Disclosure of Invention
The invention aims to provide an orthopedic implant with a multi-level micro-nano structure and a manufacturing method thereof, which are used for solving the problems in the prior art, enhancing the combination between a substrate and a coating, enhancing the biocompatibility of the implant and preventing infection without causing drug resistance.
In order to achieve the purpose, the invention provides the following scheme:
the invention provides an orthopedic implant with a multi-level micro-nano structure, which comprises an implant body, wherein a micron-level primary microstructure array is arranged on the implant body and is formed by equidistantly arranging a plurality of micron-level primary microstructure units, a micron-level primary micro groove is formed between the primary microstructure units, a micron-level secondary microstructure array is arranged on each primary microstructure unit and is a micro protrusion array or a micro groove array, the micro protrusion array is formed by equidistantly arranging a plurality of micron-level protrusions, a micron-level secondary micro groove is formed between the micron-level protrusions, the micro groove array is formed by equidistantly arranging a plurality of micron-level grooves, and the distance between every two adjacent micron-level grooves is micron level; the surface of the implant body is provided with a nano-scale tubular array and is coated with a bioactive protein coating.
Preferably, the micro-convex array is a micro-polygon prism array, the micro-polygon prism array is formed by equidistantly arranging a plurality of micron-sized polygon prisms, and micron-sized secondary micro grooves are formed between the micron-sized polygon prisms; the micro-groove array is a micro-pit array or a micro-groove array, the micro-pit array is formed by arraying a plurality of micron-sized pits at equal intervals, and the distance between every two adjacent micron-sized pits is micron; the micro-groove array is formed by equidistantly arranging a plurality of micron-sized grooves, and the distance between every two adjacent micron-sized grooves is micron-sized.
Preferably, the primary microstructure units are micron-sized regular hexagonal prisms or regular quadrangular prisms.
Preferably, the micro-polygon prism array is formed by equidistantly arranging a plurality of micron-sized regular hexagonal prisms.
Preferably, the implant body is made of a medical titanium alloy material, a medical stainless steel material or a tantalum metal material.
The invention also provides a manufacturing method of the orthopedic implant with the multistage micro-nano structure, which comprises the following steps:
s1: machining a primary micro groove on the implant blank to form a primary micro structure array;
s2: machining a secondary micro groove on the primary microstructure unit to form a micro-convex array, or machining a plurality of micron-sized grooves to form a micro-groove array;
s3: generating a nano-scale tubular array on the surface of the implant obtained in the step S2;
s4: washing the implant obtained in the step S3, drying, activating the implant by using an activating agent, and then performing coupling modification on the implant in an antibacterial polymeric protein solution to obtain an implant with a bioactive protein coating coated on the surface;
s5: the implant obtained in S4 was washed and then air-dried.
Preferably, the implant blank is made of a medical titanium alloy material, and the produced nano-scale tubular array is TiO 32An array of nanotubes.
Preferably, in S3, after the formation of the nano-scale tubular array, the implant is subjected to a heat treatment to convert the crystalline structure of the nano-scale tubular array from the amorphous state to the rutile phase.
Preferably, in S4, the coupling modification time is 16-20 h.
Compared with the prior art, the invention has the following technical effects:
the invention provides an orthopedic implant with a multistage micro-nano structure and a manufacturing method thereof, wherein a micron-scale primary microstructure array is arranged on an implant body and is formed by equidistantly arranging a plurality of micron-scale primary microstructure units, a micron-scale secondary microstructure array is arranged on each primary microstructure unit and is a micro-protrusion array or a micro-groove array, the surface area of the implant body is increased, more space is provided for the generation of a nano-scale tubular array, the nano-scale tubular array structure can stimulate cell surface protein, guide osteoblast to adhere and promote the rapid proliferation of osteoblast, thereby the embedding force of a bioactive protein coating and the surface of the implant can be enhanced, the biocompatibility of the implant is enhanced, and the infection caused by the implant can be prevented without adding medicaments by coating a bioactive protein coating, the problem of drug resistance can not be brought.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The invention aims to provide an orthopedic implant with a multi-level micro-nano structure and a manufacturing method thereof, which are used for solving the problems in the prior art, enhancing the combination between a substrate and a coating, enhancing the biocompatibility of the implant and preventing infection without bringing drug resistance.
In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in further detail below.
As shown in fig. 1-2, the present embodiment provides an orthopedic implant 100 with a multi-level micro-nano structure, including an implant body 1, a micron-level primary microstructure array is disposed on the implant body 1, the primary microstructure array is formed by equidistantly arranging a plurality of micron-level primary microstructure units 2, a micron-level primary micro groove 3 is formed between each of the primary microstructure units 2, each of the primary microstructure units 2 is provided with a micron-level secondary microstructure array, the secondary microstructure array is a micro-protrusion array or a micro-groove array, the micro-protrusion array is formed by equidistantly arranging a plurality of micron-level protrusions, a micron-level secondary micro groove 5 is formed between each of the micron-level protrusions, the micro-groove array is formed by equidistantly arranging a plurality of micron-level grooves, and the interval between adjacent micron-level grooves is micron level; the surface of the implant body 1 is provided with a nano-scale tubular array and is coated with a bioactive protein coating.
