Devices for treating incontinence

Abstract

The present invention relates to a device for the prevention and / or treatment of fecal and / or urinary incontinence. The device may fit within the vagina. The device may include a pressure sensor and electrodes. The device may include lateral protrusions on the device and / or an outer shell of the device. In response to intra-abdominal pressure, the device may apply electrical stimulation, for example, to the vaginal mucosa with the electrodes.

Description

[Technical Field]

[0001] <Related Applications> This application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application No. 63,422,055, filed November 3, 2022, which is incorporated herein by reference in its entirety.

[0002] The present invention, in some embodiments thereof, relates to devices for the prevention and / or treatment of incontinence, particularly but not exclusively in women.

[0003] The occasional loss or leakage of urine, referred to as urinary incontinence (UI), is one of the most common bladder control problems thought to affect millions of people. Urinary incontinence can be caused by, for example, loss of muscle tone due to age and disease, injury during childbirth, increased intra-abdominal pressure due to pregnancy or obesity, injury to the bladder or nearby areas during surgery, neurological conditions affecting the brain and spinal cord such as Parkinson's disease or multiple sclerosis, conditions affecting the lower urinary tract (urethra and bladder) such as a urinary tract infection (UTI) or bladder tumor, certain medications such as angiotensin-converting enzyme (ACE) inhibitors, diuretics, some antidepressants, hormone replacement therapy (HRT), and sedatives.

[0004] There are various types of urinary incontinence, for example, urge, stress, functional, and overflow incontinence.

[0005] Stress incontinence - Urine leaks when the bladder is under pressure, for example, when coughing, sneezing, or laughing. This can be caused by a lack of support for the bladder neck and / or a weakened pelvic floor. In this situation, the unsupported bladder neck is unable to contain urine when intra-abdominal pressure increases.

[0006] Urge incontinence - A strong urge to urinate or a short while afterwards can lead to leakage of urine. This can be caused by involuntary detrusor contractions that result in increased intravesical (bladder) pressure, a condition known as detrusor overactivity.

[0007] Overflow incontinence (chronic urinary retention) – This occurs when a person is unable to empty their bladder completely, which can cause frequent leakage.

[0008] Total incontinence - The bladder is unable to store urine at all, causing constant passing or frequent leakage.

[0009] In many cases, both stress and urge incontinence are present, and whichever type predominates is known as mixed incontinence.

[0010] Additionally, bowel incontinence, or fecal incontinence, occurs when a person has problems controlling their bowels. Fecal incontinence can be caused by severe or prolonged constipation or diarrhea, irritable bowel syndrome (IBS), inflammatory bowel diseases such as Crohn's disease, severe hemorrhoids (hemorrhoids), childbirth or surgery that damages the muscles or nerves used to control the bowels, diabetes, stroke, or conditions that can affect the nerves, such as spina bifida.

[0011] Urinary and fecal incontinence can occur in the same individual.

[0012] Current treatment methods for managing urinary and / or fecal incontinence include behavioral therapy, pelvic floor exercises, medication, neurostimulation, and surgery.

[0013] Therefore, there is a need for means to prevent and / or treat urinary and / or fecal incontinence. Summary of the Invention

[0014] According to an aspect of some embodiments of the present invention there is provided an electrical stimulation device for stimulating the pelvic floor, the electrical stimulation device including: electrodes configured to be in intimate contact with a vaginal or rectal mucosa; a sensor for detecting urinary activity; and a processor configured to receive signals from the pressure sensor and to direct electrical stimulation of the pelvic floor by the electrodes in response to detection by the pressure sensor of an increase in intra-abdominal pressure.

[0015] According to some embodiments of the present invention, the urinary-related activity includes at least one of intra-abdominal pressure, pelvic floor contractions, and pelvic floor myoelectric activity.

[0016] According to some embodiments of the present invention, the sensor includes a pressure sensor.

[0017] According to some embodiments of the invention, the processor and electrodes are configured to respond to sensors that sense increased pelvic floor muscle activity by stimulating the pelvic floor muscles with positive feedback.

[0018] According to some embodiments of the present invention, the positive feedback inhibits the bowel movement reflex.

[0019] According to some embodiments of the present invention, the length of the device is adaptable to fit the length of the vagina.

[0020] According to some embodiments of the present invention, the diameter and / or lateral projections from the device are adaptable to fit the width of the vagina.

[0021] According to some embodiments of the present invention, the device further comprises an edge.

[0022] According to some embodiments of the present invention, the edges of the device are flexible.

[0023] According to some embodiments of the present invention, the flexibility of the edges facilitates insertion or removal of the device.

[0024] According to some embodiments of the present invention, the device is configured to strengthen the pelvic floor and treat mild to moderate pelvic floor prolapse.

[0025] According to some embodiments of the present invention, the device further comprises a wireless communication module for transmitting data to and receiving signals from an external computer to adjust stimulation parameters.

[0026] According to some embodiments of the invention, the device further comprises a body configured to support the vaginal wall at the level of the bladder neck above the pubic bone.

[0027] According to some embodiments of the present invention, the device further comprises a flexible body that is reversibly deformed by an increase in intra-abdominal pressure.

[0028] According to some embodiments of the invention, the reversible deformation is a reversible reduction in the anterior-posterior diameter of the body of at least 5% when the intra-abdominal pressure increases by at least 1 / 10 bar.

[0029] According to some embodiments of the present invention, the body has an axially compressible region.

[0030] According to some embodiments of the present invention, the body includes a lateral protrusion.

[0031] According to some embodiments of the present invention, the lateral protrusions include a rim around the body of the device.

[0032] According to some embodiments of the present invention, the device further comprises lateral protrusions configured to support the bladder neck.

[0033] According to some embodiments of the invention, the device further includes a detachment sled depending aft from the device, the detachment sled including an antenna for wireless communication.

[0034] According to some embodiments of the present invention, the device further includes a wireless communication module.

[0035] According to some embodiments of the present invention, sensor recordings, stimulation parameters and timing are transmitted wirelessly to an external computing device, which includes a user interface for controlling the device.

[0036] According to some embodiments of the present invention, the pressure sensor is selected from the group consisting of a strain gauge, a piezoelectric crystal, a piezoelectric film, a balloon, and any combination thereof.

[0037] According to some embodiments of the invention, the device further comprises one or more additional sensors selected from the group consisting of accelerometer, position, tilt, photoplethysmography, bioimpedance, echomyography, and any combination thereof.

[0038] According to some embodiments of the invention, the processor is configured to administer the electrical stimulation in a manner that strengthens the pelvic floor muscles.

