Breast prosthesis

Abstract

A gel filled silicone rubber breast prosthesis adapted to be worn inside of a brassiere by a woman who has had her own breast removed. The breast is of variable volume in that it is provided with a specially arranged tucking or pocketing means which allows the breast to be reduced to a proper size and then to be fitted tightly against the chest and beneath a brassiere so as to give a natural looking appearance. The prosthetic device allows assimilation of several characteristics of a natural breast which is exceedingly comfortable to wear and is adaptable to the physical requirements of a wide range of female human subjects.

Description

BACKGROUND OF THE INVENTION

This invention relates to a prosthesis which simulates a surgically-removed breast.

There are two known general types of breast prostheses. The first type is worn externally in some type of brassiere arrangement and is generally employed when breasts or portions thereof have been removed by surgery. A second type involves a prosthesis for insertion into the breasts in order to change the contour thereof. This type is generally used for cosmetic purposes.

It is to the former type of prosthesis that the present invention primarily relates.

In the case of a radical mastectomy, a considerable amount of auxiliary tissue is removed wherefore a relatively large quantity of "padding" in the underarm area is needed in order to afford the patient a reasonable degree of physical comfort. The lobe extension of the present invention allows compensation for that feeling of need by allowing a prolongation of the prosthesis which extends outwardly from the breast area toward the axilla region of the anatomy. This prolongation, when the prosthesis is worn by the patient, will overlie the pectoral muscle and offer a feeling of fullness to the wearer.

Women who have undergone mastectomies not only suffer considerable physical pain but also undergo severe emotional shock at the seeming loss of part of their femininity, and a principal object hereof is to help to offset that feeling of loss by providing a breast form comprising a main breast or body bulge part with a lateral underarm extension which is adapted to be fitted to the interior wall of a cup of a brassiere so as to give the form and feel of a natural breast and to fill the created void in the underarm area.

The desideratum obviously is to restore the female figure after having been subjected to a mastectomy.

It is well known that in accordance with the severity of the problem, the area of the body involved in a mastectomy will vary. In some cases, only the main body bulge of the breast may be removed. In other cases, the area from which body tissue is removed will extend laterally under the arm or upwardly nearly to the clavicle and in some cases the body tissue may be removed almost to the rib cage in all three areas.

THE PRIOR ART

Certain U.S. patents teach the fact that a common way to form a prosthesis is to insert some type of lightweight filler into a thin case of cloth or other material. Such prior art devices suffer from such disadvantages as to limit their use. Some have tended to be hot and uncomfortable. Others have lacked breathability. Fillers often tended to harden or mat down, and removal or replacement has been inconvenient. Others have tended to slip embarrassingly or to become bulky at the top and to make their artificiality obvious.

Artificial breasts prepared heretofore have had certain defects which have prevented their acceptance by the public. In many cases, the breast pads have not fit properly and have moved and shifted around during use and have caused considerable embarrassment. In other cases, the artificial breast has not maintained the proper shape and has appeared out of line or in a different shape than the other natural breast. In still other cases, the artificial breast has been hot and uncomfortable to wear over long periods of time. In addition, the breasts prepared heretofore have in most cases been difficult to launder and clean it has been necessary to purchase new pads at frequent intervals.

It is an object of the invention, therefore, to provide a new artificial breast which corrects all of the above-noted difficulties. It is a further object to provide a new artificial breast which fits snugly against the chest and does not shift about. It is a further object to provide a new artificial breast which maintains proper shape and holds to the line of the other breast. It is a further object to provide an artificial breast which is the same weight as a human breast, takes on body temperature, and is comfortable to wear.

Various challenges have been involved in the work of development. One of them has been to retain the prosthesis on position in the body. One type of prosthesis used for this purpose consists of a hollow container made of a rubberlike synthetic plastic material which is molded to the desired size and shape. It is then filled with a liquid plastic material which can be cured; and after curing, becomes a fluid gel.

This provides the desired degree of softness and resiliency. However, because the fluid gel inside the prosthesis does not have enough rigidity to retain a particular shape, it shifts when the wearer changes position, as between lying down and standing up. The membrane or wall of the container is sufficiently flexible that it permits a certain change in shape under the shifting weight of the gel.

