cu») United States 'US 2006007449141 2) Patent Application Publication co) Pub. No.: US 2006/0074491 A1 Smith et al. (54) BORONIZED MEDICAL IMPLANTS AND. PROCESS FOR PRODUCING THE SAME (75) Inventors: Bryan Smith, Fort Wayne, IN (US); Sarah Aust, Warsaw, IN (US); Ron Overholser, Warsaw, IN (US) Comespondence Address: LEYDIG VOIT & MAYER, LID TWO PRUDENTIAL PLAZA, SUITE 4900 180 NORTH STETSON AVENUE CHICAGO, IL, 60601-6780 (US) (93) Assignee: DePuy Products, Ine., Warsaw, IN (21) Appl. Nos 101984677 (22) Filed Sep. 30, 2004 (4s) Pub. Date: ‘Apr. 6, 2006 Publication Classification 1) Inte AOIE 2/32 (2006.01) AOE 238 (2006.01), GIF 228 (2006.01) (2) (623120.28; 625/22.15; 629/28.53; 148239 6 ABSTRACT The invention provides metallic medical implants or medical ‘implant pars having # bearing surface comprising « bron- ized metal ayer. The invention further provides a process for prodicing a medical implant or medical implant part com- prising a boronized metal layer.US 2006/0074491 AI BORONIZED MEDICAL IMPLANTS AND PROCESS FOR PRODUCING THE SAME FIELD OF THE INVENTION [0001] This invention pertins to metalic medical implants oF medical implant parts comprising @ boronized mlal layer and processes for producing such medical implants or mediea! implant pars. BACKGROUND OF THE INVENTION [0002] Ozthopaedic implants typically must endure sig nificant mechanical stresses and an in vivo environment ‘nent on attacking most foreign materials introduced into @ patient's body. Therefore, the materials from which such ‘orthopaedic implants are made must combine high strength ‘corosion resistance, and tissue compatibility. Furthermore, ‘due othe rigors often associated with revision surgery, tis ‘desirable forthe in vivo lifespan of an orhopaete implant to be equal to or exceed the expected remaining lifespan of the recipient of the implant [0003] One of the variables affecting the longevity of Joad-bearing orthopaedic implants, such 36_hip-joint implants, is the rate of Wear of the implaat’s areulsting sutfaces. Atypical hip-joint implant includes femoral stem, ‘femoral head attched o the stem, and an acetabular cup against which the femoral head articulates. Wearing ofthese aniculating surfoces generates debris particles that are released into the tissues surrounding the implant. It is zenerally aecepted by orthopaedic surgeons and biomateri- ls scientists that these debris particles contrite, at last in par, to bone oss at the interface of the orthopaedic implant and the host bone. Indeed, the reaction ofthe body to these particles includes inflammation and deterioration of the fissues, particularly the bone to which the orthopaedic Jmplant i anchored, though process Known as osteolysis. As the osteolysis progresses, the orthopaedic implant may become painfully loose and require revision, [0004] The rate of wear of the articulating surfaces of ‘orthopaedic implants i dependent upon a number of factors, These factors include, but are not limited to, the eolative hardness and surfce finish of the materials from which the aniculating surfaces are made, the coeficent of friction betwoen the materials ofthe arculating surfaces, the load applied to the articulating surfaces, andthe stresses gener- ‘ated at the aniulating surfaces. Inn effort to decrease the rate of wear of the articulating surfaces of orthopaedic implants, and thereby extend the in vivo Tifespaa of such implants, several altempts have been made to address one oF ‘more of the above-ietified factors which alec the rate of wear of such ariculating surfaces. For example, onhopaedic implants have been developed which are made from rela- rly hard, wear-resistant, chemically inert oxide ceramics. Howover, ceramic implants often are brite and lack the toughness of metalic implants, which can increase the risk ‘of fracture. The britleness and low toughness of ceramic ‘implants also limits the use of such implants in certain ‘applications, such as the femoral component of & knee ‘rthroplsty, Furthermore, ceramic implants are not compat ‘ble withthe beaded, porous ingrowth structures used 0 ad biologic fixation of implants iaplanted into patents without the use of bone coment [0005] U.S. Pat. No. 5.037.438 describes a prosthetic ‘implant having a coating oF blue-black or black zirconium Apr. 6, 2006 ‘oxide on the bearing surface of the prosthesis body. Whi the aforementioned patent claims thit the coating procs a Tow fection, wear-resistant bearing surface, attempts 10 provide surfice layers of zirconium oxide greater than Approximately 8-10 microns in thickness have resulted in ‘lamination of the zirconium oxide layer from te zirco- ium alloy substrate, The eoltively thin costings produced by the process may have limited abrasion or serch resis- tance and may not be suitable for high contact stress applications, such as metal on metal hip bearings. [0006] Other efforts simed at increasing the wear perfor ‘mance of orthopaedic implants have ineluded ion bom ‘meat ofthe implant’santiculating surfaces (eg. nitrogen ion implantation), nitriding the implants aniculating surfaces, coating the articulating surfaces with diamondlike carbon or ttanium nitride coatings, and oxygen dilusion hardening of, forexample titanium alloy implants. While each ofthese techniques is capable of producing # hardened articulating surlace on