Intravaginal support devices

Abstract

This disclosure relates, in some embodiments, to a flexible and non-absorbable vaginal insertion device that is easier to insert and remove and is intended to improve and prevent symptoms associated with pelvic organ prolapse, as well as urinary and / or fecal incontinence when the device is inserted. In some embodiments, the device has an unnecessary conical upper portion that provides pelvic organ support and a removal portion or handle that facilitates insertion and removal of the device.

Description

Technical Field

[0001] This disclosure relates generally to a vaginal insertion device for improving and preventing symptoms associated with pelvic organ prolapse, and urinary and / or fecal incontinence when the device is inserted. [Related Applications]

[0002] This case relates to U.S. Provisional Application No. 62 / 644,340, filed March 16, 2018; U.S. Provisional Application No. 62 / 687,119, filed June 19, 2018; and U.S. Provisional Application No. 62 / 735,605, filed September 24, 2018, the contents of which are incorporated herein by reference. Prior Technology

[0003] Stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are increasing problems worldwide, costing healthcare systems significant sums and severely reducing the quality of life for millions of women in the United States alone. While surgical solutions can improve symptoms associated with SUI and POP, surgery is not without risks and complications, and may even leave patients in a worse condition 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, 19(4):246-58, the contents of which are referenced here and 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, the contents of which are referenced herein and incorporated herein by reference. The FDA has issued several public health notices regarding the use of surgical mesh via transvaginal placement for the treatment of POP and SUI. The FDA has identified the severity and frequency of complications associated with surgical mesh, including mesh erosion, pain, infection, bleeding, discomfort during intercourse, organ perforation, urethral problems, recurrent prolapse, neuromuscular problems, vaginal scarring / contraction, and emotional problems. Most surgical complications require interventional treatment including medication, additional surgical care, and hospitalization.

[0004] Pessaries, once the most commonly used devices for managing post-operative organ prolapse (POP) and uterine incontinence (SUI), offer a viable non-surgical option for managing both. Pessaries have few complications and side effects. However, these devices are traditionally inserted into the vagina for extended periods. They can be very uncomfortable. Furthermore, pessaries are difficult for patients to insert and remove. Insertion and removal of these devices often require regular clinic visits for several years. See Jones KA, Harmanli O, Pessary Use in Pelvic Organ Prolapse and Urinary Incontinence, Rev Obstet Gynecol, 2010, 3(1):3-9, the contents of which are incorporated herein by reference. The difficulty in self-removal and insertion of pessaries, the difficulty in dislodging them during removal, and the lack of comfort and convenience limit their widespread use.

[0005] For women, SUI is involuntary urinary incontinence caused by weakened pelvic support system and / or bladder pressure. This can be due to 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 several types of urinary incontinence, including stress incontinence, urge incontinence, and mixed incontinence. All of these are primarily caused by laxity or damage to the connecting tissues within the vagina or supporting ligaments. See An Integral Theory and Its Method for the Diagnosis and Management of Female Urinary Incontinence, Petros PE, Ulmsten UI, Smayd J Urol Nephrol Suppl, 1993, 153, 1-93, the contents of which are incorporated herein by reference. Figure 1 is a cross-sectional view of the normal anatomy of the pelvic region of a woman, showing the uterus 10, cervix 12, bladder 14, urethra 16, vagina 18, and rectum 20. Figure 2 shows incontinence 22 (e.g., leakage of urine or feces) caused by stress or pressure 24 on the bladder 14 or intestines. Involuntary leakage of urine or feces usually occurs during activities such as coughing, laughing, sneezing, lifting objects, or exercising.

[0006] Damage to the connective tissues of the three regions of the integrated system (which encompasses all three pelvic organs, including the bladder, vagina, and anal canal) is the ultimate cause of pelvic organ prolapse (POP) and dysfunction of these organs. Figure 3 is a cross-sectional view of the pelvic region of a woman with a prolapsed bladder26. Figure 4 is a cross-sectional view of the pelvic region of a woman with a prolapsed back or rectouterine prolapse28. Figure 5 is a cross-sectional view of the pelvic region of a woman with a prolapsed uterus30. POP is common due to pregnancy, but can also occur simply due to genetics and aging processes.

[0007] Therefore, there is a need for pessaries or other vaginal insertion devices that can manage, improve, treat, prevent, and / or eliminate female incontinence, post-continence episodes (POP), or both. There is a particular need for prescription-free, non-absorbable, over-the-counter, convenient, comfortable, and easy-to-insert and remove pessaries or other vaginal insertion devices with little or no physician intervention. Such vaginal insertion devices can be reusable or disposable. There remains a need for vaginal support devices and methods. Summary of the Invention

[0008] According to one 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 may include an upper portion having a conical body having a base, an inner wall, and an outer wall; and a rib within the conical body configured to apply pressure to the organ wall to improve, manage, treat, prevent, and / or eliminate symptoms associated with pelvic organ prolapse, urinary incontinence, fecal incontinence, or a combination thereof.

[0009] According to one embodiment, the vaginal insertion device may include an edge projecting from the upper end of the outer wall. According to one embodiment, a rib extends downward from an adjacent edge to the base within the conical body, wherein the rib and the edge together apply pressure to the organ wall. According to one embodiment, the vaginal insertion device may include one or more ridges projecting outward from the outer wall. According to one embodiment, a handle extends downward from the base, the handle having one or more ridges projecting outward from its outer surface. According to one embodiment, the handle is conical, outwardly inclined, triangular, cruciform, substantially flat, or a combination thereof. According to one embodiment, the rib is configured to selectively or adjustably apply pressure to the organ wall depending on the alignment of the rib with the organ wall. According to one embodiment, the rib includes a member extending radially inward from the inner wall of the conical body and longitudinally downward from a position near the top of the conical body. According to one embodiment, the member comprises two or more members equidistantly spaced around the circumference of the inner wall of the conical body, the two or more members converging at the center point of the conical body. According to one embodiment, the rib comprises a member extending transversely to the longitudinal axis of the conical body. According to one embodiment, the member extends between radially opposite points on the inner wall, the member being connected to the inner wall at these radially opposite points. According to one embodiment, the member extends longitudinally between a position near the top of the conical body and the base. According to one embodiment, in a plan view, the rib is cross-shaped, T-shaped, X-shaped, Y-shaped, K-shaped, V-shaped, star-shaped, triangular, or pentagonal. According to one embodiment, the organ wall is one of the following: the vaginal sphincter, bladder neck, rectal wall, uterine wall, or a combination thereof. According to one embodiment, the rib and the conical body are integrally formed from the same material. According to one embodiment, the rib and the conical body are integrally formed from the same material. According to one embodiment, the rib and the conical body are integrally formed from the same material. According to one embodiment, the vaginal insertion device is configured to support the organ wall during movement. According to one embodiment, the vaginal insertion device is configured to contain fluid and secrete the fluid into the vagina when the vaginal insertion device is inserted into the vagina. According to one embodiment, the fluid is a drug, hormone, or medicine. According to one embodiment, the upper portion has an open upper end. According to one embodiment, the upper portion has a closed upper end.

[0010] According to one 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 may include a conical body configured to apply pressure to an organ wall; and a handle configured to adjust the pressure applied to the organ wall. According to one embodiment, the vaginal insertion device is a member extending within the conical body, the member being configured to apply the pressure to the organ wall. According to one embodiment, the handle and the member are associated such that rotation of the handle is configured to adjust the pressure applied to the organ wall by the member. According to one 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 one embodiment, the member is a rib that extends radially inward from an inner wall of the conical body and longitudinally downward from a position near the top of the conical body. According to one embodiment, the rib is cross-shaped in plan view, and the handle is substantially flat and creates a plane, wherein the cross shape of the rib and the plane are aligned such that a position of the handle is associated with a position of the rib relative to the organ wall. According to one embodiment, in plan view, the member is a cross-shaped rib with four ends, each of the four ends intersecting the inner wall of the conical body. According to one embodiment, the conical body is configured to apply an adjustable therapeutic force to the organ wall, the therapeutic force corresponding to a force used to improve, manage, treat, prevent, and / or eliminate symptoms associated with pelvic organ prolapse, urinary incontinence, fecal incontinence, or a combination thereof. According to one embodiment, the organ wall is one of the vaginal sphincter, bladder neck, rectal wall, uterine wall, or a combination thereof.

[0011] According to one 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 may include an upper portion having a conical body having a base, an inner wall, and an outer wall; and a handle extending downward from the upper portion, the handle having a substantially flat shape. According to one embodiment, the handle may include a plurality of ridges extending from the outer surface of the handle. According to one embodiment, the plurality of ridges are uniformly spaced from the lower end of the handle. According to one embodiment, each of the plurality of ridges has the same thickness. According to one embodiment, each of the plurality of ridges extends about the circumference of the handle. According to one embodiment, the handle is configured to adjust the pressure applied to the organ wall by the vaginal insertion device. According to one embodiment, the handle and the upper portion are integrally formed of the same material. According to one embodiment, the handle is configured to be gripped by a user for inserting, removing, or placing the vaginal insertion device inside the vagina, or a combination of these actions. According to one embodiment, the handle is configured to allow the vaginal insertion device to be positioned, rotated, or both when inserted into the vagina. According to one embodiment, the vaginal insertion device may include a rib within the conical body, the rib being configured to apply pressure to an organ wall, wherein the rib and the handle are aligned such that rotation of the handle is configured to adjust the pressure applied by the rib to the organ wall.

[0012] According to one embodiment, a vaginal insertion device may include a body having an upper opening, a wall, and a hollow interior within the wall; and a member within the hollow interior of the body, wherein the member is configured to apply pressure via the wall to an intravaginal wall, and wherein the pressure is configured to improve, manage, treat, prevent, and / or eliminate symptoms associated with pelvic organ prolapse, urinary incontinence, fecal incontinence, or combinations thereof. According to one embodiment, the wall has an inner diameter that gradually decreases from the upper opening to a base of the body. According to one embodiment, the member is connected to the inner side of the wall and extends from the upper opening to the base. According to one embodiment, the member is connected to the inner side of the wall adjacent to the upper opening. According to one embodiment, the member is connected to the inner side of the wall adjacent to the upper opening. According to one embodiment, the member is connected to the inner side of the wall adjacent to the upper opening. According to one embodiment, the member is not connected to the base. According to one embodiment, a second member extends between the radially opposite sides of the wall, wherein the member and the second member are perpendicular, such that a cross shape is formed in the plan view. According to one embodiment, the member extends between the radially opposite sides of the wall. According to one embodiment, the body is a conical body having a diameter that decreases from the upper end of the opening to the base.

[0013] According to one embodiment, a vaginal insertion device may include an upper portion having a conical body and a longitudinal axis, the conical body having a base, an inner wall, and an outer wall; a member within the inner wall of the conical body, the member having a member plane aligned with the longitudinal axis; and a handle having a handle plane aligned with the longitudinal axis, wherein the member plane and the handle plane are aligned with each other. According to one embodiment, the member plane and the handle plane are arranged to be parallel or coplanar. According to one embodiment, the member plane and the handle plane are arranged to be perpendicular or at an angle to each other. According to one embodiment, the vaginal insertion device may include an edge protruding from the outer wall at an upper end of the upper portion. According to one embodiment, the member extends downward within the conical body from adjacent to the edge to the base, wherein the member and the edge together apply pressure to the organ wall. According to one embodiment, the vaginal insertion device may include one or more ridges protruding outward from the outer wall. According to one embodiment, the handle includes one or more ridges projecting outward from the outer surface of the handle. According to one embodiment, the handle is two-dimensional or flat. According to one embodiment, the handle is rectangular. According to one embodiment, the member extends radially inward from the inner wall of the conical body and longitudinally downward from a position near the apex of the conical body. According to one embodiment, the member includes two or more members equidistantly spaced around the circumference of the inner wall of the conical body, the two or more members meeting at the center point of the conical body. According to one embodiment, the member includes a member extending transversely to the longitudinal axis of the conical body. According to one embodiment, the member extends between radially opposite points on the inner wall, and the member is connected to the inner wall at these radially opposite points. According to one embodiment, in a plan view, the member is cross-shaped, "T"-shaped, "X"-shaped, "Y"-shaped, "K"-shaped, "V"-shaped, star-shaped, triangular, or pentagonal. According to one embodiment, the member is configured to apply pressure to an organ wall, wherein the organ wall is one or a combination of the vaginal sphincter, bladder neck, rectal wall, and uterine wall. According to one embodiment, the device is 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 one embodiment, the member is configured to apply pressure to an organ wall to improve, manage, treat, prevent, and / or eliminate symptoms associated with pelvic organ prolapse, urinary incontinence, fecal incontinence, or a combination thereof. According to one embodiment, the member and the conical body are integrally formed from the same material. According to one embodiment, in a plan view, the member is a cross-shaped rib with four ends, wherein each of the four ends meets the inner wall of the conical body. According to one embodiment, the member is a rib.According to one embodiment, the vaginal insertion device may include a rib within the conical body, the rib being configured to apply pressure to the organ wall, wherein the rib and the handle are aligned such that rotation of the handle is configured to adjust the pressure applied to the organ wall by the rib.

[0014] According to one embodiment, a method for improving, managing, treating, preventing, and / or eliminating symptoms associated with pelvic organ prolapse, urinary incontinence, fecal incontinence, or a combination thereof may include inserting a vaginal insertion device into the vagina, the vaginal insertion device having a conical body having a rib extending within the interior of the conical body; aligning the vaginal insertion device with an organ wall; and adjusting the pressure applied to the organ wall by rotating the vaginal insertion device. According to one embodiment, the method may include applying pressure to the organ wall by aligning the rib with the organ wall. According to one embodiment, adjusting the pressure applied to the organ wall includes reducing the pressure by rotating the rib so that the rib is not aligned with the organ wall. According to one embodiment, adjusting the pressure applied to the organ wall includes increasing the pressure by rotating the rib so that it is aligned with the organ wall. According to one embodiment, the vaginal insertion device further includes a handle extending downward from the conical body, and rotating the vaginal insertion device includes rotating the handle while the vaginal insertion device is inserted into the vagina. According to one embodiment, adjusting the pressure applied to the organ wall is performed before or after activity. According to one embodiment, the method may include increasing the pressure applied to the organ wall before activity and decreasing the pressure applied to the organ wall after activity. According to one embodiment, increasing the pressure applied to the organ wall is performed by rotating the vaginal inserter to align the rib with the organ wall, and decreasing the pressure applied to the organ wall is performed by rotating the vaginal inserter to de-align the rib with the organ wall. According to one embodiment, inserting the vaginal inserter includes: compressing the vaginal inserter from a pre-existing form into a compact form having a shape configured for insertion into the vagina; releasing the vaginal inserter once it is inserted into the vagina; and allowing the vaginal inserter to expand from the compact form back to its original form, wherein the vaginal inserter applies pressure to the organ wall due to the outer side of the vaginal inserter, the rib, and / or one or more ridges protruding from the outer side of the vaginal inserter. According to one embodiment, the method may include an edge configured to apply pressure to the organ wall together with the rib. According to one embodiment, the method may include removing the vaginal inserter by grasping the handle and pulling it out of the vagina. According to one embodiment, the method may include soaking the vaginal inserter in a fluid and maintaining the fluid within the vagina while the vaginal inserter is inserted, wherein the fluid is a medicine, drug, or hormone. According to one embodiment, the method may include collecting a sample of vaginal secretions to perform a diagnosis on the sample. According to one embodiment, the diagnosis is performed while the vaginal inserter is in the vagina. According to one embodiment, the sample is collected by a user or medical professional after the vaginal inserter has been removed and the diagnosis is performed by the user or medical professional. According to one embodiment, the vaginal inserter is a vaginal inserter according to any embodiment described herein.

[0015] According to one embodiment, the use of a vaginal insertion device may include providing a vaginal insertion device described in any of the embodiments herein, inserting the vaginal insertion device into the vagina, and applying pressure to the organ wall with the vaginal insertion device. According to one embodiment, the method may include adjusting the pressure applied to the organ wall. According to one 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, sudden activity, coughing, laughing, sneezing, lifting objects, and / or exercise. According to one embodiment, the method may include inserting the vaginal insertion device prior to cardiovascular activity. According to one embodiment, pressure is applied to the organ wall by means of features protruding from the outer side of the vaginal insertion device, from the inner side of the vaginal insertion device, or from features protruding from the outer side of the vaginal insertion device. According to one embodiment, these features are one or more ribs, one or more edges, one or more ridges, or combinations thereof. According to one embodiment, the method may include adjusting the pressure applied to the organ wall by reducing the pressure by rotating the one or more ribs to disalign them with the organ wall and increasing the pressure by rotating the one or more ribs to align them with the organ wall. According to one embodiment, adjusting the pressure applied to the organ wall is performed before or after the movement. According to one embodiment, inserting the vaginal inserter includes: compressing the vaginal inserter from a pre-existing form into a compact form having a shape configured for insertion into the vagina; releasing the vaginal inserter once it is inserted into the vagina; and allowing the vaginal inserter to expand from the compact form back to the pre-existing form, wherein the vaginal inserter applies pressure to the organ wall due to the outer side of the vaginal inserter, the one or more ribs, and / or one or more ridges protruding from the outer side of the vaginal inserter. According to one embodiment, the method may include an edge configured to apply pressure to the organ wall together with the one or more ribs. According to one embodiment, the method may include removing the vaginal inserter by grasping the handle and pulling it out of the vagina. According to one embodiment, the method may include soaking the vaginal inserter in a fluid and maintaining the fluid within the vagina while the vaginal inserter is inserted, wherein the fluid is a medicine, drug, or hormone. According to one embodiment, the method may include collecting a sample of vaginal secretions to perform a diagnosis on the sample. According to one embodiment, the diagnosis is performed while the vaginal inserter is in the vagina. According to one embodiment, the sample is collected by a user or medical professional after the vaginal inserter has been removed, and the diagnosis is performed by the user or medical professional.

[0016] According to one embodiment, a case for a vaginal insertion device may include a base configured to receive the vaginal insertion device and a lid configured to interact with and cover the vaginal insertion device. According to one embodiment, the base includes a plurality of openings on a bottom surface configured to release water or liquid from above the bottom surface to below the bottom surface. According to one embodiment, the base is configured to operate as a drying rack for the vaginal insertion device. According to one embodiment, the base includes a plurality of upwardly projecting protrusions from the bottom surface configured to hold the vaginal insertion device on the base. According to one embodiment, the base includes one or more grooves configured to interact with one or more protrusions on the lid, the lid having a first position in which the one or more protrusions engage with individual grooves of the one or more grooves to lock the lid to the base, and a second position in which the one or more protrusions disengage from individual grooves of the one or more grooves, thereby unlocking the lid from the base. According to one embodiment, the case may include one or more latches for retaining the vaginal insertion device on the base. According to one embodiment, the vaginal insertion device may be according to any of the embodiments described herein.

