Wearable electrical stimulator device with patient monitoring

Abstract

An electrical stimulator device is disclosed, comprising an inner liner, a support frame, and a front closure panel. The inner liner and support frame are connected together as a unitary element and the front closure panel is selectively attached to the unitary element to secure the electrical stimulator device about a body part. The inner liner has at least one electrode attached to an inner surface of the inner liner such that the electrodes are positionable against and in contact with a patient's body when the electrical stimulator device is worn. The at least one electrode is selectively actuated to deliver electrical stimulation.

Description

WEARABLE ELECTRICAL STIMULATOR DEVICE WITH PATIENT MONITORING TECHNICAL FIELD

[0001] The present disclosure relates generally to electrical stimulator devices, and more specifically, to wearable electrical stimulator devices configured to be worn about a portion of a user’s body. BACKGROUND

[0002] Electrical stimulator devices for muscles and nerves have been employed to treat certain medical conditions. Known systems typically include one or more electrodes that are attached to a substrate that may be worn by a patient. However, one issue that arises is proper placement of the electrodes along the patient's body part to be treated, as well as ease of securement of the device on the patient’s body such that the device imparts sufficient pressure against the patient’s body to secure the electrodes against the patient’s body to allow for therapeutic application of electrical impulses. So as to avoid a need to provide a “customized” sized substrate, there is a need for an adjustable substrate that may be applied to a variety of differently sized patients, while being able to ensure proper placement of the electrodes for maximum therapeutic advantage.

[0003] While application of electrical impulses is known to provide relief to a patient, one issue that may arise is an inability to quantitatively track a patient’s level of pain with respect to the patient’s activity level. As such, many therapists must resort to using anecdotal reporting by the patient, to judge an effectiveness of application of stimulation. For example, the therapist may need to resort to trial and error on a particular treatment plan for employing electrode stimulation to arrive at a therapeutic strategy. Accordingly, there is a need for data concerning a patient’s pain and / or activity to be captured to utilize the application of electrode therapy strategically.SUMMARY

[0004] In one exemplary arrangement, an electrical stimulator device is disclosed, comprising an inner liner, a support frame, and a front closure panel. The inner liner and support frame are connected together as a unitary element and the front closure panel is selectively attached to the unitary element to secure the electrical stimulator device about a body part. The inner liner has at least one electrode attached to an inner surface of the inner liner such that the electrodes are positionable against and in contact with a patient’s body when the electrical stimulator device is worn. The at least one electrode is selectively actuated to deliver electrical stimulation.

[0005] In an exemplary arrangement, the electrical stimulator device comprises an electronic control unit that is electrically connected to the at least one electrode and to a controller. The controller is utilized to selectively operate the at least one electrode.

[0006] In an exemplary arrangement, the inner liner of the electrical stimulator device is constructed of a first material. The support frame is constructed of a second material and the first material is more flexible than the second material.

[0007] In an exemplary arrangement, the support frame of the electrical stimulator device includes a plurality of openings or void areas therein.

[0008] In an exemplary arrangement, the support frame further comprises a mounting panel that supports an electronic control unit. The electronic control unit is electrically connected to the at least one electrode.

[0009] In an exemplary arrangement, the electronic control unit of the electrical stimulator device comprises a processor, an inertia measurement unit, and a communication circuit.

[0010] In an exemplary arrangement, the electronic control unit is operatively connected to a controller. The controller includes input elements for selectively controlling the at least one electrode.

[0011] In an exemplary arrangement, the electronic control unit of the electrical stimulator device is configured for communications with a computing device.

[0012] In an exemplary arrangement, the electrical stimulator device comprises at least one pocket. The at least one pocket includes an opening through which an electrode stimulation ECUor an inertia measurement unit ECU may be received to temporarily secure the electrode stimulation ECU and / or the inertia measurement unit ECU to the electrical stimulator device.

[0013] In an exemplary arrangement, each pocket of the electrical stimulator device is configured with a connector to which the electrode stimulation ECU and / or the inertia measurement unit ECU may be selectively coupled.

[0014] In one exemplary arrangement, a method of utilizing an electrical stimulator device is disclosed. The method comprises positioning an electrical stimulator device on a user; operating the electrical stimulator device in a monitoring mode, whereby predetermined activities are performed by the user; capturing data relating to the predetermined activities, uploading the captured data to an associated computing device; and analyzing data to determine a stimulation operation based on the data captured.

[0015] In an exemplary arrangement of the method, data concerning a user observed pain level, sleep, medication, muscle spasms, muscle tightness / tone, arm usage, psychological outlook, and / or muscle atrophy is input into the associated computing device. The captured data and the user observed pain level, sleep, medication, muscle spasms, muscle tightness / tone, arm usage, psychological outlook, and / or muscle atrophy data is utilized to determine the stimulation operation.

[0016] In an exemplary arrangement of the method, the stimulation operation is transmitted to the electrical stimulator device. The method further comprises operating one or more of electrodes that are positioned within the electrical stimulator device to deliver electrical stimulation at predefined time periods and at predefined intensity levels. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Exemplary arrangements of the present disclosure will now be described in greater detail with reference to the attached Figures, in which:

[0018] FIG. 1 is a front perspective view of an exemplary arrangement of an electrical stimulator device positioned about a portion of a patient;

[0019] FIG.2 is a back perspective view of the electrical stimulator device of FIG.1;

[0020] FIG.3 is a side perspective view of the electrical stimulator device of FIG.1;

[0021] FIG.4 is a top plan view of the electrical stimulator device of FIG.1, disposed about the portion of the patient;

[0022] FIG. 5 is a schematic view of an exemplary control circuit for use with the electrical stimulator device of FIG.1;

[0023] FIG. 6A is a process flow for a pre-treatment method to establish certain baseline parameters unique to a wearer of the electrical stimulator device;

[0024] FIG.6B is a process flow for a method of determining a stimulation scheme, using the electrical stimulator device of FIG.1;

[0025] FIG. 7 is a back perspective view of a section of an alternative arrangement of the electrical stimulator device of FIG.1;

[0026] FIG. 8 is a cross-sectional view of an example ECU pocket taken along lines 8-8 of FIG.7;

[0027] FIG.9 is a block diagram illustrating a configuration of an electrical stimulator device, a mobile device, a network, a server, and a data storage unit;

[0028] FIG. 10 is an example graph illustrating a user’s pain and activity level during predetermined time periods; and

[0029] FIGS. 11A,B-18A,B represent different exemplary graphical user interfaces for entering data concerning the wearer of an electrical stimulator device. DETAILED DESCRIPTION

[0030] 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.

