The Rheological Characterization of Materials for Biomedical Applications
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1 The Rheological Characterization of Materials for Biomedical Applications Stephen H. Spiegelberg Presented at the TA Instruments User Meeting Newport, RI 2006 Cambridge Polymer Group, Inc. Testing, Consultation, and Instrumentation for Polymeric Materials
2 History of Total Hip Replacement Charnley (1962) 258,000 THR in US (1994) Average cost: $51,000 Total: $13 billion in US alone 6 Major Orthopedic Manufacturers, hundreds of minor players
3 Structure of Total Hip Replacement
4 Cemented vs. Cementless Implants >50% of THR use cemented stems Used primarily in older patients
5 Composition of Bone Cement 97% MMA 2.6% NN-dimethyl-p-toluidine 75 ppm hydroquinone 89% PMMA/ co-ps 10% Barium sulphate 1% Benzoyl peroxide
6 Kinetics of Reaction Free radical polymerization disassociation initiation propagation termination k d I 2R R + M RM k RM + M RM n i RM + RM RM k p n+ 1 n m m+ n k t
7 Bone Cement Barium sulfate Pre-polymerized PMMA bead
8 Cement injection
9 Porosity in Cement Pores are introduced during mixing mm diameter Fatigue and compressive strength decreases with increased pore density 1, 2 Cracks initiate from pores James et al, J. Biomedical Mater. Res., 26, (1992) 1. Smeds et al, CORR, 334, (1997) 2. Lewis, J. Biomedical Mater Res, 48, (1999)
10 Porosity Reduction Vacuum mixing 1 Centrifugation mixing hand-mixed vacuum-mixed log (fatigue cycles to failure) Stress amplitude [MPa] 1. Lewis, J. Biomedical Mater Res., 53, (2000); 2: Jasty et al, CORR, 259, (1990)
11 Interfacial Porosity Asceptic loosening necessitates revision surgery in 1-12% of THR Retrieved components indicated that debonding at the cement-stem interface initiates failure of fixation 1 No dependence on surface finish, centrifugation, or alloy 2 1. Jasty et al, Br. J. Bone Joint Surg, 73-B, 551 (1991); 2. James et al, J. Biomedical Mater Res., 27, (1993)
12 Theory of Interfacial Porosity: #1 Volumetric shrinkage of bone cement during polymerization causes pore formation at cementstem interface1 Heating stem during insertion reduces interfacial porosity2 Stem heated to 23C prior to insertion Stem heated to 44C prior to insertion 1. Gilbert et al, J. Biomedical Mater Res., 52, (2000); 2. Bishop et al, JBJS, 78B, (1996).
13 Theory of Interfacial Porosity: #2 In-situ monitoring studies showed formation of pores during insertion of stem 1 Related to the rheological (flow) properties of the bone cement Relationship between the response time of the cement and the insertion rate of the femoral stem 1. James et al, J. Biomedical Mater Res., 27, (1993)
14 Hypothesis for Porosity Formation stem Vv interfacial pores cement Cement spreads on surface : relaxation time λ If stem insertion time scale f(v) << λ greater pore formation at interface
15 Experimental Program Two step program Characterize the rheological properties of the bone cement Perform stem insertion studies at different times during cure and insertion rates Quantify conditions that lead to extensive interfacial porosity
16 Experimental Program 1. Shear Rheometry Howmedica Simplex P TM Viscosity % shrinkage relaxation time, λ 2. Stem Insertion Mixing at 4 C for 1 minute, 23 C for 1 minute. Tests begin 4 minutes into cure. Interfacial porosity vs. cure time and insertion speed
17 Rheological Characterization Parallel plate controlled stress rheometer measure torque as a function of displacement Performed small amplitude oscillatory test as a function of time Measure complex viscosity, volumetric shrinkage, temperature rise oscillating plate Cement (1 mm gap) fixed plate
