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
  • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
  • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
  • A61N1/36071—Pain
• • 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
  • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
  • A61N1/36128—Control systems
  • A61N1/36135—Control systems using physiological parameters
• • 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
• • 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
  • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
  • A61N1/36128—Control systems
  • A61N1/36132—Control systems using patient feedback

Definitions

• CPP chronic pelvic pain
• CPP is non-malignant pain perceived in the pelvic area in either men or women that lasts for 6 months or longer.
• CPP is a complex, multifactorial condition that is very disabling for patients. CPP may come and go or be constant with episodes of exacerbating pain.
• aspects of the disclosure herein provide methods for reducing pain of an individual, the method comprising: (a) implanting a sensor and a stimulator electrode within a pelvic area of the individual; (b) sensing with the implanted sensor a parameter associated with an episode of pain of the individual; and (b) providing an adapted electrical stimulation with the implanted stimulator electrode that reduces pain of the individual, wherein at least one of an intensity, a frequency, or a duration of the adapted electrical stimulation varies according to the parameter detected in step (b).
• the stimulator electrode comprises a first stimulator and wherein the first stimulator is implanted at or adjacent to a first anatomical site.
• the adapted electrical stimulation comprises a first stimulation pattern and a second stimulation pattern, wherein the first stimulation pattern is provided by the first stimulator and the second stimulation pattern is provided by the second stimulator.
• the first and second stimulation patterns comprise excitation values for intensity, frequency, phase, pulse width, or any combination thereof.
• the first and second stimulation patterns are the same.
• the first and second stimulation patterns differ in intensity, frequency, phase, pulse width, or any combination thereof.
• the method further comprises using software to generate the first and second stimulation patterns based on at least the parameter.
• the generated first and second stimulation patterns are configured to reduce pain of the episode based on at least the parameter.
• the pain is associated with interstitial cystitis, painful bladder syndrome, chronic prostatitis, urethral pain syndrome, vagina pain, vulvodynia, vestibulodynia, radiation vaginitis, penile pain syndrome, proctalgia fugax, anorectal pain (e.g., unspecified functional anorectal pain syndrome), phantom rectum syndrome, levator ani syndrome, pelvic floor muscle pain syndrome, pelvic floor muscle pain dysfunction, pelvic floor myalgia, urethral pain syndrome, coccygodynia, pudendal neuralgia, or any combination thereof.
• anorectal pain e.g., unspecified functional anorectal pain syndrome
• phantom rectum syndrome e.g., unspecified functional anorectal pain syndrome
• levator ani syndrome e.g., pelvic floor muscle pain syndrome, pelvic floor muscle pain dysfunction, pelvic floor myalgia, urethral pain syndrome,
• the adapted electrical stimulation comprises a first stimulation pattern and a second stimulation pattern, wherein the first stimulation pattern is provided by the first stimulator and the second stimulation pattern is provided by the second stimulator.
• the first and second stimulation patterns comprise excitation values for intensity, frequency, phase, pulse width, or any combination thereof.
• the first and second stimulation patterns are the same.
• the first and second stimulation patterns differ in intensity, frequency, phase, pulse width, or any combination thereof.
• the method further comprises using software to generate the first and second stimulation patterns based on at least the parameter.
• the generated first and second stimulation patterns are configured to reduce pain of the episode based on at least the parameter.
• the pain comprises neuropathic pain. In some embodiments, the pain is associated with nerve damage or injury. In some embodiments, the pain is associated with dysregulated visceral smooth muscle activity. In some embodiments, the pain of the individual has diurnal variation. In some embodiments, the parameter comprises temporal or circadian functions. In some embodiments, the first anatomical site, the second anatomical site, or any combination thereof is adjacent to or at a nerve. In some embodiments, the nerve comprises a motor nerve fiber, a larger diameter afferent nerve, or any combination thereof. In some embodiments, the nerve gates peripheral nociception, spinal activity, or any combination thereof. In some embodiments, the nerve stimulates muscle contraction, modulates muscle activity, or any combination thereof.
• the senor, the implanted electrode, or a combination thereof are implanted at or adjacent to a pudendal nerve, sacral nerve, pelvic plexus nerve, or any combination thereof.
• the parameter comprises a bio-signal, extrinsic signal, learned signal, or any combination thereof.
• the dataset comprises data generated by a user, a subject, a population, or any combination thereof.
• the comparative parameter comprises an innate value, extrinsic value, learned value, or any combination thereof.
• the method further comprises using software configured to generate the first and second stimulation patterns based on the parameter.
• the software comprises a machine learning model, and wherein the machine learning model is configured to classify the parameter received by the implanted sensor and generate the stimulation patterns.
• the machine learning model comprises training a classifier of user-specific activity based on at least one of a GPS reading, time of day, or motion.
• the comparative parameter comprises a bio-signal, extrinsic signal, learned signal, or any combination thereof.
• the implanted electrode comprises a stimulator electrode.
• the stimulator electrode comprises a first stimulator and wherein the first stimulator is implanted at or adjacent to a first anatomical site.
• the stimulation pattern is generated by software.
• the parameter comprises a first parameter and a second parameter and wherein the stimulation pattern is further sustained, modified, redirected, withheld, or cancelled based on the second parameter and wherein the second parameter is later in time to the first parameter.
• the implanted sensor and implanted electrode are electrically coupled to a processor.
• the parameter is provided by the individual via a controller in wireless communication with the processor.
• the sensor is configured to transmit data to the processor, and wherein the data is associated with the parameter that is detected by the sensor.
• the parameter associated with the episode of pain of the individual comprises an electrical parameter, a pressure parameter, a motion parameter, or any combination thereof.
• the pain comprises neuropathic pain. In some embodiments, the pain is associated with nerve damage or injury. In some embodiments, the pain is associated with dysregulated visceral smooth muscle activity. In some embodiments, the pain of the individual has diurnal variation. In some embodiments, the parameter comprises temporal or circadian functions. In some embodiments, the first anatomical site, the second anatomical site, or any combination thereof is adjacent to or at a nerve. In some embodiments, the nerve comprises a motor nerve fiber, a larger diameter afferent nerve, or any combination thereof. In some embodiments, the nerve gates peripheral nociception, spinal activity, or any combination thereof. In some embodiments, the nerve stimulates muscle contraction, modulates muscle activity, or any combination thereof.
• the nerve comprises a pudendal nerve, a sacral nerve, a nerve of the pelvic plexus, or any combination thereof.
• a pudendal nerve, a sacral nerve, a pelvic plexus nerve, or a combination thereof is electrically stimulated by the stimulator electrode.
• stimulation is provided by the first stimulator to a first nerve before the parameter is detected and, after the parameter is detected, stimulation is provided to the first nerve, a second nerve, or any combination thereof.
• the first anatomical site, the second anatomical site, or any combination thereof is adjacent to or at a muscle.
• the first anatomical site, the second anatomical site, or any combination thereof is adjacent to or at a pelvic muscle.
• the first anatomical site is adjacent to or at a first pudendal nerve
• the second anatomical site is adjacent to or at a sacral nerve, the first pudendal nerve, or a second pudendal nerve.
• a first anatomical site is adjacent to or at a first pudendal nerve, a first sacral nerve, or a first pelvic plexus nerve.
• a second anatomical site is adjacent to or at a second pudendal nerve, a second sacral nerve, or a second pelvic plexus nerve.
• the adapted electrical stimulation is at a different intensity level than the base electrical stimulation.
• the implanted electrode comprises a first stimulator and a second stimulator, wherein the first stimulator stimulates one region of a pudendal nerve and the second stimulator stimulates a sacral nerve, a different pudendal nerve, or a different region of the pudendal nerve.
• the parameter associated with the episode comprises a physiological signal, EMG signal, ENG signal, digital signal, patient actuated signal based on perception of pain or increased pain, pressure signal, muscle contraction event signal, motion signal, orientation signal, posture signal, GPS signal, speed signal, location signal, time of day signal, time interval signal, or any combination thereof.
• the sensor is configured to detect the parameter.
• the sensor comprises a sensor electrode, receiver, pressure sensor, accelerometer, gyroscope, magnetometer, global positioning system, or any combination thereof.
• the parameter detected by the receiver, pressure sensor, accelerometer, gyroscope, magnetometer, global positioning system, or any combination thereof is associated with a pressure, muscle contraction event, motion, orientation, posture, GPS reading, speed, location, time of day, time interval, or any combination thereof.
• the parameter detected by the sensor electrode, receiver, pressure sensor, or any combination thereof is associated with a physiological event, EMG signal, ENG signal, digital signal, patient actuated input based on perception of pain or increased pain, pressure, muscle contraction event, or any combination thereof.
• the receiver comprises a controller receiver, digital receiver, radio receiver, or any combination thereof.
• the senor is configured to detect activity of a muscle of the individual, and wherein the activity is associated with an EMG signal, ENG signal, digital signal, patient actuated signal based on perception of pain or increased pain, pressure signal, muscle contraction event signal, or any combination thereof.
• the muscle comprises a pelvic floor muscle.
• the parameter is associated with contraction, increased tone, or any combination thereof of the pelvic floor muscle.
• the sensor is configured to detect activity of a sensed nerve of the individual, and wherein the activity is associated with an ENG signal of the sensed nerve.
• the sensed nerve comprises a motor nerve fiber, a larger diameter afferent nerve, or any combination thereof.
• the pain is associated with interstitial cystitis, painful bladder syndrome, chronic prostatitis, urethral pain syndrome, vagina pain, vulvodynia, vestibulodynia, radiation vaginitis, penile pain syndrome, proctalgia fugax, anorectal pain (e.g., unspecified functional anorectal pain syndrome), phantom rectum syndrome, levator ani syndrome, pelvic floor muscle pain syndrome, pelvic floor muscle pain dysfunction, pelvic floor myalgia, urethral pain syndrome, coccygodynia, pudendal neuralgia, or any combination thereof.
• anorectal pain e.g., unspecified functional anorectal pain syndrome
• phantom rectum syndrome e.g., unspecified functional anorectal pain syndrome
• levator ani syndrome e.g., pelvic floor muscle pain syndrome, pelvic floor muscle pain dysfunction, pelvic floor myalgia, urethral pain syndrome,
• the pain comprises neuropathic pain. In some embodiments, the pain is associated with nerve damage or injury. In some embodiments, the pain is associated with dysregulated visceral smooth muscle activity. In some embodiments, the pain of the individual has diurnal variation. In some embodiments, the parameter comprises temporal or circadian functions. In some embodiments, the first anatomical site, the second anatomical site, or any combination thereof is adjacent to or at a nerve. In some embodiments, the nerve comprises a motor nerve fiber, a larger diameter afferent nerve, or any combination thereof. In some embodiments, the nerve gates peripheral nociception, spinal activity, or any combination thereof. In some embodiments, the nerve stimulates muscle contraction, modulates muscle activity, or any combination thereof.
