Title:
Breast prosthesis
United States Patent 3896506


Abstract:
A surgical breast prosthesis adapted to be worn inside of a specially constructed brassiere comprising: a distended hermetically-sealed casing of substantially impervious material containing an elastic filling of a soft fluid gel, the casing including a substantially conical breast body portion adapted to fit into and to be worn inside the breast cup of the brassiere and including a laterally projecting tongue portion formed as an integral extension of the breast body portion, the tongue portion 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 breast body portion and terminating in a substantially straight rearward marginal edge, with flow interrupting means in the form of a plurality of projections of varying lengths disposed within the breast body portion for allowing the prosthesis to change shape readily but with a minimum of any visible change in shape due to movements of the wearer, the tongue portion being adapted for tucking within the 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 any tissue may have been removed as an incident to breast removal.



Inventors:
Hankin, George (Southwick, MA)
Hankin, Helen A. (Southwick, MA)
Application Number:
05/540681
Publication Date:
07/29/1975
Filing Date:
01/13/1975
Assignee:
HANKIN; GEORGE
HANKIN; HELEN A.
Primary Class:
Other Classes:
450/38
International Classes:
A41C3/10; A61F2/52; (IPC1-7): A61F1/24; A41C3/10
Field of Search:
3/36 128
View Patent Images:
US Patent References:
3701168BRASSIERES FOR MASTECTOMY PATIENTS1972-10-31Balow
3665520SURGICALLY IMPLANTABLE BREAST PROSTHESIS1972-05-30Perras et al.
3600718INFLATABLE PROSTHESIS1971-08-24Boone
3494365BREAST PAD1970-02-10Beals
3301260Self-inflating brassiere pad1967-01-31Ray
3196464Breast prosthesis1965-07-27McKee
2814808Artificial breast for amputees1957-12-03Berman
2542619Breast form1951-02-20Bernhardt



Primary Examiner:
Frinks, Ronald L.
Attorney, Agent or Firm:
Ross, Ross & Flavin
Parent Case Data:


This is a continuation-in-part of my copending application Ser. No. 435,229, filed Jan. 21, 1974.
Claims:
I claim

1. The cooperating combination of a prosthetic breast form and a supporting undergarment therefor adapted to restore the human female figure and provide a symmetrical foundation for outer garments after the figure has been subjected to a mastectomy, said combination comprising a prosthetic breast form, a brassiere, means cooperatively formed on said breast form and said brassiere for securing said breast form and said brassiere in their required relative positions the breast form including a distended hermetically-sealed casing of subtantially impervious material containing an elastic gel filling, the casing consisting of a substantially conical substitute breast body portion adapted to fit into and to be worn inside the breast cup of the brassiere and a laterally projecting tongue formed as an integral extension of the substitute breast body portion and a back portion adapted to be worn against the body of the figure, 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 spaced apart projections projecting from a pair of crossed ribs disposed within the substitute breast body portion and adapted for the flow of gel therebetween, 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 breast removal.

2. A surgical breast prosthesis according to claim 1, including a plurality of pads of various sizes each for use within the brassiere and disposed behind the body portion for extending the depth of the body portion.

Description:
BACKGROUND OF THE INVENTION

This invention relates to a prosthesis which simulates a surgically-removed breast and which is formed and held in situ by a specially designed brassiere.

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. A lobe extension or tongue portion of this 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 may be varied as needed to overlie the pectoral muscle and to offer a feeling of fullness to the wearer.

A principal object hereof is to help to offset the usual feeling of loss by providing a breast form comprising a main breast portion or body bulge part with a lateral underarm extension or tongue portion, which portions are fitted to the interior wall of a cup of a brassiere to give the form and feel of a natural breast.

THE PRIOR ART

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 disadvantages such 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. 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.

It is an object of the present invention to provide an 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 its proper shape by means of its supporting brassiere. That is, the artificial breast hereof is not preshaped; it is shaped by the brassiere which supports it.

Certain prior art references handle the problem of varying gel densities within a prosthesis by the use of separate packages or compartments thereof, which packages or compartments are combined together to form the prosthesis. Such separate packages or compartments are costly in their construction. Such are eliminated in the structure hereof, the prosthesis being made in a single operation using a single compartment or package.