[0039] According to some embodiments of the present invention, the processor is configured to administer the electrical stimulation in a manner that produces neuromodulation.

[0040] According to some embodiments of the present invention, the neuromodulation comprises a reflex contraction of the pelvic floor upon an increase in intra-abdominal pressure.

[0041] According to some embodiments of the invention, the neuromodulation comprises inhibition of the urge to urinate or defecate.

[0042] According to some embodiments of the present invention, the electrical stimulation causes neuromodulation that initiates elimination or defecation.

[0043] According to an aspect of some embodiments of the present invention there is provided a method for non-invasive electrical stimulation of pelvic floor muscles, the method including sensing an increase in intra-abdominal pressure and, in response to the sensing, applying electrical stimulation to the pelvic floor muscles by at least one electrode in contact with a mucosa of the vagina or rectum, causing the pelvic floor muscles to contract in response to the electrical stimulation.

[0044] According to some embodiments of the present invention, the method further comprises repeatedly sensing and electrically stimulating to induce a reflex that automatically contracts the pelvic floor upon an increase in intra-abdominal pressure.

[0045] According to some embodiments of the present invention, the electrical stimulation reduces at least one of the frequency and urgency of urination.

[0046] According to some embodiments of the invention, the method further comprises repeating the sensing and electrical stimulation to strengthen the pelvic floor muscles.

[0047] According to some embodiments of the invention, the method further comprises controlling the electrical stimulation with a processor connected to the at least one pressure sensor and the at least one electrode.

[0048] According to some embodiments of the present invention, the processor further includes an artificial intelligence (AI) module.

[0049] According to some embodiments of the invention, the method further includes determining with an AI module when an urgent risk of urinary or fecal leakage is high.

[0050] According to some embodiments of the invention, the method further comprises instructing at least one electrode to provide an electrical stimulus in response to the determining.

[0051] According to an aspect of some embodiments of the present invention, there is provided a system for electrical stimulation of pelvic floor muscles, the system comprising: an insertable device for insertion into the vagina, the insertable device including electrodes configured to be in intimate contact with a vaginal or rectal mucosa, a sensor for detecting urinary activity, a wireless communication module, and a processor configured to receive signals from a pressure sensor and to induce electrical stimulation of the pelvic floor by the electrodes in response to detection of an increase in intra-abdominal pressure by the pressure sensor; and a user interface wirelessly linked to the processor, the user interface being an application on an external computer.

[0052] According to some embodiments of the present invention, the urinary-related activity includes at least one of intra-abdominal pressure, pelvic floor contractions, and pelvic floor myoelectric activity.

[0053] According to some embodiments of the present invention, the wireless communication module is configured to transmit and receive data to and from an external computer to adjust stimulation parameters.

[0054] According to some embodiments of the present invention, the external computer includes a user interface configured to collect feedback from the user regarding at least one of the occurrence of incontinent episodes, the severity of the incontinent episodes, and the circumstances of the incontinent episodes.

[0055] According to some embodiments of the present invention, the external computer is configured to use these data to adjust stimulation parameters.

[0056] According to some embodiments of the invention, the external computer is configured to present data to the user relating to at least one of pelvic floor strength, improvement over time, and improvement relating to incontinence treatment.

[0057] According to some embodiments of the present invention, the external computer is configured to use data from multiple users for reconciliation.

[0058] According to some embodiments of the present invention, the external computer is configured to use data from multiple users to train the machine learning routine.

[0059] According to some embodiments of the present invention, the method includes at least one of vector machines and reinforcement learning.

[0060] According to some embodiments of the present invention, the user interface is configured to facilitate wireless activation, control, and / or programming of one or more parameters of the insertable device.

[0061] According to some embodiments of the present invention, the one or more parameters are selected from the group consisting of a cutoff value, voltage, current strength, stimulation pulse shape and duration, duty cycle, modulation, session duration, pattern of the pressure sensor signal inducing the electrical stimulation, and any combination thereof.

[0062] According to some embodiments of the present invention, the external computer is a mobile phone, a tablet, a phablet, a laptop, a desktop, a smartwatch, smart glasses, or a VR device.

[0063] According to some embodiments of the present invention, the external computer is configured to analyze, store, and graphically present to the user the cumulative electrical stimulation data, the cumulative sensor data, data changes, and data trends. [Brief explanation of the drawings]

[0064] Some embodiments of the present invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference to the drawings in detail, it is emphasized that the details shown are by way of example and are for the purpose of illustrating embodiments of the invention. In this regard, the description using the drawings will make apparent to those skilled in the art how embodiments of the invention may be practiced.

[0065] In the drawings, [Figure 1] FIG. 1 is a schematic side view of an intravaginal device, according to some embodiments. [Figure 2] FIG. 1 is a schematic side view of an intravaginal device, according to some embodiments. [Figure 3] 1A-1D are side views of various intravaginal devices, according to some embodiments. [Figure 4] 1 is an exemplary image of a user interface on an external computing device according to some embodiments. [Figure 5] 1 is a schematic cutaway view of an intravaginal device according to some embodiments. [Figure 6] FIG. 1 is a schematic perspective view of an intravaginal device, according to some embodiments. [Figure 7] FIG. 1 is a schematic diagram of an intravaginal device positioned within the cervix, according to some embodiments. [Figure 8] FIG. 1 is a block diagram of an intravaginal device, according to some embodiments. [Figure 9A] 1 is a flowchart of a method for treating and / or preventing stress urinary incontinence, according to some embodiments. [Figure 9B] 1 is a flowchart of a longitudinal method for treating and / or preventing stress urinary incontinence, according to some embodiments. [Figure 10A] 1 is a flowchart of a method for treating and / or preventing urge incontinence, according to some embodiments. [Figure 10B] 1 is a flowchart of a longitudinal method for the treatment and / or prevention of urge urinary incontinence, according to some embodiments. [Figure 11A] 1 is a flowchart of a method for treating and / or preventing pelvic organ prolapse, according to some embodiments. [Figure 11B] 1 is a flowchart of a method for treating and / or preventing pelvic organ prolapse, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0066] The present invention, in some embodiments thereof, relates to devices for the prevention and / or treatment of incontinence, particularly but not exclusively in women.

[0067] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Exemplary methods and / or materials are described below; however, methods and materials similar or equivalent to those described herein may be used in the practice or testing of embodiments of this invention. In case of conflict, the patent specification, including definitions, will control. Additionally, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0068] <Summary> Some embodiments relate to systems and methods for preventing and / or treating incontinence. According to some embodiments, the incontinence may be urinary and / or fecal incontinence. According to some embodiments, the user may be biologically female.