• the nerve comprises a pudendal nerve, a sacral nerve, a nerve of the pelvic plexus, or any combination thereof.
• a pudendal nerve, a sacral nerve, a pelvic plexus nerve, or a combination thereof is electrically stimulated by the stimulator electrode.
• stimulation is provided by the first stimulator to a first nerve before the parameter is detected and, after the parameter is detected, stimulation is provided to the first nerve, a second nerve, or any combination thereof.
• the first anatomical site, the second anatomical site, or any combination thereof is adjacent to or at a muscle.
• FIG. 2 shows an exemplary embodiment of a closed-loop bioelectronic system comprising a two-way neural interface comprising a sensor that detects the neural response of the subject and a processing module that can interpret the neural response.
• the system can deliver an adapted stimulation based on the neural response.
• These conditions include but are not limited to interstitial cystitis, painful bladder syndrome, chronic prostatitis, urethral pain syndrome, vagina pain, vulvodynia, vestibulodynia, radiation vaginitis, penile pain syndrome, proctalgia fugax, anorectal pain (e.g., unspecified functional anorectal pain syndrome), phantom rectum syndrome, levator ani syndrome, pelvic floor muscle pain syndrome, pelvic floor muscle pain dysfunction, pelvic floor myalgia, urethral pain syndrome, coccygodynia, pudendal neuralgia, voiding dysfunction, and constipation. In some cases, these conditions involve the pudendal nerve.
• inventions for preventing and/or reducing pain associated with an episode of pain in an individual in need thereof.
• the systems, methods, and devices, described herein are directed to treating episodes of pain associated with chronic pelvic pain (CPP) or other conditions resulting in pelvic pain using peripheral nerve stimulation.
• CPP chronic pelvic pain
• the systems, methods, and devices comprise a closed-loop configuration.
• adapted stimulation to the target nerves are provided by an implanted stimulator with an underlying physiological rationale comprising: (a) stimulating motor fibers to alter end organ muscle activity where peripheral pain is driven by spasm and/or hypertonicity (e.g., pelvic floor myalgia, some cases of bladder pain syndrome, and urethral pain associated with motor modulation); (b) stimulating larger diameter afferent fibers to modulate spinal gating of nociceptive signaling from peripheral foci of pain generation (e.g., interstitial cystitis, coccygodynia, and pelvic myalgia); (c) blocking nerve conduction (e.g., anodal block) to (i) directly block disease-related peripherally driven pain, and (ii) block noxious effects associated with providing the adapted stimulation, which facilitates higher charge delivery for therapeutic benefit; and any combination thereof.
• a stimulator with an underlying physiological rationale comprising: (a) stimulating motor fibers to alter end organ muscle activity where peripheral pain is
• the individual comprises a bladder with normal bladder compliance and no Hunner’s lesion(s) as defined by the American Urological Association (AUA) or the European Association of Urology (EAU).
• individual comprises an individual who has failed or is not a candidate for conversative treatment e.g., pelvic floor muscle therapy, biofeedback, and/or behavioral modification.
• the stimulator electrodes target different nerves (e.g., a first stimulator targeting a sacral nerve and a second stimulator targeting a pudendal nerve).
• stimulating multiple nerves within the pelvic area may broaden the field of treatment in pain syndromes having diffuse areas of pain.
• the electrical stimulation provide may be adapted to provide blocking and stimulation of electrical nerve signals on the same nerve.
• stimulator electrodes target one or more locations along a single nerve.
• the electrode provides a basal stimulation to the target nerve before an adapted stimulation (e.g., an electrical stimulation having an adapted stimulation pattern) is provided.
• an adapted stimulation e.g., an electrical stimulation having an adapted stimulation pattern
• the adapted electrical stimulation is provided by the same electrode that provided the basal stimulation.
• the adapted electrical stimulation is provided by a different electrode than the one providing the basal stimulation.
• the adapted stimulation provide at least one of: (i) a “boost” of the basal stimulation parameters (e.g., increase the amplitude of the basal stimulation); (ii) a switch to a different stimulation program (e.g., a switch from sacral to pudendal nerve stimulation or a switch from stimulating to blocking frequencies); or (iii) a change from single to dual nerve stimulation (e.g., pudendal stimulation to simultaneous pudendal, sacral and/or pelvic plexus stimulation).
• a “boost” of the basal stimulation parameters e.g., increase the amplitude of the basal stimulation
• a switch to a different stimulation program e.g., a switch from sacral to pudendal nerve stimulation or a switch from stimulating to blocking frequencies
• a change from single to dual nerve stimulation e.g., pudendal stimulation to simultaneous pudendal, sacral and/or pelvic plexus stimulation.
• devices and systems comprising one or more sensors, one or more stimulator electrodes, a processor, a power source, or any combination thereof.
• the one or more stimulator electrodes, one or more sensors, a processor, a power source, or any combination thereof may be implanted into the body of the individual.
• the device may be placed superficially on the body of the individual.
• the device may be implanted into the body of the individual.
• the device comprises a wireless transmission module capable of transmitting and receiving wireless data wireless with a remote device (e.g., a mobile phone, a tablet, a computer, etc.).
• the device comprises a hermetically sealed connector placed on the individual’s skin superficially that may electrically couple to a remote device by a cable.
• the individual or a healthcare professional may modify the settings of the sensor and/or the stimulator electrode (e.g., a threshold parameter and/or signal intensity threshold).
• the setting may be modified using a graphical user interface on the remote device.
• the device automatically modifies the setting of the sensor and/or the stimulator electrode.
• the device may automatically modify the setting of the sensor and/or the stimulator electrode based on a parameter detected by the sensor.
• the setting may comprise one or more of sensitivity of the sensor or stimulator, activity of the sensor or stimulator, a length signal acquisition period, a stimulation pattern provided by a stimulator to the surrounding tissue.
• the devices, systems, and methods described herein may prevent and/or reduce pain in an individual by detecting a parameter associated pain in an individual and adjusting an electrical stimulation by one or more stimulator electrodes based on the parameter’s characteristics.
• the sensor monitors parameters of the internal environment of the individual for activities associated with episodes of pain (e.g., detecting muscle function by pelvic floor EMG or afferent nerve conduction).
• the sensor measures one or more of EMG, ENG, pressure, temperature, blood flow, acceleration, movement, orientation, 3-D spatial location, and physical deformation/stretch at or near the target tissue.
• the sensor monitors whether anodal block associated with a basal or an adapted stimulation provided by the device has adequately reduced the pain.
• patient actuation is used to indicate an episode of pain.
• patient actuation is used to indicate an episode of pain associated with episodic exacerbations (e.g., pelvic floor myalgia) and/or intermittent pain (e.g., proctalgia fugax).
• patient actuation is used to indicate an episode of postural pain associated with a CPP condition (e.g., patients with myalgia upon sitting). After the episode of pain is indicated, the electrical stimulation may be provided to reduce pain of the episode.
• a boost to a basal stimulation pattern is provided by the adapted stimulation.
• the sensor may detect a change in posture of the individual and/or received a patient actuated signal.
• circadian functions are used to indicate pain having diurnal variation.
• the diurnal variation comprises night-time pain. In some cases, pain is worse at night and/or with movement.
• a different stimulation pattern may be provided when the individual wakes compared to when the individual sleeps.
• the parameter comprises a change in pressure, velocity, acceleration, or 3-D spatial direction.
• 3-D spatial direction is determined by GPS signal.
• the GPS signal may indicate and recognize when the individual is in proximity to locations including at least one of the individual’s home, bedroom, living room, dining room, bathroom, or office.
• the GPS signal may be configured to modulate the adapted stimulation pattern, described elsewhere herein, based on the GPS coordinates and/or GPS location of the subject.
• the GPS signal of a location and/or GPS coordinates may indicate locations to help to predict or indicate certain activities that are commonly associated with an episode of pain.
• the change in one or more of pressure, velocity, acceleration, or 3-D spatial direction may indicate a posture or a change in postures of the individual.
• changes in pressure may be measured by a pressure sensor.
• the pressure sensor comprises a differential pressure sensor, absolute pressure sensor, or any combination thereof.
• changes in velocity, acceleration, or changes in 3-D spatial direction may be measured by an accelerometer, gyroscope, magnetometer, or any combination thereof.
• the device provides an electrical stimulation using one or more implanted stimulator electrodes that, alone or together with a basal electrical stimulation, reduces pain of an episode.
• modulating the adapted stimulation pattern comprises adjusting a detection parameter (e.g., signal intensity threshold) of the classifier, described elsewhere herein.
• the trigger to start the adapted electrical stimulation is a parameter detected by the sensor.
• the trigger to start the adapted electrical stimulation is associated with patient actuation (e.g., sending a signal by the patient to the sensor prior to changing posture, during episodes of pain exacerbation).
• the trigger to start the adapted electrical stimulation is a parameter associated with pelvic muscle contraction (e.g., EMG signal and/or ENG signal).
• at least one of the basal or adapted electrical stimulation stops being provided when the sensor receives a change in the detected parameter (e.g., a patient actuated signal after the patient finishes urinating or change posture).
• the basal and/or adapted stimulation patterns have a finite duration. In some embodiments, the duration of the basal and/or adapted stimulation patterns are determined by the detected parameter. In some embodiments, the basal and/or adapted stimulation patterns last until a change in the detected parameter above or below a threshold.
• the device may be implanted in the individual in proximity to the pudendal nerve, a sacral nerve, a nerve of the pelvic plexus, or branches thereof.
• the pelvic plexus may comprise one or more nerves that that innervate tissue involved with urination and/or defecation in a pelvis of an individual.
• one or more nerves of the pelvic plexus may comprise the splanchnic nerve, hypogastric nerve, autonomic plexus nerve, or any combination thereof nerves.
• the pelvic plexus may comprise one or more parasympathetic and/or sympathetic nerves.
• the one or more stimulator electrodes may be placed at or near the pudendal nerve, the sacral nerve, and/or a nerve of the pelvic plexus. In some embodiments, the one or more stimulator electrodes or one or more sensors may be implanted in proximity to a pudendal, sacral, and/or pelvic plexus nerve unilaterally or bilaterally. In some embodiments, the one or more stimulator electrodes or one or more sensors may be implanted unilaterally or bilaterally based at least on the pain or pain episode the individual has experienced or may experience.
