Abstract:
A device for insertion into the birth canal of a female user, comprising an asymmetrical, inflatable, bulb defining an outer surface, the bulb sized and shaped so as to define a crease along at least a portion of the surface adapted to be placed in registry with the user&#39;s urethra when the bulb is inflated, the bulb further sized and shaped to contact the bulbocavernous facia, pubococcygeal facia and illiococcygeal facia when inflated, and means for inflating and deflating the bulb.

Description:
REFERENCE TO RELATED APPLICATIONS  
       [0001]    This application is based on co-pending Provisional Patent Application No. 60/330,922 Filed Nov. 2, 2001 
     
    
     
       BACKGROUND OF THE INVENTION  
         [0002]    1. Field of the Invention  
           [0003]    This invention relates generally to muscle stretching and exercise devices. More specifically, this invention relates to devices for, in one case prepartal stretching, strengthening, and in a another case, postpartal various muscles in the human female, including the pubococcygeal, iliococcgygeal, and bulbocavernous muscles as well as generally strengthening the vaginal area.  
           [0004]    2. Discussion of the Related Art  
           [0005]    One of the principle drawbacks to natural childbirth is the damage usually caused during childbirth caused by the sudden stretching of the vaginal canal and remaining musculature and tissue. In many cases, episiotomies are performed, with resultant, undesired complications.  
           [0006]    Exercising the pelvic floor musculature in women plays an integral role in maintaining the relative health and well being of the woman throughout her life. In addition, pelvic muscle dysfunction is a costly and life-altering problem. Failure to treat this dysfunction not only impairs quality of life, but also may lead to more costly complications including incontinence, urinary tract infections, skin breakdown, prolonged hospital stays, depression, and decreased sexual libido. Like the rest of the body muscle groups, the pelvic floor and vaginal muscles need to be exercised and trained to avoid the problems and complications so often associated with postpartum recuperation, maturing age, incontinence, vaginismus, and inadequate sexual gratification.  
           [0007]    In the 1940&#39;s, Dr. Arnold Kegel did pioneering work on this dysfunction, producing a series of exercises that bear his name. While Kegel exercises are the time-honored approach to treating these problems, studies have demonstrated that this technique alone is insufficient to effect real relief. Scientific literature shows that better results are obtained when mechanical conformation of the exercise device to the muscles is presented to the patient.  
           [0008]    Previous devices divide easily into a number of broad categories. Exercise may be either passive, where the device exercises the muscle without exertion by the user, and active, where the user exerts force with her muscles. The term “exercise” refers to both stretching as well as strengthening activities.  
           [0009]    The devices used for stretching are passive. One known device for affecting a stretching of the relevant tissue and musculature is known as the Epi-no® offered by Tecsana of Munich, Germany, which is comprised of a hand-held inflation bladder connected via an air inflation line to an inflatable bulb adapted to be inserted into the birthing canal of a pregnant woman. The bulb is shaped in the form of a symmetrical FIG. 8. The bladder is squeezed, which causes the bulb to inflate, increasing in diameter causing the stretching of the birthing canal. The concept of stretching the birthing canal is quite well established throughout the world, ranging anywhere from manual vaginal massage which is readily used today in the United States and elsewhere to the more primitive application, practiced among many tribes throughout Africa and elsewhere, of inserting progressively larger gourds into the canal to stretch the canal prior to delivery. The concept of employing a silicone balloon was conceived as a modern practical approach to individual training and exercise in preparation for childbirth. The devices intended to minimize birthing-related complications such as perineal damage to the mother, and to facilitate the child&#39;s passage and safe delivery, reducing the stress and physical complications on both mother and child, and promoting safer and healthier births, and reducing overall medical costs and complications. However, the bulb of the Epi-No® device does not take into account the anatomical configuration of the muscles which delineate the birthing canal.  
           [0010]    Among active devices are spring resistance exercisers. In the spring type exercisers, the user resists the force of one or more springs. In weight training, the user resists the force of gravity.  
           [0011]    Both types of exercise can be static, against a constant resistance, or progressive, against an increasing resistance.  
