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WO2025136970A1 - Systèmes et procédés permettant d'ajuster automatiquement et/ou de manière incrémentielle un ou plusieurs paramètres d'administration de signal pour une neuromodulation sacrée - Google Patents

Systèmes et procédés permettant d'ajuster automatiquement et/ou de manière incrémentielle un ou plusieurs paramètres d'administration de signal pour une neuromodulation sacrée Download PDF

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Publication number
WO2025136970A1
WO2025136970A1 PCT/US2024/060559 US2024060559W WO2025136970A1 WO 2025136970 A1 WO2025136970 A1 WO 2025136970A1 US 2024060559 W US2024060559 W US 2024060559W WO 2025136970 A1 WO2025136970 A1 WO 2025136970A1
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WIPO (PCT)
Prior art keywords
patient
amplitude
signal
alert
electrical
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English (en)
Inventor
David Miller
John Morriss
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Boomerang Medical Inc
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Boomerang Medical Inc
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    • 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
    • A61N1/36062—Spinal stimulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0551—Spinal or peripheral nerve electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control
    • 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
    • A61N1/36139—Control systems using physiological parameters with automatic adjustment
    • 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
    • A61N1/3614—Control systems using physiological parameters based on impedance measurement
    • 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
    • A61N1/36146—Control systems specified by the stimulation 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
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36132—Control systems using patient feedback

Definitions

  • the present technology is directed toward electrically modulating nervous tissue to treat a patient condition.
  • IBD Inflammatory Bowel Disease
  • Crohn's disease causes intermittent inflammation of the gastrointestinal tract
  • ulcerative colitis causes continuous inflammation of the colon. Both Crohn's disease and ulcerative colitis cause similar patient symptoms, including patient discomfort (e.g., abdominal pain), abnormal gastrointestinal tract function (e.g., diarrhea), and other complications (e.g., fever, weight loss, etc.).
  • IBD is typically treated using pharmaceutical therapies including anti-inflammatory drugs and immune system suppressors. In extreme cases, patients may even undergo surgery to remove inflamed or damaged portions of the colon or other portions of the digestive tract. However, neither pharmaceuticals nor surgery cure IBD, and symptoms often persist or recur during or after treatment. Moreover, in certain patients, pharmaceuticals and surgery have minimal efficacy and/or induce unwanted side effects. Accordingly, a need exists for improved treatments for IBD.
  • Neurological stimulation systems generally have a signal generator that generates electrical pulses, and one or more signal delivery devices such as leads that deliver the electrical pulses to neurological tissue or muscle tissue.
  • the delivered electrical pulses modulate neural activity to treat an underlying patient condition.
  • neurostimulation has been used to treat various disorders such as pain, movement disorders, cardiac disorders, and various other medical conditions.
  • Sacral neuromodulation is a type of neuromodulation in which electrical stimulation is applied to one or more sacral nerves to treat a patient condition.
  • SNM has been used to treat various urological disorders, including urinary retention, urinatory incontinence, and fecal incontinence.
  • Figure 1 is a partially schematic illustration of an implantable sacral neuromodulation system positioned at a patient's sacral region to deliver electrical signals in accordance with some embodiments of the present technology.
  • Figure 1 B illustrates sacral nerve anatomy of a patient, along with a portion of a signal delivery device of the system of Figure 1A shown as implanted at a representative location in accordance with some embodiments of the present technology.
  • Figure 2A is a partially schematic illustration of an electrical signal generated in accordance with some embodiments of the present technology.
  • Figure 2B is a partially schematic illustration of another electrical signal generated in accordance with some embodiments of the present technology.
  • Figure 3 is a flowchart of a method of treating a patient using sacral nerve stimulation in accordance with embodiments of the present technology.
  • Figure 4 is a flowchart of another method of treating a patient using sacral nerve stimulation in accordance with embodiments of the present technology.
  • Figure 5 is a flowchart of a method for determining one or more signal delivery parameters of a sacral nerve stimulation electrical signal in accordance with embodiments of the present technology.
  • Figure 6 is a flowchart of a method of monitoring a patient receiving sacral nerve stimulation in accordance with embodiments of the present technology.
  • the present technology is directed to treating Inflammatory Bowel Disease (IBD) and other similar conditions using neuromodulation.
  • IBD Inflammatory Bowel Disease
  • many of the embodiments described herein include electrically stimulating one or more sacral nerves of a patient to treat the patient's IBD.
  • the electrical signal can be delivered via an implanted signal delivery device positioned proximate one or more of the patient's sacral nerves.
  • the present technology includes automatically and/or incrementally adjusting an amplitude or other signal delivery parameter of the electrical signal. This can be done according to a predefined schedule, in response to detecting changes in electrical impedance, in response to patient input, or in response to other events or inputs. Without intending to be bound by theory, automatically and/or incrementally adjusting an amplitude or other signal delivery parameter may offset potential reductions in efficacy that a patient may experience over time.
  • modulate refer generally to electrical signals that have an inhibitory, excitatory, and/or other effect on a target neural population. Accordingly, a sacral nerve “stimulator” can have an inhibitory effect and/or an excitatory effect on certain neural populations.
  • electrical therapy signal As used herein, the terms "electrical therapy signal,” “electrical signal,” “therapy signal,” “signal,” and other associated terms are used interchangeably and generally refer to an electrical signal that can be characterized by one or more parameters, such as frequency, pulse width, and/or amplitude.
  • amplitude includes both voltage-controlled amplitude ("voltage amplitude”) and current-controlled amplitude ("current amplitude”), unless the context clearly dictates otherwise.
  • the systems and methods described herein can include automatically and/or incrementally adjusting a current amplitude of an electrical signal and/or automatically and/or incrementally adjusting a voltage amplitude of an electrical signal, depending on the device.
  • voltage amplitude a device controls voltage but the current may vary.
  • current amplitude a device controls current but the voltage may vary.
