CROSS-REFERENCE TO RELATED APPLICATION

[0001] This Application claims the benefit of United States Provisional Patent Application No. 62/358,926 filed July 6, 2016; the entire contents of 62/358,926 is hereby incorporated herein in its entirety.

FIELD

[0002] Various embodiments are described herein for a device for determining pelvic floor muscle function in women.

BACKGROUND

[0003] In biomechanics it is common to measure several aspects of physical function simultaneously. Typical measures include electromyography (EMG) to assess neural control and muscle activation, strength, forces the body exerts against the floor or other objects, and body position measures. The measurements are combined to calculate variables that cannot be measured directly and to gain a deeper understanding of how the various components of the body interact with the environment to complete tasks. While much is known about the spine and various limb joints of the body during a variety of tasks, very little is known about the biomechanics of the urinary continence system. This is important to determine considering the high prevalence of urinary incontinence among women as about one third of women under the age of 35 and more than half of the women over the age of 65 experience bothersome urinary incontinence.

[0004] The female urinary continence system is composed of the bladder neck and urethra, the striated urethral sphincters, the pelvic floor muscles (PFM), the anterior vaginal wall and various connective tissues that provide support to the pelvic organs. The whole female urinary continence system is housed within the boney pelvis. Since the female urinary continence system is hidden within the pelvis and because it does not act upon any joints, it is not possible to assess its function with conventional biomechanics tools.

SUMMARY OF VARIOUS EMBODIMENTS

[0005] In a broad aspect, at least one embodiment described herein provides a vaginal probe for measuring at least one physiological activity (i.e. at least one property) related to a female user's urinary continence system. The probe comprises a semi-enlarged section at a distal portion of the probe, the semi-enlarged section having a head portion with a height and a width, the width being larger than the height, and a transitional portion having a first end adjacent to the semi-enlarged section and a second end opposite the first end, the transitional portion having a similar height as the head portion and a tapered width where the width of the first end is similar to the width of the head portion and the width decreases towards the second end; a cylindrical section at a proximal portion of the probe, the cylindrical section having a first end adjacent to the second end of the transitional portion of the semi-enlarged section," and sensors for recording data to measure the at least one physiological activity of the female user's urinary continence system.

[0006] The semi-enlarged section and the cylindrical section generally has a common longitudinal axis.

[0007] The semi-enlarged section generally has a larger width and a similar height compared to the cylindrical section.

[0008] In at least some embodiments, the sensors comprise EMG sensors disposed on the cylindrical section and pressure sensors disposed on the cylindrical and semi-enlarged sections.

[0009] In at least some embodiments, the probe comprises three sets of EMG sensors each having two spaced apart longitudinally oriented electrodes to measure different regions of the user's pelvic floor muscles, where a first set of the electrodes are disposed about an upper longitudinal midline of the probe, a second set of the electrodes are disposed about a right lateral longitudinal midline of the probe and a third set of the electrodes are disposed about a left lateral longitudinal midline of the probe.

[0010] In at least some embodiments, the probe comprises three sets of EMG sensors each having two spaced apart longitudinal oriented electrodes that are disposed along the surface of the probe to measure EMG activity from the striated urethral sphincter, the right pelvic floor muscles and the left pelvic floor muscles, respectively, during use.

[0011] In at least some embodiments, the probe comprises a first pressure sensor disposed on a lower surface of a distal portion of the semi- enlarged section of the probe to measure intra-abdominal pressure during use.

[0012] In at least some embodiments, the pressure sensor is disposed along a curved region of the semi-enlarged section of the probe.

[0013] In at least some embodiments, the probe comprises a second pressure sensor disposed on a lower surface of the cylindrical section of the probe to be level with the pelvic floor muscles and measure pressure therefrom during use.

[0014] In at least some embodiments, the second pressure sensor is disposed such that distal and proximal longitudinal ends of the EMG sensors extend past distal and proximal longitudinal ends of the second pressure sensor.

[0015] In at least some embodiments, the pressure sensors are disposed on a common surface at opposite end portions of the probe, and both pressure sensors are disposed about a longitudinal upper midline of the probe.

[0016] In at least some embodiments, the probe comprises a housing with an upper shell and a lower shell, the upper and lower shells extending longitudinally along the length of the probe, the pressure sensors being disposed on the lower shell and the EMG sensors being disposed on the upper shell.

[0017] In at least some embodiments, the sensors are coupled to wireless transmitters and recorded data is wirelessly transmitted to an external computing device for review and analysis.

[0018] In at least some embodiments, the probe further comprises a flange that is disposed adjacent to a second end of the cylindrical section, the flange having a longitudinal axis that is orthogonal to the longitudinal axis of the semi-enlarged and cylindrical sections.

