WO2020172269A1 - Lubricious coatings for medical devices - Google Patents

Abstract

Coatings for medical devices are provided. The coatings may be lubricious coatings including one or more hydrophobic compounds, adhesion agents, shape memory polymers, free-radical initiators, and/or carrying solvents. Methods of applying the coatings to medical devices are also provided. The coatings may be applied in a single layer or in multiple layers.

Description

LUBRICIOUS COATINGS FOR MEDICAL DEVICES

RELATED APPLICATIONS

[0001] This application claims priority to United States Provisional Application No. 62/808,080 filed on February 20, 2019 and titled“LUBRICIOUS COATINGS FOR MEDICAL DEVICES,” which is hereby incorporated by reference in its entirety.

TECHNICAL FIELD

[0002] The present disclosure relates generally to lubricious coatings. The coatings may be applied to medical devices. More specifically, the present disclosure relates to lubricious coatings including one or more adhesion agents, hydrophobic compounds, shape memory polymers, free-radical initiators, and/or carrying solvents applied to a component of a joint replacement. Related methods of use and manufacture are also disclosed.

BRIEF DESCRIPTION OF THE DRAWINGS

[0003] The embodiments disclosed herein will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. These drawings depict only typical embodiments, which will be described with additional specificity and detail through use of the accompanying drawings in which:

[0004] FIG. 1 is an illustration of a total artificial hip replacement.

[0005] FIG. 2 is an illustration of a total artificial knee replacement.

[0006] FIG. 3 is an illustration of a total artificial shoulder replacement.

[0007] FIG. 4 is an illustration of a manufacturing method for producing a coated or impregnated plastic component of a joint replacement.

[0008] FIG. 5 is an illustration of another manufacturing method for producing a coated or impregnated plastic component of a joint replacement.

DETAILED DESCRIPTION

[0009] The components of the embodiments as generally described and illustrated herein can be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of various embodiments is not intended to limit the scope of the present disclosure, but is merely representative of various embodiments. It will be appreciated that various features are sometimes grouped together in a single embodiment or description thereof for the purpose of streamlining the disclosure. Many of these features may be used alone and/or in combination with one another.

[0010] Medical devices, such as joint replacements, are generally used to replace diseased or injured natural joints of a patient. In certain instances, the joint replacement may be used to replace natural hip, knee, shoulder, elbow, wrist, knuckle, finger, and toe joints. The joint replacement may include a metal or ceramic component that bears upon a plastic component formed from ultra-high molecularweight polyethylene (UHMWPE). The plastic component may be coated or impregnated with a lubricious coating that imparts one or more characteristics or properties to the plastic component. For example, the coating can be applied to the plastic component to affect, among other properties or characteristics, a level of friction between the plastic component and the metal or ceramic component (e.g., during motion of the joint). Some coatings may be configured to reduce the level of friction between the metal or ceramic and plastic components and to reduce wear of the plastic component. In some instances, wear of the plastic component can cause small particles of the plastic component to be displaced into surrounding tissue, which may result in an immune response; adverse tissue response, such as inflammation or genotoxicity.

[0011] The terms“lubricious” and“lubricity,” as used herein, refer to the characteristic of being smooth or slippery, or of possessing a low coefficient of friction. Higher levels of lubricity correspond to lower coefficients of friction, and lower levels of lubricity correspond to higher coefficients of friction.

[0012] The term“coating,” as used herein, refers to a layer or layers of material that have been applied to a surface of a medical device. A coating may create a distinct layer over a base substrate. However, as described herein, a coating may form an interpenetrating network where the boundaries between the coating layer and base substrate are less distinct due to overlap between the coating and the base substrate. As detailed below, the coatings disclosed herein may include one or more hydrophobic compounds, adhesion agents, shape memory polymers, free-radical initiators, antistatic agents, and/or carrying solvents.

[0013] The term“adhesion agent,” as used herein, refers to an additive that promotes the adhesion of a coating to the substrate of interest (e.g., a surface of a medical device) and has an affinity for the substrate and the applied coating.

[0014] The term“shape memory polymer,” as used herein, refers to an additive that has the ability to return from a deformed state to its original state when induced by an external stimulus (e.g., temperature, light, etc.).

[0015] In some embodiments, a coating of the present disclosure may be used for a medical device. The medical device may be a joint replacement. In other embodiments, the medical device may be a vascular stent. The joint may be a total artificial joint replacement or a partial joint replacement. The joint replacement may be configured to replace natural hip, knee, shoulder, elbow, wrist, knuckle, finger, or toe joints. The joint replacement may include a metal or ceramic component and a plastic component. In an exemplary embodiment, the plastic component may be configured as a liner 101 , as illustrated in FIG. 1 , for a total artificial hip replacement 100. The liner 101 is coupled to an acetabular member 102 and a metal ceramic ball of the femoral member 103 is disposed within the liner 102. In another exemplary embodiment, as shown in FIG. 2, the plastic component may be configured as a spacer 204 disposed between a metal or ceramic femoral member 205 and a tibial component 206 of a total artificial knee replacement 200. In yet another exemplary embodiment, as depicted in FIG. 3, the plastic component may be configured as a socket 307 configured to couple with a metal or ceramic ball of a humeral member 308 of a total artificial shoulder replacement 300. The metal or ceramic component may be formed from materials such as stainless steel, titanium, titanium alloys, tantalum, cobalt chromium alloy, ceramics, zirconium alloy, or any other suitable material.

[0016] The plastic component may be formed from polyolefin polymers, such as UHMWPE or ultra-high crosslinked polyethylene (UHXLPE). Other polymers can also be used to form the plastic component. The plastic component can be configured to resist wear when the metal or ceramic component movably bears upon the plastic component (e.g., when the joint is in motion). Wear of a surface of the plastic component may cause breakdown of the surface and result in release of small plastic particles into surrounding tissue. The small plastic particles may result in an immune response; adverse tissue response, such as inflammation or genotoxicity.

[0017] The coating may be a lubricious coating system for application to, or treatment of, the plastic component of the joint replacement. For example, the lubricity of a surface of the plastic component that has been treated with the coating may be altered. Additionally, the coating may be a permanent, or substantially permanent, coating for the plastic component.

[0018] Exemplary lubricious coatings described herein may create an interpenetrating polymer network with the UHMWPE substrate. Such coating components may include a hydrophobic compound, an adhesion agent, a shape memory polymer, a free-radical initiator, and a carrying solvent. Furthermore, such coating components may include a hydrophobic compound, an adhesion agent, a shape memory polymer, a free-radical initiator, a carrying solvent, a catalyst, a water carrying agent, an antioxidant, and a surfactant. Two or more of these coating components may be present in an exemplary composition, as well as any permutations, combinations, or subcombinations thereof.

[0019] The coating compositions and systems may comprise hydrophobic compounds that can affect a level of lubricity of the coating. For example, one or more hydrophobic compounds in the coating may impart enhanced lubricity to a surface that is treated with the coating. In some embodiments, the one or more hydrophobic compounds may include hydrophobic compounds that may be partially fluorinated, completely fluorinated, or a combination thereof. Exemplary hydrophobic compounds that may be used include, but are not limited to, fluorinated silanes, fluorinated hydrocarbons, fluorinated polymers, fluorinated silicones, hydrophobic non-fluorinated silanes, or combinations thereof. Other suitable hydrophobic compounds are also within the scope of this disclosure. In various embodiments, the hydrophobic compound may be a compound with fluorinated carbon side chains. Exemplary lengths of the fluorinated carbon side chains may be between about 1 and about 30 carbons. For example, the length of the fluorinated carbon side chain of the hydrophobic compound may be 1 , 2, 3, 4, 5, 6, 7, 8, 9, 10, 1 1 , 12, 13, 14, 15, 16, 17, 18, 19, 20, 21 , 22, 23, 24, 25, 26, 27, 28, 29, or 30 carbons.

