Barrier Contraceptive

This invention relates generally to contraceptive devices and in particular to barrier contraceptive devices of the diaphragm type.

Control of conception has been an important medical endeavor for many years and instructions for the manufacture of contraceptive devices and compositions are found in some of the earliest known medical manuscripts. Presently, contraceptive technologies rely upon pharmaceutical a nd mechanical methods. Pharmaceutical methods involve the use of medicinal compounds which prevent pregnancy by interfering with ovulation, implantation or spermatogenesis. Mechanical methods are directed to preventing contact of ovum and sperm and involve the use of mechanical barriers and spermicidal compounds.

Because of the increasing concern with the side effects of pharmaceutical compositions, mechanical methods of contraception are increasing in popularity. Additionally, concern with sexually transmitted diseases has engendered a renewed interest in barrier type devices.

The cervical cap is one of the earliest types of mechanical contraceptives available, having been introduced over 150 years ago. The cervical cap is a generally rigid, relatively small device fitted directly onto the cervix where it forms a barrier to the passage of spermatozoa thereinto. Although the cervical cap has been available for a relatively long period of time it is of rather limited use. In order to obtain a good fit, it is generally required that wax or latex impressions of the cervix be taken and these impressions utilized to fabricate a custom fitted cap. Such fitting is expensive, time consuming and requires the assistance of highly trained personnel. Insertion and removal of the cervical cap is relatively difficult and frequently must be done by trained personnel. The cap is generally left in place for relatively long periods of time and this placement can encourage undesired side effects such as the growth of anaerobic bacteria in the uterus, toxic shock syndrome and mechanical damage such as cervical erosion. Such technology is described in U.S. Pat. Nos. 4,517,970; 4,401,534 and 4,467,789.

A more commonly utilized type of barrier contraceptive is the diaphragm, which has been available since the end of the 19th Century and which has been in relatively wide use in the last thirty years. The diaphragm presently utilized is generally similar in design to that first invented in 1882 by Dr. C. Hasse. It is comprised of a flexible rubber barrier of generally circular shape having a rigid, thickened rim reinforced with a metal spring. In use, the diaphragm is inserted in the vagina so that it forms a barrier seal protecting the opening of the cervix.

While presently utilized diaphragms are quite well accepted, use of such devices is not without problems. The proper fitting of diaphragms is essential if reliable contraception is to be obtained. The diaphragm must contact the vaginal wall uniformly and tightly so as to prevent spermatozoa from passing therearound. Accordingly, presently available contraceptive diaphragms are provided in a wide range of sizes and must be fitted carefully by trained medical personnel. Additionally, the user must be trained in proper methods of insertion if the function of the diaphragm is to be reliable. An improperly fitted, or improperly inserted diaphragm may become dislodged during sexual activity thereby permitting conception to occur.

Since proper fit is so crucial to diaphragm function, women utilizing such devices should be carefully monitored. If a weight gain or loss of more than 15 pounds occurs it is generally advised that the diaphragm be refitted. Similarly, child birth, abdominal surgery or other such events will necessitate refitting of a contraceptive diaphragm. The rigid rim of such diaphragms can cause problems with its use. Many women cannot tolerate such a device because of the size or shape of their vaginal walls or cervix. In addition, the rigid rim can in some instances cause pressure ulceration to occur. Accordingly, it will be appreciated that there is a need for a device which eliminates these shortcomings of the presently available diaphragm.

Contraceptive sponges are another class of devices enjoying increasing popularity. The contraceptive sponge is a generally flattened, cylindrical device made of resilient polyurethane foam or similar materials impregnated with a spermicidal compound. Such a device is not strictly speaking a barrier insofar as it does not impose any impenetrable cover over the cervix. Instead, it is believed that the contraceptive sponge functions by spermicidal action. The contraceptive sponge need not be custom fitted for individual users and accordingly may be purchased over the counter without prescription, and for this reason is enjoying widespread use. The contraceptive sponge is not without shortcomings however. In general the contraceptive sponge has a lower reliability rate than does a properly fitted diaphragm. Problems occur because of dislodgement of the device, bypass of the device or ineffectiveness of the spermicide. Dislodgement and bypass can occur during sexual activity when the penis moves past the sponge pushing it away from the cervix. Ejaculation can then occur in the vicinity of the cervix and spermatozoa can pass thereinto without being exposed to the spermicidal compound in the sponge.

