Devices, systems and methods for incontinence control

Abstract

A device and method are provided for preventing incontinent episodes in an individual in need of such prevention. The device includes a sensor electrode and a stimulation electrode that can be implanted in the individual's body. Once the device is implanted in the individual, the device's sensor detects a parameter related to a response from the individual intended to prevent incontinent episodes. The device then uses the electrodes to deliver an electrical stimulus that, in conjunction with the response, helps to prevent incontinence.

Description

[Technical field]

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 160,322, filed March 12, 2021, which is incorporated by reference herein in its entirety. [Background technology]

[0002] Incontinence, or lack of bladder or bowel control, has many causes but generally involves damage or weakness of the pelvic floor muscles and the nerves that innervate these muscles and associated organs. Electrical stimulation has been used to treat incontinence by directly stimulating the muscles or sacral nerves to improve bladder and bowel control. Summary of the Invention [Problem to be solved by the invention]

[0003] The inability to voluntarily control urination, defecation, incontinence, or a combination thereof, is a problem that can affect quality of life and cause social embarrassment. Urinary incontinence, or loss of bladder control, fecal incontinence, loss of bowel control, or a combination thereof, is often associated with neurological problems.

[0004] Electrical stimulation has been used to treat incontinence by directly stimulating muscles, sacral nerves, or other pelvic nerves to improve bladder and bowel control. However, electrical nerve stimulation approaches typically only impart a set stimulation protocol and cannot adapt to the subject's condition. This can result in overstimulation or understimulation of the target area, resulting in poor bladder and bowel control. It would therefore be beneficial to deliver electrical stimulation that takes into account the subject's condition and adapts the stimulation level accordingly.

[0005] Furthermore, conventional approaches to treating incontinence overlook the fact that a person's innate response (i.e., reflex) to prevent incontinence may be insufficient, rather than absent. Some individuals who exhibit incontinence events may not completely lack innate mechanisms to prevent incontinence, but rather insufficient. For example, some individuals suffering from incontinence may experience an insufficient preventive response, such as a muscular contraction of at least one pelvic floor muscle to prevent a leakage event in response to an increase in intra-abdominal pressure. In some cases, the leakage event may be urine, or gas or stool. Furthermore, some individuals suffering from stress incontinence may have a delayed response to a stress event to prevent an incontinence event. Alternatively, some individuals may suffer from stress incontinence associated with a hypermobile (i.e., insufficient support) urethra, which may cause an increase in pressure transmitted to the bladder and subsequent incontinence. [Means for solving the problem]

[0006] Aspects disclosed herein provide a method for preventing an incontinent episode in an individual in need of prevention of an incontinent episode, the method comprising: (a) implanting a sensor electrode and a stimulation electrode in the individual's body; (b) detecting a parameter with the sensor electrode associated with a response from the individual intended to prevent an incontinent episode; and (c) using the stimulation electrode to provide an electrical stimulation to prevent the incontinent episode in conjunction with the response. In some embodiments, the incontinent episode includes fecal incontinence. In some embodiments, the sensor is configured to detect a muscle contraction of the individual resulting in a partial contraction of a sphincter or pelvic floor muscle that controls urination or defecation. In some embodiments, the sensor electrode is positioned in the individual's pelvis. In some embodiments, the stimulation electrode provides electrical stimulation to the pudendal nerve. In some embodiments, the method includes providing a constant electrical stimulation at a lower intensity level than the electrical stimulation provided in step (c). In some embodiments, the incontinent episode is urinary incontinence and is of the urge incontinence type. In some embodiments, the intensity or duration of the electrical stimulation provided in step (c) varies depending on the response detected in step (b). In some embodiments, the response detected in step (b) is insufficient by itself to prevent an episode of incontinence, and the electrical stimulation provided in step (b) in conjunction with the response adds an effect sufficient to prevent an episode of incontinence. In some embodiments, the response detected in step (b) is insufficient by itself to prevent an episode of incontinence, and the electrical stimulation provided in step (b) in conjunction with the response prevents an episode of incontinence. In some embodiments, the method includes implanting a second stimulating electrode, where a first stimulating electrode stimulates one pudendal nerve and a second stimulating electrode stimulates another pudendal nerve. In some embodiments, the stimulating electrode stimulates one pudendal nerve and a different stimulating electrode stimulates a different spatially independent region of the same pudendal nerve. In some embodiments, the method includes implanting a different stimulating electrode, where a stimulating electrode stimulates a main trunk of the pudendal nerve and a different stimulating electrode stimulates a distal nerve of the pudendal nerve. In some embodiments, the distal nerve of the pudendal nerve includes a branch of the distal pudendal nerve.In some embodiments, the method includes implanting different stimulating electrodes, where the electrode stimulates the pudendal nerve trunk and the different stimulating electrode stimulates a main branch of the pudendal nerve, e.g., the dorsal genital nerve. In some embodiments, the method includes implanting different stimulating electrodes, where a first stimulating electrode stimulates the pudendal nerve and a different stimulating electrode stimulates a sacral spinal nerve. In some embodiments, the individual suffers from various classifications of urinary incontinence. In some cases, the various classifications may include stress incontinence, urge incontinence, overflow incontinence, or any combination thereof (i.e., mixed incontinence). In some embodiments, the sensor electrodes and the stimulating electrodes are operably coupled to a non-transitory computer-readable medium including a processor and software. In some embodiments, the sensor electrodes are calibrated by the individual using an external input device in conjunction with the software. In some embodiments, the software is configured to record signals from the sensor electrodes. In some embodiments, the software is configured to adjust the sensor electrodes in response to the signals.

[0007] In some embodiments, the sensor electrodes are configured to detect an EMG signal. In some embodiments, the EMG signal determines that a contraction of the at least one pelvic muscle has occurred. In some embodiments, the strength of the EMG signal determines that a contraction of the at least one pelvic muscle has occurred. In some embodiments, the strength of the EMG signal is proportional to the strength of the contraction of the at least one pelvic muscle.

[0008] Aspects disclosed herein provide a system for preventing incontinent episodes in an individual in need of prevention of incontinent episodes, the device comprising: (a) a sensor electrode configured to detect a parameter associated with a response from the individual intended to prevent incontinent episodes; (b) a stimulation electrode configured to provide electrical stimulation; (c) a processor operatively connected to the sensor electrode and the stimulation electrode; and (d) a non-transitory computer-readable storage medium including software configured to cause the processor to: (i) receive a parameter associated with a response from the individual intended to prevent incontinent episodes; (ii) analyze the parameter associated with the response from the individual intended to prevent incontinent episodes; and (iii) provide electrical stimulation from the stimulation electrode to the individual such that the electrical stimulation in conjunction with the response from the individual intended to prevent incontinent episodes prevents incontinent episodes. In some embodiments, the software includes analyzing a global positioning system (GPS) location of the individual, in combination with the parameter associated with the response from the individual, for the purpose of preventing incontinent episodes. In some embodiments, the incontinent episodes include urinary incontinence. In some embodiments, the incontinent episodes include fecal incontinence. In some embodiments, the episode of incontinence includes a combination of urinary incontinence and fecal incontinence. In some embodiments, the episode of incontinence includes stress urinary incontinence. In some embodiments, the sensor electrode is configured to detect muscular contractions of the individual resulting in partial contraction of the sphincter that controls urination and defecation. In some embodiments, the sensor electrode is disposed in the individual's pelvis. In some embodiments, the stimulation electrode provides electrical stimulation to the pudendal nerve. In some embodiments, the sensor electrode and the stimulation electrode are disposed on a single lead. In some embodiments, the stimulation electrode is configured to provide constant electrical stimulation at a lower intensity level than electrical stimulation provided to prevent episodes of incontinence. In some embodiments, the episode of incontinence is urinary incontinence and is of the urge incontinence type. In some embodiments, the intensity or duration of the electrical stimulation is varied in response to the detected response.In some embodiments, the response detected by the sensor electrodes is insufficient by itself to prevent an episode of incontinence, and the electrical stimulation provided in conjunction with the response prevents an episode of incontinence. In some embodiments, the system provides a lower intensity stimulation to the subject, whereby the lower intensity stimulation increases or improves the subject's tolerance to the stimulation signal. In some embodiments, the increased or improved tolerance of the subject results in a tolerance to a higher intensity stimulation signal. In some embodiments, the sensor electrodes are configured to detect an EMG signal. In some embodiments, the EMG signal determines that a contraction of at least one pelvic muscle has occurred. In some embodiments, the intensity of the EMG signal is proportional to the intensity of the contraction of the at least one pelvic muscle. In some embodiments, the stimulation electrodes include a first stimulation electrode and a second stimulation electrode, the first stimulation electrode stimulating a first pudendal nerve and the second stimulation electrode stimulating a second pudendal nerve. In some embodiments, the individual suffers from mixed urinary incontinence. In some embodiments, the sensor electrodes are calibrated by the individual using an external input device in conjunction with the software. In some embodiments, the software is further configured to cause the processor to record a signal from the sensor electrodes, hi some embodiments, the software is configured to adjust the sensor electrodes in response to the signal.

[0009] Aspects disclosed herein provide a non-transitory computer-readable storage medium including software for preventing an incontinent episode in an individual in need of prevention of an incontinent episode, the computer-readable storage medium being configured to cause a processor to: (i) receive by a sensor electrode a parameter associated with a response from the individual intended to prevent an incontinent episode; (ii) analyze the parameter associated with the response from the individual intended to prevent an incontinent episode; and (iii) apply an electrical stimulus from the stimulation electrode to the individual, where the electrical stimulus in combination with the response from the individual intended to prevent an incontinent episode prevents an incontinent episode. In some embodiments, the software includes analyzing a global positioning system (GPS) location of the individual, in combination with the parameter associated with the response from the individual, to prevent an incontinent episode. In some embodiments, the incontinent episode includes urinary incontinence. In some embodiments, the incontinent episode includes fecal incontinence. In some embodiments, the incontinent episode includes a combination of urinary incontinence and fecal incontinence. In some embodiments, the incontinent episode includes stress urinary incontinence. In some embodiments, the sensor electrode is configured to detect the contraction of the individual's muscles that results in a partial contraction of the sphincter that controls urination or defecation. In some embodiments, the sensor electrode, the stimulation electrode, or any combination thereof, is placed in, adjacent to, or around the individual's pelvis. In some embodiments, the stimulation electrode provides electrical stimulation to the pudendal nerve. In some embodiments, the sensor electrode and the stimulation electrode are placed on a single lead. In some embodiments, the stimulation electrode is configured to provide constant electrical stimulation at a lower intensity level than the electrical stimulation provided to prevent an incontinent episode. In some embodiments, the incontinent episode is urinary incontinence and is of the urge incontinence type. In some embodiments, the intensity or duration of the electrical stimulation varies depending on the detected response. In some embodiments, the response detected by the sensor electrode may not be sufficient by itself to prevent an incontinent episode, and the electrical stimulation provided adds a sufficient effect to prevent an incontinent episode in conjunction with the response.The response detected by the sensor electrodes may not be sufficient by itself to prevent an episode of incontinence, and the electrical stimulation provided in conjunction with the response prevents an episode of incontinence. In some embodiments, the sensor electrodes are configured to detect an EMG signal. In some embodiments, the EMG signal can determine that a contraction of at least one pelvic muscle has occurred. In some embodiments, the strength of the EMG signal can be proportional to the strength of the contraction of the at least one pelvic muscle. In some embodiments, the stimulation electrodes may include a first stimulation electrode and a second stimulation electrode, and the first stimulation electrode may stimulate a first pudendal nerve and the second stimulation electrode may stimulate another portion of the pudendal nerve. In some embodiments, the first stimulation electrode may stimulate one pudendal nerve and the second stimulation electrode may stimulate another spatially independent region of the same pudendal nerve. In some embodiments, the first stimulation electrode may stimulate a main trunk of the pudendal nerve and the second stimulation electrode may stimulate a distal nerve of the pudendal nerve. In some embodiments, the distal nerve of the pudendal nerve may include a branch of the distal pudendal nerve. In some embodiments, the first stimulating electrode can stimulate the pudendal nerve trunk and the second stimulating electrode can stimulate a main branch of the pudendal nerve, e.g., the dorsal genital nerve. In some embodiments, the individual suffers from mixed urinary incontinence. In some embodiments, the sensor electrodes are calibrated by the individual using an external input device in conjunction with the software. In some embodiments, the software is further configured to cause the processor to record a signal from the sensor electrodes. In some embodiments, the software is configured to adjust the sensor electrodes in response to the signal. In some embodiments, the individual suffers from mixed urinary incontinence. In some embodiments, the sensor electrodes are calibrated by the individual using an external input device in conjunction with the software. In some embodiments, the software is further configured to cause the processor to record a signal from the sensor electrodes. In some embodiments, the software is configured to adjust the sensor electrodes in response to the signal.

[0010] Aspects disclosed herein provide a device for preventing an incontinent episode in an individual in need of prevention of an incontinent episode, the device comprising: (a) a sensor electrode configured to detect a parameter associated with a response from the individual intended to prevent an incontinent episode; a stimulation electrode configured to provide electrical stimulation; and a processor operably coupled to the sensor electrode and the stimulation electrode. In some embodiments, the incontinent episode includes urinary incontinence. In some embodiments, the incontinent episode includes fecal incontinence. In some embodiments, the incontinent episode includes stress urinary incontinence. In some embodiments, the sensor electrode is configured to detect a contraction of the individual's muscles that results in a partial contraction of a sphincter that controls urination or defecation. In some embodiments, the sensor electrode is positioned in the individual's pelvis. In some embodiments, the stimulation electrode provides electrical stimulation to the pudendal nerve. In some embodiments, the stimulation electrode is configured to provide a constant electrical stimulation at a lower intensity level than the electrical stimulation provided to prevent an incontinent episode. In some embodiments, the incontinent episode is urinary incontinence and is of the urge incontinence type. In some embodiments, the intensity or duration of the electrical stimulation varies depending on the detected response. In some embodiments, the detected response is insufficient by itself to prevent an episode of incontinence, and the electrical stimulation provided in conjunction with the response adds a sufficient effect to prevent an episode of incontinence. In some embodiments, the detected response is insufficient by itself to prevent an episode of incontinence, and the electrical stimulation provided in conjunction with the response prevents an episode of incontinence. In some embodiments, the sensor electrode is configured to detect an EMG signal, an ENG signal, or any combination thereof. In some embodiments, the EMG signal determines that a contraction of at least one pelvic muscle has occurred. In some embodiments, the intensity of the EMG signal is proportional to the intensity of the contraction of the at least one pelvic muscle. In some embodiments, the stimulation electrodes include a first stimulation electrode and a second stimulation electrode, the first stimulation electrode stimulating a first pudendal nerve, and the second stimulation electrode stimulating a second pudendal nerve. In some embodiments, the individual suffers from mixed urinary incontinence. In some embodiments, the device further comprises a non-transitory computer readable medium including software.In some embodiments, the sensor electrodes are calibrated by the individual using an external input device in conjunction with the software. In some embodiments, the software is configured to record a signal from the sensor electrodes. In some embodiments, the software is configured to adjust the sensor electrodes in response to the signal.

[0011] Aspects disclosed herein provide a method of data processing, the method comprising: (i) receiving a measurement of a parameter previously measured by a sensor electrode, the parameter being predictive of an incontinent episode of an individual; (ii) analyzing the parameter; and (iii) synthesizing an electrical stimulation signal for the individual, where when the electrical stimulation signal is applied to the individual by the stimulation electrodes, the electrical stimulation signal prevents an incontinent episode in conjunction with the individual's efforts to prevent incontinence. In some embodiments, the parameter is related to a response from the individual intended to prevent an incontinent episode. In some embodiments, the parameter is related to the individual's efforts to prevent an incontinent episode, and the electrical stimulation signal is synthesized to complement the individual's efforts with an electrical stimulation pattern sufficient to prevent an incontinent episode in conjunction with the individual's efforts. In some embodiments, the response from the individual is insufficient by itself to prevent an incontinent episode, and the electrical stimulation signal, when applied, adds a sufficient effect to prevent an incontinent episode in conjunction with the response. In some embodiments, the incontinent episode includes urinary incontinence. In some embodiments, the incontinent episode includes fecal incontinence. In some embodiments, the episode of incontinence includes stress urinary incontinence. In some embodiments, the parameter is a signal from a sensor electrode configured to detect a contraction of the individual's muscles associated with a partial contraction of a sphincter that controls urination or defecation. In some embodiments, the electrical stimulation signal is for electrical stimulation of the pudendal nerve. In some embodiments, the electrical stimulation signal is compounded to include a constant electrical stimulation component and a component specific to the measured parameter. In some embodiments, the episode of incontinence is urinary incontinence and is of the urge incontinence type. In some embodiments, the intensity or duration of the electrical stimulation provided by the electrical stimulation signal varies depending on the value of the received parameter. In some embodiments, the parameter is an EMG signal. In some embodiments, the EMG signal defines that a contraction of at least one pelvic muscle has occurred. In some embodiments, the intensity of the EMG signal is proportional to the intensity of the contraction of the at least one pelvic muscle. In some embodiments, the electrical stimulation signal includes a first and a second signal for stimulating a first pudendal nerve and a second pudendal nerve, respectively.In some embodiments, the method further includes recording a signal previously measured by the sensor electrodes, hi some embodiments, the method further includes synthesizing a tuning signal for tuning the sensor electrodes in response to the recorded signal. [Brief description of the drawings]

[0012] The novel features of the invention are set forth with particularity in the appended claims. The features and advantages of the present invention will be better understood by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

[0013] [Figure 1] 1 illustrates an exemplary embodiment of an open-loop bioelectronic system that includes an implantable pulse generator, provides a predefined stimulation protocol, and receives no input from the subject. [Diagram 2] 2 illustrates an exemplary embodiment of a closed-loop bioelectronic system with a bidirectional neural interface that includes sensor electrodes that capture a subject's neural response and a processing module that can interpret the neural response. The system can provide adapted stimulation based on the neural response. [Diagram 3] 3 illustrates an exemplary embodiment of the devices and methods described herein that target the pudendal nerve by placing a sensor electrode and a stimulation electrode near the pudendal nerve. The sensor electrode captures biosignals to classify stress events, and the stimulation electrode delivers stress electrical stimulation ("bio-stimulator") adjusted from the base stimulation to account for the stress event to affect the target sphincter. [Figure 4] 4 shows an exemplary embodiment illustrating the biosignals and electrical stimulation of a biostimulation device. The biosignals captured by the sensor electrodes are analyzed and classified, and stress events such as coughing or sudden movements are identified from the electromyographic (EMG) signals. The stimulation electrodes deliver a biostimulator, which is an electrical stimulus adjusted from the base stimulus to take into account the stress event. [Diagram 5]5 shows an exemplary embodiment of a system block diagram of the devices and methods described herein configured to implement slow and fast adaptation algorithms. API is application programming interface and MICS is medical information communication band. [Figure 6A] FIG. 6A shows a flow chart of a method of closed-loop operation of a device of the present disclosure. [Figure 6B] FIG. 6B shows a flow chart of a method of closed-loop operation of a device of the present disclosure. [Figure 7A] FIG. 7A illustrates an example embodiment of a patient controller module as described in certain embodiments herein. [Figure 7B] FIG. 7B illustrates an example embodiment of a patient controller module as described in certain embodiments herein. [Figure 8] FIG. 8 shows a flow diagram of purposeful patient deflation and manual operation of the devices and systems described in certain embodiments herein. [Figure 9] FIG. 9 illustrates a flow diagram of the closed loop system operation as described in certain embodiments herein. [Figure 10] FIG. 10 shows a flow diagram for signal processing and threshold detection of incontinent events as described in certain embodiments herein. [Figure 11A] FIG. 11A shows EMG data of a patient's intentional muscle contraction, Valsalva maneuver, and coughing acquired and processed with the methods of the present disclosure, as described in some embodiments herein. [Figure 11B] FIG. 11B shows EMG data of a patient's intentional muscle contraction, Valsalva maneuver, and coughing acquired and processed with the methods of the present disclosure, as described in some embodiments herein. [Figure 11C] FIG. 11C shows EMG data of a patient's intentional muscle contraction, Valsalva maneuver, and coughing acquired and processed with the methods of the present disclosure, as described in some embodiments herein. [Figure 11D]FIG. 11D shows EMG data of a patient's intentional muscle contraction, Valsalva maneuver, and coughing acquired and processed with the methods of the present disclosure, as described in some embodiments herein. [Figure 11E] FIG. 11E shows EMG data of a patient's intentional muscle contraction, Valsalva maneuver, and coughing acquired and processed with the methods of the present disclosure, as described in some embodiments herein. [Figure 12A] FIG. 12A illustrates a flow diagram for detecting intentional or purposeful contractions by a patient and delivering electrical stimulation to prevent an incontinent event, as described in certain embodiments herein. [Figure 12B] FIG. 12B illustrates a flow diagram for detecting intentional or purposeful contractions by a patient and delivering electrical stimulation to prevent an incontinent event, as described in certain embodiments herein. [Figure 13] FIG. 13 illustrates a flow diagram for training an on-board machine learning classifier of the devices and systems of the present disclosure, as described in some embodiments herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] Lack of voluntary control over urination or defecation, known as urinary and fecal incontinence, respectively, is a problem that can affect quality of life and cause social embarrassment. Urinary and fecal incontinence can affect people of all ages. In some cases, older adults are more likely to suffer from incontinence with various pathophysiologies. Both urinary and fecal incontinence can involve damage, weakness, or overactivity of the pelvic floor muscles, including the urethral sphincter, anal sphincter, and the nerves that innervate these muscles and associated organs such as the bladder, rectum, and bowel.

[0015] Urinary incontinence can be classified into one of four main types: urge incontinence, stress incontinence, overflow incontinence, and mixed incontinence. Urge incontinence is often due to an overactive bladder. People with urge incontinence have a strong and sudden need to urinate immediately and often do not have enough time to go to the bathroom. Stress incontinence is usually due to insufficient functioning of the urethral sphincter or hypermobility of the urethra or bladder neck. Some people experience stress incontinence during activities such as coughing, sneezing, laughing, and exercising. Overflow incontinence may usually be due to poor bladder contractions or obstruction of the urethra. Mixed incontinence may include features of stress incontinence and urge incontinence. Incontinence often involves neurological problems such as impaired nerve conduction between the brain and / or affected muscles, nervous system conditions or injuries (e.g., multiple sclerosis or stroke), or mental confusion. Other causes of incontinence include, but are not limited to, pelvic or urethral muscle weakness and pelvic prolapse.

[0016] Bowel incontinence, also known as fecal incontinence, is the loss of bowel control that causes an individual to expel stool unexpectedly from the rectum. Fecal incontinence can be categorized into two main types: urge incontinence and passive incontinence, or a combination of both. Urge incontinence is caused by overactivity of the bowels. People with urge incontinence have a strong, sudden desire to defecate immediately and often do not have enough time to get to the bathroom. Passive incontinence is when the rectum is full and ready to urinate, but the individual does not feel the urge to open the bowels. People who suffer from passive incontinence cannot consciously control their bowel movements and stool may be expelled without their knowledge. Incontinence often involves neurological issues such as impaired nerve conduction between the brain and / or affected muscles, nervous system conditions or injuries (e.g., multiple sclerosis or stroke), or mental confusion. Causes of fecal incontinence include, but are not limited to, nerve damage, anal sphincter damage, constipation, diarrhea, hemorrhoids, surgery, loss of rectal storage capacity, rectal prolapse, and rectocele.

[0017] Electrical galvanic stimulation of muscles has been used to treat incontinence by training the pelvic floor muscles to improve their strength and function, and / or by stimulating the sacral nerves to improve bladder and defecation control. However, these electrical nerve stimulation approaches cannot adapt to the subject's condition or situation and can only give a predefined stimulation protocol. This can lead to overstimulation or understimulation of the target area, resulting in poor control of the muscles involved in urination and defecation. It would therefore be beneficial to be able to give electrical stimulation that takes into account the subject's condition and adjusts the stimulation level accordingly.

