Patent Description:
A perineometer is a medical instrument which measures the strength of voluntary contractions of pelvic floor muscles. It widely believed that pelvic floor muscle strengthening leads to a lower likelihood of suffering from urinary incontinence. Typically a kegel exercise is used to improve strength. Several types of perineometers exist, most devices use vaginal pressure in order to provide a correlation to pelvic floor muscle strength.

The group of muscles involved in performing a kegel exercise (and hence responsible for continence) is the levator ani. Making up part of the levator ani is the pubococcygeus and the puborectalis. The pubococcygeus arises from pubis (pubic bone) and inserts into the lateral part of the coccyx (sides of coccyx) and so when contracted, presses bilaterally against the walls of the vagina. The puborectalis arises from the superior and inferior pubic rami (front part of pelvis, either side of pubis) and forms a sling around the rectum. Hence when contracted, it "pulls forward" to aid in closing off the canals. The strength of both is essential in maintaining continence.

Many perineometers currently available measure the pressure change inside the vaginal canal upon muscle contract. These devices have the disadvantage that they do not give any indication of muscle movement or actual contraction force. This may lead to deterioration of a patient's condition of the patient is performing the contraction incorrectly - the problem being that "bearing down" using the stomach muscles can also increase the pressure inside the vaginal canal, thus giving an incorrect indication of muscle contraction.

Known perineometers are described in <CIT>, <CIT>, International Patent Publication <CIT>, International Patent Publication <CIT> and <CIT>. Document <CIT> discloses an intra vaginal device to aid in determining muscle contraction, wherein the sensors are not spaced angularly about the longitudinal axis of the device. Document <CIT> discloses an intra vaginal device wherein the oscillator and the accelerometer are placed along axes parallel to each other.

The device of <CIT> differs from other types of devices through the use of a superior direct muscle force measurement and positioning of the device in the vagina.

The above discussed devices have the disadvantage that they still fail to provide sufficiently accurate information in respect of contraction of the pelvic floor muscle group.

It is the object of the present invention to overcome or substantially ameliorate the above disadvantage.

There is disclosed herein an intra vaginal device to aid in determining muscle contraction, the device including:.

Preferably, the motion detector detects acceleration or at least one linear direction.

Preferably, the motion detector detects acceleration in three mutually perpendicular directions.

Preferably, the motion detector detects angular movement about at least one axis.

Preferably, the motion detector detects angular movement about three mutually perpendicular axes.

Preferably, the motion detector includes a gyroscope.

Preferably, the motion detector includes an accelerometer.

Preferably, said side wall includes a first side wall portion to which the first sensor is attached, and a second side wall portion to which the second sensor is attached, with the second sensor being angularly displaced about said axis from the first sensor by approximately <NUM>° to <NUM>°.

Preferably, said side wall includes a third side wall portion, and the device further includes a third sensor attached to the third side wall portion, with the third sensor being spaced angularly about said axis from the first and second sensors.

Preferably, the third sensor is spaced approximately <NUM>° to <NUM>° from the first sensor.

Preferably, the wall portions are generally planar.

In an alternative preferred form, the wall portions are convex.

Preferably, at least one of the sensors provides an electrical resistance that diminishes with an increase of pressure applied thereto.

Preferably, the sensors are elongated longitudinally of said body.

Preferably, said base is elongated in a direction transverse of said direction.

Preferably, said base is adapted to engage the vaginal entrance to aid in correctly locating the sensors.

A preferred form of the present invention will now be described by way of example with reference to the accompanying drawings wherein:.

In the accompanying drawings there is schematically depicted a device <NUM> to be inserted in a woman's vagina to aid in measuring muscles operatively associated with the women's vagina.

The device <NUM> includes an elongated hollow body <NUM><NUM> having an end portion <NUM>, a base <NUM> and a longitudinally extending side wall <NUM>. The side wall <NUM> includes side wall portions <NUM>, <NUM> and <NUM>. Preferably, the side wall portions <NUM>, <NUM> and <NUM> are generally planar (or convex) and the portion <NUM> generally convex.

The device <NUM> has a longitudinal axis <NUM>.

Secured to each wall portion <NUM> and <NUM> is a sensor <NUM>, while secured to the wall portion <NUM> is a sensor <NUM>. Each of the sensors <NUM> and <NUM> is adapted to provide an indication of the pressure applied thereto. As a particular example, the sensors <NUM> and <NUM> could provide an electrical resistance that increases or decreases with pressure applied thereto, preferably decreases.

Preferably, the sensor <NUM> is spaced angularly about the axis <NUM> by an angle of approximately <NUM>° to <NUM>° from each of the sensors <NUM>.

Preferably, the sensors <NUM> are spaced from the base <NUM> by the said distance. The sensor <NUM> is placed at a desired distance from the base <NUM>, that may be the same or smaller distance from the base <NUM> than the sensors <NUM>. Preferably, the sensors <NUM> and <NUM> are elongated longitudinally relative to the body <NUM>.

Preferably, the base <NUM> is transversely elongated, relative to the axis <NUM>, to aid a user to manipulate the device <NUM> and to aid in correctly positioning the device <NUM> by having the base <NUM> engage the vaginal entrance.

The sensor <NUM> provides an indication of the puborectalis contraction forces, the sensors <NUM> provide an indication of the pressure applied by the pubococcygeus.

The device <NUM> is shaped in such a way that once inserted into the vagina, it is able to measure both modes of contraction. The device <NUM> is inserted in the direction <NUM>. The sensor <NUM> is preferably on top of the device <NUM> and measures the force applied to the device <NUM> by the urethral wall - thus capturing the contraction strength contributed by the puborectalis.