A prosthesis of this character sometimes produces wrinkles in the upper portion and tends to bulge excessively in the lower portion when the wearer stands or leans forward even though it is properly shaped when the wearer is lying down. When held in position against the chest, these wrinkles become visible from the outside and, along with the bulge towards the bottom of the prosthesis, are undesirable from a cosmetic viewpoint. Furthermore, the shifting of the contents makes the prosthesis uncomfortable to wear.

SUMMARY

The present invention provides a prosthesis for use by mastectomy patients which has the advantages of the best previously available prostheses without their disadvantages.

The device is light in weight, resilient, compressible, moisture vapor-transmitting, soft, nonirritating and convenient. It remains in place and does not move within the enclosing brassiere cup, performing its desired function in an effective yet inconspicuous manner.

Constant-volume pads for assimilating the contour of a natural female breast are known and have been used both for cosmetic purposes and also prosthetically by breast amputees. However, constant-volume breast pads have one serious limitation in the sense that they should be custom-made to complement the physical endowments of the prospective wearer in order to provide the desired cosmetic effects. Obviously, a custom-made breast pad is apt to be expensive.

A variable-volume breast pad might readily lend itself for wearing by variously endowed feminine forms. However, the volumetric variability of many prior art pads requires an uncomfortable fluid-impervious bag-like structure that is inflated to the desired degree with pressurized air or liquids which is uncomfortable to wear, difficult to maintain in a sanitary and cleansed condition, and apt to leak and deflate and thus provide embarrassment to the wearer.

Accordingly, one general object of the present invention is to provide a variable volume breast pad that overcomes the several objections and disadvantages of the prior art.

It is another object to provide a variable volume breast pad that will provide for a wide range of female human subjects a contour closely assimilating that of a natural well-developed breast.

It is another object to provide a variable volume breast pad that is readily launderable in aqueous soap or detergent solutions and thereafter quickly driable, both without impairing the shape of the breast pad.

It is a further object to provide a light weight variable volume breast pad that can be worn comfortably and unobtrusively both by those with under-developed breasts for cosmetic purposes, and by single or double breast amputees as an orthopedic appliance.

It is another object to provide a prosthesis which overcomes the shift in position of the contents and the consequent change in shape when a highly mobile gel is used as a filler.

Another important feature of the invention is the provision of means to insure that the prosthesis will remain consistently in the same location on the body of the wearer. Thus, means must be provided for the brassiere to snugly grip the prosthesis by way of being supported upwardly from beneath by a band of the brassiere which encircles the patient's body and by a properly dimensioned brassiere cup against the interior of which the prosthesis may be complementarily positioned so as to insure that the top of the artificial breast will remain firmly pressed against the body of the wearer and that it will also be properly encapsulated at least on its forward face by the breast cup of the brassiere.

BRIEF DESCRIPTION OF THE DRAWING

Understanding of the invention will be aided by reference to the accompanying drawing, in which like numbers refer to like parts in the several views, and in which:

FIG. 1 is a front elevational view showing the artificial breast of the invention as applied to the breast of a wearer;

FIG. 2 is a top plan view of the artificial breast;

FIG. 3 is a side elevational view of the FIG. 2 breast;

FIG. 4 is a top plan view showing a tuck taken in the FIG. 2 breast;

FIG. 5 is a side elevational view of the FIG. 4 breast;

FIG. 6 is a side elevational view of a modified form of the FIG. 1 breast.

FIGS. 7 and 8 are side elevational views of the FIG. 4 breast showing the tucking arrangement in two other different positions of adjustment; and

FIGS. 9 and 10 are side elevational views of a second modified form of the FIG. 1 breast showing two different adjustments made possible by the use of external padding for accommodating to extreme size cases, the external padding compensating for the inability of the breast form proper to displace beyond a certain extent.

DESCRIPTION OF PREFERRED EMBODIMENTS

Further understanding of the invention will be facilitated by a more detailed discussion of the presently preferred embodiments which are illustrative but are not to be considered limitative.

The prosthesis comprises generally a planoconvex or conoidal bust portion and a laterally-extending lobe-like portion which, when the device is placed in position lies at the side of or above the breast, so as to greatly facilitate the production of a symmetrical simulated breast.

FIG. 2 shows the one-piece casing of which the breast is partially formed; the casing representing a hollow closed shell or container having a wall of a soft flexible material which is impervious to human tissues and likewise impervious to that secondary material which fills the casing.