           [0012]    Prior devices can also be identified by the means for measuring the resistance. Most devices use some form of fluid pumped into an inflatable component. The inflatable component might utilize a substance that expands a balloon or might be comprised of a pleated or bellows device that fills out to its maximum size but does not expand further. The pressure in the inflatable component may be measured by a manometer, a Bourdon tube, a d&#39;Arsonval meter, a digital display, light emitting diodes, a liquid crystal display, a graphic display, or any other indicator. In most cases, the inflatable component is inflated with air but most descriptions use the term “fluid” which could also encompass liquids. Some inventions specifically teach use of liquids. Existing devices differ in the means for inflating the inflatable component. Some use a hand pump, some use a squeeze bulb, and some use a mechanical pump. Devices also differ with respect to the material used for the inflatable component. Early devices were usually rubber or latex, but it has subsequently been determined that not everyone tolerates latex well. Recently, there has been a shift to synthetics, especially silicone-based materials.  
           [0013]    With the above number of possibilities for each element, the number of permutations is, indeed, quite high. However, no example in the art teaches the solution to the problem of discomfort, injury, or forced micturition caused by the inflatable component pressing against the urethra prior to the disclosed invention.  
           [0014]    U.S. Pat. No. 1,213,005 to Pillsbury teaches a C-shaped, rubber-pad device used in veterinary practice, primarily for mares and cows with a postpartum dislocated uterus. The device is inserted with an inflating pipe so that the indentation of the C-shape fits against the distal surface of the womb of the animal. The tube is used to inflate the device using an air supply which is not taught. Considering that the Pillsbury patent was issued in 1917 and that it was for farm use many years before rural electrification, it is entirely possible the user was expected to blow into the tube. No subsequent device teaches this method of inflation. Releasing a check valve permits the device to be deflated for removal.  
           [0015]    The Pillsbury device differs from the disclosed invention in a number of ways. The Pillsbury device is made of rubber while the disclosed device is, in a preferred embodiment, made of a silicone-based material. The Pillsbury device is designed as a surgery substitute until natural postpartum atrophy ensues. The disclosed device exercises vaginal and other muscles. Pillsbury teaches no means for inflation and is not an exercise device. The disclosed device teaches an apparatus-type pump in the preferred embodiment. Pillsbury teaches no means for avoiding impingement on the urethra while the disclosed device teaches a novel shape for avoiding this impingement. Pillsbury teaches no means for determining the pressure to which the inflatable component is inflated. The disclosed invention teaches a variety of means for determining the inflation pressure.  
           [0016]    U.S. Pat. No. 4,050,449 to Castellana et al. teaches a device for exercising the vaginal walls. The inflatable component in Castellana is an elongated elastomeric balloon. When flaccid, the balloon is sufficiently rigid to be vaginally inserted without need for any stem member. Castellana teaches a device for inflating the balloon with a gas or liquid after the balloon is inserted. Further, Castellana teaches a pressure-indicating gauge. The balloon is deflated for removal.  
           [0017]    In contradistinction to the teachings of the disclosed invention, Castellana does not teach any indentation in the balloon for avoiding impingement of the inflatable device on the urethra. Castellana also teaches a device with a shoulder which the user must hold to prevent expulsion of the balloon. The disclosed device is held in place by its unique shape. U.S. Pat. No. 4,167,938 to Remih teaches a complex apparatus much of which is contained in a box or cabinet. Remih teaches a stretchable bladder inserted into the vagina and inflated by a compressed air source which may be a squeeze bulb. Remih also teaches a manometer coupled with a semicircular indicator to serve as a pressure indicator. The bladder is alternately expanded and distended to provide passive exercise and stretching to the muscles of the user. Remih teaches coupling the bladder around a catenoidal spool.  
           [0018]    The teachings of Remih differ from those of the disclosed invention in that Remih does not teach the use of an indentation to avoid impinging on the urethra, does not teach a stretchable bladder of any particular shape as opposed to the oviform balloon of the disclosed invention, and the disclosed invention does not require a manometer in a cabinet. Remih teaches passive exercise and stretching as opposed to the active exercise without stretching taught by the disclosed invention.  
           [0019]    U.S. Pat. Nos. 4,653,514 and 4,768,533 to Shapiro teach a number of devices for exercising vaginal muscles, all of which are composed of cuffed rods onto which are attached cylindrical inflatable covers. The teachings of Shapiro differ from those of the disclosed invention in not teaching an oviform balloon with an indentation to prevent impinging on the urethra.  
