Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis – Tissue
Reexamination Certificate
2002-05-10
2004-05-18
McDermott, Corrine (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Implantable prosthesis
Tissue
C623S023640, C606S151000
Reexamination Certificate
active
06736854
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to an implantable prosthesis, and more particularly to a prosthetic repair fabric for use in soft tissue repair and reconstruction.
DISCUSSION OF RELATED ART
Various prosthetic repair materials have been proposed to repair and reinforce anatomical defects, such as tissue and muscle wall hernias. For example, a hiatal hernia occurs when a natural opening, or “hiatus,” in the diaphragm through which the esophagus extends, becomes enlarged, allowing the stomach to pass through the hiatus into the thoracic cavity.
Representative surgical treatments for a hiatal hernia may include a cruroplasty, which involves tightening the crura of the diaphragm around the esophagus to reduce the size of the hiatal hernia. It has also been known to use a prosthetic repair fabric in the surgical treatment of a hiatal hernia. Typically, a sheet of surgical mesh fabric, such as BARD MESH, commercially available in rectangular stock sheets, was custom fashioned by a surgeon into a shape suitable for a particular patient's hiatal repair, such as a rectangular or oval shape. Typically, the surgeon placed the mesh implant over the hiatal hernia and proximate to the esophagus.
It is one object of certain embodiments of the present invention to provide a prosthesis for the treatment of tissue or muscle wall defects, including hiatal hernias.
It is another object of certain embodiments of the present invention to provide a prosthesis for the repair of tissue defects, such as hiatal hernias, that reduces the incidence of postoperative erosion to tissue and organs, such as the esophagus, stomach and/or other surrounding viscera.
SUMMARY OF THE INVENTION
In one illustrative embodiment of the invention, a prosthetic repair fabric is provided for repairing a tissue or muscle wall defect. The prosthetic repair fabric comprises a layer of fabric that is susceptible to erosion into and the formation of adhesions with tissue and organs, and an edge barrier that inhibits erosion into tissue and organs and inhibits the formation of adhesions with tissue and organs. The layer of fabric includes first and second surfaces and a fabric edge extending from the first surface to the second surface. The first surface is adapted to face the tissue or muscle wall defect and the second surface is adapted to face away from the defect. The edge barrier is disposed on a portion of the first and second surfaces adjacent the fabric edge and extends from the first surface to the second surface over the fabric edge. The edge barrier has an inner surface that is spaced from the fabric edge in a direction normal to the fabric edge to form a gap between the inner face of the edge barrier and the fabric edge to inhibit erosion of the tissue and organs by the fabric edge and to inhibit the formation of adhesions to the fabric edge.
In another illustrative embodiment of the invention, a prosthetic repair fabric is provided for repairing a tissue or muscle wall defect. The prosthetic repair fabric comprises a layer of fabric that is susceptible to the formation of adhesions with and erosion into tissue and organs, and an edge barrier that inhibits erosion into tissue and organs and inhibits the formation of adhesions. The layer of fabric includes first and second surfaces and a fabric edge extending from the first surface to the second surface. The first surface is adapted to face the muscle or tissue wall defect and the second surface is adapted to face away from the defect. The edge barrier is disposed at all times over the fabric edge. The edge barrier has an inner surface that is spaced from the fabric edge in a direction normal to fabric edge to form a gap between the inner face of the edge barrier and the fabric edge to inhibit erosion of the tissue and organs by the fabric edge and to inhibit the formation of adhesions to the fabric edge.
In one illustrative embodiment of the invention, a prosthetic repair fabric is provided for repairing a tissue or muscle wall defect. The prosthetic repair fabric comprises a body of implantable, biocompatible repair fabric. The body includes first and second surfaces and a body edge that extends from the first surface to the second surface. The body also includes first and second layers joined to each other along an inverted seam that extends inwardly from the body edge and between the first and second layers to inhibit erosion of the tissue and organs.
In a further illustrative embodiment of the invention, a prosthetic repair fabric is provided for repairing a tissue or muscle wall defect. The prosthetic repair fabric comprises a body of implantable, biocompatible repair fabric. The body includes first and second surfaces and a body edge extending from the first surface to the second surface. The first surface is adapted to face the muscle or tissue wall defect and the second surface is adapted to face away from the defect. The body includes first and second layers, each of the first and second layers having an outer surface and an inner surface. The outer surface of the first layer forms the first surface of the body and the outer surface of the second layer forms the second surface of the body with the inner surface of the first layer facing the inner surface of the second layer. The first and second layers are joined to each other along at least one seam that is disposed inwardly of the body edge between the inner surfaces of the first and second layers to inhibit erosion of the tissue and organs by the body edge.
In another illustrative embodiment of the invention, a method is provided for fabricating a prosthetic repair fabric for repairing a tissue or muscle wall defect. The method comprises joining an outer edge of a first layer of implantable, biologically compatible material to an outer edge of a second layer of implantable, biologically compatible material. Each of the first and second layers includes first and second surfaces. The first and second layers are joined to each other with the first surface of the first layer facing the second surface of the second layer. After joining the first and second layers, the method further comprises inverting the first and second layers so that the second surface of the first layer is facing the first surface of the second layer and the outer edges of the first and second layers extend inwardly between the second surface of the first layer and the first surface of the second layer, thereby isolating the outer edges of the first and second layers from tissue and organs so as to inhibit erosion into the tissue and organs when the prosthetic repair fabric is implanted to repair the tissue or muscle wall defect.
Other objects and features of the present invention will become apparent from the following detailed description when taken in connection with the accompanying drawings. It is to be understood that the drawings are designed for the purpose of illustration only and are not intended as a definition of the limits of the invention.
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Darois Roger E.
Eldridge Stephen N.
Lee Michael J.
Vadurro Valerie
C. R. Bard Inc.
McDermott Corrine
Stewart Alvin
Wolf Greenfield & Sacks P.C.
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