In addition to problems of reliability, there are also problems of a mechanical nature involved in the use of contraceptive sponges. In many instances, users have found it difficult to remove such sponges from the vaginal cavity. In those cases, the sponge tears or breaks thereby preventing removal, and medical assistance must be resorted to remove all traces of the sponge. In other instances, the use of contraceptive sponges has been associated with toxic shock syndrome. Some women also have problems retaining the sponge for a sufficient length of time to insure contraception.

Accordingly, it will be appreciated that there is a need for a contraceptive device which enjoys the reliability and general safety of heretofore employed contraceptive diaphragms and which has the additional advantages of presently utilized contraceptive sponges insofar as it eliminates the need for fitting by trained personnel. Such a contraceptive device could readily be sold over the counter in one or two basic sizes to accommodate most women. It may be preferable in some instances to fabricate such devices as one time disposable items whereas in other instances a reusable contraceptive of this type will be desired. It is further desired that such contraceptive devices be relatively easy to insert and remove and that they have sufficient flexibility so as to prevent the formation of ulcers or erosions.

The present invention provides for a barrier type contraceptive fulfilling these needs. The contraceptive of the present invention is a generally umbrella shaped article which may be readily folded into an elongated or fusiform shape for insertion or removal. Once in place, the contraceptive device of the present invention is adapted to expand so as to uniformly contact the vaginal walls thereby forming a tight barrier seal. The contraceptive of the present invention may be utilized in conjunction with spermicidal compounds and may further include reservoirs for such compounds as well as a handle or loop for removal. In addition to being utilized as a contraceptive device, the umbrella-like diaphragm of the present invention may be utilized as a therapeutic device adapted to release medicinal compounds into the vaginal environment. These and other advantages and features of the present invention will be readily apparent from the summary, drawings, detailed description and claims which follow.

There is disclosed herein a barrier-type contraceptive comprised of a flexible barrier member having a plurality of radially disposed resilient stiffening members associated therewith. These stiffening members are adapted to bias the barrier member into a generally planar configuration. Additionally, the stiffening members have sufficient flexibility to allow the device to be folded into a generally fusiform shape. In one particular embodiment, the stiffening members are joined together proximate the center of the barrier so as to provide sufficient biasing force. The stiffening members may be formed from a wide variety of materials as for example; metal, synthetic polymers, natural rubber and various combinations thereof. The stiffening members may be embedded in the barrier member so as to be completely encapsulated thereby or they may be affixed to at least one surface of the barrier member. In one specific embodiment, the stiffening members are made of the same material as the flexible barrier member and are provided by thickened portions thereof.

The flexible barrier member may be fabricated from a wide variety of materials such as; natural rubber, synthetic rubber, silicone rubber and synthetic polymeric materials. In one embodiment, the barrier member is a generally conical member having a circular perimeter and may for example have a diameter of approximately 55-95 millimeters. The conical barrier member is preferably formed from an elastic material and the stiffeners cooperate with the elastic material so as to allow for an increase in the size of the perimeter of the barrier as the conical height thereof is decreased. In this manner, the device is adapted to uniformly contact its circular perimeter to the vaginal wall.

The flexible barrier member may be configured so as to include a reservoir adapted to hold and selectively release a medicinal compound therefrom. Additionally, the device may include a handle configured so as to facilitate withdrawal thereof. The present invention also includes a generally tube-like inserter adapted to retain the folded device therein for insertion into the vaginal canal.

In one specific embodiment, a barrier contraceptive includes two flexible, generally conical barrier members each having a circular perimeter and being joined at a plurality of points along those circular perimeters. At least one of the barrier members may include a plurality of radially disposed, resilient stiffener members associated therewith and adapted to bias the barrier members into a generally planar configuration while allowing the device to be folded into a fusiform shape. A device of this particular configuration is particularly well suited for containing a medicinal compound such as a spermicidal or therapeutic compound therein.

