FLEXIBLE CONE-SHAPED INTRA-VAGINAL SUPPORT DEVICE

Abstract

In accordance with embodiments of the present disclosure, a flexible and non-absorbent vaginal insert device shaped to be held securely in place in a vagina when inserted, so as to improve symptoms associated with pelvic organ prolapse or urinary incontinence or both, is provided. The device is designed to be relatively easy to insert and remove. An applicator may be used to aid with insertion. The vaginal insert device comprises an upper portion, having a cone-shaped body, having a circular transverse cross-section throughout its length, having a wall with an interior side and an exterior side, an upper open end, a lower end, and a hollow interior, wherein the upper open end of the upper portion is the innermost portion of the device during insertion, and wherein the wall of the upper portion can be squeezed to make the upper portion more compact for easier insertion of the device, and wherein after insertion the wall expands back to its original shape. The device further comprises an exterior rim surrounding and protruding from the exterior side of the wall and being adjacent to the upper open end, and a plurality of ridges surrounding and protruding from the exterior side of the wall, and a removal portion extending from said lower end of said upper portion to assist in removal of the device. The device can also comprise one or more ventilation openings.

Claims

1-22. (canceled)

23. A vaginal insert device for inserting into a vagina to manage, improve, eliminate or prevent symptoms associated with pelvic organ prolapse, urinary incontinence, or both pelvic organ prolapse and urinary incontinence, the vaginal insert device comprising: an upper portion having a cone shaped body, an upper end, a lower end, and a hollow interior; and one or more ventilation openings located at the lower end of the upper portion, wherein the cone shaped body has a compact position configured to allow for insertion into a vagina and an expanded position configured to securely hold the vaginal insert device in the vagina.

24. The vaginal insert device of claim 23, wherein the one or more ventilation openings are configured to equalize air pressure between an inside of the vagina and an outside of the vagina when the vaginal insert device is inserted into the vagina and is in the expanded position.

25. The vaginal insert device of claim 23, further comprising a plurality of ridges located on an exterior side of the cone shaped body and being spaced apart from the upper end to the lower end.

26. The vaginal insert device of claim 25, wherein the plurality of ridges are distributed along an entire length of the cone shaped body.

27. The vaginal insert device of claim 23, further comprising a rim located on an exterior side of the cone shaped body adjacent to the upper end, the rim configured to hold to impose pressure on the urethral sphincter, to support pelvic organs, or to both impose pressure on the urethral sphincter and support pelvic organs, when the vaginal insert device is inserted into the vagina.

28. The vaginal insert device of claim 27, wherein the rim is an exterior rim surrounding and protruding from an exterior side of a wall of the cone shaped body.

29. The vaginal insert device of claim 28, wherein the exterior rim has a first section and a second section, and wherein said first section protrudes from the exterior side of the wall of the cone shaped body a greater distance than the second section.

30. The vaginal insert device of claim 27, wherein the rim is configured to (i) impose pressure on the urethral sphincter at the bladder neck, (ii) support pelvic organs, or (iii) impose pressure on the urethral sphincter at the bladder neck and support pelvic organs.

31. The vaginal insert device of claim 23, further comprising a stem extending from the lower end of the upper portion and configured to assist with removal or insertion of the vaginal insert device.

32. The vaginal insert device of claim 31, wherein the stem and the cone shaped body are an integral, one-piece device made from elastic and non-absorbent material.

33. The vaginal insert device of claim 31, wherein the one or more ventilation openings are located at a point where the lower end of the upper portion and the stem intersect.

34. The vaginal insert device of claim 23, wherein the one or more ventilation openings are in a wall of the cone shaped body.

35. The vaginal insert device of claim 23, wherein the vaginal insert device manages, improves, prevents, eliminates or reduces likelihood of pelvic organ prolapse, urinary incontinence, or both pelvic organ prolapse and urinary incontinence.

36. A vaginal insert device for inserting into a vagina to manage, improve, eliminate or prevent symptoms associated with pelvic organ prolapse and urinary incontinence, the vaginal insert device comprising: an upper portion having an upper end, a lower end, and a wall extending between the upper end and the lower end, wherein a circumference of the upper portion decreases from the upper end to the lower end; a plurality of ridges protruding from the wall and spaced apart from the upper end to the lower end, the plurality of ridges distributed along an entire length of the upper portion from the upper end to the lower end; and one or more ventilation openings configured to equalize air pressure between an inside of the vagina and an outside of the vagina when the vaginal insert device is in inserted in the vagina.

