WO2020033883A1 - Stimulation nerveuse électrique transcutanée pour le traitement d'énurésie et de troubles du plancher pelvien - Google Patents

Stimulation nerveuse électrique transcutanée pour le traitement d'énurésie et de troubles du plancher pelvien Download PDF

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Publication number
WO2020033883A1
WO2020033883A1 PCT/US2019/045990 US2019045990W WO2020033883A1 WO 2020033883 A1 WO2020033883 A1 WO 2020033883A1 US 2019045990 W US2019045990 W US 2019045990W WO 2020033883 A1 WO2020033883 A1 WO 2020033883A1
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WIPO (PCT)
Prior art keywords
stimulation
stimulation parameters
user
medical system
sensitivity level
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PCT/US2019/045990
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English (en)
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WO2020033883A9 (fr
Inventor
Andrew J. KIRSCH
Ubirajara De Oliveria BARROSO JR.
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Global Continence Llc
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Publication of WO2020033883A1 publication Critical patent/WO2020033883A1/fr
Publication of WO2020033883A9 publication Critical patent/WO2020033883A9/fr

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Classifications

    • 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
    • A61N1/0408—Use-related aspects
    • A61N1/0452—Specially adapted for transcutaneous muscle stimulation [TMS]
    • 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
    • A61N1/0492—Patch electrodes
    • 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
    • A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control

Definitions

  • the present disclosure relates to neuromodulation, and in particular to devices and techniques for delivering non-invasive neurostimulation to treat enuresis and pelvic floor disorders.
  • Enuresis and pelvic floor disorders are commonly associated with the inability to control muscles such as the bladder muscles and pelvic floor muscles. Contracting and relaxing these muscles allows an individual to control urination, bowel movements, and, for women particularly, sexual intercourse.
  • muscles and nerves must work together to hold urine in the bladder and then release the urine at the right time. Nerves carry messages from the bladder to the brain to let the brain know when the bladder is full. The nerves also carry messages from the brain to the bladder, telling the bladder muscles to either tighten or release.
  • Urinary incontinence is the involuntary voiding of urine a certain number of times (e.g., once, twice or greater during the day (diurnal enuresis) or night (nocturnal enuresis)).
  • the age at which children attain urinary continence varies, but most children (greater than 90%) are continent during the day by age 5.
  • Nighttime continence takes longer to achieve, but most children (greater than 90%) are continent during the night by age 7.
  • primary enuresis an individual (typically a child) has never achieved urinary continence for > 6 months.
  • secondary enuresis individuals have developed incontinence after a period of at least 6 months of urinary control (could be several years after developing urinary control).
  • a nerve problem might affect an individual’s bladder control if the nerves that are supposed to carry messages between the brain and the bladder do not work properly.
  • Enuresis and pelvic floor disorders have been treated in the past by medication, muscle exercises, or behavioral techniques such as scheduled eating, drinking, and trips to the bathroom, positive imagery, or bladder training with an enuresis alarm.
  • the preferred course of treatment for enuresis is bladder training because the enuresis alarm conditions the individual to inhibit the contraction of the bladder, which ultimately results in creating lasting connections between nerves and muscles for informing the brain that the bladder is full and contracting bladder muscles to hold the urine until the urine can be properly voided.
  • bladder training is well established and used worldwide, there are several problems that prevent many individuals from achieving therapeutic success. These problems include individuals who take weeks to be conditioned and during the training period the individuals continue to urinate, which causes many of the individuals to abandon bladder training.
  • bladder training e.g., woken up in the night by the alarm
  • predisposes the family to stress and conflicts While new types of diapers and bed wetting alarms have improved bladder training options, there are still deficiencies including parents failing to hear the alarm and take the child to the bathroom, the alarm becoming inadvertently disconnected, sensors failing or activating based on sweat as compared to urine, the child not waking to the alarm, or the child being taken to the bathroom without the alarm going off (confusion of the learning process).
  • PTNS posterior tibial nerve stimulation
  • an electrical stimulator pulse generator
  • a small electrode is inserted through the skin of the lower leg and attached to the tibial nerve.
  • the stimulator sends pulses to the electrode, which stimulates the tibial nerve in the leg.
  • the electrical current then affects the nerve in the lower back that controls bladder and pelvic floor function.
  • an electrical stimulator pulse generator
  • a small electrode is inserted through the skin of the back and attached to the sacrum.
  • the stimulator sends pulses to the electrode, which stimulates the sacral nerve in the back.
  • the electrical current then affects the bladder function.
  • neurostimulation being used to treat enuresis and pelvic floor disorders. Furthermore, optimizing neural stimulation parameters and identifying the subset of parameters that may cause pain or inadvertent side effects is important from a safety perspective. Accordingly, the need exists for neuromodulation systems and techniques that are non-invasive and have the capability to optimize neuromodulation stimulation parameters.
  • a medical device comprising: transcutaneous electrical nerve stimulation (TENS) device comprising an electronics module comprising: a controller configured to provide a set of stimulation parameters, and a pulse generator configured to generate neural stimulation based on the set of stimulation parameters; one or more electrodes connected to the TENS device for delivering the neural stimulation generated by the pulse generator to a region of a user; one or more sensor for detecting one or more of the following: a triggering event for the neural stimulation, a nerve response of the neural stimulation, and a sensitivity level of the patient to the neural stimulation; and a garment or pad attached to the TENS device, the one or more electrodes, and the one or more sensors.
  • TENS transcutaneous electrical nerve stimulation
  • the garment or pad is attached to the TENS device, the one or more electrodes, and the one or more sensors via one or more snap connectors.
  • the garment or pad includes one or more wires for electrically connecting the TENS device, the one or more electrodes, and the one or more sensors.
  • the medical device further comprises a remote external programmer comprising one or more interfaces configured to receive the set of stimulation parameters and communicate the set of stimulation parameters to the controller.
  • the stimulation parameters include a frequency, an intensity, a duration, and a waveform, and wherein the waveform, and the neural stimulation is delivered via the pulse generator in a stimulation burst, which is a train of stimulation pulses programmed with any combination of the frequency, the intensity, the duration, and the waveform.
  • the frequency is between 5 Hz and 150 Hz.
  • the intensity is between 0 mA and 35 mA.
  • the duration is between 40 ps to 1000 ps.
  • the waveform is a monophasic current, a biphasic current, a Russian current, Interferential current, or Premodulated current.
  • the set of stimulation parameters include a unidirectional or monophasic current waveform, with the frequency set at 50 Hz, the duration set at 700 microseconds, and the intensity set between 0 mA and 35 mA, depending on an impedance of the region of the user.
  • the one or more electrodes are attached to the garment or pad along a midline of the garment or pad.
  • the one or more electrodes are attached bilaterally or unilaterally to the garment or pad.
  • the one or more sensors comprise a humidity or moisture sensor for detecting the triggering event for the neural stimulation, and the triggering event is enuresis or defection.
  • a medical system comprising: one or more processors; and a memory coupled to the one or more processors, the memory storing a plurality of instructions executable by the one or more processors, the plurality of instructions comprising instructions that when executed by the one or more processors cause the one or more processors to perform processing comprising: monitoring for a triggering event; in response to an occurrence of the triggering event, delivering, using one or more electrodes, neural stimulation to a region of a user based on a set of stimulation parameters; monitoring a response to the neural stimulation that includes monitoring, using one or more sensors, one or more interfaces, or a combination thereof, a nerve response and a sensitivity level of the user; determining that the nerve response is not acceptable or the sensitivity level of the user is not acceptable; in response to determining the nerve response is not acceptable or the sensitivity level of the user is not acceptable, modifying, using the one or more processors, the set of the stimulation parameters to create a modified set of stimulation parameters, and
  • the nerve response is not acceptable when the neural stimulation fails to cause a motor contraction.
  • the sensitivity level is not acceptable when the sensitivity level exceeds a predetermined threshold.
  • the processing further comprises providing, by an audible alarm, a light, or an interface notice, an indication of the triggering event to the user, and recording the triggering event in a data table.