  • proximate a target neural population refers to the placement of a signal delivery element such that it can deliver electrical stimulation to the target neural population.
  • the target population includes the third sacral spinal nerve
  • proximate the target neural population includes, but is not limited to, the relative lead positions described and shown in Figure 1 B, as well as other positions not expressly described herein.
  • the modulation may in some instances be directed to other neurological structures and/or target neural populations and/or other neurological tissues throughout the body.
  • some embodiments may include modulating the vagus nerve, the splenic nerve, the splanchnic nerve, and/or other peripheral nerves.
  • Some embodiments can have configurations, components, and/or procedures different than those described herein, and other embodiments may eliminate particular components and/or procedures.
  • a person of ordinary skill in the relevant art, therefore, will understand that the present disclosure may include other embodiments with additional elements, and/or may include other embodiments without several of the features shown and described below with reference to Figures 1 A-6.
  • FIG. 1A schematically illustrates a sacral neuromodulation system 100 (“the system 100") implanted to stimulate a patient's sacral nerves and configured in accordance with embodiments of the present technology.
  • the system 100 includes a signal generator 1 10 and a signal delivery device 120.
  • the signal generator 110 can be implanted and/or implantable subcutaneously within the patient P.
  • the signal generator 110 is implanted subcutaneously at the lower back/upper buttock area of the patient P (e.g., adjacent but posterior to the iliac crest IC and/or iliac fossa IF).
  • the signal delivery device 120 extends from the signal generator 1 10 and can be implanted within the patient P proximate a target neural population.
  • the target neural population includes one or more of the sacral spinal nerves (e.g., the S1 sacral nerve, the S2 sacral nerve, the S3 sacral nerve and/or the S4 sacral nerve).
  • the signal delivery device 120 can extend through one of the sacral foramen S1 -S4 (the illustrated embodiment depicts the signal delivery device 120 extending through the sacral foramen S1 ) and adjacent one or more sacral spinal nerves when implanted.
  • the signal delivery device 120 can be implanted proximate the S1 sacral nerve, the S2 sacral nerve, the S3 sacral nerve, and/or the S4 sacral nerve.
  • the signal delivery device 120 can carry features configured to administer therapy to the target neural population.
  • the signal delivery device 120 can include one or more lead(s) or lead bodies 122 extending from the signal generator 110 toward the target neural population (e.g., toward the S3 sacral nerve).
  • the lead 122 can include or carry one or more electrical contacts or electrodes (e.g., ring electrodes, cuff electrodes, and/or other suitable electrical contacts) that deliver electrical signals to the target neural population.
  • the signal generator 1 10 can generate and transmit signals (e.g., electrical signals) to the signal delivery device 120.
  • the signal delivery device 120 can deliver the electrical signals to the target neural population, e.g., to electrically modulate neurons within the target neural population to induce a therapeutic effect in the patient.
  • Representative electrical signals that can be generated by the signal generator 1 10 and delivered to the patient P via the signal delivery device 120 are described in greater detail below with reference to Figures 2A and 2B.
  • the signal generator 110 can include a machine-readable (e.g., computer- readable) medium containing instructions for generating and transmitting electrical signals. Accordingly, generating electrical signals in accordance with the methods described herein can include executing computer-executable instructions contained by, on, or in computer-readable media located within the signal generator 1 10.
  • the signal generator 110 can also include one or more processors for executing the machine- readable instructions (e.g., to perform any of the methods disclosed herein), memory unit(s), batteries (rechargeable and/or non-rechargeable), communication devices (e.g., an antenna), and/or other software or hardware-based components.
  • the signal generator 1 10 can include a single housing for storing some or all of the foregoing components, although in other embodiments some or all of the foregoing components can be stored in separate housings.
  • the signal generator 1 10 can be configured to communicate with one or more external controllers.
  • the signal generator 110 can wirelessly communicate with a physician controller (not shown) that is external to the patient P.
  • a physician or other healthcare provider can use the physician controller to program the signal generator 1 10, e.g., to select parameters for the electrical signal to be generated by the signal generator 110.
  • the signal generator 1 10 can also communicate with a patient controller that is external to the patient P.
  • the patient P can use the patient controller to control various aspects of the therapy provided by the signal generator 1 10.
  • the patient may be able to start and stop electrical stimulation therapy using the patient controller, and/or control certain parameters (e.g., amplitude) of the electrical stimulation using the patient controller.
  • the signal generator 1 10 can transmit data to the physician controller and/or the patient controller for user review.
  • the signal generator 110 may periodically (or on demand) transmit data associated with one or more of electrode impedance, battery power, program settings (e.g., current signal parameters), historical program settings (e.g., historical signal parameters), program/parameter changes, usage data (e.g., stimulation start and stop times), or the like.
  • the physician controller and the patient controller can include a dedicated controller device, or be implemented as an application on a smartphone, tablet, etc. As described below in Section C of this Detailed Description, in some embodiments the physician controller and/or the patient controller can also perform one or more operations of methods for automatically and/or incrementally adjusting signal delivery parameters.
  • the physician controller and/or the patient controller can therefore also include one or more processors for executing machine-readable instructions, e.g., to perform any of the methods described herein.
  • the system 100 can be implanted in the patient P to treat IBD or an associated condition, including Crohn's disease or ulcerative colitis.
  • the system 100 can deliver electrical signals to one or more sacral nerves of the patient to modulate the one or more sacral nerves.
  • the electrical signal can treat, reduce, and/or ameliorate the IBD.
  • the electrical signal may reduce one or more IBD-related symptoms (e.g., diarrhea, abdominal pain, weight loss, etc.), and/or reduce inflammation causing the one or more symptoms.
  • the system 100 can be implanted in the patient P to treat another disorder, such as a disorder characterized by urinary control issues (e.g., urinary retention, overactive bladder, urinary urge incontinence, urgency-frequency, etc.), fecal incontinence, or other disorders.
  • a disorder characterized by urinary control issues e.g., urinary retention, overactive bladder, urinary urge incontinence, urgency-frequency, etc.