FIG. 1 is a perspective view of a particular barrier contraceptive device fabricated in accord with the principles of the present invention;

FIG. 2 is a top plan view of the device of FIG. 1;

FIG. 3 is a perspective view of the device of FIGS. 1 and 2 as folded into a fusiform shape;

FIG. 4 is a drawing of one particular insertion device as adapted to insert the barrier contraceptive device of the present invention into the vaginal cavity;

FIG. 5 is a perspective view of another barrier contraceptive device structured in accord with the principles of the present invention;

FIG. 6 is a perspective view of yet another barrier contraceptive device of the present invention;

FIG. 7 is a cut-away view of a barrier contraceptive of the present invention as adapted to release a medicinal compound; and

FIG. 8 is a perspective view of the medicinal compound containing a capsule of the barrier contraceptive of FIG. 7

Referring now to FIG. 1, there is shown a first embodiment of barrier-type contraceptive structured in accord with the principles of the instant invention. The device 10 of FIG. 1, is a generally umbrella-like device generally comprised of a flexible, barrier member 12, which in this embodiment is structured as a conical member having a circular perimeter. Included in the device 10 are a plurality of stiffening members 14 which are adapted to bias the conical barrier member into a generally planar configuration. As shown in FIG. 1, the contraceptive device 10 is shown as biased into what is referred to herein as "a generally planar configuration," and it will be appreciated that said planar configuration includes the conical or open umbrella-shaped configuration illustrated with reference to FIG. 1.

In addition to biasing the barrier member 12 into a planar configuration, the stiffening members 14 also have sufficient flexibility so as to allow the device 10 to be folded into a generally fusiform shape for insertion.

Referring now to FIG. 3, there is shown a folded form of the contraceptive device 10 of the present invention. By "fusiform" is meant a generally elongated or cylindrical shape substantially as shown with reference to FIG. 3.

Referring now to FIG. 2, there is shown a top plan view of the barrier contraceptive 10 of the present invention illustrating one particular embodiment of stiffening member configuration. As it will be seen from the figure, stiffening members 14 are interconnected at a common locus 16, proximate the center of the barrier member 12. Also, as illustrated, the barrier contraceptive 10 includes 8 stiffening members 14.

It will be appreciated that other configurations of stiffening member may be utilized in conjunction with the present invention. For example, a larger of smaller number of stiffening members may be utilized and those members may be joined in other manners. For example, the stiffening members 14 may fasten to a ring-like member generally encircling the central portion of the barrier member 12. Alternatively, the stiffening members 14 may not all be joined at a central locus. For example, one or two pairs of the stiffening members may join at the central region whereas others may be unattached members. Furthermore, in addition to being interconnected at a central portion, the stiffening members 14 may be additionally interconnected at various other points along the length thereof so as to form a web-like pattern. In yet other embodiments, the stiffening members 14 may be additionally encircled by a circular stiffening member 18 (shown in phantom outline herein) adapted to aid in biasing the barrier contraceptive 10 into a deployed, substantially planar configuration. The stiffening members may be disposed upon either surface of the barrier member 12, or they may be embedded within the barrier member 12, itself.

In use, the barrier contraceptive device 10 is folded into the generally fusiform shape illustrated in FIG. 3 and inserted into the vagina. The stiffening members 14 cooperate to expand the folded device 10 in a manner similar to the opening of an umbrella. Because of the flexibility of the barrier member 12 and the biasing force of the stiffening members 14 the device 10 expands until uniform contact with the vaginal walls is attained thereby forming a tight barrier. The fact that the expansion and contact is maintained by the stiffening members 14 allows for the fabrication of a device 10 having a relatively soft perimeter which thereby avoids of pressure ulceration and the like heretofore encountered with spring rim diaphragms.

The use of such a design confers additional advantages in contraceptive reliability insofar as pressure upon the face of the barrier contraceptive device occurring during sexual intercourse will tend to further bias the device into a planar configuration so as to tighten the seal thereof. In this manner, the tightest seal is achieved at the time of ejaculation, when such seal is most critical. It should be readily appreciated that the generally umbrella-like configuration of the barrier contraceptive disclosed herein further allows for ease of removal of the device insofar as it will readily fold back to the closed configuration when withdrawn.