the orthopaedic implant, some of the surface coatings of layers produced by suck techniques suller Irom Timited adhesion o the substrate. Furhermore, some of the techniques are only capable of producing Very thin coatings or layers of the harlened material, and others produce cnatings of layers exhibiting peak hardness values that are ‘ot relatively high. [0007] A need therelore exists for metallic orthopaedic Jmplants or implant parts having hardened, wear-resistant aniculating surfaces. A nesd also exists for @ process for producing orthopaedic implants or implant parts comprising such hardened, wear resistant aniculating surfaces. The invention provides such orthopaedic implants and implant paris, as wel s a process for producing the same. These and other advantages of the invention, as well 3¥ additional inventive features, will be apparent fom the description of the invention provided herein. BRIEF SUMMARY OF THE INVENTION [0008] The invention provides a medical implant or medi- ‘al implant part comprising (a) a metallic body comprising meal or metal alloy, and (b) a bearing surface disposed on the body, the bearing surface comprising a boronized layer of the metal or metal aay. [0009] The invention also provides ® medical implant for {implantation into a patient, the medical implant comprising. ()2 femoral component for replacing one oF more of the 1s femoral condyles, the femoral component having lic body comprising a metal or metal alloy and a Dearing surface disposed on the body, the bearing surface comprising a boronized layer of the metal or metal alloy, (b) tibial component for replacing at least a portion of the patient's proximal tibial anicular surface, and (6) @ poly- ‘meric bearing component which rests on the tibial compo- rent and confronts the bearing surface of the femaral ‘component. [0010] ‘The invention also provides « medical implant for implantation into a patient, the medical implant comprising (@) a femoral stem for anchoring the implant into the patient's femur, (b) a femoral head which attaches to the ‘upper end of the femoral stom, the femoral head having a retalic body comprising a metal or metal alloy and a bearing surface disposed on the body, the bearing surfaceUS 2006/0074491 AI (6) an acetabular component for replacing the patient's acetabulum, the acetabular component comprising a ince which conffonts the bearing surfee of the femoral head, [0011] The invention fanher provides « process for pro= ‘ducing @ medical implant or ‘medical implaat par, the process comprising the steps of (a) providing s: medical ‘implant or medical implant part having a metalic body, (6) providing » horoniring agent which yields boron upon heating () heating the bo ‘agent to a temperature at hici the boronizing agent yields boron (d) contacting at least a portion ofthe metallic body with the boron prodced by the boronizing agent, and () heating the medical implant ‘or medical implant pot to an elevated temperature fr atime sufficient fora least « portion of the horan produced by the boronizing agent to diffse into at least a portion of the metallic body of the medical implant or medical implant part DETAILED DESCRIPTION OF THE INVENTION [0012] The invention provides a medical implant or medi ‘al imfant pat comprising (a) metallic body comprising ‘a metal or metal alloy and (b) a bearing surface disposed on, the body. [0013] The medical implant or medical implant part can be ‘any suitable metallic medical implant or medical implant Part. Suitable implants or implant pars inelude, but are not Timited to, the femoral component (e., the component Which replaces one or more of the patient's femoral condyles) of an unicompartmental knee arthroplasty or 3 total knee arthroplasty te tibial component (et, the com- ponent which replaces at least a portion of the patient's proximal tibial aricular surface or tibial plateau) of un tii-comparimental knee arthroplasty ora total knoe arthro- plasty the femoral head ofa hip arthroplasty the acetabular ‘cup oF liner of @ hip arthroplasty, the humeral head of 3 shoulder arthroplasty, tbe humeral or ulnar component of an clbow arthroplasty, the metacarpal or radial stem of a wrist arthroplasty, the Vertebral endplate components of a disc anhroplasty (ea cervical vetwbral disc arthroplasty), and the tibial or talar component of an ankle arthroplasty [0014] The medical implant or mecca implant par ofthe ‘vention comprises a metallic body. The micallie body of the implant or implant part can comprise, consist essentially ‘for consist of any suitable metal or metal alloy (ex. any metal which readily fons hard borides upon diffusion of boron into the surface at elevated temperatures), For ‘eximple, the metallic body can comprise a metal or metal alloy selected from the group consisting of cobalt, cobalt, alloys, titanium, titanium alloys, and mixtores thereof. Pref= ‘erably, the metal or metal alloy is selected from the group. ‘consisting of cobalt, cobalt-chromitm alloy, titanium, tt nium-aluminum alloys, and mixtures. thereof. Suitable ‘cobalt-chromium alloys inclode, but are not Fimited to, the ‘east, forged, and wrought cobalt-28-chromium-6-molyde~ ‘num (Co28Cr6Mo) alloys described in, for example, ASTM Standards F75.01, F799-02, and. F1337-00, respectively Switable ttaniam-aluminum alloys include, but are