WO2015042365A1

WO2015042365A1 - Electro-stimulation systems, methods, and apparatus for treating pain

Info

Publication number: WO2015042365A1
Application number: PCT/US2014/056504
Authority: WO
Inventors: David Lin; Weidong Lu
Original assignee: Dana-Farber Cancer Institute, Inc.
Priority date: 2013-09-20
Filing date: 2014-09-19
Publication date: 2015-03-26

Abstract

Systems, apparatus, and methods are provided for preventing, reducing, and/or treating pain in a subject, including a wearable device with a plurality of non-invasive electrical contacts configured such that, when the device is worn by the subject, at least two of the plurality of electrical contacts are in contact with a first location of the subject's body and positioned in near proximity to at least one treatment point corresponding to a second location of the subject's body, the second location being remote from the at least one treatment point and at least one processor that controls the wearable device to stimulate the at least one treatment point by application of an electrical pulse signal through the at least two of the plurality of electrical contacts so as to at least one of prevent, reduce, and treat pain in the second location of the subject's body.

Description

ELECTRO-STIMULATION SYSTEMS, METHODS, AND APPARATUS

FOR TREATING PAIN

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] The application claims benefit under 35 U.S.C. § 119(e) of U.S. Provisional Application Ser. No. 61/880,267 filed Sep. 20, 2013, the contents of which are herein incorporated by reference in their entirety.

TECHNICAL FIELD

[0002] The present disclosure relates generally to systems, methods, and apparatus for applying electro-stimulation to a subject. More specifically, the present disclosure relates to electro-stimulation systems, methods, and apparatus, particularly wearable devices, for researching, measuring, preventing, reducing, and/or treating pain, particularly chronic pain, in a subject or population.

BACKGROUND

[0001] Pain felt by a subject can vary according to, among other things, the time since onset, the duration, the intensity, the pattern(s) of occurrence, the region of the body involved, and the etiology. Pain may be caused, increased, or prolonged by unpleasant stimulation of peripheral nerve fibers (i.e., nociceptive pain from, e.g., thermal, mechanical, and/or chemical stimuli); inflammation (associated with, e.g., tissue damage and/or infiltration of immune cells); disease and/or damage affecting the nervous system (i.e., neuropathic pain or dysfunctional pain); and/or mental, emotional, or behavioral factors (i.e., psychogenic pain).

[0002] While pain usually lasts only until the responsible stimulus is removed or the underlying damage or disease has healed or been treated (i.e., acute pain), some painful conditions (e.g., rheumatoid arthritis, peripheral neuropathy, cancer, and idiopathic pain) may persist for months or even years. The term "chronic pain" has been used to describe pain lasting at least three, six, or twelve months or, alternatively, pain extending beyond the expected period of healing. Chronic pain is estimated to be one of the most prevalent medical conditions in the world, with about 20% of adults currently suffering from chronic pain and about 10% adults being newly diagnosed with chronic pain each year. In the United States, approximately 100 million adults experience chronic pain, and the total cost of treatments is estimated to be between $560 and $635 billion each year.

[0003] Existing treatments for chronic pain have numerous shortcomings. For example, opioids for pain treatment may be subject to governmental control, have adverse effects, lead to addiction, and cause user anxiety regarding potential risks. Alternatively, acupuncture has been used to effectively treat various chronic pain conditions including, but not limited to, osteoarthritis, low back pain, shoulder pain, and headaches. In this ancient medical technique, a practitioner inserts fine metal needles into certain anatomical locations of a user's body. The practitioner then manually manipulates the needles to elicit neuron- hormonal responses of the nervous system. However, acupuncture has its own disadvantages including, but not limited to, the invasiveness of the procedure, the duration of pain relief (i.e., the effects of each treatment wear off within days or even hours), and restrictions on self-care (i.e., usually requiring frequent trips to a trained professional).

SUMMARY

[0004] The present disclosure provides systems, methods, and apparatus for applying electro-stimulation to a subject to, for example, measure, prevent, reduce, and/or treat pain in a subject. More specifically, the present disclosure recognizes previously -unrealized advantages to generating and applying at least one stimulation signal to one or more treatment points on a subject's body to effect therapeutic treatment of and/or minimize pain. The disclosed systems, methods, and apparatus are less restrictive on subjects'

mobility/activities (wearable and "hands-free"), while also being less invasive, thus improving usability, comfort, and availability to subjects with compromised immune systems. A treatment provider may not even be needed to use some embodiments because constant monitoring and/or adjustment is no longer required, even though longer durations of use (e.g., hours or days) may be available.

[0005] In one embodiment, an apparatus for preventing, reducing, and/or treating pain in a subject includes a wearable device including a plurality of non-invasive electrical contacts configured such that, when the device is worn by the subject, at least two of the plurality of electrical contacts are in contact with a first location of the subject's body and positioned in near proximity to at least one treatment point corresponding to a second location of the subject's body, the second location being remote from the at least one treatment point, a memory to store processor-executable instructions, and at least one processor

communicatively coupled to the wearable device, so that upon execution of the processor- executable instructions by the at least one processor, the at least one processor controls the wearable device to stimulate the at least one treatment point by application of an electrical pulse signal through the at least two of the plurality of electrical contacts so as to prevent, reduce, and/or treat pain in the second location of the subject's body.

[0006] In a further embodiment, the subject is a human subject, the wearable device is an earpiece, and the first location of the subject's body is at least a portion of the subject's external ear. In an embodiment, the apparatus may also include a signal generator configured to generate the electrical pulse signal.

