GB2425260A

GB2425260A - Intra-vaginal catamenial device with outlet

Info

Publication number: GB2425260A
Application number: GB0508010A
Authority: GB
Inventors: Christopher David Potter
Original assignee: KEA FLEX MOULDINGS Ltd
Current assignee: KEA FLEX MOULDINGS Ltd
Priority date: 2005-04-20
Filing date: 2005-04-20
Publication date: 2006-10-25
Also published as: GB0508010D0

Abstract

An intra-vaginal catamenial device 10 comprises an inlet 16, an outlet 26 and a collection chamber 12, in which the outlet is moveable in relation to the inlet to outside the vagina for the expression of menstrual fluid. A method of expressing menstrual fluid is also disclosed, comprising pooling fluid within the vagina, moving a fluid outlet 26 from a position within the vagina (Fig. 2a) to a position outside the vagina (Fig. 2b), and actuating flow of the fluid from inside to outside.

Description

Intra-vaginal Device This application relates to intra-vaginal devices.

In particular, although not exclusively, this application relates to intra-vaginal catamenial devices, especially devices for the collection and controlled expression of menstrual flow.

There are two types of intra-vaginal catamenial device which are widely used: the tampon and the menstrual cup. Tampons absorb menstrual flow and are disposable generally being used at an average rate of around three or four per day. Tampons are relatively easy to insert and withdraw, but expensive and associated with side effects, some of which, for example toxic shock syndrome, can be life threatening. Additionally, it can be difficult for a woman to judge her flow correctly day-to-day and buy a size of tampon that will both provide sufficient absorption without leakage and not be so absorbent as to dry out the vagina.

Menstrual cups are reusable or disposable devices which are placed in the vagina and collect menstrual flow. They are changed by the user as necessary, fluid which has collected in the device is disposed of, and the device itself may be disposed of or cleaned and re-inserted. Menstrual cups are more cost effective than tampons over a number of periods, but as they are relatively difficult to insert and position correctly, and because of a risk of spillage on withdrawal, they have not been as widely used.

According to this invention there is provided an intra-vaginal device comprising a collection chamber and an outlet in which the outlet is moveable in relation to the collection chamber to outside the vagina for the expression of menstrual fluid.

Preferably the device comprises an outlet conduit comprising an inlet and the outlet, the conduit inlet being moveable between a collection position for collecting fluid within the chamber in which the inlet is retracted into a relatively proximal position in the chamber, and an expression position for expressing fluid through the conduit in which the inlet is relatwely distal in the chamber.

Preferably the device comprises an outlet conduit comprising an inlet and the outlet, the conduit inlet being moveable between a collection position for collecting fluid within the chamber in which the inlet is not in fluid communication with fluid in the chamber, and an expression position in which the inlet is in fluid communication with fluid in the chamber for expressing fluid through the conduit.

The conduit may be moveable in relation to the collection chamber. Preferably the conduit is slideable in the collection chamber.

Menstrual fluid may be expressed by gravity.

The device may comprise a pump for the expression of menstrual fluid. The pump may be moveable from a collection position in which fluid in the collection chamber is in fluid communication with the vagina and a pumping position in which there is no such fluid communication.

Preferably the pump is so arranged that in the collection position there is no fluid communication between the collection chamber and the outlet, and in the pumping position there is fluid communication between the collection chamber and the outlet.

The pump may be a suction pump. The pump may comprise a piston member.

The collection chamber may form a cylinder. The piston member may comprise a stop for limiting stroke length.

The pump may comprise a pump member which provides a conduit from the collection chamber to the outlet. The pump member may be moveable from a first position in which an inlet to the pump member opens into the collection chamber to a second position in which the outlet may be outside the vagina.

Preferably there is no fluid communication between the outlet and the collection chamber when the pump member is in the first position. There may be no fluid communication between the inlet to the pump member and the collection chamber in the second position.

The inlet to the pump member may comprise an elongate slot.

The device may comprise a stop member to limit movement of the outlet.

An inlet to the collection chamber may comprise a resilient ring operable to secure the device to a vaginal wall.

