Published on February 22, 2014
Joe Macomber Feb 11, 2014 1
Tubing in Medical Applications Fused Silica Capillary Tubing Design Advantages Material Comparisons Summary Remarks – Q&A 2
Fluid Delivery & Aspiration Systems Drug Delivery and Control Catheters Oxygen/Anesthetic Gas Delivery Infusion Pumps Blood Sampling & Testing Dialysis BBB Specific Systems 3
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
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
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
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
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
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
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
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
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
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
Key Attributes – Corrosion – UV Resistance – Moisture Impact – Shelf Life Corrosion 304 SST PEEK Fused Silica 14 UV Resistance Moisture Impact Shelf Life
Key Attributes – Prototyping – NRE’s and CapEx – Production Level 15
Glass Fabrication Draw Towers Medical Assemblies 16 Coatings & Jackets Advanced Metrology Laser Fusing & Machining Cleaving & Precision Polishing Packaged & Sterilized
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
19 Molex Confidential
Calcification Inhibitors in CKD and Dialysis Patients
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