Systems for incontinence control

Abstract

A device and method for preventing an incontinence episode in an individual in need thereof is provided. The device includes a sensor and a stimulator electrode implantable in the individual. Once the device is implanted in the individual, the sensor of the device senses a parameter associated with a response from the individual intended to prevent an incontinence episode. The device then uses the electrodes to provide electrical stimulation that, together with the response, helps prevent an incontinence episode.

Description

[0001] Cross-references

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 160,322, filed on March 12, 2021, which is incorporated herein by reference in its entirety. Background Art

[0003] Incontinence, or lack of control over urination or bowel movements, has a variety of causes but often involves damage to 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 control over urination and bowel movements. Summary of the invention

[0004] Lack of voluntary control over urination, defecation, incontinence, or any combination thereof, is a problem that can affect quality of life and lead to social embarrassment. Urinary incontinence, or loss of bladder control, fecal incontinence, loss of bowel control, or any combination thereof, is often associated with neurological problems.

[0005] Electrical stimulation has been used to treat incontinence by directly stimulating muscles, sacral nerves, or other pelvic nerves to improve control over urination and defecation. However, electrical nerve stimulation methods typically only provide one set of stimulation protocols and cannot be adapted to the subject's condition. This can result in over-stimulation or under-stimulation of the target area, leading to inadequate control over urination or defecation. Therefore, it would be beneficial to provide electrical stimulation that takes into account the subject's condition and adjusts the stimulation level accordingly.

[0006] In addition, traditional methods of treating incontinence ignore that the original human response (i.e., reflex) to prevent incontinence events may be insufficient, rather than non-existent. For some individuals who exhibit incontinence events, the innate mechanisms to prevent incontinence may not be completely absent, but insufficient. For example, some individuals with incontinence may experience insufficient preventive responses (e.g., muscle contraction of at least one pelvic floor muscle) to prevent leakage events in response to increased intra-abdominal pressure. In some cases, the leakage event may be urine, or gas or stool. In addition, some individuals with stress incontinence may show delayed responses to preventing incontinence events in response to stress events. Alternatively, some individuals may suffer from stress incontinence associated with urethral hypermobility (i.e., insufficient support), which may result in increased pressure transmitted to the bladder, followed by incontinence events.

[0007] Aspects of the present disclosure provide a method for preventing the onset of incontinence in an individual in need thereof, the method comprising: (a) implanting a sensor electrode and a stimulator electrode in the individual; (b) sensing a parameter associated with a response of the individual intended to prevent the onset of incontinence with the sensor electrode; and (c) providing electrical stimulation with the stimulator electrode, the electrical stimulation and the response preventing the onset of incontinence together. In some embodiments, the onset of incontinence includes urinary incontinence. In some embodiments, the onset of incontinence includes fecal incontinence. In some embodiments, the sensor is configured to sense contraction of an individual's muscles that results in partial contraction of a sphincter or pelvic floor muscle that controls bladder or intestinal discharge. In some embodiments, the sensor electrode is positioned within the individual's pelvis. In some embodiments, the stimulator electrode provides electrical stimulation to the pudendal nerve. In some embodiments, the sensor electrode and the stimulator electrode are located on a single lead. In some embodiments, the method comprises providing a step of providing constant electrical stimulation at a lower intensity level than the electrical stimulation in step (c). In some embodiments, the onset of incontinence is urinary incontinence and is an urge incontinence type. In some embodiments, the intensity or duration of the electrical stimulation provided in step (c) varies according to the response sensed in step (b). In some embodiments, the response sensed in step (b) is not sufficient by itself to prevent the onset of incontinence, and the electrical stimulation provided in step (b) together with the response is just sufficient to prevent the onset of incontinence. In some embodiments, the response sensed in step (b) is not sufficient by itself to prevent the onset of incontinence, and the electrical stimulation provided in step (b) together with the response prevents the onset of incontinence. In some embodiments, the method includes the step of implanting a second stimulator electrode, wherein the first stimulator electrode stimulates one pudendal nerve and the second stimulator electrode stimulates a different pudendal nerve. In some embodiments, the stimulator electrode stimulates one pudendal nerve and the different stimulator electrode stimulates another spatially independent region of the same pudendal nerve. In some embodiments, the method includes the step of implanting different stimulator electrodes, wherein the stimulator electrode stimulates the trunk of the pudendal nerve and the different stimulator electrodes stimulate the distal nerve of the pudendal nerve. In some embodiments, the distal nerve of the pudendal nerve includes branches of the distal pudendal nerve. In some embodiments, the method includes the step of implanting different stimulator electrodes, wherein the electrodes stimulate the trunk of the pudendal nerve, and the different stimulator electrodes stimulate the main branches of the pudendal nerve (e.g., the dorsal genital nerve). In some embodiments, the method includes the step of implanting different stimulator electrodes, wherein the first stimulator electrode stimulates the pudendal nerve and the different stimulator electrodes stimulate the sacral spinal nerves. In some embodiments, the individual suffers from various types of urinary incontinence. In some cases, the various types can include stress incontinence, urge incontinence, overflow incontinence, or any combination thereof (i.e., mixed incontinence).In some embodiments, the sensor electrodes and stimulator electrodes are operably connected to a processor and a non-transitory computer readable medium including software. In some embodiments, the sensor electrodes are calibrated by an individual using an external input device that interfaces 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.

[0008] In some embodiments, the sensor electrodes are configured to sense electromyographic (EMG) signals. In some embodiments, the EMG signal determines that contraction of at least one pelvic muscle has occurred. In some embodiments, the intensity of the EMG signal determines that 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 at least one pelvic muscle.

[0009] Aspects of the present disclosure provide a system for preventing an episode of incontinence in an individual in need thereof, the device comprising: (a) a sensor electrode configured to sense a parameter associated with a response from the individual intended to prevent an episode of incontinence; (b) a stimulator electrode configured to provide electrical stimulation; (c) a processor operably coupled to the sensor electrode and the stimulator electrode; (d) a non-transitory computer-readable storage medium comprising software configured to cause the processor to: (i) receive a parameter associated with a response from the individual intended to prevent an episode of incontinence; (ii) analyze a parameter associated with a response from the individual intended to prevent an episode of incontinence; and (iii) cause the stimulator electrode to provide electrical stimulation to the individual such that the electrical stimulation, together with the response from the individual intended to prevent an episode of incontinence, prevents an episode of incontinence. In some embodiments, the software comprises analyzing a global positioning system (GPS) location of the individual, the global positioning system location being combined with the parameter associated with the response from the individual intended to prevent an episode of incontinence. In some embodiments, an episode of incontinence comprises urinary incontinence. In some embodiments, the onset of incontinence includes fecal incontinence. In some embodiments, the onset of incontinence includes a combination of urinary incontinence and fecal incontinence. In some embodiments, the onset of incontinence includes urinary stress incontinence. In some embodiments, the sensor electrode is configured to sense the contraction of the muscle of the individual that causes the partial contraction of the sphincter that controls bladder or intestinal excretion. In some embodiments, the sensor electrode is positioned in the pelvis of the individual. In some embodiments, the stimulator electrode provides electrical stimulation to the pudendal nerve. In some embodiments, the sensor electrode and the stimulator electrode are located on a single lead. In some embodiments, the stimulator electrode is configured to provide constant electrical stimulation at an intensity level lower than the electrical stimulation provided to prevent the onset of incontinence. In some embodiments, the onset of incontinence is urinary incontinence and is an urge incontinence type. In some embodiments, the intensity or duration of the electrical stimulation varies according to the sensed reaction. In some embodiments, the reaction sensed by the sensor electrode itself is not enough to prevent the onset of incontinence, and the electrical stimulation provided is added together with the reaction to prevent the onset 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 increase or improvement of the subject's tolerance provides tolerance to a higher intensity stimulation signal. In some embodiments, the sensor electrodes are configured to sense 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 strength of the EMG signal is proportional to the strength of the contraction of at least one pelvic muscle.In some embodiments, the stimulator electrode comprises a first stimulator electrode and a second stimulator electrode, wherein the first stimulator electrode stimulates the first pudendal nerve and the second stimulator electrode stimulates the second pudendal nerve. In some embodiments, the individual suffers from mixed type urinary incontinence. In some embodiments, the sensor electrodes are calibrated by the individual using an external input device that interfaces with the software. In some embodiments, the software is configured to further cause the processor to record signals from the sensor electrodes. In some embodiments, the software is configured to adjust the sensor electrodes in response to the signals.

[0010] Aspects of the present disclosure provide a non-transitory computer-readable storage medium including software for preventing the onset of incontinence in an individual in need, the software being configured to cause a processor to: (i) receive, via sensor electrodes, parameters associated with a response from the individual intended to prevent the onset of incontinence; (ii) analyze parameters associated with a response from the individual intended to prevent the onset of incontinence; and (iii) cause a stimulator electrode to provide electrical stimulation to the individual, such that the electrical stimulation, together with the response from the individual intended to prevent the onset of incontinence, prevents the onset of incontinence. In some embodiments, the software includes analyzing a global positioning system (GPS) location of the individual, the global positioning system (GPS) location being combined with parameters associated with a response from the individual intended to prevent the onset of incontinence. In some embodiments, the onset of incontinence includes urinary incontinence. In some embodiments, the onset of incontinence includes fecal incontinence. In some embodiments, the onset of incontinence includes urinary stress incontinence. In some embodiments, the sensor electrodes are configured to sense contractions of muscles of the individual that cause partial contractions of a sphincter that controls bladder or intestinal discharge. In some embodiments, the sensor electrodes, stimulator electrodes, or any combination thereof are positioned in, near, or around the pelvis of the individual. In some embodiments, the stimulator electrode provides electrical stimulation to the pudendal nerve. In some embodiments, the sensor electrode and the stimulator electrode are located on a single lead. In some embodiments, the stimulator electrode is configured to provide a constant electrical stimulation of a lower intensity level than the electrical stimulation provided to prevent the onset of incontinence. In some embodiments, the onset of incontinence is urinary incontinence and is an urge incontinence type. In some embodiments, the intensity or duration of the electrical stimulation varies according to the sensed reaction. In some embodiments, the reaction sensed by the sensor electrode itself is not enough to prevent the onset of incontinence, and the electrical stimulation provided is just enough to prevent the onset of incontinence together with the reaction. In some embodiments, the reaction sensed by the sensor electrode itself may not be enough to prevent the onset of incontinence, and the electrical stimulation provided prevents the onset of incontinence together with the reaction. In some embodiments, the sensor electrode may be configured to sense an EMG signal. In some embodiments, the EMG signal can determine that the contraction of at least one pelvic muscle has occurred. In some embodiments, the intensity of the EMG signal can be proportional to the intensity of the contraction of at least one pelvic muscle. In some embodiments, the stimulator electrode may include a first stimulator electrode and a second stimulator electrode, wherein the first stimulator electrode can stimulate the first pudendal nerve, and the second stimulator electrode can stimulate another part of the pudendal nerve. In some embodiments, a first stimulator electrode can stimulate one pudendal nerve, while a second stimulator electrode can stimulate another spatially separate region of the same pudendal nerve. In some embodiments, a first stimulator electrode can stimulate the trunk of the pudendal nerve, while a second stimulator electrode can 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 stimulator electrode can stimulate the trunk of the pudendal nerve, and the second stimulator electrode can stimulate the main branch of the pudendal nerve (e.g., the dorsal genital nerve). In some embodiments, the individual suffers from mixed type urinary incontinence. In some embodiments, the sensor electrodes are calibrated by the individual using an external input device that interfaces with the software. In some embodiments, the software is configured to further cause the processor to record signals from the sensor electrodes. In some embodiments, the software is configured to adjust the sensor electrodes in response to the signals.

[0011] Aspects of the present disclosure provide a device for preventing the onset of incontinence in an individual in need thereof, the device comprising: (a) a sensor electrode configured to sense a parameter associated with a response from the individual intended to prevent the onset of incontinence; a stimulator electrode configured to provide electrical stimulation; and a processor operably coupled to the sensor electrode and the stimulator electrode. In some embodiments, the onset of incontinence comprises urinary incontinence. In some embodiments, the onset of incontinence comprises fecal incontinence. In some embodiments, the onset of incontinence comprises urinary stress incontinence. In some embodiments, the sensor electrode is configured to sense a contraction of a muscle of the individual that causes a partial contraction of a sphincter that controls bladder or bowel discharge. In some embodiments, the sensor electrode is positioned within the pelvis of the individual. In some embodiments, the stimulator electrode provides electrical stimulation to the pudendal nerve. In some embodiments, the stimulator electrode is configured to provide constant electrical stimulation at a lower intensity level than the electrical stimulation provided to prevent the onset of incontinence. In some embodiments, the onset of incontinence is urinary incontinence and is of the urge incontinence type. In some embodiments, the intensity or duration of the electrical stimulation varies according to the sensed response. In some embodiments, the sensed reaction itself is not enough to prevent the onset of incontinence, and the electrical stimulation provided is just enough to prevent the onset of incontinence together with the reaction. In some embodiments, the sensed reaction itself is not enough to prevent the onset of incontinence, and the electrical stimulation provided together with the reaction prevents the onset of incontinence. In some embodiments, the sensor electrode is configured to sense an EMG signal, an electrocardiogram (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 at least one pelvic muscle. In some embodiments, the stimulator electrode includes a first stimulator electrode and a second stimulator electrode, wherein the first stimulator electrode stimulates the first pudendal nerve and the second stimulator electrode stimulates the second pudendal nerve. In some embodiments, the individual suffers from mixed types of urinary incontinence. In some embodiments, the device also includes a non-transitory computer-readable medium, which includes software. In some embodiments, the sensor electrode is calibrated by an individual using an external input device that interfaces 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.

[0012] Aspects of the present disclosure provide a data processing method, the method comprising: (i) receiving a measurement of a parameter previously measured by a sensor electrode, the parameter predicting the onset of incontinence in an 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 a stimulator electrode, the electrical stimulation signal, together with an effort from the individual to prevent the onset of incontinence, prevents the onset of incontinence. In some embodiments, the parameter is associated with a response from the individual to prevent the onset of incontinence. In some embodiments, the parameter is associated with an effort by the individual to try to prevent the onset of incontinence, and wherein the electrical stimulation signal is synthesized such that the effort of the individual is supplemented with an electrical stimulation pattern that, together with the effort of the individual, will be sufficient to prevent the onset of incontinence. In some embodiments, the response from the individual is not sufficient in itself to prevent the onset of incontinence, and the electrical stimulation signal is such that when applied, it plus the response is sufficient to prevent the onset of incontinence. In some embodiments, the onset of incontinence includes urinary incontinence. In some embodiments, the onset of incontinence includes fecal incontinence. In some embodiments, the onset of incontinence includes urinary stress incontinence. In some embodiments, the parameter is a signal from a sensor electrode configured to sense a contraction of a muscle associated with a partial contraction of a sphincter controlling bladder or bowel discharge of an individual. In some embodiments, the electrical stimulation signal is used for electrical stimulation of the pudendal nerve. In some embodiments, the electrical stimulation signal is synthesized to include a constant electrical stimulation component and a component specific to the measured parameter. In some embodiments, the onset of incontinence is urinary incontinence and is an urge incontinence type. In some embodiments, the intensity or duration of the electrical stimulation provided by the electrical stimulation signal varies according to the value of the received parameter. In some embodiments, the parameter is 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 at least one pelvic muscle. In some embodiments, the electrical stimulation signal includes a first signal 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 electrode. In some embodiments, the method further includes synthesizing an adjustment signal to adjust the sensor electrode in response to the recorded signal. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The novel features of the present invention are particularly set forth in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by referring to the following detailed description and the accompanying drawings, which set forth exemplary embodiments utilizing the principles of the present invention, wherein:

[0014] Figure 1An exemplary embodiment of an open-loop bioelectronic system including an implantable pulse generator is shown. The system provides a predefined stimulation protocol and receives no input from the subject.

[0015] Figure 2 An exemplary embodiment of a closed-loop bioelectronic system is shown, which includes a bidirectional neural interface including sensor electrodes that capture a subject's neural responses and a processing module capable of interpreting the neural responses. The system is capable of providing adapted stimulation based on the neural responses.

[0016] Figure 3 An exemplary embodiment of the apparatus and method described herein for targeting the pudendal nerve by placing sensor electrodes and stimulator electrodes near the pudendal nerve is shown. The sensor electrodes capture biosignals to classify any stress events, and the stimulator electrodes provide pressure electrical stimulation ("biosimulator") adjusted from the basal stimulation to account for stress events to act on the target sphincter.

[0017] Figure 4 An exemplary embodiment depicting biosignals and biostimulator electrical stimulation is shown. The biosignals captured by the sensor electrodes are analyzed and classified to identify any stressful events (e.g., coughing or sudden movements) from the electromyogram (EMG) signals. The stimulator electrodes provide a biosimulator, an electrical stimulation based on a base stimulus that is adjusted to account for stressful events.

[0018] Figure 5 An exemplary embodiment of a system block diagram of the apparatus and method described herein configured to implement the slow and fast adaptive algorithms is shown. API is an application programming interface (API); MICS is a Medical Information and Communication band (MICS).

[0019] Figure 6A-6B A flow chart illustrating a method of closed-loop operation of the apparatus of the present disclosure.

[0020] Figure 7A-7B An exemplary embodiment of a patient controller module as described in some embodiments herein is shown.

[0021] Figure 8 A flow chart showing purposeful patient contraction and manual operation of the devices and systems as described in some embodiments herein.

[0022] Fig. 9 A flow chart illustrating the operation of a closed loop system as described in some embodiments herein is shown.

[0023] Fig.10 A flow chart is shown for signal processing and threshold detection of incontinence events as described in some embodiments herein.

[0024] Figures 11A-11E Patient purposeful muscle contraction, Valsalva maneuver, and cough EMG data acquired and processed using the methods of the present disclosure as described in some embodiments herein are shown.

[0025] Figures 12A-12B A flow chart is shown for detecting purposeful or intention-based contractions of a patient and providing electrical stimulation to prevent an incontinence event as described in some embodiments herein.

[0026] Fig.13 A flow chart is shown for training an on-board machine learning classifier for the devices and systems of the present disclosure as described in some embodiments herein. DETAILED DESCRIPTION

[0027] Lack of voluntary control over urination or defecation, known as urinary incontinence and fecal incontinence, respectively, is a problem that can affect quality of life and lead to social embarrassment. Urinary and fecal incontinence can affect individuals of all ages. In some cases, older individuals may present with a greater prevalence of incontinence, with different pathophysiologies. Both urinary and fecal incontinence may involve damage, weakness, or overactivity of the pelvic floor muscles, which include but are not limited to the urethral sphincter and anal sphincter, and the nerves that innervate these muscles and associated organs such as the bladder, rectum, or anus.

[0028] 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. Individuals with urge incontinence have a strong and sudden need to urinate immediately, which often does not allow them enough time to go to the bathroom. Stress incontinence is often due to poor urethral sphincter function or excessive urethral movement or bladder neck movement. Individuals may experience stress incontinence during activities such as coughing, sneezing, laughing, or exercising. Overflow incontinence may often be due to poor bladder contraction or urethral obstruction. Mixed incontinence may include features of stress and urge incontinence. Incontinence often involves neurological problems, including but not limited to impaired nerve conduction between the brain and / or affected muscles, as well as neurological conditions or injuries (such as multiple sclerosis or stroke) or mental confusion. Other causes of incontinence include but are not limited to weakness of the pelvic or urethral muscles and pelvic prolapse.

