Intravaginal Support Devices and Methods

Abstract

To provide a vaginal insert device that facilitates insertion and removal, and ameliorates and prevents prescribed symptoms when being inserted.SOLUTION: A vaginal insert device for ameliorating, managing, treating, preventing, and / or eliminating symptoms associated with pelvic organ prolapse, urinary incontinence, fecal incontinence, or combinations thereof includes: a cone-shaped body configured to apply pressure onto an organ wall; and a stem configured to adjust the pressure applied to the organ wall.SELECTED DRAWING: Figure 35A

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority from U.S. Provisional Patent Application No. 62 / 644,340, filed March 16, 2018, U.S. Provisional Patent Application No. 62 / 687,119, filed June 19, 2018, and U.S. Provisional Patent Application No. 62 / 735,605, filed September 24, 2018, the entire contents of which are hereby incorporated by reference.

[0002] The present disclosure relates generally to a vaginal insertion device for use in ameliorating and preventing symptoms associated with pelvic organ prolapse, and to a vaginal insertion device for use in ameliorating and preventing symptoms associated with urinary and / or fecal incontinence when the device is inserted. [Background technology]

[0003] Stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are growing problems worldwide that not only impose huge costs on the healthcare system, but also severely impair the quality of life of tens of millions of women in the United States alone. Although surgical procedures can be successful in reversing symptoms associated with SUI and POP, surgery is not without risks and complications, and sometimes even leaves patients in a worse position than before treatment. See Huang W, Wang T, Zong H, Zhang Y, "Efficacy and Safety of Tension-Free Vaginal Tape-Secure Mini-Sling Versus Standard Midurethral Slings for Female Stress Urinary Incontinence," A Systematic Review and Meta-Analysis, International Neurourology Journal, 2015, Vol. 19, No. 4, pp. 246-258, which is incorporated herein by reference. See also Ellington DR, Erekson EA, Richter HE, Outcomes of Surgery for Stress Urinary Incontinence in the Older Woman, Clin Geriatr Med. 2015, 31(4), 487-505, which is incorporated herein by reference. The FDA has issued several public health notices regarding surgical mesh placed through the vagina (transvaginal placement) to treat POP and SUI. The FDA has identified serious and frequent complications associated with surgical mesh including mesh erosion through the vagina, pain, infection, bleeding, discomfort during intercourse, organ perforation, urinary problems, recurrent prolapse, neuromuscular disorders, vaginal scarring / contraction, and emotional disturbances. Most surgical complications require medical intervention including additional surgical treatment and hospitalization.

[0004] Pessaries, most commonly used to manage female POP and have also been used for SUI, offer a viable non-surgical option to treat SUI and POP. Pessaries have had few complications and side effects. However, these devices are traditionally placed in the vagina for extended periods of time. Similarly, they can be uncomfortable to wear. Furthermore, pessaries are difficult for patients to insert and remove. Insertion and removal of these devices often requires several years of hospital visits. See Jones KA, Harmanli O, Pessary Use in Pelvic Organ Prolapse and Urinary Incontinence, Rev Obstet Gynecol, 2010, Vol. 3, No. 1, pp. 3-9, incorporated herein by reference. Difficulty in self-removal and self-insertion of the pessary, dislodging of the pessary during bowel movements, and lack of comfort and benefits are believed to limit the widespread use of these devices.

[0005] SUI in women is the involuntary leakage of urine due to pressure on the weakened pelvic support system and / or bladder. SUI may be caused by aging, genetics, and / or childbirth. The Urology Care Foundation estimates that one in three women will experience SUI at some point in their lives. There are a few types of urinary incontinence, including stress incontinence, urge incontinence, and mixed incontinence. All of these are primarily due to loose connective tissue or damage to the vagina or supporting ligaments. See Petros PE, Ulmsten UI, Integral Theory and Its Method for the Diagnosis and Management of Female Urinary Incontinence, Smayd J Urol Nephrol Suppl, 1993, vol. 153, pp. 1-93, incorporated by reference. Figure 1 is a cross-sectional view of the pelvic region of a woman with normal anatomy showing the uterus 10, cervix 12, bladder 14, urethra 16, vagina 18, and rectum 20. Figure 2 illustrates incontinence 22 (e.g., leakage of urine or fecal material) caused by abdominal pressure or pressure 24 on the bladder 14 or bowel. Involuntary leakage of urine or fecal material often occurs during activities such as coughing, laughing, sneezing, lifting, or exercising.

[0006] Connective tissue damage to the three zones of the entire system, encompassing all three pelvic organs including the bladder, vagina, and anorectum, is the underlying cause of pelvic organ prolapse (POP) and the malfunction of these organs. Figure 3 is a cross-sectional view of the pelvic region of a woman with a cystocele 26. Figure 4 is a cross-sectional view of the pelvic region of a woman with a rectal prolapse or rectocele 28. Figure 5 is a cross-sectional view of the pelvic region of a woman with a uterine prolapse 30. POP is commonly due to childbirth, but may also be caused simply by genetics and age-related progression. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] U.S. Patent Application Serial No. 15 / 242,105 [Patent Document 2] U.S. Patent No. 10,188,545 [Non-patent literature]

[0008] [Non-Patent Document 1] Huang W, Wang T, Zong H, Zhang Y, "Efficacy and Safety of Tension-Free Vaginal Tape-Secure Mini-Sling Versus Standard Midurethral Slings for Female Stress Urinary Incontinence", A Systematic Review and Meta-Analysis, International Neurourology Journal, 2015, Vol. 19, No. 4, pp. 246-258 [Non-Patent Document 2] Ellington DR, Erekson EA, Richter HE. Outcomes of Surgery for Stress Urinary Incontinence in the Older Woman. Clin Geriatr Med. 2015, Vol. 31, No. 4, pp. 487-505. [Non-Patent Document 3] Jones KA, Harmanli O. Pessary Use in Pelvic Organ Prolapse and Urinary Incontinence. Rev Obstet Gynecol. 2010, Vol. 3, No. 1, pp. 3-9. [Non-Patent Document 4] Petros PE, Ulmsten UI, "Integral Theory and Its Method for the Diagnosis and Management of Female Urinary Incontinence", Smayd J Urol Nephrol Suppl 1993, vol. 153, pp. 1-93 Summary of the Invention [Problem to be solved by the invention]

[0009] Thus, there is a need for a pessary or other vaginal insertion device that manages, improves, treats, prevents, and / or eliminates female incontinence, POP, or both incontinence and POP. Further, there is a need for a pessary or other vaginal insertion device that does not require a prescription, is non-absorbent, commercially available, convenient, comfortable, and easy for a patient to insert and remove with no or minimal physician intervention. Such vaginal insertion devices may be reusable, but can also be disposable. There remains a need for intravaginal support devices and methods. [Means for solving the problem]

[0010] According to embodiments, a vaginal insertion device for ameliorating, managing, treating, preventing, and / or eliminating symptoms associated with pelvic organ prolapse, urinary incontinence, fecal incontinence, or a combination thereof can include an upper portion having a cone-shaped body having a base, an inner wall, and an outer wall, and ribs within the cone-shaped body configured to apply pressure to the organ wall to ameliorate, manage, treat, prevent, and / or eliminate symptoms associated with pelvic organ prolapse, urinary incontinence, fecal incontinence, or a combination thereof.

[0011] According to an embodiment, the vaginal insertion device can include a rim protruding from the outer wall at the top end of the upper portion. According to an embodiment, the rib extends downwardly within the conical body from near the rim to the base, and together the rib and rim apply pressure to the organ wall. According to an embodiment, the vaginal insertion device can include one or more ridges protruding outwardly from the outer wall. According to an embodiment, a stem extends downwardly from the base, the stem having one or more ridges protruding outwardly from an outer surface of the stem. According to an embodiment, the stem is conical, outwardly tapered, triangular, cross-shaped, substantially flat, or a combination thereof. According to an embodiment, the rib is configured to selectively or adjustably apply pressure to the organ wall based on alignment of the rib with the organ wall. According to an embodiment, the rib includes a member extending radially inwardly from the inner wall of the conical body and longitudinally downwardly from a location near the top of the conical body. According to an embodiment, the members include two or more members spaced equidistantly around the circumference of the inner wall of the conical body and meeting at a center point of the conical body. According to an embodiment, the ribs include members extending transversely to the longitudinal axis of the conical body. According to an embodiment, the members extend between diametrically opposed points on the inner wall and connect to the inner wall at diametrically opposed points. According to an embodiment, the members extend longitudinally between a location near the top of the conical body and the base. According to an embodiment, in plan view, the ribs are cross-shaped, "T"-shaped, "X"-shaped, "Y"-shaped, "K"-shaped, "V"-shaped, star-shaped, triangular, or pentagonal. According to an embodiment, the organ wall is one of the following: a urethral sphincter, a bladder neck, a rectal wall, a uterine wall, or a combination thereof. According to an embodiment, the ribs and the conical body are integrally formed of the same material. According to an embodiment, the ribs and the conical body are integrally formed of the same material. According to embodiments, the ribs and the conical body are integrally formed of the same material. According to embodiments, the vaginal insertion device is configured to support an organ wall during exercise. According to embodiments, the vaginal insertion device is configured to hold a fluid and secrete the fluid into the vagina when the vaginal insertion device is inserted therein. According to embodiments, the fluid is a medicine, a hormone, or a drug. According to embodiments, the upper portion has an open top end. According to embodiments, the upper portion has a closed top end.

[0012] According to an embodiment, a vaginal insertion device for improving, managing, treating, preventing, and / or eliminating symptoms associated with pelvic organ prolapse, urinary incontinence, fecal incontinence, or a combination thereof can include a cone-shaped body configured to apply pressure against an organ wall and a stem configured to adjust the pressure applied to the organ wall. According to an embodiment, the vaginal insertion device can include a member configured to extend within an interior of the cone-shaped body to apply pressure to the organ wall. According to an embodiment, the stem is correlated with the member such that rotation of the stem is configured to adjust the pressure applied by the member to the organ wall. According to an embodiment, in a first position, the member is aligned with the organ wall and a first pressure is applied to the organ wall, and in a second position, the member is not aligned with the organ wall and a second pressure is applied to the organ wall, the first pressure being greater than the second pressure. According to an embodiment, the member is a rib extending radially inward from an inner wall of the cone-shaped body and longitudinally downward from a location near a top of the cone-shaped body. According to an embodiment, the rib is cross-shaped in plan view and the stem is substantially flat creating a plane, the cross and plane of the rib being aligned such that the position of the stem correlates with the position of the rib relative to the organ wall. According to an embodiment, in plan view, the member is a cross-shaped rib having four ends, each of the four ends meeting at an inner wall of the cone-shaped body. According to an embodiment, the cone-shaped body is configured to apply an adjustable therapeutic force to the organ wall corresponding to a force configured to improve, manage, treat, prevent, and / or eliminate symptoms associated with pelvic organ prolapse, urinary incontinence, fecal incontinence, or a combination thereof. According to an embodiment, the organ wall is one of a urethral sphincter, a bladder neck, a rectal wall, a uterine wall, or a combination thereof.

[0013] According to embodiments, a vaginal insertion device for improving, managing, treating, preventing, and / or eliminating symptoms associated with pelvic organ prolapse, urinary incontinence, fecal incontinence, or a combination thereof, may include an upper portion having a conical body with a base, an inner wall, and an outer wall, and a stem extending downwardly from the upper portion and having a substantially flat shape. According to embodiments, the stem may include a plurality of ridges extending from an outer surface of the stem. According to embodiments, the plurality of ridges are uniformly spaced from a lower end of the stem. According to embodiments, each of the plurality of ridges has the same thickness. According to embodiments, each of the plurality of ridges extends around a circumference of the stem. According to embodiments, the stem is configured to regulate pressure applied by the vaginal insertion device on the organ wall. According to embodiments, the stem and the upper portion are integrally formed of the same material. According to embodiments, the stem is configured to be gripped by a user to insert, remove, or position the vaginal insertion device into the vagina, or a combination thereof. According to embodiments, the stem is configured to allow positioning, rotation, or both of the vaginal insertion device while the vaginal insertion device is inserted into the vagina. According to embodiments, the vaginal insertion device can include a rib positioned within the conical body and configured to apply pressure to the organ wall, the rib and stem aligned such that rotation of the stem is configured to adjust the pressure applied by the rib on the organ wall.

[0014] According to an embodiment, the vaginal insertion device may include a body having an open top end, a wall and a hollow interior within the wall, and a member within the hollow interior of the body, the member configured to apply pressure through the wall onto the inner vaginal wall, the pressure configured to ameliorate, manage, treat, prevent, and / or eliminate symptoms associated with pelvic organ prolapse, urinary incontinence, fecal incontinence, or a combination thereof. According to an embodiment, the wall has an inner diameter that gradually decreases from the open top end to the base of the body. According to an embodiment, the member is connected to an inner side of the wall and extends from the open top end to the base. According to an embodiment, the member is connected to an inner side of the wall adjacent the open top end. According to an embodiment, the member is connected to an inner side of the wall adjacent the open top end. According to an embodiment, the member is connected to an inner side of the wall adjacent the open top end. According to an embodiment, the member is not connected to the base. According to an embodiment, a second member extends between diametrically opposed sides of the wall, the member and the second member being perpendicular such that a cross shape is formed in plan view. In some embodiments, the member extends between diametrically opposed sides of the wall.In some embodiments, the body is a cone-shaped body having a diameter that decreases from the open top end to the base.

[0015] According to an embodiment, the vaginal insertion device can include a cone-shaped body having a base, an inner wall, and an outer wall, an upper portion having a longitudinal axis, a member within the inner wall of the cone-shaped body with a member plane aligned with the longitudinal axis, and a stem with a stem plane aligned with the longitudinal axis, the member plane and the stem plane being aligned with each other. According to an embodiment, the member plane and the stem plane are arranged parallel or coplanar with each other. According to an embodiment, the member plane and the stem plane are arranged perpendicularly or angled with each other. According to an embodiment, the vaginal insertion device can include a rim protruding from the outer wall at a top end of the upper portion. According to an embodiment, the member extends downwardly within the cone-shaped body from near the rim to the base, and together the member and the rim apply pressure to the organ wall. According to an embodiment, the vaginal insertion device can include one or more ridges protruding outwardly from the outer wall. According to an embodiment, the stem includes one or more ridges protruding outwardly from an outer surface of the stem. According to an embodiment, the stem is two-dimensional or flat. According to an embodiment, the stem is rectangular. According to an embodiment, the member extends radially inward from the inner wall of the conical body and longitudinally downward from a location near the top of the conical body. According to an embodiment, the member includes two or more members spaced equidistantly around the circumference of the inner wall of the conical body and meeting at a center point of the conical body. According to an embodiment, the member includes a member extending transversely to the longitudinal axis of the conical body. According to an embodiment, the member extends between and connects to the inner wall at diametrically opposed points. According to an embodiment, in plan view, the member is a cross, a "T"-shaped, an "X"-shaped, a "Y"-shaped, a "K"-shaped, a "V"-shaped, a star, a triangle, or a pentagon. According to an embodiment, the member is configured to apply pressure to an organ wall, the organ wall being one of a urethral sphincter, a bladder neck, a rectal wall, a uterine wall, or a combination thereof. According to embodiments, the device is configured to ameliorate, manage, treat, prevent, and / or eliminate symptoms associated with pelvic organ prolapse, urinary incontinence, fecal incontinence, or a combination thereof. According to embodiments, the member is configured to apply pressure to an organ wall to ameliorate, manage, treat, prevent, and / or eliminate symptoms associated with pelvic organ prolapse, urinary incontinence, fecal incontinence, or a combination thereof. According to embodiments, the member and the conical body are integrally formed of the same material.According to an embodiment, in plan view, the member is a cruciform rib having four ends, each of the four ends mating with an inner wall of the cone-shaped body. According to an embodiment, the member is a rib. According to an embodiment, the vaginal insertion device can include a rib positioned within the cone-shaped body and configured to apply pressure to the organ wall, the rib and stem being aligned such that rotation of the stem is configured to adjust the pressure applied by the rib on the organ wall.

[0016] According to embodiments, a method of improving, managing, treating, preventing, and / or eliminating symptoms associated with pelvic organ prolapse, urinary incontinence, fecal incontinence, or a combination thereof may include inserting into a vagina a vaginal insertion device having a conical body with ribs extending within an interior portion of the conical body, aligning the vaginal insertion device with an organ wall, and adjusting a pressure applied to the organ wall by rotating the vaginal insertion device. According to embodiments, the method may include applying pressure to the organ wall by aligning the ribs with the organ wall. According to embodiments, adjusting the pressure applied to the organ wall includes reducing the pressure by rotating the ribs out of alignment with the organ wall. According to embodiments, adjusting the pressure applied to the organ wall includes increasing the pressure by rotating the ribs into alignment with the organ wall. According to embodiments, the vaginal insertion device further includes a stem extending downwardly from the conical body, and rotating the vaginal insertion device includes rotating the stem while the vaginal insertion device is inserted into the vagina. According to an embodiment, adjusting the pressure applied to the organ wall is performed before or after the exercise. According to an embodiment, the method can include increasing the pressure applied to the organ wall before the exercise and decreasing the pressure applied to the organ wall after the exercise. According to an embodiment, increasing the pressure applied to the organ wall is performed by rotating the vaginal insertion device such that the ribs are aligned with the organ wall and decreasing the pressure applied to the organ wall is performed by rotating the vaginal insertion device such that the ribs are not aligned with the organ wall. According to an embodiment, inserting the vaginal insertion device includes compressing the vaginal insertion device from an original configuration to a compact configuration having a shape configured to enter the vagina, releasing the vaginal insertion device while inserted into the vagina, and allowing the vaginal insertion device to expand from the compact configuration to the original configuration, the vaginal insertion device applying pressure to the organ wall due to an exterior side of the vaginal insertion device, i.e., the ribs and / or one or more ridges protruding from the exterior side of the vaginal insertion device. According to an embodiment, the method can include a rim configured to apply pressure to the organ wall together with the ribs.According to embodiments, the method may include removing the vaginal insertion device by grasping the stem and pulling the vaginal insertion device out of the vagina. According to embodiments, the method may further include impregnating the vaginal insertion device with a fluid and secreting a fluid into the vagina when the vaginal insertion device is inserted, the fluid being a drug, medication, or hormone. According to embodiments, the method may include collecting a sample of vaginal secretions and performing a diagnosis on the sample. According to embodiments, the diagnosis is performed while the vaginal insertion device is in the vagina. According to embodiments, the sample is collected by a user or clinician after the vaginal insertion device is removed and the diagnosis is performed by the user or clinician. According to embodiments, the vaginal insertion device is a vaginal insertion device according to any one of the embodiments described herein.

[0017] According to an embodiment, a method of using a vaginal insertion device can include providing a vaginal insertion device according to any of the embodiments described herein, inserting the vaginal insertion device into a vagina, and applying pressure to an organ wall with the vaginal insertion device. According to an embodiment, the method can include regulating the pressure applied to the organ wall. According to an embodiment, the vaginal insertion device improves, manages, treats, prevents, and / or eliminates symptoms associated with pelvic organ prolapse, urinary incontinence, fecal incontinence, or combinations thereof during activity, high intensity activity, resting activity, coughing, laughing, sneezing, lifting, and / or exercise. According to an embodiment, the method can include inserting the vaginal insertion device prior to cardiovascular activity. According to an embodiment, the pressure is applied to the organ wall using an exterior side of the vaginal insertion device, a feature protruding from an interior side of the vaginal insertion device, or a feature protruding from an exterior side of the vaginal insertion device. According to an embodiment, the feature is one or more ribs, one or more rims, one or more ridges, or a combination thereof. According to an embodiment, the method may include adjusting the pressure applied to the organ wall by reducing the pressure by rotating one or more ribs out of alignment with the organ wall and increasing the pressure by rotating one or more ribs into alignment with the organ wall. According to an embodiment, adjusting the pressure applied to the organ wall is performed before or after the exercise. According to an embodiment, inserting the vaginal insertion device includes compressing the vaginal insertion device from an original configuration to a compact configuration having a shape configured to enter the vagina, releasing the vaginal insertion device while inserted into the vagina, and expanding the vaginal insertion device from the compact configuration to the original configuration, where the vaginal insertion device applies pressure to the organ wall due to an exterior side of the vaginal insertion device, i.e., the one or more ribs and / or the one or more ridges protruding from the exterior side of the vaginal insertion device. According to an embodiment, the method may include a rim configured to apply pressure with the one or more ribs. According to an embodiment, the method may include removing the vaginal insertion device by grasping the stem and pulling the vaginal insertion device out of the vagina.According to embodiments, the method may include impregnating a vaginal insertion device with a fluid and secreting the fluid into the vagina when the vaginal insertion device is inserted, the fluid being a drug, medication, or hormone. According to embodiments, the method may include collecting a sample of the vaginal secretions and performing a diagnosis on the sample. According to embodiments, the diagnosis is performed while the vaginal insertion device is in the vagina. According to embodiments, the sample is collected by a user or clinician after the vaginal insertion device is removed and the diagnosis is performed by the user or clinician.