[0018] Provided herein are devices, systems, and methods for preventing and / or reducing the severity of incontinence episodes in individuals in need thereof. In some cases, incontinence episodes may include urinary incontinence, fecal incontinence, or any combination thereof. The devices, systems, and methods disclosed herein can treat subtypes of incontinence. In some cases, subtypes of incontinence may include urge incontinence, stress incontinence, overflow incontinence, or mixed incontinence.

[0019] In some cases, the devices, systems, and methods described herein can increase bladder capacity. Bladder capacity can be measured as the maximum amount of liquid that can be contained in the bladder without causing pain or urination. In some cases, the bladder capacity of a healthy individual as a baseline value can include a liquid volume of about 400 milliliters (mL) to about 600 mL. In some cases, the bladder capacity can be measured by ultrasound computation of a static ultrasound image of the subject's bladder. The volume of the bladder can be measured by multiplying the length, width, and height of the bladder measured on the static ultrasound image. Alternatively, or in addition, the bladder capacity can be measured by cytometry, in which a catheter is inserted into the subject's urethra and filled, and the urine volume is measured. In some cases, the subject's bladder capacity can be reduced due to illness. In some cases, the devices and systems described herein can increase the bladder capacity by a percentage increase from the baseline bladder capacity. In some cases, the bladder capacity can be increased by providing the subject with electrical stimulation through the stimulation device electrode leads described herein. In some cases, the stimulation device can provide a frequency or pulse width of electrical stimulation as described elsewhere herein.

[0020] In some cases, bladder capacity can be increased utilizing either an open loop system or a closed loop system, as described elsewhere herein. In some cases, bladder capacity can be increased by about 5% to about 75%. In some cases, bladder capacity can be increased by about 5% to about 10%, about 5% to about 15%, about 5% to about 20%, about 5% to about 25%, about 5% to about 30%. About 5% to about 35%, about 5% to about 40%, about 5% to about 45%, about 5% to about 50%, about 5% to about 70%, about 5% to about 75%, about 10% to about 15%, about 10% to about 20%, about 10% to about 25%, about 10% to about 30%, about 10% to about 35%, about 10% to about 40%, about 10% to about 45%, about 10% to about 50%, about 10% to about 70%, about 10% to about 75%, About 15% to about 20%, about 15% to about 25%, about 15% to about 30%, about 15% to about 35%, about 15% to about 40%, about 15% to about 45%, about 15% to about 50%, about 15% to about 70%, about 15% to about 75%, about 20% to about 25%, about 20% to about 30%, about 20% to about 35%, about 20% to about 40%, about 20% to about 45%, about 20% to about 50%, about 20% to About 70%, about 20% to about 75%, about 25% to about 30%, about 25% to about 35%, about 25% to about 40%, about 25% to about 45%, about 25% to about 50%, about 25% to about 70%, about 25% to about 75%, about 30% to about 35%, about 30% to about 40%, about 30% to about 45%, about 30% to about 50%, about 30% to about 70%, about 30% to about 75%, about 35% to about 40% , about 35% to about 45%, about 35% to about 50%, about 35% to about 70%, about 35% to about 75%, about 40% to about 45%, about 40% to about 50%, about 40% to about 70%, about 40% to about 75%, about 45% to about 50%, about 45% to about 70%, about 45% to about 75%, about 50% to about 70%, about 50% to about 75%, or about 70% to about 75%. In some cases, bladder capacity may be increased by about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 70%, or about 75%.

[0021] In some cases, the devices, systems, and methods described herein can increase urethral closure pressure. In some cases, the urethral closure pressure can be expressed by a pressure profile. The urethral closure pressure can be described as a measurement of an integrated pressure curve from the entire length of the subject's urethra. In some cases, the urethral closure pressure can be measured by slowly withdrawing a pressure measuring catheter through the subject's urethra at a constant rate. In some cases, the urethral closure pressure can be measured by a transurethral pressure profile catheter. In some cases, the transurethral pressure can be measured in centimeters of water (cm H2O). In some cases, the devices and systems described herein can increase urethral closure pressure by stimulating one or more nerves of the subject. In some cases, the one or more nerves can include the pudendal nerve, the sacral nerve, or any combination or branch thereof. In some cases, the stimulation device described elsewhere herein can provide electrical stimulation to the subject's nerves via the stimulation electrode leads at frequencies and / or frequency ranges described elsewhere herein to increase urethral closure pressure. In some examples, the urethral closure pressure may include from about 10 centimeters of water (cmH2O) to about 75 cmH2O. In some examples, the urethral closure pressure may include from about 10 cmH2O to about 15 cmH2O, from about 10 cmH2O to about 20 cmH2O, from about 10 cmH2O to about 25 cmH2O, from about 10 cmH2O to about 30 cmH2O. From about 10 cmH2O to about 35 cmH2O, from about 10 cmH2O to about 40 cmH2O, from about 10 cmH2O to about 45 cmH2O, from about 10 cmH2O to about 50 cmH2O, from about 10 cmH2O to about 60 cmH2O, from about 10 cmH2O to about 70 cmH2O, from about 10 cmH2O to about 75 cmH2O, from about 15 cmH2O to about 20 cmH2O, from about 15 cmH2O to about 25 cmH2O, from about 10 cmH2O to about 30 cmH2O. Approximately 25cmH2O, approximately 15cmH2O to approximately 30cmH2O, approximately 15cmH2O to approximately 35cmH2O, approximately 15cmH2O to approximately 40cmH2O, approximately 15cmH2O to approximately 45c mH2O, about 15cmH2O to about 50cmH2O, about 15cmH2O to about 60cmH2O, about 15cmH2O to about 70cmH2O, about 15cmH2O to about 75cmH2O,Approximately 20cmH2O to approximately 25cmH2O, approximately 20cmH2O to approximately 30cmH2O, approximately 20cmH2O to approximately 35cmH2O, approximately 20cmH2O to approximately 40cmH2O, approximately 20cmH2O to approximately 45cmH2O, approximately 20cmH2O to approximately 50 cmH2O, about 20cmH2O to about 60cmH2O, about 20cmH2O to about 70cmH2O, about 20cmH2O to about 75cmH2O, about 25cmH2O to about 30cmH2O, about 25cmH2O to about 35cmH2O, about 25cmH2 O ~ about 40cmH2O, about 25cmH2O - about 45cmH2O, about 25cmH2O - about 50cmH2O, about 25cmH2O - about 60cmH2O, about 25cmH2O - about 70cmH2O, about 25cmH2O - about 75cmH2O, about 30cmH2O to about 35cmH2O, about 30cmH2O to about 40cmH2O, about 30cmH2O to about 45cmH2O, about 30cmH2O to about 50cmH2O, about 30cmH2O to about 60cmH2O, about 30cmH2O to about 70cm H2O, about 30cmH2O to about 75cmH2O, about 35cmH2O to about 40cmH2O, about 35cmH2O to about 45cmH2O, about 35cmH2O to about 50cmH2O, about 35cmH2O to about 60cmH2O, about 35cmH2O ~approx. 70cmH2O, approx. 35cmH2O ~ approx. 75cmH2O, approx. 40cmH2O ~ approx. 45cmH2O, approx. 40cmH2O ~ approx. 50cmH2O, approx. 40cmH2O ~ approx. 60cmH2O, approx. 40cmH2O ~ approx. 70cmH2O, approx. 40 The range may include from about cmH2O to about 75 cmH2O, from about 45 cmH2O to about 50 cmH2O, from about 45 cmH2O to about 60 cmH2O, from about 45 cmH2O to about 70 cmH2O, from about 45 cmH2O to about 75 cmH2O, from about 50 cmH2O to about 60 cmH2O, from about 50 cmH2O to about 70 cmH2O, from about 50 cmH2O to about 75 cmH2O, from about 60 cmH2O to about 70 cmH2O, from about 60 cmH2O to about 75 cmH2O, or from about 70 cmH2O to about 75 cmH2O. In some examples, the urethral closure pressure may include at least about 10 cmH2O, or about 15 cmH2O, about 20 cmH2O, about 25 cmH2O, about 30 cmH2O, about 35 cmH2O, about 40 cmH2O, about 45 cmH2O, about 50 cmH2O, about 60 cmH2O, about 70 cmH2O, about 75 cmH2O. In some examples, the urethral closure pressure may include at most about 15 cmH2O,Or about 20 cmH2O, about 25 cmH2O, about 30 cmH2O, about 35 cmH2O, about 40 cmH2O, about 45 cmH2O, about 50 cmH2O, about 60 cmH2O, about 70 cmH2O, about 75 cmH2O.

[0022] The devices and systems described herein may include one or more sensor electrodes, one or more stimulation electrodes, a processor, a power source, or any combination thereof. In some cases, one or more stimulation electrodes, one or more sensor electrodes, a processor, a power source, or any combination thereof may be implanted in the individual's body. In some cases, one or more stimulation device electrodes, one or more sensor electrodes, a processor, a power source, or any combination thereof may be placed on the surface of the individual's body. In some cases, the processor, the power source, or any combination thereof may be implanted in the individual's body. In some examples, the device may include a wireless transmission module that can wirelessly transmit and receive wireless data between a remote device (e.g., a mobile phone, a tablet, a computer, etc.) and the incontinence prevention device described herein. In some cases, the device may be implantable in the individual. Alternatively, the device may include a hermetically sealed connector that is placed on the surface of the individual's skin that can be electrically connected to a remote device by a cable. In some cases, the individual may manually modify or change parameters of one or more sensor electrodes or one or more stimulation electrodes through a graphical user interface. In some cases, the device may automatically modify or change parameters of one or more sensor electrodes or one or more stimulation electrodes.

[0023] In some cases, the embedded sensor electrodes of the device may be configured to detect one or more parameters that may be related to an incontinent episode response or an individual's intent to prevent an incontinent episode. In some cases, the parameters may include electromyography (EMG) signals that may predict an incontinent episode. In some cases, the EMG signals may include electrical activity of muscles, particularly electrical activity from action potentials of muscle fibers. In some cases, the parameters may include electroneurograms (ENGs). In some cases, electroneurograms may include electrical activity from one or more neurons, and typically refer to recordings made from bundles of axons of peripheral nerves. In some cases, the parameters may include changes in electrical impedance caused by physical deformation of the sensor electrode material. In some cases, the physical deformation may include stretching, compression, or any combination thereof. Alternatively, the parameters may include changes in pressure, velocity, acceleration, or 3D spatial orientation. In some cases, the 3D spatial orientation may be determined by a GPS signal. In some cases, the GPS signal may indicate and allow an individual to know that they are approaching a location, such as their home. In some cases, the GPS signal may be configured to adjust the stimulation device based on the subject's GPS coordinates and / or GPS location, as described elsewhere herein. In some cases, adjusting the stimulation device may include adjusting detection parameters (e.g., signal strength thresholds) of a classifier, as described elsewhere herein. In some cases, the GPS signal of location and / or GPS coordinates may indicate a traveled location and / or area to the subject that may impose a higher risk of an incontinent event. In some cases, the posture of the individual may also be measured by a three-dimensional spatial orientation. In some cases, the pressure change may be measured by a pressure sensor. In some cases, the pressure sensor may comprise a differential pressure sensor, an absolute pressure sensor, or any combination thereof. In some cases, the speed, acceleration change, or 3-D spatial orientation change may be measured by an accelerometer, a gyroscope, a magnetometer, or a combination thereof.In some cases, the device can provide electrical stimulation using one or more implanted stimulating electrodes to prevent episodes of incontinence in conjunction with a prophylactic response by the individual.

[0024] The devices, systems, and methods described herein may be able to prevent incontinent events and / or reduce the severity of incontinent events by detecting an incontinent prevention parameter of an individual and adjusting electrical stimulation by one or more stimulation electrodes based on a characteristic of the incontinent prevention parameter. In some cases, the characteristic of the incontinent prevention parameter may include a change in amplitude, frequency, phase, or any combination thereof of one or more EMG, ENG, accelerometer, gyroscope, magnetometer, pressure sensor signals, or any combination thereof. In some cases, the incontinent prevention parameter may include physical movement of the individual, one or more EMG signals, or any combination thereof. By providing adaptive electrical stimulation in accordance with the individual's response, the devices, systems, and methods described herein may prevent incontinent episodes.

[0025] Described herein are devices, systems, and methods for preventing an individual's episodes of incontinence and / or reducing the severity of an incontinence episode by providing adaptive electrical stimulation based on the individual's incontinence prevention parameters. The device can be implanted in an individual near the pudendal nerve, the sacral nerve, or their branches. In some cases, one or more stimulation electrodes of the device can be placed on or near the pudendal nerve or the sacral nerve. In some cases, one or more stimulation electrodes or one or more sensor electrodes may be implanted in close proximity to the unilateral or bilateral pudendal nerve. In some cases, one or more stimulation electrodes may be implanted to stimulate motor nerve fibers (e.g., pelvic floor and sphincter muscles). Alternatively, one or more stimulation electrodes may be implanted in, near, or adjacent to muscles (e.g., pelvic floor and sphincter muscles). The sensor electrodes of the implantable device can detect signals that indicate that the individual may be incontinent or is attempting to prevent incontinence. The device can analyze the signals and classify the signals as real-time or future episodes of incontinence. The device can generate an adjusted electrical stimulation based on the classified episode of incontinence and deliver the adjusted electrical stimulation to the target nerve using one or more stimulation electrodes. In some cases, adjusting the electrical stimulation of the one or more stimulation electrodes may include changing the frequency of the electrical stimulation, the amplitude of the electrical stimulation, the pulse width of the electrical stimulation, the configuration of the stimulation electrodes, or any combination thereof. In some cases, the one or more electrodes may comprise one or more stimulation electrodes and one or more detection electrodes. The one or more stimulation electrodes and the one or more detection electrodes may be configured to switch between stimulation and detection operations on demand, or programmatically, under user control, under medical personal control, or any combination thereof. The electrical stimulation can be adjusted to improve muscle and / or nerve response and prevent episodes of incontinence. The adjusted electrical stimulation can result in improved muscle response as measured by response time, muscle function, or other markers of incontinence prevention, preventing potential episodes of incontinence.The electrical stimulation may be adjusted to reduce the severity and / or duration of an incontinence episode. For example, a subject exhibiting an urge incontinence event (e.g., coughing) may receive electrical stimulation provided by the devices, systems, and methods provided herein in response to an incontinence episode. In some cases, the electrical stimulation may reduce the amount of uncontrolled urination and / or defecation. In some cases, the electrical stimulation may reduce the amount of uncontrolled urination and / or defecation without completely preventing an incontinence episode. In some cases, the electrical stimulation may shorten the duration of an incontinence event that would otherwise occur. In some cases, the electrical stimulation may be configured to inhibit reflex incontinence. In some cases, the electrical stimulation may inhibit the contraction of the bladder detrusor muscle experienced during reflex incontinence.

[0026] The electrical stimulation may include electrical stimulation administered over a period of time, which in some cases may include a period during which the subject may provide intent based on a deliberate muscle contraction to trigger EMG threshold detection.

[0027] In some cases, the duration of the electrical stimulation may include from about 1 second to about 30 seconds. In some cases, the duration of the electrical stimulation may include from about 1 second to about 5 seconds, from about 1 second to about 10 seconds, from about 1 second to about 15 seconds, from about 1 second to about 20 seconds, from about 1 second to about 25 seconds, from about 1 second to about 30 seconds, from about 5 seconds to about 10 seconds, from about 5 seconds to about 15 seconds, from about 5 seconds to about 20 seconds, from about 5 seconds to about 25 seconds, from about 5 seconds to about 30 seconds, from about 10 seconds to about 15 seconds, from about 10 seconds to about 20 seconds, from about 10 seconds to about 25 seconds, from about 10 seconds to about 30 seconds, from about 15 seconds to about 20 seconds, from about 15 seconds to about 25 seconds, from about 15 seconds to about 30 seconds, from about 20 seconds to about 25 seconds, from about 20 seconds to about 30 seconds, or from about 25 seconds to about 30 seconds. In some cases, the period of time may include about 1 second, about 5 seconds, about 10 seconds, about 15 seconds, about 20 seconds, about 25 seconds, or about 30 seconds. In some cases, the period of electrical stimulation may include at least about 1 second, about 5 seconds, about 10 seconds, about 15 seconds, about 20 seconds, or about 25 seconds. In some cases, the period of electrical stimulation may include up to about 5 seconds, about 10 seconds, about 15 seconds, about 20 seconds, about 25 seconds, or about 30 seconds.

[0028] Embodiments of a device for treating and preventing incontinence The present disclosure describes a device for preventing incontinent episodes, including one or more sensor electrodes, one or more stimulation electrodes, an electrical stimulation device, or any combination thereof. In some cases, the electrical stimulation device may comprise a processor, memory, a user interface, a power source, or any combination thereof, to prevent incontinent episodes. The device may be implantable. The surgical procedure to implant the device may be completed under awake sedation, general anesthesia, local anesthesia, twilight anesthesia, or any combination thereof. The device may be fully or partially implanted in the individual's pelvic region. In some cases, the device may be implanted by one or more surgical instruments. In some cases, the surgical instruments may comprise an introducer, a sheath, a directional probe, a wire, a needle, or any combination thereof.

[0029] In some cases, the device may further comprise a transmitter electrically connected to the processor that can wirelessly transmit and receive data from a remote device such as a mobile phone, tablet, or computer. In some cases, the device may be configured for an open loop configuration. In some cases, the device may be configured for a closed loop configuration or a feedback control configuration. The device described herein can be used to prevent episodes of urinary incontinence. In some cases, the urinary incontinence may include urge incontinence, stress incontinence, overflow incontinence, mixed incontinence, or any combination thereof. In some embodiments, the episode of incontinence is urinary incontinence and is of the urge incontinence type. In some cases, the device described herein can be used to prevent episodes of fecal incontinence.

[0030] Open Loop Configuration FIG. 1 illustrates an open-loop configuration of a device described herein configured to prevent episodes of incontinence in an individual 110. The device in an open-loop configuration may include an implantable pulse generator 102 with one or more stimulation electrodes 106 and a power source. In some cases, the implantable pulse generator 102 may include a processor and a wireless transmission module configured to execute software that manages the electrical stimulation pattern 104. In some cases, the power source may include a battery. In some cases, the battery may be a lithium polymer ion battery, lithium iodine, lithium manganese dioxide, lithium carbon monofluoride, or any combination thereof. In some cases, the battery may be wirelessly charged by an inductive charger. Alternatively, the battery power source may be disposable.

[0031] The implantable pulse generator 102 can send predetermined electrical stimulation patterns 104 that are configured by a healthcare provider on a remote device 100 (e.g., a mobile phone, tablet, computer, etc.) and transmitted wirelessly 105 to the implantable pulse generator 102. Alternatively, the implantable pulse generator 102 can send predetermined electrical stimulation patterns 104 that are configured by a healthcare provider on a remote computing device 100 (e.g., a mobile phone, tablet, computer, etc.) and transmitted via wires 101 to the implantable pulse generator 102. In some cases, the healthcare provider may set the predetermined electrical stimulation parameters through a graphical user interface on the remote device. In some cases, an individual 110 having an implantable pulse generator 102 can change or set the electrical stimulation parameters via an external input device 103 (e.g., a mobile phone, tablet, computer, etc.) via the wireless communication 105 of the implantable pulse generator. Alternatively, an individual 110 having an implantable pulse generator 102 can change or set the electrical stimulation parameters via an external input device 103 via the wired communication 107 of the implantable pulse generator 102. In some cases, an individual 110 with an implantable pulse generator 102 can adjust the electrical stimulation pattern 104 using a graphical user interface on an external input device 103. In some cases, adjustable electrical stimulation pattern 104 parameters include frequency, amplitude, pulse width, or any combination thereof.

[0032] Closed Loop Configuration FIG. 2 illustrates a closed-loop configuration of a device described herein configured to prevent episodes of incontinence in an individual 126. The device in the closed-loop configuration can include an implantable pulse generator 118, one or more stimulation electrodes 122, one or more sensor electrodes 120, and a power source. In some cases, the implantable pulse generator 118 can include a processor and a wireless transmission module configured to execute software to detect and analyze electromyographic (EMG) signals via the one or more sensor electrodes 120 and provide an electrical stimulation pattern 124. By way of example, the power source can include a battery. The battery can be rechargeable or disposable. In some cases, the battery can be charged through inductive charging. In some cases, the device configured in the closed-loop configuration can measure EMG signals via the one or more sensor electrodes 120 to detect episodes of stress incontinence events or levels of congenital electromyographic activity. In some cases, the device configured in a closed loop configuration can measure inertial signals, such as rapid acceleration, shock, postural orientation, or any combination thereof, via one or more sensor electrodes 120 to detect the onset of a stress incontinence event or the level of innate myoelectrical activity. In some cases, stress incontinence events may include actions such as coughing, sneezing, laughing, and movement. Once detected, the implantable pulse generator 118 can provide an electrical stimulation pattern 124 to prevent urination or uncontrollable bowel movements. In some cases, the threshold level for detecting a stress incontinence event can be modified and adjusted by the individual 126 via a graphical user interface on the external input device 114, either via wireless communication 113 or wired connection 115.

[0033] In some embodiments, the closed loop configuration of the systems and methods described herein can constitute a fully synchronized system, as shown in Figure 1. In some cases, electrodes 902, including sensor electrodes and / or stimulation electrodes, can detect EMG, ENG, and / or pressure signals via circuitry 904 (e.g., analog / digital circuitry) and then pass the detected signals to a classifier algorithm 906. If the classifier algorithm 906 classifies the detected EMG, ENG, and / or pressure signals as an incontinent event, the classifier can cause an electrical stimulus 908 to be delivered to the subject. As shown in Figure 9, the electrical stimulus can be provided by the same electrodes 902 that originally detected the EMG and / or ENG signals.

[0034] In some embodiments, the closed loop configuration of the device described herein may be configured to detect an individual's efforts to prevent an incontinent episode. In some cases, the methods and systems described herein may supplement the subject's efforts with an electrical stimulation pattern via one or more stimulation electrodes 122 sufficient to prevent urination or defecation. In some cases, the individual's efforts may include EMG, ENG, pressure, acceleration, gyroscope, magnetometer, 3D space, or any combination of those signals at threshold. In some cases, the threshold myoelectric signal may be detected by one or more sensor electrodes 120. In some cases, the supplemental excitation may include an excitation signal provided by a stimulation electrode, described elsewhere herein, with parameters such as, for example, frequency, pulse width, and / or amplitude, to prevent an incontinent episode (e.g., urination and / or defecation) in combination with the detected individual's efforts. In some cases, the supplemental excitation may include an excitation signal provided by a stimulation electrode, with parameters such as, for example, frequency, pulse width, and / or amplitude, to prevent an incontinent episode in response to detection of a stress incontinent event. In some cases, the stress incontinence event may include actions such as coughing, sneezing, laughing, or movement, detectable, for example, by gyroscopes, accelerometers, and / or magnetometers, as described elsewhere herein. In some cases, one or more parameters of the supplemental excitation may be determined on an individual subject basis and / or based on a large population of subjects exhibiting similar symptoms of incontinence. For example, one or more parameters of the supplemental excitation for a given subject may be adjusted and / or determined depending on whether such supplemental excitation signal prevented an incontinence episode in real time or after an incontinence event via a user interface of the device and system described elsewhere herein. In some cases, one or more parameters of the supplemental excitation for a subject may be adjusted to values ​​and / or parameters found to prevent incontinence events in subjects with similar clinical symptoms (e.g., age, type of incontinence, frequency of incontinence events, clinical metadata of other subjects, etc.).

