Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/36014—External stimulators, e.g. with patch electrodes
  • A61N1/36021—External stimulators, e.g. with patch electrodes for treatment of pain
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
  • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
  • A61B5/1113—Local tracking of patients, e.g. in a hospital or private home
  • A61B5/1114—Tracking parts of the body
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
  • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
  • A61B5/1118—Determining activity level
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/48—Other medical applications
  • A61B5/4806—Sleep evaluation
  • A61B5/4815—Sleep quality
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
  • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
  • A61B5/6813—Specially adapted to be attached to a specific body part
  • A61B5/6828—Leg
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/02—Details
  • A61N1/04—Electrodes
  • A61N1/0404—Electrodes for external use
  • A61N1/0408—Use-related aspects
  • A61N1/0456—Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/02—Details
  • A61N1/04—Electrodes
  • A61N1/0404—Electrodes for external use
  • A61N1/0472—Structure-related aspects
  • A61N1/0484—Garment electrodes worn by the patient
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/36014—External stimulators, e.g. with patch electrodes
  • A61N1/3603—Control systems
  • A61N1/36031—Control systems using physiological parameters for adjustment

Definitions

• This invention relates generally to Transcutaneous Electrical Nerve Stimulation (TENS) devices that deliver electrical currents across the intact skin of a user via electrodes so as to provide symptomatic relief of pain. More specifically, this invention relates to a TENS device worn during sleep, and a method for making novel measurements that broaden and enhance sleep analysis, and includes enhanced transcutaneous electrical nerve stimulation (TENS) using the same.
• TENS Transcutaneous Electrical Nerve Stimulation
• Transcutaneous electrical nerve stimulation (TENS) devices provide pain relief by stimulating sensory nerves, which leads to an increase in endogenous opioids and down- regulation of pain signal transmission to the brain.
• a TENS device which could be used during sleep would offer unique opportunities to provide pain relief during bedtime with the goal of improving sleep (see, for example, Barbarisi M, Pace MC, Passavanti MB, et al. Pregabalin and transcutaneous electrical nerve stimulation for postherpetic neuralgia treatment. Clin J Pain. Sep 2010;26(7):567- 572).
• TENS devices are designed to operate exclusively during the day (i.e., wake state) without any nighttime (i.e., sleep state) operation.
• This limitation is evident in the design of conventional TENS devices, in which the electric current is delivered through wires (called leads) that are connected to electrode pads on the skin.
• leads are cumbersome and may get tangled or pulled, and because the electrode pads can potentially peel off the skin (which will terminate TENS therapy) or, perhaps worse, can potentially partially peel off the skin, leading to increased current density and negative consequences for the user (e.g., discomfort or, in extreme cases, burns).
• IMPEDANCE (Attorney's Docket No. NEURO-64), published as U.S. Patent Application Publication No. US 2014/0296934 Al on October 2, 2014, which patent application is hereby incorporated herein by reference, there is disclosed a novel TENS device which allows TENS therapy to be applied during nighttime (i.e., during sleep state) as well as during the day (i.e., wake state).
• the key design elements that make this novel TENS device suitable for use during sleep are (1) the leads are eliminated because the electrode pads are attached directly to the housing containing the TENS stimulation circuitry, (2) the TENS housing and electrode pads are held reliably and comfortably against the skin by an adjustable strap or band, (3) the TENS device continuously measures skin-electrode contact impedance (and related electrical parameters) so as to detect if the electrode pads peel (completely or partially) off the skin and the TENS device stops delivering current if peeling is detected, (4) therapeutic stimulation may be scheduled in one- hour on-off blocks so as to provide pain relief throughout the night, and (5) the TENS device detects when the user is asleep and reduces the therapeutic stimulation level automatically so as not to disturb sleep.
• Application Serial No. 14/230,648 (and published as U.S. Patent Application Publication No. US 2014/0296934 Al) is designed to be located on the upper calf of the user. This is for three reasons. First, the TENS device needs to stimulate sensory nerve fibers in order to provide widespread pain relief through the systemic effect of an increase in endogenous opioids and down-regulation of pain signal transmission.
• the upper calf area has a cluster of sensory nerve fibers that can be activated easily with a transcutaneous electrical nerve stimulator because of their proximity to the surface of the skin.
• the novel TENS device disclosed in pending prior U.S. Patent Application Serial No. 14/230,648 (and published as U.S. Patent Application Publication No. US 2014/0296934 Al), which is designed for use during sleep, detects when the user is asleep and adjusts the therapeutic stimulation level to avoid disturbing sleep. It would be advantageous for a TENS device aimed at improving sleep quality to also quantify sleep quality and sleep disorders, since users will be more likely to use the TENS device if they are aware of, and convinced of, its benefit to their sleep.
• the gold standard in determining the sleep-wake state of a subject is polysomnography which comprises at least three distinct types of data, i.e., electroencephalogram (EEG), electrooculography (EOG) and electromyography (EMG). Because of the difficulty in recording and analyzing these types of data, actigraphy has been developed and refined over the last 30 years as a practical alternative to study sleep/awake patterns. Actigraphy is a continuous recording of body movement by means of a body- worn device, typically equipped with accelerometers [Ancoli-Israel S, Cole R, Alessi C, Chambers M, Moorcroft W, Pollak CP. The role of actigraphy in the study of sleep and circadian rhythms. Sleep. May 1 2003;26(3):342-392].