[0007] In an embodiment, the plurality of electrical contacts may be arranged in a matrixlike formation. In an embodiment, the application of the electrical pulse signal may be periodic. In an embodiment, the application of the electrical pulse signal through the at least two of the plurality of electrical contacts may follows a predetermined treatment protocol that defines the at least one treatment point and voltage, current, frequency, duty cycle, duration, periodicity, and/or sequence of the electrical pulse signal. In an embodiment, the electrical pulse signal may include a plurality of pulses, each pulse including an average current between approximately 0.25 milliamps (mA) and approximately 2.0 milliamps (mA), a peak voltage between approximately 25 millivolts (mV) and approximately 50 volts (V), an average frequency between approximately 0 hertz (Hz) and approximately 100 hertz (Hz), a duty cycle between approximately 0.1 % and approximately 1.0 %, and a duration between approximately 100 microseconds (μ8) and approximately 1000 microseconds (μ8).

[0008] In an embodiment, the at least one processor may be configured to control voltage, current, frequency, duty cycle, duration, periodicity, and/or sequence of the electrical pulse signal. In an embodiment, the at least one processor may be configured to selectively apply the electrical pulse signal through a subset of the plurality of electrical contacts. In an embodiment, the at least one processor may be configured to wirelessly acquire instructions characterizing a treatment protocol. In an embodiment, the at least one processor may be configured to measure an electrical impedance between the at least two of the plurality of electrical contacts, determine, based on the measured electrical impedance, a treatment protocol that defines the at least one treatment point and at least one of voltage, current, frequency, duty cycle, duration, periodicity, and sequence of the electrical pulse signal, and control the wearable device to stimulate the at least one treatment point by application of the electrical pulse signal through the at least two of the plurality of electrical contacts according to the determined treatment protocol.

[0009] In another embodiment, a computer- facilitated method for preventing, reducing, and/or treating pain in a subject includes the steps of positioning at least two non- invasive electrical contacts in contact with a first location of the subject's body and in near proximity to at least one treatment point corresponding to a second location of the subject's body, the second location being remote from the at least one treatment point, applying an electrical pulse signal through the at least two electrical contacts to stimulate the at least one treatment point so as to prevent, reduce, and/or treat pain in the second location of the subject's body.

[0010] In a further embodiment, the at least two electrical contacts are attached to and positioned using a wearable device. In an embodiment, the subject is a human subject, the wearable device is an earpiece, and the first location of the subject's body is at least a portion of the subject's external ear.

[0011] In an embodiment, the method also includes the steps of generating the electrical pulse signal, varying one or more of voltage, current, frequency, duty cycle, duration, periodicity, and sequence of the electrical pulse signal, and/or selecting a subset of the at least two electrical contacts through which to apply the electrical pulse signal. In an embodiment, the electrical pulse signal is applied periodically. In an embodiment, the electrical pulse signal includes a plurality of pulses, each pulse including an average current between approximately 0.25 milliamps (mA) and approximately 2.0 milliamps (mA), a peak voltage between approximately 25 millivolts (mV) and approximately 50 volts (V), an average frequency between approximately 0 hertz (Hz) and approximately 100 hertz (Hz), a duty cycle between approximately 0.1 % and approximately 1.0 %, and a duration between approximately 100 microseconds (μβ) and approximately 1000 microseconds (μβ).

[0012] In an embodiment, the computer-facilitated method also includes the steps of acquiring instructions characterizing a treatment protocol that defines the at least one treatment point and at least one of voltage, current, frequency, duty cycle, duration, periodicity, and sequence of the electrical pulse signal such that the electrical pulse signal stimulates the at least one treatment point according to the acquired treatment protocol. In an embodiment, the computer-facilitated method also includes the steps of measuring an electrical impedance between the at least two electrical contacts, and determining, based on the measured electrical impedance, a treatment protocol that defines the at least one treatment point and at least one of voltage, current, frequency, duty cycle, duration, periodicity, and sequence of the electrical pulse signal such that the electrical pulse signal stimulates the at least one treatment point according to the determined treatment protocol.

[0013] In one embodiment, at least one non-transitory computer-readable storage medium is encoded with instructions that, when executed on at least one processing unit, perform a method for preventing, reducing, and/or treating pain in a subject, the method including applying an electrical pulse signal through at least two non-invasive electrical contacts positioned in contact with a first location of the subject's body and in near proximity to at least one treatment point corresponding to a second location of the subject's body, the second location being remote from the at least one treatment point, to stimulate the at least one treatment point so as to at least one of prevent, reduce, and treat pain in the second location of the subject's body.

[0014] It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein. In particular, all combinations of claimed subject matter appearing at the end of this disclosure are contemplated as being part of the inventive subject matter disclosed herein. It should also be appreciated that terminology explicitly employed herein that also may appear in any disclosure incorporated by reference should be accorded a meaning most consistent with the particular concepts disclosed herein.

[0015] Other systems, processes, and features will become apparent to those skilled in the art upon examination of the following drawings and detailed description. It is intended that all such additional systems, processes, and features be included within this description, be within the scope of the present invention, and be protected by the accompanying claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The skilled artisan will understand that the drawings primarily are for illustrative purposes and are not intended to limit the scope of the inventive subject matter described herein. The drawings are not necessarily to scale; in some instances, various aspects of the inventive subject matter disclosed herein may be shown exaggerated or enlarged in the drawings to facilitate an understanding of different features. In the drawings, like reference characters generally refer to like features (e.g., functionally similar and/or structurally similar elements).

[0017] FIG. 1 illustrates the approximate locations of the nerves that are generally accessible on a human subject's external ear in accordance with some embodiments.

[0018] FIG. 2 illustrates the approximate locations of treatment points on a human subject's external ear with corresponding remote areas of the human subject's body in accordance with some embodiments.

[0019] FIG. 3 illustrates a system and/or apparatus for applying a stimulation signal to a subject in accordance with some embodiments.

[0020] FIG. 4 illustrates an application of a stimulation signal to a subject using two electrical contacts in accordance with some embodiments.

[0021] FIG. 5 illustrates an arrangement of four electrical contacts for applying a stimulation signal in accordance with some embodiments.

[0022] FIG. 6 illustrates a matrix arrangement of electrical contacts for applying a stimulation signal in accordance with some embodiments.

