WO2015193700A1

WO2015193700A1 - Double folded ring pessary and applicator

Info

Publication number: WO2015193700A1
Application number: PCT/IB2014/062294
Authority: WO
Inventors: John Ing Ching TANG
Original assignee: Tang John Ing Ching
Priority date: 2014-06-17
Filing date: 2014-06-17
Publication date: 2015-12-23

Abstract

A vaginal ring pessary that is double folded for easy insertion by using an applicator. The ring pessary is over sized to allow it to stay in a double folded configuration in vagina. It prevents stress urinary incontinence and pelvic organs prolapse by anchoring its distal loops against pelvic floor and its proximal arches against the prolapsing organs. The applicator has one or more loop holding compartments to hold the loops in place during insertion to ensure proper release of the ring pessary in a transverse position to give maximum circumferential distension of vagina and therefore elevation of pelvic floor. The assembly of ring pessary and applicator is also useful in securing female condom and drug delivery system in vagina.

Description

DOUBLE FOLDED RING PESSARY AND APPLICATOR

TECHNICAL FIELD

The objective of the present invention is related to management of pelvic organs prolapse and stress urinary incontinence. More specifically it is related to a vaginal device that alleviates above conditions. It is another objective of the present invention to provide a device that can be used as anchorage for female condom and as vaginal drug delivery system. Yet another objective of the present invention is to provide an applicator to enable easy and proper placement of the said device in vagina.

BACKGROUND ART

Stress urinary incontinence (SUI) and pelvic organ prolapse are common problems faced by women. SUI refers to involuntary leakage of urine when there is an increase in intra abdominal pressure, such as during sneezing or straining. It is caused by abnormal descent of urethra and bladder neck and, together with pelvic organ prolapse, is usually a result of injury to pelvic floor muscles during childbirth. Therefore the main stay of treatment for SUI is through elevating the descended urethra and bladder neck. This can be achieved by using non invasive modalities such as vaginal pessaries and practising pelvic floor exercise, or by performing invasive surgeries, such as colposuspension and tension free tapes. As a rule, conservative approach is preferred to invasive approach in mild cases of SUI and pelvic organ prolapse.

Among all the different types of vaginal pessaries, ring pessary is currently the commonest used non invasive modalities for SUI. It is a semi rigid ring that comes in different sizes tailored to fit different vaginal diameters. The placement of ring pessary involves using two fingers to squeeze or fold the ring into an elongated shape and insert it into vagina longitudinally. Once the ring is inside vagina, it springs open and pushes against the vaginal wall to elevate pelvic floor (Fig.7a). However in order to achieve maximum lifting effect on pelvic floor, the user or the caregiver has to insert his or her fingers into vagina and rotate the ring pessary 90 degrees so that it lies transversely/perpendicularly to the long axis of vagina and distends the vaginal wall circumferentially (Fig.7b).

Apart from being used in the treatment of pelvic organ prolapse and SUI, ring pessary is used to secure female condom (such as FC2 by Women Health Company) in vagina. Furthermore, it is also used as a vaginal drug delivering system (such as NuvaRing by Merck for contraception). The above methods of keeping ring pessary in vagina are similarly applicable here.

Ring pessary placement is nonetheless associated with problems. Firstly, it can be painful. In order for ring pessary to lift pelvic floor, it needs to be large enough to exert circumferential pressure on vaginal wall, diameter of which is almost always wider than introitus. That is why ring pessary has to be squeezed or folded for it to enter the relatively narrower introitus. However in order to maintain ring pessary in a squeezed or folded configuration during insertion, the two holding fingers have to enter introitus with the ring pessary, therefore it still causes undue stretching and discomfort at the introitus. Secondly, rotating the ring in vagina with fiddling fingers is often not only painful, but difficult and imprecise. Thirdly, frequently the ring, especially if not properly rotated, may revert to longitudinal position or even fall out.