[0018] According to an embodiment, the case for the vaginal insertion device may include a base configured to hold the vaginal insertion device and a cover configured to interact with the base to enclose the vaginal insertion device. According to an embodiment, the base includes a plurality of openings on the bottom surface configured to release water or liquid from above the bottom surface to below the bottom surface. According to an embodiment, the base is configured to act as a drying rack for the vaginal insertion device. According to an embodiment, the base includes a plurality of protrusions extending upward from the bottom surface, the plurality of protrusions configured to hold the vaginal insertion device on the base. According to an embodiment, the base includes one or more grooves configured to interact with one or more protrusions on the cover, the cover having a first position in which the one or more protrusions are engaged with respective ones of the one or more grooves to lock the cover to the base, and a second position in which the one or more protrusions are disengaged from respective ones of the one or more grooves such that the cover is unlocked from the base. According to an embodiment, the case may include one or more latches to hold the vaginal insertion device on the base. According to an embodiment, the vaginal insertion device may be according to any of the embodiments described herein.

[0019] According to embodiments, a kit for improving, managing, treating, preventing, and / or eliminating symptoms associated with pelvic organ prolapse, urinary incontinence, fecal incontinence, or a combination thereof may include a first vaginal insertion device having a first outer diameter and a second vaginal insertion device having a second outer diameter, where the first outer diameter is different from the second outer diameter. According to embodiments, the first vaginal insertion device and the second vaginal insertion device are selected to accommodate the changing pathology of the user's vagina. According to embodiments, the kit may include a third vaginal insertion device having a third outer diameter, where the third outer diameter is different from the first outer diameter and the second outer diameter. According to embodiments, the first vaginal insertion device, the second vaginal insertion device, and / or the third vaginal insertion device may be a vaginal insertion device according to any of the embodiments described herein.

[0020] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive of the scope of the claims set forth in this disclosure.

[0021] A more complete understanding of embodiments of the present invention and its advantages can be obtained by reference to the following description taken in conjunction with the accompanying drawings, in which like reference numerals indicate like features and in which: [Brief description of the drawings]

[0022] [Figure 1] FIG. 1 illustrates a cross-section of a female pelvic region for purposes of discussing the background of the present disclosure. [Diagram 2] FIG. 1 illustrates a cross-section of a female pelvic region for purposes of discussing the background of the present disclosure. [Diagram 3] FIG. 1 illustrates a cross-section of a female pelvic region for purposes of discussing the background of the present disclosure. [Figure 4] FIG. 1 illustrates a cross-section of a female pelvic region for purposes of discussing the background of the present disclosure. [Diagram 5] FIG. 1 illustrates a cross-section of a female pelvic region for purposes of discussing the background of the present disclosure. [Figure 6A] FIG. 1 illustrates a side view of an exemplary vaginal insertion device according to an embodiment of the present disclosure. [Figure 6B] FIG. 13 is a side view of another exemplary vaginal insertion device according to an embodiment of the present disclosure. [Figure 7] FIG. 6B is a perspective view of the vaginal insertion device of FIG. 6A. [Figure 8] FIG. 6B is a cross-sectional view of the vaginal insertion device of FIG. 6A taken along section line AA. [Figure 9] FIG. 6B is a bottom view of the vaginal insertion device of FIG. 6A. [Figure 10] FIG. 6B is a top view of the vaginal insertion device of FIG. 6A. [Figure 11] 1A-1D illustrate cross-sections of a female pelvic region and an embodiment of a vaginal insertion device inserted into the vagina. [Figure 12] 1A-1D illustrate cross-sections of a female pelvic region and an embodiment of a vaginal insertion device inserted into the vagina. [Figure 13] 1A-1D illustrate cross-sections of a female pelvic region and an embodiment of a vaginal insertion device inserted into the vagina. [Figure 14A] 1A-1D illustrate a method of inserting an embodiment of a vaginal insertion device into a patient's vagina. [Figure 14B] 1A-1D illustrate a method of inserting an embodiment of a vaginal insertion device into a patient's vagina. [Figure 15A] FIG. 1 is a side view of a pessary applicator. [Figure 15B] 15B illustrates a cross-section of the pessary applicator of FIG. 15A and how the applicator can be used to insert an embodiment of a vaginal insertion device into a patient's vagina. [Figure 15C] 15B illustrates a cross-section of the pessary applicator of FIG. 15A and how the applicator can be used to insert an embodiment of a vaginal insertion device into a patient's vagina. [Figure 16] FIG. 1 is a perspective view of a vaginal insertion device according to an embodiment of the present disclosure. [Figure 17] FIG. 17 is a side view of the vaginal insertion device of FIG. 16. [Figure 18] 18 shows a cross-section of the vaginal insertion device of FIG. 16 taken along section line 18-18 of FIG. 17. [Figure 19]FIG. 17 is a top view of the vaginal insertion device of FIG. 16. [Figure 20] FIG. 17 is a bottom view of the vaginal insertion device of FIG. 16. [Figure 21A] FIG. 2 is a perspective view of an exemplary stem according to an embodiment of the present disclosure. [Figure 21B] FIG. 2 is a perspective view of an exemplary stem according to an embodiment of the present disclosure. [Figure 21C] FIG. 2 is a perspective view of an exemplary stem according to an embodiment of the present disclosure. [Figure 21D] FIG. 2 is a perspective view of an exemplary stem according to an embodiment of the present disclosure. [Figure 21E] FIG. 2 is a perspective view of an exemplary stem according to an embodiment of the present disclosure. [Figure 21F] FIG. 2 is a perspective view of an exemplary stem according to an embodiment of the present disclosure. [Figure 22A] FIG. 2 is a perspective view of a carrying case for a vaginal insertion device and brush according to an embodiment of the present disclosure. [Figure 22B] FIG. 2 is a perspective view of a carrying case for a vaginal insertion device and brush according to an embodiment of the present disclosure. [Figure 22C] FIG. 2 is a perspective view of a carrying case for a vaginal insertion device and brush according to an embodiment of the present disclosure. [Figure 22D] FIG. 2 is a perspective view of a carrying case for a vaginal insertion device and brush according to an embodiment of the present disclosure. [Figure 22E] FIG. 2 is a perspective view of a carrying case for a vaginal insertion device and brush according to an embodiment of the present disclosure. [Figure 22F] FIG. 2 is a perspective view of a carrying case for a vaginal insertion device and brush according to an embodiment of the present disclosure. [Figure 22G] FIG. 2 is a perspective view of a carrying case for a vaginal insertion device and brush according to an embodiment of the present disclosure. [Fig. 22H] FIG. 2 is a perspective view of a carrying case for a vaginal insertion device and brush according to an embodiment of the present disclosure. [Figure 22I]FIG. 2 is a perspective view of a carrying case for a vaginal insertion device and brush according to an embodiment of the present disclosure. [Figure 22J] FIG. 2 is a perspective view of a carrying case for a vaginal insertion device and brush according to an embodiment of the present disclosure. [Figure 22K] FIG. 2 is a perspective view of a carrying case for a vaginal insertion device and brush according to an embodiment of the present disclosure. [Figure 23] FIG. 1 is a perspective view of a kit including a vaginal insertion device and a drying rack according to an embodiment of the present disclosure. [Figure 24] FIG. 13 illustrates a graph of the force applied on the urethral wall by a vaginal insertion device according to an embodiment of the present disclosure. [Figure 25A] 13A-13D illustrate forces applied to ribs of a vaginal insertion device according to an embodiment of the present disclosure. [Figure 25B] 13A-13D illustrate forces applied to spaces offset from ribs of a vaginal insertion device according to embodiments of the present disclosure. [Figure 26] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 27A] FIG. 1 is a perspective view of a vaginal insertion device according to an embodiment of the present disclosure. [Figure 27B] FIG. 27B is a top view of the vaginal insertion device of FIG. 27A in accordance with an embodiment of the present disclosure. [Figure 27C] FIG. 27B is a side view of the vaginal insertion device of FIG. 27A in accordance with an embodiment of the present disclosure. [Figure 27D] FIG. 27C is a side view of the vaginal insertion device of FIG. 27A rotated 90 degrees from the side view of FIG. 27C in accordance with an embodiment of the present disclosure. [Figure 27E] FIG. 27E illustrates a cross-section of the vaginal insertion device of FIG. 27A taken along section line 27E-27E of FIG. 27B in accordance with an embodiment of the present disclosure. [Figure 27F] FIG. 27D is a detailed view of the vaginal insertion device of FIG. 27A in cross-section of FIG. 27F in accordance with an embodiment of the present disclosure. [Figure 27G] FIG. 27B is a plan view of the stem of the vaginal insertion device of FIG. 27A in accordance with an embodiment of the present disclosure. [Fig. 27H] FIG. 27B is a bottom view of the vaginal insertion device of FIG. 27A in accordance with an embodiment of the present disclosure. [Figure 28A] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 28B] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 28C] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 28D] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 28E] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 28F] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 28G] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Fig. 28H] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 29A] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 29B] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 29C] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 29D] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 29E] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 29F] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 29G] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 29H] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 30A] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 30B] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 30C] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 30D] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 30E] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 30F] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 30G] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 30H] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 31A] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 31B] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 31C] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 31D] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 31E] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Fig. 31F] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 31G] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Fig. 31H] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 32A] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 32B] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 32C] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Fig. 32D] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 32E] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Fig. 32F] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Fig. 32G] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Fig. 32H] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 33A] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 33B] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 33C] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 33D] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 33E] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 33F] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 33G] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Fig. 33H] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 33I] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 33J] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 33K] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 33L] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 34A] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 34B]1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 34C] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Fig. 34D] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 35A] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 35B] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 35C] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 35D] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 36A] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 36B] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 36C] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 36D] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 37A] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 37B] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 37C] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 37D] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 38A] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 38B] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 38C] 1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 38D]1 illustrates a vaginal insertion device according to an embodiment of the present disclosure. [Figure 39] FIG. 1 illustrates a cross-section of a female pelvic region with an embodiment of a vaginal insertion device inserted into the vagina. [Diagram 40] FIG. 1 illustrates a cross-section of a female pelvic region with an embodiment of a vaginal insertion device inserted into the vagina. [Diagram 41] FIG. 1 illustrates a cross-section of a female pelvic region with an embodiment of a vaginal insertion device inserted into the vagina. [Diagram 42] 1A-1C are perspective views of a kit including vaginal insertion devices of various sizes, a carrying case, a drying rack, and a brush according to an embodiment of the present disclosure. [Diagram 43] FIG. 2 is an exploded perspective view of a carrying case according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] Certain embodiments and their advantages are best understood by referring to Figures 6A through 38, in which like numerals are used to indicate like and corresponding parts or sections. A vaginal insertion device such as that described in U.S. Patent Application Serial No. 15 / 242,105, now U.S. Patent No. 10,188,545, the contents of which are hereby incorporated by reference, may also be contemplated. Although the device is described and shown as being inserted into the vagina, for example, to reduce or eliminate urinary incontinence, the device of the present disclosure may also be used to treat fecal incontinence and / or involuntary leakage of fecal material, as described in more detail below. Additional uses are also contemplated, such as, for example, menstrual applications, collection of vaginal fluids or secretions, diagnosis, muscle exercise or strengthening, medicinal or hormonal secretions, monitoring of the vagina, other organs, or body parts, and the like, or combinations thereof.

[0024] The vaginal insertion device of the present disclosure can manage, improve, prevent, treat, and / or eliminate female incontinence, including urinary incontinence, fecal incontinence, POP, or POP and urinary and / or fecal incontinence, or a combination thereof. The vaginal insertion device may not require a prescription (although it may be for drug or hormone delivery or as an indicator for diagnostic aids). The vaginal insertion device may be non-implantable (although it may be implantable), non-absorbent, commercially available, convenient, flexible, comfortable, and easy for the patient to insert and remove with no or minimal physician intervention. In some cases, such a vaginal insertion device may be reusable. Alternatively or additionally, the vaginal insertion device may be disposable. The vaginal insertion device may eliminate concerns about toxic shock syndrome (TSS) by not being composed of absorbent elements that may breed bacteria, lead to infection, and / or produce odor.

[0025] In certain cases, the device of the present disclosure is fabricated by a molding process (e.g., liquid injection molding) or the like using a material. The material can be a resilient and non-absorbent material, e.g., a biocompatible elastomer, such as medical grade silicone. The material can be a medical grade material, e.g., medical grade silicone. The material can be 100% medical grade silicone. An example of a silicone material suitable for use with the device of the present invention can be NuSil Technology's MED-4950 product, which has properties as a liquid silicone rubber, Momentive's LIM6030, or Momentive's LIM6040. Alternative materials and formation methods are contemplated. For example, the vaginal insertion device can be formed of cotton, such as 100% cotton, and can be any plastic, thermoplastic, polymer, or elastomer. The material can have enough structure to apply pressure to the vaginal wall, yet be flexible enough to allow folding and compression during insertion and removal. The vaginal insertion device can be, for example, compression molded, extruded, 3D printed, rotationally molded, machined, cast, etc.

[0026] The vaginal insertion device of the present disclosure is shaped to be securely held in place within the vagina upon insertion and can be further shaped to exert pressure against the vaginal wall to achieve therapeutic forces and / or to support the pelvic organs and / or prevent further pelvic organ displacement. In one example, the vaginal insertion device of the present disclosure is directed to managing stress urinary incontinence (e.g., involuntary leakage of urine) during activities such as coughing, laughing, sneezing, lifting, and exercise for patients over the age of 18. The device can be inserted by adult women for approximately 8 to 12 hours at a time, depending on comfort level, before removal and reinsertion. The device can be implantable and can remain in the body for extended periods of time.

[0027] FIG. 6A illustrates a side view of an exemplary vaginal insertion device 40 according to an embodiment of the present disclosure. The vaginal insertion device 40 of FIG. 6A can include an upper portion 42 and a lower stem-like removal portion or stem 44. The upper portion 42 can be conical. That is, the upper portion 42 can have a first diameter that decreases to a second diameter. The decrease in diameter can be gradual. Thus, the conical body of the upper portion 42 can have a varying diameter. Although described herein as conical, other shapes of the upper portion 42 are also contemplated. Such other shapes can include a varying diameter such that the first diameter is configured to apply pressure to the inner vaginal or organ wall and the second diameter is smaller than the first diameter and configured not to interact with the inner vaginal wall. Such shapes can include a trapezoid, a sphere, a cylinder, a cube, a pyramid, a hexagonal prism, and the like.

[0028] As further illustrated and described in more detail below, the upper portion 42 can include a rim 46 projecting from the upper portion and a number of ridges 48 that can be spaced from the top of the upper portion 42 to the bottom or base of the upper portion 42. In some embodiments, the rim 46 can be omitted or absent. The ridges 48 can be spaced randomly or uniformly. The removal portion can also have ridges 48, which can be spaced from the top of the stem 44 to the bottom of the stem 44, similar to the upper portion. The ridges 48 can be semi-permeable to allow liquids, gases, lubricants, and / or medications to pass through. The ridges 48 on the stem 44 can be randomly or uniformly arranged.

[0029] 6B shows a side view of another exemplary vaginal insertion device 40 according to an embodiment of the present disclosure. In this embodiment, the device 40 is similar to the device of FIG. 6A, except that the stem 44 can be a string, cord, or ribbon (collectively referred to as a string) such as those used on tampons. The string can aid in the insertion and / or removal of the vaginal insertion device 40 from the vagina.

[0030] FIG. 7 shows a perspective view of the vaginal insertion device 40 of FIG. 6A. As shown in FIG. 7, the upper portion 42 has a conical body. The upper portion 42 can have a circular cross-section throughout its length (e.g., as shown in FIGS. 9 and 10). The circular cross-section can reduce in diameter from a top end, such as an open top end 54, to a base or bottom end 56. The reduction in diameter can be a reduction in the inner diameter of the upper portion 42, a reduction in the outer diameter of the upper portion 42, or a combination thereof. The circumference of the upper portion 42 can decrease from the open top end 54 to the bottom end 56. The upper portion 42 can have an inner wall or interior side 50 and an outer wall or exterior side 52. The upper portion 42 can include an open top end 54, a bottom end 56, and a hollow interior 58. The open top end 54 can expose the hollow interior 58 to atmospheric pressure (when not inserted) and to the vagina (when inserted).

[0031] Continuing with reference to FIG. 7, the rim 46 can be circular and can protrude from the exterior side 52 of the wall 49. The rim 46 can be adjacent to an open top end 54. The ridge 48 can be a circular ring that surrounds the exterior side 52 of the wall 49. The stem 44 can extend from a bottom end 56 of the upper portion 42. The upper portion 42 and the stem 44 can be fabricated as an integral one-piece device formed of a single material. For example, the upper portion 42 and the stem 44 can be formed of medical grade silicone. The upper portion 42 and the stem 44 can be injection molded as a single integral device composed of medical grade silicone. Alternatively, the upper portion 42 and the stem 44 can be made of more than one part and / or more than one material that can be connected and / or separated or expanded and contracted for medical, therapeutic, or sterilization purposes. The upper portion 42 and the stem 44 can be permanently or releasably attached to one another. The stem 44 may have a conical body. The conical shape may be one that increases in diameter from the lower end 56 to the distal end of the stem 44. That is, the conical body of the stem 44 may expand radially outward from the lower end 56 to the open lower end 64 (FIG. 8) of the stem 44. The conical body of the upper portion 42 may expand radially outward from the lower end 56 to the open upper end 54. Thus, the stem 44 and the upper portion 42 may expand radially outward in opposite axial directions. The circumference and / or diameter of the stem 44 and the circumference and / or diameter of the upper portion 42 may gradually increase in opposite directions.

[0032] FIG. 8 is a cross-sectional view of the vaginal insertion device 40 of FIG. 6A through section line AA. As shown in FIG. 8, the stem 44 can have a circular cross-section throughout its length. The stem 44 can have a wall 60, an upper end 62, an open lower end 64, and a hollow interior 66. The circumference and / or diameter of the stem 44 can increase from the upper end 62 to the open lower end 64. As shown, a ridge 48 can protrude from the exterior side 52 of the wall 60. Although described as a hollow stem 44, the stem 44 can be solid. The stem 44 can be any of the stems 244a-g described herein.

[0033] 8 further illustrates an embodiment of the vaginal insertion device 40 that includes a vent opening 68 in the area joining the upper portion 42 and the stem 44. The vent opening 68 can include a vent hole, a slit, a gap, or an opening. The vent opening 68 can include a screen or mesh, or any other component having an opening. Although shown as a single vent opening 68, the vent opening can be more than one opening positioned in the area joining the upper portion 42 to the stem 44. The vaginal insertion device 40 can include multiple vent openings 68. The vaginal insertion device 40 can include multiple vent openings 68 in multiple locations other than or in addition to the vent opening 68. For example, the vaginal insertion device 40 can include one or more vent openings 68 in the wall 49 of the upper portion 42, in the wall 49 of the rim 46, in the first section 70 and / or second section 72 of the rim 46, adjacent to the rim 46, adjacent to the lower end 56, in the wall 60 of the stem 44, adjacent to the upper end 62 of the stem 44, or combinations thereof. The one or more vent openings 68 can be equidistant or evenly spaced around the circumference of the device 40. The one or more vent openings 68 can make the vaginal insertion device 40 more comfortable for the patient during insertion. The one or more openings 68 can equalize air pressure between the inside and outside of the vagina 18 when the vaginal insertion device 40 is inserted ( FIG. 11 ). The one or more vent openings 68 can assist in indicating the location of the device. However, having one or more vent openings 68 is not required for the vaginal insertion device 40 to be comfortable, useful, and effective, and therefore may be omitted. The one or more vent openings 68 may prevent or limit sealing or suction that occurs between the vaginal insertion device 40 and the inner vaginal wall or organ walls.

