Paddle Lead Delivery Tool for Spinal Cord Stimulation
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Solution Overview
Problem
The challenge in neurological stimulation systems is the difficulty in accurately steering paddle leads into their proper location during implantation, which affects the effectiveness of spinal cord stimulation therapies, particularly in paresthesia-free SCS that relies on high-frequency signals without generating discomforting sensations.
Innovation Solution
A low-profile delivery tool is designed to engage paddle leads, featuring a handle with a pivotable distal region and a central projection that fits between lead legs, allowing for precise control and reduced cross-sectional area, facilitating easier insertion and positioning of the paddle lead without significant additional features or size increases.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If a paddle lead is used for spinal cord stimulation, then stability during implantation is improved, but difficulty in steering into proper location increases
Solution Approach 1:
A delivery tool is introduced as an intermediary device that engages with the paddle lead during implantation. The delivery tool includes features such as a handle, shaft, and engagement mechanism (e.g., jaws or clamps) that securely hold the lead while allowing the practitioner to steer and position it accurately in the epidural space. This mediator enables precise control during the implantation process.
Solution Approach 2:
The delivery tool is divided into functional segments: a handle for grasping and manipulating, a shaft for insertion through tissue, and a distal engagement portion for securing the paddle lead. This segmentation allows each part to perform its specific function optimally while maintaining overall control during the procedure.
2Ease of operation
If delivery tool features are added to improve steering control, then ease of operation is improved, but cross-sectional area and device complexity increase
Solution Approach 1:
The delivery tool incorporates steering and engagement features localized to specific regions rather than throughout the entire structure. For example, the engagement mechanism (jaws or clamps) is positioned only at the distal end where it needs to interact with the paddle lead, while the shaft remains relatively simple for insertion. This localized approach provides necessary functionality without unnecessarily increasing overall device complexity or cross-sectional area.
Data Source
AI summary
Paddle leads and delivery tools, and associated systems and methods are disclosed. A representative system is for use with a signal delivery paddle that is elongated along a longitudinal axis, and has a paddle length and a first cross-sectional area distribution that includes a first maxima. The system comprises a delivery tool including a proximal handle and a distal connection portion positioned to removably couple to the signal delivery paddle. The paddle and the delivery tool together have a combined second cross-sectional area distribution along the length of the paddle, with a second maxima that is no greater than the first maxima.