An intravaginal dilation therapy device and system

Abstract

An intravaginal dilation therapy wand includes a dilation probe (10, fig 3) and an umbilical tether (11, fig 3), the probe 10 having a central probe body 12, a dilation balloon 13 and at least one ele

Description

The present invention relates generally to the field of medical devices and more particularly to an intravaginal dilation therapy device and system for physical therapy. Background to the Invention Conditions such as hypertonic pelvic floor, vaginismus and other pelvic conditions require the mental and / or physical retraining of vaginal muscle or scar tissue. Many of these conditions see patients unable to mentally or physically relax the vaginal muscle tissue, or relaxation is restricted by physical trauma, and thus the patients experience pain from physical touch / penetration, or the anticipation of it. Traditional treatments for these conditions focus on two separate approaches (as applicable to the conditions), namely dilation therapy which focusses on the physical manipulation of the vaginal muscle / tissue, being more beneficial to patients requiring desensitisation exercises or those who have suffered scarring from physical trauma (post-surgical scarring, post radiotherapy treatment and the like), and intravaginal EMG - where the patient can see the muscle reflex to stimulus and learn how to better control or relax the vaginal muscle. This is mostly beneficial to patients with condition like hypertonic pelvic floor - where the muscle is either unable to relax or the patient's autonomic response to the anticipation of pain (allodynia) from touch - can induce painful spasms. United States Patent No. US 11167171 discloses a system for sensing, guiding, and / or tracking pelvic muscle exercise in men and women for the purpose of treating urinary incontinence, sexual dysfunction, and other pelvic conditions, the system comprising a device comprising a body portion comprising a first portion, a second portion, and an intermediary portion between the first and second portions, wherein the body portion comprises a flexible polymeric material and a sensor, wherein at least a portion of the sensor is embedded in the flexible polymeric material, and wherein the sensor is constructed and arranged to measure a force or a pressure applied to a surface of the body portion and a processor adapted to be in electronic communication with the device, wherein the processor is programmed to evaluate a pelvic muscle exercise profile of the user at least in part by comparing the pelvic muscle exercise profile of the user with a baseline profile comprising force and / or pressure values as a function of time, and wherein the baseline profile indicates a correct or desired profile of exercise to be followed by the user. As will be clear, this document discloses a device for measuring the force or a pressure applied to a surface of the body portion by a pelvic muscle or group but is directed nor is it fit for use for treating intravaginal physical therapy. It would therefore be an advance in the art to provide a device and system for intravaginal physical therapy which solves any one or more of the abovementioned problems. Summary of the Invention According to a first aspect of the invention, there is provided an intravaginal dilation therapy wand comprising: 1. A dilation probe to be inserted into the vagina, the dilation probe comprising: a. A central probe body with at least one inflation / deflation opening therein; b. A dilation balloon mounted relative to the central probe body and sealed relative to the probe body to inflate and deflate via the at least one inflation / deflation opening; c. At least one electromyography electrode provided relative to an external surface of the dilation balloon to capture muscle activity information during operation; and 2. An elongate umbilical tether attached to the dilation probe to communicate an inflation medium to and from the dilation probe. According to a second aspect of the invention, there is provided an intravaginal dilation therapy device for physical therapy, the device comprising: 1. A dilation probe to be inserted into the vagina, the dilation probe comprising: a. A central probe body with at least one inflation / deflation opening therein; b. A dilation balloon mounted relative to the central probe body and sealed relative to the probe body to inflate and deflate via the at least one inflation / deflation opening; c. At least one electromyography electrode provided relative to an external surface of the dilation balloon to capture muscle activity information during operation; 2. A remote drive unit to control function of the dilation probe and comprising a drive unit software application; and 3. An elongate umbilical tether provided between the dilation probe and the remote drive unit to communicate an inflation medium to and from the dilation probe. According to a third aspect of the invention, there is provided a charging dock and storage pod for an intravaginal dilation therapy device for physical therapy, the charging dock and storage pod device comprising: 1. A dilation probe to be inserted into the vagina, the dilation probe comprising: a. A central probe body with at least one inflation / deflation opening therein; b. A dilation balloon mounted relative to the central probe body and sealed relative to the probe body to inflate and deflate via the at least one inflation / deflation opening; c. At least one electromyography electrode provided relative to an external surface of the dilation balloon to capture muscle activity information during operation; 2. A remote drive unit to control function of the dilation probe and comprising a drive unit software application; and 3. An elongate umbilical tether provided between the dilation probe and the remote drive unit to communicate an inflation medium to and from the dilation probe, the charging dock and storage pod comprising: a hollow body with an internal storage hopper to receive the dilation probe therein; and a charging dock provided relative to an upper end of the hollow body and comprising an opening therein to receive the dilation probe therethrough, a charging seat to rclcasably hold the remote drive unit during charging, and a charging mechanism to charge the remote drive unit whilst in the charging seat. According to a fourth aspect of the invention, there is provided an intravaginal dilation therapy system comprising: 1. an intravaginal dilation therapy device for physical therapy, the device comprising: a. A dilation probe to be inserted into the vagina, the dilation probe comprising: i. A central probe body with at least one inflation / deflation opening therein; ii. A dilation balloon mounted relative to the central probe body and sealed relative to the probe body to inflate and deflate via the at least one inflation / deflation opening; iii. At least one electromyography electrode provided relative to an external surface of the dilation balloon to capture muscle activity information during operation; b. A remote drive unit to control function of the dilation probe and comprising a drive unit software application; and c. An elongate umbilical tether provided between the dilation probe and the remote drive unit to communicate an inflation medium to and from the dilation probe and electromyography information to and from the dilation probe. 2. A charging dock and storage pod comprising: a. a hollow body with an internal storage hopper to receive the dilation probe therein; and b. a charging dock provided relative to an upper end of the hollow body and comprising an opening therein to receive the dilation probe therethrough, a charging seat to releasably hold the remote drive unit during charging, and a charging mechanism to charge the remote drive unit whilst in the charging seat; and 3. a software application operating on a remote computing device to interface with the drive unit software application to receive the electromyography information from the dilation probe and to display biofeedback information to a user. In a broad form, the present invention provides a dilation probe to be inserted into the vagina, the dilation probe comprising a central probe body with at least one inflation / deflation opening therein, a dilation balloon mounted relative to the central probe body and sealed relative to the probe body to inflate and deflate via the at least one inflation / deflation opening, and at least one electromyography electrode provided relative to an external surface of the dilation balloon to capture muscle activity information during operation. The intravaginal dilation therapy device with integrated physical therapy probe provides physical therapy (vaginal dilation) aimed at alleviating the symptoms of hypertonic pelvic floor, vaginismus and other pelvic conditions that require the mental or physical retraining of vaginal muscle or scar tissue. The intravaginal dilation therapy device combines two therapy approaches into one by providing a device for muscle dilation (desensitisation and retraining) and contemporaneous biofeedback (EMG - muscle activity and mental awareness / psychology) in the same device. Conventional treatments do not offer these combined features and are normally of a fixed size (dimensionally stable) and form (not variably inflatable) and are only available in a very limited range sizes which cannot conform to the subtle profiles and proportions of different user’s anatomy. Offering dilation therapy allows patients to desensitise their physical and mental response to touch / penetration by exposure to the non-threatening sensations induced by the variably dilation of the therapy probe. Simultaneously, the EMG recording facility enables monitoring of the vaginal muscle's contractility and response to the effect of the expanding dilatation therapy, in real time, thus giving instantaneous feedback of the muscle contraction / relaxation. The integration of EMG biofeedback into the intravaginal dilation therapy unit provides the added benefits of allowing patients to see and understand their muscle response to stimuli and learn how to relax and control the vaginal muscle better overtime as well as gaining a better mental response. For the purpose of this document the ‘intravaginal wand’ comprises the intravaginal dilation probe and umbilical tether. The intravaginal wand and drive unit are referred to as the ‘intravaginal dilation therapy device’. The intravaginal wand, drive unit, charging dock and storage pod, and software application are referred to as the ‘intravaginal dilation therapy system’. The intravaginal dilation therapy probe and / or wand may be semi-disposable, by which it is intended that the wand may be reuseable for a number of uses and is then disposed of and replaced with a new wand. All probe materials are preferably biocompatible. All probe materials are preferably hypoallergenic. Each semi-disposable therapy probe and / or wand can preferably be electronically tracked and monitored for safety and product lifespan. The pulsation and reciprocation of the user controlled (user customised) dilation probe (waves of inflation and deflation of varying size) preferably incrementally assists a user increase their desensitisation to physical interaction with the muscle tissue (touch or penetration), retraining muscle activity patterns and user sensations through physical exposure to the therapy probe’s “non-threatening” dilation induced sensations. The user preferably has the ability to vary the size of the dilation and receive immediate EMG feedback. The intravaginal dilation therapy wand comprises a dilation probe to be inserted into the vagina. The dilation probe is preferably electro-pneumatically expandable controlled by a remote drive unit to control function of the dilation probe via a drive unit software application. This configuration preferably allows for user-controlled variable dilation sizes and patterns of exercise (for example speed of contraction / dilation). The dilation probe comprises a central probe body with at least one inflation / deflation opening therein. The central probe body preferably mounts the umbilical tether to the dilation probe. The umbilical tether may be permanently fixed to the central probe body or alternatively, may be detachable. If detachable, this allows the replacement of the dilation probe and / or reuse of the umbilical tether. Preferably, the mount for the umbilical tether includes an opening to attach the tether at least partially thereinto. The umbilical tether itself is preferably hollow in order to convey air or another inflation fluid to the dilation probe. The hollow bore of the umbilical tether preferably communicates with the hollow interior of the central probe body. The probe body is preferably provided centrally in the dilation probe. The central probe body may preferably be rigid. The central probe body will preferably be hollow. The central probe body may be elongate and preferably defines the overall length of the dilation probe. The central probe body may be tapered in dimension, preferably being thinner at the insertion end and broader at the external end. The central probe body may be multipart but preferably, the central probe body will be formed of single piece. A number of inflation / deflation openings may be provided through a side wall of the central probe body through which the inflation fluid flows in use. A number of inflation / deflation openings may be spaced radially about the circumference of the central probe body and / or over the length of the probe body. In use, an inflation fluid such as air is pumped into the central probe body and out of the inflation / deflation openings in the side wall of the central probe body to expand the dilation balloon and the inflation fluid is removed (either forced or passively) to contract the dilation balloon. The inflation / deflation openings may be provided in any number, shape and / or size. Preferably, two sets of inflation / deflation openings may be provided, with the sets spaced from one another over the length of the central probe body and the openings in each set spaced radially about the central probe body. The inflation / deflation openings may preferably be provided in a side wall of the central probe body to direct the inflation fluid outwardly against an inner surface of the dilation balloon to increase the radial dimension of the dilation balloon, rather than increasing the longitudinal dimension. One or more mounting portions may be provided on the central probe body to mount the dilation balloon thereto. Preferably, a mounting portion may be provided at an external end of the central probe body and a second mounting portions may be provided at the insertion tip of the central probe body. As mentioned above, fixing the dilation balloon to the central probe body at both the external end and the insertion tip will preferably fix the length of the dilation balloon and force expansion of the dilation balloon in a radial direction rather than in a longitudinal direction. The mounting portions may have any configuration, and the mounting portions may have a different configuration at the external end and the insertion tip. For example, the mounting portion at the external end of the central probe body may be hollow and attachable to the central probe body using a clip or threaded embodiment. A part of the dilation balloon may be inserted over a male portion of the central probe body at the external end and the mounting portion may then be screwed or clipped onto the central probe body to clamp the dilation balloon to the central probe body. At the insertion tip, part of the dilation balloon may be inserted into the hollow and of the insertion tip and a tip fixture plug may then be forced into the insertion and to clamp the dilation balloon in place. These are simply examples of forms which could be used, and other mechanisms may be used to fix the dilation balloon to the probe body either permanently or detachably. A dilation balloon is preferably mounted relative to the central probe body and is sealed relative to the central probe body to inflate and deflate via the at least one inflation / deflation opening. At least one pressure sensor may be provided in association with the dilation balloon. The dilation balloon may be provided of any material. Preferably, the dilation balloon will be elastic. Examples of materials which could be used include elasticated rubber (poly isoprene, polyurethane or equivalent). These materials allow the dilation balloon to conform to the shape of an individual body or part thereof, for example the vagina or pelvic floor. The dilation balloon will preferably have shape memory, expanding when inflation fluid is forced into the dilation balloon against the material properties of the dilation balloon and contracting due to the material properties of the dilation balloon when the inflation fluid is removed. The dilation balloon may be shaped with portions of different dimensions provided over the length of the dilation balloon. This may allow different portions of the dilation balloon to expand to different diameters. In one form, the dilation balloon is elongate, and finger shaped in the contracted or relaxed state (deflated), and is at least partially spheroid in the expanded or dilated (fully) state. As mentioned above, the dilation balloon may be fixed to the central probe body, preferably at the insertion tip and the external end thereof. The dilation balloon may include more than one portion. The dilation balloon may have a shaped profile which changes from the external end to the insertion tip. In one form, the dilation balloon may include a narrower neck portion at or towards an external end of the dilation probe. The neck portion may be smaller than a larger head portion which may be provided between the neck portion and the insertion tip of the dilation probe. The neck portion may expand to a lesser degree than the head portion. The head portion may be at least partially spheroid. The head portion is preferably a part of the dilation balloon which exerts the force to provide the dilation effect against the user's body. The neck portion of the dilation balloon may include one or more textured parts or portions to assist a user with gripping the dilation probe during insertion / removal and / or to allow gripping by the vagina wall when the dilation probe is in use to maintain the position of the dilation probe, particularly during dilation. Textured parts or portions may be provided on the head portion of the dilation balloon as well as or instead