Wearable electrical stimulator devices

Abstract

An electrical stimulation device is disclosed. The electrical stimulation device includes a first pair of electrodes configured to be applied to a first target muscle group and a second pair of electrodes configured to applied to a second target muscle group, switch circuitry; a stimulation circuit; and an EMG measurement circuit. The switch circuitry operatively connects the stimulation circuit and the EMG measurement circuit to the first pair of electrodes and to one electrode of the second pair of electrodes such that when the stimulation circuit is activated the one electrode from the second pair of electrodes serves as a reference electrode. A garment incorporating the electrical stimulation device is also disclosed, as well as a method of applying electrical stimulation.

Description

WEARABLE ELECTRICAL STIMULATOR DEVICES CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application Number 63 / 539,735, filed September 21, 2023, the entire disclosure of which is incorporated herein by reference. TECHNICAL FIELD

[0002] The present disclosure relates generally to electrical stimulation devices, and more specifically, to wearable electrical stimulation devices configured to be worn about a portion of a user’s body for a variety of physical wellness purposes. BACKGROUND

[0003] Electrical stimulation devices for muscles and nerves have been employed to treat certain medical conditions, including paralysis. Such stimulation is referred to as functional electrical stimulation or FES. Electrical massage may also be used as a pain reducer. More specifically, stimulation of the muscles causes a higher blood flow to the area, hence a massage effect. This type of stimulation is often referred to as transcutaneous electrical nerve stimulation, or TENS.

[0004] Known systems have typically included a pair of electrodes that are attached to a substrate that may be worn by a patient. Voltage pulses are applied across the electrodes. To measure the effectiveness or the progress of the application of stimulation, sensors may be used to take muscle response or electrical activity in response to a nerve’s stimulation of the muscle, i.e., EMG measurements of the muscles. More specifically, EMG is an indirect indication of the strength of a muscle contraction. Certain systems utilize the same pair of electrodes to both apply stimulation, as well as to measure the EMG pulses of the same muscle to which the stimulation is applied.

[0005] However, while using the same electrode pair to measure EMG signals when applying electrical stimulation to a muscle has been found to reduce the number of electrodes needed, one issue that arises is a time tradeoff. For example, if the same electrode pair is used for both events, different time sections need to beallocated for different activities. For example, a periodic scheme such as sending stimulation, waiting, and measuring the EMG, and then waiting again, and sending stimulation again to repeat the process is required. Accordingly, the time for application of therapy is extended to accommodate the time lag caused by the wait for measuring the EMG. Extended therapy time often results in a decrease in patient compliance, as the patient must allocate time to complete a therapy cycle. What is needed is an arrangement that reduces such therapy time to encourage patient compliance.

[0006] Another issue that arises when employing electrical stimulation devices is consistent and proper electrode placement. For example, the aim is to deliver consistent stimulation to each targeted area to be stimulated and recorded day after day for a predetermined time period. Thus, it is desirable to place the electrodes in the same locations each time to be able to monitor whether the EMG signals are increasing, decreasing, or staying the same over the predetermined therapy times, i.e., weeks or months, while avoiding errors and / or erroneous signals. What is needed is a way to ensure proper and consistent placement of the electrodes to maximize therapeutic efficacy. SUMMARY

[0007] An electrical stimulation device is disclosed. In one exemplary arrangement, the electrical stimulation device includes a first pair of electrodes configured to be applied to a first target muscle group and a second pair of electrodes configured to be applied to a second target muscle group, switch circuitry; a stimulation circuit; and an EMG measurement circuit. The switch circuitry operatively connects the stimulation circuit and the EMG measurement circuit to the first pair of electrodes and to one electrode of the second pair of electrodes such that when the stimulation circuit is activated the one electrode from the second pair of electrodes serves as a reference electrode.

[0008] In one exemplary arrangement, the switch circuitry is configured to alternate application of stimulation and taking EMG measurements.

[0009] In one exemplary arrangement, the switch circuitry further comprises a pair of stimulator switches for the first pair of electrodes, and pair of EMG switches for thefirst pair of electrodes. A first control signal is configured to turn the stimulator switches to an activated position such that the first electrode pair is put into a stimulation mode. A second control signal is configured to turn the EMG switches to an activated position such that the first electrode pair is put into an EMG measurement mode. The EMG measurement circuit may further comprise an instrumentation amplifier and signal conditioning circuitry.

[0010] A control system is operatively connected to the stimulation circuit and the EMG circuit. The control system is configured to activate the stimulation circuit and to activate the EMG circuit. Predetermined stimulation cycles and EMG measurement cycles may be employed by algorithms stored in a memory of the control system.

[0011] An input device may be operatively connected to the control system. The input device, which may be a mobile phone or tablet, is operatively connected to the control system. The input device may be utilized to input different operating parameters to the control system for operating the electrical stimulator device.

