Sequential waveforms with varying parameters and perceived intensities for neuromodulation device

Abstract

A device may include a first electrode configured to be worn on the skin of a living body at a first location. A device may include a second electrode configured to be worn on the skin of the living body at a second location. A device may include a non-transitory memory storing a first waveform and a second waveform. A device may include a controller programmed to transmit the first waveform and the second waveform to the living body via the first electrode and the second electrode, wherein the controller is configured to: transmit the first waveform to the living body, wherein the first waveform has a first parameter, and transmit the second waveform to the living body after transmitting the first waveform to the living body, wherein the second waveform has a second parameter corresponding to the first parameter, wherein the second parameter is greater than the first parameter.

Description

SEQUENTIAL WAVEFORMS WITH VARYING PARAMETERS AND PERCEIVED INTENSITIES FOR NEUROMODULATION DEVICECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to US Provisional Application No. 63 / 604,760, titled “SEQUENTIAL WAVEFORMS WITH VARYING PARAMETERS AND PERCEIVED INTENSITIES FOR NEUROMODULATION DEVICE” and filed on November 30, 2023, which is incorporated by reference herein in its entirety.TECHNICAL FIELD

[0002] Various embodiments relate to electrical neuromodulation. More particularly, methods and devices herein provide electrical neuromodulation for treating symptoms of chronic and acute pain as well as other conditions.BACKGROUND

[0003] Pain is the mental manifestation of a neurological response to various physiological and psychological ailments. Pain serves as a warning of physical injury or biological dysfunction. Sometimes pain persists much longer than it takes for the healing of the initial injury to occur, and may be very difficult to alleviate. The most common pain relief methods employ drugs (e g., opioids) that act to block neurotransmission pathways within the body. Often such drugs are not effective for pain relief over the long term, or produce unacceptable side effects. Consequently, various forms of electrical stimulation such as spinal cord stimulation (SCS) and transcutaneous electrical nerve stimulation (TENS) have also been employed to alleviate pain.

[0004] SCS is effective but is an invasive procedure and has all the typical risks associated with implantable devices, as well as the risk of serious damage to the spinal cord. Meanwhile, conventional TENS is not effective in all patients due to the difficulty in picking effective settings and it may produce effects which only last during stimulation and do not produce long-term pain relief. Moreover, manypatients find conventional TENS at therapeutically effective levels to be uncomfortable.BRIEF DESCRIPTION OF THE DRAWINGS

[0005] Figure 1 illustrates a conventional example of a neuromodulation device for applying TENS.

[0006] Figure 2 is a block diagram illustrating modules of a neuromodulation device, according to some embodiments.

[0007] Figure 3 is a block diagram illustrating phases of an electrical pulse output from a neuromodulation device, according to some embodiments.

[0008] Figure 4 is a pulse waveform diagram illustrating phases of one variation of an electrical pulse output by a neuromodulation device as a simplified waveform, according to some embodiments.

[0009] Figure 5 is a diagram illustrating an exemplary oscillating pattern modulation of a pulse waveform, according to some embodiments.

[0010] Figure 6 is a diagram illustrating an exemplary oscillating pattern modulation of a pulse waveform, according to some embodiments.

[0011] Figure 7 is a diagram illustrating an exemplary waveform applied by a neuromodulation device, according to some embodiments.

[0012] Figure 8 illustrates a neuromodulation device for applying TENS, according to some embodiments.

[0013] Figure 9 is a flow diagram for a method of operating a neuromodulation device, according to some embodiments.

[0014] Figure 10 is a flow diagram for a method of operating a neuromodulation device, according to some embodiments.

[0015] Figure 11 is a diagram illustrating a sequence of waveforms according to some embodiments.

[0016] Figure 12 is a diagram illustrating a sequence of waveforms according to some embodiments.

[0017] Figure 13 is a diagram illustrating a sequence of waveforms according to some embodiments.

[0018] Figure 14 is a diagram illustrating a sequence of waveforms according to some embodiments.

[0019] Figure 15 is a diagram illustrating a sequence of waveforms according to some embodiments.

[0020] Figure 16 is a diagram illustrating a neuromodulation device and a waveform corresponding to an electrode patch of the neuromodulation device, according to some embodiments.

[0021] Figure 17 is a diagram illustrating a neuromodulation device and a waveform corresponding to an electrode patch of the neuromodulation device, according to some embodiments.

[0022] Figure 18 is a diagram illustrating a neuromodulation device and a waveform corresponding to an electrode patch of the neuromodulation device, according to some embodiments.

[0023] Various features of the technology described herein will become more apparent to those skilled in the art from a study of the Detailed Description in conjunction with the drawings. Various embodiments are depicted in the drawings for the purpose of illustration. However, those skilled in the art will recognize that alternative embodiments may be employed without departing from the principles of the technology. Accordingly, although specific embodiments are shown in the drawings, the technology is amenable to various modifications.DETAILED DESCRIPTION

[0024] Many conventional neuromodulation devices for applying transcutaneous electrical nerve stimulation (TENS) offer limited effectiveness in patients for a variety of reasons. One reason is that the physical construction ofmany neuromodulation devices means that the neuromodulation devices are not effective in offering a user pain relief while also remaining comfortable and not interfering with daily activities. For example, many conventional neuromodulation devices are bulky or difficult to wear. Another reason is that neuromodulation devices typically are configured to apply constant electrical signals to a user, with limited adjustability. Accordingly, many users find conventional neuromodulation devices to be uncomfortable or irritating when signals are applied at a current level proven to be therapeutically effective. As a result, conventional neuromodulation signals are typically applied at levels that are less effective for therapeutic treatment.

[0025] Introduced here are neuromodulation devices that overcome the deficiencies of conventional neuromodulation devices to provide effective pain relief while avoiding many of the downsides of conventional neuromodulation devices. That is, neuromodulation devices - and methods of operating the same - according to exemplary embodiments herein are configured to improve pain relief while avoiding user discomfort.

[0026] In addition to the above, many conventional neuromodulation devices for applying TENS or other electrical signal treatments such as electrical muscle stimulation (EMS) utilize fixed parameter waveforms, for example having a constant frequency, amplitude, and shape. Some such neuromodulation devices do not offer adjustability of the waveforms. Moreover, some such neuromodulation devices do not allow different fixed parameter waveforms to be applied. These fixed parameter waveforms do not provide effective electrical signal treatment for all circumstances. For example, different types of pain may be more effectively treated by different types of waveforms, for example, waveforms having different pulse shapes, pulse widths, modulation patterns, etc. In some circumstances, different parts of the body or different nerve types may respond differently to different waveforms. It has been shown that waveforms having specific shapes in different portions of the waveform may be more therapeutically effective than the fixed parameter waveforms employed in conventional neuromodulation devices.

[0027] As further discussed below, the neuromodulation devices introduced here can overcome the deficiencies of conventional neuromodulation devices that implement fixed frequency waveforms for TENS treatments. Specifically, neuromodulation devices according to exemplary embodiments herein may apply a variety of waveforms having one or more differing parameters to provide more effective and comfortable TENS treatments. Some such neuromodulation devices may be configured to apply a plurality of different waveforms having differing parameters depending on the particular body part, pain type, nerve type, and user comfort level, among other inputs. Additionally, neuromodulation devices according to exemplary embodiments herein may apply multiple different waveforms in sequence as a part of a more therapeutically effective treatment. In some embodiments, different parameters of a pulse forming a waveform may be adjustable to ensure application of waveforms providing effective treatment. For example, periods of a portion of a pulse may be adjustable, amplitudes of a pulse may be adjustable, shapes of a pulse of may be adjustable, etc. In some embodiments, overall parameters of a waveform may be adjustable or different between multiple waveforms. For example, overall waveform parameter that may be adjustable or different between applied waveforms include mean frequency, maximum frequency, minimum frequency, amplitude modulation pattern, amplitude modulation period, frequency modulation pattern, frequency modulation period, among other parameters. In some embodiments, a neuromodulation device may be configured to transmit a waveform to a pair of electrodes from a plurality of waveforms stored in a database, for example, on local or remote non- transitory memory. A particular waveform may be streamed from the database depending on the body part, pain type, nerve type, user comfort level, and / or user input, among other inputs. The waveforms of the plurality of waveforms may differ from one another in one or more ways, for example, by having different amplitudes, periods, phases, or frequencies.

[0028] In further addition to the above, many conventional neuromodulation devices for applying TENS utilize relatively low intensity (e.g., measured in currentdelivered to a living body) in an effort to maintain user comfort during treatment. However, therapeutic efficacy from TENS treatments is largely dependent on the intensity of the waveform delivered to a living body, notwithstanding user discomfort at higher intensities. Conventional neuromodulation devices and conventional methods of TENS treatments therefore frequently “under-dose” by applying less current to a living body, resulting in inadequate relief provided for long term pain relief. Accordingly, there is a need for a neuromodulation device and method of TENS treatment that increases the intensity of applied electrical signals to a living body or more effective therapeutic treatment while avoiding the typical corresponding increase of user discomfort from irritation caused by the increased intensity.

[0029] Introduced here are neuromodulation devices that address the deficiencies of conventional neuromodulation devices that apply lower amplitude, less effective waveforms. Neuromodulation devices according to exemplary embodiments herein are configured to apply a sequence of waveforms having different perceived intensities. In some embodiments, a neuromodulation device may be configured to first apply a waveform with a low intensity, and subsequently apply a waveform with a higher intensity. The neuromodulation device may apply a plurality of different waveforms in sequence, starting with the lowest intensity and progressing to the highest intensity. The later waveforms in the sequence may have more or more parameters that are greater than corresponding parameters of the earlier waveforms. For example, a mean frequency of a first waveform may be less than a mean frequency of a second waveform applied after the first waveform. As another example, a peak amplitude of a first waveform may be less than a peak amplitude of a second waveform applied after the second waveform. Other parameters discussed herein may affect the perceived intensity of a waveform and may be varied across a sequence of waveforms, as the present disclosure is not so limited. In some embodiments, waveforms may be applied to a pair of electrodes sequentially with no intermediary period. In other embodiments, waveforms may be applied to a pair of electrodes in a sequence but with sequentialwaveforms being separated by an intermediary period. In some such embodiments, input may be received to trigger the application of a next waveform in the sequence. Based on the input, the sequence of waveforms and / or parameters of waveforms may be adjusted, for example, to conform to user tolerance.

[0030] In further addition to the above, as many conventional neuromodulation devices are configured to apply fixed parameter waveforms to a living body, they have electrical hardware configured to generate only that single fixed parameter waveform. However, as noted above, the inventors have appreciated the benefits of a neuromodulation device configured to apply different waveforms depending on the circumstances of treatment, including, but not limited to, body part, pain type, nerve type, and user tolerance. Additionally, neuromodulation devices may apply different waveforms in sequence as a part of a treatment plan. Therefore, a neuromodulation device that may be capable of applying different waveforms depending on such circumstances may be desirable.

[0031] Introduced here are neuromodulation devices that are configured to stream different waveform files from memory to apply the different waveforms having different parameters to a living body. A plurality of waveforms may be stored in non-transitory memory onboard the neuromodulation device. The neuromodulation device may include a controller configured to read the stored waveform and generate outputs to apply the waveform at a first electrode and a second electrode. Such an arrangement may also allow for waveform playlists to be easily created and applied to provide differing waveforms in sequence as a part of a TENS treatment. Such an arrangement may also allow a single neuromodulation device to adapt to different circumstances, such as body part type, pain type, nerve type, and user tolerance by streaming a waveform file corresponding to the particular circumstances. Finally, such an arrangement may allow a neuromodulation device to apply updated waveforms over time as methods of treatments evolve. For example, a neuromodulation device may receive newwaveform files from a computing device such as a mobile phone or a remote server.

