Integrated Implantable Leads for Glucose Monitoring and Spinal Stimulation
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Solution Overview
Problem
Patients with diabetes and painful diabetic neuropathy face inadequate pain relief and intolerable side effects from separate devices for spinal cord stimulation and glucose monitoring, necessitating a combined system for efficient monitoring and treatment.
Innovation Solution
Integration of implantable electrodes and a pulse generator to concurrently monitor glucose levels and provide spinal cord stimulation, utilizing a three-electrode configuration for enhanced accuracy and stability, with a potentiostat and digital filters to minimize noise interference.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If separate devices are used for spinal cord stimulation and glucose monitoring, then each device can be optimized for its specific function, but the patient burden increases and compliance decreases
Solution Approach 1:
The patent combines spinal cord stimulation electrodes and glucose monitoring electrodes into a single integrated lead assembly that is implanted together. The stimulation electrodes are positioned to deliver electrical pulses for pain relief while glucose sensing electrodes are positioned adjacent to them, allowing both functions to be performed through a single surgical procedure and single device, thereby reducing patient burden and improving compliance
2Reliability
If multiple separate devices are implanted, then each device can be specialized, but the surgical complexity and recovery time increase
Solution Approach 1:
The patent integrates multiple functions into a single lead assembly that is implanted through one surgical procedure. The lead assembly contains both stimulation electrodes for spinal cord stimulation and glucose sensing electrodes for continuous glucose monitoring, eliminating the need for separate surgical interventions and reducing overall surgical complexity
Solution Approach 2:
The integrated lead assembly serves multiple functions simultaneously: it provides spinal cord stimulation for pain management and continuous glucose monitoring for diabetes control. This multi-functional design allows a single device to replace what would traditionally require multiple separate devices and procedures
3Device complexity
If electrodes are positioned close together for integration, then the device is more compact and less invasive, but electrical interference between stimulation and sensing electrodes may occur
Solution Approach 1:
The patent applies different properties to different regions of the electrode assembly. The stimulation electrodes and glucose sensing electrodes are positioned adjacent to each other but are electrically isolated through separate insulation layers and distinct contact regions. This local differentiation allows close spacing for compactness while preventing electrical interference through localized electrical isolation
Solution Approach 2:
The patent introduces intermediary insulation layers and separate electrical contact regions between the stimulation electrodes and glucose sensing electrodes. These intermediary structures act as electrical barriers that prevent direct coupling and interference between the two functional groups while still allowing the electrodes to be positioned close together for integration
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The integrated system reduces the burden of using separate devices by providing simultaneous glucose monitoring and pain relief, enhancing patient compliance through improved accuracy and stability.
Implementation Method 1
Glucose monitoring may be effectuated using a variety of different sensing modalities, including enzymatic sensing
Implementation Method 2
Spinal cord stimulators (SCS) use programmable pulse generation systems that deliver electrical stimulation through electrodes
Data Source
AI summary
A system for continuous glucose measurement and spinal cord stimulation provides at least two implantable non-stimulation electrodes configured to continuously monitor at least one physiological parameter on a lead that also includes a plurality of implantable stimulation electrodes. The electrodes are electrically connected to an implantable pulse generator that communicates stimulation instructions and glucose measurement data.