INTRODUCTION

The present invention relates to a device and method for measuring the presence and magnitude of Pelvic Floor Muscle (PFM) contractions in a female's vagina. PFM, are also known as Levator Muscles (LVs) or Kegel muscles.

Personal exercise devices are in general known, see for instance the Tao devices invented by Yanev which are essentially executive toys, and software solutions to control them, allowing busy office workers or travellers to clench the device between their palms or knees. The Yanev patents are numerous, but include WO2013192084A1 , WO201 1130218A1 , WO201278718A1 , US20130337976A1 , US20130337975A1 , US20130337974A1 , US20120150074A1 , US20110250575A1 , US8343013B1 and US8172723B1.

However, we are focused on muscles within the core of the abdomen and pelvis, principally the PFMs. These are well known, but very hard to exercise due to their presence deep within the core of the body (abdomen). In contrast to say exercising an arm muscle, it is very hard for an individual or an instructor or health care professional to actually know whether the PFMs are being exercised, other than by conveying a feeling, which is open to misinterpretation. Not only is it advantageous to have a strong core to prevent back and other postural problems, there are also various conditions associated with damage to the PFMs, for instance through having undergone pregnancy and labour, or simply having weak PFMs (which may cause stress incontinence, sexual problems and prolapse).

Various attempts have been made to resolve this. US2014/016945A1 discloses a hinged, spring loaded and purely mechanical device. This looks unattractive for use in such a sensitive area and collects no data. For example, US8147429 (B2) teaches the use of a whole "station," based around a table or chair. This is best described as a research tool. US5483832 and EP0583456 teach the use of a pneumatic device with deformable chambers. However, pneumatic devices are not terribly sensitive nor reliable. Similarly, EP1034016(B1) discloses the use of an inflatable system.

A lot of approaches focus on EMG, for instance EP2029220B1 which relates to a device comprising electrodes which are positioned at several locations along the length and around the circumference of a vaginal probe, the electrodes detecting EMG signals. The use of electrodes is fiddly and so it is hard to ensure correct private use, as well as being unattractive. Furthermore, inter-day reliability is low. US8340786B2 relates to a device and method for treatment of urinary and faecal incontinence. The device is invasive as it inserts an electrode into the patient's muscle to stimulate it. The present device takes a comparatively noninvasive approach, which is furthermore based on sensing not stimulating the PFMs.

WO2013147992A1 has a plurality of tactile sensors around its periphery, i.e. on its external face, to directly contact the vaginal wall, allowing it to record the elasticity of the vagina, which is useful in diagnosing certain muscle deformations such as womb prolapse.

WO2012079127A relates to an apparatus (including a user interface) and a sensor for determining PFM contractions. The apparatus displays pre-determined (basal level) contraction strength and then compares the actual contraction strength that the device is reading. However, the focus is also on ridges at the rear of the housing to keep the device in place in the vagina, whilst also using a pneumatic sensor.

One of the issues with these types of devices is that they can fail to provide a consistent transfer of force (consistent force reading) to the sensor. Furthermore, the mechanism around the sensor can often jam, meaning a false-negative result may be recorded when in fact a contraction occurred or was attempted. Providing a delicate sensor encompassed within the device housing is also advantageous in terms of preventing damage, but again jamming is an issue.

SUMMARY OF THE INVENTION

Surprisingly, we have developed an elegant device which allows only a single force sensor to be used (although more are possible) and a mechanism for providing this inside (encompassed within) the housing of the device. The mechanism reduces or prevents the housing jamming (especially the moving parts) and enables forces to be recorded by a single sensor despite contractions across several possible areas of contact on the housing. The strain of high impact sports like running, too much weight gain or pregnancy and childbirth can damage the PFMs and lead to physical and sexual problems for one in three women. Our novel product promotes better core stability, sex and overall health.

Accordingly, in one aspect, the invention provides a device for measuring the presence of Pelvic Floor Muscle (PFM) contractions when located within the vagina of a female subject, the device comprising:

a housing having a body;

a force-sensing sensor encompassed within the body of the housing; and

a data receiver to receive data from the force-sensing sensor;

the housing body comprising first and second parts which are slidable together: the first part comprising a protruding finger; and

the second part comprising a guide well to receive the finger;

the two parts of the housing being slidable together, upon contraction of one or more PFMs, so as to exert force on the force-sensing sensor.

In a further aspect, the invention provides a device for measuring the presence of Pelvic Floor Muscle (PFM) contractions when located within the vagina of a female subject, the device comprising:

a housing having a body;

a force-sensing sensor encompassed within the body of the housing; and

a data receiver to receive data from the force-sensing sensor;

the housing body comprising first and second parts which are slidable together:

the first part comprising a protruding finger; and

the second part comprising a guide well to receive the finger;

the two parts of the housing being slidable together, upon contraction of one or more PFMs, so as to exert force on the force-sensing sensor, wherein the device further comprises a rotational dampener.

