AU756610B2

AU756610B2 - Breast prosthesis

Info

Publication number: AU756610B2
Application number: AU40165/99A
Authority: AU
Inventors: Margaret Jenaway
Original assignee: Individual
Current assignee: Individual
Priority date: 1998-07-20
Filing date: 1999-07-16
Publication date: 2003-01-16
Anticipated expiration: 2019-07-16
Also published as: AU4016599A

Description

P/00/011 28/5/91 Regulation 3.2

AUSTRALIA

Patents Act 1990

ORIGINAL

COMPLETE SPECIFICATION STANDARD PATENT Name of Applicant: Actual Inventor Address for service is: Margaret Jenaway Margaret Jenaway WRAY ASSOCIATES 239 Adelaide Terrace Perth, WA 6000 Attorney code: WR *0 Invention Title: "Breast Prosthesis" Details of Associated Provisional Application No: PP4781 The following statement is a full description of this invention, including the best method of performing it known to me:- Title: Breast Prosthesis Field of the Invention The present invention relates to breast prosthetic devices.

Background Art The current breast prostheses that are used by women are typically made of a silicone material and are inserted into a nylon pocket structure. These breast prostheses do not allow air to circulate through them and restrict the circulation of air around the user's upper body. Hence these breast prostheses are very uncomfortable to wear especially in hot and humid environments. Also, these devices are quite heavy, approximating the weight of the natural breast that has been removed. It is the applicant's experience, and contrary to what has been stated in a number of prior specifications, that users of breast prostheses prefer the prostheses to be as light as practicable so that they are easy to wear and do not remind the user of trauma of the operation. Breast prostheses with a weight comparable to that of a natural breast are most uncomfortable because they do not have the natural support structure of skin and tissue provided by the body for natural breasts and thus rely totally for support upon the brassiere. As a result, the weight upon the brassiere straps is considerably greater than is present from natural breasts. In addition, that weight provides a substantial momentum which causes the prosthesis to move about on the chest of the user during normal activities.

Further to these problems, recent studies have indicated that the use of silicone gel may be potentially hazardous to users and hence many users are avoiding the purchase of these devices due to the perceived potential hazard of using gee* silicone-based products.

Non-silicone based breast prostheses are disclosed in US 2,482,297, US 3,278,947 and US 4,071,914. US 2,482,297 proposes a prosthesis which comprises a substantially conical, foam rubber outer casing and foam rubber insert material. The resulting device is quite unnatural in both appearance and -3feel. Further, foam rubber does not permit air circulation to the extent considered appropriate.

US 3,278,947 proposes a device with a casing made of light weight porous flexible synthetic fibre material but requires a substantially conical shaped insert, in the form of a foam plastic cone or a series of 3 discs to define its shape. It also provides a quite unnatural appearance and the circulation of air is limited by the use of foam plastic.

US 4,071,914 proposes a pad comprised of a moulded outer casing enclosing a foam rubber inner casing and utilising foam rubber filler material. This device is of relatively complicated construction, again using an insert to provide the shape of the prosthesis. It also utilises a foam rubber or foam plastics material through which air circulation is limited.

The present invention has as one of its preferred objects, to provide a breast prosthesis which is of simple construction and provides a breast prosthesis which conforms more accurately to a natural breast in both shape and feel.

Disclosure of the Invention Accordingly, the present invention resides in a breast prosthesis comprising a permeable outer casing and an inert and porous filling material which is contained within the outer casing, wherein the permeable outer casing comprises 20 a front panel and a rear panel, the front panel comprising a plurality of subpanels, the sub-panels being configured such that when joined in an edge to edge relationship they define a breast shape wherein the outer casing defines the shape of the prosthesis when extended by the filling material.

It is a desireable object to provide a breast prosthesis which is substantially 25 lighter than a natural breast of comparable size, is made of an inert material S•which allows for circulation of air around the breast prothesis, is not rigid but is also not prone to fluid-like movement relative the body of the user in-the course of normal activities and will return to the breast shape after deformation.

The outer casing is preferably made of a stretch fabric which is flexible. A preferred fabric is a stretch fabric formed of a natural fibre which allows circulation of air through the prosthesis. According to one embodiment the fibre comprises cotton.