[0029] Fecal incontinence, also known as bowel incontinence, is a loss of bowel control that causes an individual to accidentally pass stool from the rectum. Fecal incontinence can be divided into two main types: urge incontinence, passive incontinence, or a combination. Urge incontinence is caused by an overactive bowel. Individuals with urge incontinence have a strong and sudden need to pass a bowel movement immediately, which often does not allow them enough time to go to the bathroom. Passive incontinence is when an individual feels no urge to open their bowels despite the rectum being full and ready to pass stool. Individuals with passive incontinence are unable to consciously control their bowel movements, and stool can pass without them knowing it. Incontinence often involves neurological problems, including but not limited to impaired nerve conduction between the brain and / or affected muscles, as well as neurological conditions or injuries (such as 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.

[0030] Electro galvanic stimulation has been used to treat incontinence by training the pelvic floor muscles to improve strength and function and / or by stimulating the sacral nerves to improve urinary and fecal control. However, these electro-nerve stimulation methods cannot adapt to the subject's condition and environment and can only provide predefined stimulation protocols. This can result in over-stimulation or under-stimulation of the target area, resulting in insufficient control of the muscles involved in urination or defecation. Therefore, it would be beneficial to be able to provide electro-stimulation that takes into account the subject's condition and adjusts the stimulation level accordingly.

[0031] Provided herein is a device, system and method for preventing and / or reducing the severity of an episode of incontinence in an individual in need thereof. In some cases, an episode of incontinence may include urinary incontinence, fecal incontinence, or any combination thereof. The devices, systems and methods disclosed herein may treat subtypes of incontinence. In some cases, subtypes of incontinence may include urge incontinence, stress incontinence, overflow incontinence, or mixed incontinence.

[0032] In some cases, the devices, systems and methods described herein can increase bladder capacity. Bladder capacity can be measured as the maximum volume of liquid that the bladder can hold 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 milliliters. In some cases, bladder capacity can be measured by ultrasound calculation 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 to this, bladder capacity can be measured by cytometry, in which a catheter is inserted into the subject's urethra to fill, and urine volume can be measured. In some cases, the subject's bladder capacity may be reduced due to disease. In some cases, the devices and systems described herein can increase bladder capacity by one percentage point from baseline bladder capacity. In some cases, bladder capacity can be increased by providing electrical stimulation to the patient through the stimulator electrode leads described herein. In some cases, the stimulator can provide electrical stimulation of a frequency or pulse width as described elsewhere herein.

[0033] In some cases, the bladder capacity can be increased using an open loop or closed loop system as described elsewhere herein. In some cases, the bladder capacity can be increased by about 5% to about 75%. In some cases, the 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 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 0% 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 35%, about 30% to about 40%, about 30% to about 45%, about 30% to about 50%, about 30% to about In some cases, bladder capacity can 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%, about 75%, about 40% to 45%, about 40% to 50%, about 40% to 70%, about 40% to 75%, about 45% to 50%, about 45% to 70%, about 45% to 75%, about 50% to 70%, about 50% to 75%, or about 70% to 75%. In some cases, bladder capacity can 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%. In some cases, bladder capacity can be increased by at least about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, or about 70%. In some cases, bladder capacity can be increased by at most about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 70%, or about 75%.

[0034] In some cases, the devices, systems and methods described herein can increase urethral closure pressure. In some cases, urethral closure pressure can be represented by a pressure curve. In some cases, urethral closure pressure can be described as an integrated pressure curve measured from the entire length of the subject's urethra. In some cases, urethral closure pressure can be measured by slowly withdrawing a pressure measurement catheter from the subject's urethra at a constant rate. In some cases, urethral closure pressure can be measured by a transurethral pressure curve (profile) catheter. In some cases, 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, one or more nerves can include pudendal nerves, sacral nerves or any combination thereof or their branches. In some cases, the stimulator described elsewhere herein can provide electrical stimulation at the subject's nerves via stimulator electrode leads with the frequency and / or frequency range described elsewhere herein to increase urethral closure pressure. In some cases, urethral closure pressure can include about 10 centimeters of water (cm H2O) to about 75cm H2O. In some cases, the urethral closure pressure may include about 10 cm H2O to about 15 cm H2O, about 10 cm H2O to about 20 cm H2O, about 10 cm H2O to about 25 cm H2O, about 10 cm H2O to about 30 cm H2O, about 10 cm H2O to about 35 cm H2O, about 10 cm H2O to about 40 cm H2O, about 10 cm H2O to about 45 cm H2O, about 10 cm H2O to about 50 cm H2O, about 10 cm H2O to about 60 cm H2O, about 10 cm H2O to about 70 cm H2O, about 10 cm H2O to about 75 cm H2O, about 15 cm H2O to about 20 cm H2O, about 15 cm H2O to about 25 cm H2O, about 15 cm H2O to about 30 cm H2O, about 15 cm H2O to about 35 cm H2O, about 15 cm H2O to about 40 cm H2O, about 10 cm H2O to about 45 cm H2O, about 10 cm H2O to about 50 cm H2O, about 10 cm H2O to about 60 cm H2O, about 10 cm H2O to about 70 cm H2O, about 10 cm H2O to about 75 cm H2O, about 15 cm H2O to about 20 cm H2O, about 15 cm H2O to about 25 cm H2O, about 15 cm H2O to about 30 cm H2O, about 15 cm H2O to about 35 cm H2O, about 15 cm H2O to about 40 cm H2O, about 15 cm H2O to about 45 cm H2O, about 15 cm H2O to about 50 cm H2O, about 15 cm H2O to about 60 cm H2O, about 15 cm H2O to about 70 cm H2O, about 15 cm H2O to about 75 cm H2O, about 20 cm H2O to about 25 cm H2O, about 20 cm H2O to about 30 cm H2O, about 20 cm H2O to about 35 cm H2O, about 20 cm H2O to about 40 cm H2O, about 20 cm H2O to about 45 cm H2O, about 20 cm H2O to about 50 cm H2O, about 20 cm H2O to about 60 cm H2O, about 20 cm H2O to aboutH2O to about 70cmH2O, about 20cmH2O to about 75cmH2O, about 25cmH2O to about 30cmH2O, about 25mH2O to about 35cmH2O, about 25cmH2O to about 40cmH2O, about 25cmH2O to about 45cmH2O, about 25cmH2O to about 50cmH2O, about 25cmH2O to about 60cmH2O, about 25cmH2O to about 70cmH2O, about 25cmH2O to 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 70cmH2O, about 30cmH2O to about H2O to about 75cm H2O, about 35cm H2O to about 40cm H2O, about 35cm H2O to about 45cm H2O, about 35cm H2O to about 50cm H2O, about 35cm H2O to about 60cm H2O, about 35cm H2O to about 70cm H2O, about 35cm H2O to about 75cm H2O, about 40cm H2O to about 45cm H2O, about 40cm H2O to about 50cm H2O, about 40cm H2O to about 60cm H2O, about 40cm H2O to about 70cm H2O, about 40cm H2O to about 75cm H2O, about 45cm H2O to about 50cm H2O, about 45cm H2O to about 60cm H2O, about 45cm H2O to about 70cm H2O, about 45cm H2O to about 75cm H2O, about 50cm H2O HO to about 60 cm HO, about 50 cm HO to about 70 cm HO, about 50 cm HO to about 75 cm HO, about 60 cm HO to about 70 cm HO, about 60 cm HO to about 75 cm HO, or about 70 cm HO to about 75 cm HO. In some cases, the urethral closure pressure may include about 10 cm HO, about 15 cm HO, about 20 cm HO, about 25 cm HO, about 30 cm HO, about 35 cm HO, about 40 cm HO, about 45 cm HO, about 50 cm HO, about 60 cm HO, about 70 cm HO, or about 75 cm HO. In some cases, the urethral closure pressure may include at least about 10 cm H2O, about 15 cm H2O, about 20 cm H2O, about 25 cm H2O, about 30 cm H2O, about 35 cm H2O, about 40 cm H2O, about 45 cm H2O, 50 cm H2O, 60 cm H2O, about 70 cm H2O, about 80 cm H2O, about 90 cm H2O, about 100 cm H2O, about 120 cm H2O, about 150 cm H2O, about 160 cm H2O, about 170 cm H2O, about 180 cm H2O, about 190 cm H2O, about 200 cm H2O, about 210 cm H2O, about 220 cm H2O, about 230 cm H2O, about 240 cm H2O, about 25H2O or 70 cm H2O. In some cases, the urethral closure pressure may include a maximum of about 15 cm H2O, about 20 cm H2O, about 25 cm H2O, about 30 cm H2O, about 35 cm H2O, about 40 cm H2O, about 45 cm H2O, about 50 cm H2O, about 60 cm H2O, about 70 cm H2O, or about 75 cm H2O.

[0035] The equipment and system described herein may include one or more sensor electrodes, one or more stimulator electrodes, processors, power supplies or any combination thereof. In some cases, one or more stimulator electrodes, one or more sensor electrodes, processors, power supplies or any combination thereof may be implanted in an individual body. In some cases, one or more stimulator electrodes, one or more sensor electrodes, processors, power supplies or any combination thereof may be placed superficially on the body of an individual. In some cases, processors, power supplies or any combination thereof may be implanted in an individual body. In some cases, the equipment may include a wireless transmission module that can be wirelessly transmitted and receive wireless data between a remote device (e.g., a mobile phone, a tablet computer, a computer, etc.) and an incontinence prevention device described herein. In some cases, the equipment may be implanted in an individual. Alternatively, the equipment may include a sealed connector that is placed on the skin surface of an individual and may be electrically connected to a remote device by a cable. In some cases, an individual may manually modify or change one or more sensor electrodes or one or more stimulator electrode parameters by a graphical user interface. In some cases, the equipment may automatically modify or change one or more sensor electrodes or one or more stimulator electrode parameters.

[0036] In some cases, the implanted sensor electrodes of the device may be configured to sense one or more parameters that may be associated with a reaction to an onset of incontinence or an attempt by an individual to prevent an onset of incontinence. In some cases, the parameters may include an electromyographic (EMG) signal that can predict the onset of incontinence. In some cases, the EMG signal may include the electrical activity of the muscle, particularly the action potential from the muscle fiber. In some cases, the parameters may include an electroneurogram (ENG). In some cases, the electroneurogram may include electrical activity from one or more neurons, and generally refers to the recordings made by bundled axons in 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 three-dimensional spatial direction. In some cases, the three-dimensional spatial direction may be determined by a GPS signal. In some cases, the GPS signal may indicate and identify when an individual is close to a location (e.g., an individual's home). In some cases, the GPS signal may be configured to modulate a stimulator as described elsewhere herein based on the GPS coordinates and / or GPS location of the subject. In some cases, modulating the stimulator can include adjusting the detection parameters (e.g., signal strength threshold) of the classifier as described elsewhere herein. In some cases, the GPS signal and / or GPS coordinates of the location can indicate the location and / or area to which the subject is directed, which may cause a higher risk of incontinence events. In some cases, the three-dimensional spatial direction can measure the posture of the individual. In some cases, the change in pressure can be measured by a pressure sensor. In some cases, the pressure sensor can include a differential pressure sensor, an absolute pressure sensor, or any combination thereof. In some cases, the change in speed, acceleration, or the change in three-dimensional spatial direction can be measured by an accelerometer, a gyroscope, a magnetometer, or any combination thereof. In some cases, the device can provide electrical stimulation using one or more implanted stimulator electrodes, which together with the individual's preventive response can prevent the onset of incontinence.

[0037] The devices, systems, and methods described herein can prevent and / or reduce the severity of incontinence events by detecting individual incontinence prevention parameters and adjusting the electrical stimulation of one or more stimulator electrodes based on the characteristics of the incontinence prevention parameters. In some cases, the incontinence prevention parameter characteristics may include changes in amplitude, frequency, phase, or any combination thereof, changes in one or more EMG, ENG, accelerometer, gyroscope, magnetometer, pressure sensor signals, or any combination thereof. In some cases, the incontinence prevention parameters may include individual body movements, one or more EMG signals, or any combination thereof. By providing adaptive electrical stimulation in conjunction with individual responses, the devices, systems, and methods described herein can prevent the onset of incontinence.

[0038] This article describes a device, system and method for preventing and / or reducing the severity of an individual's incontinence episode by providing adaptive electrical stimulation based on an individual's incontinence prevention parameters. The device can be implanted in an individual near the pudendal nerve, sacral nerve or their branches. In some cases, one or more stimulator electrodes of the device can be placed at or near the pudendal nerve or sacral nerve. In some cases, one or more stimulator electrodes or one or more sensor electrodes can be implanted near the pudendal nerve unilaterally or bilaterally. In some cases, one or more stimulator electrodes can be implanted to stimulate motor nerve fibers (e.g., to the pelvic floor and sphincter). Alternatively, one or more stimulator electrodes can be implanted in, near or adjacent to a muscle (e.g., the pelvic floor and sphincter). The sensor electrodes of the implanted device can sense a signal indicating that an individual may exhibit an episode of incontinence or attempt to prevent an episode of incontinence. The device can analyze the signal and classify the signal as a real-time or expected episode of incontinence. The device can generate modulated electrical stimulation based on the classified episode of incontinence, and the modulated electrical stimulation can be delivered to the target nerve using one or more stimulator electrodes. In some cases, modulation of the electrical stimulation of one or more stimulator electrodes may include changing the frequency of the electrical stimulation, changing the amplitude of the electrical stimulation, changing the electrical stimulation pulse width, changing the electrode configuration of the stimulator, or any combination thereof. In some cases, one or more electrodes may include one or more stimulator electrodes and one or more sensing electrodes. One or more stimulator electrodes and one or more sensing electrodes may be configured to switch between stimulation and sensing operations as needed, by programming, user control, medical individual control, or any combination thereof. Electrical stimulation may be modulated to improve muscle and / or nerve response to prevent the onset of incontinence. Modulated electrical stimulation may lead to improved muscle response, which is measured by reaction time, muscle function, or other markers of incontinence prevention to prevent the onset of potential incontinence. Electrical stimulation may be modulated to reduce the severity and / or duration of the onset of incontinence. For example, a subject exhibiting an urgency incontinence event (e.g., cough) may receive electrical stimulation provided by the device, system, and method provided herein in response to an incontinence attack. In some cases, electrical stimulation may reduce uncontrolled urination and / or defecation volume. In some cases, electrical stimulation can reduce the amount of uncontrolled urination and / or defecation, without completely preventing the onset of incontinence. In some cases, electrical stimulation can reduce the duration of an incontinence episode that would have occurred without electrical stimulation. In some cases, electrical stimulation can be configured to suppress reflex incontinence. In some cases, electrical stimulation can suppress bladder detrusor contractions experienced during reflex incontinence.

[0039] The electrical stimulation may include electrical stimulation provided over a period of time. In some cases, the period of time may include a period of time during which the subject may provide an intentional or purposeful muscle contraction to trigger an EMG threshold detection.

[0040] In some cases, the time period of electrical stimulation may include about 1 second to about 30 seconds. In some cases, the time period of electrical stimulation may include about 1 second to about 5 seconds, about 1 second to about 10 seconds, about 1 second to about 15 seconds, about 1 second to about 20 seconds, about 1 second to about 25 seconds, about 1 second to about 30 seconds, about 5 seconds to about 10 seconds, about 5 seconds to about 15 seconds, about 5 seconds to about 20 seconds, about 5 seconds to about 25 seconds, about 5 seconds to about 30 seconds, about 10 seconds to about 15 seconds, about 10 seconds to about 20 seconds, about 10 seconds to about 25 seconds, about 10 seconds to about 30 seconds, about 15 seconds to about 20 seconds, about 15 seconds to about 25 seconds, about 15 seconds to about 30 seconds, about 20 seconds to about 25 seconds, about 20 seconds to about 30 seconds, or about 25 seconds to about 30 seconds. In some cases, the time period 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 time period of electrical stimulation can 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 time period of electrical stimulation can include up to about 5 seconds, about 10 seconds, about 15 seconds, about 20 seconds, about 25 seconds, or about 30 seconds.

[0041] Embodiments of devices for treating and preventing incontinence

[0042] The present disclosure describes a device for preventing the onset of incontinence, which includes one or more sensor electrodes, one or more stimulator electrodes, an electrical stimulator, or any combination thereof. In some cases, the electrical stimulator may include a processor, a memory, a user interface, a power supply, or any combination thereof for preventing the onset of incontinence. The device may be implantable. The surgical procedure for implanting the device may be performed under conscious sedation, general anesthesia, local anesthesia, morning twilight anesthesia, or any combination thereof. The device may be implanted in whole or in part in the pelvic region of an individual. In some cases, the device may be implanted by one or more surgical instruments. In some cases, the surgical instrument may include an introducer, a sheath, a directable probe, a wire, a needle, or any combination thereof.

[0043] In some cases, the device may further include a transmitter electrically connected to the processor, and the processor may be capable of wirelessly sending and receiving data from a remote device (such as a mobile phone, a tablet computer, or a computer). In some cases, the device may be configured for an open loop configuration. In some cases, the device may be configured as a closed loop configuration or a feedback control configuration. The device described herein may be used to prevent the onset of urinary incontinence. In some cases, urinary incontinence may include urge incontinence, stress incontinence, overflow incontinence, mixed incontinence, or any combination thereof. In some embodiments, the onset of incontinence is urinary incontinence and is an urge incontinence type. In some cases, the device described herein may be used to prevent the onset of fecal incontinence.

[0044] Open loop configuration

[0045] Figure 1 An open-loop configuration of the device described herein is shown for preventing the onset of incontinence in an individual 110. The device in the open-loop configuration may include an implantable pulse generator 102 and a power source, the implantable pulse generator 102 including one or more stimulator electrodes 106. In some cases, the implantable pulse generator 102 may include a processor and a wireless transmission module, the wireless transmission module being configured to execute software to manage 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 via an inductive charger. Alternatively, the battery power source may be disposable.

[0046] The implantable pulse generator 102 can provide a predefined electrical stimulation pattern 104 set by a healthcare provider on a remote device 100 (e.g., a mobile phone, tablet computer, etc.) and wirelessly transmitted 105 to the implantable pulse generator 102. Alternatively, the implantable pulse generator 102 can provide a predefined electrical stimulation pattern 104 set by a healthcare provider on a remote computer device 100 (e.g., a mobile phone, tablet computer, etc.) and transmitted to the implantable pulse generator 102 via wired communication 101. In some cases, the healthcare provider can set the predefined electrical stimulation parameters through a graphical user interface on the remote device. In some cases, the individual 110 with the implantable pulse generator 102 can modify or set the electrical stimulation parameters via an external input device 103 (e.g., a mobile phone, tablet computer, etc.) via wireless communication 105 of the implantable pulse generator 102. Alternatively, the individual 110 with the implantable pulse generator 102 can modify or set the electrical stimulation parameters via an external input device 103 via wired communication 107 of the implantable pulse generator 102. In some cases, individual 110 with implanted pulse generator 102 can adjust electrical stimulation pattern 104 using a graphical user interface on external input device 103. In some cases, electrical stimulation pattern 104 parameters that can be adjusted include frequency, amplitude, pulse width, or any combination thereof.

