Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Breast prosthesis – Implantable
Reexamination Certificate
1999-08-16
2001-02-06
Milano, Michael J. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Breast prosthesis
Implantable
Reexamination Certificate
active
06183514
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to an improved prosthesis and more particularly to a dual lumen gravity oriented breast implant.
BACKGROUND FOR THE INVENTION
Surgical reconstruction of a human breast as a result of injury or as a result of a partial or total mastectomy have been performed for many years. Such reconstruction may incorporate an inflatable implant including inner and outer lumens as for example disclosed in my earlier patent for an Implant and Inflating Construction U.S. Pat. No. 4,944,749 which is incorporated herein in its entirety by reference.
In the development of breast implants there has been an effort to provide a more lifelike substitute for the breast which has been removed. One approach is disclosed in the U.S. Patent of Cronin No. 4,790,848. As disclosed therein, a multiple lumen implant includes a spherically shaped inner lumen which is unattached and free floating. This approach provides a construction which maintains a high projection and at the same time is said to simulate the natural flow of breast tissue during a variety of activities in which an individual may participate on a daily basis.
A more recent approach in the development of implants is to manufacture implants which have an oval or tear-shape so that the implant approximates the shape of a natural breast. The problem with this approach is that once in place, the implants have a tendency to rotate within an individual's body. To overcome this problem, implants have been manufactured with a textured surface which tends to resist such movement. However, the textured surface does not provide the natural feel, movement and appearance of a smooth surface implant. Despite the textured surface, these implants still have a tendency to rotate.
Accordingly, it is presently believed that there is a relatively large market for an improved implant in accordance with the present invention. It is believed that there will be a demand for an improved implant that provides a more natural appearance and feel and at the same time tends to maintain the implant and return the implant to a natural position when the individual is in a standing, sitting or semi-reclining position.
BRIEF SUMMARY OF THE INVENTION
In essence, the present invention contemplates a self-positioning implant containing materials of different densities to enable the implant to remain anatomically positioned once surgically implanted within the human body. The prosthesis or breast implant includes an outer lumen, i.e. an outer closed envelope of medical grade elastomer that defines a preferably oval or generally tear-shape with upper and lower portions. The lower portion may be somewhat more rounded or fuller to more closely resemble the shape of a human breast. The outer lumen includes a first low density fluid material such as a silicon gel or hydrogel of a first given density contained therein.
The prosthesis also includes a second or inner lumen. The second or inner lumen comprises a closed envelope of medical grade elastomer which is disposed within the outer lumen. The second or inner lumen is fixed within a lower portion and preferably the lower quartile of the outer lumen and contains a second fluid material such as a saline solution of a given density which is greater than the density of the gel in the outer lumen.
The mammary prosthesis is then maintained or returned to its predetermined position by the higher density of the second fluid material which is contained in the lower portion of the outer chamber acting as a weight (similar to a sailboat keel).
The invention will now be described in connection with the accompanying drawings wherein like reference numerals have been used to designate like parts.
REFERENCES:
patent: 3934274 (1976-01-01), Harltley, Jr.
patent: 4773909 (1988-09-01), Chaglassian
patent: 4790848 (1988-12-01), Cronin
patent: 4944749 (1990-07-01), Becker
patent: 5246454 (1993-09-01), Peterson
Dorgherty & Troxell
Milano Michael J.
Pellegrino Brian E.
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