared according to the following steps that a strontium acetate aqueous solution is used as electrolyte, a pretreated substrate is used as an anode, a platinum plate is used as a cathode, and electrolytic oxidation is carried out, namely the strontium-doped TiO 2 coating is prepared on the surface of the substrate, wherein the concentration of the strontium acetate aqueous solution is 3mol/L. Preferably, the technological parameters of the electrolytic oxidation are that the forward current is 3A, the reverse current is 1A, the pulse frequency is 1000Hz, the total duty ratio is 30%, the positive and negative duty ratios are 50%, and the treatment time is 3min. Preferably, in the step S2, the step of preparing the pure Ti transition layer by adopting the electron beam evaporation method comprises the steps of placing a substrate in a cavity of a high-vacuum electron beam evaporation coating machine, vacuumizing until the vacuum degree of the system reaches 5X 10 -4 Pa, starting an evaporation procedure, and depositing by taking Ti as a target material. The evaporation process is continued until the film thickness reaches 100nm, and the deposition is completed, so that the required device is obtained. Preferably, in step S1, the substrate is at least one of titanium, titanium alloy, tantalum alloy, and stainless steel, and the pretreatment is performed by sanding. In a second aspect, the present invention provides a medical implant comprising: A base material: The co