The inert, porous filling material is preferably a resilient material that allows circulation of air through the prosthesis. The resilient, porous filling material is preferably a plastics fibrous material or polymeric fibre. The resilient, porous filling material is also preferably hypo-allergenic and washable. According to one embodiment the filling material comprises a polyester fibre or other suitable plastics fibre.

In a preferred embodiment the panels and sub-panels are sewn together. In an alternative preferred embodiment the panels and sub-panels are seam welded together.

The breast profile is preferably formed such that the device shall be insertable into the cup of brassieres of various forms to be substantially contained within the confines of the cup.

According to a preferred feature of the invention, the breast prosthesis further comprises 15 means for detachable adhesion of the breast prosthesis to a brassiere.

According to a preferred feature of the invention, the means for detachable adhesion is adjacent an upper edge of the front panel of the breast prosthesis in a position o°°SS engageable along a cleavage line of a cup of a brassiere worn by a user of the prosthesis.

According to a preferred feature of the invention, the means for detachable adhesion comprises a strip of hook and loop fastener material.

In a further preferred embodiment an inert, relatively dense, particulate material is contained within the outer casing mixed with the filling material. The addition of the inert, relatively dense particulate material provides a small amount of weight to counteract a slight tendency for brassiere supporting one or two of the devices to ride upwardly on the user above its normal positioning on the body during normal physical activity of the user. The amount of weight required is considerably less than the weight of the breast being replaced. Preferably, the inert, relatively dense particulate material is sand.

In a further preferred embodiment, an absorbent pad is removably attached to the rear panel of the device. The absorbent pad provides a means for absorbing perspiration and body oils excreted by the user and thereby prevents or at least greatly reduces the extent to which these are absorbed by the device itself and therefore the device needs washing only occasionally. A preferred means of removably attaching the pad to the rear panel is by one or more sections of hook and loop fastener material attached either to the pad or to the rear panel.

Preferably, the absorbent pad is washable. In a preferred embodiment, the pad comprises an enclosed sleeve constructed of the same material from which the outer casing is comprised into which is positioned a layer of pressed cotton. In an alternative embodiment, the pad is comprised of a disposable material which is replaced regularly by the user.

The invention will now be more fully understood in light of the following description of one specific embodiment.

Brief Description of the Drawings The embodiment will now be described with reference to the accompanying drawings, in which: e@* Figure 1 is a front perspective view of a breast prosthesis in accordance with the embodiment; .9 Figure 2 is a rear perspective view of the breast prosthesis as shown in Figure 1;

*.S

Figure 3 is a side elevation view of the breast prosthesis as shown in Figure 1.

2 wn

**S

;•°'Figure 4 is a rear perspective view of the breast prosthesis as shown in Figure 1 with the absorbent pad detached; Figure 5 is a view of a breast prosthesis as shown in Figure 1 inserted into a cup of a brassiere; Figure 6 is a plan view of the rear panel and sub-panels of the front panel which are stitched together to make the outer casing of a breast prosthesis as shown in Figure 1.

Best Mode for Carrying Out the Invention The following description of the preferred embodiment is not to limit the generality of the invention as disclosed above.

In the drawings, there is shown a breast prosthesis 10 according to the embodiment. The breast prosthesis 10 comprises a permeable outer casing 11 and an inert and porous filling material (not shown). which is contained within the outer casing 11. The permeable outer casing 11 comprises a front panel 12 and a rear panel 13. The front panel 12 comprises three sub-panels, an upper subpanel 14, a centre sub-panel 15 and a lower sub-panel 16. Each sub-panel and the rear panel 13 is cut from fabric into predetermined shapes and sizes according to the size and shape of breast prosthesis required.

The sub-panels are configured such that when they are sewn together and to the rear panel they define a breast shape. When filled with filling material, the outer 'casing defines the shape of the prosthesis as determined by the relationship of the size and shape of the sub-panels and rear panel. In this regard, the present embodiment provides a clear advance from certain of the prior art which required inserts within the casing to define the shape of the prosthesis.

Figure 6 illustrates the rear panel 13 and the three sub-panels used to make the front panel 12 of a breast prosthesis of one particular size. The particular 25 configuration of each sub-panel and rear panel 13 and the relationship between •them will, when sewn together, provide an outer casing which will adopt a particular shape when filled with the filling material. It will readily be appreciated that the size and shape of the resulting breast prosthesis may be varied by -7altering the size and shape of the sub-panels and the rear panel. As a result, a wide variety of sizes and shapes can be produced without incurring substantial manufacturing overhead. Custom sizes may be made to order at commercially acceptable prices.

