阅读说明：本技术 柔性锥形***内支撑装置 (Flexible conical vaginal support device ) 是由 A路搴疯开 A·康迪 于 2016-08-19 设计创作，主要内容包括：一种柔性的非吸收性阴道置入装置,其形状使得在置入时将其稳固地固定在阴道内,从而改善盆腔器官脱垂或尿失禁相关的症状。所述装置易于置入。可采用施用器来协助其置入。所述阴道置入装置包含上部,所述上部具有一锥形体,具有圆形横截面,具有一个有内侧面和外侧面的壁、上开口端、下端和中空的内部,其中所述上开口端在置入时为最内侧部分,且所述上部的壁可通过挤压使上部缩小,从而更易于置入,而在置入后,所述壁扩张回其原有的形状。所述装置包括外边缘,其包围上部的壁外侧面并从其突出,且与上开口端相邻,和多个脊,其包围上部的壁外侧面并从其突出,以及从所述下端延伸的取出部分,从而协助取出。所述装置还可以含有一个或多个通气孔。(A flexible, non-absorbable vaginal insertion device shaped to securely hold it in the vagina when inserted to ameliorate pelvic organ prolapse, or urinary incontinence-related symptoms. The device is easy to deploy. Applicators may be used to assist in their placement. The vaginal insert device includes an upper portion having a conical body with a circular cross section, a wall with an inner side and an outer side, an open upper end, a lower end, and a hollow interior, wherein the open upper end is the innermost portion when inserted, and the wall of the upper portion is compressible to reduce the upper portion for easier insertion, and the wall expands back to its original shape after insertion. The device includes an outer rim surrounding and projecting from the outer side of the wall of the upper portion adjacent the upper open end, and a plurality of ridges surrounding and projecting from the outer side of the wall of the upper portion, and a removal portion extending from the lower end to assist removal. The device may also contain one or more vents.)

1. A vaginal insert device, comprising:

a cone having a hollow interior;

an edge adjacent to the upper open end of the cone; and

the cone has a contracted shape and an expanded shape,

wherein the contracted shape is configured to allow placement into a vagina and the expanded shape is configured to securely hold the vaginal insertion device in the vagina, and wherein, in an expanded position, the device is configured to exert pressure on the urethral sphincter and manage, ameliorate, reduce or prevent symptoms associated with pelvic organ prolapse, urinary incontinence, or both pelvic organ prolapse and urinary incontinence.

2. The vaginal insert device of claim 1, further including a plurality of ridges on the outer side of the cone.

3. The vaginal insert device of claim 2, wherein the rim and the plurality of ridges securely hold the vaginal insert device in place in the vagina.

4. The vaginal insert device of claim 2, wherein the plurality of ridges are evenly spaced from the upper open end of the cone to the lower end of the cone.

5. The vaginal insert device of claim 2, wherein the plurality of ridges are rings, protrusions, or bumps.

6. The vaginal insert device of claim 5, wherein the plurality of ridges are evenly spaced from the upper open end of the cone to the lower end of the cone.

7. The vaginal insert device of claim 1, further comprising a withdrawal portion configured to assist in the withdrawal or insertion of the vaginal insert device.

8. The vaginal insert device of claim 7, wherein the extractor portion and the cone are a unitary, one-piece device made of a resilient and non-absorbent material.

9. The vaginal insert device of claim 1, further including a handle or wire extending from a lower end of the cone.

10. The vaginal insert device of claim 9, wherein the handle or wire assists in removing the vaginal insert device from the vagina.

11. The vaginal insert device of claim 9, wherein the handle and the cone are a unitary, one-piece device made of a resilient and non-absorbent material.

12. The vaginal insert device of claim 1, further comprising one or more apertures, wherein in the expanded position, the one or more apertures are configured to equalize air pressure between the interior and exterior of the vagina.

13. The vaginal insert device of claim 12, wherein the one or more holes are in a wall of the cone.

14. The vaginal insert device of claim 1, wherein the rim is an outer rim that surrounds and protrudes from an outer side of a wall of the cone.

