NIPPLE EVERSION DEVICE

Abstract: A nipple eversion device comprising a container having a first portion (12) with an open end shaped to be placed over the nipple areola complex and to form a seal therewith, a second portion (14) of the container moveable relative to the first portion to increase the volume of the container and create a partial vacuum therein, and means (32; 50; 80, 82) for locating said portions relative to each other and maintaining the increased volume whereby to evert the nipple by suction thereon.

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. GB 2 240 924 describes a nipple everter in which a container is placed over the periphery of the inverted nipple. In operation, the volume of the container is first decreased by collapsing the side walls of the container, expelling air form the container, and then allowed to increase back to its original size. This creates a partial vacuum in the container that draws the inverted nipple into the container. However. the volume of air expelled from the container, and so the size of the partial vacuum, is difficult for the user to control, and the bulky external form of the device does not facilitate the continuous use of the device by office workers and women who prefer thin clothing. GB 2 262 233 discloses a nipple eversion device that offers greater control over the magnitude of the partial vacuum. The device comprises a nipple mould that is held against the nipple areola complex of the breast. Air is drawn from the mould using a syringe connected to the wall of the mould. Although offering greater user control over the partial vacuum created in the mould, the device is again bulky and requires the use of an accessory to create the vacuum, which does not facilitate discreet use of the device It is also difficult for the user to draw air from the mould whilst maintaining an even pressure on the mould to ensure that the necessary vacuum seal is created between the mould and the breast It is an object of at least the preferred embodiments of the present invention to provide a nipple eversion device that is self-contained and does not require the use of a valve mechanism, syringe or any other accessory to create and sustain a controllable partial vacuum within the device It is a further object of the preferred forms of the present invention to provide a nipple eversion device that has a compact design and a more natural appearance, and which is economical in production Accordingly, the present invention provides in one aspect a nipple eversion device comprising a container having a first portion with an open end shaped to be placed over the nipple areola complex and to form a seal therewith, a second portion of the container moveable relative to the first portion to increase the volume of the container and create a partial vacuum therein, and means for locating said portions relative to each other and maintaining the increased volume whereby to evert the nipple by suction thereon Preferably, the first portion comprises a cylinder and the second portion comprises a piston disposed therein In one preferred embodiment, the locating means may comprise at least one resilient member disposed in said container and biassed so as to force said second portion into location with said first portion The at least one resilient member mav be disposed either between said open end and said second portion or between the end wall of said first portion opposite to said open end and said second portion. The bore of the first portion may be profiled such that one end of the resilient member contacts said bore, the other end of said resilient member contacting said second portion. Preferably, the at least one resilient member is a helical spring. The present invention provides in a second aspect a nipple eversion device comprising a container having a first portion with an open end shaped to be placed over the nipple areola complex and to form a seal therewith, a second portion of the container moveable relative to the first portion to increase the volume of the container and create a partial vacuum therein, and locating means on said portions engageable to locate said portions relative to each other and maintain the increased volume whereby to evert the nipple by suction thereon. The locating means may comprise a profiled peripheral part of the second portion and a conformingly-profiled part of a bore of the first portion. Preferably, one profiled part is convex in axial cross-section and the other is concave. By "axial cross- section" we mean a section in a plane containing the axis of the bore. An end wall of said first portion opposite to the open end may also be open and of reduced internal diameter to form the conformingly profiled part. The end wall of said first portion opposite to said open end may also be open to enable the second portion to be moved relative to the first portion by applying a force thereon. The end of the device remote from the open end of the first portion may be of generally convex shape. Thus preferentially wherein the first and second portion are located relative to each other, they form a continuous blended convex surface. The second portion of the container may include manually operable means for moving the second portion relative to the first portion, and which is configured so as not to project from the external shape of the device when in use, and which preferablv comprises a thread or ribbon for pulling the second portion of the container Preferably, the open end of the first portion of the container is of frusto-conical or other flared form so as to provide a tapering sealing surface Advantageously, the volume of the container when said portions are engaged is of the order of that of the everted nipple The invention will now be described merely by way of example with reference to the accompanying drawings in which - Figures 1(a) and 1(b) show cross-sections of the nipple eversion de ice according to a first embodiment of the present invention Figures 2(a) and 2(b) show cross-sections of the nipple eversion device according to a second embodiment of the present invention Figures 3(a) and 3(b) are a cross-section of the nipple eversion device according to a third embodiment of the present invention Figures 4(a) and 4(b) show first and second examples respectively of the locking mechanism of the third embodiment of the present invention Figure 5 shows a cross-section of the nipple eversion device according to a fourth embodiment of the present invention with the portions of the container in locked engagement Figure 1 shows a cross-section though the nipple eversion device according to a first embodiment of the present invention The device comprises a container having a first portion 12 and a second portion 14 The first portion forms a cylinder and the second portion a piston disposed therein The piston 14 is moveable relative to the cylinder 12 and has a grooved sealing surface 15 similar to that of the piston in a lOcc or 20cc syringe. The cylinder 12 is open at its bottom end 16. The end 16 is shaped, preferably in a frustro-conical shape or other flared form, so that it can be placed over the nipple areola complex, and to form a seal therewith. As shown in Figure 1. the top end 18 opposite to the end 16 has a rounded shoulder so as to be of a generally convex shape. and this end 18 is also open. The piston is formed with an upper portion 20, a first intermediate portion 22. discs 24. 