Micro Medical and Pharmaceutical Devices

Presented by:Donna Bibber

2

ABOUT MESµ 8 Micro Experienced Project Engineersµ Multiple MICRO material and processing platformsµ 24+ Yrs Micro Mfg/High Speed Assemblyµ 1,000+ Successful Micro Programs

MES SERVICES

Product Development

µ

eurosurgical coil assemblies µ

harmaceutical Infused implantsµ

ydrogel orthopedic implantsµ

ollagen-induced Cardio Implantsµ

.0 cu mm Silicone valvesµ

icrofluidic chips

µ

ransdermal patchesµ

ntraocular Implantsµ

icro Needle Arraysµ

nsulin delivery pump assembly µ

mplantable Batteries µ

ioResorbable Polymer Implants

Micro Assembly Challenges

µ

ltra Precision Positioning µ

arting line/draft alignmentµ

urface finishµ

ptical finish and vision µ

nvironment/Cleanliness

Microfluidic Tooling

µ

nd Mills as small as 0.0001” (3 um)

µ

jector pins as small as .004” (100 um)

µ

avities as small as 0.007”µ

ore pins .0029”µ

ates 0.002”µ

all thicknesses 0.0015”µ

lots and Channels to 0.5 µ (~0.00002’)

Catheter Assemblyµ 50 um Lumen

tip edgeµ 0.5mm lumen

ODµ Multiple core

pins to accommodate .0002” range Lumen sizes

Scaffold Assembly

•PLA Scaffold•0.050” posts•0.003” weld bead

PLA Staple Assembly

µ Snap Fit Designµ Multiple Cavityµ Fully Automatic Loading

µ Custom end of arm toolingµ Multi-axis robotic loading

Filled and SealedSurgical Marker

µ Spin Weldingµ PEEK Vesselµ Vacuum Nestingµ Automatic Fill and

Seal System (syringe)

Micro Features

PLA Anchor

µ 0.0008” tip radiusµ OAL 0.085”µ Side Hole 0.010”µ Using Runner/Sprue as assembly aid

Endoscopy Assembly

µ Multiple machined components

µ Tolerance stack-up study

µ Scale-up to MIM

µ Membrane attachmentµ Designed-in alignment featuresµ 50 um lumens

Drug Well Assembly

Transdermal Needle Array

Glaucoma Drain Suture Assembly

µ 0.010” orifice

µ Parting line critical

µ 0.015” Side action suture holes

µ Radial wedge shape action

Intraocular Lens Assembly

•atched arc lengths

•ritical parting line across 2 components

•ritical registration/positioning of components

Intraocular Vacuum

Assembly

•ritical Parting line directly sitting on cornea

•ide action, pin shutoff

Silicone Micro Structures

µ 84 Million discrete shapes on each chip

µ 100 um Tall, 100 um Wide Shapes

µ 3 um Diameter, 3 um Depth Posts on top

µ Material- Bio-Compatible Silicone

µ Assembly Aid=Repeatable and Quantifiable Surface (tissue grasping and adhesive surface)

Gastric Bypass

Assembly

Neurosurgical Assembly

µ 0.001” wall thickness

µ 0.014” OALµ Vacuum

assist vs. Tweezers

Micro Inspection Capabilities

•aser Scanning Vision Systems

•FM

•ideo CMM

•ouch Probe Systems w/ 3 micron diameter probes

•rofilometer

•nterferometer

•pectrometer

21

Micro Assembly Methods

µ

voidance- Geometry Combiningµ

elective Sacrificial Material Melting (silicone, PET)µ

nsert or 2-shot Micro Moldingµ

eldingµ Laserµ Ultrasonic

µ

poxyµ

n Mold Assemblyµ

hemical

Micro Device Assembly

µ

Moldingµ MMµ LIMµ MIMµ CIM

µ

Stampingµ

Machinedµ

Etchedµ

Opticalµ

Bonding

Micro Assembly System

µ

nd. Vac. Nestsµ

sec cycleµ

eat sealµ

ltrasonic weldingµ

nline Psi decay testµ

embrane handling

Injection Molding Simulations, Modeling, Analysis

26

Micro Mold Flow Analysis Technology

µ

roprietary Meshing Technique for Micro Partsµ

haracterized and Analyze Resorbs, PC Lenses, Siliconeµ

nsurance Policy for First Shot Quality

Mesh Thickness

Deflection-All Effects

Conclusionµ

eveloping medical and pharmaceutical micro assemblies requires successful integration of many ultra- precision processes/materials

µ

urface finish, feature size and positioning, and extreme critical care environment results in successful micro assemblies

µ

f your micro partner has gone beyond the feature size and tolerance stack-up requirements, you are much less likely to be a science experiment

Thank you.We look forward to working with you.

Micro Engineering Solutions

www.wickedsmall.com