• Wearable electronic devices for health and fitness have become widespread, and most have accelerometers and, from acceleration data, compute various metrics of activity either to track daytime activities or to quantify sleep patterns. Most of these actigraphy-based devices are worn on the wrist however, and in certain ways that limits their ability to detect and quantify sleep.
• a novel, accelerometer-equipped TENS device on the upper calf, with tight mechanical coupling to the upper calf, may be used to support novel approaches for detecting when the user is asleep, and novel metrics for analyzing the sleep of the user, and novel approaches to quantify body and leg motions associated with poor sleep quality and/or disorders such as restless leg syndrome, and novel approaches for providing enhanced transcutaneous electrical nerve stimulation (TENS) using the same.
• novel metrics are "leg movements", “body roll events” associated with rolling over in bed, and “time-on-back” which is relevant to users suffering not only from chronic pain but also from problematic sleep positions which can cause snoring or sleep apnea.
• real-time feedback to the user based on indicator trends can also help the user to improve sleep quality.
• An example is to provide an alert (via mechanical or electrical means, for example) to the user when time-on-back duration exceeds a threshold.
• Another example is to alter TENS stimulation parameters when leg movement patterns associated with discomfort caused by nighttime pain are detected in order to enhance the analgesic effect of TENS therapy.
• the present invention comprises the provision and use of a novel TENS device which comprises a TENS stimulator designed to be placed on the user's upper calf and a pre-configured electrode array designed to provide circumferential stimulation to the upper calf of the user.
• a three-axis (x, y, z) accelerometer incorporated in the TENS device continuously measures the projection of static gravity onto each axis (i.e., x, y, z), which depends on the device orientation, and time-varying acceleration on each axis due to user motion along that axis.
• the placement of the novel TENS device on the upper calf of the user is used to support novel approaches for detecting when the user is asleep, and for quantifying sleep and assessing abnormal body and leg motions, and for providing enhanced TENS therapy using such sleep analysis.
• the novel TENS device measures leg orientation, which is highly correlated with body orientation and therefore indicative of the user's recumbent state (and thereby the user's sleep-wake state). Specifically, the novel TENS device measures two distinct aspects of leg orientation: leg “elevation” (or the angle of the lower leg relative to the horizontal), and leg “rotation” (or the angle of rotation of the lower leg about its own axis).
• the novel TENS device measures leg motion, which is also indicative of the user's sleep-wake state. Specifically, the novel TENS device measures two distinct aspects of leg motion: "net activity” (which is the magnitude of movement-related acceleration averaged within one-minute windows), and “leg movements” (or brief events that are known to occur in sleep but are not evident in net activity). Some leg movements accompanied by a large leg rotation may be further classified as “body roll events” (such as occur when rolling over in bed). Repetitive leg movements may occur in people with chronic pain and other medical conditions, and may degrade the quality of sleep experienced by the person (and his/her sleep partner). Quantification and monitoring of the repetitive leg movements may provide insights to these conditions and trends of these conditions.
• the novel TENS device combines these two measures of leg orientation (i.e., leg elevation and leg rotation) and two measures of leg motion (i.e., net activity and leg movements) to improve sleep quantification and to utilize more precise quantification metrics to enhance therapeutic benefits.
• the determination of sleep-wake state by the novel TENS device proceeds in several steps.
• the user is considered to be "in-bed” if the user's leg orientation is determined to be recumbent (i.e., near horizontal) for a selected portion (e.g., a majority) of a selected time period (e.g., a decision window).
• a selected portion e.g., a majority
• a selected time period e.g., a decision window
• “sleep onset” is defined as the first time that the user's net activity and leg movements fall below set thresholds for a specified period of time (e.g., a decision window).
• the novel TENS device measures net activity and leg movements. During all of the time intervals in which the net activity is below some specified threshold, the user is considered to be "asleep".
• apparatus for providing transcutaneous electrical nerve stimulation (TENS) therapy to a user comprising:
• an application unit for providing mechanical coupling between said housing and the user's body
• a stimulation unit for electrically stimulating at least one nerve of the user
• a sensing unit for sensing the user's body movement and body orientation
• a reporting unit for providing the user with feedback based on the user's sensed body movement and body orientation.
• a method for applying transcutaneous electrical nerve stimulation to a user comprising the steps of:
• a stimulation unit and a sensing unit to the user's body; using the stimulation unit to deliver electrical stimulation to the user to stimulate one or more nerves;
• apparatus for monitoring the sleep patterns of a user comprising: a housing;
• an application unit for providing mechanical coupling between said housing and the user's body
• a sensing unit disposed within the housing to sense the user's body movement and body orientation
• a reporting unit for providing the user with feedback based on the user's sensed body movement and body orientation.
