Hermetically-Sealed Connector for Spinal Cord Stimulation
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Solution Overview
Problem
Current spinal cord stimulation systems face challenges in maintaining optimal electrode current due to patient movement, leading to potential noxious stimulation or inadequate treatment, and require frequent surgeries for optoelectronic replacements, with existing solutions failing to provide a durable and maintenance-free solution.
Innovation Solution
A hermetically-sealed connector system that houses optoelectronics, allowing for easy replacement and integration with existing implantable pulse generators (IPGs), minimizing the need for reengineering and reducing the frequency of high-risk surgeries, while maintaining optimal electrode current adjustments using reflectometry for precise spinal cord stimulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If optical sensing is incorporated into neurostimulation systems for automatic adjustments, then stimulation effectiveness is improved, but device complexity increases
Solution Approach 1:
The patent combines optical sensing components (LED, photodetector) with the electrical stimulation electrode array into a single integrated device. This merging allows the system to perform both sensing and stimulation functions through one implant, eliminating the need for separate devices and reducing overall system complexity despite adding advanced functionality.
Solution Approach 2:
The electrode array is designed to serve multiple functions: delivering electrical stimulation to the spinal cord and simultaneously detecting optical signals for feedback. This multi-functionality allows the same structure to perform both therapeutic stimulation and automatic adjustment sensing, reducing the need for additional dedicated components.
2Reliability
If hermetically-sealed connector system is used to house optoelectronics, then device reliability is improved, but manufacturing complexity increases
Solution Approach 1:
The system is divided into distinct hermetically-sealed modules: the electrode array with integrated optoelectronics, the connector, and the IPG. Each module is sealed independently, allowing for specialized manufacturing of each component and simplifying the overall assembly process while maintaining high reliability through hermetic sealing of critical components.
3Duration of action of stationary object
If optoelectronics are integrated into the lead, then indefinite lifetime of electrode array is achieved, but ease of repair deteriorates
Solution Approach 1:
The optoelectronic components are integrated into the lead assembly rather than the IPG, allowing the lead (with embedded optoelectronics) to be replaced as a single unit if needed, while the IPG can remain in place. This extraction of the optoelectronic integration from the main generator allows for easier maintenance and replacement of specific components.
4Reliability
If frequent surgeries are performed for optoelectronic replacements, then device functionality is maintained, but patient risk increases
Solution Approach 1:
The optoelectronic components are designed with sufficient lifetime to match or exceed the IPG battery life, allowing the entire assembly to function indefinitely without intermediate replacements. This preliminary design consideration eliminates the need for frequent surgical interventions to replace depleted optoelectronic components.
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 solution ensures indefinite lifetime of the electrode array with reduced physical changes to the IPG, allows for battery changes every 10 years, and minimizes the need for repeated surgeries, maintaining effective spinal cord stimulation while avoiding noxious stimulation and ensuring long-term device reliability.
Implementation Method 1
Percutaneous lead 202 includes optical fiber 204, optical element 206, electrodes 208 and contacts 210. Optical fiber 204 is coupled to optical element 206. The optical fibers are used to transmit light signals to be used for position detection of the spinal cord
Implementation Method 2
The optical fibers are used to transmit light signals to be used for position detection of the spinal cord, as known in the art
Data Source
AI summary
A connector system is provided for a positional sensitive spinal cord stimulation apparatus using reflectometry which incorporates the ability to connect to current IPG's either in a percutaneous or laminectomy form and which utilizes a novel light to frequency converter to generate a stimulation voltage in wave form to effect spinal cord stimulation.