Introduction to Catheter Based Devices Presented by: Indaka (Indi) Gunasekara Director of Catheter Development MedVenture Technology Corp. Louisville, KY
Introduction to Catheter Based Devices • Brief History • Catheter Types & Applications • Catheterization Techniques • Catheter Materials • Catheter Construction • Regulatory Compliance
Charles T. Dotter M.D. (1920-1985) • Interventional Radiologist • Pioneer in the Field of Minimally Invasive Procedures (Catheterization) • Developed Continuous X-Ray Angio-Cardiography • Performed First Angioplasty (PTCA) Procedure in 1964.
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 performing the procedure on himself.
Dr. Thomas Forgarty • Inventor of the Forgarty Thrombolectomy Balloon Catheter. • Recipent of more than 60 U.S. Patents for his inventions.
Catheter Types and Applications • Diagnostic Catheters • Angiography • Electophysiology • ivus (Intravenious Ultrasound)
Catheter Types and Applications(continued) • Therapeutic Catheters • PTCA (Percutanious Transluminal Angioplasty) • Distal Protection Devices • Dialysis • Drainage • Drug and 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) • Reinforced Wall Sections • Braided vs. Coiled
Catheter Construction • 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 Examples • 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 expandable stent loaded
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 • 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)
Catheter Examples(continued) Parodi System
Regulatory IssuesFood and 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 and Special Controls • Peripheral devices (non-life threatening) • Examples: Forgarty thrombolectomy catheter • Class III - Devices subject to General Controls, Special Controls, and Premarket Clearance • Life sustaining and permanent implants • Examples: Coronary stents and pacemakers
Regulatory IssuesFood and Drug Admin. (FDA) • New Device Approval Processes: • PMA - Unique Device Without Precedence • Extensive and 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 IssuesInternational Organization for Standardization (ISO) • ISO is a network of the national standards institutes of 148 countries, on the basis of one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. • ISO standards are voluntary. As a non-governmental organization, ISO has no legal authority to enforce their implementation.
Regulatory IssuesInternational Organization for Standardization (ISO) • The ISO 9000 standards are primarily concerned with "quality management". • the customer's quality requirements • applicable regulatory requirements • enhance customer satisfaction • achieve continual improvement of its performance in pursuit of these objectives
Regulatory IssuesInternational Organization for Standardization (ISO) • The ISO 13485 is primarily concerned with “medical devices”. • Required for CE Mark • Design Dossier (Design Master/History File)
Current Trends in Catheter Technology • Valve Repair and replacement • Identification and treatment of Vulnerable Plaque • Stroke therapy (Ischemic and Hermoragic) • Anastomosis • Percutanious Bypass Grafts • Localized Drug delivery for Cancer Treatment • IMRI (Interoperative MRI) • Thrombolectomy • Drug-eluting Stents
Introduction to Catheter Based Devices This completes my presentation. Thank you for your interest and cooperation. Indaka (Indi) Gunasekara Director of Catheter Development MedVenture Technology Corp. Louisville, KY