CN114949356A - Orthopedic and neurologic surgical implantation instrument with composite coating and preparation method - Google Patents
Orthopedic and neurologic surgical implantation instrument with composite coating and preparation method Download PDFInfo
- Publication number
- CN114949356A CN114949356A CN202210747940.1A CN202210747940A CN114949356A CN 114949356 A CN114949356 A CN 114949356A CN 202210747940 A CN202210747940 A CN 202210747940A CN 114949356 A CN114949356 A CN 114949356A
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
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- A61L2300/602—Type of release, e.g. controlled, sustained, slow
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
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Abstract
The invention discloses an orthopedic and neurologic department implanting instrument with a composite coating and a preparation method thereof, wherein the method comprises the following steps: processing the substrate into a shape required by the implantation instrument; selecting polyether-ether-ketone powder, spraying a layer of polyether-ether-ketone powder on the surface of a base material by using an electrostatic powder spraying method, and putting the base material into a high-temperature oven for curing to form a compact first coating layer; selecting the following polyetheretherketone powder (20-85) according to the mass fraction ratio: pore-foaming agents (5-75) are mixed to form compound powder; and spraying the compound powder on the first coating, and carrying out hot melting, curing and elution to form a porous second coating. In the technical scheme of the invention, the compact polyether-ether-ketone coating can prevent metal ions of the metal implant from being separated out in a human body, the elastic modulus of the polyether-ether-ketone material is close to that of cortical bone, the stress shielding effect can be weakened or avoided, the second film coating with micron-sized holes is formed, and the attachment and fusion of cells are beneficial to tissue adsorption and bone growth.
Description
Technical Field
The invention relates to the technical field of medical orthopedics and neurology/surgical implantation instruments, in particular to an orthopedics and neurology/surgical implantation instrument with a composite coating and a preparation method thereof.
Background
The existing orthopedic and neuro-endo/surgical implantation instruments are mostly made of metal materials, and the traditional hard tissue implantation metal materials such as stainless steel, titanium and alloy thereof have high mechanical strength, good biocompatibility, fatigue resistance and other excellent performances. However, the elastic modulus of these conventional metal implant materials is much higher than that of bone tissue, so that it is difficult to form reasonable gradient strength, and the patient may damage surrounding normal organs after being subjected to a special external force, which eventually results in implant failure, i.e. a so-called "stress shielding" effect. At the same time, there is also a precipitation of metal atoms, which leads to osteolysis or the formation of allergens.
Disclosure of Invention
The invention mainly aims to provide an orthopedic and neurologic surgical implantation instrument with a composite coating and a preparation method thereof, aiming at solving the problems that the existing orthopedic and neurologic/surgical implantation instruments are mostly made of metal materials to generate the so-called stress shielding effect and have metal precipitation, and simultaneously solving the problem that PEEK materials have lower surface energy due to the relatively hydrophobic surface thereof so as to limit the adhesion of cells. So that the bone integration capability between the PEEK material implant and host bone tissues is poor.
In order to achieve the purpose, the invention provides a preparation method of an orthopedic and neurology department implantation instrument with a composite coating, which comprises the following steps:
processing the substrate into a shape required by the implantation instrument;
selecting polyether-ether-ketone powder with the particle size of 5-100 um, spraying a layer of polyether-ether-ketone powder on the surface of a base material by using an electrostatic powder spraying method, and putting the base material sprayed with the polyether-ether-ketone powder into a high-temperature oven, wherein the temperature range of the high-temperature oven is 360-460 ℃, and the baking time is 0.5-20 min, so as to form a first dense film coating with the thickness range of 0.1-0.5 mm;
selecting polyetheretherketone powder with the particle size of 5-100 um and pore-forming agent with the particle size of 100-900 um, and mixing the selected polyetheretherketone powder (20-85) according to the following mass percent: pore-foaming agents (5-75) are mixed to form compound powder;
spraying the compound powder on the first film coating by using an electrostatic powder spraying method, and baking the base material sprayed with the compound powder in a high-temperature oven at the temperature of 360-460 ℃ for 1-30 min;
after baking, the second coating with the thickness of 0.01mm-1.0mm, the aperture of 10um-900um and the porosity of 8-80% is formed by elution.
Preferably, the polyetheretherketone powder with the particle size of 5um-100um is selected, and the pore-forming agent with the particle size of 100um-900um is prepared by the following steps of (20-85): pore-forming agent (5-75), mixing to form compound powder, comprising:
selecting polyetheretherketone powder with the particle size of 5-100 um, pore-forming agent with the particle size of 100-900 um, and bioactive material powder with the particle size of 150-950 nm; selecting polyetheretherketone powder (20-85) according to the following mass fraction: porogen (5-75): bioactive material powder (5-50), and mixing to form compound powder.
