GB2580430A

GB2580430A - A vaginal device

Info

Publication number: GB2580430A
Application number: GB1900459.7A
Authority: GB
Inventors: Taylor Stephanie
Original assignee: Savantini Ltd
Current assignee: Savantini Ltd
Priority date: 2019-01-14
Filing date: 2019-01-14
Publication date: 2020-07-22
Also published as: GB201900459D0

Abstract

The device of the invention includes a plurality of resiliently deformable petals 110 capable of being displaced and a removal bar 140. The device is for insertion into the vagina to provide a means of supporting the vagina walls and therefore other surrounding muscles in order to limit or prevent incontinence. The device is also capable of deformation when force is applied by contraction of the pelvic floor muscles, therefore serving as a means of exercising the pelvic floor muscles by providing resistance so as to improve pelvic floor strength. Also disclosed an insert (200, figure 2) for placement within the device. A method of using the device with the insert is also disclosed.

Description

A VAGINAL DEVICE

Field of the Invention

The present invention relates to a vaginal device, more particularly but not exclusively a vaginal device for aiding in the prevention of stress urinary incontinence (SUI).

Background

Incontinence is an ailment that can affect women at any time during their lives. Typically incontinence involves leakage of urine from the bladder due to incomplete, or weak closure of the sphincter at the bladder neck and reduced functionality of muscles surrounding the urethra that also aid in closure.

These muscles are often referred to as the pelvic floor and weakness in this area results in partial closure of the urethra can lead to leakage during movement, a condition commonly referred to as stress incontinence.

There are two main anatomical causes of stress incontinence. One cause is due to hyper-mobility of the urethra and diminished pelvic support. The area encompassing the urethral, vaginal and anal openings is known as the pelvic floor muscles or pelvic diaphragm and comprises three different muscles. The most important of these is the levator ani complex which is under voluntary control and relaxes during emptying of the bladder. A weak levator ani muscle results in downward displacement of the urethra (hence hypermobility) and consequent reduction in urethral pressure. An increase in abdominal pressure for example, during coughing or sneezing increases the pressure on the bladder and forces urine into the urethra. This is entirely natural and a combination of the muscles surrounding the urethra and the levator ani complex are usually sufficient to prevent urine loss. However, if the muscles are weak then stress incontinence results. The second, rarer, cause of stress incontinence is known intrinsic sphincter deficiency (ISD) and is a result of the failure of the walls of the urethra to contract effectively.

Evidence shows that by strengthening these muscles stress incontinence can be treated. Many women are encouraged to carry out pelvic floor exercises in order to improve strength sand efficiency of the pelvic floor. However performing such exercises requires commitment and it may be difficult to ascertain if the muscles are being exercised correctly.

Incontinence devices have also been developed for insertion into the vaginal passage in order to encourage contraction of the pelvic floor. However such 10 devices are often provided in one size therefore effectiveness for different users may be varied.

Prior Art

A number of patent applications have been filed in an attempt to resolve the problem or similar, including the following: GB-B-2 435 215 discloses a female incontinence device for insertion into the vaginal passage wherein the device has an undulating out surface and a 20 substantially circular cross section with a retraction element at a proximal end.

GB-B-2 364 645 shows a single pieces cylindrical insert tapered towards a top end for insertion into the vagina to support the urethral and bladder wall in use.

GB-B-2401066 relates to a pelvic floor exerciser kit with a head for insertion into a user's vagina and a tail extending from the head, with means for adjusting angle of the tail.

Summary of the Invention

According to the present invention there is provided a vaginal device for improving internal muscle tone comprising: a body, the body is adapted to be received through the vaginal opening and includes a plurality of resiliently deformable petals capable of being displaced and a removal means.

In this way the device can be inserted into the vaginal passage so as to 5 enable improvement of surrounding muscles by a user actively contracting their muscles about the device to deform the petals in order to improve condition and strength of the muscles.

