GB2413286A

GB2413286A - Intra-vaginal catamenial device with collection chamber

Info

Publication number: GB2413286A
Application number: GB0508011A
Authority: GB
Inventors: Gillian Louise Harris
Original assignee: Individual
Current assignee: Individual
Priority date: 2004-04-20
Filing date: 2005-04-20
Publication date: 2005-10-26
Anticipated expiration: 2025-04-20
Also published as: GB0408768D0; GB2413286B; GB0508011D0

Abstract

An intra-vaginal catamenial device 10 comprises a collection chamber 12 with at least one storage container 14, 16 attached. The device may comprise a filter 34, 36 to separate clotted material from fluids. The device may comprise an outlet 28 and a telescopic conduit 18 defining a flow passage between a storage container 14 and the outlet. An applicator (Fig. 4) for inserting an intra-vaginal device is also disclosed.

Description

Intra-vaginal device This invention relates to intra-vaginal devices. In

particular, although not exclusively, this invention relates to intravaginal devices which collect, or direct menstrual flow.

Such devices may be disposable or reusable. This invention also relates to devices for the collection and/or storage and/or disposal of bodily fluids, such as surgical drains.

Typical devices used to collect menstrual flow include tampons and the menstrual cups. Both of these devices have problems associated with them. Tampons, which are designed to absorb menstrual flow, can, for example, dry out natural vaginal fluids when menstrual flow is too light, or leak when menstrual flow is too heavy. It can be difficult for women to find a suitably sized tampon which will neither dry out natural vaginal fluids nor leak, and to judge their flow correctly day-to-day. There are medical complications associated with the use of tampons such as Toxic Shock Syndrome, which can be life threatening. Tampons are also expensive and bad for the environment.

The menstrual cup is designed to collect menstrual flow in a chamber inserted into the vagina. The user disposes of the flow when convenient, and either disposes of, or cleans and re-inserts, the cup. The cup, particularly in its disposable version, is difficult to position correctly. The reusable cup requires repeated emptying, cleaning and reinsertion. With either the reusable or the disposable cup there is a risk of spillage, potentially on the user's clothes, on removing. These problems have meant that the market for the cup is limited.

There is, therefore, considerable potential for improvements in the field of collection and disposal of menstrual flow.

According to a first aspect of this invention there is provided an intravaginal device - 2 for the collection of menstrual flow comprising a collection chamber, and a storage container, preferably a storage bag, the storage container being attached to the collection chamber.

The storage container may be releasably attached to the collection chamber. The intra-vaginal device may comprise a plurality of storage containers, preferably bags.

The or each storage container may be disposable.

According to a second aspect of this invention there is provided an intravaginal device for the collection of menstrual flow comprising a filter operable to separate clotted material from fluids, through which filter menstrual flow may pass, and a collection chamber for collecting clotted material.

The intra-vaginal device may be adapted for storing fluids and/or clotted material, preferably separately. The intra-vaginal device may be adapted to discharge the fluids whilst the device is in place.

The filter may comprise an expanse of material having a plurality of holes. The filter may comprise a valve and an actuator, the valve may be operable to open when a pre-determined weight rests on the actuator. The filter may define separate passages for clotted and fluid material, preferably a spiral passage for clotted material.

The intra-vaginal device may comprise at least two filters. Comparatively fluid material may flow through a first filter to collect in a first storage container, and comparatively clotted material may collect in a second storage container or a second portion of the first storage container. The comparatively clotted material may pass through the first filter, or through a second filter, to the second storage container.

The filter or filters may be disposed in the collection chamber, or in a storage container, preferably at or near an inlet to the storage container.

The first filter may cover an inlet to the first storage container and a second filter may cover an inlet to a second storage container.

The intra-vaginal device may comprise a pump for transferring menstrual flow, conveniently a fluid portion of menstrual flow, from the storage container or containers to an outlet.

According to a third aspect of this invention there is provided an intravaginal device comprising an inlet, a collection chamber, an outlet and a telescopic conduit defining a flow passage between the inlet and the outlet, the telescopic conduit being operable to be extended to outside the vagina, and retracted to inside the vagina, in use.

The telescopic conduit may comprise a first, proximal, section and a second, distal, section. A pump may be disposed adjacent the outlet, and may be carried by the second section. The outlet may be provided on the second section. A thread may be carried by the second section. The first section may pass through the collection chamber. The first section may have an inlet for the collection of menstrual flow, which may be disposed in a storage container leading from the collection chamber.

