Abstract:
Disclosed is an intra-vaginal device of a new and innovative design that in combination with kegel exercises or performing ones daily routine strengthens the muscles of the pelvic floor. The device employs a combination of unique shape, materials as well as carefully engineered deflection, frictional, testing and clean-ability characteristics with particular attention to a sexually neutral appearance, comfort during insertion and exercise as well as positive physical feedback to encourage prolonged and frequent use. Benefits of the device include improvement or prevention of urinary leakage and prolapse, increases in sexual intensity, to keep the uterus, bladder or rectum in place as a pessary as well as relief for women suffering from moderate prolapse. As a dilator to aid women who suffer from vaginismus. With its multiple features and benefits, the device is a vital tool in a woman&#39;s quest for a complete and balanced wellness regimen.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     Not Applicable 
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
     Not Applicable 
     NAMES OF PARTIES TO A JOINT RESEARCH AGREEMENT 
     Not Applicable 
     REFERENCE TO SEQUENCE LISTING, A TABLE, OR A COMPUTER PROGRAM LISTING APPENDIX SUBMITTED ON A COMPACT DISC AND AN INCORPORATION-BY-REFERENCE OF THE MATERIAL ON THE COMPACT DISC 
     Not Applicable 
     BACKGROUND OF THE INVENTION 
     The present invention is a well-designed and effective kegel exercise device to strengthen a woman&#39;s pelvic muscles and aid in the prevention and reversal of incontinence. Ergonomically engineered to reinvigorate the pelvic floor, this portable intra-vaginal resistive product is compact, easy to use, and meets the needs of today&#39;s women regardless of age and active lifestyle demands. 
     The present invention is comprised of soft, pliable medical grade materials approved for short term implant applications. Its sleek precision engineered body also provides tactile feedback and progressive resistance to strengthen and tone the vaginal sphincter muscles when doing kegel exercises. 
     The limitations of kegel exercise devices in the prior art are that most involve multiple mechanical parts such as tubes, gauges, weights, balls, are cumbersome, and protrude partially outside the body. Add to the discomfort factor the inconvenience of needing to allocate specific times and private spaces to use them. 
     The present invention advances the state of the art with a one piece, unobtrusive, comfortable, lightweight, easy to insert, remove and clean product. This revolutionary discreet creation can be worn anywhere and at any time during the course of a woman&#39;s multi-tasking daily routine. In addition, with its unique combination of physical and mechanical properties, the present invention is more than a kegel muscle locator and motivator. It can be used: as an exercise device to help improve/prevent urinary leakage and prolapse, and increase sexual intensity; as a pessary to keep the uterus/bladder/rectum in place for women suffering from moderate prolapse. As a dilator to aid women who suffer from vaginismus. With its multiple features and benefits, the present invention is a vital tool in a woman&#39;s quest for a complete and balanced wellness regimen. 
     As a result, women can now take care of themselves from the inside out on their own terms because: 
     20 million women in the US are affected by urinary incontinence. 
     Notwithstanding underlying medical conditions, incontinence is not inevitable or part of the aging process because evidence exists that incontinence can be prevented and even reversed. 
     13 million women affected by urinary incontinence do not use any treatment or product to manage their condition. 
     1 in 4 women over the age of 50 suffer from prolapse. 
     BRIEF SUMMARY OF THE INVENTION 
     The preferred embodiment of the present invention is a soft, light weight, inconspicuous, comfortable, portable, intra-vaginal device with a sleek, sexually neutral, sculptured appearance that strengthens the pelvic floor, pubbococcygeal muscles, of the vagina. The device appears to be of simple design yet fulfills a number of interrelated requirements to facilitate ease of insertion, flexibility, resistance to multidirectional forces during use, providing pleasant feed back to the user and ease of removal. Additional requirements include ease of cleaning and durability for repeated use. Insertion and removal are facilitated by the device&#39;s prolate (football like) outline where the smaller width at the two ends is first to enter and exit the vaginal opening. The opening in the center of the prolate ring allows the ring to collapse further reducing resistance to entry and exit. There is also a finger pad to keep ones finger from slipping off of the ring while pushing the ring into place and a tension element that comfortably protrudes from the vaginal opening during use and aids in the removal of the device when use is completed. With the exception of the small exception of the small variation due to the finger pad the shape of the end of the prolate ring that enters the vagina first and the end that exits the vagina first are the same. The effectiveness of treatment with the device is enhanced by use of a well-known Kegel exercise routine in addition to leaving the device in place during every day activities and during conventional exercise. 
     It is the principal objective of the preferred embodiment of the present invention is to provide effective relief from incontinence, and pelvic organ prolapse, provide dilation for vaginismus, promote relaxation of vaginal muscles and to increase sexual intensity; 
     Another objective is to provide calibrated resistance to critical musculature keeping organs in their youthful positions and functioning in a reliable manner; 
     Another objective is to provide pleasant feedback to the user that motivates frequent and prolonged use; 
     Another objective is to present a neutral appearance that neither upsets the sensibilities of the user during handling, is not obtrusive during use, nor does it present the potential of an embarrassment in the eyes of others; 
     Another objective is to provide comfort during insertion, use and removal; 
