CUSTOM VALVED CERVICAL CAP

Abstract: A non-invasive birth control device in the form of a custom-formed, valved cervical cap (10). The cervical cap (10) comprises a cup-shaped elastomeric shell (22) substantially complementary with contiguous surface of portio vaginalis cervicis when in contact therewith and having an aperture (27) at the apex of the shell. The cap can also have a depending skirt (30) that is thinner than the shell and which has a plurality of spaced slits (32) about the periphery thereof. The aperture (27) is covered by an elastomeric web (29) secured to the shell (22) and defines, together with the shell (22), a one-way valve means having a discharge port (43) offset from the aperture. The cervical cap (10) can be fabricated from specially designed blank of thermoplastic elastomeric material using a replica of cervix uteri as a mold.

Description: CUSTO VALVED CERVICAL CAP Technical Field This invention relates to contraceptive devices and means for making such devices. Background of the Invention Caps for cervix uteri as a birth control means have been known for a long time and have been found among the artifacts of antiquity. It has been reported that Aetius of Amida suggested for this purpose the use of a pomegranate shell cut into a hollow cup, and that beeswax discs fashioned to fit over the cervix have been used in Europe. Modern cervical caps comprise a pre-for ed rubber cap that is positioned over the cervix uteri to act as a sperm barrier. Such caps are manufac¬ tured in several sizes to accommodate the various uterine sizes normally encountered; however, with . such caps the fit for a particular individual is inexact and necessarily a compromise. As a result, these caps often become dislodged during coitus and have to be removed periodically to accommodate normal uterine discharges. Thus, such caps are inconvenient to use and have not achieved a high degree of reli¬ ability. Premanufactured cervical caps ' with valves are also known and are shown in U.S. Patent No. 2,836,177 to Sells, U.S. Patent No. 3,952,737 to Lippert et al. and German Patent No. 475,496 to Leopold. These caps also suffer from the aforemen- tioned lack of stability and are subject to dislodge- ent during use. U.S. Patent No. 4,007,249 to Erb describes a technique for custom fabrication of a cervical cap having a valve that is inserted during manufacture. The manufacturing expedients disclosed in this particular patent contemplate the painting of a liquid, polymerizable elastomeric material onto the cervix uteri followed by the polymerization of the painted material or, in the alternative, the use of a mold which retains a liquid, polymerizable elastomeric material in contact with the exocervical surface until it is polymerized. The former expedient is impractical because the surface to which the liquid, polymerizable mate- rial is applied is wet with mucus and quite slippery, thus the applied material would fall off the exocer¬ vical surface due to gravity before polymerization of the material could take place and, in any event, it would be impossible to control the thickness of the applied polymerizable material during iri situ poly¬ merization. A cervical cap having a relatively non-uniform thickness is undesirable, however, be¬ cause it is unstable and is likely to be dislodged in use. The second expedient disclosed in the Erb patent would also produce caps having an undesirable variable cap thickness that is likely to bring about dislodgement. A further shortcoming of the caps shown in the Erb patent is that the prefabricated valving means utilized are of the leaflet or flap type. In such valves a viscous droplet of cervical mucus could hold the valve in an open position for an undesirably long time period, thereby providing an access aper¬ ture for sperm and defeating the very purpose of the cap. Moreover, inasmuch as the polymerizable mate¬ rial of the cap is in a fluid state when it surrounds the prefabricated valve, some of the fluid material may become enmeshed with the valve and interfere with its intended valving action after the material has polymerized. U.S. Patent No. 4,007,249 to Erb also mentions a technique disclosed initially . by P. A. Wilde in 1838 in Das Weibliche Gebar-Unvermogen ac¬ cording to which a cervical cap allegedly can be made from a special wax impression of the vaginal portion of the cervix. As recognized by Erb, such a tech¬ nique cannot produce an identical, negative-image, cervix-conforming inside surface because the cervix would be deformed while the wax impression is being made. The uterus is suspended in the lower abdomen by ligaments, is easily movable, and would tend to move up into the abdomen even with a gentle force applied to the cervix. As a- result, accurate regis¬ tration would be prevented by such a movement with attendant lac.k of stability for the cervical cap produced in such manner. The techniques described by Erb are also likely to suffer from the same drawback, albeit for a different reason. In particular, in practicing these techniques the vaginal wall has to be expanded using a vaginal speculum or similar implement in order to expose the cervix during cap molding. This expedient tends to distort the cervix as well, elongating it along an imaginary line between the tips of the in- serted, open vaginal speculum blades and shortening the cervix along an imaginary line at right angles to the imaginary line between the tips of the speculum blades. The attendant cervical distortion exceeds the limits for prosthetic stability of the cervical cap that is produced. Accordingly, while a stable, well-fitting cervical cap can be an effective birth-control de¬ vice, heretofore it has not been possible to produce a cervical cap that has the requisite stability against dislodgement and that can be worn for c:-TFi -4- extended periods of time such as months, or even years, without removal. Summary of Invention The present invention, in one aspect, con- templates a non-invasive birth control device in the form of a removable cervical cap. The cap is custom made and comprises a form-fitting apertured, elas¬ tomeric shell in which the aperture is situated in communication with the external os of cervix uteri when in place and is covered with an elastomeric web conforming and secured to the shell and, together with the shell, defining a one-way valve means having a. discharge port offset from the aperture. A preferred embodiment of the cap includes a cup-shaped elastomeric shell having a convex outer surface and a concave inner surface that is substan¬ tially complementary with contiguous surface of portio vaginalis cervicis when in contact therewith. The shell defines an aperture at the apex thereof. An elastomeric web positioned over the aperture con¬ forms and is secured to the outer surface of the shell about the aperture and defines a pocket com¬ municating with the aperture and providing a one-way valve having a discharge port for a uterine discharge while the birth control device is in place. The dis¬ charge port of the valve is off-set from the aperture. The shell of the cap has a depth sufficient to receive a major portion of the portio but the periphery of the shell terminates short of fornices vaginae. Preferably the shell has at least a band of substantially uniform rigidity circumscribing the portio and in contact therewith. More preferably this band of substantially uniform rigidity is a band of substantially uniform shell thickness covering the entire area of the prominent portion of .