  • the processing further comprises receiving, from the one or more interfaces, the sensitivity level of the user.
  • the triggering event is a scheduled event, a detectable enuresis event, or a detectable pain related event.
  • the triggering event is the detectable enuresis event
  • the monitoring comprises detecting the enuresis event using a humidity or moisture sensor
  • the processing further comprises in response to an occurrence of the triggering event, activating an alarm.
  • the triggering event is the scheduled event
  • the monitoring comprises detecting occurrence of the scheduled event
  • the processing further comprises in response to an occurrence of the triggering event recording the triggering event in a data table.
  • the triggering event is the detectable pain related event
  • the monitoring comprises detecting occurrence of pain in the region of the user
  • the processing further comprises in response to an occurrence of the triggering event recording the triggering event in a data table.
  • the set of stimulation parameters include a frequency, an intensity, a duration, and a waveform, and wherein the waveform, and the neural stimulation is delivered via the one or more electrodes in a stimulation burst, which is a train of stimulation pulses programmed with any combination of the frequency, the intensity, the duration, and the waveform.
  • the frequency is between 5 Hz and 150 Hz.
  • the intensity is between 0 mA and 35 mA.
  • the duration is between 40 ps to 1000 ps.
  • the waveform is a monophasic current, a biphasic current, a Russian current, Interferential current, or Premodulated current.
  • the set of stimulation parameters include a unidirectional or monophasic current waveform, with the frequency set at 50 Hz, the duration set at 700 microseconds, and the intensity set between 0 mA and 35 mA, depending on an impedance of the region of the user
  • a medical system comprises: a transcutaneous electrical nerve stimulation (TENS) device attached to a garment or pad, the TENS device comprising: one or more processors, and a memory coupled to the one or more processors, the memory storing a plurality of instructions executable by the one or more processors, the plurality of instructions comprising instructions that when executed by the one or more processors cause the one or more processors to perform processing comprising: obtaining a set of stimulation parameters; delivering, using one or more electrodes, neural stimulation to a region of a user based on the set of stimulation parameters; monitoring a response to the neural stimulation that includes monitoring, using one or more sensors, one or more interfaces, or a combination thereof, a nerve response and a sensitivity level of the user; determining that the sensitivity level of the user is not acceptable; in response to determining the sensitivity level of the user is not acceptable, modifying, using the one or more processors, the set of the stimulation parameters to create a modified set of stimulation parameters;
  • TENS transcutaneous electrical nerve stimulation
  • the sensitivity level is acceptable when the sensitivity level does not exceed a predetermined threshold.
  • the nerve response is acceptable when the neural stimulation causes a motor contraction.
  • the set of stimulation parameters include a unidirectional, square-wave-shaped electrical signal, with 50 Hz frequency and pulse width of 700
  • the processing further comprises receiving, from the one or more interfaces, the sensitivity level of the user.
  • the processing further comprises monitoring, using a sensor, for a triggering event, and the neural stimulation is delivered to the region of the user in response to an occurrence of the triggering event.
  • the triggering event is an enuresis event and the sensor is a humidity or moisture sensor.
  • the modifying the set of the stimulation parameters comprises increasing or decreasing one or more of the following: a pulse intensity, a pulse duration, or a pulse frequency.
  • the set of stimulation parameters are obtain via a wireless communication from a remote external programmer comprising one or more interfaces configured to receive the set of stimulation parameters and communicate the set of stimulation parameters to the controller.
  • a computer-implemented method is provided to perform part or all of one or more methods or processes disclosed herein.
  • a computer-program product is provided that is tangibly embodied in a non-transitory machine-readable storage medium and that includes instructions configured to cause one or more data processors to perform part or all of one or more methods or processes disclosed herein.
  • a system is provided that includes one or more data processors and a non-transitory computer readable storage medium containing instructions which, when executed on the one or more data processors, cause the one or more data processors to perform part or all of one or more methods or processes disclosed herein.
  • FIG. 1 shows a block diagram of a neuromodulation system in accordance with various embodiments
  • FIG. 2A shows a neuromodulation system in accordance with various embodiments
  • FIG. 2B shows an example of an undergarment incorporating attachment points for an electrode pad and transcutaneous electrical nerve stimulation (TENS) unit in accordance with various embodiments
  • FIG. 2C shows an example of an undergarment incorporating a humidity sensor and an electrical stimulator (electrode(s)) in accordance with various embodiments;
  • FIG. 2D the undergarment of FIG. 2C in an open configuration in accordance with various embodiments
  • FIGS. 2E, 2F, and 2G show the pudendal and other nerves and provides information about pudendal neuropathy in accordance with various embodiments
  • FIG. 3 shows a block diagram of an electronics module in accordance with various embodiments.
  • FIGS. 4-6 show exemplary flows for titrating neuromodulation therapy and providing neuromodulation therapy in accordance with various embodiments.
  • neuromodulation means the alteration of nerve activity through targeted delivery of a stimulus, such as electrical stimulation, to specific neurological sites in the body.
  • a neurostimulator is a device or system having electronic circuit components and/or software configured to deliver the stimulus to the specific neurological site (e.g., the sacral nerve) via an electrode assembly.
  • the neurostimulator may be a transcutaneous electrical nerve stimulation (TENS) device.
  • TENS transcutaneous electrical nerve stimulation
  • TENS devices apply electrical currents to a particular area of the human body in order to suppress acute and chronic pain.
  • TENS may be considered as an adjunctive or primary treatment option for patients with enuresis and pelvic floor disorders.
  • the TENS device may be connected to the skin or a cavity of an end user (i.e., a patient) using one or more electrodes.
  • the stimulus, stimulation, or neural stimulation may comprise electrical signals, and may be defined in accordance with electrical signal parameters, properties, and/or characteristics (e.g., frequency, intensity, duration, and waveform).
  • the neural stimulation is generally delivered or applied to the patient in accordance with a treatment protocol.
  • the treatment protocol specifies an optimal or best set of parameters directed toward maximally treating one or more patient symptoms through neural stimulation applied in a specified manner (e.g., applied at high frequency (>50 Hz) with an intensity below motor contraction (sensory intensity) or low frequency ( ⁇ 10 Hz) with an intensity that produces motor contraction).
  • a specified manner e.g., applied at high frequency (>50 Hz) with an intensity below motor contraction (sensory intensity) or low frequency ( ⁇ 10 Hz) with an intensity that produces motor contraction).
  • a neuromodulation device or system is provided to deliver stimulation to a nerve using a signal, which causes a nerve response such as a muscle contraction in the management of enuresis and pelvic floor disorders.
  • a technological problem associated with conventional neuromodulation devices and systems is that they are invasive (typically at least a portion of the device is implanted in the patient requiring a surgical process) and they do not have the ability to sense or determine nerve responses such as the muscle contraction or discomfort by the patient, nor provide adjustment of the stimulation parameters based on the nerve response and/or sensitivity level of the patient.
  • These systems and approaches are both inefficient in effectiveness and unreasonably risky with respect to potential for infection, neural damage and resulting physiological effects.
  • neuromodulation devices or systems comprise a TENS device to deliver stimulation to a nerve using a signal, and a controller that can be used to: (i) monitor nerve responses such as a muscle contraction, and/or (ii) discomfort (i.e., sensitivity level) of the user to the neurostimulation therapy.
  • the monitored nerve response and/or sensitivity level can then be used by the controller to control the neurostimulator to emit a modified signal, which causes muscle contraction without reaching a sensitivity threshold of the user.
  • the neuromodulation devices or systems provide on-demand neuromodulation therapy using a closed control system or closed-loop system (feedback control) where an open loop system is used as the forward path but one or more feedback loops or paths are included between the output signal and the input signal.
  • a closed control system or closed-loop system feedback control
  • the modification of stimulation parameters and subsequent burst or periodic release of neural stimulation from one or more electrodes can be triggered based on a recording from one or more sensors and/or input provided by the end user.
  • an action is “triggered by” or“based on” something, this means the action is triggered or based at least in part on at least a part of the something.
