MediSaver: An EpiPen Alternative · Project Scope 1. Problem: Anaphylaxis -> Solution: Epinephrine...
Transcript of MediSaver: An EpiPen Alternative · Project Scope 1. Problem: Anaphylaxis -> Solution: Epinephrine...
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MediSaver:AnEpiPenAlternativeVIKRAM ARUN,BENKATZMAN,LUKE ZIOLKOWSKI
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Outline•ProjectScope
•DesignSpecifications
•ExploredDesigns
•ChosenDesign
•UpdatedSchedule
•UpdatedTeamTasks
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ProjectScope1. Problem:Anaphylaxis->Solution:Epinephrineadministration
2. Designadevicethatcanbeusedtodeliveranemergencydoseofepinephrineforindividualsundergoinganaphylaxis
a. Morepractical,safe,andefficientalternativetoexistingdevicesb. Moredurableandportabledesignwithashelflifeofmorethanoneyear,minimallyinvasive
epinephrineadministrationmethod,andanaccurateandpreciselydelivereddoseofepinephrinec. Therouteofepinephrineadministrationwillensuresafeandeffectivepatientusealongwithaccurate
andrapiddrugabsorptiontotreatcustomers.
3. January: Completedesignforadevice
4. EndofApril:Completedproject,producedprototypeofthisdevicethatwillbetestedtodeliveraconsistentamountofepinephrine.
a. Devicewillbeaccompaniedbymechanicaldesigndiagrams,riskanalysis,andtestingresultsthatprovideevidencefortheproductasatemporarybutreliabletreatmentinthecaseofanaphylaxis.
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DesignSpecificationsDesignspecification DesignSpecificationgoal
Weight Lessthat1.0kg
Portability VolumeConstraints:lessthan82cubiccentimeters
Temperaturedependence Functionalbetween10degreesand40degreescelsius
Onsetofabsorption <=5minutes
Plasmaconcentrationovertime 20,000pg/mLafter40minutes
DoseAccuracy 95%ofepinephrinedose
Costtoproduce <$300
Preparation+deliverytime Canbeappliedinunder10seconds,doesnotrequireelectricalpower
Dosevariability Doseforchildrenandadults
Invasiveness Penetratesskinminimalamountneededtoapplydose
Accidents Safetymechanismtopreventaccidentaluse
Instructions Printedlargelyondevice
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DesignSpecifications(continued)Epinephrinedose Smallamount(<=5milligram)
Repeatability Canreplacedevice/doseandre-use
Safetyafteruse Retractableneedle/nosharppartsrevealed
Easeofuse Canbeadministeredbysomeoneelseifnotbreathing/conscious
Longevity Lasts>1year
Trackability Strap/keychain
Applicationsitesideeffects Minimals scarring/redness/bleeding
DeliveryObstacles canbeappliedwithclothes
Concentration Lessthan90%byweightepinephrine
Width lessthan2.54cm
ForceofActivation 10-30Newtons
Falldurability Canbedropped2metersandstillfunction
Weightdurability Canwithstand400Newtons ofappliedforceandstillfunction
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DesignsInjectors
1. (Reference)IMAutoinjector
2. SubcutaneousInjector
3. ImprovedIMInjector
4. IntravenousInjection
5. Jetinjector
6. MagneticJetinjector
7. WearableInjectorPack
Non-injectors
8. EpinephrineInhaler
9. Sublingualdelivery
10. IntranasalSpray
11. EpinephrinePatch
12. Implantablepump
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1.IMAutoinjector (Reference)•OnlycurrentexistingFDAapprovedsolution•EpiPen,the“GoldStandard”•Activation(viaforceonneedlecover)releasesaspringwhichforcestheneedleintothelegandforcesaplungerintoaprefilledcartridge,injectingtheepinephrinesolution
•Estimated89Newtons ofdynamicforceonplunge
•IMoffersbestonsetofabsorption(lessthan5minutestopeak),bestplasmaconcentrationovertime,andiseasyandquicktouse
•15mm22gaugeneedle,causesriskofwronginjectionlength
•Failedstaticloadof400N
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2.SubcutaneousInjector3.ImprovedIMinjector•Smaller,portable,voiceguidedwalkthrough
•Separationofdryandwetingredientsthataremixedtogetherduringactivationandinjectedasonesolution
•Adjustableneedlelength,replaceablecartridges
•SimilartoIMinjector,usesaspring-plungermechanismtodriveneedleintotissue
•Smallneedle(1to4mm),lessforceneededtodriveit
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4.Intravenousinjection 5.Jetinjector•Directinjectionintobloodstream
•Lessepinephrine(.1mg)
•Injectiongivenatanangleandmustpiercevein
•”Needle-free”
•Previouslyusedinmassvaccinationtoavoidneedle-stickinjuriesandcross-contamination
•Largepressures(4-40MPa)createdbyspringtoshootsolution
•Smallneedletoassistinjection
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6.MagneticJetinjector 7.WearableInjectorPack•Useselectromagneticactuatortocreatemechanicalforce(insteadofspringorgas)
•200Voltsappliedtoacoilactuatormovesaplunger,creating20MPathatdrivesfluidbeneathapatient’sskin.
