Spinal Cord Stimulation Lead with Conductor Organizer
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Solution Overview
Problem
Conventional paddle leads for spinal cord stimulation are complex to manufacture and prone to electrical connection failures, and their rigid nature can cause compression issues leading to discomfort or paralysis due to their size and dimensions.
Innovation Solution
A stimulation lead with a multi-dimensional electrode array and a conductor organizer that positions wire conductors in a designated arrangement within the lead paddle, reducing stress on the conductors and allowing the lead to flex without causing damage, and a flexible layer to minimize tissue compression.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a paddle lead with a multi-dimensional electrode array is used, then the stimulation coverage and precision are improved, but the manufacturing complexity increases
Solution Approach 1:
The paddle lead is divided into modular components: a lead body, a separate paddle structure, and a conductor organizer with individual channels for each wire conductor. This segmentation allows independent manufacturing and assembly of components, reducing overall manufacturing complexity while maintaining the multi-dimensional electrode array configuration for precise stimulation.
Solution Approach 2:
A conductor organizer is introduced as an intermediary component between the lead body and the paddle electrodes. This organizer includes channels that guide and position wire conductors to specific electrodes, simplifying the connection process and reducing manufacturing complexity by providing a structured intermediary framework.
2Stability of the object's composition
If rigid paddle leads are used to maintain structural integrity, then the lead stability is improved, but tissue compression and discomfort increase
Solution Approach 1:
The paddle lead incorporates flexible elements such as flexible wires and flexible coatings that allow the lead to bend and flex without compromising structural integrity. The lead body includes flexible wires that can deform to accommodate tissue movement, reducing compression on the spinal cord while maintaining electrical connection stability.
Solution Approach 2:
The lead design changes the mechanical parameters by incorporating flexible materials and structures that can deform under compression. The flexible wires and coatings allow the lead to change shape and accommodate tissue movement, reducing harmful compression effects while maintaining functional stability.
3Reliability
If wire conductors are routed through the paddle body, then electrical connections are established, but the likelihood of connection failure increases
Solution Approach 1:
A conductor organizer serves as an intermediary structure that systematically routes wire conductors to specific electrodes. This organizer provides dedicated channels for each conductor, ensuring proper positioning and reducing the complexity of managing multiple wire connections, thereby improving connection reliability.
Solution Approach 2:
The conductor organizer is pre-configured with channels and pathways that guide wire conductors to their designated electrodes during assembly. This preliminary arrangement of conductors within the organizer reduces the likelihood of connection failures by ensuring proper positioning before final assembly.
4Area of stationary object
If the lead paddle size is increased to cover more tissue area, then the stimulation coverage is improved, but the compression on spinal cord increases
Solution Approach 1:
The lead incorporates flexible wires and flexible coatings that allow the paddle to flex and conform to the spinal cord surface. This flexibility enables larger paddle sizes to cover more tissue area while minimizing compression forces through adaptive deformation rather than rigid pressure.
Data Source
AI summary
Stimulation lead includes an elongated lead body having distal and proximal ends and wire conductors extending therebetween. The stimulation lead also includes a lead paddle having a multi-dimensional array of electrodes positioned along a contact side of the lead paddle. The electrodes are electrically coupled to the wire conductors. The lead paddle includes a paddle body and a conductor organizer disposed within the paddle body. The conductor organizer has multiple channels extending along the lead paddle. The channels receive the wire conductors and retain the wire conductors in a designated arrangement with respect to the lead paddle. The conductor organizer has openings to the channels. The wire conductors extend through the openings and are terminated to the respective electrodes.