The outer casing 11 is made of a stretch fabric which is flexible. Fabrics which include a substantial proportion of natural fibre have been found particularly suitable because they better allow the circulation of air through them,. A stretch cotton/lycra material has been found particularly suitable.

A preferred filling material is one comprised of polyester fibre. This material, when used with the outer casing of the present embodiment provides a device with a number of superior properties. Polyester fibre filling material is fibrous and when enclosed with a pervious outer casing, air is allowed to circulate through it.

This prevents excess perspiration build-up between the prosthesis and the chest of the user which a common problem with prostheses incorporating silicone material. The polyester fibre filling material is inert and is also hypoallergenic to minimise an adverse reaction when worn by persons with sensitive skin. The use of polyester fibre filling material enables the prosthesis to be washed many times without substantial deterioration. Polyester fibre does not have a predefined shape. When it is inserted into the outer casing it urges the outer casing 20 to adopt the shape defined by the sub-panels and rear panel without causing bumps or bulges in the outer casing. Polyester fibre is resilient and provides a prosthesis according to the present invention with a feel that is much more natural than that of any of the prior art prostheses. Breast prostheses according to the prior art which incorporate foam rubber or foam plastics material have a stiff, unnatural feel both due to the nature of the material itself and also due to the use of a foam member which defines the breast shape. Further, after such devices are deformed, they return to the original shape in an abrupt, unnatural manner. A prosthesis according to the present invention responds to deformation in a manner which is much more akin to a natural breast.

As shown in Figure 5, the breast prosthesis 10 according to the present embodiment is formed such that the device is insertable into the cup 18 of a brassiere 17 to be worn by the user. The size of the prosthesis is determined so that it is substantially contained within the confines of the cup 18. In the preferred embodiment, a strip 20 of hook and loop fastener material (such as that marketed under the trade mark "Velcro") is attached by adhesive means or otherwise adjacent an upper edge 21 of the front panel of the device. The hook and loop fastener material provides means of detachable adhesion of the breast prosthesis to the inside of a brassiere worn by a user. Preferably, the hook and loop fastener material is attached to the device to be engaged with the brassiere along the cleavage line of the cup of the brassiere. Because of its size, shape and deformability, the prosthesis may be used with a wide variety of commercially available brassieres of the appropriate size. The user is not required to purchase an especially-made brassiere as is necessary with many of the prior art devices. Not only does the user thereby avoid the significant expense of the such brassieres, but she is able to continue to use a variety of styles of brassieres, instead of being severely restricted in her choices as occurs where specialised brassieres must be used.

In addition the embodiment includes an inert, relatively dense, particulate material (not shown) such as sand which is contained within the outer casing and may be mixed with the filling material. The addition of the sand provides a small 20 amount of weight to the prosthesis to counteract a slight tendency for brassiere supporting one or especially two of the devices to ride upwardly on the user above its normal positioning on the body during normal physical activity of the user. The amount of weight required is considerably less than the weight of the breast being replaced and depends upon the size of the prosthesis provided.

25 The table below indicates the weight of sand that has been found to be suitable for particular prosthesis sizes (as corresponding to commonly used brassiere sizes).

l -9- SIZE WEIGHT (Bra Cup Size) (grams) 12 14 16 18 Considerable variation from the weights given above are contemplated depending upon the individual preferences of the user. The weight as set out in the table is considerably less than that of a natural breast.

The prosthesis 10 according to the preferred embodiment also includes an absorbent pad 22 removably attached to the rear panel 13 of the prosthesis. The absorbent pad 22 provides a means for absorbing perspiration and body oils excreted by the user and thereby prevents or at least greatly reduces the extent to which these are absorbed by the device itself and therefore the device needs washing only occasionally. A means of removably attaching the pad 22 to the rear panel 13 is provided by one or more sections 23 of hook and loop fastener material attached to the rear panel 13 and with corresponding strips 24 attached to the pad. In one embodiment, the absorbent pad is washable, comprising an enclosed sleeve constructed of the same material from which the outer casing is comprised into which is positioned a layer of pressed cotton. In an alternative embodiment, the pad 22 is comprised of a disposable material which is replaced regularly by the user.

