Systems and methods for treating inflammatory bowel disease and fecal incontinence using sacral nerve stimulation

Abstract

Systems and methods for treating Inflammatory Bowel Disease (IBD) and Fecal Incontinence (FI) using neuromodulation are described herein. For example, IBD and FI can be treated by delivering an electrical signal to one or more sacral nerves of a patient via an implanted signal delivery device positioned proximate one or more of the patient's sacral nerves. In some embodiments, a first electrical signal is delivered to the patient's sacral nerve(s) with parameters selected to treat IBD and a second electrical signal is delivered to the patient's sacral nerve(s) with parameters selected to treat FI. The first and second electrical signals can be delivered in cycles that do not temporally overlap, or in an at least partially temporally overlapping pattern.

Description

SYSTEMS AND METHODS FOR TREATING INFLAMMATORYBOWEL DISEASE AND FECAL INCONTINENCE USING SACRALNERVE STIMULATIONCROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] The present application claims priority to U.S. Provisional Patent Application No. 63 / 609,097, filed December 12, 2023, the disclosure of which is incorporated by reference herein in its entirety.TECHNICAL FIELD

[0002] The present technology is directed toward electrically modulating nervous tissue to treat a patient condition.BACKGROUND

[0003] Inflammatory Bowel Disease (IBD) is a digestive disorder characterized by chronic inflammation of the gastrointestinal tract. IBD includes both Crohn's disease, which causes intermittent inflammation of the gastrointestinal tract, and ulcerative colitis, which 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.

[0004] Fecal Incontinence (Fl) is another gastrointestinal disorder characterized by the inability of a patient to control bowel movements, including the involuntary loss of liquid or solid stool. In some patients, Fl is caused by transient episodes of diarrhea and / or constipation, with the Fl improving once the diarrhea and / or constipation is resolved. In other patients, however, Fl is caused by nerve damage, muscle damage,chronic diarrhea, chronic constipation, hemorrhoids, rectal prolapse, or other conditions. Fl is typically treated using pharmaceutical therapies targeting the underlying cause of the Fl (e.g., anti-diarrheal drugs such as loperamide for diarrhealbased Fl, laxatives such as methylcellulose for constipation-based Fl, etc.). However, in certain patients pharmaceuticals have minimal efficacy and / or induce unwanted side effects.

[0005] Many patients experience both IBD and Fl. For example, a study by Kamal et al. reported that 14% of patients with IBD also have Fl. Kamal N. et al., "Fecal Incontinence in Inflammatory Bowel Disease," Crohns Colitis 360, v.3:2 (April 2021 ). Despite these conditions commonly occurring together, the underlying pathophysiology for IBD and Fl are different, and therefore the treatments differ. Accordingly, a need exists for effective interventions that can address both IBD and Fl.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] Figure 1A 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.

[0007] 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.

[0008] Figure 2A is a partially schematic illustration of an electrical signal generated in accordance with some embodiments of the present technology.

[0009] Figure 2B is a partially schematic illustration of another electrical signal generated in accordance with some embodiments of the present technology.

[0010] Figure 3A is a schematic diagram of a stimulation pattern for treating both IBD and Fl in accordance with embodiments of the present technology.

[0011] Figure 3B is a schematic diagram of another stimulation pattern for treating both IBD and Fl in accordance with embodiments of the present technology.

[0012] Figure 4 is a schematic illustration of a signal delivery device and a stimulation pattern for concurrently delivering IBD and Fl stimulation in accordance with some embodiments of the present technology.DETAILED DESCRIPTIONA. Introduction

[0013] The present technology is directed to treating Inflammatory Bowel Disease (IBD) and / or Fecal Incontinence (Fl) using neuromodulation. For example, many of the embodiments described herein include electrically stimulating one or more sacral nerves of a patient to treat the patient's IBD and Fl. As described in detail throughout this Detailed Description, a first electrical signal can be delivered to the patient's sacral nerve(s) with parameters selected to treat IBD and a second electrical signal can be delivered to the patient's sacral nerve(s) with parameters selected to treat Fl. For example, the first electrical signal may have a first frequency within a first frequency range of between about 1 Hz and about 10 Hz and can be delivered during a discrete stimulation period having a duration of between about 15 minutes and about 4 hours, whereas the second electrical signal may have a second frequency within a second frequency range of from about 10 Hz to about 60Hz. The first and second electrical signals can be delivered in cycles that do not temporally overlap, or concurrently in an at least partially temporally overlapping pattern. Without intending to be bound by theory, utilizing two separate electrical signals to individually treat concurrent IBD and Fl is expected to be more effective in certain patients than using a single electrical signal that has parameters optimized for treating only one of Fl or IBD, or has modified parameters that are not optimized for treating either IBD or Fl.

[0014] Unless otherwise stated, the terms "generally," "about," and "approximately" refer to values within 10% of a stated value. For example, the use of the term "about 100" refers to a range of 90 to 110, inclusive. In instances in which relative terminology is used in reference to something that does not include a numerical value, the terms are given their ordinary meaning to one skilled in the art.

[0015] As used herein, and unless otherwise noted, the terms "modulate," "modulation," "stimulate," and "stimulation" 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.

[0016] 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.

[0017] As used herein, "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. For example, if 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.