-the cervix GMH surrounding the external os thereof, i.e. , the cer¬ vical eminence around the external os. It is also preferable that the peripheral edge of the shell is feathered, i.e., tapered or beveled from the outer surface of the shell toward the shell periphery. The cap can also have a deformable margin such as a depending, independtly deformable skirt portion which integrally extends from and is thinner than the shell. The deformable margin is slit at a plurality of locations along its peripheral edge in a direction towards the apex of the. shell. The birth control device can be conven¬ iently formed from a blank which is a substantially planar sheet of an elastomeric thermoplastic mate- rial, preferably having a substantially uniform thickness, provided with a central aperture. The ' elastomeric web, having a thickness less than the thickness of the planar sheet, is superposed over the aperture and is secured to the planar sheet, usually about the major portion of the aperture periphery, defining a pocket which provides a one-way fluid passageway extending from the aperture, between the web and the sheet, and to a discharge port defined by the sheet and an unsealed or. free edge of the web. In order to have a deformable margin, the peripheral margin of the blank should have a thickness that is less than the thickness of the planar sheet in the region of the sheet that defines the central aperture. The custom cervical cap can also be formed utilizing a composite blank that is constituted by a relatively thicker planar sheet of an elastomeric thermoplastic material and a relatively thinner planar elastomeric web that is superposed over the relatively thicker planar sheet and extends beyond the periphery of the latter. A central aperture is Q:Λ?I provided in the planar sheet. The aperture is covered on one side of the planar sheet by the elas¬ tomeric web which is intermittently attached to the planar sheet to define between the sheet and the web a channel or channels which provide a one-way fluid passageway extending from the aperture to the peri¬ phery of the planar sheet. The cervical cap contemplated by the present invention can be fabricated by first making an impression of the exocervical surface of cervix uteri in the vagina in a substantially undistσrted, relaxed state, making a replica of the protruding portion of cervix uteri, molding the cervical cap utilizing the aforementioned blank, and then trimming away excess material. Thereafter, for caps having a deformable.margin, the margin should be slit from its peripheral edge in a direction towards the apex of the shell with straight cuts, inverted V-shaped* notches or the like. Yet another aspect of the present invention contemplates an implement for making the impression of the cervix uteri which comprises, in combination, an impression tray and a syringe having an elongated nozzle received -within said tray. The impression tray includes a hollow cup for receiving the cervix and having a flexible wall that terminates in a peripheral, outwardly flared, anterior lip. The cup is also provided with a bottom aperture. A posterior sleeve, integral with the cup, surrounds the bottom aperture. The tray also in¬ cludes a hollow, elongated stem the proximal end of which is received within the posterior sleeve. The stem defines a passageway communicating with the cup interior. The length of the stem is such as to facilitate the removal of the vaginal speculum while the tray is held in place. -7- The syringe includes a hollow body portion, a movable plunger within the body portion, and an elongated nozzle communicating with the hollow body portion and adapted to be received within the pas- sageway defined by the hollow stem of the tray. To make an impression of the cervix, the impression tray is positioned over the cervix with the stem protruding from the vagina. A physiologi¬ cally tolerable, hardenable paste is dispensed from the nozzle of the syringe when inserted into the stem.- The paste is distributed over the cervi ' x and within the confines of the hollow cup of the tray. The dispensed paste is permitted to harden in situ, and thereafter the tray, containing the fixed cervical impression, is removed from the vagina. A replica of the cervix is then cast from the obtained impression and hardened. Thereafter the cervical cap is produced by positioning the aforementioned blank over the replica, softening the blank by application of heat thereto, and then pressing the heat-softened blank against the replica by vacuum, air pressure, or otherwise. After the surface of the softened blank contiguous with the replica has been deformed to assume a contour substantially complementary to that of the replica, the deformed blank is cooled, removed from the replica, and trimmed to a desired size. The valved cervical cap embodying the present invention is a non-invasive and entirely passive birth control device. The cap does not interfere with the normal hormonal balance of the individual wearer and thus avoids the side effects commonly encountered with hormonal contraceptives. Inasmuch as the cap is not placed within a human body like an intrauterine device but, instead, is positioned on the exocervical surface of cervix -8- uteri, it does not have to be sterilized. Likewise, no foreign body reaction and attendant rejection has been encountered. The cap may be worn for extended periods of time, no preplanning, anticipation, or periodic at¬ tention is needed. Thus, there is no interference with the spontaneity of sexual activity. Addition¬ ally, the presence of the cap may protect the cervix, uterus and Fallopian tubes from undesirable external influences and infections. The cap embodying this invention can be fabricated in a relatively short time period, of the order ' of about five minutes, using a replicated cast of the prospective user's cervix uteri. Little tech- nical skill is required for fabrication. The one-way valve included in the present cap provides the further advantages of reliability and increased sperm travel distance in the unlikely event that sperm does enter the space between the web and the shell, since the possible sperm entry region is distant from the shell aperture. The normal cyclical changes in the viscosity of cervical mucus do not affect the efficacy or the barrier character¬ istics of the valve. In contradistinction to" the previously known leaflet or flap-type valves which could be held open by a viscous droplet of cervical mucus, the present valve design causes droplet-like cervical mucus descending from the cervical os to flatten out into a very thin film, which does not hold open the valve itself. Brief Description of the Drawings In the drawings, FIGURE 1 is an elevational view, partly in section, of a portion of the internal organs of the female reproductive system with a cervical cap em¬ bodying the present invention in place; FIGURE 2 is an enlarged perspective view of a valved cervical cap embodying