Abstract:
A device and method for improving fertility among couples after intercourse is disclosed. The device and method uses an intravaginal device that collects ejaculate from the vaginal canal after intercourse and presents it to the os of the cervix. The device also serves to contain ejaculate near the cervical os to increase the chances of successful fertilization.

Description:
FIELD OF THE INVENTION 
       [0001]    This disclosure generally relates to the field of fertility devices, and in particular, an intravaginal fertility device for collecting and presenting ejaculate closer to the cervix. 
       BACKGROUND OF THE INVENTION 
       [0002]    According to the National Institutes of Health, fifteen percent of couples are unable to get pregnant after twelve months of regular unprotected sexual intercourse. There are many potential reasons for reduced fecundity; one third of the cases involve male infertility, another third female infertility, with the balance involving both. Conventional therapies for fertility problems typically include medication or surgery. Both of these categories of therapies can pose health risks. Fertility medications may have undesirable side-effects and can be expensive. Surgical treatments may be seen as too invasive and risky; other treatments, such as assistive reproductive technology, may also present a level of invasiveness and expense that puts it out of reach of many couples searching for fertility assistance. 
         [0003]    Others have proposed various intravaginal devices to provide less invasive and expensive fertility treatments. These devices include artificial insemination, cervical cap, and intravaginal plug devices. Artificial insemination devices require collection and subsequent introduction of semen to the vaginal canal and cervix by mechanical methods, such as the use of a catheter with a plunger or syringe. See, e.g., U.S. Patent Application No. 2011/0087065; 2015/0196324. Existing cervical cap devices for improving fertility also require collection of semen prior to insertion of the cap, which stays in place at the cervix for up to six hours. But collection and handling of semen can be complicated and difficult, and must be carried out in a manner that will not damage the semen. Intravaginal plugs, such as that proposed in U.S. Publication No. 2005/0028824, while less complicated and easier to use than artificial insemination and cervical cap devices, are designed to keep the ejaculate from exiting the vaginal canal; however, these devices are not specifically designed to place the ejaculate in contact with the cervix and uterus, and any such contact is incidental to their use. 
         [0004]    What is needed is a method and apparatus for improving the potential for pregnancy without the invasive and complex procedures currently proposed or available. 
       SUMMARY OF THE INVENTION 
       [0005]    The present invention solves the above problems with an intravaginal device comprised of rigid and elastically-deformable portions that is inserted into the vaginal canal after intercourse. In one embodiment, the device has a rigid longitudinal shaft attached to a round, concave end cup; after intercourse, the device is inserted into the vagina and moved gently up the vaginal canal toward the cervix. As it moved, the end cup of the device makes contact with the walls of the vaginal canal to collect and present ejaculate including semen to the os of the cervix. The device is left in the vagina for up to twenty minutes, then removed using the rigid shaft. 
         [0006]    In another embodiment of the present invention similar to the above described embodiment, the device is formed using an elastically-deformable material over a rigid shaft or spine. The elastically-deformable material forms a concave cup and the end for collection and presentation of ejaculate to the os of the cervix in a manner similar to that described above in the first embodiment. 
         [0007]    In another embodiment of the present invention, an expandable end cup is attached to a longitudinal shaft which is movably positioned in a rigid plastic shell. The shell and cap of the device is inserted into the vagina. The shaft is then moved longitudinally, causing the end cap to exit the shell, and expand to contact the walls of the vaginal canal. As the expanded cap is moved by the shaft toward the cervix, the cap collects ejaculate from the walls of the vaginal canal and presents it to the os of the cervix. 
         [0008]    In yet another embodiment, the end cap of the device detaches from the shaft. When assembled into the unit prior to use, the cap is folded so as to create a smaller profile, thereby easier to insert into the entrance of the vagina. After insertion into the vagina, the cap unfolds to its full diameter, which allows the sides of the cap to contact the walls of the vaginal canal, collect ejaculate and present it to the os of the cervix. Then the shaft can be separated from the cap and removed from the vagina. After an amount of time has passed, the cap can be removed from the vagina via a wire connected to the cap. 
     
    
     
       DESCRIPTION OF DRAWINGS 
         [0009]      FIG. 1  illustrates an embodiment of the present invention in three views. 
           [0010]      FIG. 2  illustrates the embodiment of  FIG. 1  in section view. 
           [0011]      FIG. 3  is a diagram illustrating the use of the embodiment in  FIG. 1 . 
           [0012]      FIG. 4  illustrates another embodiment of the present invention in three views. 
           [0013]      FIG. 5  illustrates the embodiment of  FIG. 4  in section view. 
           [0014]      FIG. 6  illustrates another embodiment of the present invention in three views 
           [0015]      FIG. 7  illustrates the embodiment of  FIG. 6  in section view. 
           [0016]      FIG. 8  is a diagram illustrating the use of the embodiment in  FIG. 6 . 
           [0017]      FIG. 9  is a diagram illustrating the use of the embodiment in  FIG. 6 . 
       
