KR20200140673A - Coating structure of orthopedic endoprosthesis and method for modifying orthopedic endoprosthesis surface - Google Patents

Abstract

A surface coating structure of a surgical prosthesis according to an embodiment of the present invention can include: a first coating layer that is formed on one surface of the surgical prosthesis and includes an amino compound for surface adhesion; a second coating layer that is formed on one surface of the first coating layer and includes a fluorine compound that provides hydrophobicity to the surface coating structure of the surgical implant; and a third coating layer that is formed on one surface of the second coating layer and includes a lubricating component for preventing adhesion of biomaterials present in an object into which the surgical implant is inserted.

Description

Surface coating structure of surgical prosthesis and method for modifying surface of surgical prosthesis based thereon {Coating structure of orthopedic endoprosthesis and method for modifying orthopedic endoprosthesis surface}

The present invention relates to a surface coating structure of a surgical prosthesis, a surface-modified surgical prosthesis, and a method for modifying the surface of a surgical prosthesis based on the same.

Infection that occurs after orthopedic surgery is one of the important complications that can prolong the treatment period and increase the cost of the patient's treatment, and lead to the death of the patient. Legal problems may arise. There are several causes of infection that occur after orthopedic surgery, such as diabetes, immunity, and nutritional deficiencies, such as the patient's health status and external environmental factors during surgery.

In particular, in orthopedic surgery, artificial implants are used a lot. Infection around the implant is not very frequent, but once infected, treatment is not easy and most of the treatment proceeds in the direction of removing the implant. Whether or not microorganisms adhere to the surface of the prosthesis is a major concern in the occurrence of such infection.

When microorganisms are attached to the surface of the artificial implant, a biological film may be formed by combining a substance produced and secreted by the attached microorganisms and the proliferated microorganisms. In this case, antibiotics, etc., are administered to remove microorganisms existing inside the formed biological membrane, but a large amount of antibiotics, etc., to the extent that the microorganisms existing inside the biological membrane can be removed by the already formed biological membrane, do not reach the microorganism. can not do it. A method of manufacturing an artificial implant in consideration of the above difficulties has been developed.

For example, Korean Patent Application Publication No. 10-2008-0068853 discloses a method of depositing distinct nanoparticles on an implant surface.

The present invention provides a surface coating structure of a surgical prosthesis, a surface-modified surgical prosthesis, and a method for modifying the surface of a surgical prosthesis based on the same in order to solve the above-described conventional problems.

The surface coating structure of the surgical prosthesis according to an embodiment of the present invention for achieving the above object is formed on the surface of the surgical prosthesis, a first coating layer comprising an amino compound for surface adhesion, the first A second coating layer formed on one surface of the coating layer and containing a fluorine compound that imparts hydrophobicity to the surface coating structure of the surgical prosthesis, and formed on one surface of the second coating layer, in the object into which the surgical prosthesis is inserted It may include a third coating layer containing a lubricating component for preventing the adhesion of existing biomaterials.

The surface-modified prosthesis according to another embodiment of the present invention for achieving the above object is an prosthesis inserted into the fracture site in order to fix the fracture site, and is formed on the surface of the prosthesis. A first coating layer containing an amino compound for, formed on one surface of the first coating layer, a second coating layer containing a fluorine compound that imparts hydrophobicity to the surface coating structure of the artificial implant, and formed on one surface of the second coating layer, , It may include a third coating layer including a lubricating component for preventing the adhesion of the biological material present in the object into which the surgical prosthesis is inserted.

A method for modifying the surface of a surgical prosthesis according to another embodiment of the present invention for achieving the above object is, in order to create a surface coating structure for the surgical prosthesis, a first comprising an amino compound for surface adhesion Forming a coating layer on the surface of the surgical prosthesis, forming a second coating layer containing a fluorine compound that imparts hydrophobicity to the surface coating structure of the surgical prosthesis on one surface of the first coating layer, and the surgery It may include the step of forming a third coating layer including a lubricating component for preventing the adhesion of the biological material present in the object to be inserted into the implant for the second coating layer.

The surface coating structure of a surgical prosthesis according to an embodiment of the present invention, a surface-modified surgical prosthesis, and a method of modifying the surface of a surgical prosthesis based on the same, suppress the occurrence of infection due to bacterial adhesion on the prosthesis. In addition, by inhibiting the adhesion of inflammatory factors such as blood proteins, immune rejection is fundamentally suppressed, thereby reducing patient pain.