Throughout the specification, unless the context requires otherwise, the word "comprise" or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated integer or group of integers but not the exclusion of any other integer or group of integers.

It is to be understood that the present invention should not be restricted to the embodiment described above. Those skilled in the art will appreciate that the invention described herein is susceptible to variations and modifications other than those specifically described. It is to be understood that the invention includes all such variations and modifications which fall within its spirit and scope.

ooooo

Claims

11. NOV. 2002 12:36 WRAY AND ASSOCIATES NO. 301 P. 3 -11 Claims The claims defining the invention are as follows: 1. A breast prosthesis comprising a permeable outer casing and an inert and porous filling material which is contained within the outer casing, wherein the permeable outer casing comprises a front panel and a rear panel, the front panel comprising a plurality of sub-panels, the sub-panels being configured such that when joined in an edge to edge relationship they define a breast shape wherein the outer casing defines the shape of the breast prosthesis when extended by the filling material and wherein the porous filling material 10 comprises a plastics material or polymeric fibre that allows circulation of air through the prosthesis. 2. A breast prosthesis as claimed at claim 1 wherein the resilient, porous filling material is also hypoallergenic and washable. 3. A breast prosthesis as claimed at claim 2 wherein the filling material 15 comprises a polyester fibre. 4. A breast prosthesis as claimed at any one of the preceding claims wherein an inert, relatively dense, particulate material is intermixed with the filling material, the weight of particulate matter added being substantially less than the weight of a natural breast. 5. A breast prosthesis as claimed at claim 4 wherein, the inert, relatively dense particulate material is sand. 6. A breast prosthesis as claimed at any one of the preceding claims wherein the outer casing is made of a stretch fabric which is flexible. 7. A breast prosthesis as claimed at claim 6 wherein the stretch fabric is formed of a natural fibre which allows circulation of air through the prosthesis. 11. NOV. 2002 12:37 WRAY AND ASSOCIATES NO. 301 P. 4 -12- 8. A breast prosthesis as claimed at claim 3 wherein the natural fibre comprises cotton. 9. A breast prosthesis as claimed at any one of the preceding claims wherein the panels and sub-panels are sewn together. 10.A breast prosthesis as claimed at any one of claims 1 to 8 wherein the panels and sub-panels are seam welded together. 11.A breast prosthesis as claimed at any one of the preceding claims wherein the breast prosthesis is formed such that the device shall be insertable into the cup of brassieres of various forms to be substantially contained within the confines of the cup. *12.A breast prosthesis as claimed at claim 11 wherein the device further comprises means for detachable adhesion of the breast prosthesis to a brassiere.

13. A breast prosthesis as claimed at claim 12 wherein the means for detachable S 15 adhesion is adjacent an upper edge of the front panel of the breast prosthesis in a position engagable along a cleavage line of a cup of a brassiere womrn by a user of the prosthesis.

14.A breast prosthesis as claimed at claim 12 or claim 13 wherein the means for detachable adhesion comprises a strip of hook and loop fastener material.

15.A breast prosthesis as claimed at any one of the preceding claims wherein the breast prosthesis further comprises means for removably attaching an absorbent pad to the rear panel of the device.

16.A breast prosthesis as claimed at claim 15 wherein means of removably attaching the pad to the rear panel is by one or more sections of hook and loop fastener material attached to the rear panel, 11. NOV. 2002 12:37 WRAY AND ASSOCIATES NO. 301 P. -13-

17.A breast prosthesis as claimed at claim 15 or claim 16 wherein the absorbent pad is washable.

18. A breast prosthesis as claimed at any one of claims 15 to 17 wherein the pad comprises an enclosed sleeve into which is positioned a layer of pressed cotton.

19.A breast prosthesis as claimed at claim 15 or claim 16 wherein the pad is comprised of a disposable material. breast prosthesis substantially as herein described with reference to the I: accompanying drawings. 10 Dated this 7th day of November 2002. MARGARET JENAWAY Applicant S: 15 Wray Associates Perth, Western Australia Patent Attorneys for the Applicant(s) 9 *eeoc *eo