Implantable Nerve Stimulation With Asymmetric Pulse Steering

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Solution Overview

Problem

Existing implantable medical devices face challenges such as off-target delivery of stimulation, patient discomfort, and reduced efficacy due to current spread and imperfect electrode placement, leading to issues like auditory sensations, counter-active muscle contractions, and increased arousal.

Innovation Solution

The implementation of adjustable stimulation parameters, including pulse frequency, amplitude, and burst duration, along with asymmetrical electrode configurations and current steering, allows for targeted nerve recruitment and minimization of off-target effects.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional stimulation parameters and symmetrical electrode configurations are used, then device complexity is reduced and ease of manufacture is improved, but therapeutic efficacy decreases due to off-target delivery and current spread

Engineering Contradiction:
Improvetherapeutic efficacyVSAvoidelectrode configuration complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies asymmetry by using asymmetrical electrode configurations where electrodes are positioned at different distances from the nerve target, and by implementing asymmetrical pulse delivery patterns. This asymmetric design creates more focused current distribution that selectively recruits target nerve fibers while minimizing off-target effects, thereby improving therapeutic efficacy without requiring complex multi-channel systems

Inventive Principle:
Principle #4Asymmetry

Solution Approach 2:

The patent implements local quality by delivering different stimulation parameters to different electrodes based on their specific positions relative to the nerve target. Each electrode receives customized pulse characteristics (amplitude, frequency, duration) optimized for its local location, enabling precise spatial control of current distribution to enhance nerve recruitment accuracy while maintaining manageable device complexity

Inventive Principle:
Principle #3Local quality

2Reliability

If stimulation amplitude is increased to improve nerve recruitment, then therapeutic efficacy is improved, but patient discomfort and harmful factors increase

Engineering Contradiction:
Improvenerve recruitment efficacyVSAvoidpatient discomfort
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies parameter changes by dynamically adjusting multiple stimulation parameters (amplitude, frequency, pulse width, duty cycle) rather than relying solely on increasing amplitude. The system optimizes the combination of these parameters to achieve effective nerve recruitment at lower amplitude levels, thereby improving therapeutic efficacy while reducing patient discomfort and harmful effects such as auditory sensations and muscle contractions

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent implements dynamics by using adaptive stimulation patterns that can change parameters in real-time based on response feedback. The system dynamically adjusts pulse delivery to optimize nerve recruitment while minimizing discomfort, allowing flexible parameter modification during operation to maintain therapeutic efficacy without causing excessive patient discomfort

Inventive Principle:
Principle #15Dynamics

3Reliability

If electrode placement precision is improved to reduce off-target effects, then therapeutic efficacy is improved, but manufacturing precision requirements and surgical difficulty increase

Engineering Contradiction:
Improvetarget delivery precisionVSAvoidelectrode placement precision
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

The patent applies preliminary action by incorporating adjustable parameters that can be optimized after implantation based on patient-specific response. This allows the system to compensate for variations in electrode placement through software-based parameter adjustment, reducing the stringency of surgical placement precision requirements while maintaining high therapeutic efficacy through customized stimulation parameters

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent implements parameter changes by enabling post-implantation optimization of stimulation parameters to account for actual electrode-tissue contact conditions. This flexibility allows compensation for minor placement variations without requiring extremely precise manufacturing or surgical placement, thereby reducing manufacturing precision requirements while maintaining reliable target delivery

Inventive Principle:
Principle #35Parameter changes

4Reliability

If pulse frequency and duration are optimized to improve efficacy, then therapeutic effectiveness is improved, but power consumption increases

Engineering Contradiction:
Improvetherapeutic effectivenessVSAvoidpower consumption
Core Design Contradiction:
ReliabilityVSUse of energy by moving object

Solution Approach 1:

The patent applies parameter changes by optimizing the combination of pulse frequency, amplitude, and duration to achieve maximum nerve recruitment efficiency at minimum energy cost. By carefully selecting and adjusting these parameters, the system delivers effective stimulation with reduced power consumption compared to conventional approaches that use higher amplitude or frequency without optimization

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent implements periodic action by using pulsed stimulation patterns with optimized duty cycles that balance therapeutic effectiveness with energy conservation. The intermittent nature of pulse delivery allows energy-efficient nerve recruitment while maintaining therapeutic benefit, reducing overall power consumption compared to continuous or high-frequency stimulation approaches

Inventive Principle:
Principle #19Periodic action

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

Enhances therapeutic efficacy by optimizing nerve recruitment, reducing patient discomfort, and minimizing arousal, while allowing for more precise electrode placement and reduced power consumption.

Implementation Method 1

stimulation engine to deliver electrical pulses to a nerve or nerves of a patient

Methodology Applied
Scientific EffectElectrical stimulation: Electric Field

Data Source

PatentUS12390646B2Implantable medical devices
Publication Date: 2025.08.19 INSPIRE MEDICAL SYSTEMS INC
  • US12390646B2 patent drawing
  • US12390646B2 patent drawing
  • US12390646B2 patent drawing

AI summary

One example of an implantable medical device includes an output signal driver, a first electrode, a second electrode, and a controller. The output signal driver is configured to generate stimulation pulses to stimulate a nerve within a patient. The first electrode is coupled to the output signal driver. The second electrode is coupled to the output signal driver. The controller is configured to control the output signal driver to selectively apply between the first electrode and the second electrode a first pulse train and a second pulse train interleaved with the first pulse train.