Abstract:
A novel intravaginal device usable as a mechanism for introducing medicaments into the vagina of a human female. The device can be used for maintaining in the vagina medicaments and the like that otherwise might leak out and increasing the area of contact between the medicaments and the vaginal mucosa. At the same time it provides a device for the absorption of excess fluids.

Description:
This is a continuation of copending application Ser. No. 07/548,575 filed on Jul. 5, 1990, now abandoned. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates to an intravaginal device (IVD) and more particularly to such device as means for introducing medicaments into the vagina of a human female. 
     2. Description of the Prior Art 
     To facilitate normal function or to assist in the recovery and restoration of tissues and organs that have deteriorated from traumatic or systemic changes, injury or infection, it is sometimes desirable to enhance the tone, health or function of the vagina, cervix and related organs and tissues through biological, chemical and/or physical action. In this connection, it is sometimes desirable to apply lubricants, medicines, topical anesthetics or other desensitizers, antiseptics, conditioners or other medicaments to the vagina. 
     Accordingly, various techniques have been developed to achieve such ends. For example, skin patches, injections and oral administration have been employed to medicate the targeted tissues. Such methods suffer from a variety of drawbacks including the involvement of entire body systems, the necessity for the frequent engagement of medically trained personnel, inconvenience and the absence of direct physical action on the affected tissues. Many women have found other conventional methods involving topical applications by means of reusable syringes inconvenient and uncomfortable. Such methods also typically require the user to lie down for application and tend to be unsanitary and messy in that the reusable syringe must be cleaned and the medicament and/or its carrier tends to leak from the vagina. 
     Prior art methods suffer from other disadvantages as well. In particular, it is noted that the walls of the vagina in its normal relaxed state comprise a number of folds of skin. Thus, medicaments applied according to conventional techniques tend to miss areas of the walls. Further, such techniques do not generally provide the maximum benefits that can be obtained by physical action directly on the tissues. 
     The prior art devices can be considered in three connections. The first of them is the type of device that is essentially contraceptive as represented by U.S. Pat. No. 4,553,965. Such devices consist of a tampon that can be inserted into the vagina and near the cervix and also a separate removable receptacle for liquids of a contraceptive nature that is injected into the tampon prior to its insertion into the vagina. Contraceptive devices obviously differ in several respects from the present case, and they must not be of such a nature to interfere with normal sexual intercourse. 
     A second type of device is the menstrual tampon that is primarily designed for preventing menstrual flow from escaping from the vagina during menses. These devices typically are not designed to supply medicaments to the vagina. These devices may be squeezed to a small size and expand when inserted thereby to seal off the 
     Sometimes such devices have some form of medicament present but they are basically inapplicable to the invention of the present application. For example, U.S. Pat. No. 3,618,605 is a device made of elongated material that is folded up. The device contains no shield and no means of introducing medicaments at the time it is inserted. See also U.S. Pat. No. 3,731,687. U.S. Pat. No. 3,762,413 is basically the same type of device as the previously mentioned ones, save only that it provides means for mechanically expanding it. U.S. Pat. No. 3,791,385 includes a tube for admitting air to the interior of the device when it is desired to remove it. 
     The third class consists of devices that are actually designed to supply medicaments to the vagina. Such devices are represented by the U.S. Pat. No. 1,401,358 to Peterkin. This device is not supplied with a shield of the type employed in the present invention, and must be inserted by forceps. 
     The device of Rolfson-Schmidt U.S. Pat. No. 880,469 is similar to that of the foregoing patent but relies upon threadlike material to distribute the medicine. U.S. Pat. No. 1,575,123, to Martocci-Pisculli, requires an outer shell of a soluble material that dissolves after insertion, thereby exposing expansible material. No outer shield remains about this material. Medication may be applied at the top of the shell for application to the cervix, and medication may be applied to the absorbent explansible material within the shell. However, it is not seen how this device could retain a liquid medicament layer against the vaginal walls. Moreover, in that the expansible material is moisture absorbent, it appears that the material would work to absorb or withdraw the medicament from the vaginal walls. 
     Rannells U.S. Pat. No. 1,355,846 describes a device having a tube running into it through which medicines may be introduced. For obvious reasons, this device requires the service of a physician. 
