Intra-vaginal device including a pressure sensor and a force sensor, and related methods

Abstract

A device may include a pressure sensor configured to measure dynamic changes in intra-abdominal pressure. A device may include an intra-abdominal pressure sensor configured to measure dynamic changes in intra-abdominal pressure. A device may include a bi-axial force sensor spaced from the intra-abdominal pressure sensor. The bi-axial force sensor may be configured to measure a magnitude of a force of pelvic floor contractions in at least two directions. A device may include a pressure-transmitting material surrounding the intra-abdominal pressure sensor and / or the bi-axial force sensor. A device may include a housing containing the components. A method may include receiving pressure data indicative of an intra-abdominal pressure. A method may include receiving data indicative of a force of pelvic floor muscle contractions in two directions offset from a sagittal plane. A method may include communicating one or more of the pressure data and the bi-axial force data.

Description

INTRA- VAGINAL DEVICE INCLUDING A PRESSURE SENSOR AND A FORCE SENSOR, AND RELATED METHODSCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application Serial No. 63 / 661,845, filed June 19, 2024, titled “Intra-vaginal Device Including a Pressure Sensor and a Force Sensor, and Related Methods,” and U.S. Provisional Patent Application Serial No. 63 / 549,378, filed February 2, 2024, titled “Pelvic Floor Disorder Device and Method,” the disclosure of each of which applications is hereby incorporated herein in its entirety by this reference.BACKGROUND

[0002] Pelvic floor disorders (PFDs) are a condition resulting from damage or weakening of the musculoskeletal tissues that line the bottom of the abdominal cavity and affects a large percentage of women in the U.S. and worldwide. The pelvic floor acts as a supporting structure for pelvic organs, such as the bladder, the uterus, and the rectum. Pelvic floor muscles may become weakened or damaged during childbirth, aging, or repetitive intense exercises. Pelvic floor disorders can cause urinary incontinence, fecal incontinence, and pelvic organ prolapse, which is accentuated during physical exertion, such as exercise, when elevated intra-abdominal pressure (IAP) overcomes the support provided by the pelvic musculature. If the muscles are too tight (a condition known as hypertonicity), a patient may experience chronic pain. Pelvic floor disorders can range from a mild nuisance to a life-altering condition that drastically impacts the quality of life. Unfortunately, PFDs are considered to be a hidden epidemic, causing many women to reduce or stop exercising and participating in other vigorous activities, which can lead to more serious health outcomes, such as co-morbidities of obesity, cardiovascular disease, and depression.

[0003] Pelvic floor physical therapy (PFPT) is the recommended first course of treatment for women experiencing PFDs. During PFPT, women are trained to properly utilize and strengthen their pelvic floor muscles. Current methods of PFPT utilize manual, electromyographic (EMG) evaluation, and other types of biofeedback to diagnose and train patients. However, current methods require the patient to be sedentary and generate elevated IAP using a Valsalva maneuver to approximate the pelvic floor strain. However, the Valsalva maneuver does not accurately reflect how the pelvic floor responds during other dynamic activities, such as running or lifting heavy objects. In addition, the ability ofthe pelvic floor to respond to rapid increases in load, such as during high impact activities, is important for continence mechanisms, which are difficult or impossible to evaluate while the patient is sedentary.

[0004] Measuring the ability of the levator ani hiatus and distal vagina using a voluntary pelvic floor muscle contraction is important in the functional assessment of pelvic floor disorders. However, there are challenges in the accuracy of measuring vaginal closure force (VCF) in a repeatable manner. For example, it is often difficult to quantify pelvic floor muscle strength due to the frequent rise in intra-abdominal pressure (IAP) exhibited when women attempt to contract their levator ani. Contraction of the levator ani is often accompanied by co-contraction of the abdominal wall muscles and / or the diaphragm, increasing the IAP. Current devices for measuring the VCF suffer from crosstalk and cannot distinguish between increases in IAP from increases in VCF caused by levator muscle contraction.BRIEF SUMMARY

[0005] In some embodiments, an intra-vaginal device for diagnosing and treating pelvic floor disorders includes an intra-abdominal pressure sensor configured to measure dynamic changes in intra-abdominal pressure, a bi-axial force sensor spaced from the intra- abdominal pressure sensor, the bi-axial force sensor configured to measure a magnitude of a force of pelvic floor contractions in at least two directions, a pressure-transmitting material surrounding the intra-abdominal pressure sensor and the bi-axial force sensor, and a housing containing the intra-abdominal pressure sensor, the bi-axial force sensor, and the pressure-transmitting material.

[0006] In some embodiments, an intra-vaginal device includes a housing comprising a biocompatible material, an intra-abdominal pressure sensor within the housing and configured to measure an intra-abdominal pressure of a patient, a force sensor within the housing and spaced from the intra-abdominal pressure sensor, the force sensor configured to measure forces of pelvic floor contractions, and a retention mechanism configured to maintain the intra-vaginal device in a patient during ambulatory activity of the patient.

[0007] In some embodiments, a method of operating an intra-vaginal device includes receiving, from an intra-abdominal pressure sensor of the intra-vaginal device, pressure data indicative of an intra-abdominal pressure, receiving, from a bi-axial force sensor, biaxial force data indicative of a force of pelvic floor muscle contractions in two directionsoffset from a sagittal plane, and generating an output on at least one of a patient device or a provider device based on the pressure data and the bi-axial force data.

[0008] In some embodiments, a device may include an intra-abdominal pressure sensor configured to measure dynamic changes in intra-abdominal pressure. A device may include a bi-axial force sensor spaced from the intra-abdominal pressure sensor, the bi-axial force sensor configured to measure a magnitude of a force of pelvic floor contractions in at least two directions. A device may include a pressure-transmitting material surrounding the intra- abdominal pressure sensor and the bi-axial force sensor. A device may include a housing containing the intra-abdominal pressure sensor, the bi-axial force sensor, and the pressuretransmitting material.

[0009] This summary is provided to introduce a selection of concepts that are further described below in the detailed description. This summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to be used as an aid in limiting the scope of the claimed subject matter.

[0010] Additional features and advantages of embodiments of the disclosure will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by the practice of such embodiments. The features and advantages of such embodiments may be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims. These and other features will become more fully apparent from the following description and appended claims, or may be learned by the practice of such embodiments as set forth hereinafter.BRIEF DESCRIPTION OF DRAWINGS

[0011] In order to describe the manner in which the above-recited and other features of the disclosure can be obtained, a more particular description will be rendered by reference to specific implementations thereof which are illustrated in the appended drawings. For better understanding, the like elements have been designated by like reference numbers throughout the various accompanying figures. While some of the drawings may be schematic or exaggerated representations of concepts, at least some of the drawings may be drawn to scale. Understanding that the drawings depict some example implementations, the implementations will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0012] FIG. 1 A and FIG. IB are simplified perspective views of an intra-vaginal device, in accordance with at least one embodiment of the disclosure;

[0013] FIG. 1C is a simplified cutaway side view of the intra-vaginal device showing internal portions of the intra-vaginal device, in accordance with at least one embodiment of the disclosure;

[0014] FIG. ID is a simplified perspective view of the intra-vaginal device showing internal portions of the intra-vaginal device, in accordance with at least one embodiment of the disclosure;

[0015] FIG. IE is a simplified cross-sectional view of the intra-vaginal device, in accordance with at least one embodiment of the disclosure;

[0016] FIG. IF is a simplified cutaway perspective view of the intra-vaginal device, in accordance with at least one embodiment of the disclosure;

[0017] FIG. 1G is a simplified cross-sectional view from the bottom view of the intra- vaginal device illustrating internal components of the intra-vaginal device, in accordance with at least one embodiment of the disclosure;

[0018] FIG. 1H and FIG. II are simplified perspective views of a retention mechanism of the intra-vaginal device, in accordance with at least one embodiment of the disclosure;

[0019] FIG. 1J is a simplified perspective view of a retention mechanism, according to at least one embodiment of the disclosure

[0020] FIG. 2A and FIG. 2B are simplified perspective views of a force sensor that may be used in the intra-vaginal device, in accordance with at least one embodiment of the disclosure;

[0021] FIG. 3 is a simplified diagram illustrating an environment in which the intra- vaginal device may be implemented, in accordance with at least one embodiment of the disclosure;

[0022] FIG. 4 is a simplified flow diagram illustrating a method of diagnosing and / or treating a pelvic floor disorder, in accordance with at least one embodiment of the disclosure;

[0023] FIG. 5 is a simplified flow diagram illustrating an environment in which the intra- vaginal device may be operated using a machine learning application;

[0024] FIG. 6A and FIG. 6B are simplified perspective views of an intra-vaginal device, according to at least one embodiment of the disclosure;

[0025] FIG. 6C is a simplified perspective exploded view of the intra-vaginal device of FIG. 6 A and FIG. 6B;

[0026] FIG. 7 is a simplified perspective view of an intra-vaginal device, according to at least one embodiment of the present disclosure;

[0027] FIG. 8A and FIG. 8B are simplified perspective views of an intra-vaginal device, according to at least one embodiment of the disclosure; and

[0028] FIG. 9 illustrates certain components that may be included within a computer system, in accordance with at least one embodiment of the disclosure.DETAILED DESCRIPTION

[0029] This disclosure generally relates to an intra-vaginal device for monitoring and facilitating the provision of treatment for pelvic floor disorders (PFDs). The intra-vaginal device is configured to provide real time biofeedback to a patient and / or healthcare provider (e.g., physician, clinician) (hereinafter simply referred to as “provider”) treating the patient to facilitate improved pelvic floor physical therapy. The intra-vaginal device is configured to distinguish between intra-abdominal pressure and forces caused by pelvic floor contractions (e.g., caused by Kegels or other activities that cause contraction of the pelvic floor muscles). In some embodiments, the intra-vaginal device is configured to measure intra-abdominal pressure with a pressure sensor and contraction forces of the pelvic floor muscles (e.g., vaginal closure force (VCF)) with a force sensor.

[0030] The intra-vaginal device includes a housing, a pressure sensor within the housing, and a force sensor within the housing. The pressure sensor is configured to measure intra- abdominal pressure and the force sensor is configured to measure forces caused by pelvic floor contractions. The pressure sensor is spaced from the force sensor, such as by at least about 1.0 cm. For example, a distal end of the pressure sensor may be spaced from the force sensor by at least about 1.0 cm. The pressure sensor and the force sensor are located within the housing, such as an elastomeric or silicone elastomer housing. The pressure sensor and the force sensor may be positioned within the housing and with respect to each other to minimize, reduce, or otherwise substantially eliminate cross-talk between intra-abdominal pressure and the vaginal closure force of a patient. Since the intra-vaginal device minimizes (e.g., reduces, eliminates) cross-talk between intra-abdominal pressure and forces caused by contraction of the pelvic floor muscles, the intra-vaginal device may provide accurate measures of pelvic force and intra-abdominal pressure independent of one another. In addition, the intra-vaginal device provides guidance to a patient and / or healthcare provider (e.g., healthcare professional) to distinguish between intra-abdominal pressure, which loads and places strain on the pelvic floor, from pelvic floor contractions, which counteract theseloads and strains. For example, excessive intra-abdominal pressure places a strain on the pelvic floor; and pelvic floor contractions strengthen the pelvic floor or counter the strain placed on the pelvic floor by excessive intra-abdominal pressures.

[0031] The pressure sensor may be located in a first portion of the housing and the force sensor may be located in a second portion of the housing. In use and operation, the first portion may be configured to be in a distal portion of the housing configured to be located cranially with respect to a second portion when the intra-vaginal device is worn by a patient, and the second portion may be configured to be a proximal portion of the housing configured to be located in a caudal position with respect to the first portion when the intra- vaginal device is worn by the patient. The first portion may include a tapered or arcuate shape (e.g., a spherical cap) configured to facilitate placement of the intra-vaginal device inside a patient, such as in the vaginal opening of the patient. The second portion may include a hyperboloid shape, a conical shape, or another shape, and may be configured to conform to the walls defining the vaginal cavity of the patient so as to retain and align the intra-vaginal device in the correct anatomic location. In addition, the second portion may be configured to retain and align the intra-vaginal device in the desired (e.g., correct) anatomical position. In general, female anatomy may vary from person to person. In some embodiments, the size and shape of the intra-vaginal device (e.g., the second portion) may be configured to shaped to replicate the anatomical geometry of the patient. For example, the intra-vaginal device may be configured to rotate and / or align within the vaginal cavity if the intra-vaginal device is improperly placed. In some embodiments, the intra-vaginal device is sized and shaped such that the tissue of the bladder and the rectum push on the intra-vaginal device to generate a torque sufficient to align the intra-vaginal device in the proper orientation.

[0032] The pressure sensor may include a pressure transducer, such as an intra-vaginal pressure transducer. The force sensor may include a bi-axial force sensor configured to measure the force caused by pelvic floor contractions in at least two directions. The at least two directions may be offset from one another, such as by a range of from about 30° to about 60°, or may be substantially perpendicular to one another. In use and operation, the force sensor is configured to measure the force in or caused by the levator ani (including the pubococcygeus, the puborectalis, and the iliococcygeus). The force sensor may be configured to measure asymmetry in pelvic floor contractions and may detect weaknesses in the pelvic floor and the location of the weaknesses (e.g., the side of pelvic floor muscles exhibiting the weakness) based on the forces measured in the different directions. Forexample, the force sensor includes at least one axis that is oriented at an angle from (e.g., not parallel to) the sagittal plane such that by measuring the force in the at least two directions, the force sensor measures asymmetry in the forces exerted by the pelvic floor muscles. In some embodiments, both axes of the force sensor are oriented at an angle (e.g., offset) with respect to the sagittal plane of the patient such that when measurement of forces having different magnitudes by each axis indicates asymmetry in the pelvic floor contractions, which may be indicative of pelvic floor injuries or weaknesses on one side of the pelvic floor (e.g., the side measuring a weaker force). By way of comparison, the use of a pressure sensor to measure the pelvic floor forces (e.g., forces in or caused by the levator ani, forces caused by pelvic floor contractions) may not distinguish or differentiate between forces or pressures from different directions (such as abdominal pressure) and may not distinguish between asymmetric forces exerted on the pelvic floor. Determining the source of forces and pressures may be important to facilitate improved pelvic floor therapy, since the abdominal pressure may be counter-productive or harmful to pelvic floor health and pelvic floor therapy. The use of pressure measurements rather than force may give patients or healthcare providers a false positive that the pelvic muscles are being contracted (e.g., “Kegels”) correctly and may, rather, result in the patient failing to receive correct or adequate therapy. On the other hand, the force sensor is configured to measure the force in at least two directions which may be oriented relative to the sagittal plane of the patient, allowing the intra-vaginal device to detect injury to one side of levator ani muscles (which injury is common during birth) and accurately track rehabilitation relative to the uninjured side. The force sensors can be arranged to accurately measure force over a predetermined length. This length can be matched to the female anatomy allowing multiple force sensors to assess muscle contraction symmetry. The force sensors are specifically designed to measure and display force. Other techniques using pressure sensors and accelerometers can only infer force. The improved accuracy and repeatability of these force sensors allows for measurement of smaller physical changes making it especially effective for pelvic floor force measurement.

