Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis
Reexamination Certificate
2001-11-28
2004-05-11
Isabella, David J. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Implantable prosthesis
Reexamination Certificate
active
06733527
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to fabrics used with prosthetics and particularly relates to fabrics used with penile prostheses.
BACKGROUND OF THE INVENTION
Various types of penile prosthesis are currently available to cure or compensate for impotence, two of which include a non-inflatable, semi-rigid implantable prosthesis and an inflatable, implantable prosthesis. The non-inflatable, semi-rigid prosthesis is implanted within the corpora cavernosa of the penis and provides a generally constant erection. The inflatable prosthesis is also implanted in the corpora cavernosa but is connected to a hydraulic pumping device. The hydraulic pumping device is located within the patient's body and is used to inflate the prosthesis for erection and deflate the prosthesis for flaccidity.
Inflatable, implantable prostheses commonly include a cylindrically shaped pressure chamber made of silicone and a pump that is used to inflate or deflate the chamber. The chamber is encapsulated in a sleeve or sheath of biocompatible material (e.g fabric) that constrains the expansion of the silicone pressure chamber.
One of the drawbacks occasionally observed with this type of inflatable prosthesis is the presence of weak spots in the sheath or fabric that surrounds the pressure chamber. Such weak spots are typically caused by separation in the texture of the fabric that can occur upon inflation of the chamber. Such separation can be particularly acute in the “hinge area” of the chamber. As a result, an aneurysm or bulge can develop in the pressure chamber extending into the separation in the fabric and the region where the pressure chamber folds on itself in the deflated condition, sometimes referred to as the “hinge region,” thereby compromising the integrity and/or physical appearance of the prosthesis.
Therefore, it is desirable to provide a fabric for an implantable prosthetic and particularly an inflatable, implantable penile prosthesis that reduces the occurrence of or eliminates pressure chamber aneurysms without compromising the other advantageous attributes of the fabric, including tensile strength, fabric thickness or fabric width.
OBJECTS AND SUMMARY OF THE INVENTION
In view of the foregoing, it is an object of the present invention to overcome the deficiencies of existing fabrics used with inflatable, implantable prostheses.
It is a further object of the present invention to provide a penile prosthesis fabric that minimizes the occurrence of chamber aneurysms without compromising tensile strength, fabric thickness or fabric width.
It is a further object of the present invention to provide a penile prosthesis fabric with increased fabric weave density.
The present invention attempts to address these objects and other objects not specifically enumerated herein through the use of a fabric used with an implantable prosthesis comprising first denier one-ply warp yarns and second denier two-ply fill yarns having the ability to expand and contract, wherein the second denier is higher than the first denier. In addition, the number of warp yarns and fill yarns provide a high fabric weave density.
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AMS 700™Inflatable Penile Prosthesis Product Line, Inservice Scriptbrochure, American Medical Systems (1992).
Ultrex/Ultrex Plusbrochure, American Medical Systems, Inc. (1998).
Description of Ultrex Fabric and Yarns (Mar. 30, 2001).
AMS Research Corporation
Hohenshell Jeffrey J.
Isabella David J.
Matthews William
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