INSPIRATORY_RESISTOR_VALVE_SYSTEM_WITH_EXPIRATORY_PORT

US20210386961A1(19)UnitedStates(12)PatentApplicationPublication(lo)Pub.No.:US2021/0386961AlLurieetal.(43)Pub.Date:Dec.16,2021(54)INSPIRATORYRESISTORVALVESYSTEMPublicationClassificationWITHEXPIRATORYPORT(51)Int.Cl.A61M16/20(2006.01)(71)Applicant:VitaLinCLLC,Minneapolis,MN(US)A61M16/10(2006.01)(72)Inventors:KeithG.Lurie,Minneapolis,MN(52)U.S.Cl.(US);TomWllmerlng,EldoradoCPC......A61M16/208(2013.01);A61M2230/00Springs,CO(US)(2013.01);A61M2205/3584(2013.01);A61M16/1065(2014.02)(21)Appl.No.:17/412,784(57)ABSTRACTAninspiratoryresistorvalvesystem(IRV)toregulateintr-(22)Filed:Aug.26,2021athoracicpressureduringpositivepressurebreathing,spon­taneousinspirations,andCPRmayincludeaninspiratoryRelatedU.S.ApplicationDataport.TheIRVsystemmayincludepatientport.TheIRVsystemmayincludeaseparateexpiratoryport.TheIRVmay(63)ContinuationofapplicationNo.17/207,983,filedonincludeapluralityofatmosphericpressuresensitivevalves.Mar.22,2021,nowPat.No.11,103,672.Thepluralityofatmosphericpressuresensitivevalvesmay(60)ProvisionalapplicationNo.62/992,706,filedonMar.isolatetheexpiratoryportandtheinspiratoryportfromone20,2020.another.PatentApplicationPnblicationDec.16,2021Sheet1of20US2021/0386961AlPatentApplicationPnblicationSheet2of20US2021/0386961AlPatentApplicationPnblicationDec.16,2021Sheet3of20US2021/0386961AlPatentApplicationPnblicationDec.16,2021Sheet4of20US2021/0386961AlPatentApplicationPnblicationDec.16,2021Sheet5of20US2021/0386961AlPatentApplicationPnblicationDec.16,2021Sheet6of20US2021/0386961Al228PatentApplicationPnblicationDec.16,2021Sheet7of20US2021/0386961Al204PatentApplicationPnblicationDec.16,2021Sheet8of20US2021/0386961Al204PatentApplicationPnblicationDec.16,2021Sheet9of20US2021/0386961Als1200....!s............95................51sr\202b,1f?11114i1z------—s1zs111/s/1//s1/Fn9n15I8eLoo//s1M-----------------pPatentApplicationPnblicationDec.16,2021Sheet10of20US2021/0386961Al204218210202c202b2kA"'/TillfTTPatentApplicationPnblicationDec.16,2021Sheet11of20US2021/0386961Al204224218202b202e/—1———/1z11i§1§1§z1§z1§i§/—1—PatentApplicationPnblicationDec.16,2021Sheet12of20US2021/0386961Al224218214202b202cPatentApplicationPnblicationDec.16,2021Sheet13of20US2021/0386961Al328362322392PatentApplicationPnblicationDec.16,2021Sheet14of20US2021/0386961Aly7////....1....3403423027-h'\314PatentApplicationPnblicationDec.16,2021Sheet15of20US2021/0386961Al300///302a\\»a»\318370¥PatentApplicationPnblicationDec.16,2021Sheet16of20US2021/0386961Al3041310344308302"“““X1531415sS5S11TPatentApplicationPnblicationDec.16,2021Sheet17of20US2021/0386961Al77777\7\\/\308\X...7i..j.\...1...PatentApplicationPnblicationDec.16,2021Sheet18of20US2021/0386961Al77■■\//\...7..IX.314PatentApplicationPnblicationDec.16,2021Sheet19of20US2021/0386961Aly/in0lx.//\\gLLPatentApplicationPnblicationDec.16,2021Sheet20of20US2021/0386961AlCDUS2021/0386961AlDec.16,20211INSPIRATORYRESISTORVALVESYSTEM[0005]Insomeembodiments,thepluralityofatmosphericWITHEXPIRATORYPORTpressuresensitivevalvesmaybeconcentricallyarranged.ThepluralityofatmosphericpressuresensitivevalvesmayCROSS-REFERENCETORELATEDoccludetheexpiratoryportduringpositivepressurebreathAPPLICATIONSdeliveryandoccludetheinspiratoryportandopentheexpiratoryporttoenableegressofrespiratorygasesfroma[0001]ThisapplicationisacontinuationofU.S.patentpatient’sduringexpirationorchestcompressions.AlloftheapplicationSer.No.17/207,983,filedMar.22,2021,whichpluralityofatmosphericpressuresensitivevalvesinregionsclaimsprioritytoU.S.ProvisionalPatentApplicationNo.62/992,706,filedMar.20,2020,thedisclosureofwhichisoftheinspiratoryportandtheexpiratoryportmayremaininincorporatedbyreferencehereininitsentirety.aclosedpositionuntilapressurewithinthepatientportisbetween-5and-20cmofwater.OneorbothofaAlterBACKGROUNDOFTHEINVENTIONinterfacedwiththeexpiratoryportandonevalveofthepluralityofatmosphericpressuresensitivevalvesmaypro­[0002]Devicesareoftenusedtoregulateapatient’svidebetween2and10cmofwaterofexpiratoryresistance.intrathoracicpressureduringtheperformanceofcardiopul­Eachofthepluralityofatmosphericpressuresensitivemonaryresuscitation(CPR)and/orothermedicaltreat­valvesmayincludeone-wayvalvesselectedfromagroupments.Sometechniquesinvolvetheuseofavalvestructure,comprising:aduckbillvalve,aballvalve,anannularvalve,calledanimpedancethresholddevice(ITD),toperiodicallyacircularvalve,abutterflyvalve,acheckvalve,aballoonpreventorimpedetheflowinrespiratorygasesintothevalve,amushroomvalve,aflshmouthvalve,andadisklungs,whichhelpsgenerateanegativepressurewithinthevalve.Thepatientportmayincludeanon-rebreathervalvepatient’sthorax.Onceacertainnegativeintrathoracicpres­thatenablessubstantiallyresistance-freepositivepressuresureisreached,thevalveopens,allowingrespiratoryoxy­ventilationfromtheinspiratoryporttothepatientport.gentoenterthepatient’slungs.DuringCPR,positive[0006]Inanotherembodiment,aninspiratoryresistorpressurebreathsareperiodicallydeliveredthroughtheITDvalvesystem(IRV)mayincludeahousinghavinganuppertoperiodicallyinflatethelungsanddeliveroxygen.Whileregion,alowerregion,andanexpiratoryregion.TheIRVconventionaldeviceseffectivelyprovideincreasednegativemayincludeaflrstpressure-responsiveone-wayvalvedis­pressurelevels,problemscanarisewhenfluidfromtheposedbetweentheupperregionandthelowerregionforpatient,suchasthatcausedbypulmonaryedema,passesallowingforpositivepressureventilationwithlessthan5cmfromthepatient’sairwayandintothevalveorotherdevice,H2Oresistanceandforpreventingallrespiratorygasesfromtherebymakingthemlesseffectiveorineffective.Further,flowingfromtheupperregiontothelowerregionwhenaexpiratorygasesmixwithinspiratorygasesinconventionalpressureinthelowerregionissub-atmospheric.TheIRVITDs.Improvementsinintrathoracicpressureregulationaremayincludeasecondpressure-responsivevalvedisposedthereforedesired.betweentheupperregionandthelowerregionthatremainscloseduntilthepressureinthelowerregionfallsbelowaBRIEFSUMMARYOFTHEINVENTIONthresholdlevel,causingthesecondpressureresponsive[0003]Embodimentsofthepresentinventionaredirectedvalvetoopentoallowtherespiratorygasestoflowtothetodevicesthatincreasethebloodflowtoapatient’schestpatient’slungsduetoapressuredifferentialbetweenatmo­duringtherecoilphaseofCPRandduringspontaneoussphericpressureandthepressureinthelowerregion.Therespiration.Inparticular,embodimentsaredirectedtoIRVmayincludeathirdpressure-responsivevalvedisposedinspiratoryresistorvalvesystemswithexpiratoryportsbetweentheupperregionandtheexpiratoryregionfor(IRVs)thathaveaninspiratoryportandaseparateexpira­preventingallexpiratoryfluidsfromflowingtotheuppertoryporttopreventexpiratorygasesfrombeingmixedwithregionwhenthepressureinthethoraxisgreaterthaninspiratorygases,thusseparatinginflowfromoutflowandatmosphericpressure.TheIRVmayincludeafourthpres­allowingforthedeliveryofhigherconcentrationsofO2tosure-responsivevalveintheexpiratoryregionthatoccludesthepatientduringCPR.Additionally,embodimentsprovidewhenpressureinthelowerregioninterfacingwiththeanexitflowpathforanyfluids,suchasthoseresultingfrompatientisbelowatmosphericpressureandopenswhenpulmonaryedema,thatdirectssuchfluidsoutoftheIRVandpressureinthelowerregioninterfacingwiththepatientisawayfromtheinspiratoryflowpathoftheIRV.Inthisregardaboveatmosphericpressure.backflowprotectioncanbedesirabletohelpmaintainthe[0007]Insomeembodiments,thethresholdlevelmaybeintegrityoffluidsensitivevalvingmechanisms.Insomebetweenabout-5and-20cmofwater.TheIRVmayembodimentsexpiratorygasespassthroughaAltercontigu­includeaphysiologicalsensordisposedwithinoneorbothouswiththeexpiratoryporttoprotectrescuepersonnelfromoftheupperregionandthelowerregion.TheIRVmaypotentialpathogens,includingviralparticles.InsomeincludeacommunicationsinterfacethattransmitssignalsembodimentsoneormoresensorsarelocatedwithintheIRVfromthephysiologicalsensortooneorbothofaventilationandbetweentheinspiratoryandexpiratoryflowports.deviceandacompressiondevice.TheIRVmayincludea[0004]Inoneembodiment,aninspiratoryresistorvalveAlterinterfacedwiththeexpiratoryregion.Thesecondsystem(IRV)toregulateintrathoracicpressureduringposi­pressure-responsivevalvemayincludeaduck-billvalvetivepressurebreathing,spontaneousinspirations,andCPRhavinganoutersurfacethatselectivelyengagesavalveseat.isprovided.TheIRVmayincludeaninspiratoryport,aTheduck-billvalvemayopentoenableinspiratoryflowtopatientport,aseparateexpiratoryport,andapluralityofbedeliveredtothepatientwhiletheoutersurfaceengagesatmosphericpressuresensitivevalves.Thepluralityofthevalveseattooccludetheexpiratoryregionfromtheatmosphericpressuresensitivevalvesmayisolatetheexpi­upperregion.Theduck-billvalvemaycloseandtheouterratoryportandtheinspiratoryportfromoneanother.surfacemaymoveawayfromthevalveseattoexpeltheUS2021/0386961AlDec.16,20212expiratoryfluidsfromtheIRVandtopreventtheexpiratoryoneorbothofachestcompressionphaseofCPRandafluidsfromflowingtotheupperregion.patientexpiration,thesecondpressure-sensitivevalvemay[0008]Inanotherembodiment,aninspiratoryresistorbeopenwhilethefirstatmosphericpressurevalve,thefirstvalvesystem(IRV)mayincludeahousing,aventilationportpressure-sensitivevalve,andthesecondatmosphericpres­thatisconflguredtointerfacewithaventilationdevice,andsurevalvemaybeclosed,therebyenablingrespiratoryfluidsapatientportthatisconflguredtointerfacewithapatienttoexittheIRVwithoutmixingwithinspiratorygases.interfacedevice.TheIRVmayincludeaseparateexpirationDuringadecompressionphaseofCPR,theflrstatmosphericportandapositivepressureventilationflowpaththatisinpressurevalve,theflrstpressure-sensitivevalve,andthefluidcommunicationwiththeventilationportandthepatientsecondpressure-sensitivevalvemaybeclosed,therebyport.Thepositivepressureventilationflowpathmaybeloweringintrathoracicpressureandpreventingrespiratoryconflguredtodirectrespiratoryairfromtheventilationportgasesfromenteringthepatientandprovidingroomfortothepatientport.TheIRVmayincludeapatientinspirationincreasedbloodvolumetoreturntothepatient’sheartflowpaththatisinfluidcommunicationwiththepatientduringthedecompressionphasetoincreasecirculationtoport.Thepatientinspirationflowpathmaybeconfiguredtothepatient’scoronaryarteriesandlowerintracranialpres­deliverairtothepatientportintheeventofspontaneoussure.inspirationofapatient.TheIRVmayincludeanexpirationflowpaththatisinfluidcommunicationwiththepatientBRIEFDESCRIPTIONOFTHEDRAWINGSport.Theexpirationflowpathmaybeconflguredtodirect[0011]Afurtherunderstandingofthenatureandadvan­expiratoryfluidsfromthepatientoutoftheIRVviathetagesofvariousIRVembodimentsmayberealizedbyexpirationport.Theexpirationflowpathmaybeseparatedreferencetothefollowingflgures.Intheappendedflgures,fromatleastaportionofthepositivepressureventilationsimilarcomponentsorfeaturesmayhavethesamereferenceflowpathandthepatientinspirationflowpathviaaseriesoflabel.Further,variouscomponentsofthesametypemaybepressure-responsivevalvestoseparateinflowfromoutflowdistinguishedbyfollowingthereferencelabelbyadashandsuchthatexpiratoryfluidsarenotmixedwithinspiratoryasecondlabelthatdistinguishesamongthesimilarcompo­gases,thusresultingindeliveryofhigherconcentrationsofnents.Ifonlytheflrstreferencelabelisusedinthespeci-©2tothepatientduringCPR.flcation,thedescriptionisapplicabletoanyoneofthe[0009]Insomeembodiments,theseriesofpressure-re­similarcomponentshavingthesameflrstreferencelabelsponsivevalvesmayincludeaflrstatmosphericpressureirrespectiveofthesecondreferencelabel.valveinterfacedwiththepositivepressureventilationflow[0012]FIG.lAillustratesaschematicofaninspiratorypath,aflrstpressure-sensitivevalveinterfacedwiththeresistorvalvesystemwithanexpiratoryport(IRV)accord­patientinspirationflowpath,asecondpressure-sensitiveingtoembodiments.valveinterfacedbetweentheinspirationflowpathandthe[0013]FIG.IBillustratesairflowthroughtheIRVofFIG.expirationflowpath,andasecondatmosphericpressurelAduringdeliveryofapositivepressureventilation.valvethatisdisposedwithintheexpirationport.Aclosing[0014]FIG.ICillustratesairflowthroughtheIRVofFIG.pressureoftheflrstatmosphericpressurevalvemaybelesslAduringspontaneousinspiration.than-1cmH2O.Anopeningpressureoftheflrstpressure­[0015]FIG.IDillustratesairflowthroughtheIRVofFIG.sensitivevalvemaybebetweenabout-5and-20cmH2O.lAduringachestcompressionphaseofCPRorapatientThesecondpressure-sensitivevalvemayopenwhentheexpiration.pressureintheventilationflowpathisgreaterthan0cm[0016]FIG.IEillustratesastateoftheIRVofFIG.lAH2OandmayclosewhenexpirationflowpathpressureisduringadecompressionphaseofCPR.greaterthan0cmH2O.Anopeningpressureofthesecond[0017]FIG.2AillustratesaperspectiveviewofanIRVatmosphericpressurevalvemaybebetweenabout0and10accordingtoembodiments.cmH2O.Aclosingpressureoftheofthesecondatmo­[0018]FIG.2BillustratesanexplodedviewoftheIRVofsphericpressurevalvemaybelessthan-1cmH2O.TheFIG.2A.secondpressure-sensitivevalveandthesecondatmospheric[0019]FIG.2Cillustratesafrontcross-sectionalviewofpressurevalvemayformasinglenon-rebreathervalve.ThetheIRVofFIG.2A.secondatmosphericpressurevalvemayenablerespiratory[0020]FIG.2DillustratesairflowthroughtheIRVofFIG.fluidstoenterthepatientbutpreventstherespiratoryfluids2Aduringdeliveryofapositivepressureventilation.fromthelungsfromcontactwiththeflrstatmosphericpressurevalve.TheIRVmayincludeaflrstdiaphragm[0021]FIG.2EillustratesairflowthroughtheIRVofFIG.coupledwithatopsurfaceofthepositivepressureventila­2Aduringspontaneousinspiration.tionflowpath.TheIRVmayincludeaseconddiaphragm[0022]FIG.2FillustratesairflowthroughtheIRVofFIG.coupledwiththelowersurfaceoftheexpirationflowpath.2AduringachestcompressionphaseofCPRorapatientTheflrstdiaphragmandtheseconddiaphragmmayeachexpiration.haveacrackingpressurethatissubstantiallyatatmospheric[0023]FIG.2GillustratesastateoftheIRVofFIG.2Apressure.duringadecompressionphaseofCPR.