Abstract:
A cervical cap is provided having an annular rim with a first predetermined thickness. An annular collar extends from the rim and has a second predetermined thickness that is greater than the first predetermined thickness. A dome shaped wall extends from the collar and has a third predetermined thickness that is less that the second predetermined thickness. A method of forming a cervical cap is provided that includes the steps of preparing a three part mold, injecting material into the mold, and curing the material in the mold to form the cervical cap.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority to U.S. Provisional Patent Application 61/614,362 filed on Mar. 22, 2012, which is hereby incorporated by reference in its entirety. 
     
    
     TECHNICAL FIELD 
       [0002]    The present disclosure relates generally an intra-vaginal barrier device for females, and more particularly to a multi-purpose cervical cap, which fits over the cervix. 
         [0003]    Various types of intra-vaginal barrier devices that fit over the female cervix are presently available. These devices include a cervical cap, a diaphragm, a female condom or the like. A barrier device, such as a cervical cap may have several purposes. For example, the cervical cap may serve as a barrier method of contraception to prevent semen from entering the cervical canal. In another example, the cervical cap prevents the transmission of harmful bacteria related to sexually transmitted disease. The cervical cap may also be utilized in applying medicine locally to the cervix or uterus. The cervical cap is retained in place within the vaginal canal by a suction effect that formed a seal between an edge or rim of the cervical cap and the vaginal wall. 
         [0004]    Thus, to remove the cervical cap, the suction between the cervical cap and vaginal wall must be broken. Various techniques are available to displace the cervical cap, ranging from prying an instrument such as a finger between the cervical cap and the vaginal wall, to exerting pressure on a handle portion of the cervical cap. Previously, the handle projected from the rim of the cervical cap, since manufacturing constraints limited a more accessible placement of a removal handle. 
         [0005]    Thus, there is a need in the art for a cervical cap having a removal handle that can be molded in a single operation. Also, there is a need for a cervical cap that can be comfortably worn for extended periods of time, and accommodates a variety of anatomical sizes and shapes. 
       SUMMARY 
       [0006]    A cervical cap is provided having an annular rim with a first predetermined thickness. An annular collar extends from the rim and has a second predetermined thickness that is greater than the first predetermined thickness. A dome shaped wall extends from the collar and has a third predetermined thickness that is less that the second predetermined thickness. A method of forming a cervical cap is provided that includes the steps of preparing a three part mold, injecting material into the mold, and curing the material in the mold to form the cervical cap. A removal handle having a first end that is integrally formed with the collar and a second opposed end that is integrally formed with an opposite side of the collar, wherein the removal handle is spaced a predetermined distance from the base. 
         [0007]    Accordingly, an advantage of the present disclosure is that a cervical cap is provided that can be used for multiple purposes, including as a contraceptive device, a barrier to prevent a sexually transmitted disease, a drug delivery article, an implantation aid, to assist in regeneration of cervical tissue, a therapeutic device, a sample collection device or the like. Another advantage of the present disclosure is that the cervical cap can be easily removed. A further advantage of the present disclosure is that the cervical cap can be reliably molded in a cost effective manner. Yet a further advantage of the present disclosure is that the cervical cap includes a removal handle that is integrally formed with the cap wall. Still yet a further advantage of the present disclosure is that use of the device is not limited to human applications. Another advantage of the present disclosure is that the cervical cap has a flexible rim to accommodate a variety of anatomical sizes and shapes. 
         [0008]    Other features and advantages of the present disclosure will become readily appreciated as the same becomes better understood after reading the following description when considered in conjunction with the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]      FIG. 1  is an elevational front view of a cervical cap according to the present disclosure. 
           [0010]      FIG. 2  is an elevational side view of the cervical cap of  FIG. 1   
           [0011]      FIG. 3  is a cross-sectional view of the cervical cap of  FIG. 2 . 
           [0012]      FIG. 4  is an end view of the cervical cap of  FIG. 2 . 
           [0013]      FIG. 5  is a perspective view of the cervical cap of  FIG. 1 . 
           [0014]      FIG. 6  is another perspective view of the cervical cap of  FIG. 1 . 
           [0015]      FIG. 7  is a side view of the cervical cap of  FIG. 1 . 
           [0016]      FIG. 8  is another perspective view of the cervical cap of  FIG. 1 . 