     U.S. Pat. No. 4,077,409 to Murray is essentially a catamenial-type device for controlling menstrual flow. It is cited in this group only because it notes that disinfectants and medicaments can be added to the material filling the capsule. The device is obviously different from the present invention as will appear. 
     SUMMARY OF THE INVENTION 
     Briefly, therefore, the present invention is directed to a novel IVD usable as means for introducing medicaments into the vagina of a human female and holding such medicaments in contact with the vaginal mucosa. Basically the device can be used for maintaining in the vagina medicaments and the like that otherwise might leak out. At the same time it provides a tampon as a means for the absorption of excess liquids. 
     The device uses a familiar telescopic insertion mechanism for its being inserted into the vagina. It also includes a shield of relatively thin, flexible, membrane-like material such as a plastic that surrounds a pressure element, receives medicaments, holds the medicaments against the vagina walls and prevents their inadvertent contact with the pressure element or tampon material prematurely. To this end there is a tube that discharges outside of the shield at the top of the IVD or pressure element. This tube may be connected to an injection capsule or syringe that contains the medicament and it normally has a plug at the end that prevents it from discharging its material until desired. The pressure element is a material that can expand and cause the pressure element to fill and expand the vagina and to apply gentle pressure to the walls thereof. Further, there is an absorbent leaf tampon at the lower end of the pressure element. This is expansible against the walls of the vagina and acts as a means to prevent the escape of the medicaments or other liquids that are present. The device does not require the woman to lie down to apply medicaments and it does not involve the necessity of keeping clean and pure syringes and the like. 
     The foregoing arrangement enables the product to adapt itself to the shape of the vagina of a woman. The vagina is varying in shapes from the entrance to the cervix and it also varies in size. The present invention adapts to these variations. Moreover, the device expands the vagina, unfolding the walls thereof, permitting access for the medicament to sections of the walls that are otherwise concealed. In addition, the gentle pressure applied to the vaginal walls by the device provides beneficial physical action on the tissues, thereby to improve tonality and other aspects of the tissues and organs in question. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is an axial section through the device in its original state; 
     FIG. 2 is a sectional view taken along line 2--2 of the device of FIG. 1; 
     FIG. 3 is a sectional view taken along line 3--3 of the device of FIG. 1; 
     FIG. 4 is a section of the female pelvic region with the device in place; and 
     FIG. 5 is an axial section similar to FIG. 1 but of a second embodiment of the device; 
     FIG. 6 is a sectional view taken along line 6--6 of FIG. 5; 
     FIG. 7 is a view similar to FIG. 4 but of the second embodiment of the device. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring now to the drawings, and particularly, FIG. 1, shown generally at9 is an intravaginal device (IVD) of this invention. The device is shown asbeing initially mounted in a telescopic-type of applicator tubing of the type that is generally used with tampons and which facilitates axial insertion of the device into the vagina. The applicator tubing consists ofouter tube 10 and an inner tube 11. The IVD is mounted within the upper part of the outer tube 10. 
     The IVD 9 incorporates an outer shield 15 of a flexible, membrane-like material that may be the general shape of a fingerstall of approximately one and one-quarter inch diameter by three inches length from its apex A to its skirt S. Although the shield is shown in FIG. 1 as draping about the exterior of the upper end of outer tube 10, it will be understood thatthe IVD may be arranged such that the shield is situated within the upper end of the tube 10. The contact surface of the shield may be scarified or pocketed to facilitate contact between medicaments thereon, such as topically active ingredients, and the vaginal mucosa or walls. At its upper or proximal end (i.e., the end at the first inserted end of the device as it is inserted into the vagina), the shield 15 is connected to atube 16 running axially therethrough. The other end of the tube 16 may be in turn connected to a capsule 18 for containing medicaments to be introduced into the vagina, such as lubricants or estrogen-containing materials used in the treatment of post-menopausal syndrome. The upper or proximal end of the tube 16 (i.e., the end connected to the shield 15) maybe closed by a removable plug 19 to prevent the escape of the contents of the capsule 18 prior to use of the device. The plug may be of stopper-shape as shown in FIG. 1 or may be another type of seal, such as tape. 