the present inven¬ tion; FIGURE 3. is a plan view of a blank suitable for fabricating a cervical cap embodying this inven¬ tion; FIGURE 4A is a sectional view taken along plane- 4-4 in Figure 3; FIGURE 4B is a sectional view similar to that in Figure 4A but showing an alternate cross- sectional configuration for the valve means in. a cervical cap of this invention. FIGURES 5 and 6 illustrate devices suitable for practicing the present invention; FIGURE 7 is a side elevational view showing a cast replica of the cervix of female uterus; FIGURE 8 is an enlarged sectional eleva¬ tional view illustrating the manufacture of a cervi¬ cal cap in accordance with the present invention; FIGURE 9 is a plan view showing another type o ^ f blank suitable for fabricating a cervical cap with a deformable margin in accordance with the present invention; FIGURE 10 is a sectional view taken along plane 10-10 in FIGURE 9; FIGURE 11 is a bottom view of the blank shown in FIGURE 9; FIGURE 12 is an enlarged perspective view of a valved cervical cap embodying the present invention and fabricated from the blank shown in FIGURES 9-11, inclusive. FIGURE 13 is an elevational view, partly in section, of a portion of the internal organs of the female reproductive system with a cervical cap having a deformable margin in place; -f ^il - -10- FIGURΞ 14 is an enlarged perspective view of a valved cervical cap with a deformable margin; FIGURE 15 is a plan view of another blank suitable for fabricating a cervical cap with a .deformable margin; FIGURE 16A is a sectional view taken along plane 16-16 in Figure 15; and FIGURE 16B is a sectional view similar to that in Figure 16A but showing an alternate cross- sectional configuration for the valve means in a • cervical cap of this invention. Description of Preferred Embodiments Referring to FIGURE 1, valved cervical cap 10 is shown positioned on exocervical surface 17 of cervix uteri 11, i.e., on the portio vaginalis cer- vicis or that portion of uterus 13 that protrudes into vagina 12. Uterus 13 is supported by broad ligaments 14 and 15, and defines fundus 16 that terminates in cervical os 18. Vaginal wall 19 and cervix 11 together define the fornices vaginae, i.e., lateral fornices 20 and 21 as well as the anterior and posterior fornices (not shown). Cap 10 is a cup-shaped elastomeric shell 22 having convex outer surface 23 and concave inner surface 24. Surface 26 of the portio vaginalis cer- vicis is not distorted by cap 10 and is in mating contact with concave inner surface 24 at least along band 25 of shell 22 which is of substantially uniform rigidity. In the area of contact, concave inner surface 24 is substantially complementary with the contiguous surface 26 of the portio vaginalis cervicis. Preferably the thickness of shell 22 is substantially uniform, at least along peripheral band 25, for optimum stability of cap 10 when in place. Also, it is preferred that the band of substantially O ΓI -11- uniform thickness constitutes a major portion of shell 22. Aperture 27 is provided in elastomeric shell 22 at the apex thereof and, as shown in FIGURE 1, is positioned adjacent to cervical os 18 when cap 10 is in place. An external cover for aperture 27 is provided by elastomeric web 29 that is integral with shell 22. Web 29 is secured to shell 22 about a major portion of its periphery but also having an unsecured or free edge portion (FIGURE 2) that together with adjacent surface portion of convex surface 23 defines a discharge port or external open¬ ing 43. Web 29 lies against shell 22 and substan¬ tially conforms to the contour thereof. In some instances web 29 may also be under tension and/or biased against convex surface 23. Web 29 and the covered portion of outer surface 23 together define a pocket that communicates with aperture 27 and forms a one-way valve extending from aperture 27, between web 29 and surface 23, and defining discharge port 43 in a direction away ' from the apex of shell 22, and thus spaced from aperture 27. Preferably the defined discharge port is situated at least about one aper¬ ture diameter away from aperture 27, and more prefer- ably, is situated near or at shell periphery 35. This one-way valve opens under increased uterine pressure and permits the passage of fluids such as mucus, menstrual flow, and the like from fundus 16 to vagina 12 without disturbing the posi- tioning of cervical cap 10 and without permitting the entry of sperm into fundus 16. Additionally, the precise fit of cervical cap 10 onto the portio per¬ mits mucus to flow around it; however, at the same time the forces generated by the flow of mucus assist in orienting and in holding cap 10 firmly in place. -12- As shown in FIGURE 2, optionally cap 10 can be provided with an integral tactile orientation marker 31 for the purpose of facilitating orientation of cap 27 upon insertion, as well as enabling the wearer to periodically assure herself that cap 10 remains properly positioned. Visual indicia 33 may also be provided on elastomeric web 29 in some in¬ stances for the purpose of facilitating the locating of aperture 27 underneath web 29 during manufacture of cap 10 as will be described in detail hereinbelow. Shell 22 is dimensioned so as to have a depth sufficient to receive a major portion of the portio as illustrated in FIGURE 1; however, periphery 35 of shell 22 terminates short of the fornices vaginae so as to guard against dislodgment of cap 10 during activity that may cause uterus 13 to shift position and/or to deform or distend the normal configuration of the fornices. To avoid dislodgment of the cap during momentary, severe uterine displace- ment it is important that peripheral edge 35 is sufficiently elastic to remain in contact with the exocervical surface contiguous therewith even during such momentary uterine displacement. For this purpose it is preferable that peripheral edge 35 be feathered, i.e., tapered or beveled as shown in FIGURE 1 at 28. Cap 10 preferably is positioned on cervix uteri 11 so that discharge port or external ope-ning 43 of the valve defined by web 29 in conjunction with convex outer surface 23 is located in or near the posterior fornix and also at a location on surface 23 that is closer to shell periphery 35 than to the apex of the shell. In the embodiment illustrated in FIGURE 2 discharge port 43 is substantially coinci- dental with periphery 35 and preferably is situated C: ~ :Ϊ -13- no more than about 1 to about 3 millimeters from periphery 35. This results in a manifold increase in the distance that sperm must travel to reach cervical os 18. A portion of the increased distance for sperm travel is in vagina 12 where the environment is very inhospitable to sperm motility due to the rela¬ tively low ambient pH. Usually sperm can survive in the vaginal vault only for a time period of about one to two hours. Inasmuch as sperm can move at a velocity of about one to two millimeters per minute, the substantial increase in the distance that sperm must travel with cap 10 in place alone markedly re¬ duces the likelihood of fertilization. Sperm travel to cervical, os 18 via the valve means in cap 10 is possible only in close proximity to the walls defining the valve means. Inasmuch as at least shell 22, and preferably both shell 