26, a second intermediate portion 27 and a lower portion 28. The intermediate portions 22. 27 are preferably made from material with a hardness greater than that of the material of the discs 24, 26, and have a diameter which is less than that of the bore of the cylinder so that there is no frictional engagement between the outer periphery of the intermediate portions 22. 27 and the bore of the cylinder as the piston moves relative to the cylinder. In the embodiment shown in Figure 1, a piston ring 30 is disposed between the discs, although this ring may be replaced by an O-ring or such like. The outer surfaces of the end 18 of the cylinder and the domed upper portion 20 form a continuous blended convex surface. The container further includes means for locating the piston in a relativelv immovable position in the cylinder. In the embodiments of the invention shown in Figures 1 to 2, the locating means comprises at least one resilient member disposed in the container and biassed so as to force the piston into the relatively immovable position. In a first embodiment of the invention, shown in Figure 1 , a single such resilient member 32 is disposed between the top end 18 of the cylinder 12 and the piston 14. In this preferred embodiment, the resilient member is a helical tension spring. The external diameter of the spring is less than the maximum diameter of the bore of the cylinder, whilst the internal diameter of the spring is greater than the maximum external diameter of either the upper portion 20 or the intermediate portion 22 of the piston 14 so that the spring circumscribes these portions of the piston 14. As shown in Figure 1 , a groove or housing 34 may be provided on the lower surface of the shoulder 36 of the top end 18 of the cylinder to which the upper end of the resilient member 32 is attached. The lower end of the spring 32 abuts the upper surface of the intermediate portion 22 of the piston. The relaxed length of the spring 32 is chosen to be less than the length of the wall 38 of housing 34 of the cylinder. Therefore, as shown in Figure 1(b), with no manual force acting on the spring the spring is never fully relaxed and so the upper surface of first intermediate portion 22 is held in a relatively immovable engagement with the inner wall 38 of housing 34. The user may move the piston towards the open end of the cylinder against the force of the spring by pushing on the upper surface of the upper portion 20 of the piston, for example by using finger or thumb, thereby increasing the separation between the ends of the spring 32. as shown in Figure 1(a). The spring is chosen so that when the lower surface of the second intermediate portion 27 abuts the profiled bottom end 40 of the bore of the cylinder, the spring is not deformed beyond its elastic limit. When the manual force is removed, the spring relaxes, pulling the piston towards the open end 18 of the cylinder. In operation, the user pushes the piston down into the cylinder, decreasing the volume of the container. The end 16 forms a seal over the nipple areola complex and the manual force acting on the piston is released, whereby the spring pulls the piston towards the end 18 of the container, increasing the volume of the container This creates a partial vacuum in the container At the top of the cylinder the piston abuts the lower end ol the side wall 38 of the housing 34. whereby the force still being exerted by the spring on the piston acts to substantially lock the piston at the end of the cy linder This maintains the increased volume of the container, and so the partial v acuum therein so that with continued use ot the device the nipple is e erted and sucked into the container In a second embodiment of the present invention, shown in Figure 2. a single resilient member 50 is disposed between the open end 16 of the cylinder 12 and the piston 14 In this preferred embodiment, the resilient member is a helical compression spring Similar to the spring 32 used in the first embodiment, the external diameter of the spring is less than the maximum diameter of the bore of the cylinder whilst the internal diameter of the spring is greater than the maximum external diameter of the lower portion 28 of the piston 14 As shown in Figure 2, the lower end of the spring 50 is attached to the profiled bottom end. or shoulder. 40 of the open end 16 of the c linder Side walls, similar to side walls 38 in the first embodiment, may be prov ided on shoulders 40. to retain the end of the spring The upper end of the spring 50 abuts the lower surface of the second intermediate portion 27 of the piston The relaxed length of the spring 50 is chosen to be greater than the length of the c linder Therefore, as shown in Figure 2( b), with no manual force acting on the spring the spring is never fully relaxed and so the upper surface ot the first intermediate portion 22 is held in a relati ely immo able engagement with the lower surtace of the shoulder of the top end of the cv Under Operation of the device of the second embodiment of the present invention is similar to that of the first embodiment. The user pushes the piston down into the cylinder, decreasing the volume of the container as shown in Figure 2 (a). The end 16 forms a seal over the nipple areola complex and the manual force acting on the piston is released, whereby the spring pushes the piston towards the end 18 of the container, increasing the volume of the container. This creates a partial vacuum in the container. At the top of the cylinder the piston abuts the lower end of the side wall 38 of the housing 34. whereby the force still being exerted by the spring on the piston acts to substantially lock the piston at the end of the cylinder. This maintains the increased volume of the container, and so the partial vacuum therein, so that with continued use of the device the nipple is everted and sucked into the container. In each of the embodiments shown in Figures 1 and 2. the helical springs may be plastics-coated. If so desired, the first and second embodiments of the present invention may be combined, i.e. a