     Within the shield 15 and within the upper or proximal end of the outer tube10 is located a pressure element 20 that is of a cylindrical finger-shape of shape-restorative, compressible, non-reactive, human body-cavity-compatible, lightweight polyurethane foam or sponge, or any ofa number of similar materials. It is about two to about four inches in length and about one-half to about two and one-half inches in diameter when measured in a relaxed state. The center of this pressure element 20 may be provided with a passage to accommodate a cord for easy withdrawal of the device from the body, as with standard tampons. The pressure element might also receive a frangible capsule therein instead of employment of capsule 18. 
     The entire pressure element 20 is enveloped in the shield 15 with the skirtof the shield extending below the lower end of the pressure element. Thus, even if the pressure element is a moisture absorbent material, the vaginalwalls need not fight against this absorbency to maintain themselves within the medicament bath. The shield provides a moisture barrier between the absorbent material and the vaginal walls. Upon axial insertion into a vagina and release from the insertion tube 10 into which the IVD has been compressed, the pressure element attempts to regain its relaxed shape, thus filling the shield and expanding the vagina by exerting a gentle pressure upon the walls of the vagina so as to unfold and extend the vaginal walls for optimum contact with the shield and the intervening introduced substances. Additionally the gentle pressure exerted by the pressure element upon the vaginal walls may stimulate adjacent and underlying muscle tissue reaction, which may improve the tonicity of the vagina and adjacent organs. 
     As shown in the drawings, the pressure element 20 may have a conical recessextending upwardly from its bottom end. This recess receives a core such asa cone tampon 22 of lightweight cotton or other suitable, possibly absorbent material similar to that used for catamenial tampons. This is approximately two and one-fourth inches long and one-half inches in diameter at its bottom part. The core can be employed as an absorbent or as a stiffening means for adding rigidity to the device, or both. Immediately below the core there is an absorbent material, such as a sponge or leaf tampon 24 that is adapted to expand as shown in FIG. 1 whenthe confining effect of the tube 10 is removed. This insertion is done by moving the tube 10 inwardly into the vagina and then withdrawing a tube 10while maintaining the tube 11 against the device. This leaf tampon engages the walls of the vagina to trap by absorption or barrier action flow of the liquids such as medicaments, vehicles therefor or vaginal exudates which otherwise might flow from the shield 15 and leak from the vagina. The cone tampon may further serve to absorb and prevent leakage of liquidswhether excess medicament, medicinal vehicles, lubricants, body fluids, or other liquids, from the vagina during the period of IVD use. 
     The IVD of the present invention is shown in place in FIG. 4. It will be seen that it extends inwardly of the os O or open end of the vagina V and against the fornix F of the vagina V. The cervix C may extend at other angles to the vagina but as will be evident it can be accommodated in any of those by the present invention. 
     The invention as shown in FIG. 1 is ready to be inserted into the vagina ofa user. To this end, the injection capsule is filled with medicaments adapted to be applied to the walls of the vagina. The plug 19 can then be withdrawn and the device inserted axially into the vagina by the conventional techniques for insertion of tampons. The applicator tubing can then be removed in accordance with such conventional techniques. Initially the pressure element 20 will expand owing to the relief of the confining pressure of the tube 10. This will cause it to apply modest pressure to the walls of the vagina. This expansion of the pressure element tends to expand radially outwardly the walls of the vagina which may even be quite close together before insertion of the present invention. The removal of the tubes 10 and 11 then leaves the injection capsule 18 accessible. The injection capsule 18 can be squeezed to cause liquid or other jelly-like material or the like to pass through the tube 16 to the outside of the shield 15. The injection capsule is normally sized to discharge the proper amount of liquid to coat the shield 15 to form a liquid layer between the shield and the walls of the vagina. 
     The arrangement minimizes leakage of the medicaments or other liquids from the vagina. However, it is not required that there will be a total elimination of such leakage in all cases. The presence of the absorbent leaf tampon and, optionally, absorbent cone tampon means that such leakagewill normally be absorbed before it passes from the vagina. 
