Download - Summary dyneema purity® 2011
Dyneema Purity® fiberWorld strongest medical grade fiber used inmillions of patients today!
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• 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 Company profile
DSM key dataSales ~ Euro 8200 mlnEBIT ~ Euro 750 mlnWorkforce ~ 22000 (9% R&D)Material research > 300 people
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Examples of business areas
Anti-infectives
Food
Pharmaceutics
Electronics
Automotive
Constructions
Biomedical materials
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Dyneema Purity® fiber for medical use
Strong, thin and pliable sutures play animportant role in rotator cuff repair1:
Minimizes suture breakage during tightening
Reduces need for additional proceduresReduces patient discomfort
Switch to Dyneema Purity® fiber
High strength sutures made with Dyneema Purity®
have become the new ‘golden’ standard within 4years.
1Oper Tech Sports Med 12:210-214 (2004)
CASE: Rotator cuff repair
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CASE: ACL repair
Switch to Dyneema Purity® fiber
Various constructions of Dyneema Purity®
are used today to secure the soft tissuetransplant, providing strength andstiffness.
Fixation of ligament replacement in kneeEndoscopic, minimally invasive procedureReduces patient discomfort and costs
Strength and compliance essential
Dyneema Purity® fiber for medical use
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Orthopedic segmentsHigh strength sutures
ACL repair
Laminar wiring fusion (spine)
Non fusion (spine)
Scoliosis (spine)
ACL replacement
Cerclage cables (trauma)
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Cardiovascular segments
Stent grafts
Catheters
CV Sutures
Heart valves
Stimulation leads
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The basics
• Dyneema Purity® fiber is made from Ultra HighMolecular Weight Polyethylene (UHMWPE), witha very high purity, dedicated for medicalapplications
Normal Polyethylene, low orientation, lowmolecular weight, crystalinity < 60%
Dyneema Purity® fiber, very high molecularorientation and weigth, crystalinityapproximately 95%
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Extremelystrong
Soft as silk
High fatigueresistance
Low density
High abrasionresistance
Biocompatible;low irritation rate
High chemicalresistance
Low meltingpoint (~150°C)
Creeps underconstant load
Cut and tearresistance
Highpliability
Low coefficientof friction
Electricalinsulator
Hydrophobic
Lowelongation
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Benchmarking strength - IN/tex
Tenacity based on volume1
1
2
2
3
3
4
4
Nylon
Titanium Steel
Aramids
Carbon
BoronCeramic
1
1
2
2
3
3
4
4
Nylon
PET
Steel
Aramids
Carbon
Ceramic
Tena
city
bas
ed o
n w
eigh
t
N/tex
GPa
Dyneema Purity® fiber
PPePTFE
At similar weight,Dyneema Purity® fiberis about 15x strongerthan steel.
At similar volume,Dyneema Purity® fiberis about 4x strongerthan titanium
At similar volume,Dyneema Purity® fiberis about 3x strongerthan polyester
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Benchmarking strength - II
Benchmark with other fibermaterials commonly used inmedical devices shows theunique stress-strain behaviorof Dyneema Purity® fiber.
Dyneema Purity® fiberPolyester (PET) fiberNylonPolypropylene (PP)
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Benchmarking size
USP#2 suture madewith Dyneema Purity®
fiber
USP#5 Ethibond Excel™polyester suture
Two constructions with similar strength,23x magnification (SEM micrograph)
Profile reduction at same strength
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Benchmarking fatigue resistance
Analyzed in a tensile test set-up with a frequency of 2 Hz
Conclusion
Dyneema® fibers will not easilybreak or lose their strength whensubjected to cyclic or fluctuatingloads.
Test setup
Hydraulic machine0.3Hz cyclic loadsData filed at DSM
Tension fatigue testing at similar relative loading
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Conformity
• Polyethylene cables conform tobone surfaces. Metal cableshave a narrow contact surfaceand hence show high focalloads. Focal loads can causecables to cut through bone2.
• Polyethylene cables flattenwhen placed under tension.This property may make the usemore desirable for soft,osteoporotic or cartilaginousbone (i.e. in elderly or youngchildren)2.
2From SPINE, Volume 22, Nr. 6, pp. 596-604, 1997:
Dyneema® filament stretchedover the edge of a razorblade (SEM)
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Abrasion resistance - IAbrasion resistance of sutureTest set-up:
Test details:– Dyneema Purity® UG vs. polyester;– USP#2 sutures with core-sheath construction;– Hard steel pins with 0.9mm;– Sutures tensioned at 2% of their MBL (max. breaking
load);– Frequency: 114 cycles/min.
0
10000
20000
30000
40000
50000
60000
70000
UG Polyester
# C
ycle
s-to
-bre
ak
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Coefficient of friction
Coefficient of friction - ASTM D3108 yarn on metalStandard Test Method for Coefficient of FrictionYarn to Solid Material, load 22.2 mN/tex
00,050,100,150,200,250,300,35
DyneemaPurity® SGX fiber
Aramid Polyester Polyamide PTFE
Coe
ffici
ent o
f fric
tion
dry
wet
• 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.
Data filed at DSM
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Stopping power• Dyneema Purity® fiber has a very low elongation:
– Elongation at break typically is around 3-4% whereas elongation of PETtypically is around 15-20%.
– Dyneema Purity® fiber is used in medical applications for its stopping powerneeded 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 tactilefeedback for surgeon or patient.
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ISO10993
x: applicable biological tests
o: optional biological testsMaster File on Dyneema Purity®fibers available at FDA
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Chemical resistance
Ultra High Molecular Weight Polyethylene
95% crystalline
No chemical groups
Hydrophobic (Surface tension 27 mN/m)
Very resistant against chemicals
90-100 %500020100Distilled water
Others
500020100Trichloromethane
500020100Acetone
90-100 %500020100Ethanol
Organic solvents
50002010NaOH
90-100 %168600.25Ca(OH)2
Bases
90-100 %500020100CH3COOH
Organic acids
168600.24H2SO4
50002010HNO3
90-100 %50002010HCl
Inorganic acids
Exp. time[hr]
Temp.[ºC]
Conc. [%]
Tensilestrengthretention
ConditionsChemical
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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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Today, more than 10.000.000 patients have medicaldevices with Dyneema Purity® fiber in their body.
How can Dyneema Purity® fiberenable you in your next generationdevice design?
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Thank you!
www.dyneemapurity.comDyneema® 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, thecharacteristics and properties of its products and their possible application, whether in the nature of data, recommendations orotherwise, is supported by research and/or experience and believed reliable, but DSM gives no warranties of any kind, expressed orimplied, including, but not limited to, those of correctness, completeness, merchantability or fitness for a particular purpose and DSMassumes 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 regardingintellectual, industrial or other property. Any information provided by DSM does not release the user from the obligation to verify suchinformation and to perform its own testing and analysis to determine the suitability of the products for the intended process, use orspecific application. The user accepts all liability in respect of or resulting from the application, processing, use of, or reliance on, theaforementioned information or products or any consequences thereof.