The sensors <NUM> are on the longitudinal sides of the device <NUM>.

The base <NUM> is spaced from the sensors <NUM> and <NUM> so that the base <NUM> upon engaging the entrance of the vagina, correctly locates the sensors <NUM> and <NUM>.

The sensors <NUM> are able to separately measure the force directly applied by the bilateral contraction of the pubococcygeus.

Preferably, the device <NUM> includes an electronic circuit <NUM> (printed circuit board) incorporating the sensors <NUM> and <NUM>. The circuit <NUM> includes a processor <NUM> that interrogates the sensors <NUM> and <NUM> to determine their resistance, and then to provide a signal for a read out <NUM> that provides information in respect of the muscles associated with the user's vagina. The read out <NUM> may be remote from body <NUM><NUM> and communicates via wireless (Bluetooth) with the processor <NUM>.

The circuit <NUM> also includes a motion detector <NUM>. The motion detector <NUM> in one preferred form detects acceleration in at least one direction, and preferably detects acceleration in three mutually perpendicular linear directions. Again the detector is interrogated by the processor <NUM> that provides a signal to the read out <NUM>.

In another preferred form, the motion detector <NUM> is a gyroscope that detects angular movement about at least one axis, and preferably detects angular movement about three mutually perpendicular axes. Most preferably the motion detector <NUM> is a combination of a gyroscope and acceleroraeter. One example of such a device is an Invesense MPU-<NUM> device that also has a standard 12C communications interface.

In one embodiment the motion detector <NUM> is a gyroscope that provides a signal indicative of angular movement about the mutually perpendicular axes <NUM>, <NUM> and <NUM>.

In an alternative embodiment, the motion detector <NUM> provides a signal indicative of acceleration in the directions of the three axes <NUM>, <NUM> and <NUM>.

In a further embodiment, the motion detector <NUM> provides signals indicative of angular movement about the axes <NUM>, <NUM> and <NUM>, as well as acceleration in linear directions along the axes <NUM>, <NUM> and <NUM>.

In respect of the above it should be appreciated that where the motion detector <NUM> provides a signal indicative of angular movement and acceleration, the axes about which the angular movement is measured, and the axes along which the acceleration takes place, need not be coincident. That is the axes about which the angular movement is measured may be displaced from the axes along which the acceleration is measured.

However, most preferably the axes are coincident.

Connected to the circuit <NUM> is a rechargeable battery <NUM>, with the circuit <NUM> provided with a coupling <NUM> that may include a voltage regulator/charge controller. The coupling <NUM> provides for releasably attaching the battery <NUM> to the circuit <NUM>. The circuit <NUM> is also provided with contacts <NUM> that provide for connection of the circuit <NUM> to a power supply for the purposes of recharging the battery <NUM>.

In the invention the circuit <NUM> is constructed so that the motion detector <NUM> is located in or adjacent the base <NUM>.

In operation of the above device <NUM>, the force measurements provided by the sensors <NUM> and <NUM> can also be combined to give an average contraction strength output.

Separation of the measurements enables a more thorough understanding of the overall contraction and may lead to easier diagnosis of incontinence problems, as well as an invaluable teaching aide. There are many factors involved in incontinence, and this may enable clinicians to identify the muscle group that is contributing to incontinence in different case studies.

This specific feedback is also essential in encouraging and maintaining consistency with patients using the device.

The ability to distinguish between the specific muscles and modes of contraction may also be helpful in addressing a common issue of over-clenching of the pelvic floor. Many women suffer from this condition and need to be taught how to relax these muscles. The device <NUM> would be able to offer a more accurate picture of the clenching problem by measuring the full input of each muscle, and possibly pinpointing which area to focus on.

The motion detector <NUM> enables the device <NUM> to provide a more accurate determination in respect of whether the muscle movement correlates to correct exercise, as well as being able to detect a larger range of incorrect movement, that is movement in respect of lift and bearing down. The motion detector <NUM> also provides information in respect of offset angular movement.

Further to the above, the motion detector <NUM> also provides a better indication of whether contractions are correct.

The motion detector <NUM> also enables the device <NUM> to provide orientation detection such that the user's position during exercise can be recorded (standing or lying down, etc) in order to segregate the results.

Claim 1:
An intra vaginal device (<NUM>) to aid in determining muscular contraction adjacent the vagina, the device (<NUM>) including:
a body (<NUM>) to be at least partly inserted into a vagina;
the body (<NUM>) being elongated so as to have a longitudinal axis (<NUM>), an end portion (<NUM>), a base (<NUM>) spaced from the end portion (<NUM>), and a longitudinally extending side wall (<NUM>) extending between the end portion (<NUM>) and the base (<NUM>);
a first sensor (<NUM>), the sensor (<NUM>) being mounted on the side wall (<NUM>) and to provide an indication of pressure applied thereto;
a second sensor (<NUM>), the second sensor (<NUM>) being mounted on the side wall (<NUM>) so as to be spaced angularly about said axis (<NUM>) from the first sensor (<NUM>), and to provide an indication of the pressure applied to the second sensor (<NUM>),
said base (<NUM>) being adapted to engage the vaginal entrance to aid in correctly locating the sensors (<NUM>, <NUM>),
the device (<NUM>) being characterized in that:
a motion detector (<NUM>) is mounted in the body (<NUM>) to detect movement of the body (<NUM>) subjected to muscular contraction adjacent the vagina and to generate a signal indicative of the movement; and
a circuit (<NUM>) is connected to the motion detector (<NUM>) so as to receive the signals therefrom,
wherein the circuit (<NUM>) is constructed so that the motion detector (<NUM>) is in or adjacent the base (<NUM>).