Preferably, the pore-foaming agent is safe and non-toxic, the melting point of the pore-foaming agent is more than or equal to 600 ℃, and the pore-foaming agent is dissolved in water.
Preferably, the step of eluting after baking to form a second coating layer comprises: and (3) after baking, putting the coated substrate into pure water at the temperature of 25-60 ℃ for elution, so that the pore-foaming agent solvent in the coating is discharged, and a second coating is formed.
Preferably, the pore-forming agent comprises one or more of sodium chloride, sucrose, sodium bicarbonate and sodium carbonate.
Preferably, the bioactive material powder comprises hydroxyapatite and/or bioglass.
Preferably, the step of eluting after baking to form a second coating layer comprises:
and adsorbing the drug on the second film coating to form the drug coating.
Preferably, include the substrate, cover in proper order first tectorial membrane coating and second tectorial membrane coating on the substrate, first tectorial membrane coating is the polyetheretherketone coating that thickness is 0.1mm-0.5mm, the second tectorial membrane coating includes polyetheretherketone material, second tectorial membrane coating thickness is 0.15mm-1.0mm, second tectorial membrane coating aperture is 100um-900um, the porosity of second tectorial membrane coating is 5% -80%.
Preferably, the second coating comprises a polyetheretherketone material and a bioactive material.
Preferably, a drug coating is disposed on the second cover film coating.
According to the technical scheme, the first coating is a compact polyether-ether-ketone coating, so that metal ions in a human body of a metal implant can be prevented from being separated out, the second coating with micron-sized holes is formed outside the first coating in a spraying mode, cell attachment and fusion are facilitated for tissue adsorption and bone growth, the connection strength of the orthopedic and neuro/surgical implant and the human body tissue is improved, the elastic modulus of the polyether-ether-ketone material is close to that of cortical bone, and the polyether-ether-ketone coating can weaken or avoid the stress shielding effect.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the structures shown in the drawings without creative efforts.
FIG. 1 is a schematic structural diagram of an orthopaedic and neuro-surgical implantation instrument with a composite coating according to the present invention.
The reference numbers illustrate:
| reference numerals | Name (R) | Reference numerals | Name (R) | Reference numerals | Name (R) |
| 1 | |
2 | |
3 | Second film coating |
The implementation, functional features and advantages of the objects of the present invention will be further explained with reference to the accompanying drawings.
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.
It should be noted that all the directional indicators (such as up, down, left, right, front, and rear … …) in the embodiment of the present invention are only used to explain the relative position relationship between the components, the movement situation, etc. in a specific posture (as shown in the drawing), and if the specific posture is changed, the directional indicator is changed accordingly.
In addition, the descriptions related to "first", "second", etc. in the present invention are only for descriptive purposes and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of the feature. In the description of the present invention, "a plurality" means at least two, e.g., two, three, etc., unless specifically limited otherwise.
In the present invention, unless otherwise expressly stated or limited, the terms "connected," "secured," and the like are to be construed broadly, and for example, "secured" may be a fixed connection, a removable connection, or an integral part; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or they may be connected internally or in any other suitable relationship, unless expressly stated otherwise. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.
In addition, the technical solutions in the embodiments of the present invention may be combined with each other, but it must be based on the realization of those skilled in the art, and when the technical solutions are contradictory or cannot be realized, such a combination of technical solutions should not be considered to exist, and is not within the protection scope of the present invention.
Referring to fig. 1, the present invention provides a method for preparing an orthopedic and neurologic implant apparatus with a composite coating, comprising:
step S100, processing the base material 1 into a shape required by an implantation instrument;
s200, selecting polyether-ether-ketone powder with the particle size of 5-100 um, spraying a layer of polyether-ether-ketone powder on the surface of a substrate 1 by using an electrostatic powder spraying method, and placing the substrate 1 sprayed with the polyether-ether-ketone powder into a high-temperature oven, wherein the temperature range of the high-temperature oven is 360-460 ℃, and the baking time is 0.5-20 min, so as to form a first dense film coating 2 with the thickness range of 0.1-0.5 mm;
step S300, selecting polyether-ether-ketone powder with the particle size of 5-100 um and pore-forming agent with the particle size of 100-900 um, and mixing the selected powder with the following polyether-ether-ketone powder (20-85) in percentage by mass: pore-foaming agents (5-75) are mixed to form compound powder;
step S400, spraying the compound powder on a first film coating 2 by using an electrostatic powder spraying method, and baking the substrate 1 sprayed with the compound powder in a high-temperature oven at the temperature ranging from 360 ℃ to 460 ℃ for 1min to 30 min;
and S500, eluting after baking to form a second coating with the thickness of 0.01-1.0 mm, the aperture of 10-900 um and the porosity of 8-80%.
