Leadless Neurostimulation Device Closed-Loop Control
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Solution Overview
Problem
Existing implantable neurostimulation systems require invasive leads for delivering stimulation therapy, which can be cumbersome and less effective compared to a unitary, leadless design that integrates sensing capabilities for closed-loop control.
Innovation Solution
A leadless neurostimulation device with a housing containing a controller and processing circuitry, featuring primary and secondary electrodes for electrical stimulation and sensing, respectively, configured to provide closed-loop feedback for optimizing therapy parameters, particularly designed for effective stimulation of the tibial nerve with a focus on size, shape, and electrode separation to achieve efficient impedance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If lead-based neurostimulation devices are used, then electrical stimulation therapy can be delivered, but the device becomes more invasive and cumbersome
Solution Approach 1:
The patent merges the lead and housing into a single unitary structure where the housing itself forms the electrode assembly. This integration eliminates the separate lead component, reducing invasiveness while maintaining stimulation therapy delivery capability through the integrated electrode structure.
Solution Approach 2:
The housing serves multiple functions simultaneously: it provides structural support, acts as the electrode assembly for stimulation, and incorporates sensing capabilities. This multi-functionality eliminates the need for separate lead components, achieving both reduced invasiveness and maintained therapeutic effectiveness.
2Adaptability or versatility
If separate leads are used for stimulation, then therapy can be delivered to distant locations, but the device complexity increases
Solution Approach 1:
The patent combines the stimulation electrodes and sensing electrodes into a single integrated housing structure. This merging reduces device complexity by eliminating separate lead components while maintaining the ability to deliver therapy to targeted locations through the integrated electrode configuration.
Solution Approach 2:
The housing is segmented into distinct functional zones with primary electrodes for stimulation and secondary electrodes for sensing, allowing targeted therapy delivery while maintaining a simplified single-unit structure that reduces overall device complexity.
3Ease of operation
If leadless unitary design is used, then invasiveness is reduced, but sensing capability for closed loop control must be integrated
Solution Approach 1:
The patent merges stimulation electrodes and sensing electrodes into a single integrated housing structure. This integration achieves reduced invasiveness through a leadless design while incorporating sensing capability for closed-loop control through the same housing, managing complexity through functional integration rather than separate components.
Solution Approach 2:
The housing is designed as a multi-functional component that simultaneously provides structural support, delivers electrical stimulation through primary electrodes, and senses neural activity through secondary electrodes. This multi-functionality enables leadless design with integrated sensing while managing complexity through a single versatile component.
4Productivity
If electrode size and separation are optimized for impedance, then stimulation efficiency improves, but device dimensions are constrained
Solution Approach 1:
The patent applies different electrode configurations to different regions of the housing: primary electrodes are positioned on one side for stimulation while secondary electrodes are positioned on the opposite side for sensing. This local differentiation optimizes impedance and stimulation efficiency while maintaining compact device dimensions through spatial arrangement rather than increasing overall volume.
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 leadless neurostimulation device offers a more robust and minimally invasive solution, enabling precise and efficient delivery of therapy with real-time adjustment of stimulation parameters based on sensed nerve activity, improving treatment outcomes for conditions like overactive bladder and urinary incontinence.
Implementation Method 1
transmit an electrical stimulation signal between the primary electrode to the secondary electrode to provide electrical stimulation therapy to a tibial nerve
Implementation Method 2
one or more sensors arranged on the housing or footer of the device, the one or more sensors configured to sense stimulated nerve activity
Implementation Method 3
At least one controller (e.g., processor and processing circuitry) configured to receive sensed nerve activity and adjust one or more parameters of the neurostimulation therapy
Data Source
AI summary
A leadless neurostimulation device having a header unit having at least one primary electrode that defines an external surface of the device, and a housing that includes a secondary electrode positioned on the same side of device as the primary electrode, a footer coupled to the housing opposite of the header unit, and a controller. The controller configured to operate in a closed-loop to transmit an electrical stimulation signal between the primary electrode to the secondary electrode to provide electrical stimulation therapy to a tibial nerve of a patient, measure a physiologic parameter in response to transmission of the electrical stimulation therapy, and adjust one or more parameters of the electrical stimulation signal based on the measured physiologic parameter.