Scored Spinal Cord Stimulation Paddle for Epidural Conformability
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Solution Overview
Problem
Conventional paddle leads for spinal cord stimulation require invasive surgical procedures due to their dimensions and physical characteristics, which limits their flexibility and ability to conform to the epidural space, affecting the efficiency of electrical coupling with the spinal cord.
Innovation Solution
The paddle lead features elongated scoring on its surfaces, allowing for increased flexibility and conformability to the epidural space, facilitating easier implantation and optimal electrical coupling by enabling the paddle to bend and conform to the anatomical shape, thereby improving maneuverability and stability during implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If conventional paddle leads are used with rigid structures, then structural stability is maintained, but flexibility and ability to conform to epidural space deteriorates
Solution Approach 1:
The paddle lead structure is divided into multiple segments through scored surfaces that create flexible zones. These scored lines segment the rigid paddle body into regions that can bend independently, allowing the overall structure to flex while maintaining structural integrity in non-scored areas.
Solution Approach 2:
Different regions of the paddle lead are given different mechanical properties. The scored surfaces create localized flexible zones where bending is permitted, while the unscored regions maintain rigidity for structural support. This local differentiation allows simultaneous flexibility and structural stability.
2Adaptability or versatility
If conventional paddle leads with rigid structures are used, then manufacturing simplicity is maintained, but ability to conform to anatomical shape deteriorates
Solution Approach 1:
The scored surfaces are pre-formed during manufacturing to create predetermined flexible zones. This preliminary structuring allows the paddle to naturally conform to anatomical shapes during implantation without requiring complex post-manufacturing processing or assembly steps.
3Reliability
If invasive surgical procedures are used for implantation, then secure positioning is achieved, but tissue damage increases
Solution Approach 1:
The paddle lead transitions from a rigid structure to a dynamically flexible structure that can adapt its shape during implantation. The scored surfaces enable the paddle to bend and flex to navigate through tissue planes, reducing the need for forceful insertion and minimizing tissue trauma while maintaining positioning accuracy.
Data Source
AI summary
An implantable stimulation system including an epidural lead for spinal cord stimulation that includes a paddle having an array of electrodes coupled to conductors within the lead body. The paddle includes score lines that extend along the length and width of either the front or back facets of the paddle portion. The score lines increase the flexibility of the paddle in both the length and width directions which facilitate the implantation of the paddle within the epidural space of the spinal cord, and further permits the paddle to conform more uniformly to the target area of implantation to minimize the gap between the electrodes and targeted fibers.