22 and web 29 are of a thermoplastic elastomeric material, which materials exhibit an inhibitory effect on sperm motility, the likelihood of sperm reaching -cervix uteri 11 is further reduced. Shell 22 can be made of a wide variety of thermoplastic elastomeric materials, the so-called thermoplastic elastomers, such as polyolefin blends, styrene/elastomer block copolymers, copolyesters, and polyurethane block copolymers. While these thermo¬ plastic elastomers differ chemically, their morphology is similar. Blocks or domains of rela- tively hard thermoplastic constituents link elasto¬ meric constituents in a network that behaves like a chemically crosslinked rubbery structure. At forming temperatures the relatively hard thermoplastic domains of the structure soften and allow the poly- eric material to flow. Upon cooling," these -14- relatively hard domains resolidify and re-establish the rubber-like, elastic structure. Thermoplastic elastomers that exhibit a surface charge provide a further advantage for the present purposes in that the presence of such a charge on the fabricated shell and/or web tends to inhibit sperm motility. For purposes of the present invention, the shell materials particularly suitable are the styrene/elastomer block copolymers such as those commercially available from the Shell Chemical Com¬ pany, Oak Brook, Illinois, under the designation "Kraton" and "Kraton G" and described in U.S. Patent No. 3,231,635 to Holden et al. These styrenic thermoplastic elastomers are block copolymers of polystyrene and an elastomer such as polyisoprene, polybutadiene, ethylene-propylene, or ethylene- butylene rubber. While thermoplastic elastomeric materials of varying hardness may be used to fabricate shell 22, for optimum stability against dislodgment prefer¬ ably the material should be harder than the cervical tissue that comes in contact therewith, yet the hard- ι ness should not be so high as to cause discomfort to the wearer or her consort. Preferably the shell material has a Shore A durometer hardness value of about 35 to about 70, and more preferably of about 45 to about 60. The shell material can be opaque, semi- transparent or transparent; however, for ease of handling or positioning during manufacture of the cervical cap a transparent or clear material is preferred. Web 29 can be made from the same elasto- meric material or from a different elastomeric c ~ : -15- material, as long as web 29 can be secured to shell 22. For ease of manufacture it is preferred to have web 29 of the same elastomeric material as the shell material but thinner. The shell-to-web thickness ratio usually is about 7:1 to about 3:1 and prefer¬ ably about 5:1. In a typical cervical cap embodying the present invention the shell thickness is about 1.5 millimeters and the web thickness is about 0.3 to about 0.4 millimeters. The relative thicknesses of the shell and the integral web in each instance depend on a variety of factors such as the manufacturing procedure, form¬ ing temperatures, modulus of elasticity, and the like considerations. In -general, however, the web thick- ness is selected so as to provide a valve-opening pressure of about 10 to about 15 millimeters of mer¬ cury for the one-way valve formed by the coaction of web 29 with the outer surface 23 of shell 22 contiguous therewith. The material for web 29 need not be thermo¬ plastic as long as it exhibits the desired elasticity and can be secured to shell 22. Not only heat seal- ing or ultrasonic bonding but other bonding means, e.g., adhesive ' bonding, can be utilized as well. In addition to the aforementioned thermoplastic elas¬ tomers, the web portion of the present valved cervi¬ cal cap can be made from materials such as natural rubber, siliσone rubber, polyurethanes, fluorocarbon rubbers, styrene-butadiene rubbers, and the like. Valved cervical cap 10 can be fabricated by molding a blank of the type shown in FIGURES 3 and 4A wherein blank 37 comprises substantially planar sheet 39 of elastomeric material. Aperture 27 in the cen¬ tral region of sheet 39 is covered by elastomeric web 29. The contour of web 29 is not critical and can be -16- generally fan-like, bell-shaped, trapezoidal, or circular, for example, as long as the web substan¬ tially conforms to the molded shell after the cap has been fabricated. Web 29, in turn, is secured to sheet 39, e.g., by bonding peripheral region 41 thereof. The seσurement of web 29 to sheet 3 , and thus ultimately to cap 10, is sufficient to permanently attach web 29 to sheet 39 but provides an unsealed, i.e., free, edge portion which serves to define, in part, external valve opening or discharge port 43. In essence, web 29, when secured to sheet 39, defines a pocket or pockets communicating with underlying aperture 27 and provides a one-way passageway or channel between web 29 and that portion of sheet 39 which ultimately becomes a web-covered portion of the convex outer surface 23 for cap 10, terminating in discharge port 43 that is situated- at least one aperture diameter away from aperture 27. Preferably the cross-sectional area of the defined passageway increases with incresing distance from aperture 27 as measured along convex surface 23 of shell 22. Thus, in case of a trapezoidal web, for instance as shown in FIGURE 3, the relatively shorter of the two substantially parallel sides of the trapezoid is positioned nearer to aperture 27 than the relatively longer parallel side, and bonded peripheral region 41 extends about the major portion of the periphery of aperture 27. The diameter of aperture 27 is usually about 5 to about 10 millimeters. Aperture 27 can be a through-aperture with rectangular edges, if desired. However, during fab¬ rication, a relatively thin, thermoplastic, elasto¬ meric web may be drawn or forced into aperture 27 too far and may be excessively deformed or even perfor¬ ated at the line of contact with a rectangular, sharp -17- edge defining aperture 27. The use of such rela¬ tively thin webs, if desired, is facilitated if the aperture-defining edge portion adjacent to web 29 is beveled as at 45 in FIGURE 4A or rounded as at 47 in FIGURE 1. In this manner the likelihood that web 29 may be perforated or unduly distorted during fabrica¬ tion is reduced. Tactile orientation marker 31 is positioned adjacent to a sealed juncture of web 29 and sheet 39. An alternate, suitable one-way valve con¬ figuration utilizing a relatively thin web is illus¬ trated in FIGURE 4B. In this particular embodiment, aperture 44 in thermoplastic elastomeric sheet 42 is covered by web 49 having unitary protuberance 48 extending into aperture 44 and contacting beveled surface 46, i.e., the web 49 is thicker in the region of aperture 44. When a custom, valved cervical cap is fabricated using a cap blank of the type shown in FIGURE 4B, protuberance 48 will abut beveled surface 46 and thus will prevent excessive deformation of the web itself during fabrication. It should be noted, however, that even in the case of a substantially uniformly thick web some deformation into the shell aperture, such as aperture 27 (FIGURES 1, 3 and 8), is not objectionable as long as web integrity is not impaired. Such deformation, as best seen in FIGURE 8, also can provide a unitary protuberance