Preferably, this device allows both the presence and magnitude of PFM contractions to be determined and, in particular, measured. Advantageously, the frequency and/or duration of the contractions may also be measured.

The guide well may cooperate with and receive the finger. This means that the finger moves within the well (in a defined axis, e.g. its longitudinal axis and preferably along or substantially parallel to the Y axis shown in Figure 10B). The well cooperates with the finger as the outer face of the finger may abut against the inside face of the well. The well therefore guides the finger to move within it. This arrangement allows the finger to slide smoothly along this axis of movement within the guide well. This prevents jamming. This is especially when the force may be applied in a direction that is not along (but it might be parallel too) the longitudinal axis of the finger. For example, all the force could be applied to the nose of the device, but this needs to be effectively transmitted to the finger and guide well and without the two jamming or clutching.

In particular, the finger and the guide well work together to ensure that a consistent force transfer occurs, or to facilitate this. In other words, they work together to allow force to be transferred through the finger to the force-sensing sensor. In particular, force is transferred through the finger to the force-sensing sensor which therefore registers that a force was applied to the housing regardless of where the force is applied to the housing or the direction that the force is being applied to the housing. Both the guide well and the finger are preferably the same shape, for instance square or rectangular, so that the finger slides easily within the guide well and with minimal clearance. Having minimal clearance typically reduces jamming, although the use of ribs as described herein is also useful.

The force-sensing sensor may be a force-sensing unit, force transmission sensor or any sensor that can measure or monitor force. Preferred examples include a strain gauge, load cell and, most preferably, a Force-Sensitive resistor (FSR). The actual nature of the force- sensing sensor is not critical provided it can determine the force exerted on it. Ideally, an FSR is used as it is compact and allows the user to rapidly determine the force and any fluctuations over time as FSRs typically have millisecond sensitivity and this is only likely to improve over time.

Preferably only a single force sensor is required within the housing. This is because the present arrangement has been designed to be ideally adapted for only a single force sensor. A downside to having multiple force sensors is calibration between them.

The housing body may be covered with a suitable skin. This will need to be biocompatible and a typical example would be a silicone mould. It preferably engages the housing body through a suitable groove provided along one of the main axes of the device (X, Y or Z, see below).

The housing body may be egg-shaped or an elongated egg shape, orientated along the axis of vagina, so that the longer dimension of the egg (from its pointed tip to its rounder end, for example) is orientated along or substantially parallel to the axis of the vagina, see for instance the X axis in Figure 10B. It should be suitably sized to fit within the vagina of the contracting female. The egg is of the avian variety in terms of shape, with a slightly rounded bottom and a more pointed top portion, when aligned along the axis of the vagina, with the rounded bottom preferably orientated towards the vaginal opening. In some embodiments, it is preferred that the rounded bottom of the egg is orientated towards the vaginal opening. In other preferred embodiments, it is preferred that the rounded bottom of the egg is orientated away from the vaginal opening. It is ideally sized to be inserted within the vagina, such that at least 50% and more preferably at least 75% and most preferably more than 90% of the device can be placed within (inside) the vagina (i.e. within its lumen). Some elements may protrude, such as wires, provided that the bulk of the housing is positioned within the vagina. The shape may also be oval, similar in shape to a rugby-ball or a standard 400m running track, when orientated as above. Of course, vagina size may vary across or between populations and so the outer circumference and length of the device may be adjusted accordingly. To assist with this, the device may also comprise a further housing that increases one or both of the circumference and/or length of the device. This further housing may in fact be a further skin and it is simple to produce a further skin. The further housing or skin may increase in diameter (if measured as a circle in cross-section, or the equivalent circumference to this diameter if the cross-section is not substantially circular) for instance by as little as 5mm or at least 1 , 2, 3, 4, 6, 7 or even 8, 9 or 10mm for a human, but typical ranges would be 0.5-6mm; 1-5mm; 2-6mm; 2-7mm, 1- 3mm or, most preferably, 2-5mm. The equivalent increase in circumference for a 5mm increase in diameter is approx. 15.7mm based on a circular cross-section (circumference being nd or 2τττ). If the device is to be used under other circumstances, say for instance with smaller or larger humans or even non-human mammals, such as livestock, then it can be sized according to the relative vagina size of the individual, either through the housing body itself or through a further housing.