Advantageously presence of the device within the vaginal passage also serves to push against the urethral wall that lies substantially parallel to the vaginal passage. Pushing of the urethral wall can lead to narrowing or closure of the urethra, if not already closed therefore aiding to prevent stress urinary incontinence (SUI) a condition resulting in weakness of surrounding muscle resulting in incomplete or weak closure of the urethra.

Furthermore the device may also provide passive support to the bladder wall to aid in reducing SUI.

Therefore the device provides both a passive and active function wherein: -presence of the device provides support to the pelvic floor and bladder therefore providing passive function - and an active function wherein the user may actively manipulate the device with their pelvic floor muscles.

In preferred embodiments the user performs exercises when the device is inserted into the vagina so as to cause inward deformation of the petals. In this way the muscles are being engaged, typically through controlled contraction and relaxation. Therefore muscle strength and condition can be improved by repeated contraction against the device. In particular the exercises engage the voluntary external urethral sphincter which controls exit of urine from the bladder and the levator ani complex which supports the bladder to prevent downwards displacement which can predispose a person to stress incontinence.

As these muscles are under voluntary control they can be exercised so as to improve condition and strength and thereby reduce/prevent SUI.

In order to improve condition of this muscle, for example to improve strength so as to prevent incontinence the muscle must be worked, by repeated and/or prolonged contractions so as to increase muscle fibres in order to become stronger and thereby larger so as to enable closing of the urethra and support of the bladder.

In preferred embodiments the device is ovaloid. In this way the device has no sharp edges and can be readily inserted into the vaginal passage.

Ideally the device includes a distal end which is inserted first to the vagina and 15 the opposite proximal end which includes a removal means such as a bar or cord so as to allow removal of the device from the vagina.

In preferred embodiments the device includes a proximally mounted cord situate outside of the vagina in use for removing the device Advantageously 20 the cord is flexible so as to be comfortable for the user.

Ideally the cord may be formed from a flexible inner material such as a fine rope or twine, for example cotton or nylon. Typically the cord is coated in an outer flexible synthetic plastic sleeve such as silicone so as to be readily cleaned, for improved hygiene and to maintain the inner material which may degrade after repeated use if not covered Preferably the cord comprises or includes a loop so that the cord may be easily hooked and pulled by the user so as to remove the device from the 30 vagina.

In another embodiment the removal means may be in the form of an elongate bar that extends from the body in the same plane in which the device is inserted It is appreciated that different removal means may be provided for the device.

In some embodiments the removal means may also be used to aid with insertion.

In preferred embodiments the proximal base of the body may have at least indentation to receive a finger or thumb so as to aid with insertion of the device into the vagina. It may be envisaged that the indentations are arranged opposite to one another so as to aid grip during insertion.

Furthermore the proximal base may be flattened so as to provide a flat surface upon which the user can place their finger in order to push the device further into the vagina. Typically the flattened area may correspond to where the cord is fitted.

In some embodiments an applicator may be provided for assisting with insertion of the device.

Preferably the petals are arranged around the distal end of the body so that in use the petals are inserted first. It may be envisaged that the petals extend at least half way along the length of the device and preferably beyond the widest part of the device. In this way the petals can be more readily deformed in use by the user as the widest part typically engages first with the muscles when they are contracted.

In preferred embodiments the device includes at least four petals, although greater or lesser numbers of petals may be provided on different embodiments.

Ideally all the petals are arranged in the same orientation so as to provide an opening at the distal end from which position the petals are displaced inwards under force caused by contraction of surrounding muscles in use, into the hollow of the body.

Advantageously the petals are dimensioned and arranged such that they do not overlap one another when in use. Therefore the petals are less likely to cause pinching of surrounding tissues during use.

In preferred embodiments the body is capable of receiving an insert into the hollow. In this way shape, size and/or mass of the body can be altered by inclusion of the insert. Accordingly the petals may be deformed outwards in order to provide an opening sufficient to receive the insert.