The device may comprise a valve at the outlet. The device may comprise an actuator useable to move the outlet. The inlet and outlet may be joined by a telescopic conduit. The outer portion of the device may intermittently abut a wall of the vagina. The outer portion may comprise a resilient ring having a plurality of indentations.

According to the second aspect of the invention a method of expressing menstrual fluid comprising pooling the fluid within the vagina, and moving a fluid outlet from a position within the vagina to a position outside the vagina to establish a flow path from the pooled fluid in the vagina and actuating the flow -4- H output for the expression of fluid.

The method may comprise expressing the pooled fluid by pumping.

The method may comprise opening a valve for expression of fluid and closing the valve to prevent leakage.

The method of expressing menstrual fluid described herein above.

Embodiments of this invention will now be described, by way of example only, with reference to the accompanying drawings in which: Figure 1 shows schematically perspective views of an intra-vaginal device showing some hidden detail: Figure Ia shows schematically a perspective view of the assembled cup; Figure 1 b shows schematically a perspective view of a piston; and Figure Ic shows schematically a perspective view of a cap; Figure 2 shows schematically a cross-sectional view of the device of Figure 1 demonstrating how it would be used: Figure 2a shows schematically part of the cup in a collecting position; and Figure 2b shows schematically part of the cup in an expressing position; Figure 3 shows schematically perspective views of an alternative embodiment of an intra-vaginal device showing some hidden detail: Figure 3a shows schematically a perspective view of a device as assembled; Figure 3b shows schematically a perspective view of an outlet conduit; and Figure 3c shows schematically a perspective view of a cap; Figure 4 shows schematically a cross-sectional view of the device of Figure 2 demonstrating how it would be used: Figure 4a shows schematically part of the cup in a collecting position; and Figure 4b shows schematically part of the cup in an expressing position.

Figure 1 shows schematically perspective views of an intra-vaginal device, drainable menstrual cup 10 comprising a collection chamber 12 and a piston 14.

The collection chamber 12 comprises an inlet 16 leading to a proximal frustro- conical portion 18 and a distal cylindrical portion 20. The piston 14 comprises a hollow elongate member or barrel 22 having a disc-shaped head 24 at its proximal end and an outlet 26 at its distal end. The piston 14 is arranged concentrically within the collection chamber 12, in a tube 28 formed by the walls of the collection chamber 12.

The piston 14 can move along a proximal-distal axis A-A in relation to the collection chamber 12 to increase or decrease the length of conduit between the inlet 16 of the collection chamber and the outlet 26 of the piston. The stroke length of the piston 14 is defined by the head 24 at its proximal end and a stop which is disposed at substantially the opposite end of the piston from the head 24.

When the piston 14 is moved proximally, so that the stop 30 abuts the outside surface of the distal wall of the collection chamber, as shown in Figure 2a, the cup 10 is arranged to collect menstrual fluids. The diameter of the head 24 is less than the diameter of the tube 28 in the frustroconical portion 18 of the cup 10, so menstrual fluid flows past the head 24 into the cylindrical portion 20 of the cup. The flow into the cylindrical portion is assisted by the curved proximal surface of the head and the steepness of the frustro-cone. Whilst the cup is in its collecting position fluid slowly accumulates, pooling in the cylindrical portion and filling the frusto- conical portion if necessary.

To empty the fluid the piston 14 is moved in a distal direction, as shown in Figure 2b. As an elongate slot 32 in the barrel 22 of the piston 14 reaches the pooled fluid, fluid flows through the slot into the hollow barrel 22, and collects in the base of the piston.

When the head reaches the cylindrical tube, as the outside diameter of the head is substantially the same as the inner diameter of the tube 28, the cylindrical portion of the collection chamber becomes a sealed chamber and the piston acts as a pump. Continued distal motion of the piston forces fluid from the collection chamber to the piston.

The device is positioned in the vagina so that before the piston is full of fluid its distal tip 34 reaches the opening of the vagina. The distal tip 34 of the piston comprises the outlet 26, an area arranged as a finger and thumb grip 36 and a cap 38 which may be fitted over the outlet to close it. Alternatively the grip 36 may be of resilient material and include a slit which the user pinches to open the valve thus formed.

