Joe Macomber
Feb 11, 2014

1
Tubing in Medical Applications

Fused Silica Capillary Tubing
Design Advantages
Material Comparisons
Summary Remarks – Q&A...
Fluid Delivery & Aspiration Systems

Drug Delivery and Control
Catheters
Oxygen/Anesthetic Gas Delivery
Infusion Pumps
Blo...
Material Composition and Characteristics
Bio-compatibility
Efficacy of Prototyping
Scalable to Volume Manufacturing
Stable...
Material Components
– Synthesized glass drawn to targeted specifications

– Typically has a protective coating
– Coating c...
Mechanically
– High tensile strength (nominally >700kspi)

– Flexible with good memory
– Extremely smooth internal surface...
Broad range of off-the-shelf products
– Over 70 standard items
• Immediate availability

Flexibility during design cycle
–...
Efficient Scalability
– Final materials/specs at design stage

– Draw process designed for high volume production
– Cuttin...
Regulatory Requirements
– ISO 13485

– FDA registered
– CGMP compliant

Manufacturing
– Batch to batch repeatability
– Non...
Materials
– Metal - 304 SST - Hypodermic 33Ga

– Polymer – Extruded PEEK 100µm ID
– Fused Silica Capillary – 100µm ID

Cat...
Key Attributes

Highest Strength

– Strength (kpsi)

– Accuracy & Precision
– Surface Finish

– ID Inertness

800
600

400...
Key Attributes
– Strength (kpsi)
Tightest
Tolerances

– Accuracy & Precision
• Tolerances (µm)

– Surface Finish
• Roughne...
Overcoming Blood
Brain Barrier
Challenges
– Real-time Imaging and
Quantification of Brain
Delivery of Liposomes
• M.T. Kra...
Key Attributes
– Corrosion
– UV Resistance
– Moisture Impact

– Shelf Life
Corrosion

304 SST
PEEK
Fused Silica

14

UV
Re...
Key Attributes
– Prototyping

– NRE’s and CapEx
– Production Level

15
Glass
Fabrication

Draw
Towers

Medical Assemblies

16

Coatings &
Jackets

Advanced Metrology

Laser Fusing &
Machining

...
Supports a wide variety of
medical value added
assemblies
Custom design connectors
for rugged and disposable
solutions

Of...
18
19

Molex Confidential
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Advantages of pure fused silica capillary tubing in medical applications

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

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Advantages of pure fused silica capillary tubing in medical applications

  1. 1. Joe Macomber Feb 11, 2014 1
  2. 2. Tubing in Medical Applications Fused Silica Capillary Tubing Design Advantages Material Comparisons Summary Remarks – Q&A 2
  3. 3. Fluid Delivery & Aspiration Systems Drug Delivery and Control Catheters Oxygen/Anesthetic Gas Delivery Infusion Pumps Blood Sampling & Testing Dialysis BBB Specific Systems 3
  4. 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 4
  5. 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 5
  6. 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 – – 6 NAMSA ISO 10993
  7. 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 7
  8. 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 8
  9. 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 9
  10. 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 10
  11. 11. Key Attributes Highest Strength – Strength (kpsi) – Accuracy & Precision – Surface Finish – ID Inertness 800 600 400 200 0 Tensile Strength (kspi) 304 SST 11 PEEK Fused Silica
  12. 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 12 PEEK Surface Finish (nm) Fused Silica
  13. 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 13
  14. 14. Key Attributes – Corrosion – UV Resistance – Moisture Impact – Shelf Life Corrosion 304 SST PEEK Fused Silica 14 UV Resistance Moisture Impact Shelf Life
  15. 15. Key Attributes – Prototyping – NRE’s and CapEx – Production Level 15
  16. 16. Glass Fabrication Draw Towers Medical Assemblies 16 Coatings & Jackets Advanced Metrology Laser Fusing & Machining Cleaving & Precision Polishing Packaged & Sterilized
  17. 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 17
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  19. 19. 19 Molex Confidential

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