GB2522623A

GB2522623A - Covers for prostheses

Info

Publication number: GB2522623A
Application number: GB1401489.8A
Authority: GB
Inventors: Robert John Watts
Original assignee: Individual
Current assignee: Individual
Priority date: 2014-01-29
Filing date: 2014-01-29
Publication date: 2015-08-05
Also published as: GB201401489D0

Abstract

A method of making a cover for a breast form, the method comprising the steps of: (a) providing a model cast 9 having a projection 13, fig that conforms, at least in part, to the shape of a breast form 21; (b) providing a gel mould 1 having a depression 5 that is shaped to conform to the shape of a breast form associated with said model cast 9, which breast form has had a cover 17 fitted thereover; (c) inserting a measure of gel 15 into said depression 5; (d) coupling the model cast 9 and gel mould 1 together so that the projection 13 fits into said depression 5 and in so doing distributes said gel throughout a cavity formed between the coupled model cast 9 and gel mould 1; (e) allowing the gel to cure; and (f) separating the model cast 8 and gel mould 1 to reveal a cover 17 for a breast form 21.

Description

COVERS FOR PROSTHESES

Field

This invention relates to covers for prostheses, particularly but not exclusively to covers for prosthetic breasts. In another aspect, the invention relates to a method of manufacturing such covers.

Background to the Invention

Due to injury or illness, a significant number of women have had to undergo surgical procedures to have one or both of their breasts removed. Some of these women are able to have breast reconstruction surgery to restore a normal appearance, but many others are considered to be unsuitable for surgery. Many of these women, for whom surgery is not an option, choose to utilise breast prostheses to provide them with a more conventional appearance.

A typical breast prosthesis is the "Contact is Comfort+" breast prosthesis supplied by Amoena (UK) Ltd of 1 Eagle Close, Chandlers Ford, Eastleigh, Hampshire S053 4NF (see: www.amoenacouk). This prosthesis (known in the art as a "breast form") comprises a symmetrical generally triangular body of silicone that is shaped to resemble a breast. The silicone body has a rear face that is generally flat and is provided with a plurality of adhesive silicone beads so that the prosthesis can be stuck directly to the chest of the wearer Such breast form prostheses are intended to be worn under clothing and do provide the wearer with a more conventional body shape. However, these prostheses are still readily identifiable as being prostheses, and hence many users feel uncomfortable wearing clothing (for example, swimwear, or dresses with lower necklines) that might expose part of the prosthesis.

Breast removal surgery can be a traumatic experience for many women, and the fact that certain items of clothing are no longer wearable post-surgery can add to the trauma and upset experienced by these women.

The present invention has been devised with the foregoing problems in mind.

Summary of the Invention

In accordance with a presently preferred embodiment of the present invention, there is provided a method of making a cover for a breast form, the method comprising the steps of: (a) providing a model cast having a projection that conforms, at least in part, to the shape of a breast form; (b) providing a gel mould having a depression that is shaped to conform to the shape of a breast form associated with said model cast, which breast form has had a cover fitted thereover; (c) inserting a measure of gel into said depression; (d) coupling the model cast and gel mould together so that the projection fits into said depression and in so doing distributes said gel throughout a cavity formed between the coupled model cast and gel mould; (e) allowing the gel to cure; and (f) separating the model cast and gel mould to reveal a cover for a breast form.

Preferably said depression includes a smaller secondary depression shaped to resemble a nipple.

The method may further comprise the step of cosmetically enhancing the revealed cover so that said cover more closely matches at least the skin tones of a user.

The method may further comprise the step of fixedly attaching the cover revealed in step (f) to a breast form. In this implementation the breast form to which said cover is attached may be associated with said model cast.

Preferably said gel is of silicone.

Preferably the cover revealed in step (f) is of 30 to 50 shore A silicone.

Another implementation provides a breast prosthesis comprising: a breast form that can be adhered to the chest of a user, and a cover manufactured by means of a method described herein, the cover being fitted over and secured to the breast form prosthesis.

Another aspect of the invention relates to a method of making a gel mould for use with the method described herein, the method comprising: (a) providing a model cast having a projection that conforms, at least in part, to the shape of a breast form; (b) applying a cover over at least part of the projection of said model cast; and (c) creating a mould with a depression that conforms in shape to the covered projection produced in step (b).

A further aspect of the invention relates to a method of making a model cast for use with the method of any preceding claim, the method comprising: (a) creating a positive cast of a breast form; (b) mounting said positive cast on a support; (c) creating, from the positive cast on said support, a negative cast of said breast form, the negative cast having a depression that conforms, at least in part, to the shape of said breast form and at least part of said support; and (d) creating, from said negative cast, a positive cast of the breast form supported by part of said support.

Other features, advantages and embodiments incorporating the teachings of the invention are set out in the detailed description provided below.