In some embodiments the insert is a weight enabling the overall mass of the device to be increased. Therefore in use the device is biased towards exiting the vaginal passage due to the effects of gravity. In order to prevent escape from the vaginal passage the external urethral sphincter must remain contracted and thereby closed to prevent escape of the weighted device which is pushing down on this muscle.

This action therefore requires increased muscle strength to hold the device within the vaginal passage. An exercise to hold the device within the vagina passage for selected periods of time serves to engage the internal urethral 25 sphincter/pelvic floor muscles in order to retain the device.

The weights are provided in varying mass and/or size. In this way the appropriate weight can be provided to comfortably fit within the vaginal passage and of a suitable mass according to the strength of the user's 30 muscles.

Typically a user with weak or damaged muscles may as a result have less muscle mass and therefore a larger vaginal passage and/or urethra due to reduced muscle. Therefore an insert may be required to increase the size of the device by spreading the petals so that the device can connect with the muscles.

However in such situations the device may still be required to be lightweight as although the device must be larger so as to effectively engage with the muscles, muscle strength is actually reduced therefore the user may be unable to retain a weighted device.

In such situations the insert may be formed from a lightweight material such as synthetic plastic, preferably similar or the same as that of the body. In some embodiments the insert may be hollow so as to be as light as possible.

In other embodiments where the user has developed sufficient muscle strength the exercise difficulty may be increased by use of weighted inserts or weights. Typically thickness of the insert wall may be increased, or the insert may be solid so as to provide necessary mass. In this way the user is able to progress training of the muscles and thereby muscle strength by increasing mass of the weights used.

Accordingly size of the inserts/weight may be reduced to coincide with muscle expansion due to increased build-up of muscle tissue through the strength training. Therefore a heavier weight may be of small size.

In preferred embodiments the device includes a means for retaining the insert(s). Preferably the device may include a rim arranged on an internal face of the body to receive the insert. Ideally the insert includes an annular groove that corresponds to the rim so that the annular groove may receive the rim so as to secure the insert within the hollow of the body. In this way the insert remains fixed in use.

It may be envisaged that the insert is fitted to the body by a detent mechanism or resistance fit.

In some embodiments the device and insert may be designed to provide an audible click or other positive feedback as the parts are connected so as to indicate to the user that the parts are correctly connected.

In a preferred embodiment the insert may be hemispherical in shape. Preferably the insert is dimensioned so as to be seated in the proximal end of the body so as to not interfere with deformation of the petals during use.

In some embodiments the hemispherical insert may include a grip or handle on an upper face when in use so as to enable the grip or handle to be grasped in order to remove the insert from the body. For example the insert may have a tab, pull ring, or lip arranged at the circumference of the device to aid with removal and/or fitting.

In other embodiments the body may be flexed at the proximal end so as to force the insert from the body in order for it to be removed. Typically the body may be formed from a resiliently deformable material so as to allow this.

In some embodiments the inserts may be substantially octahedral so as to sit within the body wherein the annular groove is arranged part way along the insert so as to be accepted by the annular groove provided within the body. Typically the octahedral insert has a narrower top so as to allow the petals to be displaced inwards.

Furthermore the top provides a grip point for where the user may hold the insert whilst fixing it into the hollow body and that may be grasped when removing the insert from the body. In some embodiments the top may include recesses for accepting a finger or thumb so as to aid with grip the insert during fitting and removal from the body.

Ideally the device and inserts are formed from medical grade material such as silicone for example a thermoplastic elastomer such as Santaprene (RTM) or Mediprene (RIM), or medical grade Acrylonitrile butadiene styrene (ABS) so as to be safe for use within the user. Furthermore the device and inserts can be readily washed and are suitable for re-use.

Typically the vaginal device is designed to be suitable for remaining in the body for more than 8 hours and therefore constitutes a class 2 internal device. In this way the device can remain in situ as the user goes about their daily activities knowing that incontinence is begin reduced/prevented by the device.