[0019] In these embodiments, the flange comprises two curved cylindrical regions that curve away from the cylindrical section.

[0020] In these embodiments, the flange comprises an aperture to allow cables attached to the sensors to pass therethrough to wireless transmitters disposed externally of the vaginal probe.

[0021] In another broad aspect, at least one embodiment described herein provides a vaginal probe for measuring physiological activities related to a female user's urinary continence system. The probe comprises a distal portion; a proximal portion having a common longitudinal axis with the distal portion; an EMG sensor arrangement disposed about the proximal portion for measuring electrical signals from different regions of the user's pelvic floor muscles during use; and at least one pressure sensor disposed about a surface of the proximal portion midway between two EMG sensors for measuring pressure from the different regions of the user's pelvic floor muscles during use.

[0022] In another broad aspect, at least one embodiment described herein provides a vaginal probe for measuring physiological activities related to a female user's urinary continence system. The probe comprises a distal portion; a proximal portion having a common longitudinal axis with the distal portion; an EMG sensor arrangement disposed about the proximal portion, the EMG sensor arrangement comprising three sets of EMG sensors each having two spaced apart longitudinal electrodes to measure different regions of the user's pelvic floor muscles, where a first set of the electrodes are disposed about an upper longitudinal midline of the probe, a second set of the electrodes are disposed about a right lateral longitudinal midline of the probe and a third set of the electrodes are disposed about a left lateral longitudinal midline of the probe; and distal and proximal pressure sensors being disposed near opposite end portions of the probe and disposed about a longitudinal upper midline of the probe, the distal pressure sensor being located and configured to measure intra-abdominal pressure and the proximal sensor being located and configured to measure pressure from the pelvic floor muscles during use.

[0023] Other features and advantages of the present application will become apparent from the following detailed description taken together with the accompanying drawings. It should be understood, however, that the detailed description and the specific examples, while indicating preferred embodiments of the application, are given by way of illustration only, since various changes and modifications within the spirit and scope of the application will become apparent to those skilled in the art from this detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

[0024] For a better understanding of the various embodiments described herein, and to show more clearly how these various embodiments may be carried into effect, reference will be made, by way of example, to the accompanying drawings which show at least one example embodiment, and which are now described. The drawings are not intended to limit the scope of the teachings described herein.

[0025] FIG. 1 is a top view of an example embodiment of a vaginal probe. [0026] FIG. 2 is a bottom perspective view of the vaginal probe of FIG. 1

[0027] FIG. 3 is an end view of the vaginal probe of FIG. 1 oriented upside down.

[0028] FIG. 4 is a side view of the vaginal probe of FIG. 1 oriented upside down.

[0029] Further aspects and features of the example embodiments described herein will appear from the following description taken together with the accompanying drawings.

DETAILED DESCRIPTION OF THE EMBODIMENTS

[0030] Various embodiments in accordance with the teachings herein will be described below to provide an example of at least one embodiment of the claimed subject matter. No embodiment described herein limits any claimed subject matter. The claimed subject matter is not limited to devices, systems or methods having all of the features of any one of the devices, systems or methods described below or to features common to multiple or all of the devices and or methods described herein. It is possible that there may be a device, system or method described herein that is not an embodiment of any claimed subject matter. Any subject matter that is described herein that is not claimed in this document may be the subject matter of another protective instrument, for example, a continuing patent application, and the applicants, inventors or owners do not intend to abandon, disclaim or dedicate to the public any such subject matter by its disclosure in this document.

[0031] It will be appreciated that for simplicity and clarity of illustration, where considered appropriate, reference numerals may be repeated among the figures to indicate corresponding or analogous elements. In addition, numerous specific details are set forth in order to provide a thorough understanding of the embodiments described herein. However, it will be understood by those of ordinary skill in the art that the embodiments described herein may be practiced without these specific details. In other instances, well-known methods, procedures and components have not been described in detail so as not to obscure the embodiments described herein. Also, the description is not to be considered as limiting the scope of the embodiments described herein.

[0032] It should also be noted that the terms "coupled" or "coupling" as used herein can have several different meanings depending in the context in which these terms are used. For example, the terms coupled or coupling can have an electrical connotation. For example, as used herein, the terms coupled or coupling can indicate that two elements or devices can be directly connected to one another or connected to one another through one or more intermediate elements or devices via an electrical signal that can be transmitted over a physical wire or cable or transmitted wirelessly. In other instances the terms coupled or coupling can indicate that two elements are directly mechanically connected to one another or mechanically connected to one another through another element or linkage.