• an individual experiencing unilateral pain may be treated with one or more electrodes implanted at or adjacent to a single nerve, whereas an individual experiencing bilateral diffuse pain may be treated with one or more electrodes implanted at or adjacent to one or more different nerves.
• the one or more stimulator electrodes and/or one or more sensors may be implanted unilaterally at or adjacent a first region of a nerve.
• the one or more stimulator electrodes and/or one or more sensors may be implanted bilaterally at or adjacent to a first region nerve and a second region of a nerve where the first and second region are spatially independent regions of the nerve.
• unilateral pain may be treated by implanting one or more electrode leads (e.g., stimulator electrode and sensor electrode) at or adjacent to a trunk and distal pudendal nerve, pudendal and sacral nerve, pudendal and pelvic autonomic nerve, or any combination thereof.
• bilateral pain may be treated by implanting one or more electrode leads (e.g., stimulator electrode and sensor electrode) at or adjacent the pudendal nerve bilaterally, the sacral nerve bilaterally, pelvic autonomic nerve bilaterally.
• the one or more stimulator electrodes may be implanted to stimulate motor nerve fibers (e.g., to the pelvic floor).
• the one or more stimulator electrodes may be implanted within, proximate, or adjacent to the muscle (e.g., pelvic floor).
• the implanted sensor may sense a signal that indicates that an individual may exhibit an episode of pain.
• the device may analyze the signal and classify the signal as a real-time or prospective episode of pain.
• the device may generate an electrical stimulation that is modulated based on the classified episode of pain and may deliver the adapted electrical stimulation using one or more stimulator electrodes to the target nerve.
• the modulation of the electrical stimulation comprises changing the frequency, amplitude, and/or pulse width of electric stimulation.
• the modulation of the electrical stimulation comprises a modulation in simulator configuration.
• the one or more electrodes comprises one or more stimulation electrodes and one or more sensing electrodes.
• the one or more stimulation electrodes and one or more sensing electrodes may be configured to switch between stimulating and sensing operations on demand, programmatically, user controlled, medical personal control, or any combination thereof.
• the electrical stimulation may be modulated to improve the muscle and/or nerve response to prevent or reduce the episode of pain.
• the modulated electrical stimulation may result in improved muscle response, as measured by response time, muscle function, or other markers of prevention or reduction of pain, to prevent the potential episode of pain.
• the electrical stimulation may be modulated to reduce a severity and/or duration of an episode of pain. In some embodiments, the electrical stimulation may reduce the intensity or duration of pain.
• the period of time for the electrical stimulation comprises about 1 second to about 5 seconds, about 1 second to about 10 seconds, about 1 second to about 15 seconds, about 1 second to about 20 seconds, about 1 second to about 25 seconds, about 1 second to about 30 seconds, about 5 seconds to about 10 seconds, about 5 seconds to about 15 seconds, about 5 seconds to about 20 seconds, about 5 seconds to about 25 seconds, about 5 seconds to about 30 seconds, about 10 seconds to about 15 seconds, about 10 seconds to about 20 seconds, about 10 seconds to about 25 seconds, about 10 seconds to about 30 seconds, about 15 seconds to about 20 seconds, about 15 seconds to about 25 seconds, about 15 seconds to about 30 seconds, about 20 seconds to about 25 seconds, about 20 seconds to about 30 seconds, or about 25 seconds to about 30 seconds.
• the disclosure describes devices for preventing or reducing pain of an individual comprising one or more sensors and one or more stimulator electrodes.
• the device further comprises a processor, memory, a user interface, a power source, or any combination thereof for preventing or reducing an episode of pain.
• the devices may be implantable.
• the surgical procedure to implant the device may be completed under awake sedation, general anesthesia, local anesthesia, twilight anesthesia, or any combination thereof.
• the devices may be implanted wholly or partly in an individual’s pelvic region.
• the devices may be implanted by one or more surgical instruments.
• surgical instruments comprise introducers, sheaths, directable probes, wires, needles, or any combination thereof.
• the devices further comprise a transmitter electrically coupled to a processor capable of wirelessly transmitting and receiving data from a remote device, such as a mobile phone, a tablet, or a computer.
• a remote device such as a mobile phone, a tablet, or a computer.
• the device may be configured for open-loop configuration. In some embodiments, the device may be configured for a dose-loop or feedback-controlled configuration.
• the parameter comprises a bio-signal, extrinsic signal, learned signal, or any combination thereof.
• the dataset comprises data generated by a user, a subject, a population, or any combination thereof.
• the comparative parameter comprises an innate value, extrinsic value, learned value, or any combination thereof.
• software configured to generate the first and second stimulation patterns is used.
• the software comprises a machine learning model, and wherein the machine learning model is configured to classify the parameter received by the implanted sensor and generate the stimulation patterns.
• the machine learning model comprises training a classifier of user-specific activity based on at least one of a GPS reading, time of day, or motion.
• the comparative parameter comprises a bio-signal, extrinsic signal, learned signal, or any combination thereof.
• the implantable pulse generator 102 may deliver a predefined electrical stimulation pattern 104 that has been set by a healthcare provider on a remote device 100 (e.g., a mobile phone, a tablet, a computer, etc.) and transmitted wirelessly 105 to the implantable pulse generator 102.
• the implantable pulse generator 102 may deliver a predefined electrical stimulation pattern 104 that has been set by a healthcare provider on a remote computing device 100 (e.g., a mobile phone, a tablet, a computer, etc.) and transmitted via a wired communication 101 to the implantable pulse generator 102.
• the healthcare provider may set the predefined electrical stimulation parameters through a graphical user interface on the remote device.
• an implantable pulse generator 102 implanted in the pelvic region of the individual 110 may modify or set electrical stimulation parameters via an external input device 103(e.g., a mobile phone, a tablet, a computer, etc.) via a wireless communication 105 of the implantable pulse generator 102.
• an implantable pulse generator 102 implanted in the pelvic region of the individual 110 may modify or set electrical stimulation parameters via an external input device 103 via a wired communication 107 of the implantable pulse generator 102.
• an implantable pulse generator 102 implanted in the pelvic region of the individual 110 may adjust the electrical stimulation pattern 104 using a graphical user interface on the external input device 103.
• the electrical stimulation pattern 104 parameters that may be adjusted comprise frequency, amplitude, pulse width, or any combination thereof.
• FIG. 2 shows a closed-loop configuration of the device described herein configured to prevent or reduce pain of an individual 126.
• the device in a closed-loop configuration comprises an implantable pulse generator 118, one or more stimulator electrodes 122, one or more sensors 120, and a power source.
• the implantable pulse generator 118 comprises a processor, and a wireless transmission module configured to execute software to detect, analyze myoelectric electromyograph (EMG) signals via one or more sensors 120 and administer an electrical stimulation pattern 124.
• EMG myoelectric electromyograph
• the power source comprises a battery.
• the battery may be rechargeable or single use.
• the battery may be charged through inductive charging.
• the device configured in a closed-loop configuration may measure EMG signals via one or more sensors 120 to detect one or more parameters associated with an episode of pain of the individual or a level of innate myoelectric electrical activity.
• the device configured in a closed-loop configuration may measure inertial signals such as rapid acceleration, shock, posture-orientation, or any combination thereof via the one or more sensors 120 to detect one or more parameters associated with an episode of pain.
• the one or more parameters associated with the episode of pain comprise signals from actions including coughing, sneezing, laughing, or exercise.
• the implantable pulse generator 118 may provide an adapted electrical stimulation pattern 124 to reduce pain of the individual based on the one or more parameters.
• the threshold level for detecting parameters may be modified and adjusted by the individual 126 via graphical user interface on an external input device 114 either via wireless communication 113 or a wired connection 115.
• a closed-loop configuration of the device described herein may be configured to detect an episode of pain in an individual.
• the methods and systems described here may supplement the patient’s effort to reduce pain with an electrical stimulation pattern via one or more stimulator electrodes 122 sufficient to reduce or prevent an episode of pain.
• an individual’s effort may be measured with an EMG, ENG, pressure, acceleration, gyroscope, magnetometer, 3-D spatial, or any combination thereof signal at a threshold.
• the threshold myoelectric signal may be detected by one or more sensors 120.
• the adapted stimulation comprises an electrical signal provided by the stimulator electrodes, described elsewhere herein, with parameters e.g., frequency, pulse width, and/or amplitude such that, alone or in combination with the detected individual’s effort and/or basal stimulation, may reduce prevent an episode of pain.
• the one or more parameters of the adapted stimulation may be determined on an individual subject basis and/or on a large-scale population of subjects with similar presentation. For example, for a given subject’s adapted stimulation, one or more parameters may be tuned and/or determined by whether such adapted stimulation reduces an episode of pain in real-time or after the episode of pain through the sensor or a user interface of the device, described elsewhere herein.
• one or more parameters may be tuned to values and/or parameters found to reduce or prevent pain in subjects with similar clinical presentation (e.g., age, type of pain, frequency of pain episode, other subject clinical meta data, etc.).
• the system and methods described herein comprises system and methods configured to provide an electrical stimulation to prevent an episode of pain based on a subject and/or patient’s purposeful muscle contraction and/or movement, as seen in FIG. 8.
• the subject and/or patient 814 may, upon realizing that they may exhibit an episode of pain, induce movement and/or contraction of one or more muscles or muscle groups to trigger an EMG, ENG, pressure, acceleration, gyroscope, magnetometer, 3-D spatial, or any combination thereof signal 818.
• the induced movement and/or contraction of one or more muscle groups may be amplified 808, classified (by a classifier) 806, passed through a control logic algorithm 804, and used as a trigger 820 to enable the flow of therapy and respective basal 802 and/or active 801, described elsewhere herein, stimulation pattern parameters through the stimulator 810 and neural interface 812 to prevent an episode of pain.
• the classifier comprises a machine learning classifier.
• the classifier comprises an intensity threshold classifier, described elsewhere herein.
• the patient and/or subject 814 may manually 816 enable the delivery of electrical stimulation via a button on the patient controller module 156, described elsewhere herein.
• the detection threshold of the implantable pulse generator 118 may be modified and tuned via a graphical user interface on an external input device 114.
• the external input device 114 may be able to modify and tune the threshold of the implantable pulse generator 118 via a wireless communication 113 or a wired connection 115.
• the implantable pulse generator threshold may be tuned via a healthcare provider on a remote computing device 112 (e.g., a mobile phone, a tablet, a computer, etc.) and transmitted via a wired communication 116 to the implantable pulse generator 118.
• the implantable pulse generator threshold may be tuned via a healthcare provider on a remote computing device 112 (e.g., a mobile phone, a tablet, a computer, etc.) and transmitted via wireless communication 113 to the implantable pulse generator 118.
