Method and system for combining physiological and machine information to enhance function

Abstract

The present invention relates generally and specifically to combining biological sensors with external machines using machine learning to form computerized representations that can control effectors to deliver therapy or enhance performance.

Description

FIELD[0001]The present invention relates generally and specifically to combining biological sensors with external machines using machine learning to form computerized representations capable of controlling effectors to deliver therapy or enhance performance. The invention integrates sensed signals from body systems and artificial devices with outputs from measureable body systems and artificial devices to create learned networks. Measurable body systems include the central and peripheral nervous systems, cardiovascular system, respiratory system, skeletal muscles and skin well as any other body systems that are capable of producing measurable signals. Artificial devices include diagnostic sensors, medical stimulating or prosthetic devices and / or non-medical systems. The invention has applications in sleep and wakefulness, sleep-disordered breathing, memory and cognition, monitoring and responding to obesity or heart failure and other conditions, or more generally in enhancing perfor...

AI Technical Summary

Benefits of technology

[0030]The invention is designed to monitor and modulate a complex bodily function using a combined biological and machine approach. Unlike the prior art, the current invention uses machine learning to derive a robust relationship between sensed signatures of measurable body systems and bodily functions in animals and in particular human beings, but does not require presumed physiological relationships or mechanisms. The invention is then able to enhance performance of function or re-instate lost functions using this robust relationship or enciphered functional network.

Problems solved by technology

Physical constraints include an external obstacle preventing movement of a limb in an enclosed space such as may affect a warrior or scuba diver.

However, functional constraints may also include underperformance on a task due to insufficient training, knowledge or acquisition of skills, or through disuse.

What is lacking is how devices can be used to automatically (“intelligently”) tailor therapy to restore lost physiological function or enhance an existing function in a specific individual.

This inability for prior and current devices to automatically tailor therapy and restore or enhance a function is striking when examining how the human brain senses, integrates and controls bodily functions.

Moreover, other bodily functions including “higher cortical” functions are neither well defined nor conserved.

Unfortunately, such detailed knowledge is often incomplete.

Mapping of functional locations often vary between individuals—and even in the same person at different times. Many functions are poorly mapped, such as memory, cognition and mental performance.

Even for well mapped functions, studies that define physiological function often raise additional uncertainties in this functionality.

Mapping functional domains of a bodily function—the network of physiological systems associated with that function including sensed signals and biological effectors that control it—is difficult.

Mapping of functional domains is particularly difficult for functions involving the brain.

However, there is an urgent need to sense and modulate functional domains whose altered function may cause disease or suboptimal performance.

However, it is not clear what brain regions are responsible for controlling sleep, or for mediating abnormal breathing in central sleep apnea.

Yet, how nuclei are integrated into abnormal breathing to produce obstructive sleep apnea is not understood.

As a result, it has been difficult to treat this condition even using novel systems that activate tongue motion to reduce obstruction.

Interactions between the multiple organ systems impacted by sleep further complicate precise mapping.

An individual's ability to sleep may be compromised in many ways.

All sleep disorders negatively impact wakefulness, producing daytime drowsiness that impairs daily activities.

Central sleep apnea is also common, yet is under-recognized and associated with comorbidities such as heart failure.

However, this is a cumbersome test typically performed with an overnight hospital stay attended by physicians, is not well liked by patients, cannot easily be repeated to assess the impact of therapy and is difficult to perform at home.

Recent studies have shown that commercial tests offered to circumvent traditional polysomnography are suboptimal at best.

Several treatments are available for obstructive sleep apnea, but these are often not well tolerated.

Some recent devices have applied stimulation to the muscles of the tongue or face to eliminate obstruction, but it is unclear how well they will work in the broad population.

Pharmacological drug therapy is often used to induce sleep, but these agents are not useful in sleep apnea.

These drugs rarely mimic the natural stages of sleep, rarely induce rapid eye movement (REM) sleep that is essential for restfulness, and may paradoxically worsen sleep disorders and produce daytime drowsiness despite nighttime unconsciousness.

All these current modalities suffer from a significant common problem, as they attempt to perform therapy with no or minimal sensory input, feedback, or modulation of such therapy based upon the individual patient's neurological activity.

Unfortunately, the true mechanism of action of such therapy is unclear.

Similar to trigeminal nerve stimulation, the mechanism is poorly understood, the actual stimulation of the vagus nerve is unclear via this noninvasive approach, and there is no individual patient adaptation.

All of these approaches, even though they show interesting preliminary data suffer, from the same problems as above, namely, poor understanding of mechanism and lack of patient-tailored therapy due to a lack of feedback and adaptation for individual patients.

.)—are being evaluated but typically do not have individual patient-tailored therapies.

In fact, whether direct management of the obstruction resolves the problem of apnea is also unclear due to commonality of a central sleep apnea component in most patients.

However, these therapies target single components of the physiologic network for a bodily function, and are limited because they do not consider the remaining network.

This may lead to suboptimal therapy, compensatory mechanisms that further diminish the efficacy of therapy, or unwanted effects.

Moreover, these therapies are only as good as the accuracy of their specific targets, and brain / nerve regions are imprecisely defined for many bodily functions including sleep control, sleep-breathing conditions, cognition, alertness, memory, overall mental performance, or response to obesity.

Traditional therapies have also not typically been effective for managing central sleep apnea, other cognitive or performance functions, alertness, heart failure or obesity.

Unfortunately, such approaches may be limited in that normal pathways vary from individual to individual.

Thus, simulating normal often may not accurately replicate that function for an individual nor represent normal for that individual.

In other situations, the use of devices to enhance or compensate for other functions such as motor tasks are limited or constrained.

Physical constraints include an external obstacle preventing movement of a limb in an enclosed space such as may affect a warrior or scuba diver.

However, functional constraints may also include underperformance on a task due to insufficient training, knowledge or acquisition of skills, or through disuse.

However, the precise locations of the brain or other physiological systems that control each task are not well defined.

Much data has come from animal models that are not well suited to model or analyze complex human functions or mental functions.

Currently, there are few methods in the prior art to achieve these goals.

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