Bilateral Vagus Nerve Stimulation via Jugular Vein Leads
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Solution Overview
Problem
Unilateral vagus nerve stimulation can lead to nerve fatigue and requires invasive implantation procedures, precluding effective responsiveness testing before final positioning, while existing cuff electrodes may cause negative tissue interactions.
Innovation Solution
Bilateral vagus nerve stimulation is achieved using two leads, one for each side of the neck, with electrodes positioned within or beside the internal jugular veins, allowing for less frequent nerve stimulation and enabling endovascular or percutaneous placement for temporary therapy trials, along with closed-loop feedback for adjusting stimulation based on physiological parameters.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If unilateral vagus nerve stimulation is used, then the implantation procedure is simpler, but nerve fatigue occurs and therapy responsiveness cannot be tested before final positioning
Solution Approach 1:
The patent divides the stimulation system into two separate leads, with each lead targeting one vagus nerve. This segmentation allows independent positioning and testing of each lead, enabling responsiveness evaluation before final implantation while maintaining procedural simplicity through modular endovascular access.
Solution Approach 2:
The patent employs endovascular leads that can be temporarily positioned in the internal jugular veins to deliver stimulation locally to each vagus nerve. This local access method enables testing of therapy responsiveness at the specific treatment site before committing to permanent implantation, resolving the contradiction between procedural simplicity and therapeutic reliability.
2Power
If cuff electrodes are used for vagus nerve stimulation, then stimulation can be delivered, but invasive implantation is required and negative tissue interactions occur
Solution Approach 1:
The patent uses the internal jugular vein as an intermediary pathway to deliver stimulation leads to the vagus nerves. This vascular route serves as a natural conduit that avoids direct penetration of neural tissue, eliminating the need for cuff electrodes while maintaining effective stimulation delivery capability and preventing negative tissue interactions.
Solution Approach 2:
The patent replaces the mechanical cuff electrode system with an endovascular lead system. Instead of mechanically encircling and compressing the nerve, the new system delivers stimulation through electrodes positioned within the vein adjacent to the nerve, substituting a less invasive mechanical approach that avoids tissue damage while preserving stimulation power.
3Reliability
If bilateral vagus nerve stimulation is implemented, then nerve fatigue is reduced and therapy responsiveness can be tested, but the device complexity increases
Solution Approach 1:
The patent designs each endovascular lead to serve multiple functions: positioning within the internal jugular vein, delivering stimulation to the vagus nerve, and enabling responsiveness testing before final implantation. This multi-functionality allows bilateral stimulation with two leads rather than requiring more complex multi-electrode configurations, reducing overall device complexity while maintaining therapeutic reliability.
Data Source
AI summary
An example system includes a first lead configured to be positioned in or beside a left internal jugular vein (IJV) of a patient to deliver a first stimulation signal to a first vagus nerve, the first lead including one or more first segmented electrodes positioned on a distal portion of the first lead and a first anchoring mechanism; a second lead configured to be positioned in or beside a right IJV of the patient to deliver a second stimulation signal to a second vagus nerve, the second lead including one or more second segmented electrodes positioned on a distal portion of the second lead and a second anchoring mechanism; and circuitry configured to deliver electrical energy to the first lead to deliver the first stimulation signal and the second lead to deliver the second stimulation signal to provide bilateral stimulation to the first vagus nerve and the second vagus nerve.