Percutaneous Electrode With Varied Flexibility Regions and Indexed Stylet
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Solution Overview
Problem
Current percutaneous spinal cord stimulation (SCS) electrodes lack adequate steerability and flexibility during implantation, leading to difficulties in precise placement and increased risk of unwanted deviations and painful side effects due to rigid construction and cumbersome steering mechanisms.
Innovation Solution
A system comprising an electrode with varied flexibility regions and a stylet with indexed bends, allowing for adjustable bending by minimal radial and longitudinal movement of the stylet within the electrode, enabling precise steering and placement without the need for frequent stylet removal or replacement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If the electrode is constructed with rigid structure to maintain stability, then structural strength is improved, but steerability and flexibility during implantation deteriorate
Solution Approach 1:
The electrode is divided into multiple segments with different flexibility characteristics. The proximal portion has greater flexibility while the distal portion maintains rigidity, allowing the electrode to be steered during implantation while maintaining structural integrity and stability when deployed.
Solution Approach 2:
Different portions of the electrode are assigned different mechanical properties. The proximal portion is designed with higher flexibility to enable steering and navigation, while the distal portion is designed with higher rigidity to maintain stable positioning and electrical contact, resolving the contradiction between steerability and structural strength.
2Ease of operation
If the electrode is made highly flexible to improve steerability, then ease of operation is improved, but structural stability and positioning precision deteriorate
Solution Approach 1:
The electrode is segmented into proximal and distal portions with different flexibility levels. This segmentation allows the proximal portion to be flexible for steering while the distal portion remains rigid for precise positioning, resolving the contradiction between steerability and positioning precision.
Solution Approach 2:
The electrode exhibits dynamic mechanical properties where the proximal portion can be flexed during implantation for steering, but the distal portion maintains static rigidity for precise positioning. This dynamic differentiation resolves the contradiction between ease of operation and manufacturing precision.
3Device complexity
If a single rigid stylet is used for steering, then device complexity is reduced, but adaptability to different implantation scenarios deteriorates
Solution Approach 1:
The stylet is designed with variable flexibility along its length, allowing it to adapt to different implantation scenarios. The proximal portion is more flexible while the distal portion is more rigid, enabling the single stylet to handle various steering requirements without increasing overall device complexity.
Solution Approach 2:
Different portions of the stylet are assigned different flexibility characteristics to match specific implantation needs. The proximal portion's higher flexibility allows for initial navigation, while the distal portion's rigidity provides stability during final positioning, enhancing adaptability without adding complexity.
4Measurement precision
If frequent stylet removal and replacement is required to adjust bending, then steering precision is improved, but loss of time and procedural efficiency deteriorate
Solution Approach 1:
The stylet's variable flexibility allows it to be adjusted in real-time during implantation without removal. The different flexibility portions can be engaged or disengaged by simple manipulation, providing steering precision while eliminating the time loss associated with frequent removal and replacement.
Solution Approach 2:
The stylet is pre-configured with variable flexibility characteristics during manufacturing, so that during implantation the operator can simply manipulate the stylet to engage different flexibility portions as needed, rather than requiring removal and replacement. This preliminary design enables both steering precision and procedural efficiency.
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
Enhances the operator's ability to precisely place the electrode by allowing variable and controlled bending, reducing the risk of unwanted deviations and improving the accuracy of spinal cord stimulation, thereby minimizing painful side effects and maintaining stability post-implantation.
Implementation Method 1
A system comprising an electrode with varied flexibility regions and a stylet with indexed bends, allowing for adjustable bending by minimal radial and longitudinal movement of the stylet within the electrode
Data Source
AI summary
Disclosed is a system including an electrode and a stylet configured to steer the electrode towards its intended position during implantation, and a method for such system's use. An electrode is provided having regions with varied flexibility. A stylet having bends that are indexed to specific regions of flexibility of the electrode may be inserted into the electrode, and upon minimal radial and/or longitudinal movement of the stylet within the electrode, will cause the magnitude of the angle to which the lead is bent to either increase or decrease so as to aid the operator in placement of the electrode.