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  Two-layer external breast prosthesis with self-shaping feature and process for the manufacture thereofUSPTO Application #: 20050273164Title: Two-layer external breast prosthesis with self-shaping feature and process for the manufacture thereof Abstract: A two-layer external breast prosthesis comprising a first inner layer comprised of a self-shaping dispersion and a second outer layer comprised of an elastic material, wherein the second outer layer is relatively stiffer than the first inner layer. (end of abstract)
Agent: Needle & Rosenberg, P.C. - Atlanta, GA, US Inventors: Roy Wade Bowman, Robert James Halley, Lisa Marie Hughey, Larry Dale Prosser USPTO Applicaton #: 20050273164 - Class: 623007000 (USPTO) Related Patent Categories: Prosthesis (i.e., Artificial Body Members), Parts Thereof, Or Aids And Accessories Therefor, Breast Prosthesis The Patent Description & Claims data below is from USPTO Patent Application 20050273164. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS REFERENCE TO RELATED APPLICATIONS [0001] The present application is a divisional of and claims priority to co-pending U.S. patent application Ser. No. 10/081,116, filed Feb. 21, 2002, which application claims priority to U.S. Provisional Patent Application Ser. No. 60/270,382, filed Feb. 21, 2001. The aforementioned application(s) are hereby incorporated by reference in their entirety for all purposes. FIELD OF THE INVENTION [0002] The invention relates generally to a breast prosthesis. More particularly, the invention relates to a two-layer external breast prosthesis having a first outer layer filled with a relatively firm elastomeric material and an inner layer made of a flowable, self-shaping material which is adapted to hold its shape against the chest wall of a patient. BACKGROUND OF THE INVENTION [0003] A variety of breast prostheses are known. These devices have been developed so that women who have undergone a surgical procedure in which they have had one or possibly both breasts removed, for example a mastectomy, may restore not only their cosmetic appearance after surgery, but their self-confidence as well. The use of breast prostheses has thus minimized the stigma that may have otherwise been attached to a woman's appearance after breast removal surgery. One example of a prosthetic breast is disclosed in German Patent No. DE-AS 26 05 148. This prosthesis has a shell shaped component enclosed or enveloped by plastic films, and is made of a two-component silicone rubber material. A cured two-component silicone rubber material is used to form the shell of the prosthesis, which material corresponds in its weight to the approximate weight of natural breast tissue. The two-component silicone rubber material also simulates the actual conditions of a natural breast due to the soft, elastic responsiveness and mobility of the material. Additional breast prostheses of this type, which are intended for being placed in and supported by a brassiere, are disclosed in U.S. Pat. Nos. 4,172,298 and 4,249,975, respectively. [0004] In order to assure the most natural appearance of the breast prosthesis when inserted in the brassiere, a breast prostheses of the type described above may be provided with a first body portion forming the convex exterior side of the prosthesis, this portion being made of a soft set material. In addition, a second and flat shell shaped body portion forms the back or inner side of the prosthesis, which second body portion is made of a slightly harder set two-component silicone rubber material. The result of this design is that the elastically soft material of the first body portion, which due to its weight tends to sink slightly along the convex external side thereof, is supported by the rear or flat shell body portion made of the stiffer material. The disadvantage of this type of prosthesis, however, is due to the fact that as the inner shell is fabricated of a relatively harder or stiffer two-component silicone rubber material, the inner shell will press on the sensitive scar tissue area(s) of the patient's external chest wall. Additionally, the inner shell also does not adjust, i.e., it does not conform, about the scar tissue area(s) in order to protect or cushion those tissues. [0005] The problem persists in that many of the known types of external breast prostheses have not been made adaptable to fit any irregularities that may be present in the chest wall of the mastectomy patient, particularly as modern surgical techniques remove less tissue and leave more irregular chest wall contours. Although matching a patient's chest wall contours has been accomplished by the custom-molding of a prosthesis for each patient, a need exists for a prosthesis that has desirable appearance and touch characteristics, which can adapt to the chest wall contours of a wide variety of women, and can also be made available in a cost-effective manner. [0006] One attempt to satisfy this need is disclosed in U.S. Pat. No. 4,950,291 to Mulligan, the provisions of which are incorporated herein by this reference. The '291 patent discloses a 2-layer breast prosthesis comprised of an outer layer or shell filled with a relatively firm elastomeric silicone gel, and an inner layer of an extremely soft and flowable cross-linked silicone gel. The softer, flowable gel will conform to the chest wall with a minimum of applied force, but does not possess self-molding characteristics such that, for example, the flowable gel does not hold its shape when the prosthesis is removed. Also, due to the fact the inner gel readily flows, the gel can "pool" at times in and along the bottom of the prosthesis due to the influence of gravity, which in turn may lead to patient discomfort and generally does not offer any additional support to the fit and security of the prosthesis. Furthermore, the soft gel-like material disclosed in the '291 patent is of the same density as the outer gel, and can therefore result in a final product, which