[0069] In some embodiments, the present invention combines behavioral therapy, mechanical support, and / or electrical stimulation. Further advantageously, some embodiments relate to an electromechanical device including a sensor. Optionally, the sensor may measure an indicator of urinary-related activity. For example, the sensor may measure intra-abdominal pressure, pelvic floor contractions, and / or myoelectric activity (e.g., of the pelvic floor). According to some embodiments, the device may apply one or more electrical signals. For example, the signals may support the bladder neck and / or stimulate muscles to close the bladder neck. The signals may be started, stopped, and / or adjusted in response to the indicator of urinary-related activity. For example, in response to an increase in intra-abdominal pressure, the device may stimulate muscles to support the bladder neck. According to some embodiments, the device may advantageously have various sizes (e.g., widths, heights, etc.), different coverings, and / or various protrusions.

[0070] In some embodiments, the shape may be adapted and / or may be adaptable, for example, to retain the device in the vagina and / or ensure good contact and / or prevent fallout. Optionally, the length and / or width of the device may be adapted and / or protrusions from the device may be adaptable. For example, the device may have a replaceable outer shell. Optionally, the outer shell may be thicker and / or thinner and / or include protrusions, for example, to fit the width of the vagina. Optionally, the outer shell may include longitudinal extensions, for example, to fit the length of the vagina. Optionally, the outer shell may include lateral extension edges.

[0071] According to some embodiments, the device may be inserted intravaginally and / or intraanally. According to some embodiments, the device may be in intimate contact with the mucosa and / or walls of the vagina and / or rectum. According to some embodiments, the device may be non-penetrating. According to some embodiments, the device may provide electrical stimulation. According to some embodiments, the electrical stimulation may extend to the pelvic floor. According to some embodiments, the electrical stimulation may extend to one or more of the S1-S4 dermatomes, the vaginal wall, the rectal wall, and / or the perineum.

[0072] According to some embodiments, the device may include a body comprising one or more electrodes, one or more pressure sensors, and a processor. According to some embodiments, the one or more electrodes may be in intimate contact with the mucosa and / or walls of the vagina and / or rectum.

[0073] According to some embodiments, the device can be worn without concern of it becoming dislodged and / or affecting the user's daily activities. According to some embodiments, the device may be easily inserted by the user. According to some embodiments, the device may have a rounded tip to facilitate insertion. According to some embodiments, the device may be easily removed by the user. According to some embodiments, the device may include a removal thread, loop, and / or tab. According to some embodiments, the removal thread, loop, and / or tab may be integrated into and / or attached to the body of the device.

[0074] According to some embodiments, the body may be flexible. According to some embodiments, the body may be reversibly deformed by an increase in intra-abdominal pressure. According to some embodiments, reversibly flexible means that the anterior-posterior diameter can be reduced by at least 5% when the intra-abdominal pressure is increased by at least 0.01 bar, and / or the diameter can be reduced by at least 1% with an increase in pressure of at least 0.01 bar.

[0075] According to some embodiments, the body may support the vaginal wall at the level of the bladder neck above the pubic bone. According to some embodiments, the body may include one or more lateral protrusions and / or edges in the caudal portion for supporting the bladder neck. According to some embodiments, the cranial segment of the body may include an axially compressible region to accommodate vaginas of various lengths and / or position the caudal edge above the pubic bone. Alternatively or additionally, the length and / or width of the device and / or its edges may be adjusted, for example, by changing an interchangeable outer shell.

[0076] According to some embodiments, the shape of the body may be conical and / or oval, and / or shaped as an elongated egg. Optionally, the device includes one or more protrusions (e.g., protrusion rings). For example, the protrusions may be present on a caudal portion of the device. Optionally, the caudal side of the device may be wider than the cranial side. Optionally, holes may be present on the caudal side and / or below the protrusions. For example, a removal thread may be connected to the hole. According to some embodiments, the body may have a rounded tip to facilitate insertion. According to some embodiments, the body may include a central passageway.

[0077] According to some embodiments, the body may include one or more additional sensors. According to some embodiments, the one or more additional sensors may be selected from the group including accelerometer, position, tilt, photoplethysmography, bioimpedance, ultrasound electromyography, etc.

[0078] According to some embodiments, one or more pressure sensors may detect intra-abdominal pressure. According to some embodiments, the pressure sensors may be from a group including strain gauges, piezoelectric crystals, piezoelectric films, etc.

[0079] According to some embodiments, the measured pressure may be communicated to a processor. According to some embodiments, the processor may activate one or more electrodes to provide electrical stimulation in response to the detected intra-abdominal pressure. According to some embodiments, the processor may be programmed to generate electrical stimulation when an increase in intra-abdominal pressure that precedes impending urinary or fecal leakage is detected by the pressure sensor. According to some embodiments, the processor may be programmed to generate electrical stimulation when a signal from the pressure sensor that precedes impending urinary or fecal leakage is detected.

[0080] According to some embodiments, one or more pressure sensors may detect an increase in intra-abdominal pressure, thereby inducing electrical stimulation of the pelvic floor.

[0081] According to some embodiments, the body may include a battery. Optionally, the battery may be rechargeable.

[0082] In some embodiments, the body may include a wireless communication module. Optionally, the wireless communication module may include an antenna, a Bluetooth connection, a Wi-Fi connection, etc. In some embodiments, the detachment sled may include a Wi-Fi transmitter and / or an antenna for wireless communication.

[0083] In some embodiments, the device may wirelessly communicate with a user interface, a data storage module, and / or a cloud interface and / or data storage. In some embodiments, the device may be initiated and / or configured and / or controlled through the user interface. In some embodiments, the user interface may be an application (app) on an external computing device. In some embodiments, the external computing device may be a mobile phone, tablet, phablet, laptop, desktop, smartwatch, smartglasses, VR device, etc. In some embodiments, sensor data, sensor recordings, stimulation parameters, and timing may be wirelessly transmitted to the external computing device.

[0084] According to some embodiments, the App may facilitate wireless initiation, control, and programming of the device, e.g., cutoff values ​​for sensor inputs that induce electrical stimulation sessions. According to some embodiments, the App may facilitate wireless initiation, control, and / or programming of one or more parameters, such as, but not limited to, voltage, current intensity, stimulation pulse shape and duration, duty cycle, modulation, session duration, pattern, etc. According to some embodiments, the user may introduce comments, notifications, etc. at different times.