  • One illustrative embodiment of the present disclosure comprises a medical system including one or more processors and a memory coupled to the one or more processors.
  • the memory is encoded with a set of instructions configured to perform a process comprising delivering, using a TENS device, transcutaneous electrical neural stimulation to a nerve based on a first set of stimulation parameters, monitoring a response to the neural stimulation that includes monitoring, using one or more sensors (e.g., electroencephalography sensor) and/or interface input, a sensitivity level of the patient, modifying, using the one or more processors, the first set of the stimulation parameters based on the sensitivity level of the patient to create a second set of stimulation parameters, and delivering, using the TENS device, the neural stimulation to the nerve based on the second set of the stimulation parameters.
  • sensors e.g., electroencephalography sensor
  • Another illustrative embodiment of the present disclosure comprises a medical system including one or more processors and a memory coupled to the one or more processors.
  • the memory is encoded with a set of instructions configured to perform a process comprising delivering, using a TENS device, transcutaneous electrical neural stimulation to a nerve based on a first set of stimulation parameters, monitoring a response to the neural stimulation that includes monitoring, using one or more sensors (e.g., a non-invasive sensor based on a force-sensitive resistor (FSR)) and/or interface input, responses of the nerve and monitoring, using one or more sensors (e.g., electroencephalography sensor) and/or interface input, a sensitivity level of the patient, modifying, using the one or more processors, the first set of the stimulation parameters based on the responses of the nerve and the sensitivity level of the patient to create a second set of stimulation parameters, and delivering, using the TENS device, the neural stimulation to the nerve based on the second set of the stimulation parameters.
  • sensors e.g.
  • Another illustrative embodiment of the present disclosure comprises a medical device including an undergarment, a TENS device attached to the undergarment, and a moisture sensor in communication with the TENS device and attached to the undergarment.
  • the TENS device includes a pulse generator, one or more electrodes, a controller, and a memory storing program instructions.
  • the program instructions when operated on by the controller cause the controller to perform operations comprising: determining a presence of moisture above a set threshold using the moisture sensor; based on the determined presence of moisture, delivering neural stimulation using the TENS device based on a first set of stimulation parameters to a nerve, monitoring a response to the neural stimulation that includes: (i) monitoring, using one or more sensors and/or interface input, responses of the nerve, (ii) monitoring, using one or more sensors and/or interface input, a sensitivity level of the patient, or (iii) monitoring a combination of responses of the nerve and a sensitivity level of the patient, modifying, using the one or more processors, the first set of the stimulation parameters based one or more of the responses of the nerve and the sensitivity level of the patient to create a second set of stimulation parameters, determining a presence of moisture above the set threshold using the one or more sensors, and based on the determined presence of moisture, delivering, using the TENS device, the neural stimulation to the nerve based on the second set of the
  • these approaches provide neuromodulation devices and systems that are non-invasive and capable of detecting and/or tracking effects due to neuromodulation therapy and closing the loop on stimulation parameters.
  • the neuromodulation devices or systems described herein can adjust stimulation parameters to emit a signal, which causes muscle contraction without reaching a sensitivity threshold of the user.
  • FIG. 1 shows a neuromodulation system 100 in accordance with some aspects.
  • the neuromodulation system 100 includes a neurostimulator 105, optionally one or more sensors 110, and a controller 115.
  • the neurostimulator 105 includes software and/or electronic circuit components such as a pulse generator 120 that generates an electrical signal to deliver electrical stimulation to a nerve.
  • the neurostimulator 105 is a TENS device that is integrated or attached to a garment (e.g., underwear) or pad worn by a patient at a location remote from or near to the nerve and is configured to deliver the signal to the nerve via one or more electrodes 125.
  • the garment or pad may be structured to position the one or more electrodes 125 in the perineal region, sacral region, or in other locations of the patient’s body depending on a particular treatment.
  • the neuromodulation system 100 may be used to treat nocturnal enuresis by stimulation of the pelvic floor at the time of the enuresis event; treat stress incontinence by contraction of the pelvic floor at the time of the enuresis event; and/or treat sexual dysfunction by contraction of the pelvic floor.
  • the neuromodulation system 100 may be used to strengthen the perineal or perivaginal muscles of the end user by means of contractions.
  • the stimulation of the innervation of the perineal or perivaginal muscles may be used to cause contraction of the external urethral sphincter.
  • At least some of the treatments may involve causing cerebral stimulation by the pelvic innervation that goes through the medulla to higher nerve centers, and may cause neuroplasticity.
  • At least some of the treatments may result in conditioning a user to control urination and/or defecation on their own during the day.
  • At least some of the treatments may result in conditioning the user to control urination and/or defecation on their own during sleep (day or night).
  • At least some of the treatments may result in preventing urinary
  • the one or more electrodes 125 are exposed on a surface of the garment or pad such that the one or more electrodes 125 are placed in contact with the end user’s skin in the region selected depending on the treatment. In other embodiments, the one or more electrodes 125 are embedded within the garment or pad such that the one or more electrodes 125 are not placed in direct contact with the end user’s skin in the region selected depending on the treatment. Additionally or alternatively, the one or more electrodes 125 are intracavitary electrodes and may be placed in the urethra, vagina or anus of the end user depending on the particular treatment.
  • the optional one or more sensors 110 may include software and/or electronic circuit components that sense moisture or humidity. Additionally or alternatively, the one or more sensors 110 may include software and/or electronic circuit components that sense nerve responses to the stimulation.
  • the nerve responses may include muscle contractions, enuresis- based parameter changes (e.g., preventing the flow of urine or allowing the flow of urine), bowel movement parameter changes (e.g., induced defecation), sexual dysfunction parameter changes (e.g., increased blood pressure in the perineal region), or a combination thereof.
  • the one or more sensors 110 may include software and/or electronic circuit components that sense patient discomfort or sensitivity level to the neurostimulation.
  • the one or more sensors 110 are integrated or attached to a garment (e.g., underwear) or pad worn by a patient at a location remote from or near to the nerve and are configured to receive signal(s) indicative of one or more of: (i) humidity or moisture, (ii) the nerve responses, and (iii) the patient discomfort or sensitivity level to the neurostimulation.
  • the one or more sensors may be located at other locations external to the patient (e.g., around their leg) and/or may be placed in a cavity of the end user.
  • the controller 115 includes software and/or electronic circuit components that: (i) receive, determine, sense, and/or record nerve responses and sensitivity level of the end user via the one or more sensors 110 and/or one or more user interfaces 130 of the neurostimulator 110 or client device(s) 135, (ii) control stimulation parameters of the neurostimulator 105 (e.g., control stimulation parameters based on feedback from desired or adverse effects determined via nerve responses and sensitivity level), and (iii) cause delivery of the stimulation via the neurostimulator 105 and one or more electrodes 125.
  • control stimulation parameters of the neurostimulator 105 e.g., control stimulation parameters based on feedback from desired or adverse effects determined via nerve responses and sensitivity level
  • cause delivery of the stimulation via the neurostimulator 105 and one or more electrodes 125.
  • the nerve responses and/or the sensitivity level may be automatically sensed using the optional one or more sensors 110, or the nerve responses and/or the sensitivity level may be physically sensed by the user and supplied to the control 115 via one or more interfaces 130.
  • the controller 115 is a part of the neurostimulator 105 and is in communication with the pulse generator 120 and the one or more sensors 110 via a wired or wireless connection.
  • the controller 115 is also part of client device(s) 135 and is in communication with the pulse generator 120 and the one or more sensors 110 via a network 140 (e.g., a wireless connection such as Bluetooth).
  • the controller 115 may have at least two parts.
  • a first part is part of the neurostimulator 105 and is in communication with the pulse generator 120 of the neurostimulator 105 and the one or more sensors 110 via a wired or wireless connection.
  • a second part is remote from the neurostimulator 105 (e.g., implemented as part of an external programmer or application on a client device 135 such as an end user’s cell phone) and is in communication with the first part.