     Another objective is ease of cleaning and durability for repeated use; 
     Another objective is effectiveness without the use of weights; 
     Basically the present invention allows women to accomplish all of these objectives with the confidence and freedom from discomfort and pain of a much younger person, without anyone knowing and while going about their daily lives. 
    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         FIG. 1A , shows a perspective view of the preferred embodiment of the present invention;  FIG. 1B , shows a cross section of the view of  FIG. 1A ; 
         FIG. 2A , shows a front view,  FIG. 2B  shows a top view and  FIG. 2C  shows aside view of the preferred embodiment of the present invention; 
         FIG. 3A , shows a front view,  FIG. 3B  shows a top and  FIG. 3C  shows a side view of the prolate shaped spring of the preferred embodiment of the present invention; 
         FIG. 4A , shows a front view,  FIG. 4B  shows a top and  FIG. 4C  shows a side view of the prolate shaped spring embedded in preferred embodiment of the present invention; 
         FIG. 5 , is a block diagram showing the process steps for making the preferred embodiment of the present invention; 
         FIG. 6 , is a block diagram showing the steps for using the preferred embodiment of the present invention; 
         FIG. 7 , is a block diagram showing the steps for Kegel exercising with the preferred embodiment of the present invention; 
         FIGS. 8A ,  8 B,  8 C, and  8 D, is a diagram are diagrams showing the application of forces to measure the deflection characteristics of the preferred embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       FIG. 1   a  shows the preferred embodiment of the present invention  10  which is specifically designed for inter-uterine application by human females. The preferred embodiment with its unusual shape is being described as a prolate ring  11 . The term prolate is generally used to describe a family of solid geometrical shapes that includes the shape of an American football. The shape, elasticity, hysteresis characteristics, strength, frictional characteristics and weight all play an important part in delivering the two major measures of a successful device. These parameters are measures of the predicted effectiveness at overcoming a number of ailments including but not limited to effective relief from incontinence, and pelvic organ prolapse, promoting dilation for vaginismus, promoting relaxation of vaginal muscles and to increase sexual intensity and secondly providing comfort while doing so. The prolate shaped ring  11  is continuous without interruption and is symmetrical about the minor axis “II.”, except for very small exceptions at the base, making the ease of insertion and the ease of extraction approximately equal. 
     The unobstructed, through opening  12  in the center of the prolate ring  11  plays an important role during steps  605 ,  606  and  608  of the method of use shown in  FIG. 6 . The opening  12  allows the prolate ring  11  to collapse during insertion  605  and to spring back into its original shape after insertion  606  is completed. There is provided a finger pad  13  at the intersection of the outer periphery of the prolate ring  11  and the major axis “I.” that is a very slight protrusion from the prolate ring  11  with a flat or concave surface to provide traction with the tip of a user&#39;s finger while coaxing the prolate ring  11  into the bodily orifice during insertion. The long dimension of the surface of the finger pad  13  is approximately the width of a fingertip and less than half the thickness dimension of the prolate ring  11  while the center of the finger pad lies very close to a line that represents the outline of the outer periphery of the prolate ring. Tension element  14 , otherwise referred to as a string, plays an important part in removing the prolate ring  11  from the bodily orifice  608  and transmits the force of extraction from the users hand to the prolate ring  11  while the prolate ring  11  collapses with the help of the unobstructed opening  12 . The tension element  14  is only used for extraction as it is too thin and flexible to transmit a compressive force. The tension element  14  is also integral in one piece with the prolate shaped ring  11  and attaches at two points on either side of the finger pad  13 . 
       FIG. 1   b  shows a cross section “A-” of the prolate shaped ring  10  that approximates the shape of an isosceles trapezoid  15  the short parallel side “x” of the isosceles trapezoid  15  forms part of a outer periphery of the prolate shaped ring  10 . The long parallel side “w” of the isosceles trapezoid  15  forms a part of an inner periphery of the prolate shaped ring  10 . The sloped sides “y” and “Z” of the isosceles trapezoid  15  are convexly curved. The short parallel side “x” of the isosceles trapezoid  15  is also convexly curved. The cross section of the prolate ring  10  promotes ease of insertion and extraction of the prolate ring  10  as well as comfort while the prolate ring  10  is in use. 
       FIG. 2 , shows the preferred embodiment of the present invention  10  in three views. Prolate ring  11  has a opening  12  a finger pad  13  and tension element  14 . The prolate ring  11  has a major diameter “a” that is taken along the major axis “I.”, a minor diameter “b” that is taken along the minor axis “II.” and a thickness measurement “c” that is taken along the axis “III.” of the opening  12 . The prolate ring  11  also has a hoop thickness “d”, a tension element length “e” a tension element thickness of “g” and a tension element spacing of “f”. The second column of Chart 1 shows the dimensions of the prolate ring  11  in millimeters. The third to twelfth columns show the dimensions of the prolate ring  11  in millimeters to possibly adapt the preferred embodiment for users having larger or smaller body sizes. 
     From CHART 1 it is observed that the minor diameter of the prolate ring ring “b” is between 63%-77% of the Major Diameter “a” of the prolate ring  1   i . The thickness of the prolate ring “c” is between 36% and 45% of the Major Diameter “a” of the prolate ring  11 . The hoop thickness of the prolate ring “c” is between 10% and 12% of the Major Diameter “a” of the prolate ring  11 . 
     