The device may be largely orientated around, i.e. along, the axis of the vagina. The axis of the vagina is a line running along the lumen of the vagina into which the device fits when inserted. The axis of the vagina may therefore be considered to be the X axis, the line along which the device is most easily inserted or removed (so may be thought of as "forward to backward" or vice versa). The device is preferably elongated or tear-shaped along this axis, so that this axis may be considered to be the longitudinal axis of the device. This allows the device to fit in an anatomically appropriate (and therefore comfortable) manner. For the further purpose of providing an exemplary orientation, the axis vertically perpendicular to the axis of the vagina described herein typically runs from the "top" of the device to the "bottom" of the device. This may be considered to be the "Y" axis (so may be thought of as "up to down" or vice versa). The "Z" axis is therefore, according to this exemplary orientation, the axis horizontally perpendicular to the axis of the vagina (so may be thought of as "left to right" or vice versa).

The "X, Y and Z" axes are shown in Figure 10 B.

The circumference may be considered to be the distance around the widest portion of the device, which is preferably substantially circular or ovoid or elliptical in cross section, when viewed across the plane that falls perpendicular (horizontally perpendicular and vertically perpendicular) to the axis along the vagina, for instance by cutting the device in half between a nose and a tail. A substantially elliptical cross-section (i.e. an ellipse), when viewed along the axis of the vagina, is advantageous as it helps to stabilise the device in use, for instance by preventing the device from rotating along (in the sense of around or about) the axis of the vagina, as shown as "roll" in Figure 10B. Furthermore, combined with the sling-shaped nature of the PFMs this ellipse shape helps to stabilise the device during contractions which are typically along the anterior-posterior axis of the individual.

The device is preferably elongated along the axis of the vagina. In one embodiment, the device may be elongated towards the rear of an egg shaped device (the rear being the end closest to the vagina entrance once the device has been wholly inserted into the vagina). In another embodiment, the device may be elongated towards the front of an egg shaped device. The housing preferably comprises a nose at one end and a tail at the other and is preferably also elliptical in cross-section. It may have a rounded nose to aid insertion into the vagina, such that the device is substantially tear-drop-shaped. The elongated nature of the device helps control pitching and/or yawing.

A suitable, non-limiting, example of a shape for the housing(s) of the device is provided in the figures.

In some embodiments, the force-sensing sensor cooperates with the housing (so as to detect PFM contractions exerted on the housing). The force-sensing sensor is touched continuously or temporarily by an element connected to the housing such that, as the PFMs contract, the load is brought to bear on the force-sensing sensor. Some resilience or bias may be useful to separate the element for the force-sensing sensor, although this may be the natural resilience of the housing itself, a spring or resilient leaf may also be used, for example.

Although PFMs are discussed herein, it will be appreciated that, although not preferred, other muscles may contribute to exerting force on the housing.

Advantageously, the protruding finger slides inside, i.e. is received within, the guide well. Upon PFM contraction, this is either initiated or, ideally, the protruding finger merely slides further within the guide well. This arrangement helps to convey a consistent transfer of force to the force-sensing sensor regardless of the where the housing is contacted by the vagina or if the device has rotated slightly along (in the sense of around or about) the axis of the vagina. The device shown in WO 2013/147992 has a number of pressure sensors on the surface of its housing. This is specific for the role that device is designed for, namely measuring the tactile elasticity of abnormal vaginas (typically in elderly patients, where the vagina can become prolapsed). However, this arrangement does not allow those pressure sensors to be replaced with force-sensing sensors and still allow the device to be used to measure the presence and magnitude of PFM contractions. For this to be accurate, we have found that the force-sensing sensor needs to be internal. In other words, the force-sensing sensor needs to be encompassed within the device, hence the present device comprising a housing having at least two parts which slide relative to one another, preferably one within the other.

An anti-clutch mechanism is provided to stop (or alleviate or reduce the likelihood of) the protruding finger, and the guide well which receives it, from jamming.

A feature that can be provided to prevent jamming is a rib or protrusion on one or other of the faces of the protruding finger and/or guide well. For example, those faces of the guide well and finger which may contact each other when the PFM contractions cause the finger to move (slide) into the guide well.

The protruding finger is preferably joined to a first part of the housing and the guide well is preferably joined to a second part of the housing. The protruding finger substantially fits within the guide well and is slidable in and out of it as the housing parts are compressed together, i.e. by a contraction of the PFMs. The housing may be formed such that the first and second parts are integral, i.e. made of one piece. This is provided that they are able to move relative to each other under pressure from the PFMs.

Although the slidable movement of the finger within the guide may only be a few millimetres, or even less than 1 mm at the guide well, it is preferred that the device comprises or is a biasing means such as a spring or a dampening material (such as sheet rubber). This may be between the first part of the housing and the Force-Sensing Sensor. In particular, it may be positioned between the end of the finger (of the first part) and the Force-Sensing Sensor. This is exemplified in Figure 3. This serves to improve stability in the force reading and also to protect the sensor from harsh impacts. This may be achieved via a hinge or suitable flexibility in the parts of the housing.

