Electrode Leads With Inflatable Cuff Straighteners for Nerve Placement
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Solution Overview
Problem
Conventional nerve cuffs pre-set to a furled state face challenges such as difficulty in straightening, potential nerve damage, and increased surgical duration due to manual placement requirements.
Innovation Solution
An electrode lead with an inflatable nerve cuff straightener that allows the nerve cuff to be unfurled and adjusted for accurate placement around the hypoglossal nerve, using pressurized fluid to transition between furled and unfurled states, reducing the risk of damage and simplifying the implantation process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a nerve cuff is pre-set to a furled state to enable self-wrapping around the nerve, then the ease of operation is improved, but the difficulty of straightening the cuff increases and the duration of the surgical procedure increases
Solution Approach 1:
The nerve cuff is pre-set to a furled state during manufacturing, which allows it to self-wrap around the nerve during implantation without requiring manual wrapping or sutures. This preliminary configuration simplifies the surgical procedure and reduces operation time.
Solution Approach 2:
The nerve cuff transitions from a static pre-set furled state to a dynamic state during implantation where it can be temporarily straightened using a straightening tool, then returns to its furled state to self-wrap around the nerve. This dynamic behavior allows both easy placement and controlled straightening.
2Ease of operation
If a nerve cuff is pre-set to a furled state to enable self-wrapping, then the ease of operation is improved, but the risk of nerve cuff damage increases
Solution Approach 1:
A straightening tool or device is introduced as an intermediary between the surgeon's hands and the nerve cuff. This tool gently straightens the furled cuff during placement, preventing direct manual manipulation that could damage the delicate pre-set configuration while still enabling proper positioning.
3Ease of operation
If a nerve cuff is pre-set to a furled state to enable self-wrapping, then the ease of operation is improved, but the manufacturing precision requirements increase
Solution Approach 1:
The furled state is pre-configured during manufacturing with specific geometric parameters and material properties that enable reliable self-wrapping. This preliminary action establishes a controlled initial state that compensates for manufacturing tolerances and ensures consistent performance during implantation.
Solution Approach 2:
The nerve cuff material and geometry are designed with specific parameters (elasticity, thickness, curvature radius) that allow the pre-set furled state to be achieved with reasonable manufacturing precision while still enabling reliable self-wrapping function during implantation.
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
The inflatable cuff straightener facilitates easier and quicker nerve cuff placement, minimizing surgical trauma and duration, while allowing selective curvature adjustment for precise nerve stimulation.
Implementation Method 1
using pressurized fluid to transition between furled and unfurled states
Data Source
AI summary
An electrode lead comprising an elongate lead body having a proximal end, a distal end and a plurality of electrical conductors, a biologically compatible, elastic, electrically insulative nerve cuff body that is associated with the distal end of the lead body, is configured to be circumferentially disposed around a nerve, has a pre-set furled state that defines an inner lumen and is movable to an unfurled state, a plurality of electrically conductive contacts carried by the nerve cuff body and electrically associated with the electrical conductors, and an inflatable nerve cuff straightener associated with the nerve cuff body and configured to at least substantially straighten the nerve cuff body when in a fully inflated state.