[0017] According to one embodiment, 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, wherein the first outer diameter is different from the second outer diameter. According to one embodiment, the first and second vaginal insertion devices are selected to accommodate changes in the user's vaginal condition. According to one embodiment, the kit may include a third vaginal insertion device having a third outer diameter, which is different from the first and second outer diameters. According to one embodiment, the first, second, and / or third vaginal insertion devices may be vaginal insertion devices according to any of the embodiments described herein.

[0018] It should be understood that both the general description above and the detailed description below are exemplary and illustrative and not restrictive in relation to the scope of the patent application set forth in this disclosure. Simple Explanation of the Diagram

[0019] A more complete understanding of these embodiments and their benefits can be obtained by reading the following description in conjunction with the accompanying drawings, in which like element symbols represent like features, and wherein:

[0020] Each of the figures in [Figures 1-5] shows a cross-sectional view of the pelvic region of a woman to provide context for discussing the content being revealed;

[0021] [Figure 6A] shows a side view of an exemplary vaginal insertion device according to an embodiment of the present disclosure;

[0022] [Figure 6B] shows a side view of another exemplary vaginal insertion device according to an embodiment of the present disclosure;

[0023] [Figure 7] shows a perspective view of the vaginal insertion device of Figure 6A;

[0024] [Figure 8] is a cross-sectional view of the vaginal insertion device in Figure 6A along section line AA;

[0025] [Figure 9] is a bottom view of the vaginal insertion device in Figure 6A;

[0026] [Figure 10] is a top view of the vaginal insertion device of Figure 6A;

[0027] Each of Figures 11-13 shows a cross-sectional view of the pelvic region of a woman and an embodiment of the vaginal insertion device inserted into the vagina;

[0028] [Figures 14A and 14B] show a method for inserting one embodiment of the vaginal insertion device into a patient's vagina;

[0029] [Figure 15A] shows a side view of the uterine pessary applicator;

[0030] [Figures 15B and 15C] show a cross-sectional view of the uterine pessary applicator of Figure 15A, and a method of using the uterine pessary applicator to insert the vaginal insertion device into the vagina of a patient;

[0031] [Figure 16] shows a perspective view of a vaginal insertion device according to an embodiment of the present disclosure;

[0032] [Figure 17] shows a side view of the vaginal insertion device of Figure 16;

[0033] [Figure 18] shows a cross-sectional view of the vaginal insertion device of Figure 16 taken along section line 18-18 of Figure 17;

[0034] [Figure 19] shows a top view of the vaginal insertion device of Figure 16;

[0035] [Figure 20] shows a bottom view of the vaginal insertion device of Figure 16;

[0036] [Figures 21A-21F] show perspective views of exemplary handles according to embodiments of the present disclosure;

[0037] [Figures 22A-22K] show perspective views of a carrying case for a vaginal insertion device and a brush according to an embodiment of the present disclosure;

[0038] [Figure 23] shows a perspective view of a kit including a vaginal insertion device and a drying rack according to an embodiment of the present disclosure;

[0039] [Figure 24] shows a graph of the forces exerted on the urethral wall by the vaginal insertion device according to an embodiment of the present disclosure;

[0040] [Figure 25A] shows the force applied to the ribs of the vaginal insertion device according to an embodiment of this disclosure;

[0041] [Figure 25B] shows the force applied to a space that deviates from the space of a rib of a vaginal insertion device according to an embodiment of this disclosure;

[0042] [Figure 26] shows a vaginal insertion device according to an embodiment of the present disclosure;

[0043] [Figure 27A] shows a perspective view of a vaginal insertion device according to an embodiment of the present disclosure;

[0044] [Figure 27B] shows a top view of the vaginal insertion device according to an embodiment of the present disclosure, as shown in Figure 27A;

[0045] [Figure 27C] shows a side view of the vaginal insertion device according to an embodiment of the present disclosure, as shown in Figure 27A;

[0046] [Figure 27D] shows a side view of the vaginal insertion device according to an embodiment of the present disclosure, as shown in Figure 27A, rotated 90 degrees from the side view of Figure 27C;

[0047] [Figure 27E] shows a cross-sectional view of the vaginal insertion device according to an embodiment of the present disclosure, as shown in Figure 27A, taken along section line 27E-27E of Figure 27B;

[0048] [Figure 27F] shows a detailed view of the vaginal insertion device according to the embodiment of the present disclosure of Figure 27A within the area marked in Figure 27D in Figure 27F;

[0049] [Figure 27G] shows a plan view of the handle of the vaginal insertion device according to an embodiment of the present disclosure, as shown in Figure 27A;

[0050] [Figure 27H] shows a bottom view of the vaginal insertion device according to an embodiment of the present disclosure, as shown in Figure 27A;

[0051] [Figures 28A-28H] show a vaginal insertion device according to an embodiment of the present disclosure;

[0052] [Figures 29A-29H] show a vaginal insertion device according to an embodiment of the present disclosure;

[0053] [Figures 30A-30H] show a vaginal insertion device according to an embodiment of the present disclosure;

[0054] [Figures 31A-31H] show a vaginal insertion device according to an embodiment of the present disclosure;

[0055] [Figures 32A-32H] show a vaginal insertion device according to an embodiment of the present disclosure;

[0056] [Figures 33A-33L] show a vaginal insertion device according to an embodiment of the present disclosure;

[0057] [Figures 34A-34D] show a vaginal insertion device according to an embodiment of the present disclosure;

[0058] [Figures 35A-35D] show a vaginal insertion device according to an embodiment of the present disclosure;

[0059] [Figures 36A-36D] show a vaginal insertion device according to an embodiment of the present disclosure;

[0060] [Figures 37A-37D] show a vaginal insertion device according to an embodiment of the present disclosure;

[0061] [Figures 38A-38D] show a vaginal insertion device according to an embodiment of the present disclosure;

[0062] [Figure 39] shows a cross-sectional view of the pelvic region of a woman with an embodiment of the vaginal insertion device inserted into the vagina;

[0063] [Figure 40] shows a cross-sectional view of the pelvic region of a woman with an embodiment of the vaginal insertion device inserted into the vagina;

[0064] [Figure 41] shows a cross-sectional view of the pelvic region of a woman with an embodiment of the vaginal insertion device inserted into the vagina;

[0065] [Figure 42] shows a perspective view of a kit including a vaginal insertion device of different sizes, a carrying case, a drying rack, and a brush, according to an embodiment of the present disclosure; and

[0066] [Figure 43] shows an exploded perspective view of a carrying case according to an embodiment of the present disclosure. Implementation

[0067] Some embodiments and their benefits are best understood by referring to Figures 6A through 38, in which the same element symbols represent the same or corresponding parts or sections. A vaginal insertion device described in U.S. Patent Application No. 15 / 242,105, now U.S. Patent No. 10,188,545 (the contents of which are referred to herein and are incorporated herein by reference) may also be considered. While the device is described and depicted as being inserted into the vagina to reduce or eliminate, for example, urinary incontinence, the device of this disclosure may also be used to treat fecal incontinence and / or involuntary leakage of feces, which will be described in more detail. Additional uses are also considered, for example, menstrual uses, collection of vaginal fluid or secretions, diagnosis, training or strengthening of muscles, secretion of drugs or hormones, monitoring of the vagina or other organs or parts of the body, or combinations thereof.

[0068] The vaginal insertion device disclosed herein can manage, improve, prevent, treat, and / or eliminate incontinence (including urinary and fecal incontinence), point of impaction (POP), or POP and urinary and / or fecal incontinence, and combinations thereof, in women. The vaginal insertion device does not require a prescription (although a prescription may be required for medication or hormone delivery or as an indicator for diagnostic aids). The vaginal insertion device may be non-implantable (although it may also be implantable), non-absorbable, available over the counter, convenient, flexible, comfortable, and easy for the patient to insert and remove, requiring little or no physician intervention. In some cases, the vaginal insertion device may be reusable. Alternatively or additionally, the vaginal insertion device may be disposable. The vaginal insertion device can eliminate concerns about toxic shock syndrome (TSS) by not being composed of absorbent elements that could breed bacteria, cause infection, and / or produce odor.

[0069] In some instances, the device disclosed herein is manufactured, for example, using a material by molding (e.g., liquid injection molding). This material can be an elastic and non-absorbent material, such as a biocompatible elastomer, like medical-grade silicone. The material can be medical-grade, for example, medical-grade silicone. The material can be 100% medical-grade silicone. Examples of suitable silicone materials for this device could be NuSil Technology's MED-4950 product, considered a liquid silicone rubber, Momentive LIM 6030, or Momentive LIM 6040. Alternative materials and methods of formation may be considered. For example, the vaginal insertion device can be formed from cotton (e.g., 100% cotton), and can be any plastic, thermoplastic, polymer, or elastomer. The material can have sufficient structure to apply pressure to the vaginal wall but sufficient flexibility to allow folding or compression during insertion and removal. The vaginal insertion device can be compressed, extruded, 3D printed, rotary molded, machined, cast, etc.

[0070] The vaginal insertion device disclosed herein can be shaped to be firmly positioned within the vagina upon insertion, and is shaped to apply pressure to the vaginal wall for therapeutic purposes and / or to support pelvic organs and / or prevent further pelvic displacement. In one example, the vaginal insertion device disclosed herein is used for the management of stress urinary incontinence (e.g., involuntary leakage) in patients over 80 years of age during activity (e.g., coughing, laughing, sneezing, lifting objects, and exercise). The device can be inserted into an adult woman for up to 8 to 12 hours before removal and reinsertion, depending on her comfort level. The device can be implanted and remain in the body for an extended period.

[0071] Figure 6A shows a side view of an exemplary vaginal insertion device 40 according to an embodiment of the present disclosure. The vaginal insertion device 40 of Figure 6A may include an upper portion 42 and a lower handle-like, removable portion or handle 44. The upper portion 42 may be conical. That is, the upper portion 42 may have a first diameter that decreases to a second diameter. The decrease in diameter may be gradual. The conical body of the upper portion 42 may therefore include a varying diameter. Although described herein as conical, other shapes of the upper portion 42 are possible. These other shapes may include varying diameters such that a first diameter is configured to apply pressure to the vaginal wall or organ wall and a second diameter is configured to be smaller than the first diameter and not interact with the vaginal wall. These shapes may include trapezoidal, spherical, cylindrical, cubic, conical, hexagonal prism, etc.

[0072] As further illustrated and described below, the upper portion 42 may include an edge 46 projecting from the upper portion and ridges 48, which may be spaced from the top of the upper portion 42 to the lower end or base of the upper portion 42. In one embodiment, the edge 46 may be omitted and may not be present. The ridges 48 may be spaced arbitrarily or uniformly. The removed portion may also have ridges 48, which, like the upper portion, may be spaced from the top of the handle 44 to the lower end of the handle 44. The ridges 48 may also be semi-permeable to allow the passage of liquids, gases, lubricants, and / or drugs. The ridges 48 on the handle 44 may be placed arbitrarily or uniformly.

[0073] Figure 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 Figure 6A, but the handle 44 can be a rope, cord, or ribbon (collectively referred to as cord), such as that used in sanitary napkins. The cord assists in the insertion and / or removal of the vaginal insertion device 40 from the vagina.

[0074] Figure 7 shows a perspective view of the vaginal insertion device 40 of Figure 6A. As shown in Figure 7, the upper portion 42 has a conical body. The upper portion 42 may have a circular cross-section over its entire length (e.g., as shown in Figures 9 and 10). The diameter of the circular cross-section may decrease from an upper end (e.g., the upper opening end 54) to a base or lower end 56. This reduction in diameter may 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 may decrease from the upper opening end 54 to the lower end 56. The upper portion 42 may have a wall 49 having an inner wall or inner side 50 and an outer wall or outer side 52. The upper portion 42 may include the upper opening end 54, the lower end 56, and a hollow interior 58. The upper opening end 54 may expose the hollow interior 58 to atmospheric pressure (when not inserted) and the interior of the vagina (when inserted).

[0075] Referring again to Figure 7, the edge 46 may be circular and may surround and protrude from the outer side 52 of the wall 49. The edge 46 may be adjacent to the upper opening end 54. The ridge 48 may be a circular ring surrounding the outer side 52 of the wall 49. The handle 44 may extend from the lower end 56 of the upper portion 42. The upper portion 42 and the handle 44 may be made as a single, integral device of a single material. For example, the upper portion 42 and the handle 44 may be made of medical-grade silicon. The upper portion 42 and the handle 44 may be injection molded into a single, integral device of medical-grade silicon. Alternatively, the upper portion 42 and the handle 44 may be made of more than one component and / or more than one material, which may be attached and / or detached or expanded and contracted for purposes such as treatment, treatment, or sterilization. The upper portion 42 and the handle 44 may be permeably or separably coupled together. The handle 44 may have a conical body. The cone shape can be a shape in which the diameter increases from the lower end 56 to the distal end of the handle 44. That is, the conical body of the handle 44 can expand radially outward from the lower end 56 to the lower opening end 64 of the handle 44 (FIG. 8). The conical body of the upper part 42 can expand radially outward from the lower end 56 to the upper opening end 54. Therefore, the handle 44 and the upper part 42 can expand radially outward in opposite axial directions. The circumference and / or diameter of the handle 44 and the upper part 42 can gradually increase in opposite directions.

[0076] Figure 8 is a cross-sectional view of the vaginal insertion device 40 of Figure 6A across section line AA. As shown in Figure 8, the handle 44 may have a circular cross-section along its entire length. The handle 44 may have a wall 60, an upper end 62, a lower open end 64, and a hollow interior 66. The circumference and / or diameter of the handle 44 may increase from the upper end 62 to the lower open end 64. As shown, a ridge 48 may protrude from the outer side 52 of the wall 60. Although described as a hollow handle 44, the handle 44 may be solid. The handle 44 may be any of the handles 244a-244g described herein.

[0077] Figure 8 further illustrates one embodiment of the vaginal insertion device 40, which includes a vent 68 in the region connecting the upper portion 42 and the handle 44. The vent 68 may include a vent hole, slit, gap, or opening. The vent 68 may include a screen or mesh or any other member with an opening. Although described as a single vent 68, the vent may be more than one opening located in the region connecting the upper portion 42 to the handle 44. The vaginal insertion device 40 may include multiple vents 68. The vaginal insertion device 40 may include multiple vents 68 located in locations other than vents 68 or in locations other than vents 68. For example, the vaginal insertion device 40 may include one or more vents 68 on the wall 49 of the upper portion 42, the wall 49 of the edge 46, the first segment 70 and / or the second segment 72 of the edge 46, adjacent to the edge 46, adjacent to the lower end 56, on the wall 60 of the handle 44 adjacent to the upper end 62 of the handle 44, or combinations thereof. The one or more vents 68 may be equidistantly or uniformly spaced around the circumference of the device 40. The one or more vents 68 may allow the vaginal insertion device 40 to be inserted in a more comfortable manner for the patient. The one or more vents 68 may balance the air pressure between the inside and outside of the vagina 18 (FIG. 11) when the vaginal insertion device 40 is inserted. The one or more vents 68 may help indicate the location of the device. However, the one or more vents 68 are not necessary for the comfort, usability, and effectiveness of the vaginal insertion device 40 and may therefore be omitted. The one or more vents 68 can prevent or limit a seal or suction force generated between the vaginal insertion device 40 and the vaginal wall or organ wall.

[0078] Referring to Figure 8, the edge 46 may have a first segment 70 and a second segment 72. The first segment 70 and / or the second segment 72 may protrude from the outer side 52 of the wall 49, with the first segment 70 protruding a greater distance than the second segment 72. Alternative examples of the edge 46 are conceivable. For example, when the edge 46 is present, it may include only the first segment 70 or only the second segment 72. In one example, the edge 46 may include only one segment, but this segment may have a different height and / or width than the first segment 70 (e.g., a larger or smaller height and / or width). The edge 46 may protrude from the outer side 52 of the wall by the same distance from the top to the bottom of the edge 46. In one example, the edge 46 may surround the outer side 52 of the wall 49 adjacent to the upper opening end 54, and may include separate sections protruding from the outer side 52 of the wall 49 and sections not protruding from the outer side 52 of the wall 49. One side of the edge 46 may be thicker than the opposite side. The height, position, and / or width of the edge are adjustable. The edge 46 may retract and expand for therapeutic force and storage. The edge 46 may be made of one component or more components. The edge 46 may be made of one material, more than one material, or a combination of materials. The edge 46 may be configured to apply greater pressure in one area than in another area. For example, the density, thickness, material, attachments, protrusions, etc., of a portion of the edge 46 (e.g., half of the cross-section of the device) may be weighted. This portion of the edge 46 may be configured to apply greater pressure than the rest of the edge 46. The remainder of the edge 46 may be constructed in a manner similar to the remainder of the device 40 (e.g., the same material, density, thickness, etc.). As will be described in detail below, the edge 46 may be tilted, lopsided, or angled to apply pressure to different locations within the vagina, depending on the anatomy, type of incontinence, and / or prolapse, for example, as shown in Figure 27.

[0079] Referring to Figures 7 and 8, the ridge 48 can be a circular protrusion, as shown. However, other forms are considered. Therefore, the ridge 48 can include the embodiments shown in Figures 7 and 8, where the ridge 48 is a protrusion that can be a circular ring surrounding the outer side 52 of the wall 49. Alternatively, the ridge 48 can include any protrusion extending from the outer side 52 of the wall 49, such as a stud, mound, button, lettering, number, symbol, sign, or other shapes, including polygons, triangles, separate, randomly separated studs, homogeneously separated studs, squares, or combinations thereof. The ridge 48 can be arranged spirally, diagonally, longitudinally, or radially on the device 40 (on the upper part 42 and / or the handle 44). The ridges 48 on the upper part 42 and the handle 44 can be the same or different. The ridge 48 can be semi-permeable to allow liquids, pharmaceuticals, or lubricants to pass through.

[0080] The vaginal insertion device 40 can have different sizes, densities, shapes, durability, and / or different rigidities to accommodate adult women with different anatomy, women with altered or varied anatomy, to accommodate different uses of the device, or to accommodate different activities performed while using the device. Furthermore, the dimensions of different sections and portions of the device 40 can be modified from the various embodiments illustrated and disclosed herein. For example, referring to FIG8, the overall height 74 of the device 40, the diameter 76 of the upper opening 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 of the lower opening end 64, and the height 80 of the handle 44 can all be modified. These dimensions can be any of the dimensions described with reference to FIGS. 16-20 and 27-38. Modifications to these dimensions may maintain or improve the desired usefulness, effectiveness, and other advantages of the device. These dimensions can be modified in any combination or individually. Examples of the modified dimensions are described in Table 1, Figures 16-20 and 27-38, and related disclosures.

