WO2006047421A2

WO2006047421A2 - Reusable breast shield

Info

Publication number: WO2006047421A2
Application number: PCT/US2005/038191
Authority: WO
Inventors: Charles J. Pawloski
Original assignee: Pawloski Charles J
Priority date: 2004-10-22
Filing date: 2005-10-24
Publication date: 2006-05-04
Also published as: AU2005225137A1; EP1802207A2; EP1802207A4; WO2006047421A3; US20060089082A1

Abstract

A reusable, washable breast shield for use by lactating women. The shield comprises a plurality of laminated silicone compound membranes; the outer laminate of a generally higher durometer than the inner laminate. The shield is placed against the breast of the user and may be held in place with an article of clothing or may be used without supporting clothing. The shield may also be incorporated into an article of clothing. The shields thin and translucent and is relatively unnoticeable under clothing. The shield may be manufactured in decorative shapes and colors.

Description

REUSABLE BREAST SHIELD

BACKGROUND OF THE INVENTION

The present invention relates to an apparatus for controlling leakage of Iactating fluid in human females. Specifically, this invention is a thin, multi- layered silicone compound based membrane that conforms to the shape of the breast and provides pressure against the nipple.

Description of the Related Art The related art is described in PCT Patent Application US2002/018976 which is hereby incorporated in its entirety by reference.

SUMMARY OF THE I NVENTION

The present invention is a device for controlling breast milk leakage in Iactating human females. It is known that pressure to the nipple will prevent leakage, and this device operates by maintaining pressure on the nipple. The device is self contained in that it does not need the support of an ancillary garment such as a bra to hold it in place or provide the pressure necessary to prevent let-down. The device comprises a thin, flexible and breathable, liquid impervious, multi-layered shield that conforms to the shape of a human breast and is self adhesive. The device can be used in conjunction with a bra to assist in shaping the shield and providing additional pressure against the nipple of the user. However, the device is designed to maintain the necessary pressure on the nipple so that it does not require the use of ancillary clothing to perform it's function.

The shield comprises a plurality of silicon rubber compound layers laminated together. In general the layers are formed and cured independently of each other. There is no cross linking or merging of the separate layers. Generally, the innermost layer is formed and cured first. Subsequent layers are added on top of the innermost layer and then cured. In a preferred embodiment, the outermost layer is a silicon compound with a higher durometer than the inner layer. The outer layer provides rigidity and shape to the shield, and supports the layer or layers of low durometer compound. The silicon compounds are sufficiently stretchy in any direction so that a moderate pressure forces the present invention to conform to the shape of a human breast. Silicon has been chosen as the preferred material for an application of the invention that a user would have on the skin for extended periods of time. Silicon compounds have an inherent breathability or gas permeability which prevents irritation of the skin of the wearer. The present invention may also be made of other materials such as polymer gels. Although polymer gels do not have the gas permeability of silicon compounds, polymer gels would be suitable for applications such as use in fashion where the invention would not be worn for long periods of time.

The present invention has a low durometer silicon compound that forms the innermost layer next to the skin. Generally, a silicon compound known in the art as a silicon gel is used for the innermost surface. The inherent adhesive properties of a silicon gel provide a tacky inner surface. The tackiness of the gel allows it to remain in position without the use of adhesives or having to be attached to an ancillary garment such as a. bra. The tackiness of the gel in conjunction with the moderate stiffness of the outer layer or layers provides a device that stays in place on the breast, and imparts pressure to the nipple, preventing let down.

In a preferred embodiment, the present invention is pre-formed to present an elliptical surface in cross section, enabling it to conform to the shape of a human breast. In other embodiments it is anticipated that the invention could pre-formed as to more closely match the shape of a particular breast. The adhesive properties of the silicon gel material allow the shield to keep pressure on the depressed nipple and depress the nipple of the wearer. The pressure on the nipple is an effect inherent in the shield because of its shape and its adhesive qualities. The shield material is sufficiently translucent as to be almost invisible underneath clothing. The thickness of the shield is such that virtually no additional bulk is added to the breast profile of th e wearer.