•Devicethatcanbeattachedtothebodyanddeliverepinephrinebypushingabutton(likeinsulinpacks)
•Buttoncausesneedletoinjecttissueanddelivermedication
•Portable,wornaroundleg
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8.EpinephrineInhaler 9.SublingualDelivery•Inhalablesolution,similartotreatmentsforasthma
•Appliedpressuresprayssolutionwhichisbreathedinandabsorbedinalveoli
•40mgtablet
•Absorbedthroughmucusmembraneundertongue
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10.IntranasalSpray11.EpinephrinePatch12.ImplantablePump•Insufflation,absorbedthroughmucusmembraneinnasalcavity
•Downwardforceonthetopcausespressuredifferentialwhichshootsfluidoutasmallopening
•Skinpatchcoatedwithepinephrinedesignedtodiffuseacrossskin
•Difficulttomakeepinephrinetransfersubdermally
•Invasive,pumpsurgicallyplacedonmuscle
•Automaticallyapplymedication(sensinghistamines)orapplyoncommandbypatient
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DesignAnalysisRankedlowestonPughChart
2.SubcutaneousInjector- Poorabsorptionandplasmaconcentration
4.IntravenousInjection- Preparationtoolong,negativehealtheffects
7.WearableInjectorPack- Notportable,IMinjectionnotfeasible
11.EpinephrinePatch- Poorabsorption,plasmaconcentration,andaccuracy
12.Implantablepump- tooinvasive,riskofsafetyandlongevity
RankedhighestonPughChart
1.IMAutoinjector (REFERENCE)
3.ImprovedIMInjector
5.Jetinjector
6.MagneticJetinjector
8.EpinephrineInhaler
10.IntranasalSpray
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DesignAnalysis(continued)•Injectordesignsoutperformednon-injectorsforabsorption,accuracy,andplasmaconcentration
•Inhalereaseofuseverylow-can’tapplyifnotbreathing
•Non-injectorshadlessinvasivenessandbettersafety
•BestdesignoptionsfromwholePughChartwereJetinjectorandimprovedIMinjector
AbbreviatedPughChart
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ChosenDesignJETINJECTOR
•smallneedletoassistinjection(lessthan10mm)
•Springmechanismwithlargespringconstanttoreachintramuscularly
•Safetytopreventaccidentaluse,needlecover,straight-forwardinstructions
•Plasticwithsteelreinforcementfordurability
•Portabledesign(sizeofacellphone)
Component Price($)
23CCsyringes+22Gneedles 14.99
StainlessSteeltube 8.25/ft
Variousplasticpieces Varies(3Dprinted)
Knoxgelatin16oz(Forballisticgeltesting) 12.00
Compressionspring 25
Estimatedcostswereverylow;wewillnotberequestinganyfunds.
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CurrentDesignSchedule
TeamResponsibilitiesremainedthesame
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ThanksQuestions?