15. The vaginal insert device of claim 14, wherein the outer edge is an outer rounded edge.

16. The vaginal insert device of claim 14, wherein the outer rim has a first section and a second section, and wherein the first section protrudes a greater distance from an outer side of the wall of the cone than the second section.

17. The vaginal insert device of claim 1, wherein the vaginal insert device is configured to manage, ameliorate, prevent, reduce or reduce the likelihood of pelvic organ prolapse, urinary incontinence or both pelvic organ prolapse and urinary incontinence.

18. The vaginal insert device of claim 1, wherein the device is configured to: (i) applying pressure to the urethral sphincter at the neck of the bladder; (ii) supporting a pelvic organ; or (iii) to apply pressure to the urethral sphincter at the neck of the bladder and support pelvic organs.

19. The vaginal insert device of claim 1, wherein the vaginal insert device is configured to manage, ameliorate, prevent or reduce (i) urinary incontinence; (ii) pelvic organ prolapse; (iii) prolapse of the bladder; or (iv) uterine prolapse.

20. A method of managing, ameliorating, preventing or reducing pelvic organ prolapse, urinary incontinence or both pelvic organ prolapse and urinary incontinence using a vaginal insert device, the method comprising:

extruding the cone of the vaginal insertion device into a compacted shape;

placing the vaginal insert device in the contracted shape into a vagina;

positioning the vaginal insertion device adjacent to a vaginal wall;

releasing the vaginal insert device to move the taper from the contracted shape to an expanded shape; and

when the vaginal insert device is in the expanded shape, pressure is applied to the urethral sphincter at the bladder neck or pelvic organ is supported, thereby managing, ameliorating, preventing or reducing pelvic organ prolapse, urinary incontinence or both pelvic organ prolapse and urinary incontinence.

21. The method of claim 20, wherein the pelvic organ is a bladder or uterus.

22. The method of claim 20, further comprising applying pressure to the urethral sphincter at the neck of the bladder and supporting the bladder or uterus.

23. The method of claim 20, further comprising managing passive leakage during the activity.

24. The method of claim 23, wherein the activity is coughing, laughing, sneezing, lifting a weight, or exercise.

25. The method of claim 23, further comprising placing the vaginal insert device in the vagina for about 12 hours or more.

26. The method of claim 20, further comprising removing the vaginal insert device by:

holding a take-out portion extending from the cone;

compressing the cone from the expanded shape to the collapsed shape; and

withdrawing said vaginal insert device from said vagina.

27. The method of claim 20, further comprising balancing air pressure between the interior and exterior of the vagina.

28. The method of claim 27, wherein equalizing the gas pressure further comprises providing a vent in the cone.

29. The method of claim 20, wherein positioning the vaginal insert device adjacent the vaginal wall further comprises securely holding the vaginal insert device in place in the vagina via the taper.

30. The method of claim 29, wherein the cone further comprises a rim and a plurality of ridges, wherein the rim and the plurality of ridges securely fix the vaginal insert device in place in the vagina.

31. The method of claim 20, wherein the cone further comprises an edge and a plurality of ridges, wherein the edge and the plurality of ridges press against or support the pelvic organ.

32. A method of controlling passive leakage of urine during an activity using a vaginal insert device, the method comprising:

placing the vaginal insert device of claim 1 for up to about 12 hours or more,

applying pressure to the urethral sphincter of the bladder neck through the vaginal insertion device, an

Urine leakage is managed, ameliorated or reduced by the application of pressure by the vaginal insert device.

33. The method of claim 32, wherein the activity is coughing, laughing, sneezing, lifting a weight, or exercise.

Technical Field

The present invention relates generally to a flexible, non-absorbent intravaginal device for ameliorating pelvic tissue prolapse and urinary incontinence-related symptoms when the device is implanted, and more particularly to a vaginal implant device that is easy to insert and remove.