           [0020]    U.S. Pat. No. 5,256,123 to Reinbolt teaches a hollow, longitudinal member which contracts alternately about its upper and its lower girths. The member is filled with liquid which creates a rhythmic action to exercise the vaginal muscles. The teachings of Reinbolt differ from those of the disclosed invention in that Reinbolt does not teach an oviform balloon with an indentation to avoid impinging on the urethra nor does the disclosed invention employ liquid, nor is it made with a hollow longitudinally-extending member. Instead, the disclosed invention expands generally radially, except with respect to the indented area, from the core of the inserter to come into contact with the walls of the vagina.  
           [0021]    U.S. Pat. No. 5,674,238 to Sample et al. teaches a device for measuring the strength of vaginal contractions. Sample refers to his device as a perineometer. This term was used in the early work of Arnold Kegel, see also U.S. Pat. No. 2,541,520 to Kegel. Sample and Kegel teach an elongated probe which is inserted into the vagina. The teachings of Sample and Kegel differ from those of the disclosed invention in that Sample and Kegel do not teach any device for strengthening vaginal area muscles nor do they teach any inflatable balloon or oviform balloon with an indentation to avoid impinging on the urethra. Sample and Kegel teach probe-like measurement devices.  
           [0022]    U.S. Pat. Nos. 6,063,045 and 6,217,529 B1 to Wax et al. teach cylindrical devices for insertion into the vagina or rectum. The cylindrical device for insertion into the vagina as taught by Wax is described as a deformable probe which is connected to a pressure transducer. This pressure transducer feeds information to a display which may indicate the pressure against the probe as any of a number of graphic figures, including curves. The teachings of Wax differ from those of the disclosed invention in that Wax teaches a generally hemispherical shape and the disclosed invention teaches an oviform shape. Wax does not disclose a crease in the probe or a bladder with any way of avoiding impinging on the urethra.  
           [0023]    Further comparison of the teachings of the above-identified prior art, other prior art, and those of the disclosed device will reveal numerous other distinctions.  
         SUMMARY OF THE INVENTION  
         [0024]    The first aspect of the invention is found in the provision of a prepartal device for assisting an expectant mother prepare her birth canal for the act of birthing. The device enables her to effectively train for birth and significantly reduce second stage labor, lower birth anxiety/stress, reduce analgesic use, shorten the period of parturition, increase apgras, reduce the incident of perineal tears, and increase from an overall perspective a mother&#39;s and baby&#39;s well being. The birth canal stretching device of this invention is comprised of a bladder or other apparatus for creating a supply of compressed fluid, such as air, an inflatable bladder, and a fluid-tight conduit connecting the bladder to the inflation device. A biofeedback mechanism is employed to provide the user with a real-time readout of the level of progress being made. The bulb, which is adapted to be inserted into the vagina, is in the form of an asymmetrical oviform, defining an elongated crease along an upper surface thereof adapted to be aligned with the woman&#39;s urethra so as to avoid, or minimize, impingement upon the urethra upon inflation of the bulb. The bulb is preferably made of a medical grade silicon having a wall thickness in the range of 1.0-1.1 millimeters, and having a desired maximum therapeutic inflation diameter of 10 centimeters.  
           [0025]    A second aspect of the invention is a postpartal pelvic floor muscle exerciser, which is a mechanical device with a biofeedback mechanism that is distinguished from previous attempts to effect a cure for atrophied and/or flaccid pelvic muscles primarily by its protection of the urethra and its unique shape which causes it to substantially uniformly contact the relevant muscle areas when installed. The device allows for full exercise and use of the muscles of the pelvic floor and also provides greater awareness and voluntary control of those muscles. The device includes an inflatable oviform asymmetrical bulb as in the first embodiment but having a wall thickness in the range of 0.5 to 0.6 millimeters to facilitate a more sensitive bio-connection to the muscle tissue/facia and subsequent corresponding biofeedback during exercise.  
           [0026]    The pelvic floor muscle exerciser is intended to promote and maintain pelvic floor muscle strength and elasticity during all stages of a woman&#39;s life. The device is designed to help support the abdominal muscle structures for prevention of complications later in life. In order to understand the design of the device, it is necessary to understand the basic anatomy of the perineum and pelvic diaphragm because the device, when inflated, assumes the shape of the pelvic floor.  
