VOLUME-ADAPTABLE BREAST PROSTHESIS
20190021881 ยท 2019-01-24
Inventors
Cpc classification
A61F2002/523
HUMAN NECESSITIES
A61F2002/5007
HUMAN NECESSITIES
A61F2002/5015
HUMAN NECESSITIES
International classification
Abstract
The present disclosure relates to a breast prosthesis having an elastically deformable outer body whose outer surface is patterned on a shape of a breast and having a plastically deformable inner body whose inner surface can adapt to irregularities of tissue of a wearer. In an example of the breast prosthesis, the inner surface of the inner body has a three-dimensional structure and/or is provided with a textile that is respectively configured such that a ventilation of the tissue surface can be achieved, and an intermediate body having an intermediate chamber is arranged between the outer body and the inner body and is configured such that a volume of the intermediate chamber can be adapted by filling with a fluid.
Claims
1. A breast prosthesis having an elastically deformable outer body whose outer surface is patterned on a shape of a breast and having a plastically deformable inner body whose inner surface can adapt to irregularities of tissue of a wearer, wherein the inner surface of the inner body has a three-dimensional structure and/or is provided with a textile that is respectively configured to enable ventilation of a surface of the tissue, wherein an intermediate body having an intermediate chamber is arranged between the outer body and the inner body and is configured such that a volume of the intermediate chamber is adapted by filling with a fluid.
2. The breast prosthesis in accordance with claim 1, wherein the outer body has a rubber elastic compound enclosed in an outer chamber formed by a film bag.
3. The breast prosthesis in accordance with claim 2, wherein the rubber elastic compound comprises a two-component silicone rubber compound.
4. The breast prosthesis in accordance with claim 1, wherein the inner body has a plastically deformable compound enclosed in an inner chamber formed by a film bag.
5. The breast prosthesis in accordance with claim 1, wherein the intermediate body is formed by a film bag.
6. The breast prosthesis in accordance with claim 1, further comprising a closable passage opening that extends from the intermediate chamber to an outer side of the breast prosthesis, wherein a valve is provided in the passage opening.
7. The breast prosthesis in accordance with claim 6, wherein the passage opening is located at a side contour or at the inner surface of the breast prosthesis.
8. The breast prosthesis in accordance with claim 6, wherein the valve comprises a self-closing valve.
9. The breast prosthesis in accordance with claim 6, wherein the passage opening includes a channel that extends between two layers of a weld seam between films that form the intermediate body.
10. The breast prosthesis in accordance with claim 1, wherein the three-dimensional structure is shaped to the inner surface of the inner body or is worked into the inner surface of the inner body.
11. The breast prosthesis in accordance with claim 1, wherein the three-dimensional structure is adhesively bonded or welded to the inner surface of the inner body.
12. The breast prosthesis in accordance with claim 1, wherein the three-dimensional structure is a structure of plastic; and/or wherein the three-dimensional structure comprises channels, webs, and/or nubs as structural elements.
13. The breast prosthesis in accordance with claim 1, wherein the textile is adhesively bonded or welded to the inner surface of the inner body.
14. The breast prosthesis in accordance with claim 1, wherein the textile is attached to the inner surface of the inner body using a holding mechanism.
15. The breast prosthesis in accordance with claim 14, wherein the holding mechanism comprises a hook and loop surface adhesively bonded or welded to the inner surface of the inner body.
16. A method of adapting a breast prosthesis in accordance with claim 1, wherein the volume of the breast prosthesis is adapted by filling the intermediate chamber with a fluid.
17. The method in accordance with claim 16, wherein the fluid is a silicone gel.
18. The method in accordance with claim 16, further comprising, in the course of the filling of the intermediate chamber, the fluid is urged by a pump from an outer side of the breast prosthesis through a channel and a valve to the intermediate chamber.
19. The method in accordance with claim 18, wherein the valve is a self-closing flutter valve.
20. The method in accordance with claim 18, wherein the filling of the intermediate chamber takes place selectively at a sternum side or at an armpit side of the breast prosthesis after placing the prosthesis into a cup of a brassiere.
Description
BRIEF DESCRIPTION OF THE FIGURES
[0036]
[0037]
DETAILED DESCRIPTION
[0038] An embodiment of a breast prosthesis in accordance with the present disclosure that is generally marked by the reference numeral 1 is shown in
[0039] The outer side of the breast prosthesis is formed by a shell-shaped outer body 10 that is elastically deformable. The inner side of the breast prosthesis is formed by an inner body 30 likewise of shell shape. The bodies 10 and 30 are congruent, e.g., the bodies 10 and 30 have the same area and shape in a plan view. An expandable intermediate body 20 that is likewise of shell shape is arranged over the full area between the outer body 10 and the inner body 30.
[0040] The outer body 10 comprises two plastic films welded along the peripheral margin, namely an outer film 11 and an inner film 12 that form a chamber 13 in which a rubber elastic two-component silicone rubber compound is located.
[0041] The intermediate body 20 is formed by welding a further plastic film 21 to the inner side of the outer body 10.
[0042] The inner body 30 is formed by welding yet a further plastic film 31 to the inner side of the intermediate body 20 and by filling the interposed chamber 33 with a filler material. The filler material is a plastically deformable compound having thixotropic material properties which may be a low-crosslinked silicone gel of two different silicone components that further includes or contains phase change material, expanded lightweight fillers, thickening agents, aerosols, and thixotropic agents.
[0043] The plastic films 11, 12, 21, and 31 are all produced from an identical material. The plastic films 11, 12, 21, and 31 are connected along a common weld seam 2 in the marginal region of the prosthesis 1, with the weld seam not necessarily having to be disposed at the outer margin, but being able to be displaced, for example, inwardly peripherally by 10 mm-20 mm.
[0044] A structured plastic inlay 40 is adhesively bonded to the inner film 31 of the plastically deformable body 30. The adhesive surface of the inlay 40 is smooth to ensure a good adhesion to the inner film 31 of the inner body 30. The surface of the inlay 40 remote from the inner body 30 has a three-dimensional structure 41 which is a regular arrangement of nubs 42 and ventilation channels or folding channels 43.
[0045] An intermediate chamber 22 that can be filled with a fluid is formed in the interior of the intermediate body 20. Depending on the degree of filling, the thickness of the intermediate body increases by a specific amount. The volume of the breast prosthesis 1 can thus be adapted in consideration of the size of the remaining breast and of the progression of the scar tissue.
[0046] The breast prosthesis has a drop-like shape overall in a plan view, with the lower side being formed by the rounded portion 3 and with the two converging sides being formed by left and right limbs 4 and 5.
[0047] Two passage channels 23a and 23b are provided with an elastic flutter valve 24a and 24b each for filling the intermediate body 20. The channels 23 are arranged laterally at the breast prosthesis and are disposed between the films 12 and 21, that is, within the weld seam 2. They project radially outwardly starting from the intermediate chamber 20. They are arranged at the two limbs 4 and 5 of the breast prosthesis 1 so that the filling can take place selectively at the sternum side or at the armpit side after placing the prosthesis into a cup of the brassiere worn by the patient, independently of whether the prosthesis is worn at the left or right.
[0048] In the course of the filling of the intermediate chamber 22, a fluid, preferably a silicone gel, is urged by a pump from the outer side through the channel 23 and the self-closing flutter valve 24.