Three embodiments of the invention a re presented herein: All three designs have the same basic structure: A design comprising an outer frame laminated to an inner membrane wherein the inner membrane is a silicon rubber compound sufficiently low in durometer to allow adherence to the skin, the outer frame providing support and shape for the device. This basic structure and design is the subject of PCT Patent Application US2002/018976 which is hereby incorporated by reference. The first embodiment includes an inwardly protruding dimple situated to press against the human nipple. The second embodiment includes an area of stiffer silicon rubber situated in the inner shield to press against the human nipple. The third embodiment includes a thicker section of the outer shield situated to press against the human nipple, while maintaining continuity of the inner shield. The present invention is also directed toward a method of controlling leakage that utilizes the shield with a brasserie as described in PCT US2002/018976.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a cross sectional view of the invention having an inwardly protruding dimple.

Figure 2 is a cross sectional view of the invention and the mold used in production.

Figure 2a is a cross sectional view of a mold used to produce the invention.

Figure 3 is a cross sectional view of the invention shown in Figure 1 with a continuous inner layer over the dimple.

Figure 3 is a cross section view of the invention having a thicker section of the outer shield situated to press against the nipple with a continuous inner layer.

Figure 5 is -a cross sectional view of the present invention having a tapered profile as it approaches the edge. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring to Fig. 1, an embodiment of the present invention, a breast shield, can be seen generally at 10. In this embodiment, the shield 10 is a duel durometer laminated structure; the individual layers are manufactured from silicon rubber compounds of differing durometer and laminated together. In general, the shield 10 has an outer layer 11C a higher durometer silicone compound which provides a shell or frame for the shield 10," and an inner layer 12 of a lower durometer silicone compound or silicon gel, which provides the adhesive quality necessary for the shield to adhere to the human body. The shield 10 may take any shape that is suitable for conforming to the human breast. In one embodiment of the shield 10, it is formed to have an elliptical curve to the outer layer, but other shapes or curves can be imposed upon the shield 10.

Referring again to Figure 1 , the shield 10 can be seen wherein it comprises a dimple 13 protruding through the inner layer 12. The dimple 13 will generally be formed of a silicon compound with sufficient hardness or durometer to keep the human nipple depressed. In one embodiment of the shield 10, the dimple 13 is made from a silicon compound with the same durometer as the outer layer 11. The dimple 13 is located at the center of the shield 10, but may be offset to accommodate various designs of the shield 10 and various breast shapes. The dimple 13 is appropriately sized both in diameter and height to depress the nipple of the wearer thereby preventing letdown and minimizing leakage.

Referring to Figure 2, and to Figure 2a, the shield 10 and a mold 40 for manufacturing the shield 10 can be sqen. In the manufacturing process using the mold 40, the shield 10 is formed with a dimple 13, created by a depression 13a in the mold 40. Using the mold 40, an uncured silicon compound is placed on the mold 40 in a quantity sufficient to form the inner layer 12. The uncured silicon compound will become the inner layer 12. The uncured silicon compound filling the depression 13a is displaced by suitable means. The inner layer 12 is then fully heat cured for the appropriate amount of time at the appropriate temperature. The cure times and temperatures for silicon compounds are well known in the art. After the inner layer 12 is cured, a second uncured silicon compound is placed on top of the inner layer 12 in sufficient quantity to form the outer layer 11. The outer layer 11 is generally made from a silicon compound that is higher in durometer than the inner layer 12. The shield 10 is then again heat cured at the appropriate temperature and for the appropriate time to fully cure the outer layer 11. The silicon compound used to form the outer layer 11 fills in the depression 13a in the mold 40, forming a dimple 13 made of the same silicon compound as the outer layer 11. The same technique may be used to form other configurations of the invention, where the center section may be something other than an inwardly extending dimple. Various shapes of the mold 40 may be used to provide the desired shape for the shield 10.

In the above described method of manufacture, the silicon compounds are poured on top of the mold 40 shown in Figure 3, and gravity spreads the silicon compounds out over the mold. The quantity and the viscosity or both of the silicon compounds used to form the inner layer 12 and the outer layer 11 are controlled so that the, desired thickness of the layers results. In general, the inner layer 1^'2 is much thinner than the outer layer 11. In the method described above for manufacture of the present invention the relative thickness of the layers is proportionate the the viscosity of the uncured silicon compounds. The viscosity of the compounds or: amount applied can be altered to give the desired thickness to the layers.