37. The vaginal insert device of claim 36, wherein the plurality of ridges are distributed uniformly from the upper end to the lower end.

38. The vaginal insert device of claim 36, further comprising a rim located on an exterior side of the upper portion adjacent to the upper end, the rim configured to hold to impose pressure on the urethral sphincter, to support pelvic organs, or to both impose pressure on the urethral sphincter and support pelvic organs, when the vaginal insert device is inserted into the vagina.

39. The vaginal insert device of claim 38, wherein the rim is an exterior rim surrounding and protruding from an exterior side of a wall of the upper portion.

40. The vaginal insert device of claim 39, wherein the exterior rim has a first section and a second section, and wherein said first section protrudes from the exterior side of the wall of the upper portion a greater distance than the second section.

41. The vaginal insert device of claim 39, wherein the rim is configured to (i) impose pressure on the urethral sphincter at the bladder neck, (ii) support pelvic organs, or (iii) impose pressure on the urethral sphincter at the bladder neck and support pelvic organs.

42. The vaginal insert device of claim 36, further comprising a stem extending from the lower end of the upper portion and configured to assist with removal or insertion of the vaginal insert device.

43. The vaginal insert device of claim 42, wherein the stem and the upper portion are an integral, one-piece device made from elastic and non-absorbent material.

44. The vaginal insert device of claim 42, wherein the one or more ventilation openings are located at a point where the lower end of the upper portion and the stem intersect.

45. The vaginal insert device of claim 36, wherein the one or more ventilation openings are in a wall of the upper portion.

46. The vaginal insert device of claim 36, wherein the one or more ventilation openings are located at the lower end of the upper portion.

47. The vaginal insert device of claim 36, wherein the vaginal insert device manages, improves, prevents, eliminates or reduces likelihood of pelvic organ prolapse, urinary incontinence, or both pelvic organ prolapse and urinary incontinence.

48. A method for managing, improving, preventing or eliminating pelvic organ prolapse, urinary incontinence, or both pelvic organ prolapse and urinary incontinence, the method comprising: collapsing a cone shaped body of a vaginal insert device into a compact shape; inserting the vaginal insert device, in the compact shape, into a vagina; positioning the vaginal insert device adjacent a vaginal wall; releasing the vaginal insert device allowing the cone shaped body to move from the compact shape to an expanded shape; equalizing air pressure between an inside and an outside of the vagina; and applying pressure to the urethral sphincter at the bladder neck and supporting a pelvic organ to manage, improve, prevent or eliminate pelvic organ prolapse and urinary incontinence, when the vaginal insert device is in the expanded shape.

49. The method of claim 48, wherein the pelvic organ is the bladder or the uterus.

50. The method of claim 48, further comprising managing involuntary leakage of urine during an activity.

51. The method of claim 50, wherein the activity is coughing, laughing, sneezing, lifting an object, or exercising.

52. The method of claim 48, further comprising leaving the vaginal insert device in the vagina for about 12 hours or more.

53. The method of claim 48, further comprising removing the vaginal insert device by: gripping a removal portion extending from the cone shaped body; compressing the cone shaped body from the expanded shape to the compact shape; and withdrawing the vaginal insert device from the vagina.

54. The method of claim 48, wherein equalizing air pressure further comprises providing a ventilation opening in the cone shaped body.