first resilient member may be disposed between the top end 18 of the cylinder and the piston 14 and a second resilient member may be disposed between the open end 16 of the cylinder and the piston 14. One advantage of each of the above embodiments is that operation of the device may be performed using only a single hand: the container may be held comfortably in the hand to form the seal over the nipple areola complex and a finger or thumb of the same hand may be used to depress the piston. A third embodiment of the present invention is shown in Figure 3. In this embodiment, the piston may be locked in a relatively immovable position in the container bv locating means on the piston that engage with locating means on the cylinder. The locating means of the piston comprises a profiled peripheral part of the piston, and the locating means of the cylinder comprises a conformingly-profiled section. As shown in Figure 3(b). the profiled peripheral part of the piston is an outer rim 80 of the intermediate portion 22 of the piston. A section of the end 18 of the cylinder has a reduced internal diameter, and the bore of this section defines the conformingly profiled section 82 of the cylinder. Either the part 80 or the part 82 is convex in axial cross-section, the other part being concave. These alternatives are shown in expanded section in Figures 4(a) and 4(b). In a fourth embodiment of the invention, the profiled part of the piston is the periphery of the upper portion 20 of the piston, which is enlarged to have a domed shape as shown in Figure 5. In this embodiment, the convexity and width of the end 18 of the container is increased to define a concave portion 82 profiled to accommodate the profiled part of the piston. In the third and fourth embodiments of the present invention, the piston is pulled towards the end 18 of the cylinder using manually operable means 84. specifically a thread or ribbon 84 (best seen in Figure 3(b)). Being flexible, the thread 82 does not project from the external shape of the device. In operation, the end 16 forms a seal over the nipple areola complex and the piston is pulled towards the end 18 of the container, increasing the volume of the container. This creates a partial vacuum in the container. At the top of the cylinder the locating means on the piston engage with locating means on the cylinder to lock the piston at the end of the cylinder. This maintains the increased volume of the container, and so the partial vacuum therein, so that with continued use of the device the nipple is everted and sucked into the container. In the third embodiment, as the disc is pulled towards the end 18 of the container, the upper portion 20 passes through the end 18 of the casing without coming into contact with the profiled part 82 of the cylinder. As the rim 80 engages the profiled part 82 of the cylinder, the edges of profiled part 82 are deformed by the rim until the two parts register with each other, as shown in Figures 3(b) and 4. Operation of this device is a simple two-handed operation; the container is placed on the breast using one hand to form the seal over the nipple areola complex and. holding the ribbon 84 between thumb and forefinger of the other hand the piston is pulled towards the end 18 of the container. The extent of the profiling of the parts 80,82 is exaggerated in the drawings: the profiling need be sufficient only to locate the piston against the pressure differential across it. Excessive profiling would make it difficult to move the parts 80.82 into registry with each other, and also subsequently to disengage them In each embodiment, the overall size of the device is chosen so that, with the cylinder and piston engaged, the dimensions and volume of the container is of the order of that of the everted nipple. The small size of the device offers a substantial improvement over prior art nipple eversion devices in that the device mav be continuously and relatively inconspicuously worn. Moreover, the shape of the dev ice has a smooth and natural-looking external appearance, to the advantage of women who prefer thin clothing. In each embodiment of the present invention, the container is detached from the nipple areola complex by pressing on the piston to allow air to enter the container, thereby removing the partial vacuum and allowing the container to be easily removed. The device permits the user is able to accurately control the size of the partial vacuum created in the container. The size of the partial vacuum required to evert the nipple will vary between users. If too great a vacuum is created, the user may suffer discomfort during operation and the nipple may be damaged. Conversely, if the vacuum is too small, insufficient eversion of the nipple may occur. In the present invention, the magnitude of the partial vacuum created in the container is controlled by the initial position of the piston in the cylinder prior to sealing the device around the nipple areola complex. For example, if the piston initially lies at the bottom end 16 of the cylinder, the increase in the volume of the container during operation is a maximum. A maximum partial vacuum, or maximum negative pressure, is created in the container. Alternatively, if the piston initially lies midway between the ends 16 and 18 of the cylinder, an intermediate negative pressure will act on the nipple. To facilitate accurate initial positioning of the piston prior to sealing the device around the nipple areola complex, the cylinder is made from a transparent plastic material and has graduated linear markings formed on its external surface, similar to the markings on the barrel of a syringe. These markings can act as reference points for the positioning of the piston by the user prior to sealing the device around the nipple and for prescribing purposes. There is thus no requirement for a valve, syringe or any other accessory to create the partial vacuum in the device. The ease of operation of the device is greatly enhanced over prior art nipple eversion devices. The compact design of the nipple eversion device of the present invention not only makes the device more practical for continuous daytime use by the user but also makes the device economical to produce. 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. A nipple eversion device comprising a container having a first portion (12) with an open end shaped to be placed over the nipple areola complex and to form a seal therewith, a second portion ( 14) of the container moveable relative to the first portion to increase the volume of the container and create a partial vacuum therein. and means (32: 50; 80.82) for locating said portions relative to each other and maintaining the increased volume whereby to evert the nipple by suction thereon.

