Abstract:
A vaginal device such as a cervical cap diaphragm vaginal ring or other intra-vaginal device designed for delivery of biologically active materials has a first member and a second member which are selectively attached to each other, at least one of the members comprising a releasable biologically active material.

Description:
BACKGROUND OF THE INVENTION  
         [0001]    The present invention relates generally to a disposable vaginal device which can be used to deliver biologically active substances for a substantial period of time. More particularly, the present invention relates to a vaginal device comprising at least two parts, at least one of which can be used to deliver biologically active substances for a substantial period of time, and means for selectively assembling the parts into an operative device.  
           [0002]    Devices which are intended to be inserted into the vagina are known for use as contraceptive barriers or as vehicles for the delivery of medicaments or spermicides. In the past, devices for the delivery of biologically active materials have included pessaries, vaginal suppositories and various devices composed of one or more reservoirs covered by a permeable surface through which the biologically active material may migrate or leave the device and then enter the body. One of the principal requirements for a device for delivering a biologically active substance to the body is that the device remain in place long enough to administer the desired dose.  
           [0003]    Although vaginal devices have been known for some time, there is continuing development of their design and use around the world. For example, cervical caps are becoming increasingly popular for contraceptive use by the general population. Despite advances in the art, there remains a need for improved intra-vaginal devices capable of delivering a biologically active substance yet which are inexpensive and which can be self inserted. There is also a need for an improved intra-vaginal device capable of acting as a multi-purpose delivery vehicle for two or more biologically active materials. There is also a need for a vaginal device which can be readily adapted for various uses and which has a long shelf life.  
           [0004]    The present invention represents a significant conceptual advance in the art relating to the way biologically active materials are introduced intra-vaginally. The new devices of this invention are capable of being molded into parts that may be assembled interchangeably. The present invention allows intra-vaginal, sustained delivery of biological active materials to treat a variety of sexually transmitted diseases, yeast infections, warts, ulcerations, lesions, endometriosis, hormone deficiency, etc. It will be apparent to those familiar with the art that there are a tremendous number of variations and combinations of biological active materials that could be delivered intra-vaginally in order to address a whole host of problems. For example: a preferred treatment for Chlamydia involves the administration of Tetracycline and Ampicillin for a ten day period. However, patients often fail to properly comply with the terms of medication for the ten day period. The present invention allows the delivery of Tetracycline and Ampicillin in combination in such a way that patient compliance can be removed as an issue.  
           [0005]    In summary, the present invention provides an improved method and devices including cervical caps, diaphragms, vaginal rings and other intra-vaginal devices designed for delivery of biologically active materials. Further understanding of the present invention will be had from the following disclosure and claims taken in conjunction with accompanying drawings.  
         SUMMARY OF THE INVENTION  
         [0006]    The present invention relates to a vaginal device comprising first and second members which are selectively attached to each other at least one of said members comprising a biologically active material.  
           [0007]    The present invention also is directed to a method of selectively attaching two or more parts of a vaginal device used for the sustained delivery of one or more biologically active materials. The device is able to sustain delivery of a wide variety of drugs simultaneously. The parts can be located in a pharmacy so that a physician would be able to prescribe the device with the appropriate “snap ins” and the pharmacist would be able to assemble it prior to dispensing the device to the user.  
           [0008]    The parts to be used are manufactured of a biologically active loaded silicone based material that can be snap-fit together. Thus, the device is composed of two or more parts designed to be selectively snapped together prior to being inserted by the user. The parts of the current invention can be made in such a way as to promote the greatest possible amount of interchangeability.  
           [0009]    In a preferred embodiment, the invention will be composed of a cervical cap with a plurality of grooves allowing a plurality of snap-in rings to be added prior to use. Alternative preferred embodiments include a diaphragm vaginal ring, vaginal disc or vaginal suppository, upon which there would be a plurality of snap-in parts making a whole unit prior to use. Still further preferred alternative embodiments are two or more parts that when selectively snapped together, would form a cervical cap, diaphragm, vaginal disc or a vaginal suppository. Combinations of the above alternatives can also be used.  
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0010]    [0010]FIG. 1 is a perspective view of a preferred embodiment of a cervical cap of the present invention;  
         [0011]    [0011]FIG. 2 is a sectional view, broken away, taken along line  2 - 2  in FIG. 1;  
         [0012]    FIGS.  3 - 5  are sectional views analogous to FIG. 2 but showing alternative preferred embodiments of rims of cervical caps of the present invention;  
         [0013]    [0013]FIG. 6 is an exploded view in perspective, showing another alternative preferred embodiment of a cervical cap of the present invention;  
         [0014]    [0014]FIG. 7 is a sectional view, broken away, taken along line  7 - 7  in FIG. 6;  
         [0015]    [0015]FIG. 8 is an exploded view, in perspective, analogous to FIG. 6 but showing yet another alternative preferred embodiment of a cervical cap of the present invention;  
         [0016]    [0016]FIG. 9 is a sectional view, broken away, taken along line  9 - 9  in FIG. 8;  
         [0017]    FIGS.  10 - 11  are sectional views analogous to FIG. 9 but showing further alternative preferred embodiments of cervical caps of the present invention;  
         [0018]    [0018]FIG. 12 is a perspective view showing a preferred embodiment of a vaginal ring of the present invention;  
         [0019]    [0019]FIG. 13 is a sectional view, broken away, taken along line  13 - 13  in FIG. 12;  
         [0020]    FIGS.  14 - 16  are exploded views, in perspective, of alternative preferred embodiments of vaginal suppositories of the present invention.  
