Medical device radio frequency transceiver and method of use thereof

Abstract

This article describes a radio frequency (RF) transceiver that acts as a relay device to provide communication between a sensor of a medical device (e.g., an implanted medical device) and a peripheral device (such as a smartphone). The medical device can be an intraurethral, ​​intrarectal, or intravaginal device. The sensor of the medical device can be a microelectromechanical (MEM) sensor, such as an accelerometer.

Description

Background Art

[0001] Sensors, such as those of medical devices, often require wireless communication with peripheral devices, for example, to transmit data in real time. Peripheral devices, such as smartphones or tablets, represent a widely available interface used by subjects (e.g., patients) to effectively communicate with sensors of medical devices. In many cases, signals from medical devices inserted or implanted in a subject's body need to pass through the subject's body tissue in order to communicate with the peripheral device.

[0002] Smartphones are often equipped with Bluetooth Low Energy (BLE)-enabled devices that are configured to transmit at a specific radio frequency (RF). Transmitting a BLE signal through the human body results in severe signal attenuation (e.g., transmitting a BLE signal through just a few inches of body tissue results in almost complete attenuation at safe power levels). Although this limitation can be overcome by transmitting BLE signals at higher power levels, higher power levels may expose the subject to dangerous energy levels. Furthermore, the attenuation of RF signals is generally proportional to the frequency, with higher frequencies exhibiting greater attenuation.

[0003] Therefore, new devices, systems, and methods are needed to overcome signal attenuation associated with medical devices that operate by transmitting data signals from internal medical sensors to external peripheral devices, such as smartphones. Summary of the Invention

[0004] In one aspect, the present invention provides a radio frequency (RF) transceiver configured to transmit and receive a first RF signal at a first frequency greater than about 1 GHz and a second RF signal at a second frequency less than about 1 GHz. The first frequency can be greater than about 2 GHz (e.g., from about 2 GHz to about 3 GHz, such as about 2.45 GHz). The second frequency can be from about 1 MHz to about 1 GHz (e.g., about 915 MHz, about 433 MHz, or about 402 MHz).

[0005] The transceiver may be configured to transmit and receive RF signals to and from a Bluetooth Low Energy (BLE) device, the BLE device being configured to transmit and / or receive a first RF signal at a first frequency, wherein optionally, the BLE device is configured to transmit and / or receive the first RF signal at the first frequency. The transceiver may be configured to transmit and / or receive a second RF signal at a second frequency to and from an Industrial, Scientific, and Medical (ISM) or Medical Implant Communication System (MICS) device. The ISM or MICS device may be configured to transmit and / or receive the second RF signal at the second frequency. The transceiver may further include a microcontroller.

[0006] In another aspect, the present invention provides a system comprising: a relay device including the transceiver according to any of the above embodiments; a first device including a first transmitter and / or receiver configured to transmit and / or receive a first RF signal at a first frequency; and a second device including a second transmitter and / or receiver configured to transmit and / or receive a second RF signal at a second frequency. The first device may be a BLE device, and the second device may be an ISM or MICS RF device.

[0007] The system may further include a peripheral device. The peripheral device may include the first device and / or the relay device. The peripheral device may be, for example, a smartphone, a tablet computer, a computer, or a smartwatch.

[0008] The system may include a medical device. The medical device may include a second device. The system may include, for example, one or more microcontrollers located in the medical device and / or a peripheral device. At least a portion of the medical device is configured to be inserted or implanted into the body or body cavity of a subject (e.g., a human subject). For example, the portion of the inserted or implanted medical device may include the second device. The medical device may be an intravaginal, intrarectal, or intraurethral device.

[0009] The medical device may include at least one sensor, which, for example, includes a second device, in communication or connection therewith (e.g., via a wired or wireless connection). The at least one sensor may be configured to transmit a signal to the second device. The medical device may include, for example, a plurality of sensors positioned along the length of the medical device. The at least one sensor may be a position or motion sensor, for example, a microelectromechanical (MEM) sensor (e.g., an accelerometer). In some embodiments, the medical device further includes at least one sensor selected from the group consisting of a pressure sensor, a flow sensor, a muscle mass sensor, a muscle force sensor, a pH sensor, a humidity sensor, a temperature sensor, a hormone sensor, a toxin sensor, and a Hall effect sensor.

[0010] In another aspect, the present invention provides a method for using a system according to any of the above embodiments. The method may include: transmitting a first RF signal at a first frequency from a first device to a relay device; receiving the first RF signal at the first frequency by the relay device; converting the first RF signal at the first frequency by the relay device to a second RF signal at a second frequency; and transmitting the second RF signal at the second frequency to a second device. In another embodiment, for example, the reverse situation may include: transmitting a second RF signal at a second frequency from the second device to the relay device; receiving the second RF signal at the second frequency by the relay device; converting the second RF signal at the second frequency by the relay device to a first RF signal at the first frequency; and transmitting the first RF signal at the first frequency to the first device.

[0011] In another aspect, the present invention provides a method for detecting pelvic floor movement using a system according to any of the above embodiments. The method may include: inserting an intravaginal, intrarectal, or intraurethral device into the subject's body; acquiring a signal from a position or motion sensor when the pelvic floor engages or contracts; and transmitting the signal from the position or motion sensor to a peripheral device via a transceiver. The first frequency may be greater than about 2 GHz (e.g., from about 2 GHz to about 3 GHz, e.g., about 2.45 GHz). The second frequency may be from about 1 MHz to about 1 GHz (e.g., about 915 MHz, about 433 MHz, or about 402 MHz). For example, the first frequency may be about 2.45 GHz and the second RF frequency may be about 915 MHz.

[0012] The intravaginal, intrarectal or intraurethral device may include multiple position or motion sensors, such as MEM sensors (e.g., accelerometers). The MEM sensors may be positioned along the length of the device. The method may generate a position of the subject's vagina, rectum, or urethra generated by multiple position or motion sensors and displayed on a graphical user interface of a peripheral device. The position of the subject's vagina, rectum, or urethra may be displayed on a graphical user interface before and / or after performing pelvic floor exercises. The position of the subject's vagina, rectum, or urethra may also be recorded before and / or after performing pelvic floor exercises.

[0013] In another aspect, the present invention provides a medical device (e.g., an intravaginal, intrarectal, or intraurethral device) comprising a transceiver according to any of the above embodiments. The medical device may include a plurality of position or motion sensors, such as MEM sensors (e.g., accelerometers). The MEM sensors may be positioned along the length of the device.

[0014] In another aspect, the present invention provides a kit comprising one or more of the following devices: a relay device having a transceiver according to any one of the above embodiments; a first device comprising a first transmitter and / or receiver configured to transmit and / or receive a first RF signal at a first frequency; and a second device comprising a second transmitter and / or receiver configured to transmit and / or receive a second RF signal at a second frequency.

[0015] The kit may further include a medical device (e.g., an intravaginal, intrarectal, or intraurethral device). The intravaginal, intrarectal, or intraurethral device may include multiple position or motion sensors, such as MEM sensors (e.g., accelerometers). The MEM sensors may be positioned along the length of the device. The medical device may include a second device. The kit may further include instructions for use.

[0016] definition

[0017] As used herein, the singular forms "a," "an," and "the" include plural references unless otherwise indicated.

[0018] As used herein, the terms "about" and "approximately" refer to + / - 10% of the stated value. For example, a frequency of about 433 MHz refers to a frequency range of from 389.7 MHz to 476.3 MHz.

[0019] As used herein, the terms "adjacent" and "proximal" refer to a location close to a tissue surface (eg, about 0.01 mm-5 mm from or adjacent to a tissue surface, eg, around the cervix or vaginal cuff of a subject).

[0020] As used herein, the term "feedback" or "biofeedback" refers to information that can be used to train a subject to change physiological activities (e.g., pelvic floor muscle function) to improve health and performance (e.g., treat, reduce and / or prevent the occurrence or symptoms of pelvic floor disorders (PFDs)). Biofeedback can also include information collected by sensors of a device (such as an intraurethral, ​​intravaginal, or intrarectal device) during daily monitoring (e.g., substantially in real time) while the user is performing daily activities. This information can be viewed substantially in real time or at a later visit. Instruments such as the medical devices described herein can be used to measure physiological activities, such as muscle activity (e.g., position or movement), pressure (e.g., bladder or vaginal pressure), muscle mass, pH (e.g., vaginal pH), temperature, and humidity, and provide this information to the subject as biofeedback. The sensors of the devices described herein can also be used to measure molecular levels, such as hormone levels and / or toxin levels, and provide this information to the subject as biofeedback. The presentation of this information can be transmitted to the subject via visual, auditory, or tactile signals.

[0021] As used herein, the term "diagnosis" refers to the identification or classification of a disease or condition, such as a pelvic floor disorder. For example, "diagnosis" may refer to the identification of a particular type of urinary incontinence.

[0022] "Disorder" refers to any condition that would benefit from treatment, including but not limited to chronic and acute disorders or diseases, including pathological conditions that predispose a subject to the disorder.

[0023] As used herein, the term "monitoring" refers to the use of a medical device (such as an intraurethral, ​​intrarectal, or intravaginal device as described herein) to collect, track, and / or store data, such as data acquired from sensors of the device as described herein. For example, monitoring occurs when the device is located within the body (such as within the vaginal cavity, rectum, or urethra of a user) and / or when the device is used during diagnosis or treatment.