The fact that the umbrella-like device disclosed herein expands to accommodate various sizes of user is a very important feature insofar as it obviates the need to employ trained personnel for custom fitting of diaphragm-type devices as well as the need for dispensers to stock multiple sizes. It is anticipated that a diameter of approximately 55-95 millimeters for the expanded device, as measured across the circular perimeter thereof, should be sufficient to accommodate the majority of women. Umbrella-type barrier contraceptive devices may be fabricated in two size ranges, a first range capable of expanding to diameters of 50-75 millimeters, and a second size adapted to expand from 70-95 millimeters. It is further anticipated that the devices of the present invention may be manufactured in a single size adapted to be cut by the dispenser, or end user so as to achieve the proper size range. For example, the surface of the flexible barrier 12, may be marked with a line indicating where the device should be cut so as to provide a proper sizing.

The fact that the umbrella type devices of the present invention need not be custom fitted readily adapts their use for direct over the counter sales to consumers and further suits such devices for use in developing countries where trained personnel are not readily available. The device of the present invention may be fabricated as a reusable device or may be a single service item.

The umbrella-like barrier contraceptive functions quite well to prevent pregnancy, however, it may utilized in combination with spermicidal compounds to further increase the efficiency thereof in a manner analogous to the use of spermicides with heretofore available spring rim Diaphragms. For example, spermicidal compositions may be placed within the conical portion of the flexible barrier 12 prior to insertion; and similarly, such compounds may be placed along the periphery of the device. When the barrier device 10 is folded into the fusiform shape, the spermicidal compound will be retained therein.

The flexibility of the present device further enhances the efficiency of utilization of spermicidal compounds insofar as pressure upon the face of the device, as transmitted by the stiffening members 14 will tend to push any spermicidal compound retained therein onto the subjacent cervix and along to the periphery of the device further enhancing the seal and forming a strong barrier to passage of spermatozoa. In order to accommodate the use of such compounds, the barrier device may be further modified to include reservoirs and the like, and such modifications will be described in greater detail hereinbelow.

In addition to the use of spermicidal compounds, other medications may be employed in conjunction with a device of the present invention. For example, the therapeutic agent 5 Flouro-uracil is utilized as an antichondyloma compound and such an agent may be placed in a device such as that illustrated herein, which device will then retain the chemotherapeutic agent in contact with the subjacent tissues. Similarly, agents for treating cervicitis and similar conditions may be employed. Also antiviral compounds, such as those compositions for preventing herpes or AIDs infection may be similarly utilized.

There are a wide variety of materials which may be utilized in the fabrication of the umbrella-like devices of the present invention. The barrier is advantageously fabricated from a flexible material having some degree of resiliency. Among such materials are natural rubber, silicone rubber, other synthetic rubbers, and various synthetic polymeric materials. The stiffening members are preferably thin, flexible members and may be fabricated from a variety of materials. Thin metal strips may be advantageously employed, as may be coiled or otherwise spring-like members. There are a wide variety of polymeric materials having a high degree of flexibility and resiliency and such materials may be advantageously employed to lubricate the stiffeners. For example flourocarbon polymers may be fabricated into spring-like strips adapted to function as stiffening members as may be nylon, polyester, polystyrene, polyvinylacetate and the like. Use of polymeric materials confirms an advantage insofar as they allow for ready cutting therethrough so as to adjust the size of the resultant device. In some instances it may be advantageous to utilize a combination of materials to fabricate the stiffening members. For example, the members may be fabricated as strips of polymeric material circled by a metallic coil spring, as for example 18 in FIG. 2. In yet other instances, the stiffening members may be provided by thickened portions of the barrier member itself, as for example by molding in a plurality of ribs. All of such variations should be readily apparent to one of skill in the art.

The umbrella-like barrier contraceptive of the present invention may further include an inserter adapted to facilitate the use thereof.

Referring now to FIG. 4, there is shown one configuration of insertion device 20 as adapted to be used in the present invention. The inserter 20 is comprised of a generally tubular housing 22 adapted to retain the umbrella-like device of the present invention in its folded form. The tubular member 22 has a plunger 24 disposed in one end thereof and adapted to eject the folded barrier device therefrom. Obviously, other configurations of inserter may be similarly employed.

Referring now to FIG. 6 there is shown yet another umbrella-like contraceptive device 30 structured in accord with the principals disclosed herein. The device 30 of FIG. 6 is generally similar to that disclosed with reference to FIG. 1 with the exception that the stiffening members 14 are not interconnected proximate the apex of the barrier member 12, but rather are attached to a ringlike portion 32 generally encircling the apex of the conical barrier member 12. The ringlike member 32 allows for the stiffening members 14 to be affixed to one another so as to allow for easy biasing of the barrier member 12, while still allowing the central portion of the barrier member 12 to be uncovered.

