US20210378827A1(19)UnitedStates(12)PatentApplicationPublication(lo)Pub.No.:US2021/0378827AlPascaleetal.(43)Pub.Date:Dec.9,2021(54)INTERCALARYENDOPROSTHESIS(52)U.S.Cl.CPC....A61F2/28(2013.01);A61F2002/30787(71)Applicant:HowmedicaOsteonicsCorp.,Mahwah,(2013.01);A61F2002/2825(2013.01);A61BNJ(US)17/72(2013.01)(72)Inventors:KennethPascale,Hoboken,NJ(US);(57)ABSTRACTDonImaml,Hoboken,NJ(US);GuillermoMendoza,JerseyCity,NJAnintercalaryprosthesisforspanningportionsofalong(US)boneincludesafirstintramedullarycomponentthathasafirststemandafirstconnectordisposedatoneendofthefirstAppl.No.:17/336,571(21)stem.Thefirststemisconfiguredtobereceivedwithinanintramedullarycanalofalongbone.Asecondintramedul(22)Filed:Jun.2,2021larycomponenthasasecondstemandasecondconnectorRelatedU.S.ApplicationDatadisposedatoneendofthesecondstem.Thesecondstemisconfiguredtobereceivedwithinanintramedullarycanalof(60)ProvisionalapplicationNo.63/034,147,filedonJun.thelongbone.Theprosthesisalsoincludesaconnector3,2020.component.TheconnectorcomponenthasabodythatincludesopposingendseachwithaconnectorconfiguredtoPublicationClassificationrespectivelyconnecttotheconnectorsofthefirstandsecond(51)Int.Cl.intramedullarycomponents.ThebodyalsohasanoutershellA61F2/28(2006.01)andaninnerlatticestructuredisposedwithinandconnectedA61B17/72(2006.01)totheoutershell.PatentApplicationPnblicationDec.9,2021Sheet1of7US2021/0378827AlPatentApplicationPnblicationDec.9,2021Sheet2of7US2021/0378827AlPatentApplicationPnblicationDec.9,2021Sheet3of7US2021/0378827AlPatentApplicationPnblicationDec.9,2021Sheet4of7US2021/0378827Al----------------------------Z.Ji1PatentApplicationPnblicationDec.9,2021Sheet5of7US2021/0378827AlPatentApplicationPnblicationDec.9,2021Sheet6of7US2021/0378827AlPatentApplicationPnblicationDec.9,2021Sheet7of7US2021/0378827Al120US2021/0378827AlDec.9,20211INTERCALARYENDOPROSTHESIScircumferentiallyarrayedaboutalongitudinalaxisoftheconnectorforengagementbyatorqueapplyingtool.CROSS-REFERENCETORELATED[0006]Continuingwiththisaspect,thebodymaybeAPPLICATIONSbowedsuchthatalongitudinalaxisthereofiscurvedabout[0001]Thisapplicationclaimsthebenefitofthefilingdateacenterofcurvature.ThebodymayincludeananteriorofU.S.ProvisionalPatentApplicationNo.63/034,147,filedgroovethatiscoplanarwiththecenterofcurvature.TheflrstJun.3,2020,thedisclosureofwhichisherebyincorporatedandsecondconnectorsmayeachbeafemaleconnector,andbyreference.theconnectorsoftheconnectorcomponentmaybemaleconnectorsextendingfromopposingendsofthebody.TheBACKGROUNDmaleconnectorsmaybeconflguredtoberespectivelyreceivedwithinthefemaleconnectorsandlockedthereto[0002]Intercalaryskeletaldefectsmayresultfromtraumauponrotationoftheconnectorcomponentrelativetotheflrstorresectionofdiaphysealbonetumorsinlongbones,suchandsecondintramedullarycomponents.Theflrstandsecondasafemur,tibia,andthelike.Inthisregard,asegmentofconnectorsmayeachbeamaleconnectorrespectivelydamagedordiseasedbonebetweentwojointsmaybeextendingfromtheflrstandsecondstems.Theconnectorsofcompletelyremovedsothatthelongboneisnolongeronetheconnectorcomponentmaybefemaleconnectorsdiscontinuousboneextendingfromjointtojoint,butisinsteadposedatopposingendsofthebody.Themaleconnectorsdividedintotwohealthybonesegments.Sinceitisdesirablemaybeconflguredtoberespectivelyreceivedwithinthetokeepasmuchhealthyboneaspossible,particularlyatthefemaleconnectorsandlockedtheretouponrotationofthejoints,itisnecessarytojointhehealthybonesegmentsconnectorcomponentrelativetotheflrstandsecondtogetherthroughareconstructionprocess.However,thisintramedullarycomponents.presentsreconstructivechallengesfororthopedicsurgeons[0007]Inanotheraspectofthepresentdisclosure,anastheyhavetoensureastablestructure,whichmaybeloadintercalaryprosthesisforspanningportionsofalongbonebearing,whilealsoaccountingforthemissingbone,theincludesaflrstintramedullarycomponentthathasaflrstlengthofwhichvariesfrompatienttopatient.stemandaflrstconnectordisposedatoneendoftheflrst[0003]Variousreconstructionimplantshavebeendevelstem.Theflrststemisconflguredtobereceivedwithinanopedovertheyearstosalvagethehealthybone.However,intramedullarycanalofalongbone.Theprosthesisalsosuchimplantsaretypicallynotpatientspecificandthereforeincludesasecondintramedullarycomponentthathasamayleavethepatientwithawkwardbonegeometriesandasecondstemandasecondconnectordisposedatoneendoflongerorshorterlimbthanpriortotheirdiseaseorinjury.thesecondstem.ThesecondstemisconflguredtobeAdditionally,suchimplantsareoftenheavyascomparedtoreceivedwithinanintramedullarycanalofthelongbone.boneandmaybedifficulttoimplantandassemblein-situasTheprosthesisfurtherincludesaconnectorcomponentthatthehealthybonesegmentscanbedistractedonlysofar.hasabodyandthirdandfourthconnectorsdisposedatThus,furtherimprovementsaredesirable.opposedendsofthebody.TheflrstandthirdconnectorsandsecondandfourthconnectorsareconflguredtobelockedtoBRIEFSUMMARYOFTHEINVENTIONeachotheruponrotationoftheconnectorcomponentrela[0004]Inoneaspectofthepresentdisclosure,anintercativetotheflrstandsecondintramedullarycomponents.laryprosthesisforspanningportionsofalongboneinclude[0008]Additionally,theflrstandsecondconnectorsmayanintramedullarycomponentthathasafirststemandafirsteachbeafemaleconnector,andthethirdandfourthconconnectordisposedatoneendofthefirststem.Thefirststemnectorsoftheconnectorcomponentmaybemaleconnectorsisconfiguredtobereceivedwithinanintramedullarycanalextendingfromopposingendsofthebody.Themaleconofalongbone.Theprosthesisalsoincludesasecondnectorsmaybeconfiguredtoberespectivelyreceivedwithinintramedullarycomponentthathassecondstemandasecthefemaleconnectorsandlockedtheretouponrotationofondconnectordisposedatoneendofthesecondstem.Thetheconnectorcomponentrelativetothefirstandsecondsecondstemisconfiguredtobereceivedwithinanintramedintramedullarycomponents.Themaleconnectorsmayullarycanalofthelongbone.Theprosthesisfurtherincludesincludeapostandsplinekeysextendingfromthepost,andaconnectorcomponentthathasabody.Thebodyhasthefemaleconnectorsmayincludeaspiraledrecessconfigopposingendseachwithaconnectorconfiguredtorespecuredtointerferewiththesplinekeyswhenrotatedwithinthetivelyconnecttotheconnectorsofthefirstandsecondspiraledrecessforprovidingalockingconnection.Alternaintramedullarycomponents.Thebodyhasanoutershellandtively,themaleconnectorsmayincludeacamsurfaceandaninnerlatticestructuredisposedwithinandconnectedtoatooth,andthefemaleconnectorsmayincludearecesswiththeoutershell.aleafspringextendingtherein.Thecamsurfacemaybe[0005]Additionally,thefirstandsecondintramedullaryconfiguredtomovetheleafspringradiallyoutwardlyuponcomponentsmayeachincludeamodularcollarandanrotationofthemaleconnectorsinafirstdirection.Thetoothintegralcollar.Themodularcollarmaybeconnectabletothemaybeconfiguredtoengagetheleafspringtopreventintegralcollarandmayhaveanoutersurfacethatcomprisesrotationofthemaleconnectorsinaseconddirection.aporousstructure.Theintegralcollarofthefirstintramed[0009]Continuingwiththisaspect,thefirstandsecondullarycomponentmaybedisposedbetweenthefirststemconnectorsmayeachbeamaleconnectorrespectivelyandfirstconnectorportion.Thebodyoftheconnectorextendingfromthefirstandsecondstem,andthethirdandcomponentmayalsoincludeapluralityofopeningsextendfourthconnectorsoftheconnectorcomponentmaybeingthroughtheoutershelltotheinnerlatticestructure.Thefemaleconnectorsdisposedatopposingendsofthebody.latticestructuremaybecomprisedofapluralityofinterThemaleconnectorsmaybeconfiguredtoberespectivelyconnectedstrutsformingintersticestherebetween.TheconreceivedwithinthefemaleconnectorsandlockedtheretonectorcomponentmayfurtherincludeapluralityofflatsuponrotationoftheconnectorcomponentrelativetothefirstUS2021/0378827AlDec.9,20212andsecondintramedullarycomponents.Themaleconnec[0021]FIG.4Bisacross-sectionalviewoftheconnectortorsmayincludeapostandsplinekeysextendingfromthecomponentandstemcomponentofFIGS.2Aand3Aaspost,andthefemaleconnectorsmayincludeaspiraledassembled.recessconfiguredtointerferewiththesplinekeyswhen[0022]FIG.5Aisaperspectiveviewofaconnectorrotatedwithinthespiraledrecess.Alternatively,themalecomponentaccordingtoanotherembodimentofthepresentconnectorsmayincludecamsurfaceandatooth,andthedisclosure.femaleconnectorsmayincludearecesswithaleafspring[0023]FIG.SBisacross-sectionalviewofastemcomextendingtherein.Thecamsurfacemaybeconfiguredtoponentaccordingtoanotherembodimentofthepresentmovetheleafspringradiallyoutwardlyuponrotationofthedisclosure.maleconnectorsinafirstdirection.Thetoothmaybe[0024]FIG.SCisanexplodedviewoftheconnectorconfiguredtoengagetheleafspringtopreventrotationofcomponentandstemcomponentofFIGS.SAandSB.themaleconnectorsinaseconddirection.Thebodyofthe[002S]FIG.SDisacross-sectionalviewoftheconnectorconnectorcomponentmayincludeasolidshellsurroundingcomponentandstemcomponentofFIGS.SAandSBasalatticestructure.assembled.[0010]Inafurtheraspectofthepresentdisclosure,amethodofconnectingfirstandsecondportionsofalongDETAILEDDESCRIPTIONboneincludes:insertingafirststemofafirstintramedullary[0026]Whenreferringtospecificdirectionsinthefollowcomponentintoafirstportionofalongboneandasecondingdiscussionofcertainimplantabledevices,itshouldbestemofasecondintramedullarycomponentintoasecondunderstoodthatsuchdirectionsaredescribedwithregardtoportionofthelongbone.Aftertheinsertingstep,themethodtheimplantabledevice’sorientationandpositionduringincludesconnectingafirstendofaconnectorcomponenttoexemplaryapplicationtothehumanbody.Thus,asusedanendofthefirstintramedullarycomponentandasecondherein,theterm“proximal”meansclosetotheheartandtheendoftheconnectorcomponenttoanendofthesecondterm“distal”meansmoredistantfromtheheart.Thetermintramedullarycomponent.