[0024] As used herein, the terms "pelvic floor lift" and "PFL" refer to the movement of the pelvic floor (e.g., movement of the muscle fibers of the levator ani muscles (e.g., pubococcygeus, ileococcygeus, coccygeus, and puborectalis muscles, as well as the perineal muscles and anal sphincter) and associated connective tissue, which spans this region in a spherical pattern from the anterior pubic bone to the posterior sacrum and to adjacent bony structures connecting these two bones, characterized by upward movement of the pelvic floor (e.g., lifting movement, such as movement in a cranial direction). During PFL, the movement of the pelvic floor is a clearly described component of the collective movement of the entire pelvic floor (e.g., levator ani muscles, urethral and anal sphincters, bulbospongiosus muscles, ischiocavernosus muscles, superficial transverse perineal muscles). When all muscles are activated simultaneously, a combined lifting and circumferential squeezing action occurs. PFL may involve the selective engagement of the levator ani muscle portion of the pelvic floor.

[0025] As used herein, the terms "pelvic floor relaxation" and "PFR" refer to movement of the pelvic floor (e.g., the muscle fibers of the levator ani muscles (e.g., the pubococcygeus, ileococcygeus, coccygeus, and puborectalis) and associated connective tissue, which spans this region in a spherical formation from the anterior pubic bone to the posterior sacrum, and to adjacent bony structures connecting these two bones), characterized by relaxation of the pelvic floor (e.g., downward movement, such as in a caudal direction). During PFR, the movement of the pelvic floor differs from the concentric contraction of the PFL (e.g., a shortening contraction) and manifests as a lengthening or relaxation of the muscle fibers.

[0026] As used herein, "real time" refers to the actual time at which events occur, such as daily activities.

[0027] As used herein, "sensor data" refers to measurements (e.g., any one or more of muscle (e.g., pelvic floor muscle) movement, muscle mass, muscle strength, pressure, and measurements of other conditions such as pH, temperature, and / or humidity (e.g., in the vagina)) that characterize a subject's pelvic floor health and are acquired by sensors as described herein of a medical device such as the intraurethral, ​​intrarectal, or intravaginal devices described herein. Sensor data that correlates pelvic floor movement with, for example, urinary or fecal incontinence or urge incontinence may also be collected. Such data may be used, for example, to diagnose urinary or fecal incontinence.

[0028] As used herein, "radio frequency" means a frequency in the range of 10 3 Hz to 10 12 Electromagnetic waves in the Hz range.

[0029] As used herein, the terms "subject" and "patient" are used interchangeably to refer to a mammal, such as a human.

[0030] As used herein, the terms "reduce" and "inhibit" are defined as the ability to cause an overall decrease in a measurable metric by about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 75%, 80%, 85%, 90%, 95% or more. Reduce or inhibit can refer to, for example, the symptoms of the pelvic floor disorder (PFD) being treated.

[0031] As used herein, the term "treating" refers to providing treatment (e.g., treating or reducing the likelihood of urinary or fecal incontinence, or the urgency associated therewith) to a subject in need thereof, particularly in conjunction with the use of a device (e.g., a urodynamic catheter, an intravaginal device, or an intrarectal device), system, or method described herein. "Treating a disease" or for "therapeutic treatment" includes treating a subject who already has a disease to improve or stabilize the subject's condition. "Preventing" or "reducing the likelihood of developing a disease" refers to prophylactic treatment of a subject who is not yet ill or asymptomatic but is susceptible to or at risk of developing a particular disease (such as urinary or fecal incontinence or pelvic organ prolapse).

[0032] As used herein, the "female urogenital system" refers to the organ system of the female reproductive system, which includes, for example, the Bartholin glands, cervix, clitoris, clitoral frenulum, clitoral glans / glans clitoridis, clitoral hood, fallopian tubes, labia, labia majora, labia minora, frenulum of the labia minora, ovaries, sebaceous glands, uterus, vagina, and vulva; the urinary system, including, for example, the kidneys, ureters, bladder, and urethra; and surrounding and supporting nerve and muscle tissue.

[0033] As used herein, "male urogenital system" refers to the organ system of the male reproductive system, which includes, for example, the bladder, pubic bone, external urethral sphincter, penis, body of penis, corpus cavernosum, glans penis, foreskin, urethral meatus, sigmoid colon, rectum, seminal vesicles, ejaculatory ducts, prostate, Cowper's glands, anus, vas deferens, epididymis, testicles and scrotum, kidneys, ureters, bladder and urethra; as well as surrounding and supporting nerve and muscle tissue.

[0034] As used herein, "vaginal cuff" refers to the sutured tissue remaining at the top of the vaginal cavity after the cervix has been removed (eg, during a hysterectomy).

[0035] As used herein, "urinary incontinence" refers to the leakage of urine from the bladder. Incontinence can range from leaking only a few drops of urine to a completely empty bladder. Urinary incontinence can be divided into three main types: stress urinary incontinence (SUI), urge urinary incontinence, and mixed urinary incontinence. Stress urinary incontinence refers to leakage of urine when coughing, laughing, or sneezing. Leakage can also occur when a subject (e.g., a female subject) walks, runs, or exercises. Urge urinary incontinence is a sudden, strong urge to urinate that is difficult to stop. Women with this type of urinary incontinence may leak urine on the way to the bathroom. Mixed urinary incontinence combines the symptoms of stress and urge incontinence.

[0036] As used herein, "pelvic floor" refers to the muscular area at the bottom of the abdomen attached to the pelvis.

[0037] As used herein, "pelvic floor disorder" or "PFD" refers to conditions that affect the muscles and tissues that support the pelvic organs. These conditions may lead to loss of bladder or bowel control, or may cause one or more pelvic organs to sag downward, resulting in prolapse.

[0038] As used herein, a "urodynamic catheter" refers to a urethral catheter configured for performing one or more urodynamic measurements. The catheter can have multiple (eg, 2 or 3) lumens. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 is a schematic diagram showing the topology of a system as described herein, which includes a device (e.g., a medical device having a sensor implanted in the body or inserted into a body cavity, such as in the context of a medical device), a relay device, and a peripheral device (such as a smartphone). The relay device communicates with the implanted device via the 915 MHz ISM band and communicates with the smartphone via the 2.4 GHz BLE band.

[0040] Figure 2is a schematic diagram showing a system as described herein, comprising an intravaginal device (2) having a flexible printed circuit board (PCB) (4) containing six sensors and a microcontroller (MCU), and a peripheral device (6) such as a smartphone. The housing of the intravaginal device contains an RF transceiver (8) that facilitates communication with the intravaginal device's MCU via the 915 MHz ISM band and with the smartphone via the 2.4 GHz BLE band. The peripheral device is also capable of transmitting data to a cloud-based server (10) or a web-based dashboard (12) where data from the intravaginal device can be stored and / or analyzed.

[0041] Figure 3 is a schematic diagram illustrating a system that does not include a relay device. The intravaginal device (2) communicates with a peripheral device (6) (such as a smartphone) via the 2.4 GHz BLE band. The peripheral device is also capable of transmitting data to a cloud-based server (10) or web-based dashboard (12) that can store and / or analyze data from the intravaginal device. DETAILED DESCRIPTION

[0042] A radio frequency (RF) transceiver is described herein that acts as a relay device to facilitate communication between a sensor of a medical device (e.g., a medical device inserted or implanted into a subject's body or body cavity) and a peripheral device (e.g., a smartphone, tablet, or laptop). The medical device can be, for example, an intraurethral, ​​intrarectal, or intravaginal device. The sensor of the medical device can be a microelectromechanical (MEM) sensor, such as an accelerometer.

[0043] A sensor of a medical device can be configured to wirelessly communicate with a peripheral device, for example, via a microcontroller, to transmit data in real time. When a medical device is (e.g., at least partially) implanted within a subject's body, the sensor may not be able to effectively transmit its signal to the peripheral device due to signal attenuation caused by body tissue. Signal attenuation is proportional to frequency, and the higher the frequency, the greater the attenuation. In some cases, the peripheral device may only have one or more radio components that transmit and receive signals at higher frequencies. For example, most mobile phones are equipped to wirelessly communicate with peripheral devices via Bluetooth, Bluetooth Low Energy, or WiFi (all of which operate at frequencies of 2.4 GHz or higher). Therefore, the present disclosure describes devices, systems, and methods that address this problem by using a radio frequency transceiver that receives signals at low frequency levels (e.g., below 1 GHz) from a sensor within the body (e.g., via a microcontroller) and facilitates transmission of the low frequency signal to an RF transmitter and / or receiver (e.g., a transceiver) configured to receive signals at higher frequencies (e.g., greater than 1 GHz), and vice versa. The RF transceiver converts and transmits signals between the implanted device and a transmitter and / or receiver (eg, a transceiver) in a peripheral device. The devices, systems, and methods of the present disclosure are described in more detail below.