  • fecal incontinence e.g., fecal incontinence, or other disorders.
  • the system 100 can be configured to provide bilateral sacral nerve stimulation to treat the patient's IBD. Additional details of electrical signals and stimulation regimes for treating IBD are described below with reference to Figures 2A and 2B.
  • the patient P prior to receiving the signal generator 110, the patient P undergoes a trial period during which the patient P receives electrical stimulation to determine whether the patient P responds favorably to stimulation therapy.
  • the patient P may use a temporary, external trial stimulator that generates and transmits electrical signals to the target neural population via the signal delivery device 120 or another implanted signal delivery element. If the patient responds favorably during the trial period, the patient may elect to have the signal generator 1 10 implanted to facilitate chronic stimulation therapy.
  • the trial period can be omitted, and the signal generator 1 10 can be implanted without the patient previously receiving stimulation from a temporary external signal generator.
  • FIG. 1 B is an illustration of a sacral plexus SP of a patient, along with a distal portion of the lead 122 shown as implanted at a representative location.
  • the sacral plexus SP includes four sacral spinal nerves: the first sacral nerve S1 , the second sacral nerve S2, the third sacral nerve S3, and the fourth sacral nerve S4.
  • the lead 122 is shown as extending along (e.g., proximate to) the third sacral nerve S3 such that it can electrically stimulate the third sacral nerve S3.
  • the lead 122 can be positioned proximate other sacral spinal nerves, and/or proximate other nerve fibers of the sacral plexus SP, to electrically stimulate other target tissue.
  • the lead 122 can be positioned proximate other neural structures of the sacral plexus SP.
  • Figure 1 B also shows a plurality of electrodes or electrical contacts 124a-d carried by the lead 122, as described previously. Electrical signals generated by the signal generator 1 10 and transmitted through the lead 122 can be delivered to the target neural population via the electrodes 124a-d. Although shown as having four electrodes, the lead 122 can have more or fewer electrodes, such as one, two, three, four, five, six, seven, eight, or more.
  • test stimulation may be administered to a patient during a procedure to implant the signal delivery device 120. This can be done to ensure adequate placement of the lead 122, e.g., to ensure that the electrical signals delivered via the lead 122 are applied to the target neural population.
  • test stimulation is administered at or above a sensory threshold during an implant procedure such that the patient can give intraoperative feedback about the location of the sensation, and thus the location of the lead 122.
  • test stimulation is administered at or above a motor threshold during the implant procedure, and a motor response to the test stimulation is observed to determine the location of the lead 122. In other embodiments, however, placement of the lead 122 can be confirmed using other techniques (e.g., imaging), such that intraoperative test stimulation is not required.
  • FIG 2A is a partially schematic illustration of a representative electrical signal waveform 200 ("the signal 200") generated in accordance with embodiments of the present technology.
  • the signal 200 can be generated by the system 100 (e.g., by the signal generator 110) described above with respect to Figures 1A and 1 B, or by another sacral neuromodulation system. As described throughout this Detailed Description, the signal 200 can be delivered to a patient's sacral region to treat a patient condition such as IBD.
  • the signal 200 includes repeating pulse periods 201 , with each pulse period 201 having a biphasic pulse 202 followed by an interpulse interval 212.
  • Each pulse 202 includes a first pulse phase 203 having a first polarity followed by a second pulse phase 204 having a second polarity that is opposite the first polarity.
  • the first pulse phase 203 is an anodic pulse phase and the second pulse phase 204 is a cathodic pulse phase, although in other embodiments the anodic pulse phase and the cathodic pulse phase can be reversed, such that the cathodic pulse phase is the first pulse phase and the anodic pulse phase is the second pulse phase.
  • the signal 200 includes monophasic pulses. In such embodiments, the signal 200 includes repeating pulses of the same polarity.
  • the first pulse phase 203 is separated from the second pulse phase 204 by an interphase interval 208.
  • the amplitude of the signal 200 can return to baseline (e.g., zero or about zero), although in other embodiments the amplitude of the signal 200 during the interphase interval 214 can be a non-zero value.
  • the interphase interval 208 is omitted, and the signal 200 transitions directly from the first pulse phase 203 to the second pulse phase 204.
  • the first pulse phase 203 can have a pulse width 206 within a pulse width range of from about 100 microseconds to about 2 milliseconds.
  • the first pulse phase 203 can have a pulse width 206 within a pulse width range of from about 100 microseconds to about 1 .5 milliseconds, or from about 100 microseconds to about 1 millisecond, or from about 100 microseconds to about 800 microseconds, or from about 200 microseconds to about 700 microseconds, or from about 200 microseconds to about 600 microseconds, or from about 300 microseconds to about 700 microseconds, or from about 300 microseconds to about 600 microseconds, or from about 300 microseconds to about 500 microseconds, or from about 400 microseconds to about 600 microseconds, or from about 400 microseconds to about 500 microseconds.
  • the pulse width 206 can be about 100 microseconds, about 150 microseconds, about 200 microseconds, about 250 microseconds, about 300 microseconds, about 350 microseconds, about 400 microseconds, about 450 microseconds, about 500 microseconds, about 550 microseconds, about 600 microseconds, about 650 microseconds, or about 700 microseconds.
  • the foregoing pulse width ranges and values are provided by way of example only — in some embodiments, the electrical signals described herein may have pulse width values outside the foregoing ranges.
  • the second pulse phase 204 has the same or about the same pulse width as the first pulse phase 203. Accordingly, the second pulse phase 204 can have any of the pulse widths recited above with respect to the first pulse phase 203. In other embodiments, however, the second pulse phase 204 can have a different pulse width than the first pulse phase 203. For example, if the first pulse phase 203 has a pulse width of 400 microseconds or less, the second pulse phase 204 may have a pulse width of 600 microseconds or more. Likewise, if the first pulse phase 203 has a pulse width of 600 microseconds or more, the second pulse phase 204 may have a pulse width of 400 microseconds or less.