“inferior”meanstowardthefeetandtheterm“superior”[0011]Additionally,theconnectingstepmayincludemeanstowardthehead.Theterm“anterior”meanstowardrotatingtheconnectortolockthefirstandsecondintramedthefrontofthebodyortheface,andtheterm“posterior”ullarycomponentstotheconnectorcomponent.Theconmeanstowardthebackofthebody.Theterm“medial”nectingstepmayalsoincludeinsertingmaleconnectorsmeanstowardthemidlineofthebody,andtheterm“lateral”eachextendingfromopposingendsofabodyoftheconmeansawayfromthemidlineofthebody.Also,asusednectorcomponentintorespectivefemaleconnectorsoftheherein,theterms“about,”“generally”and“substantially”firstandsecondintramedullarycomponents.Alternatively,areintendedtomeanthatslightdeviationsfromabsolutearetheconnectingstepmayincludeinsertingmaleconnectorsincludedwithinthescopeofthetermsomodified.eachextendingfromarespectiveendofthefirstandsecond[0027]FIGS.1A-4Bdepictanintercalaryprosthesis10intramedullarycomponentsintorespectivefemaleconnecaccordingtoanembodimentofthepresentdisclosure.Thetorsoftheconnectorcomponent.Thefemaleconnectorsintercalaryprosthesis10generallyincludesafirstintramedmaybedisposedatopposingendsofabodyoftheconnectorullarycomponent30a,asecondintramedullarycomponentcomponent.30Z),andaconnectorcomponent20.[0028]Theconnectorcomponent20generallyincludesaBRIEFDESCRIPTIONOFTHEDRAWINGSbody21andconnectorsdisposed22atopposingendsofthe[0012]Thefeatures,aspects,andadvantagesofthepresentbody21.Thebody21hasanoutershell29andaninnerinventionwillbecomebetterunderstoodwithregardtothelatticestructure50.Theoutershell29isasolidmetalfollowingdescription,appendedclaims,andaccompanyingmaterialwithagenerallycontinuousoutersurface.Theouterdrawingsinwhich:shell29definesahollowcavity27thereinwhichisoccupied[0013]FIG.lAisaperspectiveviewofanintercalarybythelatticestructure50.Thelatticestructure50isconprosthesisaccordingtoanembodimentofthepresentdisnectedtotheoutershell29andprovidesstructuralsupportclosure.totheconnectorcomponent20whilealsoprovidingreducedweightascomparedtoaconnectorcomponentthatis[0014]FIG.IBisapartialperspectiveviewoftheproscompletelysolidthroughitsentirethickness.ThelatticethesisofFIG.lA.structure50isformedofapluralityofinterconnectedstruts[0015]FIG.2Aisaperspectiveviewofaconnector52whichdefinedinterstices54therebetween.componentoftheprosthesisofFIG.lA.[0029]Thebody21includesapluralityofopenings25[0016]FIG.2Bisacross-sectionalviewoftheconnectorextendingthroughtheoutershellandintotheinnercavity27componentofFIG.2Atakenalongamidlinethereofandsoastocommunicatewiththelatticestructure50.Thisabsentalatticestructure.facilitatestheremovalofmetallicpowderfromthecavity27[0017]FIG.2cisacross-sectionalviewoftheconnectoraftermanufacturingviaanadditivemanufacturingprocess,componentofFIG.2Atakenalongamidlinethereofandasdescribedbelow.Thebody21alsoincludesapluralityofincludingalatticestructure.flats28circumferentiallyarrayedaboutalongitudinalaxis[0018]FIG.3Aisaperspectiveviewofastemcomponentthereof.Theseflats28areangledrelativetoeachothersooftheprosthesisofFIG.lA.thattheycanbeengagedbyatorqueapplyingtool,suchas[0019]FIG.3Bisfrontelevationalviewofmodularcollarawrench,tofacilitatetherotationoftheconnectorcompooftheprosthesisofFIG.lA.nentin-situ.Intheparticularembodimentdepicted,the[0020]FIG.4Aisacross-sectionalviewoftheconnectoropenings25inthebody21eachextendthroughacorrecomponentandstemcomponentofFIGS.2Aand3Awhilespondingflat28.However,inotherembodiments,theopenbeingassembled.ings25mayextendthroughotherregionsofthebody21.US2021/0378827AlDec.9,20213[0030]Inaddition,thebody21mayhaveapatientspecificanatomy,suchasananteriorcurvatureofthepatient’scurvatureorbow.Forexample,femurstypicallyhaveanfemur,alsoknownasananteriorbow,whichisdiscussedanteriorcurvatureorbow.Thebody21maybemanufacabove.Thevirtualcomponent20couldthenbeprintedwithturedsuchthatitmatchesthecurvatureorbowofthethosesamefeaturesusingALM.patient’sparticularanatomy.Inthisregard,connectorcomponent20mayhavealongitudinalaxisthatiscurvedabout[0034]Thefirstandsecondstemassemblies30a-/)eachacenterofcurvaturewhichwouldbepositionedposteriortogenerallyincludeastemcomponent32andamodularcollarthebody21.Ananteriorgroove21a,asshowninFIG.2A,40.Thestemcomponent31includesanintramedullarystemmaybealignedwiththiscurvaturesoastoprovidethe32,integralcollar38,andaconnector34.Thestem32maysurgeontheappropriateorientation.Inthisregard,theantehaveflutes(notshown)foranti-rotationorindentedelongateriorgroove26mayhaveanaxisthatiscoplanarwiththegroovesforstrength.Theintegralcollar38ispositionedcenterofcurvature.betweenthestem32andconnector34.Theintegralcollar38hasalargercross-sectionaldimensionthanthestem32and[0031]Asshown,theconnectors22extendfromopposingmayhaveataperedoutersurface.Forembodimentsinwhichendsofthebody21andaremaleconnectors.Moreparticucollar38isaseparatecomponentthatcoupleswithstem32,larly,thesemaleconnectors22arecomprisedofapost22acollar38mayhaveataperedinnerdiametertofacilitateaandoneormoresplinekeys22bextendingradiallyouttaper-lockconnectiontothestem32.wardlyfromthepost22a.AsbestshowninFIGS.2Band2C,athrough-opening24extendsthroughtheentirelength[0035]Theconnector20mayhavealargercross-sectionalofconnectorcomponent20andthroughthecenterofeachdimensionthantheintegralcollar38soastoformashoulderoftheconnectors22.Suchthrough-opening24communi39whichactsasastopforthemodularcollar40.Thecateswiththelatticestructure50andprovidesanadditionalconnector34alsohasapluralityofnotches36onitsexterioregressrouteforpowderremoval.forreceiptofthetabs46ofthemodularcollar,asdiscussed[0032]Theconnectorcomponent20isformedlayer-by-below.Theconnector34,asbestshowninFIGS.4Aand4B,layerusingadditivelayermanufacturing(ALM),i.e.,3Disafemaleconnector.Asafemaleconnector,ithasanprinting,processsonoseparateconnectionmechanismisopening33forreceiptofthemaleconnector22ofthenecessarytobringtogetheranyofthemultiplefeaturesofconnectorcomponent20.Suchopening33hasnotches37theimplant,suchastheconnectors,shellandlatticestrucconflguredtoreceivethesplines22bofthemaleconnectorture.Insomeexamples,ALMprocessesarepowder-bed22inoneorientation,asbestshowninFIG.4A.Withinbasedandinvolveoneormoreofselectivelasersinteringopening33isaspiraledgroove35whichhasoneormore(SLS),selectivelasermelting(SLM),andelectronbeamsurfaces,dependingonthenumberofsplines22b,whichmelting(EBM),asdisclosedinU.S.Pat.Nos.7,537,664;eachhaveaprogressivelysmallerradiussoastointerfere8,728,387;9,180,010;and9,456,901,thedisclosuresofwithacorrespondingspline22binorderlockthemaleandwhichareherebyincorporatedbyreferenceintheirentirefemaleconnectors20,34together,asbestshowninFIG.4B.tiesherein.[0036]Themodularcollar40hasabody42withaporous[0033]TheALMprocessusedtoformtheconnectoroutersurface43andanopeningextending44entirelycomponent20allowsthecreationofthelatticestructure50throughthebody42alongalengthofthemodularcollar40.whichiscompletelysurroundedbytheoutershell29.ThisThethrough-opening44maybetaperedsoastofacilitateaallowstheconnectorcomponent20tobelighterweightthantaperlockbetweentheintegralcollar38andmodularcollaraconnectorcomponentmadefromtraditionalmanufactur40.Tabs46extendfromoneendofthebody42andmaybeingprocesses,suchasmachining,forgingandcasting,receivedwithinthenotches36intheconnector34soastowithoutsacrificingstrength.Theopenings25inthebody21prohibitrotationofthemodularcollar40relativetothestemandthrough-opening24facilitatetheremovalofloosecomponent31.powderfromwithinthelatticestructureaftertheconnector[0037]Asassembled,theconnectorcomponent20iscomponenthasbeenmade.Inaddition,theuseofALMpositionedbetweentheflrstandsecondintramedullarycomallowsforacustomorsemi-customdesign.Inpreparingponents30a,30/)andlockedtheretoviathecorrespondingsuchanimplant,thepatient’sanatomyaroundatleasttheconnectors22,34,asshowninFIGS.lAandIB.Theregionfortreatmentmaybescanned,suchasbyaCTscanmodularcollars40arepositionedovertherespectiveinteorotheruseofx-raysorbymagneticresonanceimaginggralcollars38ofthestemcomponents30a,30/).(MRI)orotherknownimagingdevice.Thescannedimagemaythenbeconvertedtovirtualpatient-specificboneimage[0038]Inamethodofimplantation,theconnectorcomusingcomputer-aidedmodelingandsegmentationsoftware.ponent20facilitatestheassemblyoftheendoprosthesisSuchsoftwaremaybebutisnotlimitedtoImorphics™,in-situ.Inthisregard,theflrstandsecondintramedullarywhichiswhollyownedbyImorphicsLimited,asubsidiarycomponents30a-/)areimplantedintorespectiveboneporofStryker®Corporation,Stryker®OrthopaedicsModelingtions.Forexample,afemurmayincludeaflrstorproximalandAnalytics(SOMA)byStryker®Corporation,Geoboneportionandasecondordistalboneportion.ThestemMagic®by3DSystems,Inc.,and3DSlicersoftware32oftheflrstintramedullarycomponent30amaybedevelopedbytheMassachusettsInstituteofTechnology.Ainsertedintotheintramedullarycanaloftheflrstbonemanualsegmentationoranautomaticsegmentationprocess,portion,suchasinapress-litorcementedmanner.Similarly,suchaseitheroftheprocessesdescribedinU.S.Pat.No.thestem32ofthesecondintramedullarycomponent30/)7,584,080andU.S.PatentApplicationPublicationNo.maybeinsertedintotheintramedullarycanalofthesecond2011/0194739Al,whichareherebyincorporatedbyreferboneportion,alsoinapress-litorcementedmanner.Theenceintheirentiretiesherein,maybeused.Avirtualflrstandsecondintramedullarycomponents30a-/)maybeconnectorcomponent20wouldthenbemanipulatedintheimplantedsuchthatthemodularcollars40,whicharevirtualspacetomatchcertainaspectsofthepatient’sassembledtothestemcomponents30a-/)priortoimplan-US2021/0378827AlDec.9,20214tation,abuttheendsoftherespectiveboneportions.Therationofmale/femaleconnectorsisalsocontemplatedforbonemaygrowintotheporousstructures42ofthemodularconnectorcomponent120andintramedullarycomponentscollars40.130a-Z>.[0043]Althoughtheinventionhereinhasbeendescribed[0039]Oncetheintramedullarycomponents30a-/)arewithreferencetoparticularembodiments,itistobeunderimplanted,theconnectorcomponent20ispositionedstoodthattheseembodimentsaremerelyillustrativeofthebetweentheintramedullarycomponents30a-Z).Theconnecprinciplesandapplicationsofthepresentinvention.Itistors22oftheconnectorcomponent20aretheninsertedintothereforetobeunderstoodthatnumerousmodiflcationsmaytheconnectors34oftherespectiveintramedullarycompobemadetotheillustrativeembodimentsandthatothernents30a-Z),asbestshowninFIG.4A.Inthisregard,splinesarrangementsmaybedevisedwithoutdepartingfromthe22bpassthroughnotches37.Oncesplines22bareinsertedspiritandscopeofthepresentinventionasdeflnedbythepassednotc
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