[0034] With reference to FIG. 8 , the rim 46 can have a first section 70 and a second section 72. The first section 70 and / or the second section 72 can protrude from the exterior side 52 of the wall 49, with the first section 70 protruding a greater distance than the second section 72. Alternatives to the rim 46 are also contemplated. For example, when the rim 46 is present, it may include only the first section 70 or only the second section 72. In one example, the rim 46 may include only one section, but the one section may have a different height and / or width (e.g., a greater or lesser height and / or width) than the first section 70. The rim 46 can protrude from the exterior side 52 of the wall a distance equal to the distance from the top of the rim 46 to the bottom of the rim 46. In one example, the rim 46 can surround the exterior side 52 of the wall 49 adjacent the open top end 54 and can include a separate section that protrudes and a section that does not protrude from the exterior side 52 of the wall 49. The rim 46 can be thicker on one side than the other. The rim can be adjustable in height, location, and / or width. The rim 46 can also contract and expand for retraction to achieve a therapeutic force. The rim 46 can be made of one piece or more than one piece. The rim 46 can be made of one material, more than one material, or a combination of materials. The rim 46 can be configured to apply a higher pressure in one area than another area of ​​the rim 46. For example, the rim 46 can be weighted by density, thickness, material, attachments, protrusions, etc. in one portion (e.g., half of the cross section of the device). This portion can be configured to apply a higher pressure than the remainder of the rim 46. The remainder of the rim 46 can be constructed similarly (e.g., of the same material, density, thickness, etc.) as the remainder of the device 40. As described in more detail below, the rim 46 can be sloped, biased, or angled to apply pressure to different sites within the vaginal canal based on anatomy, incontinence, and / or type of prolapse, for example, as shown in FIG.

[0035] 7 and 8, the ridges 48 can be circular protrusions as shown. However, other configurations are contemplated. Thus, the ridges 48 can include the embodiment shown in FIG. 7 and 8, where the ridges 48 are protrusions that can be circular rings surrounding the exterior side 52 of the wall 49. Alternatively, the ridges 48 can include any protrusion extending from the exterior side 52 of the wall 49, such as studs, knobs, buttons, words, numbers, symbols, logos, or other shapes including polygonal studs, triangular studs, separated studs, irregularly separated studs, uniformly spaced studs, or squares, or combinations thereof. The ridges 48 can be arranged helically, diagonally, longitudinally, or radially on the device 40 (either on the upper portion 42 and / or the stem 44). The ridges 48 can be the same or different on the upper portion 42 and on the stem 44. The ridges 48 can be semi-permeable to allow liquids, medications, or lubricants to pass through.

[0036] The vaginal insertion device 40 can come in different sizes, densities, shapes, durability, and / or different durometers to accommodate adult women with different anatomies, women with changing or fluctuating anatomies, and to accommodate different uses of the device or different activities performed while using the device. Additionally, the dimensions of the various sections and portions of the device 40 can be modified from the multiple embodiments illustrated and disclosed herein. For example, with reference to FIG. 8, the overall height 74 of the device 40, the diameter 76 at the open top end 54 of the upper portion 42, the thickness of the wall 49 of the upper portion 42 of the device 40, the diameter 82 at the open bottom end 64, and the height 80 of the stem 44 can be modified. The dimensions can be any of those described with respect to FIGS. 16-20 and 27-38. Modifications made to the dimensions can maintain or improve the intended utility, effectiveness, and other benefits of the device. These dimensions can be modified in any combination or individually. Examples of modified dimensions are set forth in Table 1, FIGS. 16-20, and 27-38, and in the associated disclosure.

[0037] The following non-limiting list of dimensions with reference to Figure 8 are non-limiting examples of embodiments of device 40 that are believed to be suitable for most women and that provide the intended utility, effectiveness, and other benefits of the device. For example, a suitable overall height 74 of device 40 can be in the range of about 45 millimeters (mm) to about 75 millimeters (mm), such as about 55 mm to about 70 mm, such as about 58 mm to about 67 mm, for example, 46 mm, 48 mm, 50 mm, 52 mm, 54 mm, 56 mm, 58 mm, 60 mm, 62 mm, 63 mm, 64 mm, 66 mm, 68 mm, 70 mm, 72 mm, or 74 mm ± 1 mm, including 58 mm ± 1 mm. In some embodiments, suitable outer diameters 76 may be in the range of about 24 mm to about 56 mm, such as about 30 mm to about 48 mm, such as about 32 mm to about 46 mm, such as about 38 mm to about 44 mm, for example, 24 mm, 26 mm, 28 mm, 30 mm, 32 mm, 34 mm, 36 mm, 38 mm, 40 mm, 42 mm, 44 mm, 46 mm, 48 mm, 50 mm, 52 mm, 54 mm, or 56 mm ± 1 mm, including 34 mm, 38 mm, or 43 mm ± 1 mm. Suitable heights 80 of stems 44 may be in the range of about 4 mm to about 20 mm, such as about 5 mm to about 10 mm or about 13 mm to about 15 mm, including 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 ± 1 mm. A suitable thickness of the walls 49 in the section of the upper portion 42 below the rim 46 that does not have the ridge 48 may be about 2.0 mm, e.g., 1.5 mm, 2 mm, or 2.5±0.25 mm. A suitable thickness of the walls 49 in the section that does have the ridge 48 may be about 2.5 mm, e.g., 2 mm, 2.5 mm, or 3±0.25 mm. The walls 60 of the stem 44 may have a suitable thickness of about 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, 2 mm, 2.25 mm, or 2.5 mm, e.g., 2 mm±0.25 mm, in the section that does not have the ridge 48.A suitable height of the rim 46 may be about 12 mm, 14 mm, 15 mm, 16 mm, or 18 mm, for example, 14 mm or 15 mm ± 0.5 mm, a suitable height of the first section 70 may be about 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, or 8 mm, for example, 4 mm or 5 mm ± 0.5 mm, and a suitable height of the second section 72 may be about 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, or 13 mm, for example, about 9 mm or 10 mm ± 0.5 mm. A suitable thickness of the first section 70 may be about 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, or 9 mm, for example, about 4 mm ± 0.25 mm. Additionally, the second section 72 may be about 3 mm, 4 mm, or 5 mm, for example, about 3 mm, 4 mm, or 5 mm ± 0.25 mm. A suitable outer diameter 82 of the open bottom end 64 may be approximately 9 mm, 10 mm, 10.5 mm, 11 mm, or 12 mm. A suitable diameter of the vent opening 68 may be approximately 1.5 mm, 2 mm, or 2.5 mm.

[0038] FIG 9 is a bottom view of the vaginal insertion device 40 of FIG 6A for an embodiment having a vent opening 68. As shown, the exterior of the device 40, as well as the interior and exterior of the stem 44, can have a circular shape in plan view. However, other shapes are also contemplated. FIG 10 is a top view of the vaginal insertion device 40 of FIG 6A for an embodiment having a vent opening 68. As shown, the interior and exterior of the device 40 can have a circular shape in plan view. However, other shapes are also contemplated.

[0039] FIG. 11 is a cross-sectional view of a female pelvic region showing an embodiment of a vaginal insertion device 40 inserted into the vagina 18 to apply pressure against the urethral sphincter 16 and / or bladder neck 15 (FIG. 33) to manage, improve, prevent, treat, and / or eliminate urinary incontinence in a woman. A user can insert the device 40 according to FIG. 14. Once inserted, the rim can be aligned with the inner vaginal wall to apply pressure to the inner vaginal wall, such as the urethral sphincter and / or bladder neck. The ridge can also apply pressure to the inner vaginal wall. The pressure applied to the urethral sphincter 16 and / or bladder neck 15 can reduce or eliminate urinary leakage. Each of FIG. 12 and FIG. 13 is a cross-sectional view of a female pelvic region showing an embodiment of a vaginal insertion device 40 inserted into the vagina 18 to manage, improve, prevent, treat, and / or eliminate POP in addition to applying pressure against the urethral sphincter 16 to manage, improve, or eliminate urinary incontinence in a woman. In particular, in FIG. 12, the vaginal insertion device 40 is inserted into the vagina 18 to manage, ameliorate, prevent, treat, and / or eliminate cystocele 26. In FIG. 12, the open top 54 can support the bladder 26. The rim and ridge can also apply pressure to the vaginal interior walls, such as the urethral sphincter 16 and / or the bladder neck 15. Pressure applied to the urethral sphincter 16 and / or the bladder neck 15 can reduce or eliminate urine leakage. In particular, in FIG. 13, the vaginal insertion device 40 is inserted into the vagina 18 to manage, ameliorate, prevent, treat, and / or eliminate uterine prolapse 30. In FIG. 13, the open top can support the uterus 30. Although described separately, the device 40 can apply pressure to the vaginal interior walls (e.g., FIGS. 11 and 12) and support the bladder and / or uterus simultaneously or as the body changes over time (e.g., as the bladder fills) (FIGS. 12 and 13).

[0040] As shown in FIGS. 11-13, the open top end 54 of the upper portion 42 is the innermost portion of the vaginal insertion device 40 when inserted into the vagina. As further shown in FIGS. 11-13, the removal portion or stem 44 of the vaginal insertion device 40 is accessible from the exterior of the vagina 18 when the vaginal insertion device is inserted. The stem 44 can aid in the insertion, removal, and / or positioning of the vaginal insertion device 40 within the vagina. The ridges 48 on the stem 44 can allow the patient to have a more secure grip for removal of the device 40. The stem 44 can be used to position the device to achieve therapeutic force, organ support, and comfort. The rims 46 and / or ridges 48 on the upper portion 42 can apply pressure to the organ walls shown in FIGS. 11-13 to manage, ameliorate, prevent, treat, and / or eliminate urinary and fecal incontinence, POP, or POP and urinary and / or fecal incontinence, and combinations thereof.

[0041] 14A and 14B illustrate a method of inserting the vaginal insertion device 40 into the vagina 18. As shown in FIG. 14A, the patient can crush the walls 49 of the upper portion 42 to make the upper portion more compact. The more compact shape can allow for easier insertion of the vaginal insertion device 40 into the vagina 18. The user can manually crush the upper portion 42 between two or more fingers or otherwise in the hand. Alternatively, the user can use a tool such as an applicator 84 to help crush the device 40 for insertion. As shown in FIG. 14B, the user can then insert the device 40 in its more compact shape into the vagina 18. The user can insert the device 40 manually (e.g., with one or both hands) or with a tool (e.g., applicator 84). With the vaginal insertion device 40 manually inserted into the vagina 18, the wall 49 of the upper portion 42 can expand back to its original or near original shape, thereby allowing the vaginal insertion device 40 to apply pressure to the inner walls of the vagina and internal organs. This method of insertion is one example with higher durometer silicone or other materials, although the device does not necessarily have to collapse for insertion.

[0042] FIG. 15A shows a side view of a pessary applicator 84 that can be used to aid in the insertion, positioning, or removal of the vaginal insertion device 40 into a patient's vagina 18 (FIG. 14B). The pessary applicator 84 can include an insertion member 86, an upper end portion 90 of the insertion member, and a plunger 88. The pessary applicator 84 can be similar to a tampon applicator. In embodiments, the insertion member 86 can have a circumference that is generally larger or smaller than a tampon applicator to include the vaginal insertion device 40 or stem 44, which can be larger than the circumference of a tampon when the entire device is compacted, and generally smaller than a tampon when only the stem is compacted into the device. FIGS. 15B and 15C show a cross-section of the pessary applicator 84 of FIG. 15A and a method of using the applicator to insert the vaginal insertion device 40 into a patient's vagina 18. As shown, the vaginal insertion device 40 is housed in a compact shape inside the insertion member 86. The insertion member 86 of the pessary applicator 84 is inserted into the patient's vagina 18 similar to the process of inserting a tampon into the vagina using an applicator, and the plunger 88 is pushed toward the insertion member to expel the vaginal insertion device 40 through the top end portion 90. The pessary applicator 84 is then removed from the vagina 18, and the vaginal insertion device 40 remains in place in the vagina, expanding back to its normal shape. The inserted vaginal insertion device 40 is positioned as shown in any of Figures 11-13. The vaginal insertion applicator 84 can assist in properly positioning the device within the vagina. The pessary applicator 84 can cooperate with the device 40 to click into place and allow the device to expand or contract to achieve therapeutic force, position, and organ support, and placement orientation to manage, ameliorate, prevent, or eliminate symptoms associated with incontinence and / or pelvic organ prolapse.The applicator 84 can be loaded with drugs and / or hormones and can be used to deliver drugs, hormones, or medications into the cone-shaped body of the device 40 for holistic, homeopathic treatment, or by prescription for treating hormone levels (e.g., hormone replacement therapy), yeast infections, sexually transmitted diseases, or for anti-fungal or anti-bacterial purposes. The applicator 84 can be constructed of one material or combination of materials. The applicator 84 can be one piece or made of multiple parts or pieces.

[0043] 16-20, an exemplary vaginal insertion device 100 is shown. The vaginal insertion device 100 can be similar to device 40. The vaginal insertion device 100 can include any of the modifications, shapes, sizes, materials, dimensions, uses, or any combination thereof, as described above with respect to the vaginal insertion device 40. The modifications or alternatives, such as the shape of the rim, stem, and upper portion, described above, can be applied to the vaginal insertion device 100 separately or in combination. The insertion methods described above in FIG. 14 and FIG. 15 can be applied to the vaginal insertion device 100.

[0044] FIG. 16 shows a side view of an exemplary vaginal insertion device 100. The vaginal insertion device 100 can include an upper portion 142 and a lower stem-like removal portion or stem 144. The upper portion 142 can be conical. That is, the upper portion 142 can have a first diameter that decreases to a second diameter. The decrease in diameter can be gradual. Thus, the conical body of the upper portion 142 can have a varying diameter. Although described herein as conical, other shapes of the upper portion 142 are also contemplated. Such other shapes can include varying diameters such that the first diameter is configured to apply pressure to the inner vaginal or organ wall and the second diameter is smaller than the first diameter and configured not to interact with the inner vaginal wall. Such shapes can include trapezoids, spheres, cylinders, cubes, pyramids, hexagonal prisms, and the like.

[0045] The upper portion 142 may include an expanding portion 142a (e.g., at the top of the upper portion 142), a narrower or constricting portion 142b (e.g., at the bottom end of the upper portion 142), and a rim 146 (e.g., at the top of the upper portion 142) that protrudes from the upper portion 142. The rim 146 may be the same as the rim 46. The rim 146 may be similar to the first section 70 and the expanding portion 142a may be similar to the second section 72. In an embodiment, the rim 146 may be omitted or absent. In an embodiment, the rim 146 is part of the expanding portion 142a. Although a conical body is shown for the narrower or constricting portion 142b, this portion may be a circular portion, a cylindrical portion, a triangular, an umbrella-shaped, or a pyramidal portion, or other shape described herein. The upper portion 142 may have a circular cross-section that may decrease in diameter from an open top end 154 to a base or bottom end 156. The reduction in diameter may be a reduction in the inner diameter of the upper portion 142, a reduction in the outer diameter of the upper portion 142, or a combination thereof. The circumference of the upper portion 142 may decrease from the open top end 154 to the bottom end 156. The open top end 154 may expose an open portion 158 to atmospheric pressure (when not inserted) and within the vagina (when inserted).

[0046] As further illustrated and described in more detail below, the upper portion 142 can include ridges 148 that can be spaced from the top of the upper portion 142 to the bottom of the upper portion 142. The ridges 148 can be spaced along the entire length of the upper portion 142 or a portion thereof. Alternatively, the ridges 148 can be indentations. The ridges 148 can be spaced irregularly or uniformly. The stem 144 can also have indentations or ridges 148 that can be spaced from the top of the stem 144 to the bottom of the stem 144, similar to the upper portion. The ridges 148 can be spaced along the entire length of the stem 144 or a portion thereof. The ridges 148 can include a logo. The ridges 148 can be a mixture of shapes, for example, circles and logos as shown. The ridges 148 can support the device in the vagina, apply pressure to the organ wall, or a combination thereof. Although shown as extending transversely or perpendicularly across the height H of the device 100 (or relative to the longitudinal axis of the device 100), the ridges 148 on either or both of the upper portion 142 and the stem 144 can be parallel, diagonal, spiral, or transverse, or combinations thereof. Although the ridges 148 are shown as being generally straight, they can be wavy, zigzag, or follow another non-linear path. The non-linear path can extend generally transversely, parallel, or diagonally relative to the longitudinal axis of the device. The ridges 148 can include any protrusions extending from the exterior side 152 of the wall 149, such as studs, knobs, buttons, words, numbers, symbols, logos, or other shapes including polygonal studs, triangular studs, separated studs, irregularly separated studs, uniformly spaced studs, or squares, or combinations thereof. The ridges 148 may be positioned helically, diagonally, longitudinally, or radially on the device 100 (either on the upper portion 142 and / or the stem 144). The ridges 148 can be the same or different on the upper portion 142 and on the stem 144. The ridges 148 may be semi-permeable to allow liquids, medications, or lubricants to pass therethrough.

[0047] Continuing with reference to FIG. 16, the vaginal insertion device 100 can include a member 180. The member 180 can be configured to apply pressure on an inner vaginal wall or an organ wall through the wall 149 of the vaginal insertion device 100. The member 180 can be positioned within the interior of the upper portion 142. The member 180 can take any shape configured to apply pressure on an inner vaginal wall and / or support an organ. In an embodiment, the member 180 extends from near the top end to the bottom end 156 of the device 100. In an embodiment, the member 180 can be positioned only near the top end, e.g., only within the upper ¼, ⅓, and / or ½ of the device 100, and / or adjacent the rim 146. In an embodiment, the member 180 extends between two or more points on the interior side 150 of the wall 149. In an embodiment, the member 180 extends from only one point on the interior side 150 of the wall 149. Any of the above or following descriptions, adjustments, and / or modifications relating to member 180 may be presented alone or in combination with device 100 for applying pressure to the vaginal wall and / or supporting an organ in accordance with the principles of the present disclosure.

[0048] Member 180 may be a rib 180, and for ease of disclosure will be referred to herein as a rib. However, other structures or configurations for providing a pressure application similar to that of rib 180 are contemplated. Rib 180 may have four rib sections or members 180a, 180b, 180c, 180d. Rib 180 may take a variety of forms, and some exemplary shapes and configurations of rib 180 are described herein. Any combination of exemplary shapes is also contemplated.

[0049] The ribs 180 can be cross-shaped, "T" shaped, or "X" shaped, although other shapes and configurations are contemplated (e.g., triangular, pentagonal, "Y" shaped, "K" shaped, "V" shaped, etc.). The ribs 180 can be star-shaped, meeting at one central location, meeting at multiple locations, or not meeting at all. For example, in FIG. 19, the ribs 180 can have four members that meet at a central location. In FIG. 32B, the ribs 180 can have six members that meet at a central location, however, more or fewer members are also contemplated. The ribs 180 can be one or more parallel ribs or members offset from a central axis, a single rib or member that crosses the central axis, both one or more parallel ribs or members offset from the central axis and a single rib or member that crosses the central axis, and / or multiple chords that run from one interior surface to another without intersecting, or any combination thereof. The ribs 180 can be spokes or members that cross or meet at the center of the spokes or are offset from the center of the spokes. These spokes or members may or may not meet the inner wall of the vaginal insertion device. The ribs 180 can extend between diametrically opposed points on the inner wall of the upper portion 142. The members can connect to the inner wall at diametrically opposed points. The members can include two or more members spaced equidistantly around the circumference of the inner wall of the cone-shaped body. The two or more members can meet at the center point of the cone-shaped body. The members can be cross-shaped ribs with four ends. Each of the four ends can meet at the inner wall of the cone-shaped body. A larger sized device 100 (e.g., the device of FIG. 32) can have more members than a smaller sized device 100 (e.g., the device of FIG. 27).