           [0027]    The central point of the perineum lies between the urogenital diaphragm and the anal triangle muscle group. The central point forms a shape similar to a figure “ 8 ” around the vagina and rectum. These muscle groups are referred to as the levator ani complex and the bulbocavernous muscle as well as the pubococcygeous and illiococcygeous muscles. The levator ani complex forms a hammock-like structure supporting the pelvic viscera as well as aiding in the constriction of the vagina during coitus, parturition, micturition, and defecation. The device is designed to work the full levator ani complex and not just the bulbocavernous muscle, the muscle which surrounds the vagina.  
           [0028]    One distinguishing aspect of this device is its asymmetrical, oviform shape with increased compliancy to allow the device to touch the vaginal walls laterally without exerting undue pressure ventrally toward the urethra while concurrently permitting appropriate dorsal expansion. The asymmetrical shape of the bulb, as opposed to a straight cylindrical shape, causes the bulb to make contact with all of the relevant muscle groups within the vaginal cavity upon inflation. In this way, when the bulb is inflated, its exterior surface will be lodged gently against the pubococcygeal, iliococcgygeal and bulbocavernous fascia.  
           [0029]    Regarding the embodiment of the invention referred to above for stretching the vaginal canal of a pregnant woman in anticipation of the rigors of child birth, it is well known that, by preparing the birth canal by pre-stretching same while an expectant mother is pregnant, the act of giving birth can be made dramatically easier and quicker. One way to accomplish this is to modify the bulb of the exercise embodiment of the instant invention by increasing the wall thickness thereof so that it can be inflated and thereby expanded to 10 centimeters, or more, without bursting. The device would also need to include a means for inflating and deflating the bulb. To operate this feature of the device, the deflated bulb is inserted into the vagina and inflated up to the recommended maximum amount, typically 10 centimeters, depending upon the advice of a physician. The diametrical expansion of the bulb can be gradually increased from a nominal amount during the beginning of treatment to a maximum amount, depending upon the person. Such treatment should begin approximately 3-4 weeks prior to giving birth. The scope and purpose of this feature of the invention is to gradually and naturally stretch the vaginal muscles, perineum and vulva prior to birth. This enables the mother&#39;s muscles to become more flexible and dynamic, facilitating the birth process and shortening the recovery period after childbirth. In addition, the device will help the mother practice the action of “pressing” or parturition phase, to help build a more dynamic pelvic floor or muscle group, helping to prevent incontinence problems after delivery, and significantly reducing the need for a perineal tear.  
           [0030]    To use the prepartal expansion device of this invention, once the device is inserted into the vagina and the crease oriented upwardly to generally align with the urethra, the bulb is inflated. It is recommended that the inflation last from 30 seconds to up to 10 minutes. In this way, the muscles, perineal area and birth canal are gently expanded over the course of 3 to 4 weeks. While the balloon is inflated, the woman should try to compress/contract the relevant muscles, noting the deflection on the pressure monitor gauge. Also, the woman should try to expel or press out the balloon by contracting the abdominal and vaginal muscles. This will help the mother practice the delivery phase at birth. Gradually the inflation size of the bulb should be increased, with 10-20 centimeters being the end point target. Training should be gauged along the 3 to 4 week scheduling to coincide with the expected birth of the child. Training should be carried out several times each day. Each session should be limited to no more than 10-30 minutes. Once the session is completed, the pressure within the bulb is released by opening a relief valve associated with the device.  
           [0031]    An object of this invention is to provide stretching and exercising of the musculature of the vaginal region. It is well-known that the general physical condition of many people needs to be improved and maintained. That need extends to many parts of the body including, in women, the vaginal region. Lack of appropriate muscle condition which leads to such problems as incontinence and diminished sexual satisfaction are overcome by use of the disclosed vaginal and pelvic muscle exerciser.  
           [0032]    Another object of this invention is to provide a vaginal and pelvic muscle stretching and exercise device comprised of an oviform, inflatable, balloon which can be inserted into the vagina.  
           [0033]    Another object of this invention is to provide a vaginal and pelvic muscle stretching and exercise device in which the oviform, inflatable, balloon expands to assume generally the shape of the vagina but which is so designed as to define a ventral crease, said crease being so located as to avoid or limit impingement on the user&#39;s urethra.  
