Suture and Fiber Material Selections

for Cardiovascular Device Components

Ed Boarini, Sr. Vice President of OEM Strategy and Business Development

Teleflex Medical OEM

Global Leader in Custom-Engineered Sutures,

Performance Fibers, Extrusions, and Catheters

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TFX OEM®

• Extrusions

• Diagnostic and Interventional

Catheters

• Sheath/Dilator Sets (Introducers)

and Kits

DEKNATEL®

• Sutures

• Performance Fibers

• Bioresorbable Yarns and Resins

Deknatel: A History of Fiber Expertise

• Founded by John Deknatel, a Dutch

immigrant, during the 1890s in Brooklyn, NY

• Remained a family business throughout the

first part of 20th century

1800’s

• Coventry, CT plant acquired 1950’s

• Deknatel expanded into medial devices

such as the Pleur Evac® System for chest

drainage

1960’s

Deknatel: A History of Fiber Expertise

• Deknatel purchased by Pfizer in 1975 1970’s

• Deknatel‟s NY operation relocated to Fall River, MA

1980’s

• During 1993, Pfizer spun off their suture business and Deknatel, Inc.

was established

• In 1995, Deknatel, Inc. merged with Snowden Pencer, which later

became part of Genzyme Biosurgery in 1996

1990’s

• Deknatel acquired by Teleflex, Inc.

• Mansfield, MA facility established during 2005 2000’s

Classification of Sutures and Components

Material Composition

• Natural

• Synthetic

Behavior in Tissue

• Absorbable

• Permanent

Physical Structure

• Monofilament

• Multifilament/Braid

Resin is Only the Beginning – Physical Structure

Resin

Monofilaments Multifilament

Assembled

into a Medical

Device or

component

Coreless Core

Monofilament Versus Multifilament

AD

VA

NTA

GE

S

DIS

AD

VA

NTA

GE

S

Monofilament

Less tissue drag

No capillary action

Has memory, wiriness

Knots more difficult,

requires more throws

Multifilament (Braided)

More pliable, flexible (better handling)

Better knot security

Less throws required

Has capillary action, braided

less than twisted

Rougher surface can cause

tissue drag (lubricity and coatings

make a difference)

Core Versus Coreless

Core

• Larger knot profile

• Requires more knot

throws

• Rounder shape

Coreless*

• Low knot profile

• Lies flat

• Better knot security

*Canadian Patent Application No. 2,509,871

Title: High-Strength Suture

Applicant: Teleflex Medical Incorporated

*US Patent No. 8,088,146

Title: High-Strength Suture

Applicant: Teleflex Medical Incorporated

Publication Date: April 26, 2012.

Selecting the Best Material for Your Application

Filament, Suture, or Construct

Absorbable Permanent

Performance Criteria

Strength Flexibility

Knot Security Size

Capillarity Surface

Characteristics

Absorbable Versus Permanent

Absorbable

• Bondek® Plus (PGA)

• PLLA

• PGLA, PLGA

• Monodek® (PDO)

Permanent

• Force Fiber ® (UHMWPE)

• Cottony® II (Polyester)

• Polydek ® and Tevdek®

(PTFE-coated Polyester)

• Deklene® II

(Polypropylene)

• Nylon

• Silk

Performance Characteristics Important

to Your Application

• Size

• Flexibility

• Surface Characteristic

• Capillarity

• Strength

• Knot Security

Performance Characteristics

Multifilament Size

DENIER or DEN

is a Unit of Measure

for the Linear Mass Density

of Fibers

It is defined as the mass in grams

per 9,000 meters.

(A 9,000-meter strand of silk weighs

about one gram.)

TEX or DTEX

is a Unit of Measure

for the Linear Mass

Density of Fibers

It is defined as the mass in grams per

1000 meters.

TEX is more likely to be used

in Canada and Continental Europe,

while DENIER remains more

common in the United States and

United Kingdom.

When measuring objects that consist

of multiple fibers the term "filament

tex" is sometimes used, referring to

the mass in grams per 1000 meters

of a single filament.

Performance Characteristics

Suture Sizing of Monofilaments and Multifilaments

USP Refers to Suture Sizes Defined by the United States

Pharmacopeia (U.S.P.)

Sutures range from #5 (heavy braided suture for orthopedics) to #11-0

(fine monofilament suture for ophthalmics).

Atraumatic needles are manufactured in all shapes for most sizes.

The actual diameter of braid for a given U.S.P. size differs depending

on the suture material class.

Profile of multifilaments, based on strength, will vary depending on materials.

Profile Reduction at Same Strength

Polypropylene PTFE Nylon Polyester Steel UHMWPE

Performance Characteristics

Flexibility

This performance characteristic is determined by the torsional

stiffness and diameter, which influences handling and feel.

Multifilament

• More pliable, flexible – better

handling

Monofilament

• Has memory

• Wiriness in handling

Performance Characteristics

Surface Characteristics

The surface of the suture influences the ease of pull through tissues

(friction or drag) and the amount of irritation.

