Focused Ultrasound Nerve Modulation with EMG Monitoring

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Solution Overview

Problem

Current methods for treating peripheral nervous system diseases are often invasive, non-specific, or associated with side effects, lacking targeted and non-invasive options for modulating peripheral nerves effectively.

Innovation Solution

Focused ultrasound (FUS) techniques are employed to modulate peripheral nerves by adjusting ultrasound parameters such as peak negative pressure, stimulation duration, duty cycle, and pulse repetition frequency, using a system that includes an imaging probe and a high-intensity focused ultrasound transducer to target specific nerves like the sciatic, tibial, or sacral nerves, eliciting physiological responses without causing damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If electrical stimulation is used to treat peripheral nerves, then physiological response is achieved, but the method is invasive and may cause tissue damage

Engineering Contradiction:
Improvephysiological responseVSAvoidtissue damage
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces electrical stimulation with mechanical vibration using focused ultrasound waves. The ultrasound transducer generates mechanical vibrations that propagate through tissue to stimulate peripheral nerves, eliminating the need for electrical currents that can cause tissue damage. This substitution maintains therapeutic efficacy while avoiding harmful electrical effects on neural tissue.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent introduces focused ultrasound as an intermediary between the treatment device and the peripheral nerve. Instead of directly applying electrical stimulation to the nerve, ultrasound waves serve as a mediator that transmits mechanical energy through the tissue to activate nerve fibers indirectly, reducing direct trauma to the nerve structure.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Adaptability or versatility

If drug therapy is used to treat peripheral nervous system diseases, then treatment coverage is broad, but the approach is non-specific and spatially untargeted

Engineering Contradiction:
Improvetreatment coverageVSAvoidspatial targeting
Core Design Contradiction:
Adaptability or versatilityVSMeasurement precision

Solution Approach 1:

The patent applies focused ultrasound energy to a specific localized region where the peripheral nerve is located. By concentrating acoustic energy at a precise focal point determined through imaging guidance, the treatment achieves spatially targeted stimulation of the affected nerve while leaving surrounding tissues unaffected. This localizes the therapeutic effect to the specific anatomical site requiring treatment.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent divides the treatment approach into distinct segments: imaging for localization, focused ultrasound delivery to the specific nerve region, and monitoring of physiological response. This segmented approach allows precise spatial targeting of the peripheral nerve while maintaining the ability to adjust treatment parameters based on real-time feedback, achieving both versatility and precision.

Inventive Principle:
Principle #1Segmentation

3Measurement precision

If invasive surgical intervention is performed on peripheral nerves, then direct nerve access is achieved, but the procedure complexity and risk increase

Engineering Contradiction:
Improvenerve access precisionVSAvoidsurgical procedure complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces invasive surgical procedures with non-invasive focused ultrasound delivery. Instead of making incisions to access the peripheral nerve, the system uses ultrasound waves that can penetrate through skin and soft tissue to reach the nerve target. This mechanical wave-based approach eliminates the need for surgical instruments, incisions, and complex surgical procedures while maintaining precise nerve targeting capability.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent employs a multi-functional system that combines imaging capabilities with focused ultrasound delivery in a single non-invasive platform. The same ultrasound transducer can be used for both visualizing the peripheral nerve location and delivering therapeutic vibrations, eliminating the need for separate surgical instruments and procedures. This universal approach simplifies the overall treatment process while maintaining precision.

Inventive Principle:
Principle #6Universality (Multi-functionality)

4Object-affected harmful factors

If high intensity focused ultrasound is applied to modulate peripheral nerves, then non-invasive stimulation is achieved, but thermal effects may cause tissue damage

Engineering Contradiction:
ImproveinvasivenessVSAvoidtissue temperature
Core Design Contradiction:
Object-affected harmful factorsVSTemperature

Solution Approach 1:

The patent employs periodic pulsed ultrasound delivery rather than continuous high-intensity exposure. By delivering ultrasound in repeated short pulses with intervals between them, the system allows tissue to cool between pulses, preventing cumulative thermal buildup. This periodic action maintains the mechanical stimulation effect on peripheral nerves while avoiding harmful temperature increases that could cause tissue damage.

Inventive Principle:
Principle #19Periodic action

Solution Approach 2:

The patent uses short-duration ultrasound pulses that rapidly deliver mechanical energy to stimulate the nerve and then immediately cease, skipping the prolonged exposure that would generate excessive heat. This brief, intensive stimulation approach achieves the desired physiological response before significant thermal effects can accumulate, effectively separating the therapeutic mechanical action from harmful thermal effects.

Inventive Principle:
Principle #21Skipping (Rushing through)

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

FUS provides a non-invasive, targeted, and safe method for stimulating peripheral nerves, eliciting comparable physiological responses to conventional electrical stimulation with minimal side effects and no detectable damage, offering a promising alternative for treating various peripheral nervous system diseases.

Implementation Method 1

Focused ultrasound (FUS) techniques are employed to modulate peripheral nerves by adjusting ultrasound parameters such as peak negative pressure

Methodology Applied
Scientific EffectAcoustic Radiation Pressure: Acoustic Radiation Pressure

Implementation Method 2

mechanical effect can be indicated during FUS stimulation, for example, the activation of mechanosensitive ion channels

Methodology Applied
Scientific EffectMechanical Vibration: Vibration

Implementation Method 3

eliciting and measuring a physiological response during or after FUS modulation. As embodied herein, and without limitation, the measuring physiological response can include acquiring EMG signals from a muscle tissue

Methodology Applied
Scientific EffectElectromyography:

Data Source

PatentUS11013938B2Methods and systems for peripheral nerve modulation using non ablative focused ultrasound with electromyography (EMG) monitoring
Publication Date: 2021.05.25 THE TRUSTEES OF COLUMBIA UNIV IN THE CITY OF NEW YORK
  • US11013938B2 patent drawing
  • US11013938B2 patent drawing
  • US11013938B2 patent drawing

AI summary

Techniques for modulating peripheral nerves using focused ultrasound (FUS) are provided. Methods include locating a peripheral nerve in a subject using an imaging probe, providing a FUS having one or more ultrasound parameters to a location on the peripheral nerve, and modulating the peripheral nerve. The methods can further include eliciting and measuring a physiological response from the FUS modulation, generating tissue deformation in the vicinity of the FUS modulation, and imaging the nerve and the tissue deformation simultaneously with FUS modulation. Systems for use in the modulation of peripheral nerves are also provided.