of on the neck portion. In use, the dilation balloon expands or dilates where in inflation fluid, such as air, is driven into the dilation balloon and contracts or relaxes as the inflation fluid is removed, either forcibly or passively. Expansion of the dilation balloon is preferably driven by a pump which may be provided on the drive unit. Removal of inflation fluid from the dilation balloon may be driven using the pump operating in reverse and / or passively by allowing the pressure on or in the dilation balloon and / or the material properties of the dilation balloon to evacuate the inflation fluid when the pump ceases injection of inflation fluid into the dilation balloon. The size of the dilation balloon or the extent of dilation is preferably controllable between a contracted position and a fully dilated position. Preferably, the extent of dilation is controlled by the drive unit and / or user in order to provide a dilation effect which is changeable over time to allow the user to increase endurance and intensity over time to gain longer term benefits. At least one electromyography (EMG) electrode is provided relative to an external surface of the dilation balloon to capture muscle activity information during operation. More than one electromyography electrode may be provided. If more than one EMG electrode is provided, the electrodes are preferably spaced radially about the dilation balloon. The EMG electrodes may be spaced over the length of the dilation balloon and / or in different locations about the periphery of the dilation balloon. The EMG information may be used by the drive unit to control or adjust the dilation of the dilation balloon. The at least one EMG electrode may be surface embedded, surface printed or similarly provided relative to an external surface of the dilation balloon, to position the at least one EMG electrode relative to an outer surface of the dilation balloon. The at least one EMG electrode may not be expandable or adjustable in size as the dilation balloon expands and contracts. One or more expansion portions may be provided relative to the at least one EMG electrode, preferably between the at least one EMG electrode and other portions of the dilation balloon so that as the dilation balloon expands, the at least one EMG electrode is not forced to expand which could damage the at least one EMG electrode. In other words, the dilation balloon will preferably expand about the at least one EMG electrode allowing the at least one EMG electrode to remain fixed in size. However, the at least one EMG electrode may be provided in a strip form in which expansion of the dilation balloon will cause the at least one EMG electrode to change size and shape (but not length). The at least one EMG electrode may preferably be connected to at least one electrical connection provided in the umbilical tether to convey information therethrough. Information may be conveyed in both directions. EMG or muscle activity information is preferably conveyed from the at least one EMG electrode to the drive unit. The at least one EMG electrode is preferably shaped. The number of EMG electrodes and shape of the EMG electrodes is preferably optimised to maximise surface contact with muscle tissue of the user's body. The at least one EMG electrode may be provided substantially on the head portion of the dilation balloon. One or more EMG electrodes may be provided in cluster or array on the dilation balloon. In a particularly preferred form, an EMG electrode may have an elongate stem extending from the external end of the dilation balloon toward the insertion tip with an enlarged lobe portion provided on the head portion of the dilation balloon. The enlarged lobe portion will typically be wider on the surface of the dilation balloon. Preferably, the at least one EMG electrode may be provided to be no thicker than the thickness of the dilation balloon, or at least, extend only minimally further outwardly from the surface of the dilation balloon, if at all. An elongate umbilical tether is preferably attached to the dilation probe to communicate an inflation medium to and from the dilation probe. As mentioned above, the umbilical tether may be hollow. The umbilical tether preferably provides a fluid connection to the dilation probe. The umbilical tether preferably also provides an electrical connection. The umbilical tether preferably allows an inflation medium to be forced into the dilation probe and to allow the inflation medium to escape from the dilation probe. A coupling may be provided at an outer end of the umbilical tether to releasably couple or attach the umbilical tether to the drive unit. The umbilical tether is preferably elongate. The umbilical tether may be any length but may preferably be between 15 and 50 cm in length. An additional fixture may be provided on the umbilical tether. This may allow the user to attach the additional fixer to the user’s body for example using an adhesive sticker or similar or a clip or class may be provided on the additional fixture to attach the umbilical tether to clothing. The probe body preferably retains the dilation balloon along its length thus providing it with a rigid internal shape to aid with insertion and to prevent the dilation balloon from stretching along its length (preventing ingress towards the cervix), allowing for expansion around its diameter. Additionally, variations in material cross section at the tip and / or the neck at the external end of the dilation balloon and about the EMG electrodes preferably minimise or prevent material stretching in areas that may damage or weaken the dilation balloon over time. The probe health and life span may be measured against the number of recorded uses (exercise routines and / or individual dilations / contractions). The life span of each probe may be directional proportional to the time and extent of use (therapy cycles) and number of charging pressure tests (explained further below). Each individual dilation probe and tether may be provided with an identifying NFC or ID chip allowing the drive unit to identify and track the use of each dilation probe. The identifying NFC or ID chip may be located within the tether coupling. The intravaginal dilation therapy device may further comprise a remote drive unit to control function of the dilation probe. The drive unit may be remote from the dilation probe but connected thereto via the umbilical tether to provide inflation medium to the dilation probe, and to allow removal of the inflation medium from the dilation probe. The remote drive unit may preferably be worn by the user either relative to their skin or relative to clothing that they wear when the dilation probe is in use. The remote drive unit will preferably be sealed against moisture. The remote drive unit will typically provide inflation / deflation instructions to the dilation probe, as well as monitoring control functions of the drive unit and dilation probe and also record EMG activity captured from the at least one EMG electrode on the dilation probe. The remote drive unit will preferably operate control software to control the dilation probe. The control software on their remote drive unit may cooperate with one or more other software applications operating on a remote computing device such as a smart phone, tablet or other computer for example. One or more manual controls may be provided on the remote drive unit. The remote drive unit will preferably have an external housing which contains operating components. The housing will preferably include a coupling to releasably attach the umbilical tether to the remote drive unit. As mentioned above, one or more control buttons may be provided on an external side of the housing to control operation of the dilation probe. If control buttons are provided, it is preferred that the buttons provide audible and / or tactile feedback of the use of the buttons. The external housing is preferably planar. The external housing may have minimal thickness to allow the external housing to be worn unobtrusively under clothing for example. One or more reference sensing electrodes may be provided on an underside of the external housing to be located against a user's skin. One or more communication pathway may be provided to allow the control software on the remote drive unit to interface with a software application provided on a remote computing device. The communication pathway may preferably be wireless. The communication pathway made be of any type with Bluetooth preferred. One or more mounting assemblies may be provided on the remote drive unit to allow mounting of the remote drive unit relative to a user skin and / or clothing. For example, one or more mounting studs may be provided. The mounting studs may be configured to mount an adhesive sticker to allow the remote drive unit to be adhered directly to the user's skin. The mounting studs may allow mounting of a clip or clasp thereto in order to mount the remote drive unit relative to a user's clothing, preferably between clothing and the user's skin. The remote drive unit will preferably include a pneumatic pump to receive air and force the air into the dilation balloon via the umbilical tether. As mentioned previously, at least one pressure sensor may be provided. The remote drive unit may preferably include an on-board