[0035] In some examples, the systems and methods described herein may include systems and methods configured to provide electrical stimulation to prevent an incontinent event based on the subject's and / or patient's intentional muscle contraction and / or movement, as seen in FIG. 8. In some cases, the subject and / or patient 814, upon realizing that they may exhibit an incontinent event, may induce movement and / or contraction of one or more muscles or muscle groups to cause EMG, ENG, pressure, acceleration, gyroscope, magnetometer, 3D spatial, or any combination thereof signals 818. In some cases, the induced movement and / or contraction of one or more muscle groups may be amplified 808, classified (by a classifier) ​​806, passed through a control logic algorithm 804, and used as a trigger 820 that enables the flow of therapy and activates the respective basic 802 and / or active 801 stimulation pattern parameters described elsewhere herein via the stimulation device 810 and neural interface 812 to prevent an incontinent event. In some cases, the classifier may include a machine learning classifier. In some cases, the classifier may include an intensity threshold classifier as described elsewhere herein. In some cases, the patient and / or subject 814 can manually 816 enable delivery of the electrical stimulation via a button on the patient controller module 156, as described elsewhere herein.

[0036] In some cases, the detection threshold of the implantable pulse generator 118 (i.e., stimulation device) can be changed and adjusted via a graphical user interface on the external input device 114. The external input device 114 may be able to modify and adjust the threshold of the implantable pulse generator 118 via wireless communication 113 or wired connection 115. In some cases, the implantable pulse generator threshold may be adjusted via a healthcare provider on a remote computing device 112 (e.g., cell phone, tablet, computer, etc.) and transmitted to the implantable pulse generator 118 via wired communication 116. Alternatively, the implantable pulse generator threshold may be adjusted via a healthcare provider on a remote computing device 112 (e.g., cell phone, tablet, computer, etc.) and transmitted to the implantable pulse generator 118 via wireless communication 113. In some cases, the implantable pulse generator threshold may be adjusted via an individual 110 on a remote computing device 112 (e.g., cell phone, tablet, computer, etc.) and transmitted to the implantable pulse generator 118 via wired communication 116. Alternatively, the implantable pulse generator thresholds may be adjusted via the individual 110 on a remote computing device 112 (e.g., a cell phone, tablet, computer, etc.) and transmitted to the implantable pulse generator 118 via wireless communication 113.

[0037] In some cases, the electrical stimulation pattern 124 provided via one or more stimulation electrodes 122 may be adjusted and adjusted by the detected threshold level to compensate for the individual's efforts to prevent episodes of incontinence. In some examples, the adjusted electrical stimulation pattern 124 may be determined by mapping the detectable physiological signal representative of the efforts and the provided electrical stimulation pattern 124 by piecewise linear mapping, linear mapping, sigmoidal mapping, or any variation thereof. The electrical stimulation pattern 124 may be adjusted by modifying or changing electrical stimulation pattern parameters including frequency, pulse width, and amplitude. In some cases, the electrical stimulation pattern parameters of the implantable pulse generator 118 may be modified and adjusted via a graphical user interface on the external input device 114. The external input device 114 may be able to change and adjust the electrical stimulation pattern parameters of the implantable pulse generator 118 via wireless communication 113 or wired connection 115. In some cases, the electrical stimulation pattern parameters of the implantable pulse generator 118 may be adjusted. The electrical stimulation pattern parameters of the implantable pulse generator 118 may be adjusted via a healthcare provider on a remote computing device 112 (e.g., a cell phone, tablet, computer, etc.) and transmitted to the implantable pulse generator 118 via wired communication 116. In some cases, the electrical stimulation pattern parameters of the implantable pulse generator 118 may be adjusted via a healthcare provider on a remote computing device 112 (e.g., a cell phone, tablet, computer, etc.) and transmitted to the implantable pulse generator 118 via wireless communication 113. In some cases, the electrical stimulation pattern parameters of the implantable pulse generator 118 may be adjusted by a machine learning model executed by a processor of the implantable pulse generator 118 based on input from the individual 126. In some cases, the machine learning model may be configured to determine whether the subject is at risk for unwanted urination and / or defecation based on muscle EMG signals detected by one or more sensor electrodes.In some cases, the machine learning model may be trained to determine the presence or absence of effort of an individual, as described elsewhere herein. For example, the machine learning model may be trained with one or more EMG signals characteristic of muscle contractions of the subject, particularly EMG signals that cause undesired urination and / or defecation. In some cases, the machine learning model may be trained to determine the presence or absence of effort of an individual, as described elsewhere herein. For example, the machine learning model may be trained with one or more EMG signals characteristic of muscle contractions of the subject, particularly EMG signals that cause undesired urination and / or defecation.

[0038] In some embodiments, the electrical stimulation pattern parameters (e.g., frequency, amplitude, etc.) may be set or determined by a stimulation machine learning model, as described elsewhere herein. In some cases, the stimulation machine learning model may include a Bayesian optimization model. In some cases, the stimulation machine learning model may be trained with stimulation patterns that users of the devices and systems described elsewhere herein indicate as suppressing incontinent events for a particular type and / or subtype of incontinence. In some cases, the stimulation machine learning model may be trained according to the type of incontinence of the patient. The stimulation machine learning algorithm may be trained on a cloud computing network and / or server in communication with the implantable device and user device, as described elsewhere herein, and redistributed or downloaded to one or more users and / or patients. Indeed, users and / or patients may update and / or download new updates to the software of the devices and systems described herein. This aspect of the invention described herein provides the unexpected result of patient-specific optimized electrical stimulation signals that could not be achieved with conventional stimulation devices.

[0039] One or more machine learning algorithms may be used to build machine learning models such as support vector machines and / or graphical models that deploy stepwise backward parameter selection, both of which may have the advantage of inferring interactions between parameters. For example, machine learning algorithms such as alternating decision trees (ADTree), decision stumps, function trees (FT), logistic model trees (LMT), logistic regression, random forests (rf), receiver operating characteristic curves (ROC), linear regression, extreme gradient boosting (xgb), classification and regression trees, support vector machines (SVM), generalized additive models with splines (such as gamSpline), glmnet, multivariate adaptive regression splint (earth), neural networks, k-means clustering, or any machine learning or statistical algorithm known in the art may be used. One or more algorithms can be used together to generate an ensemble method, which can be optimized using machine learning ensemble meta-algorithms such as boosting (e.g., AdaBoost, LPBoost, TotalBoost, BrownBoost, MadaBoost, LogitBoost, etc.) to reduce bias and variance.

[0040] In some embodiments, the machine learning algorithm may include a constrained machine learning algorithm configured to run on a microprocessor. In some cases, the machine learning algorithm may include a machine learning algorithm that operates within the TinyML framework. In some cases, the machine learning algorithm described elsewhere herein may be trained offline. The offline training may be completed on a server, cloud, or other dedicated computing cluster. In some cases, the offline trained machine learning algorithm may be downloaded, deployed, and / or imported into the device to iteratively improve the performance of the device and the system in preventing incontinent events.

[0041] Those skilled in the art will appreciate that such offline training structures are feasible and are realized in related but different implementations. For example, such machine learning architectures can be utilized in performing "wake-up word" text classification (e.g., "Hey Siri", "OK Google", etc.) commonly found on smartphone devices. In some cases, the machine learning algorithms described herein can operate within a similar framework as a "wake-up word" voice machine learning classifier. In some cases, the machine learning algorithms described herein can operate based on processing power and memory allocation determined to be sufficient for a "wake-up" voice machine learning classifier.

[0042] In some cases, the software described elsewhere herein may be executed by a processor located on the implanted stimulation device. In some cases, the software at the implanted stimulation device may utilize TinyML constrained machine learning models to accommodate the processing and memory parameters of the implanted stimulation device. In some cases, the software may be executed offline on cloud-based computing and / or dedicated computing clusters. In some cases, the offline processing workflow may include high-speed (such as BLUETOOTH, Wi-Fi, medical implant communication systems, etc.) data transfer between the implanted stimulation device and a local personal computing device (such as a smartphone, tablet, laptop, etc.). The personal processing device then communicates the implanted stimulation device data to one or more clouds and / or computer clusters, and then sends the resulting output, commands, and / or notifications back to the device. In some cases, the commands and / or notifications may include warnings, alarms, initiation of electrical stimulation, or any combination thereof. In some cases, the commands may include the output of a machine learning classifier configured to determine a threshold intensity of the EMG and / or ENG signals indicative of an incontinent event.

[0043] The machine learning model may be trained on one or more data sets. In some cases, the one or more data sets may include data generated by the user and / or the subject, or by a population or segment thereof. In some cases, the data generated by the subject and / or the population may include effort signals, excitation signals, which indicate an incontinent event and prevented an incontinent event, respectively. In some cases, the devices, systems, and corresponding methods described herein may record user data and / or user inputs when interacting with the systems and devices described elsewhere herein. In some cases, the data may include user-labeled EMG, ENG, accelerometer, gyroscope, or any combination thereof sensors that cause an incontinent event, as described elsewhere herein. In some cases, these signals may be obtained from the device 1302 and used to characterize 1304 and train the machine learning classifier 1306, as seen in FIG. 13. In some cases, the trained machine learning classifier trained on one or more data sets may be downloaded 1308 to each patient's device to further improve the accuracy of the machine learning classifier. In some cases, the machine learning model may be configured to detect the subject's effort and / or provide sufficient excitation based on, for example, frequency, amplitude, and / or pulse width parameters, as described elsewhere herein. In some cases, if the subject exhibits characteristics of similarity between clinical symptoms and excitability / sensory input parameters, one or more individual's datasets may be pooled together as a training dataset. In some cases, the clinical symptoms may include type of clinical incontinence, clinical metadata of the subject (such as gender, age, past medical history, current medications, past surgical interventions, etc.). In some cases, the pooled training dataset may be utilized for an individual during an initial period of training of the device implanted in the subject.

[0044] In some cases, one or more machine learning models described elsewhere herein may be trained based on raw signals and / or processed signals measured by the devices, sensors, and systems described elsewhere herein. In some cases, the processed signals may include original raw signals that have been filtered to optimize the signal-to-noise ratio of the raw signals. In some cases, the filters may comprise high-pass filters, low-pass filters, band-pass filters, notch filters, or any combination thereof. In some cases, one or more machine learning models may instead or additionally be trained based on previous excitation signal parameters and user feedback regarding whether such excitation signal parameters prevented an incontinent event.

[0045] In some aspects, the present disclosure provides a method 1001 of processing a detection signal to determine an incontinent event precursor signal strength threshold, as seen in Figure 10 and described elsewhere herein. In some cases, EMG, ENG, accelerometer, gyroscope, magnetometer, pressure sensor signals, or any combination thereof signals 1000 may be detected through an amplifier circuit 1002. In some cases, the amplifier circuit may comprise an operational amplifier circuit.

[0046] In some cases, the amplifier circuit may be configured to amplify the signal from about 10 microvolts (μV) to about 1000 μV. In some cases, the amplifier circuit may be configured to amplify the signal from about 10 μV to about 50 μV, about 10 μV to about 100 μV, about 10 μV to about 150 μV, about 10 μV to about 300 μV, about 10 μV to about 500 μV, about 10 μV to about 700 μV, about 10 μV to about 900 μV, about 10 μV to about 1000 μV, about 50 μV to about 100 μV, about 50 μV ~ approx. 150 μV, approx. 50 μV ~ approx. 300 μV, approx. 50 μV ~ approx. 500 μV, approx. 50 μV ~ approx. 700 μV, approx. 50 μV ~ approx. ~approx. 1,000μV, approx. 100μV ~ approx. 150μV, approx. 100μV ~ approx. 300μV, approx. 100μV ~ approx. 500μV, approx. 100μV ~ approx. 700μV, approx. 1 00μV to approx. 900μV, approx. 100μV to approx. 1000μV, approx. 150μV to approx. 300μV, approx. 150μV to approx. 500μV, approx. 150μV to approx. 700μ V, about 150μV to about 900μV, about 150μV to about 1,000μV, about 300μV to about 500μV, about 300μV to about 700μV, about 300μV The amplifier circuit may be configured to amplify signals from about 900 μV, about 300 μV to about 1,000 μV, about 500 μV to about 700 μV, about 500 μV to about 900 μV, about 500 μV to about 1,000 μV, about 700 μV to about 900 μV, about 700 μV to about 1,000 μV, or about 900 μV to about 1,000 μV. In some cases, the amplifier circuit may be configured to amplify signals from about 10 μV, about 50 μV, about 100 μV, about 150 μV, about 300 μV, about 500 μV, about 700 μV, about 900 μV, or about 1000 μV. In some cases, the amplifier circuit may be configured to amplify a signal from at least about 10 μV, about 50 μV, about 100 μV, about 150 μV, about 300 μV, about 500 μV, about 700 μV, or about 900 μV. In some cases, the amplifier circuit may be configured to amplify a signal from up to about 50 μV, about 100 μV, about 150 μV, about 300 μV, about 500 μV, about 700 μV, about 900 μV, or about 1000 μV.

[0047] In some cases, the amplifier circuit may be configured to amplify signals having frequencies from about 1 Hz to about 1,500 Hz.In some cases, the amplifier circuit may be configured to provide a frequency response ranging from about 1 Hz to about 20 Hz, about 1 Hz to about 40 Hz, about 1 Hz to about 80 Hz, about 1 Hz to about 100 Hz, about 1 Hz to about 150 Hz, about 1 Hz to about 200 Hz, about 1 Hz to about 250 Hz, about 1 Hz to about 500 Hz, about 1 Hz to about 750 Hz, about 1 Hz to about 1,000 Hz, about 1 Hz to about 1,500 Hz, about 20 Hz to about 40 Hz, about 20 Hz to about 80 Hz, about 20 Hz to about 100 Hz, about 20 Hz to about 150 Hz, about 20 Hz to about 200 Hz, about 20 Hz to about 250 Hz, about 20 Hz to about 500 Hz, about 20 Hz to about 500 Hz, about 20 Hz to about 600 Hz, about 20 Hz to about 750 Hz, about 1 Hz to about 1,000 Hz, about 1 Hz to about 1,500 Hz, 0Hz to 750Hz, 20Hz to 1,000Hz, 20Hz to 1,500Hz, 40Hz to 80Hz, 40Hz to 100Hz, 40Hz to 150Hz, 40Hz to 200Hz, 40Hz to 250Hz, 40Hz to 500Hz, 40Hz to 750Hz, 40Hz to 1,000Hz, 40Hz to 1,500Hz, 80Hz to 100Hz, 80Hz to 150Hz, 80Hz to 200Hz, 80Hz to 250Hz, 80Hz to 500Hz, 80Hz to 750Hz , about 80Hz to about 1,000Hz, about 80Hz to about 1,500Hz, about 100Hz to about 150Hz, about 100Hz to about 200Hz, about 100Hz to about 250Hz, about 100Hz to about 500Hz, about 100Hz to about 750Hz, about 100Hz to about 1,000Hz, about 100Hz to about 1,500Hz, about 150Hz to about 200Hz, about 150Hz to about 250Hz, about 150Hz to about 500Hz, about 150Hz to about 750Hz, about 150Hz to about 1,000Hz, about 150Hz to about 1,500Hz, about 200Hz to about 250Hz, about 20 The amplifier may be configured to amplify signals with frequencies of 0 Hz to about 500 Hz, about 200 Hz to about 750 Hz, about 200 Hz to about 1,000 Hz, about 200 Hz to about 1,500 Hz, about 250 Hz to about 500 Hz, about 250 Hz to about 750 Hz, about 250 Hz to about 1,000 Hz, about 250 Hz to about 1,500 Hz, about 500 Hz to about 750 Hz, about 500 Hz to about 1,000 Hz, about 500 Hz to about 1,500 Hz, about 750 Hz to about 1,000 Hz, about 750 Hz to about 1,500 Hz, or about 1,000 Hz to about 1,500 Hz.In some cases, the amplifier circuitry may be configured to amplify signals at frequencies of about 1 Hz, about 20 Hz, about 40 Hz, about 80 Hz, about 100 Hz, about 150 Hz, about 200 Hz, about 250 Hz, about 500 Hz, about 750 Hz, about 1,000 Hz, or about 1,500 Hz. In some cases, the amplifier circuitry may be configured to amplify signals at frequencies of at least about 1 Hz, about 20 Hz, about 40 Hz, about 80 Hz, about 100 Hz, about 150 Hz, about 200 Hz, about 250 Hz, about 500 Hz, about 750 Hz, or about 1000 Hz. In some cases, the amplifier circuit may be configured to amplify signals at frequencies up to about 20 Hz, about 40 Hz, about 80 Hz, about 100 Hz, about 150 Hz, about 200 Hz, about 250 Hz, about 500 Hz, about 750 Hz, about 1,000 Hz, or about 1,500 Hz.

[0048] In some cases, the amplified signal may be passed to a filter 1004. In some cases, the filter may include a low pass filter, a high pass filter, a band pass filter, a notch filter, or any combination thereof.

[0049] In some cases, the filter may be configured to filter a frequency band from about 1 Hz to about 70 Hz. In some cases, the filter may be set to a frequency of about 1 Hz to about 5 Hz, about 1 Hz to about 10 Hz, about 1 Hz to about 15 Hz, about 1 Hz to about 20 Hz, about 1 Hz to about 25 Hz, about 1 Hz to about 40 Hz, about 1 Hz to about 50 Hz, about 1 Hz to about 60 Hz, about 1 Hz to about 70 Hz, about 5 Hz to about 10 Hz, about 5 Hz to about 15 Hz, about 5 Hz to about 20 Hz, about 5 Hz to about 25 Hz, about 5 Hz to about 40 Hz, about 5 Hz to about 50 Hz, about 5 Hz to about 60 Hz, about 5 Hz to about 70 Hz, about 10 Hz to about 15 Hz, about 10 Hz to about 20 Hz, about 10 Hz to about 25 Hz, about 10 Hz to about 40 Hz, about 10 Hz to about 50 Hz, about 10 Hz to about 60 Hz, about 10 Hz to about 70 Hz , about 15 Hz to about 20 Hz, about 15 Hz to about 25 Hz, about 15 Hz to about 40 Hz, about 15 Hz to about 50 Hz, about 15 Hz to about 60 Hz, about 15 Hz to about 70 Hz, about 20 Hz to about 25 Hz, about 20 Hz to about 40 Hz, about 20 Hz to about 50 Hz, about 20 Hz to about 60 Hz, about 20 Hz to about 70 Hz, about 25 Hz to about 40 Hz, about 25 Hz to about 50 Hz, about 25 Hz to about 60 Hz, about 25 Hz to about 70 Hz, about 40 Hz to about 50 Hz, about 40 Hz to about 60 Hz, about 40 Hz to about 70 Hz, about 50 Hz to about 60 Hz, about 50 Hz to about 70 Hz, or about 60 Hz to about 70 Hz. In some cases, the filter may be configured to filter a frequency band of about 1 Hz, about 5 Hz, about 10 Hz, about 15 Hz, about 20 Hz, about 25 Hz, about 40 Hz, about 50 Hz, about 60 Hz, about 70 Hz. In some cases, the filter may be configured to filter a frequency band of at least about 1 Hz, about 5 Hz, about 10 Hz, about 15 Hz, about 20 Hz, about 25 Hz, about 40 Hz, about 50 Hz, about 60 Hz. In some cases, the filter may be configured to filter a frequency band of at most about 5 Hz, about 10 Hz, about 15 Hz, about 20 Hz, about 25 Hz, about 40 Hz, about 50 Hz, about 60 Hz, about 70 Hz.

[0050] After passing the signal through the filter, the systems and methods described herein may rectify the filtered signal 1006. As will be appreciated by those skilled in the art, in the process of rectifying the signal, the signal will be converted from an AC detection signal to a DC signal. The rectified signal may be further filtered with a low pass filter 1007, which may smooth the rectified signal. The signal may be subjected to a threshold detector 1008, which determines the onset of an incontinent event from a threshold intensity value of the rectified and smoothed signal 1000 of the EMG, ENG, accelerometer, gyroscope, magnetometer, pressure sensor signal, or any combination thereof. If an incontinent event is determined by the threshold detector 1008, the system may enable delivery of an electrical stimulus 1010, as described elsewhere herein.

[0051] In some cases, the training may be supervised training. Alternatively, the training may be unsupervised training. In some cases, the dataset may be a retrospective dataset. Alternatively, the dataset may be a prospectively developed dataset, where the machine learning model is iteratively improved over time.

[0052] In some aspects, the disclosure provided herein may include a method of training a machine learning model with a dataset including detected signal profiles and excitation signals that prevented and did not prevent an incontinent event. The method may include the steps of pre-processing, training, and prediction.

[0053] The method may extract training data from a database or incorporate new data, as described elsewhere herein. The pre-processing step may apply one or more transformations to standardize the training data or new data for the training step or the prediction step. The pre-processed training data may be passed to a training step, which may build a machine learning model based on the training data. The training step may further include a validation step configured to validate the trained machine learning model using any suitable validation algorithm (e.g., stratified K-fold cross-validation). In some cases, the k-fold cross-validation may include at least 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 folds. In some cases, the k-fold cross-validation may include at most 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 folds.

[0054] The preprocessing step may apply one or more transformations to the training data to clean and normalize the data. The preprocessing step may be configured to discard parameters that contain spurious data or parameters with very few observations. The preprocessing module may further be configured to standardize the encoding of the parameter values. The preprocessing step may recognize variations in the encoding of the same value and standardize the dataset to have a uniform encoding for certain parameter values. Thus, the processing step may reduce irregularity in the input data for the training and prediction steps, thereby improving the robustness of the training and prediction steps.

[0055] The training step may utilize machine learning or other algorithms to build and train a machine learning model used to correlate the excitation stimuli, the detected signal profile, and the presence or absence of an incontinence event. The machine learning model may be constructed to capture statistical relationships, if any, between the excitation stimulus parameters, the detected signal profile, and the presence or absence of an incontinence event based on the training data.

[0056] The machine learning algorithm may have an accuracy of greater than about 60%, 70%, 80%, 85%, 90%, 95%, or 99%. The machine learning algorithm may have a positive predictive value of greater than about 60%, 70%, 75%, 80%, 85%, 90%, 95%, or 99%. The machine learning algorithm may have a negative predictive value of greater than about 60%, 70%, 80%, 90%, 95%, or 99%.

[0057] The machine learning data analysis, the machine learning model training, or any combination thereof may be performed using one or more of many programming languages ​​and platforms known in the art, such as, for example, R, Weka, Python, and / or MATLAB.

[0058] The use of such a closed-loop bioelectronic system may provide an improved electrical stimulation device for preventing or reducing stress incontinence. In some cases, the use of such a closed-loop bioelectronic system may provide a more precise approach to prevent, reduce, or treat urge incontinence and mixed incontinence (a combination of urge and stress incontinence). In some cases, an individual with an implanted device may provide feedback on parameters that provide a positive, negative, or neutral outcome. In some cases, a positive outcome may include prevention of an incontinence event. In some cases, a negative outcome may include not preventing an incontinence event, causing pain, or a combination thereof. In some cases, a neutral outcome may include not preventing an incontinence event, not causing pain, or a combination thereof. In some cases, positive, negative, neutral results, sensor data, or any combination thereof from multiple individuals with implanted devices may be used to adjust the algorithm to suggest changes to the sensor electrode thresholds and electrical stimulation patterns 124.