  • the neurostimulator 105, optional one or more sensors 110, and controller 115 are described herein as a self-contained system integrated at least partially into a garment or pad worn by an end user with respect to several described embodiments, it should be understood that various systems and arrangements comprising the neurostimulator 105, optional one or more sensors 110, and controller 115 are contemplated without departing from the spirit and scope of the present disclosure.
  • the neuromodulation system 100 may include the neurostimulator 105, one or more sensors 110, and controller 115 within a distributed
  • the neurostimulator 105 may be in communication via one or more sensors 110, and controller 115 .
  • the neurostimulator 105 may be in communication via one or more sensors 110, and controller 115 .
  • communication networks 140 examples include, without restriction, the Internet, a wide area network (WAN), a local area network (LAN), an Ethernet network, a public or private network, a wired network, a wireless network (e.g., WiFi or
  • FIG. 2A shows a neuromodulation system 200 in accordance with some aspects.
  • the neuromodulation system 200 includes a neurostimulator 205 (e.g., a neurostimulator 105 as described with respect to FIG. 1), optionally one or more sensors 210 (e.g., one or more sensors 110 as described with respect to FIG. 1), a controller 215 (e.g., a controller 115 as described with respect to FIG. 1), and one or more electrodes 220 integrated with a garment or pad 225 to be worn by an end user.
  • the neurostimulator 205, the sensors 210 and the electrodes 220 may be embedded and fixed within the garment or pad 225.
  • the hardware needed for treatment may be concealed by the garment or pad 225.
  • some or all of the hardware may be printed on or otherwise incorporated into a flexible plastic construct (e.g., polyimide with an overmold of silicon) that is housed in the garment or pad 225.
  • the neurostimulator 205 is attached to the garment or pad 225 (FIG. 2 A shows the pad and FIG. 2B shows the garment) using one or more snaps 230, and the electrodes 220 are attached to the garment or pad 225 using one or more snaps 235.
  • the neurostimulator 205 and the electrodes 220 are attached to the garment or pad 225 using other means of attachment such as a pocket, adhesive, Velcro, etc.
  • the neurostimulator 205, the sensors 210, controller 215, and the electrodes 220 are in wired 240 or wireless communication with one another to implement the operations described in further detail herein.
  • the garment or pad 225 may be structured to position the electrode(s) 220 in or near a region of the end user’s body (e.g., the sacral region or an intracavitary region) depending on the particular treatment.
  • the electrodes 220 are positioned on an inside surface of the garment or pad 225, as shown in FIGS. 2A, 2B, 2C, and 2D.
  • the electrodes 220 are placed in an area of the garment or pad 225 that is midline, bilaterally, or unilaterally in the distribution of a target nerve such as the pudendal nerve, which, as shown in FIGS. 2E, 2F, and 2G, is located bilaterally but converges in the midline.
  • midline electrode locations may stimulate both nerves, although unilateral or bilateral stimulation may also be effective. In other embodiments (for the same or other treatment), other nerves may be targeted for stimulation.
  • the garment or pad 225 may be similar to panty-liners, panties, or underwear that has the purpose of neurostimulation in accordance with various embodiments described herein.
  • the garment or pad 225 may be fabricated of various types of fabric or polymers such as cotton, linen, polyester, polyurethane, polyimide, silicone, or the like and various combinations thereof, and the electrodes 220
  • the electrodes 220 may be formed of a conductive material such as a copper, silver, gold, platinum, stainless steel, nickel-cobalt base alloy, platinum-iridium alloy, brass, bronze, aluminum, etc., and take the form of probe electrodes, linear electrodes, paddle electrodes, pad electrodes, and the like, for example.
  • the electrodes 220 may be any size or any shape, as well as disposable or reusable.
  • the sensors 210 comprise a moisture or humidity sensor to measure the release of urine or wetting of the garment or pad 225.
  • the sensors 210 comprise a nerve response sensor placed around, within or adjacent to a region where a nerve response is to be measured.
  • a force-sensitive resistor (FSR) or a piezoresistive pressure sensor may be used to measure the contraction of a muscle in response to FSR
  • the sensors 210 comprise a sensitivity level sensor.
  • an electroencephalography sensor may be used to measure the pain or discomfort that an end user is having before, during, and after the neurostimulation. While the sensors 210 have been described at some length and with some particularity with respect to several described embodiments, it is not intended that the sensors be limited to any such particular technology or particular embodiment. Instead, it should be understood that the described embodiments are provided as examples of sensors, and the sensors 210 are to be construed with the broadest sense to include variations of sensors listed above, as well as other variations that are well known to those of ordinary skill in the art.
  • the neurostimulator 205 may be a TENS device having a housing 245, a power source 250, an antenna 255, an electronics module 260 (e.g., a computing system), and an indicator such as a light emitting diode (LED), alarm, or interface notice 265.
  • the housing 245 may be comprised of materials that are biocompatible such as bioplastics, bioceramics or bioglasses for radio frequency transparency, metals such as aluminum or titanium, and/or plastics such as polyimide or polyurethane.
  • the size and shape of the housing 245 are selected such that the neurostimulator 205 can be integrated with the garment or pad 225.
  • the power source 250 may be within the housing 245 and connected (e.g., electrically connected) to the electronics module 260 to power and operate the components of the electronics module 260. In some embodiments, the power source 250 is rechargeable.
  • the antenna 255 may be connected (e.g., electrically connected) to the electronics module 260 for wireless
  • the electronics module 260 may be connected (e.g., electrically connected) to a feedthrough 270, which is connectable (e.g., via snap 230) to wires 240 that terminate at the sensors 210, electrodes 220, and optionally a ground 275 such that the electronics module 245 is able to receive a signal from the sensors 210 or apply a signal or electrical current to electrodes 220.
  • the alarm 265 may be in the neurostimulator 205 and/or in another pre-established communication device such as an external programmer 280 (e.g., an external computing device of an end user or a care giver).
  • the electronics module 260 is a printed circuit board in combination with discrete and/or integrated electronic circuit components such as application specific integrated circuits (ASICs).
  • the electronics module 260 can be remotely accessed through the external programmer 280.
  • the external programmer 280 may comprise at least a portion of the controller 215.
  • the external programmer 280 can be used by the end user or a healthcare professional to: (i) turn on and off the neurostimulator 105, (ii) check and program the electronics module 260 via an interface after deployment with an end user, (iii) input sensory data via an interface such as whether the end user had a muscle contraction or a current sensitivity level of the end user, and (iv) input or adjust stimulation parameters via an interface during a stimulation process, e.g., providing an initial set of the stimulation parameters.
  • the external programmer 280 may communicate with the electronics module 260 via wired or wireless communication methods, such as, e.g., wireless transmission.
  • wireless communication such as Bluetooth permits a device devoid of an interface
  • this configuration may increase safety of the TENS device by not allowing an end user such as a child to purposefully manipulate the TENS device or inadvertently manipulate the TENS device while they sleep.
  • an interface on the TENS device may be optional for when external programming (e.g., Bluetooth) is not utilized.
  • the interface on the TENS device may be configured to allow the same functionality provided via the external programmer 280. Morevoer, wireless functionality may be used to send alerts to the external programmer 280 or computing device (e.g., a parent’s cell phone) in response to enuresis events or other detected or occurring events.
  • the electronics module 300 (i.e.., the electronics module 260 discussed with respect to FIG. 2A) includes discrete and/or integrated electronic circuit components that implement analog and/or digital circuits capable of producing the functions attributed to the neuromodulation devices or systems described herein.
  • the electronics module 300 includes an electro-stimulator or pulse generator 305 that generates a signal to deliver stimulation to a nerve via the one or more electrodes, at least a portion of the controller 310 that comprises one or more processors and interfaces, drive circuits 315 for interfaces and driving indicators such as LEDs, interface notices, or alarms, a communications module 320 for wired or wireless communication, a clock module 325 that maintains real time for processing, battery life, and time stamps, a battery module 330 for maintaining state of the power source, signaling circuitry 335 for receiving feedback from the one or more sensors, and a memory 340 with program instructions operable on by the pulse generator 305 and the controller 310 to perform one or more processes described herein.
