Background: AISI 316L stainless steel wire cerclage routinely used in sternotomy closure causes lateral cut-through damage and fracture, especially in cases of high-risk patients, which leads to post-operative complications. A biocompatible elastomer (Pellethane®) coating on the standard wire is proposed to mitigate the cut-through effect.
Methods: Simplified peri-sternal and trans-sternal, sternum-cerclage contact models are created and statically analyzed in a finite element (FE) software to characterize the stress-reduction effect of the polymer coating for thicknesses between 0.5 to 1.125 mm. The performance of the polymer-coated cerclage in alleviating the detrimental cortical stresses is also compared to the standard steel cerclage in a full sternal closure FE model for the extreme cough loading scenario.
Results: It was observed via the simplified contact simulations that the cortical stresses can be substantially decreased by increasing the coating thickness. The full closure coughing simulation on the human sternum further corroborated the simplified contact results. The stress reduction effect was found to be more prominent in the trans-sternal contacts in comparison to peri-sternal contacts.
Conclusions: Bearing in mind the promising numerical simulation results, it is put forth that a standard steel wire coated with Pellethane® will majorly address the cut-through complication.
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