not fim= ited to, the tianium-3-aluminum-2.5-vanadium alloy (Ti3A12'5V) described in, for example, ASTM Standard P2146-01 and the Glanivm-6-auminum-4-vanadivm (TWGAIAV) alloy described in, for example, ASTM Standard F136.02a Apr. 6, 2006 {0015} The mots implant or medial plant pet come prises bering surface dnposed on te buy. Av tied herein, the term "besring surface” is sed to ree to 8 pruton of te surhce of a medical impli or matical Implant “part which ariculstly or movably confonts ashe sree the sure of note medial plant or mica implant pr) when the medica implant or tnedical implant parts mplanted inpatient, For ample the bearing siface of the medical implant or media implant prt can corespond tothe cuter surace of femoral component of un-comparinental or tol knee arto plan, wtich sree conons the polymeric bering com Ponon ofthe arhoplosy. Asmat th bearing surface Efe medal implnt or medical inplan prt ea core. Spond to the outer sirlae ofthe femoral head of hip atoplasy, which stage contont the Finer of the acetabular cp. {0016} The bearing sure of the mesial implant or tmodica implant part prefenbly comprises bornized ayer SF the metal or metal alloy fom which the fod of the implant or implant pert is comprised. As lized herein the term “horoized™ refers to portion ofthe metal oF mata Sly which compres boron atoms that have ified into the metal or met alloy. For example, the hronized ayer an comprise a mie of borides, Sch boride can have forexample the formtla MeB, MeB,, or Me, wherin Me represent cmc prevent inthe body of te edie implant OF medical implant par. For example, when the mia implant or medial implant part comprises Co2SCrMO alley the boronined layer ean comprise mnt of borides having the formula COB, Co a ell br bods of cobalt, chromium, anor molybdenum. When the matics lant or medical implant pat comprises a tcniom- atuminan-vanadiam alloy (eg TSAIB3V or TiAl), the boroniad lier ean comprise mixture of borides faving te formula Ti Tiber as wel as other borides of ‘tin, aluminum, andor vanadium. Altematvely the boroniza layercan compris boron atoms that have dified ino the late since ofthe metal or meta alo. In sch voz layers the atively smal boron atoms pial fila portion of the infers spaces (ies the spaces beroeen adjacent ma atoms) preset inthe aie tue ture of th metal or met aby. As willbe understood by thowe of ordinary sil inthe ar, the composition of the beoronized Tayer can bo diferent at varout points in the Soronized lager (et, a varios dep nthe oronized layer). For example, the borotined layer of mia implant or medial ipl! pat according to the invention an progoitantly comprise borides having the forma ‘Med! or Main the portion ofthe bornizd lye closest, to the surface of the metalic body, while predomi Comprising bores having te formula Me or born atom ling portion ofthe nes spaees in the at Strcture ofthe metal or met aloy inthe potion of the teroized layer fits fom the surface ofthe metalic body. {0017} The boronze ayer ofthe metal or metal alloy cn ave any sitable heknes. Typically the bronzed layer fa ticknes of about Tum or more Ge. the boronized Jnyer extends at lest about I yum below the surface ofthe tmatalic bod), Preferably, tho oronzed lnyer asa thick Iss of about 2m or more, more preferably about 3 ym oF thors and most prefenbly about & mor more (es about S um oF mors oF about 8 un oesmer) The bornized ayerUS 2006/0074491 AI ‘ypically as thickness of about 75 jum of less (eq, about 70 ym or less, about 65 um oF less, about 60 um or less about $0 ym or Tes, or about 40 jum or less). In certain ‘embodiments, the boronized layer preferably has a thickness ‘of about 5 jum to about 30 ym (about 6 um to about 30 ‘um, about 8 us to about 30 yam, oF about 15 yn to about 25 um [0018] The boronized layer of the metal oF meta alloy ‘ypieally is harder than the untreated metal or metal allay (Gg. the metal or metal alloy prior to boronizing). Prefer ably the boronized layer of the metal or meta alloy has & higher Knoop hardness than the unieated metal or mictal alloy. The Knoop hardoess of the boronized layer can be determined using any suitable technigue. Typically, the Koop hardness of the boroaized layer is detemmined using the techaigue deseribed in ASTM Standard E384-99e1, Ia ‘ertiin embadiments, the boronized layer of the metal oF metal alloy has # Knoop hardness of about 1000 HK, or more, preferably about 1500 HK, or more, more preferably about 1750 HK, or more and most preferably about 2000 HK oF more (@., about 2100 HK, or more) [0019] In. prefered embodiment, the invention provides a knoe arthroplasty implant (eg, 2 uni-comipartmental knee froplasty implant ora otal knce arthroplasty implant). La such an embodiment, the medical implant preferably com prises (a) a femoral componet for replacing one or more of the patient's femora eondyes, the femoral component a= jing a metallic body comprising a metal or metal alloy and a bearing surface disposed on the body, the bearing surface ‘comprising 1 boronized layer ofthe metal or metal alloy.) a tibial component for replacing at least @ portion of the patient's proximal tibial articua surface, and (c) a poly meric beating component which rests on te tibial compo- rent and confronts the bearing surface of the femoral ‘component. The characteristics ofthis embodiment