[0032] As further discussed below, the neuromodulation devices introduced here can further overcome the deficiencies of conventional neuromodulation devices that implement low intensity electrical stimulation and / or devices that cause prolonged muscle contraction. Neuromodulation devices herein may be configured to apply a plurality of pulse waveforms in sequence to form an overall waveform. The pulse waveforms may differ from one another in amplitude (e.g., peak or average current) and / or frequency. In some embodiments, the amplitudes of sequential pulse waveforms may be modulated according to a first oscillating pattern. The first pattern may be a sinusoidal pattern, parabolic pattern, or other curved rise and fall pattern. The first pattern may have a first period of oscillation and a first magnitude. In some embodiments, the phase of sequential pulse waveforms may be modulated according to a second pattern, for example, by a phase shift. The second pattern may be a sinusoidal pattern, parabolic pattern, or other curved rise and fall pattern. The second pattern may have a second period of oscillation different than the first period and / or a second magnitude different than the first magnitude. As the first period and second period are different, the output waveform may have a perceived intensity on an irregular rising and falling pattern. That is, because the first period and second period are different, the modulation of phase and the modulation of amplitude may not be synchronous with one another, such that the output waveform has amplitude and frequencies that change at different rates while the waveform is applied to a living body. Accordingly, waveforms described herein may avoid prolonged muscle contractions while delivering a greater amount of current compared to conventionally applied electrical signals at a higher frequency with a lesser pulse width. As a result, the irregular rise and fall of the perceived intensity “beats” of a waveform may be less predictable and more comfortable for a user. As a result, neuromodulation devices described herein that employ irregular beat waveforms may be more therapeutically effective than conventional neuromodulation devices withincreased user comfort compared to those conventional devices, particularly for some treatments such as EMS.

[0033] Waveforms according to exemplary embodiments herein have parameters that greatly influence both the therapeutic effectiveness and the comfort of a user receiving the waveform. As discussed further below, these parameters include, but are not limited to, peak amplitude, pattern of modulation, oscillation period for a pattern of modulation, total period of a waveform pulse, period of different phases of a pulse (e.g., pulse width), modulation amplitude, mean frequency, period of amplitude modulation, and period of phase modulation. These parameters may be different between different waveforms. In some embodiments, a neuromodulation device may vary one or more parameters of a waveform according to input, for example received from a sensor or from a user. In some embodiments, one or more parameters correlated with perceived intensity may be increased over time, or between different applications of different waveforms. Examples of values and ranges for these parameters described herein have been shown to provide enhanced therapeutic effectiveness with increased comfort. In some cases, exemplary ranges described herein may provide enhanced therapeutic effectiveness and comfort independently of other parameters. In other cases, exemplary ranges described herein may provide enhanced therapeutic effectiveness and comfort when employed in combination with other parameters.

[0034] Given a neuromodulation device that can vary parameters of a waveform applied to a living body or apply different waveforms based on a waveform data structure, a neuromodulation device according to embodiments herein can:Apply different waveforms having one or more different parameters; Effectively treat different body parts or nerve types in a living body to reduce pain;• Allow for adjustability of waveforms to conform to user tolerance to improve user comfort and maintain therapeutic effectiveness;• Apply sequences of differing waveforms according to a treatment plan and to allow for adaptation to higher intensity waveforms;• Allow for the updating of electrical signals applied by the neuromodulation device over time; and• Transmit waveforms to a user that are therapeutically effective while improving user comfort and reducing irritation compared to conventional neuromodulation devices.

[0035] According to exemplary embodiments herein, a neuromodulation device may be operated based on input received. In some embodiments, a neuromodulation device may include a communication module through which an operator of the neuromodulation device can provide input. In some embodiments, the communication module may include an interface on the neuromodulation device itself through which an operator can provide input. In some embodiments, the communication module may be configured to communicate with one or more computing devices, such as a mobile phone or a remote server. In some embodiments, input from an operator (or another person such as a medical professional) may be received via the communication module from a computing device. For example, in some embodiments, a mobile application on a mobile device may be employed to receive input and communicate that input to the neuromodulation device, for example, wirelessly. In some embodiments, input may be employed to trigger the application of a waveform or a sequence of waveforms to a living body via a pair of electrodes. In some embodiments, input may regard a perceived intensity of a previously or currently applied waveform. For example, in some embodiments, an operator may be prompted to provide feedback input regarding the perceived intensity of a waveform that was just applied. In some embodiments, a neuromodulation device may be configured to adjust a parameter of a waveform, or adjust a parameter of a next waveform in a sequence, based on input received via the communication module. In some embodiments, inputreceived via a communication module may be compared to a predetermined nonzero threshold or another criterion. In some such embodiments, comparison to a criterion may be employed to adjust one or parameters downward or revert to a prior waveform applied in a sequence. In other embodiments, satisfaction of a criterion may be employed to trigger a sequence of waveforms, or to trigger a next waveform in a sequence. In some embodiments, input to a neuromodulation device may be provided by a sensor, which may be configured to obtain more or more physiological measurements of a living body, including, but not limited to, heart rate, skin conductance, and skin temperature.

[0036] In some embodiments, a waveform file may be a data structure that includes arrays of values. Each value in the array of value may correspond to an output from the controller. Accordingly, the controller may receive each value and output signals according to the values associated with that waveform. In this manner, a waveform file may be “streamed” from memory. As used herein, “streaming” refers to accessing a waveform file and processing the associated array of values of the waveform file in a sequence. In some embodiments, a waveform file may include at least one parameter of the waveform, which may include pulse shape, output limit, mean frequency, mean amplitude, frequency modulation, or amplitude modulation. In some embodiments, a waveform file may be streamed from local non-transitory memory by direct memory access (DMA).

[0037] Neuromodulation devices according to embodiments herein may employ waveform files to generate electrical signals that are applied to a living body based on the data stored in the waveform files. In some embodiments, a plurality of waveforms files may be stored in non-transitory memory onboard the neuromodulation device. In some embodiments, waveform files may be downloaded onto a neuromodulation device from a computing device, such as a mobile phone or a remote server. In this manner, waveform files streamed on a neuromodulation device may be updated or changed over time. In some embodiments, a plurality of waveform files stored in memory of a neuromodulation device may include waveforms from a variety of different sources.

[0038] In some embodiments, a waveform applied by a neuromodulation device may include a plurality of pulses applied in sequence. In some embodiments, amplitudes of the sequential pulses may be modulated according to a sinusoidal, parabolic, other curved rise / fall oscillating pattern, or other oscillating pattern (e.g., triangular wave, saw wave, etc.). As a part of the modulation, the amplitude of a pulse may be different than an amplitude of the preceding pulse, as well as the amplitude of the succeeding pulse. For example, a first peak amplitude of a first pulse may be less than or greater than a second peak amplitude of a succeeding second pulse. As a part of the amplitude modulation, the peak current may be oscillated across the plurality of pulses between a peak current and between about 30 and 80 percent of the peak current. In some embodiments, the peak current may be oscillated across the plurality of pulses between the peak current and about a third of the peak current. In some embodiments, a peak current may be oscillated between about 1 and 120 milliamps (mA). In some embodiments, a peak current may be oscillated between about 1 and 100 mA, while in other embodiments, a peak current may be oscillated between about 50 and 120 mA. In some embodiments, the modulation of amplitude may have a period of oscillation between about 1 and 10 seconds. For example, the modulation of amplitude may have a period of oscillation between about 2.5 and 7.5 seconds or between about 5.0 and 7.5 seconds. The period of oscillation may also affect user comfort. For example, longer periods may feel slow or be ineffective at allowing a user to perceive a break in the peak current, whereas shorter periods may feel cycle too quickly, resulting in more discomfort.

[0039] In some embodiments, a waveform applied by a neuromodulation device may include a plurality of pulses applied in sequence. In some embodiments, frequencies of sequential pulses may be modulated according to a sinusoidal, parabolic, noise pattern, other curved rise / fall oscillating pattern, or other oscillating pattern (e.g., triangular wave, saw wave, etc.). In some embodiments, the effective frequency of the waveform may be modulated by a phase shift modulation applied to a waveform. As a part of the modulation, thefrequency of a pulse may be different than a frequency of the preceding pulse, as well as the frequency of the succeeding pulse. For example, a first frequency of a first pulse may be less than or greater than a second frequency of a succeeding second pulse. As a part of the frequency modulation, a mean frequency of the pulses may be between 1 and 200 Hz. In some embodiments, the frequency of the plurality of pulses may vary between a minimum frequency of about 1 Hz and a maximum frequency of about 200 Hz over a cycle of the pattern. It has been shown that a wide frequency range for modulation provides enhanced effectiveness for TENS treatments and EMS treatments. Additionally, frequencies greater than the conventionally applied low frequencies (e.g., between 0 and 4 Hz) have been shown to be more effective for such treatments. In some embodiments, the modulation of frequency may have a period of oscillation between about 1 and 10 seconds. In some embodiments, the period of oscillation for frequency modulation may be greater than or less than a period of oscillation for amplitude modulation. In other embodiments, a period of oscillation for frequency modulation may be about the same as a period of oscillation for amplitude modulation.

[0040] In some embodiments, the modulation of phase may be within a specific frequency range for a waveform. For example, a maximum frequency may be about 200 Hz, and a minimum frequency may be about 1 Hz. In some embodiments, a maximum frequency may be no more than 250 Hz, 200 Hz, 150 Hz, 100 Hz, or 75 Hz. In some embodiments, a minimum frequency may be no less than 0.5 Hz, 1 Hz, 4 Hz, 25 Hz, 50 Hz, or 100 Hz. In some embodiments, a mean frequency may be between about 50 Hz and about 150 Hz. In some embodiments, a mean frequency may be between 50 and 200 Hz, 1 and 100 Hz, or 100 and 200 Hz.

[0041] According to exemplary embodiments herein, a modulation pattern may be a noise modulation pattern. In a noise modulation pattern, the modulation may occur randomly according to a noise distribution. That is, the pattern may not be cyclical, but rather a randomized signal according to a particular distribution of values, for example, of frequencies in the case of phase modulation, or ofamplitudes in the case of amplitude modulation. In some embodiments, a noise distribution may have a dispersion of values from a mean value. For example, in some embodiments, a noise distribution may be measured in standard deviations of a Gaussian distribution as sigma. In some embodiments, a noise modulation pattern may be a Brownian noise modulation pattern. In some embodiments, a modulation of frequency according to the Brownian noise modulation pattern may be based on a Brownian noise frequency distribution with a dispersion of frequencies between 0.05 sigma and 0.25 sigma. Brownian modulation may mimic a Brownian pattern, which may be obtained as the integral of a white noise signal. For example, Brownian noise modulation may be obtained by adding a random offset to each preceding value to obtain the next value. In this manner, Brownian noise is also known as “random walk” noise, as the value will walk randomly over time. In some embodiments, a modulation according to a noise pattern may be based on a mathematical operation including a randomized component. Optionally, in some embodiments, the mathematical operation may be applied to the preceding parameter value to obtain the succeeding parameter value. In some embodiments, the modulation according to noise pattern may be limited to within a specific range. For example, in the case of frequency modulation, a maximum frequency may be about 200 Hz, and a minimum frequency may be about 1 Hz. In some embodiments, a maximum frequency may be no more than 250 Hz, 200 Hz, 150 Hz, or 100 Hz. In some embodiments, a minimum frequency may be no less than 0.5 Hz, 1 Hz, 25 Hz, 50 Hz, or 100 Hz. In some embodiments, a mean frequency may be between about 1 Hz and about 200 Hz. In some embodiments, a mean frequency may be between 50 and 200 Hz, 1 and 100 Hz, or 100 and 200 Hz. Modulation according to a noise frequency may generate an irregular pattern which is less irritating for a user while maintaining efficacy of the waveform. While in some embodiments a Brownian noise modulation may be employed based on a Brownian noise frequency distribution, in other embodiments other noise modulation patterns may be employed, including, but not limited to, white noise or pink noise.