[0044] RF transceiver

[0045] The radio frequency (RF) transceiver transmits and receives frequencies in the range of 10 3 Hz to 10 12 RF electromagnetic waves in the Hz range. An RF transceiver can be a small electronic device that can transmit and receive radio signals between two devices, for example, to communicate wirelessly with another device. Although a transceiver is a single module with both transmit and receive capabilities, those skilled in the art will understand that a transceiver as described herein also refers to a device or system that includes a separate transmitter and receiver that are operatively configured to perform the same or similar functions as a transceiver with both capabilities.

[0046] A transceiver is a unit that contains both a transmitter and a receiver and shares common circuitry or a single housing. The module that includes the transceiver typically contains a printed circuit board (PCB), transmit and receive circuitry, an antenna, and a serial interface for communicating with a host processor. The transmitter module is a small PCB subassembly that can transmit radio waves and modulate these waves to carry data. The transmitter module is typically implemented in conjunction with a microcontroller, which provides the module with the data that can be transmitted. The receiver module receives the modulated RF signal and demodulates it.

[0047] The RF transceiver described herein is configured to transmit and receive a first RF signal at a first frequency greater than about 1 GHz and a second RF signal at a second frequency less than about 1 GHz. For example, the first frequency can be greater than about 2 GHz, such as from about 2 GHz to about 3 GHz. In some embodiments, the first frequency can be from about 1 GHz to about 3 GHz (e.g., about 1 GHz, 1.1 GHz, 1.2 GHz, 1.3 GHz, 1.4 GHz, 1.5 GHz, 1.6 GHz, 1.7 GHz, 1.8 GHz, 1.9 GHz, 2.0 GHz, 2.1 GHz, 2.3 GHz, 2.4 GHz, 2.5 GHz, 2.6 GHz, 2.7 GHz, 2.8 GHz, 2.9 GHz, 3.0 GHz). In some embodiments, the first frequency is about 2.45 GHz (e.g., from about 2.402 GHz to about 2.480 GHz MHz), which is the frequency used by Bluetooth Low Energy (BLE) devices. The second frequency can be from about 1 MHz to about 1 GHz (e.g., 1 MHz, 2 MHz, 3 MHz, 4 MHz, 5 MHz, 6 MHz, 7 MHz, 8 MHz, 9 MHz, 10 MHz, 20 MHz, 30 MHz, 40 MHz, 50 MHz, 60 MHz, 70 MHz, 80 MHz, 90 MHz, 100 MHz, 200 MHz, 300 MHz, 400 MHz, 500 MHz, 600 MHz, 700 MHz, 800 MHz, 900 MHz, or 1 GHz). In some embodiments, the second frequency is about 915 MHz, about 433 MHz (e.g., about 433.050 MHz), or about 402 MHz (e.g., about 402-405 MHz). 433 MHz and 915 MHz correspond to Industrial, Scientific, and Medical (ISM) RF frequencies, and 402 MHz corresponds to a Medical Implant Communication System (MICS) RF frequency. The topology of the system described herein is Figure 1 and 2 Depicted in.

[0048] RF transceiver described herein can be contained in any module that is suitable for promoting the communication with medical device (for example, the medical device that is inserted into or implanted in the body or body cavity of experimenter) and peripheral device.In general, transceiver is positioned outside body and can be for example very adjacent to peripheral device location.For example, transceiver can be positioned to be less than 1 meter (for example, less than 95cm, 90cm, 85cm, 80cm, 75cm, 70cm, 65cm, 60cm, 55cm, 50cm, 45cm, 40cm, 35cm, 30cm, 25cm, 20cm, 15cm, 10cm, 9cm, 8cm, 7cm, 6cm, 5cm, 4cm, 3cm, 2cm, 1cm or less) from peripheral device.In certain embodiments, transceiver can be contained together with peripheral device, contained on it or be contained adjacent to it.Transceiver can be configured to fit in experimenter's pocket so that it is substantially stationary but still located outside body. In embodiments where the medical device is an intravaginal, intraurethral, ​​or intrarectal device, the device may include a cover or cap that protects the device when not in use. The cover or cap of the device may include a transceiver located within or on the surface of the cover or cap. Thus, when the user removes the cover or cap of the device, it can remain in the user's pocket and be positioned to communicate with the medical device and peripheral devices. The RF transceiver can be attached to or integrated into a peripheral device (e.g., a smartphone, computer, or tablet). For example, the relay device can be a miniature transceiver that is attached to the back of a user's smartphone, for example.

[0049] The transceiver may further include a power source (eg, a battery). The power source may be used to operate one or more components of the transceiver, such as a microcontroller and a circuit board.

[0050] sensor

[0051] The RF transceivers described herein may be suitable for use in conjunction with any sensor technology, such as sensor technology present on or located in a medical device (e.g., a medical device inserted or implanted into a subject's body or body cavity). In some cases, the sensor is a microelectromechanical (MEM) sensor. The sensor may be an accelerometer, such as a multi-axis accelerometer or a MEM accelerometer. In other cases, the sensor is a gyroscope, such as a multi-axis gyroscope. The sensor may be a pressure sensor, a muscle mass sensor, a muscle force sensor, a biomolecule sensor (e.g., a hormone sensor and / or a toxin sensor), a temperature sensor, a moisture sensor, a humidity sensor, an electromyograph (EMG) sensor, a pH sensor, a motion sensor, a G-sensor, a tilt sensor, a rotation sensor, a light detection sensor (e.g., a light detection and ranging (LiDAR) sensor), an electrical impedance electromyograph (EIM) sensor. The medical device can include one sensor or multiple (e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 100, or more) sensors. The multiple sensors can be of the same type or different types. For example, an intravaginal, intraurethral, ​​or intrarectal device can include multiple position sensors (e.g., MEMs sensors, such as accelerometers) and at least one pressure sensor. An intraurethral device can further include a flow sensor. The device can further include a Hall effect sensor.

[0052] The sensor is configured to transmit and / or receive signals to and / or from the transceiver. Thus, the sensor may further comprise a transmitter, a receiver and / or a microcontroller operatively connected to the sensor. The sensor may be a transmitter and / or a receiver.

[0053] In some electronic systems, a microcontroller can connect to sensors via various wired connections, such as a serial peripheral interface (SPI), an inter-integrated circuit (I2C), a universal asynchronous receiver / transmitter (UART), or USB. Sensors (e.g., MEMS accelerometers) can communicate with the MCU via I2C. The MCU and ISM radio components in a device can be located on the same integrated chip. The radio components can communicate wirelessly with a relay device, for example, via the ISM band.

[0054] medical devices

[0055] The RF transceiver described herein may be suitable for use in conjunction with any medical (e.g., biomedical) device that is fully or at least partially inserted or implanted into the body of a subject. For example, a medical device can be located in, for example, an organ (e.g., heart, kidney, pancreas, brain, eye), muscle (e.g., leg, arm), or cavity (e.g., trunk, stomach, intestine (e.g., colon, small intestine), mouth, anus, vagina, urethra, or rectum) and surrounded by a thickness of tissue. Exemplary implantable medical devices are implantable cardioverter-defibrillators (ICDs), pacemakers, ostomy devices, retinal implants, smart contact lenses, glucose biosensors, cochlear implants, bladder implants or slings, implantable drug delivery systems, sleep apnea devices, wireless endoscopic capsules, vagus nerve blocking devices, and electrical stimulation devices, for example, for epilepsy, Parkinson's disease, and dystonia, pain relief and management, peripheral nerves, sacral nerves, phrenic nerves, lower esophagus. These and additional medical devices that may be used with the present invention are described, for example, in Fitzpatrick, D. Implantable electronic medical devices, Elsevier, 2014, which is hereby incorporated by reference in its entirety.

[0056] Any device that includes a sensor for tracking a biometric marker can transmit data from the sensor of the device to a peripheral device via an RF transceiver. For example, an ostomy device that senses intestinal pressure may include a pressure sensor that continuously monitors intestinal pressure in real time. When the intestinal pressure exceeds a predetermined threshold (e.g., 10 mmHg, 20 mmHg, 30 mmHg, 40 mmHg, 50 mmHg, 60 mmHg, 70 mmHg, 80 mmHg, 90 mmHg, 100 mmHg or higher) and the intestine needs to be emptied, the peripheral device can provide an alert to the user (e.g., on a graphical user interface) to enable the bag of the ostomy device to fill, thereby reducing intestinal pressure. Other devices that can be used in conjunction with the systems and methods described herein include, for example, intravaginal, intraurethral, ​​and intrarectal devices, which are described in more detail below.

[0057] Intravaginal devices

[0058] The medical device used in the systems and methods described herein can be an intravaginal device comprising one or more sensors (e.g., position or motion sensors). The intravaginal device can have an elongated shape (e.g., a linear configuration) that is configured to fit within the vagina of a female subject. The device can have a shape comprising a substantially annular body and a tether extending from the body. The intravaginal device can be used as part of a system for monitoring pelvic floor movement during, before, or after daily activities or during a diagnostic procedure. The device can be inserted into the vagina of a female subject so that the intravaginal device is located proximal to the cervix or vaginal stump. The intravaginal device can include one or more position or motion sensors (e.g., MEMS accelerometers) and / or other sensors. The position sensor and / or other sensors provide sensitive position information and / or other information that can be used to sensitively monitor pelvic floor movement and / or assess the subject's pelvic floor architecture or other health aspects.