of the ‘medical implant or medical implaat part of the invention (ea. the composition of the metalic Body, the composition ‘of the boronized layer, the thickness of the boronized layer the hardness of the horonized layer, ee.) can be the smi as those set forth above, [0020] In another preferred embodiment, the invention provides a hip aethroplsty implant. In such an embodiment, the medical implant preferably comprises (a) femoral stem for anchoring the implant into the patient's femur, (6) @ amoral head which attaches tothe upper end of the femoral sem, the Femoral head having a metalic body comprising @ metal or metal alloy and a bearing surface disposed on the body, the bearing surface comprising a boronized layer of the metal or metal alloy, and (c) an acetabular component for replacing the patents acetabulum, the acetabular compo- ‘ent comprising @ line which confronts the bearing surface ‘of the femoral head, The characteristics of this embodiment ‘of the medical implant or medical implant part of the invention (eg, the composition of the metallic body, the ‘composition of the boranized layer, the thickness of the boronized layer, the hardness of the boroaized layer, ete) ‘ean be the same as those set for above, [0021] The inventive modical implant or medical implant part can be prepared in any suitable manner. For example, the inventive medical implant or medical implant part can be prepared using methods similar to those wsed to boronize ‘ther types of metals, stich at the process described i Apr. 6, 2006 Kootek et al, “Surface Layers on Cobalt Base Alloys by Boron Dillusion,"Dhin Solid Films, 45:331-330 (1977) [0022] ‘The invention further provides a preferred process for producing # medical implant or medical implant part comprising a boronized layer of a metal or metal alloy. In particular, the process comprises the steps of (a) providing ‘medical implant or medical implant part having a metalic body, (b) providing a boronizing agent which yields boron ‘upon heating () eating the boronizing agent toa temper tore at which the boronizing agent yields boron, (d) con- ‘acting atleast a portion ofthe metallic body withthe baroa produced by the boronizing agent, and (e) heating the ‘medical implant or medical implant part to an elevated temperature fora time suficient for a east a portion of the boron produced by the oroaizing quent to dillse io at least a portion of the metallic body of the medical implant ‘or medical implant par. [0023] The medical implant or medical implant part to be ‘subjected to the process ofthe invention can be any suitable ‘metalic medical implant or medical implant part. Suitable implants or implant parts include, but are nt limited to, the ‘femorl component (eg. he component which replaces one for more of the patien’s femoral condyles) of an uni- ‘compartment knee arthroplasty orattal knee arthroplasty the ubial component (ex, the component which replaces at least « portion of the patient's proximal tbl articular surlace or tibial plateau) of an unicompartmental knee arthroplasty oF a total ace arthroplasty, the femoral head of 4 hip arthroplasty, the acetabular cup oF Finer of a hip ‘aroplasty, the humeral head ofa shoulder arthroplasty, the humeral of ulnar component of an elbow aatroplasty, the ietacarpal or radial stem of a wrist arthroplasty, the Verte bral endplate components of a dise arthroplasty (ex cervieal Vertebral dise arthroplasty), and the bial o lar ‘comportent of an ankle arthroplasty. [0024] The process ofthe invention utilizes boronizing ‘agent Which yields boron when itis heated. Cerin boron- izing agents can produce elemental boron (e-., gaseous elemental boron) ypon heating, Other boronizing agents can pradce, upon heating, boron compounds that are capable of releasing ane of more boron atoms into the metal OF metal alloy when they contact the metallic body” at elevated ‘temperatures. Accordingly, the boronizing agent comprises a source of horoa, The source of boron can be any suitable source which is capable of yielding boron (eg. boron which is available to dilluse into the metallic body’ of the medical implant of medicel implant part) upon heating. Suitable sores of horon includ, bt are not Fimited t, amorphous boron, crystalline boron, hofoa triforide (BP), boron ‘wichloride (BCI), boron tibromide (BBr,), diborane (GH), twimelbyl boride ((CH,).8), triethyl boride (C.11),B), boron carbide (B,C), Borex (Na,B,O, 1011.0 ‘or Na:B,0, ), metaborie acid (HBO,), sodium boroflworide (NaBF,), boric acid anhydride (B,0,), ferrboron, metal borides, and combinations thoreot [0025] The boronizing agent also can comprise other substances that improve the agents ability to produce boron forthe boronizing process or improve the banding eharae- teristics ofthe boronizing agent. For example, the boroniz~ ing agent ean comprise any suitable filer, such as, carbon black, silicon carbide, aluminum exides, magnesium oxides, silicon oxides, silicates, non-boridable metals, and com!US 2006/0074491 AI nations thereof. The boronizing agent also can comprise any suitable activator, such as, « Muoroboride (eg. a ttrafiuo- roborate). The process of the invention ean uilize a com mercially available boronizing agent, which typically com- prises « combination of a boron source, a filler, and un ctvator. Suitable commercially