Wherein, the primary microstructure array on the implant body 1 is preferably hundreds of microns, the primary microstructure array is preferably formed by arranging a plurality of primary microstructure units 2 with hundreds of microns at equal intervals, the secondary microstructure array on each primary microstructure unit 2 is preferably ten microns, which is convenient for mechanical processing, in the embodiment, the secondary microstructure array is a micro-convex array with ten microns, which increases the surface area of the implant body 1, provides more space for generating a nano-scale tubular array, and the nano-scale tubular array structure can stimulate cell surface protein, guide osteoblast to adhere, promote osteoblast to rapidly proliferate, thereby enhancing the embedding force of the bioactive protein coating and the surface of the implant and enhancing the biocompatibility of the implant, and the bioactive protein coating can destroy peptidoglycan of bacterial cell walls by coating the bioactive protein coating, the channel is formed, so that cytoplasm overflows, bacteria die, and bacterial infection caused by the implant can be prevented without adding medicines, and the problem of drug resistance is avoided.
As shown in fig. 1-2, in the present embodiment, the micro-protrusion array is a micro-polygon prism array, the micro-polygon prism array is formed by equidistantly arranging a plurality of micron-sized polygon prisms, a micron-sized secondary micro-groove 5 is formed between the micron-sized polygon prisms, and the micro-polygon prism array is formed by machining the micron-sized secondary micro-groove 5, which is convenient to process. When the secondary microstructure array is a micro-groove array, the micro-groove array is a micro-pit array or a micro-groove array, the micro-pit array is formed by equidistantly arranging a plurality of micron-sized pits, the distance between every two adjacent micron-sized pits is micron, the micro-groove array is formed by equidistantly arranging a plurality of micron-sized grooves, and the distance between every two adjacent micron-sized grooves is micron; the surface area of the implant body 1 can also be increased by the arrangement of the micro-pit array or the micro-groove array, providing more space for the generation of the nano-scale tubular array.
As shown in fig. 1 to 2, the primary microstructure unit 2 is a micron-sized regular hexagonal prism or regular quadrangular prism, and in this embodiment, a regular hexagonal prism is specifically selected, which is convenient to manufacture.
As shown in fig. 2, in the present embodiment, the micro-polygon array is formed by a plurality of micron-sized regular hexagonal prisms arranged at equal intervals, and has a stable structure and is convenient to manufacture.
The implant body 1 is made of medical titanium alloy material, medical stainless steel material or tantalum metal material, and in the embodiment, the implant body 1 is specifically selected to be the medical titanium alloy material, so that the strength is high, the mechanical property is close to that of human bones, and the implant has the characteristics of fatigue resistance, corrosion resistance, excellent biocompatibility and the like.
The manufacturing method of the orthopedic implant with the multistage micro-nano structure comprises the following steps:
s1: machining a primary micro groove 3 on the implant blank to form a primary microstructure array;
s2: machining a secondary micro groove 5 on the primary microstructure unit 2 to form a micro polygon prism array;
s3: generating a nano-scale tubular array on the surface of the implant obtained in the step S2;
s4: washing the implant obtained in the step S3, drying, activating the implant by using an activating agent, and then performing coupling modification on the implant in an antibacterial polymeric protein solution to obtain the implant with the surface coated with the bioactive protein coating;
s5: the implant obtained in S4 was washed and then air-dried.
The orthopedic implant manufactured by the method increases the surface area of the implant body 1, provides more space for the generation of the nano-scale tubular array, has a nano-scale tubular array structure, can stimulate protein on the surface of cells, guide the adhesion of osteoblasts, and promote the rapid proliferation of osteoblasts, thereby enhancing the embedding force of a bioactive protein coating and the surface of the implant and enhancing the biocompatibility of the implant, can prevent the infection caused by the implant without adding medicaments by coating the bioactive protein coating, and can not bring the problem of drug resistance.
The primary micro groove 3 and the secondary micro groove 5 are machined on the ultra-precise six-axis laser machine tool, so that machining precision is high; the nano-scale tubular array is generated on the surface of the implant by adopting an anodic oxidation method, and the nano-scale tubular array is conveniently and quickly generated; the activating agent is N-hydroxysuccinimide (NHS) and 1- (3-dimethylaminopropyl) -3-ethylcarbodiimide hydrochloride (EDC), so that the coupling reaction efficiency is improved; in both S4 and S5, the implant is cleaned with deionized water to remove surface impurities.
If the secondary microstructure array is a micro-pit array, S2: and machining a plurality of micron-sized grooves on the primary microstructure unit 2 to form a micro-groove array.
Selecting a medical titanium alloy material for the implant blank, and in S3, generating a nano tubular array of TiO2The nanotube array is high in medical titanium alloy strength, corrosion-resistant and excellent in biocompatibility.
In S3, after the nano-scale tubular array is generated, the implant is subjected to heat treatment, so that the crystal structure of the nano-scale tubular array is converted from an amorphous state to a rutile phase, and the corrosion resistance of the surface of the implant in a body fluid environment is enhanced.
In S4, the coupling modification time is 12-16 h, preferably 14h, so that the bioactive protein coating is coated on the surface of the implant, and the problem of drug resistance is not brought while infection is prevented.
The principle and the implementation mode of the invention are explained by applying a specific example, and the description of the embodiment is only used for helping to understand the method and the core idea of the invention; meanwhile, for a person skilled in the art, according to the idea of the present invention, the specific embodiments and the application range may be changed. In view of the above, the present disclosure should not be construed as limiting the invention.