that projects into the aperture and enhances the valving action. In addition, the web may be relatively thicker in the region overlying the aperture. In some instances, particularly when sheet 39 is relatively thick, e.g., of the order of about 2.5 millimeters or more, it is desirable to extend bevel 45 on the aperture edge portion substantially -18- to the juncture 41 of sheet 39 and web 29 so as to provide a substantially uniform thickness through¬ out. Alternatively, or in addition, the region sur¬ rounding aperture 27 and covered by web 29, in the region between juncture 41 and aperture 27 may be countersunk or thinned out for the same purpose. A prefabricated blank of the type described offers the substantial advantages of ease of custom cap fabrication by a practitioner associated with the practicing physician or with a medical laboratory. . For optimum fit, concave inner surface 24 of cap 22 is substantially complementary with the surface of the portio vaginalis cervicis contiguous therewith. While it is desirable that concave inner surface 24 projects slightly toward cervical os 18 about the periphery of aperture 27, i.e., has local convexity in the aperture region complementary to the concavity of the cervix in the region surrounding cervical os 18, no portion of surface 24 enters cervical os 18. To this end,.the cervix in its normal, undistorted configuration is first replicated as a rigid mold, e.g., in plaster, and the obtained replica is then utilized to mold the cervical cap. Initially an impression of cervix uteri is made using a physiologically tolerable, hardenable paste. Suitable for this purpose is an aqueous paste made from dental impression powder, e.g., using an algin derivative, usually an alginate such as sodium alginate. The cervical impression can be 'made utiliz¬ ing the implements shown in FIGURES 5 and 6. Syringe 50, shown in FIGURE 5, includes hollow body portion 52 having an open end 53 and opposed dispensing end 54 that terminates into elongated nozzle 56 in communication with hollow body portion 52. Plunger -19- 55 is positioned within hollow body portion 52 and is adapted to dispense the syringe contents through nozzle 56. Impression paste 57, e.g., aqueous alginate paste, is contained within hollow body por- tion 52. To facilitate the distribution of impres¬ sion paste 57 over the cervix during the course of making the impression, it is preferable to have a nozzle the distal end 59 of which is offset from the longitudinal axis of the nozzle itself. In this manner nozzle discharge port 61 is situated in a plane that is at an acute angle, preferably at an angle of about 45 degrees, with respect to the longi¬ tudinal axis of nozzle 56, and can dispense impres¬ sion paste 57 laterally over the cervix in all direc- tions by simply rotating syringe 50. In an alternate ' manner, nozzle 56 can be rotatably mounted on syringe body 52 by means of nozzle-bearing hub 62 that is rotatable with respect to syringe body 52. Preparatory to making a cervical impression as contemplated by the present invention, vagina 12 is expanded using a vaginal speculum so as to expose the cervix. Thereafter impression tray 65 (FIGURE 6) is inserted through the speculum and into the vagina, and positioned so that hollow cup 67 thereof envelops the cervix. Cup 67 has a flexible, preferably. trans¬ parent, wall 68 made from an elastomeric material such as silicone rubber, polyurethane, or the like, that terminates in a peripheral, outwardly flared, anterior lip 69 the purpose of which is to keep out adjacent vaginal wall. Wall 68 and Tip 69 are also designed so as to trap the cervix and to prevent its upward rotation with attendant closure of the anterior fornix space when the patient is in a supine position while the cervical impression is made. -20- Flexible wall 68 is further provided with a plurality of spaced perforations such as perforation 66. Cup 67 at the bottom thereof is provided with a bottom aperture surrounded by posterior sleeve 70. Proximal end 71 of hollow, elongated stem 72 is re¬ ceived within sleeve 70. Stem 72 defines a passage¬ way that communicates with the interior of cup 67. A pair of opposed mounting notches, such as notch 73, are provided in distal end 74 of stem 72. Also at or near distal end 74 marker means 75 is provided on stem 72 for indicating, a preselected orientation of cup 67. While cup 67 and stem 72 can be coaxial, for ease of manipulation and insertion during the making of a cervical impression, and also to facili¬ tate the entrapment of the cervix, it is preferred that the longitudinal axes of cup 67 and stem 72 intersect at an included angle of about 15 to about 25 degrees, and more preferably about 20 degrees. To make a cervical impression once tray 65 is appropriately positioned enveloping the cervix, nozzle 56 is inserted through hollow stem 72. Pre¬ ferably, length of nozzle 66 is selected so as to extend for substantially the length of stem 72. More preferably distal end 59 projects into cup 67 through the bottom aperture thereof but remains spaced from the cervix. Hub 62 (FIGURE 5) on syringe, upon abut¬ ting open end 77 of stem 72, provides a positive stop that prevents nozzle aperture 61 from coming in con- tact with the cervix. In instances where nozzle 56 is longer than stem 72, appropriate stop means can be provided on nozzle 56 itself or within stem 72 at the proximal end 71 received within sleeve 71. Impression paste 57 is then dispensed from syringe 50 and distributed so as to cover the cervix, -21- and speculum is removed from the vagina without re¬ moving tray 65, and the paste permitted to set with the cervix in its natural undistorted shape. The length of stem 72 is selected long enough to permit the easy removal of the speculum without disturbing the position of tray 65. As the impression paste fills cup 67, minor amounts of the paste exude through perforations 66 and, upon setting, anchor the formed impression within tray 65. After the paste has set, usually within about 90 seconds, tray 65 together with the cervical impression contained therewithin is lifted from the cervix and placed onto vibrating table 78 for casting a replica of the cervix. The casting operation entails pouring a slurry of plaster of Paris, or like casting material, into tray 65 while the latter is vibrated to permit any trapped air to rise to the surface and to assure that each and every crevice of the formed impression is filled with the slurry. After the slurry has hardened, replica 80 (FIGURE 7) is removed from tray 65 and is ready for use in fabricating cervical cap 10. To this end vacuum molding techniques, e.g., drape forming, can be readily utilized; however, any other molding technique can be utilized as long as the material to be molded can be made to conform closely to the cervical replica, for example, by means of positive air pressure. For purposes of illustration a preferred vacuum molding technique will be described in detail hereinbelow. Referring to FIGURE 8, vacuum molding appa¬ ratus 82 comprises base 83 that supports foraminous plate 84 and heat source 86, e.g., a calrod heating element or infrared lamp, in a spaced relationship -22- relative to plate 84. Alternatively, heat can be supplied by a stream of hot