[0031] Referring to FIGS. 1-5, a first exemplary arrangement of an electrical stimulator device 10 and method of using same is disclosed. In the exemplary arrangement of the electrical stimulator device 10 depicted, the electrical stimulator device 10 is configured as a belt that may be disposed about a torso 12 of a user 13 so as to provide electrical stimulation to a lower back of the user 13. For example, the electrical stimulator device 10 may be used to stimulate nerves and muscles of the lower back to alleviate chronic pain, ease muscle spasms, increase circulation to underlying muscles, and facilitate movement of the trunk, while reducing compensatory movements of the body. However, it is understood that the innovations disclosed herein may be incorporated into electrical stimulator devices 10 for other parts of the body, such as, for example, legs or arms, without departing from the disclosure.

[0032] The first exemplary arrangement of the electrical stimulator device 10 comprises an inner liner 14 (best seen in FIG. 4), a support frame 16, and a front closure panel 18. FIG. 4 illustrates the relationship of the inner line 14, support frame 16, and front closure panel 18. However, the elements are spaced from one another for clarity in FIG.4. For example, the inner liner 14 and the support frame 16 are connected directly together as a unity device, without any spacing. More specifically, the support frame 16 may be secured to the inner liner 14 by adhesive or other suitable method.

[0033] The inner liner 14 is configured with a back section 20 and a pair of side sections 22a, 22b. In one exemplary arrangement, the side sections 22a, 22b are configured with ends 24a, and 24b, respectively that are spaced apart from one another to create a void area 26 therebetween when the electrical stimulator device 10 is installed on a patient. To be adaptable to a wide range of waist circumferences, there can be a set size of the belt that would place electrodes adjacent to the lower back area despite the size of the circumference of the waist.

[0034] In the exemplary arrangement shown in FIG. 4, the inner liner 14 is constructed of a stretchable and flexible material, such as, for example, neoprene, that allows the inner liner 14 to conform to the shape of a patient, as well as being breathable to allow passage of air and moisture. At least one, and in one exemplary arrangement, a plurality of electrodes 28 are attached to an inner surface 30 of the inner liner 14 such that the electrodes 28 are positioned against and in contact with a patient’s body when the electrical stimulator device 10 is worn. In one exemplary arrangement, the electrodes 28 are used in a stimulate mode, whereby theelectrodes 28 stimulate the wearer’s muscles. Exemplary arrangements of suitable electrodes 28 may be found in co-pending U.S. Serial No.15 / 311,626, the contents of which are incorporated herein by reference in its entirety.

[0035] In one exemplary arrangement, the electrodes 28 may be constructed with a self- adhesive surface 32 such that the self-adhesive surface 32 can be selectively positioned on the inner surface 30 at desired locations. The inner surface 30 of the inner liner 14 may include an attachment strip (not shown) to which the self-adhesive surface 32 may adhere. Alternatively hook and loop fasteners, i.e., Velcro® fasteners may be utilized to connect the electrodes 28 to the inner surface 30. Other suitable fastening arrangements are also contemplated.

[0036] In another exemplary arrangement, the electrodes 28 may also be configured to be used as sensors to measure body metrics. For example, the electrodes 28 may be used to measure a patient’s pulse rate, EMG (electromyography) signals e.g., a biomedical signal that measures electrical currents generated in muscles during its contraction, and / or bioimpedance.

[0037] In other words, each electrode 28 is configured for both functions. In another exemplary arrangement, each electrode 28 is a single purpose electrode such that it may only be used for either stimulation or as a sensor.

[0038] In one exemplary arrangement, the inner liner 14 is configured with one or more openings (not shown). The openings may be used to reduce weight of the electrical stimulator device 10, as well as make the inner liner 14 more breathable during use.

[0039] The support frame 16 is overlayed over the inner liner 14 and secured thereto to provide an integrated unit. As mentioned above, the support frame 16 may be secured to the inner liner 14 in any suitable manner. The support frame 16 is constructed of a material that is more elastic than the material of the inner liner 14, such as an elastomer. This allows the support frame 16 to provide an elastic force to compress the inner liner 14 against the torso, and hold the inner liner 14 in place, thereby preventing bunching of the material of the inner liner 14. Thus, the electrodes 28 are ensured to be directed to the patient’s body. In one exemplary arrangement, the support frame 16 is a honeycombed structure, which may be a non-continuous structure, configured with struts 33 and open spaces or void areas 34 between the struts 33. The void areas 34 extend through the support frame 16 and may expose the inner liner 14. In addition toproviding a weight reduction to the electrical stimulator device 10, the void areas 34 may also allow for air passage to keep the wearer cool when worn.

[0040] In another exemplary arrangement, the support frame 16 is made from a flexible and stretchable material that allows the support frame 16 to conform to the shape of a wearer. For example, in one exemplary arrangement, the support frame 16 may be able to conform to the shape of both male (tubular) and female (hourglass) shapes.

[0041] Alternatively, the frame may be constructed of material that is non-stretchable. For example, for male wearers that have more of a tubular shape, a tubular, non-stretchable support frame 16 may be provided, with specific sizes. This configuration provides a more fitted arrangement and may increase support to the wearer.