[0018] Specific details of certain embodiments of the disclosure are described below with reference to methods for modulating one or more target neural populations (e.g., nerves) or sites of a patient, and associated implantable structures for providing the modulation. Although selected embodiments are described below with reference to modulating the sacral nerves, 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. For example, 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-4.B. Representative Embodiments of Sacral Neuromodulation Systems and Associated Stimulation Waveforms

[0019] Figure 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 asignal generator 1 10 and a signal delivery device 120. The signal generator 110 can be implanted and / or implantable subcutaneously within the patient P. For example, in the illustrated embodiment 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).

[0020] 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. In some embodiments, 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). Accordingly, in some embodiments 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. More specifically, 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. For example, 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). As described in greater detail with reference to Figure 1 B, 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.

[0021] In operation, the signal generator 1 10 can generate and transmit signals (e.g., electrical signals) to the signal delivery device 120. In turn, 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.

[0022] 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 methodsdescribed 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, memory unit(s), batteries (rechargeable and / or non- rechargeable), communication devices (e.g., an antenna), and / or other software or hardware-based components. As shown in Figure 1 A, 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.

[0023] In some embodiments, the signal generator 1 10 can be configured to communicate with one or more external controllers. For example, 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. In some embodiments, 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. For example, 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. In some embodiments, the signal generator 1 10 can transmit data to the physician controller and / or the patient controller for user review. For example, 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.

[0024] In some embodiments, the system 100 can be implanted in the patient P to treat IBD or an associated condition, including Crohn's disease or ulcerative colitis. For example, the system 100 can deliver electrical signals to one or more sacral nerves of the patient to modulate the one or more sacral nerves. As described in detail throughout this Detailed Description, the electrical signal can treat, reduce, and / or ameliorate theIBD. For example, 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.

[0025] In some embodiments, the system 100 can be implanted in the patient P to treat Fl. For example, the system 100 can deliver electrical signals to one or more sacral nerves of the patient to modulate the one or more sacral nerves. As described in detail throughout this Detailed Description, the electrical signal can treat, reduce, and / or ameliorate the Fl. For example, the electrical signal may reduce the number or frequency of involuntary leakage episodes associated with the patient's Fl.

[0026] As described in greater detail below in Section C, the system 100 can also be implanted in the patient P to treat both IBD and Fl. In such embodiments, the system 100 can deliver a first electrical signal having a first set of signal delivery parameters selected or optimized to treat the patient's IBD, and a second electrical signal having a second set of signal delivery parameters selected or optimized to treat the patient's Fl. The first and second electrical signal can be delivered separately at different times (e.g., in cycles) and / or concurrently throughout a portion or all of a stimulation period.

[0027] Moreover, although shown as providing unilateral stimulation, in some embodiments 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.

[0028] In some embodiments, 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. During the trial period, 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. In some embodiments, 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.

[0029] Figure 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. In other embodiments, however, 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. In yet other embodiments, the lead 122 can be positioned proximate other neural structures of the sacral plexus SP.

[0030] 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.

[0031] In some embodiments, 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. In some embodiments, 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. In some embodiments, 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.

[0032] Figure 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 DetailedDescri ption , the signal 200 can be delivered to a patient's sacral region to treat a patient condition such as IBD and / or Fl.

[0033] 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. For example, in the illustrated embodiment 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. In other embodiments, the signal 200 includes monophasic pulses. In such embodiments, the signal 200 includes repeating pulses of the same polarity.

[0034] In some embodiments, the first pulse phase 203 is separated from the second pulse phase 204 by an interphase interval 208. During the 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. In some embodiments, the interphase interval 208 is omitted, and the signal 200 transitions directly from the first pulse phase 203 to the second pulse phase 204.

[0035] 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. For example, 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. For example, in some embodiments 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 400microseconds, 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.

[0036] In some embodiments, 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.

[0037] Regardless of whether the first pulse phase 203 and the second pulse phase 204 have the same pulse width, a total charge delivered during the second pulse phase 204 can be equal or approximately equal in magnitude and opposite in polarity from the total charge delivered during the first pulse phase 203. In this way, the second pulse phase 204 is a charge balancing pulse that prevents or at least reduces charge buildup at the electrode used to deliver the signal 200. Accordingly, in embodiments for which the first pulse phase 203 and the second pulse phase 204 have an equal or approximately equal pulse width, the first pulse phase 203 and the second pulse phase 204 can have an equal or approximately equal and opposite amplitude. In embodiments in which the first pulse phase 203 and the second pulse phase 204 have different pulse widths, 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. In other embodiments, 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. In such embodiments, charge buildup at the electrode may passively dissipate.

[0038] 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 foregoing interpulse interval ranges and values are provided by way of example only — in some embodiments, the electrical signals described herein may have interpulse interval values outside the foregoing ranges. In some embodiments, 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.

[0039] 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 60 Hz. For example, 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. In other embodiments, 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. In other embodiments, the signal 200 can have a frequency of about 10 Hz, about 1 1 Hz, about 12 Hz, about 13 Hz, about 14 Hz, about 15 Hz, about 16 Hz, about 17 Hz, or about 18 Hz. As described in detail below in Section C, the frequency can be selected based at least in part on the indication (e.g., IBD vs. Fl) that the signal is targeting. 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.

