Method for producing a breast prosthesis having an adjustable volume

Abstract

The invention relates to a method for producing a breast prosthesis (1) having an adjustable volume, wherein the breast prosthesis comprises a first shell body (10), a second shell body (20) which is circumferentially connected thereto, and a fluid chamber (30) arranged between the shell bodies, wherein the method comprises the following steps: (a) peripherally connecting four plastic films to provide a template comprising three chambers; (b) filling the upper and lower chambers with a crosslinkable silicone filler; and (c) crosslinking the silicone filler.

Claims

1. A method of producing a breast prosthesis (1) having an adjustable volume by a user, wherein the breast prosthesis (1) has a first shell body (10), a second shell body (20) peripherally connected thereto, and a fluid space (30) arranged between said shell bodies (10, 20) and fillable by the user to a desired volume, the method comprising the following steps: (a) peripherally connecting four plastic films to provide a template comprising three chambers; (b) filling upper and lower chambers with a crosslinkable silicone compound; and (c) crosslinking the silicone compound, and (d) inserting a valve tube (40) between two middle films to form radial access to the fluid space (30) and attaching the valve tube (40) to the prosthesis (1) as part of the peripheral connection of the four plastic films in accordance with step (a).

2. A method in accordance with claim 1, wherein the peripheral connection of the four plastic films in accordance with step (a) is a peripheral welding.

3. A method in accordance with claim 1, wherein, to form access to a respective chamber, an interruption is left free between the two upper films and/or between two lower films during the peripheral connection of the four plastic films in accordance with step (a).

4. A method in accordance with claim 3, wherein the filling of the upper and/or lower chambers in accordance with step (b) takes place through the interruption.

5. A method in accordance with claim 1, wherein the crosslinking of the silicone compound takes place by increasing temperature.

6. A method in accordance with claim 1, additionally comprising a step of introducing a medium for reducing adhesive tendency of the oppositely disposed inner surfaces of the shell bodies (10, 20) bodes into the fluid space (30).

7. A method in accordance with claim 6, wherein the medium for reducing the adhesive tendency of the oppositely disposed inner surfaces of the shell bodies (10, 20) is introduced before the filling of the upper and lower chambers with a crosslinkable silicone compound in accordance with step (b).

8. A method in accordance with claim 6, wherein the medium for reducing the adhesive tendency of the oppositely disposed inner surfaces of the shell bodies (10, 20) is introduced between the filling of the upper and lower chambers with a crosslinkable silicone compound in accordance with step (b) and the crosslinking of the silicone compound in accordance with step (c).

9. A method in accordance with claim 6, wherein the medium for reducing the adhesive tendency of the oppositely disposed inner surfaces of the shell bodies (10, 20) is introduced after the crosslinking of the silicone compound in accordance with step (c).

10. A method in accordance with claim 1, wherein the valve tube (40) is inserted to externally extend into the fluid space (30) beyond a connection region between the first and second shell bodies (10, 20).

11. A method in accordance with claim 10, wherein the valve tube (40) is composed of flexible material and provided with a check valve to allow the user to subsequently fill and empty the fluid space (30), after production.

12. A method in accordance with claim 11, wherein the plastic films are peripherally welded together to form a peripheral weld seam (15) between the first and second shell bodies (10, 20), and the valve tube (40) penetrates the weld seam (15) in a radial direction, extends up to an end of the weld seam (15), projects freely into the fluid space (30) without being connected to one of the first and second shell bodies (10, 20) beyond the weld seam (15), and is freely movable within the fluid space (30).

13. A method in accordance with claim 6, wherein the medium for reducing the adhesive tendency of the oppositely disposed inner surfaces of the shell bodies (10, 20) is introduced into the fluid space (30) through the valve tube (40).

14. A method in accordance with claim 11, wherein the check valve is a flutter valve.

15. A method in accordance with claim 1, wherein the valve tube (40) is adhesively bonded or welded between the two middle films and penetrates a weld or adhesive seam between the films in a radial direction.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) Further details and advantages of the invention result from the following embodiment described with reference to the Figures. There are shown in the Figures:

(2) FIG. 1: a schematic representation of a volume-adjustable breast prosthesis produced using the method in accordance with the invention;

(3) FIG. 3: a chart of an embodiment variant of a method in accordance with the invention;

(4) FIG. 3: a chart of a further embodiment variant of a method in accordance with the invention; and

(5) FIG. 4: a chart of yet another embodiment variant of a method in accordance with the invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

(6) The breast prosthesis 1 having an adjustable volume shown in FIG. 1 can be produced using a method in accordance with the invention. The breast prosthesis 1 comprises a first shell body 10 at the lower side of the prosthesis 1 facing the wearer and a second shell body 20 peripherally connected thereto and at the upper side of the prosthesis 1 facing away from the wearer. Both shell bodies 10 and 20 are film bags that are fill with a crosslinked two-component silicone rubber compound. The film bags are each produced from two plastic film pieces that are welded to one another along the common peripheral surface.

(7) The shell bodies 10 and 20 are in turn connected along a peripheral weld seam 15 such that a fluid space 30 is formed between them that can, for example, be filled with air, but also with a liquid. The volume of the breast prosthesis 1 can be adjusted by filling and emptying the fluid space 30.

(8) To make a subsequent filling and emptying of the fluid space 30 possible, i.e. one taking place after the production, the breast prosthesis 1 comprises a valve tube 40 that is composed of a flexible plastic material, that comprises a flat flutter valve, that penetrates the weld seam 15 in the radial direction, and that is welded between the shell bodies 10 and 20 in this process. The valve tube 40 does not only reach up to the end of the weld seam 15, but projects freely, i.e. without being connected to one of the shell bodies 10 or 20, beyond the weld seam 15 into the fluid space 30. The section of the valve tube 40 projecting into the fluid space 30 is therefore freely movable in the fluid space 30.

(9) To prevent a sticking together of the plastic inner surfaces of the two shell bodies 10 and 20 due, for example, to electrostatic interaction and thus an unwanted adhesion of the fluid space 30, the fluid space 30 is filled with a smaller amount of silicone oil.

(10) Three variants of possible procedures of a method in accordance with the invention for producing the breast prosthesis 1 shown in FIG. 1 are shown schematically in FIGS. 2-4.

(11) It is common to all the methods that four plastic films for providing a template comprising three chambers are peripherally connected in a first step 100 corresponding to step (a).

(12) In a first variant of the method procedure, such as shown in FIG. 2, a step 200, corresponding to step (b), follows on directly from this, with the upper chamber, i.e. the chamber between the upper two films, and the lower chamber, i.e. the chamber between the upper two films, are filled with a crosslinkable two-component silicone compound. The hardening by the effect of heat in accordance with step 300, corresponding to step (c), then follows. The introduction of the medium for reducing the adhesive tendency of the oppositely disposed inner surfaces of the shell bodies only takes place in a last step 400 subsequent to this step.

(13) In a second variant of the method procedure such as shown in FIG. 3, step 100 is furthermore directly followed by step 200, with the medium for reducing the adhesive tendency of the oppositely disposed inner surfaces of the shell bodies in accordance with step 400, however, taking place before the hardening by the effect of heat in accordance with step 300, corresponding to step (c).

(14) In a third variant of the method procedure such as shown in FIG. 4, step 100 is directly followed by the introduction of the medium for reducing the adhesive tendency of the oppositely disposed inner surfaces of the shell bodies in accordance with step 400. The silicone compound is only subsequently introduced into the upper and lower chambers and hardened in accordance with steps 200 and 300.

(15) The hardening of the silicone compound in accordance with step 300 respectively takes place here in a shaping tool under the effect of temperature. The passages in the weld seams through which the silicone compounds are filled into the upper and lower chambers can be welded in these shaping tools, either before or after hardening.