• a method for monitoring the sleep patterns of a user comprising of the steps of:
• apparatus for providing transcutaneous electrical nerve stimulation (TENS) therapy to a user comprising:
• an application unit for providing mechanical coupling between said housing and the user's leg
• a stimulation unit for electrically stimulating at least one nerve of the user
• sensing unit for sensing the user's leg orientation and leg motion, wherein sensing the user's leg orientation comprises determining the user's leg elevation and leg rotation, and further wherein sensing the user's leg motion comprises determining the user's net activity and leg movements;
• Fig. 1 is a schematic view showing a novel TENS device formed in accordance with the present invention, with the novel TENS device being mounted to the upper calf of a user;
• Fig. 2 is a schematic view showing the novel TENS device of Fig. 1 in greater detail;
• Fig. 3 is a schematic view of the novel TENS device shown in Figs. 1 and 2 attached to the tissue of a patient;
• Fig. 4 is a schematic view of the novel TENS device of Figs. 1 and 2, including its user state (i.e., leg orientation and leg motion) detector;
• Fig. 5 is a schematic view showing the on- skin detection system of the novel TENS device shown in Figs. 1 and 2, as well as its equivalent circuits when the novel TENS device is on and off the skin of a user;
• Fig. 6 is a schematic view showing the orientation of the accelerometer incorporated in the novel TENS device of Figs. 1 and 2, when the novel TENS device of Fig. 1 is applied to the upper calf of a user;
• Fig. 7 is a schematic view showing the relationship between gravitational force vector g and the accelerometer y-axis in the novel TENS device when the novel TENS device (applied to upper calf of the user) rests at an elevation angle ⁇ with respect to the horizontal plane;
• Fig. 8 is a schematic view showing the detection of a leg movement (LM) event, and calculation of the change ⁇ in device rotational angle ⁇ after (vs. before) the LM event;
• LM leg movement
• Fig. 9 is a schematic view showing the mathematics for relating the accelerometer rotational angle ⁇ (measured by the accelerometer) to the leg rotational angle ⁇ , via a third angle a representing the rotational position of the novel TENS device on the upper calf of a user;
• Fig. 10 is a schematic flow chart showing exemplary operation of the novel TENS device, including its user state (i.e., leg orientation and leg motion) detector.
• user state i.e., leg orientation and leg motion
• Fig. 1 illustrates a novel TENS device 100 formed in accordance with the present invention, with the novel TENS device being shown worn on a user's upper calf 140. A user may wear TENS device 100 on either leg.
• TENS device 100 is shown in greater detail in Fig. 2 and preferably comprises three primary components: a stimulator 105, a strap 110, and an electrode array 120 (comprising a cathode electrode and an anode electrode appropriately connected to stimulator 105 as is well known in the art).
• Stimulator 105 preferably comprises three mechanically and electrically inter-connected compartments 101, 102, and 103. Compartments 101, 102, 103 are preferably inter-connected by hinge mechanisms 104 (only one of which is shown in Fig. 2), thereby allowing TENS device 100 to conform to the curved anatomy of a user's leg.
• compartment 102 houses the TENS stimulation circuitry (except for a battery) and user interface elements
• Compartment 102 also houses an accelerometer 152 (see Figs. 4 and 6), preferably in the form of a semiconductor chip accelerometer, for detecting user gestures, user leg and body orientation, and user leg and body motion, as will hereinafter be discussed. Compartment 102 also houses a realtime clock 505 (Fig. 4). In a preferred embodiment, compartments 101 and 103 are smaller, auxiliary compartments that house a battery for powering the TENS stimulation circuitry and other circuitry, and other ancillary elements, such as an ambient light sensor or detector 510 (Figs.
• a wireless interface unit of the sort well known in the art for allowing TENS device 100 to wirelessly communicate with other elements (e.g., a hand-held electronic device such as a smartphone 860).
• a hand-held electronic device such as a smartphone 860.
• only one or two compartments may be used for housing all of the TENS stimulation circuitry, battery, and other ancillary elements of the present invention.
• a greater number of compartments are used, e.g., to conform better to the body and to improve user comfort.
• a flexible circuit board is used to distribute the TENS stimulation circuitry and other circuitry more evenly around the leg and thereby reduce bulk.
• user interface element 106 preferably comprises a push button for user control of electrical stimulation
• user interface element 108 preferably comprises an LED for indicating stimulation status and for providing other information to the user.
• Additional user interface elements e.g., a multi-LED array, LCD display, audio feedback through a beeper or voice output, haptic devices such as a vibrating motor, etc. may also be provided and are considered to be within the scope of the present invention.
• TENS device 100 comprising stimulator 105, electrode array 120, and strap 110, is secured to upper calf 140 by placing the apparatus in position and then tightening strap 110.
• the preferred embodiment of the present invention comprises placement of the TENS device on the upper calf of the user, additional anatomical locations (such as above the knee, on the lower back, and on the upper arm) are also contemplated and are also considered to be within the scope of the present invention.
• Fig. 3 is a schematic representation of the current flow between TENS device 100 and the user.
• stimulation current 415 from a constant current source 410 flows into the user's tissue 430 (e.g., the user's upper calf) via anode electrode 420.