The dampening material may also be otherwise positioned elsewhere between the first and second parts of the housing body. Alternatively, inherent resilience within the housing may be used. These serve to separate the end of the finger from the force-sensing sensor, for example when no load is applied i.e. at the end of a contraction.

The protruding finger may preferably comprise a single horizontal rib or protrusion (or two, three, four or more of such ribs or protrusions) on a face of the finger. In addition or separately, the protruding finger may preferably (further) comprise a single or pair of vertical rib(s) or protrusion(s) on a (further, preferably adjacent or substantially perpendicular) face of the finger. Preferably, the finger may comprise two horizontal ribs - one on a 'forward' face of the finger (proximal to the front of the device) and one on an opposing 'backward' face of the finger (proximal to the rear of the device). An example of this is shown as ribs 11 in Figure 9. There are preferably two pairs of vertical ribs (on opposing faces of the finger). In some preferred embodiments, the finger comprises two horizontal ribs and four (for example two pairs) of vertical ribs, with the two horizontal ribs on one pair of opposing faces of the finger and the four vertical ribs arranged on a second pair of opposing faces. The two pairs of opposing faces are different - one pair run in parallel to the Y and Z axes shown in Figure 10B, whilst the other pair run in parallel to the X and Y axes shown in Figure 10B.

Horizontal herein means in a plane substantially perpendicular to the longitudinal axis of the finger and vertical means in a plane substantially parallel to the longitudinal axis of the finger. The finger may also be referred to as a tower.

These arrangements are most easily envisaged in relation to a substantially square or rectangular cross-sectioned finger. However, other shapes are envisaged, as discussed herein, with a similar arrangement of ribs or protrusions. The guide well and the finger are preferably corresponding in shape (when ignoring any ribs or protrusions etc.).

The ribs are preferably provided in opposed pairs, one on each opposing face of the finger. For example, a pair of opposed horizontal ribs may be provided on the finger, one on each of the faces of the finger perpendicular to the axis of the vagina. A pair of opposed vertical ribs may be provided on the finger, one on each of the faces of the finger parallel to (in the same plane as) the axis of the vagina. There is preferably one pair of horizontal ribs. There is preferably two pairs of vertical ribs.

Alternatively, the vertical ribs, preferably two opposed pairs, may be on opposed internal faces of the guide well, or there may be a mixture of vertical ribs with one member of a pair of opposed vertical ribs positioned on one face of the finger and the other member of the pair positioned on the guide well, but on the other side of the finger. Essentially, it is envisaged that one of the vertical ribs may be on either the face of the finger or on the face of the guide well, provided that they are not on abutting faces. The same also applies to the horizontal ribs as they can be on the finger or the guide well. Combinations of horizontal and vertical ribs are envisaged, with some ribs on the guide well and some on the finger.

In this embodiment, the walls of the guide well are preferably substantially in the same plane as (parallel to) the direction of insertion of the finger into the guide well and are therefore not relieved as described below. There may be some variance on this, for example +/- 5 degrees, but preferably +/- 1 degree, but it is preferred that the walls of the guide well are parallel to the direction of insertion of the finger into the guide well, bearing in mind manufacturing tolerances. Preferably, the direction of insertion of the finger into the guide well is, or is substantially parallel to, the Y axis shown in Figure 10B. The finger and guide well are preferably arranged so that they are perpendicular to the axis of the vagina. Similarly, the finger and guide well are preferably perpendicular to the (plane of) the sensor. In both cases, the finger and guide well axis referred to here is preferably substantially parallel to the Y axis shown in Figure 10B.

It is preferred that the finger and/or the guide well are substantially circular, substantially rectangular, substantially oval or substantially similarly shaped in cross-section, when viewed along or parallel to the Y axis shown in Figure 10B. In particular, it is preferred that the finger is substantially square in such cross-section. It is preferred that the finger and guide well are both substantially the same shape in cross-section, when viewed along or parallel to the Y axis shown in Figure 10B. Depending on the shapes used, the face may be a side or surface and is typically opposing another similar face, especially with reference to the positioning of any ribs or pairs of ribs.

A rotational dampener is preferably also provided. It is preferably part of a (or the) anti-clutch mechanism which may also comprise the finger and guide well. The rotational dampener serves to prevent the first and second housing parts from rotating relative to one another.

In particular, the rotational dampener functions to reduce or prevent he first and second housing parts from rotating relative to one another around the Z axis shown in Figure 10B, also referred to as pitching. In other words, the rotational dampener reduces or prevents jamming or clutching together when the two parts slide together or are under force (when force is exerted upon the housing by the PFMs). In this way, the force exerted by the PFMs can be more accurately determined by the force-sensing sensor. This is especially useful when the force exerted by the PFMs is not directly aligned with (along) the longitudinal axis of the finger. The rotational dampener therefore works in concert with, i.e. cooperates with, the finger and guide well to achieve this.

