Patent Publication Number: US-2005130818-A1

Title: Pelvic floor muscle exercisers and indicators

Description:
FIELD OF THE INVENTION  
      This invention relates to pelvic floor muscle (PFM) exercisers, indicators and kits thereof. Readers will be aware that such PFM exercisers have been used in the past to cure or at least ameliorate feminine stress incontinence, which is commonly attributable to the weakening of the PFMs with age, as a result of childbirth or as women approach the menopause.  
      Although the following description concentrates on the use of devices for increasing strength of pelvic floor muscles with regard to preventing, curing or alleviating stress incontinence, it is to be mentioned that the devices hereinafter described may equally be used to test or improve the strength of pelvic floor muscles for other reasons. Indeed, as has been proposed in the past, PFM exercisers can provide a valuable means of assessing the strength of PFMs as women have heretofore been generally unable to provide suitable information, often being unaware of their existence. Accordingly, the invention is not to be considered limited to its particular application in the field of curing, alleviating or preventing stress incontinence, although it is this application to which the invention is ideally suited.  
     BACKGROUND TO THE INVENTION  
      PFM exercisers and their use in preventing or at least reducing stress incontinence are both well known and adequately described in the prior art.  
      For instance, GB-A-2058571 describes a device for exercising the perineal muscles which comprises a shaft having a tapered portion with an enlarged spherical end for insertion into the vagina and includes provision for suspending various different weights from the alternate end of the shaft.  
      U.S. Pat. No. 4,241,912 describes an isometric vaginal exercise device comprising a rounded shaft having a flange at one end thereof. The shaft has a concave portion adjacent the flange, wherein the diameter of the concave portion decreases to a minimum value and then increases to a maximum value with increasing distance from the flange. The concave portion allows gripping of the device by perivaginal muscles of the user. The flange is oval to permit accommodation between the legs of the user. A handle is attached to the flange end of the device.  
      EP-A-0198641 describes a set of parts for testing and/or strengthening the PFMs of wearers wherein the set comprises a number of substantially identically shaped and sized devices all adapted for insertion into the vagina beyond the PFMs so that the PFMs are automatically caused to contract in an attempt to prevent the device from falling from the vagina. It is the nature of such muscles to automatically contract which can be used to strengthen same beneficially to aid or cure incontinence, as substantially the same muscle set can be used to control or prevent the flow of urine from the bladder. This patent further describes that within the set of devices, each device is of a different weight so that the PFMs can be strengthened progressively by using progressively heavier weights, each device having a lower conical portion which is in use supported by the PFMs and an upper rounded tip. The patent also mentions that the devices may be formed from a combination of materials such as for example a plastic such as polymethylmethacrylate or nylon and a metal such as brass or steel provided with a suitable physiologically acceptable coating, such as may be deposited by chromium plating.  
      This device is useful as far as satisfactorily determining the heaviest weight supportable by the PFMs of a wearer is concerned, but the devices are not generally intended for domestic use nor for use in the treatment of stress incontinence. In the form described in the patent, the above devices would meet with significant resistance from and limited market acceptance by the female public on account of the clinical nature of each of the devices and the lack of facility for changing the particular weight of one of the devices.  
      EP-A-392854 describes a PFM exerciser consisting of a casing having two parts which can be sealingly connected together to define a cavity in which one or more differently shaped weights can be provided to increase or decrease the overall weight of the PFM exerciser as required. Moreover, the patent mentions that the device is less expensive than existing products such as those described above because only a single device is proved for insertion, and furthermore only the casing need be of a physiologically acceptable material. In this manner, although the casings can of course be sterilised and re-used. Also, an appropriate set of weights can also be provided depending on the extent to which the PFM are required to be strengthened.  
      Although the above device is useful and has been widely accepted in the market place, it is unnecessarily fiddly to configure as both the casing and the weights tend to be small and may therefore pose difficulties as far as assembly is concerned for less dexterous people.  
      There is also some suggestion of multi-part PFM exercisers coming apart or breaking in a woman&#39;s vagina.  
      A user can often find it difficult to locate and contract her PFMs. PFM exercisers can be inserted past the PFMs so it does little good. Further, even when correctly inserted many women are not consciously aware of their PFMs and how to work them.  