Preferably in use the device is for insertion part way along the vaginal passage so as not to connect with the uterus or apply any pressure to the uterus opening.

For some uses, such as during more vigorous exercise such as running, the 15 device may be inserted further up the vaginal passage. This serves to provide greater support to the bladder during movement in order to prevent SUI caused by vigorous exercise.

In use the vaginal device is preferably inserted into the vagina opening, typically 4-6 cm deep. In this way the device is located part way along the vaginal passage wherein the device pushes against the vagina walls helping to close the urethra. In this way muscles surrounding the vagina may also be engaged by the user to deform the device and/or hold the device in the vaginal passage.

For the treatment of exercise induced SUI the device may be inserted higher into the vaginal passage so as to be closer to the bladder opening, therefore enabling the device to support the bladder during exercise.

Preferably the body is no longer than 70mm so as to only take up part of the length of the vaginal passage. In this way the user may position the device at chosen positions along the vaginal passage.

Ideally the widest pad of the body is at least 30mm and preferably 34mm, when the petals are closed. It may be envisaged that displacement of the petals by means of the inserts may increase body width up to 50mm. Therefore allowing the device to engage with different width vaginas.

Typically where the user has reduced or weakened muscles the vaginal passage is wider due to reduced muscle tone. Therefore a larger device may be inserted so as to engage with the vagina walls in order to push against them and perform its passive function. For example the body accepts the insert to spread the petals thereby making the body wider. In this way the petals are spread so that they engage with the wall of the vaginal passage. Advantageously therefore lesser contractions of the muscles are typically required in order to deform the petals.

Preferably the user will perform exercises to contract and relax the pelvic floor muscles thereby applying force to the device to cause deformation and the device providing resistance against the muscles so as to increase exercise intensity. It may be envisaged that contraction of the internal muscles applies force to the body and thereby the petals causing then to close and/or flex in response to muscle contraction. The action of closing or flexing the petals requires force that is provided by the pelvic floor muscles, therefore requiring the muscles to work. Repetition of such exercises improves muscle condition and strength.

Typically the petals are bias to return to their original position therefore a user must maintain muscle contraction in order to keep the petals closed or flexed. It may be envisaged that exercise may require the pelvic floor muscles to be contracted and held for periods of time.

In some embodiments the vaginal device includes a wand so that a user can observe movement of the wand whilst performing the vaginal wall exercises and pelvic floor in order to ascertain if the exercise has been correctly performed. In this way the wand serves as a visual guide to correct performance of pelvic floor and vaginal wall exercises.

The wand is an elongate member that is typically connected to a proximal end of the body of the device. Preferably the wand extends from the body of the device in a different plane to that of the direction of insertion of the device. For example the wand may extend at an angle of 120 degrees relative to the body.

Preferably the wand comprises an elongate arm extending from a collar that connects the wand to the vaginal device.

The wand is fixed in place so that it is visible during use and so as to permit the elongate arm to move and be visible whilst performing exercises.

As a vaginal exercise or pelvic floor exercise is performed the wand, and in particular the elongate arm, is observed to see in what direction the wand, and therefore the body of the device is moved during the exercise.

When a correct vaginal exercise/pelvic floor exercise is performed, that correctly engages the pelvic floor, the arm moves in a downwards direction. If the pelvic floor muscles are incorrectly engaged the arm moves upwards as the wearer is pushing down rather than contracting muscles inwards. Therefore during use a wearer can observe the wand to ensure exercises are performed correctly.

It is estimated that up to 30% of pelvic floor exercises are incorrectly performed, therefore inclusion of a wand has significant benefits.

In a preferred embodiment the wand is a displaceable part that is connected to the body and/or a substantially rigid removal means (such as a bar) of the device. In this way the wand can be removed when not in use, exchanged and easily changed Preferably the wand connects at a proximal end of the body, and/or to the bar, by means of a collar such that the wand is always external the body. For example the collar may be arranged as a sleeve around the bar from which 5 the elongate arm of the wand extends at an angle.