In the technical scheme of the invention, the first film coating 2 is a compact polyether-ether-ketone coating which can prevent metal ions of a metal implant from being separated out in a human body, the second film coating 3 with micron-sized holes is formed outside the first film coating 2 in a spraying mode, the attachment and fusion of cells are beneficial to tissue adsorption and bone growth, the connection strength of the orthopedic and neuro/surgical implant and the human body tissue is improved, the elastic modulus of a polyether-ether-ketone material is close to that of cortical bone, and the stress shielding effect can be weakened or avoided.
Specifically, a lower proportion of Poly ether ketone (PEEK) powder than the present invention does not provide excellent adhesion to the surface of the substrate 1 article. When the pore-forming agent is lower than the proportion of the invention, the porosity formed on the surface of the coating is too low to play the roles of energy absorption and cell adhesion. When the proportion of the pore-forming agent is higher than that of the invention, the porosity of the material is too large and the strength is not enough.
More specifically, the particle size of the PEEK powder is less than 5um, the production cost of the PEEK powder is increased, and the PEEK powder is easy to agglomerate and has poor dispersibility. More than 100um, the spray gun nozzle of the electrostatic spray gun is easy to block, the excessive grain diameter is not beneficial to forming a coating below 0.1mm, when the excessive grain diameter is used for electrostatic powder spraying, PEEK powder is unevenly distributed on the surface of a manufactured part, and the phenomenon of uneven thickness of the coating is easy to occur when the PEEK powder is subjected to heating treatment in an oven.
More specifically, the method of electrostatic powder spraying, the step of spraying a layer of polyetheretherketone powder on the surface of the substrate 1 comprises: the voltage for electrostatic powder spraying was: 60KV-100KV, the distance from the nozzle to the workpiece (substrate 1) is as follows: 10cm-40 cm. The higher the voltage, the closer the distance, and the longer the time, the thicker the spray will be.
More specifically, since the coating film is formed on the base material 1 after spraying the PEEK powder, the base material 1 is smaller in size than an original device without the coating film, and the coating film is used to fill the base material to the original size, thereby reducing the weight of the implant and achieving a light weight.
More specifically, the substrate 1 is a metal material or a composite material with a metal material.
In one embodiment of the present invention, Stainless Steel (Stainless Steel) is used as the substrate 1, and both PEEK powder and pore-forming agent are selected to meet medical grade standards. Selecting PEEK powder with the particle size of 5um, spraying a layer of PEEK powder on the surface of the titanium alloy by adopting an electrostatic spraying method, placing the titanium alloy in a 360 ℃ oven for 5min, cooling and solidifying to obtain a PEEK coating with the thickness of 0.05 mm.
Selecting PEEK powder with the particle size of 5um, and selecting sodium chloride with the particle size of 900um as a pore-forming agent. According to PEEK (75): weighing raw materials of the pore-forming agent (25) according to the mass fraction ratio, uniformly mixing the raw materials in a high-speed mixer to form compound powder, spraying a layer of the compound powder on the first film coating 2 with the thickness of 0.05mm by adopting an electrostatic spraying method, placing the film coating in an oven at 380 ℃ for 15min, and cooling and curing to obtain a second film coating 3 with the thickness of 0.5 mm. And (3) placing the product with the second coating layer 3 in flowing pure water at 40 ℃ for eluting for more than 24 hours to obtain the second coating layer 3 with the porosity of 23 +/-3%.
In one embodiment of the present invention, cobalt-based alloy is selected as the substrate 1, and both PEEK powder and pore-forming agent are selected to meet medical grade standards. Selecting PEEK powder with the particle size of 100um, spraying a layer of PEEK powder on the surface of the titanium alloy by adopting an electrostatic spraying method, placing the titanium alloy in a 360-DEG C oven for 5min, cooling and solidifying to obtain a PEEK coating with the thickness of 0.15 mm. Selecting 100um PEEK powder, and selecting 10um sodium chloride as pore-forming agent; according to PEEK (40): weighing raw materials of each component according to the mass fraction ratio of the pore-forming agent (60). And uniformly mixing the components in a high-speed mixer to form compound powder, spraying a layer of the compound powder on the first film coating 2 with the thickness of 0.15mm by adopting an electrostatic spraying method, placing the mixture in a drying oven at the temperature of 380 ℃ for 15min, and cooling and solidifying the mixture to obtain a coating with the thickness of 0.5 mm. And (3) placing the coated product in flowing pure water at 40 ℃ for eluting for more than 24 hours to obtain a second coating layer 3 with the porosity of 36 +/-3%.