According to a fourth aspect of the invention, there is provided an applicator for inserting an intra-vaginal device, conveniently an intravaginal device as described above, comprising an elongate member connected to a clamp. The applicator preferably has clamping surfaces which comprise formations operable to inter- connect with corresponding formations on the intra-vaginal device.

Preferably the clamp is operated by the elongate member. The applicator may comprise first and second portions which may be hinged together. Conveniently a first arm of the clamp depends from a first portion of the elongate member and a second arm of the clamp depends from a second portion of the elongate member.

The arms are may be arcuate in cross-section, or claw-like. Clamping surfaces, conveniently on the arms, preferably being facing surfaces, may comprise a series of generally parallel raised projections. These preferably create a tongue and groove effect.

Actuation of a hinge at the far end of the elongate member from the clamp may thus draw the arms of the clamp together, or cause them to become separated.

According to a fifth aspect of this invention there is provided a kit of parts comprising an intra-vaginal device as described above and an applicator as described above.

Any of the features described above may be provided independently and/or combined with any other feature in relation to any aspect of the invention.

Embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings in which: Figure 1 shows schematically a embodiment of an intra-vaginal device; Figure 2 shows schematically a second embodiment of an intra-vaginal device; Figure 3 shows schematically a third embodiment of an intra-vaginal device; and Figure 4 shows schematically an applicator for any of the devices shown in Figures 1 to 3.

Figure 1 shows an embodiment of an intra-vaginal menustration collection and filtration device having disposable storage containers. The device 10 comprises a collection chamber 12, containing a filter which directs menstrual flow into one of two storage containers 14, 16 depending whether or not it has clotted, a telescopic conduit 18 comprising an inner section 20 and an outer section 22, a pump 24, a thread 26 and an outlet 23.

The user inserts the device at the beginning of her period. At intervals thereafter, she may withdraw the outlet 28 and pump 24 by a gentle tug on the thread 26, which extends the telescopic conduit 18, and draws the pump and outlet out of her vagina.

She may then operate the pump 24 to expel fluid menstrual material from a first storage container 14 and replace the pump 24 and outlet 28. At the end of her period the whole device may be withdrawn by a sharper tug on the thread 26. The device thus provides a comfortable and convenient way of storing and disposing of menstrual flow.

The collection chamber 12 comprises a neck 30 across which is disposed a membrane 32, made of a soft and biocompatible material such as silicone. The membrane is generally circular in cross-sections and has an inlet defined by two substantially perpendicular cuts which meet towards its centre and extending towards its periphery. In use, the device is positioned so that the inlet receives a cervix of a user. By means of the cuts, the inlet can expand or contract to fit on to the neck of the users cervix.

In order to enable the device to be fitted onto the user's cervix easily, the neck 30 of the collection chamber 12 has a short cylindrical portion adjacent to the membrane for an applicator such as that shown in Figure 4 to clamp onto. The external surface of the attachment portion has a series of generally circumferential raised projections which provide a tongue and groove effect.

The body of the collection chamber 12 is bulbous and contains two filters 34, 36, which are disposed towards the distal end of the collection chamber 12, opposite to the neck 30. One of the filters 34 covers an inlet 38 to a first storage container 14 and the other filter 36 covers an inlet 40 to a second storage container 16. The purpose of the filters 34, 36 is to allow fluid material and clotted material to pass into different storage containers. - 6

The first filter 34 comprises a membrane having a plurality of small holes. Fluid menstrual material may pass through these holes to the first storage container 14, whilst clotted material collects at the base of the collection chamber. The second filter, or valve, 36 comprises an actuator in the form of a sprung trap door which opens when sufficient weight of clotted material has collected thereon. Fluid material tends to pass through the holes in the first filter rather than accumulating on the trapdoor.

The fluid element of menses, which comprises the greater portion by volume of menstrual flow, is thus separated from clotted material and can be separately disposed of, without risk of clogging. The first section of the telescopic conduit 18 leads from the first storage container 14, which stores fluid material, through the collection chamber 12 and the second section 22 of the tubing. The second section 22 of the telescopic conduit supports the pump 24, the thread 26 and leads to the outlet 28. The two sections of the tube, overlap, potentially extensively, along the length of the vagina in use.