may be heavier than a comparable single layer prosthesis. [0007] What is needed, but seemingly unavailable in the art, is an improved breast prosthesis that will have the desired outward cosmetic appearance, shape, and feel of a woman's breast, yet will be adaptable to the chest wall of the wearer by forming to the profile thereof. What is also needed is such an improved breast prosthesis which will be lighter than the known prosthetic devices for greater patient comfort during prolonged wear, and which may also be light enough that it will be self-supporting on the chest wall of the wearer. Additionally, there is a need for an improved two-layer breast prosthesis having a relatively firm outer shell component with a relatively soft and compliant inner shell component that will not settle as the prosthesis is worn by a patient. SUMMARY OF THE INVENTION [0008] Among other aspects, this invention provides an improved and lightweight breast prosthesis comprising two layers, each of which is a shell shaped component. The breast prosthesis has an external component or body portion which mimics the shape of the breast with a hardness correlating to the soft, elastic responsiveness of natural breast tissue, and has an inner component or body portion comprised of a flowable, self-shaping material possessed with an ability to hold its shape. [0009] In contrast to popular belief that the frontal area of the prosthesis must be supported by a rear shell-shaped component of a greater hardness, the breast prosthesis of this invention fabricates this rear component of a relatively softer material. The inner shell shaped component thus is soft enough, due to its consistency, that it is able to adjust to or fit about the scar tissue area(s) of the patient's chest wall without exerting any undue pressure thereon, and to maintain that shape/conformation in the absence of internal shearing forces. [0010] In a first aspect, the present invention provides a two-layer external breast prosthesis comprising a first inner layer comprised of a self-shaping dispersion, the dispersion having a specific gravity of less than 1.0, a second outer layer comprised of an elastic material, wherein the second outer layer is stiffer than the first inner layer. [0011] In a second aspect, the present invention provides a two-layer breast prosthesis comprising a first film envelope configured to define a first interior volume, and a second film envelope joined to the first film envelope along a common side edge to thereby define a second interior volume, wherein the second film envelope and the first film envelope share a common film wall. A first and a second sealed fill opening, respectively, extends from the common side edge of the first film envelope and the second film envelope to the respective first and second interior volumes. A first material positioned within the first film envelope forms an interior body portion of the prosthesis, the first material comprising a self-shaping material. A second material is positioned within the second film envelope for forming an exterior body portion of the prosthesis. The second material comprises an elastic material and/or curable elastic material precursor. [0012] In still a third aspect, the present invention provides a process for manufacturing a two-layer breast prosthesis comprising the steps of providing a first film envelope configured to define a first interior volume, and a second film envelope joined to the first film envelope along a common side edge to thereby define a second interior volume. The second film envelope and the first film envelope share a common interstitial film wall, and both the first and second film envelopes further comprise a respective first and a second fill opening extending from the common side edge of the respective first and second film envelopes to the respective first and second interior volumes. The method also comprises at least partially filling the second interior volume by passing an elastic material and/or curable elastic material precursor through the second fill opening; at least partially filling the first interior volume by passing a self-shaping dispersion through the first fill opening; and sealing the first and second fill openings. [0013] Additional advantages and embodiments of the invention will be obvious from the description, or may be learned by practice of the invention. Further advantages of the invention will also be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. Thus, it is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory of certain embodiments of the invention and are not restrictive of the invention as claimed. BRIEF DESCRIPTION OF THE DRAWINGS [0014] FIG. 1 is a front or top plan view of a breast prosthesis embodying the present invention, illustrating the first body portion thereof. [0015] FIG. 2 is a rear or bottom plan view, in partial perspective, of the prosthesis of FIG. 1, illustrating the second self-shaping body portion thereof. [0016] FIG. 3 is a rear or bottom plan view, in partial perspective, of the prosthesis of FIG. 1, illustrating an impression made in and "held" by the self-shaping body portion thereof. [0017] FIG. 4 is a cross-sectional view of the prosthesis of FIG. 1, illustrating the first and second layers or body portions thereof. DETAILED DESCRIPTION [0018] The present invention may be understood more readily by reference to the following detailed description and any examples provided herein. The terminology used herein is used only for the purpose of describing particular embodiments of the present invention and is not intended to be limiting in any way. Furthermore, it must also be noted that, as used in the specification and the appended claims, the singular form "a," "an," and "the" comprise plural referents unless the context clearly indicates otherwise. For example, reference to a component in the singular is intended to comprise a plurality of components. Continue reading... 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