power supply. The power supply may be replaceable and / or rechargeable. Wireless charging may be preferred. The remote drive unit will preferably allow control of different functions of the dilation probe. The remote drive unit may allow the dilation probe to be turned on and off. The remote drive unit may allow the dilation balloon to be expanded and contracted. The remote drive unit may allow a user to set the degree of inflation or dilation of the dilation balloon. This may be accomplished through the definition of a dilation dimension and / or a pressure setting for the dilation balloon. The remote drive unit may allow the user to set an inflation / deflation cycle for example one or more speed(s) of dilation, time(s) of dilation or any other parameter(s) in relation to dilation and contraction of the dilation balloon. In a preferred form, the control function may use pressure / dilation size as a metric related to the dilation required or desired. The system may allow monitoring of the dilation probe health and / or lifespan. Each dilation probe and / or umbilical tether may be provided with an identifier or identifying component such as an NFC or ID chip. This may allow the system to identify the dilation probe and / or umbilical tether and to track the use of the dilation probe and / or umbilical tether. Information which may be tracked could preferably include the number of dilations and / or the extent of dilations which a particular dilation probe undergoes. The dilation probe may undergo a pressure test when located in the storage pod in order to test the integrity of the dilation balloon for leaks or punctures or the like. Such pressure test may involve one or more dilations while in the storage pod as well as monitoring the pressure in the dilation balloon during any such dilation. The intravaginal dilation therapy system may further comprise a charging dock and storage pod comprising a hollow body with an internal storage hopper to receive the dilation probe therein; and a charging dock provided relative to an upper end of the hollow body and comprising an opening therein to receive the dilation probe therethrough, a charging seat to releasably hold the remote drive unit during charging, and a charging mechanism to charge the remote drive unit whilst in the charging seat. The charging dock and storage pod may be provided in a single unit with the storage pod in a lower part and a charging dock in an upper part. In one form, the charging dock may be removable from the storage pod. This configuration may allow the storage of the dilation therapy device including the dilation probe, the umbilical tether and the drive unit whilst allowing the drive unit to be charged simultaneously. Alternatively, the charging dock may be removed from the storage pod in use separately if required. Preferably, the charging dock utilises a wireless charging protocol such as induction charging. The storage pod may preferably include a hollow body. The internal storage hopper may be provided within the hollow body to receive the dilation probe. The storage hopper is preferably elongate. The storage hopper may include one or more, or preferably an array of openings in the side wall thereof such that the storage hopper has a cage configuration. The umbilical tether is preferably stored within the hollow body of the storage pod but above the storage hopper. An opening may be provided at an upper end of the storage hopper to allow the dilation probe to be inserted into and withdrawn from the storage hopper and allow the umbilical tether to extend out of an upper end of the storage hopper. The dilation probe may be oriented substantially vertically within the storage hopper. Whilst the dilation probe is stored and the drive unit is docked, the dilation probe may undergo one or more pressure tests in which the dilation balloon is dilated and released, one or more times with the pressure within the dilation balloon monitored to detect leaks or defects in the dilation balloon and any defect in the function of the dilation probe. The charging dock may preferably fit to an upper end of the hollow body of the storage pod. A lockable connection may be provided. In one form, the charging dock may include an annular collar with an upper lid portion. The lid portion may be hinged to the annular collar but may be removable. The charging dock may be provided on upper side of the lid. A shaped charging seat may be provided as part of the charging dock. An opening may be provided in a part of the collar and / or the lid to allow the tether to extend from within the storage pod to remain connected to the drive unit whilst the drive unit is charged. In use, the drive unit will normally be placed onto the shaped charging seat in order to charge. The drive unit may be retained on the charging seat during charging or when located on the charging seat. Any mechanism may be used but a magnetic mechanism may be preferred. Preferably, any mounting structure to mount the drive unit to the user’s body or clothing such as an adhesive sticker, clip or clasp, may be removed during the charging process. The drive unit may receive control information from a software application operating on remote computing device and / or from any on-board buttons. The drive unit may preferably send information to the software application on the remote computing device. The software application operating on the remote computing device may generate and display one or more interfaces on the remote computing device to control and / or monitor / report / chart activity of the dilation probe. The software application may allow a user to select one or more training regimes to control use of the dilation probe. Preferably, the drive unit has a master control unit on board. As mentioned above, one or more buttons may be provided on board to control all reset basic functions of the dilation probe. This may provide a safe default if connectivity with the software application on the remote computing device is lost. A pressure sensor may be provided on the drive unit / dilation probe or the umbilical tether to monitor pressure in the dilation balloon. The pressure sensor may operate on an override to prevent excessive pressure or excess duration of operation. Information regarding pressure may be sent back to the master control unit and / or to the software application operating on the remote computing device. Preferably, the master control unit controls the pneumatic pump. The inflation media inlet may be provided on the drive unit. The inlet may be associated with a filter and / or a valve to allow controlled inflation and deflation of the dilation balloon. As mentioned above, the umbilical tether preferably has a pneumatic portion and an electric / data portion. Both portions may preferably be two-way to provide air to / from the probe and to allow information to / from the probe. A software application operating on a remote computing device to interface with the drive unit software application to receive electromyography information from the dilation probe and to display biofeedback information to a user. The cross platform mobile app provides the user with modern smartphone convenience of a graphic device control, configuration, and interface. The software application on the remote computing device provides an easy to use and feature rich customisable user interface, essential to accessing the full range of device capabilities and customisation of use. The software application on the remote computing device may provide the user with a set of customisable base programs (therapy sessions I exercise routines), which the user can modify to incrementally and gradually increase the frequency of exercise over time and at a pace comfortable to the individual user (Duration, Size and pattern of dilation). With registration of the software application on the remote computing device, the user may unlock the full features of the device i.e., incremental dilation (pressure) sensing, customisation exercise programming, cloud data storage, progress monitoring and charting / trending / sharing along with community support features, once the device has been registered to a user and the terms and conditions of use and therapy data collection have been accepted. Collation of therapy data metrics, reports, and progress charting (cloud data) may be provided to better help the user to engage with and commit to a therapy schedule by helping them to monitor and visualise their progress and allowing them to set daily, weekly and monthly goals, tailored to their lifestyle and pattern of use. The software application on the remote computing device may also provide a platform for other users to share their experiences and use of the system on a community page. Allowing users of all stages to get the most out of their therapy and devices through shared knowledge and experiences and building a user community for those using the device and going through the same therapy. The software application on the remote computing device may also provide users with a means of replacing and maintaining therapy consumables such as probes, wearable stickers etc. as well as offering the purchase of additional accessories and upgrades (as the therapy platform matures). The software application on the remote computing device may identify and track the use of the current (semi-disposable) therapy probe, monitoring and recording its use to determine a safe expiration date and notify the user of expected lifespan and projected replacement of the probe and or associated consumables. The software application on the remote computing device may also determine probe lifespan by periodic “pressure test” on the probe between uses (whilst the unit is charging); to detect any leaks or defects in the probes function and prompt the user to replace it - making it easier and safter for the user to maintain their product. The software application on the remote computing device may prompt the user after every therapy session to clean the probe and then return the unit to the Charging dock and accompanying Storage pod, with the user confirming each step with the software application on the remote computing device. Detailed Description of the Invention In order that the invention may be more clearly understood one or more embodiments thereof will now be described, by way of example only, with reference to the accompanying drawings, of which: Figure 1 is a front view of an intravaginal dilation therapy unit according to a preferred embodiment. Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Figure 8 Figure 9 Figure 10 Figure 11 Figure 12 Figure 13 Figure 14 Figure 15 Figure 16 is a front view of a charging dock and storage pod for an intravaginal dilation therapy unit according to a preferred embodiment. is an axonometric view of the components of an intravaginal dilation therapy system according to a preferred embodiment. is a front view of the intravaginal dilation therapy unit illustrated in Figure 1, in use. is an axonometric view of the intravaginal dilation therapy unit illustrated in Figure 1, in use. is a flow diagram of the intravaginal dilation therapy system illustrated in Figure 3. is a top view of the intravaginal dilation therapy unit illustrated in Figure 1. is a top view of an intravaginal therapy probe according to a preferred embodiment. is a section view of the intravaginal therapy probe illustrated in Figure 8 along line A-A. is an axonometric view of the intravaginal therapy probe illustrated in Figure 8 in the insertion condition. is an axonometric view of the intravaginal therapy probe illustrated in Figure 10 in a mid-inflation condition. is an axonometric view of the intravaginal therapy probe illustrated in Figure 10 in a fully inflated condition. is an end view of the intravaginal therapy probe illustrated in Figure 10. is an end view of the intravaginal therapy probe illustrated in Figure 11. is an end view of the intravaginal therapy probe illustrated in Figure 12. is an axonometric view of a smartphone operating a controlling software application to control an intravaginal therapy probe. Figure 17 is a schematic view showing a possible connection of the intravaginal therapy head unit to an elongate umbilical tether. Figure 18 is a schematic view showing a possible mounting of an adhesive body sticker to the underside of the intravaginal therapy head unit. Figure 19 is a view of the configuration shown in Figure 18 when mounted. Figure 20 is a cutaway view of the charging dock and storage pod illustrated in Figure 2. Figure 21 is an exploded view of the charging dock and storage pod illustrated in Figure 2. An intravaginal dilation therapy wand according to a preferred embodiment is illustrated in the Figures. The illustrated intravaginal dilation therapy wand comprises a dilation probe 10 to be inserted into the vagina and an elongate umbilical tether 11 attached to the dilation probe to communicate an inflation medium to and from the dilation probe 10. A preferred form of dilation probe 10 is illustrated in Figures 8 to 15 in particular and comprises a central probe body 12 with a number of inflation / deflation openings 14 therein. A dilation balloon 13 is mounted relative to the central probe body 12 and sealed relative to the probe body 12 to inflate and deflate via an inflation medium provided thereinto through the inflation / deflation openings 14. A pair of electromyography electrodes 15 are provided relative to an external surface of the dilation balloon 13 to capture muscle activity information during operation. The intravaginal dilation therapy probe 10 and umbilical tether 11 may be semidisposable, by which it is intended that they may be reuseable for a number of uses and is then disposed of and replaced with a new therapy probe 10 and umbilical tether 11. The dilation probe 10 is preferably electro-pneumatically expandable, controlled by a remote drive unit 16 to control function of the dilation probe 10 via a drive unit software application. This configuration preferably allows for user-controlled variable dilation sizes and patterns of exercise (for example speed of contraction / dilation). The dilation probe 10 comprises a central probe body 12 with a number of inflation / deflation openings 14 therein. The central probe body 12 mounts the umbilical tether 11 to the dilation probe 10 at an external end thereof. The umbilical tether 11 may be permanently fixed to the central probe body 12 or alternatively, may be detachable. Preferably, the mount for the umbilical tether 11 includes an opening to attach the tether 11 at least partially therein to. The umbilical tether 11 itself is preferably hollow in order to convey air or another inflation fluid to the dilation probe 12. The hollow bore of the umbilical tether 11 preferably communicates with the hollow interior of the central probe body 12. The probe body 12 is preferably provided centrally in the dilation probe 10. The illustrated central probe body 12 is rigid and hollow. The central probe body 12 is elongate and defines the overall length of the dilation probe 12. The central probe body 12 illustrated is tapered in dimension being thinner at the insertion end and broader at the external end as shown in Figure 9 in particular. A number of inflation / deflation openings 12 are provided through a side wall of the central probe body 12 through which the inflation fluid flows, in use. In the illustrated embodiment, two sets of inflation / deflation openings 14 are provided, with the sets spaced from one another over the length of the central probe body 12 and the openings in each set spaced radially about the central probe body 12. In use, an inflation fluid such as air is pumped into the central probe body 12 and out of the inflation / deflation openings 14 in the side wall of the central probe body 12 to expand the dilation balloon 13 and the inflation fluid is removed (either forced or passively) to contract the dilation balloon 13. One or more mounting portions may be provided on the central probe body 12 to mount the dilation balloon 13 thereto. Preferably, a mounting portion may be provided at an external end of the central probe body and a second mounting portion may be provided at the insertion tip of the central probe body 12. As mentioned above, fixing the dilation balloon 13 to the central probe body 12 at both the external end and the insertion tip will preferably fix the length of the dilation balloon 13 and forces expansion of the dilation balloon 13 in a radial direction rather than in a longitudinal direction. The mounting portions may have any configuration, and the mounting portions may have a different configuration at the external end and the insertion tip. At the external end, the mounting portion 19 may be cup shaped to engage with the probe body to sandwich a portion of the dilation balloon thereto. At the insertion tip, part of the dilation balloon 12 may be inserted into the hollow end of the insertion tip and a tip fixture plug 17 may then be forced into the insertion and to clamp the dilation balloon 13 in place. A dilation balloon 13 is preferably mounted relative to the central probe body 12 and is sealed relative to the central probe body 12 to inflate and deflate via the inflation / deflation openings 14. At least one pressure sensor (not shown) may be provided in association with the dilation balloon 13. The dilation balloon 13 may be provided of any material. Preferably, the dilation balloon will be elastic. Examples of materials which could be used include elasticated rubber (poly isoprene, polyurethane or equivalent). These materials allow the dilation balloon 13 to conform to the shape of an individual body for example the vagina or pelvic floor. The dilation balloon 13 will preferably have shape memory, expanding when inflation fluid is forced into the dilation balloon 13 against the material properties of the dilation balloon 13 and contracting due to the material properties of the dilation balloon 13 when the inflation fluid is removed. The dilation balloon 13 may be shaped with portions of different dimensions provided over the length of the dilation balloon 13. This may allow different portions of the dilation balloon 13 to expand to different diameters. In one form, the dilation balloon 13 is elongate and finger shaped in the contracted or relaxed state (deflated) as shown in Figures 10 and 13 for example and is at least partially spheroid in the expanded or dilated (fully) state as shown in Figures 12 and 14. In the partially expanded or dilated state as shown in Figures 11 and 15, an upper portion may be partially