[0033] It should also be noted that, as used herein, the wording "and/or" is intended to represent an inclusive-or. That is, "X and/or Y" is intended to mean X or Y or both, for example. As a further example, "X, Y, and/or Z" is intended to mean X or Y or Z or any combination thereof.

[0034] It should be noted that terms of degree such as "substantially", "about" and "approximately" as used herein mean a reasonable amount of deviation of the modified term such that the end result is not significantly changed. These terms of degree may also be construed as including a deviation of the modified term such as 1 %, 2%, 5% or 10%, for example, if this deviation does not negate the meaning of the term it modifies.

[0035] Furthermore, the recitation of numerical ranges by endpoints herein includes all numbers and fractions subsumed within that range (e.g. 1 to 5 includes 1 , 1 .5, 2, 2.75, 3, 3.90, 4, and 5). It is also to be understood that all numbers and fractions thereof are presumed to be modified by the term "about" which means a variation of up to a certain amount of the number to which reference is being made if the end result is not significantly changed, such as 1 %, 2%, 5% or 10%, for example, as the case may be.

[0036] The example embodiments of the systems and methods described in accordance with the teachings herein may be implemented as a combination of hardware or software. Accordingly, the example embodiments described herein may be implemented, at least in part, by using one or more computer programs, executing on one or more programmable devices comprising at least one processing element, and a data store (including volatile and non-volatile memory and/or storage elements). These devices may also have at least one input device (e.g. a receiver) and at least one output device (e.g. a transmitter) or in some embodiments an input/output device such as a transceiver, depending on the nature of the device. The programmable devices may include a processor, a controller, or an Application Specific Integrated Circuit (ASIC), for example. Program code can be applied to input data to perform the functions described herein and to generate output data. The output data can be supplied to one or more output devices for outputting to one or more electronic devices.

[0037] There may be some elements that are used to implement at least part of one of the embodiments described herein that may be implemented via software that is written in a high-level procedural language or object oriented programming and/or scripting language. Accordingly, the program code may be written in C, C ⁺⁺ or any other suitable programming language and may comprise modules or classes, as is known to those skilled in object oriented programming. Alternatively, or in addition thereto, some of these elements implemented via software may be written in assembly language, machine language or firmware as needed. In either case, the language may be a compiled or an interpreted language.

[0038] At least some of these software programs may be stored on a storage media (e.g. a computer readable medium such as, but not limited to, ROM, FLASH memory and the like) or a device that is readable by a general or special purpose programmable device. The software program code, when read by the programmable device, configures the programmable device to operate in a new, specific and predefined manner in order to perform at least one of the methods described in accordance with the teachings herein.

[0039] Furthermore, at least some of the programs associated with the systems and methods of the embodiments described herein may be capable of being distributed in a computer program product comprising a computer readable medium that bears computer usable instructions for one or more processors. The medium may be provided in various forms, including non- transitory forms such as, but not limited to, one or more diskettes, compact disks, tapes, chips, magnetic and electronic storage as well as other media. In alternative embodiments, the medium may be transitory in nature such as, but not limited to, wire-line transmissions, satellite transmissions, internet transmissions (e.g. downloads), digital and analog signals, and the like. The computer useable instructions may also be in various formats, including compiled and non-compiled code.

[0001] In accordance with the teachings herein, at least one example embodiment of a telemetered vaginal probe that records both EMG and pressure is described. The vaginal probe is intended for use in pelvic floor research and rehabilitation. The vaginal probe may record both EMG and pressure simultaneously, which may provide a deeper understanding of pelvic floor biomechanics. In addition, the vaginal probe is self-retaining when placed within the vagina. Accordingly, the shape and size of the vaginal probe has been developed based in part on the female pelvic anatomy and clinical experience in treating women with pelvic floor disorders. Since the vaginal probe is telemetered and self-retaining, it can measure both EMG and pressure during activities that most frequently cause urine leakage such as, but not limited to, running and jumping, for example. Therefore, the vaginal probe can be used to measure at least one physiological activity related to (i.e. at least one property of) a female user's urinary continence system.

[0040] Referring now to FIG. 1 , shown therein is a top view of an example embodiment of a vaginal probe 10. The vaginal probe 10 comprises a first semi-enlarged section 12, a cylindrical section 14 and an end portion comprising a flange 16. The semi-enlarged section 12 is at a distal region of the vaginal probe 10. The semi-enlarged section 12 has a head portion 12a with a height and a width, and a transitional portion 12b. The transitional portion 12b has a similar or slightly smaller height as the head portion 12a and a width that increases to be the same as the width of the head portion 12a. Stated alternatively, the transitional portion 12b has a first end adjacent to the semi-enlarged section 12 and a second end opposite the first end and the transitional portion 12b has a similar height as the head portion 12a and a tapered width where the width of the first end of the transitional portion 12b is similar as the width of the head portion 12a and the width decreases towards the second end of the transitional portion 12b. The width of the head portion 12a is larger than the height of the head portion 12a.