[0042] In one exemplary arrangement, the support frame 16 may further include a mounting panel 36 positioned on a rear section 38 of the support frame 16. In one exemplary arrangement, the mounting panel 36 may support an electronic control unit (ECU) 40, which is shown schematically in FIG.5. The ECU 40 is electrically connected to the electrodes 28, as well as to a controller 42, as will be discussed in greater detail below. In one exemplary arrangement, the ECU 40 further includes a processor 46 and a communication circuit 48. For the exemplary arrangement shown in FIGS.1-4, the ECU 40 is positioned on the mounting panel 36, so as to be located at a patient’s spine 44.

[0043] In one exemplary arrangement, the electrical stimulator device 10 includes an inertial measurement unit (“IMU”) 50. The IMU 50 may also be located on the mounting panel 36 of the support frame 16 and may be part of the ECU 40. In the exemplary arrangement shown in FIGS. 1-4, the IMU 50 is positioned on the mounting panel 36 so as to be located at the patient’s spine 44. The IMU 50 is configured to measure position, velocity, and acceleration of the user. These measurements can be captured by the ECU 40 and used to indicate whether the patient is lying down, sitting, standing, or walking. In addition, the IMU 50 is also used to detect how fast the patient wearing the electrical stimulator device 10 is walking and / or the number of steps. Data captured from the IMU 50 may be communicated to the communication circuit 48. The communication circuit 48 may use Bluetooth communication protocols. Alternatively, data may be stored in the ECU 40 and transmitted selectively via a wireless connection to a mobile device 200 such as a mobile phone (FIG.9).

[0044] In one exemplary arrangement, wires, not shown, may extend from the ECU 40 through the support frame 16 to the controller 42. In one exemplary arrangement, the controller 42 may be operatively connected to the ECU 40 to selectively control the electrodes 28. The controller 42 may be sized to be a handheld device, and in addition to a power switch, may further include input buttons for indicating pain levels, as well as input buttons to selectively adjust stimulation levels of the electrodes 28, as will be discussed in further detail below. In one exemplary arrangement, the controller 42 may be configured to be removably secured to the support frame 16, such as by a wired connector 43. Optionally, the controller 42 may be selectively clipped to the support frame 14. Alternatively, or in addition, the patient may control the electrical stimulator device 10 through a mobile device application in the mobile device 200.

[0045] The ECU 40, as well as the electrodes 28 and IMU 50 may be battery powered. In one exemplary arrangement, the mounting panel 36 includes a cavity having contact elements therein for receiving one or more batteries. The batteries may be AA size or AAA size. In one exemplary arrangement, the battery may be a rechargeable battery and a charging receptacle may be provided that selectively plugs into a separate power source.

[0046] The front panel 18 serves to connect forward ends 52a, 52b of the integrated inner liner 14 and support frame 16, as best seen in FIG.1. In one exemplary arrangement, the support frame 16 may be provided with openings at end portions 54a, 54b, into which fastening elements 56 may be disposed. In one exemplary arrangement, the fastening elements 56 are secured to the inner liner 14, such that the fastening elements 56 extend through the support frame 16. The fastening elements 56 cooperate with additional fastening elements 58 that are secured to first and second ends 60a, 60b of the front panel 18 to dispose the electrical stimulator device 10 about a portion of a patient’s body, such as a patient’s torso 12. In one exemplary arrangement, the fastening elements 56 and 58 are cooperating hook and loop fasteners so as to allow for selective adjustment of the electrical stimulator device 10 about the portion of the patient’s body. To this end, the fastening elements 56 and 58 may be provided in strips having lengths that allow for a variety of positions of the front panel 18 to the inner liner 16, for example. In another exemplary arrangement, the fastening elements may include magnetic elements and employ magnetic coupling. Other types of fastening elements may also be employed. Also, to ensure proper placement of the front panel 18, in one exemplary arrangement, the front panel 18 may beprovided with an alignment element, such as a decorative emblem 59, that can be used to locate the front panel 18 over a particular area, such as, for example, the belly button of a patient.

[0047] In one exemplary arrangement, the front panel 18 may also be provided with electrodes 28 that allow stimulation on a forward portion of the torso 12. A second controller may be provided to allow independent control of the electrodes of the front panel 18 and the electrodes 28 of the inner liner 18.

[0048] To further provide adjustability, the integrated unit of the inner liner 14 and support frame 16 combination may be provided in different sizes, as well as the front panel 18. This allows a user to independently select different sizes to accommodate different body type shapes and sizes.

[0049] For the exemplary arrangement shown in FIGS. 1-4, the inner liner 14 and support frame 16 may be provided with a variable sized edge 62 such that a rear portion 64 of the electrical stimulator device 10 may extend over a greater portion of a patient’s back, when worn. In addition, the rear portion 64 may include a display 66 with one or more LEDs to indicate when the electrical stimulator device 10 is receiving power or as an indicator that the power is running low and the belt 10 needs charging. The display 66 may also serve as an indicator for electrical stimulator device 10 and aid in aligning the electrical stimulator device 10 to the torso 12.

[0050] Referring to FIGS.7-8, rather than have a single mounting panel 36 that holds a single ECU 40, in an alternative arrangement, a pair of ECUs 40a and 40b may be provided. More specifically, a first ECU 40a may be configured to connected to the electrodes 28 disposed in the electrical stimulator device 10 to provide stimulation, while the second ECU 40b may be provided to connect to the electrodes 28 or other sensors for taking EMU / IMU measurements. In one example, both ECUs 40a and 40b can be configured to be selectively positioned within the electrical stimulator device 10, simultaneously. In another example, the ECUSs 40a and 40b can the ECUs 40a and 40b can be configured to be used independently. In this case, the electrical stimulation device 10 may be configured to be used either for stimulation only, with ECU 40a, or for measuring the body of the user and collecting data with ECU 40b.

