CN113730042B - Orthopedic implant with multistage micro-nano structure and manufacturing method thereof - Google Patents
Orthopedic implant with multistage micro-nano structure and manufacturing method thereof Download PDFInfo
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- CN113730042B CN113730042B CN202111055796.7A CN202111055796A CN113730042B CN 113730042 B CN113730042 B CN 113730042B CN 202111055796 A CN202111055796 A CN 202111055796A CN 113730042 B CN113730042 B CN 113730042B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
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Abstract
本发明公开一种具有多级微纳结构的骨科植入体及制造方法，植入体本体上设有微米级的一级微结构阵列，一级微结构阵列由多个微米级的一级微结构单元等距排列而成，各一级微结构单元之间形成微米级的一级微沟槽，各一级微结构单元上均设有微米级的二级微结构阵列，二级微结构阵列为微凸起阵列或微凹槽阵列，微凸起阵列由多个微米级凸起等距排列而成，各微米级凸起之间形成微米级的二级微沟槽，微凹槽阵列由多个微米级凹槽等距排列而成，相邻的微米级凹槽之间间距为微米级；植入体本体表面设有纳米级管状阵列并涂覆有生物活性蛋白涂层。本发明能够增强基体与涂层之间的结合，增强植入体的生物相容性，在预防感染的同时不会带来抗药性的问题。
The invention discloses an orthopedic implant with a multi-level micro-nano structure and a manufacturing method. The implant body is provided with a micron-level first-level microstructure array, and the first-level microstructure array is composed of a plurality of micron-level first-level microstructures. The structural units are arranged equidistantly, and the first-level micro-grooves of the micron level are formed between the first-level micro-structure units. It is a micro-protrusion array or a micro-groove array. The micro-protrusion array is formed by equidistant arrangement of a plurality of micron-level protrusions, and a micron-level secondary micro-groove is formed between each micron-level protrusion. The micro-groove array consists of A plurality of micron-scale grooves are arranged equidistantly, and the distance between adjacent micron-scale grooves is micron-scale; the surface of the implant body is provided with a nano-scale tubular array and is coated with a biologically active protein coating. The invention can enhance the combination between the substrate and the coating, enhance the biocompatibility of the implant, and prevent the infection without bringing about the problem of drug resistance.
Description
Technical Field
The invention relates to the technical field of implant surface design and manufacturing, in particular to an orthopedic implant with a multistage micro-nano structure and a manufacturing method thereof.
Background
With the continuous development of modern medical systems, orthopedic implants play an important role in surgical operations, and as a medical instrument working in the human body for a long time, whether the structure of the orthopedic implant is safe, stable and effective or not directly affects the life health and safety of patients is very important. However, when implanted into the body in a complex physiological environment of the human body, the implant is influenced by physical, chemical, bioelectricity and other factors for a long time, has poor biocompatibility and bone ingrowth performance, and has the problems of difficult stable embedding with body cell tissues, easy initiation of inflammation, infection and the like of a patient. The main solution at the present stage is to perform surface modification treatment on the orthopedic implant, and then coat a layer of coating containing anti-inflammatory drugs on the surface of the orthopedic implant. The current methods for major surface modification include mechanical methods represented by micro-milling and shot peening, chemical methods represented by thermokalite, acid etching, anodic oxidation and micro-arc oxidation, and physical methods represented by physical deposition and plasma spraying.
The surface modification of the existing orthopedic implant is mainly to process a microstructure with specific roughness, but most of the design and processing methods can only process a simple primary microstructure, such as an orthogonal micro-groove array or a micro-pit array, the design of the microstructure is often single in functionality, the influence on the key performances of the implant, such as biocompatibility, antibacterial property and the like, is weak, the embedding between a coating and a substrate is also influenced to a certain extent, and the practicability is weak. In addition, although the drug-containing coating can prevent inflammation and infection to some extent, it also has the disadvantages of short effective drug action time and easy drug resistance.
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 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: cleaning the implant obtained in the step S3, drying, activating the implant by adopting an activating agent, and then carrying out 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.
Preferably, the implant blank is made of medical titanium alloy material, and in S3, the generated nano-scale tubular array is TiO 2 An array of nanotubes.
Preferably, in S3, after the nano-scale tubular array is generated, the implant is subjected to a heat treatment to convert the crystal structure of the nano-scale tubular array from the amorphous state to the rutile phase.
Preferably, in S4, the coupling modification time is 16 to 20 hours.
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.A micron-grade primary microstructure array is arranged on an implant body and is formed by equidistantly arranging a plurality of micron-grade primary microstructure units, a micron-grade secondary microstructure array is arranged on each primary microstructure unit and is a micro-protrusion array or a micro-groove array, so that the surface area of the implant body is increased, more space is provided for the generation of a nano-grade tubular array, and the nano-grade tubular array structure can stimulate cell surface protein, guide osteoblast to adhere and promote the osteoblast to rapidly proliferate, thereby enhancing the embedding force of a bioactive protein coating and the surface of the implant and enhancing the biocompatibility of the implant.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required in the embodiments will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art that other drawings can be obtained according to the drawings without creative efforts.
Fig. 1 is a schematic structural diagram of an orthopedic implant with a multistage micro-nano structure in an embodiment;
FIG. 2 is a schematic diagram of a secondary microstructure array on the primary microstructure unit of FIG. 1;
in the figure: 100-an orthopedic implant with a multistage micro-nano structure, 1-an implant body, 2-a primary microstructure unit, 3-a primary micro groove, 4-a polygonal prism and 5-a secondary micro groove.
