Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Breast prosthesis – Implantable
Reexamination Certificate
2001-10-16
2004-06-29
McDermott, Corrine (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Breast prosthesis
Implantable
C623S007000
Reexamination Certificate
active
06755861
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to a method for reshaping a portion of an organism through implantation of an expandable prosthesis. This invention also relates to the prosthesis. The invention is particularly suitable for providing a female breast with a desired shape.
It is not uncommon for women afflicted with breast cancer to have a breast removed in an attempt to prevent spread of a malignancy. Mastectomies are not just physically traumatic but also psychologically scarring. At the very least, women who have suffered mastectomies may lose their self confidence.
A number of methods for breast implants have been developed, but more often than not, the resulting breast has an unnatural appearance. When an implant alone is used, a silicone sack filled with saline is disposed beneath the pectoral muscle. Although this bag is usually shaped in the form of a breast, the saline acts in accordance with the laws of fluids and distributes itself in the shape of least resistance so that the middle of the bag assumes a spherical shape. The lateral aspect of this prosthetic breast, where breast tissue is supposed to exist, is now empty. The resulting unnatural appearance is that of a ball placed beneath the skin rather than the tear-drop shape of a natural breast, with the sloping of the superior part of the breast, the even tapering distribution laterally and the droop on the inferior side.
OBJECTS OF THE INVENTION
It is an object of the present invention to provide a method and/or an associated prosthetic device for reconstructing and shaping a body part.
A more specific object of the present invention is to provide such a method and/or device for reconstructing and shaping a breast.
Another object of the present invention is to provide such a method and/or device which facilitates the fashioning of a natural breast shape.
It is a further object of the present invention to provide such a method and/or device which includes computer aided design.
These and other objects of the present invention will be apparent from the drawings and descriptions hereof. It is to be noted that every embodiment of the invention is expected to achieve one of more of these objects. However, no embodiment is expected to achieve all objects of the invention.
SUMMARY OF THE INVENTION
The present invention is directed in part to a method of breast reconstruction utilizing a breast prosthesis having a plurality of chambers or compartments distributed through a body member or shell in the form of a breast. The chambers are disposed along the superior, lateral and inferior surfaces, as well as in the interior, of the body member. The chambers are differentially pressurized in order to control the shape of the prosthesis upon implantation thereof. Chambers on the superior side of the body member are underpressurized or underfilled to result in a desired sloping aspect, whereas chambers on the inferior side are filled to a greater degree to provide a rounded full aspect. Chambers on the outer lateral side of the body member of the prosthesis are filled to intermediate levels to provide a gently rounded aspect, while chambers on the inner lateral side of the body member may be filled to a lower intermediate fill ratio to provide a more tapering aspect to that side of the reconfigured breast.
The present invention contemplates that the compartments or chambers of the prosthesis have shapes, sizes, and relative positions which facilitate the formation, after differential filling or pressurization of the chambers, of a reconstructed breast of a desired shape. The chamber configuration may vary among a number of different breast prostheses designed for generating breasts of different sizes and shapes.
Generally, a prosthesis in accordance with the present invention comprises a body member made of biocompatible material and having a plurality of inflatable chambers. Fluid guide elements are operatively connected to respective chambers for enabling a differential pressurization of the chambers with a fluid. The fluid is typically a saline solution but may take the form of any biocompatible fluid.
The guide elements may include a plurality of one-way valves each disposed between two adjacent chambers for enabling a transfer of fluid from one of the adjacent chambers to another upon an application of an external compressive force to the one adjacent chambers. Thus, the valves enable a reshaping of the breast merely through manipulation. Alternatively, non-invasive sculpting of the breast may be achieved by remote control where a signal receiver is embedded on or attached to the prosthesis, together with actuators for automatically opening and closing the valves in accordance with instructions received via the signal receiver. The signal receiver may be a wireless receiver which picks up radio-frequency electromagnetic signals or ultrasonic pressure wave signals.
The fluid guide elements may alternatively include a plurality of conduits connected to and communicating with respective ones of the chambers. The conduits may be provided with one-way valves for regulating the flow of fluid through the conduits. In that case, each chamber may be provided with a pair of conduits for alternatively delivering and removing fluid from the chamber.
In accordance with another feature of the present invention, the conduits may be connected also to at least one terminal connector or holder mounted to the body member. The terminal connector may be provided with indicators for identifying which chambers are connected to which conduit terminals. The indicators may consist of color coding or other marking scheme. Thus, by a simple visual inspection, a physician or other medical practitioner can easily locate a terminal for delivery of fluid to (or removal of fluid from) a desired chamber of the prosthesis.
In a particular configuration of the body member of the prosthesis, the valves are located at the ends of the conduits, in or proximate to the terminal connector on the body member of the prosthesis. The valves may then be operated manually.
In another mode of filling the chambers, an actuator mechanism is releasably coupled to the conduits and valves via the connector. In that case, the valves may be automatically operated by the actuator mechanism under the control of a computer to introduce fluid into the different chambers of the prosthesis in predetermined amounts. The amounts of fluid may be established by selecting one of a plurality of predetermined breast shapes, the fluid amounts being previously stored in a memory of the computer. Alternatively, the amounts of fluid may be calculated by the computer upon selecting of a breast shape.
A breast shape may be selected by several methods. For instance, where shapes are stored as electronic templates in a library of the computer's memory, selection occurs upon viewing the different stored shapes on a computer monitor. For providing a better idea of the possible overall results, the various shapes from the library may be paired with an image (e.g., body-type silhouette or digitized photograph) of the woman undergoing breast reconstruction. Alternatively, a scanner may be used to digitally record the shape of her actual breast prior to removal thereof during surgery. The computer may then analyze the digitized shape and select a suitable prosthesis configuration and a set of fluid levels for the various chambers of the selected prosthesis, to most closely reproduce the recorded breast shape and size. The computer may be programmed to select or fine-tune the fluid levels in the different chambers of a selected prosthesis in order to most closely approximate the size and shape of the breast prior to surgery. Where a breast has already been removed by surgery, the other breast of the woman may serve as a template for selecting a prosthesis and pressure or fluid levels.
In accordance with another feature of the present invention, the guide elements of the prosthesis include a plurality of radio-opaque markers (e.g., rings) disposed on the body member adjacent to respe
Coleman Henry D.
Granit Medical Innovation, Inc.
Landrem Kamrin
McDermott Corrine
Sapone William J.
LandOfFree
Device for providing a portion of an organism with a desired... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Device for providing a portion of an organism with a desired..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Device for providing a portion of an organism with a desired... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3364967