[0051] The ECUs 40a, 40b may be constructed to have a thickness that is relatively thin so as to allow a wearer to lay on his or her back and not feel any additional pressure from the presenceof the ECUs 40a and 40b. In one exemplary arrangement, the ECUs 40a and 40b are configured to be generally planar. In another exemplary arrangement, ECUs 40a and 40b may be curved or contoured to match an expected body shape. The ECUs have a connector on one end and can have a tab 77 on the other end, that can be held by the user.

[0052] The rear portion 64 of the electrical stimulator device 10 may be further configured with first and second pockets 68, 70 to receive respectively the ECUs 40a and 40b. Each pocket is 68, 70 may be constructed of a rigid or semi-rigid material, having an opening 75 on one end for receiving the respective ECUs 40a, 40b and a connector 76 for coupling to the respective ECU 40a, 40b on the other end. The pockets 68, 70 are attached to the electrical stimulator device 10, for example by adhesive, by stitching, or other form of attachment. Wires (not shown), extend from the connectors 76 in the pockets 68, 70 to connect the pockets 68, 70 to each other, to the electrodes 28, the controller 42, etc.

[0053] The pockets 68, 70 are designed to be sufficiently rigid to protect the ECUs 40a, 40b while the wearer is wearing the electrical stimulator device 10. For example, when a wearer is rolling around while sleeping, the ECUs 40a, 40b will be retained by the connectors 76 and further frictionally retained by the pockets 68, 70. Further, the pockets 68, 70 allow for the ECUs 40a, 40b to be removed to allow the device 10 to be washed, without damaging the electronics.

[0054] In one exemplary arrangement, the pockets 68, 70 and the ECUs 40a and 40b may be constructed to be semi-rigid or flexible, thereby allowing a comfortable positioning on a torso 12. Alternatively, the pockets 68, 70 may be constructed of a rigid material and the ECUs 40a and 40b may also be constructed to be rigid.

[0055] While the exemplary arrangement shown in FIGS. 7-8 are illustrated with the pockets 68, 70, and hence, the positioning of the ECUs 40a and 40b being positioned horizontally in the electrical stimulator device 10, it is understood that the pockets 68, 70 may have other configurations. For example, in one exemplary arrangement, the pockets 68, 70 may be oriented vertically.

[0056] An advantage of the arrangement shown in FIGS. 7-8, is that in some cases, perhaps only an ECU 40a for stimulation is needed (or only an ECU 40b for measurement). With this configuration, only the single, ECU 40a may be positioned within the device 10, allowing for alower cost device 10. If an intelligent device 10 is desired that includes stimulation, as well as EMG, IMU and data collection, both pockets 68, 70 may receive an ECU 40a and 40b. Use of Electrical Stimulator Device for Treatment

[0057] As discussed above, in one exemplary arrangement, the electrical stimulator device 10 may be used to deliver selective stimulation to a wearer to provide pain relief and to increase circulation, among other benefits. However, the electrical stimulator device 10 may also be configured to provide data to medical professionals to assist in developing a treatment plan, or optimizing an existing treatment plan, utilizing the electrical stimulator device 10, as well as measuring outcomes based on a patient’s pain level and / or activity levels. Using the exemplary arrangement shown in FIGS.1-4 and 7-8, a method of using the electrical stimulator device 10 in this manner will now be described.

[0058] As shown in FIGS. 1-4 and 7-8, the electrical stimulator device 10 is in the form of a therapeutic belt that may be utilized to manage back pain. However, it is understood that the electrical stimulator device 10 may be constructed to treat other areas of a patient, such as arms, legs, wrists, etc., without departing from the disclosure. Using the exemplary arrangement concerning a therapeutic belt as an example, to address back pain, a physical therapist or doctor may find a relationship between a patient’s pain level and a patient’s level of activity helpful in designing a treatment plan for addressing the back pain. To this end, an example method 100 of capturing data and using the captured data to establish a baseline pain assessment as part of a treatment plan is proposed in FIGS.6A-6B.

[0059] In one exemplary arrangement, prior to starting the method 100 of treatment, an initial meeting may take place between with the wearer, and a clinician to establish some baseline parameters, Referring to FIG.6A, this pre-treatment method 101 begins in step 103 by collecting data from the wearer. More specially, data concerning a patient’s history, an evaluation of muscle tightness, pain levels, and / or medication, etc. may be collected by the clinician. In addition to collecting patient history data, in step 105, the clinician may place the electrical stimulator device 10 on the wearer. In step 107, the clinician may apply stimulation at different levels to ascertain a baseline for maximum stimulation that a wearer may be able to tolerateduring initial use. Once these initial parameters have been established by the clinician, the pre- treatment method 101 stops 109.

[0060] Once the wearer takes the electrical stimulator device 10 home, the method 100 of using the electrical stimulator device 10 begins by putting the electrical stimulator device 10 on a torso 12 of a user at step 102. As discussed above, the electrical stimulator device 10 may be provided with an IMU 50. Alternatively, the electrical stimulator device 10 may be provided with just an ECU device 40a such that the device is only focused on stimulation, and a separate ECU device 40b that receives data from electrodes 28 and IMU devices 50 may be provided. The IMU 50, in cooperation with the ECU 40 (or 40b), may be used to monitor multiple metrics about the user’s activities, over predetermined time periods, so as to quantitatively capture data about a user’s activity levels. Accordingly, in step 104, the user wears the device 10 in a monitoring mode. During the monitoring mode, the IMU 50 captures data representing a user’s activity level, over a predefined timeframe. In one exemplary arrangement, the monitoring mode timeframe may be one week, or longer.