[0059] In particular, the intravaginal device can detect patterns of angular changes during daily activities or during a diagnostic procedure. For example, specific sensors in the intravaginal device can be monitored during a diagnostic test to assess patterns and angular changes in the pelvic floor as a substitute for assessing pelvic floor muscle physiology. In order to accurately diagnose a pelvic floor disorder in a tested subject, the patterns and angular changes can be compared with patterns and angular changes observed before diagnosis or treatment of the tested subject or a subject with a known pelvic floor disorder (e.g., urinary incontinence or pelvic organ prolapse). The device can also be used to treat female subjects with pelvic floor disorders. When a female patient performs pelvic floor exercises using the device, the position of the pelvic floor muscle tissue can be monitored during the exercise to ensure that she is performing the exercises correctly and maintaining activation (e.g., holding or lifting) of the pelvic floor muscles for a sufficient duration.

[0060] Trends and patterns of angular changes of sensors (e.g., MEMS accelerometers) observed in the intravaginal device during monitoring can be used to diagnose or prognose disease states based on the position, movement, and relative orientation of the pelvic floor muscles (e.g., the various levator ani and anal sphincter muscle groups) and / or pelvic floor organs, or to assess the efficacy of a selected therapy in a subject.

[0061] Exemplary intravaginal devices, systems, and methods for treating, training, visualizing, and diagnosing the health of a subject's pelvic floor muscles have been extensively described in PCT Publication Nos. WO / 2013 / 116310, WO / 2015 / 103629, WO / 2018 / 023037, WO / 2019 / 084469, and WO / 2019 / 084468, PCT Application No. PCT / US2019 / 027168, and U.S. Application No. 62 / 752,987, the disclosures of which are hereby incorporated by reference in their entirety.

[0062] The vaginal device can have an elongated main body that is configured to fit in the vagina. The vaginal device can have a main body that has an outer edge that is configured to contact all or part of the vaginal wall around the cervix or vaginal stump, and the internal diameter size of the vaginal device can be set to roughly circumferentially around the cervix or vaginal stump. The internal diameter and external diameter of the vaginal device can be roughly equal, and their length difference is owing to the thickness of the material for making the vaginal device. The length of internal diameter and / or external diameter can be about 20mm to about 80mm (for example, about 20mm, 25mm, 30mm, 35mm, 40mm, 45mm, 50mm, 55mm, 60mm, 65mm, 70mm, 75mm or 80mm). In some cases, the internal diameter of the vaginal device may be less than the external diameter. In some cases, the intravaginal device can be manufactured with a tether (e.g., a flexible cord or belt) that can optionally be attached to the body of the intravaginal device, for example, by a removable or permanent connection, and the tether can have a length of up to about 14 cm (e.g., 1 cm, 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, 10 cm, 11 cm, 12 cm, 13 cm, or 14 cm) and a width of about 1 mm to about 10 mm (e.g., 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm). Different form factors for the device include a ring (circular or oval), a ring with a tether, and an incomplete ring (e.g., a horseshoe configuration). In some embodiments, the device can lack a ring and be substantially linear or elongated.

[0063] The outer edge of the body of the intravaginal device can be configured to apply pressure, tension, adhesion, and / or suction to the vaginal wall to maintain the position of the intravaginal device proximate to the subject's cervix or vaginal cuff. The pressure, tension, adhesion, and / or suction applied by the outer edge of the intravaginal device to the vaginal wall can be of sufficient strength to limit the intravaginal device from slipping, repositioning, or displacement from the subject's vaginal canal.

[0064] In addition, the body of the intravaginal device can include one or more (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more) features for stabilizing, orienting, and / or positioning the device within the subject's body. The feature can be selected from the group consisting of: a coating, a protrusion, and a texture. In some cases, the feature is a coating (e.g., a surface coating) comprising one or more (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more) biomaterials. Retention features can be applied as with the device shown, or they can be applied as features to other devices described herein, and retention features may be useful with devices of the present invention that are designed to remain within a female vagina for extended periods of time (e.g., at least 10 minutes, 20 minutes, 30 minutes, 40 minutes, 50 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 12 hours, 24 hours, 2 days, 3 days, 4 days, 5 days, 6 days, 1 week, 2 weeks, 3 weeks, 4 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, 12 months).

[0065] The intravaginal device includes one or more (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, or more) sensors located within the body (e.g., generally annular form) and / or the tether, the sensors being configured to detect muscle movement, e.g., PFL and / or PFR. In some cases, the sensors can be configured to detect muscle movement, e.g., PFL and / or PFR, substantially in real time. In some cases, the sensors (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, or more sensors) can be selected from the group consisting of a motion sensor, an orientation sensor, an accelerometer, a gyroscope, a micro-electro-mechanical system (MEMS) sensor (e.g., a MEMS accelerometer), a gravity sensor, a tilt sensor, a rotation sensor, a pressure sensor, a light detection sensor (e.g., a LiDAR sensor), an EIM sensor, and combinations thereof. The device may also include a light generating component for use with a light detection sensor, such as a LiDAR sensor. The device may also include electrodes for use with an EIM sensor. In addition, the intravaginal device may include one or more sensors (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, or more sensors) configured to detect, for example, levels or changes in levels of muscle strength, muscle mass, biomolecules (e.g., hormones and / or toxins), pH, temperature, and / or humidity.

[0066] In some cases, the sensors can be positioned in an arrangement similar to or different from the arrangements described in, for example, International Publication Nos. WO2015 / 103629, WO2016 / 067023, and WO2016 / 042310; U.S. Publication Nos. US20150032030, US20140066813, US20150151122, US20150133832, US20160008664, and US20150196802; and U.S. Patent Nos. US8983627, US7955241, US7645220, US7628744, US7957794, US6264582, and US6816744, each of which is incorporated herein by reference. For example, two or more sensors as described herein can be placed about the longitudinal axis of the intravaginal device, e.g., in a circle or spiral about the central axis of the body and / or tether of the intravaginal device, at approximately ±1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9°, 10°, 20°, 30°, 40°, 50°, 60°, 70°, 80°, 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, 180°, 190°, 200°, 210°, 220°, 230°, 240°, 250°, 260°, or 270° relative to each other. Alternatively or additionally, two or more sensors as described herein can be placed, for example, about 0.001 mm, 0.01 mm, 0.1 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 20 mm, 30 mm, 40 mm, 50 mm, 60 mm, 70 mm, 80 mm, 90 mm, 100 mm, 125 mm, 150 mm, 175 mm, 200 mm, 225 mm, 250 mm, 275 mm, 300 mm, 325 mm, 350 mm, or more apart along the circumference of the body and / or along the length of the tether of the intravaginal device. In some cases, two or more sensors as described herein can be placed along the central axis of the body and / or tether of the intravaginal device. In some cases, two or more sensors as described herein can be positioned so that they are not on a central axis, e.g., so that they are offset from a central axis of the body and / or tether of the intravaginal device. In certain cases, such as when the sensor is located within the tether, the body may not include a sensor. In other cases, when the sensor is located within the tether, the body may further include one or more (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, or more) sensors. In some cases, the sensor is an accelerometer, such as a multi-axis accelerometer.In other cases, the sensor is a gyroscope, such as a multi-axis gyroscope. In other cases, the sensor is a MEMS sensor. In addition, the intravaginal device may further include one or more (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, or more) additional sensors within the body and / or tether, the additional sensors selected from the group consisting of: a pressure sensor, a muscle mass sensor, a muscle force sensor, a biomolecule sensor (e.g., a hormone sensor and / or a toxin sensor), a temperature sensor, a moisture sensor, a humidity sensor, an electromyography (EMG) sensor, and a pH sensor. The sensor can be positioned on a surface of the intravaginal device (e.g., on a surface of the body and / or tether) such that all or a portion of the sensor is in direct contact with the tissue of the vaginal wall and / or cervix or vaginal cuff of the subject. In some cases, the sensor can be positioned approximately 0.001 mm, 0.01 mm, 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm, or more below the outer surface of the intravaginal device (e.g., the body and / or tethers of the intravaginal device). In some cases, the sensor can be positioned such that approximately 0.001 mm, 0.01 mm, 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm, or more of the sensor protrudes from an outer surface of the intravaginal device (e.g., the body and / or tether of the intravaginal device). Alternatively, the sensor can be positioned within the intravaginal device (e.g., within the body and / or tether) such that the sensor does not directly contact the vaginal wall and / or cervix or vaginal cuff of the subject, but is positioned to detect movement while the user performs PFL or PFR. The sensors can be positioned evenly or unevenly on or within the intravaginal device at certain intervals. Sensors within the intravaginal device (eg, within the body and / or tether) can be positioned such that when the intravaginal device is inserted into a user, the sensors face in an abdominal direction (eg, an anterior direction).

[0067] The tether can have a length of up to about 20 cm (e.g., 1 cm, 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, 10 cm, 11 cm, 12 cm, 13 cm, 14 cm, 15 cm, 16 cm, 17 cm, 18 cm, 19 cm, or 20 cm) and can be divided along its length into multiple segments containing sensors. The sensors can be positioned along the length of the tether at uniform or uneven intervals, for example, at intervals of about 1 mm to about 140 mm (e.g., 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 20 mm, 30 mm, 40 mm, 50 mm, 60 mm, 70 mm, 80 mm, 90 mm, 100 mm, 110 mm, 120 mm, 130 mm, or 140 mm). The location of the sensor within the tether may be identified on the exterior of the device by the presence of markings (eg, protrusions, symbols, writing, and / or etching) on ​​the surface of the tether.