The telescopic conduit or tube 18 is lengthened when the user pulls lightly on the thread 26 to pull the pump 24 and the outlet 28 outside her body. The telescopic conduit is preferably long enough when extended to reach past the users external genitalia. The pump 24 is a squeeze action fluid pump. The user may then operate the pump 24, using her fingers or the palm of her hand, to expel fluid menstrual material from the storage container 14 through the outlet 28 which is conveniently located in a toilet. Having done this, the user may then push the second section 22 of the telescopic conduit back onto the first section 20 to place the pump 24 and outlet 28 inside her vagina. The thread 26 remains slightly outside the vagina.

Alternatively, if desired, the user could expel fluid through the outlet using her pelvic floor muscles, with the pump being kept in the vagina.

To remove the entire device the user tugs more sharply on the thread 26. As the first - 7 section 20 of the telescopic tubing is attached to the distal end of the first storage container 14, the first storage container 14 emerges first, followed by the collection chamber 12 and finally the second storage container 16. Each of the storage containers 14, 16 is disposable and is joined to the collection chamber 12 by a screw fitting. Therefore the user may remove and dispose of the storage containers 14, 16.

The user then cleans the device 10 so it is ready to be re-used, once fresh storage containers are attached, when she has her next period. If so desired, the device may be sterilised by microwaves or by immersion in boiling water, such as can be found in a dishwasher.

This device may stay inside the users body throughout her entire period as it is made of a material, such as silicone, which is designed for prolonged internal usage. The material, and device, has no sharp edges and so may be inserted and removed with ease. The user can expel fluid menstrual flow from the device with relative ease, as hereinbefore described, and blood clots are stored for the duration of the period, preventing clogging in downstream elements of the device. The user may choose when to expel fluid from the first storage container 14. The capacity of the device is such that the user is much less likely to experience leakage than with, for example, a tampon. The expulsion process is relatively simple, unlikely to involve spillage, and the device does not need to be cleaned and re-inserted during the same period, as with a menstrual cup.

A second embodiment of the intra-vaginal device 10 is shown in Figure 2. This device is similar to the embodiment shown in Figure 1, and similar reference numerals have been used where appropriate. The main difference is in the design of the filter and in the fact that the storage containers 14, 16 may be re-used.

The filter 42 is disposed in the collection chamber 12 and comprises a helix which defines alternate passageways through the collection chamber for clotted portions and fluid portions of menstrual flow. The filter provides a spiral passageway for - 8 clotted portions of menstrual flow, but does not greatly impede the predominantly downward passage of fluid portions through the collection chamber.

The portions of the filter covering the inlet 38 to the first filter container 14 are perforated, a plurality of small holes being formed in the filter. Fluid can flow through these holes. More solid, clotted, material does not flow through these holes but passes through a spiral flow passage to the second storage container 16.

The inlets 34, 36 of the storage containers 14, 16 are fused to the collection chamber 12, so that the entire device may be cleaned between periods and re-used.

Figure 3 shows a third embodiment of an intra-vaginal device 10 having a third type of filter 44. Again, similar reference numerals denote similar elements. This filter 44 comprises two discs 46, 48. Each disc is perforated with a plurality of relatively small crescent shaped holes 50 and a single larger crescent shaped or semi-circular hole 52. Fluid material may pass through the smaller holes, and both fluid and clotted material through the larger holes. The smaller holes in the second disc are disposed over the inlet to the first storage container 14, and the larger hole in the second disc is disposed over the inlet to the second storage container 16.

The disks are set at an angle to each other and to the neck of the collection chamber. Specifically, the proximal end of the first disk is attached to the neck of the collection chamber whilst the distal end of the first disk 26 is attached to a point approximately half way up the collection chamber. The proximal end of the second disk 48 is attached to the first disk, and the collection chamber 12 whilst its distal end is attached so as to cover the inlet 38 of the second storage container 16.

Alternatively, the disks could be sprung apart rather than attached to the sides of the collection chamber.

The effect of this arrangement is that menstrual flow through the neck of the - 9 - collection chamber encounters, and flows down the first disc. More fluid flow passes through the small holes to the second disc where it again passes through the small holes to the inlet of the first storage container 14. More solid material slides down the first disc, passes through the larger hole at its base and slides down the second disc, through the second large hole and into the second storage container.