[0023] FIG. 7 illustrates an outward-facing side of a device configured to be worn on and/or secured to a human subject's ear in accordance with some embodiments.

[0024] FIG. 8 illustrates an inward- facing side of a device configured to be worn on and/or secured to a human subject's ear in accordance with some embodiments.

[0025] FIGS. 9-10 illustrate methods for researching, measuring, preventing, reducing, and/or treating pain in accordance with some embodiments.

DETAILED DESCRIPTION

[0026] The present disclosure provides systems, methods, and apparatus for applying electro-stimulation to a subject to, for example, research, measure, prevent, reduce, and/or treat pain, especially chronic pain, in a subject or population. More specifically, the present disclosure recognizes previously -unrealized advantages to generating and applying at least one stimulation signal to one or more treatment points on a subject's body to effect therapeutic treatment of and/or minimize pain.

[0027] A stimulation signal is an electrical current in the form of, for example, one or more electric pulses or a periodic electric signal, and driven by a sufficient charge or voltage differential between at least two electrodes. Furthermore, parameters of the stimulation signal can be varied as appropriate. For example, the voltage, current, frequency, duty cycle, periodicity, sequence, and/or duration of a stimulation signal can be determined, configured, and/or adjusted.

[0028] According to some embodiments, electro-stimulation can be used to measure, prevent, reduce, and/or treat pain at one or more remote locations of the subject's body. The pain can be acute or chronic and caused, increased, or prolonged by nociceptor stimulation, disease, damage, inflammation, and/or other factors. For example, application of a stimulation signal at one or more treatment points on the external ear of a human subject can treat pain conditions ranging from mild to moderate pain at locations including, but not limited to, a knee, the lower back, the shoulders, and/or the neck of the subject. One or more treatment points also can be selected to alleviate headaches, rheumatoid arthritis, peripheral neuropathy, cancer, idiopathic pain, and/or other pain conditions.

[0029] Pain is more effectively measured, prevented, reduced, and/or treated when the treatment points are more selectively stimulated, that is, targeted and localized electrostimulation improves treatment efficacy. Overstimulation can lead to confusion of the nervous system and limit and/or cancel any therapeutic effects. Thus, for example, targeted application of a stimulation signal to one or more select treatment points on the ear is more effective than electro-stimulation of large portions of an external ear or the entire ear.

[0030] A treatment point is a designated location on a subject's body. One or more treatment points may be identified, designated, and/or selected to stimulate one or more nerves to minimize and/or alleviate pain at one or more remote locations of the subject's body. Treatment points may be identified in different regions of a subject's body. For example, treatment points that correspond to remote locations in a human subject's body have been identified on the external ear. [0031] By way of further explanation of the anatomy of the human ear, the visible portion of the external ear is called the auricle and is composed mainly of cartilage covered by skin. The auricle 100 is divided into five areas indicated in FIG. 1, including the helix 102, antihelix 104, lobule 106, tragus 108, and concha 1 10. Four sensory nerves are generally accessible on the external ear. FIG. 1 illustrates the approximate locations of these nerves, including the greater auricular nerve (GAN) 112, the lesser occipital nerve (LON) 1 14, the auricular branch of the vagus nerve (ABVN) 1 16, and the auriculotemporal nerve (ATN) 118.

[0032] The GAN 112 is a branch of the cervical plexus, which is a branching network of nerves in the ventral rami of the first four cervical spinal nerves (CI to C4) in the neck vertebrae. The cervical plexus is connected to the accessory nerve, the hypoglossal nerve, and the sympathetic trunk, and innervates the posteromedial, posterolateral, and inferior portions of the auricle 100. The LON 114 innervates a small portion of the helix 102. The ABVN 1 16 innervates the concha 1 10 and most of the area around the auditory meatus (i.e., the ear canal). The vagus nerve is the longest cranial nerve and— because it passes through the neck and thorax to the abdomen— has the widest distribution in the body. The vagus nerve contains motor/somatic fibers and sensory/visceral afferent fibers, both general and special. The ATN 118 is a branch of the mandibular branch of the trigeminal nerve, and innervates the anterosuperior and anteromedial portions of the auricle 100.

[0033] According to some embodiments, a stimulation signal is applied to target at least one of the GAN 1 12, LON 114, ABVN 1 16, and ATN 1 18 in a human subject's auricle 100. Of course, the present disclosure is not limited to the external ear or human subjects in general, but may be applied to other portions of the human or non-human body. Other treatment points for a human subject may also be identified, designated, and/or selected on the palm of a hand, the sole of a foot, the scalp, etc. Likewise, treatment points may be identified, designated, and/or selected at various locations on a non-human subject's body.

[0034] FIG. 2 illustrates the approximate locations of treatment points on a human subject's auricle 100 and how the treatment points correspond to remote areas of the human subject's body in accordance with some embodiments. According to both Chinese medical theory and French auricular acupuncture systems, the shape of a human's external ear mimics an upside-down human fetus in utero, where treatment points on the ear are designated to correspond to anatomical sections of the whole body. Therapeutic benefits can be achieved in at least a designated portion of a human subject's anatomy by applying electro-stimulation to the corresponding treatment point on the auricle 100. For example, electro-stimulation at a treatment point 202 on the antihelix 104 (near the ATN 118) of a human subject's auricle 100 can be used to measure, prevent, reduce, and/or treat remote pain in the subject's toes, while electro-stimulation at a treatment point 204 on the lobule 106 (closer to the GAN 112) of the subject's auricle 100 can be used to measure, prevent, reduce, and/or treat remote pain in the subject's face. Of course, the present disclosure is not limited to treatment points as defined by any particular medical theory and/or acupuncture system.