55. The method of claim 48, the cone shaped body further comprising a rim and a plurality of ridges, wherein the rim and the plurality of ridges hold the vaginal insert device securely in place in the vagina and apply pressure to the pelvic organs or support the pelvic organs.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] 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 like reference numbers indicate like features, and wherein:

[0017] FIGS. 1-5 each illustrate a cross-section of the pelvic region of a female for purposes of discussing the background of the present disclosure;

[0018] FIG. 6A illustrates a side view of an example vaginal insert device, in accordance with embodiments of the present disclosure;

[0019] FIG. 6B illustrates a side view of another example vaginal insert device, in accordance with embodiments of the present disclosure;

[0020] FIG. 7 illustrates a perspective view of the vaginal insert device of FIG. 6A;

[0021] FIG. 8 is a cross-sectional view of vaginal insert device of FIG. 6A across section line A-A;

[0022] FIG. 9 is a bottom view of the vaginal insert device of FIG. 6A;

[0023] FIG. 10 is a top view of the vaginal insert device of FIG. 6A;

[0024] FIGS. 11-13 each illustrate a cross-section of the pelvic region of a female as well as an embodiment of the vaginal insert device inserted in the vagina;

[0025] FIGS. 14A and 14B illustrate a method for inserting an embodiment of the vaginal insert device into a patient's vagina;

[0026] FIG. 15A illustrates a side-view of a pessary applicator; and

[0027] FIGS. 15B-15C illustrate a cross-section of the pessary applicator of FIG. 15A, and a method of using same to insert an embodiment of the vagina insert device into a patient's vagina.

DETAILED DESCRIPTION

[0028] Preferred embodiments and their advantages are best understood by reference to FIGS. 6A through 15C, wherein like numbers are used to indicate like and corresponding parts or sections.

[0029] The vaginal insert device of the present invention manages, improves, or eliminates female urinary incontinence, Pelvic Organ Prolapse (POP), or both POP and urinary incontinence. It does not require a prescription, and is non-implantable, non-absorbent, over the counter, convenient, flexible, comfortable, and easy for a patient to insert and remove, with no or minimal physician intervention. Preferably such a vaginal insert device would also be reusable, but it also can be disposable. It eliminates concern of Toxic Shock Syndrome (TSS) by not consisting of an absorbency element which could produce odor and breed bacteria. The device of the present invention is fabricated, such as by a molding process, with an elastic and non-absorbent material, preferably a biocompatible elastomer such as medical grade silicone. An example of a silicone material suitable for use in the present invention is NuSil Technology's MED-4950 product, which is characterized as a liquid silicone rubber.

[0030] The vaginal insert device of the present invention is shaped so that it is held securely in place in the vagina when inserted, as well as shaped to impose pressure on the urethral sphincter and to support pelvic organs. One exemplary use of the vaginal insert device of the present invention is for management of stress urinary incontinence (SUI) and the involuntary leakage of urine during activities such as coughing, laughing, sneezing, lifting and exercise for patients over the age of eighteen. It is expected that the device will typically be inserted by an adult woman for up to about twelve hours or more, depending on their comfort level.

[0031] FIG. 6A illustrates a side view of an example vaginal insert device 40, in accordance with embodiments of the present disclosure. The vaginal insert device 40 of FIG. 6A comprises an upper portion 42 and a lower, stem-like, removal portion 44. As further illustrated and described in more detail below, the upper portion 42 includes a rim 46 as well as ridges 48 which are preferably spaced apart from the top of the upper portion to the lower end of the upper portion. Ridges 48 can be randomly or uniformly spaced. The removal portion can also have ridges 48, which like the upper portion are spaced apart from the top of the removal portion to the lower end of the removal portion.

[0032] FIG. 6B illustrates a side view of another example vaginal insert device 40, in accordance with embodiments of the present disclosure. In this embodiment, device 40 is the same as the embodiment shown in FIG. 6A except the removal portion 44 is a string, cord or ribbon (collectively referred to as “a string”), such as is used in removing a tampon.

[0033] FIG. 7 illustrates a perspective view of the vaginal insert device 40 of FIG. 6A. As shown in FIG. 7, the upper portion 42 has a cone-shaped body, having a circular transverse cross-section throughout its length, has a wall 49 with an interior side 50 and an exterior side 52, an upper open end 54, a lower end 56, and a hollow interior 58, wherein the circumference of the upper portion decreases from the upper open end to the lower end. As illustrated, rim 46 is preferably circular and surrounds and protrudes from the exterior side 52 of the wall and is adjacent to the upper open end 54. Ridges 48 are preferably circular rings which surround the exterior side 52 of wall 49. As further illustrated, a stem or removal portion 44 extends from the lower end 56 of the upper portion 42. The upper portion 42 and the stem 44 can be fabricated as an integral one-piece device. FIG. 7 also illustrates that the stem 44 can have a cone-shaped body.