[0042] In some embodiments, a waveform may be composed of a plurality of pulses. In some embodiments, each pulse may include a spike and a primary phase following the spike. The spike may represent a maximum amplitude of the pulse. In some embodiments, the primary phase may have a lesser amplitude than the spike. In some embodiments, the spike may have an amplitude sufficient to induce an electric field with a strength sufficient to induce conformational change in a tissue region through which the spike current is applied. An electric field of the primary phase may have a strength sufficient to maintain the conformational change induced by the electric field of the spike. Conformational change may refer a change in the shape of a macromolecule induced by the electric field, for example, because of electrostatic forces acting on the macromolecule. Inducing and maintaining conformational changes may modulate the physiological function of the target cellular components or molecules to reduce pain.

[0043] According to embodiments herein, a pulse overall duration, as well as the duration of a spike and primary phase of a pulse, may influence the comfort of an overall waveform when applied to a living body. An overall period of a pulse may affect user comfort as a longer pulse may generate correspondingly longer contractions which may be uncomfortable. Similarly, a duration of a spike and a primary phase (e.g., a “pulse width”) may affect the comfort of a user because of the length of time conformational change is induced within tissue. In some embodiments, a pulse may have an overall period between 9 ms and 12.5 ms, which has been shown to increase comfort without reducing overall waveform efficacy for TENS treatment and EMS. In some embodiments, an overall period of a pulse may be between 1-25 ms, 5-20 ms, 10-15 ms, 5-10 ms, or 10-12 ms. In some embodiments, an overall period of a pulse may be at least 1 ms, 5 ms, 9 ms, or 12 ms. In some embodiments, an overall period of a pulse may be no more than 25 ms, 20 ms, 15 ms, or 10 ms. Smaller periods (e.g., between about 1 and about 15 ms) may be useful for delivering interneuron effects which cause electrical sensations that mask pain. Greater periods (e.g., no less than about 20 ms) may target neurotransmitter release or release of endorphins to reduce pain. In someembodiments, a spike and primary phase of a pulse together may have a period (e.g., pulse width) between 30 ps and 200 ps, which has been shown to increase comfort without reducing overall waveform efficacy for TENS treatment and EMS. In some embodiments, a period of spike and primary phase of a pulse may be between 10-200 ps, 20-150 ps, 100-300 ps, 30-100 ps, or 40-60 ps. In some embodiments, a period of spike and primary phase of a pulse may be at least 20 ps, 30 ps, or 50 ps. In some embodiments, a period of spike and primary phase of a pulse may be no more than 60 ps, 100 ps, or 200 ps. The pulse width is related to the amount of sensory and motor nerve activation delivered by a neuromodulation device. Higher pulse widths cause more muscle contractions, whereas lower pulse widths cause fewer muscle contractions. In many cases, causing fewer muscle contractions is more comfortable for a user receiving the waveform including the pulse width.

[0044] Embodiments herein may be described in the context of a “user.” A “user” may be a living body receiving electrical signals from an electrode or transmitting signals to an electrode. While embodiments are generally described in the context of human bodies, aspects of those embodiments may be similarly applicable if the living bodies being treated are animal bodies. Accordingly, electrodes and neuromodulation devices according to embodiments herein may be used in connection with any living body.

[0045] In some embodiments herein, a neuromodulation device may be a self- contained device. For example, in some embodiments, a neuromodulation device may include a housing that houses a first electrode and a second electrode. In some embodiments, a first electrode and second electrode may have a fixed relationship to one another. In other embodiments, a first electrode and a second electrode may be independent from one another, such that the first electrode and the second electrode are able to be independently positioned on a user’s skin. In some embodiment embodiments, a first electrode and a second electrode may be connected to a controller via respective flexible wires.

[0046] Some embodiments herein are discussed with reference to a flow of current from a first electrode to a second electrode. In other embodiments, current may flow from a second electrode to a first electrode. As a part of TENS treatment, a direction of current flow may be reversed during a treatment session. Accordingly, electrodes described herein may be employed interchangeably as a source electrode or a sink electrode.

[0047] Embodiments may be described in the context of computer-executable instructions for the purpose of illustration. However, aspects of the approach could be implemented via hardware or firmware instead of, or in addition to, software.Terminology

[0048] References in the present disclosure to “an embodiment” or “some embodiments” mean that the feature, function, structure, or characteristic being described is included in at least one embodiment. Occurrences of such phrases do not necessarily refer to the same embodiment, nor are they necessarily referring to alternative embodiments that are mutually exclusive of one another.

[0049] Unless the context clearly requires otherwise, the terms “comprise,” “comprising,” and “comprised of” are to be construed in an inclusive sense rather than an exclusive or exhaustive sense. That is, in the sense of “including but not limited to.” The term “based on” is also to be construed in an inclusive sense. Thus, the term “based on” is intended to mean “based at least in part on.”

[0050] The terms “connected,” “coupled,” and variants thereof are intended to include any connection or coupling between two or more elements, either direct or indirect. The connection or coupling can be physical, logical, or a combination thereof. For example, elements may be electrically or communicatively coupled to one another despite not sharing a physical connection.

[0051] The term “module” may refer broadly to software, firmware, hardware, or combinations thereof. Modules are typically functional components that generate one or more outputs based on one or more inputs. A computer programmay include or utilize one or more modules. For example, a computer program may utilize multiple modules that are responsible for completing different tasks, or a computer program may utilize a single module that is responsible for completing all tasks.

[0052] When used in reference to a list of multiple items, the word “or” is intended to cover all of the following interpretations: any of the items in the list, all of the items in the list, and any combination of items in the list.

[0053] When used in reference to a numerical range, the word “about” refers to a value within 10 percent of the recited value. For example, “about” 50 refers to an inclusive range between 45 and 55. As another example, “about” 1 refers to an inclusive range between 0.95 and 1 .05.Overview of Conventional Neuromodulation Device

[0054] Figure 1 illustrates a conventional example of a neuromodulation device 100. The neuromodulation device 100 is configured to apply an electrical signal to a user of the neuromodulation device to inhibit transmission of pain signals through the nervous system to the brain. The neuromodulation device 100 is configured as a patch 102 configured to be worn on the skin of a user. The patch 102 may include an adhesive material allowing the device 100 to adhere to the skin. The neuromodulation device 100 includes a controller 104 configured to control generation of the electrical signal. The controller 104 may be powered by an onboard power source, such as a battery.

[0055] As shown in Figure 1 , the neuromodulation device 100 includes a first electrode 106 disposed in a first gel pad 108. Electrical current is configured to flow through the first electrode 106, through the gel pad 108, and into the skin of the user of the neuromodulation device 100. The neuromodulation device 100 also includes a second electrode 110 disposed in a second gel pad 112. Current is configured to flow from the first electrode 106, into a user’s skin, and to the second electrode 110. The passage of this electrical current is configured to disrupt pain signals in the neurological system of the user, thereby alleviating pain. The first gelpad 108 and the second gel pad 112 are configured to distribute the current over a wider area than the point input / output provided by the first electrode 106 and the point input / output provided by the second electrode 110.

[0056] Conventional neuromodulation devices like that of Figure 1 are configured to apply fixed frequency waveforms, usually at a constant current. Accordingly, conventional neuromodulation devices frequently under-dose the current applied to a living body to avoid user discomfort. However, reducing the current applied to improve user comfort results in a less therapeutically effective waveform.

[0057] As discussed further below, devices and methods described with reference to embodiments herein may address the deficiencies of conventional neuromodulation devices like those shown in Figure 1. Accordingly, neuromodulation devices and methods described herein may not only provide for more therapeutically effective treatments but may also increase user comfort during treatments by reducing irritation caused by application of waveforms with constant current.Overview of Neuromodulation Device and Method of Operation

[0058] Figure 2 is a block diagram illustrating modules of a neuromodulation device 200, according to some embodiments. The control electronics module 202 generally comprises a microcontroller which may be programmable to provide the desired pulse signals to the patient. The control electronics module 202 may also include the various electronics that are used to effect the treatment and control the output on / off state, pulse amplitude, timing, modulation, and other pulse parameters. Examples of such electronics include timers, clocks, DACs, processing units, and the like. In some embodiments, the control electronics module 202 may include a memory storing a plurality of waveforms.

[0059] In order to actuate and / or interface with the control electronics module 202, a controls module 204 may be in communication with the control electronics module 202 through any number of interface mechanisms, such as buttons, knobs,sliders, capacitive touch sensors, and the like, through which a user or other person can turn the device on / off, adjust amplitude or other settings, etc. The control electronics module 202 may receive input indicative of a request to initiate an electrical neuromodulation operation, in some embodiments. Additionally, the controls module 204 or other controller may communicate locally or remotely with the control electronics module 202 or other computing devices through a communication interface module 208 which may include any number of various wired communication mechanisms and / or wireless communication mechanisms. Examples of wireless communication mechanisms (also called “wireless communication protocols”) include Bluetooth®, Bluetooth® Low Energy or Bluetooth® Smart (Bluetooth SIG, Inc., Kirkland, Wash.), ANT, ZigBee, Wi-Fi, near field communication (NFC), infrared (e.g., Infrared Data Association (IrDA) associated wireless communications), etc. The communication interface module 208 may allow a neuromodulation device to access waveform files stored on computing devices, such as a mobile phone or remote server. The communication module 208 may be configured to receive input from a computing device, such as a mobile phone or a remote server. The control electronics module 202 may receive commands, queries, or other information from such a computing device. In some embodiments, operation of the control electronics module 202 may be controlled by a mobile application on a mobile phone. In such an arrangement the controls module 204 may include a graphical user interface on the mobile phone.

[0060] In some embodiments as shown in Figure 2, the neuromodulation device 200 may include one or more sensors 220. The sensor(s) may be configured to measure one or more aspects of the neuromodulation device and / or a living body on which the neuromodulation device is attached. In some embodiments, the sensor(s) 220 may be configured to obtain physiological information regarding a living body. The physiological information may be values that the sensor(s) 220 are configured to generate that are representative of discrete measurements of a physiological characteristic. Physiological information may include, but is not limited to, autonomic or semi-autonomic physiological indicators such as heartrate, skin conductance, and skin temperature. Physiological information may also include non-autonomic physiological measurements such as movement (e.g., acceleration, velocity) and body orientation (e.g., by gyroscope, image, or video). The sensor(s) 220 may be configured to provide the physiological information as input to the control electronics module 202.

[0061] In some embodiments, physiological information from sensor(s) 220 may be employed to trigger application of a waveform by the neuromodulation device. For example, in some embodiments, a neuromodulation device may be triggered to automatically apply a waveform in response to a physiological indicator exceeding a physiological threshold, or by satisfying some other criterion. In some embodiments, a satisfying a criterion my include, but is not limited to, exceeding a threshold, and matching a pre-defined pattern according to a pattern-matching algorithm. In some embodiments, physiological information may be employed as input to dynamically adjust one or more parameters of a waveform applied by the neuromodulation device 200. For example, the physiological information may be monitored, and an intensity of a waveform may be increased, maintained, or decreased based on the monitored physiological information. In this manner, sensor information may be employed to dynamically adjust one or more parameters of a waveform. In some embodiments, a controller of a neuromodulation device may be configured monitor values from the sensor(s) 220 to identify one or more values that satisfy a criterion and, in response to identifying the one or more values, may determine that a current waveform intensity is to be maintained for an interval of time for treatment of the tissue region. According to some such embodiments, the criterion may be based on physiological indicators that are indicative of stress remaining below threshold values.

[0062] In some embodiments, the sensor(s) 220 may be disposed on the neuromodulation device, in some embodiments. For example, the sensor(s) 220 may be formed as a part of a neuromodulation device housing. As another example, the sensor(s) may be incorporated into a patch or electrode of the neuromodulation device. In some embodiments, the sensor(s) 220 may beexternal to the neuromodulation device. For example, a sensor may include a camera or accelerometer separate from the neuromodulation device. In some embodiments, sensor(s) 220 may be optional.