[0050] The rib 180 may or may not extend to the inner surface of the base or lower end 156. That is, there may be a gap between the lower end of the rib 180 and the inner wall of the upper portion 142 at the lower end 156. In this case, the rib 180 may be positioned in an upper section of the upper portion 142, such as the upper 1 / 4, upper 1 / 3, or upper 1 / 2 of the upper portion 142. The rib 180 may be positioned adjacent to the rim 146. The rib 180 may be horizontally aligned with the rim 146 and may be flush with the rim 146 so that pressure is applied only at the location of the rim 146 (e.g., by both the rim 146 and the ribs adjacent to it). The rib 180 may take any shape or form that supports the vaginal insertion device 100, applies force and / or pressure to an organ wall, and / or prevents or inhibits organ prolapse. The rib 180 may be of any length, thickness, and / or width. The ribs 180 may not extend the entire length to the base or bottom end 156. The ribs 180 may be offset from a central axis of the device 100. The ribs 180 may allow for adjustable or selective pressure around the circumference of the device 100. For example, locations where the ribs 180 approach or meet the upper portion 142 may apply a stronger force to the organ wall than locations away from the ribs 180.

[0051] Although described as a single rib 180, the rib 180 may be comprised of two rib portions or members that intersect in the middle (e.g., a first rib portion or member in sections 180a, 180c intersects with a second rib portion or member in sections 180b, 180d) or four rib portions or members that meet in the middle (e.g., rib sections 180a, 180b, 180c, 180d that meet in the middle). If more than one rib member is provided, the rib members may be equidistantly spaced from one another. Alternatively, the rib members may be irregularly positioned and / or offset with respect to one another such that one portion of the device 100 exerts more pressure and / or provides more support than another side. That is, a side with more rib members may exert more pressure or provide more support than a side with fewer rib members. The rib 180 may be formed as an integral unit or as separate pieces that are joined together. The ribs 180 can be made from one material, two or more materials, or a combination of materials and / or portions. The ribs 180 can be semi-permeable. The ribs 180 can be integrally formed with the upper portion 142 or can otherwise be formed as a separate component fastened within the upper portion 142. The ribs 180 can be removable from the upper portion 142. The entire device 100, including the ribs 180, can be formed as a unitary, unitary, one-piece device formed from a single material.

[0052] Although rib 180 is shown having four rib sections or rib members 180a, 180b, 180c, 180d, more or less rib sections are contemplated, e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more. The number of rib sections or rib members can be selected to regulate the amount of pressure applied to an organ wall, such as a uterine wall or intestinal wall, to reduce, manage, ameliorate, prevent, or eliminate incontinence. Each rib section or rib member 180a, 180b, 180c, 180d can include one or more openings 192. The one or more openings 192 can facilitate fluid flow, equalize pressure from the vaginal insertion device 100, and / or act as indicators for placement of the device 100. The rib sections or rib members (e.g., 180a, 180b, 180c, and 180d) can define one or more open or hollow portions 158 in combination with the interior side 150 of the interior wall or wall 149. As depicted in FIG. 16, the device 100 includes four open portions 158.

[0053] The ribs 180 can provide additional support to the organs when pelvic organ prolapse occurs or to prevent displacement of the organs. The ribs 180 can provide additional pressure against the vaginal walls, urethral sphincter, and / or bladder neck to help reduce, manage, improve, prevent, treat, and / or eliminate incontinence. The ribs 180 can help prevent tissue from descending into the open portion 158 of the device. Over time, tissue and / or organs may descend into the device 100. The inclusion of the ribs 180 can prevent this descent by blocking the ingress of tissue into the device 100. The ribs 180 can prevent subsidence of the bladder, cervix, or rectum. The ribs 180 can apply sufficient pressure through the vaginal canal against the vaginal walls at the location of the bladder neck or urethral sphincter to substantially reduce leakage.

[0054] The rim 146, if included, can be expandable or contractible to vary the therapeutic force or organ support. The rim can be larger or thicker on one side and smaller or thinner on the other side to achieve the therapeutic force. The rim can be semi-permeable to allow medication, lubricant gas or liquid to pass through. The rim 146 can be aligned with the bladder when inserted. The rim 146 can apply pressure (therapeutic force) to organ walls. The rim 146 and ribs 180 together can apply pressure and / or support to organs and / or organ walls in the vagina.

[0055] The rim 146 can be configured to apply a higher pressure in one area of ​​the rim 146 than in another area. For example, the rim 146 can be weighted, either by density, thickness, material, appendages, protrusions, ribs, members, etc., in one portion (e.g., half of the cross-section of the device). This portion can be configured to apply a higher pressure than the remainder of the rim 146. The remainder of the rim 146 can be constructed similarly (e.g., of the same material, density, thickness, etc.) as the remainder of the device 100.

[0056] 16 and 17, the vaginal insertion device 100 can include one or more vent openings 168. The vent openings 168 can be evenly spaced around the circumference of the vaginal insertion device 100. Alternatively, the vent openings can be offset or irregularly spaced around the circumference of the device 100. The vent openings 168 can be located in the widening portion 142a of the upper portion 142. Alternatively or additionally, the vent openings 168 can be located in the narrowing or constricting portion (e.g., conical portion or body) 142b.

[0057] The one or more vent openings 168 can allow fluid flow through the vaginal insertion device 100 so that pressure can be equalized across the vaginal insertion device 100 and / or so that vacuum pressure within the device can be released. The one or more vent openings 168 can act as an indicator for placement of the device. The one or more vent openings 168 can act as a means for connecting an applicator (e.g., the applicator of FIG. 15) for positioning or applying therapeutic force. The one or more vent openings 168 can act as a passageway for homeopathic medicines for yeast infections, sexually transmitted diseases, hormone levels, or birth control. These vent openings can act as conduits for attaching test strips that indicate pH levels, hormone levels, or pelvic floor strength. The vent openings 168 can prevent or limit suction effects on the device when inserted into the vagina.

[0058] 18, there is shown a cross-sectional view of the vaginal insertion device 100 taken along line 18-18 of FIG. 17. The ribs 180 can extend from adjacent or just below the rim 146 to the base or lower end 156 of the upper portion 142. In this manner, the ribs 180 apply pressure to provide support to the rim 146 and upper portion 142, which in turn apply pressure to provide support to the uterine and / or rectal walls.

[0059] The vaginal insertion device of the present disclosure can be sized to fit any number of vaginal sizes. Table 1 below shows a list of example sizes for the vaginal insertion device 40, 100. The dimensions labeled in Table 1 can be found in Figures 16-20. Diameter A in Table 1 can be the same as diameter 76 in Figure 8 and / or diameter J in Figures 27-38. Angle α can be 45 degrees, rim radius R can be 0.10 inches (2.54 mm), and device length H can be 2.29 inches (58.17 mm). Distances B, C, and D that position the ridge on the upper portion can be 1.05 inches (26.67 mm), 0.80 inches (20.32 mm), and 0.55 inches (13.97 mm), respectively. Distances E and G that position the ridge above the stem may be 0.35 inches (8.89 mm) and 0.12 inches (3.05 mm), respectively. For Devices 2 and 5, distance F may be 0.24 inches (6.10 mm), and for Devices 3, 4, and 6, distance F may be 0.23 inches (5.84 mm).

[0060] [Table 1] Table 1: Exemplary diameters for vaginal insertion devices

[0061] As shown in Figures 16 and 18, the upper portion 142 can have a conical body as depicted, however, the upper portion 142 can have other shapes such as, for example, triangular, round, cylindrical, umbrella, or pyramidal. The upper portion 142 can have an open top. The upper portion 142 can have a circular cross-section (Figure 19) through its length or a cross-section of other shapes such as oval, square, rectangular, triangular, pentagonal, hexagonal, or octagonal. The upper portion 142 as depicted can have a wall 149 having an inner wall or interior side 150 and an outer wall or exterior side 152, an open top end 154, a base or bottom end 156, and a hollow interior including a plurality of open portions 158, where the circumference of the upper portion 142 decreases from the open top end 154 to the bottom end 156. As shown, the rim 146 may be circular and may surround and protrude from an exterior side 152 of the wall 149 and may be adjacent to an open top end 154. The ridge 148 may be a circular ring that surrounds the exterior side 152 of the wall 149. The ridge 148 may include a logo. The ridge 148 may be any shape including a polygon, semicircle, triangle, square, letter, symbol, number, or logo, stud, knob, button, bump, etc., or combinations thereof. Additionally, as shown, the stem 144 may extend from a bottom end 156 of the upper portion 142. The upper portion 142 and stem 144 may be fabricated as an integral one-piece device formed of a single material. Alternatively, the upper portion 42 and stem 44 may be made of one material or more than one material. The upper portion 42 and stem 44 may be made of one or more parts that may be connected and separated, expanded or contracted. The upper portion can be made of a semi-permeable material to allow medications, liquids, gases, or lubricants to pass therethrough. The upper portion 142 and stem 144 can be permanently or releasably attached to one another. The stem 144 can have a flat triangular body. The flat triangular body of the stem 144 can extend radially outward and downward from the bottom end 156. The conical body of the upper portion 142 can extend radially outward from the bottom end 156 to the open top end 154.The stem 144 may be any one of the stems 244a to 244g.

[0062] Continuing with reference to FIG. 16 and FIG. 17, the one or more vent openings 168 can include vent holes, slits, gaps, or openings. The one or more vent openings 68 can include a screen or mesh or any other component having openings. The vaginal insertion device 100 can include multiple vent openings 168. The vaginal insertion device 100 can include multiple vent openings 168 at locations other than or in addition to the vent openings 168. For example, the vaginal insertion device 40 can include vent openings in the wall 149 of the upper portion 142, in the stem 144 (similar to FIG. 8) or its sidewalls, in the rim 146, vent openings through the ridges 148 and / or ribs 180. The one or more vent openings 168 can make the vaginal insertion device more comfortable for the patient during insertion. The one or more openings can equalize air pressure between the inside and outside of the vagina 18 when the vaginal insertion device 100 is inserted. However, having vent openings 168 is not required for the vaginal insertion device 100 to be comfortable, useful, and effective. Vent openings 168 can prevent a suction effect on the device.

[0063] Continuing with reference to FIG. 18, the rim 146 and the extension portion 142a can protrude from the exterior side 152 of the wall 149, with the rim 146 protruding a greater distance than the extension portion 142a. Several alternative embodiments of the rim 146 and the extension portion 142a are possible, including embodiments in which the rim 146 and / or the extension portion 142a are omitted and the height dimension of the remaining portion is increased such that this section is of the same height as the combination of 142a and 146 according to the embodiment of FIG. 18. Certain embodiments are comprised of one or more parts and can be made from one material, more than one material, or a combination of materials. These parts and materials can be detachable, attachable, expandable, or contractible.

[0064] 16-20, the ridge 148 may not be limited to the circular protrusions shown. Thus, the ridge 148 may include the embodiment shown in FIG. 16-20, where the protrusion may be a circular ring surrounding the exterior side 152 of the wall 149. However, the ridge 148 may include any protrusion extending from the exterior side 152 of the wall 149, such as a plurality of studs, knobs, buttons, bumps, letters, logos, numbers, etc. The ridge 148 may assist in preventing displacement of the device by providing friction with the vaginal inner wall, thereby preventing organ displacement. The ridge 148 may support the device and tissue if the user is suffering from prolapse, or may prevent organ displacement, thereby preventing prolapse. The ridge 148 may assist in reducing, managing, improving, preventing, treating, and / or eliminating incontinence. The ridge 148 may be made of a semi-permeable material to allow medication, liquids, gases, or lubricants to pass through. The ridges 148 can apply pressure (therapeutic force) to the vaginal or organ walls. The ridges 148 can be evenly and / or uniformly spaced along the upper portion 142. When logos, words, numbers, etc. are provided as ridges as depicted in Figures 16 and 27-38, a line passing through the center of the logo and running parallel to the remaining ridges can be evenly and / or uniformly spaced along the upper portion 142 with the remaining ridges 148. Alternatively, the ridges 148 can extend along the entire or partial length of the upper portion 142 and can be irregular or uniform or any combination thereof.

[0065] The vaginal insertion device 100 may be used, inserted, operated, etc., in a similar or identical manner to the vaginal insertion device 40, as described with respect to Figures 11-15 and 39-41. Any of the features, modifications, or uses of the vaginal insertion device 40 may be used with the vaginal insertion device 100, and vice versa.

[0066] 21A-21F, alternative embodiments for the stem 44, 144 are shown. Stems 244a, 244b, and 144c are shown in partial cross-section in FIGS. 21A-21C. In addition to the following examples, the stem can be a ball, a loop, a handle, a tab, a + sign, or the like, or a combination thereof. The stem can be a flat rectangular stem, such as stem 244g shown in FIG. 33. The vaginal insertion device of any of FIGS. 6, 16, and 27-38 can be provided with any of stems 244a-244f, the stem 144 of FIG. 16, or the stem 44 of FIG. 7. The user can determine the position of the device based on the location of the stem 44, 144, 244 while the vaginal insertion device is inserted into the vagina. Rotation of the stem 44, 144, 244 can modify the pressure exerted on the uterine wall. Rotation of the stem 44, 144, 244 can reduce and / or increase pressure against the uterine wall. Rotation of the stem 44, 144, 244 can allow selective and / or adjustable pressure to be applied to the organ wall. For example, a slight rotation of the stem 44, 144, 244 can result in a 50% reduction in urethral pressure, see, for example, FIG. 24. The ridges 48, 148, 248 on the stem 44, 144, 244 can be one of a stud, knob, button, word, number, symbol, logo, or other shape including a polygon, triangle, or square, or combinations thereof. The ridges can assist in positioning, locating, and / or gripping the vaginal wall.

[0067] The stem 44, 144, 244 can aid in the orientation of the device 40, 100 and can have markings indicating placement, such as arrows, balls, protrusions, or number systems that can be felt or seen to determine placement. The stem 44, 144, 244 can be rotated to increase or decrease the amount of therapeutic force or pressure applied to the vaginal wall. The stem can be connected to an applicator. Both can be used together or separately to vary the amount of therapeutic force the device applies to the organs, either by rotating the device or by acting as a mechanism for the device to expand or contract. Rotation of the stem can be accomplished with a portion of the hand on the bottom end 154 of the device to aid in the movement of the device. Alternatively, rotation of the stem can be accomplished by gripping only the stem with the hand or fingers. The stem 44, 144, 244 can act as a conduit for medication, lubricant, either in conjunction with an applicator or without the need for an applicator. The stem may be constructed of one material, more than one material, or a combination of materials. An applicator may be provided to rotate, position, and / or administer the medicament, and / or a combination thereof. The applicator may assist in rotating, positioning, and / or administering the medicament, or a combination thereof. The applicator may be as described above in FIG. 15.

[0068] FIG 21A illustrates a stem 244a similar to the stem 44 of FIGs 7 and 8. The stem 244a may be substantially conical in shape with ridges 248 circumferentially disposed about an outer surface of the stem 244a. Vent openings 268a may or may not be disposed within the stem 244a. The stem 244a may have a tensile strength of about 12 lbf to about 16 lbf, such as about 13 lbf to about 15 lbf, such as about 14.03 lbf.

[0069] FIG. 21B illustrates a stem 244b similar to the stem 144 of FIG. 16. The stem 244b may be substantially flat or two-dimensional (flat or two-dimensional shapes create a plane) and may be triangular or rectangular in shape as illustrated. The stem 244b may have a (e.g., triangular) body that tapers or expands outwardly from the lower end of the upper portion to the distal end of the stem 244b. Alternatively, the stem 244b may have a (e.g., rectangular) body of constant width. In embodiments, the stem 244b may be flat or may have other shapes, such as an inwardly tapering polygon. The stem 244b may have ridges 248 disposed on its outer surface. The stem 244b may have one or more holes, openings, or other apertures that may facilitate gripping of the stem. The stem 244b can have a tensile strength of from about 4 lbf to about 6 lbf, such as from about 4.5 lbf to about 5.1 lbf, for example, about 4.8 lbf.

[0070] FIG. 21C illustrates a stem 244c that is similar to stem 244b, but thickened relative to stem 244b. Stem 244c can have ridges 248 disposed on its outer surface. As shown in FIGS. 21B and 21C, the thickness of stems 244b, 244c can be selected to aid in grasping, inserting, removing, and repositioning the vaginal insertion device 40, 100. Stem 244c can have the same or similar thickened shape as stem 244b. Stem 244c can have a tensile strength of about 10 lbf to about 12 lbf, for example, about 11.07 lbf.

[0071] FIG. 21D shows a generally cross-shaped stem 244d in plan or cross-sectional view. The stem 244d may have a ridge 248 extending generally around the outer surface of the stem 244d. The stem 244d may be solid, i.e., may have no openings in the stem 244d. Alternatively, the stem 244d may be substantially hollow with or without vent openings therein (similar to the stem 244a). The stem 244d may taper or extend radially outward from the base of the upper portion to the distal end of the stem 244d. The stem 244d may not be flared, i.e., the stem may extend downward with a constant cross-section as shown in FIG. 21F. The stem 244d can have a tensile strength of about 12 lbf to about 14 lbf, e.g., about 12.8 lbf, when it has a flared shape (FIG. 21D), and about 13.5 lbf to about 15.5 lbf, e.g., about 14.4 lbf, when it does not have a flared shape (FIG. 21F).

[0072] FIG. 21E shows stem 244e that is generally conical in shape with ridge 248 circumferentially around its outer surface. Stem 244a can be formed from generally cross-shaped stem 244d (or 244f if the stem has a constant cross section) by providing a circular ridge around the outermost point of the cross-shaped portion of stem 244e. The circular ridge can increase in diameter as the diameter of stem 244e increases. Alternatively, if the stem has a constant cross section, the circular ridge can have a constant diameter. Stem 244e can be solid, i.e., there may be no openings in stem 244e. Alternatively, stem 244e can be substantially hollow with or without vent openings therein (similar to stem 244a). Stem 244e can have a tensile strength of about 13.3 lbf to about 15.3 lbf, for example, about 14.3 lbf.

[0073] 21F shows a generally cross-shaped stem 244f in plan or cross-sectional view. The stem 244f may have a ridge 248 extending generally around its outer surface or perimeter. The stem 244f may be solid, i.e., there may be no openings in the stem 244f. Alternatively, the stem 244f may be substantially hollow with or without vent openings therein (similar to stem 244a). The stem 244f may be substantially uniform in cross-section along its length, i.e., the stem 244f may have the same outer dimensions at its top and bottom.

[0074] The stems 44, 144, 244a-244f and 244g (FIG. 33C) can allow the user to insert, remove or adjust the device, administer a drug or substance to the body or within the device, and / or reposition the vaginal insertion device 40, 100. The stems 44, 144, 244a-244g can be selected based on comfort to the user when the device is inserted, ease of grip, ease of use, etc. The stems can assist in positioning the device when inserted into the vagina. For example, the user can hold the stem to rotate the device in the vagina. A portion of the upper portion 142 near the stem 144 can be held to assist in rotating the device. In embodiments, to facilitate adjustment, the device can be folded and / or compactly packed with the stem remaining in place and / or indicating pressure applied to the vaginal wall. Rotating the device can adjust pressure against the urethral sphincter, bladder neck, and / or rectum. Thus, a user can adjust the comfort level of the device by increasing or decreasing pressure against the urethral sphincter or other organ wall by rotating the stem. The stem and / or ridges on the stem can align with ribs on the device such that when the stem is rotated, the ribs are also rotated to place higher pressure in specific locations.

