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 rigidity can cause tissue compression, leading to discomfort or paralysis due to their design and material properties.
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 tissue compression, using a neutral longitudinal force envelope to manage stress and prevent connection failures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a paddle lead with multi-dimensional electrode array is used, then stimulation coverage is improved, but manufacturing complexity increases
Solution Approach 1:
The lead paddle is divided into multiple segments or sections, each with its own electrode arrays. This segmentation allows for modular manufacturing processes where each segment can be fabricated separately and then assembled, reducing overall manufacturing complexity while maintaining the multi-dimensional stimulation coverage capability.
Solution Approach 2:
The patent employs nested structures where conductor organizers are embedded within the paddle body, and electrode arrays are integrated within the conductor organizer framework. This nesting approach consolidates multiple components into a compact integrated structure, simplifying the manufacturing process by reducing the number of separate assembly steps while preserving the complex multi-dimensional electrode configuration.
2Reliability
If wire conductors are arranged in a designated arrangement within the paddle body, then connection reliability is improved, but device complexity increases
Solution Approach 1:
Wire conductors are pre-arranged in designated positions within conductor organizers before final assembly of the lead paddle. This preliminary positioning ensures that electrical connections are established in the correct configuration early in the manufacturing process, improving connection reliability while reducing the complexity of subsequent assembly steps.
Solution Approach 2:
Conductor organizers serve as intermediary structures that hold and position wire conductors in designated arrangements. These organizers act as mediators between the wire conductors and the electrode arrays, ensuring reliable electrical connections while simplifying the overall device structure by providing a standardized interface for conductor positioning.
3Stability of the object's composition
If the lead paddle is made rigid for structural stability, then positional stability is improved, but tissue compression increases
Solution Approach 1:
The lead paddle incorporates flexible materials and thin-film structures that allow the paddle to conform to the curvature of the spinal cord. This flexibility reduces tissue compression while maintaining positional stability through the flexible yet supportive construction, eliminating the need for rigid structures that would cause harmful compression effects.
Solution Approach 2:
The patent changes the physical parameters of the lead paddle materials, transitioning from rigid to flexible materials with appropriate mechanical properties. This parameter change allows the paddle to maintain positional stability through flexibility rather than rigidity, reducing tissue compression while preserving the stability needed for effective stimulation delivery.
4Object-affected harmful factors
If the lead paddle is made flexible to reduce tissue compression, then patient comfort is improved, but wire conductor stress increases
Solution Approach 1:
Conductor organizers serve as intermediary protective structures that shield wire conductors from stress caused by paddle flexing. These organizers provide a stable framework that maintains conductor positioning and reduces mechanical stress on the wire conductors, allowing the paddle to remain flexible for patient comfort while protecting the electrical connections from failure.
Solution Approach 2:
The conductor organizers are designed to cushion and protect wire conductors from mechanical stress before it can cause damage. This beforehand cushioning effect absorbs and distributes the stress from paddle flexing, preventing direct transmission of forces to the wire conductors and reducing the risk of connection failures while maintaining paddle flexibility.
Data Source
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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.