available boronizing agents ‘include, but are not limited o, the EKABOR™™ boronizing sents sold by Borlee GmbH. [0026] Any suitable amount ofthe boronizing agent can be used in the inventive process. For example, when the boronizing agent is provided in the form of a powder, the rmdical implant or medial implant part ean he packed into sn excess of the boronizng agent such thatthe boronizing ‘agent contacts only those portions of the metallic body that are to be horonized. Those portions of the metallic body that ‘are to be boronized typically are covered with a layer of boronizing agent that is about 10 to about 20. mm ia thickness. The amount of boronizing agent used in the process typically provides an amount of boron that excoods the amount required to produce a boronized layer having the desired thickness. [0027] Any suitable portion of the metalic body of the ‘medical implant oF medical implant part ean be contacted ‘with the boron produced by the boronizing agent. Preferably, the portion of the metallic body that is contacted with the boron produced by the boronizing agent corresponds to bearing surface disposed on the outer surface of the body af the implant or implant pat. When only limited portions of the metallic body of the implant or implant part are to be boronized, a masking agent ean be applied to those portions ‘of the metallic body that are not be boronized. Suitble masking agents inehade, bi ate not limited to, silicon ‘carbide, asbestos, copper, aluminum oxide, apes (ex, Tesa tape No. 4541), or commercially available boronizing mask- ing agents, such as EKit In certain embodiments, subs tially all or all ofthe cuter surface of the metallic body can be contacted with the boron produced by the boronizing agent [0028] The process ofthe invention comprises the step of heating dhe horonizing agent to a temperature at hil the boronizing agent yields boron. The process ofthe invention ‘akko comprises the step of heating the medical implant or ‘medical implant part 10 an elevated temperature fora time sulficient for atleast a portion of the horon produced by the boronizing agent to diffse into at least 2 portion of the metalic body of the medical implant or medical implant part, While the boronizing agent and the implant or implant part can be heated to different temperatures, the implant oF the implant part and the boronizing agent typically are heated to substantially the same temperature. For example ‘when the boronizing agent is provided in the form of & Tiguid, paste, or solid, the boronizing agent typically is applied to the surface ofthe implant oF implant par that is 1o be boronized, and the implant or implant part and the boronizing agent are together heated 10 a temperature at which the boronizing agent yields boron, Altematively, the boronizing agent can be heated separately from the medical implant or medical implant par. In such a process, a carrier ‘285 (€@., an inert cari gas such as nitrogen) typically is used to transport atleast a portion ofthe boron produced by the boronizing agent tothe surface of the metallic hody so that the boron can diffwse into the metallic body. For Apr. 6, 2006 example, US. Pat, No, 4804085 describes a process ‘hick the boronizing agent is heated separately from the pivees 10 be boronized [0029] The medical implant or medical implant part and the boronizing agent can be heated to any suitable temper- ture, As will he understood by those of ordinary skill in the Aart, the temperatures suitable fer the stops o the process will ‘epend, at Teast in part, onthe identity oF dhe metal or metal ally present in the metallic body and the particular boron- ‘ving agent used in the process. Preferably, the medical ‘implant or medical implant part and the botonizing agent are Dated to a temperature of about 500° C. or more (eg about ‘550° C. oF more, about 580° C. or more, about 800° C. or ‘mon, oF about 900° C. or more). Typically, the implant or implant part and the boroniring agent are heated to a temperature that is below the solidus of the metal or metal alloy (Le. the temperature at which the metal or metal alloy begins to melt and comprises a mixture of sold and liquid phases). Preferably the medical implant or medical implant part and the boronizing agent are heated toa temperature of about 1300 C. or less (6, about 1250° C. of ess, about 1240° C. oF less, or about 1100" C. of Tess). In eerain ‘embodiments, the medical implant or medical implant part and the boronizing agent preferably are heated t0 a tem- perature of about $50" C. to about 1100° C, fe about 900° Cte about 1080° C;, oF about 1000" C.) [0030] As will be understood by those of onary skil in the art, heating the madicalimplaat or medical implant part {o certain temperatures can negatively impact the stability of the metal of metal alloy fom which the metalic body of the ator implant partis comprised. For example, when the rmeical implat ‘or medical implant part comprises Co28Cr6Mo alloy, leting the implant or implant part to a temperature of about 650" C. to about 1170! C. can lead t0 the formation ofa muliple-phase solid region inthe implant ‘or implant part in shich carbides can precipitate as the ‘microstrctire ages atthe elevated temperature. While the precipitation of sich carbides con increase the yield strength ‘and hardness ofthe