[0010]Duringdeliveryofpositivepressureventilations,[0024]FIG.3AillustratesanexplodedviewofanIRVtheflrstatmosphericpressurevalveandthesecondatmo­accordingtoembodimentsofthepresentinvention.sphericpressurevalvemayopenwhiletheflrstpressure­[0025]FIG.3Billustratesafrontcross-sectionalviewofsensitivevalveandthesecondpressure-sensitivevalvemaytheIRVofFIG.3A.beclosed.Duringspontaneousinspiration,theflrstpressure­[0026]FIG.3CillustratesairflowthroughtheIRVofFIG.sensitivevalveandthesecondatmosphericpressurevalve3Aduringdeliveryofapositivepressureventilation.maybeopen,whiletheflrstatmosphericpressurevalveand[0027]FIG.3DillustratesairflowthroughtheIRVofFIG.thesecondpressure-sensitivevalvemaybeclosed.During3Aduringspontaneousinspiration.US2021/0386961AlDec.16,20213[0028]FIG.3EillustratesairflowthroughtheIRVofFIG.thisprocessoccursfasterwithactivedecompressionofthe3AduringachestcompressionphaseofCPRorapatientchestduringthechestrecoilordecompressionphaseofexpiration.CPR.Italsooccursmoreefficientlywithelevationofthe[0029]FIG.3FillustratesastateoftheIRVofFIG.3AheadandthoraxduringCPRorinthesettingortraumaticduringadecompressionphaseofCPR.braininjury:elevationoftheheadandthoraxharnesses[0030]FIG.4illustratessensorsarrangedwithintheIRVgravitytohelpdrainvenousbloodfromthebrainanditofFIG.3A.improvesthedistributionofbloodwithinthelungs.[0031]FIG.5illustratesasamplingtubeincorporatedintheIRVofFIG.3A.[0037]Duringchestcompressions,bloodispropelledout[0032]FIG.6isagraphshowingairwaypressureandofthehearttothebrainandtherestofthebodyandtheairintrathoracicpressureduringCPRwithandwithoutanIRV.isexpelledfromthelungs.AirmaybeexpelledthroughanIRVthatcanprovidealowlevelofflxedorvariableDETAILEDDESCRIPTIONOFTHEresistance,typicallyintherangeofabout0cmFI2OtoaboutINVENTION15cmFI2O,morecommonlyabout2cmFI2Otoabout10[0033]ThesubjectmatterofembodimentsofthepresentcmFI2O.ThisresistancemaybeadjustableandmaybeinventionisdescribedherewithspecificitytomeetstatutoryprovidedbyoneormorevalvesofanIRVsystem(suchasrequirements,butthisdescriptionisnotnecessarilyintendedanexpiratoryvalveasdescribedherein),aAltermaterial,tolimitthescopeoftheclaims.Theclaimedsubjectmatterand/orothermeanshavingalowflowofpositivepressuremaybeembodiedinotherways,mayincludedifferentgases,suchasoxygen.elementsorsteps,andmaybeusedinconjunctionwithother[0038]Witheachchestcompressionairispushedoutofexistingorfuturetechnologies.Thisdescriptionshouldnotthelungs,andnotallowedbackintothelungsbecauseofthebeinterpretedasimplyinganyparticularorderorarrange­valvesystem.Thisresultsinaprogressivedecreaseinmentamongorbetweenvariousstepsorelementsexceptrespiratorygaseswithinthelungs.Thevolumeofrespiratorywhentheorderofindividualstepsorarrangementofele­gasthatisexpelledfromthelungswitheachchestcom­mentsisexplicitlydescribed.pressioncreatesspacethatisfllledbymorebloodreturning[0034]PerformanceofCPRonpatientsincardiacarresttotheheartandlungsduringthedecompressionphaseincludeschestcompressions(performedmanuallyand/orwheneverapositivepressureisnotbeingappliedtotheusinganautomateddevice)inordertoassistinthecircu­thoraxbychestcompressions.Thisprocessoccursfasterlationofbloodtothevitalorgansincludingtheheart,lungs,withactivedecompressionofthechestduringthechestandbrain.Insomeembodiments,activecompressionrecoilordecompressionphaseofCPR.Tohelpgeneratedecompression(ACD)CPRmaybeperformed,whichevenmorenegativepressurewithinthepatient’sthoraxinvolvesactivelydecompressingbetweeneachcompres­betweenchestcompressions(duringthedecompressionsion,ratherallowingthechesttorecoilonitsown.Duringphase),avalvestructureinaccordancewiththepresentthecompressionphaseofCPR,bloodispushedoutoftheinventionmaybeinterfacedwiththepatient’sairway.Suchheartintotheaortaandairispushedoutofthethoraxandvalvestructuresmayperiodicallypreventorimpedetheflowintotheatmosphereviathetracheaandairways.Duringtheinrespiratorygasesintothelungswhilepermittingrespira­decompressionphase(bothpassiveandactive),bloodfromtorygasestoescapefromthelungsduringchestcompres­areasremotefromthethoraxisdrawnintothethoraxandairsions,whilepermittingperiodicventilation.isdrawnintothethoraxviathepatient’sairways.[0039]FIG.1Aillustratesaschematicofavalvestructure[0035]Applicationofthemethodsanddevicesdescribedintheformofaninspiratoryresistorvalvewithexpiratoryinthisapplication,inconjunctionwithanyofthemethodsport(IRV)100.IRV100mayincludeanumberofvalvesofCPRnotedabove,resultinanintrathoracicvacuumthatoperatetoregulateintrathoracicpressureofapatient.duringthechestwallrecoilphase.ThisincreasescirculationIRV100mayincludeanumberofbranches,tubes,and/ortothecoronaryarteriesandlowersintracranialpressureotherlumens102thatenablerespiratorygasestoflowtoandduringthechestwalldecompressionphase.Oftentimes,afromthepatient.Asillustrated,theIRV100includespatientpositivepressureventilationneedstobedeliveredtotheinspirationlumen102a,apositivepressureventilationpatientperiodicallytoinflatethelungsandprovideoxygen.lumen102/),andapatientexpirationlumen102c(althoughThelungscanalsobeinflatedbyperiodicnegativepressureotherconflgurationsarepossible).Here,thelumens102areventilationwith,forexample,anironlungorchestcuirasscoupledtooneanotherinparallel,withaventilationportdevice.104disposedatatopendofthelumens102andapatient[0036]Duringthechestdecompressionorrecoilphaseofport106disposedatabottomendofthelumens102,CPR,orduringspontaneousinspiration,pressureswithinthehoweverotherarrangementsofthelumens102and/orportsthoraxdecreasetopressurelevelsbetween-1to-15cmarepossible.Variousone-wayvalvesmaybeprovidedH2O.Thisdrawsrespiratorygasesintothelungsunlesswithinoneormoreofthelumen102tocontroltheflowofthereisanIRVwithinthecircuit.AnIRVimpedesrespiratorrespiratorygasestoandfromthepatient.Theone-waygasesfromenteringintothelungsbecauseofthevalvevalvesmaybeintheformofcheckvalves,flshmouthsystem.Withrecoilofthechest,eitherpassiveoractive,orvalves,springvalves,duckvalves,ballvalves,and/orotherpatientinspiration,whenanIRVisinthecircuitthenegativemechanicalorelectronicallycontrolledvalvesandswitches.intrathoracicpressuregeneratedduringthechestrecoilphaseofCPRorduringaspontaneousinspirationproduces[0040]Asillustrated,thepatientinspirationlumen102aavacuumthatenhancesvenousbloodflowbackintotheincludesone-wayvalve108thatoperatesasasafetyvalvelungsandlowersintracranialpressure.Thiscollectivelytoenablerespiratorygasestobedrawnintothepatient’sincreasescardiacpreloadandincreasescar