It will be appreciated that the force is typically exerted upon contraction or partial contraction of one or more of the PFMs.

The rotational dampener is preferably an anti-roll bar. The anti-roll bar is preferably a closed loop. Ideally, it is rectangular with the longest sides running parallel to the X axis, i.e. along or parallel to the axis of the vagina.

A closed loop is preferably continuous or functionally equivalent. In some embodiments, the closed loop is similar to a 400m running track in shape, although the corners may be tighter or sharper, i.e. up to perpendicular. The closed loop may be formed continuously as a single part or mould or it may be joined, e.g. by welding. If there are separate ends, they preferably abut each other to provide a loop that is essentially continuous. The closed loop is preferably a closed rectangular metal loop.

The rotational dampener, preferably an anti-roll bar, serves to control and minimise movement of the finger in the housing rotating along the axis of the vagina, in the sense of nose and tail of one housing part pitching relative to that of the other part of the housing. The role of the rotational dampener, preferably an anti-roll bar, is to thereby prevent the finger comprising part and the guide well-comprising parts of the housing compressing unevenly, i.e. pitching (see the Z axis in Figure 10 B) with respect to each other, which will lead the finger to jam in the guide well. In other words, the rotational dampener is advantageous, especially if used in combination with the horizontal ribs, as it stabilises the pitching of the housing under compression (from the PFMs for example) which could lead to the finger jamming inside the guide well.

The anti-roll bar is preferably clamped to one part of the housing (for example the part comprising the guide well) to retain it in contact with the housing. The anti-roll bar is free to rotate under this clamp. It is also allowed to move within a groove in the (or an) other part of the housing (in this example the part comprising the finger, although the opposite arrangement is also envisaged). This groove allows the anti-roll bar to slide back and forth during any compression of the housing to accommodate movement of said housing parts along the axis perpendicular to the axis of the vagina.

WO 01/377332A1 (Medscand Medical) and its US continuation (US6905471 B2 in the name of one of the inventors, Leivseth) relate to a device for use inside the vagina or rectum. These may comprise a single sensor in one half of the body and a lever arrangement in the other half to press on the sensor. Preferably, the present invention does not rely on levers to transmit force from one half to the other half, as additional moving parts like this can introduce inaccurate tolerances and make the unit more costly to produce. Instead a finger and guide well arrangement are provided.

Alternatively, the WO 01/377332A1 and US6905471 B2 device may comprise at least two sensors and two corresponding pins to press on them. In contrast, the present invention only preferably requires one sensor. The advantages of using a single sensor, as we do, are found in reduced size and cost. For example, use of a single sensor in the present application would allow an approximately 50% reduction in size which the manufacturer can choose to exploit or not, depending on the size required, but having the option of being able to reduce the size of the device is useful, not least to address different anatomies and improve the feel of the device in use. The WO 01/377332A1 and US6905471 B2 device also requires a vibrator to provide feedback, which we don't necessarily require. As such, in some embodiments, the present invention comprises a vibrator (for example a device capable of providing a haptic, rattling or vibratory sensation to the user). However, in other embodiments, the present invention does not comprise a vibrator.

Importantly, the WO 01/377332A1 and US6905471 B2 device lacks a rotational dampener, and in particular, an anti-roll bar, which are especially preferred in the present invention.

In the present invention, the finger is preferably square or rectangular in cross-section (when cut across a plane parallel to the axis of the vagina, in other words perpendicular to the Y-axis or parallel to the Y-axis and X-axis as shown in Figure 10B). It may also be an ellipse in said cross-section, which although it may lack all 4 faces, has corresponding positions along it where ribs, if used, may be placed analogously to herein described with reference to a square or rectangular cross-section.

The guide well is shaped to accommodate the finger and is typically of the same overall shape (discounting any ribs on the finger). Ideally, the guide well is sized to allow a snug fit with the finger (including any ribs thereon) as this reduces the chance of jamming during compression. Preferably, the finger and/or the guide well have a substantially straight axis which is perpendicular to the axis of the vagina (i.e. along the Y axis of the device as orientated above).

The first part of the housing may comprise an upper part, whilst the second part of the housing may comprise a middle and a lower part. One part, preferably the housing upper part, may preferably also comprise a beam which cooperates with one or more (preferably two) posts on or in the other part, preferably on or in the middle part. This arrangement functions to prevent yawing movements. The beam is preferably of an H-shape in cross section so that one or more of the posts fit between the cross-bar of the H shape. Alternatively, as shown in Figures 10A and 10B, one or more, preferably two, posts abut the two exterior faces of the Ή'. In some embodiments, the beam may be an alternative shape such a bar or cross shape instead of an H shape in the same cross section. As such, the beam may be, in said cross section, any one of the following: H, -, + or x.

