)
(
(51)InternationalPatentClassification:
A61M5/20(2006.01)A61M5/31(2006.01)A61M5/50(2006.01)(21)InternationalApplicationNumber:
PCT/US2019/025318
(22)InternationalFilingDate:
02April2019(02.04.2019)
(25)FilingLanguage:(26)PublicationLanguage:(30)PriorityData:
15/944,709
03April2018(03.04.2018)
EnglishEnglish
US
AO,AT,AU,AZ,BA,BB,BG,BH,BN,BR,BW,BY,BZ,CA,CH,CL,CN,CO,CR,CU,CZ,DE,DJ,DK,DM,DO,DZ,EC,EE,EG,ES,FI,GB,GD,GE,GH,GM,GT,HN,HR,HU,ID,IL,IN,IR,IS,JO,JP,KE,KG,KH,KN,KP,KR,KW,KZ,LA,LC,LK,LR,LS,LU,LY,MA,MD,ME,MG,MK,MN,MW,MX,MY,MZ,NA,NG,NI,NO,NZ,OM,PA,PE,PG,PH,PL,PT,QA,RO,RS,RU,RW,SA,SC,SD,SE,SG,SK,SL,SM,ST,SV,SY,TH,TJ,TM,TN,TR,TT,TZ,UA,UG,US,UZ,VC,VN,ZA,ZM,ZW.
(84)DesignatedStates(unlessotherwiseindicated,forevery
kindofregionalprotectionavailable).ARIPO(BW,GH,GM,KE,LR,LS,MW,MZ,NA,RW,SD,SL,ST,SZ,TZ,UG,ZM,ZW),Eurasian(AM,AZ,BY,KG,KZ,RU,TJ,TM),European(AL,AT,BE,BG,CH,CY,CZ,DE,DK,EE,ES,FI,FR,GB,GR,HR,HU,IE,IS,IT,LT,LU,LV,MC,MK,MT,NL,NO,PL,PT,RO,RS,SE,SI,SK,SM,TR),OAPI(BF,BJ,CF,CG,Cl,CM,GA,GN,GQ,GW,KM,ML,MR,NE,SN,TD,TG).
(71)Applicant:AMGENINC.[US/US];LawDepartment-PatentOperations,OneAmgenCenterDrive,ThousandOaks,CA91320-1799(US).(72)Inventors:GIBSON,Scott,Robert;12141Bellando
Court,GrandaHills,CA91344(US).MCCULLOUGH,Adam,B.;2792GreatSmokeyCourt,WestlakeVillage,CA91362(US).(74)Agent:CHAVKA,Daniel,T.;Marshall,Gerstein&Borun
LLP,233S.WackerDrive,6300WillisTower,Chicago,IL60606-6357(US).(81)DesignatedStates(unlessotherwiseindicated,forevery
kindofnationalprotectionavailable):AE,AG,AL,AM,
Published:
—withinternationalsearchreport(Art.21(3))
(54)Title:SYSTEMSANDMETHODSFORDELAYEDDRUGDELIVERY
(57)Abstract:Systemsandmethodsfordelayeddeliveryofadrugaredisclosed.Adrugdeliverysystemmayincludeadeliverymemberforinsertionintoapatientandareservoirconfiguredtoreceiveavolumeofadrug.Anenergysourcemaybeactivatablebythepatienttoactuatethereservoirtodeliverthedrugtothepatientasasinglebolus.Alockoutsystemmaybeconfiguredtohavealockedstate,whereinthelockoutsystempreventsmovementofthedeliverymemberand/oractivationoftheenergysource,andanunlockedstate,whereinthelockoutsystempermitsmovementofthedeliverymemberand/oractivationoftheener?gysource.Thelockoutsystemmaybeconfiguredtoautomaticallychangefromthelockedstatetotheunlockedstateafterapreselectedtimeperiodhaselapsed.Anoutputelementmaygenerateadetectableoutputafterthepreselectedtimeperiodhaselapsedfornotifyingthepatient.
FIG.3
SYSTEMSANDMETHODSFORDELAYEDDRUGDELIVERY
CROSS-REFERENCETORELATEDAPPLICATION
[0001]
TheprioritybenefitofU.S.PatentApplicationNo.15/944,709,filedApril3,2018,isclaimed,andtheentirecontentsthereof
areexpresslyincorporatedhereinbyreference.