[0081] Referring to Figure 8, the following non-exclusive dimensional list is a non-limiting example of an embodiment of device 40, which is considered suitable for most women and provides the desired usefulness, effectiveness, and other advantages of the device. For example, a suitable total height 74 of the device 40 may be in the range of about 45 to about 75 millimeters (mm), such as about 55 to about 70 mm, such as about 58 to about 67 mm, for example, 46, 48, 50, 52, 54, 56, 58, 60, 62, 63, 64, 66, 68, 70, 72, or 74 mm ± 1 mm, including 58 mm ± 1 mm. In some embodiments, a suitable outer diameter 76 may be in the range of about 24 to about 56 mm, for example, about 30 to about 48 mm, for example, about 32 to about 46 mm, for example, about 38 to about 44 mm, for example, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, or 56 mm ± 1 mm, including 34, 38, or 43 mm ± 1 mm. A suitable height 80 of the handle 44 may be in the range of about 4 to about 20 mm, for example, about 5 to about 10 mm or about 13 to about 15 mm, including 5, 6, 7, 8, 9, or 10 mm ± 1 mm. A suitable thickness of the wall 49 below the edge 46 in the section of the upper portion 42 without the ridge 48 may be about 2.0 mm, for example, 1.5, 2, or 2.5 ± 0.25 mm. The appropriate thickness of the wall 49 in the section with the ridge 48 may be about 2.5 mm, for example, 2, 2.5, or 3 ± 0.25 mm. The wall 60 of the handle 44 may have an appropriate thickness of about 1, 1.25, 1.5, 1.75, 2, 2.25, or 2.5 mm, for example, 2 mm ± 0.25 mm, in the section without the ridge 48. An appropriate height of the edge 46 may be about 12, 14, 15, 16, or 18 mm, for example, 14 or 15 mm ± 0.5 mm, wherein the appropriate height of the first section 70 is about 3, 4, 5, 6, 7, or 8 mm, for example, 4 or 5 mm ± 0.5 mm, and the appropriate height of the second section 72 is about 7, 8, 9, 10, 11, 12, or 13 mm, for example, 9 or 10 mm ± 0.5 mm. The appropriate thickness of the first section 70 can be approximately 3, 4, 5, 6, 7, 8, or 9 mm, for example, 4 mm ± 0.25 mm. Similarly, the appropriate thickness of the second section 72 can be approximately 3, 4, or 5 mm, for example, approximately 3, 4, or 5 mm ± 0.25 mm. The appropriate outer diameter 82 of the lower opening 64 can be approximately 9, 10, 10.5, 11, or 12 mm. The appropriate diameter of the vent 68 can be approximately 1.5, 2, or 2.5 mm.

[0082] Figure 9 is a bottom view of the vaginal insertion device 40 of Figure 6A with a vent 68. As shown, the exterior of the device 40 and the interior and exterior of the handle 44 can have a circular shape in plan view. However, other shapes are contemplated. Figure 10 is a top view of the vaginal insertion device 40 of Figure 6A with a vent 68. As shown, both the interior and exterior of the device 40 can have a circular shape in plan view. However, other shapes are contemplated.

[0083] Figure 11 is a cross-sectional view of a woman's pelvic region, showing an embodiment of a vaginal insertion device 40 inserted into the vagina 18 and applying pressure to the urethral sphincter 16 and / or the bladder neck 15 (Figure 33) to manage, improve, prevent, treat, and / or eliminate female urinary incontinence. The user can insert the device 40 according to Figure 14. Once inserted, the edge can be aligned with a vaginal wall, such as the urethral sphincter and / or the bladder neck, to apply pressure thereon. These ridges also apply pressure to the vaginal wall. The pressure applied to the urethral sphincter 16 and / or the bladder neck 15 can reduce or eliminate urinary leakage. Figures 12 and 13 are each a cross-sectional view of a woman's pelvic region, showing an embodiment of a vaginal insertion device 40 inserted into the vagina 18 to manage, improve, prevent, treat, and / or eliminate female urinary incontinence, in addition to applying pressure to the urethral sphincter 16. In particular, in Figure 12, a vaginal insertion device 40 is inserted into the vagina 18 to manage, improve, prevent, treat, and / or eliminate a prolapsed bladder 26. In Figure 12, the upper opening 54 can support the bladder 26. The edges and ridges can also apply pressure to the vaginal walls, such as the urethral sphincter 16 and / or the bladder neck 15. The pressure applied to the urethral sphincter 16 and / or the bladder neck 15 can reduce or eliminate urinary leakage. In particular, in Figure 13, a vaginal insertion device 40 is inserted into the vagina 18 to manage, improve, prevent, treat, and / or eliminate a prolapsed uterus 30. In Figure 13, the upper opening can support the uterus 30. Although described separately, the device 40 can apply pressure to the vaginal walls (e.g., Figures 11 and 12) and simultaneously or as the body changes over time (e.g., when the bladder is full) support the bladder and / or uterus (Figures 12 and 13).

[0084] As shown in Figures 11-13, when the device is inserted into the vagina, the upper opening end 54 of the upper portion 42 is the innermost part of the vaginal insertion device 40. Further shown in Figures 11-13, when the vaginal insertion device is inserted, the removal portion or handle 44 of the vaginal insertion device 40 can be accessed from the outside of the vagina 18. The handle 44 can assist in the insertion, removal, and / or placement of the vaginal insertion device 40 within the vagina. Ridges 48 on the handle 44 provide the patient with a better grip to remove the device 40. The handle 44 can also be used to position the device for therapeutic force, organ support, and comfort. The edge 46 and / or the ridges 48 on the upper portion 42 can apply pressure to the organ wall as shown in Figures 11-13 to manage, improve, prevent, treat, and / or eliminate female incontinence, including urinary and fecal incontinence, POP, or POP and urinary and / or fecal incontinence, and combinations thereof.

[0085] Figures 14A and 14B illustrate a method for inserting a vaginal insertion device 40 into the vagina 18. As shown in Figure 14A, a patient can compress the wall 49 of the upper portion 42 to make it more compact. This more compact shape allows the vaginal insertion device 40 to be inserted into the vagina 18 more easily. The user can manually compress the upper portion 42 between two fingers or otherwise in their hand. Alternatively, the user can use a tool, such as the applicator 84, to assist in compressing the device 40 for insertion. As shown in Figure 14B, the user then inserts the more compacted device 40 into the vagina 18. The user can insert the device 40 manually (e.g., with one or two hands) or with a tool (e.g., the applicator 84). Once the vaginal insertion device 40 is manually inserted into the vagina 18, the wall 49 of the upper portion 42 can expand back to its original shape or near its original shape, thus allowing the vaginal insertion device 40 to apply pressure to the inner walls of the vagina and internal organs. While this insertion method is an example, in silicon or other materials with higher hardness, the device does not necessarily have to collapse for insertion.

[0086] Figure 15A shows a side view of a pessary applicator 84, which can be used to assist in the insertion, placement (Figure 14B), or removal from the vagina of a patient's vaginal insertion device 40. The pessary applicator 84 may include an insert 86, an upper portion 90 of the insert, and a plunger 88. The pessary applicator 84 may be similar to a sanitary napkin applicator. In one embodiment, the insert 86 may have a circumference generally larger or smaller than that of a sanitary napkin applicator to accommodate a vaginal insertion device 40 or a handle 44; when the entire device is compact, the insert has a shape larger than the circumference of a sanitary napkin; and if only the handle is compact within the device, the insert may be generally smaller than a sanitary napkin. Figures 15B and 15C show cross-sections of the pessary applicator 84 of Figure 15A and a method of using the applicator to insert a vaginal insertion device 40 into a patient's vaginal 18. As shown, the vaginal insertion device 40 is accommodated in a compact shape within the insert 86. Similar to the insertion of a sanitary napkin applicator into the vagina, the insert 86 of the pessary applicator 84 is inserted into the patient's vagina 18, and the plunger 88 is pushed toward the insert, pushing the vaginal insertion device 40 through the upper part 90. The pessary applicator 84 is then removed from the vagina 18, and the vaginal insertion device 40 remains in its position within the vagina and expands 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 also assists in the proper placement of the device within the vagina. The pessary applicator 84 can work in conjunction with the device 40 to position it and allows the device to expand or contract for therapeutic force, position, organ support, and orientation to manage, improve, prevent, or eliminate symptoms associated with incontinence and / or pelvic prolapse. The applicator 84 may be filled with a drug and / or hormone and may be used to deliver the drug, hormone, or medicine into the conical body of the device 40 for whole-body, homeopathic treatment, or for the treatment of prescribed hormone levels (e.g., hormone replacement therapy), treatment of yeast infections, treatment of sexually transmitted diseases, or for fertility control, antifungal, or antibacterial purposes. The applicator 84 may be made of one material or a combination of materials. The applicator 84 may be a single piece or made of multiple elements or components.

[0087] Referring now to Figures 16-20, an exemplary vaginal insertion device 100 is shown. This vaginal insertion device 100 may be similar to the vaginal insertion device 40. The vaginal insertion device 100 may include any modification, shape, size, material, dimension, purpose, or combination thereof as described with reference to the vaginal insertion device 40. Any of the modifications or alternatives to the previously described upper edge, handle, shape, etc., may be applied individually or in combination to the vaginal insertion device 100. The insertion methods shown in Figures 14 and 15 may be applied to the vaginal insertion device 100.

[0088] Figure 16 shows a side view of the exemplary vaginal insertion device 100. The vaginal insertion device 100 may include an upper portion 142 and a lower handle-shaped removal portion or handle 144. The upper portion 142 may be conical. That is, the upper portion 142 may have a first diameter that decreases to a second diameter. This decrease in diameter may be gradual. The conical body of the upper portion 142 may therefore include a varying diameter. Although described herein as conical, other shapes of the upper portion 142 are conceivable. These other shapes may include varying diameters such that a first diameter is configured to apply pressure to the vaginal wall or organ wall and a second diameter is configured to be smaller than the first diameter and not interact with the vaginal wall. These shapes may include trapezoidal, spherical, cylindrical, cubic, conical, hexagonal prism, etc.

[0089] The upper portion 142 may include an enlarged portion 142a (e.g., at the top of the upper portion 142), a narrower or tapered portion 142b (e.g., at the lower end of the upper portion 142), and an edge 146 that protrudes from the upper portion 142 (e.g., at the top of the upper portion 142). The edge 146 may be the same as edge 46. The edge 146 may resemble the first segment 70, and the enlarged portion 142a may resemble the second segment 72. In one embodiment, the edge 146 is omitted and may not exist. In one embodiment, the edge 146 may be a part of the enlarged portion 142a. Although the narrower or tapered portion 142b is shown as conical, it may also be a circular portion, a cylindrical portion, a triangular, umbrella-shaped, or pyramidal portion, or other shapes described herein. The upper portion 142 may have a circular cross-section, the diameter of which may decrease from an upper end (e.g., the upper opening end 154) to a base or lower end 156. This 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 upper opening end 154 to the lower end 156. The upper opening end 154 may expose the open portion 158 to atmospheric pressure (when not inserted) and to the interior of the vagina (when inserted).

[0090] As illustrated and described in more detail below, the upper portion 142 may include ridges 148 spaced from the top to the bottom of the upper portion 142. These ridges 148 may be spaced along the entire length of the upper portion 142 or a portion thereof. Alternatively, these ridges 148 may be indentations. These ridges 148 may be spaced arbitrarily or uniformly. The handle 144 may also have indentations or ridges 148, which, like the upper portion, may be spaced from the top to the bottom of the handle 144. These ridges 148 may be spaced along the entire length of the handle 144 or a portion thereof. These ridges 148 may include markings. These ridges 148 may be a mixture of shapes, for example, a combination of circles and markings as shown. These ridges 148 may support the device within the vagina, apply pressure to the organ wall, or a combination of both. Although shown as spanning or perpendicularly across the height H of the device 100 (or relative to the longitudinal axis of the device 100), the ridges 148 of one or both of the upper portion 142 and the handle 144 can be parallel, diagonal, spiral, or lateral, or combinations thereof. These ridges 148 are shown as generally straight, but can also be wavy, zigzag, or another non-linear path. The non-linear path can extend entirely laterally as parallel or diagonally relative to the longitudinal axis of the device. These ridges 148 may include any protrusions extending from the outer side 152 of the wall 149, including studs, mounds, buttons, letters, numbers, symbols, signs, other shapes including polygons, triangles, separate, randomly separated studs, uniformly separated studs, squares, or combinations thereof. The ridges 148 may be arranged spirally, diagonally, longitudinally, or radially on the device 100 (on the upper part 142 and / or the handle 144). The ridges 148 on the upper part 142 and the handle 144 may be the same or different. The ridges 148 may be semi-permeable to allow liquids, pharmaceuticals, or lubricants to pass through.

[0091] Referring again to FIG. 16, the vaginal insertion device 100 includes a member 180. The member 180 may be configured to apply pressure via the wall 149 of the vaginal insertion device 100 and to apply pressure to the wall of a vagina or organ. The member 180 may be disposed within the interior of the upper portion 142. The member 180 may have any shape configured to apply pressure to the vaginal wall and / or support an organ. In one embodiment, the member 180 extends from the upper end adjacent to the lower end 156 of the device 100. In one embodiment, the member 180 is disposed only near the upper end, for example, only in the upper 1 / 4, 1 / 3, and / or 1 / 2 of the device 100, and / or may be adjacent to the edge 146. In one embodiment, the member 180 extends between two or more points on the inner side 150 of the wall 149. In one embodiment, the member 180 extends only from one point on the inner side 150 of the wall 149. Any previously described or upcoming descriptions, adjustments, and / or modifications to component 180 may appear individually or in combination on device 100 to apply pressure to the vaginal wall and / or supporting organs in accordance with the principles currently disclosed.

[0092] The member 180 may be a rib 180 and will be referred to herein as a rib for ease of description. However, other structures or configurations may be implemented to achieve the same stress application as the rib 180. The rib 180 may have four rib segments or rib members 180a, 180, 180c, 180d. The rib 180 may have various forms, and some exemplary shapes and configurations of the rib 180 are described herein. Any combination of these exemplary shapes is feasible.

[0093] The rib 180 can be cross-shaped, "T"-shaped, or "X"-shaped, but other shapes and configurations are possible (e.g., triangles, pentagons, "Y", "K", "V", etc.). The rib 180 can also be star-shaped, intersect at a central point, intersect at multiple locations, or even not intersect at all. For example, in Figure 19, the rib 180 may have four members intersecting at the center. In Figure 32B, the rib 180 may have six members intersecting at the center. More or fewer members are possible. The rib 180 can be one or more parallel ribs or members offset from the central axis, a single rib or member spanning the central axis, both the one or more parallel ribs or members offset from the central axis and the single rib or member spanning the central axis, and / or chords from one inner surface to another without intersecting, or any combination thereof. The rib 180 can be a spoke or member that crosses or intersects at the center of the spoke or is offset from the center of the spoke. The spokes or components may or may not meet the inner wall of the vaginal insertion device. The rib 180 may be a component extending between radially opposite points on the inner wall of the upper portion 142. The component may connect to the inner wall at these radially opposite points. The component may include two or more components equidistantly spaced around the circumference of the inner wall of the conical body. The two or more components may meet at the center point of the conical body. The component may be a cross-shaped rib with four ends. Each of the four ends may meet the inner wall of the conical body. A larger device 100 (e.g., the device of FIG. 32) may have more components or ribs than a smaller device 100 (e.g., the device of FIG. 27).

[0094] The rib 180 may or may not extend to the inner surface of the base or lower end 156. That is, there is a distance between the lower end of the rib 180 and the upper portion 142 and the inner wall of the lower end 156. In this example, the rib 180 may be located in an upper region 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 located adjacent to the edge 146. The rib 180 may be horizontally aligned with the edge 146 and may be at the same height as the edge 146, such that pressure is applied only at the edge 146 (e.g., by both the edge 146 and the adjacent rib). The rib 180 may be of any shape or form for supporting the vaginal insertion device 100, applying force and / or pressure to the organ wall, and / or preventing or inhibiting organ prolapse. The rib 180 may be of any length, thickness, and / or width. The rib 180 may not extend all the way to the base or lower end 156. Rib 180 may be offset from the central axis of device 100. Rib 180 may allow for adjustable or selective pressure around the circumference of device 100. For example, the force applied to an organ wall at a location where rib 180 is close to or meets the upper part 142 is greater than the force applied to the organ wall at a location a distance away from rib 180.

[0095] Although described as a single rib 180, rib 180 may be constructed from two intersecting rib portions or members (e.g., segments 180a, 180c of a first rib portion or member and segments 180b, 180d of a second rib portion or member intersecting) or four meeting rib portions or members (e.g., rib segments 180a, 180b, 180c, 180d meeting in the middle). When more than one rib member is provided, these rib members may be spaced equidistant from each other. Alternatively, these rib members may be arbitrarily arranged relative to each other and / or may be offset such that a portion of the device 100 is constructed to apply greater pressure and / or greater support than the other sides. That is, the side with more rib members may apply greater pressure or support than the side with fewer rib members. Rib 180 may be formed as a single integral unit or as separate components coupled together. The rib 180 may be made of one material, two or more materials, or a combination of materials and / or components. The rib 180 may be semi-permeable. The rib 180 may be integrally formed with the upper portion 142 or may be formed as a separate component, which is otherwise secured within the upper portion 142. The rib 180 is removable from the upper portion 142. The entire device 100, including the rib 180, may be formed as a single, one-piece, integral device made of a single material.

[0096] Although rib 180 is shown as having four rib segments or rib members 180a, 180b, 180c, 180d, more or fewer rib segments may be provided, such as one, two, three, four, five, six, seven, eight, nine, ten or more rib segments may be implemented. The number of rib segments or rib members may be selected to adjust the pressure applied to the organ wall (e.g., the urethral or intestinal wall) to reduce, manage, improve, prevent or eliminate incontinence. Each rib segment or rib member 180a, 180b, 180c, 180d may include one or more openings 192. The one or more openings 192 may facilitate fluid flow and / or assist in the squeezing pressure through the vaginal insertion device 100 and / or act as an indicator for the placement of the device 100. These rib sections or rib members (e.g., 180a, 180b, 180c, 180d) combined with the inner side 150 of the inner wall or wall 149 may define one or more open or hollow portions 158. As shown in FIG16, the device 100 includes four open portions 158.