• the implantable pulse generator threshold may be tuned via the individual on a remote computing device 112 (e.g., a mobile phone, a tablet, a computer, etc.) and transmitted via a wired communication 116 to the implantable pulse generator 118.
• the implantable pulse generator threshold may be tuned via the individual on a remote computing device 112 (e.g., a mobile phone, a tablet, a computer, etc.) and transmitted via wireless communication 113 to the implantable pulse generator 118.
• the electrical stimulation pattern 124 provided via one or more stimulator electrodes 122 may be tuned and adjusted by the detected threshold level to supplement an individual’s effort to prevent an episode of pain.
• the adjusted electrical stimulation pattern 124 may be determined by mapping a detectable physiological signal representing effort and a provided electrical stimulation pattern 124 by, piecewise linear mapping, linear mapping, sigmoidal mapping, or any variations thereof.
• the electric stimulation pattern 124 may be tuned by modifying or changing the electrical stimulation pattern parameters comprising frequency, pulse-width, and amplitude.
• the electrical stimulation pattern parameters of the implantable pulse generator 118 may be modified and tuned via a graphical user interface on an external input device 114.
• the external input device 114 may be able to modify and tune the electrical stimulation pattern parameters of implantable pulse generator 118 via a wireless communication 113 or a wired connection 115.
• the electrical stimulation pattern parameters of implantable pulse generator 118 may be tuned via a healthcare provider on a remote computing device 112 (e.g., a mobile phone, a tablet, a computer, etc.) and transmitted via a wired communication 116 to the implantable pulse generator 118.
• the electrical stimulation pattern parameters of implantable pulse generator 118 may be tuned via a healthcare provider on a remote computing device 112 (e.g., a mobile phone, a tablet, a computer, etc.) and transmitted via wireless communication 113 to the implantable pulse generator 118.
• the electrical stimulation pattern parameters of implantable pulse generator 118 may be tuned by a machine learning model executed by the processor of the implantable pulse generator 118 based on input from the individual 126.
• the machine learning model may be configured to determine a whether or not a subject is at risk of unwanted micturition and/or fecal defecation based on muscle EMG signals detected by the one or more sensors.
• the machine learning model may be trained to determine the presence or lack thereof an individual’s effort, described elsewhere herein.
• the machine learning model may be trained with one or more EMG signals characteristic of a subject’s muscle contractions in particular EMG signals that lead to pain.
• the electrical stimulation pattern parameters may be set or determined by a stimulation machine learning model.
• the stimulation machine learning model comprises a Bayesian optimization model.
• the stimulation machine learning model may be trained with stimulation patterns that users of the devices and systems, described elsewhere herein, indicate as inhibiting episode of pain for types and/or subtypes of pain.
• the stimulation machine learning model may be trained with the patient’s type of pain.
• the stimulation machine learning algorithms may be trained in a cloud computing network and/or server in communication with the implantable and user-devices, described elsewhere herein, and redistributed or downloaded to one or more users and/or patients. In effect users and/or patients may update and/or download new updates to the software of the devices and systems described herein.
• One or more machine learning algorithms may be used to construct the machine learning model, such as support vector machines that deploy stepwise backwards parameter selection and/or graphical models, both of which may have advantages of inferring interactions between parameters.
• machine learning algorithms or other statistical algorithms may be used such as alternating decision trees (ADTree), decision stumps, functional trees (FT), logistic model trees (LMT), logistic regression, random forests (rf), receiver operational characteristic curves (ROC), linear regression, extreme gradient boosting (xgb), classification and regression trees, support vector machines (SVM), generalized additive model using splines (e.g., gamSpline), glmnet, multivariate adaptive regression splint (earth), neural network, k-means clustering, or any machine learning algorithm or statistical algorithm known in the art.
• splines e.g., gamSpline
• glmnet multivariate adaptive regression splint
• neural network e.g., k-means clustering, or any machine learning algorithm or statistical
• One or more algorithms may be used together to generate an ensemble method, wherein the ensemble method may be optimized using a machine learning ensemble meta-algorithm such as boosting (e.g., AdaBoost, LPBoost, TotalBoost, BrownBoost, MadaBoost, LogitBoost, etc.) to reduce bias and/or variance.
• boosting e.g., AdaBoost, LPBoost, TotalBoost, BrownBoost, MadaBoost, LogitBoost, etc.
• the machine learning algorithm comprises a constrained machine learning algorithm configured to run on micro-processors.
• the machine learning algorithm comprises a machine learning algorithm operating on within a TinyML framework.
• the machine learning algorithm, described elsewhere herein may be trained offline. The offline training may be completed on a server, cloud, or other dedicated computing clusters. In some embodiments, the offline trained machine learning algorithm could then be downloaded, deployed, and/or imported into the device to iteratively improve upon the device and system performance in preventing or reducing pain of an individual.
• Such a machine learning architecture may be utilized in performing “wake up-word” text classification that are commonly seen in smartphone devices (e.g., “hey siri”, “okay google”, etc.).
• the machine learning algorithms described herein may operate within a framework similar to the “wake up-words” speech machine learning classifier.
• the machine learning algorithms described herein may operate on processing power and memory allocation determined to be sufficient for “wake up” speech machine learning classifiers.
• the software may be executed by a processor located on the implanted stimulator.
• the software located on the implanted stimulator may utilize a TinyML constrained machine learning model to accommodate the processing and memory parameters of the implanted stimulator.
• the software may be executed offline on a cloud-based computing and/or dedicated computing duster(s).
• the offline processing workflow may include a high-speed (Bluetooth, Wi-Fi, medical implant communication systems, etc.) data transfer between the implanted stimulator and a local personal computing device (smartphone, tablet, laptop, etc.).
• the personal processing device may then communicate the implanted stimulator data to a one or more cloud and/or computer clusters that will then send back a resulting output, command, and/or notification to the device.
• the command and/or notification comprises a warning, alert, initiation of electrical stimulation, or any combination thereof.
• the command comprises the output of a machine learning classifier configured to determine a threshold intensity of EMG and/or ENG signals indicative of an episode of pain.
• the machine learning models may be trained on one or more datasets.
• the one or more datasets comprises data generated by a user and/or subject, or data generated by a population or segment thereof.
• the data generated by subject and/or the data generated by a population comprises effort signals, excitation signals, that indicated an episode of pain, and prevented an episode of pain, respectively.
• the devices, systems, and corresponding methods described herein may record user data and/or input of the user when interacting with the systems and devices described elsewhere herein.
• the data comprises user labeled EMG, ENG, accelerometer, gyroscope, or any combination thereof sensors, as described elsewhere herein, that lead to an episode of pain.
• these signals may be obtained from the device 1302, and used in characterizing 1304 and training a machine learning classifier 1306, as seen in FIG. 13.
• the trained machine learning classifiers trained on or more datasets may then be downloaded to each patient’s device 1308 to further improve the machine learning classifier’s accuracy.
• the machine learning models may be configured to sense subject effort and/or providing sufficient excitation based on e.g., parameters of frequency, amplitude, and/or pulse-width as described elsewhere herein.
• the datasets of one or more individuals may be pooled together as a training dataset where the subjects show characteristics of similarity between clinical presentation and parameters of excitatory/sensory input.
• clinical presentation comprises clinical pain type, subject clinical meta data, e.g., gender, age, past medical history, current medications taken, past surgical intervention, etc.
• a pooled training datasets may be utilized for an individual during the initial period of training a device implanted into a subject.
• the one or more machine learning models, described elsewhere herein may be trained on raw and/or processed signals measured by the devices, sensors, and systems, described elsewhere herein.
• the processed signals comprises original raw signals that have been filtered to optimize the signal-to-noise ratio of the raw signal.
• the filter comprises a high-pass, low-pass, band-pass, notch, or any combination thereof filters.
• the one or more machine learning models may be trained on user feedback regarding prior excitation signal parameters and whether or not such excitation signal parameters prevented an episode of pain.
• the disclosure provides a method of processing detected signals 1001 , described elsewhere herein to determine episode of pain precursor signal intensity thresholds, as seen in FIG. 10.
• the EMG, ENG, accelerometer, gyroscope, magnetometer, pressure sensor signals, or any combination thereof signals 1000 may be detected through an amplifier circuit 1002.
• the amplifier circuit comprises an operational amplifier circuit.
• the amplifier circuit may be configured to amplify signals from about 10 pV, about 50 pV, about 100 pV, about 150 pV, about 300 pV, about 500 pV, about 700 pV, about 900 pV, or about 1 ,000 pV. In some embodiments, the amplifier circuit may be configured to amplify signals from at least about 10 pV, about 50 pV, about 100 pV, about 150 pV, about 300 pV, about 500 pV, about 700 pV, or about 900 pV.
• the amplifier circuit may be configured to amplify signals from at most about 50 pV, about 100 pV, about 150 pV, about 300 pV, about 500 pV, about 700 pV, about 900 pV, or about 1 ,000 pV. (0062] In some embodiments, the amplifier circuit may be configured to amplify signals with a frequency of about 1 Hz to about 1 ,500 Hz.
• the amplifier circuit may be configured to amplify signals with a frequency of about 1 Hz to about 20 Hz, about 1 Hz to about 40 Hz, about 1 Hz to about 80 Hz, about 1 Hz to about 100 Hz, about 1 Hz to about 150 Hz, about 1 Hz to about 200 Hz, about 1 Hz to about 250 Hz, about 1 Hz to about 500 Hz, about 1 Hz to about 750 Hz, about 1 Hz to about 1 ,000 Hz, about 1 Hz to about 1 ,500 Hz, about 20 Hz to about 40 Hz, about 20 Hz to about 80 Hz, about 20 Hz to about 100 Hz, about 20 Hz to about 150 Hz, about 20 Hz to about 200 Hz, about 20 Hz to about 250 Hz, about 20 Hz to about 500 Hz, about 20 Hz to about 750 Hz, about 20 Hz to about 1 ,000 Hz, about 20 Hz to about 1 ,500 Hz, about 40 Hz to about 80 Hz, about 20
• the amplifier circuit may be configured to amplify signals with a frequency of about 1 Hz, about 20 Hz, about 40 Hz, about 80 Hz, about 100 Hz, about 150 Hz, about 200 Hz, about 250 Hz, about 500 Hz, about 750 Hz, about 1 ,000 Hz, or about 1 ,500 Hz. In some embodiments, the amplifier circuit may be configured to amplify signals with a frequency of at least about 1 Hz, about 20 Hz, about 40 Hz, about 80 Hz, about 100 Hz, about 150 Hz, about 200 Hz, about 250 Hz, about 500 Hz, about 750 Hz, or about 1 ,000 Hz.