1 is a reference diagram illustrating a problem of a conventional surgical implant.
FIG. 2 is a view schematically showing a state in which a surface-modified surgical implant is inserted into an object according to an embodiment of the present invention, and is a view showing an enlarged state of a part of the surface of the surgical implant.
3 is an enlarged view of a part of the surface of the surgical prosthesis of FIG.
4 is a diagram schematically showing a process of generating a surface coating structure for a surgical implant according to an embodiment of the present invention.
5 is a reference diagram illustrating a shape in which an artificial implant 10 is inserted into a fracture site of an animal according to an embodiment of the present invention.
6 is a flow chart showing a method of modifying the surface of a surgical implant according to an embodiment of the present invention.
7 is a flow chart showing a method of modifying the surface of a surgical implant according to another embodiment of the present invention.
8 is a view showing the results of an experiment to confirm the performance of the orthopedic prosthesis according to an embodiment of the present invention.
9 is a view showing the results of an experiment to confirm the performance of an orthopedic prosthesis according to an embodiment of the present invention.

In order to fully understand the present invention, the operational advantages of the present invention, and the objects achieved by the implementation of the present invention, reference should be made to the accompanying drawings illustrating preferred embodiments of the present invention and the contents described in the accompanying drawings.

Hereinafter, the present invention will be described in detail by describing a preferred embodiment of the present invention with reference to the accompanying drawings. However, the present invention may be implemented in various different forms, and is not limited to the described embodiments. Further, in order to clearly describe the present invention, parts not related to the description are omitted, and the same reference numerals in the drawings indicate the same members.

Hereinafter, an embodiment of the present invention will be described in detail with reference to the accompanying drawings. In addition, in describing the present invention, when it is determined that a detailed description of a related known configuration or function may obscure the subject matter of the present invention, a detailed description thereof may be omitted.

1 is a reference diagram illustrating a problem of a conventional surgical implant. As shown in Fig. 1, the surgical implant 10 coated by the conventional method 11 is inserted into the fracture site in the body and after a certain period of time, the fibronectin molecule 12 Is generated, the piperonetin molecule and the receptor 14 combined with the bacteria 13 in the body are combined to form a biological membrane 17, and the biological membrane 17 thus produced is an antibody 16 and an antibiotic ( 15) There is a problem that is difficult to remove with only the back.

Hereinafter, with reference to the drawings related to the surface coating structure of the surgical prosthesis and the method of modifying the surface of the surgical prosthesis according to an embodiment of the present invention will be described in detail.

2 is a view schematically showing a state in which a surface-modified surgical implant is inserted into an object according to an embodiment of the present invention, and is a view showing an enlarged state of a part of the surface of the surgical implant. It is an enlarged view in which a part of the surface of the surgical implant of FIG. 2 is enlarged.

Referring to Figure 2, the surgical implant 10 according to an embodiment of the present invention may be composed of a first fixed nail 11, a second fixed nail 12 and a third fixed nail. For example, the subject may be a human body, an animal, etc., a place where the first anchoring nail 11 is inserted may be a femur, and a place where the second anchoring nail 12 is inserted may be an acetabulum. , The place where the third fixation nail is inserted may be an area under the femur.

In addition, the shape of the prosthesis shown in FIG. 2 is not limited thereto, and in some cases, the surgical prosthesis 10 may have a shape suitable for a region suitable for a region of the object. That is, it can be used for various parts of the target, such as a hip joint, an elbow joint, and a knee joint of the surgical prosthesis 10.

The surface of the implant 10 of the present invention may be made of at least one metal material. For example, the metal material forming the surface of the prosthesis may be titanium (Ti), stainless steel, or the like.

The surgical prosthesis 10 of the present invention is a metal that is inserted into the fractured bone in the body, and naturally prevents biofouling of biomaterials that cause side effects such as proteins, inflammatory factors, and bacteria on the metal. In order to suppress the surface of the prosthesis 10 as shown in Figure 2 by sequentially coating the first coating layer 110, the second coating layer 120, and the third coating layer 130 to implement three coating layers, In addition to suppressing the occurrence of infection due to bacterial adhesion on the prosthetic implant 10, the adhesion of inflammatory factors such as blood proteins is also suppressed to fundamentally suppress immune rejection, thereby reducing patient pain.

2 and 3, the surface coating structure of the surgical implant may include a first coating layer 110, a second coating layer 120, and a third coating layer 130.

In the surface coating structure according to an embodiment of the present invention, prior to coating the first to third coating layers on the surface of the surgical implant 10, the surgical implant 10 is pretreated, and the pretreated implant After the process of forming the surface roughness on the surface of the first is performed, the first to third coating layers may be coated on the surface of the surgical implant on which the surface roughness is formed.