[0020] In some embodiments, the hydrophobic compound may include a mixture of a first fluorinated silane including a first carbon side chain and a second fluorinated silane including a second carbon side chain, wherein the length of the first carbon side chain is greater than the length of the second carbon side chain. For example, the fluorinated compound may include a first fluorinated silane having a 1 - to 8-carbon side chain (or a 1 - to 5-carbon side chain) and a second fluorinated silane having a 9- to 30-carbon side chain (or a 9- to 18-carbon side chain). Other combinations of carbon side chain lengths are also within the scope of this disclosure. In certain embodiments, the fluorinated compound may include a mixture of three, four, five, or more fluorinated silanes having different carbon side chain lengths. Alternatively, a fluorinated compound may have more than one carbon side chain with different carbon side chain lengths within the same molecule. In some other embodiments, the coating may include a single length of fluorinated carbon side chains. For example, the fluorinated compound may include a fluorinated silane having a 3- to 20-carbon side chain (or a 5- to 18-carbon side chain). [0021] In other embodiments, the hydrophobic compound may include a non-fluorinated silane compound. For example, the non-fluorinated silane compound may be methylated silane, methyl- siloxanyl silane, linear alkyl silane, dialkyl silane, branched alkyl silane, cyclic alkyl silane, phenyl silane, phenyl alkyl silane, substituted phenyl silane, substituted phenylalkyl silane, or napthyl-silane. Other suitable non-fluorinated polymers are also within the scope of this disclosure.

[0022] In various embodiments, the hydrophobic compound may be a fluorinated polymer. For example, the fluorinated polymer may be polytetrafluoroethylene (PTFE) or fluorinated ethylene propylene (FEP). Other suitable fluorinated polymers are also within the scope of this disclosure.

[0023] The amount of hydrophobic compounds that are present in the coating composition can be between about 0.1 and about 15 weight percent of the coating composition. Alternatively, the hydrophobic compounds may be present in an amount of between about 1 .0 and about 15 weight percent, or about 2.0 and about 12.5 weight percent of the coating composition.

[0024] In some embodiments, the coating may include one or more adhesion agents or promoters and one or more hydrophobic compounds. The adhesion agent can aid in adhering, binding, and/or coupling the coating to at least a portion of a surface of a medical device. For example, the adhesion agent may chemically bind (e.g., via free-radical initiators) to a portion of the surface of a medical device (e.g., a UHMWPE substrate) and provide an anchor for the hydrophobic compound. In certain embodiments, the adhesion agent may be a crosslinker. For example, upon addition of the one or more adhesion agents to a portion of the surface of a medical device the adhesion agents may promote crosslinking of the polymeric material forming a base material of the medical device. Such crosslinking can impart increased hardness and/or other desirable mechanical properties to the material of the plastic component.

[0025] Exemplary adhesion agents that may be used include, but are not limited to, organosilanes, hexachlorodisilane, poly(4-vinylphenol), polyacrylic acids, titanates, zirconates, or combinations thereof. Other suitable adhesion agents are also within the scope of this disclosure. In certain embodiments, the adhesion agent may be an organosilane. Exemplary organosilanes that may be used include, but are not limited to, vinyltrimethoxysilane, (3-aminopropyl)triethoxysilane, methyltrichlorosilane, triethoxymethylsilane, trimethoxymethylsilane, dimethoxydimethylsilane, methoxytrimethylsilane, diethoxydimethylsilane, triethoxyvinylsilane, trichlorovinylsilane, methyldiethoxysilane, triethoxy(ethyl)silane, ethoxytrimethylsilane, dimethoxyvinylsilane, tert- butyltrichlorosilane, (chloromethyl)triethoxysilane, bis(trichlorosilyl)methane, 1 ,2- bis(triethoxysilyl)ethane, 1 ,2-bis(trimethoxysilyl)ethane, 1 ,2-bis(trichlorosilyl)ethane, trichloro(dichloromethyl)silane, diethoxy(methyl)vinylsilane, 1 ,3-diethoxy-1 ,1 ,3,3-tetramethyldisiloxane, or combinations thereof. In some embodiments, the adhesion agent may be any silane with an amino functional group (e.g., aminopropyltrimethoxysilane, aminopropyltriethoxysilane, etc.) or a vinyl functional group (e.g., vinyltrimethoxysilane, vinyltriethoxysilane, etc.). Other suitable organosilanes are also within the scope of this disclosure.

[0026] The amount of adhesion agent that is present in the coating composition can be between about 0.1 and about 15 weight percent of the coating composition. Alternatively, the adhesion agent may be present in an amount of between about 1 .5 and about 15 weight percent, or between about 3.5 and about 1 1 weight percent of the coating composition.

[0027] In various embodiments, the coating compositions and systems may comprise bi-functional compounds that may include both a hydrophobic functional group or moiety and an adhesion promoter functional group or moiety. For example, a bi-functional compound in the coating may affect a level of lubricity of the coating (i.e., due to the hydrophobic functional group or moiety) and the bi-functional compound in the coating may also aid in adhering, binding, and/or coupling the coating to at least a portion of a surface (i.e., due to the adhesion promoter functional group or moiety). Exemplary bifunctional compounds that may be used include, but are not limited to, 1 ,6-divinylperfluorohexane, 1 ,4- divinylperfluorobutane, 1 ,8-divinylperfluorooctane, or combinations thereof. Other suitable bi-functional compounds are also within the scope of this disclosure. In some embodiments, 1 ,6- divinylperfluorohexane includes vinyl end groups that can promote adhesion and/or crosslinking and a fluorinated backbone that can impart hydrophobicity.

[0028] The coating may also include one or more shape memory polymers or stabilizers. The shape memory polymer may affect performance stability of the coating, for example, across a range of temperatures. In some embodiments, the coating may include a hydrophobic compound, an adhesion agent, and a shape memory polymer. Exemplary shape memory polymers that may be used include, but are not limited to, e-caprolactone, polycaprolactone (PCL), polynorbomene, polyenes, nylons, polycyclooctene (PCO), polyvinyl acetate/polyvinylidene fluoride (PVAc/PVDF), PVAc/PVDF/poly- methylmethacrylate (PMMA) blends, polyurethanes, styrene-butadiene copolymers, polyethylene (PE), trans-isoprene, polyvinyl chloride (PVC), or combinations thereof. Other suitable shape memory polymers are also within the scope of this disclosure.

[0029] The amount of shape memory polymers that are present in the coating composition can be between about 1 .0 and about 10 weight percent of the coating composition. Alternatively, the shape memory polymers may be present in an amount of between about 2.0 and about 7.5 weight percent of the coating composition.

[0030] The coating may also include one or more free-radical initiators. The free-radical initiator may aid in a free-radical initiated grafting reaction of at least a portion of the coating. In various embodiments, the free-radical initiator may induce coupling or“grafting” of the adhesion agent to the surface of the plastic component, which can then crosslink the material forming the surface (e.g., UHMWPE) following a moisture curing step or any other suitable curing step. In some embodiments, the coating may include a hydrophobic compound, an adhesion agent, and a free-radical initiator. The coating may also include a hydrophobic compound, an adhesion agent, a shape memory polymer, and a free-radical initiator. Exemplary free-radical initiators that may be used include, but are not limited to, photoinitiators, thermal initiators, chemical catalysts, or combinations thereof. Other suitable free- radical initiators are also within the scope of this disclosure.