       
         
               
               
               
               
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
               
               
               
               
             
           
               
                   
                 CHART 1 
               
               
                   
                   
               
               
                   
                 Preferred 
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
               
               
                   
                 Embodiment 
                 0.5 
                 0.6 
                 0.7 
                 0.8 
                 0.9 
                 1.0 
                 1.1 
                 1.2 
                 1.3 
                 1.4 
                 1.5 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                 “a” 
                 71.87 
                 50% 
                 60% 
                 70% 
                 80% 
                 90% 
                 100%  
                 110%  
                 120%  
                 130%  
                 140%  
                 150%  
               
               
                 
                   “b” 
                 
                 50.26 
                 35% 
                 42% 
                 49% 
                 56% 
                 
                   63% 
                 
                 70% 
                 
                   77% 
                 
                 84% 
                 91% 
                 98% 
                 105%  
               
               
                 
                   “c” 
                 
                 29.14 
                 20% 
                 24% 
                 28% 
                 32% 
                 
                   36% 
                 
                 41% 
                 
                   45% 
                 
                 49% 
                 53% 
                 57% 
                 61% 
               
               
                 
                   “d” 
                 
                 8.16 
                  6% 
                  7% 
                  8% 
                  9% 
                 
                   10% 
                 
                 11% 
                 
                   12% 
                 
                 14% 
                 15% 
                 16% 
                 17% 
               
               
                 “e” 
                 92.83 
                 65% 
                 77% 
                 90% 
                 103 
                 116 
                 129%  
                 142%  
                 155%  
                 168%  
                 181%  
                 194%  
               
               
                 “f” 
                 14.59 
                 10% 
                 12% 
                 14% 
                 16% 
                 18% 
                 20% 
                 22% 
                 24% 
                 26% 
                 28% 
                 30% 
               
               
                 “g” 
                 2.81 
                  2% 
                  2% 
                  3% 
                  3% 
                  4% 
                  4% 
                  4% 
                  5% 
                  5% 
                  5% 
                  6% 
               
               
                   
               
             
          
         
       
     
       FIG. 3 , Shows a prolate shaped spring  30  that will be shown embedded in the prolate ring  11  in  FIG. 4 . Prolate shaped spring  30  is a flat spring (has a rectangular cross section)  FIG. 3  has a notch  31  at two points in its periphery located at the tips of its prolate shape. Prolate shaped spring  30  has a major diameter “w”, a minor diameter “x”, a thickness measurement “u” and a hoop thickness “v”. The notch  31  has a notch length “y” and a notch width “z”. The second column of Chart 2 shows the dimensions of the prolate spring  30  in millimeters. The third to twelfth columns show the dimensions of the prolate spring  30  in millimeters to possibly adaptation to different body sizes. From CHART 2 it is observed that the minor diameter of the spring “x” is between 55%-67% of the Major Diameter “a” of the prolate ring  11 . 
     