  • the pulse width of the second pulse phase 204 can be 50%, 60%, 70%, 80%, 90%, 1 10%, 120%, 130%, 140%, 150%, 160%, 170%, 180%, 190% or 200% of the pulse width of the first pulse phase 203.
  • the first pulse phase 203 and the second pulse phase 204 can have different amplitudes such that the total charge delivered during the first pulse phase 203 and the second pulse phase 204 remains approximately the same.
  • the pulse 202 can be charge imbalanced, such that the first pulse phase 203 and the second pulse phase 204 do not deliver charges of the same magnitude.
  • charge buildup at the electrode may passively dissipate.
  • the interpulse interval 212 is a quiescent period between sequential pulses 202. During the interpulse interval 212, the signal 200 can return to a baseline amplitude (e.g., zero or about zero) such that little to no charge is administered to the patient. In some embodiments, the interpulse interval can be within an interpulse interval range of from about 1 millisecond to about 1 second, such as from about 5 milliseconds to about 500 milliseconds, or from about 50 milliseconds to about 500 milliseconds, or from about 100 milliseconds to about 300 milliseconds.
  • the electrical signals described herein may have interpulse interval values outside the foregoing ranges.
  • the duration of the interpulse interval 212 can be set independently from the duration of the pulses 202. In other embodiments, the duration of the interpulse interval 212 is set based on a selected pulse 202 duration and desired signal frequency.
  • the duration of the pulse period 201 determines the frequency of the signal 200. For example, if the duration of the pulse period 201 is 200 milliseconds, then the frequency of the signal is 5 Hz (i.e., five pulse periods 201 are delivered per second).
  • the signal 200 can have a frequency between about 0.5 Hz and about 50 Hz.
  • the signal 200 can have a frequency within a frequency range of from about 1 Hz to about 40 Hz, or from about 1 Hz to about 30 Hz, or from about 1 Hz to about 25 Hz, or from about 1 Hz to about 20 Hz, or from about 1 Hz to about 15 Hz, or from about 5 Hz to about 15 Hz, or from about 1 Hz to about 12 Hz, or from about 1 Hz to about 10 Hz, or from about 2 Hz to about 8 Hz, or from about 3 Hz to about 7 Hz, or from about 4 Hz to about 6 Hz, or from about 4.5 Hz to about 5.5 Hz, or from about 4.8 Hz to about 5.2 Hz.
  • the signal 200 can have a frequency of about 0.5 Hz, about 1 Hz, about 2 Hz, about 3 Hz, about 4 Hz, about 5 Hz, about 6 Hz, about 7 Hz, or about 8 Hz. In some embodiments, the signal 200 can have a frequency of about 4.2 Hz, about 4.4 Hz, about 4.6 Hz, about 4.8 Hz, about 5.0 Hz, about 5.2 Hz, about 5.4 Hz, about 5.6 Hz, or about 5.8 Hz.
  • the foregoing frequency ranges and values are provided by way of example only — in some embodiments, the electrical signals described herein may have frequency values outside the foregoing ranges.
  • the pulses 202 can have a current amplitude between about 0.1 mA and about 20 mA.
  • the pulses 202 have a current amplitude within a current amplitude range of from about 0.1 mA to about 10 mA, or from about 0.1 mA to about 7 mA, or from about 0.2 mA to about 6 mA, or from about 0.3 mA to about 5 mA, or from about 0.3 mA to about 4 mA, or from about 0.4 mA to about 3 mA, or from about 0.5 mA to about 3 mA, or from about 0.8 mA to about 2 mA, or from about 1 mA to about 1 .5 mA.
  • the pulses 202 can also have a voltage amplitude between about 0.1 V and 15 V.
  • the pulses 202 have a voltage amplitude within a voltage amplitude range of from about 0.1 V to about 10 V, or from about 0.2 V to about 8 V, or from about 0.2 V to about 6 V, or from about 0.3 V to about 5 V, or from about 0.3 V to about 4 V, or from about 0.4 V to about 3 V.
  • the amplitude (e.g., the current amplitude and/or the voltage amplitude) of the signal 200 is set based on an individual patient's sensory threshold and/or motor threshold.
  • the pulses 202 have a peak amplitude that is below the sensory or perception threshold of the patient.
  • the patient generally cannot actively feel the signal 200 as it is being administered.
  • the pulses 202 may have an amplitude that is 50% of sensory threshold, 60% of sensory threshold, 70% of sensory threshold, 80% of sensory threshold, 90% of sensory threshold, or 95% of sensory threshold.
  • the pulses 202 have an amplitude that is at or above the sensory threshold, such that the patient can perceive the signal 200 being delivered.
  • the pulses 202 have an amplitude that is below the motor threshold of the patient.
  • the signal 200 does not induce clinically discernable movement (e.g., muscle twitching) in the patient while being administered.
  • the pulses 202 may have an amplitude that is 50% of motor threshold, 60% of motor threshold, 70% of motor threshold, 80% of motor threshold, 90% of motor threshold, or 95% of motor threshold.
  • electrical signals generated in accordance with the present technology can have one more ramped parameters.
  • Figure 2B illustrates an electrical signal 250 ("the signal 250") with a ramped amplitude in accordance with some embodiments of the present technology.
  • the signal 250 can be generally similar to the signal 200, and can have any of the parameters and parameter values described above in connection with the signal 200. However, relative to the signal 200, an amplitude of the of the signal 250 can be ramped such that a peak amplitude of the signal 250 changes over time.
  • the signal 250 includes a plurality of pulses 252 (five pulses 252a-252e are shown), with each sequential pulse 252 having a different amplitude than the preceding pulse 252.
  • the amplitude of the signal 250 increases from pulse 252a to pulse 252c, and then decreases from pulse 252c to pulse 252e. This pattern can then be repeated.