[0031] In certain embodiments, the free-radical initiator may be a photoinitiator. The photoinitiators may include, but are not limited to, benzoin ethers, benzil ketals, a-dialkoxy-aceto- phenones, a-hydroxy-alkyl-phenones, a-aminoalkyl-phenones, acyl-phosphine oxides, benzo- phenones/amines, thio-xanthones/amines, titanocenes, or combinations thereof. Exemplary photoinitiators that may be used include, but are not limited to, acetophenone, anisoin, anthraquinone, anthraquinone-2-sulfonic acid (e.g., anthraquinone-2-sulfonic acid, sodium salt monohydrate), (benzene)tricarbonylchromium, benzil, benzoin, benzoin ethyl ether, benzoin isobutyl ether, benzoin methyl ether, benzophenone, benzophenone/1 -hydroxycyclohexyl phenyl ketone (e.g., 50/50 blend), 3,3’,4,4’-benzophenonetetracarboxylic dianhydride, 4-benzoylbiphenyl, 2-benzyl-2-(dimethylamino)-4'- morpholinobutyrophenone, 4,4’-bis(diethylamino)benzophenone, 4,4’- bis(dimethylamino)benzophenone, camphorquinone, 2-chlorothioxanthen-9-one,

(cumene)cyclopentadienyliron(ll) hexafluorophosphate, dibenzosuberenone, 2,2- diethoxyacetophenone, 4,4’ dihydroxybenzophenone, dimethoxyacetophenone, 2,2-dimethoxy-2- phenylacetophenone (DMPAP), 4-(dimethylamino)benzophenone, 4,4'-dimethylbenzil, 2,5- dimethylbenzophenone, 3,4-dimethylbenzophenone, diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide/2-hydroxy-2-methylpropiophenone (e.g., 50/50 blend), 4’-ethoxyacetophenone, 2- ethylanthraquinone, ferrocene, 3’-hydroxyacetophenone, 4’-hydroxyacetophenone, 3- hydroxybenzophenone, 4-hydroxybenzophenone, 1 -hydroxycyclohexyl phenyl ketone, 2-hydroxy-2- methylpropiophenone, 2-methylbenzophenone, 3-methylbenzophenone, methybenzoylformate, 2- methyl-4'-(methylthio)-2-morpholinopropiophenone, phenanthrenequinone, 4’-phenoxyacetophenone, phenylbis (2,4,6-trimethylbenzoyl)-phosphine oxide (BAPO), thioxanthen-9-one, triarylsulfonium hexafluoroantimonate salts (e.g., mixed, 50% in propylene carbonate), thioxanthone, triarylsulfonium hexafluorophosphate salts (e.g., mixed, 50% in propylene carbonate), xanthone, or combinations thereof. Other suitable photoinitiators are also within the scope of this disclosure.

[0032] In various embodiments, the free-radical initiator may be a thermal initiator. The thermal initiators may include, but are not limited to, fe/f-amyl peroxybenzoate, 4,4-azobis(4-cyanovaleric acid), 1 ,T-azobis(cyclohexanecarbonitrile), 2,2’-azobisisobutyronitrile (AIBN), benzoyl peroxide, 2,2-bis(fe/f- butylperoxy)butane, 1 ,1 -bis(fe/f-butylperoxy)cyclohexane, 2,5-bis(fe/f-butylperoxy)-2,5- dimethylhexane, 2,5-bis(fe/f-butylperoxy)-2,5-dimethyl-3-hexyne, bis(1 -(fe/f-butylperoxy)-1 - methylethyl)benzene, 1 ,1 -bis(fe/f-butylperoxy)-3,3,5-trimethylcyclohexane, fe/f-butyl hydroperoxide, fe/f-butyl peracetate, fe/f-butyl peroxide, fe/f-butyl peroxybenzoate, fe/f-butylperoxy isopropyl carbonate, cumene hydroperoxide, cyclohexanone peroxide, dicumyl peroxide, lauroyl peroxide, 2,4- pentanedione peroxide, peracetic acid, potassium persulfate, or combinations thereof. Other suitable thermal initiators are also within the scope of this disclosure.

[0033] The amount of free-radical initiators that are present in the coating composition can be between about 0.01 and about 20 weight percent of the coating composition. Alternatively, the free- radical initiators may be present in an amount of between about 0.01 and about 10 weight percent of the coating composition, between about 0.02 and about 10 weight percent of the coating composition, or between about 0.5 and about 5.0 weight percent of the coating composition.

[0034] The coating may also include one or more carrying solvents. For example, the coating may include a hydrophobic compound, an adhesion agent, and a carrying solvent. In some embodiments, the coating may include a hydrophobic compound, an adhesion agent, a shape memory polymer, and a carrying solvent. In yet other embodiments, the coating may include a hydrophobic compound, an adhesion agent, a free-radical initiator, and a carrying solvent. Moreover, in certain embodiments, the coating may include at least one of a hydrophobic compound, an adhesion agent, a shape memory polymer, a free-radical initiator, and/or a carrying solvent. Exemplary carrying solvents that may be used include, but are not limited to, water, methanol, ethanol, ethylene glycol, propylene glycol, polyols, polar aprotic solvents, hydrocarbon solvents (aliphatic or aromatic), amine-based solvents, non-polar solvents (e.g., anisole), or combinations thereof. In some embodiments, the polyols may include 5 or fewer carbons. For example, the polyols may include, but are not limited to, 1 ,3-propanediol, polyethylene glycol (PEG) or combinations thereof. Exemplary polar aprotic solvents that may be used include, but are not limited to, acetone, dimethylformamide (DMF), acetonitrile, dimethyl sulfoxide (DMSO), dichloromethane, tetrahydrofuran (THF), ethyl acetate, hexamethylphosphoric triamide (HMPT), or combinations thereof. Other suitable carrying solvents that promote the miscibility of the polymer components and the polymeric substrate (e.g., medical device base) are also within the scope of this disclosure.

[0035] The amount of carrying solvent that is present in the coating composition can be between about 25 and about 95 weight percent of the coating composition. Alternatively, the carrying solvent may be present in an amount of between about 40 and about 80 weight percent of the coating composition or between about 60 and about 70 weight percent of the coating composition.

[0036] The coating may also include one or more catalysts. The catalysts may be used to accelerate the process of moisture curing or water curing a fluorinated silane or a non-fluorinated silane to form a fluorinated silicone or a non-fluorinated silicone. In some embodiments, the hydrophobic compound may be a fluorinated silane. Accordingly, the fluorinated silane may be moisture cured to form a fluorinated silicone. For example, the fluorinated silane may undergo hydrolysis to form a fluorinated silanol and the fluorinated silanol may then undergo condensation to form a fluorinated silicone. The moisture curing process can be pH dependent. As such, exemplary catalysts that may be used include, but are not limited to, pH modifiers (e.g., acids or bases) such as acetic acid, hydrochloric acid, p-toluenesolufonic acid, ammonia water, sodium hydroxide, monoisopropanolamine, diisopropanolamine, triisopropanolamine, or combinations thereof.

[0037] The pH modifiers may control the hydrolysis and/or the condensation reactions. Other catalysts may also be used to control the hydrolysis and/or the condensation reactions including, for example, dibutyltin dilaurate, dibutyl bis(acetylacetonate), or combinations thereof. In some embodiments, catalysts such as dibutyltin dilaurate may enhance reactions between the adhesion agent and the polymeric substrate (e.g., medical device base). Other suitable catalysts are also within the scope of this disclosure. In some other embodiments, the pH modifier can act as an inhibitor. The pH modifiers can act as a catalyst at certain pH levels to enhance or increase the rate of conversion of hydrophobic silanes to hydrophobic silanols and of hydrophobic silanols to hydrophobic silicones. However, pH modifiers may also act to minimize the conversion of hydrophobic silanes to hydrophobic silanols and of hydrophobic silanols to hydrophobic silicones. Stated another way, the pH modifiers may act as an inhibitor. These processes (i.e. , enhancing or inhibiting) can have different pH optimums. In certain embodiments, a pH modifier may be used to accelerate or enhance curing (e.g., for quick curing). In certain other embodiments, a pH modifier may be used to inhibit or minimize curing. For example, inhibition of curing may increase or maximize the shelf life of the coating system or composition (e.g., the pH modifier may limit or prevent curing of the coating system or composition before it is obtained by a user, technician, or manufacturer).