• the amplifier circuit may be configured to amplify signals with a frequency of at most about 20 Hz, about 40 Hz, about 80 Hz, about 100 Hz, about 150 Hz, about 200 Hz, about 250 Hz, about 500 Hz, about 750 Hz, about 1 ,000 Hz, or about 1 ,500 Hz.
• the amplified signal is passed to a filter 1004.
• the filter comprises a low-pass, high-pass, band-pass, notch, or any combination thereof filter.
• the filter may be configured to filter the frequency band of about 1 Hz to about 70 Hz. In some embodiments, the filter may be configured to filter the frequency band of about 1 Hz to about 5 Hz, about 1 Hz to about 10 Hz, about 1 Hz to about 15 Hz, about 1 Hz to about 20 Hz, about 1 Hz to about 25 Hz, about 1 Hz to about 40 Hz, about 1 Hz to about 50 Hz, about 1 Hz to about 60 Hz, about 1 Hz to about 70 Hz, about 5 Hz to about 10 Hz, about 5 Hz to about 15 Hz, about 5 Hz to about 20 Hz, about 5 Hz to about 25 Hz, about 5 Hz to about 40 Hz, about 5 Hz to about 50 Hz, about 5 Hz to about 60 Hz, about 5 Hz to about 70 Hz, about 10 Hz to about 15 Hz, about 10 Hz to about 20 Hz, about 10 Hz to about 25 Hz, about 10 Hz to about 40 Hz,
• the systems and methods described herein may rectify 1006 the filtered signal.
• the signal will convert the alternating current detected signal to a direct current signal.
• the rectified signal may be additionally filtered with a low pass filter 1007 that may smooth the rectified signal.
• the signal may be subjected to a threshold detector 1008, where the threshold detector determines the onset of an episode of pain from a threshold intensity value of the rectified and smooth processed signals 1000 of EMG, ENG, accelerometer, gyroscope, magnetometer, pressure sensor signals, or any combination thereof. If an episode of pain is determined by the threshold detector 1008, the system may enable the delivery of electrical stimulation 1010, as described elsewhere herein.
• the method may extract training data from a database, or intake new data, described elsewhere herein.
• the preprocessing step may apply one or more transformations to standardize the training data or new data for the training step or the prediction step.
• the preprocessed training data may be passed to the training step, which may construct a machine learning model based on training data.
• the training step may further comprise a validation step, configured to validate the trained machine learning model using any appropriate validation algorithm (e.g., Stratified K-fold cross-validation).
• the k- fold cross-validation comprises at least 1-fold, 2, folds, 3 folds, 4 folds, 5 folds, 6 folds, 7 folds, 8 folds, 9 folds, or 10 folds.
• the k-fold cross-validation comprises up to 1-fold, 2 folds, 3 folds, 4 folds, 5 folds, 6 folds, 7 folds, 8 folds, 9 folds, or 10 folds.
• the training step may utilize a machine learning algorithm or other algorithm to construct and train a machine learning model to be used in the association of an excitation stimulation, sensed signal profile, and the presence or lack thereof an episode of pain.
• a machine learning model may be constructed to capture, based on the training data, the statistical relationship, if any, between excitation stimulation parameters, sensed signal profiles, and the presence or lack thereof an episode of pain.
• the machine learning algorithm may have an accuracy greater than about 60%, 70%, 80%, 85%, 90%, 95%, or 99%.
• the machine learning algorithm may have a positive predictive value greater than about 60%, 70%, 75%, 80%, 85%, 90%, 95%, or 99%.
• the machine learning algorithm may have a negative predictive value greater than about 60%, 70%, 80%, 90%, 95%, or 99%.
• Machine learning data analysis, machine learning model training, or any combination thereof may be performed using one or more of many programming languages and platforms known in the art, such as R, Weka, Python, and/or MATLAB, for example.
• closed-loop bioelectronic systems may potentially provide improved electrical stimulation devices to prevent or reduce pain of the individual.
• the use of such closed-loop bioelectronic systems may provide a more precise approach to prevent or reduce or treat pain of the individual.
• individuals having the implanted device may provide feedback to the parameters provided positive outcomes, negative outcomes, or neutral outcomes.
• positive outcomes comprise preventing an episode of pain.
• negative outcomes comprise not preventing an episode of pain, producing pain, or any combination thereof.
• neutral outcomes comprise not preventing an episode of pain, not producing pain, or any combination thereof .
• the positive outcomes, negative outcomes, neutral outcomes, sensor data, or any combination thereof from a plurality of individuals having the implanted device may be used in tuning algorithms to suggest changes to sensor thresholds and electrical stimulation patterns 124.
• the feedback and/or pain outcomes of the individual may be provided by a score or outcome of a survey, test, and/or questionnaire.
• the survey, test, and/or questionnaire may comprise the numeric pain rating scale (NPRS), patient global impression of change (PGIC), Cleveland Clinic Constipation and Incontinence Scores (CCCS and CCIS), International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF-UI), Patient Global Impression of Improvement Scale (PGI-I), Female Sexual Function Index (FSFI), McGill Pain Questionnaire (MPQ), Visual Analogue Scale (VAS), or any combination thereof.
• the feedback and/or pain outcomes of the individual may be measured.
• the pain outcomes may be measured an increase in heart rate, and/or blood pressure, that track the individual’s pain.
• the NPRS comprises a scale of 0 to 10, where a score of 0 indicates no pain and score of 10 indicates extreme pain and/or the worst pain possible reported by the individual.
• the ICIQ-SF-UI questionnaire provides one or more questions to determine frequency, severity and impact on quality of urinary incontinence of the individual.
• the PGI-I provides a seven-point scale of objective improvement to a urinary tract condition of the individual from a time point before receiving treatment to a time after receiving treatment.
• the ICIQ-SF-UI questionnaire may comprise a four-item questionnaire including three scored items and one unscored self-diagnostic item.
• the scored items of the ICIQ-SF-UI questionnaire are assigned values of 0 for no symptoms, 1 for slight symptoms, 2 for moderate symptoms, or 3 for frequent symptoms.
• the average score of the items for the scored items of the ICIQ-SF-UI questionnaire is calculated and multiplied by 33.33 arriving at scores from a range of 0 to 100, where a score of 0 is no urinary incontinence and 100 is severe urinary incontinence.
• the PGI-I scale may comprise a value of 1 corresponding to substantial improvement to the individual’s urinary tract condition and a value of 7 corresponding to substantially worsening of the individual’s urinary tract condition.
• the CCIS may comprise a score from 0 to 20, where 0 indicates perfect continence and 20 is complete incontinence. In some cases, the CCCS may comprise a score from 0 to 30, where 0 indicates no constipation and 30 indicates severe constipation.
• the FSFI comprises a 19-time survey that measures a woman’s sexual function in one or more domains. The one or more domains of the FSFI may comprise desire, arousal, lubrication, orgasm, satisfaction, pain, or any combination thereof. In some embodiments, the FSFI survey comprises a score that indicates a sum of the one or more domains, where the score may comprise a maximum of 36.
• a score of up to about 26 indicates female sexual dysfunction.
• the MPQ comprises 78 descriptors that evaluate our domains of an individual: sensory, affective, evaluative, and miscellaneous domains of an individual. Each descriptors associated with a given domain are weighted by the intensity of the descriptor on a scale of 0 as not intense, 1 mildly intense, 2 moderately intense, or 3 severe that are added together based on the individual’s select of the descriptors for the various domains.
• the VAS measures and/or assesses an individual’s pain and/or pain intensity.
• the VAS comprises a test where the test comprises a graphic display of a line (e.g., on a screen or paper) with one end point representing a value of 0 indicating no pain and another end point representing a value of 10 indicating pain as bad as it could be.
• an individual is asked to rate their pain on the VAS by drawing or indicating a line on the graphic display of the line where the individual’s pain level is at the time of the assessment.
• the electric stimulation pattern provided by an implantable pulse generator and one or more stimulator electrodes may be modified or changed to suit the needs of the individual in need thereof preventing an episode of pain.
• the one or more stimulator electrodes 122 may output an electric stimulation pattern 124 in response to what is detected by the one or more sensors 120.
• the electric stimulation pattern 124 comprises one or more electrical signals.
• the electric stimulation pattern 124 comprises a continuous wave signal (e.g., an electric stimulation signal with a constant frequency in time) and a burst or beating signal superimposed onto the continuous wave signal.
• the burst or beating signal may only be enabled for a short duration of time compared to the continual temporal aspect of the continuous wave signal.
• the combination of the continuous wave signal and/or a burst or beating signal may increase a pain threshold of a subject allowing the stimulator to provide higher amplitude electric stimulation burst pattern to prevent episode of pain.
• the frequency of the electric stimulation pattern may be modified or changed.
• the frequency pattern comprises a constant profile, swept profile, beating profile, burst profile, chirped profile, monophasic profile, biphasic profile, or any combination thereof.
• the constant profile is comprised of excitation values at a constant amplitude with a frequency value of 0 Hz.
• a swept profile comprises a signal with time varying frequency of excitation.
• a beating profile comprises any combination of one or more excitation signals of varying frequency.
• the burst profile comprises a signal with a constant frequency that is enveloped by a square, delta, sine, or any combination thereof envelope functions.
• a monophasic profile comprises an excitation signal with only positive or negative amplitude (e.g., signal with values from 0 to -5V or 0 to 5V only) with a constant frequency.
• the beating or burst profile comprises an electric stimulation pattern that is provided to a patient and/or subject for during an on-state for a first period of time and is not provided to a patient and/or subject during an off-state for a second period of time.
• beating or burst profiles may provide an excitation signal that may provide for a lengthier period of muscle excitation without suffering muscle fatigue.
• the on-state and/or off-state comprises about 0.1 second (s) to about 6.5 s. In some embodiments, the on-state and/or off-state comprises about 0.1 s to about 0.5 s, about 0.1 s to about 1 s, about 0.1 s to about 1.2 s, about 0.1 s to about 1.5 s, about 0.1 s to about 2 s, about 0.1 s to about 2.5 s, about 0.1 s to about 3 s, about 0.1 s to about 3.5 s, about 0.1 s to about 4 s, about 0.1 s to about 5 s, about 0.1 s to about 6.5 s, about 0.5 s to about 1 s, about 0.5 s to about 1.2 s, about 0.5 s to about 1.5 s, about 0.5 s to about 2 s, about 0.5 s to about 2.5 s, about 0.5 s to about 3 s, about 0.5 s to about 3.5 s.
