WO1998052511A1

WO1998052511A1 - Nipple eversion device

Info

Publication number: WO1998052511A1
Application number: PCT/GB1998/001427
Authority: WO
Inventors: Hagop Samuel Manushakian
Original assignee: University College London
Priority date: 1997-05-21
Filing date: 1998-05-18
Publication date: 1998-11-26
Also published as: GB9710492D0; GB2325411A; AU7442598A

Abstract

A nipple eversion device operating by suction on an inverted nipple has an adhesive flange or ring conformable to the areola to provide a seal. In one embodiment, suction is provided by a piston moveable within the device. Movement of the piston is controlled by a screw threaded cap engaging an external thread of the piston.

Description

NIPPLE EVERSION DEVICE

This invention relates to a nipple eversion device for the correction of inverted nipples. Inverted nipples is a disorder that affects many women and is due to short lactiferous ducts preventing projection of the nipple. For many years, surgery provided the only treatment for this condition which, although alleviating the problem, caused irreparable damage to the breast. This has lead to the emergence of non- surgical suction devices for the correction of inverted nipples that can be used by the patient outside hospital.

One such particularly effective device is that disclosed in our published PCT application number WO96/29043, the entire disclosure of which is incorporated in this specification by reference. In the embodiments discussed in that specification, a partial vacuum is created within the device by relative movement between the piston head and cylinder of the device. Whilst very effective at creating a vacuum, the vacuum is not adjustable, in some cases resulting in excessive suction being applied to the nipple. This can cause discomfort for the user. The present invention at least in preferred embodiments thereof offers a solution to this problem.

In one aspect the present invention provides a nipple eversion device comprising a container having an end adapted to fit over the nipple and to form a seal with the nipple and/or the areola, and means for creating a partial vacuum to draw the nipple into the container, said means being rotatably carried by the container such that rotation of said means creates the partial vacuum.

The rotatable means may be mounted on the outside of the container. There may be a piston axially moveable in the container, the rotatable means being connected to the piston such that rotation thereof causes axial movement of the piston to create the partial vacuum.

The rotatable means may be connected to the piston via a screw-thread. There may be means for preventing rotation of the piston relative to the container.

With all of the devices discussed in WO96/29043, it has been found that in cases of acutely inverted nipples there is a tendency for the seal between the device and the breast to fail leading to the ingress of air. The device then becomes dislodged. The present invention at least in preferred embodiments thereof offers a solution to this problem.

According to preferred embodiments of the present invention, there may be an adhesive surface around the periphery of the end of the container adapted to form a seal with the areola.

Thus, in another aspect, the present invention provides a nipple eversion device comprising a container having an end adapted to fit over the nipple, means for creating a partial vacuum in the container, and an adhesive surface around the periphery of the end of the container adapted to form a seal with the areola.

The adhesive surface may be on a sealing member of flexible and/or resilient material.

The sealing member may be detachable from the container; it may be adhesively attached thereto, or it may be mechanically connected to the container, for example, by a foundation ring. Alternatively it may have a base which is expandable to fit over and grip the end of the container.

The sealing member may be a flange extending outwardly from the end of the container.

Alternatively it may be a ring extending around the end of the container. There may be a detachable sealing member around the periphery of the end of the container adapted to bear against the areola.

Thus, in another aspect the invention provides a nipple eversion device comprising a container having an end adapted to fit over the nipple, means for creating a partial vacuum in the container, and a detachable sealing member around the periphery of the end of the container adapted to bear against the areola.

The invention also provides a sealing member configured for attachment to and for use with a nipple eversion device as set forth above.

The device or the sealing member may comprise a flexible diaphragm or sheath disposed or adapted to be disposed across the end of the container so that in use it is drawn into the container and provides a barrier between the nipple and the interior of the container.

Thus, in a yet further aspect the invention provides a nipple eversion device comprising a rigid container having an end adapted to fit over the nipple and to form a seal with the nipple and/or the areola, and a flexible diaphragm or sheath across said end and adapted to be drawn into the container and thereby to apply suction to the nipple. The invention will now be described merely by way of example with reference to the accompanying drawings wherein:

Figure 1 shows a nipple eversion device as described in our published application number WO96/29043 modified in accordance with the present invention; Figures 2 and 3 show respectively further embodiments of the invention; Figure 4 shows another embodiment; and

Figure 5 is a scrap section on line 5-5 of figure 4.

Referring to figure 1, save as hereinafter described the device is as disclosed in figure 1 of our earlier application. The reference numbers are as used in that application to which the reader is referred for full details. It will be understood that the present invention may be applied to all embodiments described in that application.

The device differs from that of the earlier device in that the frusto-conical flared open end of that device is replaced by a resilient flexible conical flange 100 which has an adhesive lower surface 102. The flange is formed of medical grade non-allergenic silicone rubber and the adhesive is of a similarly medically-approved and non-allergenic composition. For example it may be an adhesive such as is conventionally used for adhesive wound dressings.

