Radiopaque Translucent Technology for Catheters · Catheter Overview ... –Stiff proximal end...

Radiopaque Translucent Technology for Catheters

Jason Eckel

Marketing Director

PolyOne Specialty Engineered Materials, North America

Introduction

Catheter Overview• Cardiovascular / Intravenous

A study in customer-centric innovation• VOC & relevant market drivers• Framing the opportunity• Key lessons in product development• The result: NEU View™

Agenda

About PolyOne

PolyOne (NYSE: POL) is a premier global provider of specialized polymer materials, services and solutions

• More than 80 manufacturing and distribution facilities

• Over a dozen labs and innovation centers

• Operations in Americas, Europe, Africa, and Asia

NEU provides innovative material technologies for in-vivo use:• Unique, proprietary formulations

• Small lot capability

• NEUSpeedSM Rapid Response service

• Healthcare-centric manufacturing

• Dedicated technical support and R&D personnel

CONFIDENTIAL PolyOne Corporation

What are Catheters?

Catheters are flexible tubes, inserted into bodily vessels for diagnostic or therapeutic purposes, including medication introduction and assistance in surgical operations

Major application areas include:

Cardiovascular

Intravenous

Urological

Neurovascular

Specialty

Angiography (Cardiac/Peripheral Vascular)

• Delivers contrast media visible for diagnostic procedures

PTCA (Percutaneous Transluminal Coronary Angioplasty)

• Compress plaque within coronary arteries

Ablation - Atherectomy

• Cuts and removes plaque build-up

Ablation - Electrophysiology

• Delivers radio waves to repair heart arrhythmia


Cardiovascular Catheter Types

• Used for the duration of a procedure: 30-120 minutes

• Sterilization technique: Gamma or Ethylene Oxide (EtO)

• Common polymers used:

–Main body/shaft: TPU, PEBA, PA11, PA12

–Shaft tip: TPU

–Balloons: PE, PEBA, TPU

• Desired properties:

–Stiff proximal end (practitioner handling)

–Soft distal end (patient comfort and safety)

–Highly visible under x-ray imaging


Cardiovascular Catheters – Key Features

• Central Venous (CVC)

–Placed into a large vein within the neck, chest, or groin

–Diagnostic: Blood (O2 saturation) & cardiovascular measurements

–Therapy: Administer medications & fluids

• Peripherally Inserted Central (PICC)

–Inserted into a vein in the arm, extended to the heart

–Therapy: Extended delivery of fluids (chemotherapy, antibiotics)

• Peripheral Cannula/IV (PVC or PIV)

–Inserted into an arm vein by a trocar-supported needle

–Connected to a hub for manual fluid administrations

–Therapy: Shorter-term administration of medications & fluids


Intravascular Catheters Types

• May be used for extended periods: 1-30 days

• Sterilization technique: Gamma or Ethylene Oxide (EtO)

• Common polymers used:

–Main body/shaft: TPU, Silicone, PVC

–Medical tubing/bags: SBC-based TPEs, PVC

–Hubs/Luer/Trocar: PC, copolyester, acrylic

• Desired properties:

–Biocompatibility & infection mitigating

–Flexible shafts for patient comfort & mobility

–High tensile strength and compression resistance

–Highly visible under x-ray imaging (CVC & PICC)


Intravascular Catheters – Key Features

Critical Performance Properties

Radiopacity

Torque/pushability

Kink resistance

Lubricity

Chemical resistance

To increase:

• stiffness

• torque

• ease of insertion

• burst pressure

Antimicrobial

Biocompatibility

Bondable / Weldable

Sterilizable

Wall strength


Catheter Formulation – Key Design Concepts

Select materials with high:

• flex modulus

• shear modulus

• elastic modulus

• yield stress

• UV Stabilizers

• Anti-oxidants

• Impact modifiers

• Anti-static agents

• Lubricants

• Fillers

• Reinforcements

• Anti-microbial

Silver

Non-silver

• Nanocomposite concentrates

• Glass beads

• Lubricity and grip modifiers

• Colorants and pigments

• Slip agents, lubricants

• Radiopacifiers

Barium sulfate

Bismuth salts

Tungsten

Gold


Additive Options

What are they?