[0075] 22A-22E and 43 show a carrying case 300 for carrying the vaginal insertion device of the present disclosure. The carrying case 300 can allow a user to store (when not in use) the vaginal insertion device of the present disclosure in a clean and sanitary manner. The carrying case 300 can include a base 302 and a cover 304. The cover 304 can have a substantially cylindrical lower portion and a substantially hemispherical upper portion. The base 302 can have a corrugated bottom surface 306 to allow the carrying case 300 to rest flat on a surface such as a table or counter (FIG. 22B). The base 302 can be rounded. The bottom surface 306 can have a shape other than curved or corrugated. For example, the surface 306 can have a rectangular shape similar to a turret or can be flat. The bottom of the base 302 can have a protrusion or recess that will hold additional components such as a brush for sterilization or another sterilization technique. A charging station can be connected to the base 302. The base 302 may include several technologies such as infrared cleaning, a recharging feature for recharging certain components of the device, or a communication device for uploading data to either a computer or a mobile app. The base 302 may be constructed of one material, more than one material, or a combination of materials. The base 302 may have one or more parts that work together or alone, and may further work together with the cover of the device.

[0076] As shown in FIGS. 22F-22J, the base 302 can be substantially cylindrical in shape to match the shape of the vaginal insertion device and hold the vaginal insertion device in place or allow the device 40, 100 to be dried, washed, or charged. Referring to FIG. 22C, the base 302 can have an upper cylindrical portion 308 having a top surface 310. The vaginal insertion device 40, 100 can be placed on the top surface 310 such that the rim 46, 146 is flat on the top surface 310. With the vaginal insertion device 40, 100 placed on the base 302, a user can place the cover 304 over the vaginal insertion device 40, 100 and on a surface 312 positioned on the base 302. The surface 312 and the cover surface 314 can mate and, when mated, can be snap-locked, screwed, or otherwise fastened together so that the cover 304 does not fall off and can only be removed when subjected to sufficient removal pressure from the user. In an embodiment, the face 312 includes one or more (e.g., four regularly spaced) studs, knobs, or bumps projecting outwardly therefrom and sized and shaped to slide into a corresponding number of grooves (L-shaped grooves in Figs. 22F-22H) in the cover face 314 to fasten the cover 304 to the base 302. The base 302 can provide a drying rack for the vaginal insertion devices 40, 100. The base 302 can be seen in Figs. 22F-22J with the vaginal insertion devices 40, 100 removed. Fig. 22K shows a brush for cleaning the vaginal insertion devices 40, 100. The brush can be included in a kit along with the carrying case 300, which can include the drying rack 400 (Fig. 23). The container or carrying case 300 can be used to package, ship, and / or display the vaginal insertion devices of the present disclosure.

[0077] Referring to FIG. 23, a drying rack 400 is shown. The drying rack 400 can be included in the carrying case 300. The drying rack 400 can be the base 302, integral with the base 302, coupled to the base 302, or can be a component of the base 302. The drying rack 400 can be substantially cylindrical in cross section such that the vaginal insertion device of the present disclosure fits, fits, or mates onto the drying rack 400. The drying rack 400 can have a cylindrical base and can include one or more openings 402 and one or more protrusions 404. The openings 402 can allow water or other liquids to drip from the vaginal insertion device 40, 100 through the drying rack 400 (or collect water or other liquids in the drying rack 400 for disposal at a later time). The protrusions 404 can support the vaginal insertion device of the present disclosure during drying, cleaning, or charging. The protrusions 404 may be spaced apart such that, for example, when ribs 180 are included in device 100, the protrusions 404 protrude into open portions 158 (FIG. 18) to interface with the ribs and support, for example, either side of each member or rib portion 180a, 180b, 180c, and 180d. For example, the protrusions 404 may be spaced apart such that a member or rib portion may slide between the protrusions 404 to releasably secure or fasten device 100. In certain instances, the number of protrusions 404 equals the number of open portions 158, with each protrusion protruding into an open portion.

[0078] The drying, washing, or charging rack 400 may include one or more latches, clips, fasteners, binders, protrusions, and / or indentations 406. The latches 406 may latch, slide, or otherwise fasten onto the inner surface of the rim 46, 146 of the vaginal insertion device of the present disclosure to support the device during drying, charging, or washing.

[0079] The carrying case 300 may be a self-disinfecting carrying case. That is, a user may position a vaginal insertion device within the carrying case 300 such that the cover is secured to the base and the vaginal insertion device is placed therein. The user may then activate the carrying case 300 to disinfect, sterilize, or otherwise clean the vaginal insertion device. The user may initiate sterilization of the vaginal insertion device 40, 100, for example, by pressing a button and / or flipping a switch. Thus, the carrying case 300 may include a power connection, a battery, a power cord, or other power source to provide electricity to it. The carrying case 300 may include a connection for a wired or wireless connection to a mobile device or an internet-connected device so that the user may remotely control the carrying case 300 to disinfect the vaginal insertion device (e.g., through an app). In this way, the user may not need to wash and dry the vaginal insertion device separately. The user may simply place the vaginal insertion device within the carrying case 300 and the vaginal insertion device may be disinfected or sterilized without further action by the user. Disinfection / sterilization can be done without the addition of water, for example, by air plasma means, radiation means, ultraviolet light means, and / or ultrasonic means. In an embodiment, the disinfectant or sterilizer can be water or a solution. The vaginal insertion device can be placed in water or a solution for disinfection and / or sterilization during a predetermined period of non-use (e.g., when the user is asleep). The user can then rinse the device after the predetermined period. The device can then be reinserted for the next use. In this way, the user can have a predetermined schedule (e.g., nightly, weekly, biweekly) for cleaning, disinfecting, and / or sterilizing the vaginal insertion device.

[0080] In an exemplary embodiment, the carrying case may be considered self-disinfecting / self-sterilizing, in that the case is configured to disinfect the vaginal insertion device without user intervention other than activation by the user, for example. In an exemplary embodiment, the carrying case may include air plasma technology to disinfect and / or sterilize the vaginal insertion device. The carrying case 300 including air plasma technology may be plugged into a power source. The user may then activate the carrying case (e.g., with a button or switch), and the carrying case may then sterilize the vaginal insertion device using air plasma technology. In an exemplary embodiment, the carrying case may include air plasma technology, ultraviolet technology, ultrasonic technology, moist heat / dry heat technology, and / or radiation technology to sterilize and / or disinfect the vaginal insertion device.

[0081] A kit can be provided for the vaginal insertion device of the present disclosure. The kit can include one or more of the vaginal insertion device, carrying case 300, and / or drying rack 400 of any of Figures 6-10, 16-20, and 27-38. The kit can include devices of various sizes (to accommodate selection and proper sizing by the user and / or variations in the user's body) or can include a single size if the user has already determined the appropriate size. Since the vaginal insertion devices are provided in various sizes, the carrying case 300 and drying rack 400 can be sized to fit each individually sized vaginal insertion device. Alternatively, the carrying case 300 can be sized to accommodate all sizes of vaginal insertion devices. Thus, the kit can provide one or more of the vaginal insertion device, carrying case 300, and / or drying rack 400 that are sized to complement each other when provided. The kit can include a cleanser for the vaginal insertion device and optionally a cleaning brush (e.g., the brush of Figure 22K). The vaginal insertion device may be reusable and the cleanser may allow for cleaning and / or disinfection between uses. The kit may include pre-moistened paper towels for cleaning and / or disinfecting the vaginal insertion device and / or the patient's hands. The pre-moistened paper towels may allow for insertion and / or removal of the vaginal insertion device in a public facility, such as, for example, a public restroom. The kit may include a brush or cleaning tool that may or may not be clamped to a carrying case or drying rack for disinfection and cleaning purposes.

[0082] Referring to FIG. 24, there is shown a graphical representation of the therapeutic force of a vaginal insertion device according to the present disclosure, including any of FIGS. 16-20 and 27-38. The therapeutic force is the force applied to the bladder neck or urethral sphincter through the vaginal canal, i.e., the force or pressure applied to the urethral sphincter. Lines 300, 302, 304, 306, and 308 correspond to devices 2, 3, 4, 5, and 6, respectively, from Table 1. Lines 300a, 302a, 304a, 306a, and 308a show the therapeutic force or force applied to the urethral sphincter, bladder neck, or rectum at the location of the ribs. Lines 300b, 302b, 304b, 306b, and 308b show the force applied at the location of the gap or space between the ribs.

[0083] As shown in the graph of Figure 24, the force applied to the urethral sphincter (arrow F in Figures 25A, 25B) may be approximately 50% lower when pressure is applied to the gap (Figure 25B) compared to when pressure is applied to the ribs (Figure 25A). Thus, in use, a patient may rotate the vaginal insertion device such that the ribs 180 are aligned with and apply pressure against the urethral sphincter, bladder neck, or rectum prior to high intensity activity, such as exercise, to support organs during such activity. To facilitate such alignment, the location of the rib or one or more rib sections or rib members can be correlated with the orientation of the stem (e.g., stems 144, 244a-244g, e.g., flat or two-dimensional stems 144 and 244b-244c) such that the plane established by the stem width is parallel or coextensive with the plane established by the rib or one or more rib sections or rib members (see, e.g., the coextensive plane extending out of the page established by rib 180 and stem 144 in FIG. 18), or such that the plane established by the stem width is coextensive with the longitudinal axis of the device through which the rib passes (e.g., the plane established by the stem width parallel to the page and coextensive with the longitudinal axis or section line 1818 as shown in FIG. 17). Thus, by understanding the orientation of the stem by manipulating it, the user will also understand the orientation of the rib relative to the urethral sphincter, bladder neck, or rectum when the device is inserted into the vaginal cavity.

[0084] The device can be rotated by 45 degrees to provide a 50% reduction in therapeutic force. If less pressure on the urethral sphincter is desired, the patient can rotate the device so that the ribs 180 are not aligned with the urethral sphincter, bladder neck, or rectum, and force is applied to the gap or offset between portions of the ribs 180. Such alignment can be facilitated as described above. The ribs can expand or contract with rotation to apply more or less force to the urethral sphincter, bladder neck, or rectum. The user can rotate the device using the stem.

[0085] 25A and 25B, the forces applied to the vaginal insertion device of the present disclosure are shown. FIG. 25A shows the force applied to the ribs 180 of the device, e.g., the force against the urethral sphincter (e.g., the treated ribs of FIG. 24). FIG. 25B shows the force applied to the portion of the device positioned between the portions of the ribs 180, such as the force against the urethral sphincter or rectum (e.g., the treated gaps of FIG. 24). The force applied in FIG. 25B may be about 50% less than the force applied in FIG. 25A. As mentioned above, it is believed that the force applied to the urethral sphincter, bladder neck, or rectum is less when the gaps or spaces between the ribs 180 are aligned with the uterine wall or rectum than when the ribs 180 are aligned with the uterine wall, bladder neck, or rectum. Thus, the force applied by the vaginal insertion device of the present disclosure against the bladder neck, urethral sphincter, and / or rectum is adjustable and even selectively adjustable.

[0086] Although previously described as reducing or eliminating urinary incontinence, the vaginal insertion device of the present disclosure can be entered into the vagina such that the device 40, 100 exerts pressure against the intestinal or colonic wall. The device can be rotated to adjust the pressure against the intestinal or colonic wall as described above. When ribs 180 are included in the vaginal insertion device, the ribs can exert pressure against the rectum and / or intestinal or colonic wall to substantially reduce, manage, treat, prevent, and / or eliminate fecal incontinence. Thus, the vaginal insertion device can be entered into the vagina to exert pressure against the rectum to prevent fecal incontinence or rectal prolapse, or to prevent further displacement of the rectum. An insert can also be entered into the anus to prevent, manage, reduce, treat, and / or eliminate fecal incontinence.

[0087] Referring to FIG. 26, a vaginal insertion device 200 is shown. The vaginal insertion device 200 can be similar to the vaginal insertion devices 40, 100. The vaginal insertion device 200 can have a rim 246. When included, the rim 246 can be similar to the rim 46, 146. However, the plane of the rim 246 can be substantially perpendicular, i.e., parallel or angled, to a vertical axis A passing through the stem 244 and the base 256 of the body 242. For example, the device 200 can have a curved, angular shape, with the rim 246 resembling the widest end portion of the angular shape and the base 256 resembling the narrow top portion of the angular shape. The rim 246 can have a first portion 246a that is vertically offset from a second portion 246b. The first portion 246a can be higher or located away from the lower portion 246b. The first portion can be a different thickness, durometer, density, and durability than the lower portion or the opposite side. The rim can be a different shape than the opposite side. The rim can be composed of one material or portion, more than one material or portion, or a combination of materials or portions. The rim can expand or contract to exert the correct amount of force on the patient at the correct internal location. The rim can be semi-permeable to allow fluids, gases, lubricants, or medications to pass through.

[0088] The rim 246, if present, can be inclined or angled relative to the rim 46, 146 of the vaginal insertion device 40, 100. The bladder neck can be higher in the vagina than the rectal and / or intestinal walls. Thus, when placed in the vagina, the vaginal insertion device 200 can be positioned such that the second portion 246b or underside applies pressure against the rectal wall. The higher wall can apply pressure against the urethral wall. The inclined rim 246 can allow less pressure to be applied to the rectal or intestinal wall than would be applied by a substantially horizontal rim such as the rim 46, 146. Alternatively, the vaginal insertion device 40, 100 can be shortened to fit a lower location of the rectum / intestinal wall in the vagina. Although described with respect to the intestinal wall, the rim height and / or rim angle can be selected to apply pressure to other portions of the vaginal wall.

[0089] The vaginal insertion device 200 can apply pressure against the intestinal wall to eliminate and / or reduce fecal incontinence. The vaginal insertion device 200 can prevent, eliminate, or reduce rectal prolapse (e.g., rectocele). The vaginal insertion device 200 can treat, manage, prevent, eliminate, or reduce urinary and fecal incontinence due to pressure applied against both the urethral wall and the intestinal wall. As shown and described, the optional rim 246 (and / or rim 46, 146) can be biased, tilted, or otherwise angled to apply pressure to various locations within the vaginal canal based on the anatomy and the type of incontinence and / or prolapse to be prevented or reduced. The first portion can be of a different thickness, durometer, density, and durability than the lower portion or the opposite side. The rim can be a different shape than the opposite side. The rim can be constructed of one material or portion, more than one material or portion, or a combination of materials or portions. The rim can expand or contract to apply the correct amount of force to the correct internal location for the patient. The rim may be semi-permeable to allow fluids, gases, lubricants, or medications to pass through.

[0090] 27A-27H, a vaginal insertion device 2700 is shown. The vaginal insertion device 2700 can be similar to the vaginal insertion device 100, except that the stem 244F can be the cross-shaped stem 244f of FIG. 21F (although the stem can be one of the stems 244a-244e and include two-dimensional stems 144 and 244b-244c). Thus, any of the variations, uses, modifications, or features described herein above with respect to any of the vaginal insertion devices can be used, applied, or modified for the vaginal insertion device 2700. For example, any of the variations, uses, modifications, or features with respect to the ribs 180, shape, vent openings, etc. can be provided for the vaginal insertion device 2700. Additionally, any of the uses or accessories (e.g., carrying case) can be applied to the vaginal insertion device 2700 as previously described. 27A, a perspective view of a vaginal insertion device 2700 is shown in which the ribs 180 are separated a distance below the top surface of the device 2700. The upper portion, rim, ribs, vent openings, methods of insertion, methods of rotation, methods of pressure adjustment, methods of use, and any other features or embodiments described herein can be provided in the vaginal insertion device 2700.

[0091] Referring to FIG. 27B, a top view of the vaginal insertion device 2700 is shown. The vaginal insertion device 2700 can have a diameter J of about 25 mm to about 50 mm, for example, about 30 mm to about 45 mm, about 30 mm to about 36 mm (including about 33 mm), about 34 mm to about 40 mm (including about 37 mm), about 39 mm to about 45 mm (including about 42 mm), including 30 mm. The vaginal insertion device 2700 can have a width K of the rib 180 that is about 1 mm to about 1.6 mm, for example, about 1.3 mm. Each of the four portions of the cross-shaped rib can have a dimension K. Referring to FIG. 27C, a side view of the vaginal insertion device 2700 is shown. As described above with respect to the prior embodiment, the ridges and optional logo can be equidistantly spaced along the outer surface of the upper portion of the vaginal insertion device 2700. Referring to FIG. 27D, a side view rotated 90 degrees from the view of FIG. 27C is shown. The ridges on the stem 244F can be separated from one another. The lowest ridge can be separated from the bottom of the vaginal insertion device 2700 by a distance Z of about 2.7 mm to about 3.1 mm, e.g., about 2.9 mm. The middle ridge can be separated from the lowest ridge by a distance Y of about 3.1 mm to about 3.5 mm, e.g., about 3.3 mm. The top ridge can be separated from the middle ridge by a distance X of about 3.1 mm to about 3.5, e.g., about 3.3 mm.

[0092] Referring to FIG. 27E, a side cross-sectional view of the vaginal insertion device 2700 is shown. The distance P from the bottom of the device to the base of the upper portion can be about 13 mm to about 14 mm, e.g., about 13.3 mm to about 13.7 mm, e.g., about 13.5 mm. The vaginal insertion device 2700 can have a length N of about 50 mm to about 76 mm, e.g., about 55 mm to about 71 mm, e.g., about 57 mm, 58 mm, 59 mm, 60 mm, 61 mm, 62 mm, 63 mm, 64 mm, 65 mm, 66 mm, 67 mm, 68 mm, or 69 mm, including about 58 mm or about 63 mm. The width M of the extension portion can be about 3.5 mm to about 4.1 mm, e.g., about 3.8 mm. The width L of the rim can be about 4 mm to about 6 mm, e.g., about 5 mm.

[0093] Referring to FIG. 27F, a detailed view of the ridges on stem 244F is shown. Each of the ridges can extend a distance Q from stem 244F of about 0.4 mm to about 0.6 mm, e.g., about 0.5 mm. Each of the ridges can have a thickness R of about 0.7 mm to about 0.9 mm, e.g., about 0.8 mm. Referring to FIG. 27G, a cross-sectional view of stem 244F is shown. Stem 244F can have an overall width T of about 6.6 mm to about 7 mm, e.g., about 6.8 mm, and an overall width C of about 6.6 mm to about 7 mm, e.g., about 6.8 mm. Each leg of cruciform stem 244F can have a width W of about 1.3 mm to about 1.5 mm, e.g., about 1.4 mm. Referring to FIG. 27H, a bottom view of device 2700 is shown.

[0094] 28A-28H, a vaginal insertion device 2800 is shown. The vaginal insertion device 2800 can be similar to the vaginal insertion device 100, except that the stem 244F can be the cross-shaped stem 244f of FIG. 21F (although the stem can be one of the stems 244a-244e and include two-dimensional stems 144 and 244b-244c). The vaginal insertion device 2800 can be similar to the vaginal insertion device 2700, except that the sizing may be different. Thus, any of the variations, uses, modifications, or features described above with respect to any of the vaginal insertion devices herein can be used, applied, or modified for the vaginal insertion device 2800. For example, any of the variations, uses, modifications, or features with respect to the ribs 180, shape, vent openings, etc. can be provided to the vaginal insertion device 2800. Additionally, any of the uses or accessories (e.g., carrying case) can be applied to the vaginal insertion device 2800 as previously described. 28A, a perspective view of a vaginal insertion device 2800 is shown in which the ribs 180 are separated a distance below the top surface of the device 2800. The upper portion, rim, ribs, vent openings, methods of insertion, methods of rotation, methods of pressure adjustment, methods of use, and any other features or embodiments described herein can be provided in the vaginal insertion device 2800.

[0095] Referring to FIG. 28B, a top view of the vaginal insertion device 2800 is shown. The vaginal insertion device 2800 can have a diameter J of about 25 mm to about 50 mm, for example, about 30 mm to about 45 mm, about 30 mm to about 36 mm (including about 33 mm), about 34 mm to about 40 mm (including about 37 mm), about 39 mm to about 45 mm (including about 42 mm), including about 34 mm. The vaginal insertion device 2700 can have a width K of the rib 180 that is about 1 mm to about 1.6 mm, for example, about 1.3 mm. Each of the four portions of the cross-shaped rib can have a dimension K. Referring to FIG. 28C, a side view of the vaginal insertion device 2800 is shown. As described above with respect to the prior embodiment, the ridges and optional logo can be equidistantly spaced along the outer surface of the upper portion of the vaginal insertion device 2800. Referring to FIG. 28D, a side view rotated 90 degrees from the view of FIG. 28C is shown. The ridges on the stem 244F can be separated from one another. The lowest ridge can be separated from the bottom of the vaginal insertion device 2800 by a distance Z of about 2.7 mm to about 3.1 mm, e.g., about 2.9 mm. The middle ridge can be separated from the lowest ridge by a distance Y of about 3.1 mm to about 3.5 mm, e.g., about 3.3 mm. The top ridge can be separated from the middle ridge by a distance X of about 3.1 mm to about 3.5, e.g., about 3.3 mm.

