Flexible Spinal Cord Stimulation Lead with Conductor Organizer
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Solution Overview
Problem
Paddle leads used in spinal cord stimulation systems face challenges such as complex fabrication, potential electrical connection failures, and compression issues that can cause discomfort or paralysis due to their rigid nature, which can lead to unwanted tissue compression.
Innovation Solution
A stimulation lead with a multi-dimensional electrode array and a conductor organizer that positions wire conductors in a designated arrangement within a flexible paddle body, reducing stress on the wire conductors and allowing the lead to flex without causing damage, and includes a neutral longitudinal force envelope to manage tensile and compression stresses.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a rigid paddle lead is used in spinal cord stimulation, then electrical connection stability is improved, but tissue compression and discomfort increase
Solution Approach 1:
The paddle lead body is constructed as a flexible structure that can bend and conform to the epidural space geometry without rigidly compressing the spinal cord. The flexible body maintains electrical connectivity while accommodating tissue movement and curvature, eliminating compression-related discomfort and paralysis.
Solution Approach 2:
The lead body is designed to be dynamic rather than static, allowing it to flex and adapt its shape in response to the epidural space contours and tissue displacement. This dynamic flexibility enables the lead to maintain stable electrical connections while avoiding harmful compression forces on neural tissue.
2Adaptability or versatility
If a paddle lead with multi-dimensional electrode array is used, then stimulation coverage is improved, but fabrication complexity increases
Solution Approach 1:
The paddle lead is divided into discrete modular components including the flexible body, electrode array, conductor organizer, and wire conductors. This segmentation allows each component to be manufactured and tested independently, then assembled into the complete lead system, significantly simplifying the overall fabrication process while maintaining multi-dimensional stimulation capability.
Solution Approach 2:
The conductor organizer is nested within the flexible paddle body, with wire conductors routed through organized channels. This nested arrangement consolidates multiple functions (structural support, electrical conduction, and wire routing) into a single integrated component, reducing the number of separate manufacturing steps and assembly operations required.
3Reliability
If wire conductors are routed through the paddle body, then electrical connectivity is achieved, but stress on conductors increases leading to failure
Solution Approach 1:
The conductor organizer acts as an intermediary structure between the wire conductors and the external environment. It provides protected routing channels that shield the wire conductors from mechanical stress, bending, and damage while maintaining their electrical connectivity function. The organizer absorbs and distributes stress away from the conductors during paddle body flexing.
4Reliability
If the lead paddle is compressed against the spinal cord, then contact with nervous tissue is achieved, but unwanted consequences such as tingling and pain occur
Solution Approach 1:
The flexible paddle body conformally contacts the spinal cord and epidural space contours through its inherent flexibility rather than through active compression. This passive conformal contact maintains reliable neural tissue engagement while eliminating the harmful compression forces that cause tingling, pain, and potential paralysis.
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.