Background

Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP) become increasingly serious problems worldwide, which not only expends a great deal of healthcare system capital, but also severely degrades the quality of life of tens of millions of women in the united states alone. While surgical regimens may be successful in ameliorating the symptoms associated with SUIs and POPs, surgery is not without risk and complications, and may even leave the patient in a worse condition than before treatment. See Huang W, Wang T, Zong H, Zhang Y, "effectiveness and safety comparison of tension-free vaginal tape-secured mini tape to standard urethral tape for female stress urinary incontinence: systematic Review and Meta Analysis ", Journal of International neuro-urology, (effective and Safety of transition-FreeVaginal Tape-Secure Mini-sliding Versus Standard reduce slides for FemaleStrress Urinary incorporation: A Systematic Review and Meta-Analysis, International neuro-urology Journal), year 2015, 19 (4): 246-58, which are incorporated herein by reference. See also Ellington DR, Erekson EA, Richter HE, surgical outcome of Stress Urinary Incontinence in Older women (outsomes of Surgery for Stress Urinary Incontinence in the Older Wman), ClinGeriator Med, 2015,31 (4): 487-505, which is incorporated herein by reference. The FDA has issued several public health notices involving surgical mesh placement through the vagina (transvaginal placement) to treat POPs and SUIs. The FDA indicates serious and frequent complications associated with surgical meshes, including mesh erosion penetration through the vagina, pain, infection, bleeding, malaise with intercourse, organ perforation, urinary problems, recurrent prolapse, neuromuscular problems, vaginal scarring/shrinkage, and emotional problems. Most surgical complications require intervention, including medication, re-surgery and hospitalization.

In the prior art, which is most commonly used to treat female POP and has also been used for SUI, the pessary has become a viable non-surgical option for treating SUI and POP. These prior art pessaries have few complications and side effects. However, these devices are typically placed in the vagina for extended periods of time. They may also cause discomfort. In addition, these prior art devices are difficult for the patient to place and remove, and their use, placement and removal often require many years of regular follow-up by the physician. See Jones KA, Harmanli O, "Use of pessaries in Pelvic Organ Prolapse and Urinary Incontinence" (Pessary Use in Pelvic organic Prolapse and urinar incoction), journal of obstetrics and gynecology (Rev Obstet Gynecol), 2010,3 (1): 3-9, which is incorporated herein by reference. The difficulty of self-insertion and removal of the pessary, the loss of the pessary during defecation, and the lack of comfort and convenience may limit the widespread use of such devices in the prior art.

Female stress incontinence is passive leakage of urine caused by weakened pelvic support system and/or bladder pressure due to aging, heredity or childbirth. According to the urinary care foundation, it is estimated that one third of women experience SUI at a particular time in their lives. There are several types of urinary incontinence, including stress incontinence, urge incontinence, and mixed incontinence. All of this is essentially due to relaxation or damage of the connective tissue of the vagina or supporting ligaments. See "general theory and methods for diagnosis and management of female urinary incontinence", Petros PE, Ulmsten UI, scandinavia urology and the journal of renal pathology (subsidiary) (scanand J Urol Nephrol Suppl),1993,153,1-93, which is incorporated herein by reference. Fig. 1 is a cross-sectional view of a normal anatomy of a female pelvic portion showing uterus 10, cervix 12, bladder 14, urethra 16, vagina 18, and rectum 20. Fig. 2 shows urinary incontinence (i.e., leakage of urine) 22 due to pressure or pressure 24 on the bladder 14. Passive leakage typically occurs during activities such as coughing, laughing, sneezing, lifting weight or exercise.

Connective tissue destruction in three regions of the overall system, including all three pelvic tissues, including the bladder, vagina and anus-rectum, is the ultimate cause of Pelvic Organ Prolapse (POP) and dysfunction of these organs. Figure 3 is a cross-sectional view of a female pelvic region with bladder prolapse 26. Fig. 4 is a cross-sectional view of the female pelvic region with rectal prolapse 28. Fig. 5 is a cross-sectional view of a female pelvic region with uterine prolapse 30. POPs are usually caused by pregnancy and may also develop solely due to genetics or during aging.