[0033] In some embodiments, the force sensor is configured to measure the force of the pelvic floor muscles or pelvic floor contractions in at least one direction (e.g., in only one direction). In some embodiments, the force sensor may include a single in-plane force sensor.

[0034] In use and operation, the pressure sensor is positioned such that the pressure sensor is located cranially with respect to the pelvic floor opening of the patient (and withrespect to the force sensor). The force sensor may intersect the pelvic floor (e.g., the pelvic floor opening) of the patient. In some such embodiments, at least a portion of the force sensor is located caudally with respect to the pelvic floor opening and at least a portion of the force sensor is located cranially with respect to the pelvic floor opening. In some embodiments, the pressure sensor is spaced from at least a portion of the force sensor (a longitudinal center of the force sensor) at least by the pelvic floor muscles. In other words, in some embodiments, the pelvic floor muscles may intervene between the pressure sensor and at least a portion (e.g., the center) of the force sensor. In some embodiments, the pressure sensor is distal and located in a cranial position with respect to the pelvic floor muscles, and the force sensor is proximate and located in a caudal position with respect to the pelvic floor muscles. The force sensor may be positioned when worn by the patient such that contractions of the pelvic floor and / or the vaginal opening of the patient induce a force on the force sensor and such that intra-abdominal pressures are not sensed and / or do not interfere with the forces sensed by the force sensor.

[0035] The intra-vaginal device includes a retention mechanism configured to facilitate maintaining the intra-vaginal device at a desired position when the intra-vaginal device is in use and operation. The retention mechanism can have preferential mechanical characteristics that allow the intra-vaginal device to be inserted and retained in the vagina. By way of non-limiting example, the preferential mechanical characteristic may include deflection of the retention mechanism. The retention mechanism can be designed to deflect with less force during insertion than during removal, which may facilitate retention of the intra-vaginal device in the patient while the intra-vaginal device is worn by the patient, even during ambulatory motion or exercise of the patient. In some embodiments, the retention mechanism may include a retention sleeve configured to be disposed around a periphery of a housing. In some embodiments, the housing includes a retention feature, such as a groove, such as in the second portion, configured to receive an inner surface (e.g., an inner diameter) of the retention sleeve. In other embodiments, the retention mechanism is permanently attached to housing. In other embodiments, the retention mechanism is molded as part of the housing (e.g., the retention mechanism is integral with the housing of the intra-vaginal device). The retention feature may be any other suitable material, shape, or size configured to facilitate retention of the retention mechanism on the intra-vaginal device, such as around a periphery of the housing. The retention feature may be, for example, a magnet, a material or structure (e.g., shape and size) exhibiting a compressive force on the housing of the intra-vaginal device, a channel, a locking feature, or anotherstructure or material. When disposed around the housing, the retention sleeve includes a surface having a larger diameter than other portions of the housing, facilitating securing of the intra-vaginal device during use and operation. In other embodiments, the retention mechanism includes an inflatable component (e.g., a balloon), a mechanical device, or another structure having a larger dimension (e.g., diameter) than the second portion of the housing.

[0036] The housing may include an alignment feature (e.g., an alignment tab) located at a base portion of the housing. The alignment feature may be integral with the base portion, or the base portion may be configured to receive a retention sleeve including an alignment feature. The alignment feature may be oriented at a predetermined angle with respect to the force sensor, such as at least one axis of the force sensor. In some embodiments, the alignment feature is positioned such that when positioned towards a posterior region of the patient (e.g., towards a rear end or back of the patient), the alignment feature is parallel to (and coplanar with) the median plane (the sagittal plane such that the left and right side of the sagittal plane are mirror images of one another). The alignment feature may be oriented at an angle (e.g., a non-parallel angle) with respect to each of the axes of the force sensor. In some embodiments, each axis of the force sensor is located a same angle away from a longitudinal axis of the alignment feature. In some embodiments, the alignment feature includes a portion of the intra-vaginal device having a relatively larger cross-sectional area than other portions of the intra-vaginal device, which may facilitate alignment of the intra- vaginal device and substantially reduce rotation of the intra-vaginal device when worn by the patient. The alignment feature facilitates repeatable placement and positioning of the intra-vaginal device, such that the forces measured by the force sensor measure forces in the same directions in a repeatable manner.

[0037] Since the intra-vaginal device distinguishes intra-abdominal pressure, as measured with the pressure sensor, from pelvic floor contractions as measured with the force sensor, the intra-vaginal device may distinguish between proper pelvic floor exercises, which induce pelvic floor forces, and intra-abdominal pressure (which may be detrimental to pelvic floor health), facilitating improved pelvic floor therapy and biofeedback to the patient and / or the healthcare provider. The retention mechanism facilitates retention of the intra-vaginal device in the patient, even during ambulatory motion and moderate exercise. Since the intra-vaginal device remains positioned within the patient, the intra-vaginal device may measure the pressure and force during ambulatory motion of the patient, while the patient engages in day-to-day activities and while thepatient is upright (e.g., standing, walking jogging). The intra-vaginal device facilitates realtime biofeedback to the patient and / or a healthcare provider remote (e.g., outside of) the intra-vaginal device. In this manner, the patient may receive improved information and improved therapy related to their PFD. Since the patient may wear the intra-vaginal device during day-to-day activities, the intra-vaginal device may facilitate continuous measurement of intra-abdominal pressure and pelvic floor muscle forces. The continuous measurement of the intra-abdominal pressure and pelvic floor muscle forces may facilitate improved diagnoses and treatment of pelvic floor disorders compared to devices that do not measure intra-abdominal pressure and pelvic floor muscle force and that do not remain in a patient during day-to-day activities and make measurements while the patient is lying down, sitting, or remains still (is not ambulatory). For example, other devices may be configured to measure one or more parameters associated with pelvic floor health, but are unable to measure the one or more parameters continuously while the patient is engaged in day-to-day activities since such devices may not remain stationary during movement of the patient. Current methods of diagnosing pelvic floor disorders require the patient to be sedentary (e.g., on an exam table or bed).

[0038] The intra-vaginal device described herein may further include a computing unit within the housing. The computing unit may be in operable communication with the pressure sensor and the force sensor. The computing unit may be configured to receive the pressure data from the pressure sensor and receive the force data from the force sensor. In some embodiments, the computing unit is configured to analyze the pressure data and the force data. In addition, the computing unit may be configured to provide the analyzed pressure data and the analyzed force data to a location remote from the intra-vaginal device. For example, the computing unit may be configured to provide the analyzed pressure data and the analyzed force data to a patient device, to a provider device, to a server, or combinations thereof. Based on the analyzed pressure data and the analyzed force data, the computing unit may be configured to provide real-time biofeedback to the patient and / or a treatment plan to the patient. Many pelvic floor symptoms (such as prolapse and incontinence) occur while the patient is ambulatory (dynamic). Measuring the intra- abdominal pressure and the pelvic floor muscle forces during ambulatory motion of the patient facilitates instantaneous or near instantaneous feedback to the patient, such as one or more suggestions to engage in a behavioral change to improve pelvic floor health of the patient. The intra-vaginal device may aid the patient in determining the difference between proper pelvic floor contractions (Kegels) and improper bearing down maneuvers that areharmful to the pelvic floor. Since many symptoms of pelvic floor disorders are prevalent during moderate or vigorous exercises, women face significant challenges to apply proper pelvic floor contractions outside of a clinic since the pelvic floor support and loading is poorly approximated while the patient is lying down.

[0039] In some embodiments, the intra-vaginal device includes a portion of a pelvic floor treatment management system for diagnosing and / or treating pelvic floor disorders. The pelvic floor treatment management system may include, for example, the intra-vaginal device. The intra-vaginal device may include a communications interface to facilitate communicating the pressure data, the force data, the analyzed pressure data, the analyzed force data, and / or other data (e.g., acceleration data, rotational data) to one or more of a server, a patient device, or a provider device. The pressure data, the force data, the analyzed pressure data, and / or the analyzed force data may collectively be referred to herein as the “intra-vaginal device data.” In some embodiments, the intra-vaginal device data further includes the other data (e.g., acceleration data, rotational data). Based on the intra-vaginal device data, a healthcare application of the server (e.g., on the server) may determine one or more health conditions and / or provide one or more healthcare recommendations to the patient, such as to the patient device. In some embodiments, a provider may receive the intra-vaginal device data and make a healthcare determination based on the intra-vaginal device data. The healthcare determination may be received by the provider device and provided to the patient device to facilitate remote diagnoses and treatment of the patient.

[0040] In addition, the intra-vaginal device may be configured to provide biofeedback to a patient and / or a healthcare provider based on the pressure and force measured by the intra- vaginal device. In some embodiments, the biofeedback includes an indication of whether the intra-abdominal pressures exerted by the patient is within a desired range and / or whether the pelvic floor forces exerted by the patient are commensurate with a specific treatment program for the patient based on the patient’s characteristics and healthcare history. Accordingly, the intra-vaginal device may facilitate telehealth therapy of the patient. In some embodiments, the intra-abdominal pressure and the pelvic floor muscle forces measured by the intra-vaginal sensor may be recorded and analyzed using a machine learning model trained to generate an output indicative of pelvic floor health based on intra- abdominal pressure and pelvic floor muscle forces.

[0041] FIG. lA is a simplified perspective view of an intra-vaginal device 100; FIG. IB is a perspective exploded view of the intra-vaginal device 100; FIG. 1C is a simplified cutaway side view of the intra-vaginal device 100 showing internal components of the intra-vaginal device 100; FIG. ID is a simplified perspective cutaway view of the intra-vaginal device 100 showing internal components of the intra-vaginal device 100; FIG. IE is a simplified partial cross-sectional view of the intra-vaginal device 100; FIG. IF is a simplified partial perspective view through a section of the intra-vaginal device 100; and FIG. 1G is a simplified cross-sectional view from the of the intra-vaginal device 100 showing internal components of the intra-vaginal device 100, in accordance with at least one embodiment of the disclosure.

[0042] With combined reference to FIG. 1A through FIG. IF, the intra-vaginal device includes a housing 102 configured to contain a pressure sensor 120, a force sensor 130, and a printed circuit board (PCB) 140 (best seen in FIG. IE and FIG. IF). For clarity and ease of understanding the disclosure, the housing 102 is shown in broken lines in FIG. ID. With reference to FIG. IE, in some embodiments, the printed circuit board 140 is located between portions of the force sensor 130. The intra-vaginal device 100 may be configured to be placed inside a patient, such as inside a vaginal canal through the vaginal opening of the patient. When placed inside the patient, the intra-vaginal device 100 is configured to measure and record intra-abdominal pressure exerted by the patient with the pressure sensor 120 and pelvic floor muscle forces of the patient (e.g., pelvic floor contractions, vaginal closure force) with the force sensor 130. The intra-vaginal device 100 may be configured to be used (e.g., placed within, worn) by a patient during regular and ambulatory activities, such as walking, jogging, running, standing, sitting, or other day to day activities of the patient. Data obtained with the intra-vaginal device 100 may be used by a pelvic floor treatment system for monitoring and / or diagnosing the pelvic floor health of the patient, as well as for providing healthcare recommendations to the patient and / or a healthcare professional treating the patient.

[0043] With reference to FIG. IE, the housing 102 includes a first portion 104 located at a distal end 105 and including the pressure sensor 120; and a second portion 106 located at a proximal end 107 including the force sensor 130. The housing 102 includes abase portion 103 at the proximal end 107 of the housing 102. The proximal end 107 may also be referred to herein as a caudal end, a bottom end, or a lower end since, after placement of the intra- vaginal device 100, the proximal end 107 is located in the caudal position relative to the distal end 105. Similarly, the distal end 105 may be referred to herein as a cranial end, a top end, or an upper end since the distal end 105 may be configured to be located cranially relative to the proximal end 107 after placement of the intra-vaginal device 100. The distal end 105 may also be referred to as an “insertion end.”

[0044] As best seen in FIG. 1C and FIG. IE, in some embodiments, a center longitudinal axis Li of the first portion 104 is offset (e.g., oriented at an angle) with respect to a center longitudinal axis L2 of the second portion 106. In some embodiments, an angle 0i between the center longitudinal axis Li of the first portion 104 and the center longitudinal axis L2 of the second portion 106 may be within a range of from about 20° to about 60°, such as from about 20° to about 30°, from about 30° to about 40°, from about 40° to about 50°, or from about 50° to about 60°. In some embodiments, the angle 0i is about 30°. In some embodiments, the angle 0i is configured to mimic patient anatomy of the vaginal canal and may be configured to facilitate comfortable use of the intra-vaginal device 100 by a patient. While particular angles 0i between the center longitudinal axis Li and the center longitudinal axis L2 have been described, the disclosure is not so limited. In other embodiments, the center longitudinal axis Li and the center longitudinal axis L2 may be colinear with one another (such that the angle 0i is 0). As described in additional detail herein with respect to FIG. 6 A through FIG. 8B, in some embodiments, the housing 102 has a different shape including ridges configured to facilitate pliability of the intra-vaginal device 100 to the anatomy of the patient.

[0045] The first portion 104 may be sized and shaped for insertion into a vaginal opening to place the intra-vaginal device in the patient. The first portion 104 may exhibit a spherical frustrum shape, such as a spherical cap and / or a spherical segment. Surfaces 108 of the first portion 104 may be arcuate (e.g., curved), parabolic, or angled (e.g., tapered).

[0046] The second portion 106 may be sized and shaped for retention of the housing 102 proximate (e.g., intersecting) the pelvic floor muscles of the patient. In some embodiments, the second portion 106 is hyperboloid shaped. In other embodiments, the second portion 106 is conical shaped. In yet other embodiments, the second portion 106 is non-conical shaped. However, the disclosure is not so limited, and the second portion 106 may have other shapes. Surfaces 109 of the second portion 106 may be arcuate (e.g., curved). In some embodiments, the surfaces 109 may be quadric. In some embodiments, the surfaces 109 are curved inwardly towards a longitudinal center of the second portion 106. A cross-sectional area of the second portion 106 may decrease from the longitudinal ends of the second portion 106 (e.g., in the Z-direction, left and right in the view illustrated in FIG. 1C and FIG. IE). For example, the cross-sectional area of the second portion 106 (e.g., in the XY plane) may decrease with increasing distance from the first portion 104 and increasing distance from the base portion 103. In some embodiments, the second portion 106 exhibits a largest cross-sectional area at longitudinal ends thereof, and a smallest cross-sectionalarea at a longitudinal center thereof. In some embodiments, tapering of the surfaces 109 of the second portion 106 facilitates retention of the intra-vaginal device 100 in the patient, such as during ambulatory motion of the patient.