In another embodiment of the present invention, the step S300 includes the steps of:
s310, selecting polyether-ether-ketone powder with the particle size of 5-100 um, pore-foaming agents with the particle size of 100-900 um and bioactive material powder with the particle size of 150-950 nm; selecting polyetheretherketone powder (20-85) according to the following mass fraction: porogen (5-75): bioactive material powder (5-50), and mixing to form compound powder.
Specifically, the bioactive material powder is added, so that the second coating layer 3 contains bioactivity, and the second coating layer 3 containing bioactivity has higher bioactivity compared with a pure PEEK material coating layer, so that the healing of the wound is accelerated.
More specifically, the ratio of the bioactive powder is lower than the ratio of the present invention, and sufficient bioactivity cannot be provided to promote healing of the wound. When the proportion of the bioactive powder is higher than that of the present invention, the problem of powder falling exists.
More specifically, the bioactive material powder is required to be uniformly distributed in the PEEK powder, and the bioactive material powder is easy to agglomerate and not easy to disperse when the bioactive particle size is less than 150 nm. Since the maximum thickness of the coating is 1.0mm and PEEK powder must be included to achieve hot-melt adhesion to the metal surface, the bioactive particle size cannot be greater than the thickness of the second coating layer 3, combined with the content of PEEK material therein. Therefore, the particle size of the bioactive material cannot be larger than 950nm, and the larger the thickness of the second coating film layer 3, the larger the bioactive particle size.
In the first embodiment of the present invention, titanium alloy is selected as the substrate 1, and PEEK powder, bioactive material, and pore-forming agent are all selected to meet medical grade standards. Selecting PEEK powder with the particle size of 5um, spraying a layer of PEEK powder on the surface of the titanium alloy by adopting an electrostatic spraying method, placing the titanium alloy in a 360-DEG C oven for 5min, cooling and solidifying to obtain a first film coating 2 with the thickness of 0.05 mm.
Selecting PEEK powder with the particle size of 5um, hydroxyapatite with the particle size of 950nm as a bioactive material, and sodium chloride with the particle size of 900um as a pore-forming agent, wherein the PEEK powder comprises the following components in percentage by mass: 60 parts, bioactive material: 20 parts of pore-forming agent: and 20 parts. Weighing raw materials of the components, uniformly mixing the raw materials in a high-speed mixer to obtain compound powder, spraying a layer of the compound powder on the first film coating 2 with the thickness of 0.05mm by adopting an electrostatic spraying method, placing the film coating in a baking oven at 380 ℃ for 15min, cooling and solidifying to obtain a coating with the thickness of 0.5 mm. And (3) placing the coated product in flowing pure water at 40 ℃ for eluting for more than 24 hours to obtain the second coating layer 3 with the porosity of 23 +/-3% and the bioactivity.
In the second embodiment of the present invention, titanium alloy is selected as the substrate 1, and PEEK powder, bioactive material, and pore-forming agent are all selected to meet medical grade standards. Selecting PEEK powder with the particle size of 100um, spraying a layer of PEEK powder on the surface of the titanium alloy by adopting an electrostatic spraying method, placing the titanium alloy in a 360-DEG C oven for 5min, cooling and solidifying to obtain a first film coating 2 with the thickness of 0.15 mm. According to the proportion of PEEK: 20 parts, bioactive material: 50 parts of pore-forming agent: 30 parts of PEEK powder with the particle size of 100um, bioglass with the particle size of 150nm and sodium chloride with the particle size of 10um as a pore-forming agent. Weighing the raw materials of the components, uniformly mixing the raw materials in a high-speed mixer, spraying a layer of the compound powder on the first film coating 2 with the thickness of 0.15mm by adopting an electrostatic spraying method, placing the film coating in a baking oven at 380 ℃ for 15min, and cooling and solidifying the film coating to obtain a coating with the thickness of 0.5 mm. And (3) placing the coated product in flowing pure water at 40 ℃ for eluting for more than 24 hours to obtain the second coating layer 3 with the porosity of 36 +/-3% and the bioactivity.