  • the controller 310 that comprises one or more processors and interfaces, drive circuits 315 for interfaces and driving indicators such as LEDs, interface notices, or alarms, a communications module 320 for wired or wireless communication, a clock module 325 that maintains real time for processing, battery life, and time stamp
  • the pulse generator 305 may be configured to set or adjust one or more stimulation parameters based on commands from the controller 310.
  • stimulation parameters include frequency, intensity, duration, and waveform.
  • neural stimulation is delivered via the pulse generator 305 in a stimulation burst, which is a train of stimulation pulses programmed with any combination of frequency, intensity, duration, and waveform.
  • Stimulation bursts can be characterized by burst durations and burst intervals. Burst duration is the length of time that a burst lasts. Burst interval can be identified by the time between the start of successive bursts.
  • the pattern of bursts can include any combination of burst durations and burst intervals.
  • a simple burst pattern with one burst duration and burst interval can continue periodically for a programmed period or can follow a more complicated schedule.
  • the programmed pattern of bursts can be composed of multiple burst durations and burst interval sequences.
  • the programmed pattern of bursts can be characterized by a duty cycle, which refers to a repeating cycle of neural stimulation ON for a fixed time and neural stimulation OFF for a fixed time.
  • Pulse intensity may be classified as three levels depending on the nerve response of the patient; sensory, motor, microcurrent level.
  • Sensory level or low intensity is defined as the amplitude of the pulse making the patient feel a comfortable paresthesia like tingling or tapping sensation without any motor contraction.
  • Motor level or high intensity is defined as the amplitude of the pulse producing a motor contraction with or without paresthesia.
  • Microcurrent level uses a current that is very similar to the body’s own current (e.g., 1-60 mA/cm). When microcurrent level therapy is used, the natural current to the tissues restores, which in turn restores the cells, own natural energy flow. In contrast to the sensory level and the motor level, the patient will feel no stings, throbbing or any other discomfort.
  • the pulse intensity or amplitude of the pulse is set to motor level or high intensity to strengthen muscles and muscular re-education. Because various embodiments employ motor level intensities, not only are the muscle contraction monitored but also the current pain level caused by the stimulation in order to actively adjust one or more stimulation parameters (e.g., amplitude or intensity of the pulse) during the stimulation process. In some instances, the intensity is set between 0 mA to approximately 35 mA, for example between 5 mA to approximately 20 mA.
  • Pulse frequency of the electrical current may be classified as high frequency (>50 Hz), low frequency ( ⁇ 10 Hz), and burst (bursts of high frequency current applied at a much lower frequency).
  • the frequency may be adjusted between 5 Hz and 150 Hz.
  • higher frequencies are used, for example, between about 50 Hz and about 100 Hz.
  • Pulse duration is the interval between the time, during the first transition, that the amplitude of the pulse reaches a specified fraction of its final amplitude, and the time the pulse amplitude drops, on the last transition, to the same level.
  • the pulse duration may be varied from about 40 to 1000 micro seconds (ps), for example between about 40 and about 250 ps or between about 450 and about 850 ps.
  • the terms“substantially,” “approximately” and“about” are defined as being largely but not necessarily wholly what is specified (and include wholly what is specified) as understood by one of ordinary skill in the art.
  • the term“substantially,”“approximately,” or“about” may be substituted with“within [a percentage] of’ what is specified, where the percentage includes 0.1, 1, 5, and 10 percent.
  • the various waveforms used in the neurostimulation may be designed to target specific areas of the body and to provide customized forms of energy transfer. This variance in energy transfer helps address diverse therapy needs, e.g., enuresis, sexual dysfunction, pain, etc.
  • the waveform signal may vary from monophasic current (unidirectional) or biphasic current (bidirectional) and have several formats, with variable repetition rates (frequency) from 5 Hz to 150 Hz, variable pulse widths (duration) from 100 to 1000 ps, with an adjustable current intensity between 0 mA to approximately 35 mA.
  • Monophasic current refers to a single phase, or pulse, of intensity followed by a period of rest. This type of stimulation is typically used in pain management but may be used to generate a motor response. Biphasic current refers to two phases, or pulses, of two different intensities alternating with each other during treatment. Biphasic current is considered the most versatile of the stimulation therapy waveforms because the amplitude (intensity), stimulation (voltage), current, and duration may be controlled for each phase or pulse. With its versatility and effectiveness, biphasic current stimulation can be used to strengthen muscles, muscular re- education, increase circulation, and decrease swelling.
  • the pulse generator 305 may be configured to emit a particular waveform signal selected from a number of preset waveform signals of various characteristics. For instance, in one embodiment, a user may cycle through several preset waveforms of increasing current intensities (e.g., levels 1 through 5) until a minimum current intensity is reached that will achieve a nerve response such as a muscle contraction.
  • these preset or other generated waveforms may be based on Russian current waveforms on other waveforms not previously employed for the enuresis and pelvic floor treatments.
  • the Russian current waveform is a type of electrical stimulation that delivers medium frequency current in alternating pulses or bursts of energy. This type of stimulation generates a motor response which can be used to strengthen muscles and muscular re-education.
  • Interferential current may be used to address chronic, post-surgical and post-trauma acute pain in patients.
  • Premodulated current is similar in its benefits and ease of use for patients as interferential current. The main difference between the two is how the current is delivered to the patient’s muscle tissue. With premodulated current, a single channel is used to mix the frequencies prior to delivery of the current through the electrode of the body (using two electrodes rather than four). This is beneficial when treating areas of the body that have less space available for electrode placement.
  • the controller 310 includes one or more processors and interfaces to perform instructions embedded in the memory 340 to perform functions associated with the neural stimulation therapy, such as performing neural stimulation based on a stimulation schedule stored in the memory 340 and/or based on feedback received via the interfaces and/or the sensors.
  • the controller 310 is in communication with the pulse generator 305 and the one or more sensors via the signaling circuitry 335.
  • the controller 310 may be configured to perform functions associated with the neural stimulation therapy including determining a presence of moisture above a set threshold using a moisture sensor; based on the determined presence of moisture, delivering neural stimulation using the pulse generator 305 and the one or more electrodes based on a first set of stimulation parameters to a nerve, monitoring a response to the neural stimulation that includes: (i) monitoring, using one or more sensors and/or interface input, responses of the nerve, (ii) monitoring, using one or more sensors and/or interface input, a sensitivity level of the patient, or (iii) monitoring a combination of responses of the nerve and a sensitivity level of the patient, modifying, using the one or more processors, the first set of the stimulation parameters based one or more of the responses of the nerve and the sensitivity level of the patient to create a second set of stimulation parameters, determining a presence of moisture above the set threshold using the one or more sensors, and based on the determined presence of moisture, delivering, using the pulse generator 305 and the one or more electrodes, the
  • the memory 340 may be a non-transitory machine readable storage medium having instructions stored thereon that when executed by a processor (e.g., a processor of the controller 310) causes the processor to perform one or more operations such as generation of a signal or electric current based on one or more stimulation parameters.
  • the memory 340 may store operating records, pre-established waveforms and parameters for neurostimulation signals, sets or parameters currently being used by the controller 310, and operating instructions. In some embodiments, the operating records, pre-established waveforms and parameters for
  • the operating records include a record of medial events (e.g., a record of each enuresis event detected by the neuromodulation system) and therapy provided in response to the medical event (e.g., the stimulation signal used with parameters).
  • the operating records may be time stamped and may be communicated via communications module 320 to an external device such as the external programmer, a health care providers computing device, or a distributed environment system (e.g., a cloud).
  • the operating records may be accessed by a user interacting with one or more interfaces of the neurostimulator, the external programmer, or other computing device.
  • the memory 340 includes instructions operable on by the controller 310 to cause the on-demand stimulation therapy, receive therapy feedback and modify the therapy based on the feedback.
  • the modification may include gradually increasing or decreasing the intensity of the neural stimulation signal to a desired or target therapeutic level while taking into consideration nerve response and sensitivity level of the patient.