  • the signal 250 includes multiple pulses 252 at a common amplitude before being ramped up or down to a different amplitude (e.g., multiple pulses are delivered with an amplitude equal to the pulse 252a before the signal 250 is ramped to delivering pulses with an amplitude equal to the pulse 252b).
  • the signal 250 is ramped only in a single direction (e.g., the amplitude is either increased or decreased, but not both), until a maximum or minimum amplitude is reached.
  • other parameters of the signal 250 can remain constant (e.g., unchanged) as the amplitude of the pulses 252 is ramped.
  • one or more other parameters can be ramped, in addition to the amplitude being ramped.
  • both a pulse width and an amplitude of the pulses 252 is ramped.
  • the pulse width of the pulses 252 may be inversely ramped with the amplitude, such that as the amplitude increases, the pulse width decreases, and vice versa.
  • the pulse width, frequency, or other parameter is ramped instead of the amplitude.
  • the electrical signals described herein can be administered intermittently or continuously.
  • Continuous stimulation refers to delivering the electrical signals without interruption.
  • Intermittent stimulation refers to cycling between "on" times during which the signal is being administered, and "off" times during which the signal is not being administered.
  • the "on" time can be between about 1 second and about 10 minutes, and the "off” time can be between about 1 second and about 30 minutes.
  • suitable intermittent stimulation schedules include 10 seconds on, 10 seconds off; 10 seconds on, 30 seconds off; 10 seconds on, 60 seconds off; 10 seconds on, 90 seconds off; 30 seconds on, 30 seconds off; 30 seconds on, 60 seconds off; 30 seconds on, 90 seconds off; 1 minute on, 1 minute off; 10 minutes on, 10 minutes off, etc.
  • the on times and off times are provided by way of example only — in some embodiments, the electrical signals described herein may be applied according to different on times and off times.
  • the signal can be administered according to a duty cycle of between about 0.1 % and about 100%.
  • the term duty cycle refers to the fraction of a single pulse period 201 (which consists of a single pulse 202 and a single interpulse interval 212) in which the pulse 202 is being actively delivered. That is, for a single pulse period, the duty cycle can be expressed as: (pulse width/duration of pulse period) x 100.
  • the stimulation sessions can have a duration of about 5 minutes, about 15 minutes, about 30 minutes, about 45 minutes, about 1 hour, about 1 .5 hours, about 2 hours, about 2.5 hours, about 3 hours, about 3.5 hours, or about 4 hours.
  • the patient can receive one or more stimulation sessions per day. For example, in some embodiments the patient receives a single stimulation session per day. In other embodiments, the patient receives multiple (e.g., two, three, four, etc.) discrete stimulation sessions per day. During periods between stimulation sessions, the patient generally does not receive any stimulation, or at least any clinically meaningful stimulation.
  • the foregoing representative stimulation period durations are provided by way of example only — in some embodiments, the electrical signals described herein may be applied during stimulation sessions having different durations.
  • the number and/or duration of stimulation sessions can be associated with various patient events or activities.
  • the stimulation sessions may occur while the patient is prandial.
  • the patient may receive one, two, three, or four 30-minute stimulation sessions per day, timed to occur while the patient is eating.
  • the electrical stimulation may be delivered during a single, one to six hour stimulation session per day, timed to (a) precede sleep (b) occur during sleep, or (c) both (a) and (b).
  • the electrical stimulation may be delivered during one or two one-hour stimulation sessions per day, timed to occur before, during, and/or after bowel movements.
  • the electrical stimulation may be delivered during short (e.g., 5-minute) stimulation sessions that occur each hour the patient is awake and/or active.
  • short stimulation sessions e.g., 5-minute
  • the signals can be applied using any of the signal parameters described for the signal 200 with reference to Figure 2A and the signal 250 with reference to Figure 2B.
  • the stimulation sessions can be applied at other times throughout the day, tied to other patient events, and/or according to other intervals beyond those described above.
  • the patient can control when they receive the stimulation session.
  • the patient may have access to a patient controller that can control operation of the signal generator (e.g., the signal generator 110 shown in Figure 1 A) to initiate a stimulation session.
  • a patient controller that can control operation of the signal generator (e.g., the signal generator 110 shown in Figure 1 A) to initiate a stimulation session.
  • Providing the patient with control over the timing of the stimulation sessions may be beneficial because the patient can initiate stimulation during a convenient time and/or when the patient experiences IBD symptoms (or an increase in the severity of IBD symptoms).
  • the patient may select to initiate the stimulation session during the day (e.g., as opposed to at night), while avoiding certain activities (e.g., driving, periods of concentration, etc.), and/or during or after periods or activities that may lead to an increase in symptoms (e.g., during or after consuming food).
  • a signal generator can be programmed to automatically administer the stimulation session during predetermined intervals. For example, the signal generator can be programmed to automatically deliver a stimulation session every day at 1 PM or another selected time. As another example, the signal generator can be programmed to automatically deliver a stimulation session timed with certain patient activities.
  • the signal generator can be programmed to automatically deliver a stimulation session at a time the patient typically eats a meal (e.g., 8AM, 12PM, and/or 6PM). Additionally or alternatively, the signal generator can be programmed to automatically deliver a stimulation session at a time that the patient's symptoms are typically the worst, which can be determined using patient feedback such as questionnaires, symptoms logs, etc. As yet another example, the signal generator can be programmed to automatically deliver a stimulation session based on a time the patient takes other medication (e.g., concurrent with taking medication, a specified duration before taking medication, or a specified duration after taking medication). Programming the signal generator to automatically administer the stimulation session may be advantageous because it eliminates the possibility of a patient forgetting to initiate therapy, and therefore may provide a more consistent therapy.
  • a time the patient typically eats a meal e.g., 8AM, 12PM, and/or 6PM.
  • the signal generator can be programmed to automatically deliver a stimulation session at a time that the patient's symptoms are
  • Certain patients may experience a decrease in the efficacy of sacral nerve stimulation over a period of time due to a number of different factors.
  • the target neural population may accommodate or habituate to the electrical signal, and thereby respond less to the same stimulus.