Brief Description of the Drawings

Various aspects of the teachings of the present invention, and arrangements embodying those teachings, will hereaftel be described by way of illustrative example with reference to the accompanying drawings, in which: Fig. 1 is a schematic cross-sectional representation of a negative gel mould; Fig. 2 is a schematic cross-sectional representation of a positive model cast; Figs. 3(a) to 3(d) schematically represent one illustrative method of manufacturing a cover for a breast form; Fig. 4 is a schematic cross-sectional representation of a breast prosthesis; Figs. 5(a) to 5(e) schematically represent one illustrative method of manufacturing a positive model cast of the type depicted in Fig. 2; and Figs. 6(a) to 6(d) schematically represent one illustrative method of manufacturing a gel mould of the type depicted in Fig. 1.

Detailed Description of Preferred Embodiments

Referring now to the drawings, Fig. 1 is a schematic cross-sectional view of a negative gel mould 1. An illustrative manner in which the gel mould 1 may be formed will be described in detail below.

The gel mould 1 comprises a block 3 of, for example, plaster in which a breast shaped depression 5 has been formed. The depression includes a secondary depression 7 that resembles the nipple of a breast. As will later be explained in detail, the primary depression conforms in size and shape to a desired breast form that has been covered with a silicone cover. Similarly, the secondary depression conforms in size and shape to a desired nipple shape that may be of a generic shape or -in one embodiment -be chosen by the user for whom the cover is to be manufactured.

Fig. 2 is a schematic cross-sectional view of a positive model cast 9 that comprises a block 11 of, for example, plaster with a hump 13 that -at least in part -replicates the size and shape of a desired breast form (for example, the illustrative breast form mentioned above) that the cover is to used with. An illustrative method for producing this model cast will be later described in detail below.

Figs. 3(a) to 3(d) illustrate the steps of an illustrative method for producing a cover for a breast prosthesis using the gel mould of Fig. 1 and the model cast of Fig. 2.

In a first step of the method, depicted in Fig. 3(a), the depression 5 of the gel mould is covered with a release layer (for example, sprayed with wax release), following which a measure of silicone gel 15 is poured into the depression 5 of the gel mould 1. In a second step, the positive model cast 9 is inverted and mated with the gel mould 1 so that the hump 13 projects into the depression 5, and forces the silicone gel 15 up around the hump 13 to form a breast form cover 17. The gel mould 1 and model cast 9 are then clamped together, and put in an oven (for example, for about 3 hours at about 40 to 50 degrees centigrade) until the silicone get has cured. Once the silicone gel has cured, the gel mould is separated from the model cast thereby revealing the cover 17 mounted on the hump 13 of the model cast 9. Any excess silicone is then trimmed from around the periphery of the cover 17, following which the cover 17 can be removed from the model cast 9 and fixedly aftached (for example, adhered) to the breast form associated with the model cast 9 to form a breast prosthesis.

Fig. 4 is a schematic cross-sectional view of one such breast prosthesis 19. As shown the prosthesis comprises a breast form 21 (for example, a breast form of the type previously described), over which a cover 17 of the type described above has been fitted and adhered. As aforementioned, the breast form 19 has a generally flat face on which a plurality of adhesive nodules 21 (for example, of so-called sticky silicone) are mounted so that the prosthesis can be securely, and removably, adhered to the chest of the user.

It is also envisaged that the cover 17 could be cosmetically treated (for example, painted) to improve the cosmesis of the finished breast prosthesis, and to make it look more like a natural breast. Such cosmetic treatment of prosthetic covers is well known in the art, and hence will not be described here in detail.

In preferred implementations of the invention the silicone cover has a shore A hardness of between 30 and 50, preferably around 35 to 40.

Figs 5(a) to 5(e) show one illustrative method for manufacturing a model cast of the type depicted in Fig. 2. For simplicity, conventional steps -such as the inclusion of moulded natches, and the coating of moulds with wax release -have been omitted from

this description.

In a first step of the process shown in Fig. 5(a), a breast form is removed from its packaging, and the empty packaging 25 is filled with plaster 27. The plaster is allowed to harden thereby forming a reproduction of the breast form that was initially removed from the packaging. As shown in Fig. 5(b), the reproduction 29 is placed on a support 31, and then the edges of the reproduction are extended (so the cover will later properly fit over the breast form), for example by fitting and smoothing clay around the periphery of the reproduction 29 in the region represented by the dashed lines in Fig. 5(b) (care should be taken at this point to ensure that the additional clay closely follows the line of the plaster reproduction 29).

Once the edges of the reproduction 29 have been extended and the clay has dried, the extended cast 33 is placed in a cottle (as shown in Fig. 5(c)). for example of plastic sheeting 35, and plaster 37 is poured over the extended cast 33 created in Fig. 5(b). Once the plaster 37 has dried, the cottle 35 is removed and a negative impression 39 (Fig. 5(d) of the extended cast 33 is revealed. As shown in Fig. 5(e) the negative impression 39 is then placed in a cattle (for example of plastic sheeting 35) and plaster 37 is poured into the cottle. Once the plaster 37 has dried, the cottle 35 and the negative impression 39 of the extended cast are removed to reveal (as shown in Fig. 5(e)) a positive model cast 9 of the type depicted in Fig. 2.