[0068] The intravaginal device (e.g., the body (e.g., generally annular form) and / or the tether) further includes a microcontroller, e.g., within the generally annular form, configured to receive data from the sensor. The microcontroller can also be configured, or can include a separate component, to store data from the sensor non-transiently. The microcontroller can be connected to the sensor, e.g., via wires and / or a circuit board. The wires and circuit board can be flexible or rigid.

[0069] The intravaginal device may also include a transmitter and receiver within the body (e.g., a roughly annular form) and / or tether form for communicating wirelessly or via a detachable cable with a peripheral device (e.g., a handheld or portable device or computer, such as a smartphone, tablet computer, or laptop), for example, via a relay device. Alternatively, the transmitter and receiver may be located in a housing and connected to the intravaginal device wirelessly or via a detachable cable. The transmitter and receiver may be directly or indirectly connected to a microcontroller, sensor, and / or circuit board. The transmitter and receiver are configured to be used with the RF transceiver described herein. The transmitter and receiver may, for example, communicate with the transceiver using BLE, ISM, MICS, Wi-Fi, or RF. The information collected by the sensor may be transmitted (e.g., downloaded, transferred) to the peripheral device by the transmitter and receiver (e.g., via an RF transceiver relay device) and / or by using a detachable cable.

[0070] In some embodiments, the intravaginal device includes 8 or fewer (e.g., 4 or 5) sensors in the tether and 5 or fewer sensors in the main body. The tether and the main body can both share one sensor. The angle between the plane connecting the front and back sides of the main body 110 and the tether 10 can vary from 0°-180° (e.g., 10°, 20°, 30°, 40°, 50°, 60°, 70°, 80°, 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, 180°). The circumference of the main body can be from about 10 cm to about 50 cm (e.g., 15 cm, 20 cm, 25 cm, 30 cm, 35 cm, 40 cm, 45 cm, or 50 cm), or can be 27.6 cm. The tether 10 can be from about 1 cm to about 50 cm in length (e.g., 2 cm, 3 cm, 4 cm, 5 cm, 10 cm, 15 cm, 20 cm, 25 cm, 30 cm, 35 cm, 40 cm, 45 cm), or can be 25.5 cm long. The sensors 200 can be spaced about 0.5 cm to about 5 cm apart (e.g., 1 cm, 1.5 cm, 2 cm, 2.5 cm, 3 cm, 3.5 cm, 4 cm, or 4.5 cm), or can be spaced about 1.6 cm apart. At least one sensor can be placed on the tether 10 cm or less from the body (e.g., 9 cm, 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2 cm, or 1 cm).

[0071] The intravaginal device can further include a power source (eg, a battery). The power source can be used to operate one or more components of the device, such as the sensor, transmitter, receiver, and circuit board.

[0072] Intraurethral devices

[0073] The medical device used in the systems and methods described herein can be an intraurethral device comprising at least one sensor. The intraurethral device can be a catheter, such as a urodynamic catheter. The device can have an elongated body and one or more position or motion sensors (e.g., MEMS accelerometers) positioned along its length. The catheter can be used alone or as part of a system for monitoring pelvic floor movement. The catheter is configured to be inserted into the urethra of a subject (e.g., a male or female subject) so that one or more sensors (e.g., position sensors) provide data, such as position data that provides readings of the spatial orientation of the subject's urethra. The readings provided by the urethral position can serve as a substitute for the spatial arrangement of the pelvic floor and pelvic floor organs including the urethra. For male subjects, the catheter orientation can provide information about the position of the prostate. The catheter can also include one or more additional sensors, such as motion, pressure, and / or flow sensors. The catheter can be structurally configured into any suitable geometric shape to fit within the subject's urethra. The catheter can have multiple, for example, two lumens. One lumen can be used to fill the bladder, and one lumen can be used to measure pressure.

[0074] Exemplary catheters that can be used in conjunction with the devices, systems, and methods described herein are described, for example, in PCT Publication Nos. WO / 2011 / 050252 and WO / 2013 / 082006, the disclosures of which are hereby incorporated by reference in their entireties. For example, exemplary urodynamic catheters that can be used with and / or modified by additional sensors are described in U.S. Patent Nos. 6,447,462, 5,984,879, and U.S. Publication Nos. 20060122488, 20030097039, 20060276712, 20060281992, and 20170258345, the disclosures of which are hereby incorporated by reference in their entireties.

[0075] The intraurethral device may include a balloon. For example, the device may include at least one thin-walled, circumferentially extending balloon near its distal or subject end, which transmits external pressure at the proximal end of the balloon to a transducer located outside the subject's body via a small, closed air column. During a multi-channel cystometry procedure, the catheter may be inserted with the at least one balloon in a deflated state, and the balloon may be inflated after the catheter enters the subject's bladder.

[0076] The intraurethral device may include one or more (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20 or more) sensors, such as position or motion sensors. The position or motion sensor may be configured to detect muscle movement, such as PFL and / or PFR. In some cases, the sensor may be constructed to detect muscle movement, such as PFL and / or PFR, substantially in real time. In some cases, the one or more sensors may be selected from the group consisting of a motion sensor, an orientation sensor, an accelerometer, a gyroscope, a micro-electro-mechanical system (MEMS) sensor (e.g., a MEMS accelerometer), a gravity sensor, a tilt sensor, a rotation sensor, a pressure sensor, a temperature sensor, a humidity sensor, an electromyography (EMG) sensor, a light detection sensor (such as a laser radar (LiDAR) sensor), an EIM sensor, and combinations thereof.

[0077] Two or more sensors as described herein can be placed around the longitudinal axis of the catheter, for example in a circle or spiral around the central axis of the body of the catheter and / or tether, at approximately ±1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9°, 10°, 20°, 30°, 40°, 50°, 60°, 70°, 80°, 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, 180°, 190°, 200°, 210°, 220°, 230°, 240°, 250°, 260° or 270° relative to each other. Alternatively or additionally, two or more sensors as described herein can be placed, for example, along the catheter and spaced apart by about 0.001mm, 0.01mm, 0.1mm, 0.5mm, 1mm, 2mm, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 20mm, 30mm, 40mm, 50mm, 60mm, 70mm, 80mm, 90mm, 100mm, 125mm, 150mm, 175mm, 200mm, 225mm, 250mm, 275mm, 300mm, 325mm, 350mm or more. In some cases, two or more sensors as described herein can be placed along the central axis of the catheter. In some cases, two or more sensors as described herein can be placed so that they are not on the central axis, for example, so that they deviate from the central axis of the catheter. The sensor can be positioned on the surface of the catheter so that all or part of the sensor is in direct contact with the urethra tissue. In some cases, the sensor can be positioned about 0.001 mm, 0.01 mm, 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm, or more below the outer surface of the catheter (e.g., the surface in direct contact with urethral tissue). In some cases, the sensor can be positioned such that about 0.001 mm, 0.01 mm, 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm, or more of the sensor protrudes from the outer surface of the catheter. Alternatively, the sensor can be positioned within the catheter so that the sensor does not directly contact the urethra, but is positioned to detect movement, for example, during pelvic floor exercises. The sensors can be positioned evenly or unevenly on or within the catheter at certain intervals. The sensor within the catheter can be positioned so that when the catheter is inserted into the subject, the sensor faces in an abdominal direction (e.g., anterior direction).

[0078] The catheter may also include a transmitter and / or receiver for communicating with an electronic device (e.g., a peripheral device, such as a handheld or portable device or a computer, such as a smartphone, tablet computer, or laptop) wirelessly or via a detachable cable. Alternatively, the transmitter and receiver may be located in a housing and connected to the catheter wirelessly or via a detachable cable. The transmitter and receiver may be directly or indirectly connected to a microcontroller, sensor, and / or circuit board. The transmitter and receiver are configured to be used with the RF transceiver described herein. The transmitter and receiver may, for example, use BLE, ISM, MICS, Wi-Fi, or RF to communicate with the transceiver. The information collected by the sensor may be transmitted (e.g., downloaded, transferred) to the peripheral device by the transmitter and / or receiver and / or by using a detachable cable wirelessly. The peripheral device may include a user interface. The user interface may be programmed to display data and / or provide instructions for use of the intraurethral device (e.g., a catheter, such as a urodynamic catheter). The intraurethral device may further include a power source (e.g., a battery). The power source may be used to operate one or more components of the device, such as a sensor, transmitter, receiver, and circuit board.

[0079] Intrarectal devices

[0080] The medical device may be an intrarectal device comprising at least one sensor. The intrarectal device has an elongated body and can be used as part of a system for monitoring pelvic floor movements during pregnancy. Exemplary intrarectal devices are described, for example, in U.S. Patent Publication Nos. US20170281072 and US20170303843, the disclosures of which are hereby incorporated by reference herein in their entireties.