In a further embodiment, not shown in the drawings, a single storage container could be used having a filter disposed therein, or on the inlet of the storage container so that fluid menses can pass into the container and be expelled using the pump, whereas clots would be held either in the collection chamber or in the upper portion of the storage container or both.

The filters described above may be disposable. Alternatively the filters may be re- usable. In either case they may be inserted into or extracted from the collection chamber by the user through its neck for cleaning or disposal. The filters are preferably made of a semi-rigid material.

It can be seen that by using this device blood flow and blood clots may be separated so the device does not become clogged.

Figure 4 shows an applicator 44 for insertion of an intra-vaginal device, such as those shown in Figures 1 to 3. The applicator comprises an elongate member 60 which is separated at one end to form two curved arms 62, 64. The elongate member 60 and the arms 62, 64 are formed from a rigid slightly angled material.

The applicator is constructed so that there is, effectively, a hinge running along the length of the elongate member.

The inside surfaces of the curved arms, or claws 62, 64 are grooved and tongued to fit around the neck of the collection chamber 12. Portions of the elongate member 66, 68 either side of the hinge are connected to a respective arm 62, 64. Therefore, - 10 the user may move the arms 62, 64 into a clamping position on the neck of a collection chamber 12 by pushing on either side of the hinge along the elongate member 60.

The intra-vaginal device described above may be inserted into the vagina at the beginning of menstruation, using either the applicator shown in Figure 4 or fingers, and the inlet pushed onto the cervix. The collection chamber collects menstrual fluid as it flows from the cervix and the filters or filter separates more fluid material from blood clots. Preferably the fluid material is directed into a storage container and the blood clots are directed into a storage container, either different storage containers, or compartments of the same storage container.

When the user wants to express the menstrual blood flow she gives a gentle tug on the thread loop which hangs from the body and the pump and bottom section of the telescopic tubing emerges. The user pinches the pump in her hand or between finger and thumb to squirt the blood flow, preferably into a toilet. When she has expressed as much fluid as is desired, she pushes the pump back into her vagina, leaving the thread on the outside, and goes about her daily routine. She therefore has complete control of when and where the fluid is expressed.

The device is removed at the end of menstruation using the same thread with a much firmer tug. The pump and telescopic tubing emerge first followed by the blood flow container 14, as the upper section of the telescopic tubing 20 is attached to the base of the blood flow container. The collection chamber and blood clot container flow behind. The device may then be cleaned, any disposable containers removed and replace, and it is ready to use next month. This device has a universal fitting, and allows for less expensive and more long-term use as it does not need to be removed during the period. The user has complete control.

Another use for embodiments of this device is as a replacement for the use of swabs - 11 in operations or as a replacement for traditional surgical drains. Such embodiments comprise an inlet which may be resilient or attached to a source of blood by a surgeon. Drained fluid can pool in a collection chamber from which it can be pumped out. An embodiment comprising a filter, such as those described above, can be used if the fluid is likely to be clotted or mixed with solids. Currently open drains and closed drains are in existence, but both have disadvantages, the open drains are susceptible to infection and the closed drains need to be changed, which can expose the wound. Filtering and/or removing the drained fluid by pumping can ameliorate some of these problems. This can provide a marked increase in patient well being when a drain is in for a long time, or when a patient is discharged from hospital with a drain in place.

Each feature disclosed in this specification (which term includes the claims) and/or shown in the drawings may be incorporated in the invention independently of other disclosed and/or illustrated features.

Statements in this specification of the "objects of the invention" relate to preferred embodiments of the Invention, but not necessarily to all embodiments of the invention falling within the claims. The description of the invention with reference to the drawings is by way of example only.

The text of the abstract filed herewith is repeated here as part of the specification.

An intra-vaginal device for the collection of menstrual flow is described. The device may comprise a collection chamber and a storage container, the storage container being attached to the collection chamber. Alternatively, or additionally, the device may comprise a filter operable to separate clotted material from fluids. Alternatively or additionally, the device for the collection of menstrual flow may comprise an inlet, a collection chamber, an outlet and a telescopic conduit defining a flow passage between the inlet and the outlet. An applicator for inserting an intra-vagnal device is - 12 also described, the applicator comprising an elongate member connected to a clamp. - 13

Claims

1. An intra-vaginal device for the collection of menstrual flow comprising a collection chamber, and a storage container, preferably a storage bag, the storage container being attached to the collection chamber.