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 obtained by a person skilled in the art without making any creative effort based on the embodiments in the present invention, belong to 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; the surface of the implant body 1 is provided with a nano-scale tubular array and is coated with a bioactive protein coating.
The primary microstructure array on the implant body 1 is preferably hundred micrometers, the primary microstructure array is preferably formed by arranging a plurality of hundred-micrometer primary microstructure units 2 at equal intervals, the secondary microstructure array on each primary microstructure unit 2 is preferably ten micrometers, and machining is convenient.
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 micro structure 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: cleaning 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 the 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 activator adopts N-hydroxysuccinimide (NHS) and 1- (3-dimethylaminopropyl) -3-ethylcarbodiimide hydrochloride (EDC) to increase the efficiency of the coupling reaction; and in S4 and S5, the implant is cleaned by 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.
The implant blank is made of medical titanium alloy material, and in S3, the generated nano-scale tubular array is TiO 2 The 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, infection is prevented, and meanwhile, the drug resistance problem is not caused.
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.
Claims (9)
1. The utility model provides an orthopedics implant with multistage micro-nano structure, includes the implant body, its characterized in that: the implant body is provided with a micron-sized primary microstructure array, the primary microstructure array is formed by equidistantly arranging a plurality of micron-sized primary microstructure units, micron-sized primary micro grooves are formed among the primary microstructure units, micron-sized secondary microstructure arrays are arranged on the primary microstructure units, the secondary microstructure arrays are ten micron-sized structures, the secondary microstructure arrays are micro-protrusion arrays or micro-groove arrays, the micro-protrusion arrays are formed by equidistantly arranging a plurality of micron-sized protrusions, micron-sized secondary micro grooves are formed among the micron-sized protrusions, the micro-groove arrays are formed by equidistantly arranging a plurality of micron-sized grooves, and the distance between every two adjacent micron-sized grooves is micron; the surface of the implant body is provided with a nano-scale tubular array and is coated with a bioactive antibacterial polymeric protein coating.
2. The orthopedic implant with a multistage micro-nano structure according to claim 1, characterized in that: 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 among the micron-sized polygon prisms; the micro-groove array is a micro-pit 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.
3. The orthopedic implant with a multistage micro-nano structure according to claim 1, characterized in that: the micro-groove array is a micro-groove array, the micro-groove array is formed by arranging a plurality of micron-sized grooves at equal intervals, and the distance between adjacent micron-sized grooves is micron-sized.
4. The orthopedic implant with a multistage micro-nano structure according to claim 1, characterized in that: the primary microstructure units are micron-sized regular hexagonal prisms or regular quadrangular prisms.
5. The orthopedic implant with multi-level micro-nano structure according to claim 2, characterized in that: the micro-polygon prism array is formed by equidistantly arranging a plurality of micron-sized regular hexagonal prisms.
6. The orthopedic implant with a multistage micro-nano structure according to claim 1, characterized in that: the implant body is made of medical titanium alloy materials, medical stainless steel materials or tantalum metal materials.
7. A manufacturing method of the orthopaedic implant with the multilevel micro-nano structure according to any one of claims 1 to 6, characterized by comprising 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: cleaning the implant obtained in the step S3, drying, activating the implant by using an activating agent, wherein the activating agent is N-hydroxysuccinimide and 1- (3-dimethylaminopropyl) -3-ethylcarbodiimide hydrochloride, and then coupling and modifying the implant in an antibacterial polymeric protein solution for 16 to 20h to obtain the implant with the bioactive protein coating coated on the surface;
s5: the implant obtained in S4 was washed and then air-dried.
8. The manufacturing method of the orthopedic implant with the multistage micro-nano structure according to claim 7, characterized in that: selecting medical titanium alloy material for the implant blank, and in S3, generating a nano tubular array of TiO 2 An array of nanotubes.
9. The method for manufacturing the orthopedic implant with the multistage micro-nano structure according to claim 8, characterized in that: and in S3, after the nano-scale tubular array is generated, carrying out heat treatment on the implant to convert the crystal structure of the nano-scale tubular array from the amorphous state to the rutile phase.
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| WO2003046508A2 (en) * | 2001-11-09 | 2003-06-05 | Biomicroarrays, Inc. | High surface area substrates for microarrays and methods to make same |
| JP2005538809A (en) * | 2002-09-18 | 2005-12-22 | メドトロニック ヴァスキュラー インコーポレイテッド | Controllable drug release gradient coating for medical devices |
| WO2008109886A1 (en) * | 2007-03-08 | 2008-09-12 | The Regents Of The University Of California | Topographically engineered structures and methods for using the same in regenerative medicine applications |
| EP2143451A1 (en) * | 2008-07-11 | 2010-01-13 | Nobel Biocare Services AG | Bone implant application |
| AU2011209612A1 (en) * | 2010-01-28 | 2012-08-16 | President And Fellows Of Harvard College | Structures for preventing microorganism attachment |
| WO2012058605A1 (en) * | 2010-10-28 | 2012-05-03 | 3M Innovative Properties Company | Engineered surfaces for reducing bacterial adhesion |
| EP3592283B1 (en) * | 2017-03-10 | 2024-05-08 | Alps Holding Llc | Hard-tissue implant comprising a bulk implant, a face, pillars, slots, and at least one support member |
| CN109125809A (en) * | 2018-08-21 | 2019-01-04 | 华南理工大学 | To inhibit bacterial growth and promote the titanium surface and preparation method thereof of protein adherence |
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