[0038] The coating may also include one or more water carrying agents. The water carrying agents may be used to aid or enhance the moisture curing process. Exemplary water carrying agents that may be used include, but are not limited to, calcium oxalate hydrate, calcium chloride hydrate, sodium carbonate hydrate, aluminum potassium sulfate dodecahydrate (alum), or combinations thereof. Other suitable water carrying agents are also within the scope of this disclosure.

[0039] The coating may also include one or more antioxidants. The antioxidant may scavenge free radicals. For example, the antioxidant can scavenge free radicals that may be generated by the one or more photoinitiators. Scavenging of the free radicals can limit or prevent oxidation of the UHMWPE material. In some embodiments, the coating may include a hydrophobic compound, an adhesion agent, a free-radical initiator, and an antioxidant. In certain embodiments, the coating may include a hydrophobic compound, an adhesion agent, a free-radical initiator, a carrying solvent, and an antioxidant. Moreover, in various embodiments, the coating may include at least one of a hydrophobic compound, an adhesion agent, a shape memory polymer, a free-radical initiator, a carrying solvent, and/or an antioxidant. Exemplary antioxidants that may be used include, but are not limited to, carotenes, xanthophylls, flavonoids, curcuminoids, tocopherols (e.g., vitamin E), phenolic acids, lignins, tannins, or combinations thereof. Other suitable antioxidants that promote the stabilization of the polymer components and/or the polymeric substrate are also within the scope of this disclosure.

[0040] The coating may also include one or more surfactants. The surfactant may be used to form stable emulsions for hydrophobic compounds that have low or poor solubility in certain carrying solvents. Furthermore, the surfactant may be used to enhance or improve wetting properties of the coating. In some embodiments, the coating may include a hydrophobic compound, a carrying solvent, and a surfactant. In certain embodiments, the coating may include a hydrophobic compound, an adhesion agent, a carrying solvent, and a surfactant. Moreover, in various embodiments, the coating may include at least one of a hydrophobic compound, an adhesion agent, a shape memory polymer, a free-radical initiator, a carrying solvent, an antioxidant, and/or a surfactant. Exemplary surfactants that may be used include, but are not limited to, silicone surfactants, fluorinated surfactants, anionic surfactants, nonionic surfactants, cationic surfactants, zwitterionic surfactants, or combinations thereof. Other suitable surfactants that promote the miscibility of the coating components are also within the scope of this disclosure.

[0041] The coating may also include one or more antistatic agents. The antistatic agent may be used to reduce or eliminate a static charge build up along the surface of the plastic component. Furthermore, the antistatic agents may be used to enhance or improve conductive properties of the coating. In some embodiments, the coating may include a hydrophobic compound, a carrying solvent, and an antistatic agent. In certain embodiments, the coating may include a hydrophobic compound, an adhesion agent, a carrying solvent, and an antistatic agent. Moreover, in various embodiments, the coating may include at least one of a hydrophobic compound, an adhesion agent, a shape memory polymer, a free-radical initiator, a carrying solvent, an antioxidant, a surfactant and/or an antistatic agent. Exemplary antistatic agents that may be used include, but are not limited to, graphite, graphene, glycols, molybdenum disulfide, or combinations thereof. Other suitable antistatic agents that promote the conductivity of the coating components are also within the scope of this disclosure. The amount of antistatic agents that are present in the coating composition can be between about 0.25 and about 5 weight percent of the coating composition.

[0042] An aspect of the disclosure relates to compositions for application to a substrate. Such coating compositions may include one or more of the following: hydrophobic compounds, adhesion agents, shape memory polymers or stabilizers, free-radical initiators, carrying solvents, catalysts, water carrying agents, antioxidants, and surfactants. All combinations and permutations of each of these components disclosed above with respect to medical device base coating systems may also be present in the coating compositions disclosed herein. Furthermore, all preceding examples of hydrophobic compounds, adhesion agents, shape memory polymers or stabilizers, free-radical initiators, carrying solvents, catalysts, water carrying agents, antioxidants, and surfactants may also be used with the coating compositions contemplated herein. In certain situations, the substrate to which such coating compositions may be applied may also include polymeric substrates.

[0043] Methods related to use of the coatings are also disclosed herein. In some embodiments, a method of coating the plastic component of a joint replacement may optionally include combining a first hydrophobic compound and a first adhesion agent to form a first liquid mixture. The method may further include applying the first liquid mixture on at least a portion of a surface to form a first layer. For example, the first liquid mixture can be sprayed and/or spread on at least a portion of the plastic component to form the first layer.

[0044] The method of coating the plastic component may also include combining and/or obtaining a first liquid mixture that includes one or more of the following: a first shape memory polymer, a first free-radical initiator, and a first carrying solvent with the first hydrophobic compound and the first adhesion agent. Stated another way, in some embodiments, the first liquid mixture may include a first adhesion agent, a first hydrophobic compound, a first shape memory polymer, a first free-radical initiator, and a first carrying solvent, wherein the constituents are optionally mixed together. Furthermore, the first free-radical initiator may be activated to convert at least a portion of the first liquid mixture to a first interpenetrating polymer network. The first free-radical initiator may also induce chemical bonding of the first adhesion agent to at least a portion of the plastic component (e.g., the UHMWPE surface).

[0045] In certain embodiments, the method of coating the plastic component may optionally include combining a second hydrophobic compound and a second adhesion agent to form a second liquid mixture. The second liquid mixture can be applied (e.g., via spraying, spreading, etc.) on at least a portion of the first layer to form a second layer. The method can also include combining and/or obtaining one or more of the following: a second shape memory polymer, a second free-radical initiator, and a second carrying solvent with the second hydrophobic compound and the second adhesion agent in a second liquid mixture. In other words, in various embodiments, the second liquid mixture can include a second adhesion agent, a second hydrophobic compound, a second shape memory polymer, a second free-radical initiator, and a second carrying solvent. Furthermore, the second free-radical initiator can be activated to convert at least a portion of the second liquid mixture to a second interpenetrating polymer network.

[0046] In some embodiments, each of the first and second hydrophobic compounds can include carbon side chains, wherein the length of the carbon side chain of the first hydrophobic compound is greater than the length of the carbon side chain of the second hydrophobic compound.

[0047] In various embodiments, the method of coating the plastic component may include combining and/or obtaining a third hydrophobic compound and a third adhesion agent to form a third liquid mixture and applying the third liquid mixture on at least a portion of the second layer to form a third layer. The method may also include combining and/or obtaining one or more of the following: a third shape memory polymer, a third free-radical initiator, and a third carrying solvent with the third hydrophobic compound and the third adhesion agent in a third liquid mixture. Furthermore, the third free-radical initiator may be activated to convert at least a portion of the third liquid mixture to a third interpenetrating polymer network. In certain embodiments, the third hydrophobic compound may include a carbon side chain, wherein the length of the carbon side chain of the third hydrophobic compound is different than the length of the carbon side chains of the first and/or second hydrophobic compounds.