[0085] According to some embodiments, the electrical stimulation may be collected and / or stored by a processor, an app, and / or a cloud connected thereto. According to some embodiments, cumulative electrical stimulation data and / or cumulative sensor data and / or changes and / or trends in the data over time may be analyzed, stored, or presented to a user, for example, graphically. In certain embodiments, the data may be wirelessly transmitted to other devices.

[0086] In some embodiments, the external computer includes a user interface configured to collect feedback from the user regarding at least one of the occurrence of incontinent episodes, the severity of incontinent episodes, and / or the status of the incontinent episodes. For example, the status may include quality of life impacts, e.g., feelings of embarrassment, isolation, and / or depression. For example, the quality of life impacts may be difficulty participating in activities such as exercise, work, and social gatherings. Alternatively or additionally, the quality of life status may include stigma and / or concerns about being judged or ridiculed. Additionally or alternatively, the quality of life status may include financial burdens, e.g., costs for incontinent pads, diapers, and / or other medical supplies can add up quickly. Costs may also include costs for doctor's visits, tests, and / or treatments. Situational factors may also include personal factors that may contribute to female incontinence, such as age, pregnancy, childbirth, menopause, medical conditions (e.g., diabetes, neuropathy, and multiple sclerosis), obesity, habits (e.g., regular smoking and alcohol use), and / or family history.

[0087] In some embodiments, the external computer is configured to use these data to adjust stimulation parameters. For example, the external computer may include routines that calculate stimulation parameters to better control incontinence and / or reduce negative side effects based on data from the sensors and / or feedback from the user and / or other data (e.g., data from other users and / or data from medical staff and / or data from medical databases). In some embodiments, the external computer and app are configured to present data to the user, such as pelvic floor strength, improvement over time, and / or improvement in incontinence and / or change in treatment over time. Optionally, the external computer is configured to use data from the sensors, the user, multiple users, and / or other sources to train a machine learning routine. In some embodiments, the machine learning routine includes vector machines and / or reinforcement learning.

[0088] According to some embodiments, the processor may be programmable to generate an electrical stimulation signal upon an increase in intra-abdominal pressure or upon a sudden increase in intra-abdominal pressure that may lead to leakage of urine or stool.

[0089] According to some embodiments, the processor may be programmable to generate an electrical stimulation signal upon a signal from the sensor that precedes an impending urinary or fecal leakage.

[0090] According to some embodiments, an artificial intelligence (AI) module, such as a convolutional neural network (CNN), vector machine, machine learning, or the like, may be used to analyze and / or learn from the sensor data and / or determine whether urgent urinary or fecal leakage is likely. According to some embodiments, the AI ​​module may, for example, instruct a processor to stimulate the pelvic floor if it is determined that urgent urinary or fecal leakage is likely.

[0091] According to some embodiments, the device may be calibrated for each user. According to some embodiments, calibration may include determining a cutoff value of sensor data prior to urgency to leak urine or feces for triggering electrical stimulation of the pelvic floor. According to some embodiments, calibration may include determining the electrical stimulation required to prevent and / or reduce urgency to leak urine or feces. According to some embodiments, calibration may include determining a treatment program to prevent and / or reduce urgency to leak urine or feces.

[0092] According to some embodiments, the device may be used for neuromodulation. According to some embodiments, neuromodulation may include triggering a reflex contraction of the pelvic floor in the event of increased intra-abdominal pressure or other physical conditions that may result in leakage of urine and / or stool. According to some embodiments, the device may be used for neuromodulation to inhibit a strong urge to urinate or defecate. According to some embodiments, the device may be used for neuromodulation to initiate elimination and / or defecation.

[0093] According to some embodiments, the device may be used to strengthen the pelvic floor. According to some embodiments, the device may be used to treat mild to moderate pelvic prolapse by strengthening the pelvic floor.

[0094] In some embodiments, the device may exercise the user's muscles (e.g., pelvic floor, urethral sphincter, etc.). In some embodiments, the device may strengthen the user's muscles over time. In some embodiments, the device may thereby reduce and / or prevent leakage of urine and / or feces. In some embodiments, the device may train appropriate responses to urine and / or feces.

[0095] Some embodiments relate to a method for non-invasive electrical stimulation of the pelvic floor, comprising sensing a condition that may lead to urinary or fecal incontinence, applying electrical stimulation to the pelvic floor muscles by contacting electrodes on the body of the device to the S1-S4 dermatomes or the walls of the vagina or rectum, and preventing urinary or fecal incontinence or suppressing the urge to defecate or have a bowel movement.

[0096] Some embodiments relate to a system for stimulating the pelvic floor with an electrical current, comprising one or more electrodes in contact with the vaginal mucosa, rectal mucosa, perineum, and / or S1-S4 dermatomes, and at least one sensor for detecting intra-abdominal pressure, wherein detection of an increase in intra-abdominal pressure by the sensor induces electrical stimulation of the pelvic floor to prevent urinary or fecal incontinence.

[0097] <Specific embodiment> Before describing at least one embodiment of the present invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of components and / or methods set forth in the following description and / or illustrated in the drawings and / or examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0098] Referring now to the drawings,

[0099] FIG. 1 is a schematic side view of an intravaginal device according to some embodiments. For example, the device may include a body 11 having a rounded cranial tip 14 and / or a rounded caudal tip 15. Optionally, the body 11 is completely or partially covered by a flexible outer shell 10. For example, the outer shell 10 may cover the cranial portion of the body 11 and / or leave the electrodes 12a and 12b exposed on the outer surface of the body 11. For example, the electrode 12a may be charged with an opposite charge from the electrode 12b. In some embodiments, the outer shell 10 may include one or more protrusions 16, e.g., the protrusions 16 may surround the caudal portion of the shell 10 and / or protrude laterally from the caudal portion of the shell 10. Optionally, the protrusions 16 are configured to support the bladder neck of a user of the device. In some embodiments, the outer shell 10 may be removable and / or replaced with a different shell, e.g., to fit a differently shaped vagina. Optionally, a removal thread 18 is attached to the caudal portion of the body 11 .

[0100] In some embodiments, the electrical stimulus may be in the range of 5-15 volts and / or 1-5 volts and / or 0.1-1 volts and / or 15-100 volts.

[0101] In some embodiments, the electrical stimulation current may range from 1 to 5 milliamps and / or 0.1 to 1 milliamps, and / or 5 to 20 milliamps and / or 20 to 100 milliamps.

[0102] In some embodiments, the electrical stimulation current may be in the range of 10-50 Hz and / or 1-10 Hz and / or 50-250 Hz and / or 250-1000 Hz and / or 1000-20000 Hz.