• the on-state and/or off-state comprises at most about 0.5 s, about 1 s, about 1.2 s, about 1.5 s, about 2 s, about 2.5 s, about 3 s, about 3.5 s, about 4 s, about 5 s, or about 6.5 s.
• an electrical stimulation pattern provided during an on-state comprises an oscillating electric stimulation pattern.
• the oscillating electric stimulation pattern comprises one or more frequencies.
• the frequency of the oscillating electrical stimulation may be chosen based upon prior knowledge of how similar subjects respond with a particular frequency or range of frequencies of the oscillating electrical stimulation pattern.
• a low frequency e.g., 2-15 Hz
• a higher frequency e.g., 20 Hz or higher
• the frequency of the electrical stimulation pattern may be about 1 Hz to about 3000 Hz.
• the frequency of the electrical stimulation pattern isabout 1 Hz to about 5 Hz, about 1 Hz to about 10 Hz, about 1 Hz to about 50 Hz, about 1 Hz to about 100 Hz, about 1 Hz to about 500 Hz, about 1 Hz to about 1000 Hz, about 1 Hz to about 1500 Hz, about 1 Hz to about 2000 Hz, about 1 Hz to about 2500 Hz, about 1 Hz to about 3000 Hz, about 10 Hz to about 3000 Hz, about 50 Hz to about 2500 Hz, or about 100 Hz to about 2000 Hz.
• the amplitude of the electrical stimulation pattern may be about 1 V, about 2 V, about 3 V, about 4 V, about 5 V, about 6 V, about 7 V, about 8 V, about 9 V, about 10 V, about 12 V, or about 15 V.
• the amplitude of the electrical stimulation pattern may be at least about 1 V, about 2 V, about 3 V, about 4 V, about 5 V, about 6 V, about 7 V, about 8 V, about 9 V, about 10 V, or about 12 V. In some embodiments, the amplitude of the electrical stimulation pattern may be at most about 2 V, about 3 V, about 4 V, about 5 V, about 6 V, about 7 V, about 8 V, about 9 V, about 10 V, about 12 V, or about 15 V. In some embodiments, the amplitude refers to the mean amplitude. In some embodiments, the amplitude refers to the median amplitude. In some embodiments, the amplitude refers to the maximum amplitude. In some embodiments, the amplitude refers to peak to peak amplitude.
• the amplitude of the electrical stimulation pattern may be about 0.05 milliampere (mA) to about 10 mA. In some embodiments, the amplitude of the electrical stimulation pattern may be about 0.05 mA to about 1 mA, about 0.05 mA to about 2 mA, about 0.05 mA to about 3 mA, about 0.05 mA to about 4 mA, about 0.05 mA to about 5 mA, about 0.05 mA to about 6 mA, about 0.05 mA to about 7 mA, about 0.05 mA to about 8 mA, about 0.05 mA to about 9 mA, about 0.05 mA to about 10 mA, about 1 mA to about 2 mA, about 1 mA to about 3 mA, about 1 mA to about 4 mA, about 1 mA to about 5 mA, about 1 mA to about 6 mA, about 1 mA to about 7 m
• the senor comprises a sensor electrode, receiver, pressure sensor, accelerometer, gyroscope, magnetometer, global positioning system, or any combination thereof.
• the parameter detected by the receiver, pressure sensor, accelerometer, gyroscope, magnetometer, global positioning system, or any combination thereof is associated with a pressure, muscle contraction event, motion, orientation, posture, GPS reading, speed, location, time of day, time interval, or any combination thereof.
• the parameter detected by the sensor electrode, receiver, pressure sensor, or any combination thereof is associated with a physiological event, EMG signal, ENG signal, digital signal, patient actuated input based on perception of pain or increased pain, pressure, muscle contraction event, or any combination thereof.
• the senor comprises a casing and a lead.
• the casing is made of titanium, titanium alloy, tantalum, or any combination thereof.
• the lead is made of a metal alloy.
• a sensor and a stimulator electrode are attached to a single lead.
• the lead is electrically coupled to one or more sensors or one or more stimulator electrodes.
• a sensor and a stimulator electrode are attached to separate leads.
• the one or more sensors comprises bioelectrical sensors.
• the stimulator electrode comprises a first stimulator.
• the first stimulator is implanted at or adjacent to a first anatomical site.
• the first anatomical site is in the pelvic area.
• the first anatomical site is adjacent to or at a nerve, as described elsewhere herein.
• the first anatomical site is adjacent to or at a pudendal nerve.
• the first anatomical site is adjacent to or at a sacral nerve.
• the first anatomical site is adjacent to or at a pelvic plexus nerve.
• the stimulator electrode further comprises a second stimulator.
• the second stimulator is implanted at or adjacent to a second anatomical site.
• the second anatomical site is in the pelvic area.
• the second anatomical site is adjacent to or at a nerve.
• the second anatomical site is adjacent to or at a pudendal nerve.
• the second anatomical site is adjacent to or at a sacral nerve.
• the second anatomical site is at or adjacent to a muscle, wherein the muscle comprises a muscle cell, muscle fiber, muscle tissue, or any combination thereof.
• the second anatomical site is at or adjacent to a pelvic muscle. In some embodiments, the second anatomical site is at or adjacent to a pelvic floor muscle. (0094] In some embodiments, the first anatomical site is adjacent to or at a first pudendal nerve. In some embodiments, the second anatomical site is adjacent to or at the first pudendal nerve or a second pudendal nerve. In some embodiments, the first anatomical site is adjacent to or at a first sacral nerve. In some embodiments, the second anatomical site is adjacent to or at the first sacral nerve or a second sacral nerve.
• the first stimulator electrically stimulates a nerve or a muscle and the second stimulator electrically stimulates a nerve or a muscle.
• the nerve comprises a motor nerve fiber, a larger diameter afferent nerve, or any combination thereof.
• the nerve gates peripheral nociception, spinal activity, or any combination thereof.
• the nerve stimulates muscle contraction, modulates muscle activity, or any combination thereof.
• the muscle comprises a pelvic muscle. In some embodiments, the muscle comprises a pelvic floor muscle.
• the adapted electrical stimulation comprises one or more stimulation patterns.
• the adapted electrical stimulation comprises a first stimulation pattern.
• the first stimulation pattern is provided by the first stimulator.
• the adapted electrical stimulation comprises a second stimulation pattern.
• the second stimulation pattern is provided by the first stimulator, the second stimulator, or any combination thereof.
• the first stimulation pattern is based on a first parameter.
• the second stimulation pattern is based on the first parameter, a second parameter, or any combination thereof.
• the one or more stimulation patterns are configured to reduce pain of the episode based on at least one parameter associated with the episode of pain.
• the one or more stimulation patterns comprise excitation values for intensity, frequency, phase, pulse width, or any combination thereof.
• the first and second stimulation patters are the same.
• the first and second stimulation patters differ in at least one of intensity, frequency, phase, or pulse width.
• software is used to generate the one or more stimulation patterns based on at least a first parameter.
• software is used to generate a first stimulation pattern based on a first parameter and a second stimulation pattern based on at least one of the first parameter or a second parameter.
• the adapted electrical stimulation is further sustained, modified, redirected, withheld, or cancelled based on a second parameter and wherein the second parameter is later in time to the first parameter.
• the sensor and the stimulator electrode are electrically coupled to a processor.
• a parameter is provided by the individual via a controller in wireless communication with the processor.
• the sensor is configured to transmit data to the processor.
• the data is associated with the parameter that is detected by the sensor.
• the sensor and the stimulator electrode may be operatively coupled to a processor and a non-transitory computer readable medium that includes software.
• the sensor may be calibrated by the individual using an external input device that interfaces with the software.
• the software may be configured to record a signal from the sensor. In some embodiments, the software may be configured to adjust the sensor in response to the signal.
• the sensor and the stimulator electrode may be located on a single lead. In some embodiments, one or more sensors and one or more stimulator electrodes may be located on a single lead. In some embodiments, one sensor and one stimulator electrode may be located on a single lead. In some embodiments, the sensor and the stimulator electrode may be located on separate leads. In some embodiments, the sensor and the stimulator electrode may each be located on its own lead. In some embodiments, the one or more sensors and one or more stimulator electrodes may be in a linear geometry, triangular geometry, square geometry, hexagonal geometry, or a general polygonal geometry. In some embodiments, the electrodes located on a single lead may be spaced by a distance.
• the spacing provides the capability to stimulate multiple locations along the length of the nerve.
• the electrodes may be separated by a distance of at least about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 5 mm, about 10 mm, about 20 mm, about 30 mm, about 40 mm, about 50 mm, or about 60 mm. In some embodiments, the electrodes may be separated by a distance of at most about 1.5 mm, about 2 mm, about 2.5 mm, about 5 mm, about 10 mm, about 20 mm, about 30 mm, about 40 mm, about 50 mm, about 60 mm, or about 80 mm.
• the device comprises one or more leads. In some embodiments, the device comprises at least two leads. In some embodiments, the device comprises at least 1 , 2, 3, 4, 5, 6, 7, 8, 9, or 10 leads. In some embodiments, the device comprises at most 1 , 2, 3, 4, 5, 6, 7, 8, 9, or 10 leads. In some embodiments, the device comprises 1 , 2, 3, 4, 5, 6, 7, 8, 9, or 10 leads. In some embodiments, each lead comprises one or more electrodes. In some embodiments, the one or more electrodes comprises one or more sensor and/or stimulation electrodes. In some embodiments, the one or more electrodes on a lead comprises about 1 electrode to about 10 electrodes.
• the one or more leads comprises a length of about 20 cm to about 25 cm, about 20 cm to about 30 cm, about 20 cm to about 35 cm, about 20 cm to about 40 cm, about 20 cm to about 45 cm, about 20 cm to about 50 cm, about 25 cm to about 30 cm, about 25 cm to about 35 cm, about 25 cm to about 40 cm, about 25 cm to about 45 cm, about 25 cm to about 50 cm, about 30 cm to about 35 cm, about 30 cm to about 40 cm, about 30 cm to about 45 cm, about 30 cm to about 50 cm, about 35 cm to about 40 cm, about 35 cm to about 45 cm, about 35 cm to about 50 cm, about 40 cm to about 45 cm, about 40 cm to about 50 cm, or about 45 cm to about 50 cm.
• the one or more leads comprises a length of about 20 cm, about 25 cm, about 30 cm, about 35 cm, about 40 cm, about 45 cm, or about 50 cm. In some embodiments, the one or more leads comprises a length of at least about 20 cm, about 25 cm, about 30 cm, about 35 cm, about 40 cm, or about 45 cm. In some embodiments, the one or more leads comprises a length of at most about 25 cm, about 30 cm, about 35 cm, about 40 cm, about 45 cm, or about 50 cm.