[0097] When pelvic organs prolapse, rib 180 can provide support for these organs or prevent organ displacement. Rib 180 can provide additional pressure on the vaginal wall, urethral sphincter, and / or bladder neck to help reduce, manage, improve, prevent, treat, and / or eliminate incontinence. Rib 180 can also help prevent tissue from descending into the opening portion 158 of the device. After a period of time, tissue and / or organs may descend into the device 100. Rib 180 can prevent this by blocking tissue from entering the device 100. Rib 180 can prevent the descent of the bladder, cervix, and rectum. Rib 180 can apply appropriate pressure through the vaginal canal to the vaginal wall or urethral sphincter located at the bladder neck to effectively reduce leakage.

[0098] When the edge 146 is included, it can be expandable or contractible to alter the therapeutic force and organ support. One side of the edge can be larger or thicker and the opposite side smaller or thinner to apply the therapeutic force. The edge can be semi-permeable to allow the passage of medications, lubricating gases, or fluids. Upon insertion, the edge 146 can be aligned with the bladder neck. The edge 146 can apply pressure (therapeutic force) to an organ wall. The edge 146 and rib 180 can together apply pressure and / or support to organs and / or organ walls within the vagina.

[0099] The edge 146 can be configured to apply greater pressure in one region than in another region. For example, the edge 146 can be weighted using the density, thickness, material, attachments, protrusions, ribs, components, etc., of a portion (e.g., half of the circular cross-section of the device). This portion can be configured to apply a greater pressure than the rest of the edge 146. The rest of the edge 146 can be constructed similarly to the rest of the device 100 (e.g., the same material, density, thickness, etc.).

[0100] Referring to Figures 16 and 17, the vaginal insertion device 100 may include one or more vents 168. These vents 168 may be equidistantly spaced around the circumference of the vaginal insertion device 100. Alternatively, the vents may be offset or arbitrarily spaced around the circumference of the device 100. The vents 168 may be located within the enlarged portion 142a of the upper portion 142. Alternatively, or additionally, the vents 168 may be located within the narrower or constricted portion (e.g., the conical portion or body) 142b.

[0101] The one or more vents 168 allow fluid to flow through the vaginal insertion device 100, thereby balancing the pressure on both sides of the vaginal insertion device 100 and / or releasing the vacuum pressure within the device. The one or more vents 168 may also function as a placement indicator for the device. The one or more vents 168 may function as a means of connecting an applicator (e.g., the applicator in Figure 15) for placement or application of therapeutic force. The one or more vents 168 may function as a channel for administering prescription or over-the-counter homeopathic remedies for yeast infections, sexually transmitted diseases, hormone levels, or fertility control. It may function as a conduit for attaching a test strip to indicate pH levels, hormone levels, or pelvic floor strength. When inserted into the vagina, the vents 168 prevent or limit suction on the device.

[0102] Referring to Figure 18, the vaginal insertion device 100 is shown in cross-section along line 18-18 of Figure 17. The rib 180 may extend from adjacent to or below the edge 146 to the base or lower end 156 of the upper portion 142. In this way, the rib 180 can apply pressure and support to the edge 146 and the upper portion 142, thereby applying pressure and support to the urethral and / or rectal wall.

[0103] The vaginal insertion device disclosed herein can be made to fit into a variety of vaginal sizes. Table 1 below shows a list of exemplary dimensions for the vaginal insertion devices 40, 100. The dimensions indicated in Table 1 can be seen in Figures 16-20. The diameter A in Table 1 can be the same as the diameter 76 in Figure 8 and / or the diameter J in Figures 27-38. The angle α can be 45 degrees, the radius of the edge R can be 0.10 inches (2.54 mm), and the length H of the device can be 2.29 inches (58.17 mm). The distances B, C, and D for positioning the ridge on the upper part can be 1.05 inches (26.67 mm), 0.80 inches (20.32 mm), and 0.55 inches (13.97 mm), respectively. The distances E and G for positioning the ridge on the handle can be 0.35 inches (8.89 mm) and 0.12 inches (3.05 mm), respectively. The distance F can be 0.24 inches (6.10 mm) for devices 2 and 5, and 0.23 inches (5.84 mm) for devices 3, 4 and 6. Table 1: Exemplary diameters for vaginal insertion devices Device 1 Device 2 Device 3 Device 4 Device 5 Device 6 A 2.05 inches (52mm) 1.81 inches (46mm) 1.65 inches (42mm) 1.50 inches (38mm) 1.34 inches (34mm) 1.18 inches (30mm)

[0104] As shown in Figures 16 and 18, the upper part 142 may have a conical body as shown, although the upper part 142 may have other shapes, such as, for example, triangular, circular, cylindrical, umbrella-shaped, or pyramidal. The upper part 142 may have an open apex. The upper part 142 may have a circular cross-section (Figure 19) or other shaped cross-sections along its entire length, such as oval, square, rectangular, triangular, pentagonal, hexagonal, or octagonal. The upper part 142 may have a wall 149 as shown, having an inner wall or inner side 150 and an outer wall or outer side 152, an upper open end 154, a base or lower end 156, and a hollow interior including a plurality of open portions 158, wherein the circumference of the upper part 142 decreases from the upper open end 154 to the lower end 156. As shown, the edge 146 may be circular and may surround and protrude from the outer side 152 of the wall 149 and be adjacent to the upper opening end 154. The ridge 148 may be a circular ring surrounding the outer side 152 of the wall 149. The ridge 148 may also include a mark. The ridge 148 may be of any shape, including polygons, semicircles, triangles, squares, letters, symbols, numbers, or signs, studs, mounds, buttons, raised areas, etc., or combinations thereof. As further shown, a handle 144 may extend from the lower end 156 of the upper portion 142. The upper portion 142 and the handle 144 may be made of a single material as a single-piece device. Alternatively, the upper portion 142 and the handle 144 may be made of one or more materials. It may be formed from one or more components that can be assembled and disassembled, expanded, or contracted. The upper portion may be made of a semi-permeable material to allow the passage of drugs, liquids, gases, or lubricants. The upper portion 142 and the handle 144 may be permanently or detachably coupled together. The handle 144 may have a flattened triangular body. The flattened triangular body of the handle 144 may expand radially outward and downward from the lower end 156. The conical body of the upper portion 142 may expand radially outward from the lower end 156 toward the upper opening end 154. The handle 144 may be any one of handles 244a-244g.

[0105] Referring again to Figures 16 and 17, the one or more vents 168 may include a vent, slit, gap, or hole. The one or more vents 168 may include a screen, mesh, or any other component having an opening. The vaginal insertion device 100 may include multiple vents 168. The vaginal insertion device 100 may include multiple vents 168 in places other than or in addition to vents 168. For example, the vaginal insertion device 40 may include vents on the wall 149 of the upper portion 142, on the handle 144 (similar to Figure 8), on the side wall of the handle 144, on the edge 146, through the ridge 148, and / or through the rib 180. The one or more vents 168 may make the vaginal insertion device more comfortable for the patient when inserted. The one or more vents may also balance the air pressure between the inside and outside of the vagina 18 when the vaginal insertion device 100 is inserted. However, a vent 168 is not necessary for the comfort, usefulness, and effectiveness of the vaginal insertion device 100. Such a vent 168 can prevent suction on the device.

[0106] Referring again to Figure 18, the edge 146 and the enlarged portion 142a may protrude from the outer side 152 of the wall 149, with the edge 146 protruding a greater distance than the enlarged portion 142a. Several alternative embodiments of the edge 146 and the enlarged portion 142a are possible, including an embodiment in which the edge 146 and / or the enlarged portion 142a is omitted and the height dimension of the remaining portion of the edge 146 and / or the enlarged portion 142a is increased such that the height of the segment is the same as the height of the combination of 142a and 146 according to the embodiment of Figure 18. Some embodiments may consist of one or more components and be made of one or more materials or combinations thereof. These components and materials may be detachable, attachable, expandable, or retractable.

[0107] Referring to Figures 16-20, the ridge 148 is not limited to the circular protrusion shown. Therefore, the ridge 148 can include the embodiment shown in Figures 16-20, where the ridge 148 is a protrusion that can be a circular ring surrounding the outer side 152 of the wall 149. However, the ridge 148 can also include any protrusion extending from the outer side 152 of the wall 149, such as multiple studs, mounds, buttons, ridges, letters, symbols, numbers, etc. The ridge 148 can help prevent displacement of the device by providing friction with the vaginal wall, thus preventing organ displacement. If the user suffers from prolapse, the ridge 148 can also support the device and tissue or prevent tissue displacement to prevent prolapse. The ridge 148 can help reduce, manage, improve, prevent, treat, and / or eliminate incontinence. The ridge 148 can also be made of a semi-permeable material to allow the passage of drugs, liquids, gases, or lubricants. Ridge 148 can apply pressure (therapeutic force) to the vaginal wall or tissue wall. Ridge 148 may be equidistantly and / or uniformly spaced along the upper portion 142. When signs, letters, numbers, etc., are provided as ridges as shown in Figures 16 and 27-38, a straight line extending through the center of the sign and parallel to the remaining ridges may be equidistantly and / or uniformly spaced along the upper portion 142 from the remaining ridges 148. Alternatively, ridge 148 may extend along the entire length or a portion of the upper portion 142 and may extend randomly, uniformly, or any combination thereof.

[0108] The vaginal insertion device 100 can be used, inserted, manipulated, etc., in a manner similar to the vaginal insertion device 40 described with reference to Figures 11-15 and 39-41. Any feature, modification, or use of the vaginal insertion device 40 can be applied to the vaginal insertion device 100, and vice versa.

[0109] Referring now to Figures 21A-21F, alternative embodiments of handles 44 and 144 are shown. Handles 244a, 244b, and 144c are shown in cross-sectional views of Figures 21A-21C. Besides the examples below, the handle can also be a ball, ring, handle, lug, plus sign, etc., or combinations thereof. The handle can be a flat, rectangular handle, such as handle 224g as shown in Figure 33. The vaginal insertion device in any of Figures 6, 16, and 27-38 can be provided with any of handles 244a-244f, handle 144 of Figure 16, or handle 44 of Figure 7. When the vaginal insertion device is inserted into the vagina, the user can determine the position of the vaginal insertion device of this disclosure based on the position of handles 44, 144, and 244. Rotation of handles 44, 144, and 244 can change the pressure applied to the urethral wall. Rotation of handles 44, 144, and 244 can decrease and / or increase the pressure on the urethral wall. Rotation of handles 44, 144, 244 allows selection and / or adjustment of the pressure applied to the organ wall. For example, slight rotation of handles 44, 144, 244 can result in a 50% reduction in urethral pressure, as shown in Figure 24. Ribs 48, 148, 248 on handles 44, 144, 244 can be any of the following: studs, domes, buttons, letters, numbers, symbols, signs, other shapes (including polygons, triangles, or squares), or combinations thereof. Ribs assist in placement, positioning, and / or gripping of the vaginal wall.

[0110] Handles 44, 144, 244 assist in the orientation of devices 40, 100 and may have markings indicating placement, such as arrows, balls, protrusions, or a numerical system, which can be felt or seen to determine placement. Handles 44, 144, 244 may have a system in which the user can rotate the handle to increase or decrease the magnitude of therapeutic force or pressure applied to the vaginal wall. The handle may be attached to an applicator. Both can be used together or separately to change the magnitude of therapeutic force applied to the organ by rotating the device or by acting as a mechanism for widening or contracting the device. Rotation of the handle can be performed by hand assisting the movement of the device on a portion of the lower end 154. Alternatively, rotation of the handle can be performed simply by grasping the handle with the hand or fingers. Handles 44, 144, 244 can also function as a catheter for drug administration or lubrication, either in conjunction with or without the applicator. The handle may be made of one material, more than one material, or a combination of materials. An applicator may be provided for rotating, placing, and / or applying a drug, and / or a combination thereof. The applicator may assist in rotating, placing, and / or applying a drug, or a combination thereof. The applicator may be as shown in Figure 15.

[0111] Figure 21A shows a handle 244a similar to the handle 44 in Figures 7 and 8. The handle 244a may be substantially conical in shape, with ridges 248 circumferentially arranged around the outer surface of the handle 244a. A vent 268a may or may not be provided on the handle 244a. The handle 244a may have a tensile strength of about 12 to about 16 lbf, for example about 13 to 15 lbf, for example about 14.03 lbf.

[0112] Figure 21B shows a handle 244b similar to the handle 144 of Figure 16. The handle 244b is triangular or rectangular in shape, as shown, and is substantially flat or two-dimensional (creating a plane). The handle 244b may have a body that slopes outward or extends from the lower end of the upper portion toward the distal end of the handle 244b (e.g., triangular). Alternatively, the handle 244b may have a body of fixed width (e.g., rectangular). In one embodiment, the handle 244b may be flat and may have other shapes, such as tapering inward or polygonal. The handle 244b may have ridges 248 provided on its outer surface. The handle 244b may also have one or more holes, openings, or other perforations that facilitate gripping. The handle 244b may have a tensile strength of about 4 to about 6 lbf, for example, about 4.5 to 5.1 lbf, for example, about 4.8 lbf.

[0113] Figure 21C shows a handle 244c similar to handle 244b, but with a greater thickness. Handle 244c has ridges 248 on its outer surface. As shown in Figures 21B and 21C, the thickness of handles 244b and 244c can be selected to assist in the gripping, insertion, removal, and repositioning of the vaginal insertion device 40, 100. Handle 244c may have the same or similar shape as handle 244b, but with a greater thickness. Handle 244c may have a tensile strength of about 10 to about 12 lbf, for example, about 11.07 lbf.

[0114] Figure 21D shows the handle 244d, which is generally cross-shaped in plan or cross section. The handle 244d has a ridge 248 extending generally around the outer surface of the handle 244d. The handle 244d may be solid, that is, without any openings. Alternatively, the handle 244d may be substantially hollow (similar to the handle 244a), with or without a vent. The handle 244d may be radially outward from the bottom of the upper portion toward the distal end of the handle 244d. The handle 244d may not have this flared extension, that is, the handle may extend downward in a fixed cross section as shown in Figure 21F. The shank 244d can have a tensile strength of about 12 to about 14 lbf, for example about 12.8 lbf, when it has a flared development (Fig. 21D) and a tensile strength of about 13.5 to about 15.5 lbf, for example about 14.4 lbf, when it does not have a flared development (Fig. 21F).

[0115] Figure 21E shows a handle 244e, which is generally conical in shape, with ridges 248 circumferentially surrounding its outer surface. The handle 244a may be formed from a generally cross-shaped handle 244d (or handle 244f, which has a generally fixed cross-section), with circular ridges around the outermost points of the cross-shaped portion of the handle 244e. The diameter of these circular ridges increases with the diameter of the handle 244e. Alternatively, when the handle has a fixed cross-section, the circular ridges may have a fixed diameter. The handle 244e may be solid, i.e., without openings. Alternatively, the handle 244e may be substantially hollow (similar to handle 244a), with or without vents. The handle 244e may have a tensile strength of approximately 13.3 to approximately 15.3 lbf, for example, approximately 14.3 lbf.

[0116] Figure 21F shows a handle 244f, which is cross-shaped in plan or cross-section. The handle 244f may have a ridge 248 extending generally around the outer surface or periphery of the handle 244f. The handle 244f may be solid, that is, without any openings. Alternatively, the handle 244f may be substantially hollow (similar to handle 244a), with or without ventilation holes. The handle 244f has a substantially uniform cross-section along its length; that is, the handle 244f has the same outer diameter at its top and bottom.

[0117] Handles 44, 144, 244a-244g (Figure 33C) allow the user to insert, remove, or adjust the device and / or administer medication or substances into the body or device and / or reposition the vaginal insertion device 40, 100. Handles 44, 144, 244a-244g can be selected based on patient comfort, ease of grip, ease of use, etc., when the device is inserted into the vagina. When the device is inserted into the vagina, the handle assists in its placement. For example, the user can grasp the handle and rotate the device inside the vagina. The portion of the upper part 142 near the handle 144 can also be grasped to assist in rotating the device. In one embodiment, the device can be folded and / or compacted again for easy adjustment, wherein the handle still indicates the position and / or the pressure applied to the vaginal wall. Rotation of the device can adjust the pressure on the urethral sphincter, bladder neck, and / or rectum. Therefore, the user can adjust the comfort level of the device by rotating the handle to increase or decrease the pressure on the urethral sphincter or other organ walls. The handle and / or the ridge on the handle can be aligned with the ribs on the device so that when the handle is rotated, the ribs are also rotated, applying greater pressure at a specific location.

[0118] Figures 22A-22E and 43 show a carrying case 300 for carrying the vaginal insertion device disclosed herein. The carrying case 300 allows the user to store the vaginal insertion device disclosed herein in a clean and sterile manner (when not in use). The carrying case 300 may include a base 302 and a lid 304. The lid 304 may have a substantially cylindrical lower portion and a substantially hemispherical upper portion. The base 302 may be decorated with a ruffled edge on its bottom surface 306 (Figure 22B) to allow the carrying case 300 to lie flat on a surface, such as a table or stand. The base 302 may also be rounded. The bottom surface 306 may not have a curved or ruffled shape. For example, the bottom surface 306 may have a rectangular shape similar to a turret, or the bottom surface 306 may be flat. The base 302 may have a protrusion or recess at its bottom that can accommodate an additional component, such as a brush for disinfection, or another disinfection technology. The base 302 may have a replenishment station mounted thereon. The base 302 may include several technologies, such as infrared cleaning, replenishment capabilities to supplement a component of the device, or communication devices for uploading data to a computer or mobile device. The base 302 may be manufactured from one material, more than one material, or a combination of materials. The base 302 may have one or more components that work together or individually and that can work with the cover of the device.

[0119] As shown in Figures 22F-23J, the base 302 may be substantially cylindrical in shape to conform to the shape of the vaginal insertion device and hold it in place or allow the device 40, 100 to dry, clean, or replenish. Referring to Figure 22C, the base 302 may have an upper cylindrical portion 308 having an uppermost surface 310. The vaginal insertion device 40, 100 may be placed over the uppermost surface 310 such that the edges 46, 146 lie flat on the uppermost surface 310. When the vaginal insertion device 40, 100 is placed on the base 302, the user may cover the vaginal insertion device 40, 100 with the cap 304 and place it on the surface 312 located on the base 302. The surface 312 and the cap surface 314 may mate and, when mated, may be fastened together by snaps, screws, or other means so that the cap 304 will not fall off and will only be removed with sufficient removal pressure from the user. In one embodiment, the surface 312 includes one or more (e.g., four regularly spaced) studs, mounds, or ridges that protrude outward from the surface and are sized and shaped to slide into a corresponding number of grooves on the interior of the cover surface 314 to secure the cover 304 to the base 302 (e.g., the L-shaped grooves in Figures 22F-22H). The base 302 provides a drying rack for the vaginal insertion device 40, 100. The base 302 after the vaginal insertion device 40, 100 has been removed can be seen in Figures 22F-22J. Figure 22K shows a brush for cleaning the vaginal insertion device 40, 100. The brush may be included in a kit that includes the carrying case 300, and the carrying case 300 may include the drying rack 400 (Figure 23). The container or carrying case 300 may be used for packaging, shipping, and / or displaying the vaginal insertion device disclosed herein.