[0103] According to some embodiments, the body may be flexible. Optionally, the body 11 and / or the outer shell 10 may be reversibly deformed by an increase in intra-abdominal pressure, for example, the anterior-posterior diameter of the body may be reduced by at least 1%, and / or at least 5%, and / or at least 10% when the intra-abdominal pressure increases by at least 0.01 bar.

[0104] FIG. 2 is a schematic side view of an intravaginal device according to some embodiments. For example, the device may include a body 21. In some embodiments, the body 21 may have an oval shape. The body 21 optionally includes a rounded cranial tip 28 and / or a rounded caudal tip 29. Optionally, the body 21 is completely or partially covered by a flexible outer shell 20. For example, the outer shell 20 may cover the cranial portion of the body 21 and / or leave the electrodes 24 exposed on the outer surface of the body 21. In some embodiments, the outer shell 20 may include one or more protrusions 22. Optionally, a detachment thread 26 is connected to the caudal portion of the body. One or more electrodes 24 and one or more electrodes. Optionally, one or more pressure sensors may be disposed on the surface of the body and / or under the outer shell 20. Optionally, one or more pressure sensors may be disposed under the outer shell of the body near its outer surface. Optionally, the detachment sled may include a wi-fi transmitter and / or antenna.

[0105] 3 shows a side view of multiple covers for an intravaginal device, according to some embodiments. For example, device 30 may include different interchangeable flexible shells 35 for covering the device. Optionally, different regions of device 30 may include different types of shells / surface coatings. Preferably, the shells / surface coatings may be anti-allergenic, non-toxic, and / or biocompatible. For example, shell 35 may be made from rubber and / or elastomer and / or plastic and / or silicone.

[0106] According to some embodiments, outer shell 35 may be different sizes to fit different vaginas and / or rectums. Optionally, device 30 and / or outer shell 35 may have a width ranging from about 1 cm to about 2 cm, and / or from 2 cm to about 3 cm, and / or from about 3 cm to about 5 cm, etc. Optionally, device 30 and / or outer shell 35 may have a length ranging from about 2 cm to about 3 cm, and / or from about 3 cm to about 5 cm, and / or from about 5 cm to about 8 cm, etc.

[0107] According to some embodiments, device 30 and / or shell 35 may include longitudinal protrusions 34. Optionally, different interchangeable shells may have protrusions 34 of various sizes. Optionally, longitudinal protrusions 34 have axial compressible regions and / or various lengths to accommodate vaginas of various lengths, and / or to position the caudal edge above the pubic bone. Optionally, the length of the axial compressible region may range from about 0 cm to about 1 cm, and / or from about 1 cm to about 2 cm, and / or from about 2 cm to about 3 cm, and / or from about 3 cm to about 5 cm.

[0108] According to some embodiments, the device 30 and / or the outer shell 35 may include one or more lateral protrusions. For example, the lateral protrusions may include a rim 32. For example, the rim 32 may be located on a caudal portion of the device 30 and / or may be part of a replaceable outer shell 35. For example, the rim 32 may be configured to support the bladder neck. Optionally, the lateral protrusions may include protrusions of various sizes and / or diameters and / or spacing distances. Optionally, the lateral protrusions may include ridges on the sides of the device. Optionally, the one or more lateral protrusions may help maintain the device 30 in place. Optionally, the one or more lateral protrusions may prevent descent of the bladder neck. Optionally, the lateral protrusions may improve contact between the sensors and / or electrodes and the tissue. For example, the protrusions may face the sensors and / or electrodes, thereby pressing the side sensors and / or electrodes against the tissue. Optionally, the protrusions and / or projections may be flexible and / or have shape memory (e.g., memory foam), e.g., flexibility facilitates insertion and / or removal of the device while holding the device in place during use.

[0109] FIG. 4 is an exemplary image of a user interface on an external computing device, according to some embodiments. For example, the inserted device may include a wireless communication module and / or may communicate wirelessly with the user interface 40, e.g., with an app on the external computing device. According to some embodiments, the external computing device may be a mobile phone, tablet, phablet, laptop, desktop, smartwatch, smartglasses, VR device, etc. According to some embodiments, sensor data, sensor recordings, stimulation parameters, and timing may be wirelessly transmitted to the external computing device. According to some embodiments, the device may be activated, and / or settings and / or setup may be controlled and / or adjusted, according to a wireless signal from the external computing device and / or under control of the user interface. Alternatively or additionally, the app on the external device may include instructions for automatically adjusting settings of the inserted device in response to data received from the inserted device. The automatic adjustments may be optionally adjustable and / or adjusted using the user interface of the external computing device.

[0110] According to some embodiments, the App may facilitate wireless initiation, control, and programming of the device, e.g., cutoff values ​​for sensor inputs that induce electrical stimulation sessions. According to some embodiments, the App may facilitate wireless initiation, control, and / or programming of one or more parameters, such as, but not limited to, voltage, current intensity, stimulation pulse shape and duration, duty cycle, modulation, session duration, pattern, etc. According to some embodiments, the user may introduce comments, notifications, etc. at different times.

[0111] According to some embodiments, the electrical stimulation may be collected and / or stored by a processor, an app, and / or a cloud connected thereto. According to some embodiments, cumulative electrical stimulation data and / or cumulative sensor data and / or changes and / or trends in the data over time may be analyzed, stored, and presented to a user, for example, graphically. In certain embodiments, the data may be wirelessly transmitted to other devices.

[0112] 5 is a schematic cutaway view of an intravaginal device, according to some embodiments. In some embodiments, the device has an oval-shaped body 57. For example, the device's body 57 may include holes 58 for attachment, such as through which a detachment string may be threaded. Optionally, the holes 58 may be located in a caudal portion of the body 57. In some embodiments, a battery 54, which may be optionally rechargeable, one or more pressure sensors 50, one or more electrodes 52, and a processor 56 may be mounted within the interior space of the body 57.

[0113] 6 is a schematic perspective view of a body 62 of an intravaginal device, according to some embodiments. According to some embodiments, the body 62 may include a central passageway 60 and / or lateral protrusions 63. For example, the protrusions 63 may surround a caudal portion of the body 62 and / or may be configured to support the user's bladder neck.

[0114] In certain embodiments, the cranial segment 64 of the body 62 may include an axially compressible region (2) that accommodates various vaginal lengths and positions the protrusion 63 (e.g., the caudal edge) above the pubic bone. In certain embodiments, the body 62 may include a detachment sled. In certain embodiments, the detachment sled includes an antenna for wireless communication.

