Intellirod Spine: Sensing Systems for Spine Surgeons and their Patients
Richard Navarro, President & CEO
The challenge of achieving good outcomes in deformity or fusion surgery is in the hands of skilled and experienced spine surgeons. Yet lumbar fusion success struggles to reach 80% while deformity surgeries can result in 20% implant failure rates. Intellirod Spine is developing new surgeon sensing “tools” to provide adjunct data to the surgeon’s visual and tactile senses. Wireless microelectronic sensors that mount on spinal rods and measure rod strain either in the O.R. during kyphotic deformity correction surgery or post-operatively as an implant in a lumbar fusion can quantify the spinal rod strain. This quantification of tactile and visual feedback provides unprecedented data for objective use by the surgeon to assess load levels relative to the material strength of the rod material. This strain data is new biomechanical information to make more objective assessments of the loads on implants intraoperatively and postoperatively.
Intellirod Spine located in Akron, Ohio was founded by Dr. Rolando M. Puno, M.D., and professors from the University of Louisville. The company has developed both a disposable, LOADPRO™ and inductively powered implantable, ACCUVISTA™ sensor, and Ric Navarro, President and CEO of Intellirod Spine says-“With our tools surgeons can objectively and quantitatively assess the loads on their implants.”
In a pilot study, the LOADPRO was used on kyphotic deformity patients during surgery to observe strain measured during a procedure. Surgeons measured the effects of differing surgical techniques on rod strain levels.
The future is now to begin providing data to improve efficacy of devices and procedures
For the first time, they were able to observe the deleterious effects of placing auxiliary rods with mismatched curvature placed across an osteotomy. Instead of sharing load equally across four rods, strains can be drastically increased in the primary rods. Once observed, this elevated strain can be neutralized with simple in situ bending of the auxiliary rods.
Current assessment of the “mechanical integrity” of a spinal fusion is an uphill task using flexion extension x-rays to try to detect micro motion or ordering costly CT scans with 3D reconstructions. The company’s innovative wireless strain monitoring system can be used as a quantitative biomechanical metric as an adjunct to imaging and clinical judgment. The company has plans to initiate in vivo studies with the ACCUVISTA implantable sensor for pediatric patients requiring growth rods in 2019.
Now imagine being able to incorporate inductive reader electronics into a post-operative wearable that can detect implanted rod strain and provide remote monitoring and alerts through a Smartphone and cloud interface. Intellirod has taken the first step with the introduction of their iLink™ wearable Bluetooth enabled sensor for detecting orthotic and prosthetic wearing compliance. It works with the patient’s smartphone and data is hosted in a secure web portal for daily feedback to patients, clinicians and caregivers. Using iLink in a post spinal surgery brace not only monitors wearing time but also the patient’s time spent upright and their movement and the data is available, anytime, anywhere. Non-compliant patients can receive auto-alerts or receive phone calls to improve their compliance and resulting outcomes. Especially pediatric patients with scoliosis where it is proven that adhering to wearing protocols helps avoid costly and complex surgery.
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