air. In the case of a radiant heat source, such as an infrared lamp, the heat-radiating surfaces can be contoured so as to provide a substantially uniform distance between the heat source and the blank portion nearest thereto. Channel 85 in base 83 communicates with a vacuum source (not shown) and permits vacuum to be drawn through plate 84. Replica 80 is positioned on plate 84 and blank 37 positioned thereover so that visual indicia- 33 is superposed over cervical os region 81 of replica 80. A release agent, e.g., an aerosol spray of lecithin commercially available under the designa- tion "Pam" from Boyle-Midway, Inc., New York, N.Y. 10017, is applied to the exposed surface of blank 37, and between the web and the underlying sheet and the blank is then covered with thin protective sheet 88, e.g., a polyethylene terephthalate film, or the like. Preferably sheet 88 is perforated in order to facilitate the vacuum forming operation. Heat source 85 is then turned on and heat applied to sheet 37 until it begins to soften and conform to replica 80 by its own weight. Thereafter the vacuum source is turned on and vacuum drawn through foraminous plate 84 so as to press softened sheet firmly against replica 80. Heat source 86 is then turned off or removed, and the formed sheet is permitted to cool while vacuum is maintained. Once cooled to a per- manent contour, sheet 37 is removed from replica 80, and the formed cervical cap is excised therefrom and trimmed to the desired shell depth. The specific shell depth in each instance will depend on the contour of the portio vaginalis cervicis in a given case; however, the shell peripheral edge, i.e., -23- periphery 35, should not extend into the fornices vaginae. The feathering or beveling of shell peri¬ phery 35 is usually done during the final trimming operation. Valved cervical caps embodying the present invention, made from styrene/elastomer block copoly¬ mers, and having the general configuration shown in FIGURE 2 have been satisfactorily worn by sexually- active female volunteers for a cumulative time period in excess of 290 months. The cervical cap shown in Figures 13 and 14 is substantially the same as the cervical cap shown in Figures 1 and 2 except that it has a flexible skirt portion 30. For ease of understanding and for clarity, the parts and components of the cervical cap shown in Figures 13 and 14 have been given the same part numbers as similar parts and components of the cervical cap shown in Figures 1 and 2. Flexible skirt portion 30 provides a deform- able margin that depends from shell 22 and is sub- stantially thinner than the thickness of peripheral band 25, i.e., no more than about one-half the thickness of band 25. Skirt portion 30 can be unitary with shell 22 or can be made from a separate strip of the same or different elastomeric material secured to shell 22 at the peripheral edge thereof by heat sealing, adhe¬ sive bonding, ultrasonically, or in any other conven¬ ient manner. At the juncture of shell 22 and skirt portion 30, edge portion 28 of shell 22 is featured, i.e., beveled or tapered, so as to provide a rela¬ tively smooth, gradual transition from one material thickness to another. Aperture 27 is provided in elastomeric shell 22 at the apex thereof and, as shown in FIGURE -24- 13, is positioned adjacent to cervical os 18 when cap 10 is in place. An external cover for aperture 27 is provided by elastomeric web or web portion 29 that is integral with shell 22. Web 29 is secured to shell 22 about a major portion but not the entirety of its periphery so as to provide an unsecured or free edge portion (FIGURE 14) that together with adjacent sur¬ face portion of convex surface 23 defines a discharge port or external opening 43. As shown in FIGURE 14, web 29 covers only a portion of shell 22; however, web 29 can also cover the entire external surface of shell 22. If desired, web 29 may. extend also beyond shell periphery 35 up to peripheral edge 34 of skirt portion 30. As best seen in FIGURE 14, flexible skirt portion 30 is provided with a plurality of spaced slits 32 that begin at peripheral edge 34 of skirt portion 30 and which can extend toward the apex of shell 22 substantially at right angles to peripheral edge 34. Slits 32 may extend substantially across the entire width of skirt portion 30 or may terminate short of beveled portion 28 of shell 22. In one preferred embodiment of this invention the slits extend at least one-half the width of the skirt por- tion. The spacing between adjacent slits depends on the flexibility of the skirt portion and may vary in the range of about 2 millimeters to about 10 milli¬ meters. More preferably slits 32 are spaced about 4 to about 6 millimeters apart and are at least about 1.5 millimeters long. For optimum retention of the cap, it is desirable to maximize the contact area between the cap and the exocervical surface. To this end, skirt portion 30 integral with shell 22 performs a very useful function in that further contact area is -25- provided. Additionally, the relatively thin cross-section of flexible skirt portion 30, and slits 32, permit a localized deformation of skirt portion 30 upon uterine displacement or distortion without a material reduction in the contact area available for cap retention. Skirt portion 30 is preferably made out of the same material as shell 22, but may be made out of different materials or have different physical properties. Valved cervical cap 10 embodying the present invention can be fabricated by molding a blank of the type shown in FIGURES 16A and 16B wherein blank 37 comprises substantially planar sheet 39 of elasto- meric material. Sheet 39, in turn, comprises a central embossed region or land 40 of generally circular configuration from which shell 22 is formed surrounded by a relatively thinner region 51 from which skirt portion 30 is ultimately formed. Typically the central embossed region is about 1 to about 2 millimeters thick and the planar surrounding region is about 0.2 to about 0.4 millimeters thick, i.e., the surrounding, relatively thinner region has a thickness that is no more than about one-half of the thickness of the embossed region. Preferably the thickness ratio of the embossed region to the planar surrounding region is about 3:1 to about 7:1. Typi¬ cally, the embossed region or land 40 has a diameter of about 25 millimeters to about 50 millimeters. Aperture 27 in the central region of sheet 39 is covered by elastomeric web 29. The thickness ratio of the embossed region to the overlying web prefer¬ ably is about 7:1 to about 3:1, and more preferably is about 5:1. The contour of web 29 is not critical and can be generally fan-like, bell-shaped, trape- zoidal, or circular, for example, as long as the web -26- substantially conforms to the molded shell after the cap has been fabricated and defines a channel terminating at the distal end thereof in a discharge port that can accommodate the uterine discharges. For a bell- or fan-shaped web 29, for instance as shown in FIGURE 15, the bonded peripheral region 41 extends about the major portion of the periphery of aperture 27 and the maximum σross-sectional area for the defined passageway is at discharge port 43. The diameter of aperture 27 is usually about 5 to