Removal Forces of a Helical Microwire Structure Electrode.

(1) Background: Medical devices, especially neuromodulation devices, are often explanted for a variety of reasons. The removal process imparts significant forces on these devices, which may result in device fracture and tissue trauma. We hypothesized that a device's form factor interfacing with tissue is a major driver of the force required to remove a device, and we isolated helical and linear electrode structures as a means to study atraumatic removal. (2) Methods: Ductile linear and helical microwire structure electrodes were fabricated from either Gold (Au) or Platinum-Iridium (Pt-Ir, 90-10). Removal forces were captured from synthetic gel models and following chronic implantation in rodent and porcine models. Devices were fully implanted in the animal models, requiring a small incision (<10 mm) and removal via tissue forceps. (3) Results: Helical devices were shown to result in significantly lower maximal removal forces in both synthetic gel and rodent studies compared to their linear counterparts. Chronically (1 yr.), the maximal removal force of helical devices remained under 7.30 N, for which the Platinum-Iridium device's tensile failure force was 32.90 ± 2.09 N, resulting in a safety factor of 4.50. (4) Conclusions: An open-core helical structure that can freely elongate was shown to result in reduced removal forces both acutely and chronically.

Immature porcine cortical bone mechanical properties and composition change with maturation and displacement rate.

Computational models of mature bone have been used to predict fracture; however, analogous study of immature diaphyseal fracture has not been conducted due to sparse experimental mechanical data. A model of immature bone fracture may be used to aid in the differentiation of accidental and non-accidental trauma fractures in young, newly ambulatory children (0-3 years). The objective of this study was to characterize the evolution of tissue-level mechanical behavior, composition, and microstructure of maturing cortical porcine bone with uniaxial tension, Raman spectroscopy, and light microscopy as a function of maturation. We asked: 1) How do the monotonic uniaxial tensile properties change with maturation and displacement rate; 2) How does the composition and microstructure change with maturation; and 3) Is there a correlation between composition and tensile properties with maturation? Elastic modulus (p < 0.001), fracture stress (p < 0.001), and energy absorption (p < 0.014) increased as a function of maturation at the quasistatic rate by 110%, 86%, and 96%, respectively. Fracture stress also increased by 90% with maturation at the faster rate (p = 0.001). Fracture stress increased as a function of increasing displacement rate by 28% (newborn p = 0.048; 1-month p = 0.004; 3-month p= < 0.001), and fracture strain decreased by 68% with increasing displacement rate (newborn p = 0.002; 1-month p = 0.036; 3-month p < 0.001). Carbonate-to-phosphate ratio was positively linearly related to elastic modulus, and fracture stress was positively related to carbonate-to-phosphate ratio and matrix maturation ratio. The results of this study support that immature bone is strain-rate dependent and becomes more brittle at faster rates, contributing to the foundation upon which a computational model can be built to evaluate immature bone fracture.

Biomechanics of immature human cortical bone: A systematic review.

The whole bone geometry, microstructure, and mechanical properties of mature human bone are widely reported; however, immature bone (0-18 years) has not been similarly robustly characterized. There is an interest in analyzing and predicting the mechanical loading conditions associated with long bone diaphyseal fractures attributed to trauma in children. Thus, understanding the mechanical properties of immature bone in a temporal reference frame is an essential first step to understand diaphyseal fractures of pediatric long bones. The purpose of this systematic review was to ask, what is the state of knowledge regarding the 1) evolution of whole bone geometry and microstructure of immature pediatric bone as a function of maturation and 2) cortical bone density and experimental quasi-static mechanical properties at the tissue level in the diaphyseal region of immature pediatric long bones? The systematic search yielded 36 studies of the whole bone geometry, microstructure, and mechanical properties of immature pediatric long bones. The elastic modulus, yield stress, and ultimate stress were shown to generally increase with maturation, whereas the yield strain was approximately invariant; however, the specific year-to-year progression of these properties could not be characterized from the limited studies available. The results of this systematic search indicate there is a dearth of knowledge associated with the biomechanics of cortical bone from immature pediatric long bones; it also provides a basis for computational studies of immature human long bones. Additional biomechanical studies of immature human bone are necessary to develop a robust catalogue, which can be used in broad applications to understand fracture mechanics, bone pathologies, and athletic injury in the pediatric setting.

Irreversible, Self-Aligned Microfluidic Packaging for Chronic Implant Applications.

Packaging is an often overlooked component in microfluidic devices for biomedical implant applications. Robust and reliable connectors to interface microscale and macroscale features are especially critical for chronic implant applications. Existing microfluidic packaging methods are incompatible with emerging polymeric materials designed to enhance device integration with the surrounding tissue. A microfluidic connector scheme was developed to promote compatibility with novel materials and implant applications. The connectors and an adhesive wax were printed on a scaffold via additive manufacturing processes. The low-temperature packaging process entailed bonding the connector to a polymer nanocomposite-based intracortical microfluidic probe using an adhesive wax. The robustness of the packaging was assessed by measuring the tensile and shear bond strengths of the connector-adhesive wax-polymer film interface. After soak testing for 4 weeks, the bond strength continued to exceed the force required to infuse fluids through the microfluidic channel. Further, the shear bond strength exceeded typical probe insertion forces by at least 10-fold. These results support the use of the connector and thermal bonding method as a viable option for chronic implant applications.