[0047] Closed loop configuration

[0048] Figure 2A closed-loop configuration of a device described herein configured to prevent the onset of incontinence of an individual 126 is shown. The device in the closed-loop configuration may include an implantable pulse generator 118, one or more stimulator electrodes 122, one or more sensor electrodes 120, and a power source. In some cases, the implantable pulse generator 118 may include a processor and a wireless transmission module, and the wireless transmission module is configured to execute software to detect, analyze myoelectric (EMG) signals and manage electrical stimulation patterns 124 via one or more sensor electrodes 120. In some cases, the power source may include a battery. The battery may be rechargeable or disposable. In some cases, the battery may be charged by inductive charging. In some cases, a device configured as a closed-loop configuration may measure EMG signals via one or more sensor electrodes 120 to detect the onset of a stress incontinence event or the level of innate myoelectric activity. In some cases, a device configured as a closed-loop configuration may measure inertial signals (e.g., rapid acceleration, shock, posture 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 myoelectric activity. In some cases, stress incontinence events may include actions such as coughing, sneezing, laughing, or exercising. Once detected, implantable pulse generator 118 may provide electrical stimulation pattern 124 to prevent urination or uncontrolled bowel movements. In some cases, the threshold level for detecting stress incontinence events may be modified and adjusted by individual 126 via a graphical user interface on external input device 114 or via wireless communication 113 or wired connection 115.

[0049] In some embodiments, a closed-loop configuration of the systems and methods described herein may include a fully synchronized system, such as Fig. 9 As shown. In some cases, electrodes 902 including sensor and / or stimulator electrodes can detect EMG, ENG, and / or pressure signals through circuit 904 (e.g., analog-to-digital circuit), and the detected signals can then be passed to a classifier algorithm 906. Once the classifier algorithm 906 has classified the detected EMG, ENG, and / or pressure signals as an incontinence event, the classifier can enable electrical stimulation 908 to be delivered to the patient. Fig. 9 As shown, electrical stimulation may be provided by the same electrodes 902 from which the EMG and / or ENG signals were initially sensed.

[0050] In some embodiments, the closed-loop configuration of the device described herein can be configured to detect the efforts made by an individual in an attempt to prevent the onset of incontinence. In some cases, the methods and systems described herein can supplement the patient's efforts with an electrical stimulation pattern sufficient to prevent urination or defecation via one or more stimulator electrodes 122. In some cases, the individual's efforts can include signals of EMG, ENG, pressure, acceleration, gyroscope, magnetometer, three-dimensional space, or any combination thereof at a threshold. In some cases, the threshold electromyographic signal can be detected by one or more sensor electrodes 120. In some cases, supplementary stimulation can include a stimulation signal provided by a stimulator electrode as described elsewhere herein, the stimulation signal having parameters (e.g., frequency, pulse width, and / or amplitude) so as to combine with the individual's efforts detected to prevent the onset of incontinence (e.g., urination and / or defecation). In some cases, supplementary stimulation can include a stimulation signal provided by a stimulator electrode, the stimulation signal having parameters (e.g., frequency, pulse width, and / or amplitude) to prevent the onset of incontinence in response to detecting a stress incontinence event. In some cases, a stress incontinence event may include an action (e.g., coughing, sneezing, laughing, or exercising) that may be detected by, for example, a gyroscope, accelerometer, and / or magnetometer as described elsewhere herein. In some cases, one or more parameters of the supplemental stimulation may be determined on an individual subject basis and / or on a large population of subjects with similar incontinence presentations. For example, given a subject's supplemental stimulation, one or more parameters may be adjusted and / or determined by a user interface of a device and system as described elsewhere herein based on whether such a supplemental stimulation signal prevents the onset of incontinence in real time or after an incontinence event. In some cases, given a subject's supplemental stimulation, one or more parameters may be adjusted to values ​​and / or parameters found in subjects with similar clinical presentations to prevent incontinence events (e.g., age, type of incontinence, frequency of incontinence events, other subject clinical metadata, etc.).

[0051] In some cases, the systems and methods described herein may include systems and methods configured to provide electrical stimulation based on purposeful muscle contraction and / or movement of a subject and / or patient to prevent an incontinence event, such as Figure 8As shown. In some cases, the subject and / or patient 814, upon realizing that they may exhibit an incontinence event, may induce movement and / or contraction of one or more muscles or muscle groups to trigger a signal 818 of EMG, ENG, pressure, acceleration, gyroscope, magnetometer, three-dimensional space, or any combination thereof. In some cases, the induced movement and / or contraction of one or more muscle groups may be amplified 808, classified (by a classifier) ​​806, by a control logic algorithm 804, and used as a trigger 820 to enable treatment and corresponding stimulation pattern parameters of the basic 802 and / or active 801 as described elsewhere herein to flow through the stimulator 810 and the neural interface 812 to prevent incontinence events. 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 may manually 816 enable electrical stimulation to be provided via a button on the patient controller module 156 as described elsewhere herein.

[0052] In some cases, the detection threshold of the implantable pulse generator 118 (i.e., stimulator) can be modified and adjusted via a graphical user interface on the external input device 114. The external input device 114 is capable of modifying and adjusting the threshold of the implantable pulse generator 118 via wireless communication 113 or wired connection 115. In some cases, the threshold of the implantable pulse generator can be adjusted via a healthcare provider on a remote computing device 112 (e.g., a mobile phone, tablet, computer, etc.) and transmitted to the implantable pulse generator 118 via wired communication 116. Alternatively, the threshold of the implantable pulse generator can be adjusted via a healthcare provider on a remote computing device 112 (e.g., a mobile phone, tablet, computer, etc.) and transmitted to the implantable pulse generator 118 via wireless communication 113. In some cases, the threshold of the implantable pulse generator can be adjusted via the individual 110 on a remote computing device 112 (e.g., a mobile phone, tablet, computer, etc.) and transmitted to the implantable pulse generator 118 via wired communication 116. Alternatively, the threshold of the implantable pulse generator may be adjusted by the individual 110 on a remote computing device 112 (eg, a mobile phone, tablet, computer, etc.) and transmitted to the implantable pulse generator 118 via wireless communication 113 .

[0053] In some cases, the electrical stimulation pattern 124 provided via one or more stimulator electrodes 122 can be adjusted and adjusted by the detected threshold level to supplement the individual's efforts to prevent the onset of incontinence. In some cases, the adjusted electrical stimulation pattern 124 can be determined by mapping the detectable physiological signal representing the effort and the provided electrical stimulation pattern 124 through a piecewise linear mapping, a linear mapping, an S-shaped mapping, or any variation thereof. The electrical stimulation pattern 124 can be adjusted by modifying or changing the electrical stimulation pattern parameters including frequency, pulse width, and amplitude. In some cases, the electrical stimulation pattern parameters of the implantable pulse generator 118 can be modified and adjusted via a graphical user interface on an external input device 114. The external input device 114 is capable of modifying and adjusting the electrical stimulation pattern parameters of the implantable pulse generator 118 via wireless communication 113 or a wired connection 115. In some cases, the electrical stimulation pattern parameters of the implantable pulse generator 118 can be adjusted by a healthcare provider on a remote computing device 112 (e.g., a mobile phone, a tablet computer, a 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 can be adjusted via a healthcare provider on a remote computing device 112 (e.g., a mobile 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 can be adjusted based on input from the individual 126 by a machine learning model executed by a processor of the implantable pulse generator 118. In some cases, the machine learning model can be configured to determine whether the subject is at risk of unwanted urination and / or defecation based on muscle EMG signals detected by one or more sensor electrodes. In some cases, the machine learning model can be trained to determine whether the individual's efforts exist, as described elsewhere herein. For example, the machine learning model can be trained with one or more EMG signal features of the subject's muscle contraction (particularly EMG signals that cause unwanted urination and / or defecation).

[0054] In some embodiments, electrical stimulation pattern parameters (e.g., frequency, amplitude, etc.) as described elsewhere herein may be set or determined by a stimulation machine learning model. 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 a stimulation pattern that is indicated by a user of the device and system described elsewhere herein as suppressing incontinence events of a particular type and / or subtype of incontinence. In some cases, the stimulation machine learning model may be trained with a patient incontinence type. The stimulation machine learning algorithm may be trained in a cloud computing network and / or server that communicates with an implanted device and a user device, as described elsewhere herein, and redistributed or downloaded to one or more users and / or patients. In fact, users and / or patients may update and / or download new updates to the software of the device and system described herein. This aspect of the invention described herein provides the unexpected result of patient-specific and optimized electrical stimulation signals that cannot be achieved with conventional stimulators.

[0055] One or more machine learning algorithms can be used to construct a machine learning model, such as a support vector machine that deploys stepwise backward parameter selection and / or a graphical model, both of which can have the advantage of inferring the interaction between parameters. For example, a machine learning algorithm or other statistical algorithm can be used, such as alternating decision trees (ADTree), decision trees, functional 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 using spline functions (e.g., gamSpline), glmnet, multivariate adaptive regression splines (splint) (earth), neural networks, k-means clustering, or any machine learning algorithm or statistical algorithm known in the art. One or more algorithms may be used together to generate an ensemble method, wherein the ensemble method may be optimized using a machine learning ensemble meta-algorithm, such as a boosting method (e.g., AdaBoost, LPBoost, TotalBoost, BrownBoost, MadaBoost, and LogitBoost, etc.) to reduce bias and / or variance.

[0056] In some embodiments, the machine learning algorithm may include a restricted machine learning algorithm configured to run on a microprocessor. In some cases, the machine learning algorithm may include a machine learning algorithm operating within a TinyML framework. In some cases, the machine learning algorithm described elsewhere herein may be trained offline. Offline training may be completed on a server, cloud, or other dedicated computing cluster. In some cases, the offline trained machine learning algorithm may then be downloaded, deployed, and / or imported into the device to iteratively improve the performance of the device and system in preventing incontinence events.

[0057] A person of ordinary skill will appreciate that such an offline training structure is feasible and implemented in related but different implementations. For example, this machine learning architecture can be used to perform "wake-up word" text classification commonly found in smartphone devices (e.g., "Hey, Siri", "OK, Google", etc.). In some cases, the machine learning algorithms described herein can operate within a framework similar to a "wake-up word" voice machine learning classifier. In some cases, the machine learning algorithms described herein can operate based on processing power and storage allocations determined to be sufficient to "wake up" a voice machine learning classifier.

[0058] In some cases, the software described elsewhere herein can be executed by a processor located on an implanted stimulator. In some cases, the software located on the implanted stimulator can utilize the TinyML constraint machine learning model to adapt the processing and memory parameters of the implanted stimulator. In some cases, the software can be executed offline on cloud-based computing and / or dedicated computing clusters. In some cases, the offline processing workflow can include high-speed (Bluetooth, Wi-Fi, medical implant communication system, etc.) data transmission between the implanted stimulator and a local individual computing device (smart phone, tablet computer, laptop computer, etc.). Then, the individual processing device can transfer the implanted stimulator data to one or more clouds and / or computer clusters, and then the result output, command and / or notification are sent back to the device. In some cases, commands and / or notifications can include warnings, alarms, the start of electrical stimulation, or any combination thereof. In some cases, a command can include the output of a machine learning classifier configured to determine the threshold intensity of an EMG and / or ENG signal indicating an incontinence event.

[0059] The machine learning model can be trained on one or more data sets. In some cases, the one or more data sets may include data generated by users and / or subjects, or data generated by a group or a fragment thereof. In some cases, the subject-generated data and / or the group-generated data may include effort signals, stimulation signals indicating incontinence events and preventing incontinence events, respectively. In some cases, the devices, systems, and corresponding methods described herein may record user data and / or user input when interacting with the systems and devices described elsewhere herein. In some cases, the data may include sensors such as EMG, ENG, accelerometer, gyroscope, or any combination thereof that are user-marked as described elsewhere herein that lead to incontinence events. In some cases, these signals can be obtained from the device 1302 and used to characterize 1304 and train the machine learning classifier 1306, such as Fig.13 As shown. In some cases, a trained machine learning classifier trained on one or more data sets can then be downloaded to each patient's device 1308 to further improve the accuracy of the machine learning classifier. In some cases, the machine learning model can be configured to sense the subject's efforts and / or provide sufficient stimulation based on the parameters of frequency, amplitude and / or pulse width, as described elsewhere herein. In some cases, one or more individual data sets can be pooled together as a training data set, in which the subject shows features of similarities between the parameters of clinical manifestations and excitement / sensory input. In some cases, clinical manifestations can include clinical incontinence types, subject clinical metadata (e.g., sex, age, past medical history, current medications, past surgical interventions, etc.). In some cases, during the initial stage of training the device implanted in the subject, a pooled training data set can be used for the individual.

[0060] In some cases, one or more machine learning models as described elsewhere herein can be trained based on raw and / or processed signals measured by the devices, sensors, and systems described elsewhere herein. In some cases, the processed signal can include the raw signal that has been filtered to optimize the signal-to-noise ratio of the raw signal. In some cases, the filter can include a high pass, low pass, band pass, notch, or any combination thereof. In some cases, one or more machine learning models can alternatively or additionally be trained based on user feedback about previous stimulation signal parameters and whether such stimulation signal parameters prevented incontinence events.

[0061] In some aspects, the present disclosure provides a method of processing a detected signal 1001, as described elsewhere herein, to determine an incontinence event precursor signal strength threshold, such as Fig.10In some cases, a signal 1000 of an EMG, ENG, accelerometer, gyroscope, magnetometer, pressure sensor, or any combination thereof can be detected by an amplifier circuit 1002. In some cases, the amplifier circuit can include an operational amplifier circuit.

[0062] In some cases, the amplifier circuit can be configured to amplify signals from about 10 microvolts (μV) to about 1000 μV. In some examples, the amplifier circuit can be configured to increase the voltage 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 to about 150 μV, about 50 μV to about 300 μV, about 50 μV to about 500 μV, about 50 μV to about 700 μV, about 50 μV to about 900 μV, about 50 μV to about 1000 μV, about 100 μV to about 150 μV, about 100 μV to about 300 μV, about 100 μV to about 500 μV, about 100 μV to about 700 μV, about 100 μV to about 900 μV, about 100 μV to about 1000 μV, about 150 μV to about 300 μV, about 150 μV to about 500 μV, about 150 μV to about 700 μV, about 150 μV to about 900 μV, about 150 μV to about 1000 μV, about 300 μV to about 500 μV, about 300 μV to about 700 μV, about 300 μV to about 900 μV, about 300 μV to about 1000 μV, about 500 μV to about 700 μV, about 500 μV to about 900 μV, about 500 μV to about 1000 μV, about 700 μV to about 900 μV, about 700 μV to about 1000 μV, or about 900 μV to about 1000 μV amplifies the signal. In some cases, the amplifier circuit can be configured to amplify a signal 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 can 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 can be configured to amplify a signal from at most 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.

[0063] In some cases, the amplifier circuit can be configured to amplify a signal having a frequency of about 1 Hz to about 1500 Hz. In some cases, the amplifier circuit can be configured to amplify a signal having a frequency of about 1 Hz to about 20 Hz, about 1 Hz to about 40 Hz, about 1 Hz to about 80 Hz, about 1 Hz to about 100 Hz, about 1 Hz to about 150 Hz, about 1 Hz to about 200 Hz, about 1 Hz to about 250 Hz, about 1 Hz to about 500 Hz, about 1 Hz to about 750 Hz, about 1 Hz to about 1000 Hz, about 1 Hz to about 1500 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, from about 20 Hz to about 500 Hz, from about 20 Hz to about 750 Hz, from about 20 Hz to about 1000 Hz, from about 20 Hz to about 1500 Hz, from about 40 Hz to about 80 Hz, from about 40 Hz to about 100 Hz, from about 40 Hz to about 150 Hz, from about 40 Hz to about 200 Hz, from about 40 Hz to about 250 Hz, from about 40 Hz to about 500 Hz, from about 40 Hz to about 750 Hz, from about 40 Hz to about 1000 Hz, from about 40 Hz to about 1500 Hz, from about 80 Hz to about 100 Hz, from about 80 Hz to about 150 Hz, from about 80 Hz to about 200 Hz, from about 80 Hz to about 250 Hz, Hz, about 80 Hz to about 750 Hz, about 80 Hz to about 1000 Hz, about 80 Hz to about 1500 Hz, about 100 Hz to about 150 Hz, about 100 Hz to about 200 Hz, about 100 Hz to about 250 Hz, about 100 Hz to about 500 Hz, about 100 Hz to about 750 Hz, about 100 Hz to about 1000 Hz, about 150 Hz to about 200 Hz, about 150 Hz to about 250 Hz, about 150 Hz to about 500 Hz, about 150 Hz to about 750 Hz, about 150 Hz to about 1000 Hz, about 150 Hz to about 1 Hz to about 1000 Hz, about 200 Hz to about 250 Hz, about 200 Hz to about 500 Hz, about 200 Hz to about 750 Hz, about 200 Hz to about 1000 Hz, about 200 Hz to about 1500 Hz, about 250 Hz to about 500 Hz, about 250 Hz to about 750 Hz, about 250 Hz to about 1000 Hz, about 250 Hz to about 1500 Hz, about 500 Hz to about 750 Hz, about 500 Hz to about 1000 Hz, about 500 Hz to about 1500 Hz, about 750 Hz to about 1000 Hz, about 750 Hz to about 1500 Hz, or about 1000 Hz to about 1500 Hz.In some cases, the amplifier circuit can be configured to amplify a signal having a frequency of about 1 Hz, about 20 Hz, about 40 Hz, about 80 Hz, about 100 Hz, about 150 Hz, about 200 Hz, about 250 Hz, about 500 Hz, about 750 Hz, about 1000 Hz, or about 1500 Hz. In some cases, the amplifier circuit can be configured to amplify a signal having a frequency of at least about 1 Hz, about 20 Hz, about 40 Hz, about 80 Hz, about 100 Hz, about 150 Hz, about 200 Hz, about 250 Hz, about 500 Hz, about 750 Hz, about 1000 Hz, or about 1500 Hz. In some cases, the amplifier circuit can be configured to amplify a signal having a frequency of at most about 20 Hz, about 40 Hz, about 80 Hz, about 100 Hz, about 150 Hz, about 200 Hz, about 250 Hz, about 500 Hz, about 750 Hz, about 1000 Hz, or about 1500 Hz.

[0064] In some cases, the amplified signal can then be passed to filter 1004. In some cases, the filter can include a low pass, high pass, band pass, notch, or any combination thereof.

[0065] In some cases, the filter can be configured to filter a frequency band of about 1 Hz to about 70 Hz. In some cases, the filter can be configured to filter a frequency band of about 1 Hz to about 5 Hz, about 1 Hz to about 10 Hz, about 1 Hz to about 15 Hz, about 1 Hz to about 20 Hz, about 1 Hz to about 25 Hz, about 1 Hz to about 40 Hz, about 1 Hz to about 50 Hz, about 1 Hz to about 60 Hz, about 1 Hz to about 70 Hz, about 5 Hz to about 10 Hz, about 5 Hz to about 15 Hz, about 5 Hz to about 20 Hz, about 5 Hz to about 25 Hz, about 5 Hz to about 40 Hz, about 5 Hz to about 50 Hz, about 5 Hz to about 60 Hz, about 5 Hz to about 70 Hz, about 10 Hz to about 15 Hz, about 10 Hz to about 20 Hz, about 10 Hz to about 25 Hz, about 10 Hz to about 40 Hz, 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 can 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, or about 70 Hz. In some cases, the filter can 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, or about 60 Hz. In some cases, the filter can 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, or about 70 Hz.