In some embodiments the position of the wand may be adjustable to aid with fitting the device to specifically suit individual users. For example the collar may be moveable along the bar.

It is appreciated that in some embodiments the wand may be integrated with the device.

In another embodiment of the wand, the collar may be flexible and positioned 15 in use such that contraction of the pelvic floor muscles directly flexes the collar which intern displaces an arm of the wand.

Brief Description of Figures

Figure 1A and 1B show and overview of the vaginal device, from a side view (1A) and front view (1B); figures 2A, 2B and 2C reveal the vaginal device holding various inserts; figures 3A, 3B and 30 show the vaginal device holding various hemispherical shaped inserts; Figure 4 shows a vaginal device with a wand; and Figure 5 shows various views of a wand.

Detailed Description of Figures

Referring to the figures, figures 1-3 show various embodiments of the vaginal device and the inserts.

Figure 1 shows a vaginal device 50 in two orientations -figure 1A showing a side view and figure 1 B showing a front view. Figures 1A and 1 B show a body 100 that is hollow. The body is ovaloid having a distal tip 120 and a proximal base 130.

The body 100 includes four petals 110 that can be displaced by application of force. The petals are part of the body 100, extending from part way along the body 100 to the distal tip 120. The petals 110 are arranged adjacent to one another and do not overlap. In this way the petals 110 can be deformed by contraction of surrounding muscles and are less likely to pinch the vagina lining.

The proximal base 130 is a flattened portion of the body 100 and has attached a cord 140. The cord 140 is permanently fixed to the body 100. The cord 140 20 comprises a loop 135 that the user can readily grab and pull the cord for swift, effective removal.

The cord 140 is formed from cotton with a medical silicone sleeve.

The body 100 includes a pair of indentations 1055 for placement of a user's fingers and thumb (not shown) whilst inserting the device. The indentations 1055 are positioned close to the proximal base 130 on the lower half of the body 100 so that the distal end can be inserted first.

The indentations 105 are circular and concave. The indentations 105 are arranged facing one another so that the user may position a finger and opposing thumb about the body 100 in order to hold it securely during insertion into the vagina.

Figures 2A, 2B and 2C show the body 100 with inclusion of an insert 200 wherein the inserts are of different sizes so as to displace the petals 110 to varying degrees thereby altering the overall size of the body 100 dependant 5 upon the insert 200.

The insert 200 is octahedral with rounded corners having a top 210 and a bottom 220 so that the insert 200 can readily fit within the body. The top 210 is tapered to a narrower point than the bottom 220 so that the petals 110 have space in which to be deformed without coming into contact with the insert 200 and therefore not being able to be displaced any further.

The insert 200 includes an annular groove 230 for accepting a rim 240 (not shown) arranged on an inner face of the body 100. In this way the insert 200 15 is capable of being fixed within the body 100 during use to prevent movement of the insert 200. The insert 200 is fitted into the body 100 by a detent mechanism.

The octahedral insert 200 can be held by the top 210 so as to position and fix 20 the insert into the body. The top 210 may also be grasped by the user in order to remove the insert 200 from the body.

The insert 200 includes a debossed annotation of the size details of the insert 200 so as to readily identified by the user.

The indentations 105 are shown on each petal 110 therefore allowing the body to be gripped at various positions.

Figures 3A, 3B and 3C show the body 100 with hemispherical inserts 300. 30 The insert 300 has an arcuate lower section 310 and a flat upper section 320.

The hemispherical insert sits inside the body 100 so as to have the arcuate lower section 310 positioned at the proximal base 130 when fitted.

Around the perimeter of the flat upper section 320 there is an annular groove 240 for accepting the rim 230.

The insert 300 shown in each figure is of a different size so as to displace the petals 110 to different degrees.

In figure 3A the body 100 is 69.5mm long and 34mm wide. The insert is 30mm deep and 27mm wide therefore filing part of the hollow 105 within the 10 body 100.