The situation normally obtains that a woman who has had her left or right breast or both breasts removed -- and she is one of an estimated 90,000 women each year -- has a need for a proper (left or right or both) breast form. The solution hereof lies in the fact that the breast form of the invention can be used for either side; thus one form replaces the normal two.

As the breasts for both sides of the body are the same, a description of one will obviously suffice for both. As will appear, one of the main features of the invention allows for the ready adjustment of the artificial breast, same being of the variable volume type, so as to compensate for differences in appearance, size and other characteristics between a real breast and an artificial breast or between two artificial breasts.

The casing is made of a rupture-proof plastic and pliable material that has characteristics that resemble that of the normal human breast such as softness, resiliency and elasticity. A suitable material has been found to be silicone rubber, although the specific material forms no part of the present invention as such.

The casing preferentially is of a material which can withstand washing, even boiling as in sterilization.

The casing may be variously colored so as to more closely simulate the flesh of a particular wearer and it may be otherwise treated to lend thereto a realistic appearance.

The casing must look realistic, conform to the body, react to various movements of the body, and be compatible with the filler material therewithin. It must be a membranous material of highest clinical value which, when in contact with the post mastectomy tissues, is non-reactive and will contain no harmful plasticizers or softening agents.

Such casing preferentially has a wall thickness in the order of 2-4 millimeters and is seamless.

The casing is formed with a central generally rounded or circular enlargement in the form of a front panel 14 which merges smoothly into a generally flattened lobe extension 16 and a rear panel 18 on the side opposite to the front panel 14 and lobe extension 16.

The circular front panel is generally plano convex or conoidal in configuration having a continuous and smooth annular periphery interrupted only at one side by the lobe-like extension.

Desirably, the form of prosthesis should achieve a peak above the outboard portion of the breast and should achieve a maximum lateral extension for disposition toward or under and below the adjacent armpit with the intervening portion having a curvature which conforms to that of the armpit. By having a side flange which extends toward or under the armpit and around the side of the body, it is possible to provide a breast which will closely conform itself to the body and which will more readily retain itself upon the body.

Stress is laid upon the lobe-like extension 16 which is adapted to lie along the side of the bust and give to the same the rounded and symmetrical appearance which would naturally result from an increased bust.

The lobe-like extension 16 is of such configuration that it may be tucked or pocketed inwardly upon itself so as to be extended inwardly into the casing interior between the rear panel 18 and the circular front panel 14, as best shown in FIGS. 4 and 5 so that the wearer is enabled to position the prosthesis behind a brassiere B of the under-the-breast-supporting-type as in FIG. 1. Such type eliminates the need for the usual pockets, straps and special attachments. The wearer first tightens the lower band L of the brassiere tightly around her person and below the breasts so as to cause the fullness of the breasts, both the natural one and the artificial one, to bulge outwardly to the precise desired extent. The cup C of the brassiere is properly adjusted so as to accommodate a simulated breast of the desired configuration with the lobe-like extension of the artificial breast then being tucked in only to that extent or degree necessary to give the desired fullness to the simulated breast. This having been determined, the brassiere is then further tightened around the body so as to enclose and hold in situ the tucked in lobe-like extension.

Emphasis is also placed upon the fact that a single prosthesis may be readily adapted to suit any situation from one where only a breast proper may have been removed, in which case a rounded form of prosthesis may be required such as shown in FIGS. 4 and 5, or to one where not only a breast proper but also the adjacent lymph glands may have been removed, in which case a form of prosthesis having a foreshortened portion of a lobe extension is available for placement in situ such as shown in FIG. 8. Or the situation may be one where more of a portion of a lobe extension is needed for placement in situ such as shown in FIG. 7. Or the situation may be one where the full length of the lateral extension may be needed to more properly fill in the underarm area in which case the form as shown in FIGS. 2 and 3 may best serve. The salient point is that the form is enabled to accommodate to any given situation, the basic shape being adapted to be varied by the inversion of a lateral lobe extension into the form base so as to change the external shape from a greatly elongated form to a foreshortened elongated form or to a round form as necessity may dictate.

The breast form has the further advantage that it may be disposed horizontally (wherefore the lobe extension may be extended into the armpit) or vertically (wherefor the lobe extension may be extended toward the clavicle.