about 10 millimeters. An alternate, suitable one-way valve con¬ figuration utilizing a relatively thin web is illus¬ trated in FIGURE 4B. In this particular embodiment, aperture 44 in composite thermoplastic elastomeric sheet 42 forming the blank is covered by web.49 hav¬ ing unitary protuberance 48 extending into aperture 44 and contacting beveled surface 46 which provides an annular contact surface or valve seat for protu- berance 48. That is, web 49 is thicker in the region of aperture 44 and projects into the aperture. When a custom, valved cervical cap is fabricated using a cap blank of the type shown in FIGURE 16B, protuber¬ ance 48 will abut beveled surface 46 and thus not only will -provide a larger sealing area but also, in the case of a relatively thin web, will prevent ex¬ cessive deformation of the web itself during fabrica¬ tion. Composite thermoplastic elastomeric sheet 42 is a laminate of two compatible yet dissimilar mate- rial layers 53 and 64 selected to provide the desired rigidity and hardness for the shell and the desired flexibility for the skirt portion of the cap. The embossed region or land 58 in the blank derived from composite sheet 42 is provided by a substantially circular thermoplastic elastomer layer 63 superposed over and bonded to underlying layer 64. -27- Following vacuum molding in accordance with the procedures discussed with respect to Figures 5-8, the skirt portion is trimmed to the desired width. The skirt width, i.e., the distance between the junc- tion of the shell and the skirt on one hand and the peripheral edge of the skirt on the other, depends on the depth of the fornices in any given instance, but usually is about 3 to about 7 millimeters. Slits are cut into the skirt portion of the formed cervical cap during the final trimming operation. Preferably the slits are substantially uniformly spaced from one another and extend about 1.5 to about 5 millimeters from periphery 34, i.e., from the distal edge of the skirt portion. Alternatively, a valved cervical cap can be first formed using a blank of substantially uniform thickness substantially as disclosed above and then a flexible skirt portion can be affixed thereto in the form of an elastomeric band that is bonded to the shell portion of the cap at the shell periphery by heat welding, ultrasonic techniques, adhesive bonding techniques, or the like. Spaced slits are provided in the band at the distal, i.e., unattached, edge thereof before or after attachment to the shell portion, as desired. The added skirt portion can be about 3 millimeters wide, or wider, depending on the depth of the fornices. Usually a skirt portion width of about 3 to about 7 millimeters is adequate. A relatively wide skirt portion may be added during fabrication and subsequently trimmed to a desired width for optimum fit. As pointed out hereinabove, the slits in the skirt portion can be spaced about 2 millimeters to about 10 millimeters apart, preferably about 4 to about 6 millimeters apart, and are at least about 1.5 millimeters long. -28- In addition to the blanks illustrated in FIGURES 15, 16A and 16B, a cervical cap embodying the present invention can also be fabricated using a blank of the type shown in FIGURES 9, 10 and 11. Referring to these latter FIGURES, circular blank 90 comprises an elastomeric web 91 that overlies and is secured to underlying planar thermoplastic, elasto¬ meric sheet 93. If desired, elastomeric web 91 may also have a rectangular configuration, a polygonal configuration, or the like, as long as the margins of web 91 extend beyond sheet 93. As best seen in FIGURES 10 and 11, planar sheet 93 is circular and is provided with central aperture 95 having rounded or beveled edges. The outer peripheral margin 94 of planar sheet 93 is also beveled . radially outwardly . and away from web 91 so as to provide a relatively smooth transition between the downwardly depending skirt portion 102 of elastomeric web 91 and planar sheet 93 when blank 90 is transformed to a cap shape as described hereinabove. Elastomeric web 91 is intermittently bonded or otherwise secured to planar sheet 93 so as to define therebetween a channel or a plurality of chan¬ nels communicating with aperture 95 and periphery 103 of planar sheet 93. " In other words, elastomeric web 91 is not continuously bonded to planar sheet 93 at periphery 103; however, there may be a plurality of spaced spot or linear bonding sites, if desired. In any case, the bonding sites are selected so as to provide a one-way passageway for fluids entering aperture 95 and exiting at periphery 103 as well as to provide a one-way valving action as a result, of coaction between elastomeric web 91 and the portion of sheet 93 defining aperture 95. -29- One-way valving action is further enhanced by providing web 91 with integral protuberance 97 that extends at least partially into aperture 95 and sealingly abuts the aforementioned portion of sheet 93 that defines aperture 95 while permitting the opening of aperture 95 in response to a fluid pres¬ sure increase within the formed cap. Protuberance 97 can be made unitary with web 91. To facilitate registry between web 9.1 and sheet 93 when composite blank 90 is assembled, one or more nipples such as -nipple 98 may be provided on web 91 and corresponding complementary cavities such as cavity 96 in sheet 93. The materials of construction for the elas- tomeric web and for the planar sheet, as well as their thickness ratios, can be the same as those discussed hereinabove in connection with the other embodiments .of this invention. Preferably the thick¬ ness of the elastomeric web is about 0.1 to about 0.4 millimeters, more preferably about 0.2 to about 0.3 millimeters. The thickness of the planar sheet pre¬ ferably is about 0.6 to about 2 millimeters, more preferably about 1 to about 1.5 millimeters. For blank 90, the diameter of circular, planar sheet 93 can be about 15 millimeters to about 50 millimeters, preferably about 25 millimeters to about 40 milli¬ meters, depending on the desired size and depth of the cervical cap to be fabricated. The relative thicknesses of the web and the sheet alsao depend to some extent on the durometer hardness value of the particular material that is utilized. In general, the softer the material the greater can be the thick¬ ness of the web and/or the sheet. A fabricated cervical cap embodying the present invention is shown in FIGURE 12. The shell -30- portion of the cap 99 defines a concave inner surface of the cap and is entirely covered by elastomeric web portion 104 which defines the convex outer surface of cap 99. While the slits situated in skirt portion 102 in a spaced relationship to one another and ex¬ tending into cap 99 from cap peripheral edge 100 can be substantially straight linear cuts, preferably these slits have an inverted-V configuration as il¬ lustrated by slits 101. In this particular embodi- ent skirt portion 102 is unitary with web portion 104. The foregoing disclosure and the accompany¬ ing drawings are intended as illustrative and are not to be construed as limiting. Still other variations within the spirit and scope of the present invention as defined by the claims are possible and will readily present themselves to those skilled in the art.