       
         
               
               
               
               
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
               
               
               
               
             
           
               
                   
                 CHART 2 
               
               
                   
                   
               
               
                   
                 Preferred 
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
               
               
                   
                 Embodiment 
                 0.5 
                 0.6 
                 0.7 
                 0.8 
                 0.9 
                 1.0 
                 1.1 
                 1.2 
                 1.3 
                 1.4 
                 1.5 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                 “w” 
                 60.81 
                 42%  
                 51%  
                 59% 
                 68% 
                 76% 
                 85% 
                 93% 
                 102 
                 110 
                 118 
                 127 
               
               
                 “X” 
                 43.56 
                 30%  
                 36%  
                 42% 
                 48% 
                 
                   55% 
                 
                 61% 
                 
                   67% 
                 
                 73%  
                 79%  
                 85%  
                 91%  
               
               
                 “u” 
                 10.19 
                 7% 
                 9% 
                 10% 
                 11% 
                 13% 
                 14% 
                 16% 
                 17%  
                 18%  
                 20%  
                 21%  
               
               
                 “v” 
                 1.64 
                 1% 
                 1% 
                  2% 
                  2% 
                  2% 
                  2% 
                  3% 
                 3% 
                 3% 
                 3% 
                 3% 
               
               
                 “y” 
                 2.67 
                 2% 
                 2% 
                  3% 
                  3% 
                  3% 
                  4% 
                  4% 
                 4% 
                 5% 
                 5% 
                 6% 
               
               
                 “z” 
                 1.77 
                 1% 
                 1% 
                  2% 
                  2% 
                  2% 
                  2% 
                  3% 
                 3% 
                 3% 
                 3% 
                 4% 
               
               
                   
               
             
          
         
       
     
       FIG. 4 , shows the preferred embodiment of the present invention  10  with a cut away view of prolate ring  11  and also having finger pad  13  and tension element  13 . Spring  30  is shown suspended in the prolate ring  11  so that it is equi-distant from the outer surface of the opening  12  and equidistant from the sides  32  of the prolate ring  11 . 
       FIG. 5 , shows the method of making the preferred embodiment of the present invention. The preferred embodiment 10 and the spring  30  each require a mold for manufacture. Step  500  calls for molding. There are any number of molding methods, processes and machines that can be adapted to manufacture the spring and over-mold to manufacture a finished device. It is considered that it is within the skill of one of ordinary skill to choose or design the mold, process and or machinery. Some of these methods, processes or machinery may also leave molding flash or gates on the prolate shaped spring  30  or over-mold after removal from the mold. Although, the block diagram of  FIG. 5  does not include these process steps it is assumed to be within the skill of one of ordinary skill in the art to choose and or design the requisite ancillary tooling to trim and perform secondary process that are necessitated by the molding processes that are chosen. Step  501 , requires supply of molding material. The preferred embodiment of the present invention uses polycarbonate resin as the molding material and the shape and thickness of the prolate shaped spring  30  are designed to produce resilience of the prolate ring to collapse for insertion into the vaginal opening during insertion as well as providing the required resistance to motion for strengthening pelvic floor muscles during exercise as described in  FIG. 7 . Step  502  is to mold the prolate shaped spring  30  followed by step  503  to remove the prolate shaped spring  30  from the prolate shaped spring  30  mold. Step  504  is to supply the prolate ring and tension element mold which has provisions to suspend the prolate shaped spring  30  to allow molding material to flow completely around the prolate shaped spring  30  to form the finished device of  FIG. 1   a . Step  505  is to insert the prolate shaped spring  30  into the prolate ring and tension element mold followed by step  506  to supply the ring and tension element material. The preferred embodiment of the present invention uses a medical grade silicone as the molding material. Step  507 , is to mold the prolate ring and tension element, followed by step  508  to extract the prolate ring and tension element from the mold and step  509  to cool and cure the prolate ring and tension element for 24 hours before step  210  to test the flexural and surface characteristics of the finished device of  FIG. 1   a . The testing is performed to verify the device meets the resiliency for proper operation as listed in Chart 3. 
     
       
         
               
               
               
             
           
               
                 CHART 3 
               
               
                   
               
               
                 Direction of 
                   
                 High 
               
               
                 force applied to the device 
                 Low end of range 
                 end of range 
               
               
                   
               
             
             
               
                 Compressive Down Major Axis 
                 .5 mm/Newton 
                  2 mm/Newton 
               
               
                 Compressive Down Minor Axis 
                 .5 mm/Newton 
                  2 mm/Newton 
               
               
                 Compressive Down Axis of Opening 
                 .1 mm/Newton 
                 .5 mm/Newton 
               
               
                 Bending along Major Axis 
                 .02 mm/Newton  
                 .1 mm/Newton 
               
               
                   
               
             
          
         
       
     
       FIG. 6  shows the method of using the preferred embodiment of the present invention by females. The major difference in the method for the following uses is the period of time that the device remains in the vagina and whether or not exercising is performed while the device remains in the vagina. These differences are illustrated in Chart 4. 
     
