Technology and Applications of Dyneema Purity® Fiber

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Copyright © DSM Dyneema

The Life Sciences and Materials Sciences Company

Cláudia Vaz

Can the world’s strongest medical grade fiber help you to designyour next device?

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Who is DSM?

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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 profileDSM Company profile

DSM key dataSales ~ Euro 8800 mlnEBIT ~ Euro 825 mlnWorkforce ~ 24000 (9% R&D)Material research > 300 people

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Examples of business areasExamples of business areas

AntiAnti--infectivesinfectives

FoodFood

PharmaceuticsPharmaceutics

ElectronicsElectronics

AutomotiveAutomotive

ConstructionsConstructionsBiomedical materialsBiomedical materials

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DSM biomedical material portfolioDSM biomedical material portfolio

DSM UHMWPE Fiber Dyneema Purity®

DSM UHMWPE Homopolymer MG003DSM Hydrophilic coatingsDSM Antimicrobial coatingsDSM Microspheres for local drug delivery

DSM-PTG BioSpan® segmented polyurethaneDSM-PTG Elasthane™ polyether urethaneDSM-PTG Bionate® polycarbonate urethaneDSM-PTG CarboSil® silicone-polycarbonate urethaneDSM-PTG PurSil® silicone polyether-urethaneDSM-PTG Tailor-made polymers

With the acquisition of Polymer Technology Group (PTG), DSMWith the acquisition of Polymer Technology Group (PTG), DSMcan present a broad portfolio of biomaterialscan present a broad portfolio of biomaterials

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What is Dyneema® andDyneema Purity® ?

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Dyneema PurityDyneema Purity®® on market since 2004on market since 2004

Strong, thin and pliable sutures play animportant role in Rotator Cuff repair1:

Minimizes suture breakage during tighteningReduces need for additional proceduresReduces patient discomfort

Switch to Dyneema Purity®

High strength sutures made with DyneemaPurity® have become the new ‘golden’ standardwithin 4 years.

1Oper Tech Sports Med 12:210-214 (2004)

CASE: Rotator cuff repairCASE: Rotator cuff repair

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CASE: ACL repairCASE: ACL repair

Switch to Dyneema Purity®

Various constructions of DyneemaPurity® are used today to secure thesoft tissue transplant, providingstrength and stiffness.

Fixation of ligament replacement in kneeEndoscopic, minimally invasive procedureReduces patient discomfort and costsStrength and compliance essential

Dyneema PurityDyneema Purity®® on market since 2004on market since 2004

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The basicsThe basics

• Dyneema Purity® is a fiber made from Ultra HighMolecular Weight Polyethylene (UHMWPE), with a veryhigh purity, dedicated for medical applications.

Normal Polyethylene, low orientation, lowmolecular weight, crystalinity < 60%

Dyneema Purity®, very high molecularorientation and weigth, crystalinityapproximately 95%

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How is Dyneema PurityHow is Dyneema Purity®® produced?produced?

suspensionUHMW-PE

continuous extrusion

metering pump

spinning oven

• Proprietary product and production processdeveloped by DSM Dyneema to obtain highestlevel of purity dedicated for medicalapplications

• Production of Dyneema Purity® isISO13485:2003 compliant

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DSM Dyneema in a nutshellDSM Dyneema in a nutshell……

• Large, global material supplier.• Global leadership position in UHMWPE fiber technology.• Producing the strongest medical grade fiber in the world (ISO13485).• Committed to develop new and innovative Dyneema Purity® grades.

• Providing to medical device companies:

• Multiple Dyneema Purity® grades in various sizes.• Knowhow on fiber properties. Dyneema Purity® FDA Masterfile.• Experience with development of fiber constructions.• Laboratory and technical assets for prototyping and testing.

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What are the mechanicalproperties?

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Dyneema PurityDyneema Purity®® typical propertiestypical properties

Extremelystrong

Soft as silk

High fatigueresistance

Low density

High abrasionresistance

Biocompatible; lowirritation rate

High chemicalresistance

Low meltingpoint (~150°C)

Creeps underconstant load

Cut and tearresistance

High pliability

Low coefficientof friction

Electricalinsulator

Hydrophobic

Lowelongation

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Benchmarking Dyneema PurityBenchmarking Dyneema Purity®® strengthstrengthN/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®

PPePTFE

At similar weight,Dyneema Purity® isabout 15x strongerthan steel.