[0040] The pulses 202 can have a current amplitude between about 0.1 mA and about 20 mA. For example, in some embodiments the pulses 202 have a current amplitude within a current amplitude range of from about 0.5 mA to about 15 mA, or from about 1 mA to about 12 mA, or from about 2 mA to about 12 mA, or from about 3 mA to about 10 mA. The pulses 202 can also have a voltage amplitude between about 0.1 V and 15 V. For example, in some embodiments 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 0.5 V to about 4 V. In some embodiments, 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. For example, in some embodiments the pulses 202 have a peak amplitude that is below the sensory or perception threshold of the patient. In such embodiments, the patient generally cannot actively feel the signal 200 as it is being administered. For example, 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. In other embodiments, 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. In yet other embodiments, the pulses 202 have an amplitude that is below the motor threshold of the patient. In such embodiments, the signal 200 does not induce clinically discernable movement (e.g., muscle twitching) in the patient while being administered. For example, 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.

[0041] In some embodiments, electrical signals generated in accordance with the present technology can have one more ramped parameters. For example, 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. In the illustrated embodiment, for example, 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 precedingpulse 252. More specifically, 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. In some embodiments, 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). Although shown as being ramped in two directions, in other embodiments 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.

[0042] In some embodiments, other parameters of the signal 250 (e.g., pulse width, interpulse interval, frequency, etc.) can remain constant (e.g., unchanged) as the amplitude of the pulses 252 is ramped. In other embodiments, one or more other parameters can be ramped, in addition to the amplitude being ramped. For example, in some embodiments both a pulse width and an amplitude of the pulses 252 is ramped. In such embodiments, 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. Moreover, in some embodiments the pulse width, frequency, or other parameter is ramped instead of the amplitude.

[0043] The electrical signals described herein (e.g., the signal 200 of Figure 2A and the signal 250 of Figure 2B) 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. In some embodiments, the "on" time can be between about 1 second and about 30 minutes, and the "off" time can be between about 1 second and about 30 minutes. Representative examples of 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.

[0044] Regardless of whether the signal is administered intermittently or continuously, the signal can be administered according to a duty cycle of between about 0.1 % and about 100%. As used herein, and referring again to Figure 2A, 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. For example, if a pulse period comprises (1 ) a biphasic pulse with no interphase interval and with each phase of the pulse having a pulse width of 500 microseconds, followed by (2) an interpulse interval having a duration of 99 milliseconds (e.g., before the following pulse period begins), the duty cycle is 1 % (1 millisecond combined pulse width / 100 millisecond pulse period duration, x 100). In this way, the term duty cycle is different than the term intermittent, which generally refers to delivering sequential pulse periods in a row for a first duration (e.g., 10 seconds), followed by a quiescent period during which no pulse periods are delivered for a second duration (e.g., for 90 seconds).

[0045] In some embodiments, the electrical signals described herein (e.g., the signal 200 of Figure 2A and the signal 250 of Figure 2B) are administered during discrete stimulation sessions or periods that have a duration less than 24 hours. For example, the stimulation sessions may have a duration of between about 5 minutes and about 12 hours, such as between about 15 minutes and about 6 hours, or between about 15 minutes and about 4 hours, or between about 15 minutes and about 3 hours, or between about 15 minutes and about 2 hours, or between about 30 minutes and about 3 hours, or between about 30 minutes and about 2 hours, or between about 30 minutes and about 1 .5 hours, or between about 45 minutes and about 1 .5 hours. In some embodiments, 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. The foregoing representative stimulation period durations are provided by way of example only — in some embodiments, the electrical signalsdescribed herein may be applied during stimulation sessions having different durations. In some embodiments, electrical stimulation is applied for 24 hours per day.C. Stimulation Patterns for Treating both IBP and Fl

[0046] Sacral nerve stimulation has been shown to be effective in treating both IBD and Fl. However, the preferred or optimal stimulation parameters for treating IBD and Fl may not be the same. For example, stimulation programs designed to treat IBD may be delivered during discrete stimulation sessions or periods that generally have a duration of about 4 hours or less, whereas stimulation programs designed to treat Fl may be continuous or substantially continuous. As another example, stimulation waveforms designed to treat IBD may have a first frequency or frequency range, whereas stimulation waveforms designed to treat Fl may have a second frequency or frequency range different than the first frequency range. The first frequency (or the first frequency range) is generally lower than the second frequency (or the second frequency range).

[0047] The present technology provides systems and methods for treating both IBD and Fl in a patient without having to modify or otherwise "compromise" which signal delivery parameters are used. For example, the systems and methods described herein include delivering both a first electrical signal having a first set of signal delivery parameters selected to treat IBD (referred to herein as "IBD stimulation") and a second electrical signal having a second set of signal delivery parameters selected to treat Fl (referred to herein as "Fl stimulation"). As described in detail below with reference to Figures 3A-4, the IBD stimulation and the Fl stimulation can be delivered in various patterns, including in cycles (e.g., multiplexed without temporally overlapping) or concurrently (e.g., with full or partial temporal overlap over a given period).

[0048] Figure 3A is a schematic diagram of a first stimulation pattern 300 for treating both IBD and Fl in accordance with embodiments of the present technology. As shown, the IBD stimulation can be delivered during a single discrete stimulation session per 24-hour period that lasts one hour or about one hour (e.g., IBD stimulation is delivered between tO and t1 ). The IBD stimulation is not delivered during the other portions of the 24-hour period (e.g., IBD stimulation is not delivered between t1 and t24). Fl stimulation can be delivered during the portion of the 24-hour period that IBD stimulation is not being delivered (e.g., Fl stimulation is delivered between t1 and t24).In the illustrated embodiment, Fl stimulation is not delivered during the discrete IBD stimulation sessions (e.g., between tO and t1 ). Accordingly, in the illustrated embodiment the IBD stimulation sessions and the Fl stimulation sessions do not temporally overlap, but rather alternate. This pattern of alternating or cycling between a discrete IBD stimulation session and a prolonged Fl stimulation session can then be repeated over subsequent 24-hour periods.