ally, the precipitation also can deerease the ductility and toughness of the alloy, which elfects ca become signifeant when the implant or implant par is Iheated toa temperature of about SUK C. to about 1170° C. Sueh a change in the mechanical properties of the alloy may be acceptable for many applications (eg., femoral heads) ‘but may’ pose a concern where the implant or implant part bas a relatively thin erss section and experiences loading that produces cyclic tensile stresses (eg, the femoral com poneat of a kice arthroplasty). Accordingly. in certain embodiments, such 3s when the metallic body ofthe medical implant or medical implant part comprises Co28Cr6Mo alloy and msintaining the ductility ofthe eabalt-chromim substrate is of particular concer, the medical implant oF ‘medical implant part and the boronizing agent preferably are Deated t0 a temperature of about $S0° C- to about 800° C. more preferably about 650° C. to about 800° C. Altern tively, the medical implant or medical implant part and the boronizing agent ean be heated 1 a temperature of about 1180° C. to about 1250” C., preferably about 1200” C. 0 bout 1240° C. However, when the implant or implant part ‘comprises acobalt-chromium alloy (¢g., Co28Cr6Mo alloy) And it is heated to a temperature of shout 1180° C. to abot 1250° C., the implant or implant part preferably is rapidly cooled 16 a temperature of about SOO" C. oF less after the ‘desired amount of boron has diffsed into the metallic bodyUS 2006/0074491 AI ‘ofthe medical implant or medical implant part. While not Wishing 10 be bound to any particular theory, it is believed that ropidly cooling the implant or implant part to a tem- perature of about 800° C, of lest will avoid significant ‘carbide precipitation inthe implant or implant part. [0031] In another embodiment, the medical implant oF ‘medical implant part and the boronizing agent can he heated tora temperature of about SOO" C. to about 1170° C. While sueh a temperature range may lead (0 the precipitation of ‘carbides inn implant or implant part comprising 3 cabal chromium alloy (eg., Co28Cr6Mo alloy), the medical implant or medical implant pan, if desired, can be subjected to futher processing to ensure that the ductility and tough- ness of the implant of implant part are not significantly negatively affected, In one sue embodiment, such as when the metalic hody ofthe medical implant or medical implant part comprises a coball-chromium alloy (.,, Co28Ce6Mo) fnd maintaining the ductility of the cobalt-chromium sub- strate sof particular concern, the process preferably furher ‘comprises the steps of (0) heating the medical implant oF medical implant part toa temperature of about 1200° C. to ‘about 1240" C. alter atleast a portion of tae boron produced by the boronizing agent has diffs into the metallic body ‘of the medical implant or medical implant part, and (g) rapidly cooling the medical implant or medical implant part tora temperature of about 800° C. or less, While not wishing tw be bound to any panicular theory, it is belived that hating the medical implant or medical implant par to @ temperature of about 1200 C. to about 1240" C. will dissolve any carbides that may have precipitated while the Jmplant or implant part was heated 0. temperature of about 00"°C. to about 170° C. Purhermors iis believed that rapidly cooling the implant or implant part toa temperatore ‘of about 800° C, or ess will avoid say futher significant ‘earbide precipitation in the implant or implant part [0032] The medical implant or medical implant part and the boronizing agent can be heated in any suitable environ- ‘ent, In oder to reduce the potential oxidation ofthe metal ‘oF metal alloy contained in the implant or implant par, the implant o- implant par andthe boronizing auent preferably are heated in 2 vacuum or reduced pressure atmosphere, an inert atmosphere, or a reducing atmosphere. For example, the implant or implant part and the boronizing agent can be heated in an inert gascous atmosphere, such as an atmo- sphere comprising argon, nitrogen, or any suitable combi nation of ineet gases. Altematvely, the implant or implant part and the boroniring agent can be heated in a rehicing Baseous atmosphere, such as an atmosphere comprising hydrogen, dissociated ammonia, forming gas (eg. a gas ‘contsning about 530% hydrogen and about 70-95% nitro en), hydrocarbons, a mixtures of atleast two of the afone- mentioned reducing gases, or a mixture of at Teast one reducing gas with atleast one inert gas, [0033] The medical implant or medical implant pact is ‘maintained at an elevated temperature fora time sufiient {rat least a portion ofthe horan produced by the boconizing agent to dilluse into atleast a portion of dhe metallic Body (of the implant or implant part. As will be understood by those of ordinary skill in the art, the amount of time necessary forthe boron to diffuse into the metallic body of the implant or iyplant part will depend upon several aciors, sch asthe type of metal or mctal alloy present inthe body. the temperattre(s) to which the boroaizing agent and the Apr. 6, 2006 ant or implant part are heated, and the desired thickness of the resulting boronized layer. Typically, the medical implant or implant partis maintained atthe elevated tem- perature (eg. the temperature 10 which the implant