[0063] The control electronics module 202 may provide any number of details, feedback, or information about its operation through an indicator module 206 which may include any variety of indicators or displays that may be positioned directly upon the neuromodulation device or separately in communication with the control electronics module 202. Generally, the term “indicator” is used to refer to one or more illuminants that visually provide information (e.g., regarding power status, connectivity status, program, etc.) through illumination. Meanwhile, the term “display” is generally used to refer to a panel of illuminants that are collectively controlled to visually present information. Displays may comprise liquid crystal display (LCD) elements, light-emitting diodes (LEDs), organic LEDs (OLEDs), quantum dots (QDs), electrophoretic elements, and the like.

[0064] In order for the neuromodulation device to provide the electrical stimulation to the patient's body, the control electronics module 202 may be in communication with a pulse generating electronics module 210 which is in communication with electrodes 214 through connecting elements 212. The control electronics module 202 and pulse generating electronics module 210 may be in communication with a power supply module 216 which supplies the power for the electrical stimulation. The power supply module 216 may include a battery such as a lithium-ion battery with associated circuits such as voltage regulators, LDOs, boost or buck converters, etc. The device output may utilize a voltage which is much higher than that available from the battery, and therefore the power supply may optionally include a generating mechanism for providing the high voltage as well as regulated low voltages for the other internal circuits.

[0065] The pulse generating electronics module 210 may include various components, including, but not limited to, switching circuits, digital-to-analog convertors (DACs), switches, and registers, which are configured to produce theelectric pulses with controlled shape and amplitude as described herein. In some embodiments, the pulse generating electronics module 210 may generate waveforms according to the waveform data 218 corresponding to a particular waveform. In some embodiments, the control electronics module 202 may output signals that control the pulse generating electronics module 210 according to values in the waveform data 218. In some embodiments, the control electronics module 202 may output signals that control the pulse generating electronics module 210 according to input received from the controls module 204 via the communication module 208 or via the sensor(s) 220.

[0066] Each of the various components may be in electrical communication through the connecting elements 212. The connecting elements used may comprise any number of electrically conductive elements, such as connectors, printed conductive traces, flex circuit boards, and the like, which provide electrical connection from the electronics to the electrodes or between any number of electrical components.

[0067] The electrodes 214 electrically coupled to the pulse generating electronics module 210 may be shaped in various configurations for facilitating placement upon the patient depending upon the region of the body to be treated. Accordingly, the electrodes may be external for providing an electrical connection from the device output to the body through the skin, particularly to the target tissues or nerves.

[0068] External electrodes, in one variation, may be constructed of a conductive current-distributing element, an electrochemical electrode interface (such as a silver chloride coated silver, stainless steel, graphite, etc.) at which an electrochemical reaction may occur and a hydrogel (such as polyacrylamide or other stable and biocompatible gel with good adhesion) which contains a conductive solution (typically sodium chloride). The electrodes may be a driven as a pair of electrodes where the current flows from a first electrode to a second electrode, or as a more complex multi-polar setup, for example, in a quadrupolarsetup, with four electrodes driven as any one of six alternating pairs. Exemplary electrode configurations will be discussed further with reference to Figure 8.

[0069] In other variations, the neuromodulation device may additionally and / or optionally include additional features or elements. For example, in one variation, the device may be controlled entirely via a communication interface using, for example, wireless communication from a controller located remotely from the neuromodulation device. Such remotely located controllers may include, for example, smartphones or other programmable devices, which may communicate via any number of wireless communication protocols (e.g., Bluetooth® Low Energy). Such a variation may remove the need for any controls or indicators on the device itself as the controls module 204 may be located remotely. In yet another alternative, the device may directly incorporate the controls module 204 upon the neuromodulation device itself so that it may be controlled entirely through an interface located upon the device.

[0070] Additionally, and / or alternatively, the control electronics module 202 and power supply module 216 may be packaged as a compact device that may be removably attached as a unit upon electrodes 214. For example, the electrodes 214 may be embedded, suspended, or otherwise situated in polyacrylamide hydrogel with silver ink conductive traces printed on a polymer film base. The electrodes 214 may be placed upon the region of interest upon the patient body and the device may be temporarily coupled to an engagement mechanism which also allows for the electrical communication between the pulse generating electronics module 210 and the electrodes 214 to effect treatment upon the patient. This variation as well as others described may be combined in any number of combinations as practicable.

[0071] Figure 3 is a block diagram illustrating phases of an electrical pulse output from a neuromodulation device, according to some embodiments. Specifically, Figure 3 shows a block diagram of a representative pulse waveform 300 illustrating the major phases of an electrical pulse output. Using theneuromodulation device 200 of Figure 2, the control electronics module 202 may be programmed to effect a specified pulse waveform generated by the pulse generating electronics module 210 and transmitted through the electrodes 214 and to the area of the patient's body upon which the electrodes 21 are positioned for treatment. Generally, the pulse waveform 300 may have a primary phase 306 followed by an optional dead time 308 period and then a secondary phase 310. Initiating the primary phase 306 is a leading edge 302 having a relatively fast rise time which leads to a spike 304 having an intensity greater than an average intensity of the primary phase 306. The remainder of the primary phase 306 may have an intensity which is lower than the intensity of the spike 304. In some embodiments, the remainder of the primary phase 306 may have an intensity approximately half intensity of the spike 304.

[0072] The dead time 308 period, if included, may have an output amplitude of zero. If the dead time 308 period is omitted, the secondary phase 310 may follow immediately after the primary phase 306 where the secondary phase 310 may have a polarity opposite to that of the primary phase 306. Like the dead time 308 period, the secondary phase 310 may be optionally omitted entirely from the pulse waveform 300. The presence and duration of the secondary phase may also affect the perceived intensity of a paresthesia sensation in a user receiving the pulse. The treatment pulses having the pulse waveform 300 may be repeated during a treatment where a specified time interval period 312 may be present between each individual pulse waveform 300.

[0073] While the output is described here in terms of amplitude, this may include a measure of either current or voltage. In one embodiment, the pulse waveforms 300 may be produced by a circuit which is a voltage-limited current source, and the amplitudes may comprise current amplitudes. Using a current control allows for the effective movement of charges to be less dependent on the electrode impedance (which may change with skin condition or over time) and less dependent on the tissue impedance (which may change with placement or individually).

[0074] In another embodiment, the output may also comprise a voltage source or current-limited voltage source, since in the short term the tissue and electrode impedances are relatively constant and so the current is approximately equal to the voltage times a constant factor. In this case, the output may require more frequent adjustments. However, controlled or produced, the amplitude pattern shown describes the variation in electrical field strength independent of the effects of variation in electrode impedance or the specifics of the control circuit.

[0075] If any parameters (such as timings or amplitude) of the output electrical pulses depend on the load impedance, they may be measured using a resistive- capacitive test load simulating the electrodes and human body.

[0076] Figure 4 graphically illustrates an individual representative pulse waveform 300 described in Figure 3 with each of the major phases of an electrical pulse output. The primary phase 306 is shown including the leading edge 302 of spike 304 over a relatively short rise time and the remainder of the primary phase 306 where the intensity of the spike 304 is significantly greater than an average intensity of the primary phase 306 and where the intensity of the remainder is significantly lower than the intensity of the spike 304, for example, about half the intensity. This may then be followed by the secondary phase 310 which may have its polarity opposite to that of the primary phase 306, as shown.

[0077] The transition or edge rise and fall times are measured as the time from, for example, 10 to 90 percent of the change from initial to final level. Widths are measured as the time from, for example, the 10 percent level on the rising edge to the 10 percent level on the falling edge. The illustration of the pulse waveform 300 is intended to be illustrative of the relative shape of the waveform with its timing measurements. Hence, the amplitudes during the spike 304, primary phase 306 and secondary phase 310 of the pulse waveform 300 do not need to be held constant as shown in Figure 4. Any pulse shape such that the spike 304 has a relatively fast rise time and high peak amplitude 410, and the typical amplitude during the remainder of the primary phase 306 after the spike 304 is significantlyless than the spike 304, may provide an effective pulse waveform 300. For example, if it is easier for the pulse generating or control electronics to produce, the primary phase 306 and secondary phase 310 may be comprised of, for example, piecewise segments of exponentially decaying waveforms (e.g., due to capacitor discharge or inductor decay), piecewise linear, trapezoidal, or any other shape. The spike 304 itself may be shaped as, for example, a half-sine wave, sine, parabolic, or similar waveform, as it is not necessary for it to have a constant level (e.g., “flat top”).

[0078] Additionally, the transitions between the spike 304, primary phase 306, optional dead time, secondary phase 310, and interval period 312 do not need to have rapid rise and fall times, or in any case the rapid rise and fall times are not necessary for effectiveness. However, it may be desirable to have a relatively rapid and / or fall time 404 at the end of the spike 304 to increase patient comfort. Once the brief time at maximum amplitude 402 during the spike 304 has passed, it is unlikely that any high but sub-maximum amplitude would have a physiological effect; however, it may cause greater charging of the skin capacitance and thus skin discomfort and for that reason it is desirable for the spike 304 to transition to the lower level during the remainder of the primary phase 306 relatively quickly. The fall time 406 at the end of the primary phase 306 and the fall time 408 from secondary phase 310 to the interval period 312 state or inter-pulse interval may be implemented in different ways while still having a therapeutically effective pulse shape as described herein. For example, as shown in Figure 4, the fall time 406 may be stepwise, and the fall time 408 may be exponential decay. Other arrangements may be implemented, in other embodiments. The spike 304 and the primary phase 306 may have a pulse width 412. The overall pulse may have an overall pulse period 414.

[0079] Turning now to the individual portions of the pulse waveform 300, the spike 304 is comprised of a relatively high amplitude 410, short duration spike which has a leading edge 302 with a fast rise time. In some embodiments, the amplitude 410 may be between about 1 mA and about 150 mA. The amplitude 410may affect inhibition of nerve ion channels that produce effects through the skin. Additionally, the amplitude 410 may change based on a distance between electrodes. The rise time of the spike may affect the targeting of specific nerve cell membrane components. The effective electric field during the spike 304 is expected to be high enough to be able to drive conformational changes of the cellular components which are targeted therapeutically directly, by the electrostatic forces acting on fixed charges or dipoles therein. A relatively high electric field strength is desirable in order to produce conformational changes and thereby modulate the physiological function of the target cellular components or molecules in a target tissue region; hence, an initial spike 304 with an amplitude 402 which is significantly higher than the average amplitude during the primary phase 306. In some embodiments, the spike 304 may be repeated. Such repetition may affect the strength of nerve ion channel inhibition.

[0080] The transition between spike 304 and primary phase 306 may not be as fast as the leading edge 302 of the spike 304. In one embodiment, the transition is a rapid linear transition with a controlled fall time equal to the rise time of the leading edge 302 of the spike 304, but this is not required. Many variations in the transition between the spike 304 and primary phase 306 are possible which accomplish the same goal of relatively rapid transition using different profiles.

[0081] As discussed above, the pulse width 412 (e.g., a duration of a spike and a primary phase) may affect the comfort of a user because of the length of time conformational change is induced within tissue. For example, the duration of the spike and the primary phase may affect the intensity of paresthesia sensation caused by the waveform. Additionally, the pulse width 412 may affect the intensity of motor effects (e.g., muscle contractions) caused by a waveform. In some embodiments, the pulse width 412 may be between 30 ps and 200 ps, which has been shown to increase comfort without reducing overall waveform efficacy for TENS treatment. In some embodiments, the pulse width 412 may be between IQ- 200 ps, 20-150 ps, 30-100 ps, or 40-60 ps. In some embodiments, the pulse width412 may be at least 20 ps, 30 ps, or 50 ps. In some embodiments, the pulse width 412 may be no more than 60 ps, 100 ps, or 200 ps.