Various challenges have been involved in the work of development. One of them has been to retain the prosthesis in position against the body. One type of prosthesis used for this purpose consists of a hollow container made of a rubberlike synthetic plastic material 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 ridigity 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. It is a general object of the invention to overcome the shift in position of the contents and the consequent change in shape when a highly mobile fluid gel is used as a filler.

SUMMARY

This 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 of body weight, resilient, compressible, moisture vapor-transmitting, soft, and nonirritating once placed, it so remains and does not move within the enclosing cup of the brassiere, performing its function in an effective, yet inconspicuous, manner.

Constant-volume pads for assimilating the contour of a natural 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, and this means expense.

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 liquid so as to be uncomfortable to wear, difficult to maintain in a sanitary and cleansed condition, and apt to leak and deflate.

Accordingly, one object hereof is to provide a variable volume breast pad that overcomes the objections and disadvantages of the prior art and that will provide for a wide range of female human subjects a contour closely assimilating that of a natural well-developed breast.

It is a further object to provide a body 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 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 brassiere breast cup.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1 is a front perspective 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 part-sectional side elevational view of the brassiere of FIG. 1; and

FIG. 7 is a rear perspective view of the brassiere of FIG. 1.

DESCRIPTION OF THE PREFERRED EMBODIMENT

The prosthesis comprises a casing which includes a generally planoconvex or conoidal bust portion 10 and a laterally-extending lobe portion or extension 12 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.

The central generally rounded or circular enlargement in the form of bust portion 10 merges smoothly into the generally flattened lobe portion or extension 12 and an apertured rear panel 14 on the side opposite from bust portion 10 and lobe portion 12.

The bust portion has a continuous and smooth annular periphery interrupted only at one side by the lobe extension.

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 the 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 has a need for a proper breast form. The solution hereof lies in the fact that the breast form can be used for either side; thus one form replaces the normal two.

One of the main features allows for the ready adjustment of the artificial breast, same being of a variable volume type 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 invention.

The casing preferentially is of a material which can withstand washing, even boiling as in an autoclave and 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 will have a wall thickness in the order of 2-4 millimeters.

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.

Lobe extension 12 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 rear panel 14 and bust portion 10, as best shown in FIGS. 4 and 5, so that the wearer is enabled to position the prosthesis behind a brassiere of the under-the-breast-supporting-type as shown in FIG. 1, 6 and 7, thereby eliminating the need for the usual pockets, straps and special attachments.

The brassiere creates a desirable bust and prosthesis supporting contour by means of an inner structure in which a pair of interconnected chest engaging strips is positioned on the chest immediately beneath the breasts and is held in such position by a means passing around the back of the wearer and interconnecting the free ends of those strips. To the top of each strip is sewn a bust supporting band having an inwardly bowed lower edge surface.

The stitching of the inwardly bowed bottom edge surface of each bust supporting band to the straight upper edge surface of the chest engaging strips distends the bands to form the desired bust supporting contour.

A truss type of structure is used in the suspension of the bust supporting bands to carry most of the stress developed in the bands and to apply this stress in a useful manner to the flesh of the wearer. More specifically, a truss triangle is formed at the end of each band and is positioned at the back ends of the breasts underneath the arms of the wearer. The band stress is carried by a diagonal seam which causes the truss triangle to exert inward, forward, and slightly upward forces on the adjacent flesh to urge more of the breast flesh and prosthesis into the brassiere cup, but with complete comfort. Since more of the breast flesh and prosthesis is now contained within the brassiere cup, a flexure type of seam is used at the juncture between adjacent ends of the bust supporting hands and of the chest engaging strips so that this seam will lay against the chest wall between the breasts, natural or artificial, thereby providing a desirable breast separation.

Interaction of the structural principles results in a brassiere which provides improved figure control and breast separation with complete comfort while containing more breast flesh and avoiding underarm bulges.

FIG. 7 illustrates the manner in which the bust supporting bands and chest engaging strips are incorporated. A narrow elastic body encircling band 18 is provided to encircle the chest of the wearer and to define the bottom edge of the brassiere. Elastic gussets 28 and 29 are provided at the end portions of the body encircling band 18. The end of the gusset 29 is provided with fastening hooks 30. A fabric strip 31, to which are mounted a plurality of eyelets 32, is stitched to the other end of band 18 and to gusset 28 to provide the usual adjustable fastening means.