           [0034]    Another object of this invention is to provide a vaginal and pelvic muscle stretching and exercise device constructed of a non-irritating, hypoallergenic material which will not cause discomfort to the user. One material that may be used is silicone.  
           [0035]    Another object of this invention is to provide a vaginal and pelvic muscle stretching and exercise device which includes a pump for inflating the oviform balloon. The pump may be operated manually or by other means.  
           [0036]    Another object of this invention is to provide a vaginal and pelvic muscle stretching and exercise device which includes a handle with a positioning indicator. This handle may be used to allow the user to insert and properly position the crease in the oviform balloon so that impingement on the user&#39;s urethra is limited or avoided.  
           [0037]    Another object of this invention is to provide a vaginal and pelvic muscle stretching and exercise device which includes a mechanism for inflating the oviform balloon, which mechanism may be a mechanical or hand-operated pump and may be a apparatus-like mechanism.  
           [0038]    Another object of this invention is to provide a vaginal and pelvic muscle stretching and exercise device which includes a mechanism for inflating the oviform balloon along with a check valve to prevent unintended release of the pressure in the balloon and a release valve to permit release of the pressure in the balloon when the user so desires.  
           [0039]    Another object of this invention is to provide a vaginal and pelvic muscle exerciser with pressure readout indications on a gauge to provide direct, realtime bio-feedback to the user of the progress of the exercise.  
           [0040]    Another object of this invention is to provide a vaginal and pelvic muscle exerciser which a user may use in the privacy of her home or other location without need for assistance of a technician or technical or medical person.  
           [0041]    Another object of this invention is to provide a vaginal and pelvic muscle exercise device whose shape and form is anatomically similar to the actual female anatomy; uniquely designed to more accurately and efficaciously exercise the affected muscle structures/groups.  
           [0042]    A major benefit of the invention lies in the fact that the shape and form closely represent actual female vaginal anatomy, to more efficiently and efficaciously enable muscle exercise without distortion or unnatural representation. One key objective is to be able to exercise diverse muscle groups, and this can only be accomplished via biofeedback of individual muscle responses. To accomplish this task, it is imperative that the “device” be anatomically correct, and be sensitive to each muscle group individually; thus requiring the device to be similar/equal to actual female anatomy. This premise is what differentiates our device from all of the others, and needs to be clearly and concisely so identified and presented in order to be granted patent status. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0043]    [0043]FIG. 1A is a side elevational view of the inflatable component of the invention with the distal end of the component on the right.  
         [0044]    [0044]FIG. 1B is a perspective exploded view of the component shown in FIG. 1A.  
         [0045]    [0045]FIG. 2 is a cross-sectional front elevational view of the inflatable component with the crease portion of the component to the top of the figure.  
         [0046]    [0046]FIG. 3 is a cross-sectional front elevational view of the inflatable component inserted in the vaginal area.  
         [0047]    [0047]FIG. 4 is a top plan view of the inflatable component/bulb.  
         [0048]    [0048]FIG. 5 is a cross-sectional front elevational view of the device showing the positioning handle.  
         [0049]    [0049]FIG. 6 is a side elevational view showing the positioning handle.  
         [0050]    [0050]FIG. 7 is a top plan view showing the positioning handle with the handle shown to the top of the figure.  
         [0051]    [0051]FIG. 8 is a front elevational view of an example of an inflation and pressure gauge mechanism suitable for use with the invention.  
         [0052]    [0052]FIG. 9 is a front elevational view of an alternative example of an inflation and pressure gauge mechanism suitable for use with the invention.  
         [0053]    [0053]FIG. 10 is a front elevational view of a further alternative inflation and pressure gauge mechanism suitable for use with the invention.  
         [0054]    [0054]FIG. 11 is a perspective exploded view of the alternative embodiment shown in FIG. 10 showing the gauge element removed from the handle.  
         [0055]    [0055]FIG. 12 is a cross-sectional side elevational view of the embodiment shown in FIG. 10.  
         [0056]    [0056]FIG. 13 is a bottom plan view of the handle portion of the embodiment shown in FIG. 10.  
         [0057]    [0057]FIG. 14 is a right side elevational view of the handle of the embodiment shown in FIG. 10.  