[0047] The housing 102 may comprise a substantially unitary (e.g., integral) composition. The housing 102 may be formed of and include a biocompatible material 112. By way of non-limiting example, the housing 102 may include silicone, such as medicalgrade silicone. However, the disclosure is not so limited, and the housing 102 may be formed of and include another biocompatible material.

[0048] FIG. 1C is a simplified partial side view of the intra-vaginal device 100 showing internal portions of the intra-vaginal device 100, in accordance with at least one embodiment of the disclosure. In some embodiments, a pressure-transmitting material 104 may be located between the biocompatible material 112 and the pressure sensor 120. In some embodiments, the pressure-transmitting material 114 is only in the first portion 104. In some embodiments, the intra-vaginal device 100 is substantially free of the pressuretransmitting material 114 at locations caudal from a printed circuit board 122 of the pressure sensor 120. The position of the pressure-transmitting material 114 in the first portion 104 facilitates transmission of pressure applied to the surfaces 108 of the first portion 105 to the pressure sensor 120. In some embodiments, the intra-vaginal device 100 does not include the pressure-transmitting material 114 between the surfaces 109 and the force sensor 130. In some embodiments, the force sensor 130 (e.g., first plate 132 and second plates 134 of the force sensor 130) directly contact the inner walls 111 of the second portion 106. In some embodiments, the inner walls 111 are configured to move towards and contact the force sensor 130 responsive to exposure to forces, such as forces caused by pelvic floor contractions.

[0049] In some embodiments, the pressure-transmitting material 114 may substantially surround the pressure sensor 120. In some such embodiments, the pressure-transmitting material 114 may be configured to transmit pressures impinging on external surfaces (e.g., surfaces 108) of the housing 102 to the pressure sensor 120. In some embodiments, the pressure-transmitting material 114 includes a gel, such as a pressure-transmitting gel and / or silicone. In some embodiments, the pressure-transmitting material 114 includes an incompressible material (e.g., a substantially incompressible material). In some embodiments, the pressure-transmitting material 114 is between the biocompatible material 112 at the surfaces 108 of the first portion 104 and the pressure sensor 120 to facilitatetransmission of pressure on the surfaces 108 of the first portion 104 (e.g., intra-abdominal pressures) to the pressure sensor 120 through the pressure-transmitting material 114.

[0050] In some embodiments, the intra-vaginal device 100 does not include the pressuretransmitting material 114 between the pressure sensor 120 and the force sensor 130 and / or between the force sensor 130 and the inner walls 111. For example, a volume between the pressure sensor 120 and the force sensor 130 may be absent of the pressure-transmitting material 114 and may include, for example, a material 121. In some embodiments, the volume is hollow and may include air or another gas. In some embodiments, the material 121 is more rigid than the pressure-transmitting material 114. In some embodiments, the material 121 is the same as the pressure-transmitting material 114. In some embodiments, the intra-vaginal device 100 includes the pressure-transmitting material 114 only within the first portion 104, such as only between the surfaces 108 of the first portion 104 and the pressure sensor 120. In some such embodiments, the second portion 106 does not include the pressure-transmitting material 114. For example, the second portion 106 may include air or another gas and may be hollow, other than the force sensor 130 and associated electronics and circuitry. In some embodiments, the force sensor 130 contacts the inner walls 111 of the second portion 106 such that forces exerted on the surfaces 109 of the second portion 106 are transmitted to the force sensor 130. In some embodiments, forming the intra-vaginal device 100 to not include the pressure-transmitting material 114 in the second portion 106 (and to be hollow in the second portion 106) may facilitate hinged motion of the intra-vaginal device 100 and increase patient comfort when the intra-vaginal device 100 is worn by a patient. In some embodiments, the distal end 105 may hinge and bend to match the anatomy of the patient, increasing patient comfort.

[0051] In use and operation, the intra-vaginal device 100 is configured to be placed (e.g., inserted) into a patient, such as patients suffering from pelvic floor disorders. The first portion 104 may be placed into a vaginal cavity of the patient first (prior to the second portion 106) such that when placed, the first portion 104 is located distally from the vaginal opening and towards a cranial position of the patient, and the second portion 106 is located proximally to the vaginal opening and caudal to the patient. The first portion 104 may be placed past (e.g., beyond, cranially from) the pelvic floor muscles of the patient; and the second portion 106 may be placed such that the second portion 106 intersects the pelvic floor muscles of the patient. For example, the second portion 106 may intersect the pelvic floor opening such that a first part of the second portion 106 is located below the pelvic floor muscles and opening and a second part of the second portion 106 is located above thepelvic floor muscles and opening. The second portion 106 including the force sensor 130 may be located closer to the vaginal opening than the first portion 104 including the pressure sensor 120.

[0052] The intra-vaginal device 100 may include a retention mechanism 116 (shown in FIG. 1A and FIG. IB, and not shown in FIG. 1C through FIG. 1G for clarity) configured to facilitate placement of the intra-vaginal device 100 in the appropriate location and retention of the intra-vaginal device 100 during use and operation. The retention mechanism 116 may be configured to maintain the intra-vaginal device 100 in a patient during ambulatory activity of the patient, such as during the normal course of daily activity. For example, the retention mechanism 116 may be configured to facilitate retention of the intra-vaginal device 100 in the patient during walkingjogging, running, or other activities performed by the patient.

[0053] In some embodiments, the retention mechanism 116 includes a retention sleeve configured to be disposed around the external surface of the housing 102. For example, the retention mechanism 116 may be configured to seat within a groove 118 defined by external surfaces of the housing 102. The groove 118 may extend circumferentially around the housing 102. In some embodiments, the groove 118 is located between the pressure sensor 120 and the force sensor 130, such as at an interface of the first portion 104 and the second portion 106. In some such embodiments, the retention mechanism 116 is configured to be disposed around the housing 102 between the pressure sensor 120 and the force sensor 130 to maintain the intra-vaginal device 100 in the patient during ambulatory activity of the patient.

[0054] FIG. 1H and FIG. II are simplified perspective views of a retention mechanism 116, in accordance with at least one embodiment of the disclosure. An inner surface (e.g., an inner diameter) of the retention mechanism 116 may be received by the groove 118 to seat the retention mechanism 116 around the housing 102.

[0055] The retention mechanism 116 may have an outer diameter Di configured to engage with the groove 118. The outer diameter Di may be sized to facilitate retention of the intra-vaginal device 100 after placement, and patient comfort during use thereof. The retention mechanism 116 may define an inner diameter D2 configured to be disposed around the housing 102, such as the housing 102. In some embodiments, the retention mechanism 116 has a cross-sectional area that is larger than a cross-sectional area of other portions of the housing 102, such as of the first portion 104 and / or the second portion 106. The size and shape of the retention mechanism 116 may be configured to facilitate retention of theintra-vaginal device 100 at a desired location such that the intra-vaginal device 100 remains substantially stationary relative to the patient even while the patient engages in ambulatory activities (e.g., exercising, walkingjogging, running).

[0056] The retention mechanism 116 includes a flanged portion 115 including a lower surface 117 and an upper surface 119. The lower surface 117 may also be referred to as a “distal surface” or a “cranial surface” and may be configured to engage (e.g., contact) the distal (cranial portion) surface of the pelvic floor muscles to substantially prevent or reduce a likelihood of slippage of the intra-vaginal device 100 while the intra-vaginal device 100 is worn by a patient. In some embodiments, the lower surface 117 is curved. The upper surface 119 may also be referred to as a “proximal surface” or a “caudal surface” and may be curved. In some embodiments, the upper surface 119 exhibits a similar curvature as the surfaces 108 of the first portion 104. When worn by the patient, the upper surface 119 engages the upper dorsal side of the levator ani.

[0057] In some embodiments, the retention mechanism 116 is interchangeable with the housing 102 such that the intra-vaginal device 100 may include more than one size of retention mechanism 116 to facilitate comfortable use of the intra-vaginal device 100 by patients having different anatomies. For example, the intra-vaginal device 100 may include a first, second, and third retention mechanism 116, each having an outer diameter Di of a different size. A user may interchange and use a retention mechanism 116 that is most comfortable and suitable for the user.

[0058] The retention mechanism 116 may be formed of and include a biocompatible material. In some embodiments, the retention mechanism 116 is formed of and includes the substantially same material composition as the biocompatible material 112 of the housing 102.

[0059] While the retention mechanism 116 has been illustrated as including a sleeve, the disclosure is not so limited. In other embodiments, the retention mechanism 116 includes an inflatable material (e.g., a balloon) that may be inflated after placement of the intra- vaginal device 100, a mechanical device, or another structure having a larger dimension (e.g., diameter) than other portions of the intra-vaginal device 100.

[0060] In addition, while the retention mechanism 116 has been described and illustrated as being configured to seat within the groove 118, the disclosure is not so limited. In other embodiments, the retention mechanism 116 is configured to engage the surfaces 109 of the second portion 106. For example, in some embodiments, the retention mechanism 116 may be stretched to place the retention mechanism 116 at a desired location along thelongitudinal axis L2 and along the surfaces 109 of the second portion 106. Once at the desired location, the retention mechanism 116 may be placed and the inner surfaces of the retention mechanism 116 may compress on the surfaces 109 of the second portion 106 of the housing 102. In some such embodiments, the retention mechanism 116 may be placed at a desired distance from the first portion 104 and the distal end 105 of the housing 102 to facilitate comfortable use by patients having different anatomies. In some embodiments, the retention mechanism 116 is configured to engage surfaces 109 of the second portion 106 having the smallest dimension (e.g., diameter) such that the retention mechanism 116 does not substantially move up or down (e.g., cranially or caudally) while the intra-vaginal device 100 is worn by the patient.

[0061] While the retention mechanism 116 is illustrated as being disposed around an outside of the intra-vaginal device 100 between the first portion 104 and the second portion 106, the disclosure is not so limited. In other embodiments, the retention mechanism 116 is disposed around the intra-vaginal device 100 at another location, such as around a portion of the second portion 106.

[0062] In addition, while the retention mechanism 116 has been described as interacting with (e.g., seating in) the groove 118, the disclosure is not so limited. In some embodiments, the retention mechanism 116 is sized, shaped, or otherwise configured to remain at a desired position of the intra-vaginal device 100, such as at a desired position of the second portion 106 or between the first portion 104 and the second portion 106. In some embodiments, the retention mechanism 116 includes magnets configured to interact with corresponding magnets or metallic features of the intra-vaginal device 100. For example, the intra-vaginal device 100 may include magnets or metallic features rather than the groove 118, such magnets or metallic features configured to interact with magnets of the retention mechanism 116. In some embodiments, the retention mechanism 116 includes a locking feature or a spring mechanism configured to maintain the retention mechanism 116 at a desired position.

[0063] FIG. 1J is a simplified perspective view of a retention mechanism 116', according to at least one embodiment of the disclosure. In some embodiments, the retention mechanism 116' includes one or more apertures or openings 191 disposed around a perimeter (e.g., circumference) thereof. In some embodiments, the openings 191 are spaced substantially the same distance from one another. In other words, the openings 191 may be uniformly spaced along the retention mechanism 116'. While FIG. 1J illustrates that the openings 191 are circular shaped, the disclosure is not so limited, and the openings 191may be oval shaped, elliptical shaped, crescent shaped, triangular shaped, square shaped, rectangular shaped, or another shape. In addition, while FIG. 1 J illustrates that the openings 191 are uniformly spaced, the disclosure is not so limited. In some embodiments, the openings 191 are non-uniformly spaced around the circumference of the retention mechanism 116'. In some embodiments, only half of the retention mechanism 116' includes the openings 191. In some embodiments, one half or one portion of the retention mechanism 116' includes a greater density or concentration of openings 191 than the other half or portion of the retention mechanism 116'.

[0064] The size and shape of the retention mechanisms 116, 116' may be changed to alter the properties of the retention mechanisms 116, 116'. For example, one or more of the thickness of the retention mechanisms 116, 116' may be altered, the number of openings 191, the shape of the openings 191, the durometer of the material of the retention mechanisms 116, 116', and / or another property or feature of the retention mechanisms 116, 116' may be altered to adjust the properties of the retention mechanisms 116, 116'. As described above, the intra-vaginal device 100 includes the pressure sensor 120 and the force sensor 130. In some embodiments, the pressure sensor 120 may be located on a printed circuit board 122 (FIG. ID), which is, in turn, operably coupled to (e.g., electrically coupled to, in wireless communication with, in wired communication with, in operable communication with) the printed circuit board 140. The pressure sensor 120 may be configured to measure pressures exerted on the surfaces 108 of the first portion 104 of the housing 102. When the intra-vaginal device 100 is worn by a patient, the pressure sensor 120 may be configured to measure intra-abdominal pressures exerted by the patient, such as when the patient is bearing down which may cause strain and stretching of pelvic floor tissues, exacerbating any pelvic floor issues of the patient. In some embodiments, the pressure sensor 120 is configured to measure dynamic changes in the intra-abdominal pressure of the patient.

[0065] The pressure sensor 120 may include a piezoelectric sensor, a piezoresistive sensor, a strain gauge pressure sensor, a diaphragm pressure sensor, a potentiometric pressure sensor, a capacitive pressure sensor, an inductive pressure sensor, an optical pressure sensor, a micro-electro mechanical pressure sensor, or a resonant pressure sensor. However, the disclosure is not so limited, and the pressure sensor 120 may include different types of pressure sensors than those described. The pressure sensor 120 may be configured to convert the detected pressure to an output pressure signal proportional to the magnitude of the pressure. The pressure signal may be an electrical signal, such as a voltage and / or acurrent. In some embodiments, the pressure sensor 120 includes a pressure transducer configured to convert the detected pressure into a continuous applied voltage indicative and proportional to the pressure; or a pressure transmitter configured to convert the detected pressure into a current that is indicative of and proportional to the pressure.