[0034] FIG. 8 is a cross-sectional view of vaginal insert device 40 of FIG. 6A across section line A-A. As shown in FIG. 8, stem 44 can have a circular transverse cross-section throughout its length, having a wall 60, an upper end 62, a lower open end 64, and a hollow interior 66, wherein the circumference of the stem increases from the upper end to the lower open end. As illustrated, ridges 48 protrude from the exterior side 52 of the wall 49.

[0035] FIG. 8 further illustrates an embodiment of vaginal insert device 40 which includes a ventilation opening 68. The ventilation opening can include a ventilation hole, a screen or a mesh or any other component with an opening. As would be understand by one of ordinary skill of the art, vaginal insert device 40 can include a plurality of ventilation openings in locations other than, or in addition to, ventilation opening 68, such as in wall 49 of the upper portion 42. The one or more ventilation openings are intended to make the vaginal insert device more comfortable for the patient when inserted. The one or more openings may also equalize the air pressure between the inside and outside of the vagina 18, when vaginal insert device 40 is inserted. However, having a ventilation opening is not required for the vaginal insert device to be comfortable, useful and effective.

[0036] FIG. 8 illustrates further detail regarding an embodiment where rim 46 has a first section 70 and a second section 72, both of which protrude from the exterior side 52 of the wall 49, with the first section protruding a greater distance than the second section. A person of ordinary skill in the art would understand that multiple alternative embodiments of rim 46 are possible, including an embodiment in which rim 46 comprises just the first section 70, or another embodiment in which rim 46 comprises only one section but has a greater height than first section 70 and protrudes from the exterior side 52 of the wall the same distance from the top of the rim to the bottom of the rim. In another embodiment, rim 46 surrounds the exterior side 52 of the wall 49, adjacent to the upper open end 54, and comprises sections which protrude and sections which do not protrude from the exterior side of the wall.

[0037] With reference to FIGS. 7 and 8, the term “ridges” is intended to be broadly defined. Accordingly, ridges 48 can include the embodiment illustrated in FIGS. 7 and 8, in which ridges 48 are protrusions which are preferably circular rings which surround the exterior side of wall 49. However, “ridges” can also include any protrusions that extend from the exterior side 52 of wall 49, such as a plurality of studs or knobs.

[0038] A person of ordinary skill in the art would understand that the vaginal insert device 40 can come in different sizes, including different sizes to accommodate adult women with differing anatomy. Furthermore, a person of ordinary skill in the art would understand that the dimensions of the various sections and portions of the device 40 can be modified from the multiple embodiments illustrated and disclosed herein. For example, referring to FIG. 8, the total height 74 of device 40, diameter 76 at the upper open end 54 of the upper portion 42, and thickness of the wall 49 of the upper portion 42 of the device 40 can be modified, while retaining or improving on the intended usefulness, effectiveness and other benefits of the device. The following non-exclusive list of dimensions, in reference to FIG. 8, are non-limiting examples of embodiments of device 40 which are believed to be suitable for most women, and which provide the intended usefulness, effectiveness and other benefits of the device. For example, a suitable total height of device 40 is estimated to be in the range of about 58.0 to 67.0 millimeters (mm), and a suitable outer diameter 76 is estimated to be in the range of about 38.0 to 44.0 mm. A suitable height of the stem 44 is estimated to be in about the 13.0 to 15.0 mm range. A suitable thickness of the wall 49, in sections without ridges 48, of the upper portion 42, below rim 46, is estimated to be about 2.0 mm, whereas a suitable thickness of the wall 49, in sections with ridges is estimated to be about 2.5 mm. Wall 60 of stem 44 is estimated to have a suitable thickness of about 1.25 mm in sections without ridges 48. A suitable height of rim 46 is estimated to be about 15.0 mm, with a suitable height of first section 70 estimated to be about 5.0 mm and a suitable height of second section 72 estimated to be about 10.0 mm. A suitable thickness of the first section 70 is estimated to be about 6.0 mm and the second section 72 is estimated to be about 4.0 mm. A suitable outer diameter 82 of lower open end 64 is estimated to be about 10.5 mm. A suitable diameter of ventilation opening 68 is estimated to be about 2.0 mm.