[0012] The control system may be configured to collect and store data received from the electrode pairs within a memory. The collected data may be transmitted to a display device to allow a practitioner to analyze the efficacy of the treatment applied by the electrical stimulation device.

[0013] In one exemplary arrangement, the electrical stimulator device is a wearable garment having electrodes integrated therein.

[0014] An exemplary method of applying stimulation therapy is also disclosed. More specifically, a method is proposed that comprises positioning an electrical stimulator device such that a first set of electrodes are positioned across a first target muscle and a second set of electrodes are positioned across a second target muscle; selecting the target muscle to apply stimulation; selecting one or more stimulation parameters; initiating stimulation and EMG measurement collection for a predetermined time period; and aggregating data from the EMG measurement collection.

[0015] In one exemplary method, the EMG measurement collection is taken after each stimulation cycle of application of a positive pulse and a negative pulse. Inanother exemplary arrangement, the EMG measurement collection begins at about 1 millisecond (ms) after the negative pulse.

[0016] Alternatively, in one method, the EMG measurement collection is taken between each positive pulse and negative pulse of a stimulation cycle.

[0017] In one exemplary arrangement, an EMG measurement collection includes taking multiple EMG measurements in each measurement cycle. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Exemplary arrangements of the present disclosure will now be described in greater detail with reference to the attached figures, in which:

[0019] Fig.1 is a system diagram for an electrical stimulation system in accordance with an exemplary arrangement of the present disclosure;

[0020] Fig. 2 is an example circuit diagram for an electrode arrangement for stimulation and EMG measurement;

[0021] FIG.3 is a flow chart demonstrating the sequence of operation of the circuit shown in FIG.2;

[0022] FIG. 4 is a prior art timing diagram of a known stimulation and EMG measurement arrangement;

[0023] FIG. 5A is an example timing diagram of the stimulation and EMG measurement arrangement of FIG.2;

[0024] FIG. 5B is a further example timing diagram of the stimulation and EMG measurement arrangement of FIG.2;

[0025] FIG.6 is a prior art EMG measurement scheme in a known stimulation and EMG measurement arrangement;

[0026] FIG. 7 is an example EMG measurement scheme in the stimulation and EMG measurement arrangement of FIG.2;

[0027] FIG.8 a simplified circuit diagram for an alternative electrode arrangement for stimulation and EMG measurement;

[0028] FIG. 9 is a front view of an exemplary wearable electrode stimulation garment having a stimulation and EMG measurement arrangement according to the disclosure;

[0029] FIG. 10 is a rear view of the exemplary wearable electrode stimulation garment having a stimulation and EMG measurement arrangement of FIG.9;

[0030] FIG. 11 is a side view of the exemplary wearable electrode stimulation garment having a stimulation and EMG measurement arrangement of FIG.9;

[0031] FIG.12 is an alternative exemplary wearable electrode stimulation garment having a stimulation and EMG measurement arrangement according to the disclosure;

[0032] FIG.13 is an alternative exemplary wearable electrode stimulation garment having a stimulation and EMG measurement arrangement according to the disclosure; and

[0033] FIG. 14 is a flowchart outlining an example method of utilizing one of the garments of FIGS.9-13. DETAILED DESCRIPTION

[0034] Referring now to the discussion that follows, and to the drawings, illustrative approaches to the disclosed systems and methods are shown in detail. Although the drawings represent some possible approaches, the drawings are not necessarily to scale and certain features may be exaggerated, removed, or partially sectioned to better illustrate and explain the present disclosure. Further, the descriptions set forth herein are not intended to be exhaustive or otherwise limit or restrict the claims to the precise forms and configurations shown in the drawings and disclosed in the following detailed description.

[0035] Referring to Fig.1, an exemplary arrangement of an electrical stimulation system 10 is disclosed. The electrical stimulation system 10 includes an input device 12 that is operably connected to a control system 14 to operate the electrical stimulation system 10. The control system 14 includes a control algorithm configured to employ an appropriate signal pattern to different electrodes 16 that are applied to predetermined muscle groups. The electrical stimulation system 10 may be operatively connected to server 18, having a memory, which may be configured to store various signal patterns to be used by the electrical stimulation system 10.

[0036] In one exemplary arrangement, the input device 12 may be a remote device, such as a mobile phone or tablet, which is operatively connected to the control system 14. For example, the input device 12 may be connected with a wired connection to the control system 14. Alternatively, the input device 12 may be connected wirelessly, such as through a Bluetooth connection, to the control system 14.

[0037] The electrical stimulation system 10 includes a plurality of electrodes 16. While only four electrodes 16 are illustrated, it is understood that the electrical stimulation system 10 may include additional electrodes 16 or fewer electrodes 16, depending on the intended application of the electrical stimulation system 10. In one exemplary arrangement the electrodes 16 may be incorporated into a wearable garment 19, for example a pair of shorts that incorporate electrodes 16, as will be described in further detail below.