[0066] The pressure sensor 120 may be configured to generate a pressure signal indicative of a pressure exerted on the pressure sensor 120 by pressures exerted on the surfaces 108 of the first portion 104 of the housing 102, which pressures may correspond to the intra-abdominal pressure of the patient. For example, pressures exerted on the first portion 104 (such as on the surfaces 108 of the first portion 104) may be transferred through the biocompatible material 112 to the pressure-transmitting material 114 (FIG. 1C), and from the pressure-transmitting material 114 to the pressure sensor 120 and measured by the pressure sensor 120. Since the first portion 104 is configured to be located rostrally from the pelvic floor muscles and proximate the abdomen, the pressure sensor 120 is configured to measure pressures exerted by the abdomen. Accordingly, the pressure sensor 120 may be configured to measure an intra-abdominal pressure and may, therefore, be referred to herein as an “intra-abdominal pressure sensor.” The pressure sensor 120 may measure pressure data of pressures on the first portion 104 of the housing 102, such as responsive to intra-abdominal pressures of the patient.

[0067] In some embodiments, the pressure sensor 120 includes a pressure signal conditioner integrated circuit, such as within or on the printed circuit board 122. The pressure signal conditioner integrated circuit may be configured to receive the pressure signal from the pressure sensor 120 and generate a conditioned pressure signal for a next stage of processing. The pressure signal conditioner integrated circuit may include a voltage conditioning unit and / or a current conditioning unit. The pressure signal conditioner integrated circuit may be in operable communication with a computing unit 150 (also referred to as a “control unit” or a “microcontroller unit”) configured to control the operation of the intra-vaginal device 100. The pressure sensor 120 and the pressure signal conditioner integrated circuit may each independently be directly in operable communication with the computing unit 150. The pressure sensor 120 and the pressure signal conditioner integrated circuit may be wirelessly coupled to the computing unit 150 and / or may be wired to the computing unit 150. The pressure signal conditioner integrated circuit may provide the conditioned pressure signal to, for example, a pressure monitoring engine of the computing unit 150.

[0068] The force sensor 130 may be configured to measure dynamic changes in the forces of the pelvic floor muscles of the patient. As described above with reference to FIG. 1C through FIG. 1G, in some embodiments, the force sensor 130 includes a multi-axial (e.g., a bi-axial) force sensor (also referred to as a “multi-axis force sensor”). In some embodiments, the force sensor 130 includes a force plate sensor, such as a multi -axis force plate. The force sensor 130 may be configured to measure force in at least two directions. The at least two directions may be mutually orthogonal, or may be oriented at an angle other than orthogonal or parallel with respect to one another. For example, and as best seen in FIG. ID and FIG. 1G, the force sensor 130 may be configured to measure a force in a first direction 125 (or along a first axis), and in a second direction 127 (or along a second axis) that is offset from the first direction 125 at an angle within a range of from about 20° to about 90°, such as from about 20° to about 30°, from about 30° to about 45°, from about 45° to about 60°, from about 60° to about 75°, or from about 75° to about 90°. In some embodiments, the force sensor 130 is configured to measure a force in a first direction and in a second direction that is offset from the first direction by between about 30° to about 60°. The first direction 125 may correspond to a first axis along which the force sensor 130 measures pelvic floor muscle forces and the second direction 127 may correspond to a second axis along which the force sensor 130 measures pelvic floor muscle forces.

[0069] The forces measured by the force sensor 130 may correspond to the forces exerted by the pelvic floor of the patient when the intra-vaginal device 100 is worn by the patient. In some embodiments, when the intra-vaginal device 100 is worn by the patient, the first direction 125 and the second direction 127 are configured to be offset from the sagittal plane of the patient such that the forces measured by the force sensor 130 measure (and detect) asymmetry in pelvic floor contraction forces. In some embodiments, the first direction 125 may be offset from the sagittal plane by a same amount as the second direction 127. The asymmetry in the pelvic floor contraction forces may be used to diagnose injury to a particular location or side of the levator ani muscles. As described herein, in some embodiments, the first direction 125 and the second direction 127 are each oriented at a predetermined angle with respect to one or more alignment features on an external portion of the intra-vaginal device 100 (such as an alignment feature 160 (FIG. 1A, FIG. IB)).

[0070] The force sensor 130 may include one or more of a strain gauge load cell, a capacitive force sensor, an inductive force sensor, a piezoelectric force sensor, a piezoresistive force sensor, a magnetic force sensor, an optical force sensor, a load buttonand compression cell, a force sensing resistor force sensor, or another type of force sensor. In some embodiments, the force sensor 130 includes a strain gauge load cell.

[0071] The force sensor 130 may be configured to generate a force signal indicative of a force exerted on the force sensor 130 by forces exerted on the surfaces 109 of the second portion 106 of the housing 102. For example, forces exerted on the second portion 106 may be transferred through the biocompatible material 112 to the force sensor 130 and measured by the force sensor 130. As described above, in some embodiments, the force sensor 130 directly contacts the inner walls 111 of the second portion 106. Accordingly, the forces exerted on the surfaces 109 of the second portion 106 may be transmitted to the force sensor 130 through the walls of the second portion 106. Since the second portion 106 is configured to be located proximate the pelvic floor muscles and away from the abdominal muscles, the force sensor 130 is configured to measure forces exerted by the pelvic floor. Accordingly, the force sensor 130 may be configured to measure forces exerted during pelvic floor contractions.

[0072] In some embodiments, the force sensor 130 includes a dual -axis plate sensor. For example, with reference to FIG. 1C through FIG. 1G, the force sensor 130 may include a chassis 131 (e.g., body), first plate 132 (e.g., a ground plate, a reference plate) configured to measure a first force (e.g., a baseline force, a reference force), and second plates 134 (e.g., force sensing plates, force sensor push plates) configured to facilitate measuring another force relative to the first plate 132. In some embodiments, the force sensor 130 includes two second plates 134 located opposite the first plate 132. In some embodiments, the first direction 125 (first axis) intersects the first plate 132 and one of the second plates 134 and the second direction 127 (second axis) intersects the first plate 132 and the other one of the second plates 134. The force sensor 130 further includes guided force strain elements 136 in contact with the second plates 134. The guided force strain elements 136 may extend along a length of the force sensor 130. The force sensor 130 may further include strain gauges 138 configured to measure a strain caused by the guided force strain elements 136, which may be induced by second plates 134 responsive to forces exerted on the second plates 134. For example, force exerted on the second plates 134 may be transmitted through the guided force strain elements 136 to a respective one of the strain gauges 138 to measure the force along the respective direction. The forces exerted on the intra-vaginal device 100, such as on the surfaces 109 of the second portion 106 may be transferred through the biocompatible material 112 of the housing 102 to the second plates 134, from the second plates 134 to a respective one of the guided force strain elements 136, and from the guidedforce strain elements 136 to a respective one of the strain gauges 138. Thus, responsive to forces exerted on the second portion 106, the strain gauges 138 may undergo a strain, which may correspond to the forces.

[0073] In more detail, forces exerted by the pelvic floor along the first direction 125 may cause the first plate 132 and the second plate 134 intersected by the first direction 125 to compress toward one another, exerting a force on the guided force strain element 136 and the strain gauge 138 between the first plate 132 and the second plate 134 intersected by the first direction 125 to measure the force of the pelvic floor in the first direction 125. Similarly, forces exerted by the pelvic floor along the second direction 127 may cause the first plate 132 and the second plate 134 intersected by the second direction 127 to compress toward one another, exerting a force on the guided force strain element 136 and the strain gauge 138 between the first plate 132 and the second plate 134 intersected by the second direction 127 to measure the force of the pelvic floor in the second direction 127. Accordingly, the strain measured by the different strain gauges 138 may facilitate determining the direction and magnitude of the forces exerted on the force sensor 130 by the pelvic floor muscles, such as the levator ani muscles in each of the first direction 125 and the second direction 127. For example, since the first direction 125 and the second direction 127 are configured to be offset from the sagittal plane, measurement of forces of different magnitude in the first direction 125 along the first axis and the second direction 127 along the second axis may be an indication of asymmetry in the pelvic floor muscles, weakness in one side of the pelvic floor muscles, and / or injury in one side of the pelvic floor muscles. The force sensor 130 may be configured such that responsive to exposure to a force anywhere along a longitudinal axis of the force sensor 130 (e.g., anywhere along the first plate 132 (FIG. ID) or the second plates 134 (FIG. ID), the force sensor 130 measures the same force. In other words, the force measured by the force sensor 130 may be independent (e.g., substantially independent) of the location of the force sensor 130 exposed to the force. In some embodiments, pelvic floor contractions and / or vaginal closure forces cause the force sensor 130 to compress, which may be measured by the force sensor 130. Since the force sensor 130 is configured to measure the force independent of the location of the force sensor 130 exposed to the force, the force sensor 130 may facilitate the repeatable measurement of pelvic floor muscle forces, even when the intra-vaginal device 100 is not worn at exactly the same position (e.g., depth) each time the patient wears the intra-vaginal device 100. Accordingly, the force sensor 130 provides reliable and repeatable data on which healthcare recommendations and diagnoses may be based.Further, repeatable measurement of the pelvic floor muscle forces facilitates tracking of pelvic floor health and patient progress since the measured forces are independent of the location on the force sensor 130 where the forces are exerted. Further still, even if the intra- vaginal device 100 shifts or moves slightly while the patient participates in ambulator activity (e.g., exercise), the force sensor 130 may still measure the pelvic floor forces reliably (e.g., the measured forces may not be different than had the intra-vaginal device 100 not shifted or moved).

[0074] In some embodiments, the force sensor 130 includes a single plane sensor configured to measure force (e.g., pelvic floor contraction force) in at least one direction, such as in a single direction. In some embodiments, the force sensor 130 includes a single axis force sensor configured to measure force along one axis. In some embodiments, the axis may be oriented at an angle with respect to the sagittal plane. In some embodiments, the axis is oriented at an angle (e.g., a non-zero angle, a non-parallel angle) with respect to a longitudinal axis L3 (FIG. IB) of an alignment feature 160. In some embodiments, the axis is oriented parallel to or coplanar with the sagittal plane.

[0075] The force sensor 130 may include or be in operable communication with a force signal conditioner integrated circuit. The force signal conditioner integrated circuit may be configured to receive the pressure force from the force sensor 130 and generate a conditioned force signal for a next stage of processing. The force signal conditioner integrated circuit may include a voltage conditioning unit and / or a current conditioning unit. The force signal conditioner integrated circuit may be in operable communication with the computing unit 150 configured to control the operation of the intra-vaginal device 100. The force sensor 130 and the force signal conditioner integrated circuit may each independently be directly in operable communication with the computing unit 150, or may be in operable communication with the printed circuit board 140 that is, in turn, in operable communication with the computing unit 150. The force sensor 130 and the force signal conditioner integrated circuit may be wirelessly coupled to one or both of the computing unit 150 and the printed circuit board 140 and / or may be wired to the computing unit 150 and the printed circuit board 140. The force signal conditioner integrated circuit may provide the conditioned force signal to, for example, a pressure monitoring engine of the computing unit 150.

[0076] Although FIG. 1C through FIG. 1G illustrate a particular type of force sensor 130, the disclosure is not so limited. FIG. 2A and FIG. 2B are simplified perspective views of a force sensor 200, according to at least one embodiment of the disclosure. The force sensor200 may replace the force sensor 130 of FIG. 1 A through FIG. 1G. For clarity and ease of understanding the disclosure, FIG. 2A and FIG. 2B do not illustrate other components of the intra-vaginal device 100, such as the pressure-transmitting material 114, the material 121, or the biocompatible material 112. In FIG. 2A and FIG. 2B, the position of the force sensor 200 is shown with respect to a pubic bone 202, a levator ani 204 (which includes the pubococcygeus, puborectalis, and the iliococcygeus) muscles, and a urogenital hiatus of a patient. In use and operation, the intra-vaginal device 100 may be positioned such that the force sensor 200 is spaced from the pubic bone 202 by the urogenital hiatus 205. The force sensor 200 may be oriented to measure a magnitude and direction of levator ani contractions. In some embodiments, the force sensor 130, 200 is positioned such that it intersects the pelvic floor muscles, such as the levator ani 204. In some embodiments, the force sensor 200 is configured to measure the force of pelvic floor contractions in the plane of the levator ani 204.

[0077] The force sensor 200 may include a bi-axial force sensor (also referred to as a “dual axis force sensor”) configured to measure force in two directions. In some embodiments, the force sensor 200 is oriented to measure a magnitude and direction of levator ani contractions. The force sensor 200 may include a bi-axial double bending beam load cell. In some embodiments, the force sensor 200 includes two double bending beam load cells including a first double bending beam load cell 206 including a first beam 208 and a second beam 210; and a second double bending beam load cell 212 including a third beam 214 and a fourth beam 216. The first beam 208 and the second beam 210 may be located directly across from one another (about 180°) apart and may be configured to measure a force along a first axis 217 of the force sensor 200. In addition, the third beam 214 and the fourth beam 216 may be located directly across from one another (about 180°) apart and may be configured to measure a force along a second axis 218 of the force sensor 200.

[0078] As best seen in FIG. 2A, the force sensor 200 may include strain gauges 222 coupled to the beams. For example, each of the beams (e.g., the first beam 208, the second beam 210, the third beam 214, and the fourth beam 216) are configured to measure a strain responsive to deflection of each of the beams to which they are coupled. In some embodiments, the first double bending beam load cell 206 includes four strain gauges 222, each of the first beam 208 and the second beam 210 individually coupled to two strain gauges 222; and the second double bending beam load cell 212 includes four strain gauges222, each of the third beam 214 and the fourth beam 216 individually coupled to two strain gauges 222.

[0079] Responsive to forces exerted on the intra-vaginal device 100, the forces may be transmitted through the wall of the biocompatible material 112 to the force sensor 200, and the force sensor 200 may detect the magnitude and direction of the forces by the bending (deflection) of the beams of the force sensor 200. The bending of the beams may induce a strain on the strain gauges 222, which may be used to determine the direction and magnitude of the force. Accordingly, the first double bending beam load cell 206 may be configured to measure a force along the first axis 217 (or a first force component along the first axis 217); and the second double bending beam load cell 212 may be configured to measure a force along the second axis 218 (or a second force component along the second axis 218).

[0080] As shown in FIG. 2B, in some embodiments, the first axis 217 and the second axis 218 are oriented at about 90° from one another. The force sensor 200 may be positioned within the intra-vaginal device 100 such that during wearing of the intra-vaginal device 100 by a patient, the first axis 217 and the second axis 218 of the force sensor 200 are offset (e.g., not parallel to) with respect to a sagittal plane 230 of the patient. In some embodiments, the first axis 217 may be configured to be oriented at a first angle 02 from the sagittal plane 230, and the second axis 218 may be configured to be oriented at a second angle 03 from the sagittal plane 230. The first angle 02 may be the same as the second angle 03, but may be oriented in a different direction with respect to the sagittal plane 230.