[0035] FIG. 3 illustrates a system and/or apparatus for applying a stimulation signal to a subject in accordance with some embodiments. The system and/or apparatus can include at least one piece of user equipment 300 having multiple electrical contacts 302, circuitry 304, and a power source 306 in a housing 308 with a manual interface 310 and/or a wireless interface 312. The circuitry 304 may include or be in communication with at least one processor 314 and memory 316, which may be operating from a server 318 over a network connection 320 via the wireless interface 312. The at least one processor 314 may include or be in communication with a signal generator 322, which may be operating from a server 318 over a network connection 320 via a server interface 324.

[0036] The electrical contacts 302 on the user equipment 300 may be configured to be in direct contact with a portion of a subject's body and positioned in near proximity to designated treatment points located on that portion of the subject's body. The electrical contacts 302 may be electrodes or other metal plates. The electrical contacts 302 may be minimally and/or non-invasive (i.e., they do not break the skin). The user equipment 300 may include circuitry 304 to provide for application of the stimulation signal through the electrical contacts 302.

[0037] Securing the user equipment 300 and/or ensuring contact of the electrical contacts 302 to the designated portion of the subject's body can be achieved using several approaches. According to some embodiments, at least a portion of the user equipment 300 is securable to the subject's body (i.e., wearable). For example, the housing 308 of the user equipment 300 may include or be incorporated into an earpiece, eyewear frames, a headset, a cap, a helmet, a band, a wrap, a sleeve, a glove, a sock, a shoe insert, and/or another appropriate clothing item or accessory. [0038] The housing 308 of the user equipment 300 may include one or more fasteners or fastening devices 326 for pressing the electrical contacts 302 against the designated portion of the subject's body and holding the electrical contacts 302 on, around, or in near proximity to the designated treatment points. These fasteners or fastening devices 326 not only maintain contact with the body and the position of the electrical contacts 302 relative to designated treatment points but also provide greater flexibility and mobility during treatment. For example, the subject may wear the user equipment 300 while performing other tasks and changing locations by, for example, working out, resting at night, and running errands.

[0039] According to some embodiments, at least a portion of user equipment 300 may include or be incorporated into an earpiece. The earpiece may be formed using a cast or a mold of a subject's ear. The material of the cast or the mold may be selected and/or configured so as to shape to the ear but not to directly touch the subject's ear (e.g., silicone). The electrical contacts 302 and circuitry 304 may be placed on, attached to, and/or integrated into the surface of the cast or the mold such that the electrical contacts 302 are configured to be in contact with the subject's ear. Cast or mold shaping to the ear can improve contact between the electrical contacts 302 and the subject's ear.

[0040] Alternatively or in addition, the earpiece may include an ear band, headphone, silicone ear casing, and/or other clips/encasings capable of securing integrated electrical contacts 302 and circuitry 304 to at least a portion of a subject's ear. For example, a conductive patch or a conductive ear mold may be inserted into a headband, earphone, or ear cover to hold the electrical contacts 302 against the subject's ear. As a result, use and/or treatment can proceed while the user performs other tasks or changes locations.

[0041] The user equipment 300 further may include at least one power source 306 for supplying the user equipment 300 with electrical power to generate and/or apply a stimulation signal. The at least one power source may include, for example, one or more batteries.

[0042] The user equipment 300 further may include at least one signal generator 322. The at least one signal generator 322 may be part of the circuitry in the user equipment 300 or operate remotely from the user equipment 300, either as part of or separate from the at least one processor 314. According to some embodiments, the at least one signal generator 322 generates a stimulation signal for application by the electrical contacts 302 of the user equipment 300. In one implementation, the signal generator 322 includes an amplifier and a variable RC circuit (i.e., at least a variable resistor in parallel with a variable capacitor).

[0043] The user equipment 300 further may include at least one processor 314, which may include one or more memory devices 316 and/or a signal generator 322. The at least one processor 314 may be part of the circuitry in the user equipment 300 or operate remotely from the user equipment 300. The at least one processor 314 may generate a stimulation signal and/or control one or more aspects of a stimulation signal, such as voltage, current, frequency, duty cycle, duration, periodicity, and sequence. The at least one processor 314 may be preprogrammed with one or more treatment protocols and algorithms that specify treatment points and appropriate voltages, currents, frequencies, duty cycles, durations, periodicities, and sequences for a stimulation signal to apply to those specific treatment points.

[0044] Optionally, the at least one processor 314 may receive instructions to control aspects of use/treatment from an input device using, for example, the manual interface 310. Input may be received over the manual interface 310 in any form, including as acoustic, speech, and/or tactile input. The manual interface 310 may include or be communicatively coupled with various input devices including, but not limited to, buttons, switches, dials, microphones, and screens with pointing devices (e.g., a touch screen). For example, the resistance of a variable resistor and the capacitance of a variable capacitor may be manipulated to adjust the stimulation signal. In another example, the position(s) of the electrical contacts 302 may be adjusted.

[0045] Alternatively, the at least one processor 314 may receive instructions from a remote device using, for example, the wireless communications interface 312. The wireless communications interface 312 may operate using, for example, Bluetooth, Wi-Fi, other forms of radio communication, etc. The remote device may be a mobile device, a personal computer, a central monitoring station, or another remote source.

[0046] Thus, the user equipment 300 may be programmed with and/or configured to receive instructions to provide targeted pain relief to a remote location of the body by stimulating one or more specific treatment points that correspond to the remote location. According to some embodiments, the user equipment 300 can be used to target one or more physiological systems via a specific nerve in the auricle 100. For example, for any given electric pulse of the stimulation signal, the user equipment 300 may target one of the GAN 112, LON 1 14, ABVN 1 16, or ATN 118.