  • the effective charge being delivered to the target neural population may change (e.g., decrease) as a result of a change in electrode impedance and/or a change in the relative position of the electrode (e.g., caused by lead migration, changes in spine position, etc.). This decrease in efficacy can often be restored by changing one or more signal delivery parameters associated with the electrical signal, such as the amplitude, pulse width, frequency, etc.
  • Figure 3 is a flowchart of a method 300 for treating a patient using sacral nerve stimulation.
  • the method 300 can begin at block 302 by delivering an electrical signal to one or more sacral nerves, e.g., to treat a condition such as IBD.
  • the electrical signal can be any of the electrical signals described above in Section B of this Detailed Description.
  • the numerical value can alternatively be defined in terms of voltage amplitude (e.g., mV) for any of the foregoing values.
  • Potential percent values may range between about 0.5% and about 20%, and may include, but are not limited to, 0.5%, 1 %, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, 5%, 6%, 7%, 8%, 9%, etc.
  • the predetermined duration may range between about 1 day and about 90 days, or between about 1 day and about 60 days, or between about 1 day and about 30 days, and may include particular periods such as about 1 day, about 5 days, about 10 days, 20 days, 30 days, 40 days, 50 days, 60 days, etc.
  • the predetermined amount and/or the predetermined duration can be set by the physician. This can be done during an initial office visit during which the physician programs the sacral neuromodulation system, during one or more follow-up visits, and/or remotely. As a first example, the physician may program the system to automatically increase the stimulation amplitude by 0.1 mA every 30 days. As a second example, the physician may program the system to automatically increase the stimulation amplitude by 5% every 20 days.
  • the foregoing schedules are provided by way of example only — the present technology can include other predetermined amounts and predetermined durations, as set forth above.
  • the predetermined amount and/or the predetermined time can be based at least in part on one or more reference patient data sets.
  • a computing system and/or the physician can review the timing and degree of efficacy reduction for similarly situated patients (e.g., with the same or similar condition, same or similar symptoms, same or similar age, etc.), and use such data to predict when and to what degree the reduction in efficacy for a particular patient may occur.
  • the physician can then program the system to automatically increase the stimulation amplitude at intervals that coincide with the anticipated reduction in efficacy.
  • the operations at block 302 and 304 can be iteratively repeated for a prescribed number of amplitude increases and/or for a prescribed duration.
  • the amplitude could be increased by 1 % every day for a period of 30 days, and then cease to further increase absent patient or physician input.
  • the amplitude could be increased by 0.1 mA every 30 days for a period of 3 months.
  • the systems and methods described herein can include a limit on the amplitude increase, e.g., to reduce the likelihood of overstimulating the patient.
  • Figure 4 is a flowchart of another method 400 for treating a patient using sacral nerve stimulation. Similar to the method 300 of Figure 3, the method 400 can begin at block 402 by delivering an electrical signal to one or more sacral nerves via one or more implanted electrodes, e.g., to treat a condition such as IBD.
  • the electrical signal can be any of the electrical signals described above in Section B of this Detailed Description.
  • the method 400 can continue at block 404 by measuring an electrical impedance associated with the electrical signal.
  • Changes in electrical impedance can be caused by, among other things, lead migration, changes in spine position (e.g., lumbo-thoracic extension), tissue fibrosis, or other factors.
  • lead migration changes in spine position (e.g., lumbo-thoracic extension)
  • tissue fibrosis or other factors.
  • an increase in impedance will result in a decrease in the effective charge that reaches the target neural population, while a decrease in impedance will result in an increase in the effective charge that reaches the target neural population.
  • the electrical impedance can be monitored at block 404 to provide an estimate of the effective charge being delivered to the target neural population.
  • the electrical impedance can be continuously monitored.
  • the electrical impedance can be measured at discrete intervals (e.g., twice per hour, once per hour, once per day, once every 10 days, etc.). The discrete intervals can be selected based on expected changes in impedance over time. In yet other embodiments, the electrical impedance can be "on-demand" and triggered by the physician (e.g., during a periodic checkup) or by the patient.
  • the method 400 can continue at block 406 by, in response to measuring a change in the electrical impedance that is greater than a threshold value, changing an amplitude of the electrical signal to counter the change in impedance. For example, if the electrical impedance increases by the threshold value, the amplitude could be increased to offset the reduction in charge reaching the target neural population. Similarly, if the electrical impedance decreases by the threshold value, the amplitude could be decreased proportionally to the decrease in impedance.
  • the threshold value represents a change in impedance relative to an average impedance (such as a 24-hour average) of a specific magnitude.
  • the threshold value can be between about 1 Ohm and about 100 Ohms, such as a change relative to average of at least 1 Ohm, 2 Ohms, 3 Ohms, 4 Ohms, 5 Ohms, 6 Ohms, 7 Ohms, 8 Ohms, 9 Ohms, 10 Ohms, 15 Ohms, 20 Ohms, 25 Ohms, 30 Ohms, 40 Ohms, 50 Ohms, 60 Ohms, 75 Ohms, 100 Ohms, or other values.
  • the adjustment can be proportional to the detected change in impedance, and can be between about 0.1 mA and about 5 mA or other increments described herein.
  • the system delivering the electrical signal can be programmed to automatically adjust the amplitude in response to detecting the change in electrical impedance.
  • the method 400 can return the operation at block 402 and deliver the electrical signal to the one or more sacral nerves at the adjusted amplitude. Accordingly, the operations at block 402, 404, and 406 can be iteratively repeated such that the amplitude is continuously adjusted to account for changes in impedance. Moreover, the operations at block 404 and 406 can be performed without interrupting or otherwise stopping delivery of the electrical signal. Without being bound by theory, this is expected to reduce the patient's perception of any changes in therapy.
  • Figure 5 is another flowchart of a method 500 for determining a therapeutic amplitude for sacral nerve stimulation for a patient in need of treatment.