[0081] The first angle 02 may be within a range of from about 20° to about 60°, such as from about 20° to about 30°, from about 30° to about 45°, or from about 45° to about 60°. The second angle 03 may be within a range of from about 20° to about 60°, such as from about 20° to about 30°, from about 30° to about 45°, or from about 45° to about 60°. In some embodiments, the first angle 02 is the same as the second angle 03. In other embodiments, the first angle 02 is different than the second angle 03.

[0082] With reference to FIG. 2B, measurement of a force of a different magnitude along the first axis 217 (e.g., with the first double bending beam load cell 206) than the magnitude of the force measured along the second axis 218 (e.g., with the second double bending beam load cell 212) may correspond to asymmetry in the pelvic floor muscles (e.g., in the levator ani 204), which may be indicative of injury and / or weakness at one side of the pelvic floor muscles. Accordingly, the force sensor 200 may be configured to measure asymmetry in the pelvic floor muscles and / or the forces exerted by the pelvic floor muscles.

[0083] With reference to FIG. 1C, the force sensor 130 (e.g., a longitudinal end of the force sensor 130, a distal end of the force sensor 130) may be spaced from the pressure sensor 120 by a distance D. The distance D may be within a range of from about 1.0 cm to about 5.0 cm, such as from about 1.0 cm to about 2.0 cm, from about 2.0 cm to about 3.0 cm, from about 3.0 cm to about 4.0 cm, or from about 4.0 cm to about 5.0 cm. In some embodiments, the distance D is about 1.0 cm. In some embodiments, the distance D is at least about 1.0 cm, such as at least about 2.0 cm. The distance D between the force sensor 130 and the pressure sensor 120 may facilitate separately measuring and determining the intra-abdominal pressure of the patient from the pelvic floor forces (e.g., such as the vaginal closure force) exerted on the intra-vaginal device 100. Separately measuring the intra- abdominal pressure and the pelvic floor forces may facilitate treatment and diagnoses of pelvic floor disorders, such as by identifying correct and incorrect exercises to facilitate training of the patient.

[0084] With reference back to FIG. 1A through FIG. IE, the intra-vaginal device 100 includes an alignment feature 160 (e.g., an alignment tab, an alignment protrusion) configured to facilitate placement of the intra-vaginal device 100 in substantially the same orientation to facilitate consistent measurements (of intra-abdominal pressure and pelvic floor contractions) of the patient during repeated use of the intra-vaginal device 100. The alignment feature 160 may be configured to indicate a relative orientation of the force sensor 130 and / or the sagittal plane of the patient when the intra-vaginal device 100 is worn by the patient. The alignment feature 160 may be aligned with or oriented at an angle with respect to at least one axis of the force sensor 130, 200 (e.g., the first direction 125 (FIG. ID, FIG. IF), the second direction 127 (FIG. ID, FIG. IF), the first axis 217 (FIG. 2B), the second axis 218 (FIG. 2B)). For example, a longitudinal axis L3 (FIG. IB) of the alignment feature 160 may be oriented at an angle with respect to at least one axis of the force sensor 130, 200. The longitudinal axis L3 may be oriented such that after placement of the intra- vaginal device 100, the longitudinal axis L3 and the alignment feature 160 are located at an anterior region of the patient (e.g., at the front of the patient, facing towards a stomach of the patient). The alignment feature 160 may provide a handle for a user to grab during removal of the intra-vaginal device 100.

[0085] The alignment feature 160 may provide a surface for retention of the intra-vaginal device 100 in the patient during use. For example, the surface of the alignment feature 160 may increase a contact area of the intra-vaginal device 100 with, for example, a patient’s underwear or pants, reducing the likelihood of unintended slippage or extraction of theintra-vaginal device 100. In some embodiments, the intra-vaginal device includes the retention mechanism 116 and the alignment feature 160.

[0086] In some embodiments, the alignment feature 160 is integral with the housing 102. In other embodiments, the intra-vaginal device 100 includes an external sleeve configured to facilitate retention of the intra-vaginal device 100 after placement. In some such embodiments, the housing 102 defines a recess configured to receive a portion of the external sleeve including the alignment feature to seat the external sleeve in the housing 102.

[0087] When worn by a patient such that the alignment feature 160 is coaxial (e.g., in line) with a patient’s sagittal plane, the force sensor 130 may be oriented and configured to measure asymmetric forces exerted by the pelvic floor of the patient. Accordingly, and since the first direction in which the force is measured by the force sensor 130 is oriented at a different angle with respect to the alignment feature 160 (the longitudinal axis L3) than the second direction in which the force is measured, the force sensor 130 may be configured to measure asymmetry in the pelvic floor. In some embodiments, the first direction is oriented from the alignment feature 160 at a non-equal angle as the second direction is oriented from the alignment feature 160. In some embodiments, the base portion 103 of the intra-vaginal device 100 includes one or more alignment features, such as markings to facilitate determination of the orientation and / or the placement of the intra-vaginal device 100 within the patient.

[0088] In some embodiments, the first direction 125 of the force measured by the force sensor 130 is oriented at a different angle from the longitudinal axis L3 than the second direction 127 of the force measured by the force sensor 130. In some such embodiments, when the longitudinal axis L3 of the alignment feature 160 is oriented parallel with or coplanar with the sagittal plane of the patient, the force sensor 130 may be configured to measure asymmetry in the contractions of the pelvic floor, facilitating diagnosis of pelvic floor injuries.

[0089] With reference to FIG. ID and FIG. IF, the intra-vaginal device 100 may further include an accelerometer 170, an inertial measurement unit (IMU) 172, and a temperature sensor 174. The accelerometer 170 may be configured to measure an acceleration of the intra-vaginal device 100, which may correlate to movement of the patient. The inertial measurement unit 172 may be configured to measure an angular velocity or rotational motion of the intra-vaginal device 100. The temperature sensor 174 may be configured to measure a temperature proximate the intra-vaginal device 100. In some embodiments, theinertial measurement unit 172 includes a gyroscope. Data from one or more of the accelerometer 170, the inertial measurement unit 172, and the temperature sensor 174 may be used when analyzing the pressure data and the force data. For example, increases in intra-abdominal pressures measured by the pressure sensor 120 that correlate to increases in acceleration data measured with the accelerometer 170 may be an indication that the particular activity the patient is engaging in may be detrimental to the pelvic floor muscles.

[0090] The intra-vaginal device 100 may further include a communications interface 152 configured to facilitate communication (e.g., via Bluetooth®, radio, or other means) with a device (e.g., a user device, a client device) external to the intra-vaginal device 100. The communications interface 152 may include, for example, a Bluetooth radio antenna. The communications interface 152 may be in operable communication with the computing unit 150, such as by a wired connection 154. While the communications interface 152 is shown within the alignment feature 160, the disclosure is not so limited. In other embodiments, the communications interface 152 is within the base portion, such as a part of the computing unit 150, a part of the printed circuit board 140, or another location within the intra-vaginal device 100.

[0091] With reference to FIG. 1C through FIG. IF, the intra-vaginal device 100 may further include a battery management integrated circuit 156 configured to control power from one or more batteries 158 (FIG. IE) to each of the components and circuits of the intra-vaginal device 100. For example, the battery management integrated circuit 156 may be configured to control the power provided to one or more of (e.g., each of) the pressure sensor 120, the pressure signal conditioner integrated circuit, the force sensor 130, the force signal conditioner integrated circuit, the computing unit 150, the communications interface 152, and other components of the intra-vaginal device 100. With reference to FIG. 1C, the intra-vaginal device 100 may include a wireless charging coil 159 configured to facilitate wireless charging of the battery 158.

[0092] While the intra-vaginal device 100 has been described and illustrated as including the computing unit 150, the communications interface 152, the battery management integrated circuit 156, the accelerometer 170, the inertial measurement unit 172, and the temperature sensor 174 as separate components separated from the printed circuit board 140, the disclosure is not so limited. In some embodiments, one or more of (e.g., each of) the computing unit 150, the communications interface 152, the battery management integrated circuit 156, the accelerometer 170, the inertial measurement unit 172, and the temperature sensor 174 may comprise a portion of the printed circuit board 140.

[0093] In some embodiments, one or more portions of the housing include a textured surface to facilitate retention of the intra-vaginal device 100 inside of a patient. For example, the first portion 104 and / or the second portion 106 may include a textured surface. The textured surface may be microtextured and include a peak count within a range of from about 100 to about 600 peaks per square inch (in2), such as from about 100 to about 200, from about 200 to about 300, from about 300 to about 400, or from about 400 to about 600 per square inch. However, the disclosure is not so limited, and the textured surface may include a different number of peaks per given area.

[0094] The computing unit 150 may be configured to provide the pressure signal and the force signal to a location external to the intra-vaginal device 100. In addition, the computing unit 150 may be configured to determine the intra-abdominal pressure of the patient and the pelvic muscle force (PMF) of the patient. In some embodiments, the computing unit 150 is configured to determine one or more health conditions of the user based on the pressure signal and the force signal. For example, the computing unit 150 may be configured to determine whether the patient is properly exercising, diagnose pelvic floor disorders, to determine whether the intra-abdominal pressure is too high at a particular time and / or over the course of a duration, to determine a duration between an increase in intra- abdominal pressure and pelvic floor muscle force, and / or another health condition of the patient. By way of non-limiting example, based on the pressure signal and the force signal, the computing unit 150 may be configured to determine whether the patient’s pelvic floor muscles contract too long after an increase in intra-abdominal pressure. In some embodiments, the computing unit 150 is configured to determine whether the intra- abdominal pressure is too high at a given time and / or over a duration (e.g., such as during exercising).

[0095] As another example, the computing unit 150 may be configured to determine if a resting tone (e.g., a baseline force measured by the force sensor 130) of the patient increases over time (indicating that the pelvic floor muscles are becoming stronger over time), decreasing over time (indicating that the pelvic floor muscles are becoming weaker over time), or remaining substantially constant. In addition, the computing unit 150 may be configured to determine and diagnose whether the resting tone of the pelvic floor muscle forces are increasing by more than a threshold or beyond a threshold value, indicating hypertonic patients. In some such embodiments, the computing unit 150 may be configured to provide biofeedback to a patient device and a recommendation that the patient relax their pelvic floor muscles. The computing unit 150 may be configured to determine whether thepelvic floor muscles contract late relative to increases in intra-abdominal pressure, which may facilitate diagnosing neural signaling delays in the patient. In addition, in some embodiments, the computing unit 150 is configured to determine the rate of pelvic floor muscle force generation and compare the rate of the pelvic floor muscle generation to historical values for the patient. A slower generation of the pelvic floor muscle force generation may be an indication of that the pelvic floor muscles are fatigued. In some such embodiments, the computing unit 150 may generate a recommendation to a patient device that the patient refrain from continued exercise to prevent damaging fatigued muscles (e.g., relax their pelvic floor muscles).

[0096] While the intra-vaginal device 100 has been described as being used intra- vaginally, the disclosure is not so limited. In other embodiments, a device substantially similar to or the same as the intra-vaginal device 100 may be configured to be used rectally, via the esophagus, or via another means. By way of non-limiting example, where the device is used rectally, the device may be configured to measure a pressure with the pressure sensor 120 and a force with the force sensor 130. The pressure may correspond to the intra- abdominal pressure and the force may correspond to the pelvic floor muscle force (e.g., closure force).

[0097] FIG. 3 is a schematic illustrating an environment 300 in which the intra-vaginal device 100 may operate, according to at least one embodiment of the disclosure. The environment 300 may include a pelvic floor treatment system in which a pelvic floor treatment and / or pelvic floor diagnoses system is implemented. The environment 300 may include the intra-vaginal device 100, one or more server device(s) 302, one or more patient device(s) 304, and one or more provider device(s) 306.

[0098] As shown in FIG. 3, each of the intra-vaginal device 100, the server device 302, the patient device 304, and the provider device 306, may communicate with each other directly or indirectly through a network 308. The network 308 may include one or multiple networks and may use one or more communication platforms or technologies suitable for transmitting data. The network 308 may refer to any data link that enables transport of electronic data between devices and / or modules of the environment 300. The network 308 may refer to a hardwired network, a wireless network, or a combination of a hardwired and a wireless network. In one or more embodiments, the network 308 includes the Internet.

[0099] The patient device 304 may refer to various types of computing devices. For example, one or more of the patient devices 304 may include a mobile device such as a mobile telephone, a smart phone, a personal digital assistant (PDA), a tablet, or a laptop.Additionally, or alternatively, the patient devices 304 may include one or more non-mobile devices such as a desktop computer, server device, or other non-portable device. In one or more implementations, the patient device 304 refers to a mobile telephone, a smart phone, or a tablet. In one or more implementations, the patient device 304 includes one or more graphical user interfaces thereon (e.g., a screen of a mobile device). In addition, or as an alternative, the patient device 304 may be communicatively coupled (e.g., wired or wirelessly) to a display device having a graphical user interface thereon for providing a display of one or more aspects of the intra-vaginal device 100 and / or the patient. The server device(s) 302 and / or provider device(s) 306 may similarly refer to various types of computing devices. Each of the devices of the environment 300 may include features and functionality described below in connection with FIG. 3.

[0100] The patient device 304 may include a patient application 310 and a communications interface 314. The patient application 310 may be configured to facilitate gathering and display of data to the patient, such as via a graphical user interface. The patient device 304 may be configured to receive data (e.g., pressure data, force data, acceleration data (from the accelerometer 170), rotational data (e.g., from the inertial measurement unit 172), diagnoses data) from the intra-vaginal device 100 and / or from the server 302. The patient application 310 may, for example, be configured to receive one or more inputs for a patient, such as patient demographic data (e.g., patient age, patient height, patient weight, patient body mass index, patient health history (e.g., patient parity (e.g., whether the patient has had any children, and if so, number of children) whether the patient smokes, has a chronic cough, etc.), patient health goals, or other information input for the patient). In addition, the patient device 304 may be configured to receive information from the provider device 306 and the patient application 310 may be configured to display the information received by the provider device 306. For example, the patient application 310 may be configured to display one or more messages from a healthcare provider received from the provider device 306. In some such embodiments, the patient application 310 may facilitate remote monitoring and healthcare of the patient.

