Suture and Fiber Material Selections
for Cardiovascular Device Components
Ed Boarini, Sr. Vice President of OEM Strategy a...
Global Leader in Custom-Engineered Sutures,
Performance Fibers, Extrusions, and Catheters
2
TFX OEM®
• Extrusions
• Diagno...
Deknatel: A History of Fiber Expertise
• Founded by John Deknatel, a Dutch
immigrant, during the 1890s in Brooklyn, NY
• R...
Deknatel: A History of Fiber Expertise
• Deknatel purchased by Pfizer in 19751970’s
• Deknatel‟s NY operation relocated to...
Classification of Sutures and Components
Material Composition
• Natural
• Synthetic
Behavior in Tissue
• Absorbable
• Perm...
Resin is Only the Beginning – Physical Structure
Resin
Monofilaments Multifilament
Assembled
into a Medical
Device or
comp...
Monofilament Versus Multifilament
ADVANTAGESDISADVANTAGES Monofilament
Less tissue drag
No capillary action
Has memory, wi...
Core Versus Coreless
Core
• Larger knot profile
• Requires more knot
throws
• Rounder shape
Coreless*
• Low knot profile
•...
Selecting the Best Material for Your Application
Filament, Suture, or Construct
Absorbable Permanent
Performance Criteria
...
Absorbable Versus Permanent
Absorbable
• Bondek® Plus (PGA)
• PLLA
• PGLA, PLGA
• Monodek® (PDO)
Permanent
• Force Fiber ®...
Performance Characteristics Important
to Your Application
• Size
• Flexibility
• Surface
Characteristic
• Capillarity
• St...
Performance Characteristics
Multifilament Size
DENIER or DEN
is a Unit of Measure
for the Linear Mass Density
of Fibers
It...
Performance Characteristics
Suture Sizing of Monofilaments and Multifilaments
USP Refers to Suture Sizes Defined by the Un...
Performance Characteristics
Flexibility
This performance characteristic is determined by the torsional
stiffness and diame...
Performance Characteristics
Surface Characteristics
The surface of the suture influences the ease of pull through tissues
...
Performance Characteristics
Capillarity
This is the process where fluids are carried into the interstices
of multifilament...
Performance Characteristics
Strength
Absorbable
• Strength will degrade over time as it
resorbs in body
Permanent
• Streng...
Performance Characteristics
Knot Security
Knot holding capability is the strength required to untie
or break a knot of the...
19
Selected Applications
20
Selected Orthopedic Applications
Rotator Cuff Repair
• Procedure to fix a torn tendon in the shoulder
• Performed as ei...
21
Selected Cardiovascular Applications
AAA / TAA repair
• Aortic aneurysm (a bulging, weakened area in the wall of the ao...
22
Force Fiber® is a Key Product
for These Applications
• Smooth surface and custom braid design allows
for lubricious pas...
23
Customized Solutions for Performance Fibers
• EXTENSIVE IN-HOUSE CAPABILITIES separate us
from the competition.
– Compo...
24
In Summary: Basic Sutures, Filaments, and Structures
• Available in bulk or as finished sterile
product.
• Filaments ca...
25
Visit www.teleflexmedicaloem.com
©2013 Teleflex Incorporated. All rights reserved. Deknatel, Force Fiber, Bondek Plus, ...
Upcoming SlideShare
Loading in …5
×

Suture and Fiber Material Selections for Cardiovascular Device Components

1,534 views

Published on

Ed Boarini, Sr. Vice President Teleflex Medical OEM

Published in: Business, Lifestyle
0 Comments
1 Like
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total views
1,534
On SlideShare
0
From Embeds
0
Number of Embeds
1
Actions
Shares
0
Downloads
39
Comments
0
Likes
1
Embeds 0
No embeds

No notes for slide

Suture and Fiber Material Selections for Cardiovascular Device Components

  1. 1. Suture and Fiber Material Selections for Cardiovascular Device Components Ed Boarini, Sr. Vice President of OEM Strategy and Business Development Teleflex Medical OEM
  2. 2. Global Leader in Custom-Engineered Sutures, Performance Fibers, Extrusions, and Catheters 2 TFX OEM® • Extrusions • Diagnostic and Interventional Catheters • Sheath/Dilator Sets (Introducers) and Kits DEKNATEL® • Sutures • Performance Fibers • Bioresorbable Yarns and Resins
  3. 3. 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
  4. 4. Deknatel: A History of Fiber Expertise • Deknatel purchased by Pfizer in 19751970’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
  5. 5. Classification of Sutures and Components Material Composition • Natural • Synthetic Behavior in Tissue • Absorbable • Permanent Physical Structure • Monofilament • Multifilament/Braid
  6. 6. Resin is Only the Beginning – Physical Structure Resin Monofilaments Multifilament Assembled into a Medical Device or component Coreless Core
  7. 7. Monofilament Versus Multifilament ADVANTAGESDISADVANTAGES 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)
  8. 8. 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.
  9. 9. Selecting the Best Material for Your Application Filament, Suture, or Construct Absorbable Permanent Performance Criteria Strength Flexibility Knot Security Size Capillarity Surface Characteristics
  10. 10. 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
  11. 11. Performance Characteristics Important to Your Application • Size • Flexibility • Surface Characteristic • Capillarity • Strength • Knot Security
  12. 12. 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.
  13. 13. 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
  14. 14. 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
  15. 15. 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 ADVANTAGESDISADVANTAGES 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
  16. 16. 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
  17. 17. 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
  18. 18. 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
  19. 19. 19 Selected Applications
  20. 20. 20 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
  21. 21. 21 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
  22. 22. 22 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.
  23. 23. 23 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
  24. 24. 24 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
  25. 25. 25 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.

×