         [0021]    [0021]FIG. 17 is a perspective view of a preferred embodiment of a vaginal ring of the present invention.  
         [0022]    [0022]FIG. 18 is a sectional view, partly in perspective and broken away, taken along lines  18 - 18  in FIG. 17.  
         [0023]    FIGS.  19 - 20  are perspective views of alternative preferred embodiments of vaginal devices of the present invention.  
         [0024]    [0024]FIG. 21 is a perspective view of a preferred embodiment of a vaginal ring of the present invention.  
         [0025]    [0025]FIG. 22 is a perspective view of a preferred embodiment of a vaginal suppository of the present invention.  
         [0026]    [0026]FIG. 23 is a perspective view of a preferred embodiment of a diaphragm of the present invention.  
         [0027]    [0027]FIG. 24 is a sectional view taken along line  24 - 24  in FIG. 23 and broken away.  
         [0028]    [0028]FIG. 25 is a perspective view of a preferred embodiment of an alternative diaphragm of the present invention.  
         [0029]    [0029]FIG. 26 is a sectional view, broken away, taken along line  26 - 26  in FIG. 25.  
         [0030]    FIGS.  27 - 28  are sectional views, broken away, analogous to FIG. 26 but showing alternative embodiments of diaphragms of the present invention. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0031]    Now referring to FIG. 1, a preferred embodiment of a vaginal device of the present invention is shown in perspective view and indicated generally by the numeral  10 . Vaginal device  10  is a cervical cap which, broadly speaking, has a dome  12  with an annular ring  14  retained thereon. As best shown in FIG. 2, annular ring  14  is snap-fit into, and retained by, groove  16  in annular rim  18  of dome  12 .  
         [0032]    Dome  12  is generally thimble-shaped and sized to fit over the cervix in a manner conventional for cervical caps. Annular rim  18  is integrally molded with thin, flexible non-resilient cap portion  20  of dome  12 . Annular rim  18  has generally inwardly and upwardly, as viewed in FIG. 2, directed nibs  22  and  24  for gripping the cervix wall to retain vaginal device  10  in position over the cervix. Groove  16  extends around rim  18  on the radially outside face of annular rim  18 . Groove  16  and annular ring  14  are shaped in cross-section and sized so that annular ring  14  in snappingly retained groove  16 .  
         [0033]    As is illustrated in the exploded view of FIG. 3, it is contemplated that annular ring  14  will be made as an element separate from rim  18  of dome  12  and then assembled with dome  12  to provide a complete vaginal device  10 , a cervical cap.  
         [0034]    It is contemplated that dome  12  will preferably be made of a non-resilient flexible material, such as a silicone based material, and that annular ring  14  will comprise a similar or the same material but be loaded, i.e., impregnated, with a desired biologically active material such as a medicament which will be released therefrom in an amount effective to achieve its purpose during use.  
         [0035]    Types of silicone based materials suitable for use herein are known in the art and include high-consistency and low-consistency silicone-based elastomers prepared using a variety of well-known methods, e.g., platinum-cured systems, selected for compatibility with biological tissue and particular active ingredients being released by the device. An example of a biologically-active agent that could be released by the device is nonoxynol-9, commonly known as “N-9”, an anti-viral compound often used with contraceptive devices. The elastomer can be loaded with the active agent in a manner appreciated by those skilled in the art that incorporates the agent in an excipient matrix with the elastomer, providing sustained release of the agent from the matrix.  
         [0036]    Further alternative embodiments of vaginal device  10  are illustrated the remaining FIGS.  4 - 28 . The vaginal device  50  of FIG. 4 is of a construction analogous to vaginal device  10  of FIGS.  1 - 3  except that annular rim  52  has groove  54  carrying O-ring  56  which comprises a flexible material loaded or impregnated with medicament.  
         [0037]    [0037]FIG. 5 illustrates another preferred embodiment of a vaginal device of this invention vaginal device  100  which is analogous to vaginal device  10  except that groove  102  extends around face  104  to retain annular ring  106  therein.  
         [0038]    Now referring to FIGS. 6 and 7, another alternative embodiment of the present invention is shown and indicated generally by the numeral  60 . Vaginal device  60  is a cervical cap having a dome portion  62  the open end of which terminates in an annular, bulbous edge  64 . Bulbous edge  64  of dome portion  62  is adapted to snap-fit into rim  66 . Thus, vaginal device  60  comprises a first part dome  62  and a second part rim  66 . Rim  66  has an annular groove  68  adapted to receive and snappingly hold enlarged edge  64  of dome  62  to retain the two parts together.  