[0066] After passing the signal through the filter, the systems and methods described herein can rectify the filtered signal 1006. In the process of rectifying the signal, as will be understood by one of ordinary skill in the art, the signal will convert the AC detection signal into a DC signal. The rectified signal can be additionally filtered with a low pass filter 1007 that can smooth the rectified signal. The signal can be subjected to a threshold detector 1008, where the threshold detector 1008 determines the onset of an incontinence event based on 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 incontinence event is determined by the threshold detector 1008, the system can effectuate the delivery of electrical stimulation 1010, as described elsewhere herein.

[0067] In some cases, the training may be supervised training. Alternatively, the training may be unsupervised training. In some cases, the data set may be a retrospective data set. Alternatively, the data set may be a prospectively developed data set, and the machine learning model may be iteratively improved over time.

[0068] In some aspects, the disclosure provided herein may include a method for training a machine learning model with a data set including sensed signal profiles of prevented and unprevented incontinence events and stimulation signals. The method may include the following steps: preprocessing, training, and prediction.

[0069] The method can extract training data from a database, or introduce new data, as described elsewhere in this article. The preprocessing step can apply one or more transformations to standardize the training data or new data used for the training step or prediction step. The preprocessed training data can be passed to a training step that can build a machine learning model based on the training data. The training step can further include a validation step, which is configured to use any suitable validation algorithm (e.g., stratified K-fold cross validation) to validate the trained machine learning model. In some cases, K-fold cross validation can include at least 1 fold, 2 fold, 3 fold, 4 fold, 5 fold, 6 fold, 7 fold, 8 fold, 9 fold or 10 fold. In some cases, k-fold cross validation can include up to 1 fold, 2 fold, 3 fold, 4 fold, 5 fold, 6 fold, 7 fold, 8 fold, 9 fold or 10 fold.

[0070] 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 contain very few observations. The preprocessing module may further be configured to standardize the encoding of parameter values. The preprocessing step may identify encoding variations for the same value and normalize the data set to have a uniform encoding for a given parameter value. Thus, the processing step may reduce irregularities in the input data for the training and prediction steps, thereby improving the robustness of the training and prediction stages.

[0071] The training step can utilize a machine learning algorithm or other algorithm to construct and train a machine learning model for stimulation stimulus, sensed signal profile, and the presence or absence of an incontinence event. The machine learning model can be constructed to capture the statistical relationship (if any) between the stimulation stimulus parameters, the sensed signal profile, and the presence or absence of an incontinence event based on the training data.

[0072] The accuracy of the machine learning algorithm can be greater than about 60%, 70%, 80%, 85%, 90%, 95%, or 99%. The positive prediction value of the machine learning algorithm can be greater than about 60%, 70%, 75%, 80%, 85%, 90%, 95%, or 99%. The negative prediction value of the machine learning algorithm can be greater than about 60%, 70%, 80%, 90%, 95%, or 99%.

[0073] Machine learning data analysis, machine learning model training, or any combination thereof can be performed using one or more of many programming languages ​​and platforms known in the art, such as R, Weka, Python, and / or MATLAB.

[0074] The use of such a closed-loop bioelectronic system can potentially provide an improved electrical stimulation device to prevent or reduce stress incontinence. In some cases, the use of such a closed-loop bioelectronic system can provide a more accurate method to prevent or reduce or treat urge incontinence and mixed incontinence (a combination of urge and stress incontinence). In some cases, an individual with an implanted device can provide feedback on the positive results, negative results, or neutral results provided by the parameters. In some cases, a positive result may include preventing an incontinence event. In some cases, a negative result may include not preventing an incontinence event, producing pain, or any combination thereof. In some cases, a neutral result may include not preventing an incontinence event, not producing pain, or any combination thereof. In some cases, positive results, negative results, neutral results, sensor data, or any combination thereof from multiple individuals with an implanted device can be used to adjust the algorithm to suggest changes in sensor electrode thresholds and electrical stimulation patterns 124.

[0075] Electrical stimulation mode

[0076] In some cases, the electrical stimulation pattern provided by the implantable pulse generator and one or more stimulator electrodes can be modified or changed to adapt to the needs of individuals in need, thereby preventing the onset of incontinence. In some cases, one or more stimulator electrodes 122 can output an electrical stimulation pattern 124 in response to the content detected by 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 with a constant frequency in time) and a burst or beating signal superimposed on the continuous wave signal. In some cases, the burst or beating signal can be enabled only in a short duration compared to the continuous time aspect of the continuous wave signal. In some cases, the combination of a continuous wave signal and / or a burst or beating signal can increase the pain threshold of the subject to allow the stimulator to provide a higher amplitude electrical stimulation burst pattern to prevent incontinence events. In some cases, the frequency of the electrical stimulation pattern can be modified or changed. The frequency pattern may include a constant profile, a sweep profile, a beating profile, a burst profile, a chirped profile, a single-phase profile, a biphasic profile, or any combination thereof. In some cases, the constant profile is composed of an excitation value of a constant amplitude with a frequency value of 0Hz. In some cases, the sweep profile may include a signal with a time-varying excitation frequency. In some cases, the beating profile may include a combination of one or more excitation signals of varying frequencies. In some cases, the burst profile may include a signal with a constant frequency enveloped by an envelope function of square, delta, sine or any combination thereof. In some cases, the single-phase profile may include an excitation signal (e.g., a signal with a value from 0 to -5V or only from 0 to 5V) with a constant frequency that has only positive or negative amplitude. In some cases, the beating or burst profile may include an electrical simulation mode that is provided to a patient and / or subject during the on state of a first time period, and is not provided to a patient and / or subject during the off state of a second time period. In some cases, the beating or burst profile may provide an excitation signal that can provide longer muscle stimulation without suffering 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 state and / or the off state may include 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. 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, about 1 second to about 1.5 seconds, about 1 second to about 2 seconds, about 1 second to about 2.5 seconds, about 1 second to about 3 seconds, about 1 second to about 3.5 seconds, about 1 second to about 4 seconds, about 1 second to about 5 seconds, about 1 second to about 6.5 seconds, about 1.2 seconds to about 1 .... 1.2 seconds to about 2 seconds, about 1.2 seconds to about 2.5 seconds, about 1.2 seconds to about 3 seconds, about 1.2 seconds to about 3.5 seconds, about 1.2 seconds to about 4 seconds, about 1.2 seconds to about 5 seconds, about 1.2 seconds to about 6.5 seconds, about 1.5 seconds to about 2 seconds, about 1.5 seconds to about 2.5 seconds, about 1.5 seconds to about 3 seconds, about 1.5 seconds to about 3.5 seconds, about 1.5 seconds to about 4 seconds, about 1.5 seconds to about 5 seconds, about 1.5 seconds to about 6.5 seconds, about 2 seconds to about 2.5 seconds, about 2 seconds to about 3 seconds, about 2 seconds to about 3.5 seconds, In some cases, the on state and / or the off state can 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 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, about 5 seconds to about 6.5 seconds. In some cases, the on state and / or the off state can 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 state and / or the off state 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, or about 5 seconds. In some cases, the on state and / or the off state 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.

[0077] In some cases, 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 can be selected based on a priori knowledge of how similar subjects react to a specific frequency or frequency range of the oscillating electrical stimulation pattern. In some cases, low frequencies (e.g., 2 Hz to 15 Hz) can cause a decrease in bladder contractility, thereby preventing urination or potential incontinence events. In some cases, higher frequencies (e.g., 20 Hz to 50 Hz) can result in enhanced bladder contraction and urination. In some cases, the frequency of the electrical stimulation pattern can be from about 1 Hz to about 60 Hz.In some cases, the frequency of the electrical stimulation pattern can be 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 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 to about 40 Hz, about 5 Hz to about 45 Hz, about 5 Hz to about 50 Hz, about 5 Hz to about 55 Hz, about 5 Hz to about 60 Hz, about 10 Hz to about 15 Hz, about 10 Hz to about 25 Hz, about 10 Hz to about 30 Hz, about 10 Hz to about 35 Hz, about 10 Hz to about 40 Hz, about 10 Hz to about 45 Hz, about 10 Hz to about 50 Hz, about 10 Hz to about 55 Hz, about 10 Hz to about 60 Hz, about 15 Hz to about 25 Hz, about 15 Hz to about 30 Hz, about 15 Hz to about 35 Hz, about 10 Hz to about 40 Hz, 5 Hz to about 40 Hz, about 15 Hz to about 45 Hz, about 15 Hz to about 50 Hz, about 15 Hz to about 55 Hz, about 15 Hz to about 60 Hz, about 25 Hz to about 30 Hz, about 25 Hz to about 35 Hz, about 25 Hz to about 40 Hz, about 25 Hz to about 45 Hz, about 25 Hz to about 50 Hz, about 25 Hz to about 55 Hz, about 25 Hz to about 60 Hz, about 30 Hz to about 35 Hz, about 30 Hz to about 40 Hz, about 30 Hz to about 45 Hz, about 30 Hz to about 50 Hz, about 30 Hz to about In some cases, the frequency of the electrical stimulation pattern can 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, 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 cases, the frequency of the electrical stimulation pattern can 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, about 50 Hz, about 55 Hz, or about 60 Hz. In some cases, the frequency of the electrical stimulation pattern can 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 can 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, frequency refers to the average frequency of the electrical stimulation pattern. In some embodiments, frequency refers to the median frequency. In some embodiments, frequency refers to the maximum frequency.

[0078] In some cases, a burst signal having an on state and / or an off state 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, a burst electrical stimulation pattern may include one or more frequencies as described elsewhere herein.

[0079] 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 about 1 volt (V) to about 15V. In some cases, the amplitude of the electrical stimulation pattern can be about 1V to about 2V, about 1V to about 3V, about 1V to about 4V, about 1V to about 5V, about 1V to about 6V, about 1V to about 7V, about 1V to about 8V, about 1V to about 9V, about 1V to about 10V, about 1V to about 12V, about 1V to about 15V, about 2V to about 3V, about 2V to about 4V, about 2V to about 5V, about 2V to about 6V, about 2 ... about 7V, about 2V to about 8V, about 2V to about 9V, about 2V to about 10V, about 2V to about 12V, about 2V to about 15V, about 3V to about 4V, about 3V to about 5V, about 3V to about 6V, about 3V to about 7V, about 3V to about 8V, about 3V to about 9V, about 3V to about 10V, about 3V to about 12V, about 3V to about 15V, about 4V to about 5V, about 4V to about 6V, about 4V to 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, about 5V to about 10V, about 5V to about 12V, about 5V to about 15V, about 6V to about 7V, about 6V to about 8V, about 6V to about 9V, about 6V to about 10V, about 6V to about 12V, From about 6V to about 15V, from about 7V to about 8V, from about 7V to about 9V, from about 7V to about 10V, from about 7V to about 12V, from about 7V to about 15V, from about 8V to about 9V, from about 8V to about 10V, from about 8V to about 12V, from about 8V to about 15V, from about 9V to about 10V, from about 9V to about 12V, from about 9V to about 15V, from about 10V to about 12V, from about 10V to about 15V, or from about 12V to about 15V. In some cases, the amplitude of the electrical stimulation pattern can be about 1V, 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 cases, the amplitude of the electrical stimulation pattern can be at least about 1 V, about 2 V, about 3 V, about 4 V, about 5 V, about 6 V, about 7 V, about 8 V, about 9 V, about 10 V, or about 12 V. In some cases, the amplitude of the electrical stimulation pattern can be at most about 2 V, about 3 V, about 4 V, about 5 V, about 6 V, about 7 V, about 8 V, about 9 V, about 10 V, about 12 V, or about 15 V. In some embodiments, the amplitude refers to the 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 the peak-to-peak amplitude.

[0080] In some cases, the amplitude of the electrical stimulation pattern can be about 0.05 milliamperes (mA) to about 10 mA. In some cases, the amplitude of the electrical stimulation pattern can be about 0.05 mA to about 1 mA, about 0.05 mA to about 2 mA, about 0.05 mA to about 3 mA, about 0.05 mA to about 4 mA, about 0.05 mA to about 5 mA, about 0.05 mA to about 6 mA, about 0.05 mA to about 7 mA, about 0.05 mA to about 8 mA, about 0.05 mA to about 9 mA, about 0.05 mA to about 10 mA, about 1 mA A 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 8mA, about 1mA to about 9mA, about 1mA to about 10mA, about 2mA to about 3mA, about 2mA to about 4mA, about 2mA to about 5mA, about 2mA to about 6mA, about 2mA to about 7mA, about 2mA to about 8mA, about 2 ... to about 9mA, about 2mA to about 10mA, about 3mA to about 4mA, about 3mA to about 5mA, about 3mA to about 6mA, about 3mA to about 7mA, about 3mA to about 8mA, about 3mA to about 9mA, about 3mA to about 10mA, about 4mA to about 5mA, about 4mA to about 6mA, about 4mA to about 7mA, about 4mA to about 8mA, about 4mA to about 9mA, about 4mA to about 10mA, about 5mA to about 5mA, about 4mA to about 6mA, about 4mA to about 7mA, about 4mA to about 8mA, about 4mA to about 9mA, about 4mA to about 10mA, about 5mA to about In some cases, the amplitude of the electrical stimulation pattern can 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, 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 can 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 can be at least about 0.05mA, about 1mA, about 2mA, about 3mA, about 4mA, about 5mA, about 6mA, about 7mA, about 8mA, or about 9mA. In some cases, the amplitude of the electrical stimulation pattern can be at most about 1mA, about 2mA, about 3mA, about 4mA, about 5mA, about 6mA, about 7mA, about 8mA, about 9mA, or about 10mA. 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.

[0081] 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 about 60 μs to about 390 μs. In some cases, the pulse width of the electrical stimulation pattern can 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, about 90 μs to about 270 μs, about 90 μs to about 300 μs, about 90 μs to about 330 μs, about 90 μs to about 360 μs, about 90 μs to about 390 μs, about 120 μs to about 150 μs, about 120 μs to about 180 μs, about 120 μs to about 210 μs, about 120 μs to about 240 μs, about 120 μs to about 270 μs, about 120 μs to about 300 μs, about 120 μs to about 330 μs, about 120 μs to about 360 μs, about 120 μs to about 390 μs, about 150 μs to about 180 μs, about 150 μs to about 210 μs, about 150 μs to about 240 μs, 150μs to about 270μs, about 150μs to about 300μs, about 150μs to about 330μs, about 150μs to about 360μs, about 150μs to about 390μs, about 180μs to about 210μs, about 180μs to about 240μs, about 180μs to about 270μs, about 180μs to about 300μs, about 180μs to about 330μs, about 180μs to about 360μs, about 180μs to about 390μs, about 210μs to about 240μs, about 210μs to about 270μs, about 210μs to about 300μs, about 210μs to about 330μs, about 210μs to about The present invention relates to a method for producing a 360μs film-forming product of the present invention. The method comprises the following steps: a) to produce a 360μs film-forming product of the present invention and b) to produce a 360μs film-forming product of the present invention. The method comprises the following steps: (a) to produce a 360μs film-forming product of the present invention and b) to produce a 360μs film-forming product of the present invention.In some cases, the pulse width of the electrical stimulation pattern can 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 can 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 cases, the pulse width of the electrical stimulation pattern can 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.

[0082] Sensors for use with embodiments of the apparatus described herein

[0083] In some cases, the sensor electrodes used in conjunction with the embodiments of the devices described herein may be configured to sense parameters associated with the response of an individual to prevent the onset of incontinence, or parameters indicating that an individual may suffer from the onset of incontinence. In some cases, the sensor electrodes may be configured to sense muscle contractions of a portion of the sphincter that causes control of bladder or intestinal excretion. In some cases, the sensor electrodes may be configured to sense bulk motion or structural stress of an individual. In some cases, the sensor electrodes may include sensors configured to detect electromyographic (EMG) signals. In some cases, the sensor electrodes may be configured to sense 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 intensity of the EMG signal may be proportional to the intensity of the contraction of at least one pelvic muscle. In some cases, the sensor electrodes detect action potential signals. In some cases, the device includes an amplifier for amplifying the signal obtained by the sensor electrodes so that the processor analyzes and classifies the signal.

[0084] In some cases, the sensor electrodes may be implanted in the pelvis of an individual. In some cases, the sensor electrodes may be implanted at or near the pudendal nerve. In some cases, the sensor electrodes may be implanted at or near the sacral nerve. In some cases, the sensor electrodes may be implanted in or near one or more pelvic muscles. In some cases, the sensor electrodes may be implanted at or near the pelvic floor. In some cases, the sensor electrodes may be implanted at or near the urethral sphincter. In some cases, the sensor electrodes may be implanted at or near one or more of the urethra, ureter, and bladder. In some cases, the sensor electrodes may be implanted at or near the anal sphincter. In some cases, the sensor electrodes may be implanted at or near one or more of the anus, rectum, and intestines. In some cases, the device described herein may include multiple sensor electrodes. In some cases, the device described herein may include one or more sensor electrodes. In some cases, the device described herein may include different sensor electrodes or a second sensor electrode. In some cases, the sensor electrode may detect a signal from a muscle area innervated by a first pudendal nerve, and a different sensor electrode or a second sensor electrode may detect a signal from a muscle area innervated by a second pudendal nerve. In some cases, a sensor electrode may detect signals from a muscle region innervated by a first sacral nerve, and a different or second sensor electrode detects signals from a muscle region innervated by a second sacral nerve.

[0085] In some cases, the sensor electrode may include a housing and leads. In some cases, the housing may be made of titanium, titanium alloy, tantalum, or any combination thereof. In some cases, the leads may be made of metal alloys. In some embodiments, the sensor electrode and the stimulator electrode may be positioned on a single lead. In some cases, the leads may be electrically coupled to one or more sensor electrodes or one or more stimulator electrodes. In some embodiments, the sensor electrode and the stimulator electrode are positioned on separate leads. In some cases, one or more sensor electrodes may include a bioelectric sensor electrode.

[0086] Electrodes for use with embodiments of the devices described herein

[0087] In some cases, the sensor electrode and the stimulator electrode can be located on a single lead. In some cases, one or more sensor electrodes and one or more stimulator electrodes can be located on a single lead. In some cases, a sensor electrode and a stimulator electrode can be located on a single lead. In some cases, the sensor electrode and the stimulator electrode can be located on separate leads. In some cases, the sensor electrode and the stimulator electrode can each be located on its own lead. In some cases, one or more sensor electrodes and one or more stimulator electrodes can be linear geometry, triangular geometry, square geometry, hexagonal geometry or general polygonal geometry. In some cases, the electrodes located on a single lead can be spaced a certain distance apart. In some cases, the interval provides the ability to stimulate multiple positions along the length of the nerve. In some cases, the electrodes can be spaced apart by at least about 1mm, about 1.5mm, about 2mm, about 2.5mm, about 5mm, about 10mm, about 20mm, about 30mm, about 40mm, about 50mm or about 60mm. In some cases, the electrodes may be separated by a distance of at most about 1.5 mm, about 2 mm, about 2.5 mm, about 5 mm, about 10 mm, about 20 mm, about 30 mm, about 40 mm, about 50 mm, about 60 mm, or about 80 mm.