[0048] In some embodiments, the method of coating the plastic component may include a free- radical initiated grafting reaction of the first layer, the second layer, the third layer, and/or any additional layers. Stated another way, in certain embodiments, the method of coating the medical device may include grafting a coating or layer, which has been applied to a portion of a surface of the medical device. Upon application of the coating or the layer to the surface of the medical device, the coating or layer may be exposed to light energy. In various embodiments, the coating may be exposed to light having a wavelength between about 100 and about 400 nm. In some embodiments, the coating may be exposed to ultraviolet (UV) light (e.g., UVA, UVB, and/or UVC light), visible light, or combinations thereof.

[0049] In certain other embodiments, the coating or layer may be exposed to UV light, visible light, or a combination thereof in a light box. The light box may include or utilize LEDs, or any other suitable light-emitting technology, to provide light energy (e.g. , UV light, visible light, etc.). For example, the user, technician, or manufacturer may expose the coating or layer to light energy for up to about 20 minutes, up to about 15 minutes, between about 5 and about 20 minutes, between about 10 and about 20 minutes, between about 15 and about 20 minutes, or another suitable time period. In some other embodiments, the manufacturer may expose the coating or layer to light energy for up to about 5 minutes, less than about 5 minutes, or another suitable time period.

[0050] The manufacturer may also expose the coating or layer to heat. In various embodiments, a light box may also provide heat (e.g., in addition to light energy). For example, the manufacturer may expose the coating or layer to heat (e.g., in a light box) between about 70 and about 135 degrees Fahrenheit, between about 70 and about 105 degrees Fahrenheit, or another suitable temperature. The wavelength of light and/or the amount of heat may be modified by the manufacturer according to the composition of the coating, the composition of the medical device, or any other relevant variable. In certain embodiments, the user, technician, or manufacturer may expose the coating or layer to a pre- heating cycle outside of the light box. A heating tool (e.g., heat gun) may be used for the pre-heating cycle. The heat may facilitate a quicker diffusion of the coating or layer into the surface of the plastic component.

[0051] In some embodiments, a method of coating the plastic component may optionally include combining an adhesion agent and a free-radical initiator to form a first liquid mixture. The method may further include applying the first liquid mixture on at least a portion of a surface of a medical device to form a first layer. For example, the first liquid mixture can be sprayed and/or spread on at least a portion of the medical device to form the first layer.

[0052] The method of coating the plastic component may also include combining and/or obtaining a first liquid mixture that includes one or more of the following: an adhesion agent and a free-radical initiator with a hydrophobic compound, a shape memory polymer, and a carrying solvent. Stated another way, in some embodiments, the first liquid mixture may include an adhesion agent, a hydrophobic compound, a free-radical initiator, a shape memory polymer, and a carrying solvent, wherein the constituents are optionally mixed together. Furthermore, the first layer may be light polymerized as described above.

[0053] In some embodiments, the method of coating the plastic component may optionally include combining an adhesion agent and a free-radical initiator to form a second liquid mixture. The method can further include applying the second liquid mixture on at least a portion of a surface of the first layer to form a second layer. For example, the second liquid mixture can be sprayed and/or spread on at least a portion of a base of the first layer to form the second layer.

[0054] The method of coating the plastic component may also include combining and/or obtaining a second liquid mixture that includes one or more of the following: an adhesion agent and a free-radical initiator with a hydrophobic compound, a shape memory polymer, and a carrying solvent. Stated another way, in some embodiments, the second liquid mixture may include an adhesion agent, a hydrophobic compound, a free-radical initiator, a shape memory polymer, and a carrying solvent, wherein the constituents are optionally mixed together. Furthermore, the second layer may also be light polymerized as described above.

[0055] In some embodiments, a method of coating the plastic component may optionally include combining an adhesion agent and a free-radical initiator to form a first liquid mixture. The method may further include applying the first liquid mixture on at least a portion of a surface of medical device to form a first layer. For example, the first liquid mixture can be sprayed and/or spread on at least a portion of a base of the medical device to form the first layer.

[0056] The method of coating the plastic component may also include combining and/or obtaining a first liquid mixture that includes one or more of the following: a shape memory polymer and a carrying solvent with the adhesion agent and the free-radical initiator. Stated another way, in some embodiments, the first liquid mixture may include an adhesion agent, a free-radical initiator, a shape memory polymer, and a carrying solvent, wherein the constituents are optionally mixed together. Furthermore, the first layer may be light polymerized as described above.

[0057] In certain embodiments, the method of coating the plastic component may optionally include obtaining a hydrophobic compound or second liquid mixture including the hydrophobic compound. The method can further include applying the hydrophobic compound on at least a portion of a surface of the first layer to form a second layer. For example, the hydrophobic compound can be sprayed and/or spread on at least a portion of a surface of the first layer to form the second layer.

[0058] The method of coating the plastic component may also include combining and/or obtaining a second liquid mixture that includes one or more of the following: a shape memory polymer and a carrying solvent with the hydrophobic compound. Stated another way, in some embodiments, the second liquid mixture may include a hydrophobic compound, a shape memory polymer, and a carrying solvent, wherein the constituents are optionally mixed together. In some embodiments, the second liquid mixture may include the shape memory polymer and/or the carrying solvent. In some other embodiments, the second liquid mixture may include the shape memory polymer and/or the carrying solvent. In yet other embodiments, both the first liquid mixture and the second liquid mixture may include the shape memory polymer and/or the carrying solvent. Additionally, the second layer may be moisture cured or water cured. As discussed above, one or more catalysts may be used to accelerate the process of moisture curing. Water carrying agents may also be used to aid the moisture curing process.

[0059] In certain embodiments, the method of coating the plastic component may optionally include obtaining a catalyst or a third liquid mixture including the catalyst. The method can further include applying the catalyst on at least a portion of the second layer. In some embodiments, the third liquid mixture can promote the polymerization of the hydrophobic compound. For example, the hydrophobic compound may include fluorinated silanes, and the catalyst may promote the polymerization of the fluorinated silanes to fluorinated silicones. Such a configuration can decouple or separate the catalyst from the first and/or second liquid mixtures, for example, if there are difficulties in generating a stable solution that includes both the catalyst and the adhesion agent, hydrophobic compound, shape memory polymer, free-radical initiator, and/or carrying solvent. In some embodiments, the third liquid mixture may also include a pH modifier and/or a surfactant. Application of the third liquid mixture to the second layer may be a final step that can induce conversion of the fluorinated silanes to fluorinated silicones. In certain embodiments, the conversion of the fluorinated silanes to fluorinated silicones may be quick or rapid.

[0060] Application of a liquid mixture including a catalyst as described above may be incorporated into any of the methods provided herein. For example, upon application of liquid mixture including a hydrophobic compound to form a layer, a liquid mixture including a catalyst may then be applied (e.g., as a second liquid mixture, a third liquid mixture, a fourth liquid mixture, etc.) to the layer including the hydrophobic compound.

[0061] Each of the hydrophobic compounds (e.g., the first hydrophobic compound, the second hydrophobic compound, and the third hydrophobic compound) may be independently selected from at least one of a fluorinated silane, a fluorinated hydrocarbon, a fluorinated polymer, a fluorinated silicone or a hydrophobic silane. For example, the first hydrophobic compound may be a fluorinated silicone, the second hydrophobic compound may be a fluorinated ethylene propylene (or other fluorinated polymer), and the third hydrophobic compound may be a fluorinated silane, or other iterations and permutations. [0062] Each of the adhesion agents (e.g., the first adhesion agent, the second adhesion agent, and the third adhesion agent) may be independently selected from at least one of an organosilane, hexachlorodisilane, poly(4-vinylphenol), a polyacrylic acid, a titanate, or a zirconate. For example, the first adhesion agent may be an organosilane, the second adhesion agent may be a hexachlorodisilane, and the third adhesion agent may be a polyacrylic acid, or other iterations and permutations.