The paradox is, in order for the ring pessary to be inserted easily and properly, it needs to be small; whereas to fully realize its function of elevating pelvic floor or even staying in situ, it needs to be large enough and be able to stay in a transverse position in vagina. In addition to these, the ring pessaries also need to be sufficiently simple and affordable for average women to use. There are a multitude of prior arts invented with such aims in mind, such as U.S. Patent Application No. 2002/0183711 to Moser, entitled, "Urinary Incontinence Device"; U.S. Pat. No. 6,739,340 to Jensen, et al., entitled, "Device for prevention of involuntary urination"; U.S. Pat. No. 6,679,831 to Zunker, et al., entitled, "Resilient incontinence insert and a method of making the same"; U.S. Pat. No. 6,460,542 to James, entitled, "Female incontinence control device"; U.S. Pat. No. 6,413,206 to Biswas, entitled, "Intra-vaginal device"; U.S. Pat. No. ,785,640 to Kresch, entitled "Method for Treating Female Incontinence"; U.S. Pat. No. 5,771,899 to Martelly, et al., entitled, "Pessary"; U.S. Pat. No. 5,618,256 to Reimer, entitled, "Device for Arrangement in the Vagina for Prevention oflnvoluntary Urination with Females and an Applicator for use in Insertion of the Device"; U.S. Pat. No. 5,417,226 to Juma, entitled, "Female Anti-Incontinence Device"; U.S. Pat. No. 5,386,836 to Biswas, entitled, "Urinary Incontinence Device"; U.S. Pat. No. 5,007,894 to Enhorning, entitled, "Female Incontinence Device"; and U.S. Pat. No. 4,920,986 to Biswas, entitled, "Urinary Incontinence Device", but none has truly been successful in solving the above problems. There is therefore a great need for invention of a vaginal pessary that is effective in elevating pelvic floor yet easy to be inserted properly.

DETAILED DESCRIPTION OF THE INVENTION

In accordance with the preferred embodiment of the present invention there is provided a semi rigid elastic ring pessary 1 which is folded twice 10, and held in this configuration by an applicator 4. The said applicator 4 has double loop-holding compartments 5a on one end 5 and a plunger on the other end 6.

Preparing the said ring pessary for vaginal placement (Fig.4-6) involves first folding and inserting one of the loops 21 of the ring pessary 1 into one of the double loop-holding compartments 5a of the applicator. This is followed by second folding of the ring pessary 1 and insertion of the other loop 21 into second loop-holding compartment 5a of the applicator. The ring pessary is now loaded on the applicator (Fig. 6c) and ready for deployment in vagina.

The use of said applicator ensures that regardless of the size of ring pessary, it can always be inserted into vagina with ease and placement plan of ring pessary is always perpendicular to the long axis of vagina (Fig. 8).

Deployment of the said ring pessary into vagina is accomplished by inserting loaded applicator deep into vagina and pushing the plunger to release the ring pessary (Fig. 8). The ring pessary will spring open three dimensionally and distend the vagina wall circumferentially (Fig. 8b), thereby giving maximum lifting force to elevate the pelvic floor 14.

In the preferred embodiment, circumference of the ring pessary 1 is designed to be equal or larger than vagina 13. Therefore at its placement in vagina, it will stay in a double folded configuration (Fig. 9a and 9B) with two proximal arches 20 (at proximal end of vagina) and two distal loops 21 (at distal end of vagina) spreading out in four different directions against the vaginal wall (Fig. 9). It is preferable to place the ring pessary high up so that two distal loops 21 can anchor on the pelvic floor 14 (Fig.8c). In this double folded configuration, two proximal arches 20 will function like a resilient arch bridge that response according to the amount of load on it. As seen in arch bridge engineering, when more force is applied on the arches, the arches become firmer and stronger. So when there is an increase in intra abdominal pressure (such as sneezing) that pushes the prolapsed pelvic organs downward towards the proximal arches 20, they will firm up and at the same time transfer the force to the distal loops 21, which in turn will push against the vaginal wall to elevate the pelvic floor 14 to prevent organ prolapse and SUI. In the case where a distal loop 21 is resting at urethra, it may even occlude the urethra during raised intra abdominal pressure, thereby preventing SUI.

The removal of the ring pessary can be performed in one simple act of hooking it out with a finger.

In a different embodiment, the ring pessary has one or more indentations 2, notches 3 (Fig. 1 and 2) or means to allow easy double folding of the ring pessary 1 for insertion into the loop-holding compartments 5a of applicator 4.