• Monofilament versus multifilament

• Coatings

AD

VA

NTA

GE

S

DIS

AD

VA

NTA

GE

S

Monofilament

Less tissue drag

Knots more difficult,

requires more throws

Multifilament (Braided)

Better knot security

Less throws required

Rougher surface can cause

tissue drag (lubricity and coatings

make a difference)

• Lubricity of material

• Abrasion-resistance

Performance Characteristics

Capillarity

This is the process where fluids are carried into the interstices

of multifilament fibers. Coating can reduce the capillarity of some sutures.

Monofilament

• No capillary action

Multifilament

• Has capillary action

• Braided has less

capillary action than

twisted

• Coating can reduce

capillarity

Performance Characteristics

Strength

Absorbable

• Strength will degrade over time as it

resorbs in body

Permanent

• Strength remains stable over time

• Knot tensile strength is the force the braid can withstand before the

knot breaks.

• The degradation profile of absorbable filaments and the tensile

strength curve over that degradation

Performance Characteristics

Knot Security

Knot holding capability is the strength required to untie

or break a knot of the suture that forms the loop.

Monofilament

• Knots more difficult

• More throws required

Multifilament

• Better knot security

• Less throws required

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Selected Applications

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Selected Orthopedic Applications

Rotator Cuff Repair

• Procedure to fix a torn tendon in the shoulder

• Performed as either “open” or “closed” arthroscopic repair

• The rotator cuff helps to lift and rotate the arm and stabilize the ball of the shoulder within the joint

Glenoid Repair

• Glenoid: shoulder socket

• Glenoid labrum (fibrous ring that deepens the concavity of the shoulder socket) and surrounding ligaments can be torn when the arm is forced backwards. Failure to repair can lead to shoulder dislocation.

Important Properties for These Procedures

• Strong tensile strength

• Surface characteristic: lubricity – easy to glide through tissue

• Low knot profile – coreless design is ideal

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Selected Cardiovascular Applications

AAA / TAA repair

• Aortic aneurysm (a bulging, weakened area in the wall of the aorta) resulting

in abnormal widening greater than 50%

• Surgery is used to prevent rupture of the aneurysm. Grafts (such as those

made from PTFE) are also used here.

• Surgery can be “open” or minimally invasive (EVAR)

– Small incision in groin, stent graft inserted in femoral artery and

advanced up into the aorta to the site of the aneurysm.

Heart Valve Replacement

• Intervention or surgery to replace or repair diseased heart valves.

Important Properties for These Procedures

• Smallest size

• Surface characteristic: lubricity – easy to glide through tissue

• Low knot profile

• Strong tensile strength

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Force Fiber® is a Key Product

for These Applications

• Smooth surface and custom braid design allows for lubricious pass through

– Silky feel assures that tissue damage is minimized and surgeon‟s hand‟s are spared.

– Nothing has been “added” to the fibers to make them lubricious so FDA clearance for device is that much easier.

• Flatter design allows for lower knot profile and superior knot stability

– Less irritation for patient if knots below the surface have a lower profile.

– Once set, knots stay in place and maintain strength and stability for the long haul.

• Color options

– Co-Braids - color traces allow for quicker and easier suture identification as well as motion detection.

– Critical for complex multi-suture surgeries.

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Customized Solutions for Performance Fibers

• EXTENSIVE IN-HOUSE CAPABILITIES separate us

from the competition.

– Component braid/monofilament: Spooled, sterile, or NS

off the shelf items, set spool lengths

– Bulk suture: Spooled, NS off the shelf items, set spool lengths

– Cut lengths: Sterile or NS, some are standard, tipping available

– Devices/ finished goods Private label, sterile finished goods

– Assembly: Components from other sources assembled

and packaged

– Resins and fibers: PGA / PLLA / Polyesters

• Industry-leading, CUSTOMER-FOCUSED SERVICES

– Engineering and technical sales to support product development

– Project teams that act as a „second arm” to our customers‟ teams

– Regulatory support

– Sourcing options: we can manage customer identified/specified

components

– Sterilization: we can offer fully validated sterilization and

packaging scenarios

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In Summary: Basic Sutures, Filaments, and Structures

• Available in bulk or as finished sterile

product.

• Filaments can be processed as

components of customer‟s finished

devices, such as slings, meshes, and felts.

Wovens and knitted products are available

through strategic partnerships.

• Wide range of services available to our

customers including private labeling and

regulatory filings.

Sutures

• Absorbable

• Non-absorbable

• Coated and Uncoated

• Braided and Monofilament

Filaments

• Absorbable

• Non-absorbable

Configured Products

• Absorbable

• Non-Absorbable

• Needled

• Assemblies

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Visit www.teleflexmedicaloem.com

©2013 Teleflex Incorporated. All rights reserved. Deknatel, Force Fiber, Bondek Plus, Monodek,

Cottony, Polydek, Tevdek, and Deklene are registered trademarks of Teleflex Incorporated. This

presentation should not be reproduced in part or whole without the permission of Teleflex Incorporated.