[0081] The device can be inserted into the rectum of a subject (e.g., a male or female subject) such that one or more sensors (e.g., position or motion sensors) provide data, for example, in real time. For example, the position or motion sensor can provide a position reading of the spatial orientation of the subject's rectum. The position of the rectum provides a reading that serves as a surrogate for the position of the pelvic floor and the spatial arrangement of the pelvic floor organs, including the urethra and prostate. The intrarectal device can include a plurality of position sensors (e.g., accelerometers) positioned along the length of the device. The intrarectal device can also include one or more additional sensors, such as motion and / or pressure sensors. The intrarectal device can be structurally configured as any suitable geometry to fit within the rectum of a subject.

[0082] Intrarectal devices can be used to detect patterns of angular changes. For example, specific sensors in the intrarectal device can be monitored during urodynamic testing or daily activities to assess patterns and angular changes in the pelvic floor as a surrogate for assessing pelvic floor muscle physiology. In order to accurately diagnose a pelvic floor disorder in a tested subject, the patterns and angular changes can be compared with patterns and angular changes observed before diagnosis or treatment of the tested subject or a subject with a known pelvic floor disorder (e.g., urinary incontinence).

[0083] Trends and patterns of angular changes of sensors (e.g., MEMS accelerometers) observed in an intrarectal device, for example, during urodynamic testing, can be used to diagnose or prognose disease states based on the position, movement, and relative orientation of the pelvic floor muscles (e.g., the various levator ani and anal sphincter muscle groups) and / or pelvic floor organs, or to assess the efficacy of a selected therapy in a subject.

[0084] Peripheral devices

[0085] The systems and methods described herein may include a peripheral device. The peripheral device may be any suitable electronic device, such as a computer, a smart phone, a tablet computer, or a smart watch. The peripheral device may be programmed with software or a mobile application to facilitate use in combination with the devices and systems described herein. The peripheral device may be configured with a processing unit that may convert or utilize sensor data received from a medical device (e.g., a medical device inserted into or implanted in the subject's body or body cavity, such as an intraurethral, ​​intrarectal, or intravaginal device). For example, when a subject performs pelvic floor exercises, such as during daily activities (e.g., activities that change (e.g., lift and / or lower) the overall health of her urogenital system and / or pelvis), sensor data may be received to provide the subject with feedback on whether the detected activity affects her health or indicates treatment or treatment needs for a pelvic floor disorder (such as urinary incontinence and / or fecal incontinence). For example, the peripheral device can process the sensor data to generate a baseline that can be used to compare with sensor data acquired at a future time to provide feedback (e.g., an alert) to the subject regarding whether the activities she is performing are beneficial or detrimental to her health condition, or whether the pelvic floor movements indicate treatment or a need for treatment of a pelvic floor disorder. Additionally, or alternatively, the peripheral device can process the sensor data and compare the results to a previously established or predetermined baseline, and based on the comparison, can provide feedback (e.g., an alert) to the subject regarding whether the activities she is performing are beneficial or detrimental to her health condition, or whether the pelvic floor movements indicate treatment or a need for treatment of a pelvic floor disorder. Additionally, the peripheral device can include a user interface. The user interface can be programmed to display data and / or provide instructions for use of the medical device.

[0086] The peripheral device is configured to transmit and / or receive signals to and / or from the transceiver. Therefore, the peripheral device may further include a transmitter, a receiver and / or a microcontroller operatively connected to the peripheral device. The peripheral device may be a transmitter and / or a receiver.

[0087] The peripheral device may be equipped with a Wi-Fi or internet connection. For example, the peripheral device may be able to transmit data from a sensor to a cloud-based, network-based server or other information storage mechanism.

[0088] Systems and Kits

[0089] The devices and components described herein can be present as part of a kit or system. For example, the systems and kits described herein can include one or more of a radio frequency transceiver, a medical device (e.g., a medical device inserted or implanted into a subject's body or body cavity, such as an intravaginal, intraurethral, ​​or intrarectal device), a peripheral device (e.g., a smartphone), one or more sensors, a microcontroller, a transmitter, a receiver, etc. (see, e.g., Figure 2 ). If packaged in a kit, the kit may further include instructions for use. If the medical device is, for example, an intravaginal device, the system or kit may further include a cap or cover for the device. The cap or cover may optionally include an RF transceiver as described herein. The peripheral device (e.g., a smartphone) may further include a mobile application or a web-based application.

[0090] Operation

[0091] From a usability perspective, transmitting data from sensors implanted in the human body to peripheral devices is a highly desirable approach. However, RF attenuation and technology mismatches within the body can prevent the desired direct connection. Instead, a hybrid approach utilizing seamless bridging devices can be deployed to allow heterogeneous RF usage, with embedded sensors operating at frequencies in the RF band that are more penetrating to the human body, while peripheral devices operate at RF bands that are convenient for commercial accessories.

[0092] Medical sensors in devices inserted or implanted in the body often need to communicate wirelessly with external devices in order to transmit data in real time. A common interface device available to patients today is a smartphone, with Bluetooth Low Energy (BLE) being the primary wireless interface (see, e.g., Figure 1 ).

[0093] Link budget analysis

[0094] A wireless link consists of at least one transmitter and one receiver. For two-way communication, each side requires a transmitter and a receiver. The signal power received by each receiver is calculated using the following formula:

[0095] Received power (dBm) = Transmitted power (dBm) + Gain (dB) – Loss (dB)

[0096] Effective wireless communication requires that the received signal power at each end of the wireless link be significantly greater than the noise input power. The minimum received signal strength that results in an acceptable bit error rate is called receiver sensitivity. Receiver sensitivity is a function of several factors, including the noise performance of the system electronics, the efficiency of the receiving antenna, and the modulation used to encode the data onto the RF carrier. Selecting the correct modulation scheme requires a trade-off between complexity, data rate, channel bandwidth, and bit error rate for a given signal-to-noise ratio.

[0097] Channel loss is the primary loss in typical wireless systems. Free-space loss is primarily due to the propagation of energy in all directions, so only a small amount of energy radiated by the transmitting antenna reaches the receiving antenna. For biomedical systems where one or both antennas are surrounded by human tissue, tissue absorption is a second major source of loss. The conductivity and permittivity of human tissue cause it to absorb RF energy and convert it into heat, resulting in significantly higher losses than in free space.

[0098] Connection: BLE and ISM

[0099] To ensure transparent bridging of the ISM and BLE transmission segments, it may be necessary to synchronize the establishment and teardown of the two links. Because BLE is established from a peripheral device acting as a BLE Central, ISM link establishment can be managed by the peripheral device (e.g., a smartphone) over the BLE connection. The ISM link is established after the BLE connection is established. The ISM link may also need to be torn down after the existing BLE connection is torn down.

[0100] The ISM link may not need to manage the BLE connection itself. If ISM data is lost, a higher-level protocol can be used to determine what should happen on the BLE link. Beyond the actual connection formation, the fundamental properties of the two transports may need to match to allow for smooth data exchange between them. The approach described herein logically arranges each transport to appear as a full-duplex, simple serial pipe. This allows bounded data packets to be received on one transport and simply sent unmodified on the other.

[0101] Data exchange: packet-based, encoding

[0102] Once the BLE connection and ISM link are established, data can flow between the two endpoints, sensors, and peripheral devices (e.g., smartphones), with the RF transceiver bridging the two transports. ISM packets can be transparently reconstructed and sent over the BLE connection. Similarly, packets destined for sensors received at the RF transceiver relay can be reconstructed and sent over the ISM link. Both transports can utilize a simple consistent overhead byte stuffing (COBS) encoding to encapsulate the underlying data packets. COBS is an algorithm for encoding data bytes that produces efficient, reliable, and unambiguous packet framing regardless of packet content, allowing receiving applications to easily recover from malformed packets. The algorithm uses specific byte values ​​(e.g., zero) as packet delimiters, which are special values ​​that indicate the boundaries between packets. When zero is used as a delimiter, the algorithm replaces each zero data byte with a non-zero value so that no zero data bytes appear in the packet that could be misinterpreted as packet boundaries.

[0103] Energy Management

[0104] Another additional constraint on the overall system is energy management (such as batteries in the sensor or device). This is crucial because the sensor may be implanted by a physician and may not be easily removed. Therefore, it is necessary to ensure the sensor's operation for the expected duration of treatment. To achieve this, the sensor can maintain itself in a rest mode, such as a deep sleep mode, to conserve energy when not in use. The sensor may periodically wake up to briefly check for activation and return to sleep if no activation pulse is observed. This can occur over the ISM link, where the sensor can monitor for transmissions with a unique sensor-specific signature.

[0105] To induce a sensor's wakeup, the matching relay issues an activation pulse, lasting, for example, 10% longer than the sensor's wakeup period. This ensures that the next time the accompanying sensor checks for activation, it will find it. Once activated, the sensor collects and transmits data, pausing transmissions mid-transmission for an acknowledgement from the accompanying relay. Lack of acknowledgement forces the sensor to abandon further transmissions and return to a resting mode, such as deep sleep, awaiting the next activation.