oF implant part and the boronizing temperature were heated $0 that the boronizing agent would yield boron to diffuse into the implant or implant pan) for about 30 minutes or more, preferably about minutes or more, and more prefershly bout 120 minutes or more. Typically, the medical implant ‘or implant part is msintainod a the elevated temperature for bout 720 minutes or ls (e4 about 660 minutes or less) preferably about 600 minutes or less, and more preferably bout $40 minutes or loss (e.g, about 00 minutes oF les, fr about 480 minutes or less). However, those of ordinary sal in the art will weadily understand that the amount of time necessary to produce a boronized layer having a desired thickness may’ be longer when relatively low temperatures fare used (@.8, about 850°C, of less) of a relatively thick (eg, about 8 um or more) boronized layer is desired. [0034] |The characteristics ofthe metcal implant or medi- «al implant part produced by the process of the invention (ex, the composition of the metallic body, the composition ofthe boronized layer, the thickness ofthe boronizad layer, the hardness of the boronized layer, et.) can be the same as those set forth above for the medical implant or medical implant part ofthe invention, [0035] _Allreferences, including publications, patent app ‘ations and patents, cited hereia are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were sot forth in its entirety herein [0036] The use of the terms “sand “un” and “the” and Similar referents in the context of describing the invention (especially in the context of the following claims) are to be ‘construed to cover both the singular aod the plural, unless otherwise indicated herein or clearly contradicted by cone text. The terms. “comprising,*having,”ineluding,” and “eonsining” are wo be consid as open-ended tems (he. ‘meaning “ineluding, but not limited to,”) unless otherwise noted. Recitation of ranges of values herein are menly intended to serve as @ shomhand method of referting ind vidually to each separate value falling within the range, unless otherwise indicate! herein, and each separate value is incorporated into the specification as if t were individually recited herein. All methods described herein can be per- formed in any suitable onler unless otherwise indicated hetsin or otherwise clearly contradicted by context. The se ‘of any and all examples, or exemplary langage (€. "sich as") provided herein is intended merely t beter illuminate the invention and does not pose a limitation on the seope of the invention unless otherwise claimed. No language in the specification should be coastmied a indicating any non claimed element ss essential the practice of the invention. [0037] Preferred embodiments of this invention are eseribed herein, including the best mode known to the inventors for carying out the invention. Variations of those preferred embodiments may become apparent 10 those of ‘ordinary skill in the ar upon reading the foregoing deserip- tion, The inventors expect skilled artisans to employ such variations as appropeate, and the inventors intend for the fvention to he practiced otherwise than as spocifially described herein, Accordingly, this invention includes allUS 2006/0074491 AI ‘modifications and equivalents ofthe subject mater recited i the claims appeaded hereto ae permitted by applicable law. Morvover, aay combination ofthe above-deseribed elements in all possible variatons thereof is encompassed by the ‘invention unless otherwise indicated hercin of otherwise ‘clearly contradicted by context. ‘What is claimed is 1. medical implant or medical implant part compesing: (@)ametallic body comprising a metal or metal alley, and (b) a bearing surface disposed on the boxly, the bearing ‘strface comprising a boronized layer of the metal ot sca allo. 2. The meical implant or medical implant part of claim 1, wherein the metallic body comprises a metal or metal alloy selected from the group consisting of cobalt, cobalt, alloys, titanium, titanium alloys, and mixtures thoreo 3. The medical implant or medical implant part of claim 2, wherein the metal or metal alloy is selected from the roup consisting of cobalt, cobalt-chromium alloys, titae ium, tanium-aluminum alloys, and mixtures thereof, 4. The mesical implant or medical implant part of claim 3, wherein the eobalt-chromium alloy is Co28Ce6Mbo, 5, The medical implant or medical implant part of claim 5. wherein the ttaniumaluminum alloy is selected from the troup consisting of Ti3AI2.5V and Ti6AIMV 6, The medical implant or medical implant part of claim 1, wherein the boronized layer comprises borides having the formula MeB, MeB,, or Me;B, wherein Me represents @ ictal present inthe hody of the medical implant or medical implant part 7. A medical implant for implantation into @ patient, che medical implant comprising: (2) femoral component for replacing one or more ofthe ptien’s femoral condyles, the femoral component having @ metallic body comprising a metal or metal alloy and a bearing surface disposed on the body. the bearing surface comprising a boronized layer of the meal oF metal alloy. (6) tibial component for replacing atleast a portion of ‘the patient's proximal tibial articular surface, and (6) polymeric beuring component which rests on the tibial component and confronts the bearing surface