The pretreatment process is a process of removing and washing organic or inorganic substances existing on the surface of the prosthesis prior to coating the surface of the prosthesis, and the process of forming the surface roughness is a process of physically removing the lubricating fluid of the third coating layer to be coated. By forming a space for staying, it corresponds to a process for enabling long-term operation in the body when an artificial implant is inserted into an object.

The first coating layer 110 according to an embodiment of the present invention is formed on the surface of the surgical prosthesis 10 and may include an amino compound for surface adhesion. That is, the first coating layer 110 may be a layer for forming an amino group, which is a surface adhesive functional group having a strong bonding force with the second layer, on the surface of the implant. The amino compounds included in the first coating layer 110 are 3-aminopropyltrimethoxysilane, 3-aminopropylethoxydimethylsilane, and 3-aminopropyldiethoxy. In methylsilane (3-aminopropyldiethoxymethylsilane), 3-[2-(2-aminoethylamino)ethylamino]-triethoxysilane (3-[2-(2-aminoetylanmino)ethylamino]propyl-trimethoxysilane), and polydopamine There may be at least one.

The amino compound included in the first coating layer 110 according to an embodiment of the present invention may include polydopamine, and the first coating layer 110 according to another embodiment of the present invention contains an aminosilane compound. It may be configured to include. Here, the aminosilane compound is at least one of 3-aminopropyltrimethoxysilane, 3-aminopropyltrimethoxysilane (APTMS), and 3-aminopropylethoxydimethylsilane. It can be one.

First, a description will be given of the first coating layer 110 using an adhesive material containing polydopamine, which is an embodiment. The first coating layer 110 using polydopamine may be formed of a first component, a second component, and a third component. For example, the first component may be dopamine hydrochloride, the second component may be copper sulfate, and the third component may be hydrogen peroxide, and the first coating layer using polydopamine may be the first to second agents. It may be coated on the surface of the prosthetic implant 10 using a mixture of three components.

According to another embodiment of the present invention, the first coating layer 110 may be formed by being immersed in a mixture obtained by adding a fourth component to a mixture of the first to third components as described above. Here, the fourth component is a tris buffer, and serves as a solvent for dissolving the first to third components above. The concentration of the solvent may be 40 to 60 mM, and a pH of 8 to 9. Preferably, the concentration of the solvent is preferably added to 50mM, pH 8.5.

The dopamine hydrochloride forming the first coating layer 110 can form a nano-micro structure on the surface of the surgical implant through polymerization, and the second coating layer 120 coated on the first coating layer 110 with strong adhesion The bond between the liver can be made solid. The hydroxyl group (-OH) and amino group (-NH2) functional groups included in the polydopamine are to form a chemical bond with the fluorocarbon-based polymer of the second coating layer 120.

The first coating layer 110 based on polydopamine serving as an adhesiveness may be coated on the surface of the prosthesis 10 using a solution-based process, and complex shapes such as regular shape and mesh shape and various A uniform coating can be formed on the surface of the material orthopedic implant.

The chemical structural formula of the first component constituting the first coating layer 110 based on polydopamine according to an embodiment of the present invention may be (HO) ₂ C ₆ H ₃ CH ₂ CH ₂ NH ₂ ·HCl, The molecular weight may be 189.64 g/mol.

In addition, the second component is copper sulfate (CuSO ₄ ·5H ₂ O), which causes oxidation to accelerate the polymerization reaction of polydopamine on the surface of the prosthesis, thereby shortening the process time.

In addition, the third component is hydrogen peroxide (H ₂ O ₂ ), which reacts with Cu 2+ of copper sulfate to generate active oxygen such as O ₂ · ^- , HO ₂ · and OH ·. The active oxygen thus generated accelerates the polydopamine polymerization reaction and greatly improves the deposition rate.

The thickness of the first coating layer 110 using polydopamine according to an embodiment is preferably 30 to 50 nm. The thickness of the coating increases depending on the immersion time in the mixed solution.If the coating is applied for a short period of time, there is a problem that the first coating layer containing polydopamine is not deposited due to insufficient polymerization reaction.If the coating is immersed for too long, the artificial implant The nano-micro structure formed on the surface of is smooth, and problems such as peeling off of the coating may occur.

As described above, the first coating layer 110 according to another embodiment of the present invention may include 3-aminopropyltriethoxysilane (hereinafter, APTES), which is an aminosilane compound. Here, the first coating layer 110 using an adhesive material including APTES will be described.