[0063] Each of the shape memory polymers (e.g., the first shape memory polymer, the second shape memory polymer, and the third shape memory polymer) may be independently selected from at least one of e-caprolactone, polycaprolactone (PCL), polynorbomene, a polyene, a nylon, polycyclooctene (PCO), polyvinyl acetate/polyvinylidene fluoride (PVAc/PVDF), a P VAc/P VDF/poly- methylmethacrylate (PMMA) blend, a polyurethane, a styrene-butadiene copolymer, polyethylene (PE), trans-isoprene, or polyvinyl chloride (PVC). For example, the first shape memory polymer may be PCO and each of the second and third shape memory polymers may be polyurethanes, or other iterations and permutations.

[0064] Each of the free-radical initiators (e.g., the first free-radical initiator, the second free-radical initiator, and the third free-radical initiator) may be independently selected from at least one of a photoinitiator, a thermal initiator, or a chemical catalyst. For example, the first free-radical initiator may be a photoinitiator, the second free-radical initiator may be a chemical catalyst, and the third free-radical initiator may be a thermal initiator, or other iterations and permutations. Exemplary photoinitiators are described above.

[0065] Furthermore, each of the carrying solvents (e.g., the first carrying solvent, the second carrying solvent, and the third carrying solvent) may be independently selected from at least one of water, methanol, ethanol, ethylene glycol, propylene glycol, a polyol, a polar aprotic solvent, a hydrocarbon solvent, an amine-based solvent, a non-polar solvent (e.g., anisole), or other suitable carrying solvent that promotes the miscibility of the polymer coating components and the polymeric substrate (of the medical device). For example, the first carrying solvent and the second carrying solvent may be ethanol and the third carrying solvent may be ethylene glycol, or other iterations and permutations.

[0066] In certain embodiments, the coating can include one or more hydrophobic compounds, adhesion agents, shape memory polymers, free-radical initiators, carrying solvents, catalysts, water carrying agents, antioxidants, and/or surfactants in a single mixture that can be later applied to at least a portion of a surface of a medical device by a manufacturer. Additionally, components of the coating may be applied successively. Alternatively, subcombinations of the coating can be applied simultaneously while other components are applied successively/serially. For example, a solution comprising an adhesion agent may be applied initially to a surface of a plastic component followed within a few minutes by a solution comprising a hydrophobic compound. After a period of time to allow for the two solutions to soak together, the solutions could be exposed to light energy. In certain other embodiments, the coating can be applied to at least a portion of the surface of the medical device in two or more layers. For example, a first mixture including a first adhesion agent, a first hydrophobic compound, a first shape memory polymer, a first free-radical initiator, and a first carrying solvent can be applied to at least a portion of the surface of a medical device and a first interpenetrating polymer network can be formed. A second mixture including a second adhesion agent, a second hydrophobic compound, a second shape memory polymer, a second free-radical initiator, and a second carrying solvent can then be applied to at least a portion of the first layer and a second interpenetrating polymer network can be formed. In various embodiments, the first hydrophobic compound may include a longer carbon side chain than the second hydrophobic compound. The layering process described above and/or additional mixtures (e.g., a third mixture including a third hydrophobic compound) may be used to form additional layers.

[0067] The various mixtures (e.g., the first mixture, the second mixture, etc.) can begin in a liquid form that may allow for penetration and/or saturation of the coating into a porous (or micro- or nano- porous) surface of the medical device. In some embodiments, the liquid mixtures may allow for full, or substantially full, penetration and/or saturation of the coating into a porous surface of the plastic component. In other embodiments, the various mixtures may not penetrate and/or saturate the surface of the plastic component. In other words, the various mixtures may form a monomer coating layer that may be covalently bonded to the surface. Alternatively, the various mixtures may modify and be disposed on the surface of the plastic component.

[0068] In certain embodiments, wherein the free-radical initiator is a photoinitiator, upon the application of light energy (e.g., UV light) the photoinitiator may initiate a free-radical initiated grafting process to permanently, or semi-permanently, associate the coating with the base substrate. By using a liquid form of the various mixtures to achieve full, or substantially full, saturation of the coating into the base material and then inducing polymerization within the liquid mixtures, a polymer network can be formed that fills or penetrates a surface of the plastic component.

[0069] The use of an adhesion agent, as discussed above, can result in the formation of a permanent, or semi-permanent, association between the hydrophobic compound and the plastic component material. Filling the pores of the plastic component surface with a polymer coating or system as provided herein, which incorporates hydrophobic compounds, can impart the surface of the plastic component with enhanced durability and/or permanent, or substantially permanent, enhanced lubricity.

[0070] The lubricious coating system includes an interpenetrating polymer network that is absorbed into the base polymer and then bonded to the base polymer via a free-radical initiated grafting method. Furthermore, the lubricious coating system may be chemically bound (e.g., via the free-radical initiators and the adhesion agent) to the surface of the medical component. As can be appreciated, additional methods and/or method steps can be derived from the present disclosure.

[0071] The lubricious coating system may be applied to an interface surface of the plastic component such that friction between the plastic component and the metal or ceramic component is reduced when the joint is in motion. The coating system may be applied to the interface surface at different steps of the plastic component manufacturing process. In some embodiments, as illustrated in the flow chart of FIG. 4, manufacture of the plastic component includes obtaining the UHMWPE in the form of a block or rod and irradiating the UHMWPE with about 50 kilogray (kGy) to about 100 kGy of gamma or beta rays to improve the wear characteristic of the plastic component. Irradiation of UHMWPE can cause crosslinking of the polyethylene polymeric chains in an amorphous phase to harden the material and creation of free radicals in the chains in a crystalline phase, which may cause oxidation and degradation (e.g., cracking) of the material over time. The manufacturing method may further include a thermal treatment. The thermal treatment may include remelting of the UHMWPE to a temperature above 150 degrees Celsius for a period of time, such as about 24 hours or any other suitable period of time, and/or annealing of the UHMWPE at a temperature below 150 degrees Celsius for a period of time, such as about 24 hours or any other suitable period of time. Remelting can reduce the crystallinity and the number of free radicals of the material. Annealing can promote some recrystallinity and reduce residual stress of the material. Reduction of the number of free radicals in the UHMWPE material can improve the wear characteristic of the plastic component by reducing the rate of oxidation and degradation of the UHMWPE material.

[0072] With further reference to FIG. 4, the plastic component manufacturing process may further include machining of the block or rod to form the plastic component into the suitable shape of a liner, spacer, bearing, or socket member as discussed previously. The manufacturing process can additionally include treatment of the plastic component with the lubricious coating system disclosed herein to reduce the friction between the plastic component and the metal or ceramic component when the joint replacement is in motion. The reduction of friction can improve the wear characteristic of the plastic component. In some embodiments, the treated plastic component may be washed with a solvent, such as isopropyl alcohol or ethanol, or boiled in xylene. The washing may remove coating molecules that may not be covalently bonded to the UHMWPE material. The non-bonded molecules may be toxic to human tissue and may result in inflammation of the tissue. The manufacturing process may further include sterilization of the joint replacement with ethylene oxide gas, gas plasma, or any other suitable agent.

[0073] In another embodiment, as shown in the flow chart of FIG. 5, manufacture of the plastic component includes obtaining the UHMWPE material in the form of a block or rod. The manufacturing method may further include thermal treatment. The thermal treatment may include remelting of the UHMWPE to a temperature above 150 degrees Celsius for a period of time, such as about 24 hours or any other suitable length of time, and/or annealing of the UHMWPE at a temperature below 150 degrees Celsius for a period of time, such as about 24 hours or any other suitable length of time. Remelting can reduce the crystallinity and the number of free radicals of the material. Annealing can promote some re-crystallinity and reduce residual stress of the material. Reduction of the number of free radicals in the UHMWPE material can improve the wear characteristic of the plastic component by reducing the rate of oxidation and degradation of the UHMWPE material.