[0038] The server 18 is operatively connected to the controller 14 and serves to collect data received from the electrodes 16, as will be explained in further detail below. The server 18 may be operatively configured to deliver the data to a display device (not shown), to allow a practitioner to visually extrapolate the data to monitor the efficacy of the electrical stimulation system 10, as well as to use visual representations of the data to make changes to a treatment plan being employed by the electrical stimulation system 10. In an example, the controller 14 may be operatively connected to the server 18 via the input device 12.

[0039] Referring to FIG.2, an exemplary circuit 20 is shown for an electrode pair 22 that may be utilized in an electrical stimulation system 10. The electrode pair 22 includes a first electrode 24 and a second electrode 26. Each of the first and second electrodes 24, 26 are configured to be attached to an area of interest of a wearer. For example, in one exemplary arrangement, to promote consistent placement of the electrode pair 22, the electrode pair 22 may be incorporated into a pair of shorts such that the electrodes 24, 26 are disposed on same location on the quadriceps of a wearer. In addition to the electrode pair 22, the circuit 20 further comprises a stimulation circuit 28, a reference electrode 30, first and second stimulator switches 32, 34, EMG circuitry 36 and first and second EMG switches 38, 40.

[0040] The stimulation circuit 28 is operatively connected to the controller 14 and to the first and second stimulator switches 32 and 34. The first and second stimulator switches 32 and 34 are disposed between the stimulation circuit 28 and the first and second electrodes 24, 26, respectively.

[0041] In one exemplary arrangement, the EMG circuitry 36 includes an instrumentation amplifier 42 and signal conditioning circuitry 44. Operatively connected to the EMG circuitry 36 is the first and second EMG switches 38, 40. The first and second EMG switches 38, 40 are disposed between the EMG circuitry 36 and the first and second electrodes 24, 26. The first and second stimulation switches 32,34 and the first and second EMG switches 38, 40 are operatively connected to the controller 14, as will be explained in further detail below.

[0042] In some prior art systems, a different electrode is used for measuring EMG than the electrodes used for stimulation. However, the result is that this known arrangement then measures a different muscle group than the muscle group being stimulated.

[0043] In contrast, the arrangement disclosed herein uses the same electrode pair 22 for stimulation and EMG measurement, thereby allowing for measurement of the EMG signal of the same muscle group after stimulation. However, as discussed above, use of the same electrode pair 22 can result in a tradeoff in the timing of a procedure using the electrode pair 22. More specifically, different time sections of the procedure need to be allocated for different purposes, i.e., sending an initial stimulation, pausing for a predetermined time period, measuring the EMG of the treated muscle, pausing for a predetermined time period, repeating the process. For example, as shown in the prior art timing diagram shown in FIG.4, the prior art teaches the application of a rectangular form of electric pulse. The stimulation pulses are applied at intervals of 15ms. Following application of the pulse, the prior art teaches to insert a pause followed by an EMG measurement phase. The prior art teaches the pause to be approximately 2 / 3 of the time (10ms) between stimulation pauses, and the subsequent measurement phase to be approximately 1 / 3 of the time (5ms) between stimulation pulses. Accordingly, the prior art teaches the pause to be approximately twice as long as the measurement period.

[0044] In contrast, in the exemplary arrangement disclosed herein, the inventors have determined that the EMG measurements may be commenced close to the end of stimulation. More specifically, referring to FIGS.2, 3 and 5, the timing and sequence of operation 60 of the system 10 is controlled by the controller 14, to send a stimulator control signal 46 and an EMG control signal 48 to control the stimulator switches 32 and 34 and the EMG switches 38 and 40, respectively. This arrangement thus allows the bidirectional operation of the system 10.

[0045] For example, referring to FIG. 3, when the operation 60 begins, both switches 32 and 34 are turned to the Off position in step 62. In the next step 64, the stimulator control signal 46 from the controller 14 activates the stimulator switch 32 of the positive electrode 24, to turn the switch 32 to an “on” position. Further, the controller 14 initiates the stimulator control signal 46 to activate the stimulator switch34 of the negative electrode 26 in step 64, so as to operatively connect the first electrode 24 and the second electrode 26 to the stimulator circuit 28. Once connected, in step 66, a positive pulse may be sent to the electrodes 24 and 26 for a predetermined length of time and intensity. As discussed above, the controller 14 may be configured to provide the appropriate length of time and intensity for the positive pulse, based on inputs from the input device 12. In step 68, the controller 14 next sends a negative pulse to the electrodes 24 and 26. This is represented by the dotted lines in the timing diagram shown in FIG.5A, i.e., the stimulation window being in the form of a biphasic waveform.

