Leadless Vagus Microstimulator with Closed-Loop Feedback Control
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Solution Overview
Problem
Existing implantable electrical stimulation devices for treating chronic inflammation lack closed-loop feedback mechanisms, leading to variable and potentially ineffective treatment due to desensitization and patient-to-patient variability, and are susceptible to mechanical damage from bending or flexing.
Innovation Solution
A leadless implantable microstimulator with integral electrodes, configured for closed-loop feedback, is positioned on the vagus nerve using a nerve cuff with a POD to stabilize the device and minimize mechanical stress, and includes a rechargeable power source and control circuitry for precise stimulation based on neural activity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional implantable electrical stimulation devices with separate electrodes and IPG are used, then the device can provide stimulation therapy, but the system is susceptible to mechanical damage from bending or flexing of leads
Solution Approach 1:
The patent combines the IPG and electrodes into a single integrated microstimulator device that is implanted directly at the nerve site. This eliminates the need for separate lead connections, thereby removing the vulnerability to mechanical damage from bending or flexing while maintaining the stimulation therapy function.
Solution Approach 2:
The patent extracts and eliminates the lead component from the traditional stimulation system. By removing the lead that connects the IPG to electrodes, the system eliminates the source of mechanical damage while preserving the essential stimulation function through direct integration of components.
2Duration of action of stationary object
If open-loop stimulation is used, then the device can provide continuous stimulation, but the treatment becomes variable and potentially ineffective due to desensitization and patient-to-patient variability
Solution Approach 1:
The patent implements closed-loop feedback control where the microstimulator senses neural activity from the vagus nerve and uses this feedback to adaptively adjust stimulation parameters. This ensures reliable and effective treatment by preventing desensitization and accounting for patient-to-patient variability while maintaining continuous therapy.
3Reliability
If a nerve cuff with POD is used to stabilize the microstimulator, then mechanical stress is minimized, but the device complexity increases
Solution Approach 1:
The patent introduces a nerve cuff with POD as an intermediary structure that stabilizes the microstimulator at the nerve site. This mediator minimizes mechanical stress on the device while the cuff's design accommodates the nerve anatomy, providing stability without excessive complexity.
4Reliability
If leadless microstimulator is used, then surgery time is reduced and reliability is increased, but the device requires precise placement and stable positioning
Solution Approach 1:
The patent designs the microstimulator with self-positioning features and stabilization mechanisms that enable the device to secure itself at the nerve site after implantation. This reduces the need for complex external positioning procedures while ensuring reliable and stable placement, thereby improving ease of operation.
Data Source
AI summary
Devices, systems and methods for the treatment of chronic inflammatory disorders that include an implantable microstimulator and an external charger/controller wherein the microstimulator is configured to operate using closed-loop feedback. The feedback for the microstimulator can be electrical activity of the vagus nerve and/or heart sensed by the microstimulator. The feedback can be used to modulate the stimulation duration, intensity, frequency, on-time and off-time.