18 Cure Time G tanδ = G = loss modulus elastic modulus viscous liquid liquid tan δ tan (δ) 1 solid tan δ elastic solid Cure time: 264 seconds* *following 4 minutes of mixing/transfer time [s]
19 Transient Viscosity Dynamic Viscosity [Pa.s] ω=1 rad/sec Cement cured time [s] 1% strain, no temperature control
20 Volumetric Shrinkage cement 1 volume change, V/V [%] cement cured force transducer Haas (1975): 5% Gilbert (2000): 5.1% time [s]
21 Temperature Rise 38 Cure Temperature [ C] cement cured T(t) time [s]
22 Relaxation Time Characterizes response time of cement 1 λ = ω tan δ ( ω ) λ for water: sec λ for polymer: 1 sec λ for solid: sec relaxation time, λ [s] time [s]
23 Stem Insertion Studies 2 cm stem gap V Stem: PMMA Stem insertion, V: 1-5 cm/s Insertion time: seconds* Gap: 2.5 mm * following 4 min. of mixing and loading
24 Stem Insertion Studies Section and polish Light source Analyze pore distribution with NIH Image 1.57 CCD camera
25 Stem Insertion Studies Insertion Velocity: 5 cm/sec Time into cure: 24 sec* Time into cure: 204 sec* *Following 4 minutes of mixing and sample loading
26 Stem Insertion Studies Time into cure: 204 sec* Insertion rate: 1 cm/sec Insertion rate: 5 cm/sec *Following 4 minutes of mixing and sample loading
27 Cement-Stem Interfacial Porosity Pore diameter µm 60 porosity (#/mm 2 ] fast insertion rate time during cure [s] Start mixing cement slow insertion rate
28 Cement-Stem Interfacial Porosity 60 porosity (#/mm 2 ] late in cure early in cure insertion velocity [cm/s]
29 Cement-Stem Interfacial Porosity Combine 2 parameters into one universal parameter time during cure stem insertion velocity Deborah number, De response time of cement De = characteristic time of experiment λ = = λγ 1.. γ ( ) λ = relaxation time of cement (rheometry) = f(time during cure). γ = shear rate in gap between stem and bone = f(stem insertion rate)
30 Cement Stem Interfacial Porosity 6 stem insertion rate [cm/s] De: 13 De: 44 De: 59 De: 8 De: 21 De: 26 De: 3 De: 9 De: time during cure [s] cure time
31 Cement-Stem Interfacial Porosity r 2 = porosity [#/mm 2 ] slow speed/ short cure high speed/ long cure Deborah number, De = λγ.
32 How to use this information? Tell surgeons to slow down stem insertion rate, or to insert stems earlier See if there is anymore information that the rheological characterization can tell us
33 Frequency Dependence of Bone Cement howmedica simplex P T=23 C complex viscosity [Pa.s] w=1 rad/s w=3 rad/sec w=10 rad/sec time [sec]
34 Application of Rheology Oscillate the stem during cement insertion locally reduce the viscosity of the cement at stem interface Push into a lower De regime improved wetting of cement on stem fewer interfacial pores
35 Proof-of-Concept tests Stems inserted at same linear rate into cement filled cavity Left stem includes linear oscillation Cam joint
36 Does it work? Insertion rate: 1 cm/sec Same batch of cement 0.5 mm No oscillation Oscillating stem (100 rad/sec)
37 Prototype design US Patent 6,884,264 (2005)
38 Conclusions Shear rheometry a good technique to characterize the cure behavior of acrylic bone cement viscosity temperature rise cure time volumetric shrinkage relaxation time (response time of material) To be included in ASTM F451
39 Conclusions Interfacial porosity increases both with stem insertion speed and with time during cure Porosity scales well with Deborah number (relative rate of insertion vs. response time of cement). Results serve as an operating window for minimizing interfacial porosity Cambridge Polymer Group, Inc. Testing, Consultation, and Instrumentation for Polymeric Materials 52-R Roland St. Boston, MA
40 Acknowledgements G. Braithwaite G. McKinley
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