      The design of PFM exercisers is in general dictated by the following important factors. Firstly the device must be of a suitable shape and size for insertion into the vagina. This effectively limits the maximum diameter and its shape which is best described as being conical at one end, cylindrical through the middle and having a hemispherical other end. Secondly, the weight of the exerciser must be capable of being altered to suit particular conditions or to provide more or less strenuous exercise of the PFMs.  
      A further design criteria of PFM exercisers which has not been as intensively assessed as those mentioned above is the physiological aspect of the device. It will be appreciated that there is resistance among women to use a PFM exerciser which although fully sterilised, has been prior used. Additionally, the types of material used in the past for such plastics have typically been plastics which although capable of being sterilised safely are hard and inflexible and thus aesthetically unappealing.  
      Users are often also reluctant to use exercisers that require repeated cleaning for fear of infection and because of the time consuming nature of such a task.  
      It is an aim of the preferred embodiments of this invention to provide an improved PFM exerciser.  
     SUMMARY OF THE INVENTION  
      According to the present invention in a first aspect, there is provided a PFM exerciser kit comprising a first PFM exerciser and a second PFM exerciser, each PFM exerciser comprising a head for insertion into a user&#39;s vagina and a tail extending from the head, the first PFM exerciser being heavier than the second PFM exerciser and the first PFM exerciser having a smaller head than the second PFM exerciser and/or a more gradually tapered region from the head to the tail.  
      Suitably, a PFM exerciser kit according to claim  1 , in which the kit comprises a third PFM exerciser, which third PFM exerciser has a head for insertion into a user&#39;s vagina and a tail extending from the head, and which is heavier than the first PFM exerciser and has a smaller head than the first PFM exerciser and/or a more gradually tapered region from the head to the tail.  
      Suitably, the different exerciser weights are differentiated by different visual markings.  
      Suitably, between the head and the distil end of each tail there is provided a stop indicator for indicating to a user the amount of insertion of the exerciser required.  
      Suitably, the stop indicator comprises a change in the diameter of each tail.  
      Suitably, each stop indicator comprises a bulge in the tail.  
      Suitably, each stop indicator is annular about the tail.  
      According to the present invention in a second aspect, there is provided a kit comprising a PFM exerciser and a physiologically acceptable sheath in which the PFM exerciser can be inserted for insertion into a user&#39;s vagina.  
      Suitably, the sheath is provided in an infection resistant packaging.  
      Suitably, the sheath comprises a condom.  
      According to the present invention in a third aspect, there is provided a PFM exerciser comprising a head for insertion into a user&#39;s vagina and a tail extending from the head, the tail being formed from at least in part from a flexible material, and means for adjusting the angle of the tail for providing a self-supporting bend in the tail of the PFM exerciser.  
      Suitably, a tail angle adjuster comprises a jig into which the tail is inserted.  
      Suitably, the jig is a curved receptacle for the tail.  
      Suitably, the jig is generally U-shaped in cross-section.  
      Suitably, a flexible shape-retaining material can be provided at a bend region of the tail.  
      Suitably, the material is embedded in the tail.  
      Suitably, the tail is substantially self supporting.  
      Suitably, the tail is flexible along its entire length.  
      Suitably, the PFM exerciser comprises a rubber or plastics physiologically acceptable outer layer.  
      Suitably, a weight is embedded inside the PFM exerciser.  
      Suitably, a plurality of weights are distributed about the head or entire exerciser.  
      According to the present invention in a fourth aspect, there is provided a method of use of a PFM exerciser the method comprising the steps of arranging a physiologically acceptable sheath at least partly about a PFM exerciser and inserting the sheath covered PFM exerciser into a user&#39;s vagina.  
      Suitably, the PFM exerciser and sheath are a kit according to the second aspect of the present invention.  
      Suitably, the sheath is discarded after use.  
      Suitably, the method comprises the steps of using the tail angle adjusting means to adjust the tail angle and inserting the PFM indicator into a user&#39;s vagina.  
      In such a configuration a user can use the PFM exerciser to locate their pelvic floor muscles (PFMs). With the tail in the straight configuration generally it is difficult for a user to see the tail so when they flex their pelvic floor muscles and therefore move the tail it is difficult to tell whether such movement has occurred. However with the tail in a bent configuration the tail can be positioned such a way that a user can see the tail moving when their PFMs are exercised.  
      It will be appreciated that the various aspects of the present invention can be combined together. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
      The present invention will now be described, by way of example only, with reference to the drawings that follow; in which:  
       FIG. 1  is a plan view of a PFM exerciser according to an embodiment of the present invention.  