As the distal tip is withdrawn from the vagina, the user removes the cap 38, and menstrual fluid is free to flow out of the piston through the outlet. The user may pull the piston distally until the head abuts the internal surface of the distal wall of the collection chamber, expelling substantially all the fluid in the collection chamber. The cup is then in its expression position.

Fluid remaining in the piston may be expelled either by gravity, by shaking it out, or by moving the piston proximally until its distal tip is once more inside the vagina. The user then replaces the cap and moves the piston proximally into its collection position.

The piston 14 is secured in the collection position by friction between the inner walls of the cylindrical portion 20 and a thickened portion 40 of the piston above the stop 30, where the piston 14 abuts the distal wall of the collection chamber in the collection position.

Movement of the piston does not create a vacuum in the area proximal to the cup because a plurality of indentations around the inlet provide passages for air.

The inlet comprises a resilient ring which contains these plurality of indentations.

When the user inserts the collection chamber the ring springs outwards to bear against the vaginal wall, and the indentations allow for the passage of air.

The device is designed to remain in the user's vagina through her entire period, if so desired. Such a device gives women freedom to decide when and how often they wish to empty or remove the device It may be withdrawn using the piston.

The device may be inserted as present typical menstrual caps, being folded twice for insertion. Once inside the body the resilient inlet ring 16 springs outwardly as described above. To withdraw the device the user moves the piston into the expression position and then uses the piston to pull the device gently out of the vagina.

After use, the user may take the device apart for easier cleaning and storage.

To do this, the stop 30, which comprises an outwardly flaring lip, is pressed against the barrel of the piston. The piston may then be pushed in a proximal direction through the base of the collection chamber. As the base is made of resilient material the piston can be removed, and replaced with no loss of sealing. The device can be cleaned and steralised in the microwave, or the dishwasher or by boiling.

In alternative embodiments different types of pump could be used. For example, a small suction pump could be disposed on a telescopic tube having an inlet in the collection chamber and an outlet which is movable to outside the vagina.

Such a pump could be used to express fluid.

Figures 3a to 3c show schematically a further embodiment of an intravaginal device 50, a cup which drains via gravity. The cup 50 comprises a collection chamber 52 and an outlet conduit 54 which is moveable in relation to the collection chamber, being slideable along a proximaldistal axis B-B. The collection chamber 52 is shaped as an inverse bell, having a wide inlet 56 at its proximal end, and a holder 58 at its base. The collection chamber 52 is made from resilient material. The wide, resilient inlet 56 is flattened when inserting the cup and springs outwards in use to secure the cup against vaginal wall. In use, the cup may sit relatively low or high in the vagina.

The outlet conduit 54 comprises a hollow tube having a disc 60 and an inlet valve element comprising a hole 62 at its proximal end and an outlet 64, a valve 66, and a grip 68 at its distal end. A stop ring 70 towards the distal end prevents the distal end of the outlet conduit 54 moving to such a proximal position that it is within the collection chamber 52.

During a user's period the conduit 54 is moved to a collection position, shown in Figure 4a and menses flow into the cup, and collect or pool at its base. When it is convenient for the user to express the fluid, she grasps the grip and pulls the outlet conduit in a distal direction, as shown in Figure 4b until its distal tip is outside the vagina. It is advisable to pull the outlet conduit down in the holder until the disc abuts the holder to ensure that any fluid pooled at the base of the chamber can drain into the conduit. The holder 58 comprises a hole 72 sited as near as practically possible to the base of the, collection chamber 52 and when the inlet valve element 62 is in registration with this hole, the fluid flow is unobstructed and substantially all fluid pooled in the cup may drain. The user removes the cap from the outlet and fluid may then flow under the influence of gravity from the base of the collection chamber, through the outlet conduit to a suitable disposal area, for example, a toilet.

In an alternate embodiment there may be no holder and the disc may be resilient to give a final push to fluid as its outer periphery deforms as the piston is pulled to its distal limit, and the disc abuts the base of the collection chamber.