[0049] Figure 3B is a schematic diagram of a second stimulation pattern 310 for treating both IBD and Fl in accordance with embodiments of the present technology. As shown, the IBD stimulation can be delivered during a plurality (e.g., four) discrete stimulation sessions per 24-hour period that last one hour or about one hour each. For example, in the illustrated embodiment the IBD stimulation is delivered during a first discrete stimulation session from tO to t1 , a second discrete stimulation session from t6 to t7, a third discrete stimulation session from t12 to t13, and a fourth discrete stimulation session from t18 to t19. Fl stimulation can be delivered during the periods that IBD stimulation is not being delivered. For example, in the illustrated embodiment the Fl stimulation is delivered in five-hour blocks between IBD stimulation sessions, e.g., between t1 -t6, t7-t12, t13-t18, and t19-t24, inclusive of endpoints. Like the first stimulation pattern 300 shown in Figure 3A, the IBD stimulation and the Fl stimulation sessions do not temporally overlap in the second stimulation pattern 310.

[0050] Although the IBD stimulation sessions are shown as having a duration of one hour or about one hour in both Figures 3A and 3B, in other embodiments the IBD stimulation sessions can have other durations. For example, the IBD stimulation sessions can have a duration of between about 15 minutes and about 4 hours, or between about 30 minutes and about 2 hours, such as about 30 minutes, about 45 minutes, about 1 hour, about 1 .25 hours, about 1 .5 hours, about 1 .75 hours, or about 2 hours, or other durations described throughout this Detailed Description. The number of IBD stimulation sessions can also vary. For example, although the first stimulation pattern 300 of Figure 3A illustrates a single IBD stimulation session per day and the second stimulation pattern 310 of Figure 3B illustrates four IBD stimulation sessions per day, in other embodiments there can be two, three, five, six or more IBD stimulation sessions per day. In such embodiments, the IBD stimulation sessions can be equally spaced throughout a 24-hour period, and Fl stimulation can be delivered between the IBD stimulation sessions.

[0051] The IBD stimulation and the Fl stimulation can have different signal delivery parameters selected to treat IBD and Fl, respectively. For example, the IBD stimulation may have a first frequency within a first frequency range of 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, such as about 3 Hz, about 4 Hz, about 5 Hz, about 6 Hz, or about 7 Hz. In contrast, the Fl stimulation may have a second frequency within a second frequency range of from about 10 Hz to about 60 Hz, or from about 10 Hz to about 50 Hz, or from about 10 Hz to about 40 Hz, such as about 14 Hz, about 18 Hz, about 22 Hz, about 26 Hz, about 31 Hz, or about 36 Hz. Accordingly, IBD stimulation may generally have a lower frequency than Fl stimulation. The foregoing frequencies and frequency ranges are provided as examples only — in some embodiments, the electrical signals described herein may have frequency values outside the foregoing ranges. Other parameters, including pulse width, amplitude, and duty cycle, can also differ between the IBD stimulation and the Fl stimulation.

[0052] The IBD stimulation and / or the Fl stimulation can be delivered intermittently during the IBD stimulation period and the Fl stimulation period. For example, one or both of the IBD stimulation and the Fl stimulation can be delivered with any of the intermittent stimulation patterns described throughout this Detailed Description, including 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. Alternatively, one or both of the IBD stimulation and the Fl stimulation can be delivered continuously during the IBD stimulation cycle and the Fl stimulation cycle. Further, regardless of whether the IBD stimulation and the Fl stimulation are delivered intermittently or continuously, the IBD stimulation and the Fl stimulation can be delivered according to a duty cycle, as described previously.

[0053] The IBD stimulation and the Fl stimulation can be delivered using the same sacral neuromodulation system (e.g., the system 100 of Figure 1 A). The IBD stimulation and the Fl stimulation can be generated by the same signal generator (e.g., the signal generator 1 10 of Figure 1 A) and delivered to a target neural population via the same signal delivery device (e.g., the signal delivery device 120 of Figures 1 A and 1 B). In some embodiments, the IBD stimulation and the Fl stimulation are delivered using the same, or at least overlapping, set of electrical contacts. In other embodiments, the IBDstimulation and the Fl stimulation are delivered using different, non-overlapping electrical contacts. In such embodiments, the different, non-overlapping electrical contacts can nevertheless be positioned on a common lead.

[0054] The IBD stimulation and the Fl stimulation can be delivered in different stimulation patterns than those illustrated in Figures 3A and 3B. For example, rather than cycling between one or more discrete IBD stimulation sessions and Fl stimulation, in some embodiments the IBD stimulation can be continually interspersed with the Fl stimulation. This includes mixing IBD stimulation and Fl stimulation at a predetermined ratio. For example, if the IBD stimulation has a frequency of 5 Hz and the Fl stimulation has a frequency of 14 Hz, the electrical stimulation could repeatedly cycle between being administered at 5 Hz and at 14 Hz according to the predetermined ratio. Representative predetermined ratios of IBD stimulation to Fl stimulation include 1 :23, 2:22, 3:21 , 4:20, and the other similar ratios. The cycling could be administered on a defined and repeating pattern (e.g., IBD stimulation is delivered for 1 minute followed by 23 minutes of Fl stimulation, repeated for 24 hours) or stochastically generated to continuously vary the pattern.