[0047] According to some embodiments, the user equipment 300 includes at least two electrical contacts 302 configured to make electrical contact with the subject's body such that the at least one processor 314 can stimulate the region between the at least two electrical contacts 302. FIG. 4 illustrates an application of a stimulation signal to a subject (e.g., the subject's auricle) 100 using at least two electrical contacts 302 in accordance with some embodiments. The at least two electrical contacts 302 (individually designated 302a and 302b) are in contact with the auricle 100 (e.g., when the user equipment 300 is properly worn). Circuitry 304 (illustrated in FIG. 4 as wires) connects the electrical contacts 302a and 302b to the at least one processor 314, which applies stimulation signals. A charge or voltage differential is applied between the electrical contacts 302a and 302b (i.e., a positive or negative charge is applied to 302a and the opposite charge is applied to 302b) sufficient to drive an electrical current 400 across the auricle 100 in the region between the electrical contacts 302a and 302b.

[0048] The number and the placement of the electrical contacts 302 may improve precision of the user equipment 300. That is, for a given stimulation signal, the size of a stimulated region may be reduced by altering the layout and/or configuration of the electrical contacts 302. FIG. 5 illustrates an arrangement of four electrical contacts 302 for applying a stimulation signal in accordance with some embodiments. The diameter of each electrical contact 302 in FIG. 5 is, but is not limited to, approximately four millimeters. The four electrical contacts 302 (individually designated 302c, 302d, 302e, and 302f) can be placed in contact with, for example, the subject's auricle (e.g., when the user equipment 300 is properly worn), and the at least one processor 314 can target specific regions of the auricle by applying stimulation signals to at least two of the electrical contacts 302 sufficient to drive an electrical current across the auricle in the region between the electrical contacts 302.

[0049] For example, the at least one processor 314 may target the region 500 by applying a charge or voltage differential between electrical contacts 302c and 302d. Similarly, the at least one processor 314 may apply a charge or voltage differential between any of electrical contacts 302c, 302d, 302e, and 302f to stimulate one or more of regions 500, 502, and 504. The user equipment 300 may include circuitry 304 to enable the at least one processor 314 to select specific electrical contacts 302, and thereby select specific regions for stimulation. For example, the circuitry 304 may enable the at least one processor 314 to drive an electrical current between electrical contacts 302d and 302e_; but not to electrical contacts 302c or 302f.

[0050] The user equipment 300 is not limited to two or four electrical contacts 302, but can include any number of electrical contacts greater than two. Additionally, the diameter, spacing, and arrangement of the electrical contacts 302 may be varied. FIG. 6 illustrates a matrix arrangement of electrical contacts for applying a stimulation signal in accordance with some embodiments.

[0051] In FIG. 6 the at least one processor 314 may apply a stimulation signal to a region between any two or more of the matrix of electrical contacts 302, thereby stimulating treatment points that, when the user equipment 300 is properly worn, reside between the two electrical contacts. The diameter of each of the electrical contacts 302 in FIG. 6 is approximately 0.75 millimeters; however, the electrical contacts 302 are not limited to any specific diameter and, in implementation, the diameter only needs to be large enough to be able to apply the stimulation signal to the treatment point.

[0052] FIG. 7 illustrates an outward-facing side of user equipment 300 configured to be worn on and/or secured to a human subject's auricle 100, and FIG. 8 illustrates an inward- facing side of the user equipment 300 in accordance with some embodiments. The housing 308 and fastener 326 secure the user equipment 300 to the auricle 100. A manual interface 310 is provided for controlling the position of the user equipment 300 and/or characteristics of the stimulation signal. The housing 308 includes a rear support 800 to help hold the user equipment 300 to the subject's ear as well as circuitry 304 and electrical contacts 302. FIG. 7 is an illustration of a backside of the example implementation of a wearable device 100 shown in FIG. 6. A rear support 124 helps to hold the user equipment 300 to the user's auricle 100 and ensure that the electrical contacts 302 are in contact with the auricle 100.

[0053] According to some embodiments, user equipment 300 applies stimulation signals according to use/treatment protocols and/or algorithms. These protocols and/or algorithms may be predetermined, or the user equipment 300 may determine and/or receive instructions specifying a protocol and/or an algorithm. A protocol and/or an algorithm may define how to control or vary characteristics (including, but not limited to, voltage, current, frequency, duty cycle, duration, periodicity, and sequence) of a stimulation signal to achieve, for example, a therapeutic effect. [0054] According to some embodiments, a stimulation signal is applied in pulses of directional uniphasic current. The average frequency of the stimulation signal may range from approximately 2 hertz (Hz) to approximately 300 Hz, and preferably is about 30 Hz. The average current of the stimulation signal may range from approximately 0.25 milliamps (mA) to approximately 2.0 mA. The peak voltage of the stimulation signal may range from approximately 100 millivolts (mV) to approximately 50 volts (V). The duration of the stimulation signal may range from approximately 30 minutes to approximately 3 hours. The duty cycle (i.e., on/off ratio) of the stimulation signal may range from approximately 1/10 to 1/1. The length of each stimulation signal pulse (i.e., pulse width) may range from approximately 10 microseconds (μβ) to 1000 μ$ (e.g., 200 μ8, 500 μ8, or 1000 μ8).

[0055] Tissue and nerves can develop a resistance to electro-stimulation. According to some embodiments, stimulation signal parameters are varied between pulses to prevent the development of resistance to use/treatment. The alternation and/or variation of frequencies and/or other characteristics between successive stimulation signals can reduce nerve fatigue and maintain treatment intensity and efficacy. For example, stimulation signals with alternating 1/15 Hz and 2/100 Hz frequencies may be applied in some embodiments.

[0056] The frequency of a stimulation signal also may be modified based on the duration of use/treatment. When the duration of use/treatment is longer, the frequency of the stimulation signal can be lower. According to one embodiment, alternating 2 Hz and 100 Hz stimulation signals are used with duration periods of 0.5 seconds and 0.001 seconds respectively. Similarly, if a duty cycle is varied from 1/10 to 1/1, duration periods of 0.05 seconds and 0.5 seconds respectively may be used.

