Peripheral Neuromodulation for Drug-Free Physiological Perturbation
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Solution Overview
Problem
Existing diagnostic methods for clinical conditions, such as glucose tolerance tests and pharmacologic agent administration, are complex, require dietary restrictions, and may produce undesirable side effects, making them unreliable for consistent patient responses.
Innovation Solution
A neuromodulation system using an energy application device and controller to induce targeted physiological perturbations by applying energy to specific regions of interest, assessing changes in molecule concentrations, and determining clinical conditions based on these perturbations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional diagnostic methods (glucose tolerance tests, pharmacologic agents) are used, then diagnostic capability is achieved, but device complexity and side effects increase
Solution Approach 1:
The patent replaces complex pharmacologic intervention systems with a simplified neuromodulation system using focused ultrasound or electrical stimulation to activate vagal nerve terminals. This substitution eliminates the need for complex drug administration protocols, dietary restrictions, and multiple blood sampling procedures while maintaining diagnostic accuracy through direct neural activation of metabolic pathways.
Solution Approach 2:
The invention extracts and isolates the essential diagnostic function by directly stimulating vagal nerve terminals to produce metabolic perturbations, removing the need for complex test protocols, pharmacologic agents, and dietary restrictions. This extraction simplifies the diagnostic process to a single intervention with clear cause-effect relationships.
2Reliability
If pharmacologic agents are administered to induce perturbation, then physiological response is achieved, but harmful side effects increase
Solution Approach 1:
The patent substitutes pharmacologic chemical intervention with physical neuromodulation using focused ultrasound or electrical stimulation. This replacement eliminates harmful side effects of drugs while maintaining predictable physiological responses through direct activation of vagal nerve terminals, which naturally regulate metabolism without introducing foreign substances into the body.
Solution Approach 2:
The invention introduces vagal nerve terminals as an intermediary between the stimulation device and metabolic organs. This intermediary naturally transduces electrical or mechanical stimulation into physiological metabolic responses, eliminating the need for pharmacologic agents and their associated side effects while ensuring predictable and controllable perturbation patterns.
3Measurement precision
If dietary restrictions (fasting) are imposed to ensure compliance, then test accuracy is improved, but ease of operation decreases
Solution Approach 1:
The patent applies preliminary neuromodulation stimulation to activate vagal nerve terminals and establish a controlled physiological baseline before measurement. This preliminary action replaces the need for prolonged fasting periods, as the neuromodulation itself creates a standardized physiological state that ensures test accuracy without requiring extensive patient preparation or dietary restrictions.
Solution Approach 2:
The invention enables the physiological system to self-regulate and produce the desired perturbation response through neuromodulation of intrinsic vagal pathways. This self-service mechanism eliminates the need for external controls like fasting or dietary manipulation, allowing patients to undergo testing in their normal physiological state while maintaining measurement precision through neural activation.
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
Enables non-invasive, targeted, and predictable physiological perturbations for diagnosing conditions like diabetes and inflammation, avoiding side effects and improving diagnostic accuracy.
Implementation Method 1
an energy application device configured to apply energy to a first region of interest in a first organ and to a second region of interest in a second organ, wherein the energy application device is an ultrasound probe
Data Source
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AI summary
Embodiments of the present disclosure relate to techniques for inducing physiological perturbations in a subject via neuromodulation, e.g., peripheral neuromodulation of a region of interest of an organ. The nature and degree of the perturbations may be related to the subject's clinical condition. Accordingly, an assessment of one or more characteristics of the perturbations may be used to determine a clinical condition of the subject.