Figs. 6(a) to 6(d) schematically represent one illustrative method of manufacturing a gel mould of the type depicted in Fig. 1. The method commences with a positive model cast 9 of the type depicted in Fig. 2. As shown in Fig. 6(a) silicone is applied to the positive model cast 9 so that a silicone layer 41 is built up which increases smoothly in thickness to a thickness of about 2.5 mm at the peak of the hump 13. In the next step of the method, depicted schematically in Fig. 6(b), a nipple shaped projection 43 is fixed to the silicone layer 41. In one envisaged implementation, the nipple projection 43 may be chosen by the eventual user of the prosthesis from a plurality of differently shaped and sized nipples. In another envisaged implementation, the nipple projection may comprise a mould (for example a press mould) of the user's remaining nipple.

Once the nipple has been attached, the cast 45 is placed in a cottle 35 (as shown in Fig. 5(c) that is then filled with plaster 37. Once the plaster has dried and the cottle 35 and cast 45 are removed, a negative gel mould 5 of the type depicted in Fig. 1 is revealed.

In an envisaged implementation of the teachings of the invention, gel moulds and associated model casts will be created for a variety of different breast shapes and sizes so that a cover can be produced that closely matches a user's remaining breast.

As will be apparent from the foregoing, the teachings of the present invention enable realistic breast prostheses to be produced for a relatively small cost.

It will also be appreciated that whilst various aspects and embodiments of the present invention have heretofore been described, the scope of the present invention is not limited to the particular arrangements set out herein and instead extends to encompass all arrangements, and modifications and alterations thereto, which fall within the scope of the appended claims.

For example, it is envisaged that the cover 17 could be supplied to users who already own breast forms so that the users can attach the cover to their own breast forms. This would be advantageous as users can reuse their existing breast forms (which forms can be relatively expensive to purchase, for example in the order of several hundred pounds).

It is also the case that whilst plaster is a suitable material for the moulds and casts mentioned above, any of a variety of different mould/cast materials may instead be employed.

Lastly, It should also be noted that whilst the accompanying claims set out particular combinations of features described herein, the scope of the present invention is not limited to the particular combinations hereafter claimed, but instead extends to encompass any combination of features herein disclosed.

Claims

CLAIMS1. A method of making a cover for a breast form, the method comprising the steps of: (a) providing a model cast having a projection that conforms, at least in part, to the shape of a breast form; (b) providing a gel mould having a depression that is shaped to conform to the shape of a breast form associated with said model cast, which breast form has had a cover fitted thereover; (c) inserting a measure of gel into said depression; (d) coupling the model cast and gel mould together so that the projection fits into said depression and in so doing distributes said gel throughout a cavity formed between the coupled model cast and gel mould; (e) allowing the gel to cure; and (f) separating the model cast and gel mould to reveal a cover for a bleast form.
2. A method according to Claim 1, wherein said depression includes a smaller secondary depression shaped to resemble a nipple.
3. A method according to Claim 1 or 2, comprising the step of cosmetically enhancing the revealed cover so that said cover more closely matches at least the skin tones of a user.5. A method according to any preceding claim, comprising the step of fixedly attaching the cover revealed in step (f) to a breast form.6. A method according to Claim 5, wherein the breast form to which said cover is attached is associated with said model cast.7. A method according to any preceding claim, wherein said gel is of silicone.8. A method according to Claim 7, wherein the cover revealed in step (f) is of 30 to shore A silicone.9. A breast prosthesis comprising: a breast form that can be adhered to the chest of a user, and a cover manufactured by means of a method according to any preceding claim, the cover being fitted over and secured to the breast form prosthesis.10. A method of making a gel mould for use with the method of any of Claims ito 8, the method comprising: (a) providing a model cast having a projection that conforms, at least in part, to the shape of a breast form (b) applying a cover over at least part of the projection of said model cast; and (c) creating a mould with a depression that conforms in shape to the covered projection produced in step (b).ii. A method of making a model cast for use with the method of any preceding claim, the method comprising: (a) creating a positive cast of a breast form; (b) mounting said positive cast on a support; i5 (c) creating, from the positive cast on said support, a negative cast of said breast form, the negative cast having a depression that conforms, at least in part, to the shape of said breast form and at least part of said support; and (d) creating, from said negative cast, a positive cast of the breast form supported by pad of said support.12. A method substantially as hereinbefore described with reference to the accompanying drawings.13. A breast prosthesis substantially as hereinbefore described with reference to Fig. 4 of the accompanying drawings.