[0059] Electrical Simulation Pattern In some cases, the electrical stimulation pattern provided by the implantable pulse generator and the one or more stimulation electrodes may be modified or altered to suit the needs of an individual who needs to prevent incontinent episodes. In some cases, the one or more stimulation electrodes 122 may output an electrical stimulation pattern 124 in response to what is detected by the one or more sensor electrodes 120. In some cases, the electrical stimulation pattern 124 may include one or more electrical signals. For example, the electrical stimulation pattern 124 may include a continuous wave signal (e.g., an electrical stimulation signal having a constant frequency in time) and a burst or pulsatile signal superimposed on the continuous wave signal. In some cases, the burst or pulsatile signal may only be effective for a short period of time compared to the continuous temporal aspect of the continuous wave signal. In some cases, the combination of the continuous wave signal and / or the burst or pulsatile signal may increase the subject's pain threshold, allowing the stimulation device to provide a higher amplitude electrical stimulation burst pattern to prevent incontinent events. In some cases, the frequency of the electrical stimulation pattern may be modified or altered. The frequency pattern may include a constant profile, a sweep profile, a pulsatile profile, a burst profile, a chirp profile, a monophasic profile, a biphasic profile, or any combination thereof. In some cases, the constant profile is composed of an excitation value at a constant amplitude with a frequency value of 0 Hz. In some cases, the sweep profile may include a signal with an excitation frequency that varies over time. In some cases, the pulsatile profile may include a combination of one or more excitation signals of various frequencies. In some cases, the burst profile may include a signal of constant frequency enveloped by an envelope function of square, delta, sine, or any combination thereof. In some cases, the monophasic profile may include an excitation signal with only positive or negative amplitude at a constant frequency (e.g., a signal with values ​​only from 0 to -5V or 0 to 5V).In some cases, the pulse or burst profile may include an electrical simulation pattern that is provided to the patient and / or subject during a first period of an on state and not provided to the patient and / or subject during a second period of an off state. In some cases, the pulse or burst profile may provide an excitation signal that can provide a longer period of muscle excitation without suffering from muscle fatigue. In some cases, the on state and / or the off state may include about 0.1 seconds to about 6.5 seconds. In some cases, the on and / or off states may last for about 0.1 seconds to about 0.5 seconds, about 0.1 seconds to about 1 second, about 0.1 seconds to about 1.2 seconds, about 0.1 seconds to about 1.5 seconds, about 0.1 seconds to about 2 seconds, about 0.1 seconds to about 2.5 seconds, about 0.1 seconds to about 3 seconds, about 0.1 seconds to about 3.5 seconds, about 0.1 seconds to about 4 seconds, about 0.1 seconds to about 5 seconds, about 0.1 seconds to about 6.5 seconds, about 0.5 seconds to about 1 second, about 0.5 seconds to about 1.2 seconds, about 0.5 seconds to about 1. 5 seconds, about 0.5 seconds to about 2 seconds, about 0.5 seconds to about 2.5 seconds, about 0.5 seconds to about 3 seconds, about 0.5 seconds to about 3.5 seconds, about 0.5 seconds to about 4 seconds, about 0.5 seconds to about 5 seconds, about 0.5 seconds to about 6.5 seconds, about 1 second to about 1.2 seconds, Approximately 1 second to approximately 1.5 seconds, approximately 1 second to approximately 2 seconds, approximately 1 second to approximately 2.5 seconds, approximately 1 second to approximately 3 seconds, approximately 1 second to approximately 3.5 seconds, approximately 1 second to approximately 4 seconds, approximately 1 second to approximately 5 seconds, approximately 1 second to approximately 6.5 seconds, approximately 1.2 seconds to approximately 1.5 seconds, approximately 1.2 seconds Approximately 2 seconds, approximately 1.2 seconds to approximately 2.5 seconds, approximately 1.2 seconds to approximately 3 seconds, approximately 1.2 seconds to approximately 3.5 seconds, approximately 1.2 seconds to approximately 4 seconds, approximately 1.2 seconds to approximately 5 seconds, approximately 1.2 seconds to approximately 6.5 seconds, approximately 1.5 seconds to approximately 2 seconds, approximately 1.5 seconds to approximately 2. 5 seconds, approximately 1.5 seconds to approximately 3 seconds, approximately 1.5 seconds to approximately 3.5 seconds, approximately 1.5 seconds to approximately 4 seconds, approximately 1.5 seconds to approximately 5 seconds, approximately 1.5 seconds to approximately 6.5 seconds, approximately 2 seconds to approximately 2.5 seconds, approximately 2 seconds to approximately 3 seconds, approximately 2 seconds to approximately 3.5 seconds, approximately 2 seconds to approximately 4 seconds, about 2 seconds to about 5 seconds, about 2 seconds to about 6.5 seconds, about 2.5 seconds to about 3 seconds, about 2.5 seconds to about 3.5 seconds, about 2.5 seconds to about 4 seconds, about 2.5 seconds to about 5 seconds, about 2.5 seconds to about 6.5 seconds, about 3 seconds to about 3.5 seconds, about 3 seconds to about 4 seconds, about 3 seconds to about 5 seconds, about 3 seconds to about 6.5 seconds, about 3.5 seconds to about 4 seconds, about 3.5 seconds to about 5 seconds, about 3.5 seconds to about 6.5 seconds, about 4 seconds to about 5 seconds, about 4 seconds to about 6.5 seconds, or about 5 seconds to about 6.5 seconds.In some cases, the on and / or off states may include about 0.1 seconds, about 0.5 seconds, about 1 second, about 1.2 seconds, about 1.5 seconds, about 2 seconds, about 2.5 seconds, about 3 seconds, about 3.5 seconds, about 4 seconds, about 5 seconds, or about 6.5 seconds. In some cases, the on and / or off states may include at least about 0.1 seconds, about 0.5 seconds, about 1 second, about 1.2 seconds, about 1.5 seconds, about 2 seconds, about 2.5 seconds, about 3 seconds, about 3.5 seconds, about 4 seconds, about 5 seconds, or about 5 seconds. In some cases, the on and / or off states may include at most about 0.5 seconds, about 1 second, about 1.2 seconds, about 1.5 seconds, about 2 seconds, about 2.5 seconds, about 3 seconds, about 3.5 seconds, about 4 seconds, about 5 seconds, or about 6.5 seconds.

[0060] In some examples, the electrical stimulation pattern provided during the on state may include an oscillating electrical stimulation pattern. In some cases, the oscillating electrical stimulation pattern may include one or more frequencies. In some cases, the frequency of the oscillating electrical stimulation may be selected based on prior knowledge of how similar subjects respond to a particular frequency or range of frequencies of the oscillating electrical stimulation pattern. In some cases, a low frequency (e.g., 2-15 Hz) may induce a decrease in bladder contractility, preventing urination and potential incontinence. In some cases, a higher frequency (e.g., 20-50 Hz) may lead to enhanced bladder contraction and urination. In some cases, the frequency of the electrical stimulation pattern may be from about 1 Hz to about 60 Hz.In some cases, the frequency of the electrical stimulation pattern is from about 1 Hz to about 5 Hz, about 1 Hz to about 10 Hz, about 1 Hz to about 15 Hz, about 1 Hz to about 25 Hz, about 1 Hz to about 30 Hz, about 1 Hz to about 35 Hz, about 1 Hz to about 40 Hz, about 1 Hz to about 45 Hz, about 1 Hz to about 50 Hz, about 1 Hz to about 55 Hz, about 1 Hz to about 60 Hz, about 5 Hz to about 10 Hz, about 5 Hz to about 15 Hz, about 5 Hz to about 25 Hz, about 5 Hz to about 30 Hz, about 5 Hz to about 35 Hz, about 5 Hz to about 50 Hz, about 5 ... z~40Hz, 5Hz~45Hz, 5Hz~50Hz, 5Hz~55Hz, 5Hz~60Hz, 10Hz~15Hz, 10Hz~25Hz, 10Hz~30Hz, 10Hz~35Hz, Approximately 10Hz to approximately 40Hz, approximately 10Hz to approximately 45Hz, approximately 10Hz to approximately 50Hz, approximately 10Hz to approximately 55Hz, approximately 10Hz to approximately 60Hz, approximately 15Hz to approximately 25Hz, approximately 15Hz to approximately 30Hz, approximately 15Hz to approximately 35Hz, approximately 15H z~40Hz, 15Hz~45Hz, 15Hz~50Hz, 15Hz~55Hz, 15Hz~60Hz, 25Hz~30Hz, 25Hz~35Hz, 25Hz~40Hz, 25Hz~4 5Hz, approximately 25Hz to 50Hz, approximately 25Hz to approximately 55Hz, approximately 25Hz to approximately 60Hz, approximately 30Hz to approximately 35Hz, approximately 30Hz to approximately 40Hz, approximately 30Hz to approximately 45Hz, approximately 30Hz to approximately 50Hz, approximately 30Hz to approximately 55Hz, approximately The frequency of the electrical stimulation pattern may be about 30 Hz to about 60 Hz, about 35 Hz to about 40 Hz, about 35 Hz to about 45 Hz, about 35 Hz to about 50 Hz, about 35 Hz to about 55 Hz, about 35 Hz to about 60 Hz, about 40 Hz to about 45 Hz, about 40 Hz to about 50 Hz, about 40 Hz to about 55 Hz, about 40 Hz to about 60 Hz, about 45 Hz to about 50 Hz, about 45 Hz to about 55 Hz, about 45 Hz to about 60 Hz, about 50 Hz to about 55 Hz, about 50 Hz to about 60 Hz, or about 55 Hz to about 60 Hz. In some examples, the frequency of the electrical stimulation pattern may be about 1 Hz, about 5 Hz, about 10 Hz, about 15 Hz, about 25 Hz, about 30 Hz, about 35 Hz, about 40 Hz, about 45 Hz, 50 Hz, about 55 Hz, or about 60 Hz.In some examples, the frequency of the electrical stimulation pattern may be at least about 1 Hz, about 5 Hz, about 10 Hz, about 15 Hz, about 25 Hz, about 30 Hz, about 35 Hz, about 40 Hz, about 45 Hz, about 50 Hz, or about 55 Hz. In some cases, the frequency of the electrical stimulation pattern may be at most about 5 Hz, about 10 Hz, about 15 Hz, about 25 Hz, about 30 Hz, about 35 Hz, about 40 Hz, about 45 Hz, about 50 Hz, about 55 Hz, or about 60 Hz. In some embodiments, the frequency refers to the average frequency of the electrical stimulation pattern. In some embodiments, the frequency refers to the median frequency. In some embodiments, the frequency refers to the maximum frequency.

[0061] In some cases, a burst signal having on and / or off states as described elsewhere herein may be provided to the subject to prevent fatigue of one or more muscles innervated by the subject's pudendal nerve. In some cases, the burst electrical stimulation pattern may include one or more frequencies as described elsewhere herein.

[0062] In some cases, the amplitude of the electrical stimulation pattern can be modified or changed. In some cases, the amplitude of the electrical stimulation pattern can be from about 1 volt (V) to about 15 V. In some cases, the amplitude of the electrical stimulation pattern can be from about 1 V to about 2 V, from about 1 V to about 3 V, from about 1 V to about 4 V, from about 1 V to about 5 V, from about 1 V to about 6 V, from about 1 V to about 7 V, from about 1 V to about 8 V, from about 1 V to about 9 V, from about 1 V to about 10 V, from about 1 V to about 12 V, from about 1 V to about 15 V, from about 2 V to about 3 V, from about 2 V to about 4 V, from about 2 V to about 5 V, from about 2 V to about 6 V, from about 2 V to about 7 V, from about 1 V to about 8 V, from about 1 V to about 9 V, from about 1 V to about 10 V, from about 1 V to about 12 V, from about 1 V to about 15 V, from about 2 V to about 3 V, from about 2 V to about 4 V, from about 2 V to about 5 V, from about 2 V to about 6 V, from about 2 V to about 7 V, from about 2 V to about 8 V, from about 2 ... ~Approx. 7V, approx. 2V ~ approx. 8V, approx. 2V ~ approx. 9V, approx. 2V ~ approx. 10V, approx. 2V ~ approx. 12V, approx. 2V ~ approx. 15V, approx. 3V ~ approx. 4V, approx. V ~ about 7V, about 3V - about 8V, about 3V - about 9V, about 3V - about 10V, about 3V - about 12V, about 3V - about 15V, about 4V - about 5V, about 4V - about 6V, about 4V - about 7V, about 4V to about 8V, about 4V to about 9V, about 4V to about 10V, about 4V to about 12V, about 4V to about 15V, about 5V to about 6V, about 5V to about 7V, about 5V to about 8V, about 5V to about 9V, Approx. 5V ~ 10V, Approx. 5V ~ Approx. 12V, Approx. 5V ~ Approx. 15V, Approx. 6V ~ Approx. 7V, Approx. 6V ~ Approx. 8V, Approx. 6V ~ Approx. 9V, Approx. 6V ~ Approx. 10V, Approx. 6V ~ Approx. 12V, Approx. 6V ~ Approx. 1 The amplitude of the electrical stimulation pattern may be about 5V, about 7V to about 8V, about 7V to about 9V, about 7V to about 10V, about 7V to about 12V, about 7V to about 15V, about 8V to about 9V, about 8V to about 10V, about 8V to about 12V, about 8V to about 15V, about 9V to about 10V, about 9V to about 12V, about 9V to about 15V, about 10V to about 12V, about 10V to about 15V, or about 12V to about 15V. In some cases, the amplitude of the electrical stimulation pattern may be about 1V, about 2V, about 3V, about 4V, about 5V, about 6V, about 7V, about 8V, about 9V, about 10V, 12V, or 15V. In some cases, the amplitude of the electrical stimulation pattern may be at least about 1V, about 2V, about 3V, about 4V, about 5V, about 6V, about 7V, about 8V, about 9V, about 10V, or about 12V. In some cases, the amplitude of the electrical stimulation pattern may be at most about 2V, about 3V, about 4V, about 5V about 6V, about 7V, about 8V, about 9V, about 10V, about 12V, or about 15V. In some embodiments, the amplitude refers to the average amplitude. In some embodiments, the amplitude refers to the median amplitude. In some embodiments, the amplitude refers to the maximum amplitude.In some embodiments, the amplitude refers to peak-to-peak amplitude.

[0063] In some cases, the amplitude of the electrical stimulation pattern may be from about 0.05 milliamps (mA) to about 10 mA. In some cases, the amplitude of the electrical stimulation pattern may be from about 0.05 mA to about 1 mA, from about 0.05 mA to about 2 mA, from about 0.05 mA to about 3 mA, from about 0.05 mA to about 4 mA, from about 0.05 mA to about 5 mA, or from about 0.05 mA to about 5 mA. 0.05mA to approx. 6mA, approx. 0.05mA to approx. 7mA, approx. 0.05mA to approx. 8mA, approx. 0.05mA to approx. 9mA, approx. 0.05mA to approx. 10mA, approx. 1mA to about 2mA, about 1mA to about 3mA, about 1mA to about 4mA, about 1mA to about 5mA, about 1mA to about 6mA, about 1mA to about 7mA, about 1mA to about 8m A, approximately 1mA to approximately 9mA, approximately 1mA to approximately 10mA, approximately 2mA to approximately 3mA, approximately 2mA to approximately 4mA, approximately 2mA to approximately 5mA, approximately 2mA to approximately 6mA, approximately 2mA ~7mA, 2mA~8mA, 2mA~9mA, 2mA~10mA, 3mA~4mA, 3mA~5mA, 3mA~6mA, It may be about 3 mA to about 7 mA, about 3 mA to about 8 mA, about 3 mA to about 9 mA, about 3 mA to about 10 mA, about 4 mA to about 5 mA, about 4 mA to about 6 mA, about 4 mA to about 7 mA, about 4 mA to about 8 mA, about 4 mA to about 9 mA, about 4 mA to about 10 mA, about 5 mA to about 6 mA, about 5 mA to about 7 mA, about 5 mA to about 8 mA, about 5 mA to about 9 mA, about 5 mA to about 10 mA, about 6 mA to about 7 mA, about 6 mA to about 8 mA, about 6 mA to about 9 mA, about 6 mA to about 10 mA, about 7 mA to about 8 mA, about 7 mA to about 9 mA, about 7 mA to about 10 mA, about 8 mA to about 9 mA, about 8 mA to about 10 mA, or about 9 mA to about 10 mA. In some cases, the amplitude of the electrical stimulation pattern may be about 0.05 mA, about 1 mA, about 2 mA, about 3 mA, about 4 mA, about 5 mA, about 6 mA, about 7 mA, about 8 mA, about 9 mA, or about 10 mA. In some cases, the amplitude of the electrical stimulation pattern may be at least about 0.05 mA, about 1 mA, about 2 mA, about 3 mA, about 4 mA, about 5 mA, about 6 mA, about 7 mA, about 8 mA, about 9 mA. In some cases, the amplitude of the electrical stimulation pattern may be at most about 1 mA, about 2 mA, about 3 mA, about 4 mA, about 5 mA, about 6 mA, about 7 mA, about 8 mA, about 9 mA, about 10 mA. In some embodiments, the amplitude refers to the average amplitude. In some embodiments, the amplitude refers to the median amplitude.In some embodiments, the amplitude refers to the maximum amplitude.

[0064] In some cases, the pulse width of the electrical stimulation pattern can be modified or changed. In some cases, the pulse width of the electrical stimulation pattern can be from about 60 μs to about 390 μs.In some cases, the pulse width of the electrical stimulation pattern may be about 60 μs to about 90 μs, about 60 μs to about 120 μs, about 60 μs to about 150 μs, about 60 μs to about 180 μs, about 60 μs to about 210 μs, about 60 μs to about 240 μs, about 60 μs to about 270 μs, about 60 μs to about 300 μs, about 60 μs to about 330 μs, about 60 μs to about 360 μs, about 60 μs to about 390 μs, about 90 μs to about 120 μs, about 90 μs to about 150 μs, about 90 μs to about 180 μs, about 90 μs to about 210 μs, about 90 μs to about 240 μs. s, about 90μs to about 270μs, about 90μs to about 300μs, about 90μs to about 330μs, about 90μs to about 360μs, about 90μs ~390μs, 120μs~150μs, 120μs~180μs, 120μs~210μs, 120μs~2 40μs, about 120μs to about 270μs, about 120μs to about 300μs, about 120μs to about 330μs, about 120μs to about 360μs s, approximately 120μs to approximately 390μs, approximately 150μs to approximately 180μs, approximately 150μs to approximately 210μs, approximately 150μs to approximately 240μs, approximately 150μs to approx. 270μs, approx. 150μs to approx. 300μs, approx. 150μs to approx. 330μs, approx. 150μs to approx. 360μs, approx. 15 0μs to approx. 390μs, approx. 180μs to approx. 210μs, approx. 180μs to approx. 240μs, approx. 180μs to approx. 270μs, approx. 180μs ~300μs, 180μs~330μs, 180μs~360μs, 180μs~390μs, 210μs~2 40μs, about 210μs to about 270μs, about 210μs to about 300μs, about 210μs to about 330μs, about 210μs to about 360μs s, about 210 μs to about 390 μs, about 240 μs to about 270 μs, about 240 μs to about 300 μs, about 240 μs to about 330 μs, about 240 μs to about 360 μs, about 240 μs to about 390 μs, about 270 μs to about 300 μs, about 270 μs to about 330 μs, about 270 μs to about 360 μs, about 270 μs to about 390 μs, about 300 μs to about 330 μs, about 300 μs to about 360 μs, about 300 μs to about 390 μs, about 330 μs to about 360 μs, about 330 μs to about 390 μs, or about 360 μs to about 390 μs.In some examples, the pulse width of the electrical stimulation pattern may be about 60 μs, about 90 μs, about 120 μs, about 150 μs, about 180 μs, about 210 μs, about 240 μs, about 270 μs, about 300 μs, about 330 μs, about 360 μs, or about 390 μs. In some cases, the pulse width of the electrical stimulation pattern may be at least about 60 μs, about 90 μs, about 120 μs, about 150 μs, about 180 μs, about 210 μs, about 240 μs, about 270 μs, about 300 μs, about 330 μs, or about 360 μs. In some examples, the pulse width of the electrical stimulation pattern may be at most about 90 μs, about 120 μs, about 150 μs, about 180 μs, about 210 μs, about 240 μs, about 270 μs, about 300 μs, about 330 μs, about 360 μs, or about 390 μs. In some embodiments, the pulse width refers to the average pulse width. In some embodiments, the pulse width refers to the median pulse width. In some embodiments, the pulse width refers to the maximum pulse width.

[0065] Sensors for use in the device embodiments described herein In some cases, sensor electrodes for use in the device embodiments described herein may be configured to detect a parameter associated with an individual's response intended to prevent an incontinent episode or a parameter indicative of an individual possibly experiencing an incontinent episode. In some cases, the sensor electrodes may be configured to detect an individual's muscular contraction resulting in a partial contraction of a sphincter that controls the bladder or bowel movements. In some cases, the sensor electrodes may be configured to detect an individual's gross body movement or anatomical stress. In some cases, the sensor electrodes may comprise a sensor configured to detect electromyographic (EMG) signals. In some cases, the sensor electrodes may be configured to detect myoelectric activity. In some cases, an EMG signal threshold may determine that a contraction of at least one pelvic muscle has occurred. In some cases, the strength of the EMG signal may be proportional to the strength of the contraction of at least one pelvic muscle. In some cases, the sensor electrodes detect action potential signals. In some cases, the device comprises an amplifier that amplifies the signal acquired by the sensor electrodes to facilitate analysis and classification of the signal by the processor.

[0066] In some cases, the sensor electrode may be implanted in the individual's pelvis. In some cases, the sensor electrode may be implanted in or adjacent to the pudendal nerve. In some cases, the sensor electrode may be implanted in or adjacent to the sacral nerve. In some cases, the sensor electrode may be implanted in or adjacent to one or more pelvic muscles. In some cases, the sensor electrode may be implanted in or adjacent to the pelvic floor. In some cases, the sensor electrode may be implanted in or adjacent to the urethral sphincter. In some cases, the sensor electrode may be implanted in or adjacent to one or more of the urethra, ureter, and bladder. In some cases, the sensor electrode may be implanted in or adjacent to the anal sphincter. In some cases, the sensor electrode may be implanted in or adjacent to one or more of the anus, rectum, and intestine. In some cases, the devices described herein may include multiple sensor electrodes. In some cases, the devices described herein may include one or more sensor electrodes. In some cases, the devices described herein may include a different sensor electrode, or a second sensor electrode. In some cases, the sensor electrode may detect signals from a muscle area innervated by a first pudendal nerve, and the different or second sensor electrode may detect signals from a muscle area innervated by a second pudendal nerve. In some cases, the sensor electrode may detect signals from a muscle area innervated by a first sacral nerve, and the different or second sensor electrode may detect signals from a muscle area innervated by a second sacral nerve.

[0067] In some cases, the sensor electrode may include a casing and a lead. In some cases, the casing may be made of titanium, a titanium alloy, tantalum, or any combination thereof. In some cases, the lead may be made of a metal alloy. In some embodiments, the sensor electrode and the stimulating electrode may be disposed on a single lead. In some cases, the lead may be electrically connected to one or more sensor electrodes or one or more stimulating electrodes. In some embodiments, the sensor electrode and the stimulating electrode are disposed on separate leads. In some cases, the one or more sensor electrodes may include a bioelectrical sensor electrode.

[0068] Electrodes for use in the device embodiments described herein In some cases, the sensor electrodes and the stimulation electrodes may be located on a single lead. In some cases, one or more sensor electrodes and one or more stimulation electrodes may be located on a single lead. In some cases, one sensor electrode and one stimulation electrode may be located on a single lead. In some cases, the sensor electrodes and the stimulation electrodes may be located on separate leads. In some cases, the sensor electrodes and the stimulation electrodes may each be located on their own lead. In some cases, the sensor electrodes and the stimulation electrodes may be in a linear geometry, a triangular geometry, a square geometry, a hexagonal geometry, or a general polygonal geometry. In some cases, the electrodes located on a single lead may be spaced a fixed distance apart. In some cases, this spacing allows for stimulation of multiple locations along the length of the nerve. In some cases, the electrodes may be spaced a distance of at least about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 5 mm, about 10 mm, about 20 mm, about 30 mm, about 40 mm, about 50 mm, about 60 mm apart. In some cases, the electrodes may be separated by a distance of up to about 1.5 mm, about 2 mm, about 2.5 mm, about 5 mm, about 10 mm, about 20 mm, about 30 mm, about 40 mm, about 50 mm, about 60 mm, or about 80 mm.