The casing is filled with a suitable material to give the prosthesis the proper shape and resiliency. Silicone gel has been found to be suitable for the purpose although the specific material forms no part of the present invention as such.

The casing is charged through a provided opening (not shown) with a sufficiency of filling so as to give the prosthesis a desired shape, following which the casing is hermetically sealed.

It should be understood that in some cases a harder or softer material can be advantageously employed. However, regardless of the precise penetrometer readings of the gel, the material should be sufficiently soft and flexible to approximate the consistence of the natural breast. In addition, the gel material should be one which is inert toward the casing.

It is to be understood that the filling is of such a nature as to hold the walls of the casing distended, but yet capable of yielding and responding to pressure, thus making the breast comfortable for a wearer and facilitating its realistic action.

The prosthesis is desirably of such a configuration that, when the device is applied to the body, it will readily adapt itself so as to simulate the contour of a real bust.

Another situation of adapting prosthesis to wearer relates to the problem of different bra sizes, there being some 160 thereof, which break down to 11 rib cage measurements and 27 cup sizes (which include considerations not only of diameter but of depth).

The problem is thus two fold: both diameter and depth must be taken into full account.

By the construction hereof, with a very soft skinlike silicone rubber being used, the lobe extension or a part thereof is readily inverted and pocketed within the confines of the base of the article so as to change the external configuration to any desired shape.

The solution as to varying the depth of the form also lies in the capability of the inversion of one part of the form into the other, it being as possible to invert a portion of the conoidal bust portion 14 into the lobe-like portion 16 as it is to invert a part or all of the lobe-like portion into the bust portion all whereby almost the entire bra size range may be accommodated by a single breast form. Extreme situations must be accommodated by a breast form of extra large dimensions.

The interior area of the casing may be divided or interrupted by interrupting means in the form of a plurality of projections 30 projecting outwardly from a base or support 32 which preferentially is fixedly secured to the rear wall panel 18.

The projections 30 may be arranged in a T formation and spaced as to each other. They may be made of a material similar to the casing wall so that they have the characteristics of flexibility and resiliency.

The projections function to interrupt the flow of the soft fluid gel so as to allow the prosthesis to change shape readily and yet to minimize any visible change in shape due to normal movements of the wearer.

In the FIG. 6 modification, a generally planar stiffening member 122 is disposed within the hollow of the casing and may be adhesively secured to the rear wall portion 118 for purposes of adding a desired stiffness or rigidity to the entirety of the dimensions (length and width) of the rear chest-embracing wall of the prosthesis.

Another situation relates to the extreme depths required in a breast form by some women. This would normally require the addition of more silicone gel which would unreasonably increase the cost thereof.

By the modification of FIGS. 9 and 10, the problem of extending the depth of the form without changing the diameter thereof and/or without the need for an entirely new form (it being possible to displace only a certain amount of material) is readily solved by way of a domeshaped circular pad 40 of a silicone rubber foam of a closed cell construction which may be externally applied to the rear wall portion 18 of a breast form. The pad serves the function of projecting the form outwardly so as to offer the allusion of greater depth.

A plurality of such pads may be provided, pad 42 in FIG. 10 having a dome of greater height than the dome of pad 40 in FIG. 9 so as to give the appearance of a FIG. 10 form having a greater depth than the FIG. 9 form.

Claims

I claim:

1. A surgical breast prosthesis adapted to be worn inside a brassiere by a woman who has had a breast removed surgically comprising: a distended hermetically-sealed casing of substantially impervious material containing an elastic filling of gel, the casing including a substantially conical substitute breast body portion adapted to fit into and to be worn inside the breast cup of the brassiere and including a laterally projecting tongue formed as an integral extension of the substitute breast body portion, the tongue being of substantially uniform thickness throughout its extent and having a front face curved slightly rearwardly from its inner end to its outer end relative to the body portion and terminating in a substantially straight rearward marginal edge, interrupting means in the form of a plurality of projections of varying lengths disposed within the substitute breast body portion and a stiffening member within the substitute breast body portion and tongue, the tongue being adapted for tucking into the substitute breast body portion for varying the size and shape of the latter or for fitting the area of the body of the wearer which is below the underarm and from which tissue has been removed as an incident to the removal of the breast.