Leadless Vagus Nerve Microstimulator for Stable Positioning
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Solution Overview
Problem
Current leadless neural stimulation devices are larger and more massive than desired, making it difficult to stably position them on nerves, and they often require long charging times, are difficult to control, and are susceptible to mechanical damage.
Innovation Solution
The development of an implantable microstimulator system that includes a nerve cuff with integral electrodes and a microstimulator with integral contacts, which can assemble in-situ, providing stable positioning on the nerve and allowing for easy removal and replacement, while also utilizing a charging/programming device and controller to manage the stimulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current leadless neural stimulation devices are used, then neural stimulation can be achieved, but the devices become larger and more massive making difficult stable positioning on nerves
Solution Approach 1:
The device is divided into separate functional components: a lightweight microstimulator unit and a distinct positioning mechanism. The microstimulator contains only essential components (battery, circuit board, antenna, electrode contacts) while the positioning function is achieved through the cuff structure and surgical placement, not through adding mass to the stimulator itself.
Solution Approach 2:
The microstimulator is extracted as a separate, removable component that can be placed within a protective cuff. This allows the stimulator to be optimized for minimal weight and size while the cuff provides the necessary positioning and mechanical support, separating the conflicting requirements of lightweight design and stable positioning.
2Duration of action of moving object
If current leadless neural stimulation devices are used, then neural stimulation can be achieved, but they require long charging times
Solution Approach 1:
The device operates at extremely low power consumption levels (estimated 0.1-10 microwatts during stimulation, lower during charging), which fundamentally changes the energy parameters. This low-power operation allows for rapid charging times while maintaining adequate battery capacity for extended use periods, resolving the contradiction between charging duration and energy storage requirements.
3Reliability
If current leadless neural stimulation devices are used, then neural stimulation can be achieved, but they are susceptible to mechanical damage
Solution Approach 1:
The microstimulator is placed within a protective cuff structure before implantation, providing mechanical cushioning and protection from damage. The cuff acts as a protective barrier that shields the delicate electronic components from mechanical stress, bending, and tissue damage while allowing the device to function reliably in the implantation site.
4Ease of operation
If current leadless neural stimulation devices are used, then neural stimulation can be achieved, but they are difficult to control
Solution Approach 1:
The device incorporates wireless communication capability that enables two-way communication between the implanted microstimulator and external programming devices. This feedback channel allows real-time adjustment of stimulation parameters, monitoring of device status, and programming of complex stimulation patterns, providing sophisticated control without increasing the physical complexity of the implantable device itself.
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 system achieves stable and reliable neural stimulation with reduced surgery time, increased reliability, and shorter charging times, while minimizing mechanical damage and improving control over the stimulation parameters.
Implementation Method 1
an implantable microstimulator configured for implantation around a cervical portion of a vagus nerve to modulate inflammation by applying a low duty-cycle stimulation to the vagus nerve
Implementation Method 2
a charger configured to be worn around the patient's neck and to charge the implantable microstimulator implanted within the patient's neck region
Data Source
AI summary
A system for treating chronic inflammation may include an implantable microstimulator, a wearable charger, and optionally an external controller. The implantable microstimulator may be implemented as a leadless neurostimulator implantable in communication with a cervical region of a vagus nerve. The microstimulator can address several types of stimulation including regular dose delivery. The wearable charger may be worn around the subject's neck to rapidly (<10 minutes per week) charge an implanted microstimulator. The external controller may be configured as a prescription pad that controls the dosing and activity of the microstimulator.


