IE904614A1

IE904614A1 - Process for the manufacture of breast prostheses

Info

Publication number: IE904614A1
Application number: IE461490A
Authority: IE
Inventors: Hans Georg Blau
Original assignee: Otto Thaemert Textil Und Kunst
Priority date: 1989-12-22
Filing date: 1990-12-20
Publication date: 1991-07-03
Also published as: EP0433636A2; DE59008850D1; DE3942608A1; EP0433636B1; EP0433636A3

Abstract

A process is to be provided for the production of breast prostheses which have a bag comprising two polyurethane sheets joined to each other at their edges, in which process the bottom and top sheets are joined to each other in a simple way. For this purpose, the invention provides that a sheet of hot melt adhesive which is provided with a clearance and has the form of a ring is inserted between the two polyurethane sheets, the three sheets arranged one on top of the other in this way being placed onto the edge of a blowing mould, whereupon the mould is closed, at the same time opening a feed channel, and subsequently the filling takes place by the silicone material being introduced between the two outer sheets via the feed channel, whereupon the bonding between the three sheets takes place during the temperature treatment of the mould for the crosslinking operation of the silicone.

Description

OTTO THAMERT TEXTIL- UND KUNSTSTOFF GmbH & CO. KG, D3006 Burgwedel 1, Im Steinkamp 12, Germany.

JSS181290 - 1 IE 904614 The invention relates to a process for the manufacture of breast prostheses.

For the manufacture of breast prostheses, it is known to form a bag of two polyurethane foils, which are welded together at their edges, and fill the bag with silicon. It is thus required that the two polyurethane foils, i.e. the bottom foil and the cover foil, are placed at a precisely fixed position in the welding area so that the welding seam can be precisely applied. This placement and welding is comparatively labour intensive and expensive.

It is, therefore, the object of the invention to provide a process and a breast prosthesis having a bottom and a cover foil joined in a simple manner, but with comparable results to the known process.

This object is achieved according to the invention in that synthetic-resin foil is inserted between the two polyurethane foils, whereby the three foils are together placed on the edge of a hollow-body tool, the tool is closed whilst leaving open a feed channel, and a silicon material is inserted via the feed channel between the two outer foils, and the joining of the three foils takes place during temperature treatment of the tool for a silicon bonding process .

The synthetic-resin foil is advantageously also of polyurethane. Furthermore the feed channel is preferably a feed pipe.

The bottom- and cover foils are normally up to 0.08 mm thick, whilst the synthetic-resin foil can be approximately 0.03 mm thick.

JSS181290 - 2 The inventive process can be used particularly in the manufacture of breast prostheses having several chambers arranged on top of each other. In this case, at least one synthetic-resin foil is used, which is arranged to be straight and without a hole or hollow. The two chambers, which have been formed on the one side between the syntheticresin foil and the bottom foil and on the other side between the synthetic-resin foil and the cover foil, can be filled separately by two feed channels which are separated from one another, thus offering the possibility of using fillings of different hardness, density and/or consistency as required.

The inventive process and the inventive arrangement further allow in a simple manner the arrangement of three or more chambers on top of each other, if this should be required for special application. In this case, several synthetic-resin foils are arranged on top of each other in the tool, in which respect the third and the following chambers are each formed between two adjacent synthetic resin foils .

Finally, it is possible, utilising the inventive process, to enter prosthesis material in a non-liquidised state, i.e. as a finished manufacturing component, into a breast prosthesis. This is particularly advantageous in the manufacture of light prostheses.

In this case, the additional manufacturing component, for example a foam-material body, is placed on to either a straight or annular-shaped synthetic-resin foil.

Alternatively it is possible to form this body directly on the synthetic-resin foil, for example by foaming thereon.

This applies particularly to the use of a further material, such as cotton wool or the like, which can partially replace the silicon-filled body.

In this process, a silicon-filled dish-shaped JSS18129O - 3 prosthesis body can be used which consists of two polyurethane foils and a hollow, which preferably faces towards the body of the wearer. This hollow can be filled, stiffened etc. by an additional foam-material body or the like or by cotton wool or by a combination of such materials The joining of the additional body to the dish-shaped prosthesis body is achieved by means of a synthetic-resin foil which carries the additional body. The joint to the additional body is established by heating the assembled prosthesis in a respective tool.