[0046] After application of the negative pulse, the operation 60 proceeds to step 70. In step 70, the controller 14 turns the switches 32 and 34 to the OFF position, but turns the switches 38 and 40 to the on position. Thus, the electrode pair 22 is disconnected from the stimulator circuit 28, but operatively connected to the EMG circuitry 36. When step 70 is completed, the controller 14 then proceeds to step 72 to take EMG measurements of the muscle group that was just subjected to stimulation.

[0047] After the EMG measurement is taken in step 72, the process then proceeds to step 74, where the controller 14 determines if the therapy cycle is complete. If the cycle is completed, the operation ends at 76. However, if the cycle is not complete, the process proceeds to step 78, where the cycle is paused for a predetermined time period. After the pause 78, the operation 60 repeats, by returning to step 62. As may be seen in FIG. 5A, the operation 60 repeats according to the stimulation pattern received from the control system 12 until the treatment process terminates.

[0048] In one exemplary arrangement, the controller 14 may be programed to reduce the time between switches between the stimulation activation and EMG measurement to under 6ms, and in one exemplary arrangement, to 1ms. In other words, The EMG measurement starts right after the trailing edge of a pulse takes place and for the duration of the interpulse phase until the next pulse takes place, as shown in FIG. 5A. While only one EMG measurement is indicated as being taken in the phase illustrated, it is understood that multiple EMG measurements may be taken during the EMG measurement phase. That is, the EMG will be sampled at multiple times, with values and corresponding times stored in memory, so that a shape (voltage vs. time) of the EMG response over time can be stored and analyzed.

[0049] Referring to FIG.5A, on the left side, a cycle of the operation 60 is shown, contrasted with the prior art shown on the right side. As may be seen, unlike the priorart design, the speed of the circuit design allows the controller 14 to capture the full view of an EMG measurement, including the front end, immediately after conclusion of the negative pulse from the stimulation operation. In contrast, when looking at the right side of FIG.5A, as in the prior art design, there is a significant pause, or blackout zone that does not show characteristics of the EMG measurements immediately from the end of stimulation. However, the EMG measurements, particularly at the front end of EMG measurements, can yield valuable information that a practitioner may use to arrive at a diagnosis of neurological and myoneural disorders. For example, looking at FIG.5B, by having the full range of the EMG measurement, a slope of the EMG measurement can be calculated. As the slope of the rise of the EMG measurement can be indicative of certain disorders, having the full range of the EMG measurement allows a practitioner to determine if the EMG response is too rapid, within a normal range, or delayed.

[0050] Further, by having the full EMG signal available, information concerning differential EMG peak and plateau values may also be captured, which allow for quantitative determinations to be made about the effectiveness of the treatment and / or diagnoses. In contrast, in looking at the right side of FIG.5A, due to the pause required in the prior art systems, all of the information concerning how the muscle responds after the stimulation is removed, such that no information on the overall EMG response is limited.

[0051] In addition, referring back to FIG. 5B, as EMG measurements typically experience a drop from an initial peak, having the full range of EMG measurements allows for the slope of the drop in the EMG measurement to be calculated. If no drop occurs, or if the drop is faster than a normal drop range, these measurements may also be indicative of a neurological or myoneural disorder.

[0052] An alternative EMG scheme is also proposed herein in connection with FIGS.6 and 7. More specifically, FIG.6 illustrates a prior art scheme, wherein EMG is measured after a biphasic wave form. For example, the positive stimulus of pulse is applied, followed immediately by the negative pulse. An EMG measurement is then taken after a pause 47 of approximately 12ms, as discussed above, which is represented by a blank space between the negative stimulus and the EMG measurement. The process is then repeated until the therapy session is over.

[0053] In contrast to the prior art, instead of measuring EMG after a biphasic waveform, the EMG measurement is performed between the application of the positiveand negative pulses. For example, as shown in FIG. 7, the EMG is taken after application of the positive pulse, and before the corresponding negative pulse. As discussed above in connection with FIGS.5A and 5B, The EMG measurement starts right after the trailing edge of the positive pulse. After the EMG measurement is taken, the negative pulse is applied. The next EMG measurement is then taken immediately right after the negative pulse is applied, similar to the timing diagram illustrated in FIG. 5A. The process is then repeated until the therapy session is over. As this arrangement eliminates the pause 47 shown in the prior art represented in FIG. 6, each overall therapy session is therefore shortened as compared to the prior art systems, thereby improving the likelihood of patient compliance in completing the desired therapy.