In another embodiment, the ring pessary is folded only once at loading it onto the applicator. As loaded applicator advances into vagina, the curvature of folded ring will fold on its own, thereby achieving the same double folded configuration in vagina, except that in this case the ring placement may not be as precise as aforementioned.

In another embodiment, the ring is non circular.

In another embodiment, the ring pessary has more than two arches or/ and loops (Fig.lOa and 10b). The joints 22 between arches 20 and loops 21 can be fixed, flexible or rotatable.

In another embodiment the ring pessary is folded more than two times.

In another embodiment, the ring pessary is reinforced with one or more pieces of wires and/or springs.

In another embodiment, the ring pessary has one or more high friction points on it. The high friction point may consist of, but not limiting to, protrusions or textures on the ring surface. These high friction points provide stronger anchorage on vaginal wall and pelvic floor for the ring pessary.

In another embodiment, there is provided a flexible membrane or membranes on the surface of the ring for supporting prolapsed pelvic organs. The membrane or membranes may have one or more drainage perforations on it or it may be in a net form.

In another embodiment, there is provided one or more rods integrally formed and runs across the inner surface of the ring pessary. At folding the ring pessary, the said rod folds to form extra arch structures to prevent prolapsed pelvic organs from descending through the hollow of the ring pessary.

In another embodiment, proximal arches are fused together or integrally joined by one or more rods or platform structures. The purpose is to prevent prolapsed pelvic organs from descending through the hollow of the ring pessary.

In another embodiment, the applicator 4 has one or more loop-holding compartment 5a. There is a space 15 provided in the divider 16 between the said compartments 5a for plunger 6 to move through to release the double folded ring pessary 10. In another embodiment, the divider 16 does not have any space in it. The respective plungers 8 and 9 are thus constructed differently according to aforementioned types of loop-holding compartment 5a.

In another embodiment the applicator has a cushion 7 that rests on exterior of introitus to mark the depth of applicator in vagina. The cushion 7 is either fixed or detachable.

In yet another embodiment, the applicator has external features on it to indicate which direction each individual arch or loop of double folded ring is facing. This is useful in the prevention of pressure sores on vaginal wall during periodic removal and reinsertion of the ring pessary. Previous pressure points on vaginal wall can be avoided by simply rotating the applicator along the long axis of vagina.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is herein described, by way of example only, with reference to the accompanying drawings, wherein:

Fig. la: Top view of the ring pessary 1 with indentations to facilitate double folds. Note that two opposing indentations are facing upwards 2a, while two opposing indentations are facing inwards 2b. The indentations may differ in depth to give different forces at different directions.

Fig. lb: Side view of Fig.1

Fig.2a: Top view of the ring pessary 1 with notches to facilitate double folds. Note that tow opposing notches are facing upwards 3a, while two opposing notches are facing inwards 3b. Likewise the thickness of the notches may vary to give different forces at different directions.

Fig. 2b: Perspective view of Fig 2a.

Fig. 3: The applicator without the plunger being shown. It has an open end 6 for the plunger, and an opposing open end 5 for holding the double folded ring pessary. The open end 5 has a divider 16 that divides the open end 5 into two loop holding compartments 5a, each of which holds a loop 21 of the double folded ring pessary 10. A fixed or adjustable cushion 7 may be attached to the open end 6 to be used as a guide to indicate how deep the applicator is in the vagina.

Fig. 4a: Perspective view of the preferred assembly of ring pessary with applicator before loading. The assembly consists of a ring pessary 1, a cushion 7, an applicator 4, and a plunger 5. Note that divider 16 has a space 15 in this embodiment, and plunger 8 is therefore constructed to be able to pass through the space 15 to release the ring pessary.

Fig. 4b: Perspective view of another assembly as Fig.4a. Here divider 16 does not have a space in it. The plunger 9 is therefore designed differently for it to release the ring pessary 1.

Fig. 5a-6d: Perspective view of preferred steps in loading and releasing of ring pessary.

Fig. 5a: Perspective of the assembly before loading.

Fig. 5b: To assemble the parts, the user first loads the detachable cushion 7 onto the applicator 4.