• Anode electrode 420 comprises a conductive backing (e.g., silver hatch) 442 and hydrogel 444.
• the current passes through the user's tissue 430 and returns to constant current source 410 through cathode electrode 432 (cathode electrode 432 also comprises a conductive backing 442 and hydrogel 444).
• Constant current source 410 preferably provides an appropriate biphasic waveform (i.e., biphasic stimulation pulses) of the sort well known in the art of TENS therapy.
• biphasic waveform i.e., biphasic stimulation pulses
• the designation of "anode” and “cathode” electrodes is purely notational in the context of a biphasic waveform (i.e., when the biphasic stimulation pulse reverses its polarity in its second phase of the biphasic TENS stimulation, current will be flowing into the user's body via "cathode” electrode 432 and out of the user's body via “anode” electrode 420).
• TENS device 100 Further details regarding the construction and use of the foregoing aspects of TENS device 100 are disclosed in (i) U.S. Patent No. 8,948,876, issued 02/03/2015 to NeuroMetrix, Inc. and Shai N. Gozani et al. for APPARATUS AND METHOD FOR RELIEVING PAIN USING TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (Attorney's Docket No. NEURO- 5960), which patent is hereby incorporated herein by reference, and (ii) pending prior U.S. Patent Application Serial No. 14/230,648, filed 03/31/2014 by Shai N. Gozani et al.
• the User State i.e., Leg Orientation And Leg Motion
• TENS device 100 further comprises (e.g., within compartment 102) user state (i.e., leg orientation and leg motion) detector 500 for (i) determining the sleep-wake state of the user, (ii) analyzing the sleep of the user, and/or (iii) providing enhanced transcutaneous electrical nerve stimulation (TENS) using the same.
• user state i.e., leg orientation and leg motion
• TENS transcutaneous electrical nerve stimulation
• user state (i.e., leg orientation and leg motion) detector 500 generally comprises the aforementioned accelerometer 152, the aforementioned real-time clock 505, the aforementioned ambient light detector 510, a processor 515 for calculating user activity (e.g., body orientation, body movement and activity levels), and a controller 520 for modifying the stimulation current provided by the constant current source 410 of TENS device 100 in accordance with
• TENS device 100 When the TENS device is secured in position on the user's upper calf, the position and orientation of accelerometer 152 (Figs. 4 and 6) of TENS device 100 is fixed relative to the lower limb of the user. Tight mechanical coupling between TENS device 100 and lower limb 140 allows movement of the user's lower limb to be accurately measured by accelerometer 152.
• Such tight mechanical coupling is preferably established through the aforementioned strap 110.
• tight mechanical coupling may be established through other means, e.g., a flexible band encasing the TENS device.
• a tension gauge 109 (Fig. 1) may be provided on strap 110 to confirm that a tight mechanical coupling is established between TENS device 100 and upper calf 140.
• Data from accelerometer 152 are analyzed in real time by processor 515 of user state (i.e., leg orientation and leg motion) detector 500 to determine the orientation and motion of the lower limb (i.e., upper calf 140) of the user.
• the orientation, motion, and activity level of the lower limb (i.e., upper calf 140) of the user, determined by analyzing the data from accelerometer 152, are used to determine the sleep-wake state and sleep patterns of the user.
• TENS device 100 can modify its stimulation pattern (such as the stimulation intensity level and the onset of the stimulation) via controller 520, or provide the user with additional feedback (such as mechanical vibration if the duration of the sleep-on-back state exceeds a threshold).
• leg orientation and leg motion components measured by the user state (i.e., leg orientation and leg motion) detector 500 of the present invention may individually or collectively contribute to the determination of the sleep-wake state of the user.
• processor 515 of TENS device 100 measures the calf orientation of the user, which is highly correlated with the body orientation of the user. More particularly, upright body orientation is generally a reliable indicator that the user is in a wake state, while recumbent orientation suggests a resting state (e.g., such as occurs during sleep). Regular and robust body movement is more likely the result of user activities during the daytime (i.e., during wake state), while quiet or low-level spontaneous
• recumbent body orientation and a low-level of physical activity is generally a good indicator that the user is asleep.
• real-time clock 505 of user state (i.e., leg orientation and leg motion) detector 500 allows assigning a nontrivial a priori probability of the sleep-wake state at any given time of the day in order to further refine the sleep- wake state classification results obtained by the aforementioned analysis of leg orientation and leg motion data (i.e., a user is more likely to be asleep at 3:00 am and less likely to be asleep at 4:00 pm).
• the threshold value for classifying user body orientation as recumbent can be made more stringent.
• output from ambient light sensor 510 is used to improve sleep-wake classification results.
• the ambient light sensor 510 can be used to determine if the user is in an environment which has an illuminated or non-illuminated ambience, to reflect the a priori probability that a user is more likely to be sleeping in a dark setting than in a brightly lit setting. Accordingly, the threshold values for classifying user body position and motion level can be adjusted to reflect the a priori probability of sleep.
• TENS device 100 may comprise an on-skin detector to confirm that TENS device 100 is firmly seated on the skin of the user.