• the one or more leads comprises a diameter.
• the diameter of the lead may vary based upon the anatomy of the individual or subject receiving the implanted device and leads.
• the lead diameter comprises a diameter, whereby the diameter provides a form factor for minimally invasive placement of the lead in the subject.
• the diameter of the lead comprises a diameter at which the lead will resist breakage.
• the one or more leads may have an outer diameter of about 0.1 mm to about 2 mm.
• the one or more leads may have an outer diameter of about 0.1 mm, about 0.2 mm, about 0.3 mm, about 0.5 mm, about 0.8 mm, about 1 mm, about 1.2 mm, about 1.4 mm, about 1.5 mm, or about 2 mm. In some embodiments, the one or more leads may have an outer diameter of at least about 0.1 mm, about 0.2 mm, about 0.3 mm, about 0.5 mm, about 0.8 mm, about 1 mm, about 1.2 mm, about 1.4 mm, or about 1.5 mm.
• the one or more leads may have an outer diameter of at most about 0.2 mm, about 0.3 mm, about 0.5 mm, about 0.8 mm, about 1 mm, about 1.2 mm, about 1.4 mm, about 1.5 mm, or about 2 mm.
• the one or more leads may be electrically coupled to the electric stimulator, described elsewhere herein.
• the one or more leads may be coupled to the stimulator and may at a later point in time be uncoupled from the stimulator.
• the one or more leads may couple to the electric stimulator with a quick release electrical coupling.
• the one or more leads may be coupled to the electric stimulator by a set screw fastener, whereby a lead is inserted into a hollow cylindrical geometry in electrical communication with the electric stimulator internal circuitry. The lead may then be fastened i.e., held in tension against the inner wall of the hollow cylindrical geometry, to the conductive hollow cylindrical geometry with a non-conductive machine set screw. The one or more leads may be placed into the electric stimulator prior to or during the surgical implantation procedure.
• the electric stimulator comprises a width and length to provide sufficient space for a battery, where the battery comprises a lifetime after which the battery may be replaced.
• the battery lifetime comprises about 5 years to about 15 years.
• the battery lifetime comprises about 5 years to about 6 years, about 5 years to about 7 years, about 5 years to about 8 years, about 5 years to about 9 years, about 5 years to about 10 years, about 5 years to about 11 years, about 5 years to about 12 years, about 5 years to about 13 years, about 5 years to about 14 years, about 5 years to about 15 years, about 6 years to about 7 years, about 6 years to about 8 years, about 6 years to about 9 years, about 6 years to about 10 years, about 6 years to about 11 years, about 6 years to about 12 years, about 6 years to about 13 years, about 6 years to about 14 years, about 6 years to about 15 years, about 7 years to about 8 years, about 7 years to about 9 years, about 7 years to about 10 years, about 7 years to about 11 years, about 6 years to about 12 years, about 6 years to about 13 years,
• the electric stimulator battery may require charging once in about 1 day to about 12 days. In some embodiments, the electric stimulator battery may require charging once in about 1 day to about 2 days, about 1 day to about 3 days, about 1 day to about 4 days, about 1 day to about 5 days, about 1 day to about 6 days, about 1 day to about 7 days, about 1 day to about 8 days, about 1 day to about 9 days, about 1 day to about 10 days, about 1 day to about 11 days, about 1 day to about 12 days, about 2 days to about 3 days, about 2 days to about 4 days, about 2 days to about 5 days, about 2 days to about 6 days, about 2 days to about 7 days, about 2 days to about 8 days, about 2 days to about 9 days, about 2 days to about 10 days, about 2 days to about 11 days, about 2 days to about 12 days, about 3 days to about 4 days, about 3 days to about 5 days, about 3 days to about 6 days, about 3 days to about 7 days, about 3 days to about 8 days, about 3 days to about 3 days to about 5 days, about
• the electric stimulator comprises a width of about 1 mm to about 50 mm. In some embodiments, the electric stimulator comprises a width of about 1 mm to about 5 mm, about 1 mm to about 10 mm, about 1 mm to about 15 mm, about 1 mm to about 20 mm, about 1 mm to about 25 mm, about 1 mm to about 30 mm, about 1 mm to about 35 mm, about 1 mm to about 40 mm, about 1 mm to about 45 mm, about 1 mm to about 50 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 5 mm to about 20 mm, about 5 mm to about 25 mm, about 5 mm to about 30 mm, about 5 mm to about 35 mm, about 5 mm to about 40 mm, about 5 mm to about 45 mm, about 5 mm to about 50 mm, about 10 mm to about 15 mm, about 10 mm to about 20 mm, about 10 mm, about 5 mm to about
• the electric stimulator comprises a width of about 1 mm, about 5 mm, about 10 mm, about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, about 45 mm, or about 50 mm. In some embodiments, the electric stimulator comprises a width of at least about 1 mm, about 5 mm, about 10 mm, about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, or about 45 mm.
• the electric stimulator comprises a width of at most about 5 mm, about 10 mm, about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, about 45 mm, or about 50 mm.
• the electric stimulator comprises a length of about 1 mm to about 50 mm. In some embodiments, the electric stimulator comprises a length of about 1 mm to about 5 mm, about 1 mm to about 10 mm, about 1 mm to about 15 mm, about 1 mm to about 20 mm, about 1 mm to about 25 mm, about 1 mm to about 30 mm, about 1 mm to about 35 mm, about 1 mm to about 40 mm, about 1 mm to about 45 mm, about 1 mm to about 50 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 5 mm to about 20 mm, about 5 mm to about 25 mm, about 5 mm to about 30 mm, about 5 mm to about 35 mm, about 5 mm to about 40 mm, about 5 mm to about 45 mm, about 5 mm to about 50 mm, about 10 mm to about 15 mm, about 10 mm to about 20 mm, about 10 mm, about 5 mm to about
• the electric stimulator comprises a height of about 0.5 mm to about 5.5 mm. In some embodiments, the electric stimulator comprises a height of about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 0.5 mm to about 2 mm, about 0.5 mm to about 2.5 mm, about 0.5 mm to about 3 mm, about 0.5 mm to about 3.5 mm, about 0.5 mm to about 4 mm, about 0.5 mm to about 4.5 mm, about 0.5 mm to about 5 mm, about 0.5 mm to about 5.5 mm, about 1 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 2.5 mm, about 1 mm to about 3 mm, about 1 mm to about 3.5 mm, about 1 mm to about 4 mm, about 1 mm to about 4.5 mm, about 1 mm to about 5 mm, about 1 mm to about 5.5 mm, about 1 mm to about 2 mm, about 1
• the electric stimulator comprises a mass of about 1 g to about 18 g. In some embodiments, the electric stimulator comprises a mass of about 1 g to about 3 g, about 1 g to about 6 g, about 1 g to about 8 g, about 1 g to about 10 g, about 1 g to about 12 g, about 1 g to about 14 g, about 1 g to about 16 g, about 1 g to about 17 g, about 1 g to about 18 g, about 3 g to about 6 g, about 3 g to about 8 g, about 3 g to about 10 g, about 3 g to about 12 g, about 3 g to about 14 g, about 3 g to about 16 g, about 3 g to about 17 g, about 3 g to about 18 g, about 6 g to about 8 g, about 6 g to about 10 g, about 6 g to about 12 g, about 6 g to about 14 g, about 6 g to about 8 g, about
• the electric stimulator may be sterilizable with conventional methods of sterilization used in the medical field, e.g., gas sterilization, steam sterilization, UV sterilization, etc.
• the one or more stimulator electrodes may provide a base electrical stimulation, or also referred herein as basal electrical stimulation, 146 and 150 for an individual experiencing pain.
• the base electrical stimulation comprises constant frequency, amplitude, current, or any combination thereof.
• the stimulator electrode may provide a temporary electrical stimulation lasting the duration of an episode of exacerbating pain 148 for an individual experiencing chronic pelvic pain.
• the stimulator electrode may provide the base electrical stimulation (i.e., an electrical stimulation comprising a basal stimulation pattern) with a temporary activated stimulation (i.e., activation stimulation pattern) lasting the duration of a pain episode.
• the patient controller module 156 comprises a direct interface to control aspects of their electrical stimulator as described herein.
• the patient controller module 156 comprises: medical information and communication band (MICS) communication platform, manual electrical stimulator control, enable or disable algorithm functionality, algorithm patient alerts, an inductive or wired charger for the implantable pulse generator rechargeable battery, or any combination thereof.
• MIMS medical information and communication band
• the patient controller module 156 may be configured to wirelessly and/or inductively charge the implantable pulse generator rechargeable battery with a recharger of the patient controller module 156.
• the patient controller module 156 may magnetically couple to the implantable pulse generator 160 from outside the subject’s skin.
• the magnetic coupling of the controller module 156 to the implantable pulse generator 160 may be made such that the coupling is ergonomic for the subject such that the subject may conduct him/herself as if the controller module 156 is not magnetically coupled to the implantable pulse generator 160.
• the patient controller module 156 comprises a battery that may be recharged through wireless inductive charging via the recharger and/or wired charging.
• a biopotential amplifier may be electrically coupled to a computation sub module comprising a classifier, control policy, real-time clock scheduler, microprocessor, or any combination thereof.
• the biopotential amplifier, classifier, control policy, real-time clock scheduler, and microprocessor, or any combination thereof may process and interpret detected myoelectric EMG signals in the patient to determine the necessary electrical stimulation pattern provided by the actuator to the one or more stimulator electrodes to prevent an episode of pain in an individual.
• the user, patient, and/or medical care personnel may double tap a user interface object and/or a physical interface e.g., a surface or button of the implanted pulse generator to enable an emergency state.
• the physical interface may comprise an interface of the implanted pulse generator that may be touched or physically pressed and/or tapped by the individual with the implant.
• the emergency state may enable the implanted stimulator to provide electrical stimulation immediately in response to the double tap command.
• a parameter or setting value of the user interface objects may be modified and/or changed by tilting the patient controller module. In some embodiments, tilting the patient controller module in a first direction may increase the parameter and/or setting value of the user interface object whereas tilting the patient controller module in a second direction opposite the first direction may decrease the parameter and/or setting value.
• the user interface between devices such as smart phones and tablets or other personal computing device comprises a scaled version of the user interface.
• the different user interface views e.g., the view shown in FIG. 7A and FIG. 7B may display varying user interface objects.
• the user interface objects comprise one or more buttons 716, switches (711,716), and/or graphical or image based representation of data (721,730, 723).