dilated. As shown, the dilation balloon 13 may have a shaped profile which changes from the external end to the insertion tip. In one form, the dilation balloon 13 may include an outer narrower neck portion at or towards an external end of the dilation probe 10. The neck portion is smaller than a larger head portion which may be provided between the neck portion and the insertion tip of the dilation probe 10. When inflated / dilated, the neck portion expands to a lesser degree than the head portion. In the fully dilated condition, the head portion is at least partially spheroid and exerts the force to provide the dilation effect against the user's body. The neck portion of the dilation balloon 13 may include one or more textured parts 18 or portions to assist a user with gripping the dilation probe 10 during insertion / removal and / or to allow gripping by the vagina wall when the dilation probe 10 is in use, to maintain the position of the dilation probe 10, particularly during expansion / dilation. In use, the dilation balloon 13 expands or dilates where in inflation fluid, such as air is driven into the dilation balloon 13 and contracts or relaxes as the inflation fluid is removed, either forcibly or passively. Expansion of the dilation balloon 13 is preferably driven by a pneumatic pump (not shown) which may be provided on the drive unit 16. Removal of inflation fluid from the dilation balloon 13 may be driven using the pump operating in reverse and / or passively by allowing the pressure on or in the dilation balloon 13 and / or the material properties of the dilation balloon 13 to evacuate the inflation fluid when the pneumatic pump ceases injection of inflation fluid into the dilation balloon 13. The size of the dilation balloon 13 or the extent of dilation is preferably controllable between a contracted position and a fully dilated position. Preferably, the extent of dilation is controlled by the drive unit 16 and / or user in order to provide a dilation effect which is changeable over time to allow the user to increase endurance and intensity over time to gain longer term benefits. A pair of electromyography (EMG) electrodes 15 is provided relative to an external surface of the dilation balloon 13 in the illustrated embodiment, to capture muscle activity information during operation. The EMG electrodes 15 may be surface embedded, surface printed or similarly provided relative to an external surface of the dilation balloon 13, to position the EMG electrodes 15 relative to an outer surface of the dilation balloon 13. The EMG electrodes 15 may not be expandable or adjustable in size as the dilation balloon 13 expands and contracts. One or more expansion portions 20 may be provided between the EMG electrodes and other portions of the dilation balloon 13 so that as the dilation balloon 13 expands, the EMG electrode 15 is not forced to expand which could damage the EMG electrode 15. In other words, the dilation balloon 13 will preferably expand about the EMG electrode 15 and the EMG electrode 15 remains fixed in size. The EMG electrode 15 is preferably connected to at least one electrical connection provided in the umbilical tether 11 to convey information therethrough. Information may be conveyed in both directions. EMG or muscle activity information is preferably conveyed from the EMG electrode 15 to the drive unit 16. The EMG electrode 15 is preferably shaped to maximise surface contact with muscle tissue of the user's body. In the illustrated form, the EMG electrodes 15 each have an elongate stem extending from the external end of the dilation balloon 13 toward the insertion tip, with an enlarged lobe portion provided on the head portion of the dilation balloon 13. The enlarged lobe portion is wider on the surface of the dilation balloon 13. As shown, the EMG electrode is no thicker than the thickness of the dilation balloon 13, or at least, extend only minimally further outwardly from the surface of the dilation balloon 13, if at all. An elongate umbilical tether 11 is preferably attached to the dilation probe 10 to communicate an inflation medium to and from the dilation probe 10. As mentioned above, the umbilical tether 11 is hollow. The umbilical tether 11 preferably provides a fluid connection between the drive unit 16 and the dilation probe 10. The umbilical tether 11 preferably also provides an electrical connection the drive unit 16 and the dilation probe 10. The umbilical tether 11 preferably allows an inflation medium to be forced into the dilation probe 10 and to allow the inflation medium to escape from the dilation probe 10. A coupling 21 may be provided at an outer end of the umbilical tether 11 to releasably couple or attach the umbilical tether 11 to the drive unit 16. As illustrated, the umbilical tether 11 is elongate, preferably be between 15 and 50 cm in length. An additional fixture 22 may be provided on the umbilical tether. This may allow the user to attach the additional fixer to the user’s body, for example using an adhesive sticker or similar, or a clip or clasp may be provided on the additional fixture 22 to attach the umbilical tether 11 to clothing. The probe body 12 preferably retains the dilation balloon 13 along its length thus providing it with a rigid internal shape to aid with insertion and to prevent the dilation balloon 13 from stretching along its length (preventing ingress towards the cervix), but allowing for expansion around its diameter. Additionally, variations in material cross section at the tip and / or the neck at the external end of the dilation balloon 13 and about the EMG electrodes 15 preferably minimise or prevent material stretching in areas that may damage or weaken the dilation balloon 13 over time. The probe health and life span may be measured against the number of recorded uses (exercise routines and / or individual dilations / contractions). The life span of each probe may be directly proportional to the time and extent of use (therapy cycles) and number of charging pressure tests (explained further below). Each individual dilation probe 10 and / or tether 11 may be provided with an identifying NFC or ID chip allowing the drive unit 16 to identify and track the use of each dilation probe 10. The identifying NFC or ID chip may be located within the tether coupling 21. The intravaginal dilation therapy device may further comprise a remote drive unit 16 to control function of the dilation probe 10. The drive unit 16 may be separate from the dilation probe 10 but connected thereto via the umbilical tether 11 to provide inflation medium to the dilation probe 10, and to allow removal of the inflation medium from the dilation probe 10. The remote drive unit 16 may be worn by the user as shown in Figures 4 and 5, either relative to their skin or relative to clothing that they wear when the dilation probe 10 is in use. The remote drive unit 16 is therefore preferably sealed against moisture. The remote drive unit 16 will typically provide in flation / dc flation medium to the dilation probe 10, as well as monitoring control functions of the drive unit 16 and dilation probe 10 and also record EMG activity captured from the EMG electrodes 15 on the dilation probe 10. The remote drive unit 16 will preferably operate control software to control the dilation probe 10. The control software on the remote drive unit 16 may cooperate with one or more other software applications operating on a remote computing device such as a smart phone 22, tablet or other computer for example. One or more manual control buttons 23 may be provided on the remote drive unit. The remote drive unit 16 illustrated has an external housing 24 which contains the operating components. The housing 24 will preferably include a coupling opening (shown in Figure 17) to releasably attach the umbilical tether 11 to the remote drive unit 16. As mentioned above, control buttons 23 are provided on an external side of the housing 24 to control operation of the dilation probe 10. If control buttons are provided, it is preferred that the buttons provide audible and / or tactile feedback of the use of the buttons. The external housing 24 is preferably planar. The external housing 24 may have minimal thickness to allow the external housing 24 to be worn unobtrusively under clothing for example. One or more reference sensing electrodes 25 may be provided on an underside of the external housing 24 to be located against a user's skin. One or more communication pathway may be provided to allow the control software on the remote drive unit 16 to interface with a software application provided on the smartphone 22. The communication pathway may preferably be wireless. The communication pathway made be of any type with Bluetooth preferred. One or more mounting assemblies may be provided on the remote drive unit 16 to allow mounting of the remote drive unit 16 relative to a user’s skin and / or clothing. For example, as shown in Figures 18 and 19, one or more mounting studs may be provided on an underside of the remote drive unit 16 adjacent to the reference electrode 25. The mounting stud 26 and the reference electrode 25 each have a stem extending away from the housing 24 with an enlarged head and are configured to mount an adhesive sticker 27 which is provided with keyhole shaped openings 28 thereto as