• an on-skin detector 521 is provided to determine whether and when TENS device 100 is securely placed on the user's upper calf. In the preferred embodiment, and looking now at Fig. 5, on-skin detector 521 may be provided within TENS device 100. More particularly, in one preferred form of the invention, a voltage of 20 volts from voltage source 204 is applied to the anode terminal 212 of TENS stimulator 105 by closing the switch 220.
• the equivalent circuit 260 shown in Fig. 5 represents the real-world system and equivalent circuit 260 allows the anode voltage V a 204 to be sensed through the voltage divider resistors 206 and 208.
• the cathode voltage measured from the amplifier 207 will be non-zero and close to the anode voltage 204.
• the equivalent circuit 270 represents the real- world system and the cathode voltage from amplifier 207 will be zero.
• On-skin detector 521 is preferably employed in two ways.
• TENS device 100 can stop applying TENS therapy to the user.
• on-skin detector 521 indicates that electrode array 120 of TENS device 100 has become partially or fully detached from the skin of the user, processor 515 of TENS device 100 will recognize that the data from
• accelerometer 152 may not reliably reflect user leg orientation and leg motion, and user state (i.e., leg orientation and leg motion) detector 500 can take appropriate action (e.g., alert the user).
• user state i.e., leg orientation and leg motion
• detector 500 can take appropriate action (e.g., alert the user).
• the on-skin detector 521 indicates that TENS device 100 is on the skin of the user, and accelerometer 152 is closely coupled to the lower limb of the user
• the data from accelerometer 152 may be representative of user leg orientation and user leg motion.
• accelerometer 152 is not closely coupled to the lower limb of the user, and the data from accelerometer 152 will not be representative of user leg orientation and user leg motion.
• user state (i.e., leg orientation and leg motion) detector 500 comprises a processor 515 for taking the accelerometer data from accelerometer 152 and calculating user activity (e.g., body orientation, body movement and activity levels).
• user activity e.g., body orientation, body movement and activity levels.
• processor 515 uses the accelerometer data from accelerometer 152 to measure the user's leg orientation, which is highly correlated with body orientation and therefore indicative of the user's recumbent state (and thereby the user's sleep-wake state); and processor 515 uses the accelerometer data from accelerometer 152 to measure the user's leg motion, which is also indicative of the user's sleep-wake state and leg motion activity levels; and processor 515 uses the determinations of user leg orientation and user leg motion to enhance sleep quantification.
• processor 515 uses the accelerometer data from accelerometer 152 to measure two distinct aspects of the user' s leg orientation: leg “elevation” (or the angle of the lower leg relative to the horizontal plane), and leg “rotation” (or the angle of rotation of the lower leg about its own axis).
• And processor 515 uses the accelerometer data from accelerometer 152 to measure two distinct aspects of leg motion: "net activity” (which is the magnitude of movement-related acceleration averaged within one-minute windows), and “leg movements” (or brief events that are known to occur in sleep but are not evident in net activity). Some leg movements accompanied by a large leg rotation may be further classified as “body roll events” (such as occur when rolling over in bed).
• processor 515 for calculating user activity is constructed and configured to operate as follows.
• Raw accelerometer data produced at 400 Hz are decimated to 50 Hz.
• the time scale of an "instant" is defined to be equal to 0.1 sec.
• the 50 Hz data on each axis (x, y, z) are separately averaged over each instant, to provide a low-noise data stream at 10 Hz, denoted by A x ⁇ t), A y ⁇ t), and A z ⁇ t).
• the accelerometer data A x (t), A y (f), and A z (f) are used to form features which are averages of A x (f), A y (t), and A z (t) over a longer time window (e.g., a one minute window) to capture the steady-state projection of earth gravity along each axis (x, y, z). These features are used for detecting leg orientation (i.e., leg elevation and leg rotation).
• the accelerometer data A x (f), A y (t), and A z (t) are high-pass filtered to remove the static gravity component in order to isolate acceleration components caused by leg movement.
• the high-pass filter has -3dB point at 0.5 Hz.
• High-pass filtered accelerometer data are denoted as A v ( i). ⁇ ,. ( ⁇ ).
• user state detector 500 is configured to detect leg elevation.
• the present invention uses the leg elevation, which is computed by processor 515 of user state (i.e., leg orientation and leg motion) detector 500, based on measurement data from accelerometer 152 when TENS device 100 is placed on the user's upper calf 140 (Fig. 1).
• accelerometer 152 is located on the circuit board 151 of the TENS circuitry housed inside compartment 102, so that the accelerometer' s 3-axis directions, shown at 153 in Fig.
• the >-axis is aligned longitudinally along the longitudinal axis of the lower leg;
• the jc-axis is disposed tangential to the surface of the lower leg and perpendicular to the y-axis, and the z-axis points radially away from the surface of the lower leg.
• a stationary recumbent user lying with legs elevated on a bed will have a measured acceleration value along the y-axis of about Og.
• the leg elevation is considered to be upright, otherwise the leg elevation is considered to be recumbent.
• the elevation angle ⁇ (172) represents the angle between the positive accelerometer y-axis direction (174) and the true horizontal plane (170).