[0041] The cylindrical section 14 is at a proximal region of the vaginal probe 10 and a first end of the cylindrical section 14 is adjacent to the second end of the transitional portion 12b of the semi-enlarged section 12. The sides of the transition portion 12b flare outwards from the cylindrical section 14 to the head portion 12a of the semi-enlarged section 12. The flange 16 is adjacent to a second end of the cylindrical section 14 that is opposite the first end of the cylindrical section 14. Both of the first and second sections 12 and 14 have a common longitudinal axis. The semi-enlarged section 12 has a flattened shape with a portion having a larger width than the width of the cylindrical section 14 and a similar or slightly larger height compared to the cylindrical section 14. When the vaginal probe 10 is inserted into the user's vagina, the upper surface of the vaginal probe 10 will be anteriorly located with respect to the user.

[0042] From a cross-sectional perspective, the semi-enlarged section 12 has an elliptical cross-section (see FIG. 3) with a major axis that is along the width dimension of the vaginal probe 10 and a minor axis that is along the height dimension of the vaginal probe 10. Also, from a cross-sectional perspective, the cylindrical section 12 has a circular cross-section in which the height of the cylindrical section 2 is similar to or slightly less than the minor axis of the cross-section of the semi-enlarged section 12.

[0043] The shape of the vaginal probe 10 is advantageous at it is a better fit with the typical anatomy of a vagina. The vagina is wider from side to side than it is antero-posteriorly, and it is narrowed by the pelvic floor muscles where they attach to the lateral vaginal walls. The vaginal probe 10 has a cylindrical section 14 where it sits adjacent to the pelvic floor muscles when it is being worn so that it distorts that portion of the anatomy as little as possible and so that it is more comfortable for the user. Both distortion of the anatomy and discomfort may alter the user's PFMs' activity. The vaginal probe 10 then widens laterally into the semi-enlarged section 12 past the cylindrical section 14 so that the vaginal probe 10 will "self-seat" itself so that it is held in place during use. The vaginal probe 10 is positioned so that the semi-enlarged section 12 is just above the PFMs because the vagina widens at that point. This ensures that the electrodes and pressure sensor mounted on the cylindrical section 14 sit adjacent to the pelvic floor muscles, facilitating the recording of high quality signals. Being wider laterally in the semi-enlarged section 12 also ensures that the vaginal probe 10 will not rotate within the user's vagina during use, which would move the electrodes and pressure sensors out of their best recording positions. The wider portion of the semi- enlarged section 12 relative to the cylindrical section 14 also helps to maintain the vaginal probe 10 in place during use because the wider portion of the semi-enlarged section 12 resists passing through the part of the vagina that is narrowed by the PFMs. The semi-enlarged section 12 is also flattened to improve comfort.

[0044] The flange 16 has a vertically oriented longitudinal axis that is orthogonal to the longitudinal axis of the semi-enlarged and cylindrical sections 12 and 14. The flange 16 has upper and lower curved cylindrical regions 16a and 16b. The flange 16 has an aperture 28 that is inline (i.e. collinear) with the longitudinal axis of the semi-enlarged and cylindrical sections 12 and 14. One purpose of the flange 16 is to prevent the vaginal probe 0 from being inserted too far into the user's vagina. The flange 16 may be partially inserted between the user's labia to keep the vaginal probe 10 from rotating along its longitudinal axis once it is in place. The flange 16 is optional in other embodiments.

[0045] In one example embodiment, the vaginal probe 10 has a length of about 1 10 mm. The cylindrical section 14 is about 19 mm in diameter and about 55 mm in length. The semi-enlarged section 12 is about 55 mm in length, 37 mm in width and 22 mm in height. The flange 16 is about 53 mm in height.

[0046] The vaginal probe 10 further comprises an electrode arrangement having six electrodes that are arranged in three pairs at three regions of the cylindrical section 12 to provide an EMG sensor arrangement having three EMG sensors. Each set of EMG sensor comprise two spaced apart longitudinally oriented electrodes to measure different regions of the user's pelvic floor muscles. Accordingly, the pairs of electrodes are situated to be adjacent to certain muscles of the user's PFMs and to measure electrical activity from these muscles during use. The electrodes may be Delsys miniTrigno™ electrodes.