FIELDOFDISCLOSURE
[0002]
Thepresentdisclosuregenerallyrelatestoinjectorsfordrugdeliveryandrelatedmethods.Moreparticularly,thepresent
disclosurerelatestoinjectorsforuseinatreatmentregimenbenefitingfrominjectionofadrugwithinaparticulartimeframe.
BACKGROUND
[0003]
Parenteraldeliveryofvariousdrugs,i.e.,deliverybymeansotherthanthroughthedigestivetrack,hasbecomeadesired
methodofdrugdeliveryforvariousreasons.Bypassingthedigestivesystemofthepatientcanavoiddegradationoftheactiveingredientscausedbythecatalyticenzymesinthedigestivetractandliverandensurethatanecessaryamountofadrug,atadesiredconcentration,reachesthetargetedsite.Furthermore,growthintreatmentsinvolvingbiologies,whicharetypicallyinjectedin
liquidform,hasincreasedtheprevalenceofparenteraldelivery.[0004]
Injectabledrugstraditionallyhavebeenadministeredviaasyringe.Useofasyringerequiresinsertionofaneedleintoa
patient,andsubsequently,drivingaplungerthroughareservoirtoexpelavolumeofthedrugthroughtheneedleintothepatient.
Thesetasksconventionallyhavebeenperformedmanually.Insomesituations,itmaybenecessaryorconvenientforthepatienttoself-administertheinjectabledrug.Inthecaseofasyringe,self-administrationrequiresthepatienttomanuallyinserttheneedleinto
hisorhertissueandthenmanuallyadvancetheplunger.Thiscanbechallengingforindividualshavinglimitedexperiencein
operatingsyringes,dexterityproblems,alowpaintolerance,amongotherreasons.
[0005]
Toassistwiththeself-administrationofaninjectabledrug,variousautomateddrugdeliverydeviceshavebeendeveloped.
Onesuchdeviceisanambulatoryinfusionpumpusedtoadministerinsulintoadiabeticindividual.Thesepumpstypicallyhavea
processorthatfollowsaninternalprogramtoadministeraseriesofdosesofinsulintothepatientoverthecourseofaday,orseveral
days.Usuallytheprocessorisintendedforreuseandthusisdetachablefromotherportionsofthedevice,includingthosewhichareinsertedintothepatient.Otherautomateddrugdeliverydevices,suchascertainautoinjectors,aredesignedtobediscardedintheir
entiretyafterprovidinganinjection.However,besidesprovidingautomaticneedleinsertionorplungermovement,suchdisposabledevicesgenerallyarelimitedintheirabilitytoassistthepatientoruserwithcomplyingwithaprescribedtreatmentregimen.
[0006]
Thepresentdisclosuresetsforthdrugdeliverysystemsandrelatedmethodsofoperationembodyingadvantageous
alternativestoexistingdrugdeliverysystemsandmethodsofoperation,andthatmayaddressoneormoreofthechallengesorneedsmentionedherein,aswellasprovideotherbenefitsandadvantages.
SUMMARY
[0007]
Oneaspectofthepresentdisclosureprovidesasystemfordelayeddeliveryofadrug.Thesystemmayincludeahousing
havinganinteriorsurfaceandanexteriorsurface.Theinteriorsurfacemaydefineaninteriorspace.Thesystemmayincludea
deliverymemberconfiguredtohaveaninitialstateandadeliverystate.Intheinitialstate,thedeliverymembermaybewithdrawn
insidetheinteriorspaceofthehousing.Inthedeliverystate,apointedendofthedeliverymembermayextendbeyondtheexterior
surfaceofthehousingforinsertionintoapatient.Thesystemmayalsoincludeareservoirconfiguredtoreceiveavolumeofadrugandtobeinfluidcommunicationwiththedeliverymember.Additionally,thesystemmayincludeanenergysourceactivatablebythepatienttoactuatethereservoirtodeliverthevolumeofthedrugtothepatientasasinglebolus.Inaddition,thesystemmayincludealockoutsystemconfiguredtohavealockedstateandanunlockedstate.Inthelockedstate,thelockoutsystemmaypreventmovementofthedeliverymemberrelativetothehousingand/oractivationoftheenergysource.Intheunlockedstate,thelockout
WO2019195236A1用于延迟药物递送的系统和方法[专利] - 图文