[0054] There are at least three electrodes needed to measure surface EMG. For example, as shown in FIG.2, in addition to the pair of electrodes 22, there is also a reference electrode 30. In operation, the potential difference between the electrodes in the pair of the electrodes 22 is amplified by the instrumentations amplifier 42 and brought to an observable level by the signal conditioning circuitry 44. The reference electrode 30 is needed to measure the value of the difference based on a reference value. The reference electrode 30 acts as a ground and thus is placed away from the EMG detecting surfaces, i.e., on an electrically neutral surface. However, utilizing a dedicated reference electrode 30 for each electrode pair 22 increases the number of electrodes needed for a wearable garment.

[0055] Referring to FIG. 8, to maximize use of electrodes pairs 22, in one exemplary arrangement, instead of utilizing a single dedicated reference electrode 30 for each electrode pair 22, each electrode pair 22a, “borrows” one of the electrodes from a separate electrode pair 22b. In this exemplary arrangement, switch circuitry 50 is disposed between the stimulator 52 and the electrode pairs 22a, 22b, ...22n, as well as between the EMG 54 and the electrode pairs 22a, 22b, ...22n. In other words, each electrode pair 22a, 22b, 22n shares one of its electrodes to serve as a reference electrode thereby minimizing the number of electrodes needed for EMG measuring. With this arrangement, less electrodes 22a, 22b, 22n are needed for each garment, thereby reducing the overall complexity of a garment, as well as cost.

[0056] Referring to FIGS. 9-13, exemplary arrangements of wearable electrode stimulation garments 100, 102, 104, and 106 having stimulation and EMG measurement arrangements incorporated therein are shown. As discussed in thebackground, one of the challenges to delivering consistent therapy is to ensure consistent and repeatable proper placement of the electrodes. To address this issue, electrode pairs 22 may be integrated into various garments 100, 102, 104, and 106 such that when the garments are worn, the electrode pairs 22 are operatively positioned on predetermined muscle groups. Further, as the position of the electrode pairs 22 are fixed in the garment, this ensures accurate placement of the electrodes 22 each time the garment is donned, thereby promoting consistent and reliable recordings in each therapy session.

[0057] In one exemplary arrangement, referring to FIGS. 9-11, the wearable electrode stimulation garments 100 and 102 may comprise a wearable suit having leggings 100 and a top 102. For example, for stimulating abdominal muscles, one pair of electrodes 22a may be incorporated on an inside surface of the top 102 such that the electrodes 22a will be placed against the wearer’s abdomen. To ensure that the electrodes are disposed flush against the wearer’s skin, the garments 100 and 102 may be constructed of a compression type material, such as a nylon, spandex or Lycra material. Other pairs of electrodes are also envisioned. For example, a pair of electrodes 22b may be positioned in the leggings 100 along each quadricep muscle, another pair 22c may be positioned along the calf muscles. Further electrodes may be arranged to be disposed on different muscle groups on a wearer’s back.

[0058] While the top 102 is shown as a tank style garment, a long sleeve garment 104 may also be employed to provide stimulation therapy to various arm muscles. Similarly, instead of full-length leggings, compression shorts 106 may also be utilized.

[0059] While not seen, the electrode pairs 22 are electrically connected, with wired connections traversing the respective garments 100, 102, 104, and 106. To avoid pulling the wired connections from the electrode pairs 22, an inner liner (not shown) may be provided with openings therein for a contact surface of the electrode to extend through. Thus, the wired connections are disposed between the inner liner and an outer layer of the garments 100, 102, 104 and 106.

[0060] As discussed above, the electrodes are bifunctional, and thus capable of providing stimulation, as well as taking EMG measurements. While traditional electrode pairs utilize an additional, separate reference electrode, the garments 100, 102, 104 and 106 may “borrow” one of the electrodes from a separate channel. For example, when the right quadricep is being treated by stimulation, the electrode pair 22b may utilize one of the electrodes from the left calf 22c as the ground. Becausethe electrode pairs 22 are all integrated into a single garment, this arrangement minimizes the number electrodes needed for EMG measuring. Further, in situations where multiple sets of muscles are being stimulated / measured, the stimulation of multiple sets of muscles is not done at the same time, as the EMG measurement related to one muscle cannot occur during the stimulation of a different muscle, as the electrical pulses will interfere with the EMG measurement, even at a distance.

[0061] For example, when stimulating the quadricep of the right leg, one of the electrodes from the left leg can be used as the ground. The electrodes on the right quadricep would switch between stimulating the muscles on the right leg, and then measuring the EMG response of the quadricep that had just been stimulated. The process can then be switched to stimulate the muscles of the left leg.

[0062] An input device 12, such as a mobile phone, may be operatively connected to the controller 14 by wireless technology to direct therapy. Alternatively, the input device 12 may be a wired handheld device directly connected to the wired connections.

[0063] EMG measurement following stimulation is a key metric to evaluate the efficacy of the treatment plan. For example, for a given treatment session, a muscle group will be stimulated multiple times. Following each stimulation, the EMG related to that stimulation will be measured. As discussed above, in one application of the disclosure, it is contemplated to have a short “stimulation window” followed by a longer “EMG window” that is started soon after the stimulation (i.e., ~ 1ms) to reduce treatment time.