[0047] A first pair of electrodes comprising electrodes 18a and 18b is situated on an upper portion of the cylindrical section 14 on either side of a central longitudinal midline of the cylindrical section 14. In other words, the electrodes 18a and 18b are centered about the 12 o'clock position and may be referred to as the 12 o'clock pair of electrodes. During use (i.e. when the vaginal probe 10 is in situ) the electrodes 18a and 18b face forward (i.e. face towards the front of the user's body).

[0048] A second pair of electrodes comprising electrodes 20a and 20b is situated on a right side of the cylindrical section 14 on either side of a medial longitudinal midline of the cylindrical section 14. In other words, the electrodes 20a and 20b are centered about the 3 o'clock position and may be referred to as the 3 o'clock pair of electrodes. The second pairs of electrodes are mounted to be adjacent to the PFMs along the right side of the user's vagina (denoted by PFM_R).

[0049] A third pair of electrodes comprising electrodes 22a and 22b is situated on a left side of the cylindrical section 14 on either side of the medial longitudinal midline of the cylindrical section 14. In other words, the electrodes 22a and 22b are centered about the 9 o'clock position and may be referred to as the 9 o'clock pair of electrodes. The third pair of electrodes is mounted to be adjacent to the PFMs along the left side of the user's vagina (denoted by PFM_L).

[0050] The 12 o'clock pair of electrodes records EMG activity from the striated urethral sphincter, while the pairs mounted at 3 and 9 o'clock record EMG activity from the right and left pelvic floor muscles.

[0051] In an example embodiment, the electrodes 18a, 18b, 20a, 20b, 22a and 22b are made of dead-soft silver wire (i.e. silver conductor), are about 22 mm in length and 1 mm in width, and each pair of electrodes has a 10 mm centre-to-centre inter-electrode distance.

[0052] Referring now to FIG. 2, shown therein is a bottom perspective view of the vaginal probe 10. The vaginal probe 10 further comprises two pressure sensors 24 and 26 which are both located on a bottom surface of the vaginal probe 10 and centered along the longitudinal axis of the vaginal probe (e.g. centered about the 6 o'clock position). During use, the pressure sensors 24 and 26 convert pressures that are exerted upon them into electrical signals.

[0053] The pressure sensor 24 is disposed on the semi-enlarged section 12 near a distal portion of the vaginal probe 10. Accordingly, the pressure sensor 24 may be referred to as a distal pressure sensor. The pressure sensor 24 is mounted on the vaginal probe 10 so that the pressure sensor 24 is level with the user's PFMs (PFP) during use. The first pressure sensor 24 is also disposed along a curved portion or curved region of the semi-enlarged section 12 of the probe 10. [0054] The pressure sensor 26 is disposed on the cylindrical section 14 near a proximal end of the vaginal probe 10 and midway along the length of the EMG electrodes 18a, 18b, 20a, 20b, 22a and 22b. Accordingly, the pressure sensor 26 may be referred to as a proximal pressure sensor. The pressure sensor 26 is disposed mid-way along the length of the EMG electrodes so that it is in the centre of where the pelvic floor muscles act on the vagina (i.e. the region of highest force) and can measure intra-abdominal pressure (IAP). The pressure sensor 26 is disposed such that distal and proximal longitudinal ends of the EMG sensors (i.e. electrodes 18a, 18b, 20a, 20b, 22a and 22b) extend past distal and proximal longitudinal ends of the second pressure sensor 26.

[0055] In FIG. 2, the area for the pressure sensor 26 is shown as being open while the area for the pressure sensor 24 is shown as being closed. The pressure sensor 26 is shown as being open for illustrative purposes only to allow its internal structure to be shown. During use both pressure sensors 24 and 26 have closed outer surfaces.

[0056] When the vaginal probe 10 is inserted into the user's vagina, the lower (i.e. bottom) surface of the vaginal probe 10 will be posteriorly located with respect to the user. Furthermore, during use the pressure sensor 24 may also be referred to as the upper pressure sensor while the pressure sensor 26 may also be referred to as the lower pressure sensor.

[0057] In an example embodiment, the pressure sensors 24 and 26 may be implemented using two separate enclosures that have a Freescale Semiconductor MPX2300DT pressure transducer. These transducers are interfaced with Delsys Trigno™ load cell adaptors. The enclosure may be filled with water and covered with a silicon membrane. The enclosures are about 23 mm in length, about 17 mm in width and about 7 mm in depth, while the silicon membranes are about 19 mm in length and about 12 mm in width.