[0069] In some cases, the device may include one or more leads. In some cases, the device may include at least two leads. In some cases, the device may include at least 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 leads. In some cases, the device may include at most 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 leads. In some cases, the device may include 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 leads. In some cases, each lead may include one or more electrodes. In some cases, the one or more electrodes may include one or more sensor electrodes and / or stimulation electrodes. In some cases, the one or more electrodes on a lead may include about 1-10 electrodes. In some cases, one or more of the electrodes on the lead may be about 1-2 electrodes, about 1-3 electrodes, about 1-4 electrodes, about 1-5 electrodes, about 1-6 electrodes, about 1-7 electrodes, about 1-8 electrodes, about 1-9 electrodes, about 1-10 electrodes, about 2-3 electrodes, about 2-4 electrodes, about 2-5 electrodes, about 2-6 electrodes, about 2-7 electrodes, about 2-8 electrodes, about 2-9 electrodes, about 2-10 electrodes, about 3-4 electrodes, about 3-5 electrodes, about 3-6 electrodes, about 3-7 electrodes, about 3-8 electrodes, about The lead may include 3-9 electrodes, about 3-10 electrodes, about 4-5 electrodes, about 4-6 electrodes, about 4-7 electrodes, about 4-8 electrodes, about 4-9 electrodes, about 4-10 electrodes, about 5-6 electrodes, about 5-7 electrodes, about 5-8 electrodes, about 5-9 electrodes, about 5-10 electrodes, about 6-7 electrodes, about 6-8 electrodes, about 6-9 electrodes, about 6-10 electrodes, about 7-8 electrodes, about 7-9 electrodes, about 7-10 electrodes, about 8-9 electrodes, about 8-10 electrodes, or about 9-10 electrodes. In some cases, one or more electrodes on the lead may include about 1 electrode, about 2 electrodes, about 3 electrodes, about 4 electrodes, about 5 electrodes, about 6 electrodes, about 7 electrodes, about 8 electrodes, about 9 electrodes, or about 10 electrodes. In some cases, the one or more electrodes on the lead may include at least about 1 electrode, about 2 electrodes, about 3 electrodes, about 4 electrodes, about 5 electrodes, about 6 electrodes, about 7 electrodes, about 8 electrodes, or about 9 electrodes.In some cases, the one or more electrodes on the lead may include up to about 2 electrodes, about 3 electrodes, about 4 electrodes, about 5 electrodes, about 6 electrodes, about 7 electrodes, about 8 electrodes, about 9 electrodes, or about 10 electrodes.

[0070] In some cases, each electrode may have a length that may provide localized excitation of one or more nerves of the sacral or pudendal nerves. In some cases, each electrode may include a length of about 0.1 millimeters (mm) to about 2 mm. In some cases, each electrode may include a length of about 0.1 mm to about 0.3 mm, about 0.1 mm to about 0.5 mm, about 0.1 mm to about 0.7 mm, about 0.1 mm to about 0.8 mm, about 0.1 mm to about 1 mm, about 0.1 mm to about 1.2 mm, about 0.1 mm to about 1.4 mm, about 0.1 mm to about 1.5 mm, about 0.1 mm to about 2 mm, about 0.3 mm to about 0.5 mm, about 0.3 mm ~0.7mm, approx. 0.3mm~0.8mm, approx. 0.3mm~1mm, approx. 0.3mm~1.2mm, approx. 0.3mm~1.4mm, approx. 0.3mm~1.5mm, approx. 0.3mm to about 2mm, about 0.5mm to about 0.7mm, about 0.5mm to about 0.8mm, about 0.5mm to about 1mm, about 0.5mm to about 1.2mm, about 0.5mm to about 1.4mm , about 0.5mm to about 1.5mm, about 0.5mm to about 2mm, about 0.7mm to about 0.8mm, about 0.7mm to about 1mm, about 0.7mm to about 1.2mm, about 0.7mm to about 1.4mm, about 0.7mm to about 1.5mm, about 0.7mm to about 2mm, about 0.8mm to about 1mm, about 0.8mm to about 1.2mm, about 0.8mm to about 1.4mm, about 0.8mm to about The electrodes may comprise a length of about 0.1 mm, about 0.3 mm, about 0.5 mm, about 0.7 mm, about 0.8 mm, about 1 mm, about 1.2 mm, about 1.4 mm, about 1.5 mm, about 1 mm, about 2 mm, about 1.2 mm, about 1.4 mm, about 1.2 mm, about 1.5 mm, about 1.2 mm, about 2 mm, about 1.4 mm, about 1.5 mm, about 1.4 mm, about 2 mm, or about 1.5 mm. In some cases, each electrode may comprise a length of about 0.1 mm, about 0.3 mm, about 0.5 mm, about 0.7 mm, about 0.8 mm, about 1 mm, about 1.2 mm, about 1.4 mm, about 1.5 mm, or about 2 mm. In some cases, each electrode may include a length of at least about 0.1 mm, about 0.3 mm, about 0.5 mm, about 0.7 mm, about 0.8 mm, about 1 mm, about 1.2 mm, about 1.4 mm, or about 1.5 mm. In some cases, each electrode may include a length of at most about 0.3 mm, about 0.5 mm, about 0.7 mm, about 0.8 mm, about 1 mm, about 1.2 mm, about 1.4 mm, about 1.5 mm, or about 2 mm.

[0071] In some cases, the one or more leads may include a length between a proximal end of the lead to a distal end electrically coupled to the stimulation device. In some cases, the length of the lead may vary based on the anatomy of the individual or subject receiving the implanted device and the lead. In some cases, the length of the lead may include a length that reaches the placement of the stimulation device within the subject's gluteal fat pocket, although the lead electrodes may be placed near and / or adjacent to the sacral nerve and / or pudendal nerve. In some cases, the one or more leads may include a length of about 20 centimeters (cm) to about 50 cm. In some cases, the lead(s) may comprise a length of about 20 cm to about 25 cm, about 20 cm to about 30 cm, about 20 cm to about 35 cm, about 20 cm to about 40 cm, about 20 cm to about 45 cm, about 20 cm to about 50 cm, about 25 cm to about 30 cm, about 25 cm to about 35 cm, about 25 cm to about 40 cm, about 25 cm to about 45 cm, about 25 cm to about 50 cm, about 30 cm to about 35 cm, about 30 cm to about 40 cm, about 30 cm to about 45 cm, about 30 cm to about 50 cm, about 35 cm to about 40 cm, about 35 cm to about 45 cm, about 35 cm to about 50 cm, about 40 cm to about 45 cm, about 40 cm to about 50 cm, or about 45 cm to about 50 cm. In some cases, the lead(s) may comprise a length of about 20 cm, about 25 cm, about 30 cm, about 35 cm, about 40 cm, about 45 cm, or about 50 cm. In some cases, the lead(s) may comprise a length of at least about 20 cm, about 25 cm, about 30 cm, about 35 cm, about 40 cm, or about 45 cm. In some cases, the lead(s) may comprise a length of up to about 25 cm, about 30 cm, about 35 cm, about 40 cm, about 45 cm, or about 50 cm.

[0072] In some cases, the one or more leads may have a diameter. In some cases, the diameter of the lead may vary based on the anatomy of the individual or subject receiving the lead and the implanted device. In some cases, the diameter of the lead may include a diameter that provides a form factor for minimally invasive placement of the lead within the subject. In some cases, the diameter of the lead may include a diameter at which the lead is resistant to breakage. In some cases, the one or more leads may have an outer diameter of about 0.1 mm to about 2 mm. In some cases, the one or more leads may have an outer diameter of about 0.1 mm to about 0.2 mm, about 0.1 mm to about 0.3 mm, about 0.1 mm to about 0.5 mm, about 0.1 mm to about 0.8 mm, about 0.1 mm to about 1 mm, about 0.1 mm to about 1.2 mm, about 0.1 mm to about 1.4 mm, about 0.1 mm to about 1.5 mm, about 0.1 mm to about 2 mm, about 0.2 mm to about 0.3 mm. , about 0.2mm to about 0.5mm, about 0.2mm to about 0.8mm, about 0.2mm to about 1mm, about 0.2mm to about 1.2mm, about 0.2mm to about 1.4mm, about 0.2mm to about 1 .5mm, about 0.2mm to about 2mm, about 0.3mm to about 0.5mm, about 0.3mm to about 0.8mm, about 0.3mm to about 1mm, about 0.3mm to about 1.2mm, about 0.3mm to about 1.4mm, about 0.3mm to about 1.5mm, about 0.3mm to about 2mm, about 0.5mm to about 0.8mm, about 0.5mm to about 1mm, about 0.5mm to about 1.2mm, about 0.5mm ~1.4mm, 0.5mm~1.5mm, 0.5mm~2mm, 0.8mm~1mm, 0.8mm~1.2mm, 0.8mm~1.4mm, 0.8 In some cases, the lead or leads may have an outer diameter of about 0.1 mm, about 0.2 mm, about 0.3 mm, about 0.5 mm, about 0.8 mm, about 1 mm, about 1.2 mm, about 1 mm, about 1.4 mm, about 1 mm, about 1.5 mm, about 1 mm, about 2 mm, about 1.2 mm, about 1.4 mm, about 1.2 mm, about 1.5 mm, about 1.2 mm, about 2 mm, about 1.4 mm, about 1.5 mm, about 1.4 mm, about 2 mm, or about 1.5 mm.In some cases, the lead(s) may have an outer diameter of at least about 0.1 mm, about 0.2 mm, about 0.3 mm, about 0.5 mm, about 0.8 mm, about 1 mm, about 1.2 mm, about 1.4 mm, about 1.5 mm. In some cases, the lead(s) may have an outer diameter of at most about 0.2 mm, about 0.3 mm, about 0.5 mm, about 0.8 mm, about 1 mm, about 1.2 mm, about 1.4 mm, about 1.5 mm, about 2 mm.

[0073] In some cases, one or more of the leads described elsewhere herein may include an internal stylet and / or mandrel configured to provide rigidity to the lead for implantation and / or insertion into a subject. In some cases, the internal stylet may be detached from the lead after the lead is inserted and implanted. In some cases, one or more of the leads described elsewhere herein may be sterilizable using conventional sterilization methods used in the medical field, e.g., gas sterilization, steam sterilization, UV sterilization, etc.

[0074] In some cases, one or more leads described elsewhere herein may be electrically connected to an electrical stimulation device described elsewhere herein. In some cases, one or more leads may be connected to the stimulation device and may be disconnected from the stimulation device at a later time. In some cases, one or more leads may be connected to the electrical stimulation device using a quick release electrical connection. In some cases, one or more leads may be connected to the electrical stimulation device by a set screw fastener, whereby the leads are inserted into a hollow cylindrical shape that electrically connects with the internal circuitry of the electrical stimulation device. The leads may then be secured to the conductive hollow cylindrical shape using a non-conductive mechanical set screw, i.e., held in tension against the inner wall of the hollow cylindrical shape. One or more leads may be placed in the electrical stimulation device before or during a surgical implantation procedure.

[0075] In some cases, the sensor electrodes and the stimulating electrodes may be operatively connected to a non-transitory computer-readable medium including a processor and software. In some cases, an external input device in conjunction with the software may also be used by an individual to calibrate the sensor electrodes. In some cases, the software may be configured to record signals from the sensor electrodes. In some cases, the software may be configured to adjust the sensor electrodes in response to the signals.

[0076] In some cases, the stimulating electrode can provide electrical stimulation to the pudendal nerve. In some cases, the stimulating electrode can provide electrical stimulation to the sacral nerve. In some cases, the stimulating electrode can provide electrical stimulation to one or more nerves that innervate the pelvic muscles. In some cases, the electrode can include one or more electrodes or leads, e.g., a first and a second electrode. In some cases, the electrode can include one or more stimulating electrodes. In some cases, the electrode can include a first stimulating electrode configured to stimulate one pudendal nerve and a second stimulating electrode configured to stimulate another spatially independent region of the same pudendal nerve. In some cases, the first stimulating electrode can stimulate the main trunk of the pudendal nerve and the second stimulating electrode can stimulate a distal nerve of the pudendal nerve. In some cases, the distal nerve of the pudendal nerve includes a branch of the distal pudendal nerve. In some cases, the first stimulating electrode can stimulate the pudendal nerve trunk and the second stimulating electrode can stimulate a main branch of the pudendal nerve, e.g., the dorsal genital nerve. In some cases, the stimulation electrodes can provide electrical stimulation to one or more nerves that innervate the urethral sphincter. In some cases, the stimulation electrodes can provide electrical stimulation to one or more nerves that innervate the urethra. In some cases, the stimulation electrodes can provide electrical stimulation to one or more nerves that innervate the bladder. In some cases, the stimulation electrodes can provide electrical stimulation to one or more nerves that innervate the ureter. In some cases, the stimulation electrodes can provide electrical stimulation to one or more nerves that innervate the anal sphincter. In some cases, the stimulation electrodes can provide electrical stimulation to one or more nerves that innervate the anus. In some cases, the stimulation electrodes can provide electrical stimulation to one or more nerves that innervate the rectum. In some cases, the stimulation electrodes can provide electrical stimulation to one or more nerves that innervate the bowel. In some cases, the devices described herein can include multiple stimulation electrodes. In some cases, the devices described herein can include one or more stimulation electrodes. In some cases, the devices described herein can include a different stimulation electrode, or a second stimulation electrode. In some cases, a stimulating electrode can stimulate a first pudendal nerve and a different or second stimulating electrode can stimulate a second pudendal nerve.In some cases, a stimulating electrode can stimulate a first sacral nerve and a different or second stimulating electrode can stimulate a second sacral nerve.

[0077] In some cases, the stimulating electrodes of the device can provide a constant electrical stimulation. In some cases, the stimulating electrodes of the device can provide a constant electrical stimulation at a lower intensity level than the electrical stimulation provided to prevent an incontinence episode. In some cases, the constant electrical stimulation can include a constant frequency, amplitude, current, or any combination thereof. In some cases, the intensity or duration of the electrical stimulation provided to prevent an incontinence episode varies depending on the individual's response to a possible incontinence episode detected by the sensor electrodes. In some cases, the individual's response to prevent a possible incontinence episode detected by the sensor electrodes may not be sufficient by itself to prevent an incontinence episode, and the electrical stimulation delivered by the stimulating electrodes of the device, in conjunction with the individual's response, provides sufficient stimulation to prevent an incontinence episode. In some cases, the individual's response to prevent a possible incontinence episode detected by the sensor electrodes, in combination with the electrical stimulation delivered by the stimulating electrodes of the device, provides sufficient stimulation to trigger an action potential in the muscle responsible for the incontinence, resulting in muscle contraction. In some cases, the combined stimulation from the individual and the device may result in muscle contraction. In some cases, the muscle may include a urethral sphincter. In some cases, the muscles may include the anal sphincter. In some cases, the muscles may include one or more pelvic floor muscles.

[0078] In some cases, the sensor electrode may include a casing and a lead. In some cases, the casing may be made of titanium or a titanium alloy. In some cases, the lead may be made of a metal alloy.

[0079] Device Anchor In some cases, the device may be fixed when implanted by one of one or more surgical devices. In some cases, fixation of the device may be accomplished by sliding the device over the lead and then using ligatures to press the device onto the lead to prevent movement, as described elsewhere herein. These ligatures can be used to secure the fixation device to native adjacent tissues such as ligaments and periosteum. In some cases, the device may include grooves for the purpose of aligning the compression ligatures. In some cases, the fixation device may include a torque system to press the device onto the lead to prevent it from moving. In some cases, the device may be compressed at a single point on the lead. In some cases, the device is compressed at two or more points on the lead. The electrical stimulation device may include radiopaque markers that may allow visualization of the electrical stimulation device under fluoroscopy during and / or after implantation. In some cases, fluoroscopy may be used alone or in combination with EMG sensor electrode readings of the pelvic floor muscles to confirm or adjust the placement of the sensor electrode lead, stimulation device electrode lead, and / or stimulation device.

[0080] Electrical Signal FIG. 4 illustrates a detected myoelectric EMG signal and corresponding electrical stimulation provided by a device disclosed herein ("bio-stimulation device"). In some cases, the myoelectric EMG signal ("bio-signal") 140 may include electrical fluctuations 142 corresponding to contractile activity of muscles near the sensor electrodes. In some cases, the electrical fluctuations 142 may represent a cough, a sudden movement, a change in inertia, or any combination thereof from an electromyogram (EMG) reading. In some cases, the bio-signals captured by the sensor electrodes may be analyzed and classified (144) to identify a stress event, such as a cough or a sudden movement, from the EMG reading. In some cases, the identified stress event may initiate a process 146 in which the implantable electrical stimulation device delivers an electrical stimulation pattern 148 via one or more stimulation electrodes to one or more pudendal nerves to prevent an incontinent episode. In some cases, the stimulation device electrodes may deliver electrical stimulation via one or more stimulation electrodes 122 configured to supplement the innate reflex detected by one or more sensor electrodes 120 to account for the stress event causing the incontinent event.

[0081] In some cases, the electrical stimulation device may have a width and length that allows it to be easily implanted in a patient. In some cases, the electrical stimulation device may have a width and length to accommodate the circuitry and / or other system level components described elsewhere herein.

[0082] In some cases, the electrical stimulation device may have a width and length that provides sufficient space for a battery, which may constitute the lifespan before the battery needs to be replaced. In some cases, the battery life may be about 5 to about 15 years. In some cases, the battery life may be about 5 to about 6 years, about 5 to about 7 years, about 5 to about 8 years, about 5 to about 9 years, about 5 to about 10 years, about 5 to about 10 years, about 5 to about 11 years, about 5 to about 12 years, about 5 to about 13 years, about 5 to about 14 years, about 5 to about 15 years, about 6 to about 7 years, about 6 to about 8 years, about 6 to about 9 years, about 6 to about 10 years, about 6 ...12 years, about 6 to about 13 years, about 6 to about 14 years, about 5 to about 15 years, about 6 to about 14 years, about 6 to about 15 years, about 6 to about 14 years, about 6 to about 15 years, about 6 to about 14 years, about 6 to about 15 years, about 6 to about 14 years, about 6 to about 14 years, about 6 to about 14 years, about 6 to about 14 years, about 6 to about 14 years, about 6 to about 14 years, about 6 to about 10 years to 10 years, 6 to 11 years, 6 to 12 years, 6 to 13 years, 6 to 10 years, 14 years, 6 to 15 years, 7 to 8 years, 7 to 8 years Approximately 9 years, approximately 7 years to approximately 10 years, approximately 7 years to approximately 11 years, approximately 7 years to approximately 12 years, approximately 7 years to approximately 13 years, approximately 7 years to approximately 14 years, approximately 7 years to approximately 15 years, approximately 8 years to approximately 9 years, approximately 8 to 10 years, 8 to 11 years, 8 to 12 years, 8 to 13 years, 8 to 14 years, 8 to 15 years, 9 to 10 years, 9 to 12 years 11 years, about 9 years to about 12 years, about 9 years to about 13 years, about 9 years to about 14 years, about 9 years to about 15 years, about 10 years to about 11 years, about 10 years to about 12 years, about 10 years to about 1 3 years, about 10 to about 14 years, about 10 to about 15 years, about 11 to about 12 years, about 11 to about 13 years, about 11 to about 14 years, about 11 to about 15 years, about 12 to about 13 years, about 12 to about 14 years, about 12 to about 15 years, about 13 to about 14 years, about 13 to about 15 years, or about 14 to about 15 years. In some cases, the battery life may be about 5 years, about 6 years, about 7 years, about 8 years, about 9 years, about 10 years, about 11 years, about 12 years, about 13 years, about 14 years, about 14 years, about 15 years. In some cases, the battery life may be at least about 5 years, about 6 years, about 7 years, about 8 years, about 9 years, about 10 years, about 11 years, about 12 years, about 13 years, or about 14 years. In some cases, the battery life may be up to about 6 years, about 7 years, about 8 years, about 9 years, about 10 years, about 11 years, about 12 years, about 13 years, about 14 years, or about 15 years.

[0083] In some cases, the battery of the electrical stimulation device may need to be charged once every about 1 to about 12 days. In some cases, the battery of the electrical stimulation device may need to be charged once every about 1 to 2 days, about 1 to 3 days, about 1 to 4 days, about 1 to 5 days, about 1 to 6 days, about 1 to about 7 days, about 1 to about 8 days, about 1 to about 9 days, about 1 to 10 days, about 1 to 11 days, about 1 to 12 days, about 2 to 3 days, about 2 to 4 days, about 2 to 5 days, about 2 to 6 days, about 2 to 7 days, or about 3 to 4 days. days, about 2-8 days, about 2-5 days, about 2-9 days, about 2-10 days, about 2-11 days, about 2-12 days, about 3-4 days, about 3-5 days, about 3-6 days, about 3-7 days, about 3-8 days, about 3-9 days, about 3-10 days, about 3-11 days, about 3-12 days, about 4-5 days, about 4-6 days, about 4 days ~7 days, about 4-8 days, about 4-9 days, about 4-10 days, about 4-11 days, about 4-12 days, about 5-6 days, about 5-7 days, about 5-8 days, about 5-9 days, about 5-10 days, about 5-11 days, about 5-12 days, about 6-7 days, about 6-8 days, about 6-9 days, about 6-10 days, about 6-11 days, about 6-12 days , about 7-8 days, about 7-9 days, about 7-10 days, about 7-11 days, about 7-12 days, about 8-9 days, about 8-10 days, about 8-11 days, about 8-12 days, about 9-10 days, about 9-11 days, about 9-12 days, about 10-11 days, about 10-12 days, or about 11-12 days. In some cases, the battery of the electrical stimulation device may need to be charged once every about 1 day, about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 7 days, about 8 days, about 9 days, about 10 days, about 11 days, or about 12 days. In some cases, the battery of the electrical stimulation device may need to be charged at least once every about 1 day, about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 7 days, about 8 days, about 9 days, about 10 days, or about 11 days. In some cases, the battery of the electrical stimulation device may need to be charged at most once every about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 7 days, about 8 days, about 9 days, about 10 days, about 11 days, or about 12 days.

[0084] In some examples, the electrical stimulation device may include a width of about 1 mm to about 5 mm, about 1 mm to about 10 mm, about 1 mm to about 15 mm, about 1 mm to about 20 mm, about 1 mm to about 25 mm, about 1 mm to about 30 mm, about 1 mm to about 35 mm, about 1 mm to about 40 mm, about 1 mm to about 45 mm, about 1 mm to about 50 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 5 mm to about 20 mm, about 5 ... 5mm, about 5mm to about 30mm, about 5mm to about 35mm, about 5mm to about 40mm, about 5mm to about 45mm, about 5mm to about 50mm, about 10mm to about 15mm, about 10mm to about 20mm, Approximately 10mm to approximately 25mm, approximately 10mm to approximately 30mm, approximately 10mm to approximately 35mm, approximately 10mm to approximately 40mm, approximately 10mm to approximately 45mm, approximately 10mm to approximately 50mm, approximately 15mm to approximately 20mm, Approximately 15mm to approximately 25mm, approximately 15mm to approximately 30mm, approximately 15mm to approximately 35mm, approximately 15mm to approximately 40mm, approximately 15mm to approximately 45mm, approximately 15mm to approximately 50mm, approximately 20mm to approximately 25mm , about 20mm to about 30mm, about 20mm to about 35mm, about 20mm to about 40mm, about 20mm to about 45mm, about 20mm to about 50mm, about 25mm to about 30mm, about 25mm to about 35mm , about 25 mm to about 40 mm, about 25 mm to about 45 mm, about 25 mm to about 50 mm, about 30 mm to about 35 mm, about 30 mm to about 40 mm, about 30 mm to about 45 mm, about 30 mm to about 50 mm, about 35 mm to about 40 mm, about 35 mm to about 45 mm, about 35 mm to about 50 mm, about 40 mm to about 45 mm, about 40 mm to about 50 mm, or about 45 mm to about 50 mm. In some examples, the electrical stimulation device may have a width of about 1 mm, about 5 mm, about 10 mm, about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, about 45 mm, or about 50 mm. In some examples, the electrical stimulation device may have a width of at least about 1 mm, about 5 mm, about 10 mm, about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, or about 45 mm. In some examples, the electrical stimulation device may have a width of at most about 5 mm, about 10 mm, about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, about 45 mm, or about 50 mm.