           [0017]      FIG. 9  is another perspective view of the cervical cap of  FIG. 1  showing the parting lines for molding purposes. 
           [0018]      FIG. 10  is a side view of the cervical cap of  FIG. 1  showing the parting lines for molding purposes. 
           [0019]      FIG. 11  is an enlarged edge detail view of the cervical cap of  FIG. 1 . 
           [0020]      FIG. 12  is a perspective view of the interior of the cervical cap of  FIG. 1 . 
           [0021]      FIG. 13  is an end view of the interior of the cervical cap of  FIG. 1 . 
           [0022]      FIG. 14  is a flowchart of a method of forming a cervical cap. 
           [0023]      FIG. 15  is a flowchart of method of using a cervical cap. 
       
    
    
     DETAILED DESCRIPTION 
       [0024]    Referring to  FIGS. 1-13  a cervical cap  10  is illustrated. The cervical cap  10  of this example has many different uses, from disease prevention to a contraceptive barrier device, to a clinical sample collection device. Further, the cervical cap  10  can be placed in any type of female, including humans and other animals. 
         [0025]    The cervical cap  10  includes an annular rim  12  that forms a flange for retention of the cervical cap  10  around the cervix. The cervical cap  10  also includes a dome or cup shaped wall that is continuous with the rim  12 . The dome wall  16  and rim each have an external surface  16   a  and an interior surface  16   b.  The interior surface of the dome wall is accessible via a central opening formed in a center of the rim. The rim  12  has at least one integrally formed step that is progressively reduced in diameter from an outermost edge of the rim. In this example, there are five steps. The thin, stepped rim flange  12  rises upward from the collar  14  diagonally at a predetermined angle, such as 65 degree. The rim  12  can have another profile, such as an accordion pattern or the like. The rim has a predetermined height, such as 4 mm. 
         [0026]    A portion of the dome wall  16  that is immediately adjacent the rim is thicker in diameter that the rest of the dome wall and forms an annular collar  14 . The collar  14  may have a length of about 10 mm. The remaining portion of the dome wall  16  is thinner in diameter than the collar portion in a manner to be described. The end of the dome wall forms a base for the cervical cap, as shown at  18 . 
         [0027]    The cervical cap  10  also includes an integrally formed removal handle  20 . The removal handle  20  is generally planar and includes a first end and a second end. The first end  20   a  of the removal handle  20  is integrally secured to the outer surface of the dome wall just below the rim, in the vicinity of the collar. The second end  20   b  of the removal handle is integrally secured to the outer surface of the dome wall on an opposite to the first end. Thus, a first portion of the removal handle is integrally formed with the dome wall and as shown at  20   a , and a second portion of the removal handle is spaced apart from the dome wall as shown at  20   b . The removal loop  20  is spaced from the base of the dome wall to accommodate grasping. For example, the removal handle may be approximately 4 mm in width, and approximately 1 mm in thickness. 
         [0028]    The circumference of the rim  12  can vary depending on the width of the cervix to which it is secured. Similarly, the length of the dome wall  16  varies depending on the anatomical characteristics of the cervix. For example, the diameter of the interior of the cervical cap is about 28 mm at the collar  14 , and about 42 mm in height from an edge of the rim to the base  18 . Advantageously, the rim  12  is flexible and can accommodate multiple cervical sizes and shapes. 
         [0029]    The thickness of the dome wall  16  varies along the length of the dome wall. For example, the thickness of the rim is about 0.25 mm. In the area of the collar and integrally formed handle, the thickness is approximately 3 mm. As the handle  20  diverges from the dome wall, the thickness of the dome wall is reduced to approximately 0.25 mm. The thin, stepped rim flange  12  gradually tapers to a thickness of less than 0.25 mm at the outer edge of the opening  10 . 
         [0030]    The diameter of the cup  16  may be narrowest at the base, and gradually widens toward the opening formed by the rim, such as approximately 20 mm near the base, approximately 28 mm inside the thick collar  14 , and approximately 39 mm at the outer edge of the rim flange  12 . 