         [0058]    [0058]FIG. 15 is a side elevational, exploded view of the embodiment shown in FIG. 10. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0059]    While this specification concludes with claims defining the features of the invention that are regarded as novel, it is believed that the invention will be better understood from a consideration of the following description in conjunction with the drawing figures.  
         [0060]    The description with respect to FIGS.  1 - 7  which follows is a applicable to both the birth training device as well as the exercise device. FIG. 1 shows the inflatable component  20  which is preferably a semi-flexible inflatable bulb with a distal end  24  to the right in the drawing. The figure shows that the bulb  20  has an oviform shape with the major axis  30  horizontal in the figure and the minor axis  40  disposed vertically. At  50  is a positioning handle having a proximal part of the inserter at  52 . Tubing  80  connects the inflatable component  110  to the inflation components of the invention described below.  
         [0061]    [0061]FIG. 2 shows the bulb  20  with a crease or elongated V-shaped relief  26  at the top. This crease  26  is positioned by the handle  50  so that the bulb  20  does not impinge upon the urethra. At  110  is the distal end of an inserter  100 .  
         [0062]    [0062]FIG. 3 shows the bulb  20  inserted in a vagina (not shown) viewed toward the distal end  24  with the portions of the bulb  20  which contact the areas of the respective muscles of the vaginal area identified. The portion of bulb  20  which contacts the bulbocavernous muscle is generally indicated by reference number  25 , the pubococcygeous muscle at  27 , the portion of bulb  20  that contacts the illiococcygeous muscle is shown at  28 , and, the portion of bulb  20  that contacts the urethra is shown at  330 .  
         [0063]    [0063]FIG. 4 shows the bulb  20  inserted in the vagina with the portions of the bulb  20  which contact the areas of the respective muscles of the vaginal area identified as in FIG. 3. The portion of the bulb  20  which contacts the bulbocavernous is shown at  25 . The bulb  20  defines a hollow inner cavity  21  for the inserter  100 .  
         [0064]    FIGS.  5 - 7  show the positioning handle  50  with a raised stop member  52  to the top, the inserter  100  to the right, and the graspable part of the inserter  53  to the left. A pair of lateral stop members  54 ,  56  may also be used.  
         [0065]    [0065]FIG. 8 shows an apparatus used for inflating and deflating the inflatable bulb  20 . Apparatus  120  may be an openable or completely closed inflation/deflation device. By openable is meant a system wherein cavity  21  of bulb  20  can be filled with pressurized fluid, such as air, by a means of a bellows or other air pressurizing device in connection with which is used an “openable” and closeable relief valve (not shown). By “completely closed” is meant a system, such as that shown in FIG. 8, wherein no relief valve is utilized and the fluid within the system used to pressure bulb  20  does not communicate with the ambient. Although only a closed system is shown in FIG. 8 herein, it is to be understood that either an openable or a completely closed device may be utilized with the invention without departing from the scope of the invention. Devices such as the squeeze bulb  1  and a releaseable check valve  2  disclosed in U.S. Pat. No. 4,167,938 are considered to be within the knowledge of those skilled in the art and can be utilized as the openable pressure and release means contemplated by this invention.  
         [0066]    At  122  is the fitting which connects the apparatus to tubing  80 , which in turn is fluidly and sealingly connected to bulb  20  via handle  50  and inserter  100 . Inserter  100  is, preferably, manufactured of an atraumatic semi-rigid plastic, nylon or polyoxymethalenes which is/are bio-compatible with the human body The end  110  of inserter  100  is open fluidly communicating with interior  21  of bulb  20  with conduit  80  and inflation device  120 . At  124  is the handle or handle of the apparatus  120 . At  126  is the shaft of the apparatus shown with the handle  124  of the apparatus in its fully extended position. At  130  in both FIG. 8 and FIG. 9 is a muscle deflection indicating pressure gauge, which in the embodiment shown in FIG. 9 includes a circular needle gauge which is a visual, and may be color-coded, indicator of the extent of the deflection of the bulb  20  brought about by the user contracting her muscles. In this way, direct visual feedback is given to the user. In the embodiment shown in FIG. 8, the indicator is a linear gauge, which may utilize numerical gradations or color gradations such as the blue, pink, orange and red zones shown at  130 . A movable indicator (not shown) within apparatus  120  will be moved or deflected in response to the insertion of pressure on bulb  20  by the user. IN this way, direct, real time, visual feedback is given to the user during use. Gradually, the degree of deflection of the indicator will be increased as the muscles are strengthened. Alternatively, an illuminated indicator or audio indicator, or any other suitable construction which will occur to one of skill in the art. Alternatively, mechanism  120  can be a simple squeeze bulb, hand or machine operated bellows, or pressurized air source.  