[0061] The data that may be captured in step 104 may include one or more of the following: time interval of standing activity, time interval of sitting activity, time interval of lying prone, and / or time interval of walking activity. In addition, the number of steps taken by the user may also be captured in step 104. In step 106, the data captured, i.e., 6 minutes of standing, 20 minutes of sitting, 5 minutes of walking, etc., stored by the ECU 40. In addition to activity levels, information concerning muscle data may also be captured by the electrodes 28. For example, EMG measurements indicative of the muscles’ respective response to different activity levels may be captured.

[0062] At periodic intervals, the captured data may be uploaded in step 108 into a paired computing device, such as the mobile device 200, a server 602 and / or cloud-based storage 604. For example, referring to FIG. 9, the device 10 may be operatively connected to an application on the mobile device 200. The mobile device 200 may be connected, via a network 600 to the server 602 and further to a data storage unit 604.

[0063] The predetermined time periods used to capture data are dependent upon a willingness of a user to wear the electrical stimulator device 10. In one exemplary arrangement, the user willwear the electrical stimulator device 10 at least during waking hours. In other exemplary scenarios, the user will wear the electrical device 10 even while sleeping.

[0064] Once the data is captured, in step 110, the data may be analyzed to determine average and maximum time intervals of different activities. In one exemplary arrangement, a medical professional or clinician may review the data. In another exemplary arrangement, the paired computing device (i.e., mobile device 200 or server 602) may utilize predefined algorithms or artificial intelligence to reach conclusions related to the user’s reported and observed activity level. For example, as people in pain cannot sit for extended periods of time, determining the average and maximum times of a sitting activity session may provide a valuable insight as to a patient’s pain experiences. Similar calculations may be made for average and maximum length of standing sessions and / or walking sessions.

[0065] In conjunction with capturing the data concerning a patient’s activity level, in step 112, the user may also be prompted to input pain levels, i.e., for example on a scale of 1-10, on the paired computing device, i.e., mobile device 200, or recorded for later input into the data storage system (602 and / or 604). The pain level data capture in step 112 may be entered multiple times a day.

[0066] In one exemplary arrangement, data concerning use of medication, such as anti- inflammatories, as well as pain medications may also be recorded at periodic intervals in step 114.

[0067] Steps 110, 112 and 114 may be performed simultaneously, or at separate time periods.

[0068] In one exemplary arrangement, in addition to the data captured by the IMU 50 and the ECUs 40, 40b, the paired computing device 200, 602 may include a graphical user interface (“GUI”) 202 that may have multiple screens to prompt a user to input certain data, including the data for steps 110, 112 and 114. For example, referring to FIGS. 11A-11B, in one exemplary arrangement, the paired computer device 200, 602 may have a GUI 202 with various data input options 203, 205, 207, and 209. For example, the GUI 202 may include input options for parameters 203 for the electrical stimulator device 10, a patient reporting input 205, a usage option 207, and a clinician input option 209.

[0069] Using the patient reporting input 205, a new screen 211 appears with a number of different patient data options 204, 206, 208, 210, 212, 214, 216 and 218 that are available for capturing certain data. For example, as shown in FIG.11A, a patient may select the “arm usage” option 207. Selection of “arm usage” (shown shaded in FIG. 11A), will open a new data entry screen 220 (shown in FIG. 11B) to input arm usage data information at the start 222a of therapeutic usage of the electrical stimulator device 10, arm usage data information currently 222b and a calculation of the increase / decrease of the arm usage ability 222c. In addition, the user may also be able to enter usage ability data 224 using a 1-10 scale.

[0070] As another example, the user may enter observational data concerning muscle atrophy 218, as shown in FIG. 12A. Selection of the muscle atrophy 218 input option opens another screen 224 that allows for entry of measurements of different body areas 226 by the wearer, as shown in FIG.12B.

[0071] As another example, referring to FIG. 13A, the user may enter information about the user’s pain level (i.e., step 112) by selecting the “pain” input option 204 from the report screen 211. Once selected, a pain data entry screen 228 opens, an example of which may be found in FIG. 13B. The pain data entry screen 228 may allow provide data prompts for the time of day 230, allow selection of the location 232 of the pain being reported on, as well as providing a level of pain 234, such as on a scale from 0-10, where 0 is no pain and 10 is maximum pain. In one exemplary arrangement, the wearer may point to a body location on an image of a body 232. Alternatively, a person may input the location using text 236. It is further contemplated that a drop down menu with selected body parts (not shown) may also be provided.

[0072] As yet a further example, referring to FIG.14A, a patient may enter information about the user’s psychological outlook by selecting a “psychological outlook” input option 216 from the report screen 211. Once selected, a psychological outlook data entry screen 238 opens, an example of which may be found in FIG.14B. In one exemplary arrangement, the psychological outlook data entry screen 238 includes a row of options 240 to indicate the wearer’s mood, i.e., “very sad” to “very happy”. In addition, the psychological outlook data entry screen 238 may also include a quantitative score entry location 242, based on the wearer’s mood from the start of wearing the electrical stimulator device 10 to the current outlook, as well as a location that indicates the progress 244.

[0073] As still another further example, referring to FIG. 15A, a patient may also enter information about the user’s sleep by selecting a “sleep” input option 206 from the report screen 211. Once selected, a “sleep” report screen 246 opens, an example of which may be found in FIG. 15B. In one exemplary arrangement, the sleep report screen 246 includes a scale 248 by which the user may report on the quality of sleep, such as a scale from 0-10, where 0 represents very poor sleep, and 10 represents a very satisfactory and restful sleep. In addition, a user may report on whether the sleep was interrupted or complete, as indicated by selections 250a, 250b.

[0074] As another example, referring to FIG.16A, a patient may also enter information about the user’s muscle tone / tightness by selecting the “muscle tightness / tone” input option 212 from the report screen 211. Once selected, a muscle tightness / tone report screen 252 opens, an example of which may be found in FIG. 16B. In one exemplary arrangement, the muscle tightness / tone screen 252 includes options for reporting on different body parts, such as legs 254a, arms 254b, back 254c, and abdominal muscles 254d. Once the body part is selected, the user may then report on the perceived tightness / tone by selecting from a scale 256 that ranges from 0-10, where 0 indicates no tightness or tone, and 10 represents a maximum tone or tightness.