[0115] 7 is a schematic diagram of an intravaginal device positioned within the cervix, according to some embodiments. For example, a device body 70 may be inserted into the cervix, and the device body may contact the vaginal mucosa and / or wall 71. An optional pressure sensor 72 on the device may detect intra-abdominal pressure. Data from the pressure sensor 72 may be analyzed by a processor 74, and electrical stimulation may be provided by one or more electrodes 78 to prevent urine or fecal leakage. Optionally, a wireless communication module and / or antenna 76 provides connection to an external device.

[0116] 8 is a block diagram of an intravaginal device 80 according to some embodiments. For example, the device may include a body 90 having a rounded tip, an axially compressible region, one or more lateral protrusions, and a detachment sled 88 that may include an antenna. The body may include one or more pressure sensors 82, one or more electrodes 86, a processor 84, and / or a battery (not shown).

[0117] 9A is a flowchart of a method 900 for treating and / or preventing stress urinary incontinence, according to some embodiments. Alternatively or additionally, the method may be used for other urinary problems. For example, in method 900, a device is inserted 92 into the vagina of a user with stress urinary incontinence 91. An increase in intra-abdominal pressure above a certain threshold is detected 93 by a sensor in the device. The device delivers electrical stimulation 94 to the pelvic floor, causing the pelvic floor to contract 95. For example, the contraction 95 may cause pressure of the pelvic floor and / or urethra against the edges of the device. Optionally, the contraction 95 and / or pressure inhibit and / or prevent leakage.

[0118] FIG. 9B illustrates a chronic method 901 of using the device, according to some embodiments. According to some embodiments, the device may be used for a specific treatment period 96, such as one week, two weeks, three weeks, one month, one and a half months, two months, etc. At the end of the treatment period, if the contractions help prevent urinary leakage 97, effectively alleviating stress incontinence, strengthening the pelvic floor, and triggering a reflex that automatically contracts the pelvic floor when intra-abdominal pressure increases 98, preventing urinary leakage 99, then continued use of the device is not necessary. If the user still suffers from stress urinary incontinence at the end of the treatment period 100, a second treatment period may be initiated. Optionally, one or more parameters of the electrical stimulation, such as voltage, current intensity, stimulation pulse shape and duration, duty cycle, modulation, session duration, pattern, etc., may be altered during the second treatment period.

[0119] 10A is a flowchart of a method for treating and / or preventing urge urinary incontinence (UUI) 101, according to some embodiments. Alternatively or additionally, the method may be used for other urinary problems. For example, in method 1000, a device is inserted into the vagina of a user with urge urinary incontinence 102. The user may experience a sudden urge to urinate 103. The device may detect an increase in pressure and / or a contraction of the pelvic floor, which may occur reflexively or intentionally 104. For example, the pressure may be intra-abdominal pressure and / or pelvic floor pressure. Optionally, the device may deliver electrical stimulation (e.g., to the pelvic floor) 105. For example, the stimulation may be in response to the increase in pressure and / or the contraction of the pelvic floor. In some embodiments, the stimulation may cause the abdomen and / or pelvic floor to contract 106 and / or prevent the urge to urinate and / or leakage.

[0120] FIG. 10B is a flowchart of a longitudinal method 1001 for treating and / or preventing urge urinary incontinence (UUI) 101, according to some embodiments. According to some embodiments, the device may be used for a specific treatment period, e.g., at least one week, two weeks, three weeks, one month, one and a half months, two months, etc. In some cases, at the end of the treatment period, the device trains the nerves and muscles of the pelvic floor to help the user increase the amount of bladder filling before feeling the need to urinate (neuromodulation 107) 108. This results in reduced urination frequency and / or urgency 109 and a strengthened pelvic floor. If the user still suffers from urge urinary incontinence at the end of the treatment period 110, a second treatment period may be initiated. Optionally, one or more parameters of the electrical stimulation, such as, for example, voltage, current intensity, stimulation pulse shape and duration, duty cycle, modulation, session duration, pattern, etc., may be altered in the second treatment period.

[0121] 11A is a flowchart of a method for treating and / or preventing pelvic organ prolapse (POP) 102, according to some embodiments. For example, in method 1100, a user may be interested in strengthening their pelvic floor. A device is inserted into the user's vagina 121. The user self-contracts their pelvic floor 122. The device detects an increase in pelvic floor pressure 123. The device delivers electrical stimulation 124 to the pelvic floor, causing it to contract 125. In some embodiments, the contraction 125 may improve POP. Alternatively or additionally, the method may be used for other urinary problems.

[0122] 11B is a flowchart of a longitudinal method 1101 for treating and / or preventing pelvic organ prolapse (POP) 120, according to some embodiments. According to some embodiments, the device may be used for a specific treatment period 126, e.g., one week, two weeks, three weeks, one month, one and a half months, two months, etc. At the end of the treatment period, if the pelvic floor has been strengthened 127 and the POP has been alleviated 128, continued use of the device is not necessary. If the user still suffers from pelvic organ prolapse 129 at the end of the treatment period, a second treatment period may be initiated. Optionally, one or more parameters of the electrical stimulation, such as, for example, voltage, current intensity, stimulation pulse shape and duration, duty cycle, modulation, session duration, pattern, etc., may be altered in the second treatment period.

[0123] It is expected that numerous related architectural technologies, artificial intelligence methods, computer user interfaces, and image capture devices will be developed during the term of the patent arising from this application, and the scope of the terms design elements, analysis routines, and user devices is intended a priori to include all such new technologies.

[0124] As used herein, the term "about" refers to ±10%.

[0125] The terms "comprises," "comprising," "includes," "including," "having," and their conjugations mean "including, but not limited to."

[0126] The term "consisting of" means "including but not limited to."

[0127] The term "consisting essentially of" means that a composition, method, or structure may include additional ingredients, steps, and / or moieties so long as the additional ingredients, steps, and / or moieties do not materially alter the basic and novel characteristics of the claimed composition, method, or structure.

[0128] As used herein, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. For example, the term "a compound" or "at least one compound" can include a plurality of compounds, including mixtures thereof.

[0129] Throughout this application, various embodiments of the present invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Thus, the description of a range should be considered to include all the possible subranges specifically disclosed as well as individual numerical values ​​within the range. For example, the description of a range such as 1 to 6 should be considered to include individual numbers within the range such as 1, 2, 3, 4, 5, and 6, as well as specifically disclosed subranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, and 3 to 6. This applies regardless of the size of the range.

[0130] Whenever a range of values ​​is given herein, it is meant to include all numbers (fractions or integers) within the given range. The phrases "ranging across / between a first denoted number and a second denoted number" and "ranging from a first denoted number to a second denoted number" are used interchangeably herein and are meant to include the first and second denoted numbers and all fractions and integers therebetween.