[0055] Another example stimulation pattern includes changing stimulation parameters between subsequent "on" periods of the intermittent stimulation. For example, stimulation could be administered in intermittent patterns such as 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 stimulation parameters could alternate between IBD stimulation (e.g., at 5 Hz) and Fl stimulation (e.g., at 14 Hz) over subsequent "on" periods of the intermittent stimulation. For example, a first "on" period could include delivering IBD stimulation (e.g., at 5 Hz), a second "on" period could include delivering Fl stimulation (e.g., at 14 Hz). In some embodiments, signal frequency can vary between each subsequent "on" period, such as between 2 Hz and 40 Hz. In some embodiments, rather than defining the "on" periods by a particular duration, the "on" periods can be defined by a number of pulses to be delivered at a given frequency. In such embodiments, "on" periods for lower frequencies will have a longer duration than "on" periods for high frequencies if the number of pulses being administered are the same.

[0056] Any of the foregoing stimulation patterns can further include one or more quiescent periods in which no stimulation, or at least no clinically meaningful stimulation, is delivered to the patient. The quiescent periods can have a duration of between about 30 minutes and about 6 hours, or between about 30 minutes and about 3 hours, or between about 30 minutes and about 2 hours. Without intending to be bound by theory, incorporating quiescent periods into the stimulation patterns may allow the stimulated nerves to return to a baseline state, reducing the likelihood of accommodation or habituation. This may also allow for neurologic consolidation.

[0057] The stimulation can also be ramped as it transitions between "off" and "on" periods or between IBD stimulation and Fl stimulation. For example, the amplitude of the signal can be gradually and incrementally ramped up to a target amplitude over a ramping period, which can be between about 2 seconds and about 1 minute, or between about 3 seconds and 30 seconds, or over other suitable timeframes. Other parameters such as frequency and pulse width can also be ramped. Without intending to be bound by theory, ramping the transition between "off" and "on" periods and / or between IBD and Fl stimulation may make the changes in stimulation less jarring or surprising to the patient in embodiments in which the stimulation is being delivered above the sensation threshold.

[0058] The foregoing stimulation patterns each involve cycling between IBD stimulation and Fl stimulation in a non-temporally overlapping manner. However, the present technology further includes embodiments in which the IBD stimulation and the Fl stimulation are administered concurrently. In such embodiments, IBD stimulation can be delivered via one or more first channels coupled to one or more first electrical contacts, and Fl stimulation can be delivered via one or more second channels coupled to one or more second electrical contacts. The first and second electrical contacts can be on the same or different lead, and the IBD stimulation and the Fl stimulation can be generated by the same or different signal generator.

[0059] Figure 4 is a schematic illustration of a portion of the lead 122 of the signal delivery device 120 of Figures 1 A and 1 B and illustrates a pattern of concurrently delivering IBD stimulation and Fl stimulation in accordance with embodiments of the present technology. As shown, IBD stimulation can be delivered using the first electrode 124a and the second electrode 124b, and Fl stimulation can be delivered using the thirdelectrode 124c and the fourth electrode 124d. In this way, IBD stimulation and Fl stimulation can be delivered at the same time. However, the IBD stimulation and the Fl stimulation can still be delivered according to various stimulation schedules. For example, the IBD stimulation can be administered in one or more discrete stimulation sessions per day that generally have a duration of less than about 4 hours, such as about 1 hour, while the Fl stimulation can be administered continuously or nearly continuously for 24 hours. Indeed, any of the stimulation parameters described throughout this Detailed Description can be used for the IBD stimulation and the Fl stimulation because each stimulation type can be separately programmed without needing to account for the other stimulation type. Delivering IBD stimulation and Fl stimulation from separate electrodes or electrode pairs therefore eliminates the need to cycle between IBD stimulation and Fl stimulation.

[0060] Other electrode combinations can also be used. For example, the IBD stimulation can be administered using any combination of one or more of the electrodes 124, and the Fl stimulation can be administered using any combination of the remaining one or more electrodes 124. For example, the IBD stimulation could be administered via the first electrode 124a and the fourth electrode 124d, and the Fl stimulation could be administered via the second electrode 124b and the third electrode 124c. As another example, the IBD stimulation could be administered via the second electrode 124b and the fourth electrode 124d, and the Fl stimulation could be administered via the first electrode 124a and the third electrode 124c. The foregoing are provided by way of example only — in other embodiments the IBD stimulation and Fl stimulation are delivered using other electrode combinations.D. Representative Examples