[0064] In one application, multiple samples of the EMG response over time are taken, for example, one sample per millisecond, to gather more information about the muscle response. For example, one parameter that could be tracked is how long it takes the muscle to respond, and the time course of the response. In such a situation, there will be an initial buildup of the response to a maximum level, and then the muscle will relax back to a rest state. The data from the entire course of this response can be tracked. Indeed, tracking changes of different metrics (for example, response time to maximum response, level of maximum response, period the response stays that the maximum level, relaxation time from the maximum response to the rest level (or some intermediate level)), could be used by a practitioner to determine the effectiveness of a treatment plan, provide clues for adjusting the treatment plan, etc.

[0065] In a therapeutic application, a patient will receive regular sessions over anextended period. Because the electrodes are located in a garment 100, 102, 104, and 106, that can be worn by the patient at any time, it is possible to have one or multiple sessions per day, or whatever other frequency makes sense for a given treatment. Moreover, because the electrodes are fixed within the garment, the electrodes will be accurately positioned each time the garment is worn, such that the patient receiving the treatment can properly position the electrodes without requiring further medical assistance, providing more convenience for the wearer, and thus increasing compliance.

[0066] An exemplary method 200 of applying therapy utilizing one or more of the garments 100, 102, 104, and 106 will now be explained in connection with FIG.14. In step 202, one or more of the garments 100, 102, 104, and 106 are put on a person needing therapy. Once positioned, the input device 14 is powered on and an area for stimulation to be applied is selected in step 204.

[0067] During each therapeutic session, there will be a sequence of stimulations followed by EMG measurements. However, it is understood that the length, intensity, and frequency of each stimulation can be varied. Accordingly, at step 206, the stimulation parameters are selected from the input device 12.

[0068] Once the stimulation parameters are selected, in the next step 208, the stimulation sequence is initiated by the controller 14. In certain situations, the sequence may be based on predetermined patterns stored in the memory of the controller 14. Alternatively, the controller 14, using the stimulation parameters selected, may initiate a unique stimulation sequence. In connection with each cycle of stimulation of the sequence, data will also be collected from EMG measurements in step 208. As mentioned above, multiple measurements may be taken during an EMG phase, after application of each stimulation cycle. The collected data is stored in the controller 14 memory to be ultimately transmitted to the server 18 in step 210. For example, data that is collected may be organized according to the session, the stimulation event within the session, and correlated with the various parameters and may be stored on the server 18. In connection with step 210, the server 18 may employ AI to undertake data analytics of the data captured during the EMG phase, including identifying any patterns, correlations, anomalies, and trends in the data collected over time. The method 200 then ends until the next therapeutic session.

[0069] For each stimulation event, many different metrics may be recorded. As non-limiting examples, the following metrics may be captured: a. length of each phase(positive and negative) of each stimulation; b. Intensity (voltage level) of each stimulation; c. frequency (time between) each stimulation; d. response time for the muscle to begin contraction following stimulation; e. rise time to maximum response; f. level of maximum response; g. length of maximum response; and h. fall time to relaxation level.

[0070] It is well known that muscles fatigue. Therefore, although the above metrics represent secondary data, such may assist the practitioner to understand how the EMG changes during a session. For example, after how many stimulation cycles does the maximum response diminish, the hold time at the maximum level diminish, the response time for the muscle to begin contraction to become longer, etc.? This information can be used to adjust treatment plans. It is also contemplated that the artificial intelligence may be employed to identify correlations between stimulation parameters that might not be evident to human practitioners.

[0071] To the extent permitted by law, patient data may be aggregated together and anonymized to determine effectiveness of different treatment plans. Again, artificial intelligence may also be employed in connection with aggregated data, eliminating duplicate data points, identifying anomalies, and demonstrating trends from the data collected.

[0072] For partially paralyzed patients, base line data can be captured, for example, measurement of EMG after requesting that the patient try to activate a muscle group (e.g., move his or her leg), before treatment is initiated. Baseline data may be captured using the method 200 shown in FIG.14, modifying step 208 to having a patient activating a muscle group and measuring EMG. Any of the EMG parameters identified above can be measured. Repetitions of the measurements (asking the patient to try to move the muscle multiple times) can be performed to get an idea of when the muscle begins to fatigue. For fully paralyzed patients, a baseline can be generated by stimulation and measurement before treatment begins. By establishing baseline data points, the practitioner will be able to ascertain the effectiveness of the treatment, as well as measure ongoing progress.