         [0067]    The user deflates the bulb  20  by withdrawing the handle  124 . In another embodiment, a pressure release valve is opened to release any pressure remaining in the bulb  20  above atmospheric. Once bulb  20  is deflated, the user grasps the lower part of the inserter  50  and inserts bulb  20  by pressing the distal end of bulb  20  against and through the vulva and labia until bulb  20  is fully inserted into the vagina.  
         [0068]    The user then rotates bulb  20 , if necessary, using the positioning handle  50  until the stop member  52  is ventrally positioned such that the crease  26  is positioned so that bulb  20  will not impinge on the urethra  330 .  
         [0069]    The user then inflates bulb  20  by pushing down on the handle  124  of the apparatus  120 , which forces air or other fluid through the tubing  80 . The tubing connects to the proximal part  53  of the inserter  50 .  
         [0070]    Inflation of the bulb  20  can be brought about by either moving handle  124  to the position immediately adjacent housing  120  shown in FIG. 8, by squeezing an inflation bulb or bellows, (not shown), or by any other means which will occur to those of skill in the art. The bulb  20  is sized and shaped in such a way that its exterior surface will come into contact with the interior walls of the woman adjacent the iliococcgygeal, pubococcygeal and bulbocavernous and other pelvic floor muscles. Once the user has inflated bulb  20 , the user may undertake whatever exercise regimen she or her practitioner selects. In general, contraction of the relevant muscles by the user will cause bulb  20  to deflect inwardly, decreasing the size of cavity  21  and forcing air or other fluid back through tube  80  into apparatus  120 . This, in turn, raises the pressure within apparatus  120  causing the gauge  140  or other visual or audio indicator to be deflected in correspondence with the magnitude of deflection of bulb  20  by the user. In this way, the user gets direct feedback as to the strength of her musculature, and progress can be closely monitored. Upon completion, the user deflates bulb  20  by withdrawing handle  124  or releasing the fluid which has filled bulb  20  through any other means such as a manual release valve. Then, by drawing upon the inserter  50 , withdraws bulb  20 .  
         [0071]    In one embodiment, bulb  20  is deflated by the user extending handle  124  until it is positioned as shown in phantom in FIG. 8. In other embodiments, the user simply opens a relief valve to release the pressure. Inflation/measurement apparatus  120  can be calibrated in such a way that only one stroke of handle  124  is required to fully inflate or fully deflate bulb  20 .  
         [0072]    In some embodiments, the inflatable component  20  may have a disposable cover. This cover assists in maintaining hygiene. In other embodiments, the inflatable component  20  is sanitized after each use, thus readying it for the next use.  
         [0073]    The recommended wall thickness of the bulb for the exercise embodiment is between 0.5 and 0.7 millimeters. The inflation range for the utilization of the device as an exerciser is 2psi-6psi. Consequently, gauge  130  in FIG. 8 or gauge  140  of FIG. 9 should be calibrated accordingly. To utilize the invention as a stretching device, the wall thickness of bulb  20  should be increased. The recommended wall thickness for a silicone bulb is between 0.9 and 1.1 millimeters when used as a stretching device. The recommenced inflation pressure range for use of the device as a stretching aid is between 10 psi-30 psi, although other values may be appropriate under appropriate circumstances.  
         [0074]    It is to be understood that the gauges  130  and  140  need not necessarily utilize numerals. All that is called for is to have a visual or other indication of the magnitude of deflection of the bulb  20  to provide bio-feedback in real time.  