• users may customize the user interface object with a selection of one or more user interface objects (e.g., buttons, switch button to enable various device operation modes, graphical displays of device data, etc.).
• the user views may be a predetermine set of views with set user interface object.
• the user may customize and/or create one or more views accessible by a menu icon 702.
• the menu icon 702 may be configured to display one or more submenu options.
• the one or more submenu options comprises personal identification, account information, device registration, customer support, or any combination thereof submenus.
• one submenu comprises information of how to connect the device platform to pre-existing health care providers.
• the one or more user interface objects comprises text and/or mixed text and vector objects representations of the various API function calls and/or sub-user interface views, as seen in FIGS. 7A-7B.
• the user interface comprises mixed text and vector objects that permit the subject or user to activate 705 or de-activate 711 electrical stimulation of the device 716, adjust device parameters 715, indicate therapy state 717, view device measured EMG signals 721 , view stimulator electrode electrical signal characteristics (e.g., frequency, amplitude, pulse width, etc.) delivered, view a medical portal to submit user data to a health care provider, log resulting episodes of pain 719 overlaid on top of measured ENG/EMG signals, or any combination thereof.
• the user interface may further comprise a battery 712 and wireless communication connectivity indicator for the users and/or subjects to visualize patient controller module 156 operating properties.
• the patient controller module 156 comprises visual indicators (715, 717, 712), configured to indicate whether the implanted electrical stimulator is outputting electrical stimulation and/or the presence or lack thereof connectivity with a second or third device.
• the patient controller module comprises a device adjustment parameter, where the device adjustment parameter comprises a stimulation indicator, or an activation of a stimulation mode 715.
• the stimulation indicator may be in electrical communication with a processor, described elsewhere herein, configured to display a visual indicator when the stimulator is providing an electrical stimulation to a subject.
• the patient controller module comprises a connectivity indicator.
• the connectivity indicator may be in electrical communication with a processor, described elsewhere herein, and configured to provide a visual indicator when the patient controller module is connected to one or more discrete devices, data servers, local WIFI or ad-hoc WIFI networks, Bluetooth, medical implant communication system (MICS), or any combination thereof.
• the connectivity indicator may indicate the wireless connection with the implanted electrical stimulator.
• the connectivity indicator comprises one or more states.
• a first state my comprise a solid image indicator, where such a solid image indicator may notify a user, subject, individual, and/or health care personnel, a successfully established communication pairing between the patient controller module and a third device, server, etc.
• device data e.g., EMG/ENG, accelerometer, gyroscopic, magnetometer, 3-D spatial movement, global positioning system (GPS) data, or any combination thereof
• GPS global positioning system
• the duration of stimulation 227 comprises about 1 second to about 30 seconds. In some embodiments, the duration of stimulation 227 comprises about 1 second to about 2 seconds, about 1 second to about 3 seconds, about 1 second to about 4 seconds, about 1 second to about 5 seconds, about 1 second to about 10 seconds, about 1 second to about 12 seconds, about 1 second to about 14 seconds, about 1 second to about 16 seconds, about 1 second to about 20 seconds, about 1 second to about 25 seconds, about 1 second to about 30 seconds, about 2 seconds to about 3 seconds, about 2 seconds to about 4 seconds, about 2 seconds to about 5 seconds, about 2 seconds to about 10 seconds, about 2 seconds to about 12 seconds, about 2 seconds to about 14 seconds, about 2 seconds to about 16 seconds, about 2 seconds to about 20 seconds, about 2 seconds to about 25 seconds, about 2 seconds to about 30 seconds, about 3 seconds to about 4 seconds, about 3 seconds to about 5 seconds, about 3 seconds to about 10 seconds, about 3 seconds to about 12 seconds, about 3 seconds to about 14 seconds, about 3 seconds to about 16 seconds, about 3 seconds to about 5 seconds, about 3 seconds
• the extension of stimulation comprises about 1 s to about 30 s. In some embodiments the extension of stimulation comprises about 1 s to about 3 s, about 1 s to about 5 s, about 1 s to about 8 s, about 1 s to about 10 s, about 1 s to about 12 s, about 1 s to about 15 s, about 1 s to about 18 s, about 1 s to about 20 s, about 1 s to about 22 s, about 1 s to about 24 s, about 1 s to about 30 s, about 3 s to about 5 s, about 3 s to about 8 s, about 3 s to about 10 s, about 3 s to about 12 s, about 3 s to about 15 s, about 3 s to about 18 s, about 3 s to about 20 s, about 3 s to about 22 s, about 3 s to about 24 s, about 3 s to about 30 s, about 5 s to about 8 s, about 1 s to about 10 s,
• the extension of stimulation 1211 comprises about 1 s, about 3 s, about 5 s, about 8 s, about 10 s, about 12 s, about 15 s, about 18 s, about 20 s, about 22 s, about 24 s, or about 30 s. In some embodiments the extension of stimulation 1211 comprises at least about 1 s, about 3 s, about 5 s, about 8 s, about 10 s, about 12 s, about 15 s, about 18 s, about 20 s, about 22 s, or about 24 s.
• various ambulatory assessments may be taken to determine the effectiveness of the implantation procedure.
• the implanted IPG permits telemetric downloading of data (inputs, outputs, and event classification).
• the participant may be in an awake ambulatory setting and a series of resting and provoked electrophysiological data may be recorded.
• sensory and motor responses may be determined from the different sensors on the implanted leads.
• the electrodes with the most adequate response may be selected to initiate treatment.
• range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the disclosure. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1 , 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.
• a sample includes a plurality of samples, including mixtures thereof.
• determining means “determining”, “measuring”, “evaluating”, “assessing,” “assaying,” and “analyzing” are often used interchangeably herein to refer to forms of measurement and include determining if an element is present or not (for example, detection). These terms can include quantitative, qualitative, or quantitative and qualitative determinations. Assessing can be relative or absolute. “Detecting the presence of includes determining the amount of something present, as well as determining whether it is present or absent.
• a “subject” comprises a biological entity containing expressed genetic materials.
• the subject comprises an animal, mammal, or human.
• the subject is diagnosed or suspected of being at high risk for at least one of chronic pelvic pain (CPP), an associated condition, or an allied syndrome.
• CPP chronic pelvic pain
• in vivo is used to describe an event that takes place in a subject’s body.
• ex vivo is used to describe an event that takes place outside of a subject’s body.
• An “ex vivo” assay is not performed on a subject. Rather, it is performed upon a sample separate from a subject.
• An example of an “ex vivo” assay performed on a sample is an “in vitro” assay.
• a number refers to that number plus or minus 10% of that number.
• the term ‘about’ a range refers to that range minus 10% of its lowest value and plus 10% of its greatest value.
• treatment or “treating” are used in reference to an intervention regimen for obtaining beneficial or desired results in the recipient.
• beneficial or desired results include but are not limited to a therapeutic benefit and/or a prophylactic benefit.
• a therapeutic benefit may refer to prevention or amelioration of symptoms or of an underlying disorder being treated.
• a therapeutic benefit can be achieved with prevention or amelioration of one or more of the physiological symptoms associated with the underlying disorder such that an improvement is observed in the subject, notwithstanding that the subject may still be afflicted with the underlying disorder.
• a prophylactic effect includes delaying, preventing, or eliminating the appearance of a disease or a condition, delaying or eliminating the onset of symptoms of a disease or a condition, slowing, halting, or reversing the progression of a disease or a condition, or any combination thereof.
• a subject at risk of developing a particular disease or a condition, or to a subject reporting one or more of the physiological symptoms of a disease or a condition may undergo treatment.
• muscle refers to a “myocyte”, “muscle cell”, “muscle fiber”, “muscle tissue”, or any combination thereof.
• base electrical stimulation and “basal electrical stimulation” are used interchangeably.
• the term “sensor” comprises a detection apparatus that is attached to an implanted lead, including an “electrode”, “sensor electrode”, “sensory electrode”, or any combination thereof.
• the sensor detects one or more parameters associated with pain in the individual.
• electrode lead or “lead” comprises an implantable lead of an electrode that has at least one of a sensing or stimulating component, including a “stimulator”, “stimulator electrode,” “sensor,” “sensor electrode,” or any combination thereof.
• the electrode as used herein, provides an electrical signal to the target site in the individual.
• Example 3 Preventing Pain of Episodes Associated with Nerve Compression
• Example 4 Preventing and Reducing Pain of Episodes Associated with Dysrequlated Visceral Smooth Muscle Activity
• the systems, methods, and devices, described herein reduce the pain of conditions mainly associated with dysregulated visceral smooth muscle activity (e.g. painful bladder syndrome, proctalgia fugax) by modulating motor activity to affect organ smooth muscle activity, afferent gate control, anodal block, or any combination thereof.
• dysregulated visceral smooth muscle activity e.g. painful bladder syndrome, proctalgia fugax
• motor activity to affect organ smooth muscle activity, afferent gate control, anodal block, or any combination thereof.
• a pulse generator is implanted in the individual and electrically coupled to the one or more electrode leads.
• the implanted device is then configured by medical care personnel (e.g., an attending physician, nurse, or operating theater room medical support staff) based at least on the individual’s known unilateral pain.
• NPRS numeric pain rating scale
• the systems, methods, and/or devices, described elsewhere herein, may be used to treat an individual’s bladder pain syndrome.
• one or more electrode leads e.g., one or more stimulation or sensing electrodes
• the one or more electrode leads are implanted bilaterally on pudendal nerves to reduce pain and stabilize bladder functions.
• the one or more electrode leads are implanted at or adjacent a pudendal nerve and a pelvic autonomic nerve to reduce pain and facilitate bladder emptying.
• a pulse generator is implanted in the individual and electrically coupled to the one or more electrode leads in either case as described above.
• the implanted device is then configured by medical care personnel (e.g., an attending physician, nurse, or operating theater room medical support staff) based at least on the individual’s bladder pain syndrome.
• NPRS numeric pain rating scale
• the systems, methods, and/or devices, described elsewhere herein, may be used to treat an individual’s chronic anal and/or perineal pain.
• Such subjects presenting with chronic anal and/or perineal pain may have pain associated with or without defecatory symptoms including symptoms of obstructive defecation and/or fecal incontinence.
• one or more electrode leads e.g., one or more stimulation or sensing electrodes
• defecatory symptoms may be measured using other questionnaire-based scoring instruments including: Cleveland Clinic Constipation and Incontinence scores, St Marks Incontinence Score; the Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire; fecal incontinence severity index (FISI).
• PAC-SYM Patient Assessment of Constipation-Symptoms
• FISI fecal incontinence severity index

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