[0058] The aperture 28 in the centre of the flange 16 allows cables from the sensors of the vaginal probe 10 to exit the vaginal probe 10 and be coupled to transmitters that are mounted on the user who is wearing the vaginal probe 10 as will be described in further detail below.

[0002] Referring now to FIGS. 3 and 4, shown therein is an end view and a side view, respectively, of the vaginal probe 10 (with its bottom surface oriented upwards). The thick black line identifies that the housing of the vaginal probe 10 comprises a lower shell 30 and an upper shell 32 that extend longitudinally along the length of the vaginal probe 0 and are adjacent to one another.

[0003] The upper shell 32 houses the EMG electrodes 18a, 18b, 20a, 20b, 22a, and 22b associated electronics including pre-amplifiers, filters, analog to digital converters and micro-processors. Somewhat similar electronics may be used for the pressure sensors or the pressure sensors and the EMG sensors may be coupled to an internal circuit board that has common electronic components for providing amplification, filtering digitization and processing depending on the implementation. In one embodiment, the electrode electronics are provided by Delsys miniTrigno™ electrode packages that are coupled to the sliver conductors (on the surface of the housing 32) using friction fittings, so that the Delsys miniTrigno™ electrodes can be used in multiple shells. In other words, the shells (i.e. housing portions 30 and 32) may be removed after usage and the internal electrical components can be used with a new pair of shells for use with a new user for sanitary reasons as well as reducing the cost of using the vaginal probe 10 with different users. A first set of cables (referred to herein as EMG cables) attach the pre-amplifiers of the Delsys miniTrigno™ electrode packages to transmitters (not shown) that are disposed on the user's body.

[0004] The lower shell 30 houses the pressure sensors 24 and 26. A second set of cables (referred to herein as pressure cables and not shown) are soldered to the pressure sensors 24 and 26 and are also coupled to transmitters (not shown) disposed on the user's body. The transmitters may be Delsys miniTrigno™ transmitters. There is no preprocessing of the signals obtained from the pressure sensor 24 and 26 before these signals are sent to the respective transmitters.

[0005] The EMG cables and the pressure cables exit the aperture 28 at the cylindrical end of the vaginal probe 10, between the flange portions 16a and 16b, to be coupled with the respective transmitters on the user's body. The transmitters may be attached to user's body at the proximal medial thigh. Reference electrodes are housed with the Delsys miniTrigno™ transmitters and are adhered to the user's skin and a multi-differential subtraction processing technique is employed by a Delsys Trigno™ telemetered EMG system to reduce noise in the recorded data.

[0006] In embodiments where the transmitters are not housed inside the vaginal probe 10, the vaginal probe 10 is light-weight which allows it to stay in place during physical activity and do not require the user's PFMs to actively contract to retain the vaginal probe 10 in place. In addition, since the transmitters are on the user's body, this reduces any noise or interference that are encountered when the transmitters are disposed within the vaginal probe 0 and have to transmit through tissue during use.

[0007] During use, the EMG and pressure sensors each provide a recording channel to record EMG and pressure data. The recorded EMG and pressure data can then be transmitted by the transmitters to an external hardware unit (not shown) that serves as both a receiver and a sensor charging station. The receiver is connected to a computing device such as a laptop, a tablet, or a desktop computer by a cable. The computing device is running the Delsys Trigno™ telemetered software program which is used to review and analyze the recorded EMG and pressure data. A user can trigger the software to begin the receiving the data. In one embodiment, the data may be recorded and stored by the probe 10 for transmission by the transmitters to the receiver when the user triggers the telemetered software program. In another embodiment, the data may be recorded and transmitted after receiving a trigger from the telemetered software program. [0008] In alternative embodiments, some components of the vaginal probe 10 may have different sizes. For example, the cylindrical section 14 may have a diameter as large as about 30 mm. The height of the semi- enlarged section 12 is similar to the diameter of the cylindrical section 14, and can range to as much as about 30 or 35 mm. The width of the semi-enlarged section 12 may range from about 30 mm to up to about 70 mm. In addition, the pressure sensors may range in length from about 23 mm to about 45 to 50 mm. The length of the pressure sensor 26 on the cylindrical section 12 may be increased on any sized vaginal probe, but will be proportionate to the size of the semi-enlarged section 12.

[0059] A prototype of the vaginal probe 10 was modeled in clay and ultrasound imaging was used to confirm that the device seated itself correctly in a user's vagina and that the planned positions of the EMG sensors are aligned with the muscles whose activity they were intended to record. Following this in vitro reliability testing of the pressure sensors was completed. The vaginal probe may be manufactured using a three- dimensional printer and biocompatible plastic. A prototype of the vaginal probe was tested for reliability and validity in vivo as described below.