[0085] In some examples, the electrical stimulation device may include a length of about 1 mm to about 50 mm. In some examples, the electrical stimulation device may include a length of about 1 mm to about 5 mm, about 1 mm to about 10 mm, about 1 mm to about 15 mm, about 1 mm to about 20 mm, about 1 mm to about 25 mm, about 1 mm to about 30 mm, about 1 mm to about 35 mm, about 1 mm to about 40 mm, about 1 mm to about 45 mm, about 1 mm to about 50 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 5 mm to about 20 mm, about 5 mm to about 25mm, about 5mm to about 30mm, about 5mm to about 35mm, about 5mm to about 40mm, about 5mm to about 45mm, about 5mm to about 50mm, about 10mm to about 15mm, about 10mm to about 20mm, Approximately 10mm to approximately 25mm, approximately 10mm to approximately 30mm, approximately 10mm to approximately 35mm, approximately 10mm to approximately 40mm, approximately 10mm to approximately 45mm, approximately 10mm to approximately 50mm, approximately 15mm to approximately 20mm, Approximately 15mm to approximately 25mm, approximately 15mm to approximately 30mm, approximately 15mm to approximately 35mm, approximately 15mm to approximately 40mm, approximately 15mm to approximately 45mm, approximately 15mm to approximately 50mm, approximately 20mm to approximately 25mm , about 20mm to about 30mm, about 20mm to about 35mm, about 20mm to about 40mm, about 20mm to about 45mm, about 20mm to about 50mm, about 25mm to about 30mm, about 25mm to about 35mm , about 25 mm to about 40 mm, about 25 mm to about 45 mm, about 25 mm to about 50 mm, about 30 mm to about 35 mm, about 30 mm to about 40 mm, about 30 mm to about 45 mm, about 30 mm to about 50 mm, about 35 mm to about 40 mm, about 35 mm to about 45 mm, about 35 mm to about 50 mm, about 40 mm to about 45 mm, about 40 mm to about 50 mm, or about 45 mm to about 50 mm. In some examples, the electrical stimulation device may include a length of about 1 mm, about 5 mm, about 10 mm, about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, about 45 mm, or about 50 mm. In some examples, the electrical stimulation device may include a length of at least about 1 mm, about 5 mm, about 10 mm, about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, or about 45 mm. In some examples, the electrical stimulation device may include a length of up to about 5 mm, about 10 mm, about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, about 45 mm, or about 50 mm.

[0086] In some examples, the electrical stimulation device may include a height of about 0.5 mm to about 5.5 mm. In some examples, the electrical stimulation device may include a height of about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 0.5 mm to about 2 mm, about 0.5 mm to about 2.5 mm, about 0.5 mm to about 3 mm, about 0.5 mm to about 3.5 mm, about 0.5 mm to about 4 mm, about 0.5 mm to about 4.5 mm, about 0.5 mm to about 5 mm, about 0.5 mm to about 5.5 mm, about 1 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm ~2.5mm, 1mm~3mm, 1mm~3.5mm, 1mm~4mm, 1mm~4.5mm, 11mm~5mm, 1mm~5.5mm, 1.5mm~2mm, Approximately 1.5mm to approximately 2.5mm, approximately 1.5mm to approximately 3mm, approximately 1.5mm to approximately 3.5mm, approximately 1.5mm to approximately 4mm, approximately 1.5mm to approximately 4.5mm, approximately 1.5mm to approximately 5mm, approximately 1.5mm to approximately 5. 5mm, about 2mm to about 2.5mm, about 2mm to about 3mm, about 2mm to about 3.5mm, about 2mm to about 4mm, about 2mm to about 4.5mm, about 2mm to about 5mm, about 2mm to about 5.5mm, about 2.5m m ~ about 3mm, about 2.5mm - about 3.5mm, about 2.5mm - about 4mm, about 2.5mm - about 4.5mm, about 2.5mm - about 5mm, about 2.5mm - about 5.5mm, about 3mm - about 3.5mm, about 3m In some examples, the electrical stimulation device may include a height of about 0.5 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 4 mm, about 4.5 mm, about 5 mm, or about 5.5 mm. In some examples, the electrical stimulation device can include a height of at least about 0.5 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, or about 5 mm.In some examples, the electrical stimulation device may include a height of up to about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, or about 5.5 mm.

[0087] In some examples, the electrical stimulation device may include a mass of about 1 g to about 18 g. In some cases, the electrical stimulation device may include a mass of about 1 g to about 3 g, about 1 g to about 6 g, about 1 g to about 8 g, about 1 g to about 10 g, about 1 g to about 12 g, about 1 g to about 14 g, about 1 g to about 16 g, about 1 g to about 17 g, about 1 g to about 18 g, about 3 g to about 6 g, about 3 g to about 8 g, about 3 g to about 10 g, about 3 g to about 12 g, about 3 g to about 14 g, about 3 g to about 16 g, about 3 g to about 17 g, about 3 g to about 18 g, about 6 g to about 8 g, about 6 g to about 10 g, about 6 g to about 12 g, about 6 g to about 14 g, about 6 g to about 16 g, about 6 g to about 17 g, about 6 g about 18g, about 8g to about 10g, about 8g to about 12g, about 8g to about 14g, about 8g to about 16g, about 8g to about 17g, about 8g to about 18g, about 10g to about 12g, about 10g to about 14g, about 10g to about 16g, about 10g to about 17g, about 10g to about 18g, about 12g to about 14g, about 12g to about 16g, about 12g to about 17g, about 12g to about 18g, about 14g to about 16g, about 14g to about 17g, about 14g to about 18g, about 16g to about 17g, about 16g to about 18g, or about 17g to about 18g. In some examples, the electrical stimulation device may include a mass of about 1 g, about 3 g, about 6 g, about 8 g, about 10 g, about 12 g, about 14 g, about 16 g, about 17 g, or about 18 g. In some examples, the electrical stimulation device may include a mass of at least about 1 g, about 3 g, about 6 g, about 8 g, about 10 g, about 12 g, about 14 g, about 16 g, or about 17 g. In some examples, the electrical stimulation device may include a mass of up to about 3 g, about 6 g, about 8 g, about 10 g, about 12 g, about 14 g, about 16 g, about 17 g, or about 18 g.

[0088] In some examples, the electrical stimulation device may be sterilizable using conventional sterilization methods used in the medical field, such as gas sterilization, steam sterilization, UV sterilization, etc.

[0089] In some cases, the one or more stimulation electrodes can provide a constant electrical or baseline stimulation 146 and 150 to an individual experiencing urge incontinence. In some cases, the constant electrical stimulation can include a constant frequency, amplitude, current, or any combination thereof. In some cases, the stimulation device electrodes can provide a temporary electrical stimulation that lasts for the duration of an episode of stress incontinence 148 to an individual experiencing stress incontinence. In some cases, the stimulation device electrodes can provide a constant electrical stimulation (i.e., a baseline stimulation pattern) with a temporary activation stimulation (i.e., an activation stimulation pattern) that lasts for the duration of an episode of stress incontinence to an individual experiencing mixed incontinence.

[0090] In some examples, the devices disclosed herein may include a non-transitory computer-readable medium including software. In some cases, the software may be configured to record signals from one or more sensor electrodes. In some cases, the software may be configured to process the recorded signals from one or more sensor electrodes to determine whether an electrical stimulation pattern should be delivered to one or more stimulation electrodes innervating one or more pudendal nerves. In some cases, the software may be configured to adjust parameters of the sensor electrodes in response to the observed signals. In some cases, signals may be observed in the sensor electrode signals recorded by the software that saturate the dynamic range of the sensor electrodes. In some cases, the gain of the sensor electrodes may also be adjusted by the software to allow sufficient monitoring and thresholding of the individual's electromyographic EMG signals.

[0091] Device-based neurostimulation 3 illustrates an exemplary embodiment of the devices and methods described herein implanted in an individual. In some cases, the implantable device can target the pudendal nerve 133 by placing sensor electrodes 134 and 136 and stimulation electrodes near the pudendal nerves 130 and 132. The sensor electrodes 134 and 136 can capture biosignals to classify stress events, and the stimulation device electrodes 130 and 132 deliver stress electrical stimulation ("bio-stimulants") that are adjusted from the base stimulation to account for the stress event, acting on the target sphincter.

[0092] In some cases, greater accuracy may be obtained by applying electrical stimulation to the pudendal nerve instead of the sacral nerve, as the pudendal nerve or its branches are lower than the sacral nerve and closer to the organs and tissues involved in incontinence than the sacral nerve. The device's sensor electrodes capture the biosignals to classify the stress event, and the device's stimulation electrodes deliver a stress electrical stimulus ("bio-stimulator") that is adjusted from the base stimulus to take into account the stress event, acting on the target sphincter.

[0093] Neurostimulation Systems for Incontinence Management 5 shows an exemplary embodiment of a system block diagram of the devices and methods described herein with slow and fast adaptation algorithms. In some cases, the systems disclosed herein can include multiple sub-modules. In some cases, the sub-modules can include an offline analysis module 152, a clinical control module 154, a patient controller module 156, an implantable module 160, or any combination thereof.

[0094] In some cases, the offline analysis module 152 may comprise a data repository 130, analysis software 130, visualization software 130, or any combination thereof. In some cases, the offline analysis module may be used to retrospectively analyze and graphically visualize the performance of an individual's implant to prevent episodes of incontinence. The offline analysis module 152 may be programmatically coupled to a clinical control module via an application programming interface (API) 130. In some cases, the clinical control module may comprise software that can adjust or modify the electrical stimulation patterns of an individual's electrical stimulation implant.

[0095] In some cases, the clinical control module 154 may include stimulation management and device monitoring software, stimulation programming maps, classification configuration dashboards, streaming data collection dashboards, or any combination thereof. In some cases, medical personnel may assist with the individual's electrical implant by updating or modifying the individual's electrical implant parameters through the clinical control module 154. In some cases, the clinical control module may be utilized to initialize the individual's electrical implant after implantation via a USB interface to the patient controller module 156.

[0096] In some cases, the patient controller module 156 may include a direct interface for controlling aspects of the patient's electrical stimulation device as described herein. In some examples, the patient controller module 156 may include a medical information communication band (MICS) communication platform, manual electrical stimulation device control, enabling or disabling algorithmic functionality, algorithmic patient alerts, an inductive or wired charger for an implantable pulse generator rechargeable battery, or any combination thereof.

[0097] In some cases, the patient controller module 156 may be configured to wirelessly and / or inductively charge the rechargeable battery of the implantable pulse generator with a charger for the patient controller module 156. In some cases, the patient controller module 156 may be magnetically coupled to the implantable pulse generator 160 from outside the subject's skin. In some cases, the magnetic coupling of the controller module 156 to the implantable pulse generator 160 may be done to be ergonomic for the subject and to allow the subject to act as if the controller module 156 is not magnetically coupled to the implantable pulse generator 160. In some cases, the patient controller module 156 may include a battery that can be recharged through wireless inductive charging and / or wired charging via a recharger. In some cases, the patient controller module 156 may include a rechargeable lithium ion battery. In some cases, the recharger may include one or more inductive coils that are used when charging the patient controller module 156 and / or when using the patient controller module 156 to charge the implantable pulse generator 160. 7B may be configured 722 to accept additional memory storage 723. In some cases, the additional memory storage may be used to transfer patient data and / or information between the patient / subject and a healthcare provider.

[0098] In some cases, the patient controller module 156 can directly or automatically control the implantable pulse generator 160. In some cases, the implantable pulse generator 160 may include a MICS telemetry communication platform corresponding to the MICS telemetry communication platform of the MICS communication platform of the patient controller module, allowing communication between the two devices via an ad-hoc Wi-Fi network 158. In some cases, the implantable pulse generator 160 may further include a three-axis accelerometer biopotential amplifier that may be electrically coupled to one or more electrode leads 214. In some cases, the one or more electrode leads may include one or more stimulation device and / or sensor electrodes. In some cases, the biopotential amplifier may be electrically coupled to a computation sub-module that includes a classifier, a control policy, a real-time clock scheduler, a microprocessor, or any combination thereof. In some cases, the biopotential amplifier, the classifier, the control policy, the real-time clock scheduler, and the microprocessor, or any combination thereof, may process and interpret the patient's detected myoelectric EMG signals to determine the required electrical stimulation pattern to be applied by the actuator. The one or more stimulation electrodes prevent episodes of incontinence in the individual. In some cases, the patient controller module 156 may include a user interface, ports, indicators, or any combination thereof, as seen in Figures 7A-7B. The patient controller module user interface and / or ports may include an input charging socket 704, keypad navigation buttons 706, a stimulation indicator, a communication indicator, an output charging adapter port, a battery level indicator 712 in both percentage and days, a manual excitation override button 716, or any combination thereof. In some cases, the input charging socket may be configured to accept USB A, B, and / or C, Firewire, any micro versions thereof, or any combination thereof.In some cases, the patient controller module 156 can be connected to a power converter via a corresponding cable that fits into an input charging socket to charge the patient controller module 156 .

[0099] User Interface The patient controller module 156 may include a user interface 700, which may include one or more user interface objects (701, 702, 705, 711, 712, 715, 716, 717, 721, 730, 723) and / or those seen in FIGS. 7A-7B. In some cases, the user interface 700 may include a touch screen display configured to receive touch or press input from a user, patient, and / or healthcare professional. In some cases, the user, patient, and / or healthcare professional may press and / or interact with a mixed graphic and text indicator and / or toggle a mixed graphic and text indicator based on a button 716 (705, 711). In some cases, the user, patient, and / or healthcare professional may double tap a user interface object to activate an emergency state. In some cases, the emergency state may enable the implantable stimulation device to immediately provide electrical stimulation in response to a double tap command. In some cases, tilting the patient controller module may modify and / or change a parameter or setting of a user interface object. In some cases, tilting the patient controller module in a first direction may increase a parameter and / or setting of a user interface object, while tilting the patient controller module in a second direction opposite the first direction may decrease the parameter and / or setting.

[0100] In some cases, the user interface between devices such as a smartphone and a tablet or other personal computing device may include a scaled version of the user interface. In some cases, different user interface views are displayed, such as the views shown in Figures 7A and 7B. Figure 7B may display various user interface objects. In some cases, the user interface objects may include one or more buttons 716, switches (711, 716), and / or graphic or image-based representations of data (721, 730, 723).

[0101] A user can customize the user interface objects by selecting one or more user interface objects (e.g., buttons, switch buttons to enable various device operating modes, graphical display of device data, etc.). In some cases, the user view may be a set of predefined views with configured user interface objects. In some cases, the user can customize and / or create one or more views accessible by the menu icon 702. In some cases, the menu icon 702 may be configured to display one or more submenu options. In some cases, the one or more submenu options may include personal identification, account information, device registration, customer support, or any combination of those submenus. In some cases, one submenu may include information on how to connect the device platform to an existing healthcare provider. In some cases, the user interface may include a notification object 701. If a specific notification is to be given to the user of the device regarding device performance, detection of an incontinent event, or any combination thereof, the notification object can display a unique or highlighted state. The user can press and interact with the notification object to display the specific notification in the form of a pop-up dialog.

[0102] In some cases, one or more user interface objects may include a mixture of text and / or text and vector object representations of various API function calls and / or sub-user interface views, as seen in Figures 7A-7B. In some cases, the user interface may include mixed text and vector objects that allow the subject or user to enable 705 or disable 711 electrical stimulation of the device 716, adjust device parameters 715, indicate treatment status 717, display EMG signals 721 measured at the device, display delivered stimulation device electrode electrical signal characteristics (e.g., frequency, amplitude, pulse width, etc.), display a medical portal for submitting user data to a healthcare provider, overlay and record resulting incontinent events 719 on top of the measured ENG / EMG, or any combination thereof. In some cases, the user interface may further include a battery 712 and wireless communication connection indicators for the user and / or subject to visualize the operating characteristics of the patient controller module 156.

[0103] In some cases, the keypad navigation buttons 706 may be configured to navigate between various user interface views, for example, the user interface views shown in FIGS. 7A and 7B.

[0104] In some examples, the patient controller module 156 may include visual indicators (715, 717, 712) configured to indicate whether the implanted electrical stimulation device is outputting electrical stimulation and / or whether there is a connection with a second or third electrical stimulation device. In some cases, the patient controller module may include device adjustment parameters, which may include a stimulation indicator, or activation of a stimulation mode 715. In some cases, the stimulation indicator may be in electrical communication with a processor, as described elsewhere herein, configured to display a visual indicator when the stimulation device is providing electrical stimulation to the subject. In some cases, the patient controller module may include a connection indicator. In some cases, the connection indicator may be in electrical communication with a processor, as described elsewhere herein, and configured to provide a visual indicator when the patient controller module is connected to one or more individual devices, a data server, a local WIFI or ad-hoc WIFI network, Bluetooth, a medical implant communication system (MICS), or a combination thereof. In some cases, the connection indicator may indicate a wireless connection with the implanted electrical stimulation device. In some cases, the connection indicator may include one or more states. In some cases, the first state may include a personal image indicator, such personal image indicator may inform a user, subject, individual, and / or medical personnel that communication pairing between the patient controller module and a third device, such as a server, has been successfully established. The second state may include a flashing image indicator, such flashing image indicator indicating a paired communication state between the patient controller module and a third device, such as a server. In some cases, the image indicator may include a Bluetooth® universal symbol that may be observed on smart devices and / or devices with Bluetooth® connectivity.In some cases, the image indicator may include a graphic of the universal symbol indicator for Wi-Fi (e.g., concentric quarter circles) commonly found on smart devices and / or devices with Wi-Fi connectivity.

[0105] In some cases, device data (e.g., EMG / ENG, accelerometer, gyroscope, magnetometer, 3-D spatial movement, Global Positioning System (GPS) data, or any combination thereof) may be transmitted over Wi-Fi, Bluetooth, MICS, or other ad-hoc networks between one or more devices (718), as described elsewhere herein.

[0106] FIG. 7B illustrates a different user interface view than FIG. 7A. In some cases, the user interface of FIG. 7B may include one or more user interface objects (721, 730, 723), each of which displays device data 718 received via wireless transmission 707, as described above. In some cases, one of the user interface objects may include a graphical therapy object 721. The graphical therapy object may display detected EMG / ENG signals 726 and corresponding stimulation profiles 728. In some cases, the graphical therapy object may display leakage events 719 where the user indicated an incontinent event, but the device did not provide stimulation. Another user interface object may include a GPS and motion activity object 730. In some cases, the motion activity object 730 may display the subject's GPS and motion data over time. The GPS and motion data may be useful considerations in improving the classifiers described elsewhere herein. Another user interface object may include a charging indicator object 723. In some cases, the charging indicator object may display the charge capacity of the implanted stimulation device over a period of time. In some cases, a charging indicator object may be used to monitor the status of a battery in an implantable stimulation device. A user interacting with the display view shown in FIG. 1 does the following: The user of FIG. 7B can pinch, swipe, or otherwise manipulate the data in each user interface object (721, 730, 723) to view other time domains of the data or to zoom in on a particular scale of measurement. In some cases, through menu object 702, the user and / or subject can export their medical data to one or more providers.

[0107] How to prevent incontinence attacks FIG. 6A illustrates a workflow of a method 216 for preventing episodes of incontinence in an individual patient. The method may include: (a) implanting a sensor electrode and a stimulation electrode in the body of the individual (218); (b) detecting a parameter with the sensor electrode associated with a response from the individual to prevent episodes of incontinence (220); and (c) applying electrical stimulation with the stimulation electrode to prevent episodes of incontinence in conjunction with the response from the individual (222). In many cases, the methods described herein prevent episodes of urinary incontinence. In some cases, the urinary incontinence may include at least one of urge incontinence, stress incontinence, overflow incontinence, or mixed incontinence. In some cases, the methods described herein may prevent episodes of fecal incontinence. In some cases, the method may include applying constant electrical stimulation at a lower intensity level than the electrical stimulation applied in step (c). Applying continuous electrical stimulation at a low intensity may help a person suffering from urge incontinence. In some cases, the intensity or duration of the electrical stimulation provided in step (c) may vary in response to the response detected in step (b). The response may vary in step (c) due to a stress event such as coughing, laughing, or movement that requires increased electrical stimulation to prevent an incontinent episode. In some cases, the time between detection of parameter 224 and providing electrical stimulation 226 may be represented as response time 228 as shown in FIG. 6B. In some cases, stimulation may be provided for the duration of stimulation 227.

[0108] In some cases, the duration of the stimulus 227 may include from about 1 second to about 30 seconds. In some cases, the duration of the stimulus 227 may include from about 1 second to about 2 seconds, from about 1 second to about 3 seconds, from about 1 second to about 4 seconds, from about 1 second to about 5 seconds, from about 1 second to about 10 seconds, from about 1 second to about 12 seconds, from about 1 second to about 14 seconds, from about 1 second to about 16 seconds, from about 1 second to about 20 seconds, from about 1 second to about 25 seconds, from about 1 second to about 30 seconds, from about 2 seconds to about 3 seconds, from about 2 seconds to about 4 seconds, from about 2 seconds to about 5 seconds, from about 2 seconds to about 10 seconds, from about 2 seconds to about 12 seconds, from about 2 seconds to 14 seconds, 2 seconds to 16 seconds, 2 seconds to 20 seconds, 2 seconds to 25 seconds, 2 seconds to 30 seconds, 3 seconds to 4 seconds, 3 seconds to 5 seconds, 3 seconds to 10 seconds, 3 seconds to 12 seconds, approx. 3 seconds to approximately 14 seconds, approximately 3 seconds to approximately 16 seconds, approximately 3 seconds to approximately 20 seconds, approximately 3 seconds to approximately 25 seconds, approximately 3 seconds to approximately 30 seconds, approximately 4 seconds to approximately 5 seconds, approximately 4 seconds to approximately 10 seconds, approximately 4 seconds to approximately 12 seconds, approximately 4 seconds to approximately 14 seconds, approximately 4 seconds to 16 seconds, 4 seconds to 20 seconds, 4 seconds to 25 seconds, 4 seconds to 30 seconds, 5 seconds to 10 seconds, 5 seconds to 12 seconds, 5 seconds to 14 seconds, 5 seconds to 16 seconds, 5 seconds to 20 seconds , approximately 5 seconds to approximately 25 seconds, approximately 5 seconds to approximately 30 seconds, approximately 10 seconds to approximately 12 seconds, approximately 10 seconds to approximately 14 seconds, approximately 10 seconds to approximately 16 seconds, approximately 10 seconds to approximately 20 seconds, approximately 10 seconds to approximately 25 seconds, approximately 10 seconds to approximately 30 seconds, approximately The duration of the stimulation 227 may include about 1 second, about 2 seconds, about 3 seconds, about 4 seconds, about 5 seconds, about 6 seconds, about 7 seconds, about 8 seconds, about 9 seconds, about 10 seconds, about 11 seconds, about 12 seconds, about 14 seconds, about 16 seconds, about 14 seconds, about 20 seconds, about 14 seconds, about 25 seconds, about 14 seconds, about 30 seconds, about 16 seconds, about 20 seconds, about 25 seconds, about 20 seconds, about 30 seconds, or about 25 seconds. In some cases, the duration of the stimulation 227 may include about 1 second, about 2 seconds, about 3 seconds, about 4 seconds, about 5 seconds, about 10 seconds, about 12 seconds, about 14 seconds, about 16 seconds, about 20 seconds, about 25 seconds, or about 30 seconds. In some cases, the duration of the stimulus 227 may include at least about 1 second, about 2 seconds, about 3 seconds, about 4 seconds, about 5 seconds, about 10 seconds, about 12 seconds, about 14 seconds, about 16 seconds, about 20 seconds, about 25 seconds, etc. In some cases, the duration of the stimulus 227 may include at most about 2 seconds, about 3 seconds, about 4 seconds, about 5 seconds, about 10 seconds, about 12 seconds, about 14 seconds, about 16 seconds, about 20 seconds, about 25 seconds, about 30 seconds, etc.

