Introduction to Catheter Based Devices Presented by: Indaka (Indi) Gunasekara Di

Introduction to Catheter Based Devices Presented by: Indaka (Indi) Gunasekara Di www.phwiki.com

Introduction to Catheter Based Devices Presented by: Indaka (Indi) Gunasekara Di

Gersema, Emily, Gilbert Schools Reporter has reference to this Academic Journal, PHwiki organized this Journal Introduction to Catheter Based Devices Presented by: Indaka (Indi) Gunasekara Director of Catheter Development MedVenture Technology Corp. Louisville, KY Brief History Catheter Types & Applications Catheterization Techniques Catheter Materials Catheter Construction Regulatory Compliance Introduction to Catheter Based Devices Charles T. Dotter M.D. (1920-1985) Interventional Radiologist Pioneer in the Field of Minimally Invasive Procedures (Catheterization) Developed Continuous X-Ray Angio-Cardiography Per as long as med First Angioplasty (PTCA) Procedure in 1964.

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Trademark of Dr. Dotter “If a plumber can do it to pipes, we can do it to blood vessels.” Charles T. Dotter M.D. Melvin P. Judkins M.D. (1922-1985) A pioneer Radiologist whos techniques are still used today in Angiography Dr Andreas Gruentzig (1935 – 1985) German Physician who convinced the medical community of the safety/efficacy of PTCA by per as long as ming the procedure on himself.

Dr. Thomas Forgarty Inventor of the Forgarty Thrombolectomy Balloon Catheter. Recipent of more than 60 U.S. Patents as long as his inventions. Catheter Types in addition to Applications Diagnostic Catheters Angiography Electophysiology ivus (Intravenious Ultrasound) Catheter Types in addition to Applications (continued) Therapeutic Catheters PTCA (Percutanious Transluminal Angioplasty) Distal Protection Devices Dialysis Drainage Drug in addition to Stent Delivery RF Ablation

Catheterization Techniques Vascular / Coronary Insertion Techniques Transfemoral Approach Brachial (Arm) Approach Catheterization Techniques Neurological Insertion Techiniques (Intrathecal Space) Lumbar Approach Ventricular Approach with Tunneling Other Non-Vascular Insertion Techniques Endoscopic Assisted Placement Catheter Materials (Samples) Thermoplastics: Nylon, PET, Urethane, PE, PVC, PEEK, etc. Thermosets: Silicone, PTFE, Polyimide, etc. Composites / Filled: Liquid Crystal Polymers (LCP) Radiopaque Fillers (20 to 40%) Barium Sulfate, Bismuth Oxychloride, Tantulum, etc.

Catheter Construction (Equipment) Extrusion Line Catheter Construction (Equipment) Extruder Catheter Construction (Equipment) Vacuum Tank (Sizing)

Catheter Construction (Equipment) Laser OD Gauge (Feedback Loop to Puller) Catheter Construction (Equipment) Puller (Sizing) Catheter Construction (Equipment) Steeger Braider

Catheter Construction (Equipment) Custom Braider Catheter Construction (Equipment) Insert Molding Machine Catheter Construction Lumens (Longitudinal Passages) Single Lumen Multi-Lumen Segmented Catheter (Multi-Durometer) Tip (Distal) Body Hub (Proximal) Rein as long as ced Wall Sections Braided vs. Coiled

Tipping: Radiused Tip Glass Tube / Two Part Cutting Dies Tappered Tip Fenestrations (Holes): Drilled (hollow drilling tube with knife edge) Laser Cut Catheter Construction Coatings: Hydrophilic Lubricious Anti-thrombogenic Antibiotic Anti-coagulant (Pyralene) Anti-fungal (Ag-N3) Liquid Silicone Drug-eluting Stents (anti-neoplasty) Catheter Construction Foley Catheter Single lumen latex therapeutic drainage catheter Angioplasty Catheter(s) Coaxial nylon catheter with nylon ballon therapeutic PTCA catheter Rapid exchange catheter w/ a stainless steel balloon exp in addition to able stent loaded Catheter Examples

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Catheter Examples (continued) Lumbar Drainage Catheter Single lumen polyurethane catheter with an integrated nickel alloy flat wire coil (MRI compatible) Neurological Catheter Single lumen nylon drug/adhesive delivery catheter Catheter Examples (continued) Distal Protection Filter Laser drilled urethane membrane filter at end of Guidewire Parodi System PAEC (Parodi Anti Embolic Catheter) PAED ( Parodi Anti Embolic Dialator) PEB ( Parodi Embolic Balloon) PBRS (Parodi Blood Return System) Distal Protection Catheter Examples (continued) Parodi System

Regulatory Issues Food in addition to Drug Admin. (FDA) Device Classifications Class I – Devices subject to General Controls Simple with no blood contact Example: Wound dressings Class II – Devices subject to General Controls in addition to Special Controls Peripheral devices (non-life threatening) Examples: Forgarty thrombolectomy catheter Class III – Devices subject to General Controls, Special Controls, in addition to Premarket Clearance Life sustaining in addition to permanent implants Examples: Coronary stents in addition to pacemakers Regulatory Issues Food in addition to Drug Admin. (FDA) New Device Approval Processes: PMA – Unique Device Without Precedence Extensive in addition to lengthy approval process Clinical trials maybe required 510K – References Predicate Device(s) Minimal clinical data required to prove safety Shorter approval process (i.e. as little as 3 months) Regulatory Issues International Organization as long as St in addition to ardization (ISO) ISO is a network of the national st in addition to ards institutes of 148 countries, on the basis of one member per country, with a Central Secretariat in Geneva, Switzerl in addition to , that coordinates the system. ISO st in addition to ards are voluntary. As a non-governmental organization, ISO has no legal authority to en as long as ce their implementation.

This completes my presentation. Thank you as long as your interest in addition to cooperation. Indaka (Indi) Gunasekara Director of Catheter Development MedVenture Technology Corp. Louisville, KY Introduction to Catheter Based Devices

Gersema, Emily Gilbert Schools Reporter

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