[0096] Referring to FIG. 28E, a side cross-sectional view of the vaginal insertion device 2800 is shown. The distance P from the bottom of the device to the base of the upper portion can be about 13 mm to about 14 mm, e.g., about 13.3 mm to about 13.7 mm, e.g., about 13.5 mm. The vaginal insertion device 2800 can have a length N of about 50 mm to about 76 mm, e.g., about 55 mm to about 71 mm, e.g., about 57 mm, 58 mm, 59 mm, 60 mm, 61 mm, 62 mm, 63 mm, 64 mm, 65 mm, 66 mm, 67 mm, 68 mm, or 69 mm, including about 58 mm or about 63 mm. The width M of the extension portion can be about 3.5 mm to about 4.1 mm, e.g., about 3.8 mm. The width L of the rim can be about 4 mm to about 6 mm, e.g., about 5 mm.

[0097] Referring to FIG. 28F, a detailed view of the ridges on stem 244F is shown. Each of the ridges can extend a distance Q from stem 244F of about 0.4 mm to about 0.6 mm, e.g., about 0.5 mm. Each of the ridges can have a thickness R of about 0.7 mm to about 0.9 mm, e.g., about 0.8 mm. Referring to FIG. 28G, a cross-sectional view of stem 244F is shown. Stem 244F can have an overall width T of about 6.6 mm to about 7 mm, e.g., about 6.8 mm, and an overall width C of about 6.6 mm to about 7 mm, e.g., about 6.8 mm. Each leg of cruciform stem 244F can have a width W of about 1.3 mm to about 1.5 mm, e.g., about 1.4 mm. Referring to FIG. 28H, a bottom view of device 2800 is shown.

[0098] 29A-29H, a vaginal insertion device 2900 is shown. The vaginal insertion device 2900 can be similar to the vaginal insertion device 100, except that the stem 244F can be the cross-shaped stem 244f of FIG. 21F (although the stem can be one of the stems 244a-244e and include two-dimensional stems 144 and 244b-244c). The vaginal insertion device 2900 can be similar to the vaginal insertion devices 2700, 2800, except that the sizing may be different. Thus, any of the variations, uses, modifications, or features described above with respect to any of the vaginal insertion devices herein can be used, applied, or modified for the vaginal insertion device 2900. For example, any of the variations, uses, modifications, or features with respect to the ribs 180, shape, vent openings, etc. can be provided to the vaginal insertion device 2900. Additionally, any of the uses or accessories (e.g., carrying case) can be applied to the vaginal insertion device 2900 as previously described. 29A, a perspective view of a vaginal insertion device 2900 is shown in which the ribs 180 are separated a distance below the top surface of the device 2900. The upper portion, rim, ribs, vent openings, methods of insertion, methods of rotation, methods of pressure adjustment, methods of use, and any other features or embodiments described herein can be provided in the vaginal insertion device 2900.

[0099] Referring to FIG. 29B, a top view of the vaginal insertion device 2900 is shown. The vaginal insertion device 2900 can have a diameter J of about 25 mm to about 50 mm, for example, about 30 mm to about 45 mm, about 30 mm to about 36 mm (including about 33 mm), about 34 mm to about 40 mm (including about 37 mm), about 39 mm to about 45 mm (including about 42 mm), including about 38 mm. The vaginal insertion device 2700 can have a width K of the rib 180 that is about 1 mm to about 1.6 mm, for example, about 1.3 mm. Each of the four portions of the cross-shaped rib can have a dimension K. Referring to FIG. 29C, a side view of the vaginal insertion device 2900 is shown. As described above with respect to the prior embodiment, the ridges and optional logo can be equidistantly spaced along the outer surface of the upper portion of the vaginal insertion device 2900. Referring to FIG. 29D, a side view rotated 90 degrees from the view of FIG. 29C is shown. The ridges on the stem 244F can be separated from one another. The lowest ridge can be separated from the bottom of the vaginal insertion device 2900 by a distance Z of about 2.7 mm to about 3.1 mm, e.g., about 2.9 mm. The middle ridge can be separated from the lowest ridge by a distance Y of about 3.1 mm to about 3.5 mm, e.g., about 3.3 mm. The top ridge can be separated from the middle ridge by a distance X of about 3.1 mm to about 3.5, e.g., about 3.3 mm.

[0100] Referring to FIG. 29E, a side cross-sectional view of the vaginal insertion device 2900 is shown. The distance from the bottom of the device to the base of the upper portion can be a distance P of about 13 to about 14 mm, e.g., about 13.3 to about 13.7 mm, e.g., about 13.4 mm. The vaginal insertion device 2900 can have a length N of about 50 mm to about 76 mm, e.g., about 55 mm to about 71 mm, e.g., about 57 mm, 58 mm, 59 mm, 60 mm, 61 mm, 62 mm, 63 mm, 64 mm, 65 mm, 66 mm, 67 mm, 68 mm, or 69 mm, including about 58 mm or about 63 mm. The width M of the extension portion can be about 3.5 mm to about 4.1 mm, e.g., about 3.8 mm. The width L of the rim can be about 4 mm to about 6 mm, e.g., about 5 mm.

[0101] Referring to FIG. 29F, a detailed view of the ridges on stem 244F is shown. Each of the ridges can extend a distance Q from stem 244F of about 0.4 mm to about 0.6 mm, e.g., about 0.5 mm. Each of the ridges can have a thickness R of about 0.7 mm to about 0.9 mm, e.g., about 0.8 mm. Referring to FIG. 29G, a cross-sectional view of stem 244F is shown. Stem 244F can have an overall width T of about 6.6 mm to about 7 mm, e.g., about 6.8 mm, and an overall width C of about 6.6 mm to about 7 mm, e.g., about 6.8 mm. Each leg of cruciform stem 244F can have a width W of about 1.3 mm to about 1.5 mm, e.g., about 1.4 mm. Referring to FIG. 29H, a bottom view of device 2900 is shown.

[0102] 30A-30H, a vaginal insertion device 3000 is shown. The vaginal insertion device 3000 can be similar to the vaginal insertion device 100, except that the stem 244F can be the cross-shaped stem 244f of FIG. 21F (although the stem can be one of the stems 244a-244e and include two-dimensional stems 144 and 244b-244c). The vaginal insertion device 3000 can be similar to the vaginal insertion devices 2700, 2800, 2900, except that the sizing may be different. Thus, any of the variations, uses, modifications, or features described above with respect to any of the vaginal insertion devices herein can be used, applied, or modified for the vaginal insertion device 3000. For example, any of the variations, uses, modifications, or features with respect to the ribs 180, shapes, vent openings, etc. can be provided to the vaginal insertion device 3000. Additionally, any of the methods of use or accessories (e.g., carrying cases) may be applied to the vaginal insertion device 3000 as previously described. Referring to FIG. 30A, a perspective view of the vaginal insertion device 3000 is shown in which the ribs 180 are separated a distance below the top surface of the device 3000. The upper portion, rim, ribs, vent openings, methods of insertion, methods of rotation, methods of pressure adjustment, methods of use, and any other features or embodiments described herein may be provided to the vaginal insertion device 3000.

[0103] Referring to FIG. 30B, a top view of the vaginal insertion device 3000 is shown. The vaginal insertion device 3000 can have a diameter J of about 25 mm to about 50 mm, for example, about 30 mm to about 45 mm, about 30 mm to about 36 mm (including about 33 mm), about 34 mm to about 40 mm (including about 37 mm), about 39 mm to about 45 mm (including about 42 mm), including about 42 mm. The vaginal insertion device 3000 can have a width K of the rib 180 that is about 1 mm to about 1.6 mm, for example, about 1.3 mm. Each of the four portions of the cross-shaped rib can have a dimension K. Referring to FIG. 30C, a side view of the vaginal insertion device 3000 is shown. As described above with respect to the prior embodiment, the ridges and optional logo can be equidistantly spaced along the outer surface of the upper portion of the vaginal insertion device 3000. Referring to FIG. 30D, a side view rotated 90 degrees from the view of FIG. 30C is shown. The ridges on the stem 244F can be separated from one another. The lowest ridge can be separated from the bottom of the vaginal insertion device 3000 by a distance Z of about 2.7 mm to about 3.1 mm, e.g., about 2.9 mm. The middle ridge can be separated from the lowest ridge by a distance Y of about 3.1 mm to about 3.5 mm, e.g., about 3.3 mm. The top ridge can be separated from the middle ridge by a distance X of about 3.1 mm to about 3.5, e.g., about 3.3 mm.

[0104] Referring to FIG. 30E, a side cross-sectional view of the vaginal insertion device 3000 is shown. The distance P from the bottom of the device to the base of the upper portion can be about 13 to about 14 mm, e.g., about 13.3 to about 13.7 mm, e.g., about 13.4 mm. The vaginal insertion device 3000 can have a length N of about 50 mm to about 76 mm, e.g., about 55 mm to about 71 mm, e.g., about 57 mm, 58 mm, 59 mm, 60 mm, 61 mm, 62 mm, 63 mm, 64 mm, 65 mm, 66 mm, 67 mm, 68 mm, or 69 mm, including about 58 mm or about 63 mm. The width M of the extension portion can be about 3.5 mm to about 4.1 mm, e.g., about 3.8 mm. The width L of the rim can be about 4 mm to about 6 mm, e.g., about 5 mm.

[0105] Referring to FIG. 30F, a detailed view of the ridges on the stem 244F is shown. Each of the ridges can extend a distance Q from the stem 244F of about 0.4 mm to about 0.6 mm, e.g., about 0.5 mm. Each of the ridges can have a thickness R of about 0.7 mm to about 0.9 mm, e.g., about 0.8 mm. Referring to FIG. 30G, a cross-sectional view of the stem 244F is shown. The stem 244F can have an overall width T of about 6.6 mm to about 7 mm, e.g., about 6.8 mm, and an overall width C of about 6.6 mm to about 7 mm, e.g., about 6.8 mm. Each leg of the cruciform stem 244F can have a width W of about 1.3 mm to about 1.5 mm, e.g., about 1.4 mm. Referring to FIG. 30H, a bottom view of the device 3000 is shown.

[0106] 31A-31H, a vaginal insertion device 3100 is shown. The vaginal insertion device 3100 can be similar to the vaginal insertion device 100, except that the stem 244F can be the cross-shaped stem 244f of FIG. 21F (although the stem can be one of the stems 244a-244e and include two-dimensional stems 144 and 244b-244c). The vaginal insertion device 3100 can be similar to the vaginal insertion devices 2700, 2800, 2900, 3000, except that the sizing may be different. Thus, any of the variations, uses, modifications, or features described above with respect to any of the vaginal insertion devices herein can be used, applied, or modified for the vaginal insertion device 3100. For example, any of the variations, uses, modifications, or features with respect to the ribs 180, shapes, vent openings, etc. can be provided to the vaginal insertion device 3100. Additionally, any of the methods of use or accessories (e.g., carrying cases) may be applied to the vaginal insertion device 3100 as previously described. Referring to FIG. 31A, a perspective view of the vaginal insertion device 3100 is shown in which the ribs 180 are separated a distance below the top surface of the device 3100. The upper portion, rim, ribs, vent openings, methods of insertion, methods of rotation, methods of pressure adjustment, methods of use, and any other features or embodiments described herein may be provided to the vaginal insertion device 3100.

[0107] As depicted in FIG. 31A, due to the larger size of the vaginal insertion device 3100, additional rib sections can be provided to the ribs 180 such that there are six individual rib portions or individual rib members and six open portions 158. The additional rib portions can provide additional force to the organ wall as well as additional support for the device. The additional rib portions can help prevent and inhibit prolapse in the larger sized device 3100. That is, since the device 3100 has a larger opening inner diameter, the six rib portions of the ribs 180 can provide a smaller opening space than if only four rib portions were provided as in the prior embodiment. The smaller opening space can help prevent prolapse.

[0108] Referring to FIG. 31B, a top view of the vaginal insertion device 3100 is shown. The vaginal insertion device 3100 can have a diameter J of about 25 mm to about 50 mm, for example, about 30 mm to about 45 mm, about 30 mm to about 36 mm (including about 33 mm), about 34 mm to about 40 mm (including about 37 mm), about 39 mm to about 45 mm (including about 42 mm), including about 48 mm. The vaginal insertion device 3100 can have a width K of the rib 180 that is about 1 mm to about 1.6 mm, for example, about 1.3 mm. Each of the six portions of the cross-shaped rib can have a dimension K. Referring to FIG. 31C, a side view of the vaginal insertion device 3100 is shown. As described above with respect to the prior embodiment, the ridges and optional logo can be equidistantly spaced along the outer surface of the upper portion of the vaginal insertion device 3100. Referring to FIG. 31D, a side view rotated 90 degrees from the view of FIG. 31C is shown. The ridges on the stem 244F can be separated from one another. The lowest ridge can be separated from the bottom of the vaginal insertion device 3100 by a distance Z of about 2.7 mm to about 3.1 mm, e.g., about 2.9 mm. The middle ridge can be separated from the lowest ridge by a distance Y of about 3.1 mm to about 3.5 mm, e.g., about 3.3 mm. The top ridge can be separated from the middle ridge by a distance X of about 3.1 mm to about 3.5, e.g., about 3.3 mm.

[0109] Referring to FIG. 31E, a side cross-sectional view of the vaginal insertion device 3100 is shown. The distance P from the bottom of the device to the base of the upper portion can be about 13 mm to about 14 mm, e.g., about 13.3 mm to about 13.7 mm, e.g., about 13.5 mm. The vaginal insertion device 3100 can have a length N of about 50 mm to about 76 mm, e.g., about 55 mm to about 71 mm, e.g., about 57 mm, 58 mm, 59 mm, 60 mm, 61 mm, 62 mm, 63 mm, 64 mm, 65 mm, 66 mm, 67 mm, 68 mm, or 69 mm, including about 58 mm or about 63 mm. The width M of the extension portion can be about 3.5 mm to about 4.1 mm, e.g., about 3.8 mm. The radius L of the rim can be about 4 mm to about 6 mm, e.g., about 5 mm.

[0110] Referring to FIG. 31F, a detailed view of the ridges on the stem 244F is shown. Each of the ridges can extend a distance Q from the stem 244F of about 0.4 mm to about 0.6 mm, e.g., about 0.5 mm. Each of the ridges can have a thickness R of about 0.7 mm to about 0.9 mm, e.g., about 0.8 mm. Referring to FIG. 31G, a cross-sectional view of the stem 244F is shown. The stem 244F can have an overall width T of about 6.6 mm to about 7 mm, e.g., about 6.8 mm, and an overall width C of about 6.6 mm to about 7 mm, e.g., about 6.8 mm. Each leg of the cruciform stem 244F can have a width W of about 1.3 mm to about 1.5 mm, e.g., about 1.4 mm. Referring to FIG. 31H, a bottom view of the device 3100 is shown.

[0111] 32A-32H, a vaginal insertion device 3200 is shown. The vaginal insertion device 3200 can be similar to the vaginal insertion device 100, except that the stem 244F can be the cross-shaped stem 244f of FIG. 21F (although the stem can be one of the stems 244a-244e and include two-dimensional stems 144 and 244b-244c). The vaginal insertion device 3100 can be similar to the vaginal insertion devices 2700, 2800, 2900, 3000, 3100, except that the sizing may be different. Thus, any of the variations, uses, modifications, or features described above with respect to any of the vaginal insertion devices herein can be used, applied, or modified for the vaginal insertion device 3200. For example, any of the variations, uses, modifications, or features with respect to the ribs 180, shapes, vent openings, etc. can be provided to the vaginal insertion device 3200. Additionally, any of the methods of use or accessories (e.g., carrying cases) may be applied to the vaginal insertion device 3200 as previously described. Referring to FIG. 32A, a perspective view of the vaginal insertion device 3200 is shown in which the ribs 180 are separated a distance below the top surface of the device 3200. The upper portion, rim, ribs, vent openings, methods of insertion, methods of rotation, methods of pressure adjustment, methods of use, and any other features or embodiments described herein may be provided to the vaginal insertion device 3200.

[0112] As depicted in FIG. 32A, due to the larger size of the vaginal insertion device 3200, additional rib sections can be provided to the ribs 180 such that there are six individual rib portions or individual rib members and six open portions 158. The additional rib portions can provide additional force to the organ wall as well as additional support for the device. The additional rib portions can help prevent and inhibit prolapse in the larger sized device 3200. That is, since the device 3200 has a larger opening inner diameter, the six rib portions of the ribs 180 can provide a smaller opening space than if only four rib portions were provided as in the prior embodiment. The smaller opening space can help prevent prolapse.

[0113] Referring to FIG. 32B, a top view of the vaginal insertion device 3200 is shown. The vaginal insertion device 3200 can have a diameter J of about 25 mm to about 50 mm, for example, about 30 mm to about 45 mm, about 30 mm to about 36 mm (including about 33 mm), about 34 mm to about 40 mm (including about 37 mm), about 39 mm to about 45 mm (including about 42 mm), including about 52 mm. The vaginal insertion device 3200 can have a width K of the rib 180 that is about 1 mm to about 1.6 mm, for example, about 1.3 mm. Each of the six portions of the cross-shaped rib can have a dimension K. Referring to FIG. 32C, a side view of the vaginal insertion device 3200 is shown. As described above with respect to the prior embodiment, the ridges and optional logo can be equidistantly spaced along the outer surface of the upper portion of the vaginal insertion device 3200. Referring to FIG. 32D, a side view rotated 90 degrees from the view of FIG. 32C is shown. The ridges on the stem 244F can be separated from one another. The lowest ridge can be separated from the bottom of the vaginal insertion device 3200 by a distance Z of about 2.7 mm to about 3.1 mm, e.g., about 2.9 mm. The middle ridge can be separated from the lowest ridge by a distance Y of about 3.1 mm to about 3.5 mm, e.g., about 3.3 mm. The top ridge can be separated from the middle ridge by a distance X of about 3.1 mm to about 3.5, e.g., about 3.3 mm.

[0114] Referring to FIG. 32E, a side cross-sectional view of the vaginal insertion device 3200 is shown. The distance P from the bottom of the device to the base of the upper portion can be about 13 mm to about 14 mm, e.g., about 13.3 mm to about 13.7 mm, e.g., about 13.5 mm. The vaginal insertion device 3200 can have a length N of about 50 mm to about 76 mm, e.g., about 55 mm to about 71 mm, e.g., about 57 mm, 58 mm, 59 mm, 60 mm, 61 mm, 62 mm, 63 mm, 64 mm, 65 mm, 66 mm, 67 mm, 68 mm, or 69 mm, including about 58 mm or about 63 mm. The width M of the extension portion can be about 3.5 mm to about 4.1 mm, e.g., about 3.8 mm. The width L of the rim can be about 4 mm to about 6 mm, e.g., about 5 mm.

[0115] Referring to FIG. 32F, a detailed view of the ridges on stem 244F is shown. Each of the ridges can extend a distance Q from stem 244F of about 0.4 mm to about 0.6 mm, e.g., about 0.5 mm. Each of the ridges can have a thickness R of about 0.7 mm to about 0.9 mm, e.g., about 0.8 mm. Referring to FIG. 32G, a cross-sectional view of stem 244F is shown. Stem 244F can have an overall width T of about 6.6 mm to about 7 mm, e.g., about 6.8 mm, and an overall width C of about 6.6 mm to about 7 mm, e.g., about 6.8 mm. Each leg of cruciform stem 244F can have a width W of about 1.3 mm to about 1.5 mm, e.g., about 1.4 mm. Referring to FIG. 32H, a bottom view of device 3200 is shown.