[0088] 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 up to 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 sensors and / or stimulation electrodes. In some cases, the one or more electrodes on a lead may include about 1 electrode to about 10 electrodes. In some cases, the one or more electrodes on the lead can include about 1 electrode to about 2 electrodes, about 1 electrode to about 3 electrodes, about 1 electrode to about 4 electrodes, about 1 electrode to about 5 electrodes, about 1 electrode to about 6 electrodes, about 1 electrode to about 7 electrodes, about 1 electrode to about 8 electrodes, about 1 electrode to about 9 electrodes, about 1 electrode to about 10 electrodes, about 2 electrodes to about 3 electrodes, about 2 electrodes to about 4 electrodes, about 2 electrodes to about 5 electrodes, about 2 electrodes to about 6 electrodes, about 2 electrodes to about 7 electrodes, about 2 electrodes to about 8 electrodes, about 2 electrodes to about 9 electrodes, about 2 electrodes to about 10 electrodes, about 3 electrodes to about 4 electrodes, about 3 electrodes to about 5 electrodes, about 3 electrodes to about 6 electrodes, about 3 electrodes to about 7 electrodes, about 3 electrodes to about 8 electrodes, The present invention relates to a plurality of electrodes, comprising: a plurality of electrodes, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode, at least one electrode In some cases, the 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 can 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.

[0089] In some cases, each electrode can include a length whereby the length can provide localized stimulation of one or more nerves of the sacral nerve or pudendal nerve. In some cases, each electrode can include a length of about 0.1 millimeters (mm) to about 2 mm. In some cases, each electrode may comprise 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 to about 0.7 mm, about 0.3 mm to about 0.8 mm, about 0.3 mm to about 1 mm, about 0.3 mm to about 1.2 mm, about 0.3 mm to about 1.4 mm, about 0.3 mm to about 1.5 mm, about 0.3 mm to about 2 mm, about 0.5 mm to about 0.7 mm, about 0.5 mm to about 0.8 mm, about 0.3 mm to about 1 mm, about 0.5 mm to about 1. The length of the present invention can be about 1.4 mm, about 0.5 mm to about 1.5 mm, about 0.5 mm to about 2 mm, about 0.7 mm to about 0.8 mm, about 0.7 mm to about 1 mm, about 0.7 mm to about 1.2 mm, about 0.7 mm to about 1.4 mm, about 0.7 mm to about 1.5 mm, about 0.7 mm to about 2 mm, about 0.8 mm to about 1 mm, about 0.8 mm to about 1.2 mm, about 0.8 mm to about 1.4 mm, about 0.8 mm to about 1.5 mm, about 0.8 mm to about 2 mm, about 1 mm to about 1.2 mm, about 1 mm to about 1.4 mm, about 1 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 2 mm, about 1.2 mm to about 1.4 mm, about 1 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1.2 mm to about 1.4 mm, about 1.2 mm to about 1.5 mm, about 1.2 mm to about 2 mm, about 1.4 mm to about 1.5 mm, about 1.4 mm to about 2 mm, or about 1.5 mm to about 2 mm. In some cases, each electrode can include 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 can 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 can 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.

[0090] In some cases, one or more leads can include a length from the proximal end of the lead to the distal end electrically connected to the stimulator. In some cases, the length of the lead can vary depending on the anatomy of the individual or subject receiving the implanted device and the lead. In some cases, the lead length can include a length whereby the lead electrode can be placed near and / or adjacent to the sacrum and / or pudendal nerve, but can reach the position of the stimulator in the subject's buttock fat pockets. In some cases, one or more leads can include a length of about 20 centimeters (cm) to about 50 cm. In some cases, one or more leads may include 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 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, one or more leads may include 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, one or more leads may include 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, one or more leads may include a length of at most about 25 cm, about 30 cm, about 35 cm, about 40 cm, about 45 cm, or about 50 cm.

[0091] In some cases, one or more leads can include a diameter. In some cases, the diameter of the lead can vary according to the anatomical structure of the individual or subject receiving the implant device and the lead. In some cases, the lead diameter can include a diameter, whereby the diameter provides a form factor for minimally invasive placement of the lead in the subject. In some cases, the diameter of the lead can include a diameter that the lead will resist fracture. In some cases, one or more leads can have an outer diameter of about 0.1 mm to about 2 mm. In some cases, one or more leads may have a 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 0.2 mm to about 0.5 mm, about 0.2 mm to about 0.8 mm, about 0.2 mm to about 1 mm, about 0.2 mm to about 1.2 mm, about 0.2 mm to about 1.4 mm, about 0.2 mm to about 1.5 mm, about 0.2 mm to about 2 mm, about 0.3 mm to about 0.5 mm, about 0.3 mm to about 0.8 mm, about 0.2 mm to about 1 mm, about 0.3 mm to about 1. An outer diameter of about 1.4 mm, about 0.3 mm to about 1.5 mm, about 0.3 mm to about 2 mm, about 0.5 mm to about 0.8 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.2 mm, about 0.5 mm to about 1.4 mm, about 0.5 mm to about 1.5 mm, about 0.5 mm to about 2 mm, about 0.8 mm to about 1 mm, about 0.8 mm to about 1.2 mm, about 0.8 mm to about 1.4 mm, about 0.8 mm to about 1.5 mm, about 0.8 mm to about 2 mm, about 1 mm to about 1.2 mm, about 1 mm to about 1.4 mm, about 1 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1.2 mm to about 1.4 mm, about 1 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1.2 mm to about 1.4 mm, about 1.2 mm to about 1.5 mm, about 1.2 mm to about 2 mm, about 1.4 mm to about 1.5 mm, about 1.4 mm to about 2 mm, or about 1.5 mm to about 2 mm. In some cases, one or more leads can have an outer diameter of about 0.1 mm, about 0.2 mm, about 0.3 mm, about 0.5 mm, about 0.8 mm, about 1 mm, about 1.2 mm, about 1.4 mm, about 1.5 mm, or about 2 mm. In some cases, one or more leads can have an outer diameter of at least about 0.1 mm, about 0.2 mm, about 0.3 mm, about 0.5 mm, about 0.8 mm, about 1 mm, about 1.2 mm, about 1.4 mm, or about 1.5 mm.In some cases, one or more leads can have an outer diameter of at most about 0.2 mm, about 0.3 mm, about 0.5 mm, about 0.8 mm, about 1 mm, about 1.2 mm, about 1.4 mm, about 1.5 mm, or about 2 mm.

[0092] In some cases, one or more leads described elsewhere herein may include an internal probe and / or mandrel configured to provide rigidity to the lead for implantation and / or insertion into a subject. In some cases, once the lead has been inserted and implanted, the internal probe may be removed from the lead. In some cases, one or more leads described elsewhere herein may be sterilized with conventional sterilization methods used in the medical field (e.g., gas sterilization, steam sterilization, ultraviolet sterilization, etc.).

[0093] In some cases, one or more leads described elsewhere herein can be electrically connected to an electrical stimulator described elsewhere herein. In some cases, one or more leads can be connected to a stimulator and can be disconnected from the stimulator at a later point in time. In some cases, one or more leads can be connected to an electrical stimulator with a quick release electrical connection. In some cases, one or more leads can be connected to an electrical stimulator by a set screw fastener, thereby inserting the lead into a hollow cylindrical geometry that is electrically connected to the internal circuit of the electrical stimulator. The lead can then be fixed to the conductive hollow cylindrical geometry with a non-conductive machine set screw, that is, the lead is pressed against the inner wall of the hollow cylindrical geometry. One or more leads can be placed in the electrical stimulator before or during a surgical implantation procedure.

[0094] In some cases, the sensor electrodes and stimulator electrodes are operably connected to a processor and a non-transitory computer readable medium including software. In some cases, the sensor electrodes can be calibrated by an individual using an external input device that interfaces with the software. In some cases, the software can be configured to record signals from the sensor electrodes. In some cases, the software can be configured to adjust the sensor electrodes in response to the signals.

[0095] In some cases, the stimulator electrode may provide electrical stimulation to the pudendal nerve. In some cases, the stimulator electrode may provide electrical stimulation to the sacral nerve. In some cases, the stimulator electrode may provide electrical stimulation to one or more nerves that innervate the pelvic muscles. In some cases, the electrode may include one or more electrodes or leads, such as a first and a second electrode. In some cases, the electrode may include one or more stimulator electrodes. In some cases, the electrode may include a first stimulator electrode and a second stimulator electrode, the first stimulator electrode being configured to stimulate a pudendal nerve, and the second stimulator electrode being configured to stimulate another spatially independent region of the same pudendal nerve. In some cases, the first stimulator electrode may stimulate the trunk of the pudendal nerve, and the second stimulator electrode may stimulate the 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 stimulator electrode may stimulate the trunk of the pudendal nerve, and the second stimulator electrode may stimulate the main branch of the pudendal nerve (e.g., the dorsal genital nerve). In some cases, the stimulator electrode may provide electrical stimulation to one or more nerves that innervate the urethral sphincter. In some cases, the stimulator electrode may provide electrical stimulation to one or more nerves that innervate the urethra. In some cases, the stimulator electrode may provide electrical stimulation to one or more nerves that innervate the bladder. In some cases, the stimulator electrode may provide electrical stimulation to one or more nerves that innervate the ureter. In some cases, the stimulator electrode may provide electrical stimulation to one or more nerves that innervate the anal sphincter. In some cases, the stimulator electrode may provide electrical stimulation to one or more nerves that innervate the anus. In some cases, the stimulator electrode may provide electrical stimulation to one or more nerves that innervate the rectum. In some cases, the stimulator electrode may provide electrical stimulation to one or more nerves that innervate the bowel. In some cases, the device described herein may include multiple stimulator electrodes. In some cases, the device described herein may include one or more stimulator electrodes. In some cases, the device described herein may include different stimulator electrodes or a second stimulator electrode. In some cases, the stimulator electrode may stimulate a first pudendal nerve, while a different stimulator electrode or a second stimulator electrode stimulates a second pudendal nerve. In some cases, the stimulator electrode may stimulate a first sacral nerve, while a different stimulator electrode or a second stimulator electrode stimulates a second sacral nerve.

[0096] In some cases, the stimulator electrodes of the device can provide constant electrical stimulation. In some cases, the stimulator electrodes of the device can provide constant electrical stimulation at a lower intensity level than the electrical stimulation provided to prevent the onset of incontinence. In some cases, the constant electrical stimulation may include a constant frequency, amplitude, current, or any combination thereof. In some cases, the intensity or duration of the electrical stimulation provided can prevent the onset of incontinence, which varies according to the individual's response to the onset of possible incontinence sensed by the sensor electrodes. In some cases, the individual's response to prevent possible incontinence attacks sensed by the sensor electrodes may not be sufficient to prevent the onset of incontinence, and the electrical stimulation provided by the stimulator electrodes of the device provides sufficient stimulation, together with the response, to prevent the onset of incontinence. In some cases, the individual's response to prevent possible incontinence attacks sensed by the sensor electrodes is combined with the electrical stimulation provided by the stimulator electrodes of the device, providing sufficient stimulation to trigger the action potential of the muscle that causes incontinence, resulting in muscle contraction. In some cases, the combined stimulation from the individual and the device can cause muscle contraction. In some cases, the muscle may include the urethral sphincter. In some cases, the muscle may include the anal sphincter. In some cases, the muscle may include one or more pelvic floor muscles.

[0097] In some cases, the sensor electrode can include a housing and leads. In some cases, the housing can be made of titanium or a titanium alloy. In some cases, the leads can be made of a metal alloy.

[0098] Device Anchors

[0099] In some cases, when implanted by one or more surgical instruments, the device can be anchored. In some cases, the anchoring of the device can be achieved by sliding the device on the lead, as described elsewhere in this article, and then using a bandage (ligatures) to squeeze it onto the lead so that it is fixed. These bandages can be used to fix the anchoring device to native adjacent tissue (native adjacent tissue) (such as ligaments or periosteum). In some cases, the device can include a groove for aligning the extrusion bandage. In some cases, the anchoring device may include a torque system to squeeze the device onto the lead so that it is fixed. In some cases, the device can be squeezed on the lead at a single point. In some cases, the device is squeezed on the lead at two or more points. The electrical stimulator may include a radiopaque marker, which may allow the electrical stimulator to be visualized under x-rays (such as fluoroscopy) during and / or after implantation. In some cases, fluoroscopy can be used alone or in combination with the EMG sensor electrode readings of the pelvic floor muscles to verify or adjust the placement of the sensor electrode lead, stimulator electrode lead and / or stimulator.

[0100] electric signal

[0101] Figure 4 Sensed myoelectric EMG signals and corresponding electrical stimulation ("biostimulators") provided by the devices disclosed herein are described. In some cases, the myoelectric EMG signals ("biosignals") 140 may include electrical fluctuations 142 corresponding to contraction activity of muscles near the sensor electrodes. In some cases, the electrical fluctuations 142 may represent coughs, sudden movements, inertia changes, or any combination thereof from electromyogram (EMG) readings. In some cases, the biosignals captured by the sensor electrodes may be analyzed and classified 144 to identify any stress events (e.g., coughs or sudden movements) based on the EMG readings. In some cases, the identified stress event may initiate a process 146, through which an implantable electrical stimulator may provide an electrical stimulation pattern 148 to one or more pudendal nerves via one or more stimulator electrodes to prevent the onset of incontinence. In some cases, the stimulator electrode may deliver electrical stimulation via one or more stimulator electrodes 122, which is configured to supplement the innate reflexes detected by one or more sensor electrodes 120 to explain stress events that otherwise cause incontinence events.

[0102] In some cases, the electrical stimulator can include a width and length that is easily implanted in a patient. In some cases, the electrical stimulator can include a width and length that accommodates circuitry and / or other system-level components as described elsewhere herein.

[0103] In some cases, the electrical stimulator can include a width and length that provides sufficient space for a battery, wherein the battery can include a lifespan after which the battery can be replaced. In some cases, the battery lifespan can include about 5 years to about 15 years. In some cases, the battery life can include about 5 years to about 6 years, about 5 years to about 7 years, about 5 years to about 8 years, about 5 years to about 9 years, about 5 years to about 10 years, about 5 years to about 11 years, about 5 years to about 12 years, about 5 years to about 13 years, about 5 years to about 14 years, about 5 years to about 15 years, about 6 years to about 7 years, about 6 years to about 8 years, about 6 years to about 9 years, about 6 years to about 10 years, about 6 years to about 11 years, about 6 years to about 12 years, about 6 years to about 13 years, about 5 years to about 14 years, about 5 years to about 15 years, about 6 years to about 7 years, about 6 years to about 8 years, about 6 years to about 9 years, about 7 years to about 10 years, about 7 years to about 11 years, about 7 years to about 12 years, about 7 years to about 13 years, about 7 years to about 14 years, about 7 years to about 15 years, about 8 years to about 9 years, 8 years to about 10 years, about 8 years to about 11 years, about 8 years to about 12 years, about 8 years to about 13 years, about 8 years to about 14 years, about 8 years to about 15 years, about 9 years to about 10 years, about 9 years to about 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 13 years, about 10 years to about 14 years, about 10 years to about 15 years, about 11 years to about 12 years, about 11 years to about 13 years, about 11 years to about 14 years, about 11 years to about 15 years, about 12 years to about 13 years, about 12 years to about 14 years, about 12 years to about 15 years, about 13 years to about 14 years, about 13 years to about 15 years, or about 14 years to about 15 years. In some cases, the battery life may include 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, or about 15 years. In some cases, the battery life may include 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 include 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.

[0104] In some cases, the electrostimulator battery may need to be recharged once every about 1 day to about 12 days. In some cases, the electrostimulator battery may need to be recharged once every about 1 day to about 2 days, about 1 day to about 3 days, about 1 day to about 4 days, about 1 day to about 5 days, about 1 day to about 6 days, about 1 day to about 7 days, about 1 day to about 8 days, about 1 day to about 9 days, about 1 day to about 10 days, about 1 day to about 11 days, about 1 day to about 12 days, about 2 days to about 3 days, about 2 days to about 4 days, about 2 days to about 5 days, about 2 days to about 6 days, about 2 days to about 7 days, about 2 days to about 8 days, about 2 days to about 9 days, about 2 days to about 10 days, about 2 days to about 11 days, about 2 days to about 12 days, about 3 days to about 4 days, about 3 days to about 5 days, about 3 days to about 6 days, about 3 days to about 7 days, about 3 days to about 8 days, about 3 days to about 9 days, about 3 days to about 10 days, about 3 days to about 11 days, about 3 days to about 12 days, about 4 days to about 5 days, about 4 days to about 6 days, about 4 days to about 7 days, about 4 days to about 8 days, about 4 days to about 9 days, about 4 days to about 10 days, about 4 days to about 11 days, about 4 days to about 12 days, about 5 days to about 6 days, about 5 days to about 7 days, about 5 days to about 8 days, about 5 days to about 9 days, about 5 days to about 10 days, about 5 days to about 11 days, about 5 days to about 12 days, about 6 days to about 7 days, about 6 days to about 8 days, about 6 days to about 9 days, about 6 days to about 10 days, about 6 days to about 11 days, about 6 days In some cases, the electro-stimulator battery may need to be recharged once in 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, about 12 days, about 8 days to about 9 days, about 8 days to about 10 days, about 8 days to about 11 days, about 8 days to about 12 days, about 9 days to about 10 days, about 9 days to about 11 days, about 9 days to about 12 days, about 10 days to about 11 days, about 10 days to about 12 days, or about 11 days to about 12 days. In some cases, the electro-stimulator battery may need to be recharged once in 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 electro-stimulator battery may need to be recharged in at least 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 electro-stimulator battery may need to be recharged in at most 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.

[0105] In some cases, the electrical stimulator may comprise a width of about 1 mm to about 50 mm. In some cases, the electrical stimulator may include about 1 mm to about 5 mm, about 1 mm to about 10 mm, about 1 mm to about 15 mm, about 1 mm to about 20 mm, about 1 mm to about 25 mm, about 1 mm to about 30 mm, about 1 mm to about 35 mm, about 1 mm to about 40 mm, about 1 mm to about 45 mm, about 1 mm to about 50 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 5 mm to about 20 mm, about 5 mm to about 25 mm, about 5 mm to about 30 mm, about 5 mm to about 35 mm, about 5 mm to about 40 mm, about 1 mm to about 45 mm, about 1 mm to about 50 mm, about 10 mm to about 15 mm, about 10 mm to about 20 mm, about 10 mm to about 25 mm, about 10 mm to about 30 mm, about 10 mm to about 35 mm, about 10 mm to about 40 mm, about 10 mm to about 45 mm, about 10 mm to about 50 mm m, about 15 mm to about 25 mm, about 15 mm to about 30 mm, about 15 mm to about 35 mm, about 15 mm to about 40 mm, about 15 mm to about 45 mm, about 15 mm to about 50 mm, about 20 mm to about 25 mm, about 20 mm to about 30 mm, about 20 mm to about 35 mm, about 20 mm to about 40 mm, about 20 mm to about 45 mm, about 20 mm to about 50 mm, about 25 mm to about 30 mm, about 25 mm to about In some cases, the electrical stimulator may comprise 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 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 cases, the electrical stimulator may comprise 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 cases, the electrostimulator can include 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 cases, the electrostimulator can include 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.