shown in Figures 18 and 19, to allow the remote drive unit 16 to be adhered directly to the user's skin under clothing. Figure 18 also shows the underside of the coupling 21 to attach the tether 11 to the remote drive unit 16. The remote drive unit 16 will preferably include a pneumatic pump (not shown) to receive air and force the air into the dilation balloon 13 via the umbilical tether 11. As mentioned previously, at least one pressure sensor may be provided. The remote drive unit may preferably include an on-board power supply. The power supply may be replaceable and / or rechargeable. Wireless charging may be preferred. The remote drive unit 16 will preferably allow control of different functions of the dilation probe 10. The remote drive unit 16 may allow the dilation probe 10 to be turned on and off. The remote drive unit 16 may allow the dilation balloon 13 to be expanded and contracted. The remote drive unit 16 may allow a user to set the degree of inflation or dilation of the dilation balloon 13. This may be accomplished through the definition of a dilation dimension and / or a pressure setting for the dilation balloon 13. The remote drive unit 16 may allow the user to set an inflation / deflation cycle for example one or more speed(s) of dilation, time(s) of dilation or any other parameter(s) in relation to dilation and contraction of the dilation balloon 13. In a preferred form, the control function may use pressure / dilation size as a metric related to the dilation required or desired. The system may allow monitoring of the dilation probe health and / or lifespan. Each dilation probe 10 and / or umbilical tether 11 may be provided with an identifier or identifying component such as an NFC or ID chip. This may allow the system to identify the dilation probe 10 and / or umbilical tether 11 and to track the use of the dilation probe 10 and / or umbilical tether 11. Information which may be tracked could preferably include the number of dilations and / or the extent of dilations which a particular dilation probe 10 undergoes. The dilation probe 10 may undergo a pressure test when located in the storage pod 30 in order to test the integrity of the dilation balloon 13 for leaks or punctures or the like. Such a pressure test may involve one or more dilations while in the storage pod 30 as well as monitoring the pressure in the dilation balloon 13 during any such dilation. The intravaginal dilation therapy system may further comprise a charging dock and storage pod which is illustrated in the Figures as a two-part unit 31. The unit 31 comprises a storge pod 30 with a hollow outer body 33 and an internal storage hopper 34 to receive the dilation probe therein. The unit 31 is connected to a power supply cord 35 and is provided with a power conversion assembly 36 in the base of the storage pod 30, under the storage hopper 34. The charging dock and storage pod may be provided in a single unit 31 as shown with the storage pod 30 in a lower part and a charging dock 32 in an upper part. This configuration may allow the storage of the dilation therapy device including the dilation probe 10, the umbilical tether 11 and the drive unit 16 whilst allowing the drive unit 16 to be charged simultaneously. In the illustrated embodiment, the charging dock 32 is removable from the storage pod 30. Preferably, the charging dock 32 utilises a wireless charging protocol such as induction charging. In the illustrated embodiment, the internal storage hopper 34 is provided within the hollow body 33to receive the dilation probe. The storage hopper 34 is elongate and is provided with an array of openings in the side wall thereof such that the storage hopper 34 has a cage configuration as shown in Figure 21. As shown in Figure 20, the umbilical tether 11 is preferably stored within the hollow body 31of the storage pod 30 in an upper part of the storage hopper 34. As shown in Figure 21, the upper end of the storage hopper 34 is open to allow the dilation probe 10 to be inserted into and withdrawn from the storage hopper 34 and allow the umbilical tether 11 to extend out of an upper end of the storage hopper 34. The dilation probe 10 may be oriented substantially vertically within the storage hopper 34 as shown in Figure 20. Whilst the dilation probe 10 is stored and the drive unit 16 is docked, the dilation probe 10 may undergo one or more pressure tests in which the dilation balloon 13 is dilated and contracted, one or more times with the pressure within the dilation balloon 13 monitored to detect leaks or defects in the dilation balloon 13 and any defect in the function of the dilation probe 10. The charging dock 32 (shown separated from the storage pod 30 in Figure 21) preferably fits to an upper end of the hollow body 31 of the storage pod 30. A lockable connection may be provided. In the illustrated form, the charging dock 32 includes an annular collar 36 with an opening therein to receive the dilation probe 10 therethrough, and an upper lid 37. The lid 37 is hinged to the annular collar 36. The charging dock 32 is provided on upper side of the lid 37. A shaped charging seat 38 best illustrated in Figure 3) is provided as part of the charging dock 32. An opening 39 is provided in a part of the collar 36 and / or the lid 37 to allow the tether 11 to extend from within the storage pod 30 to remain connected to the drive unit 16 whilst the drive unit 16 is charged. In use, the drive unit 16 will normally be placed onto the shaped charging seat 38 in order to charge. The drive unit 16 may be retained on the charging seat 38 during charging or when located on the charging seat 38. Any mechanism may be used but a magnetic mechanism or engagement of the mounting stud 26 / reference electrode 25 could be used. Preferably, any adhesive sticker 27, clip or clasp, may be removed during the charging process. The drive unit 16 may receive control information from a software application operating on remote computing device, such as the Smartphone 22 and / or from any onboard buttons 23. The drive unit 16 may preferably send information to the software application on the Smartphone 22. The software application operating on the Smartphone 22 may generate and display one or more interfaces on the Smartphone 22 to control and / or monitor / report / chart activity of the dilation probe 10. The software application may allow a user to select one or more training regimes to control use of the dilation probe 10. Preferably, the drive unit 16 has a master control unit onboard. As mentioned above, one or more buttons 23 may be provided onboard to control all reset basic functions of the dilation probe 10. This may provide a safe default if connectivity with the software application on the Smartphone 22 is lost. A pressure sensor may be provided on the drive unit / dilation probe 10 or the umbilical tether 11 to monitor pressure in the dilation balloon. The pressure sensor may operate on an override to prevent excessive pressure or excess duration of operation. Information regarding pressure and EMG activity may be sent back to the master control unit and / or to the software application operating on the Smartphone 22. Preferably, the master control unit controls the pneumatic pump. The inflation media inlet may be provided on the drive unit 16. The inlet may be associated with a filter and / or a valve to allow controlled inflation and deflation of the dilation balloon 13. As mentioned above, the umbilical tether 11 preferably has a pneumatic portion and an electric / data portion. Both portions may preferably be two-way to provide air to / from the probe and to allow information to / from the probe. A software application operating on the Smartphone 22 interfaces with the drive unit 16 software application to receive electromyography information from the dilation probe and to display biofeedback information to a user. The cross platform mobile app provides the user with modern smartphone convenience of a graphic device control, configuration, and interface. The software application on the Smartphone 22 provides an easy to use and feature rich customisable user interface, essential to accessing the full range of device capabilities and customisation of use. The software application on the Smartphone 22 may provide the user with a set of customisable base programs (therapy sessions / exercise routines), which the user can modify to incrementally and gradually increase the frequency of exercise over time and at a pace comfortable to the individual user (Duration, Size and pattern of dilation). The software application on the Smartphone 22 may identify and track the use of the current (semi-disposable) therapy probe, monitoring and recording its use to determine a safe expiration date and notify the user of expected lifespan and projected replacement of the probe 10 and or associated consumables. The software application on the remote computing device may prompt the user after every therapy session to clean the probe and then return the unit to the Charging dock and accompanying Storage pod, with the user confirming each step with the software application on the Smartphone 22. The one or more embodiments are described above by way of example only. Many variations are possible without departing from the scope of protection afforded by the appended claims.