[0116] 33A-33L, a vaginal insertion device 3300 is shown. The vaginal insertion device 3300 can be similar to the vaginal insertion device described above in FIGS. 27-32, except that the stem 244g can be a flat, rectangular, two-dimensional stem. Thus, any of the variations, uses, modifications, or features described above with respect to any of the vaginal insertion devices herein can be used, applied, or modified for the vaginal insertion device 3300. For example, any of the variations, uses, modifications, or features with respect to the ribs 180, shape, vent openings, etc. can be provided to the vaginal insertion device 3300. Additionally, any of the uses or accessories (e.g., carrying case) can be applied to the vaginal insertion device 3300 as previously described. Referring to FIG. 33A, a perspective view of the vaginal insertion device 3300 is shown with the ribs 180 separated a distance below the top surface of the device 3300. The upper portion, rim, ribs, vent openings, methods of insertion, methods of rotation, methods of pressure adjustment, methods of use, and any other features or embodiments described herein can be provided in the vaginal insertion device 3300.

[0117] Referring to FIG. 33B, a top view of the vaginal insertion device 3300 is shown. The vaginal insertion device 3300 can have a diameter J of about 25 mm to about 50 mm, for example, about 30 mm to about 45 mm, about 30 mm to about 36 mm (including about 33 mm), about 34 mm to about 40 mm (including about 37 mm), about 39 mm to about 45 mm (including about 42 mm), including about 34 mm. The vaginal insertion device 3300 can have a width K of the rib 180 that is about 1 mm to about 1.6 mm, for example, about 1.3 mm. Each of the four portions of the cross-shaped rib can have a dimension K. Referring to FIG. 33C, a side view of the vaginal insertion device 3300 is shown. As described above with respect to the prior embodiment, the ridges and optional logo can be equidistantly spaced along the outer surface of the upper portion of the vaginal insertion device 3300. Referring to FIG. 33D, a side view rotated 90 degrees from the view of FIG. 33C is shown. The ridges on the stem 244g can be separated from one another. The lowest ridge can be separated from the bottom of the vaginal insertion device 3300 by a distance Z of about 2.2 mm to about 2.6 mm, e.g., about 2.4 mm. The middle ridge can be separated from the lowest ridge by a distance Y of about 2.0 mm to about 2.4 mm, e.g., about 2.2 mm. The top ridge can be separated from the middle ridge by a distance X of about 2.0 mm to about 2.4 mm, e.g., about 2.2 mm.

[0118] 33E, a side cross-sectional view of the vaginal insertion device 3300 is shown. The distance from the bottom of the device to the base of the upper portion can be a distance P of about 7 to about 8 mm, such as about 7.1 to about 7.4 mm, such as about 7.3 mm. The vaginal insertion device 3300 can be about 45 mm to about 75 mm, such as about 50 mm to about 70 mm, such as about 54 mm to about 58 mm, such as about 54.5 mm to about 58.4 mm, such as about 46 mm, 46.5 mm, 48 mm, 48.5 mm, 50 mm, 50.5 mm, 52 mm, 52.5 mm, 54 mm, 54.5 mm, 56 mm, 56.5 mm, 58 The length N may be from about 56.4 mm ±1 mm, or may be from about 58.5 mm, 60 mm, 60.6 mm, 62 mm, 62.5 mm, 63 mm, 63.5 mm, 64 mm, 64.5 mm, 66 mm, 66.5 mm, 68 mm, 68.5 mm, 70 mm, 70.5 mm, 72 mm, 72.5 mm, 74 mm, 74 / 5 mm ±1 mm or ±.1 mm, inclusive. The width M of the extension portion may be from about 3.5 mm to about 4.1 mm, for example about 3.8 mm. The width L of the rim may be from about 4 mm to about 6 mm, for example about 5 mm.

[0119] Referring to FIG. 33F, a detailed view of the ridges on stem 244g is shown. Each of the ridges can extend a distance Q from stem 244g of about 0.4 mm to about 0.6 mm, e.g., about 0.5 mm. Each of the ridges can have a thickness R of about 0.7 mm to about 0.9 mm, e.g., about 0.8 mm. Referring to FIG. 33G, a top view of stem 244g is shown. Stem 244g can have an overall width T of about 5.8 mm to about 6.2 mm, e.g., about 6.0 mm, and an overall width V of about 2.1 mm to about 2.5 mm, e.g., about 2.3 mm. Referring to FIG. 33H, a bottom view of device 3300 is shown.

[0120] 33I-33L, a perspective view of the device 3300 is shown. As shown, the stem 244g can be aligned with the ribs 180. That is, a plane extending through the longitudinal center of the stem 244g can extend through the longitudinal center of at least a portion of the ribs. As shown in FIG. 34I, the stem 244g is thereby aligned with one rib 180 and perpendicular to the other rib 180. This alignment allows the device to be positioned within the vagina. This alignment can allow the user to know by simply touching the stem that the rib is aligned with the inner vaginal wall or that the rib is misaligned with the inner vaginal wall. The alignment can help control the pressure applied by the device and the support provided.

[0121] Referring to Figs. 34-38, vaginal insertion devices 3400, 3500, 3600, 3700, and 3800 are shown, respectively. The vaginal insertion devices can be similar to the vaginal insertion device described above in Fig. 33 with different overall outer diameters. Thus, any of the variations, uses, modifications, or features described herein with respect to any of the vaginal insertion devices can be used, applied, or modified for the vaginal insertion devices of Figs. 34-38. For example, any of the variations, uses, modifications, or features with respect to ribs 180, shape, vent openings, etc. can be provided to the vaginal insertion devices of Figs. 34-38. Additionally, any of the uses or accessories (e.g., carrying cases) can be applied to the vaginal insertion devices of Figs. 34-38 as previously described. Referring to Figs. 34A-38A, a perspective view of a vaginal insertion device is shown with ribs 180 separated a distance below the top surface of the device. The upper portion, rim, ribs, vent openings, insertion method, rotation method, pressure adjustment method, use method, and any other features or embodiments described herein may be provided for this vaginal insertion device. Referring to Figs. 34B-38B, side views of the vaginal insertion device are shown. As described above with respect to the prior art embodiment, the ridges and optional logo may be equidistantly spaced along the outer surface of the upper portion of this vaginal insertion device. Referring to Figs. 34C-38C, side views rotated 90 degrees from the views of Figs. 34B-38B are shown. The ridges on the stem 244g may be separated from each other. Referring to Fig. 34D, a side cross-sectional view of the vaginal insertion device is shown.

[0122] The vaginal insertion device can have a diameter J of about 25 to about 50 mm, e.g., about 30 to about 45 mm, about 30 to about 36 mm (including about 33 mm), about 34 to about 40 mm (including about 37 mm), about 39 to about 45 mm (including about 42 mm), including about 30 mm (FIG. 34), about 38 mm (FIG. 35), 42 mm (FIG. 36), 48 mm (FIG. 37), and about 52 mm (FIG. 38). Dimensions K, L, M, N, P, Q, R, T, V, X, Y, and Z can be the same or in the same range for all of FIGS. 33-38. Alternatively, any of these dimensions can vary between sizes to accommodate the varying anatomy of women. For example, in smaller diameter devices, stem height, length, rim and / or ridge width, or combinations thereof can be sized differently (e.g., smaller) than devices having larger diameters. In each of Figures 33-38, the stem 244g can be aligned with the ribs 180 as described above in Figures 33I-33L. As described above, the device can include more than four ribs, such as six ribs. For example, in the larger size of Figures 37 and 38, six ribs can be provided in the manner described above.

[0123] 39-41, the vaginal insertion devices of FIGS. 16-20 and 26-38 can be inserted into the vagina 18 as described above with respect to FIGS. 11-13. For example, a device such as device 3400 can be inserted into the vagina to apply pressure to the urethral sphincter 16. Pressure can be applied to the bladder neck. As can be seen in FIG. 40, device 3400 can apply pressure when the bladder is full so that there is little or no leakage. In FIG. 40, it is shown where device 3400 supports a full bladder, thereby further improving, preventing, eliminating or inhibiting prolapse. Support and assistance to prevent prolapse can be due to pressure applied by the ribs and / or rims of the device. FIG. 41 shows device 3400 inserted into vagina 18 to support a prolapsed uterus to manage, improve, prevent or eliminate uterine prolapse.

[0124] In an exemplary embodiment, the vaginal insertion device of the present disclosure can be used during exercise or other activity. For example, the vaginal insertion device can be inserted into the body in the manner described above before (e.g., 5 to 60 minutes before) walking, running, strength training, cardiovascular activity, kickboxing, or other high-intensity activity. The vaginal insertion device can hold or support the pelvic organs, bladder, and / or rectum during the activity. The vaginal insertion device can prevent, eliminate, or inhibit organ prolapse or displacement during the activity. The user can insert the vaginal insertion device into the body before performing the activity. The activity may cause abdominal pressure to exert pressure on the pelvic organs, bladder, and / or rectum. In the absence of the device, the abdominal pressure or pressure associated with the activity may cause the pelvic organs, bladder, and / or rectum to displace and / or prolapse, and may further cause discomfort to the user during the activity. The vaginal insertion device may support the pelvic organs, bladder, and / or rectum, such as to relieve, support, contain, or eliminate discomfort, abdominal pressure, or pressure caused by activity on the organs. A user may use the vaginal insertion device only during activity or during both rest (e.g., sleeping, resting, sitting) and activity. In embodiments, a user may use one size device during activity and another size device during less active or resting times. For example, a user may use a larger size device during activity and a smaller size device during less active or resting times.

[0125] Referring to FIG. 42, a kit 4000 is shown. The kit 4000 may include one or both of a storage kit 4100 and a vaginal insertion kit 4200. The storage kit 4100 may include a carrying case 4120 and an optional brush 4110. The carrying case 4120 may be the carrying case described above and may include a drying kit described above. The brush 4110 may be the brush described above. The vaginal insertion kit 4200 may include multiple vaginal insertion devices 4210, 4220, and 4230. The multiple devices may be provided in multiple sizes. In this manner, a user may select a desired size for a particular application or performance. For example, a user may select a larger sized device for more support in one application and a smaller sized device for support in another application. The vaginal insertion devices 4210, 4220, 4230 may be various sizes or styles of any of the vaginal insertion devices described above. Alternatively, the kit 4000 may provide multiple vaginal insertion devices of the same size.

[0126] In an embodiment, the kit 4000 may include the storage kit 4100 and the vaginal insertion kit 4200 in a single compartment of the kit 4000. In some embodiments, the kit 4000 is a box with a lid that is attached or detachable.

[0127] The vaginal insertion devices 40, 100, 200 or any of the vaginal insertion devices of Figures 27-38 can be formed of one or more materials and portions that allow the device to collapse, fold, or compress when pressed by the patient for insertion into the vagina or to be collapsible or small for storage. The peak folding force can be from about 1.5 lbf to about 1.9 lbf, e.g., about 1.7 lbf. The peak folding force can be from about 1.8 lbf to about 2.4 lbf, e.g., about 2.1 lbf for a material that is 40% harder than a material exhibiting a peak folding force of 1.7 lbf. Once inside the vagina, the device can move or expand from the folded or compressed configuration during insertion back to an original configuration, e.g., as seen in Figure 16. The durometer or hardness of the material (e.g., a non-absorbent material such as silicone), density, size, shape, and durability selected for the vaginal insertion devices 40, 100, 200 can be selected based on the desired compressibility and crushability of the device and / or the pressure applied to the urethral sphincter, bladder neck, or rectum. The durometer or hardness of the material (e.g., silicone) can be lower or softer for one size of vaginal insertion device and / or harder for a different size of vaginal insertion device.

[0128] The device can be made of one material. However, some embodiments can be made of multiple pieces and / or made from one different material or a combination of different materials and can be detachable or attachable. The device can be disassembled and reassembled for cleaning, sterilization, or for the introduction of various technologies such as drug impregnation, weight or indicator strips, or Bluetooth chips, radio, microwave, or Wi-Fi connectivity.

[0129] If ribs 180 are provided, a softer or harder material may be used. A softer or harder material (e.g., silicone) may allow for a more comfortable wear while the ribs 180 provide additional pressure. That is, the ribs 180 may accommodate the pressure applied by the softer or harder material, thereby allowing for a more comfortable and effective device.

[0130] The vaginal insertion device of the present disclosure can have multiple functions. The main function of the device can be to support the urethral sphincter, bladder neck, or bowel to reduce, prevent, treat, and / or eliminate incontinence or to prevent prolapse or support prolapsed organs, as previously described. Alternatively, the device can be a commercially available device, but the device can be impregnated with drugs such as prescription or non-prescription homeopathic medicines or substances to treat conditions related to hormone levels, sexually transmitted diseases, yeast infections, birth control, spermicidal, and other beneficial substances such as anti-fungal or anti-infective substances to slow bacterial, fungal growth, or disease. The device can secrete substances or drugs. The device can provide for hormone replacement therapy. Thus, the device can have the function of drug delivery to the vaginal cavity, for example, with a controlled non-transient or sustained release profile. Drug delivery can be achieved by releasing the drug from the exterior or interior surface of the device, which can be made of one or more materials or components that can be detachable or attachable. The device may include diagnostic capabilities such as by including an attachable / removable or fixed indicating strip that can determine hormone levels, ovulation levels, pH levels, pelvic floor or muscle strength or such an indicating strip as an early detection component to achieve health benefits. The device may have a detachable component for use during the menstrual cycle or after or before sexual activity. The device may have a detachable component, e.g., weights, used to exercise the pelvic floor. These embodiments may be non-prescription, however parts or embodiments of the device may be for drug delivery or for use as indicators for diagnosis of diseases and conditions.

[0131] The vaginal insertion device of the present disclosure can further include weights that can be added or removed or can be constructed of weighted material that can exercise the pelvic floor muscles during exercises or Kegels, or simply encourage the end user to hold the device in place while the end user goes about their daily life, thereby exercising the muscles.

[0132] The vaginal insertion device of the present disclosure may include weights, small balls, stainless steel small balls, indicator strips, pressure sensors, nanotechnology, or other addenda described herein. When additional features or components are included in the vaginal insertion device of the present disclosure, these addenda may be placed in a mold prior to injection molding (or other process) so that the features or components are integral with the device, and / or may be inserted with material during injection molding (or other process) to make the features or components integral with the device. Alternatively, the additional features or components may be secured to the device by post-processing such as fastening, adhering, bonding, or joining to the device, the device walls, a depression or recess formed in the device specifically for the component, or the like.

[0133] The vaginal insertion device of the present disclosure can be formed of a material that changes color based on the number of uses and / or based on the state of the vaginal environment (e.g., pH level) or the state of the device itself. That is, the user has the potential to remove the device and know based on the color that it is time to clean, recharge, replace, and / or discard the device. The user can also remove the device, which can include diagnostic features that indicate that the user is ovulating, has a yeast infection, a sexually transmitted disease, certain hormone levels (e.g., unhealthy hormone levels), and / or an infection, etc.

[0134] The vaginal insertion device of the present disclosure can be embedded with a chip that communicates with Bluetooth capabilities, Wi-Fi capabilities, radio waves, microwaves, or other technologies. Thus, the user has the potential to communicate with a mobile device such as a phone or tablet. For example, the device can communicate pH levels or other usage indications so that the user knows when it is time to clean, recharge, replace, and / or discard it. The device can communicate the number of pelvic floor exercises performed and can be used to track pelvic floor strength. The device can communicate the vaginal environment and can be used to diagnose disease. The device can be equipped with apps for mobile or other technologies to monitor ovulation, urethral sphincter strength, or pelvic floor strength. The device can be used for Wi-Fi. Furthermore, when the device is worn during exercise, the device can immobilize the organs and prevent further prolapse due to prolonged strenuous constant movement such as running.

[0135] The vaginal insertion device of the present disclosure can prevent further movement of the organ and hold the organ in place. The rim, cone shape, and ridges cooperate to exert pressure against the urethral sphincter, bladder neck, or intestine to prevent displacement of the organ. The devices 40, 100 described herein can exert pressure against the urethral sphincter, bladder neck, or intestine. The device can be adjustable so that it is comfortable for the user to wear. The device can be adjusted by movement of the stem. Over time, the device in place can reduce the probability of further prolapse when the user is active, for example, during running, walking, hand-raising exercises, etc.

[0136] The vaginal insertion device of the present disclosure can capture or collect vaginal secretions. The vaginal secretions can be evaluated either by the device or by a clinician after removal. The secretions can be used to diagnose sexually transmitted diseases, whether a woman is pregnant or ovulating, hormone levels, yeast infections or other non-sexually transmitted diseases, abnormal cells, interstitial cystitis, and can help manage interstitial cystitis. In embodiments, the device of the present disclosure does not create a seal or suction, but the device can collect some amount of secretions. In contrast to menstrual cups, which are intended to collect all menstrual fluid, the device of the present disclosure can collect a sample of secretions for diagnosis and evaluation.

[0137] The removal portion of the present disclosure can be composed of multiple parts and one, two or a combination of detachable, attachable, contractible and expandable materials. The stem can rotate and / or click into place to adjust the tension or size of the device. The stem can be used to change the orientation of the device. The stem can also have markings that correlate with the placement or strength of the device, such as arrows or number systems protruding therefrom. The markings can have holes in them to be used as indicators or with drying racks. When the stem is rotated, the vaginal insertion device can increase or decrease pressure. The vaginal insertion device can include attachable and / or replaceable weights. The vaginal insert can include strips or other accessories that can determine ovulation, pH levels, etc.

[0138] Although the vaginal insertion device of the present disclosure is depicted herein as including ribs and rib sections or rib members, in other embodiments, the vaginal insertion device of the present disclosure does not include ribs and rib sections or rib members. For example, in one instance of a vaginal insertion device that does not include ribs and rib sections or rib members, the device includes a rim that can exert sufficient pressure or force on the urethral sphincter, bladder neck, bowel, and / or vaginal wall to provide pelvic organ support to the patient when it is inserted into the patient. In an embodiment, the rim includes one or more portions that exert a higher pressure or force than other portions. The one or more portions that exert a higher pressure or force can be thicker, more strongly reinforced, or made of a material with a higher hardness (e.g., harder silicone) than other portions of the device. The one or more portions of the rim that impart the higher pressure or force may be aligned with the stem (in much the same way that ribs and rib sections or rib members may be aligned with the stem as described herein) so that the user has the ability to orient the one or more portions of the rim that impart the higher pressure or force to a location adjacent the vaginal wall that provides pelvic organ support, such as a location closer to the urethral sphincter, bladder neck, or intestine.

[0139] Although the vaginal insertion device of the present disclosure is depicted herein as including one or more hollow portions 58, 158 therein (e.g., between rib sections or rib members), in other embodiments, the vaginal insertion device of the present disclosure does not include such hollow portions, but is solid or semi-solid, for example, by being filled with the same material as the vaginal insertion device (e.g., silicone of the same or different hardness) or one or more different materials (e.g., foam or gel). A solid or semi-solid vaginal insertion device can still be crushed or deformed for easier insertion of the device, and then the device can resume its original shape after insertion. In one embodiment, the vaginal insertion device includes ribs, which can be divided into multiple rib sections or rib members to add support as described herein, and further includes a filler material in the hollow portion 158 between these rib sections or rib members. In alternative embodiments, the vaginal insertion device does not include ribs, but includes a filler material in the hollow portion 58. In some instances of such alternative embodiments, the device includes a rim having one or more portions that exert a higher pressure or force than other portions as described herein. In embodiments, the upper portion may be closed, covered, or otherwise blocked so that the inside of the device (either the hollow, solid, and / or semi-solid portions) is not exposed to the atmosphere and / or to the inside of the vagina during insertion.