       FIG. 2  is a plan view of a PFM exerciser kit according to an embodiment of the present invention.  
       FIG. 3  is a plan view of a PFM exerciser kit according to another embodiment of the present invention.  
       FIG. 4  is a schematic perspective illustration of a tail adjuster for use with a PFM exerciser.  
       FIG. 5  is a side view of a PFM exerciser used in a PFM indicator configuration.  
       FIG. 6  is a schematic illustration of a PFM exerciser according to a yet further embodiment of the present invention. 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS  
      Referring to  FIG. 1  of the drawings that follow, there is shown a PFM exerciser  2  comprising a head  4  and a tail  6 . The exerciser  2  is circular symmetrical about its longitudinal axis.  
      The head  4  is generally conically shaped and is suitable for insertion into a user&#39;s vagina. The tail  6  extends from the head  4  to a distil end  8 . Intermediate the head  4  and distil end  8  is a stop indicator  10  comprising an annular bulge in the tail. This stop indicator bulge  10  changes the diameter of the tail in such a way that it can be felt by a user during insertion. A further bulge  12  is provided at the distal end  8 . The bulge  12  can be useful for withdrawing the PFM exerciser  2 , especially if the tail  6  has been lubricated; the bulge  12  provides purchase for a user to grip the PFM exerciser  2 .  
      The PFM exerciser  2  is formed by injection moulding a SANTOPRENE (Trade Mark) thermoplastic rubber material to encapsulate a weight (indicated by dashed lines  14 ) therein. SANTOPRENE from 35 Shore A to 40 Shore D is preferred as a physiologically acceptable material that users find satisfactory from a tactile perspective. This ensures the tail is substantially self-supporting. A degree of bend in the tail is permissible. This manufacturing process creates a line  16  that provides a convenient delineation between head  4  and tail  6 . Strictly there is no absolute distinction between the two.  
      It is noted that there is a narrowing tapered section  18  graduating head  4  into tail  6 .  
      In use the head  4  of PFM exerciser  2  is manually inserted into the user&#39;s vagina until the user feels the stop indicator  10  indicating that the exerciser  2  has been inserted sufficiently into the user&#39;s vagina. The act of holding the exerciser in the user&#39;s vagina exercises the PFMs.  
      In practice it has been found that users vary greatly in their ability to hold a given exerciser in position. Further, as a user progresses with the exerciser the improvement they gain diminishes because their improved PFMs are not being worked as hard with an initial exerciser. In the prior art this has been addressed by providing means for adjusting the weight of a single PFM exerciser, usually by the insertion therein of weights of varying masses into an exerciser capable of disassembly and re-assembly. However, it is believed that on occasion such exercisers, especially if not done up properly, can become disassembled in use leading to difficulties for the user.  
      Accordingly, with reference to  FIG. 2  of the drawings that follow there is shown a PFM exerciser kit  20  comprising a first PFM exerciser  22 , a second PFM exerciser  24  and a third PFM exerciser  26 . Each PFM exerciser  22 - 26  is similar to PFM exerciser  2  of  FIG. 1  (similar reference numerals are used for like parts) except for variations in the shape of the head  4  and mass of the exerciser (governed primarily by mass  14  (not shown in  FIG. 2 )).  
      Thus in  FIG. 2 , first exerciser  22  has the largest head  4  and lowest mass (compared with second and third exercisers  24 ,  26 , respectively). Second exerciser  24  has a head  4  size and mass intermediate first and third exercisers  22 ,  26 , respectively and third exerciser  26  has a smaller head  4  and higher mass than first and second exercisers  22 ,  24 , respectively.  
      For a user, first exerciser  22  is the easiest to hold in place due to the larger head  4  and lower weight. Second exerciser  24  and third exerciser  26  become progressively harder to hold in place as their head sizes diminish and weight increases. Thus, a user can work her way through the PFM kit using progressively harder to hold exercisers  22 , then  24  and then  26 . As the weight of the PFM exerciser increases in the kit, so the size of the head  4  decreases. This can be done without disassembly/re-assembly of the exerciser being required.  
      Although the kits shown include three exercisers, it will be appreciated that any number of exercisers from  2  upwards can provide benefits. However three or four exercisers in a kit is thought to be preferable for providing a suitable range of exercisers for the majority of users. The different weights can be differentiated by visual markings, such as by being different colours eg darker colours being heavier weights.  