  • the memory 340 includes instructions operable on by the controller 310 to control titration of the therapy.
  • the neural stimulation signal may be delivered using different combinations of stimulation parameters and the effects of the stimulation (e.g., the desired physiological effects and/or adverse physiological effects such as absence of muscle contraction or increased pain) are evaluated for the different parameter combinations to determine an optimal set or combination of stimulation parameters that provide the desired therapeutic effect while minimizing or preventing adverse physiological effects.
  • the memory includes instructions operable on by the controller to adjust or select a combination of stimulation parameters that is determined to be effective at generating a desired nerve response while using feedback from sensitivity level to improve therapy and minimize or prevent adverse physiological effects.
  • FIGS. 4-6 depict simplified flowcharts depicting processing performed for delivering neuromodulation according to various embodiments.
  • the flowcharts of FIGS. 4- 6 illustrate the architecture, functionality, and operation of possible implementations of systems, methods, and computer program products according to various embodiments.
  • each block in the flowchart or block diagrams may represent a module, segment, or portion of code, which comprises one or more executable instructions for implementing the specified logical functions.
  • the functions noted in the block may occur out of the order noted in the figures. For example, two blocks shown in succession may, in fact, be executed substantially concurrently, or the blocks may sometimes be executed in the reverse order, depending upon the functionality involved.
  • FIG. 4 depicts a simplified flowchart 400 illustrating a titration process used to gradually increase stimulation intensity to a desired therapeutic level.
  • a desired therapeutic level may be defined based on a composite target intensity level comprising one or more of the following: a target level for one or more of the stimulation parameters and a target physiological effect.
  • the titration process gradually increases stimulation intensity within a tolerable level and maintains that intensity for a period of time to permit the patient to adjust to each increase in intensity, thereby gradually increasing the stimulation intensity towards a desired physiological effect while monitoring for patient discomfort. The titration process continues until adequate adaptation is achieved.
  • adequate adaptation includes achieving one or more of the following objectives: a target intensity level, a target physiological effect, and a tolerable discomfort or sensitivity level. As will be described in greater detail below, adequate adaptation may be determined based on a composite threshold comprising one or more of the following: an acceptable level for discomfort, a target intensity level for one or more stimulation parameters, and a target physiological effect (e.g., muscle contraction).
  • the titration process is automated and is executed by the TENS device without manual adjustment of the stimulation intensity by the patient or health care provider. In other embodiments, the titration process is manual and is executed by an end user or healthcare professional via an interface of an external programmer or the TENS device.
  • a neuromodulation system (e.g., neuromodulation system 100 or 200 described with respect to FIGS. 1 and 2) including a neurostimulator is provided for an end user (i.e., a patient).
  • the neurostimulator is incorporated into a wearable garment or pad.
  • one or more electrodes are positioned within the garment or pad such that, when the patient wears the garment or pad, the one or more electrodes will be in contact with a region of the body comprising a target nerve such as the pudendal nerve.
  • a stimulation therapy process is initiated.
  • the stimulation therapy process may be initiated based on a triggering event such as detection of enuresis, or in response to other types of input (e.g., detection of a muscle contraction or a user interaction with an interface).
  • a triggering event such as detection of enuresis, or in response to other types of input (e.g., detection of a muscle contraction or a user interaction with an interface).
  • the triggering event could be automated and executed based on a predetermined schedule to titrate therapy or provide therapy such as in the instance of managing chronic pain or constipation.
  • Initiation of the stimulation therapy may include obtaining or generating an initial set of stimulation parameters and providing stimulation to the patient using the initial set of stimulation parameters.
  • the initial set of stimulation parameters may comprise one or more of frequency, intensity (amplitude), duration, and waveform.
  • the various initial parameter settings may vary, but may be selected so that one or more of the parameters are set at levels below a predefined target parameter set level, such that the titration process is used to gradually increase the intensity parameters to achieve adequate adaptation.
  • the initial frequency and initial waveform configuration are set at target levels or configurations, while the initial intensity and the initial duration are set below their respective target levels.
  • initial waveform is set at a target level or configuration, while the initial frequency, the initial intensity, and the initial duration are set below their respective target levels.
  • stimulation therapy is provided using the initial set of stimulation parameters and titrated by setting or adjusting the stimulation parameters using a titration schedule to obtain or generate subsequent sets of stimulation parameters with the goal of achieving adequate adaptation.
  • the titration process includes delivering stimulation using a neurostimulator based on a set of stimulation parameters, monitoring a response to the stimulation that includes monitoring of nerve responses, sensitivity level changes, or a combination thereof, modifying one or more of the stimulation parameters based on a titration schedule, the nerve responses, and/or the sensitivity level changes to create a subsequent set of stimulation parameters, and delivering the neural stimulation using the neurostimulator based on the subsequent set of stimulation parameters. This process may be repeated until adequate adaptation is achieved.
  • adequate adaptation includes achieving one or more of the following objectives: acceptable levels for the tolerable discomfort or sensitivity level, a target intensity level for one or more stimulation parameters, and a target physiological effect.
  • acceptable levels for the tolerable discomfort or sensitivity level e.g., a target intensity level for one or more stimulation parameters
  • a target physiological effect e.g., a target physiological effect
  • FIG. 5 depicts a simplified flowchart 500 illustrating a detailed titration process used to gradually increase stimulation intensity to a desired therapeutic level.
  • titration sessions are automatically initiated by the neuromodulation system or initiated by the patient without requiring any intervention by the health care provider. This can eliminate the need for the patient to schedule a subsequent visit to the health care provider, thereby potentially reducing the total amount of time needed for the titration process to complete.
  • the neuromodulation system includes one or more sensors, e.g., a humidity sensor, a nerve response sensor, and a sensitive level sensor, that communicates with the
  • the neuromodulation system's control system to enable the control system to detect a triggering event and/or the patient's physiological response to the titration and automatically make adjustments to the titration processes described herein with limited or no inputs from the patient or health care provider.
  • the monitored signals can also enable the control system to detect when the target physiological effect has been achieved and conclude the titration process.
  • the neuromodulation system could in addition or alternatively include a patient control input via an interface to permit the patient to communicate to the control system that a triggering event has occurred, a nerve response has occurred, and/or an acceptable sensitivity level has been exceeded.
  • the neuromodulation system may be configured to wait a period of time after completing one session before initiating the next session. This period of time may be
  • predetermined e.g., two or three days, or programmable.
  • the neuromodulation system is configured to obtain or generate a set of stimulation parameters. For example, in some embodiments, when initiating an initial titration session (e.g., step 410 as described with respect to FIG. 4), the neuromodulation system is configured to obtain or generate an initial set of stimulation parameters to initialize the stimulation therapy. In other embodiments, when executing a subsequent titration session (e.g., a maintenance titration session), the neurostimulator is configured to obtain or generate a set of stimulation parameters based on the previously determined therapeutic set of stimulation parameters (e.g., step 420 as described with respect to FIG. 4). [0089] Optionally at step 510, the neuromodulation system monitors for input indicative of a triggering event.
  • the neuromodulation system monitors for input from a humidity or moisture sensor indicative of an enuresis or defecation event. In other embodiments, the neuromodulation system monitors for input based on a predetermined schedule.
  • the neuromodulation system determines whether a triggering event occurred. Upon the triggering even occurring, proceed to step 520. Upon no triggering event, the process may return to monitoring at step 510.
  • the neuromodulation system delivers stimulation to the patient using the set of stimulation parameters (e.g., a first set of stimulation parameters). If this were the first titration session, then the stimulation would be delivered with the initial set of stimulation parameters described above with respect to step 410. If this were a subsequent titration session, then the stimulation intensity would remain at the same level at the conclusion of the previous titration session described above with respect to step 420 of FIG. 4.
  • the stimulation is a stimulation signal or electrical current.
  • the neuromodulation system monitors a nerve response (e.g., muscle contraction) and sensitivity level using one or more sensors (e.g., sensors 210 described with respect to FIG. 2A).
