METHOD FOR MANUFACTURING A BREAST PROSTHESIS

Abstract

The invention relates to a method for manufacturing a breast prosthesis, in which a first dispersion of a first granular material is introduced into a cross-linkable silicone compound. The silicone compound subsequently is cured in order to form a prosthesis body, wherein the prosthesis body is heated to a shrinking temperature which lies above the melting point of the thermoplastic material.

Claims

1. A method for manufacturing a breast prosthesis, comprising the following steps: (b) introducing a first dispersion of a first granular material in a crosslinkable silicone compound into a cavity of a casting mold, wherein the first granular material is a porous and preferably foamed thermoplastic material; (d) curing of the silicone compound to form a prosthesis body; and (f) heating of the prosthesis body to a shrinking temperature which lies above the melting point of the thermoplastic material.

2. The method according to claim 1, wherein the plastic material is expanded polystyrene, expanded polyethylene or expanded polypropylene.

3. The method according to claim 1, wherein the plastic material has a melting point of 120-180 C. and that the shrinking temperature lies between 140-200 C.

4. The method according to claim 1, wherein the method furthermore comprises the following step preceding step (b): (a) manufacturing a skin layer of the breast prosthesis, wherein a cross-linkable silicone compound is poured into the cavity, brought into layer form and cured.

5. The method according to claim 1, wherein the method furthermore comprises the following step carried out between steps (b) and (d): (c) manufacturing a pore-free terminal zone of the prosthesis body.

6. The method according to claim 1, wherein the method furthermore comprises the following step carried out between steps (d) and (f): (e) manufacturing a contact layer of the breast prosthesis, wherein a second dispersion of second granular material in a cross-linkable silicone compound is introduced into the cavity already containing the prosthesis body such that the back of the prosthesis body is at least partly covered, and the silicone compound of the second dispersion subsequently is cured.

7. The method according to claim 6, wherein the second granular material also is a foamed thermoplastic material whose melting point lies below the shrinking temperature.

8. The method according to claim 6, wherein the average particle diameter of the second granular material is greater than the average particle diameter of the first granular material.

9. The method according to claim 5, wherein a phase-change material is introduced into the pore-free terminal zone and/or the contact layer.

10. A breast prosthesis with a porous prosthesis body, wherein the prosthesis is manufactured by a method according to claim 1.

11. The breast prosthesis according to claim 10, wherein the breast prosthesis includes a pore-free skin layer adjoining the front side of the prosthesis body, and/or the prosthesis body includes a pore-free backside terminal zone, and/or the breast prosthesis includes a porous contact layer adjoining the back of the prosthesis body.

12. The method according to claim 2, wherein the plastic material has a melting point of 120-180 C. and that the shrinking temperature lies between 140-200 C.

13. The method according to claim 12, wherein the method furthermore comprises the following step preceding step (b): (a) manufacturing a skin layer of the breast prosthesis, wherein a cross-linkable silicone compound is poured into the cavity, brought into layer form and cured.

14. The method according to claim 3, wherein the method furthermore comprises the following step preceding step (b): (a) manufacturing a skin layer of the breast prosthesis, wherein a cross-linkable silicone compound is poured into the cavity, brought into layer form and cured.

15. The method according to claim 2, wherein the method furthermore comprises the following step preceding step (b): (a) manufacturing a skin layer of the breast prosthesis, wherein a cross-linkable silicone compound is poured into the cavity, brought into layer form and cured.

16. The method according to claim 15, wherein the method furthermore comprises the following step carried out between steps (b) and (d): (c) manufacturing a pore-free terminal zone of the prosthesis body.

17. The method according to claim 14, wherein the method furthermore comprises the following step carried out between steps (b) and (d): (c) manufacturing a pore-free terminal zone of the prosthesis body.

18. The method according to claim 13, wherein the method furthermore comprises the following step carried out between steps (b) and (d): (c) manufacturing a pore-free terminal zone of the prosthesis body.

19. The method according to claim 12, wherein the method furthermore comprises the following step carried out between steps (b) and (d): (c) manufacturing a pore-free terminal zone of the prosthesis body.

20. The method according to claim 4, wherein the method furthermore comprises the following step carried out between steps (b) and (d): (c) manufacturing a pore-free terminal zone of the prosthesis body.

Description

[0025] Further details and advantages of the invention can be taken from the exemplary embodiment described below with reference to the Figures. In the Figures:

[0026] FIG. 1: shows an embodiment of a breast prosthesis according to the invention;

[0027] FIG. 2: shows another embodiment of a breast prosthesis according to the invention;

[0028] FIG. 3: shows a casting mold for manufacturing a breast prosthesis according to the invention with a nipple imitation inserted into the cavity;

[0029] FIG. 4: shows the casting mold of FIG. 3 with a skin layer covering the cavity;

[0030] FIG. 5: shows the casting mold of FIG. 4 with a first dispersion poured in; and

[0031] FIG. 6: shows the casting mold of FIG. 5 with a second dispersion poured in.