Accordingly, there is a need for a pessary or other vaginal insert device that manages, ameliorates, or reduces female incontinence and/or POP. There is also a need for a pessary or other vaginal insertion device that does not require prescription and is non-absorbent, over-the-counter, convenient, comfortable, and easy for the patient to insert and remove with no or minimal physician intervention. Preferably, the vaginal insert device is also reusable, but may be disposable.

Disclosure of Invention

In accordance with the teachings of the present invention, the disadvantages or problems associated with prior art pessaries may be substantially solved or eliminated.

In accordance with an embodiment of the present invention, a vaginal insert device for ameliorating symptoms associated with pelvic tissue prolapse and/or urinary incontinence can include an upper portion formed of a resilient, non-absorbent material having a tapered body portion with a circular cross-section along its length with a wall having an inner side and an outer side, an open upper end, a lower end, and a hollow interior, wherein the circumference of the upper portion decreases from the open upper end to the lower end, wherein the open upper end of the upper portion is the innermost portion of the vaginal insert device when inserted into a vagina, and wherein the wall of the upper portion can be compressed to reduce the upper portion, thereby facilitating insertion of the vaginal insert device, and wherein the wall expands back to its original shape after insertion. Such vaginal insert device may further comprise: an outer rim surrounding and projecting from the upper outer wall side and adjacent to the upper open end; and a plurality of ridges surrounding and projecting from the outer side of the wall of the upper portion and spaced from the upper open end to the lower end.

In accordance with these and other embodiments of the present invention, the vaginal insert device may further include an extraction portion extending from a lower end of the upper portion, wherein the extraction portion is accessible from outside the vagina when the vaginal insert device is inserted therein, and the extraction portion facilitates extraction of the vaginal insert device from the vagina. The removal portion may comprise a wire or a handle. In embodiments where the removal device is a handle, the handle may extend from a lower end of the upper portion, wherein the upper portion and the handle comprise a unitary, one-piece device made of a resilient, non-absorbent material, wherein the handle has a conical body with a circular cross-section in length, with a wall, an upper end, a lower open end, and a hollow interior, and wherein the handle increases in circumference from the upper end to the lower open end. Similar to the upper portion, the extraction portion may also have a plurality of ridges.

According to these and other embodiments of the present invention, the vaginal insert device may include one or more vent holes. The vent hole may be located at a position where a lower end of the upper portion intersects the handle portion. One or more vents may also be located in the wall of the upper portion.

In accordance with these and other embodiments of the present invention, the vaginal insert device may include a rounded outer edge having a first segment and a second segment, wherein the first segment protrudes a greater distance from an outer side of the wall of the upper portion than the second segment.

In accordance with these and other embodiments of the present invention, a vaginal insert device may include an applicator for use in inserting the device, wherein the applicator may receive at least the upper portion when the upper portion is in a more compact shape, and the applicator assists in the insertion of the device.

The medical and other advantages of the present invention will be readily apparent to those skilled in the art from the drawings, specification, and claims herein. The objects and advantages of the embodiments may be realized and attained by means of at least the elements, features, and combinations particularly pointed out in the appended claims.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention as claimed.

Brief description of the drawings

A more complete understanding of the present embodiments and advantages thereof may be acquired by referring to the following description taken in conjunction with the accompanying drawings, in which corresponding reference numbers indicate corresponding features, and wherein:

figures 1 through 5 show cross-sectional views of a female pelvic portion, respectively, for purposes of explaining the background of the invention.

Figure 6A illustrates a side view of one embodiment of a vaginal insert device in accordance with embodiments of the present invention.

Figure 6B illustrates a side view of another embodiment of a vaginal insert device in accordance with embodiments of the present invention.

