Method for making breast prosthesis

Adhesive bonding and miscellaneous chemical manufacture – Methods – Surface bonding and/or assembly therefor

Reexamination Certificate

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Details

C156S088000, C156S145000, C264S222000, C623S007000, C623S008000

Reexamination Certificate

active

06451139

ABSTRACT:

BACKGROUND OF THE INVENTION
The invention relates to a breast prosthesis with a flexible plastic body comprising two plastic sheets connected to each other along their common edge and a plastic mass enclosed between the two plastic sheets, wherein the plastic body has a front side formed to resemble the shape of the natural breast and a back side capable of facing the torso of the wearer, and an elastically deformeable thin part secured with its edge to the back side of the plastic body. The invention also relates to a method for making the breast prosthesis. Breast prosthesis of this type are worn in bras, bikini tops, swimsuits and the like.
BRIEF DISCUSSION OF THE PRIOR ART
A breast prosthesis of this type is known from DE 44 21 516 C1. The state of the art provides a breast prosthesis which is very comfortable to wear and has a natural appearance. Since breast prosthesis are often worn for a long time and in addition simulate a part of the body which is very important for the self esteem of the woman, even slight improvements in the wear comfort and in the simulation of the natural appearance, respectively, represent a significant progress.
SUMMARY OF THE INVENTION
It is the object of the invention to design the breast prosthesis in such a way that the wear comfort and the simulation of the natural appearance, respectively, are further improved, as well as to provide a method for the manufacture thereof.
Since the prosthesis in the edge regions preferably only includes the plastic sheets enclosing the plastic mass, an almost continuous or natural transition between the prosthesis and the skin of the wearer can be achieved. This advantage of the embodiment of the invention is particularly evident when fabric material is used for the thin part, since the thickness of the fabric material requires a stepped transition.
Some wearers prefer to wear the breast prosthesis directly on their skin. With the embodiment of the invention, the risk that the prosthesis slips is reduced, which could otherwise make an unnatural and thus undesirable impression. Here, the edge portion of the prosthesis is not covered by the thin part which is made preferably of fabric material, and advantageously has a larger friction coefficient than the thin part when it makes contact with the skin of the wearer. This effect is enhanced by the natural moistness of the skin.
After partial amputations or after reconstruction of a new, but smaller breast after a full amputation, cup prosthesis are preferably used which only simulate the contour of a portion of the natural breast. In order to provide a transition between the remaining or reconstructed breast and the prosthesis which appears as natural and continuous as possible, the thickness of the plastic body of such cup prosthesis usually decreases towards the edge. As a result, the thickness and thus the stiffness of the flexible plastic body is reduced in comparison to a full prosthesis. According to the invention, the possibility for the edge of the plastic body to curl up as a result of the force created by the tension of the thin part is reduced, since the thin part is displaced towards the inside. The plastic body is therefore at most dented, but never curls. The deformation is further reduced by the increased wall thickness of the plastic body and the increased stiffness resulting therefrom. Preferably, the thin part is secured to the back side of the plastic body 1 to 4 cm inside the edge of the breast prosthesis. This distance can vary, preferably with the size of the breast to be simulated and with the point of attachment.
Preferably, an opening is provided in the thin part and/or between the thin part and the plastic body for inserting filler material between the thin part and the back side of the breast prosthesis. In this way, the prosthesis can be individually fitted to the upper body, i.e. to the remaining breast or to the breast to be reconstructed, respectively. In particular, changes can be accommodated. In addition, the wearer herself can adjust the position of the filler material by trial and error for providing a better wear comfort and fit of the prosthesis.
Preferably, the thin part is deep drawn in such a way that a tensionless fit with the concave form of the back side of the plastic body is provided, which has the advantage that the thin part also contacts without tension the breast tissue which is left or remains intact after a partial amputation, thereby providing enhanced wear comfort.
It is another advantage of the breast prosthesis of the invention that it can be used as a cup evening out a breast, both for a breast reduction and for a breast enlargement. Furthermore, the breast prosthesis can easily be adapted to the changing volume and weight of the breast during the course of a step-by-step reconstruction through a step-by-step reduction of the filler material.
On the breast prosthesis of the invention, the thin part is secured to the plastic body inside the common edge of the plastic sheets connected to each other. In this way, the thin part is located closer to the front part of the breast or, expressed differently, farther inward of the breast prosthesis. Furthermore, a material can advantageously be selected for the thin part which is molded not at all or only slightly during the deep drawing process, but which is elastic enough so that the thin part essentially regains the same surface area it had before the deep drawing process. This creates an area with only slight tension. In first approximation, the breast prosthesis of the invention can then be regarded as an elastic hollow body. If a force is applied to an elastic hollow body as to compress it in one direction, then the cross sectional area between the delimiting surfaces increases. This enlargement is, for example, greatest for a cylinder or a sphere at their respective centers. If the envelope of the hollow body is connected along the cross sectional area, then the connection means will also be distorted when the cross sectional area increases. The force necessary to accomplish this opposes the compressing force. In addition to the rigidity residing in the envelope, the body is reinforced by connecting means opposing the increase in cross section.
In a breast prosthesis of the invention of this type, the plastic body is at its attachment line reinforced by the thin part, in addition to having its own rigidity. With the same stiffness, the breast prosthesis can thus be constructed to have less weight, whereby the wear comfort is enhanced. In addition, the breast prosthesis can be manufactured less expensively. Depending on the requirement for and the size of the breast to be simulated, one, two or more thin parts can be connected to the plastic body. Through a suitable selection of the number and the placement of the thin parts, the breast prosthesis can be optimally fitted to resemble the features of the natural breast. Satisfactory results are achieved with a first thin part in the rearward third and a second thin part in the forward third of the breast prosthesis.
In order to increase the wear comfort for women who do not desire a direct contact between the plastic sheet of the breast prosthesis and their skin, the thin part closest to the torso of the wearer is preferably enlarged by a marginal section extending to the common edge of the plastic sheets, wherein the marginal section contains preferably microfibers.
Advantageously, the outer edge of the marginal section is joined to the plastic body using the same method which is used for connecting the two plastic sheets. This can be accomplished by welding or gluing. The fixed connection between the outer edge of the marginal section and the plastic body allows the outer edge exactly to be even with the edge of the plastic sheets. An overhanging edge which could protrude from the garment under which the breast prosthesis is worn, is thereby avoided.
The marginal section of the thin part is advantageously joined to the back side facing the torso of the wearer in form of a grid pattern. This can, for example,

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