[0073] The electrode arrangement for stimulation and EMG measurement can be used for various different purposes. For example, the arrangement may be used for training muscles. More specifically, muscles can be stimulated and monitored over time to increase strength, which may be evidenced by a higher maximum response. During an initial phase, stimulation can start at a low level, and be increased to seewhen the maximum response of the muscle stops increasing. This maximum level of stimulation can be used to stimulate the muscle. When, during the session, the maximum response of the muscle starts to decline, the stimulation can be increased, to “push” the muscle back to its maximum response. Warm-up phases and cool down phases can also be considered for a session.

[0074] Muscles can also be trained to have more endurance. When muscles are not used, fibers in the muscles change from slow twitch fibers to fast twitch fibers. Fast twitch fibers fatigue more quickly. Programs can be designed that monitor when a muscle begins to fatigue and continue the stimulation for a period after the detection, to exercise the muscle, change the fibers from fast twitch to slow twitch over time, thereby increasing the muscle endurance.

[0075] The electrode arrangement for stimulation and EMG measurement can also be used for controlling spasticity. More specifically, a healthy nervous system controls muscle spasms. Fully and partially paralyzed people lose this control of muscle spasticity. Types of spasms include hyperreflexia and hypertonicity. Muscle spasms can be detected by measuring the EMG measurements. Then, stimulation can be applied to relieve the spasm. Using the EMG measurements, the type and severity of a spasm can be determined, as well as its timing. Different levels and frequencies of stimulation can be implemented, while monitoring EMG measurements. Based on the collected data, the stimulation can be optimized over time to improve outcomes.

[0076] Further, for some it may be, for example, that spasms occur at times of the day. Based on the EMG measurement data, it may be possible to anticipate these spasms, and proactively apply stimulation before they occur, or when they start to occur. For example, sometimes, spasms may occur when the person is sleeping, and they may interfere with sleep. Such spasms may be controlled by the garment, either by continuously applying a low-level stimulation, anticipating spasms based on known patterns, or detecting spasms when they are starting, and applying stimulation to control them.

[0077] Some patients utilize implanted baclofen pumps to control spasms. The pump injects baclofen into the spinal cord. Measuring EMGs can provide data to feed into the control circuitry to adjust the use of baclofen based on measured spasms. For example, EMGs can be measured on a regular basis when electrodes are included in a garment worn by the person.

[0078] Another exemplary use of the electrode arrangement of the presentdisclosure is to address back pain caused by muscle spasms. For example, the spasms can be treated in the ways described above. Also, in the case of back pain, data from muscles on the left side of the back with muscles on the right side of the back can be compared. This data point is important as often, back pain is asymmetric. That is muscles on one side of the back spasm more than on the other side. Measuring EMGs can help to identify this asymmetry and devise treatments to correct it over time.

[0079] In some situations, it may be beneficial to provide quasi-continuous stimulation. More specifically, while wearing a garment 100, 102, 104, and 106 that includes stimulation and EMG measurement, treatments can be devised that involve quasi-continuous stimulation, rather than session-based stimulation. Different rhythms and intensities of stimulation can be implemented, to determine which treatment regimens are most effective.

[0080] In another exemplary arrangement, the garment 100, 102, 104, and 106 may be utilized to manage blood circulation. More specifically, the heart pumps blood to all parts of the body. However, the circulatory system relies on movement from muscle contractions to pump the blood back to the heart from the extremities (arms and legs). When muscles are not used due to paralysis, blood can accumulate in the extremities. For example, if a person’s legs are paralyzed, blood may accumulate in the ankles and lower legs causing swelling. This swelling may be managed by applying stimulation at regular time intervals (or quasi-continuously) to the muscles of the extremities to improve this circulation.

[0081] The garment 100, 102, 104, and 106 may also be utilized for weight management. For sedentary people, (including children) that are not getting enough exercise, the garment 100, 102, 104, 106 may be used to stimulate muscle groups, for example the muscles in the thigh, to burn calories. Also, as mentioned above, this can be done in conjunction with heart rate monitoring. For example, a heart rate can be targeted to optimize calorie burn.

[0082] The garments 100, 102, 104, 106 may also be utilized during sleep. For example, the garment 100, 102, 104, and 106 may be programed to apply stimulation to muscles during sleep, such action may prevent / reduce spasms to support better sleep. Also, muscles can be stimulated during sleep as a treatment to strength or increase the endurance of these muscles, to promote calorie burn during sleep or support blood circulation during sleep.

[0083] In addition to supplying therapy, the garments may be utilized to capture keymetrics of the body’s overall performance. For example, the electrodes may be programmed to measure bio-impedance as a measure of body fat composition. This information can be useful as a method to monitor metabolism and metabolic syndrome. Reduction of body fat could be an indication that muscle training is working.

[0084] Another metric for which the garment may be utilized is heart rate monitoring: For example, muscle contractions can be used to increase a patient’s heart rate to a target level to increase calorie burn.