  • the method 500 can begin at block 502 by delivering an electrical signal to one or more sacral nerves at a first test amplitude.
  • the first test amplitude can include any of the values described herein, and can generally range between about 0.1 mA and about 20 mA, or between about 0.1 mA and about 10 mA, or any of the other current amplitude ranges described herein (for current-controlled stimulation) or between about 0.1 V and about 15 V, or between about 0.1 V and about 10 V, or any of the other voltage amplitude ranges described herein (for voltage-controlled stimulation).
  • the patient can input the patient's rating into the patient controller. Accordingly, the patient rating can be received by a computing system that is operably coupled to the patient's stimulator.
  • Additional test amplitudes can be delivered to receive additional ratings. Indeed, the method 500 can continue at block 506 by determining whether there are additional stimulation amplitudes to test. If there are, the method 500 can continue at block 508 by changing the test amplitude, e.g., to a second test amplitude. The change can be an increase or a decrease relative to the first test amplitude. The change can be defined as a numerical value (e.g., between about 0.1 mA and 5 mA) or a percent value (e.g., between about 0.5% and about 20%). The method 500 can then repeat the operations at block 502 and 504, but at the second test amplitude.
  • the change can be an increase or a decrease relative to the first test amplitude.
  • the change can be defined as a numerical value (e.g., between about 0.1 mA and 5 mA) or a percent value (e.g., between about 0.5% and about 20%).
  • the method 500 can then repeat the operations at block 502 and 50
  • the method 500 can be performed in a healthcare setting, e.g., via a physician controller that is a part of the sacral nerve stimulation system. This can be done during the initial patient visit to program the system, and/or during one or more follow-up visits.
  • the method 500 can be performed at the patient's home or without the direct supervision of a healthcare provider.
  • the patient controller can have a software program that directs the patient through the method 500 and determines, based on the patient ratings, the appropriate therapeutic amplitude.
  • the method 500 can be scheduled based on expected changes in impedance over time, such that the amplitude can be periodically adjusted to account for changes in impedance.
  • the operations described with reference to the methods 300-500 of Figures 3-5 can be performed (e.g., automatically performed) by one or more devices of a programmed neuromodulation system, such as the system 100 described with reference to FIGS. 1 A and 1 B. Accordingly, the present technology further includes programming a system to perform the operations of the methods 300- 500 of Figures 3-5, as well as systems programmed to perform the operations of the methods 300-500 of Figures 3-5.
  • patients typically can turn their implanted stimulation system on and off. For example, if the patient is receiving continuous stimulation, the patient may elect to turn stimulation off during periods in which they want a break from stimulus induced sensations. As another example, if the patient is receiving one or more discrete stimulation sessions per day, the patient may elect to turn the stimulator off during periods of non-use, e.g., to reduce the frequency with which the patient must recharge the battery. Other example situations in which a patient may wish to turn the implanted system off include MRI scans, surgeries, other medical procedures, driving, becoming pregnant, or other situations.
  • One downside of enabling a patient to turn the system off is that the patient may forget to turn the system back on. This is particularly problematic if the stimulation is being delivered below the sensation threshold, meaning that the patient cannot feel whether stimulation is being actively delivered. Forgetting to turn the system back on may contribute to a loss of treatment efficacy over time.
  • the present technology provides systems and methods expected to reduce the likelihood that a patient forgets to turn their stimulator on after turning it off.
  • the systems described herein can automatically generate an alert if the signal generator has been turned off for defined duration, which can be set by a physician and be between about 1 hour and about 5 days (e.g., off for at least one hour, off for at least one day, etc.).
  • the alert can be sent to the patient, e.g., via the patient controller or via the patient's mobile phone.
  • the systems described herein can automatically generate an alert if the patient has not initiated a stimulation session as prescribed.
  • the sacral nerve stimulation described herein is delivered during one or more discrete stimulation sessions per day.
  • a patient may be prescribed two one-hour stimulation sessions per day. If fewer than two stimulation session are administered on a given day, the systems described herein can generate an alert and display it to the patient via the patient controller. If the triggering condition responsible for the alert is not addressed within a certain time frame (e.g., within one hour, within one day, etc.), then an alert can be sent to the patient's healthcare provider.
  • a certain time frame e.g., within one hour, within one day, etc.
  • Figure 6 is a flowchart of a method 600 for monitoring a patient being treated using sacral nerve stimulation.
  • the method 600 can begin at block 602 by determining that (a) the patient has missed a stimulation session, and/or (b) the patient's stimulator has been turned off for a defined duration.
  • the operation at block 602 can be performed by the patient controller (which can be a dedicated hardware device or implemented as an application on the patient's mobile phone or tablet).
  • the patient controller can be programmed to assume that the implanted stimulator is not active and/or is turned off unless it receives a notification from the implanted stimulator indicating otherwise.
  • the patient controller can determine that the stimulator is off or is not active if it does not receive a notification from the implanted stimulator.
  • the operation at block 602 can be performed by another device, including by the implanted stimulator itself.
  • the method 600 can continue at block 604 by providing a first alert to the patient indicating that the patient has missed a stimulation session and/or that the patient's stimulator has been off for the defined duration.
  • the alert can be generated by a device operably coupled to the implanted stimulator such as the patient controller.
  • the alert can be generated by another device (e.g., the implanted stimulator) and transmitted to the patient controller for review by the patient. If the device is not within range of the patient controller, the device can store the first alert until the device is within range of the patient controller, at which point it can transmit the first alert to the patient controller.
  • the patient can silence or clear the first alert using the patient controller.
  • the patient may optionally be able to confirm they intentionally skipped the stimulation session or turned the stimulator off.
  • the first alert is only cleared once the condition that caused the first alert to be generated is cured (e.g., after the missing stimulation session is administered and/or after the stimulator is turned back on). Regardless, if a suitable response is received from the patient at block 606, then the method can continue at block 610 by turning the first alert off.