In the third embodiment of the present invention, titanium alloy is selected as the base material 1, and PEEK powder, bioactive material, and pore-forming agent are all selected to meet medical grade standards. Selecting PEEK powder with the particle size of 50um, spraying a layer of PEEK powder on the surface of the titanium alloy by adopting an electrostatic spraying method, placing the titanium alloy in a 360-DEG C oven for 5min, cooling and solidifying to obtain a first film coating 2 with the thickness of 0.05 mm. Selecting PEEK powder with the particle size of 50um, hydroxyapatite with the particle size of 600nm as a bioactive material, and sodium chloride with the particle size of 60um as a pore-forming agent. According to the proportion of PEEK: 50 parts, bioactive material: 10 parts of pore-forming agent: 40 parts, weighing the raw materials of the components, uniformly mixing the raw materials in a high-speed mixer to obtain compound powder, spraying a layer of the compound powder on the first film coating 2 with the thickness of 0.05mm by adopting an electrostatic spraying method, placing the film coating in a baking oven at 380 ℃ for 15min, and cooling and solidifying the film coating to obtain a coating with the thickness of 0.5 mm. And (3) placing the coated product in flowing pure water at 40 ℃ for eluting for more than 24 hours to obtain the second coating layer 3 with the porosity of 45 +/-3% and the bioactivity.
In the fourth embodiment of the present invention, titanium alloy is selected as the base material 1, and PEEK powder, bioactive material, and pore-forming agent are all selected to meet medical grade standards. Selecting PEEK powder with the particle size of 80 micrometers, spraying a layer of PEEK powder on the surface of the titanium alloy by adopting an electrostatic spraying method, placing the titanium alloy in a baking oven at 360 ℃ for 5min, and cooling and solidifying to obtain a first film coating 2 with the thickness of 0.05 mm. Hydroxyapatite with the grain diameter of 200nm is selected as a bioactive material, and sodium chloride with the grain diameter of 300um is selected as a pore-forming agent. According to the proportion of PEEK: 20 parts, bioactive material: 5 parts of pore-forming agent: 75 parts of PEEK with the particle size of 30 micrometers, weighing raw materials of the components, uniformly mixing the raw materials in a high-speed mixer to obtain compound powder, spraying a layer of the compound powder on the first film coating 2 with the thickness of 0.05mm by adopting an electrostatic spraying method, placing the first film coating in an oven at 380 ℃ for 15min, and cooling and curing to obtain a coating with the thickness of 0.2 mm. The product with the coating is put into flowing pure water with the temperature of 30 ℃ for elution for more than 24 hours, and the second film coating 3 with the porosity of 78 +/-3 percent and the bioactivity is obtained.
In the fifth embodiment of the present invention, titanium alloy is selected as the base material 1, and PEEK powder, bioactive material, and pore-forming agent are all selected to meet medical grade standards. Selecting PEEK powder with the particle size of 60um, spraying a layer of PEEK powder on the surface of the titanium alloy by adopting an electrostatic spraying method, placing the titanium alloy in a baking oven at 385 ℃ for 5min, and cooling and solidifying to obtain a first film coating 2 with the thickness of 0.025 mm. Selecting PEEK powder with the particle size of 30um, selecting bioglass with the particle size of 500nm as a bioactive material, and selecting sodium bicarbonate with the particle size of 600um as a pore-forming agent. According to the proportion of PEEK: 85 parts, bioactive material: 10 parts of pore-forming agent: 5 parts, weighing the raw materials of the components, uniformly mixing the raw materials in a high-speed mixer to obtain compound powder, spraying a layer of the compound powder on the first film coating 2 with the thickness of 0.025mm by adopting an electrostatic spraying method, placing the film coating in a baking oven at 380 ℃ for 15min, and cooling and solidifying to obtain a coating with the thickness of 0.5 mm. And (3) putting the product with the coating in flowing pure water at 30 ℃ for eluting for more than 24 hours to obtain the second coating layer 3 with the porosity of 8 +/-3% and the bioactivity.
The first to fifth examples and the control group were subjected to the following performance tests:
and (3) titanium ion precipitation: referring to YY/T4802-2021, the sample is soaked in the artificial simulated body fluid for 7 days, and the content of titanium ions is tested by adopting an inductively coupled plasma mass spectrometer.