[0085] It will be appreciated that the electrical stimulation systems and methods described herein have broad applications. The foregoing embodiments were chosen and described in order to illustrate principles of the methods and systems as well as some practical applications. The preceding description enables others skilled in the art to utilize methods and systems in various embodiments and with various modifications as are suited to the particular use contemplated. In accordance with the provisions of the patent statutes, the principles and modes of operation of this disclosure have been explained and illustrated in exemplary arrangements.

[0086] It is intended that the scope of the present methods and arrangements be defined by the following claims. However, it must be understood that this disclosure may be practiced otherwise than is specifically explained and illustrated without departing from its spirit or scope. It should be understood by those skilled in the art that various alternatives to the arrangements described herein may be employed in practicing the claims without departing from the spirit and scope as defined in the following claims. The scope of the disclosure should be determined, not with reference to the above description, but should instead be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. It is anticipated and intended that future developments will occur in the arts discussed herein, and that the disclosed systems and methods will be incorporated into such future examples. Furthermore, all terms used in the claims are intended to be given their broadest reasonable constructions and their ordinary meanings as understood by those skilled in the art unless an explicit indication to the contrary is made herein. In particular, use of the singular articles such as “a,” “the,” “said,” etc. should be read to recite one or more of the indicated elements unless a claim recites an explicit limitation to the contrary. It is intended that the following claims define the scope of the invention and that the method and apparatus within the scope of theseclaims and their equivalents be covered thereby. In sum, it should be understood that the invention is capable of modification and variation and is limited only by the following claims.

Claims

CLAIMS What is claimed is:

1. An electrical stimulator device, comprising: a first pair of electrodes configured to be applied to a first target muscle group; a second pair of electrodes configured to be applied to a second target muscle group; switch circuitry; a stimulation circuit; and an EMG measurement circuit; wherein the switch circuitry operatively connects the stimulation circuit and the EMG measurement circuit to the first pair of electrodes and to one electrode of the second pair of electrodes such that when the stimulation circuit is activated, the one electrode from the second pair of electrodes serves as a reference electrode.

2. The electrical stimulator device of claim 1, wherein the switch circuitry is configured to alternate application of stimulation and taking EMG measurements.

3. The electrical stimulator device according to claims 1 or 2, wherein the switch circuitry further comprises a pair of stimulator switches for the first pair of electrodes, and a pair of EMG switches for the first pair of electrodes, wherein a first control signal is configured to turn the pair of stimulator switches to an activated position such that the first pair of electrodes is put into a stimulation mode; and wherein a second control signal is configured to turn the pair of EMG switches to an activated position such that the first pair of electrodes is put into an EMG measurement mode.

4. The electrical stimulator device according to any of the preceding claims, wherein the EMG measurement circuit further comprises an instrumentation amplifier and signal conditioning circuitry.

5. The electrical stimulator device according to any of the preceding claims, further comprising a control system operatively connected to the stimulation circuit and the EMG measurement circuit, wherein the control system is configured to activate the stimulation circuit and to activate the EMG measurement circuit.

6. The electrical stimulator device according to claim 5, further comprising an input device operatively connected to the control system, wherein the input device may be utilized to input different operating parameters to the control system for operating the electrical stimulator device.

7. The electrical stimulator device according to claims 5 or 6, wherein the control system is configured to collect and store data received from the electrode pairs within a memory.

8. The electrical stimulator device according to any of the preceding claims, wherein the electrical stimulator device is a wearable garment (102, 104, 106).

9. A method of applying a stimulation therapy (200), comprising: positioning an electrical stimulator device (202) such that a first set of electrodes are positioned across a first target muscle and a second set of electrodes are positioned across a second target muscle; selecting the target muscle to apply stimulation (204); selecting one or more stimulation parameters (206); initiating the stimulation and EMG measurement collection for a predetermined time period (208); and aggregating data from the EMG measurement collection (210).

10. The method (200) of claim 9, wherein the EMG measurement collection (208) is taken after each stimulation cycle of application of a positive pulse and a negative pulse.

11. The method (200) of claim 10, wherein the EMG measurement collection (208) is taken at about 1ms after the negative pulse.

12. The method (200) of claim 9, wherein the EMG measurement collection is taken between a positive pulse and a negative pulse of each stimulation cycle.

13. The method (200) of claim 12, wherein the EMG measurement collection begins about 1ms after the positive pulse and then again at about 1ms after the negative pulse of each stimulation cycle.

14. The method (200) of any of claims 9-13, wherein multiple EMG measurements are taken during the EMG measurement collection to ascertain characteristics of a muscle response to the stimulation between each stimulation cycle.

15. The method (200) of claim 14, wherein differential EMG peak and plateau values, slope of a beginning EMG rise and / or a slope of an EMG signal drop are calculated from the EMG measurement collection.

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