of the femoral component, 8. The medical implant of claim 7, wherein the metallic body of the femoral component comprises a metal or metal alloy selected from the group consisting of cobalt, cobalt alloys tanium, tanium alloys, and mixtures thereof 9, The medical implant of claim 8, wherein the metal oF ‘tal alloy is selected from the group consisting of eobalt ‘cobalt-chromium alloys, titanium, ttanium-aluminum, alloys, and mixtures thereof 10. The modical implant of claim 9, wherein the eobal- ‘eromiium alloy is Co28Cr6Mo. 1 The medical implant of claim 9, wherein te titanium sluminum alloy selected ftom the group consisting of TI3AISV and TI6AIAY. 12, The medical implant of elaim 7, wherein the boron- ‘ned layer comprises borides having’ the formula. MeB, MeR., oF Me,B. wherein Me represents @ metal present ia the body of the medical implant or medieal implant pa (@) a femoral stem for anchoring the implant into the patient's femur, (b) femoral head which attaches tothe upper end ofthe femoral stem the femoral head having # metallic body ‘comprising a metal or metal alloy and a bearing suc «disposed on the body; the bearing steface comprising 2 horonized layer of the metal or metal alloy, and (6) an acetabular component for replacing the patients ‘acetabulum, the acetabular component comprising a liner which confronts the bearing surface of the femoral head. 14, The medical implant ofelaim 13, wherein the metalic body of the femoral head comprises @ metal or metal alloy selected from the grou consisting of cobalt, cobalt alloys titanium, titanium alloys, and mixtures thereof. 18, The medical implant of elaim 14, wherein the metal or metal alloy is selected from the group consisting of cobalt, cobalt-chromium alloys, titanium, ttanium-aluminam alloys, and mixtures thereo 16, The medical implant of claim 1 chromium alloy is Co28Cr6Mo, 17. The medical implant of claim 15, wherein the ttt sium-aluminum alloy selected from the group consisting of TSADSV and TI6ALY. 18. The medical implant of claim 13, wherein the boron- ined layer comprises borides having the formula MeB, ‘MeB, or MesB, wherein Me represents @ metal present in the body of the medical implant or medical implant pat. 19, The medical implant of claim 13, wherein the finer is comprised of a metal or metal alloy. 20, The medical implant of claims 19, wherein the portion ‘of the finer which conffonts the bearing surface of the Temoral head comprises a boronized layer of the metal oF ‘etal alloy of which the liner is comprise. 21. 4 process for producing a medical implant or medical implant part, the process comprising the steps of ‘wherein the cobalt () providing a medical implant or medical implant part having a metallic body, (b) providing a boronizing agent which yields boron upon heating, (€) beating the boronizing agent toa temperature at which the boronizing ageat yields boron, (@) contacting atleast portion of the metallie body with the boron produced by the boronizing agent, and () beating the medical implant or metcal implant pat to ‘an elevated temperature fora time suficent for at least ‘portion of the boron produced by the horonizing agent to diffe into at least a portion ofthe metallic Body of the modical implant or medical implant part. 22, The process of claim 21, wherein the metalic body comprises & metal or metal alloy selected from the group ‘consisting of cobalt, cobalt alloys, titanium, Gtanium alloys, and mixtures there 23. The process of claim 22, wherein the metal or metal ally is sleeted from the group consisting of cobalt, cobal chromium alloys, titanium, titanium-aluminum alloys, and tures thereot.US 2006/0074491 AI the cobaltchro- 24, The process of claim 23, wherein smilum alloy is Co28C+6Mo, 25, The process of claim 23, wherein the ttaniva-funi- tum alloy is selected fom the group consisting of “TSAI SV and Ti6AMV 26, The process of claims 21, wherein the medical implant ‘or medical implant part and the boroaizing agent are heated to a temperate of about 850° C. to about 1300" C. 27. The process of claim 24, wherein the medical implant ‘or medical implant part and the boronizing agent are heated © a temperatire of about 550° C. to about 800° C 28, The process of claim 27, wherein the medical implant ‘or medical implant part and the boronizing agent are heated 1o a temperature of about 650° C. to about 800° C. 28, The procos of claim 24, wherein the medical implant ‘or medical implant part and the boronizing agent are heated 10 a temperature of about 800° C. to about 170° C. Apr. 6, 2006 30, The process of claim 29, wherein the process further comprises the steps of (O beating the medival implant or medical implant part to ‘s temperature of about 1208 C. to about 1240° C. after ‘at Teast a portion ofthe boeon prodeed by the boron= izing agent has diffased into the metallic body of the medical implant or modieal implant par, and (2) rapidly cooling the medical implant or medical Implant part (oa temperature of about 800°C. or les. 31. The process of elaim 24, wherein the medical implant ‘or medical implant part and the boronizing agent are heated to a femperatie of about 1180" C, to about 1250" C 32, The process of claim 31, wherein the medical implant ‘or medical implant part and the boronizing agent are heated {0 a temperature of about 1200° C. to about 1240” C,