  • the system may regenerate the first alert after a predefined duration, such as after 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, or 24 hours. If the alert was cleared by the patient (either by fulfilling the triggering condition or indicating that the triggering condition was intentional), the method can return to monitoring the status of the stimulator as if the triggering condition did not occur.
  • the method 600 can continue at block 608 by providing a second alert to the patient's healthcare provider indicating that the patient has missed a stimulation session and/or that the patient's stimulator is off. The healthcare provider can then follow up with the patient as needed.
  • the operation at block 608 is performed regardless of whether the patient responds to the first alert. That is, the second alert is sent to the healthcare provider at the same time that the first alert is sent to the patient.
  • the method 600 is expected to improve patient adherence to prescribed stimulation regimens and reduce the likelihood the patient inadvertently is not receiving stimulation therapy as intended. In this way, the method 600 may help improve patient outcomes.
  • Some or all of the operations described with reference to the method 600 of Figure 6 can be performed (e.g., automatically performed) by one or more devices of a programmed neuromodulation system, such as the system 100 described with reference to FIGS. 1 A and 1 B. Accordingly, the present technology further includes programming a system to perform the operations of the method 600 of Figure 6, as well as systems programmed to perform the operations of the method 600 of Figure 6.
  • a method of treating a patient using sacral nerve stimulation comprising: delivering an electrical signal to one or more sacral nerves of the patient via one or more implanted signal delivery elements, wherein the electrical signal has an amplitude in a current amplitude range of from about 0.1 mA to about 10 mA or in a voltage amplitude range of from about 0.1 V to about 10 V; and automatically increasing the amplitude of the electrical signal by a predetermined amount after a predetermined duration.
  • a system for treating a patient comprising: an implantable signal delivery element positionable proximate a sacral nerve of the patient; and a signal generator programmed with instructions that, when executed, cause the signal generator to: deliver an electrical signal to the sacral nerve of the patient via the implantable signal delivery element, wherein the electrical signal has an amplitude in a current amplitude range of from about 0.1 mA to about 10 mA or in a voltage amplitude range of from about 0.1 V to about 10 V; and automatically increase the amplitude of the electrical signal by a predetermined amount after a predetermined duration.
  • predetermined amount is a numerical value between about 0.1 mA and about 5 mA or between about 0.1 V and about 5 V. 10. The system of example 8 wherein the predetermined amount is a percent value between about 0.5% and 20%.
  • IBD Inflammatory Bowel Disease
  • a method of treating a patient using sacral nerve stimulation comprising: delivering an electrical signal to one or more sacral nerves of the patient via one or more implanted signal delivery elements, wherein the electrical signal has an amplitude in a current amplitude range of from about 0.1 mA to about 10 mA or in a voltage amplitude range of from about 0.1 V to about 10 V; measuring an electrical impedance associated with the electrical signal; and in response to measuring a change in the electrical impedance that is greater than a threshold value, changing an amplitude of the electrical signal.
  • measuring the electrical impedance includes continuously measuring the electrical impedance.
  • a system for treating a patient comprising: an implantable signal delivery element positionable proximate a sacral nerve of the patient; and a signal generator programmed with instructions that, when executed, cause the signal generator to deliver an electrical signal to the sacral nerve of the patient via the implantable signal delivery element, wherein the electrical signal has an amplitude in a current amplitude range of from about 0.1 mA to about 10 mA or in a voltage amplitude range of from about 0.1 V to about 10 V, wherein the system is further configured to: measure an electrical impedance associated with the electrical signal; and in response to measuring a change in the electrical impedance that is greater than a threshold value, change an amplitude of the electrical signal
  • measuring the electrical impedance includes measuring the electrical impedance at predefined intervals.

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Abstract

L'invention concerne des systèmes et des méthodes permettant de traiter une maladie intestinale inflammatoire (IBD) et d'autres états à l'aide d'une neuromodulation. Par exemple, une IBD peut être traitée en administrant un signal électrique à un ou plusieurs nerfs sacrés d'un patient au moyen d'un dispositif d'administration de signal implanté, positionné à proximité d'un ou de plusieurs des nerfs sacrés du patient. Dans certains modes de réalisation, une amplitude ou un autre paramètre d'administration de signal est ajusté automatiquement et/ou de manière incrémentielle pour décaler des réductions potentielles dans l'efficacité de la stimulation des nerfs sacrés.
PCT/US2024/060559 2023-12-20 2024-12-17 Systèmes et procédés permettant d'ajuster automatiquement et/ou de manière incrémentielle un ou plusieurs paramètres d'administration de signal pour une neuromodulation sacrée Pending WO2025136970A1 (fr)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100280569A1 (en) * 2007-08-28 2010-11-04 Eric Bobillier Device and method for reducing weight
US20210046317A1 (en) * 2019-08-12 2021-02-18 Auckland Uniservices Limited Sacral nerve stimulation
US20210252278A1 (en) * 2018-01-17 2021-08-19 Cala Health, Inc. Systems and methods for treating inflammatory bowel disease through peripheral nerve stimulation
US11123569B2 (en) * 2015-01-09 2021-09-21 Axonics, Inc. Patient remote and associated methods of use with a nerve stimulation system
US20230017399A1 (en) * 2016-02-29 2023-01-19 Galvani Bioelectronics Limited Neuromodulation Device

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100280569A1 (en) * 2007-08-28 2010-11-04 Eric Bobillier Device and method for reducing weight
US11123569B2 (en) * 2015-01-09 2021-09-21 Axonics, Inc. Patient remote and associated methods of use with a nerve stimulation system
US20230017399A1 (en) * 2016-02-29 2023-01-19 Galvani Bioelectronics Limited Neuromodulation Device
US20210252278A1 (en) * 2018-01-17 2021-08-19 Cala Health, Inc. Systems and methods for treating inflammatory bowel disease through peripheral nerve stimulation
US20210046317A1 (en) * 2019-08-12 2021-02-18 Auckland Uniservices Limited Sacral nerve stimulation

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