MediSaver: An EpiPen Alternative · Project Scope 1. Problem: Anaphylaxis -> Solution:...

MediSaver:AnEpiPenAlternativeVIKRAM ARUN,BENKATZMAN,LUKE ZIOLKOWSKI

Outline•ProjectScope

•DesignSpecifications

•ExploredDesigns

•ChosenDesign

•UpdatedSchedule

•UpdatedTeamTasks

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.

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

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

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

1.IMAutoinjector (Reference)•OnlycurrentexistingFDAapprovedsolution•EpiPen,the“GoldStandard”•Activation(viaforceonneedlecover)releasesaspringwhichforcestheneedleintothelegandforcesaplungerintoaprefilledcartridge,injectingtheepinephrinesolution

•Estimated89Newtons ofdynamicforceonplunge

•IMoffersbestonsetofabsorption(lessthan5minutestopeak),bestplasmaconcentrationovertime,andiseasyandquicktouse

•15mm22gaugeneedle,causesriskofwronginjectionlength

•Failedstaticloadof400N

2.SubcutaneousInjector3.ImprovedIMinjector•Smaller,portable,voiceguidedwalkthrough

•Separationofdryandwetingredientsthataremixedtogetherduringactivationandinjectedasonesolution

•Adjustableneedlelength,replaceablecartridges

•SimilartoIMinjector,usesaspring-plungermechanismtodriveneedleintotissue

•Smallneedle(1to4mm),lessforceneededtodriveit

4.Intravenousinjection 5.Jetinjector•Directinjectionintobloodstream

•Lessepinephrine(.1mg)

•Injectiongivenatanangleandmustpiercevein

•”Needle-free”

•Previouslyusedinmassvaccinationtoavoidneedle-stickinjuriesandcross-contamination

•Largepressures(4-40MPa)createdbyspringtoshootsolution

•Smallneedletoassistinjection

6.MagneticJetinjector 7.WearableInjectorPack•Useselectromagneticactuatortocreatemechanicalforce(insteadofspringorgas)

•200Voltsappliedtoacoilactuatormovesaplunger,creating20MPathatdrivesfluidbeneathapatient’sskin.

•Devicethatcanbeattachedtothebodyanddeliverepinephrinebypushingabutton(likeinsulinpacks)

•Buttoncausesneedletoinjecttissueanddelivermedication

•Portable,wornaroundleg

8.EpinephrineInhaler 9.SublingualDelivery•Inhalablesolution,similartotreatmentsforasthma

•Appliedpressuresprayssolutionwhichisbreathedinandabsorbedinalveoli

•40mgtablet

•Absorbedthroughmucusmembraneundertongue

10.IntranasalSpray11.EpinephrinePatch12.ImplantablePump•Insufflation,absorbedthroughmucusmembraneinnasalcavity

•Downwardforceonthetopcausespressuredifferentialwhichshootsfluidoutasmallopening

•Skinpatchcoatedwithepinephrinedesignedtodiffuseacrossskin

•Difficulttomakeepinephrinetransfersubdermally

•Invasive,pumpsurgicallyplacedonmuscle

•Automaticallyapplymedication(sensinghistamines)orapplyoncommandbypatient

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

DesignAnalysis(continued)•Injectordesignsoutperformednon-injectorsforabsorption,accuracy,andplasmaconcentration

•Inhalereaseofuseverylow-can’tapplyifnotbreathing

•Non-injectorshadlessinvasivenessandbettersafety

•BestdesignoptionsfromwholePughChartwereJetinjectorandimprovedIMinjector

AbbreviatedPughChart

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.

CurrentDesignSchedule

TeamResponsibilitiesremainedthesame

ThanksQuestions?