[0140] According to an embodiment, the present disclosure provides a method of applying pressure or force to a location on a vaginal wall of a patient, comprising inserting a vaginal insertion device into the patient's vagina and aligning or orienting a portion of the vaginal insertion device that applies the force or pressure to a location on the vaginal wall of the patient such that the portion is adjacent to the location. In certain embodiments, the location on the vaginal wall is proximate to the urethral sphincter, the bladder neck, or the intestine. In some embodiments, applying pressure or force to the location on the vaginal wall applies pelvic organ support to the patient. In certain cases, the vaginal insertion device includes a rib or one or more rib sections or rib members as described herein, and the portion of the vaginal insertion device that applies the force or pressure corresponds to a location where the rib or one or more rib sections or rib members join an inner wall of the device. In some embodiments, the vaginal insertion device includes a rim (e.g., a rim that is circular in plan view as described herein), and the portion of the vaginal insertion device that applies the force or pressure corresponds to one or more portions of the rim that apply a higher pressure or force than other portions of the rim. In an embodiment, the vaginal insertion device includes a stem that is aligned with the portion of the vaginal insertion device that applies the force or pressure as described herein. In certain cases, directing the portion of the device that exerts the force or pressure includes rotating the device, such as by rotating a stem. In embodiments, the vaginal insertion devices of the present disclosure can include components or features that align the device with the pelvic floor, or the device itself can align with the pelvic floor.

[0141] One embodiment of the vaginal insertion device can be made from one material or one part, while other embodiments can be made from multiple parts and / or multiple materials. These parts can include accessories such as detachable accessories. These parts can be, for example, additional parts related to the menstrual cycle, for adding weights to exercise the pelvic floor, indicator strips for determining ovulation or pH levels, or compounds or parts of material for administering medication. The device or its parts can be expandable and contractible. The device can be semi-permeable to allow liquids, lubricants, or medications to pass through.

[0142] According to an embodiment, a vaginal insertion device for managing, treating, ameliorating, reducing, eliminating, or preventing incontinence may include an upper portion having a cone-shaped body, an outer wall, and an inner wall, a stem extending from a base of the upper portion, one or more first ridges projecting outwardly from the outer wall, and a rib projecting inwardly from the inner wall and configured to apply pressure to an organ wall. The stem may include one or more second ridges projecting outwardly from an outer surface of the stem. The stem may be one of a cone, a triangle, a flat, or a cross. The one or more first ridges may be one or more of a stud, a knob, a button, a word, a number, a symbol, a logo, a circle, a semicircle, a protrusion, a polygon, a triangle, a square, or a combination thereof. The rib may include a plurality of intersecting ribs. The rib may be a cross, a "T" shaped, an "X" shaped, a "Y" shaped, a "K" shaped, a "V" shaped, a triangle, or a pentagon. The ribs may be star-shaped and may connect at one central location, more than one location, or not connect at all. The ribs may protrude from the outer wall and extend from near the rim to the base of the upper portion. There may be one or more vent openings in at least one of the upper portion or the ribs. The device may support an organ wall, which may be at least one of a urethral wall, a bladder wall, a colon wall, or a rectal wall.

[0143] According to an embodiment, a kit for reducing or eliminating incontinence may include one or more of a first vaginal insertion device, a carrying case including a base and a cover, and a drying rack, as well as an optional brush and cleanser. The kit may include a second vaginal insertion device (larger or smaller) having a different outer diameter than the first vaginal insertion device. The first vaginal insertion device may be one of a plurality of vaginal insertion devices, each having the same or different outer diameter, durometer or hardness, shape, density, size, or durability. The base may have a curved lower surface configured to rest flat on a surface. The cover may have a substantially cylindrical lower portion and a substantially hemispherical upper portion, and is configured to mate with the base. The rim of the first vaginal insertion device may be configured to fit over or mate with the upper surface of the base. The cover may be configured to fit over the first vaginal insertion device and fit over or mate with the second upper surface of the base. The drying rack may, in an embodiment, include a cylindrical base having one or more of a plurality of holes, one or more protrusions, and one or more latches.

[0144] According to embodiments, a method of reducing or eliminating incontinence in a female patient can include inserting a vaginal insertion device described herein into the patient's vagina. For example, the method can include inserting a vaginal insertion device having a body, a rim, a rib, and a stem into the vagina and applying pressure to an organ wall with the rim and rib of the vaginal insertion device. The method can include adjusting the pressure applied to the organ wall including rotating the vaginal insertion device by rotating the rib.

[0145] According to embodiments, a method of regulating pressure on a wall of a patient's organ can include inserting a vaginal insertion device described herein into a patient. For example, the method can include inserting a vaginal insertion device into a patient, aligning ribs of the vaginal insertion device with the organ wall, and reducing pressure on the organ wall by rotating the vaginal insertion device to bring the ribs and the organ wall out of alignment. The rotating step can be performed using a stem extending from the vaginal insertion device. The device can expand or contract when rotated to regulate pressure on the vaginal wall.

[0146] According to embodiments, a method for adjusting pressure on an organ wall can include inserting a vaginal insertion device, misaligning ribs of the vaginal insertion device with the organ wall, and increasing pressure against the organ wall by rotating the vaginal insertion device to align the ribs with the organ wall. The rotating step can be performed using a stem extending from the vaginal insertion device. The device can expand or contract when rotated to adjust pressure against the vaginal wall.

[0147] Current menstrual cup products cannot be used to prevent, reduce, or eliminate incontinence. The cervix or bladder may become lodged in the menstrual cup of the device creating suction. The woman may pull on the organs and cause injury to herself when trying to remove the device. The internal ribs and / or vents of the vaginal insertion device of the pending present disclosure eliminate the risk of organs becoming lodged in the device as well as the risk of suction to the cervix or bladder. The additional support added by the vaginal insertion device of the pending present disclosure is beneficial with regard to patient safety, especially for patients who have cervical atrophy or no cervix at all, as is common, and for patients whose bladders will or do drip or descend through the vagina (prolapse).

[0148] Menstrual cups are intended to create a seal against the cervix, thereby creating suction. By creating a seal, the possibility of blood leakage is eliminated. Such suction may result in the user pulling on their organ during removal. Therefore, in certain embodiments of the devices disclosed herein, holes are provided on either the bottom or sides of the device to prevent suction. In some embodiments, the vaginal insertion device of the pending disclosure supports the cervix. The vaginal insertion device of the pending disclosure may exert pressure (therapeutic force) through the vaginal canal against the urethral sphincter. In contrast, the menstrual cup does not exert pressure against the urethral sphincter. In addition, the menstrual cup may seal against the organ wall and prevent blood flow outside the menstrual cup. The vaginal insertion device of the present disclosure does not need to be liquid-tight and / or seal against the organ wall. In fact, such a seal / liquid-tightness may result in the suction described above.

[0149] By the teachings of the present disclosure, disadvantages and problems associated with known pessaries may be substantially reduced or eliminated.

[0150] According to an embodiment of the present disclosure, a vaginal insertion device for use in managing, ameliorating, eliminating, or preventing symptoms associated with pelvic organ prolapse, urinary or fecal incontinence, or both pelvic organ prolapse and urinary / fecal incontinence can include an upper portion made of a resilient and non-absorbent material, having a circular cross-section throughout its length, having a conical body having a wall with an inner side and an outer side, an open upper end, a lower end, and a hollow interior, the circumference of the upper portion decreasing from the open upper end to the lower end, the open upper end of the upper portion being the innermost portion of the vaginal insertion device during insertion, the wall of the upper portion can be compressed to pack the upper portion more compactly for easier insertion of the vaginal insertion device, and after insertion the wall expands back to its original shape. Such a vaginal insertion device can further include an optional external rim surrounding and projecting from the outside of the wall of the upper portion adjacent the open upper end, and a plurality of ridges surrounding and projecting from the outside of the wall of the upper portion spaced from the open upper end to the lower end.

[0151] In certain embodiments, the present disclosure relates to a vaginal insertion device for use in managing, ameliorating, eliminating, treating, and / or preventing symptoms associated with pelvic organ prolapse, urinary incontinence, and / or fecal incontinence, or any combination thereof. In some cases, the device includes an upper portion, optionally made of elastic and / or non-absorbent material. In some embodiments, the upper portion has one or more of the following features: a body, a circular or elliptical cross-section over all or part of its length, a wall having an inner side and an outer side, an open top end, a bottom end, and a hollow or semi-hollow interior. In certain embodiments, the body has a conical shape, with the bottom of the cone corresponding to the open top end, and the cone gradually tapers to the bottom end. In some cases, the circumference of the upper portion decreases from the open top end to the bottom end. In certain embodiments, the open top end of the upper portion is the innermost portion of the vaginal insertion device during insertion, i.e., the upper portion is the portion of the device that is inserted into the vagina first. In certain cases, the wall of the upper portion can be crushed to pack the upper portion more compactly for easier insertion of a vaginal insertion device. In some embodiments, the wall expands back to its original shape after insertion. The vaginal insertion device can further include an optional exterior rim surrounding and projecting from the exterior of the wall of the upper portion adjacent the open top end. In some embodiments, the device includes a plurality of ridges surrounding and projecting from the exterior of the wall of the upper portion and spaced (regular, irregular, increasing or decreasing intervals) from the open top end to the bottom end.

[0152] According to these and other embodiments of the present disclosure, the vaginal insertion device can include an extraction portion extending from the lower end of the upper portion, which can be accessed from outside the vagina when the vaginal insertion device is inserted into the vagina and aids in the extraction of the vaginal insertion device from the vagina. The extraction portion can be a string or a stem. In embodiments where the extraction portion is a stem, the stem can extend from the lower end of the upper portion, and the upper portion and the stem can be an integral one-piece, but can have multiple detachable device portions made of elastic and non-absorbent material or other materials, and the stem has a circular cross section throughout its length, a conical body with a wall, an upper end, an open lower end, and a hollow interior, and the circumference of the stem increases from the upper end to the open lower end. The extraction portion can also have multiple ridges, similar to the upper portion.

[0153] In some embodiments, the present disclosure relates to a vaginal insertion device that includes an extraction portion extending from a lower end of the body of the device. In certain embodiments, the extraction portion is accessible from the outside of the vagina when the vaginal insertion device is inserted into the vagina. In some cases, the extraction portion assists in the extraction of the vaginal insertion device from the vagina. The extraction portion can be a string, stem, tab, flap, or other protrusion from the lower end of the body of the device. In certain cases, the body of the device (including, for example, the upper portion) and the extraction portion (when, for example, the stem, tab, or flap) can be a unitary structure, such as a one-piece molded silicone structure. In some embodiments, the unitary structure can have multiple detachable portions made of elastic and / or non-absorbent materials or other materials. In certain embodiments, the extraction portion (when, for example, the stem, tab, or flap) has one or more of the following features: a body, a circular cross-section over all or part of its length, a wall, a top end, an open bottom end, and a hollow or semi-hollow interior. In certain embodiments, the body has a conical shape, e.g., a conical shape that tapers from the base to the area where it joins the body of the device, e.g., the upper portion. In some cases, the circumference of the removal portion (e.g., when a circular stem, tab, or flap) increases from the top end to the open bottom end. The removal portion can include a number of ridges, nubs, bumps, divots, or other structured surface features on the exterior of the removal portion, which can facilitate gripping of the removal portion (and thus the device) by the user's fingers. In some embodiments, the removal portion has a rectangular or box shape that protrudes from the bottom portion of the body of the device.

[0154] In accordance with these and other embodiments of the present disclosure, the vaginal insertion device can include one or more vent openings (e.g., holes, slits, gaps, or openings). The vent openings can be located at the point where the lower end of the upper portion intersects with the stem. The one or more vent openings can be located in a wall or rim on the upper portion. The vent openings can be used as a position indicator, for venting, or both as a position indicator and for venting.

[0155] In accordance with these and other embodiments of the present disclosure, the vaginal insertion device can include an optional external rim, optionally circular, having a first section and a second section. In certain cases, the first section protrudes a greater distance from the outside of the wall of the upper portion than the second section. The rim can be of various sizes and thicknesses. The rim can be thinner on one side and thicker on the other side. The rim can expand or contract to achieve therapeutic force and support.

[0156] In accordance with these and other embodiments of the present disclosure, the vaginal insertion device can include an applicator that is used during insertion and / or removal of the device. In some embodiments, the applicator confines at least the upper portion when the upper portion is in a more compact configuration. The applicator can be attached to the device and detached therefrom. The applicator can act as an indicator for positioning, expanding, and / or contracting the device. The applicator can have indicators for positioning, such as ridges, arrows, bumps, protrusions, lettering, or number systems. The applicator can have indentations or holes to indicate position. The applicator and device can snap into place or otherwise clamp together.

[0157] Those skilled in the art will be able to readily understand the medical and other advantages of the present disclosure from the figures, specification, and claims contained herein, and the object and advantages of these embodiments will be realized and attained at least by the elements, features, and combinations particularly pointed out in the claims.

[0158] Those skilled in the art will understand that the disclosure of the present invention encompasses all interchangeable, permutation, variation, modification, and alteration of the exemplary embodiments herein. Likewise, those skilled in the art will understand that the claims encompass, where appropriate, all interchangeable, permutation, variation, modification, and alteration of the exemplary embodiments herein. Furthermore, references within the claims to an apparatus, device, or system, or a component, section, or portion thereof, adapted, positioned, functional, configured, enabled, operable, or operative to perform a particular function, encompass such apparatus, device, system, or component, so long as such apparatus, system, device, or component is so adapted, positioned, functional, configured, enabled, operative, or operative, regardless of whether such or such particular function is used, activated, turned on, or unlocked.

[0159] All examples and conditional language described in this specification are intended for teaching purposes to help the reader understand the disclosure of the present invention and further understand the concepts contributed by the inventor to advance the art, and should not be construed as being limited to such examples and conditions specifically described. Although the embodiments of the disclosure of the present invention have been described in detail, it should be understood that various exchanges, substitutions, and modifications can be made to these embodiments without departing from the spirit and scope of the disclosure of the present invention. [Explanation of symbols]

[0160] 3500 Vaginal insertion device

Claims

1. 1. A vaginal insertion device for ameliorating, managing, treating, preventing, and / or eliminating symptoms associated with pelvic organ prolapse, urinary incontinence, fecal incontinence, or a combination thereof, comprising: a conical body configured to apply pressure on an organ wall; a member extending within an interior of the conical body and configured to apply the pressure to the organ wall; a stem configured to adjust the pressure applied to the organ wall; Including, 13. A vaginal insertion device, comprising: in a first position, the member is aligned with the organ wall and a first pressure is applied to the organ wall; and in a second position, the member is not aligned with the organ wall and a second pressure is applied to the organ wall, the first pressure being greater than the second pressure.

2. 2. The vaginal insertion device of claim 1, wherein the stem is configured to correlate with the member such that rotation of the stem adjusts the pressure applied by the member to the organ wall.

3. 2. The vaginal insertion device of claim 1, wherein the member is a rib extending radially inward from an inner wall of the conical body and longitudinally downward from a location near the top of the conical body.

4. the rib is cross-shaped in plan view and the stem is substantially flat and creates a plane; the cross and the plane of the rib are aligned such that the position of the stem correlates with the position of the rib relative to the organ wall. The vaginal insertion device according to claim 3 .

5. In plan view, the member is a cruciform rib having four ends; Each of the four ends mates with an inner wall of the conical body; The vaginal insertion device according to claim 3 .

6. 6. The vaginal insertion device of claim 1, wherein the conical body is configured to apply an adjustable therapeutic force to the organ wall corresponding to a force configured to ameliorate, manage, treat, prevent, and / or eliminate symptoms associated with pelvic organ prolapse, urinary incontinence, fecal incontinence, or a combination thereof.

7. 7. The vaginal insertion device of claim 6, wherein the organ wall is one of a urethral sphincter, a bladder neck, a rectal wall, a uterine wall, or a combination thereof.

8. The vaginal insertion device of claim 1, wherein the stem extends downwardly from an upper portion having the conical body and has a substantially flat shape.

9. 10. The vaginal insertion device of claim 8, wherein the stem further comprises a plurality of ridges extending from an outer surface of the stem.

10. 10. The vaginal insertion device of claim 9, wherein the plurality of ridges are evenly spaced from the bottom end of the stem.

11. 11. The vaginal insertion device of claim 9 or 10, wherein each of the plurality of ridges has the same thickness.

12. 12. The vaginal insertion device of claim 9, wherein each of the plurality of ridges extends around a circumference of the stem.

13. 13. The vaginal insertion device of any one of claims 8 to 12, wherein the stem is configured to regulate the pressure applied by the vaginal insertion device on an organ wall.

14. 14. The vaginal insertion device of claim 8, wherein the stem and the upper portion are integrally formed from the same material.

15. 15. The vaginal insertion device of any one of claims 8 to 14, wherein the stem is configured to be grasped by a user to insert, remove and / or position the vaginal insertion device within the vagina.

16. 16. The vaginal insertion device of any one of claims 8 to 15, wherein the stem is configured to allow positioning, rotation, or both of the vaginal insertion device while the vaginal insertion device is inserted into the vagina.

17. 2. The vaginal insertion device of claim 1, wherein the member and the stem are aligned such that rotation of the stem is configured to adjust the pressure applied by the member on the organ wall.

18. 1. A vaginal insertion device, comprising: a body having an open top, a wall and a hollow interior within the wall; and a member within the hollow interior of the body; the member is configured to apply pressure through the wall onto an inner vaginal wall; in a first position, the member is aligned with the inner vaginal wall and a first pressure is applied to the inner vaginal wall, and in a second position, the member is not aligned with the inner vaginal wall and a second pressure is applied to the inner vaginal wall, the first pressure being greater than the second pressure; The pressure is configured to ameliorate, manage, treat, prevent, and / or eliminate symptoms associated with pelvic organ prolapse, urinary incontinence, fecal incontinence, or a combination thereof. A vaginal insertion device.

19. 20. The vaginal insertion device of claim 18, wherein the wall has an inner diameter that gradually decreases from the open top end to the base of the body.

20. 20. The vaginal insertion device of claim 19, wherein the member is connected to an interior side of the wall and extends from the open top end to the base.

21. 20. The vaginal insertion device of claim 18 or 19, wherein the member is connected to an interior side of the wall adjacent the open top end.

22. 22. The vaginal insertion device of claim 21, wherein the member is not connected to a base.

23. 23. The vaginal insertion device of any one of claims 18 to 22, wherein the member extends between diametrically opposed sides of the wall.

24. a second member extending between opposite sides of the wall; said member and said second member are perpendicular such that a cross is formed in plan view; 24. The vaginal insertion device of claim 23.

25. 25. The vaginal insertion device of any one of claims 18 to 24, wherein the body is a cone-shaped body having a diameter that decreases from the open top end to a base.

26. A case for the vaginal insertion device of claim 1, comprising: a base configured to hold the vaginal insertion device; and A cover configured to interact with the base to enclose the vaginal insertion device of claim 1 ; A case comprising:

27. 27. The case of claim 26, wherein the base includes a plurality of openings in a bottom surface, the openings configured to eject water or liquid from above the bottom surface to below the bottom surface.

28. 28. The case of claim 26 or claim 27, wherein the base is configured to act as a drying rack for the vaginal insertion device.

29. 29. The case of any one of claims 26 to 28, wherein the base includes a plurality of protrusions extending upwardly from a bottom surface configured to retain the vaginal insertion device on the base.

30. 30. A case as claimed in any one of claims 26 to 29, wherein the base includes one or more grooves configured to interact with one or more protrusions on the cover, the cover having a first position in which the one or more protrusions are engaged with a respective one of the one or more grooves to lock the cover to the base, and a second position in which the one or more protrusions are disengaged from the respective one of the one or more grooves such that the cover is unlocked from the base.

31. 31. The case of any one of claims 26 to 30, further comprising one or more latches for retaining the vaginal insertion device on the base.

32. 1. A kit for ameliorating, managing, treating, preventing, and / or eliminating symptoms associated with pelvic organ prolapse, urinary incontinence, fecal incontinence, or a combination thereof, comprising: a first vaginal insertion device having a first outer diameter; a second vaginal insertion device having a second outer diameter; and Including, the first outer diameter is different from the second outer diameter; 13. A kit, comprising: at least one of the first vaginal insertion device or the second vaginal insertion device, the vaginal insertion device of claim 1.

33. 33. The kit of claim 32, wherein the first vaginal insertion device and the second vaginal insertion device are selected to accommodate changing vaginal conditions of a user.

34. 34. The kit of claim 32 or claim 33, further comprising a third vaginal insertion device having a third outer diameter different from the first outer diameter and the second outer diameter.

Images