[0057] FIGS. 9-10 illustrate methods for researching, measuring, preventing, reducing, and/or treating pain in accordance with some embodiments. In FIG. 9, a process flow diagram 900 illustrating a method of treating pain in a subject. At step 902, at least one treatment point (e.g., a nerve location) and a treatment protocol are acquired and/or determined. Based on the location and/or treatment protocol, in step 904, two or more electrical contacts are positioned and/or secured on, around, or in near proximity to the at least one treatment point. The electrical contacts may be arranged in an array, matrix, or another appropriate configuration on a device. Based on the location and/or treatment protocol, in step 906, a subset of the two or more electrical contacts are selected for the stimulation signal. The selection may be based on which treatment points and/or nerves lie in the region between each pair of electrical contacts and whether those treatment points and/or nerves correspond to a remote location of the body where pain is intended to be treated.

[0058] At step 908, a stimulation signal is driven through two or more of the electrical contacts by applying electrical pulses. The electrical pulses are configured to relieve pain in the remote location of the body where pain is intended to be treated according to a treatment protocol and/or algorithm. The treatment protocol and/or algorithm may define

characteristics of each electrical pulse such as the treatment point, voltage, current, frequency, duty-cycle, duration, periodicity of pulses, and pulse sequence. The treatment protocol and/or algorithm may vary the characteristics between pulses. For example, the frequency and duration of an electrical pulse may vary between consecutive pairs of pulses.

[0059] According to some embodiments, electrical impedance of the skin between pairs of electrical contacts (i.e., corresponding to treatment points) can be measured. For example, pain at a remote location of the user's body may correspond to reduced electrical impedance at a corresponding treatment point. In some embodiments, impedance of a treatment point (e.g., located on the auricle) is measured to determine whether the impedance is lower than some relative and/or threshold value. Because impedance measurements can vary based on skin surface, electrode geometry, contact pressure, etc., normal skin impedance

measurements range from 1-4 M-ohms, with treatment points ranging from 50-300 k-ohms. Impedance measurements may be used to automatically trigger or adjust electro-stimulation relative to a predetermined threshold (e.g., when impedance at a treatment point is measured/calculated to be below 40 k-ohms). Thus, some embodiments may determine appropriate treatment with limited or no instruction or monitoring by a treatment provider and/or the subject.

[0060] In FIG. 10, a process flow diagram 1000 illustrates a method of treating pain in a subject. At step 1002, the electrical impedance between two or more electrical contacts is measured and/or calculated by complex division of voltage and current. The impedance phase and magnitude between a given pair of electrical contacts may be obtained by, for example, applying a sinusoidal voltage to the given pair of electrical contacts in series with a resistor, and measuring the voltage across the resistor and across the given pair of electrical contacts by sweeping the frequencies of the applied signal. [0061] At step 1004, the measured and/or calculated impedance of a particular treatment point is compared to a predetermined normal value and/or the impedance values for other surrounding treatment points. If the measured and/or calculated impedance is less than the predetermined and/or relative values, a treatment protocol is determined based on the measured and/or calculated impedance in step 1006 and a stimulation signal applied according to the treatment protocol in step 1008. If the measured and/or calculated impedance is greater than the predetermined and/or relative values, the treatment point may need to be adjusted as in step 1010.

Conclusion

[0062] While various inventive embodiments have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the function and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the inventive teachings is/are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific inventive embodiments described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, inventive embodiments may be practiced otherwise than as specifically described and claimed. Inventive embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and/or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and/or methods, if such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the inventive scope of the present disclosure.

[0063] The above-described embodiments can be implemented in any of numerous ways. For example, the subject matter described herein can be implemented in digital electronic circuitry, integrated circuitry, specially designed ASICs (application specific integrated circuits), firmware, software, hardware, including the structural means disclosed in this specification and structural equivalents thereof, or in combinations of them. These various implementations may include implementation in one or more computer programs that are executable and/or interpretable on a programmable system including at least one

programmable processor, which may be special or general purpose, coupled to receive data and instructions from, and to transmit data and instructions to, a storage system, at least one input device, and at least one output device.

[0064] A computer program (also known as a program, software, software application, or code) can be tangibly embodied in an information carrier (e.g., in a machine-readable medium), or embodied in a propagated signal, for execution by, or to control the operation of, data processing apparatus (e.g., a programmable processor, a computer, or multiple computers). A computer program includes machine instructions for a programmable processor, and may be implemented in a high-level procedural and/or object-oriented programming language, and/or in assembly/machine language. As used herein, the term "machine-readable medium" refers to any computer program product, apparatus and/or device (e.g., magnetic discs, optical disks, memory, Programmable Logic Devices (PLDs)) used to provide machine instructions and/or data to a programmable processor, including a machine-readable medium that receives machine instructions as a machine-readable signal. The term "machine-readable signal" refers to any signal used to provide machine instructions and/or data to a programmable processor.

[0065] A computer program can be written in any form of programming language, including compiled or interpreted languages, and it can be deployed in any form, including as a stand-alone program or as a module, component, subroutine, or other unit suitable for use in a computing environment. A computer program does not necessarily correspond to a file. A program can be stored in a portion of a file that holds other programs or data, in a single file dedicated to the program in question, or in multiple coordinated files (e.g., files that store one or more modules, sub programs, or portions of code). A computer program can be deployed to be executed on one computer or on multiple computers at one site or distributed across multiple sites and interconnected by a communication network.

[0066] Further, it should be appreciated that a computer may be embodied in any of a number of forms, such as a rack-mounted computer, a desktop computer, a laptop computer, or a tablet computer. Additionally, a computer may be embedded in a device not generally regarded as a computer but with suitable processing capabilities, including a Personal Digital Assistant (PDA), a smart phone or any other suitable portable or fixed electronic device.