         [0031]    The cervical cap  10  can be made from various flexible medical grade materials. For example, medical grade silicone, such as latex, plastic and the like may be utilized. Depending on the use of the cervical cap, it may be desirable that the material be impermeable. I.e. the material could be impermeable to sperm and sexually transmitted viruses or bacteria and not impermeable to drugs or hormones. Alternatively, the wall of the cup portion may be permeable to a spermicidal preparation contained within the cup portion, but impermeable to sperm. In this manner, the spermicide may expand within the vagina and around the cervix. In still another example, based on the principle of occlusion, the cervical cap  10  would be put in place over the cervix, and the cup material would be impenetrable to STI pathogens and, resultantly, the device would act as a physical barrier to offer protection from certain sexually transmitted infections, such as HIV/AIDS, HPV, Chlamydia, Gonorrhea, and Syphilis. In still another example, based on the inclusion of a microbicide or other chemical medicament, the cap would act as a physical and chemical barrier to offer protection from certain sexually transmitted infections, such as HIV/AIDS, HPV, Chlamydia, Gonorrhea and Syphilis. 
         [0032]    In a further example, the predetermined material placed in the cup portion of the cap could be a drug or hormone-loaded delivery system. Certain cup construction materials may be permeable in a way that they can be loaded with drugs and/or hormones. Accordingly, the cervical cap would become a mechanism for the intra-vaginal, controlled release of a range of drugs and/or hormones, where local or trans-dermal/trans-mucosal delivery is preferred. In still another example of a conception aid, the predetermined material is live sperm be placed over the cervix to directly deliver that sperm to the uterus, or opening of the cervix, to facilitate conception. In yet another example, the cervical cap  10  could be placed on the cervix to protect and enable regeneration of the cervical tissue, with, or without added material or medication. Similarly, as a protective device, the cervical cap could be used therapeutically to protect the cervix, such as prior to or after a fertility treatment. 
         [0033]    Referring to  FIG. 14 , a method of molding a cervical cap  10  is provided. The methodology begins in block  100  with the step of preparing a precision mold. For example, a mold is prepared using a high precision CNC machine such as a 3D printer/rapid prototyping machine is utilized. The mold will have 3 pieces that splits across two distinct parting lines as shown in  FIG. 8 . 
         [0034]    The methodology advances to block  105  and a material is injected into the mold. An example of a material is a medical grade flexible material. 
         [0035]    The methodology advances to block  110  and the material is cured for a predetermined period of time and at a predetermined temperature and pressure. 
         [0036]    The methodology advances to block  115  and the molded cervical cap is removed from the mold. 
         [0037]    The methodology may includes other steps that are conventionally known in the art of molding, such as cooling, coating or the like. 
         [0038]    Referring to  FIG. 15 , a method a using the cervical cap as a contraceptive device is illustrated. The method begins at  200  with the step of optionally placing a predetermined material in the cup portion of the cap. At step  205 , the cervical cap is folded in half lengthwise and inserted, open-end first, into the vagina, and guided up the vaginal canal. At step  210 , the cervical cap is placed over the cervix at the far inner end of the vagina so that the cup portion completely covers the cervix, and the thin, stepped rim flange encircles the cervix and is nestled up against the cul de sac of the vagina, at the fornix. The thin, pliable material of the cup effectively lies against, or “marries” up against the surface of the cervix via surface adhesion to retain the device against the cervix. The rim forms a seal against the fornix and/or the vaginal wall at the cul de sac of the back of the vagina, by way of adjusting to the depth of the space, between the cervix and the vaginal wall, terminating as the fornix. The rim automatically adjusts as necessary to the varied depth at the fornix, to flexibly reach to, and seal against it. The seal that is formed at the fornix provides an added barrier to sperm, blocking possible travel of the sperm into the inner side of the device, and ultimately to the cervix and uterus. Further, the seal “locks” the device in place until that seal is interrupted by exerting an opposite force on the removal loop. The device could stay in place for an extended period of time, as needed, possibly up to several days. Once removed, the cervical cap may be cleaned and reused. It should be appreciated that the cup portion of the cap may be filled with a material have a specific purpose prior to insertion. For example, a spermicidal may be placed inside the cup portion of the cervical cap. The methodology advances to step  215  and a force is applied to the handle in order to remove the cervical cap  10 . 
         [0039]    The present disclosure has been described in an illustrative manner. It is to be understood that the terminology which has been used is intended to be in the nature of words of description rather than of limitation. Many modifications and variations of the present example are possible in light of the above teachings. Therefore, within the scope of the appended claims, the present disclosure may be practices other than as specifically described.