In the process of coating the first coating layer 110 in this embodiment, prior to immersion in the mixed solution of APTES, oxygen plasma is first treated with the surgical implant to form a hydroxyl group (- OH) can be formed.

In addition, the surface of the artificial implant in which the hydroxyl group is formed through oxygen plasma treatment may be immersed in a mixture of APTES and ethanol to coat the first coating layer.

The first coating layer 110 using APTES may be formed of a first component and a second component. For example, the first component is an aminosilane compound, N-beta-(Aminoethyl)-gamma-aminopropyltrimethoxysilane, 1,3,5-tris[2-(trimethoxysilyl)propyl]-1,3,5-triazine-2,4, It may be one of 6(1H, 3H, 5H)-trion (TTMSPI), and (3-aminopropyl) triethoxysilane (APTES). Preferably, the first component may be APTES ((3-aminopropyl) triethoxysilane), the second component may be ethanol, and the first coating layer using APTES is a mixture of the first component and the second component. It may be coated on the surface of the artificial implant 10 using the mixed solution. The first coating layer 110 including APTES may be coated on the surface of the prosthesis by being immersed in a mixture of 2 to 10% of the first component and 90 to 98% of the second component. Most preferably, it is desirable to create the first coating layer 110 by immersing the surface of the prosthesis in a mixture of 5% of the first component and 95% of the second component.

The first coating layer 110 based on APTES is also a coating layer that serves to strengthen the bonding between the second coating layer 120 with strong adhesion on the surface of the surgical implant, like a polydopamine-based coating layer. The -NH2 functional group contained in APTES, which is one component, is intended to form a chemical bond with the amorphous fluorine polymer of the second coating layer.

The chemical structural formula of the first component constituting the first coating layer 100 based on APTES according to an embodiment of the present invention may be H ₂ N(CH ₂ ) ₃ SI(OC ₂ H ₅ ) ₃ , and the molecular weight May be 221.37 g/mol.

In addition, the second component is ethanol, which acts so that APTES can be polymerized evenly on the surface of the prosthesis.

The thickness of the first coating layer 110 using such APTES is preferably 8 to 80 nm. The thickness of the coating varies depending on the immersion time in the mixture of the first to second components. If the coating is performed for a short period of time, the first coating layer 110 including APTES may be insufficiently deposited due to insufficient polymerization reaction. have.

In addition to the above method, the first coating layer of the present invention may be produced by using a self-assembled molecular membrane treatment method ending with -NH2 functional group, and 3-aminopropyltriethoxyl as a self-assembled molecular membrane ending with -NH2 functional group. Silane ((3-aminopropyl)trimethoxysilane), 3-aminopropylethoxydimethylsilane, 3-aminopropyldiethoxymethylsilane, 3-[2-(2-aminoethylamino ) Ethylamino]-triethoxysilane (3-[2-(2-aminoetylanmino)ethylamino]propyl-trimethoxysilane) may be selected from the group consisting of.

The second coating layer 120 according to the embodiment of the present invention is formed on one surface of the first coating layer 110 and includes a fluorine compound that imparts hydrophobicity to the coating structure coating the surface of the surgical implant 10. I can.

When the second coating layer 120 is formed between the first coating layer 110 and the third coating layer 130, it is possible to prevent damage to the surface of the surgical implant 10 by impact or abrasion transmitted from the outside. , Distribution of the third coating layer 130 on the first coating layer 110 due to the nature of spontaneous formation of the second coating layer 120 even if the distribution balance of the third coating layer 130 on the first coating layer 110 is broken Balance can be restored.

The second coating layer 120 using an adhesive material containing a fluorine compound, which is an embodiment, will be described. The second coating layer 120 including a fluorine compound may be formed of a first component and a second component. For example, the first component is a polymer consisting of fluorine and carbon, and the second component is selected from the group consisting of perfluoroalkane, perfluorodialkyleter, and perfluorotrialkylamine. The second coating layer using a fluorine compound can be coated on the first coating layer 110 by immersing the artificial implant 10 coated with the first coating layer 110 in a mixture of the first component and the second component. I can.

The polymer made of fluorocarbon forming the second coating layer 120 serves to convert the surface properties of the surgical implant into hydrophobicity, and the second coating layer 120 has a chemical affinity with the third coating layer 130. The third coating layer can be maintained for a long time.

The chemical structural formula of the first component constituting the second coating layer 120 based on polydopamine according to an embodiment of the present invention may be [C ₆ F ₁₀ O] _N , and the molecular weight may be 278.05 g/mol. have.