[0131] It will be understood that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination, or in any other described embodiment of the invention, as appropriate. Certain features described in the context of various embodiments are not to be regarded as essential features of those embodiments, unless the embodiment is inoperable without those elements.

[0132] While the present invention has been described in conjunction with specific embodiments, it is evident that many alternatives, modifications and variations will become apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0133] As will be appreciated by those skilled in the art, some embodiments of the present invention may be embodied as a system, a method, or a computer program product. Accordingly, some embodiments of the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, microcode, etc.), or an embodiment combining software and hardware aspects, which may be generally referred to herein as a "circuit," "module," or "system." Furthermore, some embodiments of the present invention may take the form of a computer program product embodied in one or more computer-readable medium(s) having computer-readable program code embodied thereon. Implementation of the method and / or system of some embodiments of the present invention may involve performing and / or completing selected tasks manually, automatically, or a combination thereof. Furthermore, depending on the actual implementation and device of some embodiments of the method and / or system of the present invention, some selected tasks may be implemented by hardware, software, or firmware, and / or a combination thereof, using, for example, an operating system.

[0134] For example, hardware for performing selected tasks according to some embodiments of the present invention may be implemented as a chip or circuit. As software, selected tasks according to some embodiments of the present invention may be implemented as a plurality of software instructions executed by a computer using any suitable operating system. In some exemplary embodiments of the present invention, one or more tasks according to exemplary embodiments of the methods and / or systems as described herein are performed by a data processor, such as a computing platform, for executing a plurality of instructions. Optionally, the data processor includes volatile memory for storing instructions and / or data, and / or non-volatile storage, e.g., a magnetic hard disk and / or removable media, for storing instructions and / or data. Optionally, a network connection is also provided. Optionally, a display and / or a user input device, such as a keyboard or mouse, are also provided.

[0135] Any combination of one or more computer-readable medium(s) may be utilized for some embodiments of the present invention. The computer-readable medium may be a computer-readable signal medium or a computer-readable storage medium. The computer-readable storage medium may be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination thereof. More specific examples (non-exhaustive list) of computer-readable storage media include an electrical connection having one or more wires, a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable and programmable read-only memory (EPROM or flash memory), an optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination thereof. In the context of this document, a computer-readable storage medium may be any tangible medium that contains or stores a program for use by or in connection with an instruction execution system, apparatus, or device.

[0136] A computer-readable signal medium may include a propagated data signal embodied with computer-readable program code, for example, in baseband or as part of a carrier wave. Such a propagated signal may take various forms, including, but not limited to, electromagnetic, optical, or any suitable combination thereof. A computer-readable signal medium is not a computer-readable storage medium but may be any computer-readable medium that can communicate, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device.

[0137] The program code embodied on the computer readable medium and / or data used may be transmitted using any suitable medium, including but not limited to wireless, wired, fiber optic cable, RF, etc., or any suitable combination thereof.

[0138] Computer program code for carrying out operations of some embodiments of the present invention may be written in any combination of one or more programming languages, e.g., object-oriented programming languages ​​such as Java, Smalltalk, C++, etc., and conventional procedural programming languages ​​such as the "C" programming language or similar programming languages. The program code may execute entirely on the user's computer, partially on the user's computer, as a standalone software package, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer via any type of network, including a local area network (LAN) and / or a mesh network (meshnet, emesh) and / or a wide area network (WAN), or may be connected to an external computer (e.g., over the Internet using an Internet Service Provider).

[0139] Some embodiments of the present invention may be described below with reference to flowchart illustrations and / or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the invention. It will be understood that each block of the flowchart illustrations and / or block diagrams, and combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented by computer program instructions. These computer program instructions may be provided to a processor of a general-purpose computer, special-purpose computer, or other programmable data processing apparatus that generates a machine, whereby the instructions, via the processor of the computer or other programmable data processing apparatus, generate means for performing the function / acts specified in the block or blocks of the flowchart illustrations and / or block diagrams.

[0140] These computer program instructions may also be stored on a computer-readable medium that can instruct a computer, other programmable data processing apparatus, or other device to function in a particular manner, whereby the instructions stored on the computer-readable medium produce an article of manufacture including instructions that implement the function / acts specified in a block or blocks of the flowcharts and / or block diagrams.

[0141] Computer program instructions may also be loaded into a computer, other programmable data processing apparatus, or other device and cause the computer, other programmable apparatus, or other device to perform a series of operating steps to create a computer-implemented process, whereby the instructions executing on the computer or other programmable apparatus provide a process for implementing the function / operations specified in a block or blocks of the flowcharts and / or block diagrams.

[0142] Some of the methods described herein are generally designed for use with a computer only and may not be operable or practical to be performed purely manually by a professional. A professional wishing to perform a similar task manually would be expected to use an entirely different method, for example, leveraging the professional's knowledge and / or the pattern recognition capabilities of the human brain, which may be much more efficient than performing the steps of the methods described herein manually.

[0143] Data and / or program code may be accessed and / or shared via a network, e.g., the Internet. For example, data may be shared and / or accessed using a social network. A processor may, for example, include remote processing capacity available via a network (e.g., the Internet). For example, resources may be accessed via cloud computing. The term "cloud computing" refers to the use of computational resources that are remotely available via a public network, such as the Internet, and may be provided, for example, at low cost and / or on an hourly basis. Any virtual or physical computer in electronic communication with such a public network may be available as a computational resource. To provide computational resources via a cloud network on a secure basis, computers accessing the cloud network may employ standard security encryption protocols, such as SSL and PGP, known in the industry.

[0144] All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference in their entirety to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated herein by reference. Furthermore, citation or identification of a reference in this application should not be construed as an admission that it is available as prior art to the present invention. To the extent section headings are used, they should not be construed as necessarily limiting.

Claims

1. 1. An electrical stimulation device for stimulating the pelvic floor, comprising: an electrode configured to be in intimate contact with the vaginal or rectal mucosa; a sensor for detecting urinary activity; a processor configured to receive signals from the sensor and induce electrical stimulation of the pelvic floor by the electrodes in response to detection of urinary-related activity by the sensor.

2. The device of claim 1 , wherein the urinary-related activity includes at least one of an increase in intra-abdominal pressure, a contraction of the pelvic floor, and myoelectric activity of the pelvic floor.

3. The device of claim 1 , wherein the sensor comprises a pressure sensor and the urinary-related activity is an increase in intra-abdominal pressure.

