An in vivo biocompatibility assessment of MEMS materials for spinal fusion monitoring

Sensors and Actuators A: Physical, 2007

A MEMS (microelectromechanical system) capacitive-based pure bending strain sensor is presented for use in spinal fusion monitoring. The sensor is designed to interface with a telemetry system that does not require a battery and contained in a housing that is attached to spinal fusion rods. The cantilever structure of the sensor is composed of two parallel plates with a narrow gap and a conjoint end. Nine permutations of the design with different metal coverage areas (14 mm 2 , 9.3 mm 2 and 4.7 mm 2 ) and gaps (3 m, 6 m and 7.4 m) were examined. The nominal capacitance ranges from 7.6 pF to 42 pF. The capacitance changes 31.4-65.1% for a strain range of 0-1000 depending on the design parameters. An analytical model is developed for the sensor mounted to a cantilever test bar and compared to experimental results of actual devices. The model and experimental results show an average difference of 5% for all nine designs investigated. The final sensor design achieved a linear gauge factor of 252 and was fabricated for the spinal fusion application. Published by Elsevier B.V.

SAS Journal, 2008

Background In this preliminary study we used a goat model to quantify pressure at an interbody bone graft interface. Although the study was designed to assess fusion status, the concept behind the technology could lead to early detection of implant failure and potential hazardous complications related to motion-preservation devices. Th e purpose of this study was to investigate the feasibility of in vivo pressure monitoring as a strategy to determine fusion status. Methods Telemetric pressure transducers were implanted, and pressure at the bone graft interfaces of cervical interbody fusion autografts placed into living goats (Groups A and B) was evaluated. Group A constituted the 4-month survival group and Group B the 6-month survival group. One goat served as the study control (Group C) and was not implanted with a pressure transducer. An additional six cadaveric goat cervical spines (Group D) were obtained from a local slaughterhouse and implanted with bone grafts and ventral plates and used for in vitro biomechanical comparison to the specimens from Groups A and B. Results All goats demonstrated an increase in interface pressure within the fi rst 10 days postoperatively, with the largest relative change in pressure occurring between the sixth and ninth days. Th e goats from Groups A and B had a 200% to 400% increase in relative pressure. Conclusions Although this was a pilot study to assess pressure as an indicator for a fusion or pseudarthrosis, the preliminary data suggest that early bone healing is detectable by an increase in pressure. Th us, pressure may serve as an indicator of fusion status by detecting altered biomechanical parameters.

Neurosurgical Focus, 2004

Object An in vivo study was conducted in an ovine model to investigate the biomechanical changes after the animals underwent single-level anterior cervical discectomy followed by fusion in which autologous tricortical graft was used and implantation of cervical plates for which bioresorbable polymer screws and plates were used. The specific aims of the study were to evaluate whether implant failure or screw backout would occur over time and to measure the change in stiffness at the treated level at various postoperative time periods (3, 6, and 12 months). Methods A total of 58 x-ray films were evaluated over the 12-month survival period. No screw breakage or displacement was observed in any animal during the temporal radiographic analysis. Radiographically confirmed fusion appeared to be complete at all time periods longer than 6 months. The biomechanical testing demonstrated dramatic reductions in range of motion at the fusion level in the animals allowed to survive for 6 and 12 mo...

IEEE Transactions on Biomedical Engineering, 2013

We report the development of a surrogate spinal cord for evaluating the mechanical suitability of electrode arrays for intraspinal implants. The mechanical and interfacial properties of candidate materials (including silicone elastomers and gelatin hydrogels) for the surrogate cord were tested. The elastic modulus was characterized using dynamic mechanical analysis, and compared with values of actual human spinal cords from the literature. Forces required to indent the surrogate cords to specified depths were measured to obtain values under static conditions. Importantly, to quantify surface properties in addition to mechanical properties normally considered, interfacial frictional forces were measured by pulling a needle out of each cord at a controlled rate. The measured forces were then compared to those obtained from rat spinal cords. Formaldehydecrosslinked gelatin, 12 wt% in water, was identified as the most suitable material for the construction of surrogate spinal cords. To demonstrate the utility of surrogate spinal cords in evaluating the behavior of various electrode arrays, cords were implanted with two types of intraspinal electrode arrays (one made of individual microwires and another of microwires anchored with a solid base), and cord deformation under elongation was evaluated. The results demonstrate that the surrogate model simulates the mechanical and interfacial properties of the spinal cord, and enables in vitro screening of intraspinal implants.