     FIG. 5 illustrates a second embodiment of the device, which employs different kind of expansion arrangement. In this case, the pressure element consists of an expansible member of generally cylindrical shape such as about one and a quarter inch in diameter by three inches in length. It is formed of very flexible but reasonably strong plastic material. The expansible member has a tube 36 extending through it and opening at the top end in the same manner as does the tube 16 of the earlier type. Alternatively, the tube 36 may extend along the side of the expansible member. In any event, the expansible member is surrounded by a shield 37 that is in effect the same as the shield 15 of the previous type. However, as opposed to the open skirt of the shield 15, the shield 37 connects to tube 36 at the lower end as well as at its upper end, thereby to form an axially extended, balloon-like structure, referred to hereinafter as an expandible member or bulb 39. As with the first embodiment, there is an absorbant such as the leaf tampon 40 that is similar to the one for the leaf tampon 24 of the previous description. 
     In addition there is a tube 41 connecting from a supply 42 of fluid such aswater or other liquid or gas that opens into the expandible member or bulb 39. If the tube 36 extends axially through the center of the bulb 39 as shown in FIGS. 5, 6 and 7, the bulb 39 is in the form of an axially extended, balloon-like torus structure, with the tube 36 extending throughthe central axis thereof and the tube 41 extending to the interior thereof.On the other hand, if the tube 36 extends along the side of the bulb 39, the bulb 39 is generally cylindrical in its expanded condition. Alternatively, tube 36 may be eliminated and the medicament may be appliedin another manner. For example, the device may be compacted in its pre-expanded or deflated form and placed within a small receiving vessel shaped as a cup at the end of a rod. The medicament may then be placed as a glob on the compacted device. The device may be inserted into the vaginaby means of the rod, the rod withdrawn and the device inflated. The action of insertion and inflation would then tend to spread the medicament over the shield of the device and tube 36 may thereby be unnecessary. In another form, the medicament may be applied by a syringe. 
     By any of these arrangements a charging member 42 (as shown in FIG. 7, which illustrates the second embodiment of the device in place in a vagina) can be activated to discharge liquid or gas into the expansible member 39 to cause it to fill the vagina and to seal off the cervix. As inthe first embodiment, a capsule 43 may be provided for injection of medicament if a tube 36 (or other such mechanism) is employed for introduction of medicament. The shield 37 may be the outer surface of the bulb 39. Alternatively, a separate membrane-like material may be applied to the outer surface of the bulb 39 to form the shield 37. 
     In certain respects, this fluid activated embodiment may be preferable to the sponge-type embodiment. For example, this second embodiment might morereadily adapt to asymmetries or inconsistencies in the vagina or the walls thereof. Thus, if the muscles associated with one portion of the walls arerelatively strong while the muscles associated with another portion are relatively weak, the stronger portion may apply a force against the deviceand fluid therein to distort the device to apply greater pressure against the weaker portion, thereby to exercize the weaker muscles in compensation. 
     In the preferred construction, the filler material for the bulb 39 is gaseous. It is also preferably non-reactive gas that will not react with the body or with the medicaments. Such a gas would be air or carbon dioxide, for example. The incompressibility of liquid produces two disadvantages. The first is that the incompressibility limits the ability of the device to yield once it is set in place. Thus, it may be uncomfortable to the wearer. The other is that introduction of even a slight excess of a liquid risks rupture of the bulb 39, whereas a gas is compressible and so may allow great room for error in this respect. Also, a gas filled bulb might more sensitively adapt itself to the variations inshape and size of the vagina as indicated in the drawing. 
     In either of these two forms of the device, it will be understood that it may be inserted by being mounted into the telescopic tubes 10, 11, which are then removed. The insertion of the second embodiment may require an initial admission of a certain amount of fluid into the bulb 39 so that itmay be inserted into the vagina. Alternatively or additionally, tube 36 maybe of rigid material to aid insertion. Withdrawal of each device may be by standard techniques as employed in conjunction with standard tampons, suchas by pulling a cord or the tube 36 attached thereto. I the fluid activatedembodiment, it may be preferable to remove the fluid from within the devicebefore withdrawal of the device from the vagina. 
     As the injection capsule in both cases is activated, the vagina is essentially cut off from leakage and the medicaments from the injection capsules are then effective to act on the vagina. 
     In view of the above, it will be seen that the several advantages of the invention are achieved and other advantageous results attained. 
     As various changes could be made in the above methods and devices without departing from the scope of the invention, it is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.