The flange is extended axially of itself as a tubular portion 104 which is expanded to fit over the end 106 of the cylindrical container portion 12. Whilst the elasticity of the rubber is usually sufficient to form an air-tight seal between the tube 104 and the cylinder 12, if preferred the adhesive coating may be extended to the base of the tube so that it is firmly attached to the cylinder.

The device is supplied with a releasable cover strip adherent to the adhesive surface of the flange to protect the adhesive, similar to the protective covering used on adhesive dressings. When required for use, the cover strip is removed, the piston 14 is depressed in preparation for creation of a partial vacuum as described in our earlier application and the flange applied to the areola surrounding the nipple proper. The resilience and flexibility of the flange material is such that it can be deformed into close contact with the areola and to adhere thereto, forming an air-tight seal. The piston 14 is then released, creating a partial vacuum. Preferably the stiffness of the flange material is no greater than that of the tissue to which it is attached. Because of the need to adjust the seal into good contact with the areola, it is expected that the embodiments of figures 3 to 5 of our earlier application may prove easier to use when modified with an adhesive flange as described above, because the piston does not have to be held down against spring force whilst fitting the device. Figure 2 shows an alternative embodiment of the invention. In this embodiment the resilient flexible flange 100 is attached to an annular foundation ring 110 which has an internally screw-threaded base. The end 116 of the container 12 has a matching external screw thread, so that the foundation ring may be screwed on to it. The base of the foundation ring has a shoulder 118 upon which is disposed an O-ring or other flexible gasket 120 which is trapped between the shoulder and the bottom 116 of the container 12 to prevent air leakage through the screw thread.

Another form of mechanical connection such as a simple bayonet fitting may be employed instead of the screw thread, provided that steps are taken to ensure that it is air-tight.

In both the figure 1 and figure 2 embodiments the adhesive flange may easily be replaced by detaching it from the container 12. Therefore, to permit repeated use of the main part of the device (container 12 and piston 14), the device is supplied with a member of spare flanges, and furthermore additional flanges may be packaged for supply separately from the main part of the device.

Use of the device on a severely inverted nipple enables suction to be applied to the nipple with a greatly reduced tendency for the device to become dislodged. When the nipple has become partially everted then it will tend to seal around the inner circumferential edge of the bore of the cylinder 12. The adhesive flange may then be replaced by a non-adhesive equivalent, since its function becomes one of stabilisation rather than sealing. In a further variant shown in figure 3, the detachable flange 100 may be provided with a flexible impermeable (air-tight) tubular diaphragm or sheath 122, preferably formed integrally therewith. The diaphragm or sheath is drawn into the container 12 when the partial vacuum is created and forms a protective barrier between nipple and the interior of the container. This may be found advantageous in connection with the embodiment of figures 2(a) and 2(b) of WO96/29043, where it is desirable to prevent contact between the nipple and the compression spring 50. In another variant of the invention, it is envisaged that instead of providing a flange around the base of the container 12 it may be sufficient merely to coat the end surface, and perhaps a short portion of the bore with adhesive. Alternatively the adhesive surface, whilst more than just the end of the container 12, need not be flange-like. It could be for example a compressible impermeable hollow rubber ring adhesively coated on its surface so to provide both a sealing effect and a capability of moulding itself to the surface of the areola more effectively than a flange. The ring may be detachably attached to the container by any of the methods described above, and for some indications, for example, partially inverted nipples need not be adhesively coated. Also, instead of being attached to the flange 100 or compressible ring, the sheath 122 may be moulded or otherwise adhered around the bottom edge of the container 12.

Figures 4 and 5 illustrate a further embodiment of the invention. The flange 100 is as already described with reference to figure 1 and will not be described again, it being understood that the variations described above may also be employed. This embodiment however has an alternative and particularly convenient arrangement for creating a partial vacuum to apply suction to the nipple.

The piston 14, instead of being moveable by a spring or ribbon as in WO96/29043, has a rear portion 123 slightly smaller in diameter than the piston head 126 so as to be freely moveable in the cylinder 12. The rear portion 123 has an external screw thread 124.

The upper portion of the cylinder 12 is provided with a hollow cap 128 with groove around its bottom edge which receives a lip 130 around the top of the cylinder

12. The lip 130 in a loose sliding fit in the groove so that the cap is rotatable relative to the cylinder 12 whilst being axially fixed relative thereto. The lowermost inner edge of the cap is relieved so that the cap can be snap-fitted on to the lip 130.

The cap 128 has an internally threaded bore 132, which engages the external thread 124 of the piston 14. The thread of the piston is interrupted by a longitudinally-extending groove 136 which engages a radially-inwardly extending projection 138 (figure 5) in the top edge of the cylinder 12. The piston 14 then is prevented from rotating, and can be moved axially towards and away from the open end of the cylinder 14 by rotation of the cap 128. In use, the cap 128 is rotated to move the piston to the lower (open) end of the cylinder. The device is applied to the nipple and sealed to the areola. The cap is rotated in the opposite direction to withdraw the piston, creating a partial vacuum and applying suction to the nipple. This embodiment permits the degree of suction to be adjusted easily simply by rotation of the cap; indeed the suction can be adjusted during use without removing the device from the nipple.