[0082] As discussed above, the overall pulse period 414 may also affect the comfort of a user because of the length of time muscle contractions are induced (e.g., during the spike 304, the primary phase 306, and secondary phase 310) and the length of time muscles are allowed to relax (e.g., during the interval period 312). The overall pulse period may affect the repetition rate of the pulse, which affects the quality of the paresthesia sensation (e.g., tingling, massaging, etc.). In some embodiments, the overall pulse period 414 may be between 9 ms and 12.5 ms, which has been shown to increase comfort without reducing overall waveform efficacy for TENS treatment. In some embodiments, the overall pulse period 414 may be between 1 -25 ms, 5-20 ms, 10-15 ms, 5-10 ms, or 10-12 ms. In some embodiments, the overall pulse period 414 may be at least 1 ms, 5 ms, 9 ms, or 12 ms. In some embodiments, the overall pulse period 414 of a pulse may be no more than 25 ms, 20 ms, 15 ms, or 10 ms.

[0083] According to some embodiments herein, a plurality of pulse waveforms as shown in the example of Figure 4 may be applied in sequence to form an overall waveform. In some embodiments, one or more parameters of a pulse waveform may be varied as the pulse waveforms are applied. For example, a pulse width 412 and / or pulse period 414 may be varied to change a frequency of the overall waveform. In some embodiments, a pulse width and / or pulse period may be modulated according to a sinusoidal, parabolic, or other oscillating pattern, examples of which will be discussed with reference to Figures 5-7. In some embodiments, a first pulse of a plurality of pulses may have a first frequency, and a second pulse of the plurality of pulses following the first pulse may have a second frequency that is a modulation of the first frequency. As another example, an amplitude 410 of the spike 304 and / or an amplitude of the primary phase 306 may be varied between sequential pulse waveforms. In some embodiments, an amplitude 410 of the spike 304 and / or an amplitude of the primary phase 306 maybe modulated according to a sinusoidal, parabolic, or otherwise curved riseand fall pattern. In some embodiments, a first pulse of a plurality of pulses may have a first peak amplitude, and a second pulse of the plurality of pulses following the first pulse may have a second peak amplitude that is a modulation of the first peak amplitude.

[0084] Figure 5 is a diagram 500 illustrating an exemplary oscillating pattern modulation of a pulse waveform, according to some embodiments. The diagram 500 illustrates a modulation of an amplitude of a waveform. The example of Figure 5 depicts a sinusoidal oscillating pattern 502, which is employed to modulate the amplitude of a waveform, for example, as shown as described further with reference to Figure 7. In some embodiments, the sinusoidal oscillating pattern 502 may represent a limit of the amplitude of the waveform. In some embodiments, the sinusoidal oscillating pattern may represent a gain factor applied to the amplitude of the waveform.

[0085] As shown in Figure 5, the sinusoidal oscillating pattern 502 has a period 504. In some embodiments, the period 504 of the sinusoidal oscillating pattern 502 may be between 1 and 10 seconds, which may provide a more comfortable sensation while a waveform is applied to target tissue of a living body. In the example shown in Figure 5, the period 504 is about 2.5 seconds. In other embodiments, the period 504 of the sinusoidal oscillating pattern 502 may be between 1 second and 7.5 seconds, 2 and 3 seconds, 0.5 and 5 seconds, 5 and 15 seconds, or 2 and 8 seconds. In some embodiments, the period 504 may be no more than 15 seconds, 10 seconds, 8 seconds, or 5 seconds. In some embodiments, the period 504 may be no less than 0.5 seconds, 1 second, 2 seconds, or 5 seconds. While a sinusoidal oscillating pattern is shown in Figure 5, in other embodiments other patterns may be employed to modulate an amplitude of a waveform. In some such embodiments, the period of the pattern may be like that of the sinusoidal oscillating pattern, for example, between 2 and 3 seconds, or between 1 and 10 seconds. In some embodiments, a period of an oscillating pattern for modulating amplitude may be at least two seconds.

[0086] As shown in Figure 5, the sinusoidal oscillating pattern 502 has an amplitude 506. The amplitude 506 of the sinusoidal oscillating pattern 502 may change the amplitude of an output waveform. In the example of Figure 5, the sinusoidal oscillating pattern 502 may limit the amplitude of the waveform. Accordingly, the sinusoidal oscillating pattern 502 may cyclically modulate the amplitude of a waveform from a peak amplitude to another amplitude less than the peak amplitude. Such a modulation may allow more intense, therapeutically effective pulses to be interspersed with less intense, less uncomfortable pulses. In this manner, therapeutic effectiveness may be maintained, while reducing or eliminating the discomfort usually associated with pulses having the peak amplitude. In some embodiments, the sinusoidal oscillating pattern 502 may modify the amplitude of a waveform from a peak amplitude to between 30 and 70 percent of the peak amplitude. In some embodiments, the sinusoidal oscillating pattern 502 may modify the amplitude of a waveform from a peak amplitude to about half of the peak amplitude.

[0087] Figure 6 is a diagram 600 illustrating an exemplary oscillating pattern modulation of a pulse waveform, according to some embodiments. The diagram 600 illustrates a modulation of a phase of a waveform, which changes the effective frequency of the waveform. The example of Figure 6, like the example of Figure 5 depicts a sinusoidal oscillating pattern 602, which is employed to modulate the phase of a waveform 603 with a constant amplitude. In some embodiments, the sinusoidal oscillating pattern 602 may represent phase shift of the waveform 603, increasing or decreasing the effective frequency of the waveform. As shown in Figure 6, at a maximum of the sinusoidal oscillating pattern 602, the waveform 603 has a high frequency portion 606. As shown in Figure 7, at a minimum of the sinusoidal oscillating pattern 602, the waveform 603 has a low frequency portion 608. It has been shown that the higher frequency portions 606 have a higher perceived intensity than the lower frequency portions 608 for a constant amplitude waveform 603.

[0088] As shown in Figure 6, the sinusoidal oscillating pattern 602 has a period 604. In some embodiments, the period 604 of the sinusoidal oscillating pattern 602 may be between 1 and 10 seconds, which may provide a more comfortable sensation while a waveform is applied to target tissue of a living body. In the example shown in Figure 5, the period 604 is about 1 second. In other embodiments, the period 604 of the sinusoidal oscillating pattern 502 may be between 1 second and 5 seconds, 3 and 4 seconds, 0.5 and 5 seconds, 5 and 15 seconds, or 2 and 8 seconds. In some embodiments, the period 604 may be no more than 15 seconds, 10 seconds, 8 seconds, 5 seconds, or 4 seconds. In some embodiments, the period 604 may be no less than 0.5 seconds, 1 second, 2 seconds, or 5 seconds. While a sinusoidal oscillating pattern is shown in Figure 6, in other embodiments other patterns may be employed to modulate a phase or frequency of a waveform. In some such embodiments, the period of the pattern may be like that of the sinusoidal oscillating pattern, for example, between 3 and 4 seconds, or between 1 and 10 seconds. In the example of Figure 6, the period of oscillation for the modulation of phase is less than the period of oscillation for the modulation of amplitude of Figure 5 (e.g., about 1 second versus about 2.5 seconds, respectively). In other embodiments, the period of oscillation for the modulation of phase may be greater than the period of oscillation for the modulation of amplitude. In some embodiments, a period of an oscillating pattern for modulating phase may be at least two seconds.

[0089] In some embodiments, an oscillation pattern for modulation of amplitude may be the same type of pattern as the oscillation pattern for modulation of phase or frequency. For example, as shown in Figures 5 and 6, both modulation patterns may employ a sinusoidal oscillating pattern for modulation. In other embodiments different types of oscillating patterns may be employed for modulation of amplitude and phase or frequency, as the present disclosure is not so limited. Additionally, while sinusoidal patterns are shown in the embodiments of Figures 5-6, other patterns of modulation may be employed, which may change the perceived intensity of the waveform, and which may be more appropriate for treatment ofcertain tissue regions or pain types. For example, an amplitude modulation pattern may be sinusoidal or parabolic, in some embodiments. As another example, a phase modulation pattern may be sinusoidal, noise, or another oscillating pattern other than sinusoidal (e.g., parabolic).

[0090] Figure 7 is a diagram 700 illustrating an exemplary waveform 702 applied by a neuromodulation device, according to some embodiments. The waveform 702 depicted in Figure 7 may represent an output of a waveform from a neuromodulation device based on the modulation of amplitude according to the sinusoidal pattern 502 of Figure 5, and the modulation of phase according to the sinusoidal oscillating pattern 602 of Figure 6. As shown in Figure 7, a perceived intensity 704 of the waveform 702 is shown adjacent the waveform 702. The perceived intensity is based on the demonstrated relationship between frequency and amplitude of pulse driven waveforms applied by a neuromodulation device, as discussed further below.

[0091] As shown in Figure 7, the amplitude and the frequency of the waveform 702 varies over time according to the modulation of phase and the modulation of amplitude as described in Figures 5 and 6. As the modulation of phase has a different period than the modulation of amplitude, the change in frequency is not synchronous with change in amplitude. Accordingly, the waveform 702 has high frequency low amplitude portions 706, high amplitude low frequency portions 708, high amplitude high frequency portions 710, and low amplitude low frequency portions 712 at irregular intervals. Over an internal of time, the modulation patterns may align such that they are momentarily synchronous. The modulation of amplitude and phase may not be synchronous more often than every ten seconds, in some embodiments. In some embodiments, an interval between synchronicity of a first modulation pattern and a second modulation pattern may be no less than 5 seconds, 10 seconds, 15 seconds, or 20 seconds. Accordingly, a sensation experienced by a living body from the waveform may not repeat more often than every 5 seconds, 10 seconds, 15 seconds, or 20 seconds.

[0092] In the example of Figure 7, the perceived intensity varies according to irregular beats based on the different periods of modulation of phase and amplitude. The perceived intensity 704 increases based on an increase in amplitude of the waveform 702. Conversely, the perceived intensity 704 decreases based on a decrease in the amplitude of the waveform 702. The perceived intensity 704 also increases based on an increase in frequency of the waveform 702. Conversely, the perceived intensity 704 decreases based on a decrease in the frequency of the waveform 702. As shown in Figure 7, the perceived intensity has non-constant local minima and maxima based on the changing underling amplitude and frequency of the waveform 702. The perceived intensity 704 is highest at the high amplitude and high frequency portions 710, and lowest at the low amplitude and low frequency portions 712. Intermediate values of the perceived intensity are based on a combination of frequency and amplitude, where in some portions of the waveform 702 intensity is primarily driven by amplitude (e.g., in high amplitude low frequency portions 708) and in other portions of the waveform intensity is primarily driven by frequency (e.g., in low amplitude high frequency portions 706). The changes in perceived intensity and the change in the aspect of the waveform 702 driving the perceived intensity over an interval of time provides a more comfortable sensation as the waveform is applied to tissue, because the aspect of stimulation varies and is not perceptible as being periodic.

[0093] As discussed above, the parameters discussed with reference to Figures 4-7 affect the perceived intensity of a particular waveform. Accordingly, the parameters discussed with reference to Figures 4-6, among others, may be different between different waveforms. For example, a first waveform may have a first pulse width, and a second waveform may have a second pulse width different greater than the first pulse width. In this example, the second waveform may have a greater perceived intensity than the first waveform, because the larger pulse width causes a more prolonged conformational change, and therefore a longer muscle contraction. As another example, a first waveform may have a first period of amplitude modulation, and a second waveform may have a second period ofamplitude modulation greater than the first period. In this example, the second waveform may have a greater perceived intensity than the first waveform, because the longer period of oscillation results in a longer period of high amplitude and therefore a longer more intense muscle contraction. Additional examples of parameters and their effect on perceived intensity are discussed further with reference to Figures 11-15.