FIG. 7 shows a perspective view of the vaginal insert device of FIG. 6A;

FIG. 8 is a cross-sectional view of the vaginal insert device of FIG. 6A taken along section line A-A;

FIG. 9 is a bottom view of the vaginal insert device of FIG. 6A;

FIG. 10 is a top view of the vaginal insert device of FIG. 6A;

figures 11 through 13 illustrate cross-sectional views of a female pelvic region and one embodiment of the vaginal insert device inserted into the vagina, respectively;

figures 14A and 14B illustrate a method of placing one embodiment of a vaginal insert device into a patient's vagina;

fig. 15A shows a side view of a pessary applicator; and

fig. 15B-15C show cross-sectional views of the pessary applicator of fig. 15A and a method for using it to place the vaginal insert device of one embodiment into a patient's vagina.

Detailed Description

A better understanding of the preferred embodiments and their advantages may be had by reference to fig. 6A-15C, in which like numerals are used to designate like or corresponding parts or features.

The vaginal insert device of the present invention can manage, ameliorate or reduce female urinary incontinence and/or pelvic tissue prolapse (POP). It is prescription-free, non-implantable, non-absorbent, over-the-counter, convenient, flexible, comfortable, and easy for the patient to place and remove with no or minimal intervention by the physician. Preferably, the vaginal insert device is reusable, but may also be disposable. It eliminates the concern of Toxic Shock Syndrome (TSS) by not being made of an absorbent component that can produce odors and harbor bacteria. The device of the present invention may be manufactured by a molding process using an elastic, non-absorbent material, preferably a biocompatible material such as medical grade silicone. An example of a medical silica gel useful in the present invention is MED-4950 from NuSil technologies, which is characterized by liquid silicone rubber.

The vaginal insert device of the present invention is shaped so as to be firmly secured within the vagina when inserted and is shaped to apply pressure to the urethral sphincter and support pelvic organs. One exemplary application of the vaginal insert device of the present invention is for the management of stress urinary incontinence, and passive leakage of urine during activity (e.g., coughing, laughing, sneezing, lifting weight, and exercising) in patients over eighteen years of age. It is contemplated that the device may typically be placed in an adult female for up to about twelve hours or more, depending on their level of comfort.

Figure 6A illustrates a side view of one embodiment of a vaginal insert device 40 in accordance with embodiments of the present invention. The vaginal insertion device 40 of fig. 6A includes an upper portion 42 and a lower handle-like removal portion 44. As described in greater detail below, the upper portion 42 includes a rim 46 and ridges 48 that are preferably spaced from the top of the upper portion to the lower end of the upper portion. The ridges 48 may be randomly or uniformly spaced. The take-out portion may also have ridges 48 and, like the upper portion, the ridges are spaced from the top of the take-out portion to the lower end of the take-out portion.

Figure 6B illustrates a side view of another embodiment of a vaginal insert device 40, in accordance with embodiments of the present invention. In this embodiment, the device 40 is identical to the embodiment of fig. 6A, except that the removal portion 44 is a string, string or belt (collectively referred to as "string"), as used in removing a tampon.

Figure 7 shows a perspective view of the vaginal insert device of figure 6A. As shown in FIG. 7, upper portion 42 has a conical shape with a circular cross-section along its length, having a wall 49 with an inner side 50 and an outer side 52, an upper open end 54, a lower end 56, and a hollow interior 58, wherein the perimeter of the upper portion tapers from the upper open end to the lower end. As shown, the rim 46 is preferably circular and surrounds the upper, outer wall side 52 and projects from the outer wall side 52 adjacent the upper open end 54. The ridge 48 is preferably circular in shape and surrounds the outer side 52 of the wall 49. As further shown, a handle or removal portion 44 extends from a lower end 56 of the upper portion 42. The upper portion 42 and the shank portion 44 may be formed as an integral, one-piece device. Fig. 7 also shows that the shank 44 may have a conical shape.

FIG. 8 is a cross-sectional view of the vaginal insertion device of FIG. 6A taken along section line A-A. As shown in FIG. 8, the shank 44 may have a circular cross-section in the length direction with a wall 60, an upper end 62, a lower open end 64, and a hollow interior 66, wherein the shank increases in circumference from the upper end to the lower open end. As shown, the ridge 48 protrudes from the outer side 52 of the wall 49.