4. The device of claim 3 , wherein the pressure sensor is selected from the group consisting of a strain gauge, a piezoelectric crystal, a piezoelectric film, a balloon, and any combination thereof.

5. 10. The device of claim 1, wherein the processor and electrodes are configured to respond to the sensor sensing increased activity of the pelvic floor muscles by stimulating the pelvic floor muscles with positive feedback.

6. The device of claim 5 , wherein the positive feedback inhibits the bowel movement reflex.

7. 10. The device of claim 1, wherein the length of the device is adaptable to fit the length of the vagina.

8. 10. The device of claim 1, wherein at least one of the diameter and lateral projections from the device are adaptable to fit the width of the vagina.

9. The device of claim 1 further comprising a rim.

10. The device of claim 9 , wherein the edge is flexible.

11. The device of claim 10 , wherein the flexibility of the edges facilitates insertion or removal of the device.

12. 10. The device of claim 1, wherein the device is configured to strengthen the pelvic floor and treat mild to moderate pelvic floor prolapse.

13. 10. The device of claim 1, further comprising a wireless communication module for transmitting data to and receiving signals from an external computer to adjust stimulation parameters.

14. 10. The device of claim 1, further comprising a body configured to support the vaginal wall at the level of the bladder neck above the pubic bone.

15. The device of claim 1 , further comprising a flexible body that is reversibly deformed by an increase in intra-abdominal pressure.

16. 16. The device of claim 15, wherein the reversible deformation is a reversible reduction in the anterior-posterior diameter of the body of at least 5% when the intra-abdominal pressure increases by at least 1 / 10 bar.

17. The device of claim 14 , wherein the body has an axially compressible region.

18. The device of claim 14 , wherein the body includes a lateral protrusion.

19. The device of claim 18 , wherein the lateral protrusion comprises a rim around the body of the device.

20. 20. The device of claim 18, further comprising lateral protrusions configured to support the bladder neck.

21. 10. The device of claim 1, further comprising a detachment sled depending aft from the device, the detachment sled comprising an antenna for wireless communication.

22. The device of claim 1 further comprising a wireless communication module.

23. 23. The device of claim 22, wherein sensor recordings, stimulation parameters, and timing are transmitted wirelessly to an external computing device, the external computing device comprising a user interface for controlling the device.

24. 10. The device of claim 1, further comprising one or more additional sensors, wherein the one or more additional sensors are selected from the group consisting of an accelerometer, position, tilt, photoplethysmography, bioimpedance, echomyography, and any combination thereof.

25. The device of claim 1 , wherein the processor is configured to administer the electrical stimulation in a manner that strengthens pelvic floor muscles.

26. The device of claim 1 , wherein the processor is configured to administer the electrical stimulation in a manner that produces neuromodulation.

27. 27. The device of claim 26, wherein the neuromodulation comprises reflex contraction of the pelvic floor upon an increase in intra-abdominal pressure.

28. 27. The device of claim 26, wherein the neuromodulation comprises inhibition of the desire to urinate or defecate.

29. 10. The device of claim 1, wherein the electrical stimulation causes neuromodulation that initiates elimination or defecation.

30. 1. A method for non-invasive electrical stimulation of pelvic floor muscles, comprising: Sensing urinary-related activity and In response to said sensing, applying electrical stimulation to said pelvic floor muscles by at least one electrode in contact with a mucosa of the vagina or rectum, causing said pelvic floor muscles to contract in response to said electrical stimulation.

31. 31. The method of claim 30, further comprising repeating the sensing and electrical stimulation to induce a reflex that automatically contracts the pelvic floor upon an increase in intra-abdominal pressure.

32. 31. The method of claim 30, wherein the electrical stimulation reduces at least one of urination frequency and urgency.

33. 31. The method of claim 30, further comprising repeating the sensing and electrical stimulation to strengthen pelvic floor muscles.

34. 31. The method of claim 30, further comprising controlling the electrical stimulation with a processor connected to at least one pressure sensor and at least one electrode.

35. 35. The method of claim 34, wherein the processor further comprises an artificial intelligence (AI) module.

36. 36. The method of claim 35, further comprising determining with the AI ​​module when an imminent risk of urinary or fecal leakage is high.

37. 37. The method of claim 36, further comprising instructing the at least one electrode to provide an electrical stimulus in response to the determining.

38. 1. A system for electrical stimulation of pelvic floor muscles, comprising:

1. An insertable device for insertion into the vagina, comprising: an electrode configured to be in intimate contact with the vaginal or rectal mucosa; a sensor for detecting urinary activity; a wireless communication module; a processor configured to receive signals from the sensor and to induce electrical stimulation of the pelvic floor by the electrodes in response to detection of an increase in intra-abdominal pressure by the pressure sensor; and a user interface wirelessly linked to the processor, the user interface being an application on an external computer.

39. 39. The system of claim 38, wherein the urinary-related activity includes at least one of an increase in intra-abdominal pressure, a contraction of the pelvic floor, and myoelectric activity of the pelvic floor.

40. 40. The system of claim 38, wherein the wireless communication module is configured to transmit data to and receive signals from the external computer to adjust stimulation parameters.

41. 39. The system of claim 38, wherein the external computer comprises a user interface configured to collect feedback from a user regarding at least one of the occurrence of incontinent episodes, the severity of incontinent episodes, and the circumstances of incontinent episodes.

42. 42. The system of claim 41, wherein the external computer is configured to use these data to adjust parameters of the stimulation.

43. 42. The system of claim 41, wherein the external computer is configured to present data to the user regarding at least one of pelvic floor strength, improvement over time, and improvement regarding incontinence treatment.

44. 43. The system of claim 42, wherein the external computer is configured to use data from multiple users for the adjustment.

45. 45. The system of claim 44, wherein the external computer is configured to use the data from multiple users to train a machine learning routine.

46. 46. ​​The system of claim 45, comprising at least one of a vector machine and a reinforcement learning.

47. 40. The system of claim 38, wherein the user interface is configured to facilitate wireless activation, control, and / or programming of one or more parameters of the insertable device.

48. 48. The system of claim 47, wherein the one or more parameters are selected from the group consisting of a cutoff value, voltage, current strength, stimulation pulse shape and duration, duty cycle, modulation, session duration, pattern of the sensor signal inducing the electrical stimulation, and any combination thereof.

49. 39. The system of claim 38, wherein the external computer is a mobile phone, tablet, phablet, laptop, desktop, smartwatch, smartglasses, or VR device.

50. 50. The system of claim 49, wherein the external computer is configured to analyze, store, and graphically present to a user cumulative electrical stimulation data, cumulative sensor data, changes in said data, and trends in said data.

Images