[0060] The vaginal probe 10 has several advantages over existing technology. First, the vaginal probe 10 is designed according the SENIAM (Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles) principles for high-quality EMG recordings and to conform to the anatomy of the vagina and pelvic floor. The shape of the vaginal probe 10 ensures that the EMG electrode pairs are positioned adjacent to the muscles that each pair of electrodes is intended to be recording electrical activity from, that one of pressure sensors is compressed by the contraction of the pelvic floor muscles and that the other pressure sensor is compressed by increases in intraabdominal pressure. Together, these features allow the vaginal probe 10 to record EMG activity that is relatively free from noise, such as cross-talk and movement artefact, and also allow the two pressure sensors to record independent signals. [0061] Since the vaginal probe 10 is also able to record both EMG and pressure simultaneously, different aspects of muscle function can be measured thereby permitting a deeper understanding of PFM function. For example, using two different measurement methods permits the calculation of variables that cannot be recorded directly using conventional devices. In addition, using two different measurement methods allows for the separation of different pelvic floor problems that appear very similar if only one measurement method is used. For example, assume measurements are made on a woman with urinary incontinence with relatively high PFM EMG amplitudes, but low amplitude pressure recordings. In this case, using EMG measurements alone may suggest that she has an effective PFM contraction and using pressure measurements alone may suggest that she does not have an effective PFM contraction. However, in combination, these measurements suggest that this woman is able to contract her PFMs, but that they are not able to transmit force through the vagina, perhaps due to avulsion of the PFMs or injury to the connective tissue.

[0062] The vaginal probe 10 is telemetered and shaped so that it is retained in the user's vagina without external support. Conventional devices are wired to their base units and do not remain within the vagina when the user is standing without being held in place. These improvements provided by the vaginal probe 10 allow a user's PFMs to be assessed while the user is performing physical activities such as lifting, running and jumping. As women who leak urine most frequently report that these types of activities cause their urine leakage, assessing these activities may lead to improvements in the current understanding of pelvic floor biomechanics and to improved therapies for urinary incontinence.

[0063] The vaginal probe 10 may be used to record EMG from the striated urethral sphincter. While it has been established that urethral sphincter activity is the primary actor in maintaining urinary continence, very little is actually understood about patterns of urethral sphincter activity. Being able to record this activity may greatly improve the current understanding of the biomechanics of the urinary continence system and may lead to more effective treatment as well as sound urinary incontinence prevention strategies.

[0064] This vaginal probe 10 may also be used to provide biofeedback during pelvic floor rehabilitation exercises to teach women to activate their PFMs appropriately during various functional tasks. It may be possible to combine the EMG recordings from the vaginal probe 10 with EMG recordings obtained from other muscles so that the vaginal probe 10 may be used to train core muscle synergies for back pain rehabilitation and to improve athletic performance.

[0065] The vaginal probe 10 also has a design that users have found to be comfortable during use. In preliminary testing, test subjects have reported that the vaginal probe 0 is still comfortable at the end of an hour-long testing session.

[0066] In research settings, the vaginal probe 10 may be used to better understand the role of the PFMs as part of the core musculature, to understand normal PFM activity during movement (e.g. during sports activities or dancing) and to understand how these normal muscle activity patterns are changed in women with urinary incontinence. These findings may also prove useful for developing predictive computer models of female pelvic floor and core muscle function.

[0067] Eight women with experience performing PFM contractions (mostly physiotherapists who practice in the area of pelvic floor rehabilitation) were recruited for testing the vaginal probe while performing functional activities (this is in contrast to previous tests in this area which use static tests). These test subjects had a mean age of 42 years and a variety of obstetric histories. Four of the test subjects were nulliparous. The other four test subjects had given birth from two to five times with a median of three. Four of the test subjects had urinary incontinence with three predominantly due to stress. Vaginal probes in accordance with the teachings herein were made for each participant using the same shape and size. Each test subject completed two testing sessions about one week apart. In each test, the test subjects performed three repetitions each of PFM maximum voluntary contractions (MVCs) and maximum effort coughs, in supine and standing positions.

[0068] During the testing, EMG and pressure data were recorded simultaneously at 2,000 Hz using a Delsys Trigno™ wireless EMG system. The EMG data was rectified and smoothed using a root mean square, 200 ms sliding window, with 199 ms overlap. Peak values were then extracted. The independence of the data recording channels was first determined. Cross- correlation functions were performed to determine the time lag between the pressure data recording channels. Repeated measures analyses of variance (ANOVAs) were computed to compare the pressure data recording channels and the PFM sides. The mean absolute difference between the sides was calculated and normalized to the higher side (nMAD). The between trial reliability was then determined. Repeated measures ANOVAs were computed for each data recording channel and each task. The coefficient of variation (CV) was computed for each data recording channel, by task and day. The test-retest reliability was also determined. Spearman's Rho was calculated between days for each data recording channel and each task. Repeated measures ANOVAs were computed for each data recording channel and each task. The between days nMAD was also calculated.