[0120] Referring to Figure 23, a drying rack 400 is shown. The drying rack 400 may be included with the carrying case 300. The drying rack 400 may be the base 302, integrated with the base 302, coupled to the base 302, or a component of the base 302. The drying rack 400 may have a substantially cylindrical cross-section, such that the vaginal insertion device of this disclosure is fitted, engaged with, or interfaced onto the drying rack 400. The drying rack 400 may have a cylindrical bottom and may include one or more openings 402 and one or more protrusions 404. The openings 402 may allow water or other liquids to drip from the vaginal insertion device 40, 100 through the drying rack 400 (or be collected within the drying rack 400 and subsequently discarded). The protrusions 404 may support the vaginal insertion device of this disclosure during drying, cleaning, or replenishment. The protrusions 404 may be spaced apart such that when the ribs 180 are included, for example, in the device 100, the protrusions 404 extend into and contact the openings 158 (FIG. 18), for example, to support the sides of each member or rib 180a, 180b, 180c, and 180d. For example, the protrusions 404 may be spaced apart such that the members or ribs can slide into the protrusions 404 for detachably securing or anchoring the device 100. In some examples, the number of protrusions 404 is equal to the number of openings 158 to allow each protrusion to extend into one opening.

[0121] The drying, cleaning, or replenishing holder 400 may include one or more latches, clips, fasteners, couplings, protrusions, and / or recesses 406. These latches 406 may hook, slide, or otherwise secure to the inner surface of the edges 46,146 of the vaginal insertion device disclosed herein to support the device during drying, replenishing, or cleaning.

[0122] The carrying case 300 can be a self-sterilizing carrying case. That is, the user can place the vaginal inserter into the carrying case 300, so that the lid is secured to the base and the vaginal inserter is locked inside. The user can then activate the carrying case 300 to sterilize, disinfect, or otherwise clean the vaginal inserter. The user can start the sterilization of the vaginal inserter 40, 100, for example, by pressing a button and / or toggling a switch. The carrying case 300 may therefore include a power cord, battery, power cable, or other power source to provide power to the carrying case. The carrying case 300 may also include a wired or wireless connection for connecting to a mobile device or a device connected to the Internet, allowing the user to remotely (e.g., through an application) operate the carrying case 300 to sterilize the vaginal inserter. In this way, the user does not need to wash and dry the vaginal inserter separately. The user can easily place the vaginal inserter into the carrying case 300 and activate the case to disinfect or sterilize the vaginal inserter without any further action from the user. This disinfection / sterilization can be performed without adding water, for example, by plasma, infrared, ultraviolet, and / or ultrasound. In one embodiment, the disinfection or sterilization can be water or a solution. The vaginal inserter can be placed in the water or solution for disinfection and / or sterilization during a predetermined non-use period (e.g., while the user is sleeping). 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 for cleaning, disinfecting, and / or sterilizing the vaginal inserter (every night, every week, every two weeks, etc.).

[0123] In one exemplary embodiment, the carrying case can be considered self-sterilizing / sterilizing because it is configured to sterilize the vaginal insertor without user intervention, except through user initiation, for example. In one exemplary embodiment, the carrying case may include air plasma technology for sterilizing and / or disinfecting the vaginal insertor. A carrying case 300 incorporating air plasma technology can be plugged into a power source. The user then activates (e.g., using a button or switch) the carrying case, which then uses the air plasma technology to sterilize the vaginal insertor. In one exemplary embodiment, the carrying case may include air plasma, ultraviolet light, ultrasound, wet / dry heat, and / or radiation technologies to sterilize and / or disinfect the vaginal insertor.

[0124] A kit may be provided for use with the vaginal insertion device disclosed herein. The kit may include one or more vaginal insertion devices according to Figures 6-10, 16-20, and 27-38, a carrying case 300, and / or a drying rack 400. The kit may include multiple sizes of the vaginal insertion device (for user selection and appropriate size grading and / or to accommodate changes in the user's body) or may include a single size if the user has decided on a suitable size. Because the vaginal insertion device may be provided in different sizes, the carrying case 300 and the drying rack 400 may be made to accommodate each size of the vaginal insertion device. Alternatively, the carrying case 300 may be made to accommodate all sizes of vaginal insertion devices. Therefore, when a kit is provided, it may provide one or more vaginal insertion devices, a carrying case 300, and a drying rack 400, all made to be compatible in size. The kit may also include a cleaner for the vaginal insertion device and a non-essential cleaning brush (e.g., the brush in Figure 22K). The vaginal insertion device may be reusable, and the cleaner may allow for cleaning and / or disinfection between uses. The kit may include a small towel for cleaning and / or disinfecting the vaginal insertion device and / or the patient's hands. This allows for insertion and / or removal of the vaginal insertion device in a public facility (e.g., a shared toilet). The kit may also include a brush or cleaning tool, which may or may not be attached to the carrying case or the drying rack for disinfection and cleaning purposes.

[0125] Referring to Figure 24, it shows a graph of the therapeutic force of the vaginal insertion device (including Figures 16-20 and 27-38) according to this disclosure. This therapeutic force is the force applied to the bladder neck or vaginal sphincter through the vaginal canal. That is, the force or pressure applied to the vaginal sphincter. Lines 300, 302, 304, 306, and 308 correspond to devices 2, 3, 4, 5, and 6 from Table 1, respectively. Lines 300a, 302a, 304a, 306a, and 308a show the therapeutic force or force applied to the vaginal sphincter, bladder neck, or rectum at the ribs. Lines 300b, 302b, 304b, 306b, and 308b show the force applied in the gaps or spaces between the ribs.

[0126] As shown in the diagram in Figure 24, the force applied to the vaginal sphincter (arrow F in Figures 25A and 25B) when pressure is applied to the intercostal space (Figure 25B) is approximately 50% smaller than the pressure applied to the ribs (Figure 25A). Therefore, during use, the patient can rotate the vaginal insertion device before high-intensity activities (such as exercise) so that the rib 180 is aligned with the vaginal sphincter, bladder neck, or rectum and pressure is applied to support these organs during the activity. To facilitate this alignment, the position of the rib or one or more rib segments or components can be associated with the orientation of the handle (e.g., handles 144, 244a-244g, such as flat or two-dimensional handles 144 and 244b-c), such that the plane created by the width of the handle is parallel to the plane created by the rib or one or more rib segments or components, or coextensively with them (e.g., see Figure 18, where the plane coextensively with the rib 180 and the handle 144 protrudes from the page), or the plane created by the width of the handle and the longitudinal axis of the device are in the same space, with the rib passing through the longitudinal axis (e.g., as shown in Figure 17, the plane created by the width of the handle 144 is parallel to the page and coexists with the longitudinal axis or section line 18-18). Therefore, when the device is inserted into the vagina, by grasping the handle to understand its orientation, the user will also understand the orientation of the rib relative to the vaginal sphincter, bladder neck, or rectum.

[0127] The device can be rotated 45 degrees to reduce the therapeutic force by 50%. When less pressure is desired on the urethral sphincter, the patient can rotate the device so that rib 180 is not aligned with the vaginal sphincter, bladder neck, or rectum, and the force is applied to a gap or offset between the parts of rib 180. This alignment can be facilitated as described above. The rib can also be rotated to expand or contract to apply greater or less force to the vaginal sphincter, bladder neck, or rectum. The user uses the handle to rotate the device.

[0128] Referring now to Figures 25A and 25B, the forces applied to the vaginal insertion device of this disclosure are shown. Figure 25A shows the forces applied to the ribs 180 of the device (e.g., the treatment ribs of Figure 24) (e.g., the force on the urethral sphincter). Figure 25B shows the forces applied to a position of the device between portions of the ribs 180 (e.g., the treatment gaps of Figure 24) (e.g., the force on the vaginal sphincter or rectum). The forces applied in Figure 25B can be approximately 50% smaller than the forces applied in Figure 25A. As previously described, the forces applied to the vaginal sphincter, bladder neck, or rectum when the gaps or spaces between the ribs 180 are aligned with the urethral wall or rectum can be less than the forces applied when the ribs 180 are aligned with the urethral wall, bladder neck, or rectum. Therefore, the forces applied to the bladder neck, urethral sphincter, and / or rectum by the vaginal insertion device of this disclosure are adjustable and selectively adjustable.

[0129] While the reduction or elimination of urinary incontinence has been described above, the vaginal insertion device of this disclosure can be inserted into the vagina such that device 40, 100 applies pressure to the intestinal or colonic wall. The device can be rotated to adjust the pressure on the intestinal or colonic wall as described above. When rib 180 is included in the vaginal insertion device, the rib can provide pressure on the rectal and / or intestinal or colonic wall to effectively reduce, manage, treat, prevent, and / or eliminate fecal incontinence. Therefore, the vaginal insertion device can be inserted into the vagina to apply pressure to the rectum to prevent fecal incontinence or a prolapsed rectum or to prevent further rectal displacement. The vaginal insertion device can also be inserted into the anus to prevent, manage, reduce, treat, and / or eliminate fecal incontinence.

[0130] Referring to Figure 26, a vaginal insertion device 200 is shown. The vaginal insertion device 200 may be similar to vaginal insertion devices 40, 100. The vaginal insertion device 200 may have an edge 246. When the edge 246 is included, the edge 246 may be similar to edges 46, 146. However, the plane of the edge 246 may be substantially vertical, i.e., parallel to a vertical axis A passing through the handle 244 and the base 256 of the body 242, or at an angle relative to the vertical axis A. For example, the device 200 may have a curved angle, with the edge 246 resembling the widest end of the angle and the base 256 resembling the narrowest tip of the angle. The edge 246 may have a first portion 246a that is vertically offset from a second portion 246b. The first portion 246a may be located at a position higher than or spaced apart from the second portion 246b. The first part may differ from the lower part or the opposite side in thickness, hardness, density, and durability. The edge may differ in shape from the opposite side. The edge may be made of one material, more than one material, or a combination of materials and components. The edge may be expanded or contracted to apply the correct force to the correct location within the patient's body. The edge may be semi-permeable to allow the passage of fluids, gases, lubricants, or medications.

[0131] If edge 246 is present, it can be inclined or angled relative to edges 46, 146 of the vaginal insertion device 40, 100. The bladder neck may be positioned higher than the rectal wall and / or intestinal wall within the vagina. Therefore, when the vaginal insertion device 200 is inserted into the vagina, it can be positioned such that the second portion 246b or the lower side applies pressure to the rectal wall. The higher wall may apply pressure to the urethral wall. The inclined edge 246 may allow less pressure to be applied to the rectal wall or intestinal wall than pressure would be applied with a substantially horizontal edge (e.g., edges 46, 146). Alternatively, the vaginal insertion device 40, 100 may be shortened to accommodate a lower position of the rectal / intestinal wall within the vagina. Although described in relation to the intestinal wall, the height and / or angle of the edge may be selected to apply pressure to other portions of the vaginal wall.

[0132] The vaginal insertion device 200 can apply pressure to 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 by applying pressure to both the urethral wall and the intestinal wall. As shown and described, the unnecessary edge 246 (and / or edges 46, 146) can be unilateral, inclined, or otherwise angled to apply pressure at different locations within the vaginal canal according to anatomy and the type of incontinence and / or prolapse to be prevented or reduced. The first portion can also differ from the lower portion or the opposite side in thickness, hardness, density, and durability. The shape of the edge can differ from the opposite side. The edge can be made of one material, more than one material, or a combination of materials and components. The edge can be enlarged or contracted to apply the correct force to the correct location within the patient's body. The edge can be semi-permeable to allow fluids, gases, lubricants, or drugs to pass through.

[0133] Referring to Figures 27A-27H, a vaginal insertion device 2700 is shown. This vaginal insertion device 2700 may be similar to vaginal insertion device 100, but the handle 244F may be the cross-shaped handle 224f of Figure 21F (but the handle may also be one of handles 244a-244e, which includes two-dimensional handles 144 and 244b-c). Therefore, any variation, use, modification, or feature described herein regarding any of the vaginal insertion devices may be used, applied, or modified on this vaginal insertion device 2700. For example, any variation, use, modification, or feature regarding the rib 180, shape, vent, etc., may be provided on this vaginal insertion device 2700. Furthermore, any use or accessory (e.g., a carrying case) may be applied to this vaginal insertion device 2700 as previously described. Referring to Figure 27A, a perspective view of the vaginal insertion device 2700 is shown, with the rib 180 below and at a distance from the top surface of the device 2700. The upper portion, edges, ribs, vents, insertion method, rotation, pressure adjustment, use, and any other features or embodiments described herein may be presented on the vaginal insertion device 2700.

[0134] Referring to Figure 27B, a top view of the vaginal insertion device 2700 is shown. The vaginal insertion device 2700 may have a diameter J, approximately 25 to approximately 50 mm, such as approximately 30 to approximately 45 mm, approximately 30 to approximately 36 mm (including approximately 33 mm), approximately 34 to approximately 40 mm (including approximately 37 mm), approximately 39 to approximately 45 mm (including approximately 42 mm), and including approximately 30 mm. The vaginal insertion device 2700 may also have a rib 180 of width K, approximately 1 to approximately 1.6 mm, such as 1.3 mm. Each of the four portions of the cross-shaped rib has the dimension K. Referring to Figure 27C, a side view of the vaginal insertion device 2700 is shown. These ridges and unnecessary markings may be equidistantly spaced along the upper outer surface of the vaginal insertion device 2700, as described with reference to the previous embodiments. Referring to Figure 27D, a side view rotated 90 degrees from the view of Figure 27C is shown. The ridges on the handle 244F are spaced apart from each other. The lowest ridge is at a distance Z from the bottom of the vaginal insertion device 2700, approximately 2.7 to 3.1 mm, for example, approximately 2.9 mm. The middle ridge is at a distance Y from the lowest ridge, approximately 3.1 to 3.5 mm, for example, approximately 3.3 mm. The highest ridge is at a distance X from the middle ridge, approximately 3.1 to 3.5 mm, for example, approximately 3.3 mm.

[0135] Referring to Figure 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 upper base can be about 13 to about 14 mm, for example, about 13.3 to 13.7 mm, or for example, about 13.5 mm. The vaginal insertion device 2700 can have a length N of about 50 to about 76 mm, for example, about 55 to about 71 mm, or for example, about 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, or 69 mm, including about 58 or about 63 mm. The width M of the enlarged portion can be about 3.5 to about 4.1 mm, for example, about 3.8 mm. The width L of the edge can be about 4 to about 6 mm, for example, about 5 mm.

[0136] Referring to Figure 27F, details of the ridges on the handle 244F are shown. Each of these ridges extends from the handle 244F by a distance Q of about 0.4 to about 0.6 mm, for example, about 0.5 mm. Each of these ridges may have a thickness R of about 0.7 to about 0.9 mm, for example, about 0.8 mm. Referring to Figure 27G, a cross-sectional view of the handle 244F is shown. The handle 244F may have an overall width T of about 6.6 to about 7 mm, for example, about 6.8 mm, and an overall width C of about 6.6 to about 7 mm, for example, about 6.8 mm. Each leg of the cross-shaped handle 244F may have a width W of about 1.3 to about 1.5 mm, for example, about 1.4 mm. Referring to Figure 27H, a bottom view of the device 2700 is shown.

[0137] Referring to Figures 28A-28H, a vaginal insertion device 2800 is shown. This vaginal insertion device 2800 may be similar to vaginal insertion device 100, except that the handle 244F may be the cross-shaped handle 244F of Figure 21F (but the handle may also be one of handles 244a-244e, which includes two-dimensional handles 144 and 244b-c). This vaginal insertion device 2800 may be similar to vaginal insertion device 2700, but the dimensions will be different. Therefore, any variation, use, modification, or feature described herein regarding any of the vaginal insertion devices may be used, applied, or modified on this vaginal insertion device 2800. For example, any variation, use, modification, or feature regarding rib 180, shape, vent, etc., may be provided on this vaginal insertion device 2800. Furthermore, any use or accessory (e.g., a carrying case) may be applied to this vaginal insertion device 2800 as previously described. Referring to Figure 28A, a perspective view of the vaginal insertion device 2800 is shown, with the rib 180 below and at a distance from the top surface of the device 2800. The upper portion, edges, ribs, vents, insertion method, rotation, pressure adjustment, use, and any other features or embodiments described herein may be presented on the vaginal insertion device 2800.

[0138] Referring to Figure 28B, a top view of the vaginal insertion device 2800 is shown. The vaginal insertion device 2800 may have a diameter J, which is about 25 to about 50 mm, for example, 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), and including about 34 mm. The vaginal insertion device 2800 may also have a rib 180 of width K, which is about 1 to about 1.6 mm, for example, 1.3 mm. Each of the four portions of the cross-shaped rib has the dimension K. Referring to Figure 28C, a side view of the vaginal insertion device 2800 is shown. These ridges and unnecessary markings may be equidistantly spaced along the upper outer surface of the vaginal insertion device 2800, as described with reference to the previous embodiments. Referring to Figure 28D, a side view rotated 90 degrees from the view of Figure 28C is shown. The ridges on the handle 244F are spaced apart from each other. The lowest ridge is about 2.7 to about 3.1 mm, for example, about 2.9 mm, away from the bottom of the vaginal insertion device 2800. The middle ridge is about 3.1 to about 3.5 mm, for example, about 3.3 mm, away from the lowest ridge. The highest ridge is about 3.1 to about 3.5 mm, for example, about 3.3 mm, away from the middle ridge.

[0139] Referring to Figure 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 upper base can be about 13 to about 14 mm, for example, about 13.3 to 13.7 mm, or for example, about 13.5 mm. The vaginal insertion device 2800 can have a length N of about 50 to about 76 mm, for example, about 55 to about 71 mm, or for example, about 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, or 69 mm, including about 58 or about 63 mm. The width M of the enlarged portion can be about 3.5 to about 4.1 mm, for example, about 3.8 mm. The width L of the edge can be about 4 to about 6 mm, for example, about 5 mm.

[0140] Referring to Figure 28F, details of the ridges on the handle 244F are shown. Each of these ridges extends from the handle 244F by a distance Q of about 0.4 to about 0.6 mm, for example, about 0.5 mm. Each of these ridges may have a thickness R of about 0.7 to about 0.9 mm, for example, about 0.8 mm. Referring to Figure 28G, a cross-sectional view of the handle 244F is shown. The handle 244F may have an overall width T of about 6.6 to about 7 mm, for example, about 6.8 mm, and an overall width C of about 6.6 to about 7 mm, for example, about 6.8 mm. Each leg of the cross-shaped handle 244F may have a width W of about 1.3 to about 1.5 mm, for example, about 1.4 mm. Referring to Figure 28H, a bottom view of the device 2800 is shown.