[0106] In some cases, the electrical stimulator may comprise a length of about 1 mm to about 50 mm. In some cases, the electrical stimulator may include about 1 mm to about 5 mm, about 1 mm to about 10 mm, about 1 mm to about 15 mm, about 1 mm to about 20 mm, about 1 mm to about 25 mm, about 1 mm to about 30 mm, about 1 mm to about 35 mm, about 1 mm to about 40 mm, about 1 mm to about 45 mm, about 1 mm to about 50 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 5 mm to about 20 mm, about 5 mm to about 25 mm, about 5 mm to about 30 mm, about 5 mm to about 35 mm, about 5 mm to about 40 mm, about 1 mm to about 45 mm, about 1 mm to about 50 mm, about 10 mm to about 15 mm, about 10 mm to about 20 mm, about 10 mm to about 25 mm, about 10 mm to about 30 mm, about 10 mm to about 35 mm, about 10 mm to about 40 mm, about 10 mm to about 45 mm, about 10 mm to about 50 mm m, about 15 mm to about 25 mm, about 15 mm to about 30 mm, about 15 mm to about 35 mm, about 15 mm to about 40 mm, about 15 mm to about 45 mm, about 15 mm to about 50 mm, about 20 mm to about 25 mm, about 20 mm to about 30 mm, about 20 mm to about 35 mm, about 20 mm to about 40 mm, about 20 mm to about 45 mm, about 20 mm to about 50 mm, about 25 mm to about 30 mm, about 25 mm to about In some cases, the electrical stimulator 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 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 cases, the electrical stimulator 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 cases, the electrical stimulator 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 cases, the electrical stimulator may comprise a length 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.

[0107] In some cases, the electrical stimulator can include a height of about 0.5 mm to about 5.5 mm. In some cases, the electrical stimulator can 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 ... about 2.5 mm, about 1 mm to about 3 mm, about 1 mm to about 3.5 mm, about 1 mm to about 4 mm, about 1 mm to about 4.5 mm, about 1 mm to about 5 mm, about 1 mm to about 5.5 mm, about 1.5 mm to about 2 mm, about 1.5 mm to about 2.5 mm, about 1.5 mm to about 3 mm, about 1.5 mm to about 3.5 mm, about 1.5 mm to about 4 mm, about 1.5 mm to about 4.5 mm, about 1.5 mm to about 5 mm, about 1.5 mm to about 5.5 mm .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 2.5mm to about 3mm, about 2.5mm to about 3.5mm, about 2.5mm to about 4mm, about 2.5mm to about 4.5mm, about 2.5mm to about 5mm, about 2.5mm to about 5.5mm, about 3mm to about 3.5mm , about 3 mm to about 4 mm, about 3 mm to about 4.5 mm, about 3 mm to about 5 mm, about 3 mm to about 5.5 mm, about 3.5 mm to about 4 mm, about 3.5 mm to about 4.5 mm, about 3.5 mm to about 5 mm, about 3.5 mm to about 5.5 mm, about 4 mm to about 4.5 mm, about 4 mm to about 5 mm, about 4 mm to about 5.5 mm, about 4.5 mm to about 5 mm, about 4.5 mm to about 5.5 mm, or about 5 mm to about 5.5 mm. In some cases, the electrical stimulator may comprise 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 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, or about 5 mm to about 5.5 mm. In some cases, the electrostimulator 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 cases, the electrostimulator can include a height of at most 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.

[0108] In some cases, the electrical stimulator can include a mass of about 1 g to about 18 g. In some cases, the electrical stimulator can 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 1 7g, about 6g to 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 cases, the electrostimulator 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 cases, the electrostimulator 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 cases, the electrostimulator may include a mass of at most 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.

[0109] In some cases, the electrical stimulator can be sterilized using conventional sterilization methods used in the medical field (e.g., gas sterilization, steam sterilization, ultraviolet sterilization, etc.).

[0110] In some cases, one or more stimulator electrodes can provide constant electrical stimulation, or basal stimulation 146 and 150, to individuals 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 stimulator electrodes can provide temporary electrical stimulation for the duration of an episode of stress incontinence 148 to individuals experiencing stress incontinence. In some cases, the stimulator electrodes can provide constant electrical stimulation (i.e., basal stimulation mode) with temporary activation stimulation (i.e., activation stimulation mode) for the duration of an episode of stress incontinence to individuals experiencing mixed incontinence.

[0111] In some cases, the device disclosed herein may include a non-transitory computer-readable medium including software. In some cases, the software may be configured to record a signal from one or more sensor electrodes. In some cases, the software may be configured to process a recorded signal from one or more sensor electrodes to determine whether it is necessary to provide an electrical stimulation pattern to one or more stimulator electrodes that dominate one or more pudendal nerves. In some cases, the software may be configured to adjust the parameters of the sensor electrodes in response to the observed signal. In some cases, the recorded signal of the sensor electrode by the software can observe a signal that saturates the dynamic range of the sensor electrode. In some cases, the gain of the sensor electrode can be adjusted by software to allow the myoelectric EMG signal of an individual to be fully monitored and thresholded.

[0112] Using a device for neurostimulation

[0113] Figure 3 An exemplary embodiment of the devices and methods described herein implanted in an individual is shown. In some cases, the implanted 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 any stress events, and the stimulator electrodes 130 and 132 can provide pressure electrical stimulation ("biosimulator") to act on the target sphincter, which is adjusted according to the basal stimulation to respond to the stress event.

[0114] In some cases, providing electrical stimulation to the pudendal nerve rather than the sacral nerves may provide greater precision because the pudendal nerve or its branches are inferior to the sacral nerves and closer to organs and tissues involved in incontinence than the sacral nerves. The device's sensor electrodes capture biosignals to classify any stressful events, and the device's stimulator electrodes provide pressure electrical stimulation ("biosimulator") to act on the target sphincter, which is adjusted based on the basal stimulation to respond to the stressful event.

[0115] Neurostimulation systems for managing incontinence

[0116] Figure 5 An exemplary embodiment of a system block diagram for the apparatus and methods described herein utilizing slow and fast adaptive algorithms is shown. In some cases, the system disclosed herein may include multiple submodules. In some cases, the submodules may include an offline analysis module 152, a clinician control module 154, a patient controller module 156, an implantable module 160, or any combination thereof.

[0117] In some cases, the offline analysis module 152 may include a data repository, analysis software, visualization software, or any combination thereof. In some cases, the offline analysis module may be used to retrospectively analyze and graphically visualize individual implant performance to prevent the onset of incontinence. The offline analysis module 152 may be programmatically connected to the clinician control module via an application programming interface (API). In some cases, the clinician control module may include software that adjusts or changes the electrical stimulation mode of an individual's electrical stimulation implant.

[0118] In some cases, clinical control module 154 may include stimulation management and device monitoring software, stimulation programming diagrams, a classification configuration dashboard, a streaming data collection dashboard, or any combination thereof. In some cases, a health care provider may assist an individual with electrical implantation by updating or modifying the individual's electrical implantation parameters via clinical control module 154. In some cases, the clinical control module may be used to initialize the individual's electrical implantation after implantation via a USB interface to patient controller module 156.

[0119] In some cases, the patient controller module 156 can include a direct interface to control aspects of its electrical stimulator as described herein. In some cases, the patient controller module 156 can include: a medical information and communication band (MICS) communication platform, manual electrical stimulator control, enabling or disabling algorithm functions, algorithm patient alarms, an inductive or wired charger for an implantable pulse generator rechargeable battery, or any combination thereof.

[0120] In some cases, the patient controller module 156 can be configured to wirelessly and / or inductively charge an implantable pulse generator rechargeable battery with a charger of the patient controller module 156. In some cases, the patient controller module 156 can 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 can make the coupling ergonomic for the subject, so that the subject can guide him / herself as if the controller module 156 was not magnetically coupled to the implantable pulse generator 160. In some cases, the patient controller module 156 can include a battery that can be recharged via the charger by wireless inductive charging and / or wired charging. In some cases, the patient controller module 156 can include a rechargeable lithium-ion battery. In some cases, the charger can 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. In some cases, such as Figure 7B The patient controller module shown may be configured 722 to accept additional memory 723. In some cases, the additional memory may be used to transfer patient data and / or information between the patient / subject and the provider.

[0121] 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 can include a MICS telemetry communication platform corresponding to the MICS communication platform of the patient controller module, so that communication between the two devices can be performed through an ad hoc Wi-Fi network 158. In some cases, the implantable pulse generator 160 can further include a three-axis accelerometer biopotential amplifier, which can be electrically connected to one or more electrode leads 214. In some cases, one or more electrode leads can include one or more stimulators and / or sensor electrodes. In some cases, the biopotential amplifier can be electrically connected to a computing submodule, which includes a classifier, a control strategy, a real-time clock scheduler, a microprocessor, or any combination thereof. In some cases, the biopotential amplifier, the classifier, the control strategy, the real-time clock scheduler, and the microprocessor, or any combination thereof, can process and interpret the myoelectric EMG signals detected in the patient to determine the necessary electrical stimulation pattern provided by the actuator to the one or more stimulator electrodes to prevent the onset of incontinence in the individual.

[0122] In some cases, the patient controller module 156 may include a user interface, a port, an indicator, or any combination thereof, such as Figure 7A-7BAs shown. The user interface and / or ports of the patient controller module may include an input charging receptacle 704, keyboard navigation buttons 706, stimulation indicators, communication indicators, an output charging adapter port, a battery level indicator 712 in percentage and days, a manual stimulation over-ride button 716, or any combination thereof. In some cases, the input charging receptacle may be configured to accept USB A, B, and / or C, FireWire, any micro version thereof, or any combination thereof. Connections. In some cases, the patient controller module 156 may be connected to a power converter via a corresponding cable suitable for the input charging receptacle to charge the patient controller module 156.

[0123] user interface

[0124] The patient controller module 156 may include a user interface 700, wherein the user interface may include one or more user interface objects (701, 702, 705, 711, 712, 715, 716, 717, 721, 730, 723) and / or views, such as Figure 7A-7B As shown. In some cases, user interface 700 may include a touch screen display configured to receive touch or press input from a user, patient and / or medical caregiver. In some cases, a user, patient and / or medical caregiver can press and / or interact with button 716 based on a mixed graphic and text indicator and / or switch mixed graphic and text indicator (705, 711). In some cases, a user, patient and / or medical caregiver can double-click a user interface object to enable an emergency state. In some cases, an emergency state can enable an implanted stimulator to provide electrical stimulation immediately in response to a double-click command. In some cases, a parameter or setting value of a user interface object can be modified and / or changed by tilting a patient controller module. In some cases, tilting a patient controller module in a first direction can increase a parameter and / or setting value of a user interface object, and tilting a patient controller module in a second direction opposite to the first direction can reduce a parameter and / or setting value.

[0125] In some cases, the user interface between devices (e.g., a smartphone and a tablet or other individual computing device) may include scaled versions of the user interface. In some cases, different user interface views (e.g., Fig. 7A and Figure 7B The view shown in ( ) can display the changing user interface object. In some cases, the user interface object may include one or more buttons 716, switches (711, 716) and / or data representations (721, 730, 723) based on graphics or images.

[0126] In some cases, a user can customize a user interface object by selecting one or more user interface objects (e.g., a button, a switch button for enabling various device operation modes, a graphical display of device data, etc.). In some cases, a user view may be a predefined view set of user interface objects with settings. In some cases, a user can customize and / or create one or more views accessible by menu icon 702. In some cases, menu icon 702 may be configured to display one or more submenu options. In some cases, one or more submenu options may include personal identification, account information, device registration, customer support, or any combination of its submenus. In some cases, a submenu may include information on how to connect the device platform to a pre-existing healthcare provider. In some cases, a user interface may include a notification object 701. If a specific notification of device performance, detection of an incontinence event, or any combination thereof is to be provided to a user of the device, the notification object may display a unique or highlighted state. A user may interact with a pressed notification object to view a specific notification in the form of a pop-up dialog box.

[0127] In some cases, one or more user interface objects may include text and / or mixed text and vector object representations of various API function calls and / or sub-user interface views, such as Figure 7A-7B As shown. In some cases, the user interface may include mixed text and vector objects that allow a subject or user to activate 705 or deactivate 711 electrical stimulation of a device 716, adjust device parameters 715, indicate treatment status 717, view EMG signals measured by the device 721, view provided stimulator electrode electrical signal characteristics (e.g., frequency, amplitude, pulse width, etc.), view a medical portal to submit user data to a health care provider, record generated incontinence events 719 overlaid on measured ENG / EMG signals, or any combination thereof. In some cases, the user interface may further include a battery 712 and a wireless communication connection indicator for a user and / or subject to visualize patient controller module 156 operating characteristics.

[0128] In some cases, keyboard navigation buttons 706 may be configured to navigate between various user interface views (e.g., Fig. 7A and Figure 7B Navigate between the user interface views provided in .

[0129] In some cases, the patient controller module 156 may include a visual indicator (715, 717, 712) configured to indicate whether the implanted electrical stimulator is outputting electrical stimulation and / or the presence or absence of its connection to a second or third device. In some cases, the patient controller module may include device adjustment parameters, wherein the device adjustment parameters may include a stimulation indicator, or activation 715 of a stimulation mode. In some cases, the stimulation indicator may be electrically communicated with a processor, as described elsewhere herein, and the processor is configured to display a visual indicator when the stimulator provides 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 electrically communicated with a processor, as described elsewhere herein, and is configured to provide a visual indicator when the patient controller module is connected to one or more discrete devices, a data server, a local WIFI or ad hoc WIFI network, Bluetooth, a medical implant communication system (MICS), or any combination thereof. In some cases, the connection indicator may indicate a wireless connection to an implanted electrical stimulator. In some cases, the connection indicator may include one or more states. In some cases, the first state may include a stereoscopic image indicator, wherein such stereoscopic image indicator may notify the user, subject, individual and / or health care personnel of a successful communication pairing established between the patient controller module and a third device, server, etc. The second state may include a flashing image indicator, wherein such a flashing image indicator indicates the pairing communication state between the patient controller module and the third device, server, etc. In some cases, the image indicator may include a universal Bluetooth symbol that may be observed on a smart device and / or a device with a Bluetooth connection. In some cases, the image indicator may include a graphic of a universal Wi-Fi symbol indicator (e.g., a quarter circle of concentric rings) commonly seen on smart devices and / or devices with a Wi-Fi connection.

[0130] In some cases, device data (e.g., EMG / ENG, accelerometer, gyroscope, magnetometer, three-dimensional space motion, global positioning system (GPS) data, or any combination thereof) can be transmitted 718 between one or more devices as described elsewhere in this document via Wi-Fi, Bluetooth, MICS, or other ad hoc networks.

[0131] Figure 7B Shown with Fig. 7A In some cases, Figure 7BThe user interface 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 incontinence 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 GPS and motion data of the subject over time. GPS and motion data may be useful considerations when 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 charging capacitance of the implanted stimulator over a period of time. In some cases, the charging indicator object may be used to monitor the health of the battery of the implanted stimulator. Figure 7B A user interacting with the display view shown in can pinch, swipe, or otherwise interact with the data of each user interface object (721, 730, 723) to view other time regions of the data or to zoom in on a specific scale of measurement. In some cases, through menu object 702, users and / or subjects can export their medical data to one or more providers.

[0132] Ways to prevent incontinence episodes

[0133] Fig. 6AA workflow of a method 216 for preventing an onset of incontinence in an individual patient is shown. The method may include the following steps: (a) implanting sensor electrodes and stimulator electrodes 218 in the body of the individual; (b) sensing parameters associated with a response from the individual for preventing an onset of incontinence 220 with the sensor electrodes; and (c) providing electrical stimulation with the stimulator electrodes, which together with the response prevents an onset of incontinence 222. Typically, the methods described herein prevent the onset of urinary incontinence. In some cases, 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 the onset of fecal incontinence. In some cases, the method may include a step of providing a constant electrical stimulation at a lower intensity level than the electrical stimulation provided in step (c). The constant electrical stimulation provided at a lower intensity may help individuals with urge incontinence. In some cases, the intensity or duration of the electrical stimulation provided in step (c) may vary according to the response sensed in step (b). In step (c), the response may vary due to stressful events (e.g., coughing, laughing, or exercising) that may require increased electrical stimulation to prevent the onset of incontinence. In some cases, the time period between sensing parameter 224 and providing electrical stimulation 226 may be described as response time 228, such as Figure 6B In some cases, stimulation may be provided for a duration 227 of stimulation.

[0134] In some cases, the duration 227 of the stimulation may include about 1 second to about 30 seconds. In some cases, the duration 227 of the stimulation may include about 1 second to about 2 seconds, about 1 second to about 3 seconds, about 1 second to about 4 seconds, about 1 second to about 5 seconds, about 1 second to about 10 seconds, about 1 second to about 12 seconds, about 1 second to about 14 seconds, about 1 second to about 16 seconds, about 1 second to about 20 seconds, about 1 second to about 25 seconds, about 1 second to about 30 seconds, about 2 seconds to about 3 seconds, about 2 seconds to about 4 seconds, about 2 seconds to about 5 seconds, about 2 seconds to about 10 seconds, about 2 seconds .... seconds, about 2 seconds to about 14 seconds, about 2 seconds to about 16 seconds, about 2 seconds to about 20 seconds, about 2 seconds to about 25 seconds, about 2 seconds to about 30 seconds, about 3 seconds to about 4 seconds, about 3 seconds to about 5 seconds, about 3 seconds to about 10 seconds, about 3 seconds to about 12 seconds, about 3 seconds to about 14 seconds, about 3 seconds to about 16 seconds, about 3 seconds to about 20 seconds, about 3 seconds to about 25 seconds, about 3 seconds to about 30 seconds, about 4 seconds to about 5 seconds, about 4 seconds to about 10 seconds, about 4 seconds to about 12 seconds, about 4 seconds to about 14 seconds, about 4 seconds to about 16 seconds, about 4 seconds to about 20 seconds, about 4 seconds to about 25 seconds, about 4 seconds to about 30 seconds, about 5 seconds to about 10 seconds, about 5 seconds to about 12 seconds, about 5 seconds to about 14 seconds, about 5 seconds to about 16 seconds, about 5 seconds to about 20 seconds, about 5 seconds to about 25 seconds, about 5 seconds to about 30 seconds, about 10 seconds to about 12 seconds, about 10 seconds to about 14 seconds, about 10 seconds to about 16 seconds, about 10 seconds to about 20 seconds, about 10 seconds to about 25 seconds, about 10 seconds In some cases, the duration 227 of the stimulation 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 14 seconds, about 20 seconds, about 14 seconds to 25 seconds, about 14 seconds to about 30 seconds, about 16 seconds to about 20 seconds, about 16 seconds to about 25 seconds, about 16 seconds to about 30 seconds, about 20 seconds to about 25 seconds, about 20 seconds to about 30 seconds, or about 25 seconds to about 30 seconds. In some cases, the duration 227 of the stimulation 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 227 of stimulation can 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, or about 25 seconds. In some cases, the duration 227 of stimulation can 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, or about 30 seconds.

[0135] In some cases, the reaction time 228 may include about 60 μs to about 100 μs. In some cases, the reaction time 228 may include about 60 μs to about 65 μs, about 60 μs to about 70 μs, about 60 μs to about 75 μs, about 60 μs to about 80 μs, about 60 μs to about 85 μs, about 60 μs to about 90 μs, about 60 μs to about 95 μs, about 60 μs to about 100 μs, about 65 μs to about 70 μs, about 65 μs to about 75 μs, about 65 μs to about 80 μs, about 65 μs to about 85 μs, about 65 μs to about 90 μs, about 65 μs to about 95 μs, about 65 μs to about 100 μs, about 70 μs to about 75 μs, about 70 μs to about 80 μs, about 70 μs to about To about 85μs, about 70μs to about 90μs, about 70μs to about 95μs, about 70μs to about 100μs, about 75μs to about 80μs, about 75μs to about 85μs, about 75μs to about 90μs, about 75μs to about 95μs, about 75μs to about 100μs, about 80μs to about 85μs, about 80μs to about 90μs, about 80μs to about 95μs, about 80μs to about 100μs, about 85μs to about 90μs, about 85μs to about 95μs, about 85μs to about 100μs, about 90μs to about 95μs, about 90μs to about 100μs, or about 95μs to about 100μs. In some cases, reaction 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 100 μs. In some cases, reaction 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, reaction 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. By developing an iteratively trained machine learning classifier, reaction time can be minimized and improved incontinence prevention can be achieved.