At similar volume,Dyneema Purity® isabout 4x stronger thantitanium

At similar volume,Dyneema Purity® isabout 3x stronger thanpolyester

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Typical mechanical propertiesTypical mechanical propertiesDyneema PurityDyneema Purity®® SGX gradesSGX grades

3.5%1000 cN/dtex97 GPa

30 cN/dtex2.9 GPa

66 N15 pounds

172.2100220 dtex


31 cN/dtex3.0 GPa

50 N12 pounds

202.565165 dtex

Elongationat break

E-modulusTenacityat break

Loadat break

FilamentSGXGrades


32 cN/dtex3.1 Gpa

140 N30 pounds

172.2200440 dtex


33 cN/dtex3.2 GPa

36 N8 pounds

172.250110 dtex

3.5%1100 cN/dtex107 GPa

33 cN/dtex3.2 GPa

18 N4 pounds

172.22555 dtex

Size[ m]

Density[dtex]

Nr

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Typical mechanical propertiesTypical mechanical propertiesDyneema PurityDyneema Purity®® UG and TG gradesUG and TG grades

Elongationat break


Loadat break

FilamentUGGrades

3.2%1300 cN/dtex126 GPa

39 cN/dtex3.8 Gpa

172 N39 pounds

90.55800440 dtex

3.2%1300 cN/dtex126 GPa

40 cN/dtex3.9 GPa

66 N15 pounds

90.55300165 dtex

3.2%1300 cN/dtex126 GPa

41 cN/dtex4.0 GPa

45 N10 pounds

90.55200110 dtex

Size[ m]

Density[dtex]

Nr

Elongationat break


Loadat break

FilamentTGGrade(provisional)

3.4%1250 cN/dtex120 GPa

38 cN/dtex3.7 Gpa

10 N2 pounds

1212525 dtex

Size[ m]

Density[dtex]

Nr

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Benchmarking Dyneema PurityBenchmarking Dyneema Purity®® sizesize

USP#2 suture madewith Dyneema Purity®

USP#5 Ethibond Excel™polyester suture

Two constructions with similar strength,23x magnification (SEM micrograph)

Profile reduction at same strength

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Fatigue resistanceFatigue 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

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AbrasionAbrasion

• The number of cycles obtained in abrasion testing is very dependent on the set-up of the test.Results presented above show an example that Dyneema® fiber outperforms other syntheticfibers. If abrasion is relevant in an application design, it is recommended to perform test perapplication to determine the absolute cycles to failure in the specific case.

Test setupLife cycle small braids with similar breaking strength

1

10

100

1000

10000

0 1 2 3 4 5 6 7 Load [%MBL]

Cyc

le to

failu

re

Dyneema®

Nylon

Polyester (PET)Aramid- Cyclic movement- Frequency of 0.3Hz- Wet environment- 3mm diameter pin

Data filed at DSM

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ConformityConformity

• 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 theuse more desirable for soft,osteoporotic or cartilaginousbone (i.e. in elderly or youngchildren)2.

2 From SPINE, Volume 22, Nr. 6, pp. 596-604, 1997:

Dyneema® filament stretchedover the edge of a razorblade (SEM)

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Coefficient of frictionCoefficient 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

Aramid Polyester Polyamide PTFE

Coe

ffici

ent o

f fric

tion

dry

wet

• Low coefficient of friction contributes to ‘soft touch’ 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 powerStopping power

• Dyneema Purity® has a very low elongation:

• Elongation at break typically is around 3-4% whereas elongation of PETtypically is around 15-20%.

• Dyneema Purity® is used in medical applications for its stopping powerneeded to prevent dimensions or structures go beyond a pre-specifiedrange.

• Modulus of Dyneema Purity® is 130N/tex or 126GPa

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What about the chemicaland biological properties?

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ISO10993ISO10993 BiocompatibilityBiocompatibility testingtesting

Non-hemolytic by contact with human blood red cellsSlightly higher hemostasis activation (clotting time and TATcomplex formation) when compared w negative control (similarin terms of kinetic and intensity to polyester)

HemocompatibilityISO 10993 - 4

No sensitizing properties for polar and non-polar extracts(Guinea pig maximization test)

SensitizationISO 10993 - 10

No adverse effects. See slidesImplantationISO 10993 - 6

Non-mutagenic in the bacterial reverse mutation assay(Ames assay using Salmonella Typhimunium)

GenotoxicityISO 10993 – 3

Non-irritant/corrosive properties for polar and non-polarextracts (intradermal application in NZW rabbits)

IrritationISO 10993 - 10

Non-cytotoxic(L929 cells response after extraction @ 37 ºC/24 hrs)

CytotoxicityISO 10993 - 5

UnitTypical ValueProperty

ISO 10993 tests have been executed by various specialized, independent third party institutes. Reports available at DSM.