[0069] The test results are shown in Table 1 where MVC means maximum voluntary contraction, Cough means the maximum effort cough, PFM means pelvic floor muscle, nMAD means normalized mean absolute difference, CV means coefficient of variation, IAP means intra-abdominal pressure, PFP means pelvic floor pressure, R means right, L means left, PFM_R means the right pelvic floor muscle(s) and PFM_L means the left pelvic floor muscle(s). There were no between day differences for the IAP in standing or the PFMs, so the data from both days were pooled when calculating the CVs. [0070] The test results show that there were no time lags between the pressure signals (p>0.05). The amplitudes were different between the pressure channels for all tasks (p≤0.01 ) except the supine cough (p=0.66). During the MVCs, PFP was higher than IAP, while during the standing cough IAP was higher. The PFM_R was higher than the PFM_L (p≤0.0Q3). See Table 1 for the nMADs. There were no between trial differences in the peak amplitudes (p>0.2). See Table 1 for the CVs and the results for the between day Spearman's correlations and nMADs. The test-retest ANOVAs displayed significant between day differences in the pressure data (p<0.02), but not in the EMG.

TABLE 1. Reliability Measures between Recording Channels, Trials and Days for the test data

Task MVC Cough

Position Supine Standing Supine Standing

Between Channel PFM nMAD

28.67% 41 .31 % 40.75% 48.50%

Between Trial

Channel CV

IAP day 1 31.16% 21.32%

19.36% 19.37%

IAP day 2 27.83% 22.38%

PFP day 1 56.34% 61.20% 51.08% 41.86%

PFP day 2 69.03% 59.61 % 67.63% 47.89%

PFM_R 37.5% 18.75% 45.16% 28.57%

PFM_L 72.0% 94.12% 41.66% 53.33%

Between Day Spearman's Rho

IAP 0.43 0.79 0.89 0.82

PFP 0.82 0.86 0.82 0.71

PFM_R 1.00 0.97 0.50 0.53

PFM_L 0.72 0.83 0.61 0.37

nM AD

IAP 20% 10.45% 10.80% 8.34%

PFP 32.29% 18.77% 29.97% 25.55%

PFM_R 16.03% 3.09% 21.41 % 13.48%

PFMJL 32.54% 46.76% 52.85% 29.17% [0071] From the test results, it can be seen that the pressure data signals recorded by the two pressure sensors were clearly independent of one another, as were the EMG data recorded for the two sides (i.e. left and ride sides) of the PFMs. Between trials, the pressure and EMG amplitudes were not different. Between days the EMG signals were not different, but the pressure recordings did change in a way that suggests learning or functional adaptation. The ANOVA analysis showed that the PFM EMG amplitudes recorded from the test subjects were statistically not different when doing the tasks on both days. However, the pressure amplitudes that were recorded from the test subjects where higher when doing the tasks on the second testing day than on the first testing day. The recorded data seemed to be less variable in standing than in supine for both the EMG and pressure measurements. From the data recorded during the test sessions, it also appears that the vaginal probe was comfortable and well retained within the test subjects. The EMG and pressure data that was recording during the testing did not have much noise, for example, from movement artifact.

[0072] It should be noted that there may be various alternative embodiments for the vaginal probe 10.

[0073] For example, in an alternative embodiment, the vaginal probe does not include the flange.

[0074] In another alternative embodiment, the vaginal probe does not include the anterior (i.e. 12 o'clock) pair of electrodes 8a and 18b.

[0075] In another alternative embodiment, the vaginal probe does not include the pressure sensor 24 that measures intra-abdominal pressure.

[0076] In another alternative embodiment, the vaginal probe does not include two or more of the flange, the anterior (i.e. 12 o'clock) pair of electrodes 18a and 18b and the pressure sensor 24 that measures intra-abdominal pressure.

[0077] While the applicant's teachings described herein are in conjunction with various embodiments for illustrative purposes, it is not intended that the applicant's teachings be limited to such embodiments as the embodiments described herein are intended to be examples. On the contrary, the applicant's teachings described and illustrated herein encompass various alternatives, modifications, and equivalents, without departing from the embodiments described herein, the general scope of which is defined in the appended claims.