[0032] FIGS. 1-2 show two different embodiments of breast prostheses according to the invention. Both prostheses comprise a porous prosthesis body 10 which on its front side has a pore-free skin layer 20 and on its back a pore-free terminal zone 11. On the front side of the skin layer 20 a nipple imitation 21 furthermore is mounted. The layers 10 and 20 as well as preferably also the nipple imitation 21 are fabricated from silicone rubber.

[0033] The breast prosthesis shown in FIG. 21 additionally comprises a porous contact layer 30 which adjoins the back of the prosthesis body 10. All layers 10, 20 and 30 as well as preferably also the nipple imitation 21 are fabricated from silicone rubber, wherein the layers 10 and 30 have a different porosity and different pore structures.

[0034] The pores 32 of the porous contact layer 30 are larger than the pores 12 of the prosthesis body 10. Furthermore, the pore structure of the porous contact layer 30 is open-pored with a high porosity close to the space filling degree of a densest sphere packing, while the prosthesis body 10 has a closed-pore structure with lower porosity.

[0035] Due to a pore-free terminal zone 11 of the prosthesis body 10, impurities cannot advance from the contact layer 30 into the prosthesis body 10.

[0036] With reference to FIGS. 3-6 a method for manufacturing the illustrated prostheses according to the invention can be explained.

[0037] The casting mold 1 shown in FIG. 3 includes a cavity 2 which is shaped corresponding to a female breast. The casting mold 1 typically is manufactured from a temperature-resistant material. The shape of the cavity 2 can be custom-made or suitable for series production. The nipple imitation 21 is inserted into the cavity 2 at a corresponding point. The imitation 21 can be fabricated from an especially colored silicone rubber. The softness likewise can deviate from the remaining silicone. A useful silicone for example is Silpuran 2420 of the firm Wacker-Chemie. The nipple imitation 11 can be fabricated by introducing a curable silicone compound into the cavity 2 and curing the same. The corresponding area can be delimited by a plastic ring temporarily inserted into the cavity 2. Cross-linking can be effected at room temperature or also at higher temperatures.

[0038] Next, the skin layer 20 is fabricated, as can be seen in FIG. 4. For this purpose, a cross-linkable silicone compound is filled into the open cavity 2 and the same subsequently is closed with a non-illustrated counterpart in order to produce the skin layer 20 having a thickness of 2-3 mm by subsequent cross-linkage. Alternatively, the silicone compound can be pressed into the cavity 2 closed already with the counterpart. Cross-linking in turn can be effected at room temperature or also at higher temperatures.

[0039] Subsequently, as shown in FIG. 5, a first dispersion comprising expanded polystyrene (EPS) spheres with an average particle diameter of 1-2 mm, which are dispersed in a cross-linkable silicone compound, is filled into the open cavity 2. The cavity 2 then is closed with a non-illustrated counterpart and the silicone compound is cross-linked.

[0040] The enriched silicone compound is coated with another, thin silicone layer having a thickness of about 1-2 mm, in order to form the pore-free terminal zone 11. This can be effected for example by applying a higher-viscosity silicone compound onto the back of the prosthesis body to be cured or by filling a low-viscosity silicone compound into a gap between the prosthesis body to be cured and the counterpart.

[0041] In the variant of FIG. 2 another layer is applied, as can be seen in FIG. 6. This layer results in the porous contact layer 30 which adjoins the back of the prosthesis body 10. Namely, a second dispersion comprising expanded polystyrene (EPS) spheres with an average particle diameter of more than 2 mm, which are dispersed in a cross-linkable silicone compound, is filled into the open cavity 2 and crosslinked.

[0042] To the second dispersion, a paraffin with an average carbon number of about twenty is added in addition, whose phase transition temperature is close to the body temperature. By adding the phase-change material especially to the second dispersion, from which the porous contact layer 30 results, the phase-change material acts where its action is needed, namely directly at the body of the wearer.

[0043] The molded parts on the back can be adjusted to the scar contour of the female customer, in case it is no series tool.

[0044] Finally, the molded part on the back is removed. The shrinkback of the plastic spheres is effected at about 150-180 C. for about 2 h. Either the mold 1 together with the prosthesis is heated or the silicone prosthesis first is removed from the mold. Heating in the mold 1 has proved its worth, as the difficult removal of the yet compact prosthesis from the mold is omitted.

[0045] As the silicone surface can be slightly tacky, which can render insertion into the bra pocket considerably more difficult, the silicone surface is also treated with a Low Friction Silicone Coating MED10-6670 of the firm NuSil.