Joe Macomber, Product Manager, Polymicro Technologies, a Subsidiary of Molex Inc.

1. Joe Macomber
Feb 11, 2014
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2. Tubing in Medical Applications
Fused Silica Capillary Tubing
Design Advantages
Material Comparisons
Summary Remarks – Q&A
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3. Fluid Delivery & Aspiration Systems
Drug Delivery and Control
Catheters
Oxygen/Anesthetic Gas Delivery
Infusion Pumps
Blood Sampling & Testing
Dialysis
BBB Specific Systems
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4. Material Composition and Characteristics
Bio-compatibility
Efficacy of Prototyping
Scalable to Volume Manufacturing
Stable, Long Term Sourcing
Cost to Design and Manufacture
Ease of Use
Product Evolution
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5. Material Components
– Synthesized glass drawn to targeted specifications
– Typically has a protective coating
– Coating can be designed to add functionality
Glass Composition
– Silicon dioxide (SiO2)
– SiCl4 + 2H2 + O2 → SiO2+ 4HCl
– Purest of all glasses
– Low metal ion Content
• Na, K, B, Fe, Cu, Mg….
• Corrosion free
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6. Mechanically
– High tensile strength (nominally >700kspi)
– Flexible with good memory
– Extremely smooth internal surface
– Dimensional tolerances are small
– Easy to cleave or cut
Biocompatibility
–
–
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NAMSA
ISO 10993

7. Broad range of off-the-shelf products
– Over 70 standard items
• Immediate availability
Flexibility during design cycle
– Rapid prototyping
– Custom sizes built to request
– Short lead times
– Zero to minimal NRE
– Raw Materials are stock items
– On site glass fab & prep
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8. Efficient Scalability
– Final materials/specs at design stage
– Draw process designed for high volume production
– Cutting, cleaving, packaging automation
– Minimal tooling investment
Proven Performance
–
Biocompatibility
–
Evidentiary data published
–
Approved devices in use
–
Emerging devices pending
approval
Picture courtesy of TherOx
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9. Regulatory Requirements
– ISO 13485
– FDA registered
– CGMP compliant
Manufacturing
– Batch to batch repeatability
– Non-perishable tooling
– State of the art process monitoring
– Packaging & Sterilization
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10. Materials
– Metal - 304 SST - Hypodermic 33Ga
– Polymer – Extruded PEEK 100µm ID
– Fused Silica Capillary – 100µm ID
Categories
– Mechanical
• Strength, Tolerances, Surface Finish &
Inertness
– Environmental
• Corrosion, UV Exposure, Moisture & Shelf Life
– Price
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11. Key Attributes
Highest Strength
– Strength (kpsi)
– Accuracy & Precision
– Surface Finish
– ID Inertness
800
600
400
200
0
Tensile Strength (kspi)
304 SST
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PEEK
Fused Silica

12. Key Attributes
– Strength (kpsi)
Tightest
Tolerances
– Accuracy & Precision
• Tolerances (µm)
– Surface Finish
• Roughness Average (nm)
– ID Inertness
Smoothest
ID Surface
30
25
20
15
10
5
0
ID Tolerance
(µm)
304 SST
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PEEK
Surface Finish
(nm)
Fused Silica

13. Overcoming Blood
Brain Barrier
Challenges
– Real-time Imaging and
Quantification of Brain
Delivery of Liposomes
• M.T. Krauze, J.
Forsayeth,J.W. Park, &
S.Bankiewicz, Pharmaceutical
Research, Vol. 23, No. 11
Nov 2006
– rAAV Activity Retention
• Molecular Therapy vol. 18
No.4 April 2010 p 670
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14. Key Attributes
– Corrosion
– UV Resistance
– Moisture Impact
– Shelf Life
Corrosion
304 SST
PEEK
Fused Silica
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UV
Resistance
Moisture
Impact
Shelf
Life

15. Key Attributes
– Prototyping
– NRE’s and CapEx
– Production Level
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16. Glass
Fabrication
Draw
Towers
Medical Assemblies
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Coatings &
Jackets
Advanced Metrology
Laser Fusing &
Machining
Cleaving &
Precision Polishing
Packaged & Sterilized

17. Supports a wide variety of
medical value added
assemblies
Custom design connectors
for rugged and disposable
solutions
Offers data, power, video
- custom fiber solutions
High density interfaces
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Molex Confidential