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ISO10993ISO10993 BiocompatibilityBiocompatibility testingtesting

Extended long term biological safety literature ofUHMWPE as used for decades in various kinds ofimplants

Systemic (acute) toxicitySub-acute/sub-chronic toxicityChronic toxicityISO 10993 - 11

No components can leach out that can causecarcinogenic response.UHMWPE is IARC classified under Group 3 (nonclassifiable as to carcinogenicity to human)Extended long term biological safety literature ofUHMWPE as used for decades in various kinds ofimplants

Carcinogenicity&Reproductive/DevelopmentaltoxicityISO 10993 – 3

UnitTypical ValueProperty

Non-pyrogenic(no substances were detected inducing a rise intemperature in rabbits after intravenous injection ofmaterial’s extract)

PyrogenicityUSP30 NF25

Concentration of leachables < 150 g/kg in both polar andnon-polar extracts

Leaching testISO 10993 - 12

ISO 10993 tests have been executed by various specialized, independent third party institutes. Reports available at DSM.

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Implantation ISO 10993Implantation ISO 10993 -- 66

Materials

Animal model: rattus norvegicus (304-372 g)

Time: 28 days

Braid: USP#2 suture (16*1*112 dtex)Polyester Fiber(Dacron®)

Braid: USP#2 suture (16*1*110 dtex)UHMWPE fiber(Dyneema Purity®)

Irritation Score3

Neo-vascularization

Colonization

EncapsulationInfiltrate / Inflammation

HistomorphometryHistology

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ImplantationImplantation testtest -- resultsresults

GT = [2x (inflammation score + encapsulation

score + necrosis score) + fibroplasia score +fibrosis score + fatty

infiltrate score]0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

polym

orphonu

clear

lymph

ocytes

plasm

a cell

s

macrop

hage

s

giant

cells

necro

sis

0.0

5.0

10.0

15.0

20.0

25.0

30.0

35.0

inflammation encapsulation GT regeneration

scor

e

PET

SGX

Polyester

Dyneema Purity®

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ImplantationImplantation testtest -- conclusionsconclusions

Multinucleated giant cells

Macrophage

Implant filament

Fibrocyte

Fibrocyte

Fibroconnective matrix

Vessel

Implant filament

Conclusions for braids made withDyneema Purity® SGX

-Milder presence giant cells andmacrophages

-Less inflammatory reaction

-Less irritant (Irritation score* -9compared to PET)

-Both implant materials present thesame level of encapsulation (~23m capsule)

-Similar level of formation offibro-connective tissue

* Irritation Score = GT (Dyneema Purity®) – GT (PET)

Braid madeof DyneemaPurity® SGX

Braid madeof polyester

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What can we conclude?

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• Dyneema Purity® provides extreme strength and many additional features• Dyneema Purity® brings new design options to medical device companies• Many patients in the world have devices with Dyneema Purity® implanted

• Produced conform ISO13485 by DSM, a large and global company• DSM offers extensive support program and prototyping facilities

mailto:[email protected]

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Questions?Suggestions?Ideas?www.dyneemapurity.com

[email protected]+ 31 61 250 6068

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Disclaimer• All information supplied by or on behalf of DSM Dyneema LLC and/or DSM Dyneema B.V. (“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, as contained in this presentation is supported by research and/or experience and believedto be reliable, but DSM gives no warranties of any kind, expressed or implied, including, but not limited to, those ofcorrectness, completeness, merchantability or fitness for a particular purpose and DSM assumes no liability whatsoever inrespect of application, processing, use of, or reliance on, the aforementioned information or products, or any consequencethereof, including but not limited to any infringement of the rights owned or controlled by a third party in intellectual, industrialor other property. Any information provided by DSM does not release the user from the obligation to verify such informationand 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 relianceon, the aforementioned information or products or any consequences thereof.

• Dyneema® and Dyneema Purity® are registered trademarks of Royal DSM N.V.

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Technology and Applications of Dyneema Purity® Fiber