[0106] A medical device (e.g., one inserted or implanted within a subject's body or body cavity, such as an intravaginal, intraurethral, ​​or intrarectal device) may include a Hall-effect sensor. The Hall-effect sensor can be used to detect when the device is activated (e.g., removed from its housing) to trigger a transceiver and / or a microcontroller and / or radio within the medical device. The sensor can also be used to detect when the device is deactivated, for example, when the housing is replaced. The Hall-effect sensor features omnipolar magnetic flux detection. Its output remains at its VCC (common collector voltage) level until the magnitude of its magnetic flux exceeds 4.8 mT, after which it switches its output to GND (ground). Once the magnetic field weakens or is removed, its output returns to VCC. A microcontroller can check the Hall-effect sensor output level once per second to determine its status. The Hall-effect sensor's status can be used to determine whether the device should be in active operation or standby mode. For example, if the magnetic field is no longer detected, the device is likely outside the housing, and the device can enter its active mode. Conversely, the presence of a magnetic field may indicate that the device is inside the housing and the system should enter or remain in standby mode.

[0107] Pelvic floor disorders

[0108] The devices, systems and kits of the present invention can be used to monitor and diagnose pelvic floor disorders. Pelvic floor disorders include: urinary tract disorders, which are disorders that cause difficulty in bladder storage; and incontinence, which includes the body's inability to control the discharge of urine. The types and prevalence of urinary incontinence in ambulatory adult women include stress urinary incontinence (SUI), detrusor instability (urge incontinence), mixed urinary incontinence (stress and urge), and other urinary incontinence (overflow, neurogenic). The prevalence of detrusor instability and mixed urinary incontinence has been observed to increase with the age of the subject sample. Male subjects may experience similar urinary incontinence problems, which are often associated with prostate enlargement. Men also have urinary retention problems due to the prostate.

[0109] SUI can be characterized as involuntary urination that occurs when intravesical pressure exceeds maximum urethral pressure in the absence of detrusor contraction. Stress urinary incontinence may include accidental urination due to laughing, sneezing, coughing, or standing up, as any such exertion results in increased abdominal pressure that, when transmitted to the bladder and the urine contained therein, exceeds the flow resistance created by the urethra, primarily the urethral sphincter. SI can be further categorized as bladder neck hypermobility and intrinsic sphincteric deficiency (ISD).

[0110] Bladder neck hypermobility may result from pelvic floor descent and can be attributed to weakened pelvic floor muscles and connective tissue. This may be observed in conjunction with external genital nerve damage caused by childbirth but may also occur in young women who have not given birth. In its normal position, the bladder is supported by the pelvic muscles, which prevent abdominal pressure from increasing beyond urethral pressure. When the pelvic muscles become weak or damaged, the bladder neck displaces abnormally during abdominal pressure, and urethral sphincter closing pressure becomes insufficient to maintain continence. Urination due to hypermobility-related SI often occurs in a cyclical manner, and the volume of urine may be proportional to the severity of the condition.

[0111] ISD is a severe form of stress urinary incontinence that can occur due to inherent defects in the urethral closure mechanism or due to a dysfunctional urethra in which the bladder neck is open at rest. Severe ISD results in persistent urine leakage or leakage in response to minimal exertion by the subject. In ISD, the bladder neck may be fixed or hypermobile. ISD occurs in a significant number of cases due to urethral scarring from past incontinence surgery, but it can also result from other causes. Only a minority of subjects exhibit stress urinary incontinence that can be attributed to ISD.

[0112] Examples

[0113] The following examples are presented to provide one of ordinary skill in the art with a description of how the compositions and methods described herein may be used, prepared, and evaluated, and are intended to be merely exemplary of the invention and are not intended to limit the scope of what the inventors regard as their invention.

[0114] Example 1. Simulation of sensor implantation in phantom solution

[0115] Phantom simulations in a water-based solution were used to simulate the communication between sensors in human tissue and peripheral devices when performing benchmark tests. The phantom solution was constructed using the following process:

[0116] A. Heat approximately 3 gallons (+ / - 0.1 gallons) of water to 104°F (+ / - 1°F);

[0117] B. Fill a 5-gallon bucket with warm water;

[0118] C. Add 22 pounds (+ / - 1 pound) of sugar (sucrose) to the bucket while stirring;

[0119] D. Add 10.6 ounces (+ / - 0.1 ounces) of salt to the bucket while stirring;

[0120] E. Heat the water to 98°F (+ / - 2°F) using a temperature stabilizer.

[0121] Two prototypes were designed and built to compare the RF performance of a BLE radio and a 915MHz ISM radio. The radios were configured to transmit a continuous wave signal at similar output power values ​​without any modulation. The receiver was approximately 30cm from the prototype transmitter and received the following power:

[0122] The received signal strength for the BLE radio in free space is: -53dBm.

[0123] The received signal strength in free space for an ISM radio is: -50dBm.

[0124] Each prototype transmitter was then immersed in the phantom solution and the received power was measured:

[0125] The received signal strength for the BLE radio component in the phantom is: less than -101dBm.

[0126] The received signal strength for the ISM radio component in the phantom is: -85dBm.

[0127] The sensitivity of a BLE receiver is approximately -101dBm. The received signal strength is below the sensitivity limit, so the attenuation caused by the phantom solution is at least 48dB (the difference between -53dBm and -101dBm). For ISM radio components, the attenuation is 35dB (the difference between -85dBm and -50dBm). Phantom solution experiments show that the attenuation of a 915MHz radio signal in the phantom solution is at least 18dB lower than that of a BLE radio signal.

[0128] Example 2. Testing of sensor devices in the human body

[0129] A system comprising a smartphone (6) and an intravaginal device (2) having six accelerometers positioned along the length of the device was tested in four human subjects using four separate prototypes. The system did not include a relay device ( Figure 3 All four prototypes functioned properly in free space. However, when the devices were inserted into each subject's vagina, the wireless connection was lost. This confirmed the phantom tests' indication that the BLE signal was attenuated to a level below the sensitivity of a typical BLE receiver when placed inside the human body.

[0130] An updated system (which includes a relay device (8) ( Figure 1 and Figure 2)) was subsequently tested in humans. The relay device is contained within the housing of the intravaginal device and includes two radio components: a 915 MHz ISM radio and a 2.4 GHz Bluetooth Low Energy (BLE) radio. The BLE component communicates with a mobile phone via Bluetooth Low Energy. The system was tested using the following two modulation schemes:

[0131] WB-DSSS: 60kbps, 195kHz deviation, 2-GFSK, 4x spread spectrum.

[0132] GFSK: 50kbps, 25kHz deviation, 2-GFSK, no spread spectrum.

[0133] ISM radios allow for adjustment of various RF settings to optimize trade-offs based on the specific requirements of an application. These settings include transmitter output power, channel frequency, modulation scheme, data rate, and filter bandwidth. The maximum output power achievable with the ISM radio is +15dBm. However, this output power level consumes considerable current. FCC regulations, described in Title 47, Part 15, set limits on various metrics, including radiated power and occupied bandwidth. Specifically, Part 15.247 defines rules for devices employing frequency hopping and digital modulation, while Part 15.249 does not impose restrictions on modulation schemes but rather sets a lower limit on the maximum permissible field strength. To meet the FCC guidelines for Part 15.249, the maximum permissible field strength is 50mV / m, which is approximately equivalent to a conducted power of -1dBm at the antenna port.

[0134] Initial prototypes of the system used an output power of +5dBm. Because this exceeded the maximum output power specified in FCC Guidelines Part 15.249, operation at this power level necessitated the use of frequency hopping, digital modulation, and a 6dB bandwidth exceeding 500kHz. To meet these requirements, a wideband direct-sequence spread spectrum (WB-DSSS) scheme and a Gaussian frequency-shift keying (GFSK) modulator were implemented in the ISM radio. Using WB-DSSS yielded a sufficiently wide frequency band to meet FCC requirements. However, the wider bandwidth resulted in a higher noise floor, which resulted in suboptimal bit error rates during manual testing.

[0135] A total of 15 human subjects were given devices using WB-DSSS modulation and asked to use the devices in their homes. Depending on the subject and their environment, an average of 14.65% of the sessions resulted in connection failures. A connection failure is defined as a 1-second data packet with at least one data bit error. The results comparing the percentage of connection failures between the system without a relay device and the system with a relay device are shown in Table 1 below. Although this modulation scheme will result in some errors, the overall performance is significantly better than Figure 3A system in which the system attempts to communicate directly with peripheral devices using a 2.4GHz BLE radio component.

[0136] A second modulation scheme was also tested, which limited the output power at the antenna to -1 dBm and did not employ frequency hopping. As shown in Table 1, GFSK modulation resulted in significantly fewer connection errors than WB-DSSS modulation.

[0137] Table 1. Probe connection failure rate

[0138]

[0139]

[0140] Overall, these data show that both WB-DSSS and GFSK modulation schemes perform better than a system without a relay device, which is unable to establish a connection between the device and the smartphone.

[0141] Example 3. Treatment of urinary incontinence using a relay device with an intravaginal device

[0142] An intravaginal device (2) comprising a plurality of accelerometers positioned along the length of the device can be used to treat a subject suffering from urinary incontinence (UI). The subject (e.g., a subject who has recently undergone a vaginal birth) may have been identified as being at risk for UI or has been diagnosed with UI by a physician. Alternatively, a subject experiencing UI symptoms may self-identify as needing pelvic floor muscle training to reduce the frequency and / or severity of UI symptoms. The subject may obtain the device from a licensed physician or a retailer.