Claims: CLAIMS 1. A nipple eversion device comprising a container having a first portion with an open end shaped to be placed over the nipple areola complex and to form a seal therewith, a second portion of the container moveable relative to the first portion to increase the volume of the container and create a partial vacuum therein, and means for locating said portions relative to each other and maintaining the increased volume whereby to evert the nipple by suction thereon. 2. A nipple eversion device as claimed in Claim 1. wherein said first portion comprises a cylinder and the second portion comprises a piston disposed therein. 3. A nipple eversion device as claimed in Claim 1 or Claim 2. wherein said locating means comprises at least one resilient member disposed in said container and biassed so as to force said second portion into location with said first portion. 4. A nipple eversion device as claimed in Claim 3, wherein said at least one resilient member is disposed between said open end and said second portion. 5. A nipple eversion device as claimed in Claim 3. wherein said at least one resilient member is disposed between the end wall of said first portion opposite to said open end and said second portion. 6. A nipple eversion device as claimed in any one of Claims 3 to 5. wherein the bore of said first portion is profiled such that one end of the resilient member contacts said bore, the other end of said resilient member contacting said second portion. 7. A nipple eversion device as claimed in any one of Claims 3 to 6. wherein said at least one resilient member is a helical spring. 8. A nipple eversion device comprising a container having a first portion with an open end shaped to be placed over the nipple areola complex and to form a seal therewith, a second portion of the container moveable relative to the first portion to increase the volume of the container and create a partial vacuum therein, and locating means on said portions engageable to locate said portions relative to each other and maintain the increased volume whereby to evert the nipple by suction thereon. 9. A nipple eversion device as claimed in Claim 8, wherein said locating means comprise a profiled peripheral part of the second portion and a conformingly-profiled part of a bore of the first portion. 10. A nipple eversion device as claimed in Claim 9. wherein one said profiled part is convex in axial cross-section and the other is concave. 11. A nipple eversion device as claimed in any one of the preceding claims, wherein the end wall of said first portion opposite to said open end is also open to enable the second portion to be moved relative to the first portion by applying a force thereon. 12. A nipple eversion device as claimed in any one of Claims 9 to 1 1. wherein an end wall of said first portion opposite to said open end is also open and is of reduced internal diameter and forms the conformingly profiled part. 13. A nipple eversion device as claimed in any preceding claim, wherein said second portion of the container includes manually operable means for moving the second portion relative to the first portion, and which is configured so as not to project from the external shape of the device when in use. 14. A nipple eversion device as claimed in Claim 13, wherein said manually- operable means comprises a thread or ribbon for pulling the second portion of the container. 15. A nipple eversion device as claimed in any preceding claim, wherein the end of the device remote from the open end of the first portion is of generally convex shape. 16. A nipple eversion device as claimed in Claim 15. wherein when the first and second portions are located relative to each other, they form a continuous blended convex surface. 17. A nipple eversion device as claimed in any preceding claim, wherein the open end of the first portion of the container is frustro-conical or other flared form so as to provide a tapering sealing surface.

Inventors: MANUSHAKIAN HAGOP SAMUEL, MANUSHAKIAN, HAGOP, SAMUEL
Applicants: MANUSHAKIAN HAGOP SAMUEL, UNIV LONDON, MANUSHAKIAN, HAGOP, SAMUEL, UNIVERSITY COLLEGE LONDON
Application year: 1996
Main classification: A61H9
IPC codes: A61H9, A61M1