Journal of Biomedical Materials Research Part B, 2018

Polyetheretherketone (PEEK) is commonly used as a spinal spacer for intervertebral fusion surgery. Unfortunately, PEEK is bioinert and does not effectively osseointegrate into living bone. In contrast, comparable spacers made of silicon nitride (Si 3 N 4) possess a surface nanostructure and chemistry that encourage appositional bone healing. This observational study was designed to compare the outcomes of these two biomaterials when implanted as spacers in an adult caprine model. Lumbar interbody fusion surgeries were performed at two adjacent levels in eight adult goats using implants of PEEK and Si 3 N 4. At six-months after surgery, the operative and adjacent spinal segments were extracted and measured for bone fusion, bone volume, bone-implant contact (BIC) and soft-tissue implant contact (SIC) ratios, and biodynamic stability. The null hypothesis was that no differences in these parameters would be apparent between the two groups. Fusion was observed in seven of eight implants in each group with greater bone formation in the Si 3 N 4 group (52.6%) versus PEEK (27.9%; p 5 0.2). There were no significant differences in BIC ratios between PEEK and Si 3 N 4 , and the biodynamic stability of the two groups was also comparable. The results suggest that Si 3 N 4 spacers are not inferior to PEEK and they may be more effective in promoting arthrodesis. V

Journal of neurosurgery. Spine, 2016

OBJECTIVE Instrumented spinal fusion continues to exhibit high failure rates in patients undergoing multilevel lumbar fusion or pseudarthrosis revision; with Grade II or higher spondylolisthesis; or in those possessing risk factors such as obesity, tobacco use, or metabolic disorders. Direct current (DC) electrical stimulation of bone growth represents a unique surgical adjunct in vertebral fusion procedures, yet existing spinal fusion stimulators are not optimized to enhance interbody fusion. To develop an advanced method of applying DC electrical stimulation to promote interbody fusion, a novel osteogenic spinal system capable of routing DC through rigid instrumentation and into the vertebral bodies was fabricated. A pilot study was designed to assess the feasibility of osteogenic instrumentation and compare the ability of osteogenic instrumentation to promote successful interbody fusion in vivo to standard spinal instrumentation with autograft. METHODS Instrumented, single-level,...

Journal of Biomedical Materials Research Part B: Applied Biomaterials, 2005

Currently, spine fusion is determined using radiography and clinical evaluation. There are discrepancies between radiographic evidence and direct measurements of fusion, such as operative exploration and biomechanical or histological measurements. In order to facilitate the rapid return of patients to normal activities, a monitoring technique to accurately detect fusion in vivo and to prevent overload during the postoperative period would be useful. The objectives of this study were to develop an implantable monitoring system consisting of CPC-coated strain gauges and a radio transmitter to detect the onset of fusion and measure strain during postsurgical activities. A patient underwent anterior release and fusion, followed by posterior instrumentation and fusion with segmental spinal instrumentation. Four strain gauges were placed during surgery. One was attached to the left-side rod and one to each of the lamina at T9, T10, and T11. An externally powered implanted radio transmitter attached to the gauges was placed in a subcutaneous pouch. Strains were monitored weekly and tabulated during various activities for 7 months. Peak strains during twisting and bending were tabulated to detect the onset of fusion. Strains were also recorded during activities such as climbing off an examination table, rising from a chair, and climbing stairs. Strains collected from the left rod indicated that, immediately postoperatively, it was loaded at acceptable levels. The largest and most consistent strain changes measured from the lamina were recorded during twisting.

Operative Neurosurgery, 2021

Spinal fusion has undergone significant evolution and improvement over the past 50 yr. Historically, spine fusion was noninstrumented and arthrodesis was based entirely on autograft. Improved understanding of spinal anatomy and materials science ushered in a new era of spinal fusion equipped with screw-based technologies and various interbody devices. Osteobiologics is another important realm of spine fusion, and the evolution of various osteobiologics has perhaps undergone the most change within the past 20 yr. A new element to spinal instrumentation has recently gained traction—namely, surface technology. New data suggest that surface treatments play an increasingly well-recognized role in inducing osteogenesis and successful fusion. Until now, however, there has yet to be a unified resource summarizing the existing data and a lack of consensus exists on superior technology. Here, authors provide an in-depth review on surface technology and its impact on spinal arthrodesis.

Medical Engineering & Physics, 1996

PubMed, 2013

Objective: The purpose of this study was to evaluate the bioPlex bioresorbable interbody device in a sheep lumbar fusion model and compare it to the concorde, a standard carbon fiber interbody cage. Background: Lumbar interbody fusion devices are made from a variety of materials, including titanium alloys, carbon-fiber, and PEEK. The BioPlex Continuous Phase Composite (CPC) is a unique bioresorbable material comprised of Pro Osteon 500R and 70:30 Poly (L/D, L-lactic acid). The BioPlex device is radiolucent, resorbable and due to its bulk nanoporosity of 8%, has a more consistent degradation profile as compared to a polymer alone. Methods: A total of twenty five male Suffolk sheep were used in this study; nineteen of which were implanted with a bioPlex or concorde device at the L3-L4 and L5-L6 levels using a modified transforaminal/lateral approach. A discectomy was performed and each implant (filled with autologous bone) was placed within the disc space. The sheep were sacrificed at 6, 12, 24 months postimplantation. Fusion was assessed via motion, radiographic and histological data. Results: The BioPlex and Concorde implanted levels had significantly less motion (p<0.05) than the normal controls in flexion/extension and lateral bending at 6, 12, and 24 months. No significant difference in motion was detected between the bioPlex and concorde implants. CT fusion scores correlated with the motion analysis in all the three cases. Conclusion: In comparison to the concorde device, the bioPlex implant appears to have equivalent radiographic and biomechanical fusion success.