Introduction to Catheter Based Devices

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Introduction to Catheter Based Devices

• Presented by
• Indaka (Indi) Gunasekara
• Director of Catheter Development
• MedVenture Technology Corp.
• Louisville, KY

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Introduction to Catheter Based Devices

• Brief History
• Catheter Types Applications
• Catheterization Techniques
• Catheter Materials
• Catheter Construction
• Regulatory Compliance

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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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Catheter Construction

• Tipping
• Radiused Tip
• Glass Tube / Two Part Cutting Dies
• Tappered Tip
• Fenestrations (Holes)
• Drilled (hollow drilling tube with knife edge)
• Laser Cut

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Catheter Construction

• Coatings
• Hydrophilic
• Lubricious
• Anti-thrombogenic
• Antibiotic
• Anti-coagulant (Pyralene)
• Anti-fungal (Ag-N3)
• Liquid Silicone
• Drug-eluting Stents (anti-neoplasty)

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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

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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

• 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)

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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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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

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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