The position of the or each force-sensing sensor is internal, so that it may be encompassed within the housing. Thus, the force-sensing sensor is not at, near or on the periphery of the device. Instead, it is preferably positioned between two parts of the housing. Most preferably, the force-sensing sensor is positioned along the axis of the vagina which runs through the central nose-tail axis of the device (the X axis described herein). It is additionally preferable that the sensor is parallel to the Z-axis. These axes are shown in Figure 10B. It will be appreciated that the PFM contraction(s) exert force on the force-sensing sensor through or via the finger which presses (directly or indirectly) on the force-sensing sensor. It will also be appreciated that reference to the Pelvic Floor Muscle (PFM) or Muscles (PFMs) is interchangeable and may refer to a single muscle or group of muscles.

The positioning of the anti-clutch mechanism within the housing is such that the alignment of the finger and guide well is preferably central along the Z Axis. It may vary in position along the Y axis (i.e. 'higher' or 'lower' when viewed in Figure 10B, for example). In some embodiments, is approximately 1/3 distance along X axis from the bottom/tail when egg or elongated egg-shaped. This enables it to be largely aligned with widest portion of egg (the bottom, more rounded part of the egg being at the tail). Ideally, the positioning of the anti- clutch mechanism is such that it is approx. 10-20mm, and most preferably about 15mm (in an average adult female and corrected accordingly if not), from the bottom of the device when measured along the axis of the vagina. It is most preferable that the positioning should be such that it aligns with the PFMs. These are typically 15mm above introitus. The bottom or tail of the device preferably abuts or is substantially adjacent the introitus when positioned in the vagina.

The present device is suitable for measuring the presence and magnitude of the Pelvic Floor Muscles (PFMs), i.e. the force exerted by the Pelvic Floor Muscles (PFMs). The force-sensing sensor is able to detect the presence of a contraction, i.e. a binary answer (yes or no) to the question of whether a contraction has occurred. What is particularly useful is that the force- sensing sensor is also capable of determining the force exerted per contraction. This data can be mapped over time to build up a pattern of contractions during a session or to compare between sessions.

The data may be stored and sent (transmitted or downloaded) to a computer, smartphone or other such device.

Thus, in a further aspect, the invention also provides a method of treating conditions associated with weak or impaired PFM function, including urinary or faecal incontinence or post-labour issues or damage, comprising use of the device to determine the presence and optionally the magnitude of force exerted by one or more PFM contractions. Optionally, this may be assessed over time by comparing magnitude data collected from the force-sensing sensor and determining a change in said magnitude over time. This may be over the course of a single session, or over multiple sessions. A course of physiotherapy may be suggested or amended to reflect any changes determined. The frequency of the contractions may also be assessed as part of this determination. Provided is therefore a method of treating conditions associated with weak or impaired PFM function comprising:

I. insertion of the device in the vagina of a female subject in need thereof;

II. determining the magnitude of force exerted by one or more PFM contractions and, optionally, the frequency of said contractions (if more than one); and

III. providing feedback to the subject on the contractions.

The feedback provided to the subject on the contractions may include an assessment of the strength of (force exerted by) the or each contraction. As mentioned above, the data may be stored and sent (transmitted or downloaded) to a computer, smartphone or other such device.

Accordingly, this method may be part of a course of treatment that may be provided or administered by a physiotherapist.

The condition(s) associated with weak or impaired PFM function may include conditions associated with weakness of the PFMs due to, for example, inactivity: or damage to the PFMs, for instance through having undergone pregnancy and labour. They may also include simply having weak PFMs (which may cause stress incontinence, sexual problems and prolapse). Accordingly, methods of treating stress incontinence, sexual problems and/or womb or vaginal prolapse are provided.

The present device and methods promote improved core stability (including treatment of back and postural problems), sex and/or overall women's health.

A device for use in methods of treatment is also provided.

Although the device may be used in methods of medical treatment, it may also be suitable for and used in personal training, exercise and/or wellness programmes. For instance, programmes that are devised and administered by those that are not health care professionals, for instance the user herself, for example self-administered and monitored programmes. As such, the device itself may be referred to as a personal wellness or personal exercise device.

The present anti-clutch mechanism may also have a number of other uses. For instance, it is envisaged that it could be used in a button or a key. The button or key may sense whether force has been applied to it and optionally, the magnitude, duration and/or frequency of the force being applied. Thus, in a further aspect, there is provided a key comprising an anti-clutch mechanism as described herein. In particular, there is provided a key suitable for use in a keyboard comprising a housing body comprising first and second parts which are slidable together: the first part comprising a protruding finger; and the second part comprising a guide well to receive the finger; the two parts of the housing being slidable together, upon force being applied to the housing body, so as to exert force on the force-sensing sensor. The rotational dampener, in particular the anti-roll bar, is also preferably included. Particularly preferred features include the one or more ribs as discussed herein.