The first component constituting the second coating layer 120 of the present invention according to an embodiment is a chemical bond with a hydroxyl group (-OH) and an amino group (-NH2) functional group formed in the first coating layer 110 among fluorocarbons. It may be selected as a fluorocarbon containing a carboxy group (-COOH) functional group to form. For example, the first component constituting the second coating layer 120 of the present invention is perfluorodecanoic acid, perfluorooctanoic acid, trifluoroacetic acid, and perfluoroacetic acid. It may be one of the perfluorocarboxylic acids.

The thickness of the second coating layer 120 including the fluorine compound according to an embodiment is preferably 100 to 200 nm.

In this embodiment, the second component may be selected from the group consisting of perfluoroalkane, perfluorodialkyleter, and perfluorotrialkylamine (fluorine-based solvent). The second component is mixed with the first component and used to control the concentration of the mixture, and the higher the second component of the mixture is, the thinner the coating thickness of the second coating layer is adjusted.

The third coating layer 130 according to the embodiment of the present invention is formed on the second coating layer 120 and may include a lubricating component for reducing friction with a human body in contact with the surgical implant 10.

The third coating layer 130 is a lubricant layer serving as a lubricant and may wet the surface of the surface coating structure of the surgical implant 10. Accordingly, microorganisms such as bacteria and bacteria may not adhere to the surface of the surgical prosthesis 10 and may slide along the surface of the prosthesis 10.

The third coating layer 130 may be coated on the second coating layer 120 to have a set surface energy. Here, the material constituting the third coating layer 130 may have a low surface energy suitable for modifying the surface of the surgical prosthesis 10 as a lubricating fluid. For example, the lubricating fluid may be a perfluorocarbon liquid.

As another example, the lubricating fluid is perfluorotri-n-pentylamine FC-70, perfluoropolyether Krytox-100, Krytox-103, perfluorodecaline ), Flutec PP6, Fluorinert™ FC-70, FC-40, perfluorohexane, FC-72, perfluorooctane, PF5080, perfluorooctyl bromide, 1-bro Morperfluorooctane, perfluoroperhydrophenanthrene Vitreon, FluoroMed APF-215HP, 3-ethoxy-1,1,1,2,3,4,4,5,5,6,6,6- Dodecafluoro-2-trifluoromethyl-hexane (3-ethoxy-1,1,1,2,3,4,4,5,5,6,6,6-dodecafluoro-2-trifluoromethyl-hexane) Phosphorus HFE-7500, Krytox FG-40, Krytox-105, Krytox-107, and may be one of Perfluorodecalin.

For example, the viscosity of the lubricating fluid may be between 0.1 and 0.8 cm ² /s, and the density may be between 1500 and 2000 kg/m ³ . In this way, according to the viscosity and density characteristics of the lubricating fluid constituting the third coating layer 130 in consideration of the point in which the artificial implant 10 is inserted into the object, the repellency of the third coating layer 130 against microorganisms is improved, It is possible to improve the sliding of microorganisms on the third coating layer 130.

4 is a diagram schematically showing a process of generating a surface coating structure for a surgical implant according to an embodiment of the present invention. Referring to FIG. 4, first, the substrate 10 forming the surface of the artificial implant is immersed in a mixture of dopamine hydrochloride and copper sulfate to coat the first coating layer 110 on the substrate 10, and the first coating layer is coated. The surface of the artificial implant is immersed in a mixture of fluorocarbon polymer to coat the second coating layer 120 on the first coating layer 110, and the surface of the implant coated with the second coating layer is based on perfluorocarbon. The third coating layer 130 may be coated on the second coating layer 120 by immersion in one lubricating fluid.

5 is a reference diagram illustrating a shape in which an artificial implant 10 is inserted into a fracture site of an animal according to an embodiment of the present invention. Figure 5 (a) shows the insertion of the prosthesis 510 without a coating layer into the fracture site, (b) shows the insertion of the prosthesis 520 coated with the coating structure of the present invention into the fracture site will be.

6 is a flow chart showing a method of modifying the surface of a surgical implant according to an embodiment of the present invention.

Referring to FIG. 6, in the method for modifying the surface of the prosthesis according to an embodiment of the present invention, first, the surface of the surgical prosthesis is pretreated (S100). The pretreatment process is a process for removing and cleaning organic substances or inorganic substances present on the surface of the prosthesis.The prosthesis is immersed in acetone, an organic solvent, to remove organic substances on the surface of the prosthesis, and then After immersing the prosthesis in alcohol (alcohol) as an organic solvent to remove organic substances once again, the prosthesis is immersed in deionized water as an inorganic solvent to remove organic matter on the surface of the prosthesis It can remove acetone and alcohol, which have been used to make, and at the same time remove polar minerals.