  • the neuromodulation system determines whether the stimulation provided using the set of stimulation parameters had an adverse physiological effect on the patient (e.g., raised the discomfort or sensitivity level of the patient).
  • the determining includes the neuromodulation system obtaining a current discomfort or sensitivity level of the patient and comparing the discomfort or sensitivity level to one or more predetermined thresholds (e.g., the threshold may be set by the healthcare professional or the patient) to determine whether the stimulation had an adverse physiological effect (e.g., the discomfort felt by the stimulation exceeded a pain threshold for the patient).
  • the threshold may be set by the healthcare professional or the patient
  • the process proceeds to step 535.
  • the process proceeds to step 540.
  • the neuromodulation system may be configured to wait a period of time after delivering the stimulation at step 520 before determining whether the stimulation did not have an adverse physiological effect and proceeding to step 540. This period of time may be predetermined, e.g., two or three days, or programmable at which time the neuromodulation system continues to monitor the patient for an adverse physiological effect.
  • baseline values for discomfort or sensitivity may be determined and recorded for a patient. Once neural stimulation begins on the patient, the values obtained for discomfort or sensitivity may be compared respectively to the baseline values for discomfort or sensitivity to determine the extent of change in the patient’s discomfort or sensitivity. The determined extent of change may then be compared to
  • predetermined threshold values set for discomfort or sensitivity e.g., threshold values that may be indicative of an adverse physiological effect
  • one or more of the stimulation parameters is modified to bring the adverse physiological effect within acceptable levels or achieve a target physiological effect.
  • one or more of the stimulation parameters is modified (e.g., using the one or more processors) based on the responses of the nerve and/or the discomfort or sensitivity level of the patient to create a modified set of stimulation parameters (e.g., a second set of stimulation parameters).
  • a modified set of stimulation parameters e.g., a second set of stimulation parameters.
  • one or more of the frequency, intensity (amplitude), duration, and waveform is changed to bring the adverse physiological effect within acceptable levels.
  • the changes in the parameter settings may vary, but may be selected so that one or more of the parameters are set at levels below previously set levels, such that the adverse physiological effect is minimized or prevented.
  • step 520 to deliver stimulation to the patient using the modified set of stimulation parameters and monitor nerve responses and the discomfort or sensitivity level of the patient to determine whether the stimulation provided using the modified set of stimulation parameters achieved a target physiological effect and/or still had an adverse physiological effect on the patient.
  • the neuromodulation system determines whether the stimulation provided using the set of stimulation parameters achieved a target physiological effect on the patient (e.g., caused a muscle to contract).
  • the determining includes the neuromodulation system obtaining a current nerve response level of the patient (e.g., sensory, motor, microcurrent level) and comparing the current nerve response level to one or more predetermined thresholds (e.g., the threshold may be set by the healthcare professional or the patient) to determine whether the stimulation had a target physiological effect (e.g., muscle contraction).
  • the process proceeds to step 545.
  • the process proceeds to step 535.
  • the neuromodulation system may be configured to wait a period of time after delivering the stimulation at step 520 before
  • This period of time may be predetermined, e.g., one or two minutes, or
  • the neuromodulation system continues to monitor the patient for a target physiological effect.
  • the neuromodulation system delivers stimulation to the patient using the set of stimulation parameters during the remainder of stimulation therapy, as further described herein with respect to FIG. 6.
  • FIG. 6 depicts a simplified flowchart 600 illustrating a process used to provide a therapeutic level of neural stimulation to achieve a desired or target physiological effect during a remainder of stimulation therapy while minimizing or preventing an adverse physiological effect.
  • the remainder of stimulation therapy is automatically performed by the neuromodulation system without requiring any intervention by the patient or health care provider. This can eliminate the need for the patient to schedule a subsequent visit to the health care provider, thereby potentially reducing prolong adverse physiological effects suffered by a patient.
  • the neuromodulation system includes one or more sensors, e.g., a humidity sensor, a nerve response sensor, and a sensitive level sensor, that communicates with the neuromodulation system's control system to enable the control system to detect a triggering event and/or the patient's physiological response to the therapy and automatically make adjustments to the therapy processes described herein with limited or no inputs from the patient or health care provider.
  • the monitored signals can also enable the control system to detect when the target physiological effect has been achieved.
  • the neuromodulation system could in addition or alternatively include a patient control input via an interface to permit the patient to communicate to the control system that a triggering event has occurred, a nerve response has occurred, and/or an acceptable sensitivity level has been exceeded.
  • the neuromodulation system may be configured to wait a period of time after completing one session before initiating the next session. This period of time may be predetermined, e.g., two or three days, or programmable.
  • the neuromodulation system monitors for input indicative of a triggering event.
  • the neuromodulation system monitors for input from a humidity or moisture sensor indicative of an enuresis or defecation event. In other embodiments, the neuromodulation system monitors for input based on a predetermined schedule.
  • the neuromodulation system determines whether a triggering event occurred. Upon the triggering even occurring, proceed to step 615. Upon no triggering event, the process may return to monitoring at step 605.
  • the process may return to monitoring at step 605.
  • the triggering event upon occurrence of the triggering event, the
  • the neuromodulation system delivers stimulation to the patient using the set of stimulation parameters.
  • the set of stimulation parameters are the set of stimulation parameters determined at step 415 or step 535 of FIGS. 4 and 5, respectively, that has achieved adequate adaptation.
  • the stimulation is a stimulation signal or electrical current.
  • the neuromodulation system may provide an alarm to the user that the triggering event has occurred. For example, an indicator such as an audible alarm or light may be activated.
  • the neuromodulation system monitors a nerve response (e.g., muscle contraction) and sensitivity level using one or more sensors (e.g., sensors 210 described with respect to FIG. 2A).
  • the neuromodulation system determines whether the stimulation provided using the set of stimulation parameters had zero or minimal physiological effect, failed to achieve a target physiological effect, and/or had an adverse physiological effect on the patient.
  • the determining includes the neuromodulation system obtaining a current nerve response level of the patient (e.g., sensory, motor, microcurrent level) and comparing the current nerve response level to one or more predetermined thresholds (e.g., the threshold may be set by the healthcare professional or the patient) to determine whether the stimulation had a target adverse physiological effect (e.g., muscle contraction).
  • the determining further includes the neuromodulation system obtaining a current discomfort or sensitivity level of the patient and comparing the discomfort or sensitivity level to one or more predetermined thresholds (e.g., the threshold may be set by the healthcare professional or the patient) to determine whether the stimulation had an adverse physiological effect (e.g., the discomfort felt by the stimulation exceeded a pain threshold for the patient).
  • the process proceeds to step 640.
  • the neuromodulation system may be configured to wait a period of time after delivering the stimulation at step 610 before determining whether the stimulation did not have an adverse physiological effect and proceeding to step 605. This period of time may be predetermined, e.g., two or three days, or programmable at which time the neuromodulation system continues to monitor the patient for an adverse physiological effect.
  • one or more of the stimulation parameters is modified to achieve a target physiological effect and have no adverse physiological effect on the patient.
  • one or more of the stimulation parameters is modified (e.g., using the one or more processors) based on the responses of the nerve and/or the discomfort or sensitivity level of the patient to create a new set of stimulation parameters.
  • one or more of the frequencies, intensity (amplitude), duration, and waveform is changed to achieve a target physiological effect and have no adverse physiological effect on the patient.
  • the changes in the parameter settings may vary, but may be selected so that one or more of the parameters are set at levels above or below previously set levels, such that a target physiological effect is achieved without an adverse physiological effect on the patient.
  • the electrodes that will allow conduction of electric current to the skin may be superficial and may be placed in the perineal region.
  • the humidity sensor is not only used to warn that urinary loss is occurring, but to activate the electrostimulator and interrupt urination.
  • the user does not urinate in bed at all since the brain is "taught" when the bladder contracts.
  • the contraction of the perineal musculature by the device causes a cerebral (brain center) stimulus by the pelvic innervation that goes through the spinal cord to higher nervous centers within the brain.