[0061] The following examples are provided to further illustrate embodiments of the present technology and are not to be interpreted as limiting the scope of the present technology. To the extent that certain embodiments or features thereof are mentioned, it is merely for purposes of illustration and, unless otherwise specified, is not intended to limit the present technology. It will be understood that many variations can be made in the procedures described herein while still remaining within the bounds of the present technology. Such variations are intended to be included within the scope of the presently disclosed technology.1. A method of using sacral nerve stimulation to treat a patient with Inflammatory Bowel Disease (IBD) and Fecal Incontinence (Fl), the method comprising: delivering a first electrical signal having a first frequency within a first frequency range of from about 1 Hz to about 10 Hz to a sacral nerve of the patient for a first stimulation period, wherein the first electrical signal treats the patient's IBD; and delivering a second electrical signal having a second frequency that is different than the first frequency and is within a second frequency range of from about 10 Hz to about 60 Hz to the sacral nerve of the patient for a second stimulation period, wherein the second electrical signal treats the patient's Fl, wherein the first electrical signal and the second electrical signal are delivered in cycles.2. The method of example 1 wherein the first stimulation period has a duration of between about 15 minutes and about 4 hours.3. The method of example 1 or example 2 wherein the first stimulation period has a duration of between about 30 minutes and about 2 hours.4. The method of any of examples 1 -3 wherein the first electrical signal is administered during a single stimulation session per 24-hour period.5. The method of any of examples 1 -3 wherein the first electrical signal is administered during two, three, or four stimulation sessions per 24-hour period.6. The method of example 1 wherein delivery of the first electrical signal is interspersed with delivery of the second electrical signal according to a predetermined ratio of between about 1 :23 and 4:20.7. The method of any of examples 1 -5 wherein the first electrical signal is delivered intermittently during the first stimulation period, and / or wherein the second electrical signal is delivered intermittently during the second stimulation period.8. The method of any of examples 1 -5 wherein the first electrical signal is delivered continuously during the first stimulation period, and / or wherein the second electrical signal is delivered continuously during the second stimulation period.9. The method of any of examples 1 -8, further comprising providing at least one quiescent period per 24-hour period during which no stimulation is delivered, wherein the quiescent period has a duration of between about 30 minutes and about 6 hours.10. The method of any of examples 1 -9 wherein delivery of the first electrical signal and delivery of the second electrical signal do not temporally overlap.1 1 . The method of any of examples 1 -10 wherein the first frequency is 5 Hz and the second frequency is 14 Hz.12. The method of any of examples 1 -11 wherein the first electrical signal and the second electrical signal are generated via the same signal generator.13. The method of any of examples 1 -12 wherein the first electrical signal and the second electrical signal are delivered via the same signal delivery device.14. A system for treating a patient with Inflammatory Bowel Disease (IBD) and Fecal Incontinence (Fl), the system comprising: an implantable signal delivery device positionable proximate a sacral nerve of the patient; and a signal generator programmed with instructions that, when executed, cause the signal generator to: deliver a first electrical signal having a first frequency within a first frequency range of from about 1 Hz to about 10 Hz to the sacral nerve of the patient, via the implantable signal delivery device, for a first stimulation period, wherein the first electrical signal treats the patient's IBD; anddeliver a second electrical signal having a second frequency that is different than the first frequency and is within a second frequency range of from about 10 Hz to about 60 Hz to the sacral nerve of the patient, via the implantable signal delivery device, for a second stimulation period, wherein the second electrical signal treats the patient's Fl, wherein the first electrical signal and the second electrical signal are delivered in cycles.15. The system of example 14 wherein the first stimulation period has a duration of between about 15 minutes and about 4 hours.16. The system of example 14 or example 15 wherein the first stimulation period has a duration of between about 30 minutes and about 2 hours.17. The system of any of examples 14-16 wherein the first electrical signal is administered during a single stimulation session per 24-hour period.18. The system of any of examples 14-17 wherein the first electrical signal is administered during two, three, or four stimulation sessions per 24-hour period.19. The system of example 14 wherein delivery of the first electrical signal is interspersed with delivery of the second electrical signal according to a predetermined ratio of between about 1 :23 and 4:20.20. The system of any of examples 14-19 wherein the first electrical signal is delivered intermittently during the first stimulation period, and / or wherein the second electrical signal is delivered intermittently during the second stimulation period.21 . The system of any of examples 14-19 wherein the first electrical signal is delivered continuously during the first stimulation period, and / or wherein the second electrical signal is delivered continuously during the second stimulation period.22. The system of any of examples 14-21 wherein the instructions, when executed, further cause the signal generator to provide least one quiescent period per 24-hour period during which no stimulation is delivered, wherein the quiescent period has a duration of between about 30 minutes and about 6 hours.23. The system of any of examples 14-22 wherein delivery of the first electrical signal and delivery of the second electrical signal do not temporally overlap.24. The system of any of examples 14-23 wherein the implantable signal delivery device includes at least four electrodes, and wherein: the first electrical signal is delivered to the sacral nerve via a first electrode and a second electrode of the at least four electrodes, and the second electrical signal is delivered to the sacral nerve via a third electrode and a fourth electrode of the at least four electrodes.25. The system of any of examples 14-25 wherein the first frequency is 5 Hz and the second frequency is 14 Hz.26. A method of using sacral nerve stimulation to treat a patient with Inflammatory Bowel Disease (IBD) and Fecal Incontinence (Fl), the method comprising: delivering a first electrical signal having a first frequency within a first frequency range of from about 1 Hz to about 10 Hz to a sacral nerve of the patient via a first electrode and a second electrode of a signal delivery device for a first stimulation period, wherein the first electrical signal treats the patient's IBD; and delivering a second electrical signal having a second frequency that is different than the first frequency and is within a second frequency range of from about 10 Hz to about 60 Hz to the sacral nerve of the patient via a third electrode and a fourth electrode of the signal delivery device, wherein the second electrical signal treats the patient's Fl, wherein delivery of the first electrical signal and delivery of the second electrical signal at least partially temporally overlap.27. The method of example 26 wherein the first stimulation period has a duration of between about 15 minutes and about 4 hours.28. The method of example 26 or example 27 wherein the first stimulation period has a duration of between about 30 minutes and about 2 hours.29. The method of any of examples 26-28 wherein the first electrical signal is administered during a single stimulation session per 24-hour period.30. The method of any of examples 26-28 wherein the first electrical signal is administered during two, three, or four stimulation sessions per 24-hour period.31 . The method of any of examples 26-30 wherein the second electrical signal is delivered intermittently or continuously for about 24 hours per day.32. The method of any of examples 26-31 wherein the first frequency is 5 Hz and the second frequency is 14 Hz.33. The method of any of examples 26-32 wherein the first electrical signal and the second electrical signal are generated by the same signal generator.34. A system for treating a patient with Inflammatory Bowel Disease (IBD) and Fecal Incontinence (Fl), the system comprising: an implantable signal delivery device positionable proximate a sacral nerve of the patient, the implantable signal delivery device having at least four electrodes; and a signal generator programmed with instructions that, when executed, cause the signal generator to: deliver a first electrical signal having a first frequency within a first frequency range of from about 1 Hz to about 10 Hz to a sacral nerve of the patient via a first electrode and a second electrode of the at least four electrodes for a first stimulation period, wherein the first electrical signal treats the patient's IBD; anddeliver a second electrical signal having a second frequency that is different than the first frequency and is within a second frequency range of from about 10 Hz to about 60 Hz to the sacral nerve of the patient via a third electrode and a fourth electrode of the at least four electrodes, wherein the second electrical signal treats the patient's Fl, wherein delivery of the first electrical signal and delivery of the second electrical signal at least partially temporally overlap.35. The system of example 34 wherein the first stimulation period has a duration of between about 15 minutes and about 4 hours.36. The system of example 34 or example 35 wherein the first stimulation period has a duration of between about 30 minutes and about 2 hours.37. The system of any of examples 34-36 wherein the first electrical signal is administered during a single stimulation session per 24-hour period.38. The system of any of examples 34-36 wherein the first electrical signal is administered during two, three, or four stimulation sessions per 24-hour period.39. The system of any of examples 34-38 wherein the second electrical signal is delivered intermittently or continuously for about 24 hours per day.40. The system of any of examples 34-38 wherein the first frequency is 5 Hz and the second frequency is 14 Hz.E. Conclusion