Next, a surface roughness is formed on the surface of the pretreated surgical implant (S200). In the method of forming the surface roughness on the surface of the prosthesis according to an exemplary embodiment, polygonal crushed grains are sprayed together with compressed air on the surface of the prosthesis to form a surface roughness on the surface of the pre-treated prosthesis.

For example, the size of the crushed grains is preferably 2.0 to 3.3 μ (microns). The surface roughness formed on the surface of the prosthesis increases according to the size of the crushed grain. If the size of the crushed grain is larger than 3.3 μ, damage to the surface of the prosthesis may occur. On the other hand, when the size of the crushed grains is less than 2.0 μ, it is difficult to form a surface roughness on the surface of the artificial implant, and accordingly, a space for the lubricating oil film (third coating layer) to stay may not be formed.

The spraying time of the crushed grains is preferably 120 to 300 seconds. Depending on the injection time, the surface roughness formed on the surface of the prosthesis may increase. It goes without saying that the injection time of the crushed grain can be appropriately changed between 120 seconds and 300 seconds depending on the material of the surface of the target prosthesis or the strength of the material.

Next, a first coating layer is formed on the surface of the surgical implant on which the surface roughness is formed (S300). Although described above with reference to Figs. 2 and 3, there are largely two methods for forming the first coating layer on the surface of the prosthesis of the present invention.

As a first method, the first coating layer 110 may be coated based on an adhesive material including polydopamine. According to the first method, the surface of the artificial implant having the surface roughness formed may be immersed in a mixture of dopamine hydrochloride, copper sulfate, and hydrogen peroxide in a tris buffer solution to coat the first coating layer 110. More detailed information related to this is duplicated as described in detail with reference to FIGS. 2 and 3, and thus will be omitted here.

As a second method, the first coating layer 110 may be coated based on an adhesive material including APTES. Referring to FIG. 7 for a more detailed description of the first coating layer coating process using APTES.

First, the surface of the surgical implant is immersed in a mixture of APTES, an aminosilane compound, and ethanol (S320). Thereafter, excess APTES on the surface of the prosthesis that has been immersed in the mixture of APTES and ethanol is removed using an ultrasonic disperser (S340), and the surface of the prosthesis is annealed in a high temperature environment ( S360).

Referring back to FIG. 6, a second coating layer is formed on the surface of the surgical implant coated with the first coating layer 110 having an amino group by the first method or the second method (S400). In the method of coating the second coating layer 120 on the first coating layer 110 according to an embodiment, the surface of the artificial implant coated with the first coating layer is fluorocarbon having a carboxy group, perfluoroalkane, and perfluoro. It can be coated by immersing in a mixture of at least one of rhodialkylether and perfluorotrialkylamine.

Next, a third coating layer is formed on the surface of the surgical implant on which the second coating layer 120 is coated (S500). The method of coating the third coating layer 130 on the second coating layer 120 according to an exemplary embodiment may be coated by immersing the surface of the prosthesis coated with the second coating layer in a perfluorocarbon liquid, which is a lubricant.

Manufacturing Example 1

Step 1: After placing the orthopedic implant in acetone solution, it is washed for 15 minutes using an ultrasonic disperser. Thereafter, the orthopedic implant is placed in an alcohol solution and washed for 15 minutes using an ultrasonic disperser. After taking out the cleaned orthopedic prosthesis and drying the surface of the prosthesis, put the dried prosthesis in deionized water solution and wash it for 15 minutes using an ultrasonic disperser.

Step 2: The surface roughness of the micro/nano unit is formed by spraying a polygonal grit having a size of 2.5 μ on the surface of the orthopedic implant cleaned through step 1 for 200 seconds.

Step 3: Dopamine hydrochloride (dopamine hydrochloride) 2mg/ml, copper sulfate (CuSO ₄ 5H ₂ O) 1.347mg/ml, hydrogen peroxide 2.2μl/ml, Tris buffer solution 50mM mixed solution, surface roughness formed through step 2 The surface of the surgical implant is immersed at room temperature for 20 minutes to coat the first coating layer.

Step 4: Perfluorodecanoic acid (perfluorodecanoic acid) 9%, perfluoroalkane (perfluoroalkane) in a mixed solution of 91% solvent, the first coating layer coated orthopedic implant through step 3 at 80 degrees The second coating layer is coated by curing for 1 hour in the above environment.