Claims: -31- WE CLAIM: 1. A blank for a removable cervical cap which comprises a substantially planar sheet of a ther o- plastic elastomeric material having a central aper¬ ture; and an elastomeric web superposed over said aperture; said elastomeric web having a thickness less than the thickness of said sheet and being secured to said sheet about said aperture but provid¬ ing a one-way passageway from said aperture between the web and said sheet. 2. The blank in accordance with claim 1 wherein said blank has a margin thickness that is less than the thickness of said sheet in the region thereof defining said central aperture. 3. A non-invasive birth control device which comprises a cup-shaped elastomeric shell having a convex outer surface and a concave inner surface that is substantially complementary with contiguous, surface of portio vaginalis cervicis in its actual configuration when in contact therewith, said shell defining an aperture at the apex thereof and having a depth sufficient to receive a major portion of said portio, but the periphery of said shell terminating short of fornices vaginae; and an elastomeric web over said aperture and secured to said outer surface about said aperture defining a passageway communicating with said aper¬ ture and providing a discharge port along said convex outer surface and offset from said aperture; said web conforming to and coacting with a contiguous portion of said convex outer surface to G\:ΓI -32- provide a one-way valve means for uterine discharge entering said aperture from within said shell. 4. The birth control device in accordance with claim 3 including a skirt portion integral with said shell, depending from said shell at the periphery of said shell, and having a thickness that is less than the thickness of said shell, and wherein said skirt portion has a plurality of spaced slits extending from the peripheral edge of the skirt portion'. 5. An impression tray suitable for making an impression of a cervix uteri which comprises a hollow cup for receiving the cervix and having a flexible wall terminating in a peripheral, outwardly flared anterior lip and a bottom aperture; a posterior sleeve integral with said cup and surrounding said bottom aperture; and a hollow elongated stem having a proximal end thereof received within said posterior sleeve and defining a passageway communicating with the interior of said cup. 6. An implement for making an impression of a cervix uteri which comprises, in combination, an impression tray and a syringe having an elongated * nozzle received within said tray, said tray comprising a hollow cup for re¬ ceiving the cervix and having a flexible wall termin¬ ating in a peripheral, outwardly flared anterior lip and a bottom aperture; a posterior sleeve integral with said cup and surrounding said bottom aperture; and a hollow elongated stem having a proximal end thereof received within said posterior sleeve and defining a passageway communicating with the interior of said cup; and said syringe comprising a hollow body por¬ tion, a movable plunger within said body portion, and -33- an elongated nozzle communicating with said body portion and adapted to be received within said pas¬ sageway of the hollow elongated stem. 7. A method for making a removable cap for cervix uteri which comprises the steps of contacting a substantially undistorted exocervical surface of said cervix uteri with a physiologically tolerable, hardenable paste for a time period sufficient to harden the paste and pro- duce an impression of said exocervical surface; introducing a plaster of paris slurry into the produced impression and setting said slurry to form a substantial replica of said exocervical sur¬ face; removing said replica from said impression; positioning a sheet of thermoplastic elas¬ tomeric material over said replica; applying heat to the positioned sheet in an amount sufficient to soften the sheet; pressing the softened sheet against the replica to deform and conform the softened sheet to the surface of the replica contiguous therewith; cooling the pressed sheet to produce a cup-shaped elastomeric shell having a convex outer surface and a concave inner surface that is substan¬ tially complementary with that portion of said exo¬ cervical surface which defines the surface of the portio vaginalis cerviσis; and trimming the produced cup-shaped elastomeric shell to a desired size. 8. A method for fabricating a valved cervical cap which comprises the steps of applying a physiologically tolerable, hardenable paste to cervix uteri in normal configura- tion and forming an impression of said cervix; -34- replicating said cervix as a rigid mold; positioning a blank for a valved cervical cap made of a thermoplastic elastomeric material over said rigid mold; applying heat to said blank in an amount sufficient to soften said material; pressing the softened material against said rigid mold; and cooling the pressed, softened material. 9. In a method for fabricating a valved cervical cap that includes an elastomeric shell by applying a physiologically tolerable, hardenable paste to cervix uteri in normal configuration and forming an impression of said cervix, replicating said cervix as a rigid mold, positioning a thermo¬ plastic elastomeric material blank for a valved cer¬ vical cap over said rigid mold, applying heat to said blank in an amount sufficient to soften said mate¬ rial, pressing the softened material against said rigid mold to produce a formed article, cooling the formed article, removing the cooled, formed article from said rigid mold, and trimming excess material from the formed article to produce said valved cervi¬ cal cap, the improvement which comprises affixing to said valved cervical cap at the shell periphery thereof a flexible skirt portion that depends from said cap. 10. A cervical cap having a convex outer surface and a concave inner surface that is substan- tially complementary with contiguous surface of portio vaginalis cervicis in its actual configuration when in contact therewith which comprises a shell portion defining said concave inner surface and an aperture at the apex thereof, and having a depth sufficient to receive a major portion X* - : - -35- of said portion, but the periphery of the shell por¬ tion terminating short of fornices* vaginae; an elastomeric web portion positioned over said aperture, secured to said shell portion, and defining at least a portion of said convex outer surface and further defining in conjunction with said shell portion a one-way valve means and a passageway communicating with said aperture and a discharge port offset from said aperture; and an integral skirt portion at the periphery of said shell portion and having a thickness that is less than the thickness of the shell portion; said skirt portion having a plurality of spaced slits extending from the peripheral edge of the skirt portion. c ~ : ~ .

Inventors: FREESE U, GOEPP R, LOEB M
Applicants: FREESE U, GOEPP R, LOEB M
Application year: 1980
Main classification: A61B19
IPC codes: A61F6