[0039] FIG. 9 is a bottom view of the vaginal insert device 40 of FIG. 6A for an embodiment having ventilation opening 68. FIG. 10 is a top view of the vaginal insert device 40 of FIG. 6A for an embodiment having ventilation opening 68.

[0040] FIG. 11 is a cross-section of the pelvic region of a female illustrating an embodiment of the vaginal insert device 40 inserted in the vagina 18 and applying pressure on the urethral sphincter 16 to manage, improve, or eliminate female urinary incontinence. FIGS. 12 and 13 are each a cross-section of the pelvic region of a female illustrating an embodiment of the vaginal insert device 40 inserted in the vagina 18 to manage, improve, or eliminate POP, in addition to applying pressure on the urethral sphincter 16 to manage, improve, or eliminate female urinary incontinence. In particular, in FIG. 12, vaginal insert device 40 is inserted in the vagina 18 to manage, improve, or eliminate a prolapsed bladder 26. In particular, in FIG. 13, vaginal insert device 40 is inserted in the vagina 18 to manage, improve, or eliminate a prolapsed uterus 30. As illustrated in FIGS. 11-13, the upper open end 54 of the upper portion 42 is the innermost portion of the vaginal insert device 40 during insertion. As further illustrated in FIGS. 11-13, the removal portion or stem 44 of an embodiment of vaginal insert device 40 can be accessed from the exterior of the vagina 18 when the vaginal insert device is inserted and assists in removal of the vaginal insert device. Ridges 48 on stem 44 provide better grip for removal of the device 40 by a patient.

[0041] FIGS. 14A and 14B illustrate a method for comfortably inserting vaginal insert device 40 into vagina 18. As illustrated in FIG. 14A, a patient can manually squeeze the wall 49 of the upper portion to make the upper portion more compact for easier insertion of the vaginal insert device 40. As illustrated in FIG. 14B, once vaginal insert device 40 is manually inserted into vagina 18, wall 49 expands back to its original shape.

[0042] FIG. 15A illustrates a side-view of a pessary applicator 84 which can be used to assist in inserting a vaginal insert device 40 into a patient's vagina 18. Pessary applicator 84 comprises an insertion member 86, a top portion 90 of the insertion member, and a plunger 88. Pessary applicator 84 is generally similar to a tampon applicator. However, the insertion member 86 will generally have a greater circumference than a tampon applicator to accommodate a vaginal insert device 40, which when compacted has a shape which is generally larger than the circumference of a tampon. FIGS. 15B-15C illustrate a cross-section of the pessary applicator 84 of FIG. 15A, and a method of using the applicator to comfortably insert a vaginal insert device 40 into a patient's vagina 18. As is illustrated, vagina insert device 40 is housed inside insertion member 86 in a compacted shape. Similar to the process of insertion of a tampon into a vagina using an applicator, insertion member 86 of applicator 84 is inserted into the patient's vagina 18, and the plunger 88 is pushed towards the insertion member, ejecting the vaginal insert device 40 through the top portion 90. The applicator 84 is then removed from the vagina 18, and the vaginal insert device 40 remains in place in the vagina, expanded back to its normal shape. The vaginal insert device 40 which has been inserted is positioned such as is illustrated in FIG. 11.

[0043] This disclosure encompasses all changes, substitutions, variations, alterations, and modifications to the example embodiments herein 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 herein that a person having ordinary skill in the art would comprehend. Moreover, reference in the appended claims to an apparatus, device or system or a component, section, or portion of an apparatus, device or system being adapted to, arranged to, capable of, configured to, enabled to, operable to, or operative to perform a particular function encompasses that apparatus, device, system, or component, whether or not it or that particular function is used, activated, turned on, or unlocked, as long as that apparatus, system, device or component is so adapted, arranged, capable, configured, enabled, operable, or operative.

[0044] All examples and conditional language recited herein are intended for pedagogical objects to aid the reader in understanding the disclosure and the concepts contributed by the inventor to furthering the art, and are construed as being without limitation to such specifically recited examples and conditions. Although embodiments of the present disclosure have been described in detail, it should be understood that various changes, substitutions, and alterations could be made hereto without departing from the spirit and scope of the disclosure.