Dense metal powders with high atomic numbers

Barium Sulfate, Bismuth, Tungsten, Tantalum

Added to polymer via melt compounding

Absorb/scatter x-rays (attenuation)

Why are they used?

Polymers are inherently transparent to x-ray

Radiopaque fillers allow surgeons to view devices using x-ray imaging or fluoroscopy (contrast)


Radiopaque (RO) Additives

Regulations increasingthe cost of innovation

Resistance to issuing new reimbursement codes

Growing concern of 510k “free-loading”

Focus on a device’s total ownership costs

R&D resources diverted to cost-out projects


Trends in Healthcare

• Medical professionals require catheters that are:

–Clearly visible during X-ray procedures (radiopaque)

–Translucent to the naked eye to detect air bubbles & fluid flow

• Current market options impose a compromise…

Radiopaque catheters that are highly visible under X-ray but not translucent

Striped radiopaque catheters with limited visibility under X-ray, less translucent, and costly to manufacture


Dilemma

• Offer catheter designers a breakthrough technology that maximizes the return of their R&D investment & enable marketplace differentiation

Clearly visible during fluoroscopic and other X-ray procedures (radiopaque)

Translucent to the naked eye so that air bubbles can be detected


Our Mission

1. Optimize dispersion process to maintain surface smoothness and physical properties

2. Ensure the technology is compatible with a wide array of polymer bases

3. Avoid sacrificing any visibility under X-ray


Product Development Challenge


Problem: The “average smoothness” value is not always indicative of actual “feel”

Solution: Set an upper specification limit to minimize outliers, and conduct testing on thin-wall tubes

Challenge #1 – Identify a Measurement System


Problem: Positive correlation between product translucency and system viscosity

Solution: Establish recommended processing guidelines to ensure processing and properties are maximized

Challenge #2 – Qualify Multiple Polymer Systems


NEU™ View

Radiopaque, not translucent

Radiopaque, striped

SkyScan1172 Micro CT – high-resolution micro computed tomography scanner

Comparison tests on samples of each material using Al gradient chip

Performed at the University of Akron National Polymer Innovation Center

Micro CTNational Polymer Innovation Center

Method and location

Samples compared

Al gradient chip

Challenge #3 – Confirm Radiopacity


The resulting shadow projection is analyzed via software to produce cross sectional and 3D volume images

Shadow Projection Reconstructed Cross Section 3D Volume

1.5mm

Challenge #4 – Maintain Radiopacity

Sample

Detector

Clay

Rotating Stage

X-ray source

NEU™ View Radiopaque, not translucent Radiopaque, striped

NEU™ View provides the radiopacity performance of traditional (non-translucent) catheters with superior translucency over catheters made with radiopaque-striped tubing


Results


What is NEU™ View?

• A patent-pending technology that enables the design and manufacture of high-value catheters featuring:

Visual confirmation of fluid flow

Detection of embolism-causing air bubbles

Increased manufacturing efficiencies

• ISO 10993 / USP VI tested, including cytotoxicity and hemolysis

• Compatible with a wide range medical grade polymers, additives, and colorants

For the Clinician: safety, performance, cost

Confirmation of catheter function

Improved patient comfort & retention

Decreased operating costs

For the Device OEM and supplier: sustainable product differentiation, cost

Increased device value

Decreased manufacturing costs


Benefits?

THANK YOU!


Q&A

PolyOne AsiaGuoshoujing Road No. 88

Z.J Hi-Tech Park, Pudong

Shanghai, 201203, China

+86 (0) 21 5080 1188

PolyOne Europe6 Giällewee

Fischbach, Luxembourg L-9749

+32 (0) 83 660 211

PolyOne North America33587 Walker Road

Avon Lake, Ohio 44012

United States

+1 440 930 1000

1 866 POLYONE

PolyOne South AmericaRua Bilac, 280 - Vila Conceicao, CEP:

Diadema, Sao Paulo, 09912-260 Brazil

+55 (11) 3576-2500

Radiopaque Translucent Technology for Catheters · Catheter Overview ... –Stiff proximal end...

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