The invention will be described further, by way of example with reference to the accompanying drawings in which: Fig. 1 shows in a perspective illustration a breast 15 prosthesis to which the invention applies; Fig. 2 is a cross-section II-II through the breast prosthesis as in Fig. 1 in a reversed basic state, in which the foils are placed in a tool, but not yet joined; Fig- 3 is the view III-III as in Fig. 2; Fig. 4 is a cross-section similar to Fig. 2 of a different form of embodiment; Fig . 5 is a cross-section similar to Fig. 2 of a further form of embodiment; Fig. 6 is a top view of a breast prosthesis which a light prostheseis; Fig. 7 is the cross-section VII-VII as in Fig. 6; Fig. 8 is a cross-section similar to Fig. 7 in a modified form of embodiment of the breast prosthesis.

JSS181290 - 4 According to Fig. 1, a breast prosthesis 1 formed according to the invention comprises two polyurethane foils which are joined along their outer edges 2. The thus formed bag is filled via a feed pipe 3 with additionally bonding silicon. After having been filled, the breast prosthesis is subjected to heat treatment for bonding of the silicon and the foils.

Fig. 2 is an inverted cross-section of the breast prosthesis as shown in Fig. 1 and manufactured according to the inventive process. The breast prosthesis, is shown in Fig. 2 in its initial state before bonding.

It consists of a bottom foil 4, a synthetic-resin foil 5, a cover foil 6, and a feed pipe 7, which are placed together into a hollow-body tool 8.

In the embodiment illustrated in Fig. 2, the synthetic-resin foil 5 is annularly-shaped with a central hole or hollow 9. In this way the entire chamber, defined by the bottom foil 4 and cover foil 6, can be filled with silicon.

After placement of the foils in the described and illustrated manner, the cover 8a of the tool is closed, so that three foils 4, 5, 6 are pressed against each other.

Then, the chamber within the foils is filled with silicon, causing the foils to expand and abut against the walls. The heat treatment of the silicon takes place with the tool closed, which causes the synthetic-resin foil 5 to be delivered to the adhesion area, thus forming a deep joint with the two-adjacent foils 4 and 6.

Fig. 3 is a cross-sectional view of Fig. 2, showing the synthetic-resin foil 5 in the annular arrangement in which it encases the hollow 9. For clarity, the edge of tool 8 in Fig. 3 is shown, however, in practice the foils rest JSS181290 - 5 fully on the edge 8b (see Fig. 2) and even extend beyond it so that it would not normally be seen in the view of Fig. 3.

Fig. 4 shows a further embodiment whereby again an adjesive foil is used, here denoted 13 and without a hollow.

The synthetic-resin foil 13 then divides the bag, formed by foils 4 and 6, into two chambers 14 and 15, which can be separately filled with silicon via respective feed pipes 11 and 12. The use of different materials to fill each chamber 14, 15, in particular those of different elasticity or consistency, is thereby possible.

In the form of embodiment according to Fig. 5, two straight synthetic-resin foils 16 and 17 are used, which are arranged between polyurethane foils 4 and 6, thus creating three separate chambers 18, 19 and 20, which can also be separately filled with different materials. Chambers 18, 19 and 20 are each associated with respective feed pipes 21, 22 and 23 to permit such filling.

Fig. 6 offers a top view of a form of embodiment of a so-called light prosthesis including a substantially rigid additional prosthesis body 25 of a foam material or the like arranged on a synthetic-resin foil 24, which body is joined thereto when the synthetic-resin foil 24 is heated. The additional prosthesis body 25 can also be formed directly on the foil, for example by foaming thereon.

Fig. 7 is a cross-section of Fig. 6, showing the arrangement of the additional prosthesis body 25 on the synthetic-resin foil 24. The entire prosthesis can, like other known prostheses, be encased by a sleeve 26.

Fig. 8 is a cross-section generally similar to Fig. 7 of a modified embodiment of the invention. With this prosthesis, a dish-shaped prosthesis body 34, consisting of two polyurethane foils 27 and 28, is formed, thereby JSS18129O - 6 establishing a dish-shaped chamber 29 between the two polyurethane foils 27 and 28. The chamber 29 is filled by silicon or a similar material which enters via a supply pipe 30 for the purpose of stiffening.

Due to the dish-shape, the prosthesis body 34, consisting of polyurethane foils 27 and 28, has a hollow 31, which preferably faces towards the body of the wearer and is stiffened by means of for example a foam material, cotton wool or the like. The hollow 31 can then be covered again by a synethetic-resin foil 32, which is connected in the edge region 33 with the dish-shaped prosthesis body 34. Prior to this, the two foils 27 and 28 of the dish-shaped prosthesis body 34 can be welded to one another.