  • the individual becomes conditioned and self-controls micturition during sleep, unconsciously.
  • the treatment has the great advantage over all the devices currently used, which is to prevent nighttime incontinence while brain conditioning is occurring
  • the sensing threshold may not be reached, only the motor (muscle contraction) threshold.
  • the user can utilize the device at home without the need of a health professional to calibrate it, and the intensity of the device does not need to be raised to a point where the user senses discomfort. As a result, the discomfort that could lead the user to give up the method for fear that they would feel it again during the enuresis episode, would be curtailed.
  • the user can attach the electrode(s) to their body and activate a calibration function of the TENS unit or otherwise adjust the output of the unit from a minimal / zero setting upwardly until the user senses a muscle contraction, which should be well below a pain or other sensory threshold.
  • the current frequency and electrical waveform conformation are modified so that there is no need for mandatory calibration by a professional. This is because, at least in this example, only the motor muscle contraction frequency, not the sensitivity threshold (e.g. a pain or discomfort threshold) perceived by the user, is reached. There will, however, be different levels of intensity that best apply to the individual user. With this intensity of current the perineal muscles contract, occluding the urethra, inhibiting the bladder contraction by reflex, thus preventing urinary loss.
  • the TENS unit generates an alternating Russian waveform to stimulate muscle contraction.
  • the system will include a sound or visual alarm as an option, but is not required.
  • the humidity sensor is not only used to warn that urinary loss is occurring, but to activate the electrostimulator and interrupt urination. In this way, the user does not urinate in bed at all since the brain is "taught" when the bladder contracts.
  • the contraction of the perineal musculature by the device causes a cerebral (brain center) stimulus by the pelvic innervation that goes through the spinal cord to higher nervous centers within the brain. Over time, the individual becomes conditioned and self-controls micturition during sleep, unconsciously.
  • the treatment prevents nighttime incontinence while brain conditioning is occurring.
  • Table 1. illustrates differences between one embodiment of the present neuromodulation system and current standards for treatment of enuresis.
  • the systems, devices, and methods described above for addressing night wetting may be used to address daytime incontinence. That is, a humidity sensor that when detecting the presence of urine will activate an electrical circuit that, without pain, will contract the perineal musculature, and urination is interrupted. This offers some benefits: 1) It will keep the user dry during the day and at night; 2) The brain will be trained in the moment of incontinence, promoting neuroplasticity; 3) The prescriber of the device and user can measure the frequency of incontinence during the day (i.e. keep a diary); 4) Strengthen the perineal musculature through contractions.
  • the current system may be used to both (1) acting to stop urinary incontinence by means of muscle contraction in response to urine loss or (2) as a method of exercising the pelvic floor muscles to improve proprioception and pelvic floor strength (e.g. Kegel excercises).
  • This "exercise" of the pelvic floor musculature through perineal contractions also lends itself to the treatment of bowel and sexual dysfunction, as discussed herein.
  • Urinary incontinence due to problems in the urethral musculature can be treated by means of reinforcement of this musculature.
  • This reinforcement can be performed by means of electrostimulation. This is done by means of intracavitary electrodes, in the urethra, vagina or anus, or surface electrodes.
  • intracavitary electrodes in the urethra, vagina or anus, or surface electrodes.
  • adhesive-shaped electrodes are used.
  • a humidity sensor is not necessary, and a prescription or schedule for treatment (e.g. an“on” /“off’ schedule) can be programed into the TENS unit, either by a medical profession or by the user (preferably following a medical professional or other authority’s suggested schedule).
  • FSD Female sexual dysfunction
  • FSD is a prevalent problem, afflicting approximately 40% of women and there are few treatment options.
  • FSD is more typical as women age and is a progressive and widespread condition.
  • Common symptoms associated with FSD include diminished vaginal lubrication, pain and discomfort upon intercourse, decreased sense of arousal and difficulty in achieving orgasm. Only a small percentage of women seek medical attention.
  • the stimulation action may be direct to the perineal and perivaginal musculature, causing contraction and gain of proprioception of this musculature.
  • neuromodulation system described herein allows the performance of the conditioning in private environments and by the patient herself. In contrast to urinary incontinence treatment, there is no need for a humidity sensor.
  • the electrical stimulation of the pelvic musculature may occur on a schedule and improves proprioception.
  • Constipation affects both genders at all ages. This may result from pelvic floor dysfunction similar to that seen with bladder, urinary sphincter and sexual dysfunction.
  • Constipation is typically treated with laxatives, enemas, and/or a high fiber diet. However, while the condition may be managed this way, the pelvic floor dysfunction may still go untreated and lead to prolonged management or failure in therapy.
  • Perineal nerve stimulation improves proprioception of the muscles used in the relaxation and contraction required for efficient defecation. The principle used is the same as described herein for sexual dysfunction.
  • Combined BBD affects both genders and at all ages. This may result from overactive bladder and pelvic floor dysfunction similar to that seen with bladder, urinary sphincter and sexual dysfunction.
  • Perineal nerve stimulation improves proprioception of the muscles used in the relaxation and contraction required for efficient defecation and cessation of involuntary bladder muscle contractions. The principle used is the same as described herein for daytime incontinence and constipation. Similar to urinary incontinence treatment discussed herein, there may be a need for a humidity sensor when overactive bladder leads to urinary incontinence. While the electrical stimulation of the pelvic musculature may occur on a schedule and improves proprioception, additional stimulation can occur to prevent urine loss when a humidity sensor is used.
  • Pudendal neuralgia is pain related to the pudendal nerve. The pain may occur in the perineal / pelvic region, and can also coincide with secondary extremity ailments.
  • the TENS systems described above may be used to treat pudendal neuralgia in similar manners to other treatments described above.
  • Some embodiments of the present disclosure include a system including one or more data processors.
  • the system includes a non-transitory computer readable storage medium containing instructions which, when executed on the one or more data processors, cause the one or more data processors to perform part or all of one or more methods and/or part or all of one or more processes disclosed herein.
  • Some embodiments of the present disclosure include a computer-program product tangibly embodied in a non-transitory machine- readable storage medium, including instructions configured to cause one or more data processors to perform part or all of one or more methods and/or part or all of one or more processes disclosed herein.
  • circuits, systems, networks, processes, and other components may be shown as components in block diagram form in order not to obscure the embodiments in unnecessary detail.
  • well-known circuits, processes, algorithms, structures, and techniques may be shown without unnecessary detail in order to avoid obscuring the embodiments.

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Abstract

La présente invention concerne une neuromodulation et, en particulier, des dispositifs et des techniques pour délivrer une neurostimulation non-invasive pour traiter l'énurésie et des troubles du plancher pelvien. En particulier, des aspects de la présente invention concernent un dispositif de stimulation nerveuse électrique transcutanée (TENS) comprenant un dispositif de commande configuré pour fournir un ensemble de paramètres de stimulation, et un générateur d'impulsions configuré pour générer une stimulation neuronale sur la base de l'ensemble de paramètres de stimulation ; une ou plusieurs électrodes connectées au dispositif TENS pour délivrer la stimulation neuronale générée par le générateur d'impulsions à une région d'un utilisateur ; un ou plusieurs capteurs pour détecter un ou plusieurs des éléments suivants : un événement déclencheur de la stimulation neuronale, une réponse nerveuse de la stimulation neuronale, et un niveau de sensibilité du patient à la stimulation neuronale ; et un vêtement ou coussinet fixé au dispositif TENS, à l'au moins une électrode et l'au moins un capteur.
PCT/US2019/045990 2018-08-09 2019-08-09 Stimulation nerveuse électrique transcutanée pour le traitement d'énurésie et de troubles du plancher pelvien WO2020033883A1 (fr)

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WO2024057025A1 (fr) * 2022-09-15 2024-03-21 Amber Therapeutics Ltd Stimulateur nerveux pour dysfonctionnement sexuel
WO2024086375A1 (fr) * 2022-10-21 2024-04-25 Global Continence, Inc. Stimulation nerveuse électrique transcutanée pour le traitement de l'énurésie

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