Smart Interbody Spacer With Load Sensing and Electrical Stimulation
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Solution Overview
Problem
Lumbar spine fusion outcomes are inconsistent due to pseudarthrosis and subsidence issues, leading to mechanical failure, pain, and the need for invasive revision surgery, with existing implants failing to adequately stabilize the construct, promote bone growth, and prevent biofilm formation.
Innovation Solution
Integration of electronic circuits in spinal implants for load sensing, biofilm detection, and electrical stimulation to monitor fusion progress, detect infection, and promote bone growth, using electrochemical impedance spectroscopy and electrical stimulation to enhance osteogenic activity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional interbody spacers and fixation implants are used, then structural support is provided, but pseudarthrosis occurs due to insufficient stabilization and low osteogenic activity
Solution Approach 1:
The patent replaces passive mechanical stabilization with active electrical stimulation. Implantable electrodes deliver electrical currents directly to the bone tissue at the fusion site, substituting the insufficient mechanical osteogenic stimulation with controlled electrical fields that actively promote bone formation and prevent pseudarthrosis.
Solution Approach 2:
The system incorporates sensors that automatically monitor fusion progress and adjust stimulation parameters in real-time. The implantable device self-regulates the electrical stimulation based on detected bone healing status, eliminating the need for manual intervention and ensuring optimal osteogenic activity throughout the fusion process.
2Shape
If interbody spacers are used to restore disc height, then alignment is improved, but subsidence occurs over time due to bone deformation under load
Solution Approach 1:
The patent incorporates load sensors and displacement sensors that continuously monitor the mechanical environment and spacer position. This feedback system detects early signs of subsidence and automatically adjusts the electrical stimulation parameters or provides mechanical counterforce to prevent further deformation, maintaining stable disc height restoration throughout the fusion process.
3Reliability
If implants are placed in the spine, then structural support is provided, but biofilm formation occurs on implant surfaces causing infection
Solution Approach 1:
The patent replaces passive implant surfaces with active electrical fields. Implantable electrodes deliver electrical stimulation that creates an environment hostile to biofilm formation while promoting bone growth. The electrical fields disrupt bacterial adhesion and prevent biofilm maturation, substituting the passive mechanical implant surface with an active biological control mechanism.
4Reliability
If multiple sensors and electrodes are integrated into the implant, then monitoring and treatment capabilities are enhanced, but device complexity increases
Solution Approach 1:
The patent combines multiple functional components into a single integrated implantable device. Load sensors, displacement sensors, electrical stimulation electrodes, and communication interfaces are merged into one cohesive unit that can be implanted as a single construct. This integration reduces the number of separate implantation steps and simplifies the overall system while maintaining advanced monitoring and treatment capabilities.
Data Source
AI summary
An interbody spacer configured for implantation between spinal vertebrae. The interbody spacer including electrical circuitry within an electronics housing of the interbody spacer and a plurality of load sensors spaced apart on carriers of the interbody spacer. The plurality of load sensors electrically connectable to the electrical circuitry and configured to provide to the electrical circuitry a load signal indicative of a measurement of force exerted onto the plurality of load sensors of the interbody spacer. The interbody spacer further including a plurality of electrodes spaced apart on a surface of the interbody spacer. The plurality of electrodes electrically connectable to the electrical circuitry and configured to at least one of provide to the electrical circuitry an electrode signal indicative of an impedance measurement and generate an electrical field between at least two electrodes of the plurality of electrodes.