[0101] The provider device 306 may include a provider application 312 and a communications interface 316. The provider application 312 may be configured to facilitate gathering and displaying of data to the provider, such as via a graphical user interface. The provider device 306 may be configured to receive data (e.g., pressure data, force data, acceleration data (from the accelerometer 170), rotational data (e.g., from the inertial measurement unit 172), diagnoses data) from the intra-vaginal device 100 and / or from theserver 302. In some embodiments, the provider device 306 receives analyzed pressure data and force data and at least one indication of a pelvic floor health of the patient based on the analyzed pressure data and force data. In some embodiments, the provider application 312 receives user input from a provider. For example, the provider may analyze the pressure data, the force data, and / or the analyzed pressure data and force data received from the server 302 or the intra-vaginal device 100 and generate a healthcare recommendation based on the data. Accordingly, the provider device 306 may receive a healthcare recommendation (e.g., a diagnosis, a treatment plan). The provider device 306 may provide the healthcare recommendation to the patient device 304.

[0102] The server device 302 may include a data collection manager 320, a healthcare application 322, data storage 324, and a communications interface 326. The data storage 324 may be configured to receive and store data from the intra-vaginal device 100, the patient device 304, the provider device 306, and / or the healthcare application 322. For example, the data storage 324 may be configured to store pressure data, force data, analyzed pressure data, analyzed force data, acceleration data, rotational data, temperature data, patient demographic data, healthcare recommendations from the provider device 306, or other data. In embodiments where the intra-vaginal device 100 analyzes the pressure data and the force data, the server 302 receives the analyzed pressure data and force data from the intra-vaginal device 100. The data storage 324 may provide data to the data collection manager 320 and / or the healthcare application 322.

[0103] The healthcare application 322 may be configured to analyze data from the data storage 324 and / or the data collection manager 320 to diagnose a pelvic floor disorder and / or provide one or more healthcare recommendations to the patient device 304 (such as to the patient application 310) and / or the provider device 306 (such as to the provider application 312). In some embodiments, the healthcare application 322 is configured to determine one or more health conditions of the patient based on the pressure signal and the force signal. For example, the healthcare application 322 may be configured to determine whether the patient is properly exercising, diagnose pelvic floor disorders, determine whether the intra-abdominal pressure is too high at a particular time and / or over the course of a duration, determine a duration between an increase in intra-abdominal pressure and pelvic floor muscle force, and / or another health condition of the patient. By way of nonlimiting example, based on the pressure signal and the force signal, the healthcare application 322 may be configured to determine whether the patient’s pelvic floor muscles contract too long after an increase in intra-abdominal pressure. In some embodiments, thehealthcare application 322 is configured to determine whether the intra-abdominal pressure is too high at a given time and / or over a duration (e.g., such as during exercising). In some embodiments, the healthcare application 322 may be configured to determine pelvic muscle endurance via peak force decline over several consecutive Kegels. In some embodiments, the healthcare application 322 is configured to determine whether pelvic muscles are increasing in tone (measured as passive or baseline force) over several hours, possibly indicating hypertonicity and alerting the patient. In some embodiments, the healthcare application 322 is configured to determine whether tissue vibrations, as measured by the accelerometer 170, are not sufficiently dampened by pelvic muscles, indicating pelvic muscle fatigue. In some embodiments, tissue vibrations measured by the accelerometer 170 may relate to muscle fatigue and specific pathophysiology for diagnosis.

[0104] In some embodiments, and only as one example, the healthcare application 322 may be configured to determine allowable activity levels for the patient based on the pressure data and the force data. By way of non-limiting example, the healthcare application 322 may be configured to determine whether the intra-abdominal pressure (as determined based on the pressure data) is commensurate with a patient’s level of recovery and / or pelvic floor health. The healthcare application 322 may determine whether the patient’s intra-abdominal pressure has exceeded a predetermined threshold, such as based on a total intra-abdominal pressure experienced within a predetermined time (e.g., a day, twelve hours, six hours, four hours, three hours, one hour) from prolonged exposure (e.g., a jog), or from a single exposure limit. As the pelvic floor of the patient strengthens over the course of treatment, the allowable intra-abdominal pressure for the patient may be increased. In some embodiments, the healthcare application 322 determines an allowable intra-abdominal pressure exposure of the patient based on the force data. For example, the allowable intra-abdominal pressure may be based on the total forces measured with the force sensor 130 over a predetermined duration since the total force may be proportional to the pelvic floor health of the patient. In some embodiments, the healthcare application 322 generates a healthcare recommendation, which may be received by the patient device 304 and / or the provider device 306. In some embodiments, the healthcare recommendation includes coordination to separate a Kegel from the Valsalva maneuver. The healthcare application 322 may facilitate providing (e.g., identifying) to the patient (e.g., at the patient device 304) from the server 302 and / or the provider device 306 a list of activities that incite pelvic floor disorders and a corresponding recommendation that the patient reduce, minimize, and / or not participate in such activities. In addition, the healthcare application322 may provide to the patient (e.g., at the patient device 304) from the server 302 and / or to the provider device 306 a list of recommended activities (e.g., physical therapy) to facilitate strengthening the pelvic floor muscles and / or improving pelvic floor health.

[0105] In some embodiments, the healthcare application 322 is configured to diagnose stress incontinence. In some embodiments, the healthcare application 322 is configured to determine whether the pelvic floor forces are commensurate with the intra-abdominal pressures. For example, the healthcare application 322 may determine whether the pelvic floor forces exhibit increases corresponding to increases in the intra-abdominal pressure of the patient. In some embodiments, the healthcare application 322 determines that the patient’s pelvic floor muscles are weak responsive to determining that the pelvic floor forces do not increase and / or do not increase for a predetermined duration after increases in the intra-abdominal pressure. In some embodiments, responsive to determining that the patient has weak pelvic floor muscles, the healthcare application 322 generates a recommendation for the patient to train pelvic floor muscles, such as by performing one or more Kegel exercises (e.g., Kegel holds). Responsive to determining that the patient has delayed contractions responsive to increases in intra-abdominal pressure, the healthcare application 322 may generate a healthcare recommendation for the patient to focus on rapid and short pelvic floor contractions to strengthen the patient’s pelvic floor muscles. The healthcare application 322 may be configured to determine an effectiveness of pelvic floor contractions based on the pressure data and the force data.

[0106] In some embodiments, the healthcare application 322 may be configured to analyze the pressure data, the force data, and optionally, acceleration data (as measured with the accelerometer 170 within the intra-vaginal device 100 and / or as received from the patient device 304 (which may include an accelerometer and / or GPS configured to determine an acceleration of the patient)) and / or orientation data (e.g., an angular velocity or rotational motion of the intra-vaginal device, as measured by the inertial measurement unit 172) to determine when pelvic floor muscles of the patient become fatigued. In some embodiments, the healthcare application 322 is configured to generate (and provide) instantaneous feedback to the patient device 304 to indicate that the pelvic floor muscles may be damaged from continued exercise and may generate a recommendation for the patient to stop the exercise. In some embodiments, the healthcare application 322 is configured to generate recommended exercises based on previous exercise levels of the patient. As one example, if the patient recently had a long duration of exercise, the healthcare application 322 may generate a recommendation that the patient have a day ofrest without exercise to allow the pelvic floor muscles to recover, followed by light exercise to prevent a repetitive stress injury.

[0107] In some embodiments, one or more of the healthcare application 322, the patient application 310, or the provider application 312 may be configured to determine one or more conditions and / or diagnoses described above with reference to the computing unit 150. For example, one or more of the healthcare application 322, the patient application 310, or the provider application 312 may be configured to determine whether a resting tone of the patient is increasing, decreasing, or remaining substantially constant over time (e.g., to diagnose hypertonic patients); whether pelvic floor muscles contract after too large (long) a duration after an increase in intra-abdominal pressure; the rate of muscle force generation and a comparison of a current rate of the pelvic floor muscle forces relative to historical values for the patient; and / or other conditions. With continued reference to FIG. 3, each of the communications interfaces 152, 314, 316, 326 may be configured to receive and transmit data, such as from each of the respective intra-vaginal device 100, the patient device 304, the provider device 306, and / or the server 302 to another device of the environment 300 and / or the network 308. For example, the intra-vaginal device 100, the patient device 304, the provider device 306, and the server 302 may be configured to be in operable communication with one another over the network 308, which may include a cloud network.

[0108] FIG. 4 is a simplified flow diagram illustrating a method of diagnosing and / or treating a pelvic floor disorder, in accordance with at least one embodiment of the disclosure. The method 400 may include receiving, with an intra-vaginal device, pressure data indicative of intra-abdominal pressure of a patient, as shown in act 402. Receiving the pressure data may include receiving the pressure data with a pressure sensor located within the intra-vaginal device.

[0109] The method 400 may further include receiving, with the intra-vaginal device, force data indicative of pelvic floor forces (e.g., pelvic muscle forces) of the patient, as shown in act 404. Receiving the pelvic floor forces may include receiving the force data with a force sensor located within the intra-vaginal device.

[0110] Responsive to receiving the pressure data and the force data, the method 400 may include generating a healthcare diagnosis and / or generating a healthcare recommendation based on the pressure data and the force data, as shown in act 406. Generating the healthcare diagnosis and / or the healthcare recommendation may be substantially the same as that described above with reference to the healthcare application 322 with reference to FIG. 3.In some embodiments, the healthcare diagnosis and / or the healthcare recommendation may be displayed on at least one of a patient device or a provider device. The healthcare diagnosis and / or the healthcare recommendation may be displayed at a location remote (e.g., away) from the intra-vaginal device.

[0111] Accordingly, the intra-vaginal device 100 may be configured to facilitate diagnosing one or more pelvic floor health conditions of a patient. The location of the pressure sensor 120 relative to the force sensor 130 in the intra-vaginal device 100 may facilitate independently measuring and reducing cross-talk between intra-abdominal pressures and pelvic floor forces. In use and operation, the pressure sensor 120 may be located above a pelvic floor of the patient and the force sensor 130 may be located below the pelvic floor. Reducing the cross-talk between intra-abdominal pressure and pelvic floor forces may facilitate improved diagnosis and treatment of pelvic floor disorders and may reduce misdiagnoses.

[0112] In some embodiments, one or more of the healthcare application 322, the patient application 310, or the provider application 312 may implement one or more machine learning models and / or artificial intelligence to facilitate personalized healthcare to the patient based on historical data of the patient measured with the intra-vaginal device 100. FIG. 5 is a simplified flow diagram illustrating an environment 500 in which the intra- vaginal device 100 may be operated. The environment 500 includes a machine learning model 502 configured to receive features (e.g., patient demographic data 504 and intra- vaginal device data 520) as input data and generate outputs 560 including one or more healthcare recommendations and / or diagnoses based on the features. In some embodiments, the machine learning model 502 may receive additional inputs, such as from the provider device 306. The machine learning model 502 may provide the outputs 560 to the patient device 304 and / or the provider device 306.

[0113] The values of the outputs 560 are based on labeled and / or unlabeled datasets used to train the machine learning model 502. The features of the datasets used to train the machine learning model may include patient demographic data, such as one or more of age, height, weight, body mass index (BMI), parity, nationality, or race; and intra-vaginal data, such as one or more of intra-abdominal pressure, pelvic muscle force, or acceleration, e.g., obtained from intra-vaginal devices, such as those discussed herein.

[0114] The machine learning model 502 may be configured to receive patient demographic data 504 and the intra-vaginal device data 520. For example, the machinelearning model 502 may receive the patient demographic data 504 from the patient device 304; and may receive the intra-vaginal device data 520 from the intra-vaginal device 100.

[0115] A patient may input the patient demographic data 504 into, for example, the patient device 304, such as via the patient application 310. In some embodiments, the data is received by the healthcare application 322, which may include the machine learning model 502. The patient demographic data 504 may include, for example, patient age 506, patient height 508, patient weight 510, patient body mass index 512, patient parity 514, and other patient demographic data 516 (e.g., whether the patient smokes, drinks, has a chronic cough, healthcare history of the patient, etc.).

[0116] The intra-vaginal device data 520 may be received by the machine learning model 502 from the intra-vaginal device 100 and may include, for example, intra-abdominal pressure data 530 (as measured by the pressure sensor 120), pelvic floor muscle force data 540 (as measured by the force sensor 130), and acceleration data 550 (as measured by the accelerometer 170). Each of the intra-abdominal pressure data 530, the pelvic floor muscle force data 540, and the acceleration data 550 may include instantaneous values, a mean value, a maximum value, and a total (cumulative) value of the respective intra-abdominal pressure, pelvic floor muscle force, and acceleration data over a duration. For example, the intra-abdominal pressure data 530 may include instantaneous intra-abdominal pressure data 532, a mean intra-abdominal pressure and a maximum intra-abdominal pressure 534 over a duration, and a total (cumulative) value of the intra-abdominal pressure 536 over a duration; the pelvic floor muscle force 540 may include instantaneous pelvic floor muscle force 542, a mean pelvic floor muscle force and a maximum pelvic floor muscle force 544 over a duration, and a total (cumulative) value of the pelvic floor muscle force 546 over a duration; and the acceleration data 550 may include instantaneous acceleration data 552, a mean acceleration and a maximum acceleration 554 over a duration, and a total (cumulative) value of the acceleration 556 over a duration.

[0117] As described above, the machine learning model 502 may be configured to generate the outputs 560, and the values of the outputs 560 may be based on the patient demographic data 504 and intra-vaginal device data 520. The outputs 560 may include a pathophysiologic diagnosis 562, a treatment recommendation 564, instantaneous (e.g., substantially instantaneous) patient feedback 566, and / or a probable prognosis 568. The pathophysiologic diagnosis 562 may include, for example, a determination of the root cause of patient symptoms. For example, the pathophysiologic diagnosis 562 may include a diagnosis of whether incontinence is caused by excessive exercise or some other condition.The treatment recommendations 564 may include a recommendation of a treatment modality that is most likely to treat the patient. The instantaneous (e.g., substantially instantaneous) patient feedback 566 may include alerts during activities that are likely to cause pelvic floor injuries to the patient. The probable prognosis 568 may include an indication of a likelihood of resolution of patient symptoms.

[0118] The machine learning model 502 may consider, in its calculations, the intra- vaginal device data 520 obtained over a duration and while the patient is participating in day-to-day ambulatory activities. Since the intra-vaginal device data 520 may be gathered over a duration as the patient engages in various activities, the machine learning model 502 may be configured to provide individualized therapy and biofeedback to each particular patient based on data that is obtained by the intra-vaginal device 100 when worn by that particular patient. As a non-limiting example, the machine learning model 502 may be configured to determine an allowable activity level of a patient based on pelvic floor health and recovery of the patient using the intra-vaginal device data 520 and the patient demographic data 504. The machine learning model 502 may be configured to generate prompt (e.g., instantaneous) feedback to the patient device 304 (e.g., to display promptly to the patient) responsive to determining that intra-abdominal pressure exceeds a threshold pressure due to a single exposure (such as by lifting a large object) or prolonged exposure (such as from a jog) to a high intra-abdominal pressure. As the pelvic floor muscles are strengthened over the course of treatment, the machine learning model 502 may increase an allowable intra-abdominal pressure to which the patient may be exposed. Increasing the allowable intra-abdominal pressure may facilitate strengthening the pelvic floor of the patient without damaging the pelvic floor muscles by exposure to excessive intra- abdominal pressures.

