Breast prosthesis having a closure stopper for a filling passage

Abstract

The invention relates to a method of manufacturing a breast prosthesis having a shell-like body that has a film bag having a filling, wherein the method comprises the following steps: welding and/or adhering plastic films while leaving a region free to form a film bag having a filling passage; injecting a flowable filler material through the filling passage into the film bag; and welding and/or adhering the plastic films in the region of the filling passage to close the film bag, wherein a flowable sealing compound is injected that comes to lie between the filling passage and the filler material and forms a stopper after the injection of the filler material and before the closing of the film bag.

Claims

1. A method of manufacturing a breast prosthesis having a shell-like body that has a film bag having a filling, the method comprising: welding and/or adhering plastic films while leaving a region free to form a film bag having a filling passage; injecting a flowable filler material through the filling passage into the film bag; and welding and/or adhering the plastic films in the region of the filling passage to close the film bag, wherein a flowable sealing compound is injected that comes to lie between the filling passage and the filler material and forms a stopper after the injection of the filler material and before the closing of the film bag.

2. The method in accordance with claim 1, wherein the sealing compound is configured such that it can be solidified to form an elastic sealing material.

3. The method in accordance with claim 2, wherein the sealing compound is a curable silicone.

4. The method in accordance with claim 2, wherein the sealing compound is a hot melt adhesive that is injected at an elevated injection temperature in a liquid state; or wherein the sealing compound is a chemically hardening and silicone-free plastic adhesive.

5. The method in accordance with claim 1, further comprising solidifying the sealing compound.

6. A method of manufacturing a breast prosthesis having a shell-like body that has a film bag having a filling, wherein the method comprises: welding and/or adhering plastic films while leaving a region free to form a film bag having a filling passage; injecting a flowable and curable filler material through the filling passage into the film bag; and welding and/or adhering the plastic films in the region of the filling passage to close the film bag, wherein after the injection of the filler material and before the closing of the film bag, a curing agent is injected that mixes with the filler material in the region of the filling passage, or wherein a curing agent is externally applied to the plastic films in the region of the filling passage.

7. A breast prosthesis having a shell-like body that has a film bag having a filling, wherein the film bag comprises plastic films connected along a weld seam and/or adhesive seam, wherein a stopper of a sealing material is located between the filling and a part section of the weld seam and/or adhesive seam.

8. The breast prosthesis in accordance with claim 7, wherein the sealing material is a non-flowable elastic material.

9. The breast prosthesis in accordance with claim 7, wherein the stopper adjoins the part section of the weld seam and/or adhesive seam in a cap shape.

10. The breast prosthesis in accordance with claim 7, wherein the filling is a shear thinning compound having a flow limit.

11. The method in accordance with claim 3, wherein the sealing compound is liquid silicone.

12. The method in accordance with claim 5, further comprising curing the sealing compound.

13. The method in accordance with claim 8, wherein the sealing material is silicone rubber.

14. The method in accordance with claim 10, wherein the filling is a low-cured silicone gel.

Description

[0026] Further details and advantages of the invention will be described with reference to the embodiment shown in the Figures. There are shown in the Figures:

[0027] FIG. 1: a plan view of a film bag of a breast prosthesis in accordance with the invention; and

[0028] FIG. 2: an enlarged representation of the region of the closed filling opening with a stopper.

[0029] The Figures show a shell-like film bag of a breast prosthesis in accordance with the invention in a plan view. The film bag is generally marked by the reference numeral 1. It forms a breast prosthesis in addition to at least one further shell-like film bag that can adjoin in the form of a sandwich as well as, optionally, further elements such as textile inserts.

[0030] The film bag 1 is formed by two congruent film pieces 2 of a thermoplastic plastic film that are welded along the common peripheral margin and form a weld seam 3. A low-cured silicone gel is located as a filler material, that is plastically deformable, in the chamber 4 that is bounded by the plastic films 2. The film bag 1 shown therefore forms the part of a breast prosthesis that can deform plastically and thus makes it possible that the breast prosthesis can be matched to the shape of the scar tissue.

[0031] A stopper 5 of cured silicone rubber contacts the weld seam 3 in a small marginal region of the chamber 4. The stopper extends, starting from a section 6 of the weld seam at which the filling opening was located during the manufacturing process of the film bag 1, into the interior of the chamber 4 in a cap shape. The material of the stopper is also present in the region 6 of the weld seam and serves as a welding aid or as a thermally activated adhesive in this region.

[0032] On the manufacture of the shown film bag 1, the two plastic films 2 are first welded along the common periphery while leaving free the region 6 to form a film bag. The filling opening for the chamber 4 is located in the region left free. Subsequently, a flowable filler material is injected into the chamber 4 through the filling passage. A further injection process subsequently takes place in which a small quantity of a curable sealing compound of liquid silicone is injected that later forms the stopper. The plastic films 2 are subsequently also welded in the region 6 of the filling passage. The liquid silicone of the stopper is thermally activated in this process and serves as a welding aid. The stopper 5 is already vulcanized during this welding closed of the filling passage and also as part of a subsequent furnace process such that it is hardened into a rubber-elastic silicone rubber.

[0033] It is thus achieved that the stopper protects the region 6 of the weld seam 3 that represents a weak point for conventional products against the effect of pressure in wear and as part of the quality control and thus the stability and service life of the breast prosthesis is increased.