The force being applied to the housing body will, for example, be a user pressing on the housing body (for instance as part of a keyboard). The terms key and button may be used interchangeably here, provided that either require a force to be detected. The key may form part of a keyboard, for instance a computer keyboard, or a keypad, for instance on an electronic locking mechanism or in a lift. Accordingly, a keyboard or keypad comprising one or more of said keys is also provided.

BRIEF DESCRIPTION OF THE FIGURES

The invention will now be referenced with respect to the accompanying drawings wherein:

Figure 1 shows an underside view of the device 1 (i.e. looking up the Y axis of the device);

Figure 2 shows a nose - end view taken along the line A-A in Figure 1 ;

Figure 3 shows a tail - end view taken along the line B-B in Figure 1 , with a sectioned anti-roll bar 7;

Figure 4 shows a tail - end view taken along the line B-B in Figure 1 , where the anti-roll bar 7 has not been sectioned;

Figure 5 shows a tail - end view;

Figure6 shows a side-on view taken along the line C-C in Figure 5; Figure7 shows a side-on view without the cut-away seen in Figure 6; Figure 8 shows a partially exploded perspective view of the device; Figure 9 shows a side view of the upper part 3 of the housing 2; and Figure 10 A shows an underneath perspective view of the upper part 3 of the housing 2, whilst Fig 10 B shows the axes of the device referred to herein. Arrows D and E show the direction of insertion into the vagina (which is along the axis of the vagina);

Figures 1 1 and 12 show block surfaces useful for keys.

DETAILED DESCRIPTION

The device is configured to determine the presence of one or more PFM contractions. The presence of a contraction can be detected due to the change (increase) in force exerted by the contracting muscle on the housing. This moves or urges the first and second parts together such that the finger presses on the force-sensing sensor and a change is thus detected. Data is sent to, i.e. received by, the data receiver to record this change. The data receiver can also receive data from other sensors if there are more than one force-sensing sensor. It may also be able to process and/or store data. It preferably comprises a Printed Circuit Board (PCB) and may also comprise a data store. The device may therefore collect and store force data.

The force-sensing sensor is typically a Force-Sensitive Resistor. Preferably, it is not a pneumatic sensor.

The device preferably comprises a power source such as a battery, for example a rechargeable battery. A suitable port for re-charging the battery and, optionally, for providing wired data transfer is also provided, ideally at the rear of the device. Alternatively, the device may be re-charged wirelessly.

The device is preferably a standalone unit, i.e. one that does not require any physical linkage back outside the vagina. As such, it may be inserted so that the housing is at least substantially invisible from outside the body. This is in contrast to a number of prior devices that include chair-like devices and so forth.

Slidable may mean moving back and forth within.

A specific embodiment of the device will now be described with reference to the accompanying drawings. As shown in Figures 1 , 2 and especially 3, the device 1 is substantially egg or elongated egg-shaped and has a nose 27 and a tail 28. It is made, for instance by injection moulding, from a moulded hard plastic housing body 2. The housing body 2 includes three parts: an upper 3, middle 4, and lower 5. The middle and lower parts (4 and 5) may be ultrasonically welded together and they clamp the PCB 16 in position. They also clamp one long arm 18a of the anti-roll bar 7, as shown in Figure 3 (and also in Figure 4). The arm is rotationally-free.

The anti-roll bar 7 is typically metal. The anti-roll bar is particularly shown in Figures 2, 3, 4, 6 and 8. It is a closed rectangular loop and may be moulded as such or made by welding two ends of a piece of wire together. It may be made by bending a bar or bars and welding them into one rectangular shape.

Referring to Figure 3, the middle part 4 of the housing body 2 includes a rectangular guide well 8 feature with four vertical side walls 9 (with ideally no draft or relief) which receives the finger 10 of the upper part 3. This is also shown in Figure 4. The guide well 8 is of a similar cross-sectional shape to the finger 10, in this case a square cross section when viewed across the longitudinal axis of the finger 10.

In general, the middle part 4 and the lower part 5 can be considered together and can form a single part.