[0136] Figures 12A-12B A workflow of a method 1200 for preventing an episode of incontinence in an individual patient is shown. The method may include the following steps: (a) implanting sensor electrodes and stimulator electrodes into the body of the individual 1202; (b) sensing a parameter associated with a response from the individual, wherein the response is user-induced stimulation 1204; and (c) providing electrical stimulation with the stimulator electrodes to prevent an incontinence event 1206. In some cases, user-induced stimulation may be used to prevent an episode of incontinence. Fig. 12BAs shown, the detected EMG signal 1208 can be analyzed by a classifier 1210 described elsewhere herein to determine when a signal of an EMG, ENG, accelerometer, gyroscope, magnetometer, pressure sensor signal, or any combination thereof has exceeded a predetermined threshold value described elsewhere herein. Once the classifier 1210 has determined that the signal 1208 does represent an incontinence event, the processor described elsewhere herein can enable stimulation 1212 to prevent the occurrence of the incontinence event. In some cases, the stimulation 1212 can include an extended period of stimulation 1211, which can extend beyond the time that the classifier 1210 determines that an incontinence event exists. In some cases, the extended period of stimulation 1211 can include a duration equal to the duration that the subject continues to purposefully or intentionally produce a muscle contraction.

[0137] In some cases, the extended period of stimulation 1211 may include about 1s to about 30s. In some cases, the extended period of stimulation 1211 may include about 1s to about 3s, about 1s to about 5s, about 1s to about 8s, about 1s to about 10s, about 1s to about 12s, about 1s to about 15s, about 1s to about 18s, about 1s to about 20s, about 1s to about 22s, about 1s to about 24s, about 1s to about 30s, about 3s to about 5s, about 3s to about 8s, about 3s to about 10s, about 3s to about 12s, about 3s to about 15s , about 3s to about 18s, about 3s to about 20s, about 3s to about 22s, about 3s to about 24s, about 3s to about 30s, about 5s to about 8s, about 5s to about 10s, about 5s to about 12s, about 5s to about 15s, about 5s to about 18s, about 5s to about 20s, about 5s to about 22s, about 5s to about 24s, about 5s to about 30s, about 8s to about 10s, about 8s to about 12s, about 8s to about 15s, about 8s to about 18 s, about 8s to about 20s, about 8s to about 22s, about 8s to about 24s, about 8s to about 30s, about 10s to about 12s, about 10s to about 15s, about 10s to about 18s, about 10s to about 20s, about 10s to about 22s, about 10s to about 24s, about 10s to about 30s, about 12s to about 15s, about 12s to about 18s, about 12s to about 20s, about 12s to about 22s, about 12s to about 24s, about In some cases, the extended period 1211 of stimulation may include about 1 s, about 3 s, about 5 s, about 8 s, about 10 s, about 12 s, about 15 s, about 18 s, about 20 s, about 15 s to about 22 s, about 15 s to about 24 s, about 15 s to about 30 s, about 18 s to about 20 s, about 18 s to about 22 s, about 18 s to about 24 s, about 18 s to about 30 s, about 20 s to about 22 s, about 20 s to about 24 s, about 20 s to about 30 s, about 22 s to about 24 s, about 22 s to about 30 s, or about 24 s to about 30 s. In some cases, the extended period 1211 of stimulation may include about 1 s, about 3 s, about 5 s, about 8 s, about 10 s, about 12 s, about 15 s, about 18 s, about 20 s, about 22 s, about 24 s, or about 30 s. In some cases, the extended period of stimulation 1211 may include at least about 1 s, about 3 s, about 5 s, about 8 s, about 10 s, about 12 s, about 15 s, about 18 s, about 20 s, about 22 s, or about 24 s. In some cases, the extended period of stimulation 1211 may include at most about 3 s, about 5 s, about 8 s, about 10 s, about 12 s, about 15 s, about 18 s, about 20 s, about 22 s, about 24 s, or about 30 s.

[0138] In some cases, there may be a delay between the onset of an incontinence event in the raw EMG, ENG, accelerometer, gyroscope, magnetometer, pressure sensor, or any combination thereof signal data and the start of electrical stimulation 1209. Once the classifier is trained 1210 on a sufficiently large and varied data set, such delays can be minimized, thereby further improving the performance of the device in preventing incontinence events. In some cases, sensing can include determining the individual's global positioning system (GPS) location, which is combined with parameters associated with responses from the individual for use in preventing the onset of incontinence.

[0139] Various aspects of the disclosure provided herein may include a data processing method. In some cases, the data processing method may include: (i) receiving a measurement of a parameter previously measured by a sensor electrode, the parameter predicting the onset of incontinence of an individual; (ii) analyzing the parameter; and (iii) synthesizing an electrical stimulation signal for an individual so that when the electrical stimulation signal is provided to the individual by the stimulator electrode, the electrical stimulation signal prevents the onset of incontinence together with the effort from the individual to prevent the onset of incontinence. In some cases, the parameter may be associated with a reaction from the individual to prevent the onset of incontinence. In some cases, the parameter may be associated with the effort of the individual to try to prevent the onset of incontinence, and wherein the electrical stimulation signal is synthesized to supplement the effort of the individual with an electrical stimulation pattern, which together with the effort of the individual will be sufficient to prevent the onset of incontinence. In some cases, the reaction from the individual may not be sufficient to prevent the onset of incontinence by itself, and the electrical stimulation signal is sufficient to prevent the onset of incontinence when applied, plus the reaction.

[0140] In some cases, the onset of incontinence may include urinary incontinence. In some cases, the onset of incontinence may include fecal incontinence. In some cases, the onset of incontinence may include urinary stress incontinence. In some cases, the onset of incontinence is urinary incontinence and is an urge incontinence type.

[0141] In some cases, the parameter may include a signal from a sensor electrode configured to sense a contraction of an individual muscle associated with a partial contraction of a sphincter controlling bladder or bowel discharge. 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 measurement parameter. In some cases, the intensity or duration of the electrical stimulation provided by the electrical stimulation signal may vary according to 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 at least one pelvic muscle. In some cases, the electrical stimulation signal may include a first signal 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 to adjust the sensor electrode in response to the recorded signal.

[0142] Evaluation of incontinence treatment

[0143] Postoperative ambulatory assessment

[0144] In some embodiments, various dynamic assessments can be performed to determine the effectiveness of the implantation procedure. In some embodiments, the implanted IPG allows the downloading of telemetry data (input, output, and event classification). In some embodiments, the participant can be in a conscious dynamic setting, and a series of resting and stimulating electrophysiological data can be recorded. In some embodiments, at the beginning of treatment (24-48 hours after implantation), sensory and motor responses can be determined from different sensor electrodes on the implanted leads. In some embodiments, based on the response, the electrode with the most adequate response can be selected to start treatment.

[0145] In some embodiments, the patient may experience different physiological events to program the IPG. In some embodiments, these events may include coughing, Valsalva maneuvers, lifting 5kg weights, or any combination thereof. In some embodiments, pelvic floor EMG can be measured using transvaginal and / or anal probes. In some embodiments, urethral pressure can be measured. In some embodiments, a continuous "still" recording of 1 hour can be performed for input and output (downloaded via telemetry). In some embodiments, a recording during an event (e.g., coughing, Valsalva maneuvers, lifting 5kg weights) caused by a controlled participant can be obtained. In some embodiments, a recording during pelvic floor surface EMG (from a transvaginal probe: only female) can be obtained to associate the input from the lead with the surface EMG. In some embodiments, the patient's tolerance and actuation parameters for basic stimulation promotion can be obtained. In some embodiments, standard urodynamic testing is performed at 48 hours. In some embodiments, UDC (with or without reported urgency) can be recorded during bladder filling to assess the acute effects of the patient's actuation device. In some embodiments, a standard 1-hour pad test can be performed.

[0146] Clinical Results

[0147] In some embodiments, clinical outcomes can be assessed using a 5-day voiding diary that records the number of voiding episodes, number of urgency episodes, number of leaks, and severity of leaks to yield: stress and urge UI (summed) episodes per unit time; stress UI episodes per unit time; urgency UI episodes per unit time; urgency of voiding episodes per unit time; total voiding frequency per unit time; response rate: based on >50% reduction in UI episodes per unit time; functional cure rate, defined as >90% reduction in mean total UI episodes relative to baseline or an average of less than 1 UIE per week; the International Consultative Committee on Incontinence Questionnaire-Short Form for Urinary Incontinence (ICIQ-SF-UI) questionnaire; or any combination thereof.

[0148] definition

[0149] Unless otherwise defined, all technical terms, symbols 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 belongs. In some cases, terms with commonly understood meanings are defined herein for clarity and / or ease of reference, and such definitions included herein should not necessarily be construed to represent a substantial difference from what is generally understood in the art.

[0150] In the present application, various embodiments can be presented in range format.It should be understood that the description of range format is only for convenience and brevity, and should not be interpreted as an inflexible limitation of the scope of the present disclosure.Therefore, the description of the range should be considered to have specifically disclosed all possible sub-ranges and each numerical value within the range.For example, the description of the range (e.g., 1 to 6) should be considered to have specifically disclosed sub-ranges (e.g., 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc.), and single digits (e.g., 1, 2, 3, 4, 5, and 6) within the range.No matter how big the scope is, this applies.

[0151] As used in the 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.

[0152] The terms "determine," "measure," "assess," "evaluate," "assay," and "analyze" are often used interchangeably herein to refer to forms of measurement, and include determining whether an element is present (e.g., detecting). These terms can include quantitative, qualitative, or both quantitative and qualitative determinations. Assessments are either relative or absolute. "Detecting the presence" includes determining the amount of something that is present, as well as determining whether it is present or absent.

[0153] The terms "subject," "individual," or "patient" are often used interchangeably herein. A "subject" can be a biological entity comprising 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 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 is not necessarily diagnosed or suspected of being at high risk for the disease.

[0154] The term "in vivo" is used to describe events that occur within the body of a subject.

[0155] The term "in vitro" is used to describe an event that occurs outside the body of a subject. An "in vitro" test is not performed on a subject. Instead, it is performed on a sample that is separated from the subject. An example of an "in vitro" test performed on a sample is an "in vivo" test.

[0156] As used herein, the term "about" a number refers to the number plus or minus 10%. The term "about" a range refers to the range minus 10% of the lowest number of the range and plus 10% of the highest number of the range.

[0157] As used herein, the term "treatment" or "treating" is used to refer to an intervention regimen that obtains a beneficial or desired result in a recipient. Beneficial or desired results include, but are not limited to, therapeutic benefit and / or preventive benefit. Therapeutic benefit can refer to the prevention or improvement of the symptoms being treated or the underlying condition. In addition, therapeutic benefit can be achieved by preventing or improving one or more physiological symptoms associated with the underlying condition, so that although the subject may still suffer from the underlying condition, the improvement can be observed in the subject. The preventive effect includes delaying, preventing or eliminating the appearance of the disease or condition, delaying or eliminating the onset of symptoms of the disease and condition, slowing, stopping or reversing the progression of the disease or condition, or any combination thereof. For the benefit of prevention, a subject at risk of developing a particular disease or condition, or a subject reporting one or more physiological symptoms of a disease or condition, can receive treatment.

[0158] The section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described.

[0159] Although preferred embodiments of the present invention have been shown and described herein, it will be apparent to those skilled in the art that these embodiments are provided by way of example only. Without departing from the present invention, many changes, modifications and substitutions will occur for those skilled in the art. It should be understood that various alternatives to the embodiments of the present invention described herein may be adopted in practicing the present invention. The following claims define the scope of the present invention, and methods and structures within the scope of these claims and their equivalents are thus covered.

[0160] Numbered Examples

[0161] Numbered Example 1 includes a method for preventing an episode of incontinence in an individual in need thereof, the method comprising: (a) implanting a sensor electrode and a stimulator electrode in the individual; (b) sensing a parameter associated with a response from the individual intended to prevent an episode of incontinence with the sensor electrode; and (c) providing electrical stimulation with the stimulator electrode, the electrical stimulation together with the response preventing an episode of incontinence. Numbered Example 2 includes the method of Example 1, wherein the episode of incontinence includes urinary incontinence. Numbered Example 3 includes the method of Example 1, wherein the episode of incontinence includes fecal incontinence. Numbered Example 4 includes the method of Example 1, wherein the episode of incontinence includes urinary stress incontinence. Numbered Example 5 includes the method of Example 1, wherein the sensor electrode is configured to sense a contraction of a muscle of the individual that causes a partial contraction of a sphincter that controls bladder or bowel discharge. Numbered Example 6 includes the method of Example 5, wherein the sensor electrode is positioned within the pelvis of the individual. Numbered Example 7 includes the method of Example 1, wherein the stimulator electrode provides electrical stimulation to the pudendal nerve. Numbered Example 8 includes the method of Example 7, wherein the sensor electrode and the stimulator electrode are located on a single lead. Numbered Example 9 includes the method of Example 1, including the step of providing a constant electrical stimulation at a lower intensity level than the electrical stimulation provided in step (c). Numbered Example 10 includes the method of Example 9, wherein the onset of incontinence is urinary incontinence and is of the urge incontinence type. Numbered Example 11 includes the method of Example 1, wherein the intensity or duration of the electrical stimulation provided in step (c) varies according to the reaction sensed in step (b). Numbered Example 12 includes the method of Example 11, wherein the reaction sensed in step (b) is not sufficient by itself to prevent the onset of incontinence, and the electrical stimulation provided in step (b) plus the reaction is just sufficient to prevent the onset of incontinence. Numbered Example 13 includes the method of Example 11, wherein the reaction sensed in step (b) is not sufficient by itself to prevent the onset of incontinence, and wherein the electrical stimulation provided in step (b) together with the reaction prevents the onset of incontinence. Numbered Example 14 includes the method of Example 1, wherein the sensor electrode is configured to sense an EMG signal. Numbered Example 15 includes the method of Example 14, wherein the EMG signal determines that a contraction of at least one pelvic muscle has occurred. Numbered Example 16 includes the method of Example 15, wherein the strength of the EMG signal is proportional to the strength of the contraction of at least one pelvic muscle. Numbered Example 17 includes the method of Example 1, including the steps of implanting a first stimulator electrode and a second stimulator electrode, wherein the first stimulator electrode stimulates one area of ​​the pudendal nerve and the second stimulator electrode stimulates a different area of ​​the pudendal nerve. Numbered Example 18 includes the method of Example 1, wherein the individual suffers from mixed type urinary incontinence.Numbered embodiment 19 includes the method of embodiment 1, wherein the sensor electrodes and stimulator electrodes are operably connected to a processor and a non-transitory computer-readable medium including software. Numbered embodiment 20 includes the method of embodiment 19, wherein the sensor electrodes are calibrated by an individual using an external input device that interfaces with the software. Numbered embodiment 21 includes the method of embodiment 19, wherein the software is configured to record signals from the sensor electrodes. Numbered embodiment 22 includes the method of embodiment 21, wherein the software is configured to adjust the response of the sensor electrodes to the signals. Numbered embodiment 23 includes the method of embodiment 19, wherein the software includes a machine learning model, and wherein the machine learning model is configured to classify the signals detected by the sensor electrodes and generate signals using the stimulator electrodes. Numbered embodiment 24 includes the method of embodiment 23, wherein the machine learning model is trained based on previous data obtained from an individual or a group of individuals and corresponding information on incontinence prevention or lack of incontinence prevention. Numbered embodiment 25 includes the method of embodiment 24, wherein the previous data includes signals detected by the sensor electrodes, generated signals generated by the stimulator electrodes, or any combination thereof. Numbered embodiment 26 includes the method of embodiment 1, wherein the sensing further comprises determining a global positioning system (GPS) location of the individual, the global positioning system (GPS) location combined with a parameter associated with a response from the individual to prevent an onset of incontinence.

[0162] Numbered embodiment 27 includes a system for preventing an episode of incontinence in an individual in need thereof, the device comprising: (a) a sensor electrode configured to sense a parameter associated with a response from the individual intended to prevent an episode of incontinence; (b) a stimulator electrode configured to provide electrical stimulation; (c) a processor operably coupled to the sensor electrode and the stimulator electrode; and (d) a non-transitory computer-readable storage medium comprising software configured to cause the processor to: (i) receive a parameter associated with a response from the individual intended to prevent an episode of incontinence; (ii) analyze the parameter associated with the response from the individual intended to prevent an episode of incontinence; and (iii) cause the stimulator electrode to provide electrical stimulation to the individual such that the electrical stimulation, together with the response from the individual intended to prevent an episode of incontinence, prevents an episode of incontinence. Numbered embodiment 28 includes the system of embodiment 27, wherein the episode of incontinence includes urinary incontinence. Numbered embodiment 29 includes the system of embodiment 27, wherein the episode of incontinence includes fecal incontinence. Numbered embodiment 30 includes the system of embodiment 27, wherein the episode of incontinence includes urinary stress incontinence. Numbered Example 31 includes the system of Example 27, wherein the sensor electrode is configured to sense a contraction of a muscle of the individual that causes a partial contraction of a sphincter that controls bladder or bowel discharge. Numbered Example 32 includes the system of Example 27, wherein the sensor electrode is positioned within the pelvis of the individual. Numbered Example 33 includes the system of Example 27, wherein the stimulator electrode provides electrical stimulation to the pudendal nerve of the individual. Numbered Example 34 includes the system of Example 27, wherein the sensor electrode and the stimulator electrode are located on a single lead. Numbered Example 35 includes the system of Example 27, wherein the stimulator electrode is configured to provide constant electrical stimulation at a lower intensity level than the electrical stimulation. Numbered Example 36 includes the system of Example 27, wherein the onset of incontinence is urinary incontinence and is of the urge incontinence type. Numbered Example 37 includes the system of Example 27, wherein the intensity or duration of the electrical stimulation varies according to the sensed reaction. Numbered Example 38 includes the system of Example 27, wherein the reaction sensed by the sensor electrode itself is not sufficient to prevent the onset of incontinence, and the electrical stimulation provided plus the reaction is just sufficient to prevent the onset of incontinence. Numbered Example 39 includes the system of Example 27, wherein the reaction sensed by the sensor electrode is not sufficient by itself to prevent the onset of incontinence, and wherein the electrical stimulation provided in step (b) together with the reaction prevents the onset of incontinence. Numbered Example 40, the system of Example 27, wherein the sensor electrode is configured to sense an EMG signal. Numbered Example 41 includes the system of Example 40, wherein the EMG signal determines that a contraction of at least one pelvic muscle has occurred. Numbered Example 42 includes the system of Example 41, wherein the strength of the EMG signal is proportional to the strength of the contraction of at least one pelvic muscle.Numbered embodiment 43 includes the system of embodiment 27, wherein the stimulator electrode includes a first stimulator electrode and a second stimulator electrode, wherein the first stimulator electrode stimulates the first pudendal nerve and the second stimulator electrode stimulates the second pudendal nerve. Numbered embodiment 44 includes the system of embodiment 27, wherein the individual suffers from mixed type urinary incontinence. Numbered embodiment 45 includes the system of embodiment 27, wherein the sensor electrode is calibrated by the individual using an external input device that interfaces with the software. Numbered embodiment 46 includes the system of embodiment 27, wherein the software is configured to further 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, and wherein the machine learning model is configured to classify the signals detected by the sensor electrodes and generate signals using the stimulator electrodes. Numbered embodiment 49 includes the system of embodiment 48, wherein the machine learning model is trained based on previous data obtained from an individual or a group of individuals and corresponding incontinence prevention or lack of incontinence prevention information. Numbered embodiment 50 includes the system of embodiment 49, wherein the prior data includes signals detected by sensor electrodes, generated signals generated by stimulator 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 combined with parameters associated with a response from the individual to prevent the onset of incontinence.