[0074] Thermal treatment can occur before machining or after irradiation (discussed infra). With further reference to FIG. 5, the plastic component manufacturing process may further include machining of the block or rod of UHMWPE to form the plastic component into the shape of a liner, spacer, bearing, or socket member as previously discussed. The manufacturing process can further include treatment of the plastic component with the lubricious coating system to reduce the friction between the plastic component and the metal or ceramic component when the joint replacement is in motion. In some embodiments, the treated plastic component may be washed with a solvent, such as isopropyl alcohol or ethanol, or boiled in xylene. The washing may remove coating molecules that may not be covalently bonded to the UHMWPE material. The non-bonded molecules may be toxic to human tissue and may result in inflammation of the tissue. The manufacturing process can also include irradiating the plastic component with about 50 kGy to about 100 kGy of gamma or beta rays to crosslink the UHMWPE polymer chains to improve the wear characteristic of the plastic component. In other embodiments, the irradiation may crosslink the molecules of the coating system. The manufacturing process may further include sterilization of the joint replacement with ethylene oxide gas, gas plasma, or any other suitable agent.

[0075] Any methods disclosed herein include one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. For example, the washing step could occur after coating but before irradiation or, alternatively, after coating and irradiation. Furthermore, as outlined above the thermal treatment step may be performed at different points in the process. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified. Moreover, sub-routines or only a portion of a method described herein may be a separate method within the scope of this disclosure. Stated otherwise, some methods may include only a portion of the steps described in a more detailed method.

[0076] References to approximations are made throughout this specification, such as by use of the term“substantially.” For each such reference, it is to be understood that, in some embodiments, the value, feature, or characteristic may be specified without approximation. For example, where qualifiers such as“about” and “substantially” are used, these terms include within their scope the qualified words in the absence of their qualifiers. For example, where the term“substantially full” is recited with respect to a feature, it is understood that in further embodiments, the feature can have a precisely full configuration.

[0077] Reference throughout this specification to“an embodiment” or“the embodiment” means that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the quoted phrases, or variations thereof, as recited throughout this specification are not necessarily all referring to the same embodiment.

[0078] Similarly, it should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment or description thereof for the purpose of streamlining the disclosure. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than those expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment.

[0079] The claims following this written disclosure are hereby expressly incorporated into the present written disclosure, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of the independent claims with their dependent claims. Moreover, additional embodiments capable of derivation from the independent and dependent claims that follow are also expressly incorporated into the present written description.

[0080] Without further elaboration, it is believed that one skilled in the art can use the preceding description to utilize the invention to its fullest extent. The claims and embodiments disclosed herein are to be construed as merely illustrative and exemplary, and not a limitation of the scope of the present disclosure in any way. It will be apparent to those having ordinary skill in the art, with the aid of the present disclosure, that changes may be made to the details of the above-described embodiments without departing from the underlying principles of the disclosure herein. In other words, various modifications and improvements of the embodiments specifically disclosed in the description above are within the scope of the appended claims. Moreover, the order of the steps or actions of the methods disclosed herein may be changed by those skilled in the art without departing from the scope of the present disclosure. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order or use of specific steps or actions may be modified. The scope of the invention is therefore defined by the following claims and their equivalents.

Claims

1. A medical device, comprising:

a plastic component; and

a lubricious coating system comprising:

a hydrophobic compound; and

an adhesion agent configured to promote adhesion of the hydrophobic compound to a surface of the plastic component.

2. The medical device of claim 1 , wherein the plastic component comprises a polyolefin polymer.

3. The medical device of claim 2, wherein the plastic component comprises ultra-high molecular weight polyethylene (UHMWPE).

4. The medical device of claim 3, wherein the UHMWPE is crosslinked.

5. The medical device of claim 4, wherein the crosslinked UHMWPE is formed by irradiation of gamma or beta irradiation.

6. The medical device of claim 5, wherein the irradiation dosage is between 50 kilograys and 100 kilogray.

7. The medical device of any one of claims 1 -6, wherein the medical device is a joint replacement or a vascular stent.

8. The medical device of claim 7, wherein the medical device is a joint replacement selected from at least one of a hip joint, a knee joint, a shoulder joint, a wrist joint, a knuckle joint, a finger joint, an ankle joint, or a toe joint.

9. The medical device of any one of claims 1 -8, wherein the plastic component is selected from at least one of a liner, a spacer, a bearing, or a socket member.

10. The medical device of any one of claims 1 -9, wherein the coating system is configured to reduce friction between the plastic component and a metal or ceramic component of the medical device.

11. The medical device of claim 10, wherein the coating system is configured to reduce wear of the plastic member when the medical device is in motion.

12. The medical device of any one of claims 1 -11 , wherein the hydrophobic compound is present in an amount of between 0.1 and 15 weight percent and the adhesion agent is present in an amount of between 0.1 and 15 weight percent of the coating system.

13. The medical device of any one of claims 1 -12, wherein the adhesion agent is selected from at least one of an organosilane, hexachlorodisilane, poly(4-vinylphenol), a polyacrylic acid, a titanate, or a zirconate.

14. The medical device of any one of claims 1 -13, wherein the adhesion agent is an organosilane selected from at least one of vinyltrimethoxysilane, (3-aminopropyl)triethoxysilane, methyltrichlorosilane, triethoxymethylsilane, trimethoxymethylsilane, dimethoxydimethylsilane, methoxytrimethylsilane, diethoxydimethylsilane, triethoxyvinylsilane, trichlorovinylsilane, methyldiethoxysilane, triethoxy(ethyl)silane, ethoxytrimethylsilane, dimethoxyvinylsilane, tert- butyltrichlorosilane, (chloromethyl)triethoxysilane, bis(trichlorosilyl)methane, 1 ,2- bis(triethoxysilyl)ethane, 1 ,2-bis(trimethoxysilyl)ethane, 1 ,2-bis(trichlorosilyl)ethane, trichloro(dichloromethyl)silane, diethoxy(methyl)vinylsilane, or 1 ,3-diethoxy-1 ,1 ,3,3- tetramethyldisiloxane.

15. The medical device of any one of claims 1 -14, wherein the hydrophobic compound is selected from at least one of a fluorinated silane, a fluorinated hydrocarbon, a fluorinated polymer, a fluorinated silicone, or a non-fluorinated silane.

16. The medical device of any one of claims 1 -15, wherein the hydrophobic compound comprises a fluorinated silane that includes a carbon side chain, and wherein a length of the carbon side chain of the fluorinated silane is between 1 and 30 carbons.

17. The medical device of any one of claims 1 -16, wherein the hydrophobic compound comprises a first fluorinated silane including a first carbon side chain and a second fluorinated silane including a second carbon side chain, and wherein the length of the first carbon side chain of the first fluorinated silane is greater than the length of the second carbon side chain of the second fluorinated silane.

18. The medical device of claim 17, wherein the first carbon side chain has between 9 and 30 carbons and the second carbon side chain has between 1 and 8 carbons.

19. The medical device of any one of claims 1 -18, wherein the hydrophobic compound comprises a fluorinated polymer that is at least one of polytetrafluoroethylene (PTFE) or fluorinated ethylene propylene (FEP).

20. The medical device of claim 15, wherein the hydrophobic compound comprises a non- fluorinated silane selected from at least one of methylated silane, methyl-siloxanyl silane, linear alkyl silane, dialkyl silane, branched alkyl silane, cyclic alkyl silane, phenyl silane, phenyl alkyl silane, substituted phenyl silane, substituted phenylalkyl silane, or napthyl-silane.

21 . The medical device of any one of any one of claims 1 -20, further comprising a shape memory polymer.