[0062] From the foregoing, it will be appreciated that specific embodiments of the disclosed technology have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. For example, electrical signals described herein can be delivered at combinations of parameter values within the foregoing ranges at values that are not expressly disclosed herein.Certain aspects of the technology described in the context of particular embodiments may be combined or eliminated in other embodiments. Further, while advantages associated with certain embodiments of the disclosed technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the present technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.

[0063] The use of "and / or," as in "A and / or B" refers to A alone, B alone, and both A and B. Additionally, the term "comprising" is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and / or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with certain embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.

[0064] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, to between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the disclosure. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the disclosure, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the disclosure.

Claims

CLAIMSI / We claim:

1. A method of using sacral nerve stimulation to treat a patient with Inflammatory Bowel Disease (IBD) and Fecal Incontinence (Fl), the method comprising: delivering a first electrical signal having a first frequency within a first frequency range of from about 1 Hz to about 10 Hz to a sacral nerve of the patient for a first stimulation period, wherein the first electrical signal treats the patient's IBD; and delivering a second electrical signal having a second frequency that is different than the first frequency and is within a second frequency range of from about 10 Hz to about 60 Hz to the sacral nerve of the patient for a second stimulation period, wherein the second electrical signal treats the patient's Fl, wherein the first electrical signal and the second electrical signal are delivered in cycles.

2. The method of claim 1 wherein the first stimulation period has a duration of between about 15 minutes and about 4 hours.

3. The method of claim 1 wherein the first stimulation period has a duration of between about 30 minutes and about 2 hours.

4. The method of claim 1 wherein the first electrical signal is administered during a single stimulation session per 24-hour period.

5. The method of claim 1 wherein the first electrical signal is administered during two, three, or four stimulation sessions per 24-hour period.

6. The method of claim 1 wherein delivery of the first electrical signal is interspersed with delivery of the second electrical signal according to a predetermined ratio of between about 1 :23 and 4:20.

7. The method of claim 1 wherein the first electrical signal is delivered intermittently during the first stimulation period, and / or wherein the second electrical signal is delivered intermittently during the second stimulation period.

8. The method of claim 1 wherein the first electrical signal is delivered continuously during the first stimulation period, and / or wherein the second electrical signal is delivered continuously during the second stimulation period.

9. The method of claim 1 , further comprising providing at least one quiescent period per 24-hour period during which no stimulation is delivered, wherein the quiescent period has a duration of between about 30 minutes and about 6 hours.

10. The method of claim 1 wherein delivery of the first electrical signal and delivery of the second electrical signal do not temporally overlap.11 . The method of claim 1 wherein the first frequency is 5 Hz and the second frequency is 14 Hz.

12. The method of claim 1 wherein the first electrical signal and the second electrical signal are generated via the same signal generator.

13. The method of claim 1 wherein the first electrical signal and the second electrical signal are delivered via the same signal delivery device.