[0094] In some embodiments, a first waveform with a lower perceived intensity may be applied to a living body. The lower perceived intensity may allow the living body to adapt to the sensation of the waveform. The second waveform with a higher perceived intensity may be applied after the first waveform once the living body has had time to adapt to the sensation. As a result, the living body may be able to tolerate the second waveform better than if the second waveform was applied first due to the adaptation period provided by the first waveform. In this manner, a sequence of waveforms may be applied that build a user tolerance to electrical stimulation. As a result, higher amplitude waveforms may be applied that are more therapeutically effective while maintaining user comfort. In some embodiments, feedback input may be obtained from a user or one or more sensors to determine if a next waveform in a sequence corresponding to a higher intensity should be applied.

[0095] As noted above and according to embodiments discussed further with reference to Figures 11-15, sequential waveforms may be applied as a part of a treatment plan and / or to allow for adaptation to electrical stimulation. In some embodiments, parameters of a waveform may be varied dynamically to allow for higher amplitude waveforms to be applied to a living body. For example, one or more parameters may increase over a time period from initial value to Tamp” to a target value. The increase may be linear, quadratic, cubic, or non-linear. In this manner, waveforms may start at lower perceived intensities, and may increase over an interval to time to a higher intensity. In this manner, a living body may adapt to the lower intensity portion of the waveform, allowing the later higher intensity portion of the waveform to be more comfortable and less irritating. Insome embodiments, such a ramp of parameters may be combined with sequential waveforms as described herein. For example, a first waveform may have a first parameter that ramps from an initial value to a first target value, and a second waveform may have a second corresponding parameter that ramps from a second initial value to a second target value. In some embodiments, the second target value may be greater than the first target value. In some embodiments, the second initial value may be greater than the first initial value. In some embodiments, the second parameter may have a greater average value than the first parameter.

[0096] Figure 8 illustrates a neuromodulation device 800 for applying waveforms according to exemplary embodiments described herein. The neuromodulation device 800 is configured to apply an electrical signal to a user of the neuromodulation device to inhibit transmission of pain signals through the nervous system to the brain. The neuromodulation device 800 is configured as a patch 802 configured to be worn on the skin of a user. The patch 802 may include an adhesive material allowing the device 800 to adhere to the skin. In some embodiments, the patch 802 may include one or more gel pads configured to adhere to the skin. The neuromodulation device 800 includes a controller 803 configured to control generation of the electrical signal. The controller 803 may be powered by an onboard power source, such as a battery. In other embodiments, the controller 803 may be powered by an external power source. In some embodiments, the controller 803 may be proximate a geometric center of the neuromodulation device 800.

[0097] As shown in Figure 8, the neuromodulation device 800 includes a first controller input / output 804 and a second controller input / output 806 for providing electrical connections to a first electrode 805 and a second electrode 807, respectively. The first electrode 805 includes a first conductive trace mesh 808 connected to the first controller input / output 804 via traces 810. The second electrode 807 includes a second conductive trace mesh 812 connected to the second controller input / output 806 via traces 814. The first trace mesh 808 and thesecond trace mesh 812 are configured to assist in spreading current across a greater area of each respective electrode.

[0098] The neuromodulation device 800 differs from the conventional neuromodulation device 100 of Figure 1 in the process of applying the electrical signals to the user. Specifically, the neuromodulation device 800 of Figure 8 is configured to modulate an amplitude and / or frequency of a waveform according to one or more oscillating patterns having different periods of oscillation, for example as discussed with reference to Figures 5-7. Additionally, the neuromodulation device is configured to apply waveforms having specific parameters that have been shown to improve user comfort while remaining therapeutically effective for TENS treatments and EMS.

[0099] In the example of Figure 8, the neuromodulation device 800 is self- contained. That is, the first electrode 805 and the second electrode 807 form portions of the same patch 802. Accordingly, the relative spacing and positions of the first electrode 805 is fixed relative to the second electrode 807. In other embodiments, the first electrode 805 and the second electrode 807 may be separate from one another, for example, as separate patches. In some such embodiments, the first electrode 805 and the second electrode 807 may be independently positioned relative to one another. In some such embodiments, a controller of the neuromodulation device may also be independently positioned relative to one or both of the electrodes. For example, a controller may be integrated with one or more electrodes of a neuromodulation device or may be disposed in an independent housing.

[0100] In some embodiments as shown in Figure 8, a neuromodulation device may include a sensor 816. The sensor 816 may be configured to measure one or more aspects of the neuromodulation device and / or a living body on which the neuromodulation device is attached. In some embodiments, the sensor 816 may be configured to generate values that are representative of discrete measurements of a physiological characteristic. Physiological characteristics may include, but arenot limited to, autonomic or semi-autonomic physiological indicators such as heart rate, skin conductance, and skin temperature. Physiological characteristics measured by the sensor 816 may also include non-autonomic physiological measurements such as movement (e.g., acceleration, velocity). The sensor 816 may be configured to provide the physiological information as input to a controller of the neuromodulation device, for example, to control the value of one or more parameters and / or to control the generation of one or more waveforms.

[0101] Figure 9 is a flow diagram for a method 900 of operating a neuromodulation device, according to some embodiments. The method 900 may be a method for providing a TENS treatment or EMS, in some embodiments. In act 902, the method includes transmitting a first waveform having at least a first parameter to a pair of electrodes. In optional act 904, the method includes receiving input regarding a perceived intensity of the waveform. The input in act 904 may be provided via a communication module, in some embodiments. In some embodiments, a person may provide the input via an interface on the neuromodulation device or via an interface on a computing device such as a mobile phone. In some embodiments, the person may be a user of the neuromodulation device. In some embodiments, the input may be a binary in response to a query. For example, the query may be whether the first waveform was comfortable or not. In other embodiments, the input may be a numerical value on a scale. For example, in some embodiments the input may be a numerical value on a ten-point scale.

[0102] In act 906, the method includes transmitting a second waveform having a second parameter to the pair of electrodes. The second parameter may correspond to the first parameter. The second parameter may be different than the first parameter, for example, greater than or less than the first parameter. In some embodiments, the first and second parameter may be a pulse width of a pulse of each respective waveform. In some embodiments, the first and second parameter may be an amount of modulation, for example, an amount of amplitude modulation or an amount of phase oscillation. In some embodiments, the first and secondparameter may be a type of oscillation pattern, for example, for amplitude modulation or phase modulation. In some embodiments, the first and second parameter may be a period of a modulation pattern, for example for amplitude modulation and / or phase modulation. In some embodiments, the first and second parameter may be a dispersion of frequencies for a noise modulation pattern. The second parameter of the second waveform may yield a different perceived intensity for the second waveform as compared to a first waveform. For example, the second parameter may make the second waveform more intense compared to the first waveform.

[0103] In some embodiments, the transmission of the second waveform in act 906 may be in response to the input received in act 904. For example, the second waveform may be triggered based on the input regarding the perceived intensity of the first waveform. In some embodiments, the input from act 904 may be compared against one or more criteria. For example, in some embodiments, the input may be compared against a pre-determined non-zero threshold. One such threshold may be a threshold comfort level. For example, if the input is a numerical value on a ten-point scale, the transmission of the second waveform in act 906 may be based on the input being less than a non-zero threshold value on the ten- point scale. In this manner, the second waveform may only be triggered if the first waveform was well tolerated by a living body, and the perceived intensity is lower than a threshold value. In some embodiments, if the input exceeds a criterion (e.g., a predetermined non-zero threshold), the second parameter may be less than the first parameter, such that the second waveform is less intense than the first waveform. In embodiments where the input from act 904 is a binary, the input may similarly trigger the transmission of the second waveform in act 906. For example, if the binary is whether the first waveform was comfortable or uncomfortable, the input being comfortable may trigger transmission of the second waveform in act 906 with the second parameter being greater than the first parameter. Conversely, the input being indicative of an uncomfortable waveform may trigger transmissionof the second waveform in act 906 with the second parameter being less than the first parameter.

[0104] In some embodiments, depending on the input in act 904, the method may end after act 904 and may not proceed to act 906 and transmission of the second waveform. In some embodiments, depending on the input in act 904, the method may include repeating transmission of the first waveform in act 902. For example, if the input satisfies one or more criteria, the method may end or may return to act 902. For example, if the input is numerical value on a scale, if the value is equal to a predetermined non-zero threshold the method may include repeating act 902, as the first waveform may correspond to a maximum tolerable waveform for a living body. In some embodiments, if the input in act 904 exceeds a threshold, an interval period may be applied between a subsequent retransmission of the first waveform or transmission of any other waveform. For example, if a first waveform exceeds a comfort threshold and is too intensive, the method may include waiting for an interval period before applying another waveform. In some embodiments, an interval period may be about 1 minute. In some embodiments, an interval period may be between 20 seconds and 2 minutes, 1 minute and 5 minutes, or 10 seconds and 1 minute. In some embodiments, an interval period may be no less than 10 seconds, 20 seconds, 45 seconds, or 1 minute. In some embodiments, an interval period may be no more than 5 minutes, 3 minutes, 2 minutes, or 1 minute.

[0105] According to the embodiment of Figure 9, in optional act 908, second input is received regarding a perceived intensity of the second waveform. The second input may be like that of the input received in optional act 904. In some embodiments, the second input may be obtained via an interface on the neuromodulation device or on a computing device such as a mobile phone. In some embodiments, the second input may be a binary. In other embodiments, the second input may be a numerical value. In some embodiments, as discussed above, the second input may be compared to one or more criteria to determine the subjective perception of a living body receiving the second waveform from act 906.

[0106] In some embodiments, in optional act 910 the method includes transmitting a third waveform having a third parameter to the pair of electrodes. In some embodiments, the third waveform may be transmitted based on the second input from act 908. In some embodiments, the third parameter may be greater than the second parameter. In some embodiments, the third parameter may be less than the second parameter. In some cases, the application of the third waveform may be based on a comparison of the second input from act 908 to one or more criteria, as discussed above with reference to act 904.

[0107] In some embodiments, the sequence shown and described with reference to Figure 9 may be extended as a part of a treatment plan. For example, fourth, fifth, sixth, seventh, and so on waveforms may be transmitted to a pair of electrodes. In some embodiments, in between sequential waveforms input may be obtained. In some cases, the input may be compared to one or more criteria to determine if it is appropriate to proceed to the next waveform, or if the previous waveform should be repeated, or if no waveform should be applied until waiting an interval period. In this manner, a living body may gradually adapt to the stimulation from the sequentially more intense waveforms. Accordingly, at higher intensities a living body may have less irritation once adapted to the lower intensity waveforms. Additionally, by incorporating input in between waveforms, transmission of any waveform that is too intense for a living body may be avoided.

[0108] In some embodiments the first parameter, second parameter, and third parameter are the same type of parameter but different values. In other embodiments, the first parameter, second parameter, and third parameters may be different parameters that still vary the perceived intensity of the corresponding waveforms. In some embodiments, the first waveform, second waveform, and third waveform may have predetermined parameter values. In some such embodiments, the first waveform, second waveform, and the third waveform may be as part of a predetermined sequence of waveforms that form a treatment plan for a particular ailment or body region. In some embodiments, the parameters of the second waveform and third waveform may be adjusted according to the inputreceived prior to the transmission of those waveforms. For example, the second parameter may be adjusted according to the input received in act 904. Similarly, the third parameters may be adjusted according to the input received in act 908. In some embodiments, the parameters of waveforms may be adjusted dynamically according to received input.

[0109] In some embodiments, the inputs received in act 904 and act 908 may be received from a person via an interface. In some embodiments, the input may be received in response to a prompt presented on an interface regarding a previously transmitted waveform. In some embodiments, the input may be received via a sensor. In some embodiments, the sensor may be disposed on a neuromodulation device. In some such embodiments, the sensor may be configured to obtain physiological information regarding a living body on which the neuromodulation device is worn. In some embodiments, the sensor may be a camera configured to obtain an image or video of a living body on which the neuromodulation device is worn. In some such embodiments, the image and / or video may be processed to determine an orientation of a body part of the wearer, which may inform waveforms and / or parameters to transmit to the wearer.

