Anisotropic Paddle Lead Delivery Tool for Minimally Invasive Spinal Implantation
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Conventional methods for implanting large, multi-electrode paddle leads require large incisions and substantial vertebral displacement, leading to trauma, longer procedure times, and tissue damage, necessitating a minimally invasive approach with reduced vertebral displacement.
Innovation Solution
A delivery tool with a tool body designed to resist bending in one plane while facilitating bending in a perpendicular plane, allowing for flexible configurations like an 's-shape' to minimize incision size and vertebral displacement, featuring structural members and a lead retention feature to securely position the paddle lead during implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional methods are used to implant paddle leads, then the electrodes can be positioned adjacent to spinal nerves, but large incisions and substantial vertebral displacement are required causing trauma and tissue damage
Solution Approach 1:
The delivery tool is divided into multiple segments or sections that can be collapsed or expanded. The tool body includes a proximal section and distal section that can be independently positioned, allowing the paddle lead to be delivered through a smaller incision while maintaining positioning accuracy. The segmented design reduces the overall profile during insertion, minimizing tissue trauma.
Solution Approach 2:
The paddle lead is nested within the delivery tool during insertion. The lead is positioned within a protective sheath or channel of the delivery tool, allowing it to be guided through the spinal canal or epidural space without direct contact with surrounding tissues. This nesting mechanism protects the lead and minimizes tissue damage during the implantation process.
2Reliability
If conventional delivery tools are used, then the paddle lead can be implanted, but the procedure time is extended
Solution Approach 1:
The delivery tool is pre-assembled with the paddle lead attached in a predetermined configuration. The tool includes pre-positioned channels and guides that are prepared before the procedure begins, eliminating the need for intraoperative assembly steps. This preliminary preparation allows for rapid insertion and positioning of the lead, significantly reducing procedure time while maintaining implantation stability.
Solution Approach 2:
The delivery tool incorporates dynamic elements such as expandable or deployable mechanisms that can change configuration during the procedure. The tool can transition from a compact insertion state to an expanded delivery state, allowing for quick deployment of the paddle lead into its final position. This dynamic capability enables faster implantation without compromising the stability of the lead in its target location.
3Strength
If a rigid delivery tool is used to ensure structural strength, then the tool can withstand implantation forces, but the tool cannot be configured into shapes like an s-shape to minimize vertebral displacement
Solution Approach 1:
The delivery tool is constructed with segmented or modular components that can bend relative to each other. The tool body includes multiple sections connected by flexible joints or articulation points, allowing the tool to be configured into S-shape or other curved paths. This segmented design maintains overall structural strength while enabling the necessary flexibility to navigate around vertebral structures and minimize displacement.
Solution Approach 2:
The delivery tool incorporates composite materials that combine rigid and flexible properties. The tool body may use materials such as shape-memory alloys or composite structures that provide strength when needed but can be flexed into specific configurations. This composite approach allows the tool to maintain the structural integrity required for implantation while being adaptable enough to be shaped into S-curves or other configurations to minimize vertebral displacement.
4Object-affected harmful factors
If the delivery tool body is made flexible to reduce incision size, then tissue trauma is reduced, but the tool may not maintain sufficient resistance to bending to ensure stable lead positioning
Solution Approach 1:
The delivery tool employs dynamic structural elements that can change their bending resistance based on the operational phase. During insertion, the tool maintains high flexibility to navigate through tissue with minimal incision. Once the paddle lead reaches its target position, the tool can be rigidized or locked into place to ensure stable positioning. This dynamic transition from flexible to rigid state allows the tool to achieve both small incision size and stable lead positioning.
Solution Approach 2:
The delivery tool includes intermediary structures such as expansion mechanisms or locking features that mediate between the flexible insertion phase and the stable positioning phase. These intermediary elements allow the tool to transition from a flexible state that minimizes incision size to a rigid state that ensures lead positioning stability. The intermediary mechanisms act as a bridge, enabling the tool to fulfill both requirements without compromise.
Data Source
AI summary
A delivery tool is provided for use in implanting a paddle lead including a paddle electrode array disposed at a distal end of a paddle lead body. The delivery tool has a proximal tool end and a distal tool end opposite the proximal end and a tool body extending therebetween. The tool body is adapted to receive a portion of the paddle lead body and includes a longitudinal member extending along the tool body and a plurality of structural members extending from the longitudinal member. The structural members are distributed along the longitudinal member such that gaps are defined between longitudinally adjacent structural members. The tool body is structured to have increased resistance to bending in a first direction and reduced resistance to bending in a second direction perpendicular to the first direction.