Prosthesis and method of making

Details Prosthesis and method of making Prosthesis and method of making

2001-05-02

2003-05-13

Isabella, David J. (Department: 3738)

Surgery

Diagnostic testing

Detecting nuclear, electromagnetic, or ultrasonic radiation

C356S370000, C600S407000

Reexamination Certificate

active

06564086

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to the fields of imaging and biomedical devices. More specifically, the present invention relates to prosthesis profilometry and manufacture.
2. Description of the Related Art
In the United States, between 1990 and 1994, the incidence of developing breast cancer stabilized at approximately 110 cases per 100,000 women. Women who develop breast cancer have a 5-year relative survival rate of 79-87%.
Often, women who have had breast cancer and receive a mastectomy, choose to use a breast prosthesis to hide the loss of one or both breasts, and to give an outward appearance to others and themselves as aesthetically appealling. Today, there are about 1,000,000 women wearing external (i.e., not implanted) breast prostheses, and about 100,000 new fittings are done every year. Many more implants of internal breast prostheses are done every year.
While there are several different models of external breast prostheses, they are imperfect either because of a multitude of reasons, such as having an unattractive shape, a shape different from the remaining breast (if one remains), and because the color does not match that of the patient's skin. The forms of internal prostheses are typically only poor representations of the shape of a real breast. While recent technological advances have led to the development of hollow external breast prosthesis, there is still a limitation in the ease at which these and other external prostheses are fitted as they require that the patient visit a mold-maker whereupon a negative impression of her breast(s) is made. Not only is this inconvenient and potentially expensive, but by using material such as plaster-of-paris to make the mold, and by having the patient in a prone or other position during the molding process, the shape obtained is not only unique to the shape of the breast while the patient is in that position, but it is slightly altered by the additional weight of the plaster.
The prior art is deficient in the lack of effective apparatus and/or methods for measuring the shape of various parts of anatomy. The present invention fulfills this long-standing need and desire in the art.
SUMMARY OF THE INVENTION
The present invention provides a novel apparatus for measuring the shape of various parts of anatomy that is quick, non-contact, and results in digital contour information which can be used to control computer-operated machines to make the mold for a n internal or external prosthesis or an orthotic. These devices may alternatively be used for capturing and digitizing an image of any anatomical part for the purpose of creating prosthetic or orthotic devices which match previously existing parts, for providing bilateral symmetry or for creating a new anatomical part based on aesthetic or practical physical considerations. Other applications include orthotic devices for the foot and facial prostheses for reconstruction following cancer.
Also provided are methods of measuring anatomical profiles involving physical contact with the breast or other body parts, and methods of manufacturing internal or external prosthetic and orthotic articles which mimic natural body parts in texture and motion characteristics, and in some cases, appearance.
Other and further aspects, features, and advantages of the present invention will be apparent from the following description of the presently preferred embodiments of the invention given for the purpose of disclosure.


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