• the y-axis acceleration measurement threshold level is set to 0.50g, corresponding to a leg elevation angle ⁇ 3 ⁇ 4 30° from the horizontal plane, however, other threshold values may also be used, and users may have the option of adjusting this value to better distinguish their sleep and wake behaviors.
• the acceleration measured along the y-axis will include not only the projection of gravity onto that axis, but also a contribution from motion:
• a y (t) ⁇ sin W(t) ⁇ + m(t) [in unit of g] where t is time, and m(t) is the contribution due to leg motion.
• the specific + sign depends upon the TENS device placement on upper calf 140 and is fixed for each placement.
• the motion component m(t) is considered "noise" in the context of determining leg elevation, and will have zero mean over a sufficiently large window.
• a leg elevation algorithm taking into account user body movement, is implemented by processor 515 of user state (i.e., leg orientation and leg motion) detector 500 in the following manner.
• Step 1 Set a target angle threshold ⁇ (this is the "Thresholdl” shown at step 910 in Fig. 10) for the angle ⁇ so that ⁇ corresponds to the case where the upper calf 140 of the user is recumbent.
• the target angle threshold ⁇ is set to 30°.
• Step 2. Define non-overlapping windows of length N, called “epochs". The time at the end of each epoch is denoted T.
• the accelerometer data in units of g, standard earth gravity
• the mean A y and the standard error of the mean SE Y T are calculated based on samples in each epoch.
• the hysteresis parameter Q H is set to 2.5°, but other values are possible (but should be small compared to ⁇ ).
• Step 4 The ability of the hysteresis band to prevent erratic switching of the leg elevation state depends upon the amount of noise in the data, characterized by SEy j , which is the standard error of the mean A yj .
• processor 515 of user state (i.e., leg orientation and leg motion) detector 500 processor 515 compares the acceleration data to the thresholds A + . However, instead of comparing the mean A y per se to the thresholds A + , processor 515 compares the "confidence interval" A y ⁇ r ⁇ SE Y to the thresholds A + . More specifically, for each epoch, if the prior elevation state was recumbent, in order to classify the next state as upright, processor 515 of user state (i.e., leg orientation and leg motion) detector 500 requires
• processor 515 of user state (i.e., leg orientation and leg motion) detector 500 requires A .
• ⁇ 3, but other values are possible.
• processor 515 of user state (i.e., leg orientation and leg motion) detector 500 may be configured to detect
• TENS device 100 when TENS device 100 is worn on the user's upper calf 140, the user' s activity will be captured by accelerometer 152 of the TENS device.
• Each axis (x, y, z) of accelerometer 152 measures the projection of the acceleration vector along that axis. As described above, the measured
• acceleration includes the static effect of earth gravity, as well as contributions from leg movement.
• the acceleration component for each individual axis of the accelerometer contains unique and useful information for body movement analysis, the vector magnitude of acceleration, called the “instantaneous acceleration”, denoted _ f (t) and defined in equation below, is commonly used to quantify the overall motion-related activity:
• Mt) jA x (t) 2 + A Y (t) 2 + A z (t) 2
• processor 515 of user state (i.e., leg orientation and leg motion) detector 500 uses this instantaneous acceleration J f f i) for the actigraphy calculations.
• J f f i instantaneous acceleration
• calculations based on other combinations of acceleration axes may also be used. For example, rather than combining all three axes equally as done with A s (t) as defined above, only some axes may be used, or certain axes may be contrasted through subtraction.
• processor 515 of user state (i.e., leg orientation and leg motion) detector 500 may be configured to detect leg movement. More particularly, the instantaneous acceleration A j (i) is a time series comprised of brief events, such as leg movements known to occur during normal and abnormal sleep, and sustained activity, such as occurs during walking, running, or climbing stairs.
• leg movements (LM) are computed in a manner that is consistent with the detection of periodic leg movements (PLM) defined in the clinical literature (Bonnet et al, 1993; Zucconi et al, 2006), however, other approaches to detecting brief leg movements are possible and are considered to be within the scope of the present invention.
• a leg movement (LM) detection algorithm is implemented by processor 515 of user state (i.e., leg orientation and leg motion) detector 500 in the following manner.
• Step 1 Define two thresholds (these are the "Threshold2" and
• Theshold3 shown at steps 914 and 918, respectively, in Fig. 10.
• these thresholds are 0.02g (816 in Fig. 8) and 0.03g (815 in Fig. 8), but other values may also be used.
• Step 2 Define an instantaneous activity state (IAS) and initialize the IAS to False.
• IAS instantaneous activity state
• Step 3 Compute instantaneous acceleration A r (t) for each time instant.
• LM leg movement
• the top panel (810) in Fig. 8 shows an example of the leg movement (LM) detection algorithm applied to real data.
• Time is measured in instants, i.e., steps of 0.1 second.
• the dots, and the line 812 connecting them, are the instantaneous accelerations A s (i).
• the vertical line 814 shows the instant when J f ⁇ £) first went below the second threshold 816 for more than 0.5 second so the LM period was terminated.
• the net result is an LM period with a duration of 89 instants (i.e., 8.9 seconds).