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 is provided comprising an inlet, an outlet and a collection chamber in which the outlet is moveable in relation to the inlet to outside the vagina for the expression of menstrual fluid. A method of expressing menstrual fluid is provided comprising pooling the fluid within the vagina, moving a fluid -10-.

outlet from a position within the vagina to a position outside the vagina to establish a flow path from the pooled fluid in the vagina to express pooled fluid.

Claims

1. An intra-vaginal device comprising a collection chamber and an outlet in which the outlet is moveable in relation to the collection chamber to outside the vagina for the expression of menstrual fluid.

2. An intra-vaginal device according Claim I comprising an outlet conduit comprising an inlet and the outlet, the conduit inlet being moveable between a collection position for collecting fluid within the chamber in which the inlet is retracted into a relatively proximal position in the chamber, and an expression position for expressing fluid through the conduit in which the inlet is relatively distal in the chamber.

3. An intra-vaginal device according to Claim 2 in which the conduit is moveable in relation to the collection chamber.

4. An intra-vaginal device according to Claim 3 in which the conduit is slideable in the collection chamber.

5. An intra-vaginal device according to any of claims I to 4 in which menstrual fluid is expressed by gravity.

6. An intra-vaginal device according to any of claims 1 to 5 comprising a pump for the expression of menstrual fluid.

7. An intra-vaginal device according to Claim 6 in which the pump is moveable from a collection position in which fluid in the collection chamber is in fluid communication with the vagina and a pumping position in which there is no 12.

such fluid communication.

8. An intra-vaginal device according to Claim 7 in which when the pump is so arranged that in the collection position there is no fluid communication between the collection chamber and the outlet, and in the pumping position there is fluid communication between the collection chamber and the outlet.

9. An intra-vaginal device according to any of claims 6 to 8 in which the pump is a suction pump.

10. An intra-vaginal device according to any of claims 6 to 9 in which the pump comprises a piston member.

11. An intra-vaginal device according to Claim 10 in which the collection chamber forms a cylinder.

12. An intra-vaginal device according to Claim 10 or Claim 11 in which the piston member comprises a stop for limiting stroke length.

13. An intra-vaginal device according to any of claims 6 to 12 in which the pump comprises a pump member which provides a conduit from the collection chamber to the outlet.

14. An intra-vaginal device according to Claim 13 in which the pump member is moveable from a first position in which an inlet to the pump member opens into the collection chamber to a second position in which the outlet is outside the vagina.

15. An intra-vaginal device according to Claim 14 in which there is no fluid communication between the outlet and the collection chamber when the pump member is in the first position.

16. An intra-vaginal device according to Claim 14 or Claim 15 in which there is no fluid communication between the inlet to the pump member and the collection chamber in the second position.

17. An intra-vaginal device according to any of claims 14 to 16 in which the inlet to the pump. member comprises an elongate slot.

18. An intra-vaginal device according to any preceding claim comprising a stop member to limit movement of the outlet.

19. An intra-vaginal device according to any preceding claim in which the inlet comprises a resilient ring operable to secure the device to a vaginal wall.

20. An intra-vaginal device according to any preceding claim comprising a valve at the outlet.

21. An intra-vaginal device according to any preceding claim comprising an actuator useable to move the outlet.

22. An intra-vaginal device according to any preceding claim in which the inlet and outlet are joined by a telescopic conduit.

23. An intra-vaginal device according to any preceding claim in which an outer portion of the device intermittently abuts a wall of the vagina.

24. An intra-vaginal device according to Claim 17 in which the outer portion comprises a resilient ring having a plurality of indentations.

25. An intra-vaginal device substantially as described herein and as shown in the accompanying drawings.

26. A method of expressing menstrual flow comprising pooling the fluid within the vagina, and moving a flow outlet from a position within the vagina to a position outside the vagina to establish a flow path from the pooled fluid in the vagina and actuating the flow output for expression of fluid.

27. A method according to Claim 26 comprising expressing the pooled fluid by pumping.

28. A method according to Claim 26 or Claim 27 comprising opening a valve for expression of fluid and closing the valve to prevent leakage.

29. A method of expressing menstrual fluid substantially as described herein.