Referring to Figures 6, 9 and 10 A, the finger 10 of the upper part 3 comprises bumps or ribs (1 1 , 12) projecting outwards. As shown in Figure 6, bumps or ribs 11 engage the vertical side walls 9a of the guide well 8. Bumps or ribs 12 engage the vertical walls 9b (not shown). There are horizontal ribs 11 and vertical ribs 12 and these are parallel to the vertical side walls 9a and 9b, respectively. These serve to stabilise the finger 10 within the guide well 8 and prevent it from jamming when force is applied across the housing body 2 by the PFMs. This anti- clutch mechanism (which may also include the anti-roll bar 7) also allows the presence of a contraction to be detected, largely irrespective of where contact is made or force exerted on the housing body 2. Horizontal ribs 1 1 contact vertical side walls 9a. Vertical side walls 9a are aligned in a plane along the Y and Z axes (shown in Figure 10B). The vertical ribs 12 contact vertical side walls 9b. The vertical side walls 9b are not shown, but aligned along the Y and X axes (of Figure 10B) of the guide well 8 when the finger 10 slides within the guide well 8. This may not necessarily be continuous contact.

As shown in Figures 6 and 9 for instance, the end 13 of the finger 10 furthest from the upper part 3 projects down (along or parallel to the Y axis) into the guide well 8. At the base of the guide well 8 is positioned the force-sensing sensor, a Force Sensitive Resistor (FSR) 14. A circular disc 15 is positioned at the end 13 of the finger 10 so as to contact/press on the FSR 14 upon contraction of the PFMs. The alternative arrangement where the FSR 14 sits at the end 13 of the finger 10 and the circular disc 15 sits at or within the base of the guide well 8 is also envisaged. Once assembled, the circular disc 15 at the end 13 of the finger 10 should sit lightly on top of the FSR 14, without introducing any force. A sheet of damper material (rubber or the like) 31 is provided between the FSR 14 and the end 13 of the finger 10 to protect the sensor 14 from sudden impacts. It also serves to increase the force reading range (e.g. up to 30N instead of 20N). The PCB is shown as 16.

Figure 4 shows the upper part 3 of housing body 2 which also includes a clamp 17 that locates the other long arm 18b of the anti-roll bar 7. The clamp 17 includes a groove 19 (see Figure 4) which allows small horizontal movements of the arm 18b when the device 1 is compressed from the outside. Reference is also made to Figure 8 and Figure 11.

Referring to Figures 4 and 10B, forces applied onto the exterior 20 of the housing body 2 will be transmitted to the FSR 14 sitting on the lower part 5 via movements between the finger 10 and the guide well 8. While the guide well 8 has four vertical sides in opposing pairs 9a and 9b, the finger 10 has double (a pair of) vertical (no draft) ribbings, bumps (protrusions) 12 on two opposite faces 21 a (said faces being aligned along the Y and X axis, with the vertical ribbings (ribs) aligned along the Y axis on said face) and single horizontal ribbings or bumps (protrusions) 11 on the other two faces 21 b (said faces being aligned along the Z and Y axes and said ribbings, bumps (protrusions) being aligned along the Z axis on said face)). These are highlighted in Figure 10 A.

Referring to Figures 10A and 10B, the vertical (no draft) ribbings 12 constrain rolling movements 22 between the top and the middle parts (3 and 4) and ensure alignment between the parts (3, 4 and 5). The horizontal ribbings or bumps 1 1 prevent the parts (3 and 4) from jamming as the two parts (3 and 4) slide. The upper part, towards the nose, has an H beam extrusion 23 which fits between two posts 24 in the middle part 4 to prevent yawing movements 25. The role of the anti-roll bar 7 becomes more and more important as site of application of the forces shift away from the finger 10 and the well 8, i.e. further forward towards nose 27, or further back towards tail 28, but especially the former. When a force is applied across the upper and lower parts (3 and 5), the anti-roll bar 7 prevents the upper and the middle parts (3 and 4) from pitching (pitching movement 26). Preferably, the anti-roll bar 7 stops the parts from contacting directly (which means the force will not be transmitted entirely onto the FSR 14). The anti-roll bar 7 and the extrusion 23 work together to prevent jamming and therefore ensure force transmission to the FSR 14.

Also shown are moulding feature 29 (Figure 1), and groove 30 (Figures 1 and 5) for aligning the skin (the skin is not shown). Similar features will be apparent in Figures 11 and 12, corresponding to Figures 4 and 6, where the housing is adapted to be squared off, suitable for use in a key.

The following features are used in the figures:

1. device

2. housing body

3. upper part

4. middle part

5. lower part

6. Not Used

7. anti-roll bar

8. guide well

9. vertical side walls 9a and 9b of guide well 8

10. finger

1 1. horizontal ribs

12. vertical ribs

13. end (of finger)

14. FSR / force-sensing sensor

15. circular disc

16. PCB

17. clamp

18. long arms 18a and 18b of anti-roll bar 7

19. groove

20. exterior of the housing body 2

21. side walls 21a and 21 b of finger 10

22. rolling movements

23. H beam extrusion

24. posts

25. yawing movements

26. pitching movement

27. nose

28. tail

29. moulding feature

30. groove for aligning the skin (not shown)

31. damper material