Claims

1. An intravaginal dilation therapy wand comprising:a. A dilation probe to be inserted into the vagina, the dilation probe comprising:i. A central probe body with at least one inflation / deflation opening therein;ii. A dilation balloon mounted relative to the central probe body and sealed relative to the probe body to inflate and deflate via the at least one inflation / deflation opening;iii. At least one electromyography electrode provided relative to an external surface of the dilation balloon to capture muscle activity information during operation; andb. An elongate umbilical tether attached to the dilation probe to communicate an inflation medium to and from the dilation probe.

2. An intravaginal dilation therapy wand as claimed in claim 1 wherein the inflation / deflation openings are provided in a side wall of the central probe body to direct the inflation fluid outwardly against an inner surface of the dilation balloon to increase a radial dimension of the dilation balloon rather than a longitudinal dimension.

3. An intravaginal dilation therapy wand as claimed in claim 1 or claim 2 further comprising at least one pressure sensor e provided in association with the dilation balloon.

4. An intravaginal dilation therapy wand as claimed in any one of the preceding claims wherein the dilation balloon is elastic with shape memory.

5. An intravaginal dilation therapy wand as claimed in any one of the preceding claims wherein the dilation balloon is elongate and finger shaped in a contracted or relaxed state and is at least partially spheroid in a fully expanded or dilated state.

6. An intravaginal dilation therapy wand as claimed in any one of the preceding claims wherein the dilation balloon comprises one or more textured parts or portions to assist a user with gripping the dilation probe during insertion / removal and / or to allow gripping by the vagina wall when the dilation probe is in use to maintain the position of the dilation probe.

7. An intravaginal dilation therapy wand as claimed in any one of the precedingclaims wherein the dilation of the dilation balloon is controllable between a contracted position and a fully dilated position.

8. An intravaginal dilation therapy wand as claimed in any one of the preceding claims wherein the at least one EMG electrode is surface embedded, surface printed or similarly provided relative to an external surface of the dilation balloon, to position the at least one EMG electrode relative to an outer surface of the dilation balloon.

9. An intravaginal dilation therapy wand as claimed in any one of the preceding claims wherein further comprising one or more expansion portions provided between the at least one EMG electrode and other portions of the dilation.

10. An intravaginal dilation therapy wand as claimed in any one of the preceding claims wherein the at least one EMG electrode is connected to at least one electrical connection provided in the umbilical tether to convey information therethrough.

11. An intravaginal dilation therapy wand as claimed in any one of the preceding claims wherein the at least one EMG electrode is shaped to maximise surface contact with muscle tissue of a user's body.

12. An intravaginal dilation therapy wand as claimed in any one of the preceding claims wherein the at least one EMG electrode has an elongate stem extending from an external end of the dilation balloon toward an insertion tip with an enlarged lobe portion provided the dilation balloon.

13. An intravaginal dilation therapy wand as claimed in any one of the preceding claims wherein the elongate umbilical tether is attached to the dilation probe to communicate an inflation medium to and from the dilation probe providing afluid connection to the dilation probe and providing an electrical connection for the muscle activity information.

14. An intravaginal dilation therapy wand as claimed in any one of the preceding claims wherein the dilation balloon has different material cross sections about the at least one EMG electrode to minimise or prevent material stretching.

15. Preferably, the at least one EMG electrode may be provided to be no thicker than the thickness of the dilation balloon, or at least, extend only minimally further outwardly from the surface of the dilation balloon, if at all.

16. An intravaginal dilation therapy wand as claimed in any one of the preceding claims wherein further comprising an identifying NFC or ID chip allowing the identification and tracking of the use of each dilation probe.

17. An intravaginal dilation therapy device for physical therapy, the device comprising an intravaginal dilation therapy wand as defined in any one of claims 1 to 16 and a remote drive unit to control function of the dilation probe and comprising a drive unit software application.

18. An intravaginal dilation therapy device as claimed in claim 17 wherein the remote drive unit provides inflation medium to the dilation probe, as well as monitoring control functions of the drive unit and dilation probe and also record muscle activity information captured from the at least one EMG electrode on the dilation probe.

19. An intravaginal dilation therapy device as claimed in claim 17 or claim 18 wherein the remote drive unit further comprises one or more reference EMG sensing electrodes to be located against a user's skin.

20. An intravaginal dilation therapy device as claimed in any one of claims 17 to 19 wherein the remote drive unit further comprises one or more communication pathway to allow the drive unit software application to interface with a software application provided on a remote computing device.

21. An intravaginal dilation therapy device as claimed in any one of claims 17 to 20 wherein the remote drive unit further comprises a pneumatic pump to receive air and force the air into the dilation balloon via the umbilical tether.

22. An intravaginal dilation therapy device as claimed in any one of claims 17 to claim 22 wherein the remote drive unit further comprises one or more manual control buttons.

23. An intravaginal dilation therapy device as claimed in any one of claims 17 to claim 22 when dependent on claim 16 wherein the drive unit software application tracks the use of each dilation probe and alerts the user when the dilation probe should be replaced.

24. A charging dock and storage pod for an intravaginal dilation therapy device for physical therapy, the charging dock and storage pod device comprising:a. A dilation probe to be inserted into the vagina, the dilation probe comprising:i. A central probe body with at least one inflation / deflation opening therein;ii. A dilation balloon mounted relative to the central probe body and sealed relative to the probe body to inflate and deflate via the at least one inflation / deflation opening;iii. At least one electromyography electrode provided relative to an external surface of the dilation balloon to capture muscle activity information during operation;b. A remote drive unit to control function of the dilation probe and comprising a drive unit software application; andc. An elongate umbilical tether provided between the dilation probe and the remote drive unit to communicate an inflation medium to and from the dilation probe,the charging dock and storage pod comprising:10a. a hollow body with an internal storage hopper to receive the dilation probe therein; andb. a charging dock provided relative to an upper end of the hollow body and comprising an opening therein to receive the dilation probe therethrough, a charging seat to releasably hold the remote drive unit during charging, and a charging mechanism to charge the remote drive unit whilst in the charging seat.

25. An intravaginal dilation therapy system comprising an intravaginal dilation therapy device as claimed in any one of claims 1 to 16, a charging dock and storage pod as claimed in claim 24; and a software application operating on a remote computing device to interface with the drive unit software application to receive the muscle activity information from the dilation probe and to display biofeedback information to a user.15

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