[0119] As another non-limiting example, the machine learning model 502 may facilitate treatment of a patient experiencing stress incontinence (e.g., during coughing and / or sneezing), such as a patient who has recently experienced childbirth. The machine learning model 502 may be configured to determine whether the patient has weak pelvic floor muscles and / or whether the patient contracts their pelvic floor muscles late relative to the increase in the intra-abdominal pressure. Responsive to determining that the patient has weak pelvic floor muscles, the machine learning model 502 may generate an output providing a recommendation to the patient to perform long pelvic floor contractions (Kegels) to strengthen the pelvic floor muscles. Responsive to determining that the patient has delayed pelvic floor contractions relative to the increase in the intra-abdominalpressure, the machine learning model 502 may generate an output providing a recommendation to the patient to perform rapid and short pelvic floor contractions. The output may be modified as additional data (e.g., intra-vaginal device data 520) are generated. In some embodiments, the output is received by one or both of the patient device 304 or the provider device 306 and displayed thereon.

[0120] In some embodiments, the machine learning model 502 may be configured to provide a treatment recommendation to the patient. For example, a patient may not have experienced childbirth, and may experience stress incontinence during prolonged exercises (e.g., long runs). The intra-vaginal device 100 may receive intra-abdominal pressure data, pelvic floor muscle data, and acceleration data while the patient exercises. In some embodiments, the machine learning model 502 may provide instantaneous feedback to the patient device 304 and / or the provider device 306 to indicate the pelvic muscles may be damaged from continued exercise. For example, the machine learning model 502 may generate an output for instantaneous feedback to the patient recommending that the patient discontinue exercising and rest based on the intra-vaginal device data 520. In some embodiments, the machine learning model 502 may generate an output including a recommendation for an exercise level based on recent exercise levels (e.g., which may be received by the machine learning model 502 as patient demographic data 504 or may be determined based on the acceleration data). By way of non-limiting example, responsive to determining that the patient recently had a long and intense exercise, the machine learning model 502 may generate an output including a recommendation of at least a day of no exercise to allow the pelvic floor muscles to recover, followed by light exercise to prevent a repetitive stress injury to the pelvic floor muscles.

[0121] While the intra-vaginal device 100 has been described and illustrated as having a particular shape and configuration, the disclosure is not so limited. FIG. 6A is a simplified perspective view of an intra-vaginal device 600, according to at least one embodiment of the disclosure; FIG. 6B is another simplified perspective view of the intra-vaginal device 600; and FIG. 6C is a simplified perspective exploded view of the intra-vaginal device 600 wherein a first portion 604 is separated from a second portion 606. For clarity and ease of understanding the description, components within the intra-vaginal device 100 are shown in broken lines in FIG. 6 A and FIG. 6B. The first portion 604 and the second portion 606 may be substantially the same as the respective first portion 104 and second portion 106 described above. For example, the first portion 604 may include the pressure sensor 120 (and the force sensor 130. The intra-vaginal device 600 may be substantially the same asthe intra-vaginal device 100 described above with reference to FIG. 1 A through FIG. 1G, except that the shape of the intra-vaginal device 600 may be different than the shape of the intra-vaginal device 100 and may not include the retention mechanism 116. In some embodiments, each of the pressure sensor 120, the force sensor 130, the printed circuit board 140, the printed circuit board 122, and the computing unit 150 are substantially the same as described above with reference to the intra-vaginal device 100.

[0122] With reference to FIG. 6A through FIG. 6C, the intra-vaginal device 600 may include a retention feature 602 including ridges 608 and valleys 610 defining an external surface of the intra-vaginal device 600. The retention feature 602 may be configured to facilitate retention of the intra-vaginal device 600 in a patient and substantially reduce movement of the intra-vaginal device 600 in the patient while the intra-vaginal device 600 is worn by the patient. In some embodiments, the retention feature 602 is located between the first portion 604 and the second portion 606 of the intra-vaginal device 600. In some embodiments, the retention feature 602 is configured to allow hinged movement between the first portion 604 and the second portion 606 such that the angle between a longitudinal axis of the first portion 604 and a longitudinal axis of the second portion 606 changes. Hinging about the retention feature 602 may facilitate confirming the intra-vaginal device 600 to the anatomy of each patient. In addition, the hinging action of the retention feature 602 may improve patient comfort when wearing the intra-vaginal device 600.

[0123] In some embodiments, the durometer and / or the material (e.g., the biocompatible material 112) from which the intra-vaginal device 600 is formed may affect the hinging action of the retention feature 602. For example, increasing the durometer of the material from which the intra-vaginal device 600 is formed may increase the force required to cause the intra-vaginal device 600 to hinge about the retention feature 602. In addition, in some embodiments, the geometry of the retention feature 602 may affect the hinging action of the retention feature 602. For example, increasing a wall thickness of the intra-vaginal device 600 may increase the force required to cause the intra-vaginal device 600 to hinge about the retention feature 602; and decreasing the wall thickness of the intra-vaginal device 600 may decrease the force required to cause the intra-vaginal device 600 to hinge about the retention feature 602.

[0124] In some embodiments, the retention feature 602 facilitates increasing a friction between the patient anatomy and the intra-vaginal device 600, substantially reducing undesired movement of the intra-vaginal device 600 when worn by the patient. In some embodiments, the retention feature 602 including the ridges 608 and valleys 610 mayfacilitate placement of external sleeves (e.g., retention mechanisms 116 (FIG. 1A, FIG. IB). In addition, hinging of the intra-vaginal device 600 about the retention feature 602 may improve retention of the intra-vaginal device 600 when worn by a patient by allowing the intra-vaginal device 600 to alter shape responsive to changes in body position of the patient.

[0125] FIG. 7 is a simplified perspective view of an intra-vaginal device 700, according to at least one embodiment of the present disclosure. The intra-vaginal device 700 may be substantially the same as intra-vaginal device 100 described above with reference to FIG. 1 A through FIG. 1G, except that the shape of the intra-vaginal device 700 may be different than the shape of the intra-vaginal device 100 and may not include the retention mechanism 116. The intra-vaginal device 700 may include a retention feature 702 integral (e.g., unitary, continuous) with a body of the intra-vaginal device 700. An outer diameter D3 of the intra-vaginal device 700 may be largest at the retention feature 702 than at other portions of the intra-vaginal device 700.

[0126] The retention feature 702 may be located between a first portion 706 including the pressure sensor 120 (not shown in FIG. 7 since the pressure sensor 120 is located inside the intra-vaginal device 700) and a second portion 708 including the force sensor 130 (not shown in FIG. 7 since the force sensor 130 is located inside the intra-vaginal device 700). The retention feature 702 may be sized, shaped, and configured to be positioned at and intersect the pelvic floor muscles of the patient while the intra-vaginal device 700 is worn by the patient. The intra-vaginal device 700 may be configured to hinge about the retention feature 702, as described above with reference to the retention feature 602 (FIG. 6A through FIG. 6C). In addition, in some embodiments, an external retention mechanism (e.g., retention mechanism 116 (FIG. 1A, FIG. IB)) may be placed and seated within a groove of the retention feature 702.

[0127] FIG. 8A and FIG. 8B are simplified perspective views of an intra-vaginal device 800, according to at least one embodiment of the present disclosure. The intra-vaginal device 800 may be substantially the same as intra-vaginal device 100 described above with reference to FIG. 1 A through FIG. 1G, except that the shape of the intra-vaginal device 800 may be different than the shape of the intra-vaginal device 100 and may not include the retention mechanism 116 and may not include the alignment feature 160.

[0128] With reference to FIG. 8A, the intra-vaginal device 800 may include a retention and alignment feature 802 configured to facilitate alignment of the intra-vaginal device 800 each time the intra-vaginal device 800 is worn by the patient. For example, the retention and alignment feature 802 may include wings 804 defining a dimension D4 of the intra-vaginal device 800. The dimension D4 defined by the wings 804 may define the largest transverse dimension (e.g., width, diameter) of the intra-vaginal device 800 other than the length of the intra-vaginal device. The intra-vaginal device 800 may be configured such that a distal end 806 including the pressure sensor 120 (not illustrated in FIG. 8A and FIG. 8B since the pressure sensor 120 is located inside the intra-vaginal device 800) is oriented to face the anterior region of the patient (and a proximal end 808 including the force sensor 130 (not illustrated in FIG. 8A and FIG. 8B since the force sensor 130 is located inside the intra-vaginal device 800)), the wings 804 are oriented along the frontal (e.g., coronal) plane perpendicular to the sagittal plane and the transverse plane. In other words, the wings 804 are oriented such that a plane that extends along the dimension D4 intersects the hips of the patient. Stated another way, the intra-vaginal device 800 may be positioned and aligned in the patient such that the wings 804 extend between the hips of the patient and the largest transverse dimension of the intra-vaginal device 800 extends in the transverse plane. Accordingly, in some embodiments, the retention and alignment feature 802 may comprise an internal alignment feature 802.

[0129] The retention and alignment feature 802 of the intra-vaginal device 800 may not have a circular or substantially circular cross-sectional shape. Rather, in some embodiments, the cross-sectional shape of the retention and alignment feature 802 may be elliptical, oval, or another shape having a larger dimension D4 in a first direction perpendicular to a longitudinal axis of the intra-vaginal device 800 than a dimension in a second direction perpendicular to the longitudinal axis and the first direction. In some embodiments, the size and shape of the intra-vaginal device 800, such as the size and shape of the retention and alignment feature 802 reduces and / or substantially prevents rotational movement of the intra-vaginal device 800 when worn by the patient, even during ambulatory movement of the patient. Accordingly, the retention and alignment feature 802 including the wings 804 may facilitate repeatable alignment of the intra-vaginal device 800 each time the intra-vaginal device 800 is worn; and may further facilitate retention of the intra-vaginal device 800 and reduce movement of the intra-vaginal device 800 when the intra-vaginal device 800 is worn by the patient, even during ambulatory movement of the patient. In some embodiments, the intra-vaginal device 800 including the retention and alignment feature 802 may be self-aligning. For example, the intra-vaginal device 800 may be shaped to replicate the anatomical geometry of the patient. In particular, since the vaginal cavity is between the bladder and the rectum and is compressed between the bladder and the rectum, with a shortest dimension of the vaginal cavity along the sagittal plane, if theintra-vaginal device 800 is placed improperly, the tissue of the bladder and the rectum may push on the wings 804 of the retention and alignment feature 802 and generate a torque that rotates the intra-vaginal device 800 to align the intra-vaginal device 800.

[0130] FIG. 9 illustrates certain components that may be included within a computer system 900, in accordance with at least one embodiment of the disclosure. One or more computer systems 900 may be used to implement the various devices, components, systems, and methods described herein. For example, one or more of the intra-vaginal device 100, 600, 700, 800, the computing unit 150, patient device 304, the provider device 306, and the server 302 may include a computer system. In addition, the method 400 may be performed with a computer system.

[0131] The computer system 900 includes a processor 901. The processor 901 may be a general -purpose single or multi-chip microprocessor (e.g., an Advanced RISC (Reduced Instruction Set Computer) Machine (ARM)), a special purpose microprocessor (e.g., a digital signal processor (DSP)), a microcontroller, a programmable gate array, etc. The processor 901 may be referred to as a central processing unit (CPU). Although just a single processor 901 is shown in the computer system 900 of FIG. 9, in an alternative configuration, a combination of processors (e.g., an ARM and DSP) could be used.

[0132] The computer system 900 also includes memory 903 in electronic communication with the processor 901. The memory 903 may be any electronic component capable of storing electronic information. For example, the memory 903 may be embodied as random access memory (RAM), read-only memory (ROM), magnetic disk storage media, optical storage media, flash memory devices in RAM, on-board memory included with the processor, erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM) memory, registers, and so forth, including combinations thereof.

[0133] Instructions 905 and data 907 may be stored in the memory 903. In some embodiments, each of the patient application 310, the provider application 312, and the healthcare application 322 includes instructions 905 and data 907. The instructions 905 may be executable by the processor 901 to implement some or all of the functionality disclosed herein. Executing the instructions 905 may involve the use of the data 907 that is stored in the memory 903. Any of the various examples of modules and components described herein may be implemented, partially or wholly, as instructions 905 stored in memory 903 and executed by the processor 901. Any of the various examples of datadescribed herein may be among the data 907 that is stored in memory 903 and used during execution of the instructions 905 by the processor 901.

[0134] The computer system 900 may also include one or more communication interfaces 909 for communicating with other electronic devices. The communication interface(s) 909 may be based on wired communication technology, wireless communication technology, or both. Some examples of communication interfaces 909 include a Universal Serial Bus (USB), an Ethernet adapter, a wireless adapter that operates in accordance with an Institute of Electrical and Electronics Engineers (IEEE) 802.11 wireless communication protocol, a Bluetooth® wireless communication adapter, and an infrared (IR) communication port.

[0135] The computer system 900 may also include one or more input devices 911 and one or more output devices 913. Some examples of input devices 911 include a keyboard, mouse, microphone, remote control device, button, trackball, and touchpad. For example, where the computer system 900 includes a patient device 304 (such as a mobile phone), the input device 911 may include a touchscreen. The input device 911 of the provider device 306 comprising a desktop computer may include a mouse and a keyboard. Some examples of output devices 913 include a speaker and a printer. One specific type of output device that is typically included in a computer system 900 is a display device 915. Display devices 915 used with embodiments disclosed herein may utilize any suitable image projection technology, such as liquid crystal display (LCD), light-emitting diode (LED), gas plasma, electroluminescence, or the like. A display controller 917 may also be provided, for converting data 907 stored in the memory 903 into text, graphics, and / or moving images (as appropriate) shown on the display device 915.

[0136] The various components of the computer system 900 may be coupled together by one or more buses, which may include a power bus, a control signal bus, a status signal bus, a data bus, etc. For the sake of clarity, the various buses are illustrated in FIG. 9 as a bus system 919.

