Dyneema Purity® fiber is a medical grade fiber made from ultra high molecular weight polyethylene. It is the strongest fiber available for medical use. The document discusses the properties of Dyneema Purity® fiber that make it suitable for applications such as sutures and ligament repair, including its high strength, flexibility, durability, and biocompatibility. Over 10 million patients have had medical devices implanted using Dyneema Purity® fiber due to its unique combination of properties.

1. Dyneema Purity® fiber
World strongest medical grade fiber used in
millions of patients today!

2. DSM Company profile
• Active worldwide in performance materials & life sciences
• Among global leader in approximately 75% of businesses
• History of 100+ years. Highly ranked in Dow Jones Sustainability Index
• Focus on growth by means of innovation
DSM key data
Sales ~ Euro 8200 mln
EBIT ~ Euro 750 mln
Workforce ~ 22000 (9% R&D)
Material research > 300 people
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3. Examples of business areas
Food Electronics
Biomedical materials
Pharmaceutics Constructions
Anti-infectives Automotive
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4. Dyneema Purity® fiber for medical use
CASE: Rotator cuff repair
Strong, thin and pliable sutures play an
important role in rotator cuff repair1:
Minimizes suture breakage during tightening
Reduces need for additional procedures
Reduces patient discomfort
Switch to Dyneema Purity® fiber
High strength sutures made with Dyneema Purity®
have become the new ‘golden’ standard within 4
years.
1Oper Tech Sports Med 12:210-214 (2004)
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5. Dyneema Purity® fiber for medical use
CASE: ACL repair
Fixation of ligament replacement in knee
Endoscopic, minimally invasive procedure
Reduces patient discomfort and costs
Strength and compliance essential
Switch to Dyneema Purity® fiber
Various constructions of Dyneema Purity®
are used today to secure the soft tissue
transplant, providing strength and
stiffness.
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6. Orthopedic segments
High strength sutures
ACL repair
Laminar wiring fusion (spine)
Non fusion (spine)
Scoliosis (spine)
ACL replacement
Cerclage cables (trauma)
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7. Cardiovascular segments
Stent grafts
Catheters
CV Sutures
Heart valves
Stimulation leads
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8. The basics
• Dyneema Purity® fiber is made from Ultra High
Molecular Weight Polyethylene (UHMWPE), with
a very high purity, dedicated for medical
applications
Normal Polyethylene, low orientation, low
molecular weight, crystalinity < 60%
Dyneema Purity® fiber, very high molecular
orientation and weigth, crystalinity
approximately 95%
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9. High
Soft as silk pliability Hydrophobic
Extremely Low melting
strong point (~150°C)
Cut and tear High fatigue
resistance resistance
Creeps under High chemical
constant load resistance
High abrasion
Low coefficient resistance
of friction
Low density
Electrical
insulator
Biocompatible; Low
low irritation rate elongation
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10. Benchmarking strength - I
N/tex
4
Dyneema Purity® fiber At similar weight,
N/tex Dyneema Purity® fiber
is about 15x stronger
Tenacity based on weight
than steel.
3
Aramids At similar volume,
Aramids
Dyneema Purity® fiber
2 is about 4x stronger
Carbon
Carbon than titanium
Ceramic
Ceramic Boron
1 PP PET
Nylon ePTFE At similar volume,
Dyneema Purity® fiber
Nylon Steel
is about 3x stronger
Steel than polyester
Titanium
11 22 33 44
Tenacity based on volume GPa
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11. Benchmarking strength - II
Benchmark with other fiber
materials commonly used in
medical devices shows the
unique stress-strain behavior
of Dyneema Purity® fiber.
Dyneema Purity® fiber
Polyester (PET) fiber
Nylon
Polypropylene (PP)
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12. Benchmarking size
Profile reduction at same strength
Two constructions with similar strength,
23x magnification (SEM micrograph)
USP#2 suture made
with Dyneema Purity®
fiber
USP#5 Ethibond Excel™
polyester suture
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13. Benchmarking fatigue resistance
Tension fatigue testing at similar relative loading
Test setup
Hydraulic machine
Data filed at DSM 0.3Hz cyclic loads
Conclusion
Dyneema® fibers will not easily
break or lose their strength when
subjected to cyclic or fluctuating
loads.
Analyzed in a tensile test set-up with a frequency of 2 Hz
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14. Conformity
Dyneema® filament stretched
over the edge of a razorblade (SEM)
• Polyethylene cables conform to
bone surfaces. Metal cables
have a narrow contact surface
and hence show high focal
loads. Focal loads can cause
cables to cut through bone2.