[0067] Processors suitable for the execution of a computer program include, by way of example, both general and special purpose microprocessors, and any one or more processor of any kind of digital computer. Generally, a processor will receive instructions and data from a read only memory or a random access memory or both. The essential elements of a computer are a processor for executing instructions and one or more memory devices for storing instructions and data. Generally, a computer will also include, or be operatively coupled to receive data from or transfer data to, or both, one or more mass storage devices for storing data, e.g., magnetic, magneto optical disks, or optical disks. Information carriers suitable for embodying computer program instructions and data include all forms of nonvolatile memory, including by way of example semiconductor memory devices, (e.g., EPROM, EEPROM, and flash memory devices); magnetic disks, (e.g., internal hard disks or removable disks); magneto optical disks; and optical disks (e.g., CD and DVD disks). The processor and the memory can be supplemented by, or incorporated in, special purpose logic circuitry.

[0068] Also, a computer may have one or more input and output devices. These devices can be used, among other things, to present a user interface. To provide for interaction with a user, the subject matter described herein can be implemented on a computer having a display device (e.g., a CRT (cathode ray tube) monitor, LCD (liquid crystal display) monitor, or printer) for displaying information to the user and a keyboard and/or a pointing device (e.g., a mouse, touch pad, trackball, or touch screen), by which the user can provide input to the computer. As another example, a computer may receive input information through speech recognition or in other audible format. Other kinds of devices can be used to provide for interaction with a user as well. For example, feedback provided to the user can be any form of sensory feedback, (e.g., visual feedback, auditory feedback, or tactile feedback), and input from the user can be received in any form, including acoustic, speech, or tactile input.

[0069] The subject matter described herein can be implemented in a computing system that includes a back end component (e.g., a data server), a middleware component (e.g., an application server), or a front end component (e.g., a client computer having a graphical user interface or a web browser through which a user can interact with an implementation of the subject matter described herein), or any combination of such back end, middleware, and front end components. The components of the system can be interconnected by any form or medium of digital data communication, e.g., a communication network. Examples of communication networks include a local area network ("LAN") and a wide area network ("WAN"), such as an enterprise network, an intelligent network (IN), or the Internet. Such networks may be based on any suitable technology and may operate according to any suitable protocol and may include wireless networks, wired networks, or fiber optic networks.

[0070] The processes and logic flows described in this specification, including the method steps of the subject matter described herein, can be performed by one or more programmable processors executing one or more computer programs to perform functions of the subject matter described herein by operating on input data and generating output. The various methods or processes outlined herein may be coded as software that is executable on one or more processors that employ any one of a variety of operating systems or platforms. Additionally, such software may be written using any of a number of suitable programming languages and/or programming or scripting tools, and also may be compiled as executable machine language code or intermediate code that is executed on a framework or virtual machine. The processes and logic flows can also be performed by, and apparatus of the subject matter described herein can be implemented as, special purpose logic circuitry, e.g., an FPGA (field programmable gate array) or an ASIC (application specific integrated circuit).

[0071] Also, various inventive concepts may be embodied as one or more methods, of which an example has been provided. The acts performed as part of the method may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments.

[0072] All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety.

[0073] All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and/or ordinary meanings of the defined terms.

[0074] The indefinite articles "a" and "an," as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean "at least one." [0075] The phrase "and/or," as used herein in the specification and in the claims, should be understood to mean "either or both" of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with "and/or" should be construed in the same fashion, i.e., "one or more" of the elements so conjoined. Other elements may optionally be present other than the elements specifically identified by the "and/or" clause, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, a reference to "A and/or B", when used in conjunction with open-ended language such as "comprising" can refer, in one embodiment, to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.

[0076] As used herein in the specification and in the claims, "or" should be understood to have the same meaning as "and/or" as defined above. For example, when separating items in a list, "or" or "and/or" shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as "only one of or "exactly one of," or, when used in the claims, "consisting of," will refer to the inclusion of exactly one element of a number or list of elements. In general, the term "or" as used herein shall only be interpreted as indicating exclusive alternatives (i.e. "one or the other but not both") when preceded by terms of exclusivity, such as "either," "one of," "only one of," or "exactly one of." "Consisting essentially of," when used in the claims, shall have its ordinary meaning as used in the field of patent law.

[0077] As used herein in the specification and in the claims, the phrase "at least one," in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements. This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase "at least one" refers, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, "at least one of A and B" (or, equivalently, "at least one of A or B," or, equivalently "at least one of A and/or B") can refer, in one embodiment, to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B); in another embodiment, to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A); in yet another embodiment, to at least one, optionally including more than one, A, and at least one, optionally including more than one, B (and optionally including other elements); etc.

[0078] In the claims, as well as in the specification above, the terms "about,"

"approximately," and the like are to be understood to mean +/- 10% of the total amount stated, e.g., about 5 would include 4.5 to 5.5, about 10 would include 9 to 11, and about 100 would include 90-110.

[0079] In the claims, as well as in the specification above, all transitional phrases such as "comprising," "including," "carrying," "having," "containing," "involving," "holding," "composed of," and the like are to be understood to be open-ended, i.e., to mean including but not limited to. Only the transitional phrases "consisting of and "consisting essentially of shall be closed or semi-closed transitional phrases, respectively, as set forth in the United States Patent Office Manual of Patent Examining Procedures, Section 211 1.03.

[0080] It is to be understood that the disclosed subject matter is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The disclosed subject matter is capable of other embodiments and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting.

[0081] As such, those skilled in the art will appreciate that the conception, upon which this disclosure is based, may readily be utilized as a basis for the designing of other structures, methods, and systems for carrying out the several purposes of the disclosed subject matter. For example, the logic flow depicted in the accompanying figures and described herein does not require the particular order shown, or sequential order, to achieve desirable results. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the disclosed subject matter.

[0082] Although the disclosed subject matter has been described and illustrated in the foregoing exemplary embodiments, it is understood that the present disclosure has been made only by way of example, and that numerous changes in the details of implementation of the disclosed subject matter may be made without departing from the spirit and scope of the disclosed subject matter, which is limited only by the claims which follow.