The lower edge surfaces of a pair of generally trapezoidal back panels 33 and 34 are stitched to band 18, the shorter end of the panels being stitched to respective gussets 28 and 29, the longer end on the panels extending around the back of the wearer to a point beneath the arms. The length of back panels 33 and 34 is determined by the brassiere size. These back panels are desired to extend to the back of the breasts of the wearer.

The lowermost end of a vertically extending fabric strip 19 is stitched to band 18 to define the mid point of the brassiere, the fabric strip 19 being centered between the breasts. The lower edge portions of the chest engaging strips and the lower ends of the triangular portions of the bust supporting bands are stitched to body encircling band 18 on either side of strip 19 with end surfaces 13 and 23 of the bust supporting bands stitched to strip 19. The ends 13 and 23 of the bust supporting bands are individually sewn to strip 19 to provide an individual hinging action which would not otherwise occur. This desired hinging action enables band 18 and elastic strips 15 and 25 to hold center strip 19 substantially flat against the chest wall between the breasts, thereby providing desirable bust separation.

A vertically extending strip 38 is sewn to the inside of the brassiere, covering the seam at the juncture between the longer end of back panel 33 and bust encircling band 36. A similar vertical strip 39 is stitched to adjoining portions of back panel 34 and bust encircling band 37. Bust supporting band 10 is stitched as at 41 to strip 38. The stitching 41 extends vertically and defines the third side of the triangular end portion 11 of band 10. In a similar manner, bust supporting band 20 is stitched as at 42 to vertical strip 39. In this manner, the triangular end portions of the bust supporting bands form truss structures to carry the bust supporting band stresses.

A fabric loop 46 is sewn to the vertex of the bust encircling band 36, the loop 46 being provided with a buckle 47. In a similar manner, the vertex of the bust encircling band 37 is provided with a loop 48 and a buckle 49. One end of a shoulder strap 51 is sewn to the elastic gusset 28, the other end of the shoulder strap being threaded through the buckle 47 to provide an adjustment of strap length. A shoulder strap 52 is connected in a similar manner to the gusset 29 and the buckle 49.

A pair of identically constructed bust containing cups 53 and 54 are connected together at a central seam 55. Each of cups 53 and 54 is fabricated from two or more pieces of material cut and sewn to provide a generally cup-shaped contour, in accordance with well known brassiere practices. These cups perform the bust containing function. The cups are stitched to the brassiere proper only along their lowermost and end edges. The vertices of the cups 53 and 54 are provided with respective fabric loops 56 and 57, these loops being detachably secured to the respective buckles 47 and 48. The lower edge surface of each of the cups is stitched to the seam between the corresponding bust supporting band and chest engaging strip. The central seam 55 is not secured to the vertical strip 19, except by the bottom edge stitching of the cups. The outermost edge of the cup 53 is stitched to the large end of the back panel 33 in alignment with the vertical strip 38, the outermost end of the cup 54 being aligned with the vertical strip 39 and stitched to the large end of the back panel 34. Thus, when the cup loops are disengaged from the buckles, the cups can be dropped forward, as shown in FIG. 7.

To put the brassiere on, the cups 53 and 54 are dropped to the open position and the brassiere is put on by positioning the elastic band 18 about the chest and immediately beneath the breast flesh and the fastening hooks 30 engaged with the proper eyelets 32. The breasts real or artificial are manipulated so that the breasts protrude through the openings defined between the bust encircling bands and the bust supporting bands. The shoulder straps are then adjusted and the cups brought up into position and there secured by engaging each of the cup loops with its associated buckle.

The bust supporting bands, which are constructed of heavier material than the rest of the brassiere, are positioned at the bottom of the breasts and adjacent the chest wall, whereby the bust supporting bands provide the main support for the breasts. The bust encircling bands and shoulder straps form a harness assemblage which maintains the bust supporting bands in the proper position, the bust encircling strap defining the lateral perimeter of bust confinement. The main band stress is carried by the diagonally stitched seam of the triangular portion of the bust supporting bands. This is different from the ordinary brassiere wherein the bust supporting stresses are distributed throughout the breast cups and the back panels, together with a typical bunching of flesh above the side and back panel. In the present brassiere structure, on the other hand, the breast support stress, which is concentrated in the truss triangles at the back of the breasts and underneath the arms, is usefully applied to push the additional breast flesh forward into the brassiere cups instead of bulging upwards. The length of the triangle hypotenuse is not critical, although it has been found that the angle between the hypotenuse and the base of the triangle (along the band 18) should not be greater than about 60°, in order to provide the desired control. As previously stated, the brassiere cups provide primarily a breast containing function to shape and direct the properly supported breast flesh. It has been found that since more of the breast flesh is now contained within the brassiere cups, a larger cup size is usually required for proper fitting of the present invention brassiere.