In a modification the top of the cap 128 may be removed and its length reduced so that it becomes a relatively shallow internally-threaded ring. The top of the rear piston portion 123 then projects through the ring as it is withdrawn and is domed or otherwise convexly-shaped similarly to the top of the cap 128 shown in figure 4. The overall length of the device is reduced compared to the figure 4 embodiment.

In another modification of the figure 4 embodiment the piston 123, 126 is in the form of a threaded plug which engages an internally threaded bore of the cylinder. The head 126 of the piston does not make air-tight contact with the bore, and is pivotally connected to the portion 123 so that the latter may rotate without rotating the head 126. A sheath or diaphragm such as in figure 3 is also fixed at its centre point in an air-tight manner (for example, adhesively) to the centre of the piston head 126. The rear portion 123 of the piston is shaped and accessible for the user to rotate it and thereby either advance or withdraw the piston head 126 in the cylinder 12. Withdrawal of the piston head into the cylinder 12 draws the diaphragm 122 with it, thereby creating a partial vacuum in the open end of the cylinder (now lined by the diaphragm) to apply suction to the nipple.

With this arrangement there is no need for an air-tight seal between the piston head 126 and the cylinder, and no tendency for the vacuum to be destroyed by air leaking past the piston head, which may occasionally happen with the other embodiments. The diaphragm also protects the nipple from contact with the screw threads. Non-rotation of the piston head 126 can be ensured by providing it with a projection similar to projection 138 but oppositely directed and which engages a corresponding groove in the internally-threaded cylinder wall.

In figure 5, the cylinder and piston head are illustrated as having substantially circular outer profiles. However, the outer profile of the cylinder and piston head may take any form, for example, an hexagonal or other polygonal form.

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.

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

Claims

1. A nipple eversion device comprising a container having an end adapted to fit over the nipple and to form a seal with the nipple and/or the areola, and means for creating a partial vacuum to draw the nipple into the container, said means being rotatably carried by the container such that rotation of said means creates the partial vacuum.

2. A device as claimed in claim 1 wherein the rotatable means is mounted on the outside of the container.

3. A device as claimed in claim 1 or 2 comprising a piston axially moveable in the container, the rotatable means being connected to the piston such that rotation thereof causes axial movement of the piston to create the partial vacuum.

4. A device as claimed in claim 3 wherein the rotatable means is connected to the piston via a screw-thread.

5. A device as claimed in claim 3 or 4 comprising means for preventing rotation of the piston relative to the container.

6. A device as claimed in any of claims 1 to 5 comprising an adhesive surface around the periphery of the end of the container adapted to form a seal with the areola.

7. A nipple eversion device comprising a container having an end adapted to fit over the nipple, means for creating a partial vacuum in the container, and an adhesive surface around the periphery of the end of the container adapted to form a seal with the areola.

8. A device as claimed in claim 6 or 7 wherein the adhesive surface is on a sealing member of flexible material.

9. A device as claimed in claim 6, 7 or 8 wherein the adhesive surface is on a sealing member of resilient material.

10. A device as claimed in claim 8 or 9 wherein the sealing member is detachable from the container.

11. A device as claimed in claim 8 or 9 wherein the sealing member is adhesively attached to the container.

12. A device as claimed in claim 10 wherein the sealing member is carried by a foundation ring mechanically connected to the container.

13. A device as claimed in any of claims 8 to 11 wherein the sealing member has a bore which is expandable to fit over and grip the end of the container.

14. A device as claimed in any of claims 8 to 13 wherein the sealing member is a flange extending outwardly from the end of the container.

15. A device as claimed in any of claims 8 to 13 wherein the sealing member is a ring extending around the end of the container.

16. A device as claimed in any of claims 1 to 5 comprising a detachable sealing member around the periphery of the end of the container adapted to bear against the areola.

17. A nipple eversion device comprising a container having an end adapted to fit over the nipple, means for creating a partial vacuum in the container, and a detachable sealing member around the periphery of the end of the container adapted to bear against the areola.

18. A device as claimed in claim 16 or 17 wherein the sealing member is a flange or a ring.

19. A device as claimed in claim 16, 17 or 18 wherein the sealing member is flexible and/or has an adhesive surface.

20. A sealing member configured for attachment to and for use with a nipple eversion device as claimed in any preceding claim.

21. A sealing member as claimed in claim 20, provided with an adhesive sealing surface.

22. A sealing member as claimed in claim 20 or 21 being a flange or a ring.

23. A device or a sealing member as claimed in any preceding claim, comprising a flexible diaphragm or sheath disposed or adapted to be disposed across the end of the container so that in use it is drawn into the container and provides a barrier between the nipple and the interior of the container.

24. A nipple eversion device comprising a rigid container having an end adapted to fit over the nipple and to form a seal with the nipple and/or the areola, and a flexible diaphragm or sheath across said end and adapted to be drawn into the container and thereby to apply suction to the nipple.

25. A nipple eversion device or a sealing member therefor substantially as herein described with reference to the accompanying drawings.