[0110] Figure 10 is a flow diagram for a method 1000 of operating a neuromodulation device, according to some embodiments. In act 1002, the method includes receiving a first input that is indicative of an instruction to begin treating a tissue region. In some embodiments, the first input may be received via an interface on a neuromodulation device and / or an interface of a computing device in communication with the neuromodulation device. For example, a wearer of a neuromodulation device may provide input initiating a TENS or EMS treatment. In some embodiments, the first input may be received from a sensor configured to obtain physiological information regarding a wearer of a neuromodulation device. In some such embodiments, the first input may be compared to one or more criteria to determine if the physiological information should trigger transmission of a waveform. For example, physiological information associated with a particularailment or pain may be employed to indicate an instruction to begin treating a tissue region.

[0111] In act 1004, the method includes transmitting, through a pair of electrodes proximate to the tissue region, a first waveform. In some embodiments, the first waveform may have one or more parameters that yield a first intensity. In act 1006, the method includes receiving a second input that is indicative of a request to increase the intensity of the waveform. In some embodiments, the second input may be received via the same mechanism as the first input. In some embodiments, the second input may be received via an interface on a neuromodulation device and / or an interface of a computing device in communication with the neuromodulation device. The second input may be a confirmation that the first waveform was comfortable, in some embodiments. In act 1008, the method includes transmitting, through the pair of electrodes proximate to the tissue region, a second waveform with a higher intensity than the first waveform.

[0112] In some embodiments, in the event that no input indicative of a request to increase the intensity is received in act 1006, a most recently transmitted waveform of the plurality of waveforms may continually transmitted through the pair of electrodes. For example, an initial waveform may be retransmitted through the pair of electrodes until a treatment is completed or until an input indicative of a request to increase the intensity is received.

[0113] Figure 11 is a diagram 1100 illustrating a sequence of waveforms according to some embodiments. In the diagram 1100 of Figure 11 , three waveforms 1102 are shown, waveform A, waveform B, and waveform C. In the example of Figure 11 , each waveform includes a plurality of pulses. In some cases, the pulses may be representative of pulses like that described with reference to Figure 4. Each of the three waveforms in Figure 11 has a parameter that differs between the three waveforms. In the example of Figure 11 , that parameter is frequency. As shown in Figure 11 , the first waveform A has a first frequency, thesecond waveform B has a second frequency, and the third waveform C has a third frequency. In the example of Figure 11 , the third frequency is greatest and is greater than the second frequency and the first frequency. The second frequency is greater than the first frequency. In some embodiments, greater frequency (e.g., mean frequency or peak frequency) may contribute to perceived intensity of a waveform. In some embodiments, the first waveform A may be transmitted to a living body before the second waveform B. Likewise, the second waveform B may be transmitted to a living body before the third waveform C. In this manner, the living body may adapt to the change in frequency so that the third waveform C is more comfortable and less irritating than if the third waveform was applied first.

[0114] Figure 12 is a diagram 1200 illustrating a sequence of waveforms according to some embodiments. In the diagram 1200 of Figure 12, three waveforms 1202 are shown, first waveform A, second waveform B, and third waveform C. In the example of Figure 12, each waveform includes a plurality of pulses. In some cases, the pulses may be representative of pulses like that described with reference to Figure 4. Each of the three waveforms in Figure 12 has a parameter that differs between the three waveforms. In the example of Figure 12, that parameter is amplitude. As shown in Figure 12, the first waveform A has a first amplitude, the second waveform B has a second amplitude, and the third waveform C has a third amplitude. In the example of Figure 12, the third amplitude is greatest and is greater than the second amplitude and the first amplitude. The second amplitude is greater than the first amplitude. In some embodiments, greater amplitude (e.g., mean amplitude or peak amplitude) which may be measured in current may contribute to perceived intensity of a waveform. In some embodiments, the first waveform A may be transmitted to a living body before the second waveform B. Likewise, the second waveform B may be transmitted to a living body before the third waveform C. In this manner, the living body may adapt to the change in amplitude so that the third waveform C is more comfortable and less irritating than if the third waveform was applied first.

[0115] Figure 13 is a diagram 1300 illustrating a sequence of waveforms according to some embodiments. In the diagram 1300 of Figure 13, three waveforms 1302 are shown, first waveform A, second waveform B, and third waveform C. In the example of Figure 13, each waveform includes a plurality of pulses. In some cases, the pulses may be represented by pulses like that described with reference to Figure 4. Each of the three waveforms in Figure 13 has a parameter that differs between the three waveforms. In the example of Figure 13, that parameter is pulse width. As shown in Figure 13, the first waveform A has a first pulse width, the second waveform B has a second pulse width, and the third waveform C has a third pulse width. In the example of Figure 13, the third pulse width is greatest and is greater than the second pulse width and the first pulse width. The second pulse width is greater than the first pulse width. In some embodiments, greater pulse width (e.g., mean pulse width or peak pulse width) may contribute to perceived intensity of a waveform. In some embodiments, the first waveform A may be transmitted to a living body before the second waveform B. Likewise, the second waveform B may be transmitted to a living body before the third waveform C. In this manner, the living body may adapt to the change in pulse width so that the third waveform C is more comfortable and less irritating than if the third waveform was applied first.

[0116] Figure 14 is a diagram 1400 illustrating a sequence of waveforms according to some embodiments. In the diagram 1400 of Figure 14, three waveforms 1402 are shown, first waveform A, second waveform B, and third waveform C. In the example of Figure 14, each waveform includes a plurality of pulses. In some cases, the pulses may be represented by pulses like that described with reference to Figure 4. Each of the three waveforms in Figure 14 has a parameter that differs between the three waveforms. In the example of Figure 14, that parameter is a period of amplitude modulation of a modulation pattern 1404. As shown in Figure 14, the first waveform A has a first period of amplitude modulation, the second waveform B has a second period of amplitude modulation, and the third waveform C has a third period of amplitude modulation.In the example of Figure 14, the first waveform A has an effectively infinite period of amplitude modulation, in that no amplitude modulation is applied to the pulses. The third period is shortest and is less than the second period of the second waveform B. Accordingly, the third waveform C has a higher frequency of amplitude modulation compared to the second waveform B. In some embodiments, a greater period of amplitude modulation may yield a more intense waveform, as there are no periods of lower amplitude pulses. Accordingly, in the example of Figure 14, the first waveform A may be more intense than the second waveform B which is more intense than the third waveform C. In some embodiments, the third waveform C may be transmitted to a living body before the second waveform B. Likewise, the second waveform B may be transmitted to a living body before the first waveform A. In this manner, the living body may adapt to the reduction in modulation so that the first waveform A is more comfortable and less irritating than if the first waveform A was applied first.

[0117] In some embodiments, a first oscillating pattern for modulation of a first waveform may have a first magnitude (e.g., an amount of modulation). In some such embodiments, a second oscillating pattern for modulation of a second waveform may have a second magnitude different than the first magnitude. For example, in some embodiments the second magnitude may be greater than the first magnitude. In other embodiments, the second magnitude may be less than the first magnitude. Like other parameters discussed herein, the magnitude of an oscillating modulation pattern may affect the perceived intensity of a waveform.

[0118] Figure 15 is a diagram 1500 illustrating a sequence of waveforms according to some embodiments. In the diagram 1500 of Figure 15, three waveforms 1502 are shown, first waveform A, second waveform B, and third waveform C. In the example of Figure 15, each waveform includes a plurality of pulses. Each of the three waveforms in Figure 15 have a parameter that differs between the three waveforms. In the example of Figure 14, that parameter is a shape of a pulse applied as a part of each respective waveform. As shown in Figure 15, the first waveform A has a first pulse shape, the second waveform Bhas a second pulse shape, and the third waveform C has a third pulse shape. In the example of Figure 15, the first waveform A has a square wave shape. The second waveform B has a pulse shape 1504 including a spike and a primary phase, as described with reference to Figure 4. The third waveform C has a pulse shape 1506 including a ramp profile. In some embodiments, the shape of a pulse may affect the perceived intensity of the waveform. In some embodiments, the first waveform A may be transmitted to a living body before the second waveform B. Likewise, the second waveform B may be transmitted to a living body before the third waveform C. In this manner, the living body may adapt to the differences in pulse shape so that the third waveform C is more comfortable and less irritating than if the third waveform C was applied first. In some embodiments, other sequences of waveforms with different pulse shapes may be applied, as the present disclosure is not so limited.

[0119] According to the examples of Figures 11 -15, specific parameters are isolated and change between waveforms. While single parameters may affect perceived intensity, in some cases different waveforms may have combinations of parameters that change as a part of a sequence of waveforms transmitted to a living body. In some embodiments, successive waveforms may differ in terms of amplitude, period, phase, frequency, or any combination thereof. A perceived intensity of a waveform may be based on the combination of parameters of a waveform. Accordingly, in some embodiments, a neuromodulation device may transmit a plurality of waveforms with differences in a single parameter. In other embodiments, a neuromodulation device may transmit a plurality of waveforms with differences in multiple parameters. In either case, the plurality of waveforms may have differences in expected perceived intensity. Accordingly, less intensive waveforms may be applied prior to more intensive waveforms, to allow a living body to adapt to electrical stimulation. In some embodiments, across a sequence of waveforms different parameters may be varied independently to reduce irritation and provide a more effective treatment. In some cases, this may include reducing one parameter while increasing another parameter. For example, a first waveformmay have a first frequency and a first amplitude, and a second waveform may have a second frequency and a second amplitude. In some embodiments, the second frequency may be less than the first frequency, but the second amplitude may be greater than the first amplitude. Despite the lower second frequency, in combination with the higher second amplitude, the second waveform may still have a greater perceived intensity than the first waveform.

[0120] Figures 16-18 are diagrams illustrating neuromodulation devices and waveforms corresponding to an electrode patch of the neuromodulation device, according to some embodiments. In some cases, it may be desirable to provide a visual indicator for a wearer of a neuromodulation device as to the type of waveform applied by the neuromodulation device so that a user can apply the most effective waveforms for their target body region or ailment. Different waveforms with different parameters may be more effective and less irritation for certain body regions or ailments. In some embodiments, a neuromodulation device may be configured to apply a particular waveform based on an electrode patch coupled to the neuromodulation device. The neuromodulation device may be configured to detect and recognize an electrode patch attached to the neuromodulation device. For example, a neuromodulation device may be configured to detect a resistance of an electrode patch to identify of type of electrode patch. As another example, a neuromodulation device may be configured to communicate with or otherwise access an identifier on the electrode patch. In some embodiments, an operator of the neuromodulation device may provide input to the neuromodulation device (e.g., via a communication module) identifying the electrode patch and / or a target body region and / or ailment. For example, a user may provide input via a graphical user interface of a mobile phone in communication with the neuromodulation device. As another example, a user may scan a barcode on the electrode patch with a camera of the mobile phone.