[0143] The intravaginal device (2) can be an elongated probe with a sheath. The sheath can include an RF transceiver relay device (8) as described herein. The subject has a personal smartphone device (6). The subject downloads an application that is configured to operate with the intravaginal device (2). The subject can first remove the sheath and place it in her side pocket. The subject can insert the intravaginal device into her vagina and position it near the cervix, or in the case of subjects who have undergone a hysterectomy, at the vaginal cuff.

[0144] The subject will then perform a series of pelvic floor lifts (PFLs) to strengthen her pelvic floor muscles. The subject may perform a series of PFLs for, for example, 2 minutes, then rest the muscles for 2 minutes, repeating the series a total of 5 times over 20 minutes. The device measures and collects data via an accelerometer on the device. Position and motion data acquired from the sensor is transmitted to a radio frequency transceiver at 915 MHz (ISM RF band). The transceiver (8) receives the signal from the accelerometer and converts the signal to 2.45 GHz, i.e., the BLERF band. The transceiver (8) transmits the signal to a peripheral device (6). The peripheral device may, for example, use an algorithm to process the data acquired from the transceiver so as to display real-time data on a graphical user interface of a smartphone (6). The graphical user interface may display data such as the intensity of activation of the pelvic floor muscles during the pelvic floor muscle exercise and the duration of activation. The subject will perform the training program at least once a day (or more often, for example, three times a day) for about one week to about three months. The vaginal device (2) may be removed before each set of exercises, or the device may remain inserted for the duration of the treatment cycle. A smartphone app can track this data over time and score it to provide the subject with feedback on her pelvic floor muscle strength and symptom improvement. Over time, symptoms resolve.

[0145] Other embodiments

[0146] Although the invention has been described with reference to specific embodiments thereof, it will be understood that the invention is capable of further modification and this application is intended to cover any variations, uses or adaptations thereof, and in general, the principles of the invention and including such departures therefrom as come within the known or customary practice in the art to which the invention pertains and as applied to the basic features hereinbefore set forth and which fall within the scope of the claims.

[0147] Other embodiments are within the scope of the following claims.

Claims

1. A system comprising: (a) a relay device, the relay device comprising a radio frequency transceiver configured to transmit and receive a first radio frequency signal at a first frequency greater than 1 GHz to and from a first device, and to transmit and receive a second radio frequency signal at a second frequency less than 1 GHz to and from a second device; wherein the first device comprises a first transmitter and / or receiver configured to transmit and / or receive the first radio frequency signal at the first frequency; as well as (b) an intravaginal, intrarectal, or intraurethral device comprising the second device, the second device comprising a second transmitter and / or receiver configured to transmit and / or receive the second radio frequency signal at the second frequency, wherein the intravaginal, intrarectal, or intraurethral device comprises at least one position or motion sensor configured to transmit a signal to the second device, and at least a portion of the intravaginal, intrarectal, or intraurethral device comprising the position or motion sensor is configured to be inserted into a body cavity of a subject.

2. The system according to claim 1, wherein The first frequency is greater than 2 GHz.

3. The system according to claim 2, wherein: The first frequency is from 2 GHz to 3 GHz.

4. The system according to claim 3, wherein: The first frequency is 2.45 GHz.

5. The system according to claim 1, wherein The second frequency is from 1 MHz to 1 GHz.

6. The system according to claim 5, wherein: The second frequency is 915 MHz, 433 MHz or 402 MHz.

7. The system according to claim 1, wherein: The transceiver is configured to transmit and receive radio frequency signals to and from a Bluetooth Low Energy (BLE) device, the BLE device being configured to transmit and / or receive the first radio frequency signal at the first frequency.

8. The system according to claim 1, wherein: The transceiver is configured to transmit to and receive the second radio frequency signal at the second frequency from an Industrial, Scientific, and Medical (ISM) or Medical Implant Communications System (MICS) device.

9. The system of claim 1, further comprising a microcontroller.

10. The system according to claim 1, wherein The first device is a BLE device.

11. The system according to claim 1, wherein: The second device is an ISM or MICS radio frequency device.

12. The system of claim 1, further comprising a peripheral device.

13. The system according to claim 12, wherein: The peripheral device includes the first device and / or the relay device.

14. The system according to claim 12 or 13, wherein: The peripheral device is a smartphone, a tablet computer, a computer or a smart watch.

15. The system of claim 1, further comprising one or more microcontrollers.

16. The system according to claim 15, wherein The one or more microcontrollers are located in the intravaginal, intrarectal, or intraurethral device.

17. The system of claim 1, wherein: The subject is a human.

18. The system of claim 1, wherein: The intravaginal, intrarectal, or intraurethral device includes a plurality of position or motion sensors.

19. The system according to claim 18, wherein The plurality of position or motion sensors are positioned along the length of the intravaginal, intrarectal, or intraurethral device.

20. The system of claim 1, wherein: The position or motion sensor is a micro-electromechanical (MEM) sensor.

21. The system of claim 1, wherein: The position or motion sensor is an accelerometer.

22. The system of claim 1, wherein: The intravaginal, intrarectal or intraurethral device further comprises at least one sensor selected from the group consisting of a pressure sensor, a flow sensor, a muscle mass sensor, a muscle force sensor, a pH sensor, a humidity sensor, a temperature sensor, a hormone sensor, a toxin sensor and a Hall effect sensor.

23. The system of claim 22, wherein: The intravaginal, intrarectal or intraurethral device includes the Hall effect sensor.

24. A method of using the system according to claim 1, the method comprising: (a) transmitting the second radio frequency signal at the second frequency from the second device to the relay device; (b) receiving, by the relay device, the second radio frequency signal at the second frequency; (c) converting, by the relay device, the second radio frequency signal at the second frequency into the first radio frequency signal at the first frequency; as well as (d) transmitting the first radio frequency signal at the first frequency to the first device.

25. A method of using the system according to claim 1, the method comprising: (a) transmitting the first radio frequency signal at the first frequency from the first device to the relay device; (b) receiving, by the relay device, the first radio frequency signal at the first frequency; (c) converting, by the relay device, the first radio frequency signal at the first frequency into the second radio frequency signal at the second frequency; as well as (d) transmitting the second radio frequency signal at the second frequency to the second device.

26. The method according to claim 24 or 25, wherein The system is used to detect pelvic floor movement by the following steps: (a) inserting the intravaginal, intrarectal, or intraurethral device including the second device into the body cavity of the subject, wherein the position or motion sensor is located within the body cavity of the subject; (b) acquiring a signal from the position or motion sensor upon engagement or contraction of the pelvic floor; as well as (c) transmitting, via the transceiver, a signal from the position or motion sensor to a peripheral device including the first device.

27. The method according to claim 24 or 25, wherein The first frequency is greater than 2 GHz.

28. The method according to claim 27, wherein The first frequency is from 2 GHz to 3 GHz.

29. The method according to claim 28, wherein The first frequency is 2.45 GHz.

30. The method according to claim 24 or 25, wherein The second frequency is from 1 MHz to 1 GHz.

31. The method according to claim 30, wherein The second frequency is 915 MHz, 433 MHz or 402 MHz.

32. The method of claim 29, wherein: The first frequency is 2.45 GHz and the second frequency is 915 MHz.

33. The method of claim 32, wherein: The intravaginal, intrarectal, or intraurethral device includes a plurality of position or motion sensors.

34. The method of claim 33, wherein The plurality of position or motion sensors are MEM sensors.

35. The method of claim 34, wherein: The MEMs sensor is an accelerometer.

36. The method according to claim 34 or 35, wherein The MEMs sensors are positioned along the length of the device.

37. The method of claim 33, wherein The position of the vagina, rectum, or urethra of the subject generated by the plurality of position or motion sensors is displayed on a graphical user interface of a peripheral device including the first device.

38. The method of claim 37, wherein The location of the vagina, rectum, or urethra of the subject is displayed on the graphical user interface before and / or after performing the pelvic floor exercise.

39. The method of claim 38, wherein The position of the vagina, rectum or urethra of the subject is recorded before and / or after performing the pelvic floor exercise.

40. A kit comprising: (a) a relay device, the relay device comprising a radio frequency transceiver configured to transmit and receive a first radio frequency signal at a first frequency greater than 1 GHz to and from a first device, and to transmit and receive a second radio frequency signal at a second frequency less than 1 GHz to and from a second device; wherein the first device comprises a first transmitter and / or receiver configured to transmit and / or receive the first radio frequency signal at the first frequency; as well as (b) an intravaginal, intrarectal, or intraurethral device comprising the second device, the second device comprising a second transmitter and / or receiver configured to transmit and / or receive the second radio frequency signal at the second frequency, wherein the intravaginal, intrarectal, or intraurethral device comprises at least one position or motion sensor configured to transmit a signal to the second device, and at least a portion of the intravaginal, intrarectal, or intraurethral device in which the position or motion sensor is included is configured to be inserted or implanted into the body or body cavity of a subject.

41. The kit of claim 40, wherein The intravaginal, intrarectal, or intraurethral device includes a plurality of position or motion sensors.

42. The kit of claim 41, wherein The plurality of position or motion sensors are MEM sensors.

43. The kit of claim 42, wherein The MEMs sensor is an accelerometer.

44. The kit of claim 40, further comprising instructions for use of the kit.

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