Claims

1. A process for the manufacture of breast prostheses comprising a silicon filled bag, composed of two polyurethane foils which are joined together at their edges, characterised 5 in that the prosthesis includes a synthetic-resin foil, the three foils being stacked together and placed on the edge of a hollow-body tool, whereupon the tool is closed, whilst leaving open a feed channel to a chamber between the foils, the chamber being subsequently filled by a silicon material 10 entering via the feed channel and the three foils are joined by the temperature treatment of the tool for a silicon bonding process.

2. A process according to claim 1, characterised in that the synthetic-resin foil is also composed of polyurethane. 15

3. A process according to claim 1 or 2, characterised in that the feed channel is a feed pipe (7).

4. A process according to one of the preceding claims, characterised in that the outer polyurethane foils (4, 6), which serve as bottom- and cover foil, have a thickness of up 20 to 0.08 mm, whilst the synthetic-resin foil is approximately 0.03 mm thick.

5. A process according to any of the preceding claims characterised in that the synthetic-resin foil is of annular configuration providing a central hole therein. 25

6. A process according to any preceding claim characterised in that the synthetic resin foil is placed between the two polyurethane foils.

7. A process according to claim 1 for the manufacture of breast prostheses having a plurality of chambers stacked on 30 top of each other, characterised in that the synthetic-resin JSS18129O - 8 foil is arranged between the two outer polyurethane foils and is formed as continuous sheet so as to provide two separated chambers .

8. A process according to claim 7 characterised in that the 5 two chambers are formed on the one side between the synthetic-resin foil and the bottom foil and on the other side between the synthetic-resin foil and the cover foil and are filled separately via two separate feed channels.

9. A process according to claim 8 characterised in that the 10. Fillings of different chambers are of different hardness, density and/or consistency.

10. A process according to one of claims 7 to 9 characterised in that three or more chambers are arranged on top of each other inside the breast prosthesis, in which 15 respect the third and the following chambers are each formed between two adjacent synthetic foils.

11. A process according to claim 1 characterised in that an additional prosthesis body of foam material or the like is applied to, and joined with the synthetic resin foil. 20

12. A process according to claim 11, characterised in that the foam-material body is formed directly on the syntheticresin foil by foaming thereon.

13. A process according to claim 11, characterised in that the additional prosthesis body is composed of an easily 25 deformable material formed onto the synthetic-resin foil.

14. A process according to claim 1 or 11, characterised in that a silicon-filled dish-shaped prosthesis body is formed which body consists of two polyurethane foils and includes a hollow which faces towards the body of the wearer. JSS18129O

15. A process according to claim 14, characterised in that the hollow includes a first supplementary body of deformable material and by a second supplementary body consisting of a combination of deformable materials. 5

16. A process according to claim 15, characterised in that the joining between the dish-shaped prosthesis body is achieved by means of a synthetic-resin foil which carries one supplementary body.

17. A process according to one of claims 10 to 16, 10 characterised in that the joining between the synthetic-resin foil and the additional prosthesis body and/or the supplementary body and/or dish-shaped prosthesis body is achieved by heating in a respective tool.

18. A process for the manufacture of breast prosthesis, the process 15 being substantially as described herein with reference to and as illustrated in the accompanying drawings.

19. A breast prosthesis manufactured according to the process of any of Claims 1 to 18.

20. Breast prosthesis substantially as described herein with 20 reference to and as illustrated in the accompanying drawings. Dated this 20th day of December 1990 Agents for the Applicants, Clifton House, Lower Fitzwilliam Street, Dublin 2. JSS18129O 10 PROCESS FOR THE MANUFACTURE OF BREAST PROSTHESES A process for the manufacture of breast prostheses including a bag of two polyurethane foils 4, 6 which are joined to one another at their edges 2, is provided, 5 permitting the bottom- and the cover foil 4, 6 to be joined in a simple manner. The invention thus provides a process comprising the insertion of a synthetic-resin foils preferably between the two polyurethane foils 4, 6 which foil may be of annular 10 shape and provided with a hole or hollow whereby the three foils, which are arranged on top of each other, are placed on the edge of a hollow-body tool 8, the tool being closed whilst leaving open a feed channel 7 to a chamber between the foils, the chamber being subsequently fitted by the silicon 15 material which enters via the feed channel inbetween the two outer foils, and the joining of the three foils takes place by temperature treatment of the tool for a silicon bonding process .'•11