2. An intra-vaginal device according to Claim 1 in which the storage container is releasably attached to the collection chamber.

3. An intra-vaginal device according to Claim 1 or Claim 2 comprising a plurality of storage containers, preferably bags.

4. An intra-vaginal device according to any of claims 1 to 3 in which the or each storage container is disposable.

5. An intra-vaginal device for the collection of menstrual flow comprising a filter operable to separate clotted material from fluids through which filter menstrual flow may pass, and a collection chamber for collecting clotted material.

6. An intra-vaginal device according to Claim 5 adapted for storing the fluids.

7. An intra-vaginal device according to Claim 5 or Claim 6 adapted to discharge the fluids whilst the device is in place.

8. An intra-vaginal device according to any of claims 5 to 7 in which the filter comprises an expanse of material having a plurality of holes.

9. An intra-vaginal device according to any of claims 5 to 8 in which the filter comprises a valve and an actuator, the valve being operable to open when a pre- determined weight rests on the actuator. - 14

10. An intra-vaginal device according to Claim 8 and Claim 9 comprising at least two filters.

11. An intra-vaginal device according to any of claims 5 to 10 in which the filter defines separate passages for clotted material and fluid material, preferably a spiral passage for clotted material.

12. An intra-vaginal device according to any of claims 1 to 3 and to any of claims 5to 11.

13. An Intra-vaginal device according to Claims 3 and any of claims 5 to 12 in which comparatively fluid material flows through the filter to collect in a first storage container, and comparatively clotted material collects in a second storage container.

14. An intra-vaginal device according to Claim 12 or Claim 13 in which the filter is disposed in the collection chamber.

15. An intra-vaginal device according to Claim 14 in which the filter is disposed at an inlet to the storage container.

16. An intra-vaginal device according to Claim 15 as dependent on claims 3 and in which a first filter is disposed at an inlet to a first storage container and a second filter is disposed at an inlet to a second storage container.

17. An intra-vaginal device according to Claim 13 or Claim 14 in which the filter is disposed in a storage container.

18. An intra-vaginal device according to any preceding claim comprising a pump for transferring menstrual flow from a storage container to an outlet. - 15

19. An intra-vaginal device for the collection of menstrual flow comprising an inlet, a collection chamber, an outlet and a telescopic conduit defining a flow passage between the inlet and the outlet.

20. An intra-vaginal device according to Claim 19 in which the telescopic conduit is operable to be extended to outside the vagina, and retracted to inside the vagina, in use.

21. An intra-vaginal device according to any of claims 1 to 18 and Claim 19 or Claim 20.

22. An intra-vaginal device according to any of claims 19 to 21 in which the telescopic conduit comprises a first, proximal, section and a second, distal, section.

23. An intra-vaginal device according to Claim 22 comprising a pump disposed adjacent the outlet

24. An intra-vaginal device according to any of claims 21 to 23 in which the outlet is provided on the second section, and the inlet is provided on the first section.

25. An intra-vaginal device according to any of claims 21 to 24 in which the inlet is disposed in a storage container depending from the collection chamber.

26. An intra-vaginal device substantially as hereinbefore described and as shown in the accompanying drawings.

27. An applicator for inserting an intra-vaginal device according to any preceding claim into the vagina comprising surfaces operable to interconnect with corresponding surfaces on the device. - 16

28. An applicator for inserting an intra-vaginal device comprising an elongate member connected to a clamp.

29. An applicator according to Claim 28 in which the clamp is operated by the elongate member.

30. An applicator according to Claim 28 or Claim 29 comprising first and second portions which may be hinged together.

31. An applicator according to Claim 30 in which a first arm of the clamp depends from a first portion of the elongate member and a second arm of the clamp depends from a second portion of the elongate member.

32. An applicator according to any of claims 28 to 31 in which clamping surfaces, conveniently being facing surfaces, comprise a series of generally parallel raised projections.

33. An applicator for an intra-vaginal device, the applicator being substantially as hereinbefore described and as shown in the accompanying drawings.

34. A kit of parts comprising an intra-vaginal device according to any of claims to 27 and an applicator according to any of claims 28 to 33.