Step 5: The third coating layer is coated by immersing the orthopedic implant coated with the second coating layer in the perfluorocarbon liquid through Step 4 for 10 minutes at room temperature.

Manufacturing Example 2

Step 1: After placing the orthopedic implant in acetone solution, it is washed for 15 minutes using an ultrasonic disperser. Thereafter, the orthopedic implant is placed in an alcohol solution and washed for 15 minutes using an ultrasonic disperser. After taking out the cleaned orthopedic prosthesis and drying the surface of the prosthesis, put the dried prosthesis in deionized water solution and wash it for 15 minutes using an ultrasonic disperser.

Step 2: The surface roughness of the micro/nano unit is formed by spraying a polygonal grit having a size of 2.5 μ on the surface of the orthopedic implant cleaned through step 1 for 200 seconds.

Step 3: A hydroxyl (-OH) functional group is formed on the surface of the prosthesis by irradiating oxygen plasma on the surface of the orthopedic prosthesis in which the surface roughness of micro/nano units is formed. In addition, after immersing the surface of the orthopedic prosthesis having surface roughness formed through step 2 in a mixture of 5% APTES ((3-aminopropyl)triethoxysilane) and 95% ethanol at room temperature for 60 minutes, , Using an ultrasonic disperser, drop and remove APTES that does not bind to hydroxyl groups on the surface of the orthopedic implant, and anneal the orthopedic implant in an environment of 60 degrees or more.

Step 4: Perfluorodecanoic acid (perfluorodecanoic acid) 9%, perfluoroalkane (perfluoroalkane) in a mixed solution of 91% solvent, the first coating layer coated orthopedic implant through step 3 at 80 degrees The second coating layer is coated by curing for 1 hour in the above environment.

Step 5: A third coating layer is coated by immersing the orthopedic implant coated with the second coating layer in the perfluorocarbon liquid through Step 4 for 10 minutes at room temperature.

Experimental Example 1

The surface-modified orthopedic implant prepared by the above-described method was placed in a medium free of methicillin-resistant Staphylococcus aureus and incubated for 72 hours in a 37° environment. FIG. 8 is a view showing a culture pattern on the surface of an orthopedic prosthesis coated with a fluorescence microscope by culturing the surface of the orthopedic prosthesis coated in this way, and then fixing and dyeing.

Experimental Example 2

9 is a view showing the result of measuring the angle at which the liquid moves when a contact angle and an inclination are applied on the surface of the orthopedic prosthesis after dropping about 5 μl of liquid on the surface of the prosthesis. Figure 9 (a) is the state of the surface before coating, (b) is the state of the surface coated with the first coating layer, (c) is the state of the surface coated with the second coating layer on the first coating layer, (d ) Represents the state of the surface coated with the third coating layer on the second coating layer.

The surface-modified surgical implant of the present invention as described above can be used in fracture treatment (metal nail, bone fixed plate). For example, in the event of a fracture, as it is applied as an artificial implant to fix the fracture site by inserting it in the bone marrow or over the fractured site, it is possible to effectively suppress the source of acute infection that may occur in contaminated medical devices. Fracture treatment takes from 6 to 12 months to cure. At this time, if the patient's immunity is reduced and bacteria present in the body adhere to the prosthesis, chronic infection may occur. The surface of the present invention is modified. In the case of using the prosthesis, the adhesion of biomaterials on the surface of the prosthesis can be suppressed for a long period of time, and thus the threat of chronic infection is also effective.

The surface-modified surgical prosthesis of the present invention can also be used to treat worn joints (artificial joints). Worn joint replacement is an operation in which a joint damaged due to wear is replaced with an artificial joint made of metal, plastic, ceramic, etc. to maintain its function. In the case of artificial joints, due to wear, the period of use is not long and reoperation is required. The surface-modified surgical implant of the present invention minimizes abrasion through the third coating layer to prolong its use period, and suppresses adhesion of inflammatory factors, thus minimizing the inflammatory reaction to reduce patient pain. I can. In addition, as the load is concentrated, the inflammatory reaction may be actively caused to become susceptible to infection.At this time, in the case of the artificial joint with the modified surface of the present invention, chronic infection from suspended bacteria in the body can be suppressed. There is an effect.

The above description is merely illustrative of the technical idea of the present invention, and those of ordinary skill in the technical field to which the present invention belongs can make various modifications, changes, and substitutions within the scope not departing from the essential characteristics of the present invention. will be. Accordingly, the embodiments disclosed in the present invention and the accompanying drawings are not intended to limit the technical idea of the present invention, but to explain, and the scope of the technical idea of the present invention is not limited by these embodiments and the accompanying drawings. . The scope of protection of the present invention should be interpreted by the following claims, and all technical ideas within the scope equivalent thereto should be construed as being included in the scope of the present invention.

