Spinal Implant System for Reduction & Internal Implant Stabilization of Human Spondylolisthesis Deformity

Description:

The Hercules spinal implant device and system is to be used for reduction and internal implant stabilization of human vertebral spondylolisthesis deformity. It is a standalone system with unique design that allows an anterior surgical approach to realign and simultaneously stabilize the spinal vertebral segments while protecting and preserve nerve function and not damaging other human body visceral anatomy in order to correct all grades of spondylolisthesis. The proposed solution is to use two implants in the interbody space, allowing greater flexibility to handle high grades of spondylolisthesis that utilize a locking mechanism when the spine has returned to proper alignment to provide the same stability as that of a single implant. Additionally, the reduction system used to realign the spine is designed to minimize the physical strain of the surgeon while realigning the spine, which could have high resistive forces in high grades of spondylolisthesis.  This spinal reduction system is able to treat any grade of spondylolisthesis without supplemental fixation. This is used to treat patients with the spondylolisthesis deformity that causes extreme back or leg pain, and who have found no improvement with more conservative treatment options.

 

There is currently a functional prototype that has shown proof of concept, constructed of aluminum and stainless steel that has been showcased at RPI’s senior design showcase. A finite element analysis (FEA) has been completed to assess the forces, sites of failure, and any additional stress concentrations.

 

Overview: Spondylolisthesis is found in approximately 5.8% of men and 9.1% of women, with approximately 40,000 degenerative spondylolisthesis procedures completed annually.  Currently, high-grade spondylolisthesis (forward displacement of a vertebral bone) has no good surgical treatment plan. Posterior approaches can correct high grades of spinal deformity; however, it is difficult to access the pedicles for screw placement which are attached to the spine and used to bring the mal-aligned vertebra back to proper alignment. Also, posterior reduction approaches for high grade deformity carry approximately 25% risk of neurologic injury.  Additionally, posterior approaches require significant disruption of the back muscles and the approach does not allow release of the deforming forces from anterior ligaments. Currently, anterior approaches have an associated risk of damaging critical vessels (i.e. descending aorta), the devices generally require supplemental fixation and are only approved by the FDA for the correction of a deformity greater than grade 1. Stand-alone anterior surgery with associated interbody fusion has a relatively high chance of failure from loss of reduction if not combine with a second stage posterior surgery. As such, a system is needed that address the complications and shortcomings of current anterior and posterior devices and approaches in order to better serve this patient population.

 

Competitive Implant Products & Systems: Currently, “Monument” (produced and sold by Globus Medical) is the only FDA approved product for anterior approach and implant designed to treat lumbar spondylolisthesis. The Monument product is approved for use with associated posterior spine segmental screw fixation and fusion as a second surgical procedure. Other products designed as implant interbody disc spacers have been employed for only low grade spondylolisthesis (e.g. grade 1.)  Numerous spinal implant companies offer a version of the lumbar spinal implant spacer product which is approved for additional associated use with posterior spine surgery fusion and fixation. Other types of competitive spine implant products used for reduction and stabilization of lumbar spondylolisthesis include the many segmental posterior pedicle screw fixation devices that are manufactured and marketed by many spinal implant companies. As discussed above, these screw fixation products have higher: risks of adverse events, failure rates, and difficulty in use by spine surgeons. 

 

Applications: Reduction and internal implant stabilization of human vertebral spondylolisthesis deformity.

Advantages:  Allows an anterior surgical approach to realign and simultaneously stabilize the spinal vertebral segments while protecting and preserve nerve function and not damaging other human body visceral anatomy in order to correct all grades of spondylolisthesis.

Key Words: Spondylolisthesis, spine, reduction, implant, anterior, posterior, fixation, vertebra, stability

 

Inventors:  Bart Sachs, Trevor Langley, Pace Fabiano, Alexandra Wells, Carolyn Chlebek, Christine Perrone, Cara Yocum, Joshua Peterson

Patent Status:       Provisional Application Filed 05/13/2016

MUSC-FRD Technology ID: P1713

 

Patent Information:
Category(s):
Device
For Information, Contact:
Chelsea Ex-Lubeskie
Licensing Manager, Devices
MUSC Foundation for Research Development
843-876-1900
exlubesk@musc.edu
Inventors:
Trevor Langley
Pace Fabiano
Alexandra Wells
Carolyn Chlebek
Christine Perrone
Cara Yocum
Bart Sachs
Joshua Peterson
Keywords:
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