[0109] In some cases, the response time 228 may include from about 60 μsec to about 100 μsec. In some cases, the response time 228 is between about 60 μs and about 65 μs, between about 60 μs and about 70 μs, between about 60 μs and about 75 μs, between about 60 μs and about 80 μs, between about 60 μs and about 85 μs, between about 60 μs and about 85 μs, between about 60 μs and about 90 μs, between about 60 μs and about 95 μs, between about 60 μs and about 100 μs, between about 65 μs and about 70 μs, between about 65 μs and about 75 μs, between about 65 μs and about 80 μs, between about 65 μs and about 85 μs, between about 65 μs and about 90 μs, between about 65 μs and about 95 μs, between about 65 μs and about 100 μs, between about 70 μs and about 75 μs, between about 70 μs and about 80 μs, between about 70 μs and about 80 μs, may include about 70 μs to about 85 μs, about 70 μs to about 90 μs, about 70 μs to about 95 μs, about 70 μs to about 100 μs, about 75 μs to about 80 μs, about 75 μs to about 85 μs, about 75 μs to about 90 μs, about 75 μs to about 95 μs, about 75 μs to about 100 μs, about 80 μs to about 85 μs, about 80 μs to about 90 μs, about 80 μs to about 95 μs, about 80 μs to about 100 μs, about 85 μs to about 90 μs, about 85 μs to about 95 μs, about 85 μs to about 100 μs, about 90 μs to about 95 μs, about 90 μs to about 100 μs, or about 95 μs to about 100 μs. In some cases, the response time 228 may include about 60 μs, about 65 μs, about 70 μs, about 75 μs, about 80 μs, about 85 μs, about 90 μs, about 95 μs, or about 100 μs. In some cases, the response time 228 may include at least about 60 μs, about 65 μs, about 70 μs, about 75 μs, about 80 μs, about 85 μs, about 90 μs, or about 95 μs. In some cases, the response time 228 may include at most about 65 μs, about 70 μs, about 75 μs, about 80 μs, about 85 μs, about 90 μs, about 95 μs, or about 100 μs. Through the development of an iteratively trained machine learning classifier, the response time may be minimized and improved incontinence prevention may be realized.

[0110] 12A-12B show a workflow of a method 1200 for preventing incontinent episodes in an individual patient. The method can include steps of (a) implanting sensor and stimulation electrodes in the individual's body (1202), (b) detecting a parameter associated with a response from the individual, the response being a user-induced stimulation 1204, and (c) applying electrical stimulation with the stimulation device electrodes to prevent an incontinent event 1206. In some cases, the user-induced stimulation may be intended to prevent an incontinent episode. As shown graphically in FIG. 12B, the detected EMG signal 1208 can be analyzed by a classifier 1210, described elsewhere herein, to determine when the EMG, ENG, accelerometer, gyroscope, magnetometer, pressure sensor signal, or any combination thereof, exceeds a predetermined threshold, described elsewhere herein. If the classifier 1210 determines that the signal 1208 represents an incontinent event, a processor, described elsewhere herein, can enable a stimulus 1212 to prevent the occurrence of an incontinent event. In some cases, the stimulus 1212 can include an extension of the stimulus 1211 that can extend beyond the time that the classifier 1210 determined that there is an incontinent event. In some cases, the extension of the stimulus 1211 can include a duration equal to the duration that the subject intentionally continues or intentionally continues to cause a muscle contraction.

[0111] In some cases, the extension of the stimulus 1211 may include from about 1 second to about 30 seconds. In some cases, the extension of the stimulus 1211 may include from about 1 second to about 3 seconds, from about 1 second to about 5 seconds, from about 1 second to about 8 seconds, from about 1 second to about 10 seconds, from about 1 second to about 12 seconds, from about 1 second to about 15 seconds, from about 1 second to about 18 seconds, from about 1 second to about 20 seconds, from about 1 second to about 22 seconds, from about 1 second to about 24 seconds, from about 1 second to about 30 seconds, from about 3 seconds to about 5 seconds, from about 3 seconds to about 8 seconds, from about 3 seconds to about 10 seconds, from about 3 seconds to about 12 seconds, from about 3 seconds to about 15 seconds, from about 3 seconds to about 18 seconds, from about 3 seconds to about 20 seconds, from about 3 seconds to about 22 seconds, from about 3 seconds to about 24 seconds, from about 3 seconds to about 30 seconds, from about 5 seconds ~8 seconds, approximately 5 seconds to approximately 10 seconds, approximately 5 seconds to approximately 12 seconds, approximately 5 seconds to approximately 15 seconds, approximately 5 seconds to approximately 18 seconds, approximately 5 seconds to approximately 20 seconds, approximately 5 seconds to approximately 22 seconds, approximately 5 seconds to approximately 24 seconds, approximately 5 seconds to approximately 30 seconds, about 8 seconds to about 10 seconds, about 8 seconds to about 12 seconds, about 8 seconds to about 15 seconds, about 8 seconds to about 18 seconds, about 8 seconds to about 20 seconds, about 8 seconds to about 22 seconds, about 8 seconds to about 24 seconds, about 8 seconds to about 3 0 seconds, about 10 seconds to about 12 seconds, about 10 seconds to about 15 seconds, about 10 seconds to about 18 seconds, about 10 seconds to about 20 seconds, about 10 seconds to about 22 seconds, about 10 seconds to about 24 seconds, about 10 seconds to about 30 seconds , about 12 seconds to about 15 seconds, about 12 seconds to about 18 seconds, about 12 seconds to about 20 seconds, about 12 seconds to about 22 seconds, about 12 seconds to about 24 seconds, about 12 seconds to about 30 seconds, about 15 seconds to about 18 seconds, about 1 The stimulation 1211 may include an extension of about 1 second, about 3 seconds, about 5 seconds, about 15 seconds, about 22 seconds, about 15 seconds, about 24 seconds, about 15 seconds, about 30 seconds, about 18 seconds, about 20 seconds, about 18 seconds, about 22 seconds, about 18 seconds, about 24 seconds, about 18 seconds, about 30 seconds, about 20 seconds, about 22 seconds, about 20 seconds, about 24 seconds, about 22 seconds, about 30 seconds, or about 24 seconds. In some cases, the extension of the stimulation 1211 may include about 1 second, about 3 seconds, about 5 seconds, about 8 seconds, about 10 seconds, about 12 seconds, about 15 seconds, about 18 seconds, about 20 seconds, about 22 seconds, about 24 seconds, or about 30 seconds. In some cases, the extension of the stimulus 1211 may include at least about 1 second, about 3 seconds, about 5 seconds, about 8 seconds, about 10 seconds, about 12 seconds, about 15 seconds, about 18 seconds, about 20 seconds, about 22 seconds, or about 24 seconds. In some cases, the extension of the stimulus 1211 may include up to about 3 seconds, about 5 seconds, about 8 seconds, about 10 seconds, about 12 seconds, about 15 seconds, about 18 seconds, about 20 seconds, about 22 seconds, about 24 seconds, or about 30 seconds.

[0112] In some cases, there may be a delay 1209 between the onset of an incontinent event in the raw EMG, ENG, accelerometer, gyroscope, magnetometer, pressure sensor, or any combination thereof signal data and the onset of electrical stimulation. Training the classifier 1210 on a sufficiently large and diverse data set can minimize such delays, further improving the device's performance in preventing incontinent events. In some cases, the detection includes determining the individual's Global Positioning System (GPS) location, which, in combination with parameters related to a response from the individual, is used to prevent an incontinent episode.

[0113] Aspects of the disclosure provided herein may include a method of data processing. In some cases, the data processing method includes: (i) receiving a measurement of a parameter previously measured by the sensor electrodes, the parameter being predictive of an incontinent episode of the individual; (ii) analyzing the parameter; and (iii) synthesizing an electrical stimulation signal for the individual, where when the electrical stimulation signal is applied to the individual by the stimulation electrodes, the electrical stimulation signal, in conjunction with efforts from the individual intended to prevent an incontinent episode, prevents an incontinent episode. In some cases, the parameter may be associated with a response from the individual intended to prevent an incontinent episode. In some cases, the parameter may be associated with an individual's efforts to prevent an incontinent episode, and the electrical stimulation signal is synthesized to supplement the individual's efforts with an electrical stimulation pattern sufficient to prevent an incontinent episode in conjunction with the individual's efforts. In some cases, the response from the individual alone may be insufficient to prevent an incontinent episode, and the electrical stimulation signal, when applied, is such that, in conjunction with the response, it adds a sufficient effect to prevent an incontinent episode.

[0114] In some cases, the incontinence episode may include urinary incontinence. In some cases, the incontinence episode may include fecal incontinence. In some cases, the incontinence episode may include stress urinary incontinence. In some cases, the incontinence episode is urinary incontinence and is of the urge incontinence type.

[0115] In some cases, the parameter may include a signal from a sensor electrode configured to detect a contraction of the individual's muscles associated with a partial contraction of a sphincter that controls the bladder or defecation. In some cases, the electrical stimulation signal may include electrical stimulation of the pudendal nerve. In some cases, the electrical stimulation signal may be synthesized to include a constant electrical stimulation component and a component specific to the measured parameter. In some cases, the intensity or duration of the electrical stimulation provided by the electrical stimulation signal may vary depending on the value of the received parameter. In some cases, the parameter may include an EMG signal. In some cases, the EMG signal may determine that a contraction of at least one pelvic muscle has occurred. In some cases, the intensity of the EMG signal may be proportional to the intensity of the contraction of the at least one pelvic muscle. In some cases, the electrical stimulation signal may include a first and a second signal for stimulating a first pudendal nerve and a second pudendal nerve, respectively. In some cases, the method may further include recording a signal previously measured by the sensor electrode. In some cases, the method may further include synthesizing an adjustment signal for adjusting the sensor electrode in response to the recorded signal.

[0116] Evaluation for treatment of incontinence Post-Procedure Outpatient Evaluation In some embodiments, various outpatient assessments can be performed to determine the effectiveness of the implantation procedure. In some embodiments, the implanted IPG allows for telemetry download of data (input, output, and event classification). In some embodiments, the participant is in an awake ambulatory environment and a series of resting and evoked electrophysiological data can be recorded. In some embodiments, at the initiation of treatment (24-48 hours after implantation), sensory and motor responses can be determined from different sensor electrodes on the implanted lead. In some embodiments, based on the responses, the electrode with the most appropriate response can be selected to begin treatment.

[0117] In some embodiments, the patient may be exposed to different physiological events to program the IPG. In some embodiments, these events may include coughing, Valsalva maneuver, lifting a 5 kg weight, or any combination thereof. In some embodiments, pelvic floor EMG may be measured using a transvaginal probe and / or anal probe. In some embodiments, intraurethral pressure may be measured. In some embodiments, a 1 hour continuous "resting" recording of input and output (downloaded by telemetry) may be obtained. In some embodiments, recordings during controlled participant-induced events such as coughing, Valsalva, lifting a 5 kg weight, etc. may be obtained. In some embodiments, recordings during pelvic floor surface EMG (from transvaginal probe: females only) may be obtained to correlate input from induced EMG and surface EMG. In some embodiments, patient tolerance and operating parameters of basal stimulation ramping may be obtained. In some embodiments, a standard urodynamic test is performed after 48 hours. In some embodiments, UDC (with or without reports of urge) may be recorded during bladder filling to assess the acute effects of activation of the device by the patient. In some embodiments, a standard 1 hour pad test may be performed.

[0118] Clinical endpoints In some embodiments, clinical endpoints are assessed using a 5-day voiding diary recording number of urinations, number of urgency attacks, number of urinary leakage and severity of urinary leakage, i.e., stress and urgency urinary incontinence (total) attacks per unit time, stress UI attacks per unit time, urgency UI attacks per unit time, stress UI attacks per unit time, urgency UI attacks per unit time, number of urgency attacks per unit time, total urination frequency per unit time, response rate: greater than 90% reduction from baseline in mean total UI attacks based on ≥50% (>) reduction in UI attacks per unit time, or functional cure rate defined as an average of ≤1 UIE per week (<), ICIQ-SF-UI questionnaire, or any combination thereof.

[0119] definition Unless otherwise defined, all technical terms, notations, and other technical and scientific terms or terminology used herein are intended to have the same meaning as commonly understood by one of ordinary skill in the art to which the claimed subject matter pertains. In some cases, terms having a commonly understood meaning are defined herein for clarity and / or ease of reference, and the inclusion of such definitions herein should not necessarily be construed as representing a substantial difference from what is commonly understood in the art.

[0120] Throughout this application, various embodiments may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity, and should not be interpreted as a flexible limitation of the scope of the present disclosure. Thus, the description of a range should be considered as specifically disclosing all possible subranges and individual numerical values ​​within that range. For example, a description of a range such as 1-6 should be considered as specifically disclosing not only the individual numbers within that range, such as 1, 2, 3, 4, 5, 6, but also subranges such as 1-3, 1-4, 1-5, 2-4, 2-6, 3-6, etc. This applies regardless of the breadth of the range.

[0121] As used in this specification and claims, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. For example, the term "a sample" includes a plurality of samples, including mixtures thereof.

[0122] The terms "determining," "measuring," "assessing," "assessing," "assaying," and "analyzing" refer to forms of measurement, including determining whether an element is present, and are often used interchangeably herein (e.g., detecting). These terms may include quantitative, qualitative, or quantitative and qualitative measurements. Assessment may be relative or absolute. "Detecting the presence of" includes not only determining whether something is present, but also determining the amount of what is present.

[0123] The terms "subject," "individual," or "patient" are often used interchangeably herein. A "subject" can be a biological entity that includes expressed genetic material. The biological entity can be an animal. The subject can be a mammal. The mammal can be a human. The subject can be diagnosed with or suspected of being at high risk for a disease or condition. The disease can be incontinence. In some cases, the disease can be urinary incontinence. In some cases, the disease is fecal incontinence. In some cases, the subject has not necessarily been diagnosed with or is suspected of being at high risk for the disease.

[0124] The term "in vivo" is used to describe events that take place within a subject's body.

[0125] The term "in vitro" is used to describe events that take place outside the subject's body.

[0126] An "in vitro" test is not performed on a subject. Rather, it is performed on a sample separate from the subject. An example of an "in vitro" test that is performed on a sample is an "in vivo" test.

[0127] As used herein, the term "about" of a numerical value refers to that numerical value plus or minus 10%. The term "about" of a range refers to the range minus 10% of its lowest value and plus 10% of its highest value.

[0128] As used herein, the term "treatment" or "treating" is used in reference to an intervention regimen to obtain a beneficial or desired result in a recipient. Beneficial or desired results include, but are not limited to, therapeutic benefit and / or prophylactic benefit. A therapeutic benefit may refer to the prevention or amelioration of the symptoms or underlying disease being treated. A therapeutic benefit may also be achieved by preventing or ameliorating one or more of the physiological symptoms associated with the underlying disease such that an improvement is observed in the subject, even though the subject may still suffer from the underlying disease. A prophylactic benefit includes delaying, preventing, or eliminating the appearance of the disease or condition, delaying or eliminating the onset of a symptom of the disease or condition, slowing, halting, or reversing the progression of the disease or condition, or other effects. Combinations thereof. For prophylactic benefit, subjects at risk of onset of a particular disease or condition or subjects reporting one or more physiological symptoms of the disease or condition may be treated.

[0129] The section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described.

[0130] While preferred embodiments of the present invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will occur to those skilled in the art without departing from the invention. It is understood that various alternatives to the embodiments of the invention described herein may be used in carrying out the invention. It is intended that the following claims define the scope of the invention, and that methods and structures within the scope of these claims, and their equivalents, be covered thereby.

[0131] Numbered embodiments Numbered embodiment 1 includes a method for preventing an incontinent episode in an individual in need of prevention of an incontinent episode, the method comprising: (A) implanting a sensor electrode and a stimulating electrode in the individual's body; (b) using the sensor electrode to detect a parameter associated with a response from the individual intended to prevent an incontinent episode; and (c) using the stimulating electrode to apply an electrical stimulus, in conjunction with the response, to prevent an incontinent episode. Numbered embodiment 2 includes the method of embodiment 1, wherein the incontinent episode comprises urinary incontinence. Numbered embodiment 3 includes the method of embodiment 1, wherein the incontinent episode comprises fecal incontinence. Numbered embodiment 4 includes the method of embodiment 1, wherein the incontinent episode comprises stress urinary incontinence. Numbered embodiment 5 includes the method of embodiment 1, wherein the sensor electrode is configured to detect a muscular contraction of the individual resulting in a partial contraction of a sphincter that controls urination or defecation. Numbered embodiment 6 includes the method of embodiment 5, wherein the sensor electrode is positioned in the individual's pelvis. Numbered embodiment 7 includes the method of embodiment 1, in which the stimulating electrode provides electrical stimulation to the pudendal nerve. Numbered embodiment 8 includes the method of embodiment 7, in which the sensor electrode and the stimulating electrode are arranged on a single lead. Numbered embodiment 9 includes the method of embodiment 1, in which the step of providing a constant electrical stimulation at a lower intensity level than the electrical stimulation provided in step (c). Numbered embodiment 10 includes the method of embodiment 9, in which the incontinence episode is urinary incontinence and is of the urge incontinence type. Numbered embodiment 11 includes the method of embodiment 1, in which the intensity or duration of the electrical stimulation provided in step (c) varies depending on the response detected in step (b). Numbered embodiment 12 includes the method of embodiment 11, in which the response detected in step (b) is insufficient by itself to prevent an incontinence episode, and the electrical stimulation provided in step (b) in conjunction with the response adds an effect sufficient to prevent an incontinence episode. Numbered embodiment 13 includes the method of embodiment 11, wherein the response detected in step (b) is insufficient by itself to prevent an episode of incontinence, and the electrical stimulation provided in step (b) in conjunction with the response prevents an episode of incontinence. Numbered embodiment 14 includes the method of embodiment 1, wherein the sensor electrodes are configured to detect EMG signals.Numbered embodiment 15 includes the method of embodiment 14, in which the EMG signal determines that a contraction of at least one pelvic muscle has occurred. Numbered embodiment 16 includes the method of embodiment 15, in which the strength of the EMG signal is proportional to the strength of the contraction of at least one pelvic muscle. Numbered embodiment 17 includes the method of embodiment 1, including implanting a first stimulating electrode and a second stimulating electrode, the first stimulating electrode stimulating one area on the pudendal nerve and the second stimulating electrode stimulating a different area on the pudendal nerve. Numbered embodiment 18 includes the method of embodiment 1, in which the individual suffers from mixed urinary incontinence. Numbered embodiment 19 includes the method of embodiment 1, in which the sensor electrode and the stimulating electrode are operably coupled to a non-transitory computer-readable medium including a processor and software. Numbered embodiment 20 includes the method of embodiment 19, in which the sensor electrode is calibrated by the individual using an external input device in conjunction with the software. Numbered embodiment 21 includes the method of embodiment 19, where the software is configured to record signals from the sensor electrodes. Numbered embodiment 22 includes the method of embodiment 21, where the software is configured to adjust the response of the sensor electrodes to the signals. Numbered embodiment 23 includes the method of embodiment 19, where the software includes a machine learning model, where the machine learning model is configured to classify signals detected by the sensor electrodes and generate signals by the stimulating electrodes. Numbered embodiment 24 includes the method of embodiment 23, where the machine learning model is trained based on prior data obtained from an individual or a collection of individuals and corresponding incontinence prevention or incontinence information. Numbered embodiment 25 includes the method of embodiment 24, where the prior data includes signals detected by the sensor electrodes, generated signals generated by the stimulating electrodes, or any combination thereof. Numbered embodiment 26 includes the method of embodiment 1, where the detecting further includes determining a global positioning system (GPS) location of the individual and combining with a parameter related to the response from the individual to prevent an incontinence episode.

[0132] Numbered embodiment 27 includes a system for preventing incontinent episodes in an individual in need of prevention of incontinent episodes, the device comprising: (a) a sensor electrode configured to detect a parameter associated with a response from an individual intending to prevent incontinent episodes; (b) a stimulation electrode configured to provide electrical stimulation; (c) a processor operatively connected to the sensor electrode and the stimulation electrode; and a non-transitory computer-readable storage medium including software configured to cause the processor to: (i) receive a parameter associated with a response from an individual intending to prevent incontinent episodes; (ii) analyze the parameter associated with the response from the individual intending to prevent incontinent episodes; and (iii) the stimulation electrode provides electrical stimulation to the individual such that the electrical stimulation in conjunction with the response from the individual intending to prevent incontinent episodes prevents incontinent episodes. Numbered embodiment 28 includes the system of embodiment 27, in which the incontinent episodes include urinary incontinence. Numbered embodiment 29 includes the system of embodiment 27, in which the incontinent episodes include fecal incontinence. Numbered embodiment 30 includes the system of embodiment 27, wherein the episode of incontinence includes stress urinary incontinence. Numbered embodiment 31 includes the system of embodiment 27, wherein the sensor electrode is configured to detect muscular contractions of the individual resulting in partial contraction of a sphincter that controls urination or defecation. Numbered embodiment 32 includes the system of embodiment 27, wherein the sensor electrode is disposed in the individual's pelvis. Numbered embodiment 33 includes the system of embodiment 27, wherein the stimulating electrode applies electrical stimulation to the individual's pudendal nerve. Numbered embodiment 34 includes the system of embodiment 27, wherein the sensor electrode and the stimulating electrode are disposed on a single lead. Numbered embodiment 35 includes the system of embodiment 27, wherein the stimulating electrode is configured to apply constant electrical stimulation at a lower intensity level than the electrical stimulation. Numbered embodiment 36 includes the system of embodiment 27, wherein the episode of incontinence is urinary incontinence and is of the urge incontinence type. Numbered embodiment 37 includes the system of embodiment 27, wherein the intensity or duration of the electrical stimulation varies depending on the detected response.Numbered embodiment 38 includes the system of embodiment 27, wherein the response detected by the sensor electrodes is insufficient by itself to prevent an incontinent episode, and the electrical stimulation provided in conjunction with the response adds a sufficient effect to prevent an incontinent episode. Numbered embodiment 39 includes the system of embodiment 27, wherein the response detected by the sensor electrodes is insufficient by itself to prevent an incontinent episode, and the electrical stimulation provided in step (b) in conjunction with the response prevents an incontinent episode. Numbered embodiment 40 includes the system of embodiment 27, wherein the sensor electrodes are configured to detect an EMG signal. Numbered embodiment 41 includes the system of embodiment 40, wherein the EMG signal determines that a contraction of at least one pelvic muscle has occurred. Numbered embodiment 42 includes the system of embodiment 41, wherein the intensity of the EMG signal is proportional to the intensity of the contraction of at least one pelvic muscle. Numbered embodiment 43 includes the system of embodiment 27, wherein the stimulating electrodes include a first stimulating electrode and a second stimulating electrode, the first stimulating electrode stimulating the first pudendal nerve, and the second stimulating electrode stimulating the second pudendal nerve. Numbered embodiment 44 includes the system of embodiment 27, wherein the individual suffers from mixed urinary incontinence. Numbered embodiment 45 includes the system of embodiment 27, wherein the sensor electrodes are calibrated by the individual using an external input device in conjunction with the software. Numbered embodiment 46 includes the system of embodiment 27, wherein the software is further configured to cause the processor to record signals from the sensor electrodes. Numbered embodiment 47 includes the system of embodiment 46, wherein the software is configured to adjust the response of the sensor electrodes to the signals. Numbered embodiment 48 includes the system of embodiment 27, wherein the software includes a machine learning model, wherein the machine learning model is configured to classify signals detected by the sensor electrodes and generate signals by the stimulating electrodes. Numbered embodiment 49 includes the system of embodiment 48, in which the machine learning model is trained based on prior data obtained from an individual or a collection of individuals and corresponding information on incontinence prevention or lack thereof.Numbered embodiment 50 includes the system of embodiment 49, wherein the prior data includes a signal detected by the sensor electrodes, a generated signal generated by the stimulating electrodes, or any combination thereof. Numbered embodiment 51 includes the system of embodiment 27, wherein the software includes analyzing a global positioning system (GPS) location of the individual and combining it with a parameter related to a response from the individual to prevent an incontinent episode.