[0141] Referring to Figures 29A-29H, a vaginal insertion device 2900 is shown. This vaginal insertion device 2900 may be similar to vaginal insertion device 100, except that the handle 244F may be the cross-shaped handle 244f of Figure 21F (but the handle may also be one of handles 244a-244e, which includes two-dimensional handles 144 and 244b-c). This vaginal insertion device 2900 may be similar to vaginal insertion devices 2700 and 2800, but the dimensions will be different. Therefore, any variation, use, modification, or feature described herein regarding any of the vaginal insertion devices may be used, applied, or modified on this vaginal insertion device 2900. For example, any variation, use, modification, or feature regarding the rib 180, shape, vent, etc., may be provided on this vaginal insertion device 2900. Furthermore, any use or accessory (e.g., a carrying case) may be applied to this vaginal insertion device 2900 as previously described. Referring to Figure 29A, a perspective view of the vaginal insertion device 2900 is shown, with the rib 180 below and at a distance from the top surface of the device 2900. The upper portion, edges, ribs, vents, insertion method, rotation, pressure adjustment, use, and any other features or embodiments described herein may be presented on the vaginal insertion device 2900.

[0142] Referring to Figure 29B, a top view of the vaginal insertion device 2900 is shown. The vaginal insertion device 2900 may have a diameter J, approximately 25 to approximately 50 mm, such as approximately 30 to approximately 45 mm, approximately 30 to approximately 36 mm (including approximately 33 mm), approximately 34 to approximately 40 mm (including approximately 37 mm), approximately 39 to approximately 45 mm (including approximately 42 mm), and including approximately 38 mm. The vaginal insertion device 2900 may also have a rib 180 of width K, approximately 1 to approximately 1.6 mm, such as 1.3 mm. Each of the four portions of the cross-shaped rib has the dimension K. Referring to Figure 29C, a side view of the vaginal insertion device 2900 is shown. These ridges and unnecessary markings may be equidistantly spaced along the upper outer surface of the vaginal insertion device 2900, as described with reference to the previous embodiments. Referring to Figure 29D, a side view rotated 90 degrees from the view of Figure 29C is shown. The ridges on the handle 244F are spaced apart from each other. The lowest ridge is about 2.7 to about 3.1 mm, for example, about 2.9 mm, away from the bottom of the vaginal insertion device 2900. The middle ridge is about 3.1 to about 3.5 mm, for example, about 3.3 mm, away from the lowest ridge. The highest ridge is about 3.1 to about 3.5 mm, for example, about 3.3 mm, away from the middle ridge.

[0143] Referring to Figure 29E, a side cross-sectional view of the vaginal insertion device 2900 is shown. The distance P from the bottom of the device to the upper base can be about 13 to about 14 mm, for example, about 13.3 to 13.7 mm, or for example, about 13.4 mm. The vaginal insertion device 2900 can have a length N of about 50 to about 76 mm, for example, about 55 to about 71 mm, or for example, about 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, or 69 mm, including about 58 or about 63 mm. The width M of the enlarged portion can be about 3.5 to about 4.1 mm, for example, about 3.8 mm. The width L of the edge can be about 4 to about 6 mm, for example, about 5 mm.

[0144] Referring to Figure 29F, details of the ridges on the handle 244F are shown. Each of these ridges extends from the handle 244F by a distance Q of about 0.4 to about 0.6 mm, for example, about 0.5 mm. Each of these ridges may have a thickness R of about 0.7 to about 0.9 mm, for example, about 0.8 mm. Referring to Figure 29G, a cross-sectional view of the handle 244F is shown. The handle 244F may have an overall width T of about 6.6 to about 7 mm, for example, about 6.8 mm, and an overall width C of about 6.6 to about 7 mm, for example, about 6.8 mm. Each leg of the cross-shaped handle 244F may have a width W of about 1.3 to about 1.5 mm, for example, about 1.4 mm. Referring to Figure 29H, a bottom view of the device 2900 is shown.

[0145] Referring to Figures 30A-30H, a vaginal insertion device 3000 is shown. This vaginal insertion device 3000 may be similar to vaginal insertion device 100, except that the handle 244F may be the cross-shaped handle 244f of Figure 21F (but the handle may also be one of handles 244a-244e, which includes two-dimensional handles 144 and 244b-c). This vaginal insertion device 3000 may be similar to vaginal insertion devices 2700, 2800, and 2900, but the dimensions will be different. Therefore, any variations, uses, modifications, or features described herein regarding any of the vaginal insertion devices may be used, applied, or modified on this vaginal insertion device 3000. For example, any variations, uses, modifications, or features regarding the rib 180, shape, vent, etc., may be provided on this vaginal insertion device 3000. Furthermore, any use or accessory (e.g., a carrying case) may be applied to this vaginal insertion device 3000 as previously described. Referring to Figure 30A, a perspective view of the vaginal insertion device 3000 is shown, with the rib 180 below and at a distance from the top surface of the device 3000. The upper portion, edges, ribs, vents, insertion method, rotation, pressure adjustment, use, and any other features or embodiments described herein may be presented on the vaginal insertion device 3000.

[0146] Referring to Figure 30B, a top view of the vaginal insertion device 3000 is shown. The vaginal insertion device 3000 may have a diameter J, which is about 25 to about 50 mm, for example, 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), and including about 42 mm. The vaginal insertion device 3000 may also have a rib 180 of width K, which is about 1 to about 1.6 mm, for example, 1.3 mm. Each of the four portions of the cross-shaped rib has the dimension K. Referring to Figure 30C, a side view of the vaginal insertion device 3000 is shown. These ridges and unnecessary markings may be equidistantly spaced along the upper outer surface of the vaginal insertion device 3000, as described with reference to the previous embodiments. Referring to Figure 30D, a side view rotated 90 degrees from the view of Figure 30C is shown. The ridges on the handle 244F are spaced apart from each other. The lowest ridge is at a distance Z from the bottom of the vaginal insertion device 3000, approximately 2.7 to 3.1 mm, for example, approximately 2.9 mm. The middle ridge is at a distance Y from the lowest ridge, approximately 3.1 to 3.5 mm, for example, approximately 3.3 mm. The highest ridge is at a distance X from the middle ridge, approximately 3.1 to 3.5 mm, for example, approximately 3.3 mm.

[0147] Referring to Figure 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 upper base can be about 13 to about 14 mm, for example, about 13.3 to 13.7 mm, or for example, about 13.4 mm. The vaginal insertion device 3000 can have a length N of about 50 to about 76 mm, for example, about 55 to about 71 mm, or for example, about 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, or 69 mm, including about 58 or about 63 mm. The width M of the enlarged portion can be about 3.5 to about 4.1 mm, for example, about 3.8 mm. The width L of the edge can be about 4 to about 6 mm, for example, about 5 mm.

[0148] Referring to Figure 30F, details of the ridges on the handle 244F are shown. Each of these ridges extends from the handle 244F by a distance Q of about 0.4 to about 0.6 mm, for example, about 0.5 mm. Each of these ridges may have a thickness R of about 0.7 to about 0.9 mm, for example, about 0.8 mm. Referring to Figure 30G, a cross-sectional view of the handle 244F is shown. The handle 244F may have an overall width T of about 6.6 to about 7 mm, for example, about 6.8 mm, and an overall width C of about 6.6 to about 7 mm, for example, about 6.8 mm. Each leg of the cross-shaped handle 244F may have a width W of about 1.3 to about 1.5 mm, for example, about 1.4 mm. Referring to Figure 30H, a bottom view of the device 3000 is shown.

[0149] Referring to Figures 31A-31H, a vaginal insertion device 3100 is shown. This vaginal insertion device 3100 may be similar to vaginal insertion device 100, except that the handle 244F may be the cross-shaped handle 244f of Figure 21F (but the handle may also be one of handles 244a-244e, which includes two-dimensional handles 144 and 244b-c). This vaginal insertion device 3100 may be similar to vaginal insertion devices 2700, 2800, 2900, and 3000, but the dimensions will be different. Therefore, any variations, uses, modifications, or features described herein regarding any of the vaginal insertion devices may be used, applied, or modified on this vaginal insertion device 3100. For example, any variations, uses, modifications, or features regarding the rib 180, shape, vent, etc., may be provided on this vaginal insertion device 3100. Furthermore, any use or accessory (e.g., a carrying case) may be applied to this vaginal insertion device 3100 as previously described. Referring to Figure 31A, a perspective view of the vaginal insertion device 3100 is shown, with the rib 180 below and at a distance from the top surface of the device 3100. The upper portion, edges, ribs, vents, insertion method, rotation, pressure adjustment, use, and any other features or embodiments described herein may be presented on the vaginal insertion device 3100.

[0150] As shown in Figure 31A, because the vaginal insertion device 3100 is larger in size, an additional rib segment can be provided for the rib 180, resulting in six individual rib portions or members and six opening portions 158. These additional rib portions allow greater force to be applied to the organ wall and provide greater support for the device. These additional rib portions also help prevent and inhibit prolapse in the larger device 3100. That is, because the device 3100 has a larger opening diameter, the six rib portions of the rib 180 can provide a smaller opening space than would be provided with only four rib portions (as in the previously described embodiment). The smaller opening space helps prevent prolapse.

[0151] Referring to Figure 31B, a top view of the vaginal insertion device 3100 is shown. The vaginal insertion device 3100 may have a diameter J, approximately 25 to approximately 50 mm, such as approximately 30 to approximately 45 mm, approximately 30 to approximately 36 mm (including approximately 33 mm), approximately 34 to approximately 40 mm (including approximately 37 mm), approximately 39 to approximately 45 mm (including approximately 42 mm), and including approximately 48 mm. The vaginal insertion device 3100 may also have a rib 180 of width K, approximately 1 to approximately 1.6 mm, such as 1.3 mm. Each of the six portions of the cross-shaped rib has the dimension K. Referring to Figure 31C, a side view of the vaginal insertion device 3100 is shown. These ridges and unnecessary markings may be equidistantly spaced along the upper outer surface of the vaginal insertion device 3100, as described with reference to previous embodiments. Referring to Figure 31D, a side view rotated 90 degrees from the view of Figure 31C is shown. The ridges on the handle 244F are spaced apart from each other. The lowest ridge is about 2.7 to about 3.1 mm, for example, about 2.9 mm, away from the bottom of the vaginal insertion device 3100. The middle ridge is about 3.1 to about 3.5 mm, for example, about 3.3 mm, away from the lowest ridge. The highest ridge is about 3.1 to about 3.5 mm, for example, about 3.3 mm, away from the middle ridge.

[0152] Referring to Figure 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 upper base can be about 13 to about 14 mm, for example, about 13.3 to 13.7 mm, or for example, about 13.5 mm. The vaginal insertion device 3100 can have a length N of about 50 to about 76 mm, for example, about 55 to about 71 mm, or for example, about 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, or 69 mm, including about 58 or about 63 mm. The width M of the enlarged portion can be about 3.5 to about 4.1 mm, for example, about 3.8 mm. The width L of the edge can be about 4 to about 6 mm, for example, about 5 mm.

[0153] Referring to Figure 31F, details of the ridges on the handle 244F are shown. Each of these ridges extends from the handle 244F by a distance Q of about 0.4 to about 0.6 mm, for example, about 0.5 mm. Each of these ridges may have a thickness R of about 0.7 to about 0.9 mm, for example, about 0.8 mm. Referring to Figure 31G, a cross-sectional view of the handle 244F is shown. The handle 244F may have an overall width T of about 6.6 to about 7 mm, for example, about 6.8 mm, and an overall width C of about 6.6 to about 7 mm, for example, about 6.8 mm. Each leg of the cross-shaped handle 244F may have a width W of about 1.3 to about 1.5 mm, for example, about 1.4 mm. Referring to Figure 31H, a bottom view of the device 3100 is shown.

[0154] Referring to Figures 32A-32H, a vaginal insertion device 3200 is shown. This vaginal insertion device 3200 may be similar to vaginal insertion device 100, except that the handle 244F may be the cross-shaped handle 244f of Figure 21F (but the handle may also be one of handles 244a-244e, which includes two-dimensional handles 144 and 244b-c). This vaginal insertion device 3200 may be similar to vaginal insertion devices 2700, 2800, 2900, 3000, 3100, but the dimensions will be different. Therefore, any variation, use, modification, or feature described herein regarding any of the vaginal insertion devices may be used, applied, or modified on this vaginal insertion device 3200. For example, any variation, use, modification, or feature regarding the rib 180, shape, vent, etc., may be provided on this vaginal insertion device 3200. Furthermore, any of the uses or accessories (e.g., a carrying case) may be applied to the vaginal insertion device 3200 as previously described. Referring to FIG32A, a perspective view of the vaginal insertion device 3200 is shown, with the rib 180 below and at a distance from the top surface of the device 3200. The upper portion, edges, ribs, vents, insertion method, rotation, pressure adjustment, use, and any other features or embodiments described herein may be presented on the vaginal insertion device 3200.

[0155] As shown in Figure 32A, because the vaginal insertion device 3200 is larger in size, an additional rib segment can be provided for the rib 180, resulting in six individual rib portions or members and six opening portions 158. These additional rib portions allow greater force to be applied to the organ wall and provide greater support for the device. These additional rib portions also help prevent and inhibit prolapse in the larger device 3200. That is, because the device 3200 has a larger opening diameter, the six rib portions of the rib 180 can provide a smaller opening space than would be provided with only four rib portions (as in the previously described embodiment). The smaller opening space helps prevent prolapse.

[0156] Referring to Figure 32B, a top view of the vaginal insertion device 3200 is shown. The vaginal insertion device 3200 may have a diameter J, which is about 25 to about 50 mm, for example, 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), and including about 52 mm. The vaginal insertion device 3200 may also have a rib 180 of width K, which is about 1 to about 1.6 mm, for example, 1.3 mm. Each of the six portions of the cross-shaped rib has the dimension K. Referring to Figure 32C, a side view of the vaginal insertion device 3200 is shown. These ridges and unnecessary markings may be equidistantly spaced along the upper outer surface of the vaginal insertion device 3200, as described with reference to the previous embodiments. Referring to Figure 32D, a side view rotated 90 degrees from the view of Figure 32C is shown. The ridges on the handle 244F are spaced apart from each other. The lowest ridge is about 2.7 to about 3.1 mm, for example, about 2.9 mm, away from the bottom of the vaginal insertion device 3200. The middle ridge is about 3.1 to about 3.5 mm, for example, about 3.3 mm, away from the lowest ridge. The highest ridge is about 3.1 to about 3.5 mm, for example, about 3.3 mm, away from the middle ridge.

[0157] Referring to Figure 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 upper base can be about 13 to about 14 mm, for example, about 13.3 to 13.7 mm, or for example, about 13.5 mm. The vaginal insertion device 3200 can have a length N of about 50 to about 76 mm, for example, about 55 to about 71 mm, or for example, about 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, or 69 mm, including about 58 or about 63 mm. The width M of the enlarged portion can be about 3.5 to about 4.1 mm, for example, about 3.8 mm. The width L of the edge can be about 4 to about 6 mm, for example, about 5 mm.

[0158] Referring to Figure 32F, details of the ridges on the handle 244F are shown. Each of these ridges extends from the handle 244F by a distance Q of about 0.4 to about 0.6 mm, for example, about 0.5 mm. Each of these ridges may have a thickness R of about 0.7 to about 0.9 mm, for example, about 0.8 mm. Referring to Figure 32G, a cross-sectional view of the handle 244F is shown. The handle 244F may have an overall width T of about 6.6 to about 7 mm, for example, about 6.8 mm, and an overall width C of about 6.6 to about 7 mm, for example, about 6.8 mm. Each leg of the cross-shaped handle 244F may have a width W of about 1.3 to about 1.5 mm, for example, about 1.4 mm. Referring to Figure 32H, a bottom view of the device 3200 is shown.

[0159] Referring to Figures 33A-33L, a vaginal insertion device 3300 is shown. This vaginal insertion device 3300 may be similar to the vaginal insertion device described in Figures 27-32, except that the handle 244g may be a flat, rectangular, two-dimensional handle. Therefore, any variation, use, modification, or feature described herein regarding any of the vaginal insertion devices may be used, applied, or modified on this vaginal insertion device 3300. For example, any variation, use, modification, or feature regarding the rib 180, shape, vent, etc., may be provided on this vaginal insertion device 3300. Furthermore, any use or accessory (e.g., a carrying case) may be applied to this vaginal insertion device 3300 as previously described. Referring to Figure 33A, a perspective view of the vaginal insertion device 3300 is shown, with the rib 180 below and at a distance from the top surface of the device 3300. The upper part, edge, rib, vent, insertion method, rotation, pressure adjustment, use, and any other features or embodiments described herein may be presented on the vaginal insertion device 3300.

[0160] Referring to Figure 33B, a top view of the vaginal insertion device 3300 is shown. The vaginal insertion device 3300 may have a diameter J, which is about 25 to about 50 mm, for example, 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), and including about 34 mm. The vaginal insertion device 3300 may also have a rib 180 of width K, which is about 1 to about 1.6 mm, for example, 1.3 mm. Each of the four portions of the cross-shaped rib has the dimension K. Referring to Figure 33C, a side view of the vaginal insertion device 3300 is shown. These ridges and unnecessary markings may be equidistantly spaced along the upper outer surface of the vaginal insertion device 3300, as described with reference to the previous embodiments. Referring to Figure 33D, a side view rotated 90 degrees from the view of Figure 33C is shown. The ridges on the handle 244g are spaced apart from each other. The lowest ridge is about 2.2 to about 2.6 mm, for example, about 2.4 mm, away from the bottom of the vaginal insertion device 3300. The middle ridge is about 2.0 to about 2.4 mm, for example, about 2.2 mm, away from the lowest ridge. The highest ridge is about 2.0 to about 2.4 mm, for example, about 2.2 mm, away from the middle ridge.

[0161] Referring to Figure 33E, a side cross-sectional view of the vaginal insertion device 3300 is shown. The distance from the bottom of the device to the upper base can be about 7 to about 8 mm, such as about 7.1 to 7.4 mm, for example, a distance P of about 7.3 mm. The vaginal insertion device 3300 may have a length N of approximately 45 to approximately 75 mm, such as approximately 50 to approximately 70 mm, such as approximately 54 to approximately 58 mm, such as approximately 54.5 to approximately 58.4 mm, for example approximately 46, 46.5, 48, 48.5, 50, 50.5, 52, 52.5, 54, 54.5, 56, 56.5, 58, 58.5, 60, 60.6, 62, 62.5, 63, 63.5, 64, 64.5, 66, 66.5, 68, 68.5, 70, 70.5, 72, 72.5, 74, 74.5 mm + / - 1 mm or + / - 0.1 mm, including 56.4 + / - 1 mm. The width M of the enlarged portion may be approximately 3.5 to approximately 4.1 mm, for example approximately 3.8 mm. The width L of the edge can be approximately 4 to approximately 6 mm, for example, approximately 5 mm.