14. A system for treating a patient with Inflammatory Bowel Disease (IBD) and Fecal Incontinence (Fl), the system comprising: an implantable signal delivery device positionable proximate a sacral nerve of the patient; anda signal generator programmed with instructions that, when executed, cause the signal generator to: deliver a first electrical signal having a first frequency within a first frequency range of from about 1 Hz to about 10 Hz to the sacral nerve of the patient, via the implantable signal delivery device, for a first stimulation period, wherein the first electrical signal treats the patient's IBD; and deliver a second electrical signal having a second frequency that is different than the first frequency and is within a second frequency range of from about 10 Hz to about 60 Hz to the sacral nerve of the patient, via the implantable signal delivery device, for a second stimulation period, wherein the second electrical signal treats the patient's Fl, wherein the first electrical signal and the second electrical signal are delivered in cycles.

15. The system of claim 14 wherein the first stimulation period has a duration of between about 15 minutes and about 4 hours.

16. The system of claim 14 wherein the first stimulation period has a duration of between about 30 minutes and about 2 hours.

17. The system of claim 14 wherein the first electrical signal is administered during a single stimulation session per 24-hour period.

18. The system of claim 14 wherein the first electrical signal is administered during two, three, or four stimulation sessions per 24-hour period.

19. The system of claim 14 wherein delivery of the first electrical signal is interspersed with delivery of the second electrical signal according to a predetermined ratio of between about 1 :23 and 4:20.

20. The system of claim 14 wherein the first electrical signal is delivered intermittently during the first stimulation period, and / or wherein the second electrical signal is delivered intermittently during the second stimulation period.

21. The system of claim 14 wherein the first electrical signal is delivered continuously during the first stimulation period, and / or wherein the second electrical signal is delivered continuously during the second stimulation period.

22. The system of claim 14 wherein the instructions, when executed, further cause the signal generator to provide least one quiescent period per 24-hour period during which no stimulation is delivered, wherein the quiescent period has a duration of between about 30 minutes and about 6 hours.

23. The system of claim 14 wherein delivery of the first electrical signal and delivery of the second electrical signal do not temporally overlap.

24. The system of claim 14 wherein the implantable signal delivery device includes at least four electrodes, and wherein: the first electrical signal is delivered to the sacral nerve via a first electrode and a second electrode of the at least four electrodes, and the second electrical signal is delivered to the sacral nerve via a third electrode and a fourth electrode of the at least four electrodes.

25. The system of claim 14 wherein the first frequency is 5 Hz and the second frequency is 14 Hz.

26. A method of using sacral nerve stimulation to treat a patient with Inflammatory Bowel Disease (IBD) and Fecal Incontinence (Fl), the method comprising: delivering a first electrical signal having a first frequency within a first frequency range of from about 1 Hz to about 10 Hz to a sacral nerve of the patient via a first electrode and a second electrode of a signal delivery device for a first stimulation period, wherein the first electrical signal treats the patient's IBD; anddelivering a second electrical signal having a second frequency that is different than the first frequency and is within a second frequency range of from about 10 Hz to about 60 Hz to the sacral nerve of the patient via a third electrode and a fourth electrode of the signal delivery device, wherein the second electrical signal treats the patient's Fl, wherein delivery of the first electrical signal and delivery of the second electrical signal at least partially temporally overlap.

27. The method of claim 26 wherein the first stimulation period has a duration of between about 15 minutes and about 4 hours.

28. The method of claim 26 wherein the first stimulation period has a duration of between about 30 minutes and about 2 hours.

29. The method of claim 26 wherein the first electrical signal is administered during a single stimulation session per 24-hour period.

30. The method of claim 26 wherein the first electrical signal is administered during two, three, or four stimulation sessions per 24-hour period.31 . The method of claim 26 wherein the second electrical signal is delivered intermittently or continuously for about 24 hours per day.

32. The method of claim 26 wherein the first frequency is 5 Hz and the second frequency is 14 Hz.

33. The method of claim 26 wherein the first electrical signal and the second electrical signal are generated by the same signal generator.

34. A system for treating a patient with Inflammatory Bowel Disease (IBD) and Fecal Incontinence (Fl), the system comprising: an implantable signal delivery device positionable proximate a sacral nerve of the patient, the implantable signal delivery device having at least four electrodes; and a signal generator programmed with instructions that, when executed, cause the signal generator to: deliver a first electrical signal having a first frequency within a first frequency range of from about 1 Hz to about 10 Hz to a sacral nerve of the patient via a first electrode and a second electrode of the at least four electrodes for a first stimulation period, wherein the first electrical signal treats the patient's IBD; and deliver a second electrical signal having a second frequency that is different than the first frequency and is within a second frequency range of from about 10 Hz to about 60 Hz to the sacral nerve of the patient via a third electrode and a fourth electrode of the at least four electrodes, wherein the second electrical signal treats the patient's Fl, wherein delivery of the first electrical signal and delivery of the second electrical signal at least partially temporally overlap.

35. The system of claim 34 wherein the first stimulation period has a duration of between about 15 minutes and about 4 hours.

36. The system of claim 34 wherein the first stimulation period has a duration of between about 30 minutes and about 2 hours.

37. The system of claim 34 wherein the first electrical signal is administered during a single stimulation session per 24-hour period.

38. The system of claim 34 wherein the first electrical signal is administered during two, three, or four stimulation sessions per 24-hour period.

39. The system of claim 34 wherein the second electrical signal is delivered intermittently or continuously for about 24 hours per day.

40. The system of claim 34 wherein the first frequency is 5 Hz and the second frequency is 14 Hz.

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