• processor 515 of user state (i.e., leg orientation and leg motion) detector 500 is configured to function as a body roll detector.
• the TENS device 100 (Fig. 9) is worn on the lower leg (i.e., upper calf 140) of a user
• its accelerometer 152 will sense the projection of the gravity in its x-z plane when the user is in a recumbent position.
• the angle ⁇ between the device x-axis and the gravity vector -g can be calculated based on the projected gravity value in the x and z axis.
• Axis z' is aligned with the "big toe" direction of the user's leg to which the TENS device 100 is attached.
• Angle a between the device z-axis and the leg x'-axis is fixed when the TENS device is securely placed on the lower leg (i.e., upper calf 140) of the user.
• the body orientation angle ⁇ defines the relative rotational position between the leg (defined as the direction in which the big toe is pointed, i.e., the z'-axis) and the earth gravity (z"-axis).
• the angular value remains the same when measuring from the x'-axis to the x"-axis. It is straightforward to derive the relationship between ⁇ and ⁇ as follows:
• the leg rotation angle ⁇ can be derived from the angle ⁇ as measured by the accelerometer 152.
• leg movement Some brief increases in activity that are classified as leg movement (LM) are associated with large changes in the roll angle ⁇ measured by the TENS device 100. Rolls of sufficient magnitude are unlikely to involve only the leg, but rather are likely to indicate that the entire body is rolling over while in bed, e.g., from the left side to the right side, or from the back to the left side or the right side. Some leg movements (LMs) may therefore be classified as "body roll events”.
• a body roll detection algorithm is implemented by processor 515 in user state (i.e., leg orientation and leg motion) detector 500, using only the angle change ⁇ , in the following manner:
• Step 1 For each LM period detected, select the raw acceleration vector A(i) in short windows before and after the leg movement. In a present invention, this window is an instant (0.1 seconds).
• Step 2 Before and after each LM period, take the instant values of A(i) (not high-pass filtered) on each axis separately so as to obtain A x (t), A y (t), and A z (t).
• the inverse tangent function atan2 returns an angle in the range- 180° ⁇ (p(t) ⁇ 180°, i.e., a result in all four possible quadrants.
• Step 4. Compute the change in rotational angle In order to facilitate comparison with a threshold (this is the "Threshold4" shown at step 924 in Fig. 10), this difference is put in the range -180° ⁇ 180°, i.e., if ⁇ >180° then subtract 360°, but if ⁇ - 180° then add 360°.
• Step 5 Compare the absolute value ⁇ with a threshold value. In the present invention, this threshold value is 50°, but other values may be used. If ⁇ l>50°, then classify the LM event as a "body roll event".
• the middle panel (820) in Fig. 8 shows this body roll detection algorithm applied to real data.
• the acceleration values A x (f), A y (f), and A z (f) are plotted in traces 821, 822, and 823.
• a x (t) and A z (f) show significant activities, especially between time instants 30 and 70.
• the steady state value for A x (f) changed from +lg (before the LM period) to -lg (after the LM period), suggesting a body roll event.
• the bottom panel (830) of Fig. 8 shows the calculation of the elevation angle ⁇ (833) and the rotation angle ⁇ (834) for each instant.
• the elevation angle ⁇ -0 throughout the event, consistent with the lower leg being in recumbent elevation.
• the rotation angle ⁇ changes from ⁇ +90° (indicated by the empty circle 831) to ⁇ -88° (indicated by the filled circle 832).
• the angular change is ⁇ 178°, consistent with a (rightward) roll of the entire body.
• body rolls may be reported directly to the user to inform them about their sleep patterns.
• body roll events may be brief, the associated increase in activity may not be evident in the epoch average of activity, and therefore may not cause that epoch to be classified as awake.
• the mean or median values of A(t) over several instants before and after the LM are used to improve robustness to noise.
• a body roll detection algorithm is implemented by processor 515 of user state (i.e., leg orientation and leg motion) detector 500 using the angle change ⁇ in the following manner. Consider a person lying on their back, with the TENS device placed on their right leg.
• the threshold for detecting a body roll may be adjusted depending upon the leg on which the device is placed. That is to say, in addition to the magnitude of the change ⁇ , the value of the leg rotation angle ⁇ before and after the leg movement (LM), and the sign of the angle change ⁇ across the leg movement (LM), may be used to improve performance of the body roll detector.
• processor 515 of user state (i.e., leg orientation and leg motion) detector 500 may be configured to function as a static body rotational position detector.
• leg rotational position is highly correlated with body position, e.g., when sleeping on one's back, the toes of either foot are pointed upward above the horizontal plane to varying degrees, not likely exactly on the horizontal plane, and never below the horizontal plane.
• the double-primed coordinate system i.e., x", y" , z", with y" not being seen in Fig. 9 since it extends down the axis of the leg
• the single-primed coordinate system i.e., x', y', z' , with y' not being seen in Fig. 9 since it extends down the axis of the leg
• the unprimed coordinate system i.e., x, y, z, with y not being seen in Fig. 9 since it extends down the axis of the leg
• the TENS device measuring A (t) and r (t).