[0133] Numbered embodiment 52 comprises a non-transitory computer readable storage medium including software for preventing an incontinent episode in an individual in need of prevention of an incontinent episode, the software being configured to cause a processor to (i) receive by the sensor electrodes a parameter associated with a response from the individual intended to prevent an incontinent episode, (ii) analyze the parameter associated with the response from the individual intended to prevent an incontinent episode, and (iii) cause the stimulation electrodes to apply an electrical stimulus to the individual, the electrical stimulus, in conjunction with the response from the individual intended to prevent an incontinent episode, prevents an incontinent episode. Numbered embodiment 53 comprises a non-transitory computer readable storage medium including the software of embodiment 52, the incontinent episode includes urinary incontinence. Numbered embodiment 54 comprises a non-transitory computer readable storage medium including the software of embodiment 52, the incontinent episode includes fecal incontinence. Numbered embodiment 55 comprises a non-transitory computer readable storage medium including the software of embodiment 52, the incontinent episode includes stress urinary incontinence. Numbered embodiment 56 comprises a non-transitory computer readable storage medium including the software of embodiment 52, wherein the sensor electrode is configured to detect muscle contractions of the individual resulting in partial contraction of the sphincter that controls urination or defecation. Numbered embodiment 57 comprises a non-transitory computer readable storage medium including the software of embodiment 52, wherein the sensor electrode is disposed in the individual's pelvis. Numbered embodiment 58 comprises a non-transitory computer readable storage medium including the software of embodiment 52, wherein the stimulation electrode provides electrical stimulation to the individual's pudendal nerve. Numbered embodiment 59 comprises a non-transitory computer readable storage medium including the software of embodiment 52, wherein the sensor electrode and the stimulation electrode are disposed on a single lead. Numbered embodiment 60 comprises a non-transitory computer readable storage medium including the software of embodiment 52, wherein the electrode of the stimulation device is configured to provide constant electrical stimulation at a lower intensity level than the electrical stimulation. Numbered embodiment 61 comprises a non-transitory computer readable storage medium including the software of embodiment 52, wherein the incontinence episode is urinary incontinence and is of the urge incontinence type.Numbered embodiment 62 comprises a non-transitory computer readable storage medium including the software of embodiment 52, wherein the intensity or duration of the electrical stimulation varies in response to the detected response. Numbered embodiment 63 comprises a non-transitory computer readable storage medium including the software of embodiment 62, wherein the response detected by the sensor electrodes is insufficient by itself to prevent an incontinent episode, and the electrical stimulation applied in conjunction with the response adds a sufficient effect to prevent an incontinent episode. Numbered embodiment 64 comprises a non-transitory computer readable storage medium including the software of embodiment 62, wherein the response detected by the sensor is insufficient by itself to prevent an incontinent episode, and the electrical stimulation applied in conjunction with the response prevents an incontinent episode. Numbered embodiment 65 comprises a non-transitory computer readable storage medium including the software of embodiment 52, wherein the sensor electrodes are configured to detect EMG signals. Numbered embodiment 66 comprises a non-transitory computer readable storage medium including the software of embodiment 65, wherein the EMG signals determine that a contraction of at least one pelvic muscle has occurred. Numbered embodiment 67 comprises a non-transitory computer-readable storage medium including the software of embodiment 66, wherein the strength of the EMG signal is proportional to the strength of the contraction of at least one pelvic muscle. Numbered embodiment 68 comprises a non-transitory computer-readable storage medium including the software of embodiment 52, wherein the stimulating electrodes include a first stimulating electrode and a second stimulating electrode, the first stimulating electrode stimulating a first pudendal nerve, and the second stimulating electrode stimulating a second pudendal nerve. Numbered embodiment 69 comprises a non-transitory computer-readable storage medium including the software of embodiment 52, wherein the individual suffers from mixed urinary incontinence. Numbered embodiment 70 comprises a non-transitory computer-readable storage medium including the software of embodiment 52, wherein the sensor electrodes are calibrated by the individual using an external input device associated with the software. Numbered embodiment 71 comprises a non-transitory computer-readable storage medium including the software of embodiment 52, wherein the software is further configured to cause the processor to record signals from the sensor electrodes.Numbered embodiment 72 comprises a non-transitory computer-readable storage medium including the software of embodiment 71, the software being configured to adjust the response of the sensor electrodes to the signal. Numbered embodiment 73 comprises the non-transitory computer-readable storage medium of embodiment 52, the software comprising a machine learning model, the machine learning model being configured to classify the signal detected by the sensor electrodes and generate a signal by the stimulating electrodes. Numbered embodiment 74 comprises the non-transitory computer-readable storage medium of embodiment 73, the machine learning model being trained based on prior data obtained from an individual or a set of individuals and corresponding prevention of incontinence or lack of information. Numbered embodiment 75 comprises the non-transitory computer-readable storage medium of embodiment 74, the prior data comprising signals detected by the sensor electrodes, signals generated, or any combination thereof. Numbered embodiment 76 comprises the non-transitory computer-readable medium of embodiment 52, the software comprising analyzing the individual's global positioning system (GPS) location and combining with a parameter associated with the response from the individual to prevent episodes of incontinence.

[0134] Numbered embodiment 77 includes a method of data processing, the method including: (i) receiving a measurement of a parameter previously measured by the sensor electrodes and predicting an incontinent episode of the individual; (ii) analyzing the parameter; and (iii) synthesizing an electrical stimulation signal for the individual, such that when the electrical stimulation signal is provided to the individual by the stimulation electrodes, the electrical stimulation signal prevents an incontinent episode in conjunction with the individual's efforts to prevent an incontinent episode. Numbered embodiment 78 includes the method of embodiment 77, the parameter is associated with a response from the individual intended to prevent an incontinent episode. Numbered embodiment 79 includes the method of embodiment 78, the parameter is associated with the individual's efforts to prevent an incontinent episode, and the electrical stimulation signal is synthesized to supplement the individual's efforts to prevent an incontinent episode with an electrical stimulation pattern sufficient to prevent an incontinent episode in conjunction with the individual's efforts. Numbered embodiment 80 includes the method of embodiment 79, wherein the response from the individual is insufficient by itself to prevent an incontinent episode, and the electrical stimulation signal, when applied, is such that in conjunction with the response, it adds a sufficient effect to prevent an incontinent episode. Numbered embodiment 81 includes the method of any one of embodiments 77 to 80, wherein the incontinent episode includes urinary incontinence. Numbered embodiment 82 includes the method of embodiment 77 or 80, wherein the incontinent episode includes fecal incontinence. Numbered embodiment 83 includes the method of any one of embodiments 77 to 80, wherein the incontinent episode includes stress urinary incontinence. Numbered embodiment 84 includes the method of any one of embodiments 77 to 83, wherein the parameter is a signal from a sensor electrode configured to detect a contraction of the individual's muscle associated with a partial contraction of a sphincter that controls urination or defecation. Numbered embodiment 85 includes the method of any one of embodiments 77 to 84, wherein the electrical stimulation signal is for electrical stimulation of the pudendal nerve. Numbered embodiment 86 includes the method of any one of embodiments 77-85, wherein the electrical stimulation signal is compounded to include a constant electrical stimulation component and a measurement parameter specific component. Numbered embodiment 87 includes the method of any one of embodiments 77-86, wherein the incontinence episode is urinary incontinence and is of the urge incontinence type.Numbered embodiment 88 includes the method of any one of embodiments 77-87, in which the intensity or duration of the electrical stimulation provided by the electrical stimulation signal varies depending on the value of the received parameter. Numbered embodiment 89 includes the method of any one of embodiments 77-88, in which the parameter is an EMG signal. Numbered embodiment 90 includes the method of embodiment 89, in which the EMG signal determines that a contraction of at least one pelvic muscle has occurred. Numbered embodiment 91 includes the method of embodiment 9066, in which the intensity of the EMG signal is proportional to the intensity of the contraction of at least one pelvic muscle. Numbered embodiment 92 includes the method of any one of embodiments 77-91, in which the electrical stimulation signal includes first and second signals for stimulating a first pudendal nerve and a second pudendal nerve, respectively. Numbered embodiment 93 includes the method of any one of embodiments 77-92, further including recording the signal previously measured by the sensor electrodes. Numbered embodiment 94 includes the method of embodiment 93, further including synthesizing an adjustment signal for adjusting the sensor electrodes in response to the recorded signal.

[0135] Working Example Example 1: Reproducibility of EMG measurements Using the systems, methods, and devices described herein, EMG signals from patients were measured and processed as the patients performed muscle contractions, coughs, and Valsalva maneuvers, as seen in Figures 11A-11E. For each patient, raw EMG data 1102 was recorded and amplified, as described elsewhere herein. The raw EMG data was then filtered (1106), rectified, and smoothed (1104).

[0136] From the data shown in Figures 11A-11C, where one patient performed the same sequence of muscle contractions three times, three distinct groups of signals can be observed in the temporal EMG data. Such findings support the repeatability of the sensor electrodes of the devices and systems described herein, and the potential ability of the trained classifier to temporally differentiate EMG signals. Similar data from a different patient shown in Figures 11D-11E show similar results to the patient in Figures 11A-11C.

Claims

1. A system for preventing incontinence episodes in a patient, comprising: one or more sensor electrodes configured to detect a parameter related to a response from the patient intended to prevent an incontinent episode; one or more stimulation electrodes configured to provide a base electrical stimulation level that is constant in frequency, amplitude, current, or a combination thereof; a processor operatively connected to at least one of the sensor electrodes and to at least one of the stimulation electrodes; The processor, receiving the parameters associated with the response from the patient; Analyzing said parameters; The system is configured to, in response to the parameter, provide an increased electrical stimulation level to the patient via at least one of the stimulation electrodes such that the increased electrical stimulation level in combination with the response prevents episodes of incontinence.

2. The system described in claim 1, wherein the intensity or duration of the increased electrical stimulation level varies depending on the detected parameter.

3. A system for preventing episodes of incontinence in a patient, comprising: one or more sensor electrodes configured to detect a parameter related to a response from the patient intended to prevent an incontinent episode; one or more stimulation electrodes configured to provide electrical stimulation; a processor operatively connected to at least one of the sensor electrodes and to at least one of the stimulation electrodes; The processor, receiving the parameters associated with the response; Analyzing said parameters; A system configured to provide the electrical stimulation to the patient via at least one of the stimulation electrodes such that the electrical stimulation, in conjunction with the response from the patient, prevents episodes of incontinence.

4. The system described in claim 3, wherein the one or more stimulating electrodes comprise a first stimulating electrode and a second stimulating electrode, the first stimulating electrode configured to stimulate a first pudendal nerve and the second stimulating electrode configured to stimulate a second pudendal nerve.

5. The system described in claim 3, wherein the intensity or duration of the electrical stimulation varies depending on the detected parameter.

6. A system for preventing episodes of incontinence in a patient, comprising: one or more sensor electrodes configured to detect a parameter related to the patient's efforts to prevent incontinent episodes; one or more stimulation electrodes configured to provide a base level of electrical stimulation; a processor operatively connected to at least one of the sensor electrodes and to at least one of the stimulation electrodes; The processor, receiving said parameters; Analyzing said parameters; configured to increase a level of electrical stimulation to the patient from the baseline electrical stimulation level for at least one of the stimulation electrodes based on the parameter; The increased level of electrical stimulation is suitable for preventing incontinent episodes.

7. A system described in any one of claims 1 to 6, wherein the one or more sensor electrodes comprise embedded electrodes.

8. A system described in any one of claims 1 to 7, wherein the one or more stimulation electrodes comprise implantable electrodes.

9. A system for preventing incontinent episodes in a patient, comprising: one or more implantable sensor electrodes configured to detect a parameter related to the patient's efforts to prevent incontinent episodes; one or more implanted stimulation electrodes configured to provide a baseline electrical stimulation level; a processor operatively connected to the one or more implanted sensor electrodes and the one or more implanted stimulating electrodes; The processor, receiving said parameters; Analyzing said parameters; configured to cause at least one of the implanted stimulation electrodes to increase a level of electrical stimulation to the patient from the baseline electrical stimulation level based on the parameter; said increased level of electrical stimulation being suitable for preventing said episodes of mixed urinary incontinence; The parameters include an EMG signal; The one or more implanted stimulation electrodes are configured to apply electrical stimulation to the patient's pudendal nerve.

10. A system described in any one of claims 1 to 9, wherein the sensor electrodes include one to four electrodes and the stimulating electrodes include one to four electrodes.

11. A system described in any one of claims 1 to 10, wherein electrodes having the most appropriate sensory and motor responses are selected for detecting the parameters.

12. A system described in any one of claims 1 to 8, wherein the incontinence episodes include urinary incontinence or fecal incontinence.

13. A system described in any one of claims 1 to 8, wherein the incontinence episodes include mixed urinary incontinence.

14. A system described in any one of claims 6 to 12, wherein the intensity or duration of the increased level of electrical stimulation varies depending on the parameter detected.

15. A system as described in any one of claims 1 to 8, wherein the implantable stimulation electrode is configured to provide the baseline electrical stimulation level or the increased level of electrical stimulation to the patient's pudendal nerve.

16. A system as described in any one of claims 1 to 12, 15, wherein the detected effort of the patient includes a contraction of the patient's muscles resulting in a partial contraction of a sphincter that controls urination or defecation.

17. A system as described in any one of claims 1 to 8, wherein the embedded sensor electrode is configured to detect EMG signals.

18. A system as described in claim 9 or 17, wherein the EMG signal indicates a sphincter contraction.

19. A system as described in claim 9 or 17, wherein the EMG signal indicates contraction of pelvic muscles.

20. A system as described in claim 9 or 17, wherein the EMG signal indicates an intentional contraction of the pelvic muscles.

21. A system described in any one of claims 1 to 20, wherein the sensor electrode and the stimulating electrode are arranged on a single lead wire.

22. A system described in any one of claims 3 to 21, wherein the basic electrical stimulation level is a constant basic electrical stimulation level.

23. The system described in claim 22, wherein the frequency of the basic electrical stimulation level is constant.

24. The system described in claim 22, wherein the amplitude of the basic electrical stimulation level is constant.

25. The system described in claim 22, wherein the basic electrical stimulation level is a constant current.

26. A system as described in any one of claims 1 to 25, wherein the stimulating electrodes include a first stimulating electrode and a second stimulating electrode, the first stimulating electrode configured to stimulate a first pudendal nerve, and the second stimulating electrode configured to stimulate a second pudendal nerve.

27. ​​The system of claim 26, further comprising a first lead wire and a second lead wire configured to be implanted on either side in proximity to the pudendal nerve.

28. The system described in claim 27, wherein the first lead wire comprises a first sensor electrode and the first stimulating electrode, and the second lead wire comprises a second sensor electrode and the second stimulating electrode.

29. The system described in claim 27 or 28, wherein the pulse generator is configured to provide the increased level of electrical stimulation to the same lead that detects the parameter indicative of the patient's efforts to prevent an incontinence episode.

30. A system as described in any one of claims 1 to 29, further comprising an external input device configured to adjust parameters of the increased level of electrical stimulation.

31. A system as described in any one of claims 1, 2, and 6-30, wherein the increased level of electrical stimulation is based at least in part on a real-time clock scheduler.

32. A system described in any one of claims 1 to 31, wherein the parameters related to the patient's efforts to prevent incontinence attacks are analyzed based on a machine learning model, and the machine learning model is configured to classify the signal detected by the implanted sensor electrode.

33. A system for preventing episodes of incontinence in a patient, comprising: a first sensor electrode and a second sensor electrode configured to detect a parameter indicative of the patient's efforts to prevent incontinent episodes; a first stimulating electrode and a second stimulating electrode configured to provide electrical stimulation to or near the pudendal nerve; an implantable pulse generator operably connected to the first and second stimulating electrodes and to the first and second sensor electrodes; the implantable pulse generator is configured to provide a baseline electrical stimulation level to the patient; the implantable pulse generator is configured to provide an increased level of electrical stimulation configured to prevent episodes of incontinence in response to detecting the parameter indicative of the patient's efforts to prevent episodes of incontinence; The increased electrical stimulation level is greater than the base electrical stimulation level.

34. The system described in claim 33, wherein the first sensor electrode and the second sensor electrode comprise implantable electrodes.

35. The system described in claim 33 or 34, wherein the first stimulating electrode and the second stimulating electrode comprise implantable electrodes.

36. A system as described in any one of claims 33 to 35, wherein each of the first sensor electrode and the second sensor electrode is configured to detect an EMG signal.

37. The system of claim 36, wherein the EMG signal indicates a sphincter contraction.

38. The system of claim 36, wherein the EMG signal indicates contraction of pelvic muscles.

39. The system described in claim 36, wherein the EMG signal indicates an intentional contraction of the pelvic muscles.

40. The system of any one of claims 33 to 39, further comprising a first lead wire and a second lead wire configured to be implanted on either side in proximity to the pudendal nerve.

41. The system described in claim 40, wherein the first lead wire comprises the first sensor electrode and the first stimulating electrode, and the second lead wire comprises the second sensor electrode and the second stimulating electrode.

42. A system as described in any one of claims 33 to 41, wherein the pulse generator is configured to provide the increased level of electrical stimulation to the same lead that detects the parameter indicative of the patient's efforts to prevent episodes of incontinence.

43. A system described in any one of claims 33 to 42, wherein the increased electrical stimulation level is higher than the basic electrical stimulation level in one or more of frequency, amplitude, and current.

44. A system described in any one of claims 33 to 43, wherein the basic electrical stimulation level is constant in frequency, amplitude, current, or a combination thereof.

45. A system as described in any one of claims 33 to 43, wherein the increased electrical stimulation level is based at least in part on a real-time clock scheduler.

46. A system as described in any one of claims 33 to 45, further comprising an external input device configured to adjust parameters of the increased electrical stimulation level.

47. A system for preventing episodes of incontinence in a patient, comprising: a first sensor configured to detect EMG signals indicative of the patient's efforts to prevent an incontinent episode; at least one stimulation electrode configured to apply electrical stimulation to or near the pudendal nerve; an implantable pulse generator operatively connected to the at least one stimulation electrode and the at least one first sensor; the implantable pulse generator is configured to provide a baseline electrical stimulation level; The system, wherein the implantable pulse generator is configured to provide an elevated electrical stimulation level configured to prevent episodes of incontinence in response to detecting the EMG signal indicative of the patient's efforts to prevent episodes of incontinence.

48. The system described in claim 47, wherein the first sensor comprises an embedded electrode.

49. The system described in claim 47 or 48, wherein at least one stimulating electrode comprises an implantable electrode.

50. A system described in any one of claims 47 to 49, wherein the basic electrical stimulation level is constant in frequency, amplitude, current, or a combination thereof.

51. A system as described in any one of claims 47 to 50, wherein the EMG signal indicates a sphincter contraction.

52. A system described in any one of claims 47 to 50, wherein the EMG signal indicates contraction of pelvic muscles.

53. A system described in any one of claims 47 to 50, wherein the EMG signal indicates an intentional contraction of the pelvic muscles.

54. A system described in any one of claims 47 to 53, wherein the intensity of the higher electrical stimulation level is greater than the intensity of the basic electrical stimulation level.

55. A system described in any one of claims 47 to 54, wherein in response to detecting the EMG signal indicative of the patient's efforts to prevent an incontinence episode, the higher electrical stimulation level varies the pulse width of the electrical stimulation.

56. A system described in any one of claims 47 to 54, wherein in response to detecting the EMG signal indicative of the patient's efforts to prevent incontinence episodes, the higher electrical stimulation level varies the frequency of electrical stimulation.

57. A system described in any one of claims 47 to 54, wherein in response to detecting the EMG signal indicative of the patient's efforts to prevent an incontinence episode, the higher electrical stimulation level varies the amplitude of the electrical stimulation.

58. The system of any one of claims 47 to 57, further comprising a second sensor configured to detect a second parameter indicative of the patient's efforts to prevent episodes of incontinence, and the implantable pulse generator configured to provide the higher electrical stimulation level configured to prevent episodes of incontinence in response to detecting the EMG signal and the second parameter.

59. The system described in claim 58, wherein the second sensor is configured to detect physical movement of the patient.

60. The system described in claim 58, wherein the second sensor comprises an acceleration sensor.

61. The system described in claim 58, wherein the second sensor comprises a pressure sensor.

62. A system described in any one of claims 47 to 61, wherein the higher electrical stimulation level is based at least in part on a real-time clock scheduler.

63. A system for preventing episodes of incontinence in a patient, comprising: a first lead configured to be implanted bilaterally adjacent to the pudendal nerve, the first lead including a first stimulating electrode; a second lead configured to be implanted bilaterally adjacent the pudendal nerve, the second lead including a second stimulation electrode; a sensor configured to detect physical movements of the patient indicative of the patient's efforts to prevent an incontinent episode; an implantable pulse generator comprising a processor; The system, wherein the implantable pulse generator provides a level of activation electrical stimulation configured to prevent an incontinent episode and / or reduce the severity of an incontinent episode in response to detecting the physical movement.

64. The system described in claim 63, wherein the sensor is an acceleration sensor.

65. A system as described in claim 63 or 64, wherein the sensor is on the first lead wire.

66. A system described in any one of claims 63 to 65, wherein the implantable pulse generator is further configured to provide a basal stimulation level.

67. The system described in claim 66, wherein the basal stimulation level is constant.

68. A system as described in claim 66 or 67, wherein the basal stimulation level has a lower intensity level than the pattern of activating electrical stimulation.

69. A system described in any one of claims 63 to 68, wherein the implantable pulse generator is configured to provide the pattern of activating electrical stimulation to the same lead that detects the parameter indicative of the patient's efforts to prevent episodes of incontinence.

70. The system described in any one of claims 63 to 69, further comprising an external input device configured to adjust parameters of the pattern of the activating electrical stimulation.

71. A system for preventing episodes of incontinence in a patient, comprising: a lead configured to be implanted proximate to the pudendal nerve, the lead comprising a stimulation electrode; an acceleration sensor configured to detect a parameter indicative of the patient's efforts to prevent incontinent episodes; an implantable pulse generator comprising a processor; The system, wherein the implantable pulse generator is configured to provide an activation electrical stimulation pattern configured to prevent incontinent episodes and / or reduce the severity of incontinent episodes in response to detecting the parameter indicative of the patient's efforts to prevent incontinent episodes.

72. The system described in claim 71, wherein the implantable pulse generator is further configured to provide a basic stimulation pattern.

73. The system described in claim 72, wherein the implantable pulse generator is configured to provide the activating electrical stimulation pattern together with the basic stimulation pattern.

74. A system as described in claim 72 or 73, wherein the intensity of the activating electrical stimulation pattern is different from the intensity of the basic stimulation pattern.

75. A system described in any one of claims 71 to 74, wherein in response to detecting EMG signals indicative of the patient's efforts to prevent incontinent episodes, the activation electrical stimulation pattern varies the pulse width of the electrical stimulation.

76. A system described in any one of claims 71 to 74, wherein in response to detecting EMG signals indicative of the patient's efforts to prevent incontinence episodes, the activation electrical stimulation pattern varies the frequency of electrical stimulation.

77. A system described in any one of claims 71 to 74, wherein in response to detecting EMG signals indicative of the patient's efforts to prevent incontinent episodes, the activation electrical stimulation pattern varies the amplitude of the electrical stimulation.

78. A system as described in any one of claims 71 to 77, further comprising an external input device configured to adjust parameters of the activation electrical stimulation pattern.

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