[0163] Numbered embodiment 52 includes a non-transitory computer-readable storage medium including software for preventing an episode of incontinence in an individual in need thereof, the software being configured to cause a processor to: (i) receive, via sensor electrodes, parameters associated with a response from the individual intended to prevent an episode of incontinence; (ii) analyze parameters associated with a response from the individual intended to prevent an episode of incontinence; and (iii) cause a stimulator electrode to provide electrical stimulation to the individual such that the electrical stimulation, together with the response from the individual intended to prevent an episode of incontinence, prevents an episode of incontinence. Numbered embodiment 53 includes the non-transitory computer-readable storage medium including software of embodiment 52, wherein the episode of incontinence includes urinary incontinence. Numbered embodiment 54 includes the non-transitory computer-readable storage medium including software of embodiment 52, wherein the episode of incontinence includes fecal incontinence. Numbered embodiment 55 includes the non-transitory computer-readable storage medium including software of embodiment 52, wherein the episode of incontinence includes urinary stress incontinence. Numbered embodiment 56 includes the non-transitory computer-readable storage medium including software of embodiment 52, wherein the sensor electrode is configured to sense a contraction of a muscle of the individual that causes a partial contraction of a sphincter that controls bladder or bowel discharge. Numbered embodiment 57 includes the non-transitory computer-readable storage medium including software of embodiment 52, wherein the sensor electrode is positioned within the pelvis of the individual. Numbered embodiment 58 includes the non-transitory computer-readable storage medium including software of embodiment 52, wherein the stimulator electrode provides electrical stimulation to the pudendal nerve of the individual. Numbered embodiment 59 includes the non-transitory computer-readable storage medium including software of embodiment 52, wherein the sensor electrode and the stimulator electrode are located on a single lead. Numbered embodiment 60 includes the non-transitory computer-readable storage medium including software of embodiment 52, wherein the stimulator electrode is configured to provide constant electrical stimulation at a lower intensity level than the electrical stimulation. Numbered embodiment 61 includes the non-transitory computer-readable storage medium including software of embodiment 52, wherein the onset of incontinence is urinary incontinence and is of the urge incontinence type. Numbered embodiment 62 includes the non-transitory computer-readable storage medium including software of embodiment 52, wherein the intensity or duration of the electrical stimulation varies based on the sensed reaction. Numbered embodiment 63 includes the non-transitory computer-readable storage medium including software of embodiment 62, wherein the reaction sensed by the sensor electrode is not sufficient by itself to prevent the onset of incontinence, and the electrical stimulation provided in addition to the reaction is just sufficient to prevent the onset of incontinence. Numbered embodiment 64 includes the non-transitory computer-readable storage medium including software of embodiment 62, wherein the reaction sensed by the sensor is not sufficient by itself to prevent the onset of incontinence, and the electrical stimulation provided together with the reaction prevents the onset of incontinence. Numbered embodiment 65 includes the non-transitory computer-readable storage medium including software of embodiment 52, wherein the sensor electrode is configured to sense EMG signals.Numbered embodiment 66 includes the non-transitory computer-readable storage medium including software of embodiment 65, wherein the EMG signal determines that a contraction of at least one pelvic muscle has occurred. Numbered embodiment 67 includes the non-transitory computer-readable storage medium including 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 includes the non-transitory computer-readable storage medium including software of embodiment 52, wherein the stimulator electrode includes a first stimulator electrode and a second stimulator electrode, wherein the first stimulator electrode stimulates a first pudendal nerve and the second stimulator electrode stimulates a second pudendal nerve. Numbered embodiment 69 includes the non-transitory computer-readable storage medium including software of embodiment 52, wherein the individual suffers from mixed type urinary incontinence. Numbered embodiment 70 includes the non-transitory computer-readable storage medium including software of embodiment 52, wherein the sensor electrodes are calibrated by the individual using an external input device that interfaces with the software. Numbered embodiment 71 includes the non-transitory computer-readable storage medium including software of embodiment 52, wherein the software is configured to further cause the processor to record signals from the sensor electrodes. Numbered embodiment 72 includes the non-transitory computer-readable storage medium of embodiment 71 including software, wherein the software is configured to adjust the response of the sensor electrode to the signal. Numbered embodiment 73 includes the non-transitory computer-readable storage medium of embodiment 52, wherein the software includes a machine learning model, and wherein the machine learning model is configured to classify the signals detected by the sensor electrodes and generate signals with the stimulator electrodes. Numbered embodiment 74 includes the non-transitory computer-readable storage medium of embodiment 73, wherein the machine learning model is trained based on previous data obtained from an individual or a group of individuals and corresponding incontinence prevention or lack of incontinence prevention information. Numbered embodiment 75 includes the non-transitory computer-readable storage medium of embodiment 74, wherein the previous data includes signals detected by the sensor electrodes, the generated signals, or any combination thereof. Numbered embodiment 76 includes the non-transitory computer-readable medium of embodiment 52, wherein the software includes analyzing the individual's global positioning system (GPS) location, which is combined with parameters associated with the response from the individual to prevent the onset of incontinence.

[0164] Numbered embodiment 77 comprises a method of data processing, the method comprising: (i) receiving a measurement of a parameter previously measured by a sensor electrode, the parameter predicting an onset of incontinence in an 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 stimulator electrode, the electrical stimulation signal, together with an effort from the individual intended to prevent an onset of incontinence, prevents an onset of incontinence. Numbered embodiment 78 comprises the method of embodiment 77, wherein the parameter is associated with a response from the individual intended to prevent an onset of incontinence. Numbered embodiment 79 comprises the method of embodiment 78, wherein the parameter is associated with an effort from the individual intended to prevent an onset of incontinence, and wherein the electrical stimulation signal is synthesized to supplement the effort of the individual with an electrical stimulation pattern that, together with the effort of the individual, will be sufficient to prevent an onset of incontinence. Numbered embodiment 80 comprises the method of embodiment 79, wherein a response from the individual is not sufficient by itself to prevent an onset of incontinence, and the electrical stimulation signal is such that when applied, the electrical stimulation signal plus the response is sufficient to prevent an onset of incontinence. Numbered Example 81 includes the method of any one of Examples 77 to 80, wherein the onset of incontinence includes urinary incontinence. Numbered Example 82 includes the method of Examples 77 or 80, wherein the onset of incontinence includes fecal incontinence. Numbered Example 83 includes the method of any one of Examples 77 to 80, wherein the onset of incontinence includes urinary stress incontinence. Numbered Example 84 includes the method of any one of Examples 77 to 83, wherein the parameter is a signal from a sensor electrode configured to sense a muscle contraction of an individual associated with a partial contraction of a sphincter that controls bladder or bowel discharge. Numbered Example 85 includes the method of any one of Examples 77 to 84, wherein the electrical stimulation signal is used for electrical stimulation of the pudendal nerve. Numbered Example 86 includes the method of any one of Examples 77 to 85, wherein the electrical stimulation signal is synthesized to include a constant electrical stimulation component and a component specific to the measurement parameter. Numbered Example 87 includes the method of any one of Examples 77 to 86, wherein the onset of incontinence is urinary incontinence and is of the urge incontinence type. Numbered embodiment 88 includes the method of any of embodiments 77 to 87, wherein the intensity or duration of the electrical stimulation provided by the electrical stimulation signal varies according to the value of the received parameter. Numbered embodiment 89 includes the method of any of embodiments 77 to 88, wherein the parameter is an EMG signal. Numbered embodiment 90 includes the method of embodiment 89, wherein the EMG signal determines that a contraction of at least one pelvic muscle has occurred. Numbered embodiment 91 includes the method of embodiment 9066, wherein 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 of embodiments 77 to 91, wherein the electrical stimulation signal includes a first signal and a second signal for stimulating a first pudendal nerve and a second pudendal nerve, respectively.Numbered embodiment 93 includes the method of any of embodiments 77 to 92, further comprising recording a signal previously measured by the sensor electrode. Numbered embodiment 94 includes the method of embodiment 93, further comprising synthesizing an adjustment signal to adjust the sensor electrode in response to the recorded signal.

[0165] Example

[0166] Example 1: EMG measurement reproducibility

[0167] like Figures 11A-11E As shown, using the systems, methods and devices described herein, patient EMG signals are measured and processed when the patient performs muscle contraction, coughing and Valsalva maneuvers. For each patient, raw EMG data 1102 is recorded and amplified, as described elsewhere herein. Subsequently, the raw EMG data is filtered 1106, corrected and smoothed 1104.

[0168] according to Figures 11A-11C In the data shown in , where a single 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 reproducibility of the sensor electrodes of the device and system described herein and the potential ability of the trained classifier to distinguish EMG signals in time. Similarly, Figures 11D-11E The data for different patients shown in Figures 11A-11C Similar results were found in patients with

Claims

1. A system for preventing the onset of incontinence in an individual in need thereof, the system comprising: (a) an implantable sensor electrode configured to sense a parameter associated with a response from the individual intended to prevent an episode of incontinence; (b) an implantable stimulator electrode configured to provide electrical stimulation; (c) a processor operably coupled to the sensor electrodes and the stimulator electrodes; and (d) a non-transitory computer-readable storage medium comprising software configured to cause the processor to: (i) receiving a parameter associated with a response from said individual intended to prevent an onset of said incontinence; (ii) analyzing parameters associated with a response from said individual aimed at preventing the onset of said incontinence; and (iii) causing the stimulator electrode to provide electrical stimulation to the individual, wherein a level of the electrical stimulation provided varies based on the sensed response such that the electrical stimulation prevents the onset of incontinence based on a response from the individual intended to prevent the onset of incontinence.

2. A system for preventing the onset of incontinence in an individual in need thereof, the system comprising: (a) an implantable sensor electrode configured to sense a parameter associated with a response from the individual intended to prevent an episode of incontinence; (b) an implantable stimulator electrode configured to provide electrical stimulation and a constant or basal electrical stimulation at a lower level than the electrical stimulation, the constant or basal electrical stimulation having a lower frequency, amplitude, current, or a combination thereof; (c) a processor operably coupled to the sensor electrodes and the stimulator electrodes; and (d) a non-transitory computer-readable storage medium comprising software configured to cause the processor to: (i) receiving a parameter associated with a response from said individual intended to prevent an onset of said incontinence; (ii) analyzing parameters associated with a response from said individual aimed at preventing the onset of said incontinence; and (iii) causing the stimulator electrodes to provide electrical stimulation to the individual such that the electrical stimulation prevents the onset of incontinence based on a response from the individual intended to prevent the onset of incontinence.

3. A system for preventing the onset of incontinence in an individual in need thereof, the system comprising: (a) an implantable sensor electrode configured to sense a parameter associated with a response from the individual intended to prevent an episode of incontinence; (b) an implantable stimulator electrode configured to provide electrical stimulation; (c) a processor operably coupled to the sensor electrodes and the stimulator electrodes; and (d) a non-transitory computer-readable storage medium comprising software configured to cause the processor to: (i) receiving a parameter associated with a response from said individual intended to prevent an onset of said incontinence; (ii) analyzing parameters associated with a response from said individual aimed at preventing the onset of said incontinence; and (iii) causing said stimulator electrodes to provide electrical stimulation to said individual intended to prevent the onset of said incontinence, wherein the response itself is insufficient to prevent the onset of the incontinence, and wherein the electrical stimulation prevents the onset of the incontinence based on the response.

4. A system according to claim 1, 2 or 3, wherein: The episodes of incontinence include urinary incontinence or fecal incontinence or a combination thereof.

5. A system according to claim 1, 2 or 3, wherein: The episodes of incontinence include urinary stress incontinence or urinary urge incontinence or a combination thereof.

6. A system according to claim 1, 2 or 3, wherein: The individual suffers from mixed type urinary incontinence.

7. A system according to claim 1, 2 or 3, wherein: The level of electrical stimulation provided in step (iii) is varied depending on the response sensed by the sensor.

8. The system of claim 1, 2 or 3, wherein: The stimulator electrode provides electrical stimulation to the pudendal nerve of the individual.

9. The system of claim 1, 2 or 3, wherein: The stimulator electrodes include a first stimulator electrode and a second stimulator electrode, wherein the first stimulator electrode stimulates one area on the pudendal nerve and the second stimulator electrode stimulates a different area on the pudendal nerve.

10. The system of claim 1, 2 or 3, wherein: The software is configured to adjust the sensor electrode's response to the signal.

11. The system of claim 1, 2 or 3, wherein: The software includes a machine learning model, and wherein the machine learning model is configured to classify signals detected by the sensor electrodes and generate signals with the stimulator electrodes.

12. A non-transitory computer readable storage medium comprising software for preventing an episode of incontinence in an individual in need thereof, the software configured to cause a processor to: (a) receiving, via implantable sensor electrodes, parameters associated with a response from the individual intended to prevent an episode of incontinence; (b) analyzing parameters associated with a response from the individual intended to prevent an episode of incontinence; and (c) causing an implantable stimulator electrode to provide electrical stimulation to the individual, wherein a level of the electrical stimulation provided is varied based on the sensed response such that the electrical stimulation prevents the onset of incontinence based on the response from the individual intended to prevent the onset of incontinence.

13. A non-transitory computer readable storage medium comprising software for preventing an episode of incontinence in an individual in need thereof, the software configured to cause a processor to: (a) causing an implantable stimulator electrode to provide a constant or basal electrical stimulation having a relatively low frequency, amplitude, current, or a combination thereof; (b) receiving, via implantable sensor electrodes, parameters associated with a response from the individual intended to prevent an episode of incontinence; (c) analyzing parameters associated with a response from the individual intended to prevent an episode of incontinence; and (d) causing the stimulator electrodes to provide electrical stimulation to the individual such that the electrical stimulation prevents the onset of incontinence based on a response from the individual intended to prevent the onset of incontinence, wherein The electrical stimulation is at a higher level than the constant or basal electrical stimulation.

14. A non-transitory computer readable storage medium comprising software for preventing an onset of incontinence in an individual in need thereof, the software configured to cause a processor to: (a) receiving, via implantable sensor electrodes, parameters associated with a response from the individual intended to prevent an episode of incontinence; (b) analyzing parameters associated with a response from the individual intended to prevent an episode of incontinence; and (c) causing an implantable stimulator electrode to provide electrical stimulation to the individual such that the electrical stimulation prevents the onset of incontinence based on a response from the individual intended to prevent the onset of incontinence, wherein The reaction itself is not sufficient to prevent the onset of incontinence.

15. The non-transitory computer-readable storage medium of claim 12, 13 or 14, wherein: The episodes of incontinence include urinary incontinence or fecal incontinence or a combination thereof.

16. The non-transitory computer-readable storage medium of claim 12, 13 or 14, wherein: The episodes of incontinence include urinary stress incontinence or urinary urge incontinence or a combination thereof.

17. The non-transitory computer-readable storage medium of claim 12, 13 or 14, wherein: The individual suffers from mixed type urinary incontinence.

18. The non-transitory computer-readable storage medium of claim 12, 13 or 14, wherein: The stimulator electrode provides electrical stimulation to the pudendal nerve of the individual.

19. The non-transitory computer-readable storage medium of claim 12, 13 or 14, wherein: The stimulator electrodes include a first stimulator electrode and a second stimulator electrode, wherein the first stimulator electrode stimulates one area on the pudendal nerve and the second stimulator electrode stimulates a different area on the pudendal nerve.

20. The non-transitory computer-readable storage medium of claim 12, 13 or 14, wherein: The software is configured to adjust the sensor electrode's response to the signal.

21. The non-transitory computer-readable storage medium of claim 12, 13 or 14, wherein: The software includes a machine learning model, and wherein the machine learning model is configured to classify signals detected by the sensor electrodes and generate signals with the stimulator electrodes.

22. A data processing method, the method comprising: (a) receiving a measurement of a parameter previously measured by an implantable sensor electrode, the parameter predicting an onset of incontinence in an individual; (b) analyzing said parameters; and (c) synthesizing an electrical stimulation signal for the individual such that when the electrical stimulation signal is provided to the individual by an implantable stimulator electrode, the level of electrical stimulation provided varies as a function of the sensed response such that the electrical stimulation signal prevents the onset of incontinence based on efforts from the individual intended to prevent the onset of incontinence.

23. A data processing method, the method comprising: (a) providing constant or basal electrical stimulation with an implantable stimulator electrode, the constant or basal electrical stimulation having a relatively low frequency, amplitude, current, or a combination thereof; (b) receiving a measurement of a parameter previously measured by an implantable sensor electrode, the parameter predicting the onset of incontinence in the individual; (c) analyzing said parameters; and (d) synthesizing an electrical stimulation signal for the individual such that when the electrical stimulation signal is provided to the individual by an implantable stimulator electrode, the electrical stimulation signal prevents an onset of incontinence based on efforts from the individual intended to prevent an onset of incontinence, wherein the electrical stimulation is at a higher level than the constant or basal electrical stimulation.

24. A data processing method, the method comprising: (a) receiving a measurement of a parameter previously measured by an implantable sensor electrode, the parameter predicting the onset of incontinence in an individual; (b) analyzing said parameters; and (c) synthesizing an electrical stimulation signal for the individual such that when the electrical stimulation signal is provided to the individual by an implantable stimulator electrode, the electrical stimulation signal prevents the onset of incontinence based on efforts from the individual intended to prevent the onset of incontinence, wherein the efforts themselves are insufficient to prevent the onset of incontinence.

25. The method of claim 22, 23 or 24, wherein: The episodes of incontinence include urinary incontinence or fecal incontinence or a combination thereof.

26. The method of claim 22, 23 or 24, wherein: The episodes of incontinence include urinary stress incontinence or urinary urge incontinence or a combination thereof.

27. The method of claim 22, 23 or 24, wherein: The individual suffers from mixed type urinary incontinence.

28. The method of claim 22, 23 or 24, wherein: The stimulator electrode provides electrical stimulation to the pudendal nerve of the individual.

29. The method of claim 22, 23 or 24, wherein: The stimulator electrodes include a first stimulator electrode and a second stimulator electrode, wherein the first stimulator electrode stimulates one area on the pudendal nerve and the second stimulator electrode stimulates a different area on the pudendal nerve.

30. The method of claim 22, 23 or 24, wherein: The sensor electrodes and the stimulator electrodes are operably coupled to a processor and a non-transitory computer-readable medium comprising software, and wherein the software is configured to adjust a response of the sensor electrodes to a signal.

31. The method according to claim 30, wherein: The software includes a machine learning model, and wherein the machine learning model is configured to classify signals detected by the sensor electrodes and generate signals with the stimulator electrodes.

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