[0137] The techniques described herein may be implemented in hardware, software, firmware, or any combination thereof, unless specifically described as being implemented in a specific manner. Any features described as modules, components, or the like may also be implemented together in an integrated logic device or separately as discrete but interoperable logic devices. If implemented in software, the techniques may be realized at least in part by a non-transitory processor-readable (computer-readable) storage medium comprising (having) instructions thereon that, when executed by at least one processor,perform one or more of the methods described herein. The instructions may be organized into routines, programs, objects, components, data structures, etc., which may perform particular tasks and / or implement particular data types, and which may be combined or distributed as desired in various embodiments.

[0138] Additional non-limiting example embodiments of the disclosure are described below.

[0139] Embodiment 1 : An intra-vaginal device for diagnosing and treating pelvic floor disorders, the intra-vaginal device comprising: an intra-abdominal pressure sensor configured to measure dynamic changes in intra-abdominal pressure; abi-axial force sensor spaced from the intra-abdominal pressure sensor, the bi-axial force sensor configured to measure a magnitude of a force of pelvic floor contractions in at least two directions; a pressure-transmitting material surrounding the intra-abdominal pressure sensor; and a housing containing the intra-abdominal pressure sensor, the bi-axial force sensor, and the pressure-transmitting material.

[0140] Embodiment 2: The intra-vaginal device of Embodiment 1, wherein: a first axis of the bi-axial force sensor is configured to be oriented at an angle from a sagittal plane of a patient; and a second axis of the bi-axial force sensor is configured to be oriented at a different angle from the sagittal plane and offset from the first axis.

[0141] Embodiment 3: The intra-vaginal device of Embodiment 1 or Embodiment 2, wherein the bi-axial force sensor includes a first axis that is oriented at an angle within a range of from about 30° to about 60° with respect to a second axis of the bi-axial force sensor.

[0142] Embodiment 4: The intra-vaginal device of any one of Embodiments 1 through 3, wherein the bi-axial force sensor includes a first axis that is substantially perpendicular to a second a second axis of the bi-axial force sensor.

[0143] Embodiment 5: The intra-vaginal device of any one of Embodiments 1 through 4, wherein bi-axial force sensor is spaced from the intra-abdominal pressure sensor by at least about 3.0 cm.

[0144] Embodiment 6: The intra-vaginal device of any one of Embodiments 1 through 5, wherein the bi-axial force sensor includes a double bending beam load cell.

[0145] Embodiment 7: The intra-vaginal device of any one of Embodiments 1 through 6, wherein the bi-axial force sensor includes two double bending beam load cells.

[0146] Embodiment 8: The intra-vaginal device of Embodiment 7, wherein the double bending beam load cells are oriented to provide a magnitude and direction of levator ani contractions.

[0147] Embodiment 9: The intra-vaginal device of any one of Embodiments 1 through 8, wherein the bi-axial force sensor is configured to measure asymmetry in the pelvic floor contractions.

[0148] Embodiment 10: The intra-vaginal device of any one of Embodiments 1 through9, wherein the housing defines a hyperboloid shape or a conical shape surrounding the biaxial force sensor.

[0149] Embodiment 11 : The intra-vaginal device of any one of Embodiments 1 through10, wherein the bi-axial force sensor is configured to intersect pelvic floor muscles.

[0150] Embodiment 12: The intra-vaginal device of any one of Embodiments 1 through 11, further comprising a retention mechanism configured to be disposed around the housing between the intra-abdominal pressure sensor and the bi-axial force sensor.

[0151] Embodiment 13: The intra-vaginal device of any one of Embodiments 1 through12, wherein the housing includes: a first portion including the intra-abdominal pressure sensor having a first longitudinal axis; and a second portion including the bi-axial force sensor having a second longitudinal axis offset from the first longitudinal axis.

[0152] Embodiment 14: The intra-vaginal device of any one of Embodiments 1 through13, wherein the pressure-transmitting material comprises a gel.

[0153] Embodiment 15: The intra-vaginal device of any one of Embodiments 1 through14, wherein the pressure-transmitting material is within a central portion of the bi-axial force sensor.

[0154] Embodiment 16: The intra-vaginal device of any one of Embodiments 1 through15, wherein the pressure-transmitting material comprises silicone.

[0155] Embodiment 17: The intra-vaginal device of any one of Embodiments 1 through16, wherein the housing comprises an alignment feature configured to indicate a relative orientation of the bi-axial force sensor.

[0156] Embodiment 18: The intra-vaginal device of any one of Embodiments 1 through17, further comprising a computing system within the housing, the computing system in operable communication with the intra-abdominal pressure sensor and the force sensor.

[0157] Embodiment 19: The intra-vaginal device of Embodiment 18, wherein the computing system is configured to: analyze pressure data from the intra-abdominal pressure sensor; and analyze force data from the bi-axial force sensor.

[0158] Embodiment 20: The intra-vaginal device of Embodiment 19, wherein the computing system is configured to provide the analyzed pressure data and the analyzed force data to a remote location.

[0159] Embodiment 21 : An intra-vaginal device, comprising: a housing comprising a biocompatible material; an intra-abdominal pressure sensor within the housing and configured to measure an intra-abdominal pressure of a patient; a force sensor within the housing and spaced from the intra-abdominal pressure sensor, the force sensor configured to measure forces of pelvic floor contractions; and a retention mechanism between the intra- abdominal pressure sensor and the force sensor, the retention mechanism configured to maintain the intra-vaginal device in a patient during ambulatory activity of the patient.

[0160] Embodiment 22: The intra-vaginal device of Embodiment 21, wherein the retention mechanism comprises an external retention sleeve configured to seat in a groove defined in an external surface of the housing.

[0161] Embodiment 23: The intra-vaginal device of Embodiment 22, wherein the external retention sleeve comprises a flanged portion configured.

[0162] Embodiment 24: The intra-vaginal device of Embodiment 21, wherein the retention mechanism comprises a portion of the housing having a larger cross-sectional area than other portions of the housing.

[0163] Embodiment 25: The intra-vaginal device of any one of Embodiments 21 through24, further comprising an alignment feature at a base of the housing configured to facilitate alignment of the intra-vaginal device during placement of the intra-vaginal device.

[0164] Embodiment 26: The intra-vaginal device of any one of Embodiments 21 through25, wherein the intra-abdominal pressure sensor is located in a portion of the housing defined by a spherical cap.

[0165] Embodiment 27: The intra-vaginal device of any one of Embodiments 21 through26, wherein the force sensor is spaced from the intra-abdominal pressure sensor by at least about 3.0 cm.

[0166] Embodiment 28: The intra-vaginal device of any one of Embodiments 21 through27, further comprising a computing unit within the housing, the computing unit in operable communication with the intra-abdominal pressure sensor and the force sensor and configured to: analyze pressure data from the intra-abdominal pressure sensor; analyze force data from the force sensor; and provide the analyzed pressure data and the analyzed force data to a location remote from the intra-vaginal device.

[0167] Embodiment 29: The intra-vaginal device of any one of Embodiments 21 through 28, wherein the force sensor is configured to measure a force of pelvic floor contractions in two different directions within a plane of a levator ani of the patient.

[0168] Embodiment 30: A method of operating an intra-vaginal device, the method comprising: receiving, from an intra-abdominal pressure sensor of the intra-vaginal device, pressure data indicative of an intra-abdominal pressure; receiving, from a bi-axial force sensor, bi-axial force data indicative of a force of pelvic floor muscle contractions in two directions offset from a sagittal plane; and generating an output on at least one of a patient device or a provider device based on the pressure data and the bi-axial force data.

[0169] Embodiment 31 : The method of Embodiment 30, further comprising displaying on the at least one of the patient device or the provider device, an effectiveness of a pelvic floor contraction.

[0170] One or more specific embodiments of the present disclosure are described herein. These described embodiments are examples of the presently disclosed techniques. Additionally, in an effort to provide a concise description of these embodiments, not all features of an actual embodiment may be described in the specification. It should be appreciated that in the development of any such actual implementation, as in any engineering or design project, numerous embodiment-specific decisions will be made to achieve the developers’ specific goals, such as compliance with system-related and business-related constraints, which may vary from one embodiment to another. Moreover, it should be appreciated that such a development effort might be complex and time consuming, but would nevertheless be a routine undertaking of design, fabrication, and manufacture for those of ordinary skill having the benefit of this disclosure.

[0171] The articles “a,” “an,” and “the” are intended to mean that there are one or more of the elements in the preceding descriptions. The terms “comprising,” “including,” and “having” are intended to be inclusive and mean that there may be additional elements other than the listed elements. Additionally, it should be understood that references to “one embodiment” or “an embodiment” of the present disclosure are not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the recited features. For example, any element described in relation to an embodiment herein may be combinable with any element of any other embodiment described herein. Numbers, percentages, ratios, or other values stated herein are intended to include that value, and also other values that are “about” or “approximately” the stated value, as would be appreciated by one of ordinary skill in the art encompassed by embodiments of the present disclosure.A stated value should therefore be interpreted broadly enough to encompass values that are at least close enough to the stated value to perform a desired function or achieve a desired result. The stated values include at least the variation to be expected in a suitable manufacturing or production process, and may include values that are within 5%, within 1%, within 0.1%, or within 0.01% of a stated value.

[0172] A person having ordinary skill in the art should realize in view of the present disclosure that equivalent constructions do not depart from the spirit and scope of the present disclosure, and that various changes, substitutions, and alterations may be made to embodiments disclosed herein without departing from the spirit and scope of the present disclosure. Equivalent constructions, including functional “means-plus-function” clauses are intended to cover the structures described herein as performing the recited function, including both structural equivalents that operate in the same manner, and equivalent structures that provide the same function. It is the express intention of the applicant not to invoke means-plus-function or other functional claiming for any claim except for those in which the words ‘means for’ appear together with an associated function. Each addition, deletion, and modification to the embodiments that falls within the meaning and scope of the claims is to be embraced by the claims.

[0173] The terms “approximately,” “about,” and “substantially” as used herein represent an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, the terms “approximately,” “about,” and “substantially” may refer to an amount that is within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of a stated amount. Further, it should be understood that any directions or reference frames in the preceding description are merely relative directions or movements. For example, any references to “up” and “down” or “above” or “below” are merely descriptive of the relative position or movement of the related elements.

[0174] The present disclosure may be embodied in other specific forms without departing from its spirit or characteristics. The described embodiments are to be considered as illustrative and not restrictive. The scope of the disclosure is, therefore, indicated by the appended claims rather than by the foregoing description. Changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims

CLAIMSWhat is claimed is:

1. An intra-vaginal device for diagnosing and treating pelvic floor disorders, the intra-vaginal device comprising: an intra-abdominal pressure sensor configured to measure dynamic changes in intra-abdominal pressure; a bi-axial force sensor spaced from the intra-abdominal pressure sensor, the biaxial force sensor configured to measure a magnitude of a force of pelvic floor contractions in at least two directions; a pressure-transmitting material surrounding the intra-abdominal pressure sensor; and a housing containing the intra-abdominal pressure sensor, the bi-axial force sensor, and the pressure-transmitting material.

2. The intra-vaginal device of claim 1, wherein: a first axis of the bi-axial force sensor is configured to be oriented at an angle from a sagittal plane of a patient; and a second axis of the bi-axial force sensor is configured to be oriented at a different angle from the sagittal plane and offset from the first axis.

3. The intra-vaginal device of claim I, wherein bi-axial force sensor is spaced from the intra-abdominal pressure sensor by at least about 3.0 cm.

4. The intra-vaginal device of claim I, wherein the bi-axial force sensor includes a double bending beam load cell.

5. The intra-vaginal device of claim I, wherein the bi-axial force sensor is configured to measure asymmetry in the pelvic floor contractions.

6. The intra-vaginal device of claim 1, wherein the bi-axial force sensor is configured to intersect pelvic floor muscles of a patient.

7. The intra-vaginal device of claim 1, further comprising a retention mechanism configured to be disposed around the housing between the intra-abdominal pressure sensor and the bi-axial force sensor.

8. The intra-vaginal device of claim 1, wherein the housing includes: a first portion including the intra-abdominal pressure sensor having a first longitudinal axis; and a second portion including the bi-axial force sensor having a second longitudinal axis offset from the first longitudinal axis.

9. The intra-vaginal device of claim 1, wherein the pressure-transmitting material comprises a gel or silicone.

10. The intra-vaginal device of claim 1, wherein the housing comprises an alignment feature configured to indicate a relative orientation of the bi-axial force sensor.

11. The intra-vaginal device of claim 1, further comprising a computing system within the housing, the computing system in operable communication with the intra-abdominal pressure sensor and the force sensor.

12. The intra-vaginal device of claim 11, wherein the computing system is configured to: analyze pressure data from the intra-abdominal pressure sensor; and analyze force data from the bi-axial force sensor.

13. The intra-vaginal device of claim 12, wherein the computing system is configured to provide the analyzed pressure data and the analyzed force data to a remote location.

14. An intra-vaginal device, comprising: a housing comprising a biocompatible material; an intra-abdominal pressure sensor within the housing and configured to measure an intra-abdominal pressure of a patient; a force sensor within the housing and spaced from the intra-abdominal pressure sensor, the force sensor configured to measure forces of pelvic floor contractions; and a retention mechanism configured to maintain the intra-vaginal device in a patient during ambulatory activity of the patient.

15. The intra-vaginal device of claim 14, wherein the retention mechanism comprises one of an external retention sleeve configured to seat in a groove defined in an external surface of the housing; or a portion of the housing having a larger cross-sectional area than other portions of the housing.

16. The intra-vaginal device of claim 14, further comprising an alignment feature at a base of the housing configured to facilitate alignment of the intra-vaginal device during placement of the intra-vaginal device.

17. The intra-vaginal device of claim 14, further comprising a computing unit within the housing, the computing unit in operable communication with the intra- abdominal pressure sensor and the force sensor and configured to: analyze pressure data from the intra-abdominal pressure sensor; analyze force data from the force sensor; and provide the analyzed pressure data and the analyzed force data to a location remote from the intra-vaginal device.

18. The intra-vaginal device of claim 14, wherein the force sensor is configured to measure a force of pelvic floor contractions in two different directions within a plane of a levator ani of the patient.

19. A method of operating an intra-vaginal device, the method comprising: receiving, from an intra-abdominal pressure sensor of the intra-vaginal device, pressure data indicative of an intra-abdominal pressure; receiving, from a bi-axial force sensor, bi-axial force data indicative of a force of pelvic floor muscle contractions in two directions offset from a sagittal plane; and generating an output on at least one of a patient device or a provider device based on the pressure data and the bi-axial force data.

20. The method of claim 19, further comprising displaying on the at least one of the patient device or the provider device, an effectiveness of a pelvic floor contraction.