And (3) biological activity: cell proliferation was measured by the CCK-8 method to assess material bioactivity. After 1, 3 and 5 days of cell culture, the original culture medium was discarded and fresh culture medium containing 10% CCK-8 was added to each well. After further culturing in an incubator at 37 ℃ for 2 hours, 100. mu.L of the culture solution per well was taken out to a corresponding 96-well plate, and the absorbance value at a wavelength of 450nm was measured using a microplate reader.
And testing the sample by referring to a GJB 981-90 viscoelastic damping material forced non-resonance dynamic test method, representing the energy absorption effect of the sample, and obtaining the loss coefficient.
The samples were tested for thermal conductivity with reference to ASTM-E1461.
The control group used the same materials as the examples, oven and spray equipment to control experimental variables
Control group 1:
no first film coating; selecting PEEK powder with the particle size of 50um, selecting hydroxyapatite with the particle size of 600nm as a bioactive material, selecting sodium chloride with the particle size of 60um as a pore-forming agent, and mixing the second film-coated coating with the composite powder according to the proportion of PEEK: 50 parts, bioactive material: 10 parts of pore-forming agent: 40 parts of the components. Weighing raw materials of the components, uniformly mixing the raw materials in a high-speed mixer, spraying a layer of the compound powder on the surface of the titanium alloy by adopting an electrostatic spraying method, placing the titanium alloy in a baking oven at 380 ℃ for 15min, and cooling and solidifying to obtain a first film coating 2 with the thickness of 0.5 mm. And (3) placing the coated product in flowing pure water at 40 ℃ for eluting for more than 24 hours to obtain the second coating layer 3 with the porosity of 45 +/-3% and the bioactivity.
Control group 2:
selecting PEEK powder with the particle size of 50um, spraying a layer of PEEK powder on the surface of the titanium alloy by adopting an electrostatic spraying method, placing the titanium alloy in a 360-DEG C oven for 5min, cooling and solidifying to obtain a first film coating 2 with the thickness of 0.05 mm. Selecting PEEK powder with the particle size of 50um, selecting hydroxyapatite with the particle size of 600nm as a bioactive material, and mixing the PEEK powder with the hydroxyapatite powder: 50 parts, bioactive material: 50 parts, weighing the raw materials of the components, uniformly mixing in a high-speed mixer, spraying a layer of the compound powder on the first film coating 2 with the thickness of 0.05mm by adopting an electrostatic spraying method, placing in a 380 ℃ oven for 15min, cooling and solidifying to obtain a second film coating 3 with the thickness of 0.5 mm.
Control group 3:
selecting PEEK powder with the particle size of 50um, spraying a layer of PEEK powder on the surface of the titanium alloy by adopting an electrostatic spraying method, placing the titanium alloy in a 360-DEG C oven for 5min, cooling and solidifying to obtain a first film coating 2 with the thickness of 0.05 mm. Selecting PEEK powder with the particle size of 50um, and selecting sodium chloride with the particle size of 60um as a pore-forming agent: according to the PEEK powder: 50 parts, sodium chloride: 50 parts of the raw materials. Weighing raw materials of the components, uniformly mixing the raw materials in a high-speed mixer, spraying a layer of the compound powder on a first coating 2 with the thickness of 0.05mm by adopting an electrostatic spraying method, placing the mixture in a baking oven at 380 ℃ for 15min, and cooling and solidifying the mixture to obtain a second coating 3 with the thickness of 0.5 mm.
Control group 4:
the surface is not coated.
The results of the experiments are shown in the following table:
the results of the experiment were analyzed as follows:
the first example and the control 2 are different in that the control 1 has no first coating layer, and the first example has no metal ion deposition as compared with the control 1.
The first example and the control 2 are different in that the second coating layer 3 of the control 2 does not have a pore-forming agent, the second coating layer does not generate micropores, and the biological activity (OD value) of the first example is higher than that of the control 2.
The first example and the control group 3 are different in that the second coating layer 3 of the control group 2 has no bioactive substance and the bioactivity (OD value) of the first example is high compared to the control group 3.
In yet another embodiment of the present invention, the porogen is safe and non-toxic, the melting point of the porogen is greater than or equal to 600 ℃, and the porogen is soluble in water.
In another embodiment of the present invention, the step S500 includes:
and step S510, after baking, putting the coated substrate into pure water at the temperature of 25-60 ℃ for elution, so that the pore-foaming agent solvent in the coating is discharged, and a second coating layer 3 is formed.
Specifically, pure water is used for elution to prevent other chemical substances from causing modification of the PEEK material, and the temperature is related to the elution speed of the coating, wherein the higher the temperature is, the faster the elution speed is, more specifically, the temperature is 60-100 ℃, and the temperature does not exceed the temperature of the pure water.