Fig. 6a-b: The ring pessary 1 is double folded 10 to be placed in loop holding compartments 5a of applicator 4. The loops 21 may be inserted one after the other or simultaneously as shown here. It is preferable that only a small portion of the loops 21 are loaded into loop holding compartments 5a of applicator 4. By exposing nearly full length of the ring, the user will have a better idea of how deep the ring pessary is being inserted in vagina.

Fig. 6c: The plunger 8 is inserted into the applicator 4, short of firing/releasing the loaded ring pessary. The assembly is now ready for deployment.

Fig. 6d: After the assembly is inserted into vagina, plunger 8 is depressed fully to release double folded ring pessary 10, which will spring open transversely to elevate the pelvic floor circumferentially. The applicator 4 with cushion 7 and plunger 8 are then removed from vagina.

Fig. 7a: Side view of a female pelvic region with a ring pessary 1 lying longitudinally in vagina. As the vagina is distended sideways with the ring pessary in this position, there is relatively less elevating force compared to circumferential distension of vagina.

Fig. 7b: Side view of a female pelvic region with a ring pessary 1 lying transversely in vagina. As the vagina is distended circumferentially in this position, there is relatively more elevating force compared to longitudinal distension of vagina.

Fig. 8a: Side view of a female pelvic region with loaded assembly of double folded ring pessary 10, applicator 4, cushion 7 and plunger 8 in vagina ready for deployment of ring pessary 10.

Fig. 8b: The plunger 8 is fully depressed to release the double folded ring pessary 10. The ring pessary 10 springs open to distend the vagina 13 circumferentially.

Fig. 8c: In its designated position in vagina, the loops 21 of the double folded ring pessary 10 will be anchoring on pelvic floor 14 while the arches 20 will be supporting the prolapsing pelvic organs, such as bladder neck 11 and uterus 12. Both loops 21 and arches 20 are distending the vagina 13 circumferentially at the same time while performing the above functions. The ring pessary 10 can be maintained in this double folded working position because of firstly its large circumference, and secondly proper insertion using the applicator as aforementioned.

Fig. 9a and 9b: Perspective view of a semi double folded configuration of ring pessary with two upper proximal arches 20 and two lower distal loops 21.

Fig. 10a and 10b: Perspective view of a vaginal pessary with four proximal arches 20 and four distal loops 21. The four joints 22 may be flexible, fixed or rotatable. In this embodiment the applicator will have four loop holding compartments and a plunger modified accordingly for releasing the pessary.

Claims

THE CLAIMS My claims are:

1. An assembly consists of

a) A vaginal ring pessary double folded into a configuration of two proximal arches and two distal loops.

b) An applicator with one or more loop-holding compartments on one end and a plunger on the other end.

2. The ring pessary as in claim 1, wherein there are one or more indentations, notches or means to facilitate its folding. The indentations, notches or means may have varying depth, thickness or elasticity to give different distending forces on vagina in different directions.

3. The ring pessary as in claim 1, wherein the ring pessary is non circular.

4. The ring pessary as in claim 1, wherein it is reinforced with one or more wires or springs.

5. The ring pessary as in claim 1, wherein it has one or more high friction points on it. The high friction point may consist of, but not limiting to, protrusions or textures on the ring surface.

6. The ring pessary as in claim 1, wherein the ring is folder more than two times.

7. The ring pessary as in claim 1, wherein the ring pessary comprises more than two arches and two loops. The joints between the arches and the loops may be flexible, fixed or rotatable.

8. The ring pessary as in claim 1, wherein there is one or more membranes or rods disposed along the surface of the ring to support the prolapsing pelvic organs. The membranes may have one or more perforations or be net-like to allow drainage of discharges.

9. The ring pessary as in claim 1, wherein the proximal arches are fused, or connected by rod/rods or platform/platforms , to support prolapsing pelvic organs.

10. The applicator as in claiml, wherein the applicator has either a fixed or a detachable cushion.

11. The applicator as in claim 1 , wherein there are one or more spaces in the divider/dividers of the loop holding compartments to allow the plunger to pass through to release the ring pessary.

12. The applicator as in claim 1, wherein there are external features or markings to indicate the directions of individual arch and loop.