• the Earth coordinate system has its z"-axis along the vertical
• the leg coordinate system has its z'-axis in the direction of the toes
• the leg rotational angle ⁇ is the angle between the Earth jc"-axis and leg jc'-axis.
• the TENS device angle a is the location of the TENS device on the leg measured from the leg jc'-axis.
• processor 515 of user state (i.e., leg orientation and leg motion) detector 500 determines whether the user is on-back through an estimation of the angle ⁇ .
• Step 1 The user places the TENS device on the lower leg of the user and fastens the strap 110 snugly around their upper calf 140, lies recumbent with the leg nearly horizontal, points their toes vertically upward, and remains still.
• Step 2 The user indicates to the TENS device that the aforementioned conditions have been met.
• This indication may take the form of a series of button presses (e.g., with button 106), a series of taps on compartment 102 detected by the accelerometer 152, or an indication on a smartphone 860 in communication with the TENS device 100.
• Step 5 Define a range of values for ⁇ that correspond to the user lying or sleeping on their back.
• the thresholds (which would reside at step 930 in Fig. 10) depend upon the leg on which the device is placed. For example, if the device is placed on the left leg, the most likely range of angles while lying on the back is 0° ⁇ 7 ⁇ 80 ⁇ .
• Step 6 If the user with sleep apnea selects this option for TENS device 100, then when the user is determined to be asleep, i.e., recumbent with low activity, the TENS device notifies the user if they are on their back for more than some set amount of time, e.g., a few minutes. This indication can be in the form of a vibration of the TENS device itself, or an alarm on their smartphone 860, for example.
• Step 7 After determining the span(s) of minutes in which the user was likely to be asleep, i.e., recumbent with low activity, determine the fraction of minutes in which the user was determined to be on their back. Report this percentage to this user, e.g., with smartphone 860.
• TENS device 100 including its user state (i.e., leg orientation and leg motion) detector 500, its processor 515 and its controller 520, are programmed to operate in the manner shown in the flowchart of Fig. 10.
• user state i.e., leg orientation and leg motion
• user state detector 500 collects data from accelerometer 152, real-time clock 505 and ambient light detector 510, as shown at step 902.
• on-skin detector 521 confirms that electrode array 120 of TENS device 100 is in contact with the user's skin, as shown at step 904 (and hence confirms that TENS device 100 is secured to the upper calf 140 of the user).
• Processor 515 analyzes data from accelerometer 152, real-time clock 505 and ambient light detector 510, as shown at step 906.
• Processor 515 determines the user's leg elevation orientation, as shown at step 908, and determines if the user is in bed by comparing elevation angle with a threshold (i.e., "Threshold4"), as shown at step 910.
• a threshold i.e., "Threshold4"
• processor 515 determines the user's leg activity, as shown at step 912.
• the user's leg activity is compared against a threshold (i.e.,
• processor 515 determines that the user is in a restful sleep, as shown at step 916.
• Processor 515 also compares the user's leg activity (determined at step 912) against another threshold (i.e., "Threshold2"), as shown at step 918, and, if the user's leg activity is above that threshold, processor 515 determines that the user has excessive leg movement, as shown at step 920.
• a threshold i.e., "Threshold2”
• processor 515 also determines the user's leg rotation orientation, as shown at step 922, and compares the change in the angle of the user's leg rotation against another threshold (i.e., "Threshold3”), as shown at step 924, and, if the change in the angle of the user's leg rotation is above that threshold, and if the user's leg movement exceeds a threshold (i.e., "Threshold2") as shown at step 918, processor 515 determines that a body roll event has occurred, as shown at step 926.
• a threshold i.e., "Threshold2
• processor 515 looks at the user's leg rotation orientation, as determined at step 922, the accelerometer data analysis, as determined at step 906 and the user's user limb and toe-up indication, as determined at step 928, and determines the user's body position classification, as shown at step 930.
• Processor 515 then characterizes the user's position as “on back”, “on side (left/right)” or “on stomach”, as shown at step 932.
• the information derived at steps 916, 920, 926 and 932 is then utilized by processor 515 to analyze the user's sleep session, as shown at step 934.
• the results of this sleep analysis may then be displayed (as shown at step 936), used to provide feedback to the user or the user's caregiver (as shown at step 938) and/or used to direct controller 520 (as shown at step 940) to modulate the stimulation current provided by TENS device 100.
• the present invention provides a transcutaneous electrical nerve stimulator with automatic monitoring of leg activities and leg orientations.
• Leg orientations include leg elevation and leg rotation state, and changes in leg elevation and leg rotation states.
• the TENS stimulator may be pre-programmed to modify its operations in response to the detected user leg activities and leg positions during bed time.
• leg orientation and leg activities are used to assess sleep quality and sleep position, all are important aspects to improve sleep and health.
• Leg activity patterns can also be used to diagnose sleep disorders such as periodic leg movement and the TENS stimulator can be used to alleviate excessive leg movement activities that are disruptive to sleep.
• the present invention can also be realized without the nerve stimulation functionality.
• Body movement and position can be monitored and quantified using the present invention without the need of nerve stimulation.
• the monitoring apparatus can also be placed in other body positions like upper arm of either limb.

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