    
    
     DETAILED DESCRIPTION 
       [0018]      FIG. 1  illustrates one embodiment of the invention in three views. As shown in  FIG. 1 , the device has a rigid shaft  110  terminating with a larger diameter concave end cup  120 . The end cup is an elastically deformable material such that it can form to the shape of the walls of the vaginal canal.  FIG. 2  show additional details of the device according to a first embodiment of the invention. As shown in  FIG. 2 , the end cap has a concave section  210  at the end to facilitate the collection of ejaculate. 
         [0019]      FIG. 3  illustrates the use of the embodiment of the invention shown in  FIGS. 1 and 2 . After intercourse resulting in ejaculation, the cup end of the device is inserted into the vaginal opening and slid into a positions at the os of the cervix. As the device travels through the vaginal canal, the sides of the end cup  120  collect ejaculate present in the vaginal canal and present it to the cervix. The end cup  120  remains in the vicinity of the cervix for a prescribed amount of time, for example between ten minutes to several hours. After the time has passed, the device is removed by pulling the rigid shaft  110  until the end cap  120  clears the vaginal opening. 
         [0020]      FIGS. 4 and 5  illustrate a second embodiment of the invention, similar to the embodiment discussed in connection with  FIG. 1 . The key difference between the two embodiment is that the embodiment shown in  FIGS. 4 and 5  is manufactured and assembled differently. As shown in  FIG. 5 , the device is comprised of a rigid shaft piece  510  and is covered with an elastically deformable material  520 . The concave end cap  530  is formed using the deformable materials  520 . Use of the device illustrated in  FIGS. 4 and 5  is the same as described above for the embodiment shown in  FIGS. 1 and 2 . 
         [0021]      FIGS. 6 and 7  illustrate a third embodiment of the present invention.  FIG. 6  shows the device of the third embodiment prior to use. The device of  FIG. 6  includes a shaft  610  and end cap  620 , as well as a shell  630 . The shaft  610  and shell  630  are made of rigid material; the end cap  620  is made of elastically deformable materials. The shaft protrudes through a hole in the shell  630  and connects to the end cap  620 . When assembled prior to use, the wall of the end cap is compressed by the shell so as to present a small profile to the vaginal entrance.  FIG. 7  illustrates the difference in profiles before and after actuation of the shaft  610 . The top view  710  of  FIG. 7  shows the device prior to insertion into the vaginal opening. The bottom view  720  shows the device after insertion into the vaginal opening and after actuation of the shaft. As can be seen in the top view  710 , the overall device diameter is smaller than the diameter of the device when the shaft is actuated, owing to the expansion of the cap material after it clears the lip of the shell. In this way, the device diameter is smaller when it is inserted into the vaginal open, yet the end cap expands to effectively contact the vaginal walls to collect ejaculate. 
         [0022]      FIGS. 8 and 9  illustrate the use of the device according to the embodiment shown in  FIGS. 6 and 7 . Similar to the first and second embodiments, the device of  FIGS. 6  is inserted into the vaginal opening after intercourse and ejaculation.  FIG. 8  shows the device after insertion into the vaginal opening. As shown in  FIG. 8 , the shell  630  of the device is placed in the vaginal opening and remains positioned there throughout use. Once the shell is seated into the vaginal opening, the shaft is actuated to deploy the end cap to its fullest diameter and move the end cap to the vicinity of the cervix. After deployment, the end cap  620  contacts the walls of the vaginal canal to collect ejaculate and present it to the os of the cervix, as shown in  FIG. 9 . The device remains in this position for the prescribed amount of time, between ten minutes and several hours. 
         [0023]      FIG. 10  illustrates a device according to a fourth embodiment of the present invention. The device of  FIG. 10  has similar features to the other embodiments already discussed. The device has a shaft assembly  1010 , a cap  1020 , a shell  1030 , and a wirelocker  1040 . In this embodiment, the cup  1020  is designed to fold to present a smaller profile to the vaginal opening, and also to detach from the shaft  1010  and shell  1030  assembly. As shown in  FIG. 11 , the shaft assembly is comprised of two shaft halves,  1010   a  and  1010   b.  The cup  1020  is connected to the wirelocker  1040  by a wire-like linkage  1110  such as a length of wire or string. The wirelocker  1040  locks onto a locking feature  1120  on one side of the two-piece shaft  1010   a,  holding the cup  1020  in position at the end of the shaft assembly  1010  as shown in  FIG. 10 . 
         [0024]      FIGS. 12 and 13  illustrate the procedure for inserting the device according to the embodiment shown in  FIG. 11  into the vaginal canal and placing the cap in proximity to the cervix. The top view  1210  of  FIG. 12  shows the initial position of the device upon insertion into the vaginal opening, where dotted line  1240  indicates the exterior surface of the vaginal opening. As mentioned above, the end cup  1020  is folded by the shaft halves  1010   a  and  1010   b  to present a smaller profile to the vaginal opening. View  1210 f shows the folded cap  1020  in the end of the shaft when the shaft is fully retracted into shell  1030  during insertion. 
         [0025]    Once inserted and seated into the vaginal opening, the shaft is actuated in the direction of the vaginal canal as shown in the middle view  1220  of  FIG. 12 . As can be seen in the middle view  1220 , as the shaft is longitudinally actuated through the shell, the two shaft halves allow the cup  1020  to expand to its full diameter and contact the walls of the vaginal canal. Continuing the procedure, the shaft is further actuated longitudinally until the cap reaches the os of the cervix as shown in bottom view  1230  of  FIG. 12 . As the cap travels through the vaginal canal, it contacts the walls of the vaginal canal collecting ejaculate and presenting it to the cervix. 
         [0026]      FIG. 13  illustrated the procedure for detaching and deploying the end cap onto the cervix. In the top view  1310  of  FIG. 13 , the shaft of the device has been extended to reach the cervix. Wirelocker  1040  is shown at the external end of the shaft in the locked position, securing the end cup to the device. Middle view  1320  illustrated unlocking of the end cap by rotating the wirelocker  1040  to free it from the locking feature  1120 . As shown in the bottom view of  FIG. 13 , once the wirelocker is removed from the locking feature  1120 , it is free to pass through the shaft assembly  1010 , detaching the end cap from the device. At this point, the shaft  1010  and shell  1030  assembly is removed from the vagina, leaving the end cap in the vicinity of the cervix. After the prescribed amount of time passes, the cap is removed using the wirelocker  1040  and wire-like linkage  1110 .