[0075] As another example, referring to FIG.17A, a patient may also enter information about the user’s pain medication (i.e., step 114) by selecting the “pain med” input option 208 from the report screen 211. Once selected, a pain med reporting screen 258. The pain med reporting screen 258 includes options for entering the time of day 260, as well as the type of medication 262 taken.

[0076] As yet another example, a patient may also enter information about any muscle spasms the wearer experiences. For example, a patient may select the “spasm” option 210 from the report screen 211. Once selected, a spasms report screen 264 opens, an example of which may be found in FIG.18A. In one exemplary arrangement, the muscle spasms report screen 264 includes options for reporting on different body parts, such as legs 266a, arms 266b, back 266c, and abdominal muscles 266d. Once the body part is selected, the user may then report on the spasms experienced by the wearer by selecting from a scale 268 that ranges from 0-10, where 0 indicates no spasms, and 10 represents a maximum spasm.

[0077] In addition to providing valuable observational data from the patient, the GUI also provides incentive for the patient to wear the electrical stimulator device 10 and be able to observe improvements or gains achieved from wearing the device 10. Indeed, compliance with wearing the device 10 enough to provide a therapeutic benefit is often a concern for healthcare professionals. Accordingly, the method 100 may include alerts sent to the paired computing device 200, 602 by the healthcare professional.

[0078] Once all of the data has been captured by the computing device 200, 602 during a predetermined time period and the monitoring mode 104, the computing device 200, 602 is configured to analyze the data to determine an initial stimulation plan in step 116, i.e., predetermined times to initiate operation of the electrodes 28 to apply stimulation to help reduce pain. For example, the data entered by the wearer into the application on the mobile device 200 may be combined with the data sent to the server 602. Based on the data, predefined stimulation protocols that may be stored on the server 602 and / or in the data storage unit 604 may be sent to the device 10. As part of the stimulation plan, the intensity of the stimulation that the electrodes 28 shall produce, as well as the duration may also be established. The method then ends at step 118.

[0079] Once the initial stimulation plan has been implemented, the electrical stimulator device 10 may continue to be worn in a treatment mode, whereby the electrical stimulator device 10 may apply stimulation based on a quantitative analysis of the data concerning activity levels and reported pain, for example. During the treatment mode, the method 100 may be repeated to continually monitor the effectiveness of the electrical stimulation, as well as allowing for continuous improvement of the treatment plan. The user may also be prompted to enter observational data on the GUI screens to measure the user’s perceived progress.

[0080] In one exemplary arrangement, when the device 10 is worn in the treatment mode, the device 10 may be programmed via the ECU 40, 40a to automatically initiate the stimulation cycle by the electrodes 28 at predetermined time intervals, based on the data collected during the pre-treatment method 101 and the monitoring mode 104. In one exemplary arrangement, the programming may be done remotely through the same application on the mobile device 200 where the user enters the observational data. As the wearer uses the electrical stimulator device 10 and additional data is collected, both from the device 10 itself, as well as the observationaldata inputted by the user, the stimulation levels being applied by the electrodes 28 may be adjusted up or down, also remotely, by a healthcare professional. For example, it is contemplated that the GUI 202 may also include an input button for the clinician 270 that would open a subsequent screen where the clinician may set stimulation parameters for operating the electrical stimulator device 10.

[0081] Due to the data being collected, a patient’s compliance with use of the electrical stimulator device 10 may also be monitored. The application may prompt the user, with notifications, to use the device 10. In one exemplary arrangement, the application may provide reward incentives for entering various data, either by the user or through use of the electrical stimulator device 10. For example, after predetermined days of wearing the electrical stimulator device 10, a video may play, or credits toward a gift card may be earned.

[0082] In another exemplary arrangement, using the data collected, the application and or the server, may adjust the stimulation based on parameters detected from use of the electrical stimulator device 10. For example, in one exemplary arrangement, if the EMG measurements detect high tonicity (i.e., the muscles are contracted), the stimulation may be automatically activated. Once the tonicity eases, the stimulation may be automatically turned off.

[0083] There may be times where the wearer needs or wants to turn off stimulation. Accordingly, the electrical stimulator device 10 may include a kill switch 272 to allow a user to selectively turn off the device 10. The kill switch 272 can take any suitable form, but in one exemplary arrangement, may be of a simple push button arrangement, which may be activated through clothing.

[0084] Referring to FIG. 10, an exemplary implementation of the method 100 may be illustrated. For example, as set forth above, the method 100 may be embodied in a handheld device, such as mobile device 200, that provides prompts for the user to implement the activity level 110, pain level 112, and / or any medication during different predetermined time periods. During a baseline assessment time period, as set forth above, the electrical stimulator device 10 does not apply any electrical stimulation. Data associated with the user’s reported activity levels (whether self-reported in the mobile device app, captured by the electrodes / sensors 28, or both) is captured and tracked during the baseline assessment time period (area on left). For example, pain levels using the visual analog scale (VAS) may be inputted at predetermined time periods,whether prompted by the mobile device app, or selectively inputted by the user. These data points may be visually represented by line 300.

[0085] In conjunction with tracking the pain levels 112, a user’s activity level 110 is also tracked. For example, a user may input his or her own activity level. Additionally, or alternatively, the IMU 50 may also be programmed to capture data and deliver the data via the communication circuit 48 to an app on the mobile device 200, the server 602 or even the data storage unit 604. For example, as discussed above, in the method 100 at step 140, the IMU 50 may track the time interval of standing activity, time interval of sitting activity, time interval of lying prone, and / or time interval of walking activity. These data points may be visually represented by one or more lines. In the example shown in FIG. 10, walking activity is tracked and represented as line 350.

