Collapsible Introducer for Parallel Spinal Cord Lead Placement
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Solution Overview
Problem
The precise and delicate placement of two parallel medical leads on either side of the spinal cord for spinal cord stimulation is challenging due to anatomical considerations and requires skilled expertise.
Innovation Solution
A method and device utilizing an introducer with collapsible and expandable lumens and side sheaths allow for the easy insertion and positioning of two leads parallel to each other and the spinal cord midline, facilitating efficient epidural placement by maintaining a low profile during insertion and expanding for proper orientation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If traditional lead placement methods are used, then leads can be inserted into the spinal cord, but proper positioning of parallel leads requires great skill and is difficult to achieve
Solution Approach 1:
The introducer device serves as an intermediary tool that facilitates lead placement. It includes a needle hub with a needle lumen for inserting the first lead, and a balloon that can be inflated to create space for a second lumen. This intermediary device makes the complex task of placing parallel leads much easier and more precise.
Solution Approach 2:
The introducer device is segmented into multiple functional components: a needle hub with a needle lumen for the first lead, and a balloon that can be inflated to create a second lumen for the second lead. This segmentation allows each component to perform its specific function, making the overall lead placement process more manageable and precise.
2Reliability
If two leads are placed parallel to each other on either side of the midline, then proper spinal cord stimulation is achieved, but the procedure becomes complex and time-consuming
Solution Approach 1:
The introducer device is pre-configured with the needle hub and balloon in specific spatial relationships. The balloon is pre-positioned relative to the needle lumen, and when inflated, it automatically creates the second lumen in the correct position. This preliminary configuration ensures that when the leads are placed, they will be properly positioned for effective spinal cord stimulation, while greatly simplifying the surgical procedure.
3Volume of moving object
If the introducer uses a collapsible and expandable lumen structure, then the profile is reduced for insertion, but the structure becomes more complex
Solution Approach 1:
The balloon is designed to be collapsible during insertion and expandable after positioning. When deflated, the balloon maintains a low profile that allows easy insertion through the needle hub. After the first lead is placed and the balloon is inflated, it expands to create the second lumen for the second lead. This dynamic transformation allows the device to adapt its shape to different stages of the procedure, reducing the profile during insertion while providing the necessary structure for dual lead placement.
Data Source
AI summary
Devices and methods for implanting leads along a spinal cord include an introducer having a main body defining a lumen and one or more collapsible and expandable side sheaths attached to the main body. The side sheaths may be collapsed as the introducer is positioned in a desired location of a patient to maintain a low profile. Once the introducer is placed, the side sheaths may be expanded to receive a lead. A lead may also be inserted through a lumen of the main body. Once the leads are inserted, the introducer may be withdrawn over the leads, leaving the leads implanted in the desired region in a desired orientation.