Figure 8 further illustrates an embodiment of the vaginal insert device 40 that includes a vent 68. The vent may contain a vent hole, screen or mesh surface or any other component with holes. As will be appreciated by those skilled in the art, the vaginal insert device 40 may contain a plurality of vent holes, which may be located differently than the vent holes 68, or in locations other than the vent holes 68, such as on the wall 49 of the upper portion 42. One or more vent holes may make the vaginal insert device more comfortable to the patient when inserted. The one or more (vent) holes may also equalize the pressure inside and outside the vagina when the vaginal insert device 40 is inserted. However, the vent is not necessary for the vaginal insert device to be more comfortable, suitable, and effective.

Figure 8 shows a further detail of an embodiment, the edge 46 of which has a first segment 70 and a second segment 72, both protruding from the outer side 52 of the wall 49, the first segment protruding a greater distance than the second segment. Those skilled in the art will appreciate that various alternatives to the embodiment of the edge 46 are possible, including one embodiment in which the edge 46 comprises only the first segment 70, or another embodiment in which the edge 46 comprises only one segment, but is substantially taller than the first segment 70, and the same distance from the top of the edge to the bottom of the edge that protrudes beyond the outer side 52 of the wall. In another embodiment, the rim 46 comprises an outer side 52 of the wall 49 adjacent the upper open end 54 and comprises segments that protrude beyond the outer side of the wall and segments that do not protrude beyond the outer side of the wall.

Referring to fig. 7 and 8, the term "ridge" is used in a broad sense. Thus, ridge 48 may comprise an embodiment as shown in fig. 7 and 8, wherein ridge 48 is a protrusion, preferably a ring, surrounding the outer side of wall 49. However, "ridge" may also include any protrusion, such as studs or bumps, extending from the outer side 52 of the wall 49.

As will be appreciated by those skilled in the art, the vaginal insert device 40 can be of various sizes, including various sizes to accommodate adult females having different anatomies. In addition, one skilled in the art will appreciate that the dimensions of the various sections and portions of the device 40 may be modified based on the various embodiments of the invention illustrated and disclosed herein. For example, referring to FIG. 8, the overall height 74 of the device 40, the diameter 76 of the upper open end 54 of the upper portion 42, and the thickness of the wall 49 of the upper portion 42 of the device 40 can be adjusted to maintain or improve the intended use, effectiveness, and benefits of the device. Referring to fig. 8, the following non-exclusive list of dimensions, which is a non-limiting example of an embodiment of the device 40, is believed to be applicable to most women and is capable of providing the intended use, effectiveness, and benefits of the device. For example, a suitable overall height of the device 40 is estimated to be in the range of approximately 58.0-67.0 millimeters (mm), and a suitable outer diameter 76 is estimated to be in the range of approximately 38.0-44.0 mm. Suitable heights for the shank 44 are estimated to be in the range of about 13.0-15.0 mm. A suitable thickness of wall 49 at the section of upper portion 42 below edge 46 and without ridge 48 is estimated to be about 2.0mm, while at the section with the ridge, a suitable thickness of wall 49 is estimated to be about 2.5 mm. A suitable thickness of the wall 60 of the shank 44 at a segment without the ridge 48 is estimated to be about 1.25 mm. A suitable height of the edge 46 is estimated to be about 15.0mm, a suitable height of the first segment 70 is estimated to be about 5.0mm, and a suitable height of the second segment 72 is estimated to be about 10.0 mm. A suitable thickness for the first segment 70 is estimated to be about 6.0mm and the thickness for the second segment 72 is estimated to be about 4.0 mm. A suitable outer (straight) diameter 82 of the lower open end 64 is estimated to be about 10.5 mm. A suitable diameter for the vent 68 is estimated to be about 2.0 mm.