It will also be noted from the figure that the central portion of the barrier member 12 is configured as a reservoir 34 adapted to hold a medicinal compound such as a spermicide or a therapeutic agent therein. While such agents may be utilized in conjunction with a device as shown in FIG. 1, the inclusion of a large reservoir 34 allows for higher capacity of such agents. It will also be noted that the device 30, includes a handle 36, formed from a loop of flexible material such as a polymeric fiber or the like, and to facilitate removal of the contraceptive device 30 from the vagina. As depicted, the handle 36 is attached to the ring 32 and it will appreciated that by pulling upon the handle, the device 30 is collapsed to its closed shape for withdrawal. Obviously, other such handle configurations may be similarly employed.

Referring now to FIG. 5 there is shown yet another configuration of device as structured in accord with the principles disclosed herein. The barrier contraceptive device 40 illustrated in FIG. 5 is fabricated by affixing two flexible, generally conical barrier members 12a, 12b along at least a portion of the perimeters thereof. It is generally preferred that at least one of the two barrier members 12a, 12b have stiffening members associated therewith and as illustrated both barrier members 12a, 12b have stiffening members 14 associated therewith.

As shown in the figure, the two barrier 12a, 12b are affixed to one another along a plurality of points on the perimeters thereof so as to define a number of openings 41. A device in this configuration is readily adapted to retain therein a relatively large amount of spermicide or other medicinal compound and furthermore, is capable of providing a relatively tight seal to the vaginal walls during use. The plurality of openings 41 allow for escape of spermicidal compounds therefrom so as to further complete the seal. The device 40 of FIG. 5 is also capable of folding into a fusiform shape for insertion and folding may be accomplished by either moving the apices of the two conical barrier members 12a, 12b in opposite directions from one another so as to provide a elongated, folded device or by moving the two apices together so as to fold one conical member inside the other.

As was mentioned previously, the device of the present invention may be further adapted to release a medicated compound into the vagina. Referring now to FIG. 7, there is shown one such adaptation. The device 50 of FIG. 7 includes a flexible barrier member 12 as shown previously. The stiffening members are not visible in this cut-away view. Also included is a medication releasing capsule 52 adapted to retain and release a medicinal compound such as a contraceptive or therapeutic agent.

The capsule 52 which is shown in enlarged 10 detail in FIG. 8, includes an upper 56a and lower 56b membrane adapted to release the medicinal compound from the regions 60,58 bounded thereby. The capsule further includes an impervious barrier layer 54 extending thereacross and generally contiguous with the flexible barrier 12 The barrier layer 54 and flexible barrier 12 cooperate to provide a contraceptive shield.

The barrier layer 54 divides the capsule 52 into two compartments 58 and 60 bounded by the porous membranes 56a, 56b. Each compartment is adapted to store and release a medicinal agent; and accordingly, the capsule can accommodate a spermicide and a therapeutic agent. The membrane 56a,56b can be porous polymeric materials, perforated materials and the like.

In one embodiment, the capsule 52 can be fabricated from a foam-like material impregnated with a spermicide and in that sense is similar to presently utilized contraceptive sponge. Such an embodiment would combine the advantages of the contraceptive sponge with those of the flexible umbrella-like device disclosed hereinabove.

Various other modifications of the depicted devices are possible within the scope of the present invention. For example, the stiffening members may not be separate members but may be provided by merely thickening a portion of the barrier member 12 so as to provide sufficient support and biasing force to enable proper function of the device. In another embodiment, the entire carrier member 12 may be fabricated from a porous or absorbent material adapted to retain and release spermicide or other medicinal compounds.

The umbrella-like barrier contraceptives of the present invention may be packaged for use as a single service item in a form preloaded with spermicidal compounds. Similarly, when the device is utilized as a delivery agent for chemotherapeutic compounds it may be dispensed with the therapeutic agent already in place. These and other modifications will be readily apparent to one of skill in the art and accordingly the foregoing drawings, discussion and description are merely meant to be illustrative of particular embodiments of the present invention and not limitations upon the practice thereof. It is the following claims, including all equivalents which define the scope of the instant invention.