      Referring to  FIG. 3  of the drawings that follow, there is shown a PFM exerciser kit  30  comprising a first PFM exerciser  32 , a second PFM exerciser  34  and third PFM exerciser  36 . Each PFM exerciser  32 ,  34 ,  36  is similar to that shown in  FIG. 1 , except for variations in the shape of the head  4 , the taper  18  and the weight of the respective exerciser, and similar reference numerals are used for like parts.  
      Use of the kit  30  shown in  FIG. 3  is substantially similar to that shown in  FIG. 2 . However, the difference in ease of holding for a user between the exercisers  32 ,  34 ,  36  is exacerbated by their different narrowing tapers  18  from head  4  to tail  6 . First exerciser  32  (the lightest) has an almost stepped taper  18  making it the easiest to hold. Second exerciser  34  has a move gradual narrowing taper  18  making it harder to hold than first exerciser  32 . Third exerciser (the heaviest)  36  has a long gradual taper  18  making it harder to hold than exercisers  32  and  34 .  
      Thus the difficulty of holding can be controlled through heavier exercisers by smaller heads and/or a more gradually tapered tail.  
      Another difficulty users have experienced with PFM exercisers is the problem of locating and being able to flex or work their PFMs. A woman is often not consciously aware of flexing of her PFMs.  
      Referring to  FIG. 4  of the drawings that follow, there is shown a PFM indicator tail angle adjuster  40  which is a curved jig, generally U-shaped in cross-section, but so as to receive more than half of the perimeter of the tail jig. Thus tail angle adjuster  40  provides a channel  42  into which the tail is inserted. The tail angle adjuster  40  is a polypropylene moulding.  
      Referring to  FIG. 5  of the drawings that follow there is shown a PFM indicator  50  that can also be used as a PFM exerciser. The PFM indicator  50  is substantially the same as the PFM exerciser  2  shown in  FIG. 1 .  
      The PFM indicator  50  has had its tail  6  inserted through into channel  42  of tail angle adjuster  40  to create the approximate 90° angle in the tail  6 . The tail angle adjuster  40  is applied between stop indicator  10  and the distal end  8 . The SANTOPRENE (trade mark) material of the tail  6  is substantially self supporting so with the tail angle adjuster  40  attached, the PFM indicator  50  adopts substantially the configuration shown in  FIG. 5 .  
      For use as a PFM indicator, the device is inserted into the user&#39;s vagina until the stop indicator  10  is reached.  
      The stop indicator  10  thus can serve a double purpose of avoiding the tail angle adjuster  40  contracting a user&#39;s vaginal area. When the stop indicator  10  is felt the end  8  of the PFM indicator can be seen by a user because of the angle at which the tail  6  is held. A user then attempts various muscle contractions until the end  8  of tail  6  is seen to twitch or move, a sign of PFM movement. The user can then recognise the muscle flexing/contractions required for PFM exercises ie to hold in the various PFM exercisers described herein.  
      An alternative tail angle adjuster can be provided by a flexible shape retaining strip, typically a metal strip in a bending region of the tail  6 . Such a strip can be embedded in the tail  6  during the injection moulding manufacturing process. A strip  52  is shown diagrammatically in  FIG. 6  (see below) for ease of reference.  
      Referring to  FIG. 6  of the drawings that follow, there is shown a PFM exerciser  60  substantially similar to PFM exerciser  2  of  FIG. 1  (similar reference numerals are used for like parts). Additionally in  FIG. 6  there is shown a physiologically acceptable sheath  62 , such as a condom into which at least the head  4  of PFM exerciser  60  is inserted for subsequent insertion into a user&#39;s vagina. Thus the sheath  62  protects the PFM exerciser  60  from contact with the user&#39;s vagina. After use the sheath  62  can be discarded and the PFM exerciser  60  re-used without time-consuming cleaning. It will be appreciated that the sheath  62  can be used with PFM indicators as well. The sheath  62  can be provided in a foil, plastics or other infection resistant packaging.  
      The reader&#39;s attention is directed to all papers and documents which are filed concurrently with or previous to this specification in connection with this application and which are open to public inspection with this specification, and the contents of all such papers and documents are incorporated herein by reference.  
      All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive.  
      Each feature disclosed in this specification (including any accompanying claims, abstract and drawings), may be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features.  
      The invention is not restricted to the details of the foregoing embodiment(s). The invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.