Referring to figure 3B an insert 300 of 34mm wide and 27mm deep is inserted to the body 100 causing the petals 110 to be displaced so that the body 100 width is 41.5mm at its widest point.

Figure 3C shows a device with an insert 300 of 36mm wide by 24mm deep causing petal 110 displacement to create a body 100 width of 49mm at its widest point.

Figures 4 and 5 disclose a wand 150.

Figure 4 shows an example of a wand 150 fixed to proximal end of the body 100. Figure 5 shows various views of a displaceable wand in isolation of the device.

The wand 150 has a collar 155 and an elongate arm 156. The collar 155 is arranged around the removal means 140 and a proximal part of the body 100. The collar 155 is shaped and dimensioned to correspond to the proximal end of the body 100 and removal means 140. The distal end of the collar 155 is flared to match the shape of the body.

The removal means 140 is an elongate bar that extends from a proximal end of the body 100. The bar is substantially rigid and extends from the body 100 in the same plane as that of insertion of the body.

The bar 140 has a rounded, bulbous end 145 to permit a user to readily identify the end of the removal means and to ensure the device has no sharp portions.

The bar 140 is integrated with the body so as to be permanently fixed to the 10 body 100.

The wand attaches about part of the body 100 and part of the bar 140.

The indicator 156 is an elongate arm which extends from an external face of the collar 155. The indicator extends at an angle relative to the plane of insertion of the device so that the wand can be readily observed during performance of pelvic floor exercises The distal end of the indicator 156 is rounded.

The collar has an opening 157 to allow the collar 155 to be easily arranged about the bar 140. At least part of the collar 155 is formed from a resiliently deformable material so as to allow the collar to flex such that it can be arranged about and removed from the bar 140 and body 100.

The invention has been described by way of examples only and it will be appreciated that variation may be made to the above-mentioned embodiments without departing from the scope of invention.

Claims

Claims 1 A vaginal device for improving internal muscle tone comprising: a body, the device is adapted to be received through the vaginal opening and includes a plurality of resiliently deformable petals capable of being displaced; and a removal means.
2. A vaginal device according to claim 1 wherein the body is hollow and is capable of receiving an insert.
3. A vaginal device according to claim 1 or 2 wherein the body is ovaloid.
4. A vaginal device according to any of claims 1 to 3 wherein the petals are arranged around an upper portion of the body.
5. A vaginal device according to claim 4 wherein the petals are arranged in the same orientation so as to provide an opening at a distal tip from which position the petals are displaced.
6. A vaginal device according to any preceding claim wherein the petals are dimensioned and arranged such that they do not overlap one another when in use.
7. A vaginal device according to any preceding claim wherein at least one insert, in use, is received in the hollow body so as to alter the size and/or mass of the device.
8. A vaginal device according to any preceding claim wherein the insert is weighted.
9. A vaginal device according to any preceding claim wherein inserts are of varying mass and/or size.
10.A vaginal device according to claim 7 or 8 has a means for retaining the insert.
11.A vaginal device according to claim 9 wherein the means includes an annular groove arranged on an internal face of the body.
12.An insert for use in the vaginal device according to any of claims 8 to wherein the insert includes a rim for accepting into the annular groove so as to secure the weight within the device.
13.A vaginal device according to any preceding claim having an insert that is hemispherical in shape.
14.A vaginal device according to any preceding claim wherein the body is formed from medical grade plastic.
15. A vaginal device according to any preceding claim wherein the removal means comprises a proximally mounted cord.
16.A vaginal device according to claim 15 wherein the cord is flexible.
17.A vaginal device according to claims 15 or 16 wherein the cord comprises a loop.
18.A vaginal device according to any of claims 1 to 14 wherein the removal means is a bar.
19.A vaginal device according to any preceding claim including a wand.
20.A method of using the vaginal device wherein at least one petal is displaced so as to allow addition of the insert to the hollow body.