         [0039]    [0039]FIGS. 8 and 9 illustrate another alternative embodiment of the present invention wherein a vaginal device  70  has a dome  71  and an annular rim  72  having an annular ring  73  snap-fit therein. Annular ring  73  in turn comprises a plurality of buttons  74  press fit therein. Thus a cervical device  70  comprises a plurality of parts including dome  71 , annular ring  73  and a plurality of buttons  74 . Annular ring  73  and each of buttons  74  can comprise the same of different biologically active materials.  
         [0040]    [0040]FIGS. 10 and 11 are sectional views analogous to FIG. 9 but showing alternative arrangements for means for retaining buttons  74  in annular ring  73 . Thus in the embodiment shown in FIG. 10 a button  75  has shoulders  76  which fit in corresponding recesses  77  in annular ring  78  to provide a snap fit therein.  
         [0041]    In FIG. 11, annular ring  92  which is analogous to annular ring  72  of FIG. 8, carries annular ring  92  which is snap-fit therein. A plurality of buttons  94  are in turn snap-fit into annular ring  93 . Thus, as is shown in FIG. 11, annular ring  93  has shoulders  95  which fit into corresponding recesses  96  in ring-like buttons  94  to provide a snap-fit for buttons  94  into ring  93 .  
         [0042]    [0042]FIG. 12 shows a vaginal device  100  which is a vaginal ring comprising a first part  101  and a second part  102 . End  103  of part  101  snap-fits into end  104  of part  102  as is illustrated in FIG. 13.  
         [0043]    [0043]FIG. 14 shows a vaginal device  110  having a plurality of buttons  111  fit into strip  112 .  
         [0044]    [0044]FIG. 15 shows a vaginal device  120  comprising a first part  121  and a second part  122  each of which are in strip form. Part  121  has a recess  123  into which snappingly fits a projection  124  of part  122 .  
         [0045]    [0045]FIG. 16 shows a three part vaginal device  130  comprising a first strip  131 , a second strip  132  and a third strip  133 . First strip  131  has a recess  134  into which snappingly fits projection  135  of strip  132 . Strip  132  also has a projection  136  at the end opposite thereof from projection  135 . Projection  136  fits into a corresponding recess  137  and strip  133 .  
         [0046]    [0046]FIG. 17 shows a vaginal ring  140  comprising a first annular piece  141  and a second annular piece  142 . As is best shown in FIG. 18, first annular piece  141  has a projection  143  which snappingly fits into a corresponding recess  144  in annular piece  142 .  
         [0047]    Now referring to FIGS. 19 and 20, two alternative embodiments of vaginal devices of the present invention are shown and indicated as vaginal device  150  and  160 , respectively. Vaginal device  150 , as shown in FIG. 19, comprises two disc halves  151  and  152 . Vaginal disc half  151  has a recess  153  into which snappingly fits projection  154  of disc half  152 . The vaginal device  160  as shown in FIG. 20 comprises three parts, vaginal disc third  161 , vaginal disc third  162  and vaginal disc third  163 . The vaginal disc thirds have recesses  164 ,  165 , and  166  into which snappingly fit projections  167 ,  168  and  169 .  
         [0048]    [0048]FIG. 21 illustrates a vaginal device  170  which is a vaginal ring comprising four parts or segments  171 ,  172 ,  173  and  174 . The opposite ends of each segment are provided with means for snappingly attaching to the adjacent opposite end of another segment. Thus segment  171  has one end having recess  175  therein which snappingly receives projection  176  of segment  172 . The other end of segment  171  has projection  178  therein which snappingly fits into recess  177  of segment  174 . Each of segments  172 ,  173  and  174  have corresponding means at each end to snappingly retrain adjacent ends of other segments.  
         [0049]    [0049]FIG. 22 illustrates a vaginal device  180  comprised of two parts  181  and  182  and suitable for use as a vaginal suppository. Length  181  snappingly engages length  182 .  
         [0050]    FIGS.  23 - 28  illustrate alternative embodiments of vaginal devices of the present invention which are diaphragms. The vaginal device  200  of FIG. 23 has a dome portion  201  with an enlarged rim  202  which is snappingly retained within an annular ring  203 .  
         [0051]    The vaginal device  300  shown in FIG. 25 is a diaphragm having a dome  301  with an annular rim  302  press fit over enlarged annular edge  303 . Annular rim  302  in turn carries snappingly fit therein an annular ring  304  into which are press fit a plurality of buttons  305 .  
         [0052]    [0052]FIGS. 27 and 28 show alternative press fit arrangements. In FIG. 27 vaginal device  310  which is analogous to vaginal device  300  has an annular ring  314  which carries a plurality of buttons  315 . In FIG. 28 vaginal device  320  has an annular ring  324  which carries a plurality of buttons  325 .  
         [0053]    From the above description of variations of the present invention it will be appreciated that the present invention is subject to substantial modification and variation by one skilled in the art within the scope of the present invention. Therefore, it is intended that the present invention be limited only by the scope of the appended claims.