In another embodiment of the present invention, the pore-forming agent comprises one or more of sodium chloride, sucrose, sodium bicarbonate and sodium carbonate.
In yet another embodiment of the present invention, the bioactive material powder comprises hydroxyapatite and/or bioglass.
Specifically, the second coating layer 3 contains hydroxyapatite and/or bioglass, and has biological activity and is capable of promoting tissue growth.
In another embodiment of the present invention, after the step S500, the method includes:
step S511, the drug is adsorbed on the 3 to form a drug coating.
Specifically, the method comprises the following steps:
step S512, the medicine solution powder or the medicine mixed solution is sprayed or dipped on the surface of the second coating layer 3 to form a medicine coating.
The invention also provides an orthopedic and neurologic and surgical implantation instrument with the composite coating, which comprises a base material 1, and a first coating 2 and a second coating 3 which are sequentially covered on the base material 1, wherein the first coating 2 is a polyether-ether-ketone coating with the thickness of 0.1-0.5 mm, the second coating 3 comprises a polyether-ether-ketone material, the thickness of the second coating 3 is 0.15-1.0 mm, the pore diameter of the second coating 3 is 100-900 um, and the porosity of the second coating 3 is 5-80%.
Specifically, the invention sprays a layer of PEEK material on the surface of the metal implant to form a compact film layer. The metal implant is isolated from being contacted with body fluid and tissues of a human body, and the separation of metal ions is avoided.
In order to solve the problems of high elastic modulus and high heat conductivity coefficient of the metal implant, the invention coats a PEEK material (a first film coating layer 2) on the outer layer of a base material 1, and then coats a PEEK porous material (a second film coating layer 3), when an appliance is subjected to external force, the inner and outer PEEK material coatings can play a role in energy absorption and vibration reduction, the plastic deformation capacity is endowed to the implantation appliance, and the stress shielding effect generated by overhigh elastic modulus and rigidity of the pure metal implant is solved. Meanwhile, the PEEK coating can effectively reduce the heat conductivity coefficient of the implantation instrument, avoids discomfort of a human body caused by severe temperature change, is provided with micron-sized holes, is beneficial to cell attachment and fusion, tissue adsorption and bone growth, and improves the connection strength of the implant and the human body tissue.
In yet another embodiment of the present invention, the second coating layer 3 comprises a polyetheretherketone material and a bioactive material.
In particular, PEEK coatings suffer from bio-inertness. Compared with a pure PEEK coating, the PEEK porous coating containing the biological activity has higher biological activity and accelerates the healing of a wound.
In yet another embodiment of the present invention, a drug coating is disposed on the second coating layer 3.
Specifically, the drug coating comprises drugs with hemostatic or/and anti-inflammatory effects, and the anti-inflammatory drugs comprise one or more of antibiotics such as quinolones-removing penicillins (such as amoxicillin and the like), cephalosporins (such as ceftriaxone and the like), aminoglycosides (such as gentamicin, amikacin and the like), tetracyclines (such as mibocyclins and the like), macrolides (such as roxithromycin, azithromycin and the like), corticosteroids (such as dexamethasone and the like); the hemostatic medicament comprises a hemostatic agent comprising blood coagulation factors (blood coagulation factors I, II, III, IV, V, VI, VII, VIII, IX, X, XI, XII, Xlll and the like), prothrombin complex and thrombin, anluo blood, hemostatic aronic acid, hemostatic sensitivity, vitamin K1, vitamin K3, vitamin K4, acetic glycine ethylenediamine, carbazochrome sodium sulfonate, aminocyclic acid, aminocaproic acid and snake venom, a device with a porous second coating layer 3 is immersed in the medicament (solution or powder), and the medicament is adsorbed and stored in the pores through capillary action of the pores. After being implanted into human body, the medicine is dissolved in body fluid under the moistening of body fluid to stop bleeding and/or diminish inflammation. Has the characteristics of quick release and quick response.
In another embodiment of the present invention, the drug coating layer comprises a drug with hemostatic or/and anti-inflammatory effects, and one or more of PE (polyethylene), EVA (vinyl acetate), polylactic-co-glycolic acid (PLGA), polyurethane, hyaluronic acid, hydrogel, phospholipid polymer, parylene and derivatives thereof, and polyvinyl carbonate to form a mixed solution, and the mixed solution is sprayed or dipped on the surface of the porous second coating layer 3 to form a drug coating layer, which cannot be rapidly released due to the drug being encapsulated, thereby having a sustained release function. Can be used for long-term implantation instruments.