[0162] Referring to Figure 33F, details of the ridges on the handle 244g are shown. Each of these ridges extends from the handle 244g by a distance Q of about 0.4 to about 0.6 mm, for example, about 0.5 mm. Each of these ridges may have a thickness R of about 0.7 to about 0.9 mm, for example, about 0.8 mm. Referring to Figure 33G, a plan view of the handle 244g is shown. The handle 244g may have an overall width T of about 5.8 to about 6.2 mm, for example, about 6.0 mm, and an overall width V of about 2.1 to about 2.5 mm, for example, about 2.3 mm. Referring to Figure 33H, a bottom view of the device 3300 is shown.

[0163] Referring to Figures 33I-33L, a perspective view of the device 3300 is shown. As shown, the handle 244g can be aligned with the ribs 180. That is, a plane extending longitudinally through the handle 244g can extend longitudinally through at least a portion of the ribs. As shown in Figure 34I, this results in the handle 244g being aligned with one rib 180 and perpendicular to the other ribs 180. This alignment allows the device to be placed inside the vagina. This alignment allows the user to know whether the rib is aligned with or not with the vaginal wall simply by touching the handle. This alignment helps control the pressure and support applied by the device.

[0164] Referring to Figures 34-38, vaginal insertion devices 3400, 3500, 3600, 3700, and 3800 are shown respectively. These vaginal insertion devices may be similar to the vaginal insertion device described in Figure 33, differing only in their overall outer diameter. Therefore, any variation, use, modification, or feature described herein regarding any of the vaginal insertion devices may be used, applied, or modified on the vaginal insertion devices of Figures 34-38. For example, any variation, use, modification, or feature regarding rib 180, shape, vent, etc., may be provided on the vaginal insertion devices of Figures 34-38. Furthermore, any use or accessory (e.g., a carrying case) may be applied to the vaginal insertion devices of Figures 34-38 as previously described. Referring to Figures 34A-38A, a perspective view of the vaginal insertion device is shown, with rib 180 below and at a distance from the top surface of the device. The upper portion, edges, ribs, vents, insertion method, rotation, pressure adjustment, use, and any other features or embodiments described herein may be presented on the vaginal insertion device. Referring to Figures 34B-38B, side views of these vaginal insertion devices are shown. These ridges and unnecessary markings may be equidistantly spaced along the outer surface of the upper portion of the vaginal insertion device, as described with reference to the preceding embodiments. Referring to Figures 34C-38C, a side view rotated 90 degrees from the views of Figures 34B-38B is shown. The ridges on the handle 244g may be spaced apart from each other. Referring to Figure 34D, a side sectional view of these vaginal insertion devices is shown.

[0165] These vaginal insertion devices may have a diameter J, which is about 25 to about 50 mm, for example, 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), and including about 30 mm (Fig. 34), about 38 mm (Fig. 35), about 42 mm (Fig. 36), about 48 mm (Fig. 37), and about 52 mm (Fig. 38). The dimensions K, L, M, N, P, Q, R, T, V, X, Y, and Z may be the same as or within the same range as all the dimensions in Figs. 33-38. Alternatively, any of these dimensions may vary in size to accommodate anatomical variations in women. For example, in a device with a smaller diameter, the height, the length of the handle, the width of the edge and / or the ridge, or combinations thereof, may be made to a different size (e.g., smaller) than a device with a larger diameter. In each of Figures 33-38, the handle 244g may be aligned with the rib 180 as shown in Figures 33I-33L. As previously described, these devices may include more than four ribs, such as six ribs. For example, in the larger dimensions of Figures 37 and 38, six ribs may be provided in the manner previously described.

[0166] Referring to Figures 39-41, 16-20, and 26-38, the vaginal insertion device can be inserted into the vagina 18 as described with reference to Figures 11-13. For example, the device, such as device 3400, can be inserted into the vagina to apply pressure to the urethral sphincter 16. This pressure can be applied at the bladder neck. As shown in Figure 40, device 3400 can apply pressure so that there is little or no leakage when the bladder is full. The device 3400 shown in Figure 40 supports the full bladder, thus improving, preventing, eliminating, or inhibiting prolapse. The support and assistance in preventing prolapse may be due to the pressure applied by the ribs and / or edges of the device. Figure 41 shows the device 3400 inserted into the vagina 18 supporting, managing, improving, preventing, or eliminating prolapsed urethra.

[0167] In an exemplary embodiment, the vaginal insertion device of this disclosure can be used during exercise or other activities. For example, the vaginal insertion device can be inserted into the body in the manner described above before walking, running, weight training, cardiovascular activity, kickboxing, or other high-intensity activities, etc. (e.g., 5 to 60 minutes). 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 will create stress or apply pressure to the pelvic organs, bladder, and / or rectum. Without this device, the stress or pressure associated with the activity can cause displacement and / or prolapse of the pelvic organs, bladder, and / or rectum and cause discomfort to the user during the activity. The vaginal insertion device can support the pelvic organs, bladder, and / or rectum to resist, support, inhibit, or eliminate the discomfort, stress, or pressure caused to these organs by the activity. Users can use the vaginal insertion device only during active periods or during periods of sedentary activity (e.g., sleeping, resting, sitting, etc.) and active periods. In one embodiment, a user can use one size of vaginal insertion device during active periods and then use another size during periods of less activity or sedentary activity. For example, a user can use a larger size of vaginal insertion device during active periods and a smaller size during periods of less activity or sedentary activity.

[0168] Referring to Figure 42, a kit 4000 is shown. The kit 4000 may include one or more storage kits 4100 and a vaginal insertion kit 4200. The storage kit 4100 may include a carrying case 4120 and a non-essential brush 4110. The carrying case 4120 may be the carrying case described previously and may include the drying kit described previously. The brush 4110 may be the brush described previously. The vaginal insertion kit 4200 may include multiple vaginal insertion devices 4210, 4220, and 4230. These multiple devices may be provided in various sizes. In this way, the user can select the desired size for a specific purpose or function. For example, the user may select a larger device that provides more support in one use and a smaller device that provides support in another use. The vaginal insertion devices 4210, 4220, and 4230 may be different sizes or different types of the vaginal insertion devices described previously. Alternatively, the kit 4000 may provide multiple vaginal insertion devices of the same size.

[0169] In one embodiment, the kit 4000 may include the storage kit 4100 and the vaginal insertion kit 4200 within a single compartment of the kit 4000. In some embodiments, the kit 4000 is a box with an attached or detachable lid.

[0170] Any of these vaginal insertion devices 40, 100, 200, or the vaginal insertion devices of Figures 27-38, may be formed of one or more materials and components, allowing the device to collapse, fold, compress, or be inserted into the vagina when pressed by the user, or to fold for storage or to become smaller. A maximum folding force may be from about 1.5 to about 1.9 lbf, for example, 1.7 lbf. For a material that is 40% harder than the material exhibiting a maximum folding force of 1.7 lbf, its maximum folding force may be from about 1.8 lbf to 2.4 lbf, for example, about 2.1 lbf. Once located in the vagina, the device may move or expand from its folded or compressed form during insertion back to its original form, for example, as seen in Figure 16. The hardness, density, size, shape, and durability of the material (e.g., non-absorbent material, such as silicon) selected for vaginal insertion devices 40, 100, 200 can be chosen based on the desired compressibility and collapseability of the device and / or the pressure applied to the urethral sphincter, bladder neck, or rectum. The hardness of the material (e.g., silicon) used for a vaginal insertion device of one size can be lower or softer, and / or the hardness of the material used for vaginal insertion devices of different sizes can be higher or harder.

[0171] The device can be manufactured using a single material. However, some embodiments may be manufactured using multiple components and / or using a different material or a combination of different materials, and may be detachable or attachable. The device may be disassembled and reassembled for cleaning, disinfection, medication administration, weights or indicators, or various technologies (e.g., Bluetooth chip, radio waves, microwaves, or Wi-Fi connectivity).

[0172] When rib 180 is provided, a softer or harder material can be used. This softer or harder material (e.g., silicon) allows for more comfortable wear while the rib 180 provides additional pressure. In other words, rib 180 can accommodate the pressure exerted by a softer or harder material, thus allowing for a more comfortable and effective device.

[0173] The vaginal insertion device disclosed herein can have multiple functions. As described above, the primary function of the device can be to support the urethral sphincter, bladder neck, or intestines to reduce, prevent, treat, and / or eliminate incontinence or prevent or support prolapsed organs. Furthermore, while the device may be available over the counter, it may contain medications, such as prescription or over-the-counter homeopathic or other substances to address hormonal imbalances, sexually transmitted infections, yeast infections, fertility control, spermicides, and other beneficial substances, such as antifungal or anti-infective substances that inhibit the growth of bacteria, fungi, or diseases. The device may secrete substances or medications. The device may be provided for hormone replacement therapy. Therefore, the device can deliver medication into the vaginal cavity, for example, by means of a controlled, long-term, or extended release curve. This medication delivery can be achieved by releasing medication from the outer or inner surface of the device and can be made of one or more separable or attachable materials or components. The device may also include diagnostic capabilities, such as determining hormone levels, ovulation levels, pH levels, pelvic floor or muscle strength, or serving as an early detection component for health benefits, by including an attachable / releasable or fixed indicator strip. The device may have a detachable component for use during the menstrual cycle or before or after sexual intercourse. It may also have a detachable component (e.g., weight) for use during pelvic floor exercises. While embodiments may be over-the-counter, components of the device or embodiments of the device may be used for drug delivery or for the diagnosis of a disease or condition.

[0174] The vaginal insertion device disclosed herein may further include weight, which may be added or removed or made of a weighting material. This weight may be used to exercise the pelvic floor muscles during exercise or Kegel exercises, or simply to force the end-user to keep the device in place while performing their daily activities, thereby exercising the muscles.

[0175] The vaginal insertion device disclosed herein may include weights, projectiles, stainless steel projectiles, indicator strips, pressure sensors, nanotechnology, or other additives described herein. When additional features or components are included in the vaginal insertion device of this disclosure, they may be placed in a mold prior to injection molding (or other manufacturing processes) so that they are integrated with the device and / or they may be inserted together with the material during injection molding (or other manufacturing processes) for integration with the device. Alternatively, such additional features or components may be secured to the device, device walls, recesses or depressions formed on the device specifically for the component by post-processing (e.g., binding, gluing, adhesive, bonding, etc.).

[0176] The vaginal insertion device disclosed herein can be made of a material that changes color according to the frequency of use and / or according to vaginal conditions (e.g., pH level) or the device itself. That is, the user can remove the device and use the color to determine when it needs to be cleaned, replenished, replaced, and / or discarded. The user can also remove the device, and it may include diagnostic capabilities, informing the user of ovulation, yeast infection, sexually transmitted diseases, certain hormone levels (e.g., unhealthy hormone levels), and / or infections, etc.

[0177] The vaginal insertion device disclosed herein can be used with a chip that communicates via Bluetooth, Wi-Fi, radio waves, microwaves, or other technologies. Therefore, the user can communicate with mobile devices, such as smartphones or tablets. For example, the device can communicate pH levels or other usability indicators that inform the user when it is time to clean, replenish, replace, and / or discard the device. 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 diseases. The device may come with an application for mobile devices or other technologies to monitor ovulation, urethral sphincter strength, or pelvic floor strength. The device can be used with Wi-Fi. Furthermore, if the device is worn during exercise, it can keep organs in position and prevent prolapse caused by prolonged and strenuous fixed movements (such as running).

[0178] The vaginal insertion device disclosed herein prevents further displacement of the organ and keeps it in place. The edge, conical shape, and ridge work together to apply pressure to the urethral sphincter, bladder neck, or intestine and prevent organ displacement. Devices 40,100 described herein apply pressure to the urethral sphincter, bladder neck, or intestine. The device may be adjustable to ensure comfort for the user. The device can be adjusted by moving the handle. Over time, the device in its position can reduce the likelihood of further prolapse during activity (e.g., running, walking, jumping jacks, etc.).

[0179] The vaginal insertion device disclosed herein can capture or collect vaginal secretions. These secretions can be analyzed by the device or by a clinician after removal. The secretions can be used to diagnose sexually transmitted infections, whether a woman is pregnant or ovulating, hormone levels, yeast infections or other non-sexually transmitted infections, abnormal cells, interstitial cystitis, and can help manage interstitial cystitis. Although in one embodiment the vaginal insertion device of this disclosure does not create a seal or suction, the device can collect a certain amount of secretions. Unlike a menstrual cup intended to collect all menstrual fluid, this device can collect secretion samples for diagnostic and evaluation purposes.

[0180] The removable portion of this disclosure can be made of multiple components and one, two, or a combination of materials, and can be detachable, attachable, retractable, and expandable. The handle can be turned in and / or snapped into position to adjust the tension or size of the device. The handle can be used to reorient the device. The handle may have markings protruding from it and associated with the placement or strength of the device, such as an arrow or a numerical system. The handle may have a hole for use as an indicator or be located next to a drying rack. When the handle is turned, the vaginal insertion device can increase or decrease pressure. The vaginal insertion device may include attachable and / or interchangeable weights. The vaginal insertion device may include a strap or other attachments that can determine ovulation, pH levels, etc.

[0181] While the vaginal insertion device of this disclosure is described herein as including ribs and rib segments or rib members, in other embodiments, the vaginal insertion device of this disclosure does not include ribs or rib segments or rib members. For example, in an example where the vaginal insertion device does not include ribs or rib segments or rib members, the device includes an edge similar to edges 46, 146, 246, wherein when the device is inserted into a patient's body, the edge is capable of providing sufficient pressure or force to the urethral sphincter, bladder neck, intestine, and / or vaginal wall to provide support for the patient's pelvic organs. In one embodiment, the edge includes one or more portions that provide greater pressure or force than other portions. The one or more portions providing greater pressure or force may be thicker, more reinforced, or composed of a material with greater rigidity (e.g., harder silicon) than other portions of the edge. One or more portions of the edge that provide greater pressure or force may be aligned with the handle (much like the rib or rib segment or rib member aligned with the handle as described herein), allowing the user to position one or more portions of the edge that provide greater pressure or force in a position adjacent to the vaginal wall that provides support for pelvic organs, such as a position near the urethral sphincter, bladder neck, or intestines.

[0182] While the vaginal insertion device of this disclosure is described herein as including one or more hollow portions 58, 158 within the device (e.g., between rib segments or members), in other embodiments, the vaginal insertion device of this disclosure does not include these hollow portions, but is instead solid or semi-solid, for example, by being filled with the same material as the vaginal insertion device (e.g., silicon of the same or different hardness) or filled with one or more different materials (e.g., foam or gel). A solid or semi-solid vaginal insertion device can still be compressed or deformed as described herein to facilitate insertion, and the device can then return to its original shape after insertion. In one embodiment, the vaginal insertion device includes a rib that can be divided into rib segments or members to provide support as described herein, and a filling material within a hollow portion 158 between such rib segments or members. In an alternative embodiment, the vaginal insertion device does not include a rib but includes filling material within the hollow portion 158. In some examples of this alternative embodiment, the device includes an edge having one or more portions that provide greater pressure or force than other portions, as described herein. In one embodiment, the upper portion may be closed, covered, or plugged in such that the interior of the device (whether the hollow, solid, and / or semi-solid portions) is not exposed to the atmosphere and / or the interior of the vagina when inserted.

[0183] According to one embodiment, this disclosure provides a method of applying pressure or force to a location on the vaginal wall of a patient. The method includes inserting a vaginal insertion device into the patient's vagina and orienting a force or pressure-providing portion of the vaginal insertion device to align or be adjacent to the location on the vaginal wall of the patient. In some embodiments, the location on the vaginal wall is close to the urethral sphincter, bladder neck, or intestine. In some embodiments, applying pressure or force to the location on the vaginal wall provides support for the patient's pelvic organs. In some examples, the vaginal insertion device includes a rib, rib segment, or rib member as described herein, and the force or pressure-providing portion of the vaginal insertion device corresponds to a location where the rib, rib segment, or rib member meets the inner wall of the device. In some embodiments, the vaginal insertion device includes an edge (e.g., a circular edge in a plan view as described herein), and the force or pressure-providing portion of the vaginal insertion device corresponds to one or more portions of the edge that provide greater pressure or force than other portions of the edge. In one embodiment, the vaginal insertion device includes a handle as described herein, aligned with the force or pressure providing portion of the vaginal insertion device. In some examples, orienting the force or pressure providing portion of the device includes rotating the device, for example by rotating the handle. In one embodiment, the vaginal insertion device of this disclosure may include a member or feature that aligns the device with the pelvic floor, or the device itself may be aligned with the pelvic floor.

[0184] While one embodiment of the vaginal insertion device may be made of a single material or component, other embodiments may be made of multiple components and / or multiple materials. These components may include accessories, such as detachable accessories. Examples of these components include, for instance, an add-on for menstrual cycle support to increase weight for pelvic floor exercises, an indicator bar for ovulation detection or pH level assessment, or a mixture of materials or components for medication administration. The device or portions thereof may be expandable and contractile. The device may be semi-permeable to allow the passage of liquids, lubricants, or medications.

[0185] According to one embodiment, a vaginal insertion device for managing, treating, improving, reducing, eliminating, or preventing incontinence may include one or more upper portions having a conical body, an outer wall, and an inner wall; a handle extending from a base of the upper portion; one or more first ridges projecting outward from the outer wall; and a rib projecting inward from the inner wall, the rib being configured to apply pressure to an organ wall. The handle may include one or more second ridges projecting outward from the outer surface of the handle. The handle may be conical, triangular, flat, or cruciform. The one or more first ridges may be one or more studs, mounds, buttons, letters, numbers, symbols, signs, circles, semicircles, protrusions, polygons, triangles, squares, or combinations thereof. The rib may include multiple intersecting ribs. The rib may be cruciform, "T"-shaped, "X"-shaped, "Y"-shaped, "K"-shaped, "V"-shaped, triangular, or pentagonal. The rib may also be star-shaped and connected at one, more, or no locations. The rib may protrude from the outer wall, extending from an adjacent edge to the upper base. One or more vents may be formed on at least one of the upper portion or the rib. The device may support an organ wall, which may be at least one of the following: urethral wall, bladder wall, colonic wall, or rectal wall.