         [0075]    The bulb makes direct contact with the pubococcygeous muscle frontal/anterior and lateral of the vagina. The bulb also makes direct contact with the illiococcygeous muscle s posterior and ventrally of the vagina. A low inflation pressure (2-3 psi) allows for sensitive deflection of the wall of bulb  20  when muscle contraction takes place. The bio-feedback via the pressure gauge allows the patient to confirm the muscle contractions and better determine muscular isolation and exercise. The effective exercise and control of the pubococcygeous, bulbocavernous and illiococcygeous muscles brought about by this device enhance sexual gratification and reduce incidence of incontinence by strengthening the overall pelvic floor muscles. The egg shape of the bulb  20  and the exercise activity performed in connection herewith pull the rectum and perineal body (muscles) toward the pubic bones and squeeze the lumina of the pelvic viscera closed, coming in contact with key muscle groups of the pelvis, the coccygeus muscles (pubococcygeous and illiococcygeous), and furthermore promoting a vaginal integrity via exercising the bulbocavernous muscle as well. This total exercise function, with bio-feedback, permits the patient (user) to actively exercise these muscle groups and promote muscular elasticity and contractivity resulting in long term benefits. The unique asymmetrical egg or ovoid shape of the bulb  20  simulates the actual anatomy facilitating direct muscle contact and bio-feedback. When inflated the bulb  20  will expand laterally, ventrally and dorsally, maximizing the muscular contact for bio-feedback, yet preventing ventral pressure on the urethra, and forming a compliant interface with muscles lateral/ventral and dorsal. The unique shape of the bulb  20  also assists users in overcoming vaginismus, the voluntary or involuntary contraction of muscles around the opening of the vagina, by exercising or controlling muscle contractions and relaxation, evidenced by the bio-feedback gauge. The foregoing helps overcome fear, pain, trauma or negative attitudes about sexual intercourse. The bulb anatomically conforms to the female pelvic anatomy when inflated and used as an exercise device. The bulb is designed to work the full levator ani complex muscle group. The lower half of the bulb  20  will stimulate the illiococcgygeous muscle while the middle to upper part will stimulate the pubococcygeal muscle and the bulbocavernous muscle.  
         [0076]    [0076]FIGS. 10 through 15 show an alternative embodiment  200  of this invention which is comprised of a handle  210  to which is removably connected a feed back indicator  220 . A pump bladder  225  foldable communicates with bulb  20  (not shown) via conduit  80  as herein before described.  
         [0077]    This embodiment is directed to an ambidextrous hand-held apparatus. The ambidextrousness is obtained by placing gauge housing  205  upon extension  230  of hand-held  210  in a direction in which the face  207  of gauge  205  faces the user. Thus, it can be seen that when a right-handed user grasps handle  210  by placing bulb  225  against the palm and the fingers against finger cutouts  211 , gauge dial face  207  will face the user. Conversely, a left-handed user will reverse the position of gauge  205  with respect to that shown in FIG. 10 (FIG. 10 being the orientation which a right-handed user would use). One embodiment of removable attachment of gauge  205  to handle  210  is a dowel-and-groove arrangement in which elongated cylindrical element  231  connected to the bottom of gauge hosing  205  is adapted to the slidably removably disposed within the correspondingly shaped slot  232  of handle extension  230 . A spring biased lock mechanism  234 , or any other suitable mechanism, may be employed to retain gauge housing  205  in connection with handle extension  230 . The housing  205 , bladder  225 , fluid passage conduit  234 , element  231  and release valve  237  are all integrally connected in fluid tight relation such that all of these parts can be removed as one unit, reversed and replaced on handle  210  so that gauge  207  will be facing in the opposite direction. An O-ring  228  or other means for sealing can be used to render the connection between passageway  234  and chamber A fluid tight. O-ring  228  is placed into annular O-ring band  268  when conduit  234  is abutted against shoulder  266 . The interior of inflation bladder  225  is fluidly communicated both with the interior of tubing  80  (and consequently with the interior  21  of bulb  20 ), using fluid outlet nipple  239 , as well as with the gauge mechanism within housing  205  via fluid passage conduit  234 . A pressure release valve, such as needle valve  237 , may be utilized to deflate bulb  20  when desired.  
         [0078]    It is to be appreciated that any suitable pressure indicator may be employed as an alternative to gauge and dial  207 , such as the linear gauge shown in FIG. 8, the radial gauge shown in FIG. 9, or any other audio or visual device which will serve the purpose of informing the user of a degree of inflation of bulb  20  and, for the exercise version of the device, if the level of muscle contraction occurring.  
         [0079]    Various modifications and alterations of this invention will become apparent to those skilled in the art without departing from the scope and spirit of this invention, and it is understood that this invention is not limited to the illustrative embodiments set forth hereinbefore.