A typical problem encountered in brassieres of the larger cup sizes is the difficulty in maintaining the central vertical seam of the brassiere flat against the chest wall between the breasts to achieve desirable breast separation. This problem has been overcome in the present brassiere by individually sewing the ends of the bust supporting bands and adjacent portions of the bust encircling bands to the central strip 19 to provide a hinge type of action which facilitates bending of the material at the seam. In the very large cup sizes the ends of the bust supporting bands will be quite wide (since there is much more breast flesh to support) and extend almost to the top of the vertical strip 19, whereby the hinge action becomes even more pronounced.

The wearer first tightens the lower band 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 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.

A single prosthesis may be readily adapted to suit any specific situation from one where only a breast proper may have been removed, in which case a rounded form of prosthesis may be required or to one where not only a breast proper but also the adjacent lymph gland may have been removed, in which case a prosthesis having a foreshortened portion of a lobe extension may be made available for placement in situ. 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 prosthesis 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 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 prosthesis 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 shaped to as near the actual shape of the removed breast as it is possible to come with respect to diameter and depth. Understandably, it is not necessary to make an exact reproduction of the removed breast, it being sufficient to employ, for a specific case, a casing from a range of some 150 different sizes which comes closest to the dimensions and configuration of the removed breast.

For the reason that, in actual practice, the prosthesis will be supported by and covered by the cup (of proper size) of a bra, an approximation as to size of casing will suffice.

That casing is filled with the appropriate gel G, silicone gel having been found to be most suitable.

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 is desirably sufficiently soft and flexible to approximate the consistency of the natural breast. In addition, the gel material should be inert with respect to the casing. brassiere in

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

By the construction hereof, with a very soft skinlike silicone rubber being used, the lobe extension or a part thereof may be readily inverted and pocketed so as to change the external configuration to any desired shape. That is, the solution as to varying the depth of the form lies in the capability of the inversion of one part of the form into another, it being as possible to invert a portion of the conoidal bust portion 10 into the lobe-like portion 12 as it is to invert a part or all of the lobe-like portion into the breast portion, all whereby almost an entire bra size range may be accommodated by a single breast form.

The interior of the casing is interspersed with a plurality of spaced "breakwaters" or interrupters or stabilizers in the form of projections or protuberances projecting outwardly of a circular domed base or support 62 which is secured to the rear wall panel 14 at the aperture thereof by being sealed therearound.

The projections or protuberances 60 are arranged in a criss cross formation and project outwardly from a pair of crossing ribs 61 which extend across the diameter of the circular base or support 62 at right angles to each other and which rise slightly in an arcuate manner from each end of the rib toward the center in a crown or dome manner, the crossing point of the ribs being the highest point of the ribs from the plane of the circular base or support 62.

The projections 60 are equi-spaced as to each other and are preferably of equal lengths. They may be made of a material similar to the casing wall so that they have the characteristics of flexiblity and resiliency.

The interrupters or stabilizers comprise a generally cross shaped array of outwardly projecting pins which protrude a substantial distance into the interior of the container from the rearward face thereof. They protrude a distance of at least a quarter of the thickness of the container from the back wall to the front wall.

The purpose of the projections is to increase the surface area of the mass and the container enclosing the mass relative to the volume of the mass.

This imparts a greater displacement to the contained mass, conforming the displacement properties of the prosthesis more closely to the soft feel of a human bosom.

The projections function as "breakwaters" and serve to interrupt the flow of the gel as the wearer changes positions as for instance in moving from side to side or in turning around or in changing between standing and prone positions during which movements the gel anticipatorily can be expected to shift in its position and to flow in varying degrees and at varying speeds from one area to another within the casing. By interrupting the gel flow and causing it to pass between the breakwaters, it is slowed down in its travel so that changes of casing shape are accordingly slowed down and a visible change in shape to normal movements of the wearer is minimized.

As a further addition, a plurality of pads of various sizes can be provided each for use within the brassiere and disposed behind the breast body protion for extending the depth of the body portion.