[0086] Using the difference between the user’s pain level 112 and a user’s activity level 110, a Pain-Activity-Walking-Sedentary Score (PAWS) may be calculated. For example, as shown in FIG. 10, on the left side of the graph, an initial PAWS score is calculated during the baseline assessment period 400. The baseline assessment period 400 will allow average pain levels to be calculated for a variety of activities. In one exemplary arrangement, the baseline assessment period 400 may take 1-4 weeks, depending on the quality of the data collected and the amount of time the patient spends wearing the electrical stimulator device 10 during the baseline assessment period 400.

[0087] After the baseline assessment period 400 has expired, for example, after a two- week period, a treatment plan can be implemented whereby the electrical stimulator device 10 is then operated to provide electrical stimulation based on the initial baseline assessment period 400. The user’s pain levels 112 and activity levels 110 continue to be tracked after stimulation therapy is initiated, during a second time period 500, i.e., a treatment phase. These data points may also be plotted, similarly to the baseline assessment data, continuing with lines 300 and 350. Using the data from those data captures, the PAWS score may be continually monitored by the user, as well as healthcare professionals in an effort to drive the PAWS score into a positive number, whereby activity level is increased, while pain levels decrease. As a further advantage, this data may also be used with insurance carriers to demonstrate treatment outcomes. In other words, effectiveness of the stimulation may be tracked, allowing for adjustment of therapy (eithermodifying stimulation levels or frequency or both) to provide increased therapeutic benefit for the user. Health Monitoring using Electrode Sensing

[0088] The electrodes 28 or sensors of the electrical stimulator device 10 may further be used for measuring biometric data about a wearer to assist in developing treatment. For example, the electrical stimulator device 10 may be used to measure pulse rate, EMG (electromyography) signals and / or bioimpedance. The EMG signals may be used to indicate levels of muscle contractions such that capturing the EMG signals may be used to determine if a user is experiencing muscle spasming. In addition, information about a specific muscle spasm may also be monitored and tracked. For example, the measurements about a muscle spasm may be used to determine a time of day when muscle spasms occur, and to what extent a muscle is spasming. In addition, the measurements may be used to determine body imbalances, for example when one side of a body is spasming more than another. Such information can be useful to assist in diagnosing and treating a patient. In one exemplary arrangement, the electrodes 28 and / or sensors may be placed at different locations on the electrical stimulator device 10 to measure various different areas of the body.

[0089] In yet a further exemplary arrangement, the EMG signals may also be used to measure a level of muscle activity following stimulation. For example, a muscle can be stimulated by one or more specific electrodes 28, and the EMG signal from the muscle being targeted may be measured. Using this information, a maximum muscle contraction possible for a muscle may be determined by continuing to increase stimulation until the corresponding EMG signal does not increase.

[0090] A rate of fatigue of a muscle may also be determined in one exemplary arrangement. For example, the electrical stimulator device 10 may be configured to apply stimulation over a period of time, and the EMG signal may be continuously monitored while the stimulation is being applied. In this instance, the degree of stimulation is held constant, and a decrease of the EMG signal provides the rate of muscle fatigue.

[0091] Using the measurement techniques outlined above, treatment plans may be determined using applied electrical stimulation. For example, in one exemplary arrangement, a treatmentplan using periodic electrical stimulation at predetermined times, and intensity, may be employed to strengthen a muscle over time. As the electrical stimulator device 10 may also continuously measure various signals relating to the muscle being treated, the effectiveness of the treatment may be monitored and selectively adjusted, depending on the progress.

[0092] In a further exemplary arrangement, bioimpedance measurements may be used to determine body fat and lean muscle mass of an area of the user. For example, in one exemplary arrangement the electrodes 28 and / or sensor may be positioned on the front closure panel 18 and abdominal fat and lean muscle mass may be tracked, providing quantitative data to a user that may be utilized in making other health related decisions.

[0093] In one exemplary arrangement, the electrical stimulator device 10 may be utilized to assist a user with falling asleep by applying stimulation to an affected area. For example, for a person that experiences back pain due to muscle spasms, the electrical stimulator device 10 may be worn by a wearer, such that the electrodes 28 are configured to apply stimulation to the lower back muscles to reduce pain. In one exemplary arrangement, the time intervals of the stimulation application, as well as the intensity level of the stimulation may be determined by the method 100 discussed above. Moreover, biometric data, such as heart rate data that may be captured by the electrodes 28 and / or sensors, may assist in determining when a user has fallen asleep such that the stimulation may be turned off or reduced.

[0094] As another example, the electrical stimulator device 10, using the biometric data captured by the electrodes / sensor 28, or movement data from the IMU 50, may detect when a sleeping person is waking up. In this instance, the electrical stimulator device 10 may be activated to apply stimulation to promote further pain management to allow the user to return to sleep. Gait Monitoring

[0095] In an exemplary arrangement, the electrical stimulator device 10 may be utilized to monitor and / or evaluate a gait of a patient. For example, multiple IMUs 50 may be incorporated in the electrical simulator device 10, or peripheral to, and communicatively connected to the electrical stimulator device 10. Together with EMG measurements from electrodes 28, the multiple IMUs 50 may make it possible to monitor body movements and positions in real-time, enabling detection of muscle activation patterns. This information can be used to evaluate thegait of a patient. For example, an asymmetrical body position, asymmetrical movement of legs, asymmetrical rhythm associated with walking may indicate that the patient is favoring one leg over another, has a condition such as foot drop, or has lower back pain, causing an imbalance during walking or standing. Data from the detection of such conditions can be used to tailor a treatment plan including electrical stimulation for the patient. Integrating Additional Sensors in the Electrical Stimulator Device

[0096] In addition to electrodes 28 and IMUs 50, other sensors may be integrated into the electrical stimulator device 10. Respiratory rate sensors can be integrated to measure breathing patterns and evaluate respiratory response to muscle stimulation. Understanding the interplay between respiratory, cardiac, and muscular systems can help optimize stimulation protocols to enhance performance without overtaxing the cardiorespiratory response. Galvanic Skin Response (GSR) sensors can be integrated which measure skin conductivity changes, indicating stress levels and autonomic nervous system activity. This can provide insights into the physiological stress response to muscle stimulation and physical activity. Temperature sensors, monitoring either skin or core body temperature, can assess the thermal response to muscle stimulation, ensuring user comfort and safety during sessions.