10: Orthopedic implant
110: first coating layer
120: second coating layer
130: third coating layer

Claims (13)

In the surface coating structure of the surgical implant,
A first coating layer formed on the surface of the surgical implant and comprising an amino compound for surface adhesion;
A second coating layer formed on one surface of the first coating layer and comprising a fluorine compound that imparts hydrophobicity to the surface coating structure of the surgical implant; And
A surface coating structure of a surgical implant including a third coating layer formed on one surface of the second coating layer and comprising a lubricating component for preventing adhesion of biomaterials present in the object into which the surgical implant is inserted. . The method of claim 1,
The amino compound is a surface coating structure of a surgical implant, characterized in that it contains a polydopamine or aminosilane compound. The method of claim 2,
The polydopamine is dopamine hydrochloride,
The first coating layer is formed by applying a mixture of dopamine hydrochloride, copper sulfate, and hydrogen peroxide to the surgical prosthesis. Surface coating structure of a surgical implant, characterized in that . The method of claim 2,
The aminosilane compound is 3-aminopropyltriethoxysilane (APTES),
The first coating layer is formed by applying the surgical implant to the mixture of the 3-aminopropyltriethoxysilane and ethanol, and further comprises a hydroxyl group formed through an oxygen plasma process. Surface coating structure of a surgical implant, characterized in that. The method of claim 1,
The fluorine compound is a fluorocarbon compound,
The second coating layer is a surgical implant, characterized in that formed by applying a mixture of a compound obtained by combining a carboxylic acid with the fluorocarbon compound by applying a surgical implant coated with the first coating layer Surface coating structure. The method of claim 1,
The lubricating component is perfluorotri-n-pentylamine, perfluoropolyether, perfluorodecalin, perfluorohexane, perfluorooctane, perfluorooctyl bromide, perfluoroperhydrophenanthrene, and perfluoro. Surface coating structure of a surgical implant, characterized in that it comprises a material selected from the group consisting of rhodecalin. The method of claim 1,
The surface coating structure of the surgical implant, characterized in that the thickness of the first coating layer is formed of 30 to 50 nanometers (nm). The method of claim 1,
The first coating layer is coated on the surface of the surgical prosthesis in which the surface roughness is formed as the polygonal crushed lip is sprayed on the surface of the surgical prosthesis together with compressed air. Structure. An artificial implant inserted into the fracture site to fix the fracture site;
A first coating layer formed on the surface of the prosthesis and containing an amino compound for surface adhesion;
A second coating layer formed on one surface of the first coating layer and comprising a fluorine compound that imparts hydrophobicity to the surface coating structure of the artificial implant; And
A third coating layer formed on one surface of the second coating layer and comprising a lubricating component for preventing the attachment of biomaterials present in the object into which the surgical prosthesis is inserted. The method of claim 9,
The amino compound is dopamine hydrochloride,
The first coating layer is formed by applying a mixture of the dopamine hydrochloride, copper sulfate, hydrogen peroxide and tris buffer to the surgical implant. Modified prosthesis. Forming a first coating layer comprising an amino compound for surface adhesion on the surface of the surgical prosthesis in order to create a surface coating structure of the surgical prosthesis;
Forming a second coating layer containing a fluorine compound that imparts hydrophobicity to the surface coating structure of the surgical implant on one surface of the first coating layer; And
Forming a third coating layer containing a lubricating component for preventing adhesion of biomaterials present in the object into which the surgical implant is inserted, on one surface of the second coating layer;
Surface modification method of a surgical implant comprising a. The method of claim 11,
The amino compound is dopamine hydrochloride,
The first coating layer is formed by applying a mixture of the dopamine hydrochloride, copper sulfate, hydrogen peroxide, and tris buffer to the surgical implant. Methods of modifying the surface of the prosthesis The method of claim 11,
Pre-treating the surface of the surgical implant using at least one of acetone, alcohol, and deionized water to remove organic or inorganic substances present on the surface of the surgical implant;
Forming a surface roughness on the surface of the pre-treated surgical prosthesis by spraying the polygonal crushed lip with compressed air on the surface of the pre-treated surgical prosthesis; further comprising,
The first coating layer is a surface modification method of a surgical implant, characterized in that formed on the surface of the implant on which the surface roughness is formed.

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