Figure 9 is a bottom view of the embodiment of the vaginal insert device of figure 6A with a vent 68 therein. Fig. 10 is a top view of the embodiment of the vaginal insert device of fig. 6A with a vent 68 therein.

Figure 11 is a cross-sectional view of the female pelvic region showing an embodiment of a vaginal insert device 40 placed into the vagina 18 to apply pressure to the urethral sphincter muscle 16 to manage, ameliorate or reduce female urinary incontinence. Figures 12 and 13 are each a cross-sectional view of the female pelvic region showing the placement of the vaginal insert device 40 into the vagina 18 to manage, ameliorate and reduce POP in addition to applying pressure to the urethral sphincter muscle 16 to manage, ameliorate or reduce female urinary incontinence. Specifically, in FIG. 12, a vaginal insert device 40 is placed into the vagina 18 to manage, ameliorate or reduce the bladder prolapse 26. Specifically, in FIG. 13, a vaginal insert device 40 is placed into the vagina 18 to manage, ameliorate or reduce the uterine prolapse 30. As shown in Figs. 11-13, the upper open end 54 of upper portion 42 is the innermost portion of vaginal insert device 40 when inserted. As further shown in Figs. 11-13, the removal portion or handle 44 of the vaginal insert device 40 embodiment can access and assist in removing the vaginal insert device from outside the vagina 18 when the vaginal insert device is inserted. The ridges 48 of the handle 44 provide the patient with a better grip when removing the device 40.

Figures 14A and 14B illustrate a method of comfortably inserting the vaginal insert device 40 into the vagina 18. As shown in FIG. 14A, the patient can manually squeeze the wall 49 of the upper portion to make the upper portion more constricted, thereby making the vaginal insert device 40 easier to insert. As shown in FIG. 14B, once vaginal insert device 40 is manually inserted into vagina 18, walls 49 expand back to their original shape.

Fig. 15A shows a side view of a pessary applicator 84 that may be used to assist in placing the vaginal insert device 40 into the patient's vagina 18. Pessary applicator 84 includes an applicator 86, an applicator tip 90, and a piston 88. Pessary applicator 84 is generally similar to a tampon applicator. However, the applicator 86 generally has a larger circumference than the tampon applicator to accommodate the vaginal insert device 40, and the circumference of the vaginal insert device 40 in the contracted shape is generally larger than the tampon. Fig. 15B-15C show a cross-sectional view of pessary inserter 84 of fig. 15A and a method of using the applicator to comfortably insert vaginal insert device 40 into a patient's vagina 18. As shown, the vaginal insert device 40 is placed inside the insert 86 in a contracted configuration. Similar to the procedure for inserting a tampon into the vagina with an applicator, the applicator member 86 of the applicator 84 is placed into the patient's vagina 18 and the piston 88 is pushed against the applicator member, thereby pushing the vaginal insert device 40 through the tip 90. The applicator 84 is then removed from the vagina 18 and the vaginal insert device 40 is left in the vagina, expanding back to its normal shape. The vaginal insert device 40 is then placed in position, as shown in FIG. 11.

The present invention covers all changes, substitutions, variations, alterations, and modifications to the exemplary embodiments of the present invention that a person having ordinary skill in the art would comprehend. Similarly, where appropriate, the appended claims encompass all changes, substitutions, variations, alterations, and modifications to the example embodiments of the invention that a person having ordinary skill in the art would comprehend. Furthermore, in the appended claims, a device, apparatus, or system, or a component, section, or portion of a device, apparatus, or system, that is adapted to, disposed to, usable with, configured to, capable of being used for, operating on, or performing a particular function, is inclusive of the device, apparatus, system, or component, whether used, activated, actuated, or unlocked, so long as the device, system, apparatus, or component is applicable, disposed, usable, set, capable, operable, or capable.

All examples and conditional language recited herein are intended for pedagogical purposes to aid the reader in understanding the disclosure and the concepts contributed by the inventor to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions. Although the embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and alterations can be made hereto without departing from the spirit and scope of the present disclosure.