       
         
               
               
               
               
             
               
               
               
               
               
             
           
               
                   
                 CHART 4. 
               
               
                   
                   
               
               
                   
                   
                   
                 Extended 
               
               
                   
                 Used With 
                 One Day 
                 Periods 
               
               
                   
                 Exercise 
                 or Less 
                 Possible 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 Medical Exercise 
                 X 
                   
                 X 
               
               
                   
                 Device 
               
               
                   
                 Non-implant 
                   
                 X 
                 X 
               
               
                   
                 Pessary Device 
               
               
                   
                 Dilator to Relieve 
                   
                 X 
                 X 
               
               
                   
                 Vaginismus 
               
               
                   
                 Aid for Heightening 
                 X 
                 X 
                 X 
               
               
                   
                 Sexual Pleasure 
               
               
                   
                   
               
             
          
         
       
     
     The steps of  FIG. 6  are: Step  600 , remove the device from container. The container serves to keep the device clean and physically protected. Cleanliness is mandatory for the good health of the user and the tension element is the most vulnerable part of the device to damage when carried in a pocket or purse. The container that is initially envisioned is a plastic travel box. However, there are any number of containers that would provide the requisite cleanliness and physical protection. The container is considered an accessory that would be within the skill of one of ordinary skill in the art to design or choose. Step  601 , supply cleaning solution. The cleaning solution removes any body fluids, odors and sloughed off dead cells from the vaginal area. Soapy water or 70% by volume isopropyl alcohol has been found to be effective. Step  602  clean the device, is performed by a combination of applying cleaning solution with or without a wipe, optionally rinsing off the cleaning solution from the device and either wiping or allowing the device to air dry. Step  603  Supply Lubricant, any water based personal lubricant has been found to be effective as a lubricant to allow insertion of the device through the vaginal opening and into position for optimum use with a minimum of force and discomfort. Step  604 , apply lubricant to device at end opposite the finger pad is achieved by dispensing a drop of the supplied lubricant in the specified location. The cleaning solution, any wipe or rinse material and lubricant are considered a depreciable supply items for device users that would be within the skill of one of ordinary skill in the art to design or choose for use either with or without wipe and rinse materials. Step  605 , Insert device into body opening is achieved by positioning the device with the lubricated end entering first, flat sides of the device oriented vertically pinching the sides together and pushing the device with ones finger on the finger pad. Step  606  moving the device into position using the finger pad. This is done until the device is in a comfortable position within the vagina and the tension element protrudes from the vaginal opening. Step  607 , exercise or perform daily routine is performed according to Chart 1, depending on the results that the user wants to achieve. Step  608 , remove device from body opening by pulling on tension element is self-explanatory. One should adjust the force and speed of performing this step to minimize discomfort or any damage to sensitive tissues. Step  609 , Clean the device is performed in the same manner as in step  602  except it is assumed that the device requires more cleaning and possibly repeating the procedure of step  602  multiple times to achieve the requisite cleanliness. Step  610  return device to container is perhaps the simplest yet most critical step. 
       FIG. 7  shows the recommended steps for performing the Kegel exercise for use with the preferred embodiment of the present invention. Step  700  of the exercise involves following steps  600 - 610  of  FIG. 6  to insert the device into the vaginal opening followed by step  701  to position the body in a lying down, sitting or standing position, followed by step  702  to deeply inhaling air into the lungs, and step  703  to exhale slowly while squeezing and lifting the pelvic floor without moving the abdomen or buttocks, followed by step  704  to hold the position of step  703  for 10 seconds, and step  705  to fully relax for 5 seconds. The sequence of steps  700  to step  705  is repeated a total of 10 times in step  706 . The user then begins the much more rapid sequence of step  707  squeezing and lifting the pelvic floor without moving the abdomen or buttocks for one second, followed by step  708  to fully relax for 1 second and repeating the sequence step  707  and  708  a total of 10 times ending with fully relaxing at step  710 . The coordinated breathing in and out are key to the successful outcome of performing these exercises. 
       FIGS. 8   a - 8   d , show the test set up for determining the deflection of the prolate ring  11  with forces applied.  FIG. 8   a , shows a compressive force in the direction of the major axis “I.” of the prolate ring  11 .  FIG. 8   b , shows a compressive force in the direction of the minor axis “II.” of the prolate ring  11 .  FIG. 8   c , shows a compressive force in the direction of the opening axis “III.” of the prolate ring  11 .  FIG. 8   d  shows a bending force applied so as to bend the major axis “I.” of the prolate ring  11 .