Claims

1. An apparatus for at least one of preventing, reducing, and treating pain in a subject, the apparatus comprising:

a wearable device including a plurality of non-invasive electrical contacts configured such that, when the device is worn by the subject, at least two of the plurality of electrical contacts are in contact with a first location of the subject's body and positioned in near proximity to at least one treatment point corresponding to a second location of the subject's body, the second location being remote from the at least one treatment point;

a memory to store processor-executable instructions; and

at least one processor communicatively coupled to the wearable device, wherein upon execution of the processor-executable instructions by the at least one processor, the at least one processor controls the wearable device to stimulate the at least one treatment point by application of an electrical pulse signal through the at least two of the plurality of electrical contacts so as to at least one of prevent, reduce, and treat pain in the second location of the subject's body.

2. The apparatus of claim 1, wherein the subject is a human subject, the wearable device is an earpiece, and the first location of the subject's body is at least a portion of the subject's external ear.

3. The apparatus of claim 1, further comprising a signal generator configured to generate the electrical pulse signal.

4. The apparatus of claim 1, wherein the application of the electrical pulse signal is periodic.

5. The apparatus of claim 1, wherein the electrical pulse signal comprises a plurality of pulses, each pulse comprising:

an average current between approximately 0.25 milliamps (mA) and approximately 2.0 milliamps (mA);

a peak voltage between approximately 25 millivolts (mV) and approximately

50 volts (V); an average frequency between approximately 0 hertz (Hz) and approximately 100 hertz (Hz);

a duty cycle between approximately 0.1 % and approximately 1.0 %; and

a duration between approximately 100 microseconds (μβ) and approximately

1000 microseconds (μβ).

6. The apparatus of claim 1, wherein the at least one processor is configured to control one or more of voltage, current, frequency, duty cycle, duration, periodicity, and sequence of the electrical pulse signal.

7. The apparatus of claim 1, wherein the at least one processor is configured to selectively apply the electrical pulse signal through a subset of the plurality of electrical contacts.

8. The apparatus of claim 1, wherein the plurality of electrical contacts are arranged in a matrix-like formation.

9. The apparatus of claim 1, wherein the application of the electrical pulse signal through the at least two of the plurality of electrical contacts follows a predetermined treatment protocol that defines the at least one treatment point and at least one of voltage, current, frequency, duty cycle, duration, periodicity, and sequence of the electrical pulse signal.

10. The apparatus of claim 1, wherein the at least one processor is configured to wirelessly acquire instructions characterizing a treatment protocol.

11. The apparatus of claim 1 , wherein the at least one processor is configured to:

measure an electrical impedance between the at least two of the plurality of electrical contacts;

determine, based on the measured electrical impedance, a treatment protocol that defines the at least one treatment point and at least one of voltage, current, frequency, duty cycle, duration, periodicity, and sequence of the electrical pulse signal; and control the wearable device to stimulate the at least one treatment point by application of the electrical pulse signal through the at least two of the plurality of electrical contacts according to the determined treatment protocol.

12. A computer-facilitated method for at least one of preventing, reducing, and treating pain in a subject, the method comprising:

positioning at least two non-invasive electrical contacts in contact with a first location of the subject's body and in near proximity to at least one treatment point corresponding to a second location of the subject's body, the second location being remote from the at least one treatment point;

applying an electrical pulse signal through the at least two electrical contacts to stimulate the at least one treatment point so as to at least one of prevent, reduce, and treat pain in the second location of the subject's body.

13. The computer-facilitated method of claim 12, wherein the at least two electrical contacts are attached to and positioned using a wearable device.

14. The computer-facilitated method of claim 13, wherein the subject is a human subject, the wearable device is an earpiece, and the first location of the subject's body is at least a portion of the subject's external ear.

15. The computer-facilitated method of claim 12, further comprising at least one of:

generating the electrical pulse signal;

varying one or more of voltage, current, frequency, duty cycle, duration, periodicity, and sequence of the electrical pulse signal; and

selecting a subset of the at least two electrical contacts through which to apply the electrical pulse signal.

16. The computer-facilitated method of claim 12, wherein the electrical pulse signal is applied periodically.

17. The computer-facilitated method of claim 12, wherein the electrical pulse signal comprises a plurality of pulses, each pulse comprising:

a peak voltage between approximately 25 millivolts (mV) and approximately

50 volts (V);

an average frequency between approximately 0 hertz (Hz) and approximately

100 hertz (Hz);

a duty cycle between approximately 0.1 % and approximately 1.0 %; and

a duration between approximately 100 microseconds (μβ) and approximately

1000 microseconds (μβ).

18. The computer-facilitated method of claim 12, further comprising:

acquiring instructions characterizing a treatment protocol that defines the at least one treatment point and at least one of voltage, current, frequency, duty cycle, duration, periodicity, and sequence of the electrical pulse signal such that the electrical pulse signal stimulates the at least one treatment point according to the acquired treatment protocol.

19. The computer-facilitated method of claim 12, further comprising:

measuring an electrical impedance between the at least two electrical contacts; and determining, based on the measured electrical impedance, a treatment protocol that defines the at least one treatment point and at least one of voltage, current, frequency, duty cycle, duration, periodicity, and sequence of the electrical pulse signal such that the electrical pulse signal stimulates the at least one treatment point according to the determined treatment protocol.

20. At least one non-transitory computer-readable storage medium encoded with instructions that, when executed on at least one processing unit, perform a method for at least one of preventing, reducing, and treating pain in a subject, the method comprising:

applying an electrical pulse signal through at least two non-invasive electrical contacts positioned in contact with a first location of the subject's body and in near proximity to at least one treatment point corresponding to a second location of the subject's body, the second location being remote from the at least one treatment point, to stimulate the at least one treatment point so as to at least one of prevent, reduce, and treat pain in the second location of the subject's body.