Introduction to Catheter Based Devices Presented by: Indaka (Indi) Gunasekara Director of Catheter...

Introduction to Catheter Based Devices

Presented by:

Indaka (Indi) GunasekaraDirector 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

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

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

expandable stent loaded

Catheter Examples

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 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)

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

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