22. The medical device of claim 21 , wherein the shape memory polymer is present in an amount of between 1 .0 and 10 weight percent of the coating system.

23. The medical device of claim 21 or 22, wherein the shape memory polymer is selected from at least one of e-caprolactone, polycaprolactone (PCL), polynorbomene, a polyene, a nylon, polycyclooctene (PCO), polyvinyl acetate/polyvinylidene fluoride (PVAc/PVDF), a P VAc/P VDF/poly- methylmethacrylate (PMMA) blend, a polyurethane, a styrene-butadiene copolymer, polyethylene (PE), trans-isoprene, or polyvinyl chloride (PVC).

24. The medical device of any one of claims 1 -23, further comprising a free-radical initiator.

25. The medical device claim 24, wherein the free-radical initiator is present in an amount of between 0.01 and 10 weight percent of the coating system.

26. The medical device of claim 24 or 25, wherein the free-radical initiator is selected from at least one of a photoinitiator, a thermal initiator, or a chemical catalyst.

27. The medical device of any one of claims 24-26, wherein the free-radical initiator comprises a photoinitiator selected from at least one of acetophenone, anisoin, anthraquinone, anthraquinone-2- sulfonic acid, (benzene)tricarbonylchromium, benzil, benzoin, benzoin ethyl ether, benzoin isobutyl ether, benzoin methyl ether, benzophenone, benzophenone/1 -hydroxycyclohexyl phenyl ketone, 3,3’,4,4’-benzophenonetetracarboxylic dianhydride, 4-benzoylbiphenyl, 2-benzyl-2-(dimethylamino)-4'- morpholinobutyrophenone, 4,4’-bis(diethylamino)benzophenone, 4,4’- bis(dimethylamino)benzophenone, camphorquinone, 2-chlorothioxanthen-9-one,

(cumene)cyclopentadienyliron(ll) hexafluorophosphate, dibenzosuberenone, 2,2- diethoxyacetophenone, 4,4’ dihydroxybenzophenone, dimethoxyacetophenone, 2,2-dimethoxy-2- phenylacetophenone (DMPAP), 4-(dimethylamino)benzophenone, 4,4'-dimethylbenzil, 2,5- dimethylbenzophenone, 3,4-dimethylbenzophenone, diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide/2-hydroxy-2-methylpropiophenone, 4’-ethoxyacetophenone, 2-ethylanthraquinone, ferrocene, 3’- hydroxyacetophenone, 4’-hydroxyacetophenone, 3-hydroxybenzophenone, 4-hydroxybenzophenone, 1-hydroxycyclohexyl phenyl ketone, 2-hydroxy-2-methylpropiophenone, 2-methylbenzophenone, 3- methylbenzophenone, methybenzoylformate, 2-methyl-4'-(methylthio)-2-morpholinopropiophenone, phenanthrenequinone, 4’-phenoxyacetophenone, phenylbis (2,4,6-trimethylbenzoyl)-phosphine oxide (BAPO), thioxanthen-9-one, triarylsulfonium hexafluoroantimonate salts, thioxanthone, triarylsulfonium hexafluorophosphate salts, or xanthone.

28. The medical device of any one of claims 1 -27, further comprising a carrying solvent.

29. The medical device of claim 28, wherein the carrying solvent is present in an amount of between 25 and 95 weight percent of the coating system.

30. The medical device of claim 28 or 29, wherein the carrying solvent is selected from at least one of water, methanol, ethanol, ethylene glycol, propylene glycol, a polyol, a polar aprotic solvent, a hydrocarbon solvent, an amine-based solvent, or any combination thereof.

31. A method of coating a medical device, the method comprising:

obtaining a first liquid mixture comprising a first hydrophobic compound and a first adhesion agent; and

applying the first liquid mixture on a portion of a surface of a plastic component of a medical device to form a first layer.

32. The method of claim 31 , wherein applying the first liquid mixture comprises applying the first liquid mixture to the plastic component comprising UHMWPE.

33. The method of claim 31 or 32, wherein applying the first liquid mixture comprises applying the first liquid mixture to the plastic component comprising crosslinked UHMWPE.

34. The method of any one of claims 31-33, wherein the first liquid mixture further comprises a first carrying solvent.

35. The method of claim 34, further comprising:

mixing the first hydrophobic compound, the first adhesion agent, and the first carrying solvent to form the first liquid mixture.

36. The method of any one of claims 31-35, wherein the first liquid mixture further comprises a first shape memory polymer and a first free-radical initiator.

37. The method of claim 36, further comprising:

mixing the first hydrophobic compound, the first adhesion agent, the first shape memory polymer, the first free-radical initiator, and the first carrying solvent to form the first liquid mixture.

38. The method of claim 36 or 37, further comprising: activating the first free-radical initiator to convert a portion of the first liquid mixture to a first interpenetrating polymer network.

39. The method of any one of claims 31-38, further comprising:

obtaining a second liquid mixture comprising a second hydrophobic compound and a second adhesion agent; and

applying the second liquid mixture on a portion of the first layer to form a second layer.

40. The method of claim 39, wherein the second liquid mixture further comprises a second carrying solvent.

41. The method of claim 39 or 40, wherein the second liquid mixture further comprises a second shape memory polymer and a second free-radical initiator.

42. The method of claim 41 , further comprising:

activating the second free-radical initiator to convert a portion of the second liquid mixture to a second interpenetrating polymer network.

43. The method of any one of claims 39-42, wherein the first and second hydrophobic compounds each include carbon side chains, and wherein a length of the carbon side chain of the first hydrophobic compound is greater than a length of the carbon side chain of the second hydrophobic compound.

44. The method of any one of claims 39-43, further comprising:

obtaining a third liquid mixture comprising a third hydrophobic compound, a third adhesion agent, and a third carrying solvent; and

applying the third liquid mixture on a portion of the second layer to form a third layer.

45. The method of claim 44, wherein the third liquid mixture further comprises a third shape memory polymer and a third free-radical initiator.

46. The method of claim 45, further comprising:

activating the third free-radical initiator to convert a portion of the third liquid mixture to a third interpenetrating polymer network.

47. A method of manufacturing a plastic component of a medical device, comprising

obtaining a block or rod of UHMWPE material;

crosslinking the UHMWPE material;

thermal conditioning the UHMWPE material;

machining the block or rod to form a plastic component; and

coating a surface of the plastic component with a lubricious coating system comprising:

a hydrophobic compound;

an adhesion agent configured to promote adhesion of the hydrophobic compound to the surface of the plastic component; and

a carrying solvent.

48. The method of claim 47, wherein the coating system further comprises:

a shape memory polymer; and

a free-radical initiator.

49. The method of claim 47 or 48, wherein the UHMWPE material is crosslinked using gamma or beta irradiation.

50. The method of claim 48 or 49, further comprising activating the free-radical initiator.

51 . The method of any one of claims 47-50, further comprising sterilizing the plastic component.

52. A method of manufacturing a plastic component of a medical device, comprising:

obtaining a block or rod of UHMWPE material;

thermal conditioning the UHMWPE material;

machining the block or rod to form a plastic component;

coating a surface of the plastic component with a lubricious coating system comprising:

a hydrophobic compound;

an adhesion agent configured to promote adhesion of the hydrophobic compound to the surface of the plastic component; and

a carrying solvent; and

crosslinking the UHMWPE material.

53. The method of claim 52, wherein the coating system further comprises:

a shape memory polymer; and

a free-radical initiator.

54. The method of claim 53, further comprising activating the free-radical initiator.

55. The method of any one of claims 52-54, wherein the UHMWPE is crosslinked using gamma or beta irradiation.

56. The method of any one of claims 52-55, further comprising sterilizing the plastic component.