[0186] According to one embodiment, a kit for reducing or eliminating incontinence may include one or more first vaginal insertion devices; a carrying case including a base and a lid; a drying rack; and an optional brush and cleaner. The kit may include a second vaginal insertion device having an outer diameter different from that of the first vaginal insertion device (e.g., a larger or smaller vaginal insertion device). The first vaginal insertion device may be one or more vaginal insertion devices, each having the same or different outer diameter, hardness or stiffness, shape, density, size, or durability. The base may have a curved lower surface configured to lie flat on a surface. The lid may have a substantially cylindrical lower portion and a substantially hemispherical top, configured to mate with the base. The edge of the first vaginal insertion device may be configured to fit over and mate with a first upper surface of the base. The lid may be configured to cover the first vaginal insertion device and fit over and mate with a second upper surface of the base. In one embodiment, the drying rack may include a cylindrical base having one or more protrusions with multiple holes and one or more latches.

[0187] According to one embodiment, a method for reducing or eliminating incontinence in a female patient may include inserting a vaginal insertion device, as described herein, into the patient's vagina. For example, the method may include inserting a vaginal insertion device having a body, an edge, a rib, and a handle into the vagina; and applying pressure to the organ wall using the edge and the rib of the vaginal insertion device. The method may include adjusting the pressure applied to the organ wall and includes rotating the vaginal insertion device by rotating the rib.

[0188] According to one embodiment, a method for adjusting the pressure on the organ wall of a patient may include inserting a vaginal insertion device, as described herein, into the patient's vagina. For example, the method may include inserting the vaginal insertion device into the patient's body, aligning one rib of the vaginal insertion device with an organ wall, and reducing pressure on the organ wall by rotating the vaginal insertion device to disalign the rib with the organ wall. This rotation may be achieved using a handle extending from the vaginal insertion device. When the device is rotated, it can expand or contract to adjust the pressure on the vaginal wall.

[0189] According to one embodiment, a method for adjusting pressure on an organ wall may include inserting a vaginal insertion device, disaligning the ribs of the vaginal insertion device with the organ wall, and increasing pressure on the organ wall by rotating the vaginal insertion device to align the ribs with the organ wall. This rotation may be achieved using a handle extending from the vaginal insertion device. When the device is rotated, it can expand or contract to adjust the pressure on the vaginal wall.

[0190] Current menstrual cup products cannot be used to prevent, reduce, or eliminate incontinence. The cervix or bladder may sink into the menstrual cup of the device, creating suction. When a woman attempts to remove the device, she may pull on these organs, causing injury. The internal ribs and / or vents of the vaginal insertion device disclosed herein eliminate the risk of organs sinking into the device and the suction on the cervix or bladder. The additional support provided by the vaginal insertion device disclosed herein is beneficial for patients, especially those with cervical atrophy or complete absence of the cervix, and for those whose bladder will pass through or has already prolapsed (prolapse).

[0191] The menstrual cup is intended to create a seal at the cervix, thereby generating suction. This seal eliminates the possibility of leakage. Suction can cause the user to pull on her own organ during removal. Therefore, in some embodiments of the device disclosed herein, an opening is provided at the bottom or side of the device to prevent this suction. In some embodiments, the vaginal insertion device of this disclosure supports the cervix. The vaginal insertion device of this disclosure can apply pressure (therapeutic force) to the urethral sphincter via an intravaginal canal. Conversely, the menstrual cup does not apply pressure to the urethral sphincter. Furthermore, the menstrual cup can be sealed against the organ wall to prevent blood from flowing outside the menstrual cup. The vaginal insertion device of this disclosure does not need to be leak-proof and / or seal against the organ wall. In fact, such a seal / leak-proof seal would create the aforementioned suction.

[0192] Based on the teachings of this disclosure, the disadvantages and problems associated with conventional pessaries can be substantially reduced or eliminated.

[0193] According to embodiments of this disclosure, a vaginal insertion device for managing, improving, eliminating, or preventing symptoms associated with pelvic organ prolapse, urinary incontinence, or fecal incontinence, or both pelvic organ prolapse and urinary / fecal incontinence, may include an upper portion made of an elastic and non-absorbent material, having a conical body, a circular cross-section along its entire length, a wall having an inner and outer side, an upper open end, a lower end, and a hollow interior, wherein the circumference of the upper portion decreases from the upper open end to the lower end, wherein the upper open end of the upper portion is the innermost part of the vaginal insertion device during insertion, and wherein the wall of the upper portion can be compressed to make the upper portion more compact for easier insertion of the vaginal insertion device, and wherein after insertion, the wall expands back to its original shape. This vaginal insertion device may further include: a non-essential outer edge that surrounds and protrudes from the outer side of the upper wall and is adjacent to the upper opening end; and a plurality of ridges that surround and protrude from the outer side of the upper wall and are spaced apart from the upper opening end to the lower end.

[0194] In some embodiments, this disclosure relates to a vaginal insertion device for managing, improving, eliminating, treating, and / or preventing symptoms associated with pelvic organ prolapse, urinary incontinence, and / or fecal incontinence, or any combination thereof. In some examples, the device includes an upper portion which is not necessarily made of an 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 oval cross-section over its entire length or a portion thereof, a wall having inner and outer sides, an upper open end, a lower end, and a hollow or semi-hollow interior. In some embodiments, the body has a conical shape, wherein the base of the cone corresponds to the upper open end and the cone gradually tapers toward the lower end. In some examples, the circumference of the upper portion decreases from the upper open end toward the lower end. In some embodiments, the upper open end of the upper portion is the innermost part of the vaginal insertion device during insertion (i.e., the upper portion is the part of the device that is first inserted into the vagina). In some examples, the upper wall can be compressed to make the upper portion more compact, facilitating insertion of the vaginal insertion device. In some embodiments, after insertion, the wall expands back to its original shape. The vaginal insertion device may further include a non-essential outer edge that surrounds and protrudes from the outer side of the upper wall and is adjacent to the upper opening end. In some embodiments, the device includes a plurality of ridges that surround and protrude from the outer side of the upper wall and are spaced apart from the upper opening end to the lower end (e.g., with regular, irregular, increasing, or decreasing spacing).

[0195] According to these and other embodiments of this disclosure, a vaginal insertion device may include a removable portion extending from the lower end of the upper portion, wherein when the vaginal insertion device is inserted into the vagina, the removable portion can be accessed from the outside of the vagina, and wherein the removable portion assists in removing the vaginal insertion device from the vagina. The removable portion may be a cord or a handle. In embodiments where the removable portion is a handle, the handle may extend from the lower end of the upper portion, wherein the upper portion and the handle may be a single integral component, but may have multiple separable parts of the device made of the elastic and non-absorbent material or other materials, wherein the handle has a conical body, a circular cross-section along its entire length, a wall, an upper end, a lower open end, and a hollow interior, and wherein the circumference of the handle increases from the upper end to the lower open end. The removable portion, like the upper portion, may also have multiple ridges.

[0196] In some embodiments, this disclosure relates to a vaginal insertion device including a removable portion extending from the lower end of the device body. In some embodiments, the removable portion is accessible from the outside of the vagina when the vaginal insertion device is inserted into the vagina. In some examples, the removable portion facilitates removal of the vaginal insertion device from the vagina. The removable portion may be a cord, handle, lug, flap, or other protrusion extending from the lower end of the device body. In some examples, the device body (e.g., including the upper portion) and the removable portion (e.g., when it is a handle, lug, or flap) may be an integral structure, such as a one-piece molded silicon structure. In some embodiments, the integral structure may have multiple separable components made of elastic and / or non-absorbent materials or other materials. In some embodiments, the removable portion (e.g., when it is a handle, lug, or wing) has one or more of the following features: a body, a circular cross-section over its entire length or a portion thereof, a wall, an upper end, a lower open end, and a hollow or semi-hollow interior. In some embodiments, the body has a conical shape, for example, a cone that tapers from a base to a region attached to the base of the device. In some examples, the circumference of the removable portion (when it is a circular handle, lug, or wing) increases from the upper end to the lower open end. The removable portion may also include a plurality of ridges, nodules, mounds, turf-like features, or other structural surface features on the exterior of the removable portion that facilitate a user's fingers gripping the removable portion (and the device). In some embodiments, the removable portion has a rectangular or box shape that protrudes from the bottom of the body of the device.

[0197] According to these and other embodiments disclosed herein, a vaginal insertion device may include one or more vents (e.g., holes, slits, gaps, or openings). A vent may be located at the point where the lower end of the upper portion meets the handle. One or more vents may be located on the wall or edge of the upper portion. The vent may be used as a position indicator, for ventilation, or both.

[0198] According to these and other embodiments disclosed herein, a vaginal insertion device may include a non-essential outer edge, which is non-circular and has a first segment and a second segment. In some examples, the first segment protrudes a greater distance from the outer side of the upper wall than the second segment. The edge may have different sizes and thicknesses. It may be thinner on one side and thicker on the opposite side. The edge may be widened or narrowed for therapeutic force and support.

[0199] According to these and other embodiments of this disclosure, a vaginal insertion device may include an applicator for use during insertion and / or removal of the device. In some embodiments, the applicator includes at least the upper portion, when it is in a more compact shape. The applicator may be attached to and detached from the device. The applicator may function as an indicator for placing, expanding, and / or retracting the device. The applicator may have an indicator for placement, such as a ridge, arrow, bump, protrusion, alphanumeric system, etc. The applicator may have recesses or holes to indicate position. The applicator and the device may snap into a positioning device or otherwise secure them together.

[0200] The medical or other benefits of this disclosure will be readily apparent to those skilled in the art from the figures, descriptions, and claims included herein. The objects and benefits of these embodiments can be realized and achieved, at least by means of the elements, features, and combinations specifically pointed out in the claims.

[0201] This disclosure covers all changes, substitutions, variations, alterations, and modifications that would be conceived by those skilled in the art of the art in relation to the exemplary embodiments herein. Similarly, where appropriate, the appended claims cover all changes, substitutions, variations, alterations, and modifications that would be conceived by those skilled in the art in relation to the exemplary embodiments herein. Furthermore, the reference in the appended claims to a device, apparatus, or system, or a component, section, or portion thereof, designed, arranged, enabled, constructed, endowed, operable, or operationally performing a particular function, includes that device, apparatus, system, or component, whether or not it or the particular function is used, activated, started, or unlocked, provided that the device, system, apparatus, or component is so designed, arranged, enabled, constructed, endowed, operable, or operational.

[0202] All examples and conditional language described herein are for educational purposes, intended to assist the reader in understanding the disclosure and the inventor's future contributions to this field, and are not to be construed as limiting the specific examples and conditions described. While embodiments of the disclosure have been described in detail, it should be understood that various changes, substitutions, and variations can be made without departing from the spirit and scope of the disclosure.

[0203] 10: Uterus 12: Cervix 14: Bladder 16: Urethra 18: Vagina 20: Rectum 22: Incontinence 24: Stress or pressure 26: Prolapsed bladder 28: Prolapsed back or rectal prolapse 30: Prolapsed uterus 40: Vaginal insertion device 42: Upper part 44: Removable part or handle 46: Edge 48: Convex Ridge 50: Inner wall or inner side 52: outer wall or outer side 54: Upper open end 56: Lower end 58: Hollow interior 49: wall 64: Lower opening end 60: wall 62: Top 66: Hollow interior 68: Vent 70: Section 1 72: Second Section 74: Height of the device 76: Diameter of the upper opening end 82: Diameter of the lower opening end 80: Handle height 84: Uterine pessary application device 86: Insert 88: Plunger 90: upper part 100: Vaginal insertion device 142: Upper part 144: Removable part or handle 146: Edge 148: Convex Ridge 142a: Enlarged portion 142b: Narrower or constricted portion 154: Upper open end 156: Base or lower end 158: Open Section 180: Components 149: wall 152: Outer side H: Height of the device 150: Inner side 180a: Rib section or rib member 180b: Rib section or rib member 180c: Rib section or rib member 180d: Rib section or rib member 192: One or more openings 168: Vent 244a: handle 244b: handle 244c: handle 244d:handle 244e:handle 244f: handle 244g: handle 248: Convex Ridge 268a: Vent 300: Carrying case 302: Base 304: Lid 306: Bottom 308: Upper cylindrical section 310: The topmost surface 312: Surface 314: Lid surface 400: Drying rack 402: Opening 404: Protrusion 406: Latch 200: Vaginal insertion device 242:Ontology 244:handle 246: Edge 256: Base 246a: Part 1 246b: Part Two 2700: Vaginal insertion device 2800: Vaginal insertion device 2900: Vaginal insertion device 3000: Vaginal insertion device 3100: Vaginal insertion device 3200: Vaginal insertion device 3300: Vaginal insertion device 3400: Vaginal insertion device 3500: Vaginal insertion device 3600: Vaginal insertion device 3700: Vaginal insertion device 3800: Vaginal insertion device 4000: Kit 4100: Storage Kit 4200: Vaginal Insertion Kit 4120: Carrying case 4110: Brush 4210: Vaginal insertion device 4220: Vaginal insertion device 4230: Vaginal insertion device

Claims

1. 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, the vaginal insertion device comprising: an upper portion having a conical body having a base, an inner wall, and an outer wall; a rib within the conical body configured to apply pressure to the organ wall to improve, manage, treat, prevent, and / or eliminate symptoms associated with pelvic organ prolapse, urinary incontinence, fecal incontinence, or a combination thereof, wherein the rib includes a member extending transversely to a longitudinal axis of the conical body; and one or more open portions defined by the rib and the inner wall.

2. The vaginal insertion device of claim 1 further includes an edge that protrudes from the outer wall at the upper end of the upper portion.

3. The vaginal insertion device of claim 2, wherein the rib extends downward from the adjacent edge to the base within the conical body, and wherein the rib and the edge together apply pressure to the organ wall.

4. The vaginal insertion device of claim 1 further includes one or more ridges protruding outward from the outer wall.

5. The vaginal insertion device as claimed in claim 1 further includes a handle extending downward from the base.

6. The vaginal insertion device of claim 5, wherein the handle includes one or more ridges projecting outward from the outer surface of the handle.

7. The vaginal insertion device as claimed in claim 5, wherein the handle is configured to allow the vaginal insertion device to be positioned, rotated, or both once the vaginal insertion device is inserted into the vagina.

8. The vaginal insertion device as claimed in item 5, wherein the handle is two-dimensional or flat.

9. The vaginal insertion device as claimed in item 5, wherein the handle is rectangular.

10. The vaginal insertion device of claim 1, wherein the rib is configured to selectively or adjustably apply pressure to the organ wall depending on the alignment of the rib with the organ wall.

11. The vaginal insertion device of claim 1, wherein the member extends radially inward from the inner wall of the conical body and longitudinally downward from a position near the apex of the conical body.

12. The vaginal insertion device of claim 11, wherein the component comprises two or more components spaced equidistantly around the circumference of the inner wall of the conical body, the two or more components meeting at the center point of the conical body.

13. The vaginal insertion device of claim 1, wherein the member extends between radially opposite points on the inner wall, and the member is connected to the inner wall at such radially opposite points.

14. The vaginal insertion device of claim 13, wherein the member extends longitudinally between a position near the top of the conical body and the base.

15. The vaginal insertion device of claim 1, wherein the rib is cross-shaped, "T"-shaped, "X"-shaped, "Y"-shaped, "K"-shaped, "V"-shaped, star-shaped, triangle-shaped, or pentagonal in plan view.

16. The vaginal insertion device of claim 1, wherein the wall of the organ is one of the vaginal sphincter, bladder neck, rectal wall, uterine wall, or a combination thereof.

17. The vaginal insertion device of claim 1, wherein the vaginal insertion device is configured to support the organ wall during movement.

18. The vaginal insertion device of claim 1, wherein the vaginal insertion device is configured to contain fluid and secrete the fluid into the vagina when the vaginal insertion device is inserted into the vagina.

19. The vaginal insertion device of claim 1, wherein the rib includes one or more components, and the components and the inner wall together define the one or more opening portions.

20. The vaginal insertion device as claimed in claim 1, wherein the rib and the conical body are integral.

21. 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, the vaginal insertion device comprising: an upper portion having a body having a base, an inner wall, and an outer wall; a rib within the body configured to apply pressure to the organ wall to improve, manage, treat, prevent, and / or eliminate symptoms associated with pelvic organ prolapse, urinary incontinence, fecal incontinence, or a combination thereof, wherein the rib includes a member extending transversely to a longitudinal axis of the body; and one or more openings defined by the rib and the inner wall.

22. The vaginal insertion device of claim 21 further includes an edge that protrudes from the outer wall at the upper end of the upper portion.

23. The vaginal insertion device of claim 22, wherein the rib extends downward from the adjacent edge to the base within the body, and wherein the rib and the edge together apply pressure to the organ wall.

24. The vaginal insertion device of claim 21 further includes one or more ridges protruding outward from the outer wall.

25. The vaginal insertion device of claim 21 further includes a handle extending downward from the base.

26. The vaginal insertion device of claim 25, wherein the handle includes one or more ridges projecting outward from the outer surface of the handle.

27. The vaginal insertion device of claim 25, wherein the handle is configured to allow the vaginal insertion device to be positioned, rotated, or both once the vaginal insertion device is inserted into the vagina.

28. The vaginal insertion device as claimed in claim 25, wherein the handle is two-dimensional or flat.

29. The vaginal insertion device as claimed in claim 25, wherein the handle is rectangular.

30. The vaginal insertion device of claim 21, wherein the rib is configured to selectively or adjustably apply pressure to the organ wall depending on the alignment of the rib with the organ wall.

31. The vaginal insertion device of claim 21, wherein the member extends radially inward from the inner wall of the body and longitudinally downward from a position near the top of the body.

32. The vaginal insertion device of claim 31, wherein the component comprises two or more components spaced equidistantly around the circumference of the inner wall of the body, the two or more components meeting at the center point of the body.

33. The vaginal insertion device of claim 21, wherein the member extends between radially opposite points on the inner wall, and the member is connected to the inner wall at such radially opposite points.

34. The vaginal insertion device of claim 33, wherein the member extends longitudinally between a position near the top of the body and the base.

35. The vaginal insertion device of claim 21, wherein the rib is cross-shaped, "T"-shaped, "X"-shaped, "Y"-shaped, "K"-shaped, "V"-shaped, star-shaped, triangle-shaped, or pentagonal in plan view.

36. The vaginal insertion device of claim 21, wherein the organ wall is one of the vaginal sphincter, bladder neck, rectal wall, uterine wall, or a combination thereof.

37. The vaginal insertion device of claim 21, wherein the vaginal insertion device is configured to support the organ wall during movement.

38. The vaginal insertion device of claim 21, wherein the vaginal insertion device is configured to contain fluid and secrete the fluid into the vagina when the vaginal insertion device is inserted into the vagina.

39. The vaginal insertion device of claim 21, wherein the rib includes one or more components, and the components and the inner wall together define the one or more opening portions.

40. The vaginal insertion device as claimed in claim 21, wherein the rib and the body are integral.

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