The above description is only a preferred embodiment of the present invention, and not intended to limit the scope of the present invention, and all modifications and equivalents of the present invention, which are made by the contents of the present specification and the accompanying drawings, or directly/indirectly applied to other related technical fields, are included in the scope of the present invention.
Claims (10)
1. A preparation method of an orthopedic and neurologic surgical implantation instrument with a composite coating is characterized by comprising the following steps:
processing the substrate into a shape required by the implantation instrument;
selecting polyether-ether-ketone powder with the particle size of 5-100 um, spraying a layer of polyether-ether-ketone powder on the surface of a base material by using an electrostatic powder spraying method, and putting the base material sprayed with the polyether-ether-ketone powder into a high-temperature oven, wherein the temperature range of the high-temperature oven is 360-460 ℃, and the baking time is 0.5-20 min, so as to form a first dense film coating with the thickness range of 0.1-0.5 mm;
selecting polyetheretherketone powder with the particle size of 5-100 um and pore-forming agent with the particle size of 100-900 um, and mixing the selected polyetheretherketone powder (20-85) according to the following mass percent: pore-foaming agents (5-75) are mixed to form compound powder;
spraying the compound powder on the first film coating by using an electrostatic powder spraying method, and baking the base material sprayed with the compound powder in a high-temperature oven at the temperature ranging from 360 ℃ to 460 ℃ for 1min to 30 min;
after baking, the second coating with the thickness of 0.01mm-1.0mm, the aperture of 10um-900um and the porosity of 8-80% is formed by elution.
2. The method for preparing the implanting apparatus with the composite coating for orthopaedics and neurology and surgery as claimed in claim 1, wherein the polyetheretherketone powder with the particle size of 5um-100um is selected, the pore-forming agent with the particle size of 100um-900um is prepared by mixing the polyetheretherketone powder (20-85) with the pore-forming agent according to the following mass fraction ratio: pore-forming agent (5-75), mixing to form compound powder, comprising:
selecting polyether-ether-ketone powder with the particle size of 5-100 um, pore-foaming agent with the particle size of 100-900 um and bioactive material powder with the particle size of 150-950 nm; selecting polyetheretherketone powder (20-85) according to the following mass fraction: porogen (5-75): bioactive material powder (5-50), and mixing to form compound powder.
3. The method for preparing an orthopedic and neurologic surgical implantation instrument with a composite coating according to claim 1, wherein the pore-forming agent is safe and non-toxic, the melting point of the pore-forming agent is not less than 600 ℃, and the pore-forming agent is soluble in water.
4. The method for preparing an orthopedic and neurologic implant device with a composite coating according to claim 3, wherein the step of eluting after baking to form a second coating comprises: and (3) after baking, putting the coated substrate into pure water at the temperature of 25-60 ℃ for elution, so that the pore-foaming agent solvent in the coating is discharged, and a second coating is formed.
5. The method for preparing an orthopedic and neurologic surgical implantation instrument with a composite coating according to claim 2, wherein the pore-forming agent comprises one or more of sodium chloride, sucrose, sodium bicarbonate and sodium carbonate.
6. The method for preparing an orthopaedic and neuro-surgical implant device with a composite coating according to claim 2, wherein the bioactive material powder comprises hydroxyapatite and/or bioglass.
7. The method for preparing an orthopedic and neurologic implant device with a composite coating according to claim 1, wherein the step of eluting after baking to form a second coating layer comprises:
and adsorbing the drug on the second film coating to form the drug coating.
8. The utility model provides an orthopedics and department of neurology implants apparatus with composite coating, its characterized in that includes the substrate, covers in proper order first tectorial membrane coating and second tectorial membrane coating on the substrate, first tectorial membrane coating is the polyether ether ketone coating that thickness is 0.1mm-0.5mm, second tectorial membrane coating includes polyether ether ketone material, second tectorial membrane coating thickness is 0.15mm-1.0mm, second tectorial membrane coating aperture is 100um-900um, the porosity of second tectorial membrane coating is 5% -80%.
9. The orthopaedic and neurosurgical implant apparatus having a composite coating according to claim 8, wherein the second coating comprises a polyetheretherketone material and a bioactive material.
10. The orthopaedic and neurosurgical implant apparatus having a composite coating of claim 8, wherein the second film coating has a drug coating disposed thereon.
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| CN118924953A (en) * | 2024-07-18 | 2024-11-12 | 华中科技大学 | A polyetheretherketone-silicon nitride composite nanobiological coating and its preparation process |
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