[0097] Oxygen saturation (SpO2) sensors can be used to help evaluate the efficiency of oxygen delivery to muscle regions during stimulation, offering valuable insight for understanding muscle performance and recovery. The electrical stimulator device 10 could also have sensors which evaluate blood pressure and blood pressure responses at the level of the garment. Additionally, perfusion monitors and pulse volume recording sensors can be used to assess blood flow and tissue perfusion at the level of the garment, offering valuable data on how well the involved body region is supplied with oxygen and nutrients during stimulation. By combining data from various biosensors with IMU data, a comprehensive profile of human performance in response to muscle stimulation can be obtained. This integrated approach allows for more precise and personalized adjustments to stimulation protocols, enhancing the effectiveness and safety of muscle stimulation therapies.Collecting Research Data

[0098] To the extent authorized by law, the electrical stimulator device 10 can be used to collect data that can be used by researchers and physicians. Data collected by the electrical stimulator device 10 and uploaded to the mobile device 200. The mobile device 200 or other computing device 600 can anonymize the data and provide the data to datasets from multiple users. The datasets can then be used to facilitate studies on the efficacy of muscle stimulation treatments and the development of new protocols. Other Exemplary Electrode Stimulator devices

[0099] As discussed above, while the disclosure has been embodied in certain instances in a belt designed to be worn about a user’s torso 12, it is understood that the disclosure may be embodied in other exemplary arrangements. For example, the electrodes 28 and sensing arrangement may be employed in a spinal orthotic device. In such an instance, the spinal orthotic device is used to immobilize the lower body of a patient. The electrodes / sensors 28 may be included in the spinal orthotic device for treatment and monitoring of the wearer’s muscles, using the same data capture method outlined in connection with method 100.

[0100] 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.

[0101] 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 theappended 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 these claims 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 (10), comprising: an inner liner (14), a support frame (16), and a front closure panel (18); wherein the inner liner (14) and the support frame (16) are connected together as a unitary element and the front closure panel (18) is selectively attached to the unitary element to secure the electrical stimulator device (10) about a body part (12); wherein the inner liner (14) further comprises at least one electrode (28) attached to an inner surface of the inner liner (14) such that the at least one electrode (28) is positionable against and in contact with a patient’s body when the electrical stimulator device (10) is worn; and wherein the at least one electrode (28) is selectively actuatable to deliver electrical stimulation.

2. The electrical stimulator device (10) of claim 1, further comprising an electronic control unit (40, 40a) that is electrically connected to the at least one electrode (28) and to a controller (42), wherein the controller (42) is utilized to selectively operate the at least one electrode (28).

3. The electrical stimulator device (10) of claims 1 or 2, wherein the inner liner (14) is constructed of a first material, and wherein the support frame (16) is constructed of a second material, wherein the first material is more flexible than the second material.

4. The electrical stimulator device (10) of any of the preceding claims, wherein the support frame (16) includes a plurality of openings or void areas (34) therein.

5. The electrical stimulator device (10) of any of the preceding claims, wherein the support frame (16) further comprises a mounting panel (36) that supports an electronic control unit (40) that is electrically connected to the at least one electrode (28).

6. The electrical stimulator device (10) of claim 5, wherein the electronic control unit (40) further comprises a processor (46), an inertia measurement unit (50) and a communication circuit (48).

7. The electrical stimulator device (10) of claims 5 or 6, wherein the electronic control unit (40) is operatively connected to a controller (42), and wherein the controller (42) further includes input elements for selectively controlling the at least one electrode (28).

8. The electrical stimulator device (10) of any of claims 5 -7, wherein the electronic control unit (40) of the electrical stimulator device (10) is configured for communications with a computing device.

9. The electrical stimulator device (10) of any of claims 1-4, wherein the electrical stimulator device (10) further comprises at least one pocket (68) that includes an opening (75) through which an electrode stimulation ECU (40a) or an inertia measurement unit ECU (40b) may be received to temporarily secure the electrode stimulation ECU (40a) and / or the inertia measurement unit ECU (40b) to the device (10).

10. The electrical stimulator device (10) of claim 9, wherein each pocket (68) is configured with a connector (76) to which the electrode stimulation ECU (40a) and / or the inertia measurement unit ECU (40b) may be selectively coupled.

11. A method (100) of utilizing an electrical stimulator device (10), comprising: positioning (102) the electrical stimulator device (10) on a user; operating the electrical stimulator device in a monitoring mode (104), whereby predetermined activities are performed by the user; capturing data relating to the predetermined activities (106), uploading the captured data to an associated computing device (108); andanalyzing data (110) to determine a stimulation operation based on the captured data.

12. The method of claim 11, wherein data concerning a user observed pain level (112), sleep, medication (114), muscle spasms, muscle tightness / tone, arm usage, psychological outlook, and / or muscle atrophy is input into the associated computing device, wherein the captured data and the user observed pain level, sleep, medication, muscle spasms, muscle tightness / tone, arm usage, psychological outlook, and / or muscle atrophy data is utilized to determine the stimulation operation.

13. The method of claims 11 or 12, wherein the stimulation operation is transmitted (116) to the electrical stimulator device (10) and the method further comprises operating one or more of electrodes (28) that are positioned within the electrical stimulator device (10) to deliver electrical stimulation at predefined time periods and at predefined intensity levels.

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