introduction to catheter based devices presented by: indaka (indi) gunasekara director of catheter...
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![Page 1: Introduction to Catheter Based Devices Presented by: Indaka (Indi) Gunasekara Director of Catheter Development MedVenture Technology Corp. Louisville,](https://reader031.vdocuments.net/reader031/viewer/2022013112/56649d5f5503460f94a3fcd0/html5/thumbnails/1.jpg)
Introduction to Catheter Based Devices
Presented by:
Indaka (Indi) GunasekaraDirector of Catheter Development
MedVenture Technology Corp.
Louisville, KY
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Brief History
Catheter Types & Applications
Catheterization Techniques
Catheter Materials
Catheter Construction
Regulatory Compliance
Introduction to Catheter Based Devices
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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.
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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.
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Melvin P. Judkins M.D. (1922-1985)
A pioneer Radiologist whos techniques are still used today in Angiography
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Dr Andreas Gruentzig (1935 – 1985)
German Physician who convinced the medical community of the safety/efficacy of PTCA by performing the procedure on himself.
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Dr. Thomas Forgarty
Inventor of the Forgarty Thrombolectomy Balloon Catheter.
Recipent of more than 60 U.S. Patents for his inventions.
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Catheter Types and Applications
Diagnostic Catheters – Angiography – Electophysiology – ivus (Intravenious Ultrasound)
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Catheter Types and Applications(continued)
Therapeutic Catheters – PTCA (Percutanious Transluminal Angioplasty)– Distal Protection Devices– Dialysis– Drainage – Drug and Stent Delivery– RF Ablation
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Catheterization Techniques
Vascular / Coronary Insertion Techniques – Transfemoral Approach – Brachial (Arm) Approach
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Catheterization Techniques
Neurological Insertion Techiniques (Intrathecal Space) – Lumbar Approach– Ventricular Approach with Tunneling
Other Non-Vascular Insertion Techniques– Endoscopic Assisted Placement
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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.
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Catheter Construction(Equipment)
Extrusion Line
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Catheter Construction(Equipment)
Extruder
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Catheter Construction(Equipment)
Vacuum Tank (Sizing)
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Catheter Construction(Equipment)
Laser OD Gauge (Feedback Loop to Puller)
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Catheter Construction(Equipment)
Puller (Sizing)
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Catheter Construction(Equipment)
Steeger Braider
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Catheter Construction(Equipment)
Custom Braider
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Catheter Construction(Equipment)
Insert Molding Machine
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Catheter Construction
Lumens (Longitudinal Passages)– Single Lumen– Multi-Lumen
Segmented Catheter (Multi-Durometer)– Tip (Distal)– Body– Hub (Proximal)
Reinforced Wall Sections– Braided vs. Coiled
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Tipping:– Radiused Tip
• Glass Tube / Two Part Cutting Dies– Tappered Tip
Fenestrations (Holes):– Drilled (hollow drilling tube with knife edge)– Laser Cut
Catheter Construction
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Coatings:– Hydrophilic – Lubricious– Anti-thrombogenic– Antibiotic– Anti-coagulant (Pyralene)
– Anti-fungal (Ag-N3)
– Liquid Silicone– Drug-eluting Stents (anti-neoplasty)
Catheter Construction
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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
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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
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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
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Catheter Examples(continued)
Parodi System
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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
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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)
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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.
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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
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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)
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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
Current Trends in Catheter Technology
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This completes my presentation.
Thank you for your interest and cooperation.
Indaka (Indi) Gunasekara
Director of Catheter Development
MedVenture Technology Corp.
Louisville, KY
Introduction to Catheter Based Devices