Nylon lattice design parameter effects on additively manufactured structural performance.

Lattice structures are used in a multitude of applications from medical to aerospace, and their adoption in these applications has been further enabled by additive manufacturing. Lattice performance is governed by a multitude of variables and estimating this performance may be needed during various phases of the design and validation process. Numerical modeling and constitutive relationships are common methodologies to assess performance, address risks, lower costs, and accelerate time to market for innovative and potentially life altering products. These methods are usually accompanied by engineering rationales to justify the methods appropriateness. However, engineering analyses and numerical models should be validated using experimental data when possible to quantify the accuracy of their predictions under conditions relevant to their planned use. In this work, a set of lattice design parameters are evaluated using numerical modeling and experimental methods under quasi-static tensile, compressive, and shear modalities. Regular body centered cubic (BCC) and stochastic Voronoi Tessellation Method (VTM) lattices are constructed with three different cell lengths (2.5 mm, 4.0 mm, 5.0 mm) and various strut diameter thicknesses (ranging from 0.536 mm-1.3506 mm) while maintaining the lattice's relative density (0.2 and 0.3). Some strut diameters were selected to challenge the AM process limits. Specimens were fabricated in nylon 12 on a laser powder bed fusion system. Optical microscopy showed up to a 28.6% difference between as-designed and fabricated strut diameters. Simulated reaction loads revealed up to a 4.6% difference in BCC lattices within a constant relative density at a 1.4 mm displacement boundary condition while the VTM samples had up to a 19.5% difference. Errors between the experimental and simulated lattice reaction loads were as high as 97.0%. This error magnitude appears to strongly correlate with lattice strut diameter. These results showcase that a computational estimation, even one with reasonable assumptions, may erroneously characterize the performance of these lattice structures, and that these assumptions should be challenged by experimentally evaluating and validating critical quantities of interest.

Development of an in vitro test method to simulate intra-operative impaction loading on lumbar intervertebral body fusion devices.

Intervertebral body fusion devices (IBFDs) are commonly used in the treatment of various spinal pathologies. Intra-operative fractures of polyether-ether-ketone (PEEK) implants have been reported in the literature and to the FDA as device-related adverse events. The device and/or implant inserter failures typically occur during device impaction into the disc space and require implant removal and replacement. These additional steps may cause further complications along with increased surgical time and cost. Currently, there are no standardized test methods that evaluate clinically relevant impaction loading conditions on IBFDs. This study aims to develop an in vitro test method that would evaluate implant resistance to failure during intra-operative impaction. To achieve this, (1) surgical implantations of IBFDs were simulated in nine lumbar cadaver specimens by three different orthopedic spine surgeons (n = 3/surgeon). Impact force and mallet speed data were acquired for each surgeon. (2) Based on the acquired surgeon data, a benchtop mechanical test setup was developed to differentiate between two TLIF IBFD designs and two inserter designs (for a total of four IBFD-inserter combinations) under impaction loading. During implant insertion, impact force measurements indicated that lumbar IBFDs are subjected to high energy forces that may exceed their mechanical strength. Our test method successfully replicated clinically-relevant loading conditions and was effective at differentiating failure parameters between different implant and inserter instrument designs. The mechanical test method developed shows promise in its ability to assess impaction resistance of IBFD/inserter designs and evaluate potential risks of device failure during intraoperative loading.

Chronic softening spinal cord stimulation arrays.

OBJECTIVE: We sought to develop a cervical spinal cord stimulator for the rat that is durable, stable, and does not perturb the underlying spinal cord. APPROACH: We created a softening spinal cord stimulation (SCS) array made from shape memory polymer (SMP)-based flexible electronics. We developed a new photolithographic process to pattern high surface area titanium nitride (TiN) electrodes onto gold (Au) interconnects. The thiol-ene acrylate polymers are stiff at room temperature and soften following implantation into the body. Durability was measured by the duration the devices produced effective stimulation and by accelerated aging in vitro. Stability was measured by the threshold to provoke an electromyogram (EMG) muscle response and by measuring impedance using electrochemical impedance spectroscopy (EIS). In addition, spinal cord modulation of motor cortex potentials was measured. The spinal column and implanted arrays were imaged with MRI ex vivo, and histology for astrogliosis and immune reaction was performed. MAIN RESULTS: For durability, the design of the arrays was modified over three generations to create an array that demonstrated activity up to 29 weeks. SCS arrays showed no significant degradation over a simulated 29 week period of accelerated aging. For stability, the threshold for provoking an EMG rose in the first few weeks and then remained stable out to 16 weeks; the impedance showed a similar rise early with stability thereafter. Spinal cord stimulation strongly enhanced motor cortex potentials throughout. Upon explantation, device performance returned to pre-implant levels, indicating that biotic rather than abiotic processes were the cause of changing metrics. MRI and histology showed that softening SCS produced less tissue deformation than Parylene-C arrays. There was no significant astrogliosis or immune reaction to either type of array. SIGNIFICANCE: Softening SCS arrays meet the needs for research-grade devices in rats and could be developed into human devices in the future.