The present invention,, id all embo.dihnerits. disclosed herein, may also be formed by compression molding. Using this method, the uncured silicon compound would be placed in one half of a mold, compressed by the second half of the mold, and heated to cure. Generally, the first compound in the mold would bσ the compound with the higher durometer number that would form the outer layer. The inner layer would generally be the silicon gel or compound of a lower durometer. The compound for the second layer would be placed in the mold over the already formed outer layer. The second half or top part of the mold would then compress the second compound. The second compound would then be heated to cure. The completed part would then be removed from the mold. This type of compression molding with heat curing is well known in the art.

Referring to Fig. 3, a second embodiment of the shield may be seen at 20, having an outer layer 21 , an inner layer 22, and a inwardly extending dimple 23. As in the previous embodiment, the inner layer 22 is of a low durometer silicon compound allowing the shield 20 to adhere to the skin of the wearer. The outer layer 21 is a silicon rubber compound with a durometer sufficiently high to give shape to the shield 20 and support the inner layer 22. The shield 20 comprises an inwardly extending dimple 23, centrally located in the shield 20 as in the first embodiment. The method of manufacture of the shield 20 is similar to that of the first embodiment. In this case however, the silicon compound comprising the inner layer 22 is not fully displaced before the silicon compound forming the outer layer 21 is poured onto the moid 40. Since the silicon compound forming the inner layer 22 is not fully displaced, a thin skin of the uncured silicon compound covers the dimple formed when the harder silicon compound used for the outer layer 21 is placed over the cured inner layer 22. This results in a finished product that has a continuous inner layer 22. Displacement of the compound comprising the inner layer 22 may be done with any suitable mechanical means. Alternatively, the amount of the compound used to form the inner layer 22 may be less in the nipple area at the beginning of the curing process. Referring to Fig. 4, a third embodiment, of the present invention may be seen at 30. The structure of the shield 30 is similar to the previous embodiments, having an inner layer 32 of low durometer and an outer layer 31 of a higher durometer silicon compound. A centrally lopated reinforcement 33 is provided that provides additional pressure on the nipple of the wearer. In a preferred embodiment, the reinforcement 33 is a single layer of a silicon compound comprised of the same material as the outer layer 31. This embodiment is manufactured in a manner similar to the methods discussed above.

Referring to Fig. 5, a fourth embodiment of the shield may be seen at 50. This embodiment of the invention is similar to all other embodiments with the difference that the thickness of the structure of the shield 50 narrows nears the edges. It has been found that making the shield 50 thinner as it approaches the edges does not detract from the ability of the shield 50 to adhere to the breast, nor does it detract from the ability of the shield 50 to put pressure on the nipple of the wearer to prevent let down. Narrowing the shield 50 makes it less noticeable underneath clothing and presents a more natural shape to an observer. The shield 50 may be manufactured as shown, or may be manufactured with a central reinforced area, or inwardly extending nipple, as in the other embodiments. The method of manufacture of the device as shown in Fig. 5 is similar to the previously discussed methods.

Claims

WE CLAIM:

1. A re-usable breast shield comprising a silicone rubber compound exterior frame, a silicone rubber compound interior membrane, said exterior frame and inner membrane each separately cured, said exterior frame and inner membrane laminated together forming a laminate structure with a single contiguous edge.

2. The device as recited in Claim Λ wherein said shield further comprises a centrally located inwardly extending nipple.

3. The device as recited in Claim 2 wherein said nipple is continuous with and comprises the same silicon rubber compound as said exterior frame.

4. The device as recited in Claim 3 wherein said inner membrane is continuous and covers said nipple.

5. The device as recited in Claim i wherein said shield further comprises a centrally located reinforcement, said reinforcement continuous with and comprising the same silicon compound as said exterior frame.

6. The device as recited in Claim 5 wherein said inner membrane is continuous with and comprises the same silicon rubber compound as said exterior frame.

7. The device as recited in Claim 1 wherein said shield varies in thickness from a center location to said edge, said thickness becoming less towards said edge.