• Polyethylene cables flatten
when placed under tension.
This property may make the use
more desirable for soft,
osteoporotic or cartilaginous
bone (i.e. in elderly or young
children)2.
2
From SPINE, Volume 22, Nr. 6, pp. 596-604, 1997:
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15. Abrasion resistance - I
Abrasion resistance of suture
Test set-up:
70000
60000
50000
# Cycles-to-break
40000
30000
Test details: 20000
– Dyneema Purity® UG vs. polyester;
– USP#2 sutures with core-sheath construction; 10000
– Hard steel pins with 0.9mm;
– Sutures tensioned at 2% of their MBL (max. breaking 0
load); UG Polyester
– Frequency: 114 cycles/min.
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16. Coefficient of friction
Coefficient of friction - ASTM D3108 yarn on metal
Standard Test Method for Coefficient of Friction
Yarn to Solid Material, load 22.2 mN/tex
0,35
Coefficient of friction
0,30 Data filed at DSM dry
0,25 wet
0,20
0,15
0,10
0,05
0
Dyneema Aramid Polyester Polyamide PTFE
Purity® SGX fiber
• Low coefficient of friction contributes to ‘soft touch’, silky feeling.
• Because of its low coefficient of friction, products made with Dyneema Purity®
fibers slide more easily through tissue.
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17. Stopping power
• Dyneema Purity® fiber has a very low elongation:
– Elongation at break typically is around 3-4% whereas elongation of PET
typically is around 15-20%.
– Dyneema Purity® fiber is used in medical applications for its stopping power
needed to prevent dimensions or structures go beyond a pre-specified range.
– Modulus of Dyneema Purity® fiber is 130N/tex or 126GPa
• Low elongation can be used to improve tactile
feedback for surgeon or patient.
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18. ISO10993
Master File on Dyneema Purity® x: applicable biological tests
fibers available at FDA o: optional biological tests
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19. Chemical resistance
Chemical Conditions Tensile
strength
Conc. [%] Temp. Exp. time retention
[ºC] [hr]
Inorganic acids
HCl 10 20 5000 90-100 %
HNO3 10 20 5000
H2SO4 0.24 60 168
Ultra High Molecular Weight Polyethylene
Organic acids
CH3COOH 100 20 5000 90-100 %
95% crystalline
Bases No chemical groups
Ca(OH)2 0.25 60 168 90-100 %
Hydrophobic (Surface tension 27 mN/m)
NaOH 10 20 5000
Organic solvents
Very resistant against chemicals
Ethanol 100 20 5000 90-100 %
Acetone 100 20 5000
Trichloromethane 100 20 5000
Others
Distilled water 100 20 5000 90-100 %
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20. Sterilization
Preferred sterilization method for Dyneema Purity® fiber is EtO:
EtO and steam sterilization hardly affects the mechanical strength.
Steam should be avoided because Dyneema Purity® fiber is sensitive to too high temperatures.
Gamma- and e-beam sterilization significantly reduce the mechanical strength due to chain scission.
Sterilization-induced oxidation might be partly prevented by sterilizing in N2.
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21. Today, more than 10.000.000 patients have medical
devices with Dyneema Purity® fiber in their body.
How can Dyneema Purity® fiber
enable you in your next generation
device design?
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22. Thank you!
www.dyneemapurity.com
Dyneema® and Dyneema Purity® are registered trademarks of Royal DSM N.V.
All information supplied by or on behalf of DSM Dyneema LLC and/or DSM Dyneema BV (“DSM”) in relation to its products, the
characteristics and properties of its products and their possible application, whether in the nature of data, recommendations or
otherwise, is supported by research and/or experience and believed reliable, but DSM gives no warranties of any kind, expressed or
implied, including, but not limited to, those of correctness, completeness, merchantability or fitness for a particular purpose and DSM
assumes no liability whatsoever in respect of application, processing, use of, or reliance on, the aforementioned information or products,
or any consequence thereof, including but not limited to any infringement of the rights owned or controlled by a third party regarding
intellectual, industrial or other property. Any information provided by DSM does not release the user from the obligation to verify such
information and to perform its own testing and analysis to determine the suitability of the products for the intended process, use or
specific application. The user accepts all liability in respect of or resulting from the application, processing, use of, or reliance on, the
aforementioned information or products or any consequences thereof.
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