[0121] As shown in Figure 16, a neuromodulation device 1600 includes a controller 1602 and a first electrode patch 1604. Based on detection of the first electrode patch 1604, the neuromodulation device 1600 is configured to generateand transmit to the first electrode patch a first waveform 1606. As shown in Figure 17, a neuromodulation device 1700 includes a controller 1702 and a second electrode patch 1704. The controller 1702 may be the same as the controller 1602 of Figure 16. Based on detection of the second electrode patch 1704, the neuromodulation device 1700 is configured to generate and transmit to the second electrode patch a second waveform 1706 that is different than the first waveform 1606 of Figure 16. As shown in Figure 18, a neuromodulation device 1800 includes a controller 1802 and a third electrode patch 1804. The controller 1802 may be the same as the controllers of Figures 16 and 17. Based on detection of the third electrode patch 1804, the neuromodulation device 1800 is configured to generate and transmit to the third electrode patch a third waveform 1806 that is different than the first waveform 1606 of Figure 16 and the second waveform 1706 of Figure 17. In some embodiments, each of the electrode patches 1604, 1704, 1804 may be removable and replaceable. In this manner, electrode patches may be interchanged to cause a neuromodulation device to apply different waveforms with different parameters.Remarks

[0122] The foregoing description of various embodiments of the claimed subject matter has been provided for the purposes of illustration and description. It is not intended to be exhaustive or to limit the claimed subject matter to the precise forms disclosed. Many modifications and variations will be apparent to one skilled in the art. Embodiments were chosen and described in order to best describe the principles of the invention and its practical applications, thereby enabling those skilled in the relevant art to understand the claimed subject matter, the various embodiments, and the various modifications that are suited to the particular uses contemplated.

[0123] Although the Detailed Description describes certain embodiments and the best mode contemplated, the technology can be practiced in many ways no matter how detailed the Detailed Description appears. Embodiments can varyconsiderably in their implementation details, while still being encompassed by the specification. Particular terminology used when describing certain features or aspects of various embodiments should not be taken to imply that the terminology is being redefined herein to be restricted to any specific characteristics, features, or aspects of the technology with which that terminology is associated. In general, the terms used in the following claims should not be construed to limit the technology to the specific embodiments disclosed in the specification, unless those terms are explicitly defined herein. Accordingly, the actual scope of the technology encompasses not only the disclosed embodiments, but also all equivalent ways of practicing or implementing the embodiments.

[0124] The language used in the specification has been principally selected for readability and instructional purposes. It may not have been selected to delineate or circumscribe the subject matter. It is therefore intended that the scope of the technology be limited not by this Detailed Description, but rather by any claims that issue on an application based hereon. Accordingly, the disclosure of various embodiments is intended to be illustrative, but not limiting, of the scope of the technology as set forth in the following claims.

Claims

CLAIMSWhat is claimed is:1 . A neuromodulation device comprising: a first electrode configured to be worn on the skin of a living body at a first location; a second electrode configured to be worn on the skin of the living body at a second location; a non-transitory memory storing a first waveform and a second waveform; and a controller programmed to transmit the first waveform and the second waveform to the living body via the first electrode and the second electrode, wherein the controller is configured to: transmit the first waveform to the living body, wherein the first waveform has a first parameter, and transmit the second waveform to the living body after transmitting the first waveform to the living body, wherein the second waveform has a second parameter corresponding to the first parameter, wherein the second parameter is greater than the first parameter.

2. The neuromodulation device of claim 1 , wherein the first parameter and the second parameter are pulse width.

3. The neuromodulation device of claim 2, wherein the first parameter and the second parameter are between 30 ps and 90 ps.

4. The neuromodulation device of claim 1 , wherein the first waveform and the second waveform each include a modulation of amplitude, wherein thefirst parameter and the second parameter are an amount of amplitude modulation.

5. The neuromodulation device of claim 4, wherein the first parameter and the second parameter are between a peak amplitude and 30 percent of a peak amplitude.

6. The neuromodulation device of claim 1 , wherein the first waveform and the second waveform each include a modulation of amplitude, wherein the first parameter and the second parameter are a type of oscillating pattern for the modulation of amplitude.

7. The neuromodulation device of claim 6, wherein the first parameter is a sinusoidal oscillating pattern, and wherein the second parameter is a parabolic oscillating pattern.

8. The neuromodulation device of claim 1 , wherein the first waveform and the second waveform each include a modulation of amplitude, wherein the first parameter and the second parameter are a period of amplitude modulation.

9. The neuromodulation device of claim 8, wherein the first parameter and the second parameter are between 1 second and 7.5 seconds.

10. The neuromodulation device of claim 1 , wherein the first waveform and the second waveform each include a modulation of phase, wherein the first parameter and the second parameter are a frequency range of phase modulation.11 . The neuromodulation device of claim 10, wherein the first parameter and the second parameter are between 50 Hz and 150 Hz.

12. The neuromodulation device of claim 1 , wherein the first waveform and the second waveform each include a modulation of phase, wherein the first parameter and the second parameter are a type of oscillating pattern for the modulation of phase.

13. The neuromodulation device of claim 12, wherein the first parameter is a sinusoidal oscillating pattern, and wherein the second parameter is a noise pattern.

14. The neuromodulation device of claim 1 , wherein the first waveform and the second waveform each include a modulation of phase, wherein the first parameter and the second parameter are a period of phase modulation.

15. The neuromodulation device of claim 14, wherein the first parameter and the second parameter are between 1 second and 5 seconds.

16. The neuromodulation device of claim 1 , wherein the first parameter and the second parameter are dispersion of frequencies.

17. The neuromodulation device of claim 16, wherein the first parameter and the second parameter are between 0.05 sigma and 0.25 sigma.

18. The neuromodulation device of claim 1 , wherein the non-transitory memory is further storing a third waveform, wherein the controller is further configured to transmit the third waveform to the living body after transmitting the second waveform to the living body, wherein the thirdwaveform has a third parameter corresponding to the first parameter and the second parameter, wherein the third parameter is greater than the first parameter and the second parameter.

19. The neuromodulation device of claim 1 , further comprising a communication module, wherein the controller is further configured to: receive input regarding a perceived intensity of the first waveform from the living body via the communication module; and in response to receiving the input, transmit the second waveform.

20. The neuromodulation device of claim 1 , further comprising a communication module, wherein the controller is further configured to: receive input regarding a perceived intensity of the second waveform from the living body via the communication module; determine whether the input exceeds a predetermined non-zero threshold; and upon determining the input exceeds the threshold, transmitting the first waveform to the living body.21 . The neuromodulation device of claim 1 , further comprising a communication module, wherein the controller is further configured to: receive input regarding a perceived intensity of the first waveform from the living body via the communication module; and adjust the first parameter to generate the second waveform with the second parameter based on the input.

22. A neuromodulation device comprising: a first electrode configured to be worn on the skin of a living body at a first location;a second electrode configured to be worn on the skin of the living body at a second location; a communication module configured to wirelessly communicate with a computing device that is accessible to an operator; and a controller connected to the first electrode, the second electrode, and the communication module, wherein the controller is configured to: transmit, to the living body via the first electrode and the second electrode, a first waveform that has a first parameter, receive, via the communication module, input that is representative of an instruction from the operator, and based on the input, transmit, to the living body via the first electrode and the second electrode, a second waveform that has a second parameter corresponding to the first parameter, wherein the second parameter has a different value than the first parameter.

23. The neuromodulation device of claim 22, wherein the second parameter is greater than the first parameter.

24. The neuromodulation device of claim 22, wherein the second parameter is less than the first parameter.

25. The neuromodulation device of claim 22, wherein the input includes a perceived intensity of the first waveform by the living body.

26. The neuromodulation device of claim 25, wherein the controller is further configured compare the perceived intensity to a predetermined non-zero threshold, and wherein transmitting the second waveform is based on the comparison of the perceived intensity to the threshold.

27. The neuromodulation device of claim 22, wherein the controller is further configured to adjust the first parameter to generate the second waveform with the second parameter based on the input.

28. The neuromodulation device of claim 22, wherein the input is a first input, wherein the controller is further configured to: receive second input from the living body via the communication module after transmission of the second waveform to the living body, and based on the second input from the communication module, transmit a third waveform to the living body via the first electrode and the second electrode, wherein the third waveform has a third parameter corresponding to the first parameter and the second parameter.

29. The neuromodulation device of claim 28, wherein the third parameter is greater than the first parameter and the second parameter.

30. The neuromodulation device of claim 28, wherein the third parameter is less than the second parameter and greater than the first parameter.31 . The neuromodulation device of claim 28, wherein the first parameter is equal to the first parameter, such that the third waveform is the same as the first waveform.

32. A method of operating a neuromodulation device, the method comprising: transmitting a first waveform to a living body, wherein the first waveform has a first parameter, and wherein a first electric field of the first waveform has a first strength sufficient to produce a conformational change in cellular components of a tissue region of interest, and transmitting a second waveform to the living body after transmitting the first waveform to the living body, wherein the second waveform hasa second parameter corresponding to the first parameter, wherein the second parameter is greater than the first parameter, and wherein a second electric field of the second waveform has a second strength sufficient to produce a conformational change in cellular components of the tissue region of interest, wherein the second strength is greater than the first strength.

33. The method of claim 32, wherein the first parameter and the second parameter are pulse width.

34. The method of claim 32, wherein transmitting the first waveform comprises modulating an amplitude of the first waveform according to a first oscillating pattern, and wherein transmitting the second waveform comprises modulating an amplitude of the second waveform according to a second oscillating pattern.

35. The method of claim 34, wherein the first oscillating pattern has a first period, and wherein the second oscillating pattern has a second period greater than the first period.

36. The method of claim 34, wherein the first oscillating pattern has a first magnitude, and wherein the second oscillating pattern has a second magnitude greater than the first magnitude.

37. The method of claim 32, wherein transmitting the first waveform comprises modulating a phase of the first waveform according to a first oscillating pattern, and wherein transmitting the second waveform comprises modulating a phase of the second waveform according to a second oscillating pattern.

38. The method of claim 37, wherein the first oscillating pattern has a first period, and wherein the second oscillating pattern has a second period greater than the first period.

39. The method of claim 37, wherein the first oscillating pattern has a first magnitude, and wherein the second oscillating pattern has a second magnitude greater than the first magnitude.

40. The method of claim 32, further comprising transmitting a third waveform to the living body after transmitting the second waveform to the living body, wherein the third waveform has a third parameter corresponding to the first parameter and the second parameter, wherein the third parameter is greater than the first parameter and the second parameter.41 . The method of claim 32, further comprising: receiving input from the living body regarding a perceived intensity of the first waveform; and in response to receiving the input, transmitting the second waveform.

42. The method of claim 32, further comprising: receiving input from the living body regarding a perceived intensity of the second waveform; and in response to receiving the input, repeating transmission of the first waveform.

43. A method of operating a device to treat a tissue region of a living body through electrical neuromodulation, the method comprising: receiving input that is indicative of an instruction to begin treating the tissue region; andtransmitting, through a pair of electrodes proximate to the tissue region, a plurality of waveforms in order of intensity as perceived by the living body, beginning with a lowest intensity and progressing to a higher intensity in response to receiving another input that is indicative of a request to increase the intensity.

44. The method of claim 43, wherein the instruction is provided through a computing device that is connected to the device via a wireless communication protocol.

45. The method of claim 43, wherein in the event that no input indicative of a request to increase the intensity is received, a most recently transmitted waveform of the plurality of waveforms is continually transmitted through the pair of electrodes.

46. The method of claim 43, wherein successive waveforms differ in terms of amplitude, period, phase, frequency, or any combination thereof.

47. A device for treating a tissue region of a living body through electrical neuromodulation, the device comprising: a pair of electrodes that are to be positioned proximate to the tissue region; a memory that includes a plurality of waveforms having different amplitudes, periods, phases, or frequencies; and a controller that is configured to transmit, through the pair of electrodes, the plurality of waveforms in order of intensity as perceived by the living body, wherein the controller begins with a lowest intensity and progresses to a higher intensity in response to receiving input that is indicative of an instruction to increase the intensity.

48. The device of claim 47, further comprising: a communication module that is configured to wirelessly communicate with a computing device through which the instruction is provided.

49. The device of claim 47, further comprising: a sensor that is configured to generate values that are representative of discrete measurements of a physiological characteristic.

50. The device of claim 49, wherein the controller is further configured to monitor the values to determine whether to increase the intensity.51 . The device of claim 50, wherein the controller is further configured to monitor the values to identify one or more values that satisfy a criterion and, in response to identifying the one or more values, determine that a current intensity is to be maintained for an interval of time for treatment of the tissue region.

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