Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis – Tissue
Reexamination Certificate
2001-07-05
2004-04-20
Lucchesi, Nicholas D. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Implantable prosthesis
Tissue
C606S151000
Reexamination Certificate
active
06723133
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to an implantable prosthesis, and more particularly to a prosthesis for repairing a hernia.
2. Description of the Related Art
A defect in a muscle or tissue wall, such as a hernia, is commonly repaired with an implantable prosthesis that is configured to cover and/or fill the defect. In many instances, a flat sheet of an implantable, non-resorbable, flexible mesh material, such as BARD MESH, has been employed for the parietal repair of hernias and eventrations of the abdominal wall. However, a surgeon may experience some difficulty positioning the mesh between the parietal peritoneum and the abdominopelvic wall. The mesh may also fold or wrinkle and be difficult to maintain in position.
Applicant previously developed an implantable prosthesis for repairing a defect in a muscle or tissue wall to alleviate some of these concerns. The prosthesis, which is disclosed in WO 95/07666 and is assigned to C. R. Bard, the assignee of the present application, is made of an implantable, nonabsorbable and flexible material that is formed to independently assume a curved shape adapted to conform to the anatomical shape of the wall. The prosthesis includes a body comprised of a first portion having a substantially spherical shape and a second portion connected to an outer edge of the first portion.
This prosthesis has proven useful and has become established in the practice of muscle or tissue wall repair in the inguinofemoral region. The prosthesis is not subject to stresses when deformed and, therefore, has no tendency to shift upon implantation.
It has nevertheless been observed that the prosthesis at times may wrinkle or fold between the first and second portions, thereby reducing the overall size of the prosthesis which may result in a prosthesis that does not adequately cover the region being repaired.
It is an object of the present invention to provide an improved prosthesis for repairing a defect in a muscle or tissue wall.
SUMMARY OF THE INVENTION
The present invention is an implantable prosthesis for repairing a defect in a muscle or tissue wall. The prosthesis includes a body of prosthetic material having a preformed three-dimensional contoured shape that independently assumes a curved shape adapted to conform to the wall. The body includes a first portion that is configured with a substantially spherical shape and a second portion that is connected to the first portion at an outer edge thereof. The body is configured to substantially reduce the incidence of wrinkles or folds between the first and second portions so that the first and second portions do not partially cover each other upon or after implantation, thereby ensuring that the overall size of the prosthesis is sufficient to adequately cover the desired portion of the wall.
According to one embodiment of the invention, the first portion has a first radius of curvature and the second portion has a second radius of curvature that is substantially equal to the first radius of curvature along the outer edge.
According to another aspect of the invention, the first portion includes a first lower edge and the second portion includes a second lower edge, and the body further includes a third portion connected to the first lower edge and a fourth portion connected to the second lower edge. Each of the third and fourth portions is configured with a substantially spherical shape to enhance conformance to a particular anatomical shape.
According to a further aspect of the invention, the prosthesis has a total surface area greater than approximately 40,000 mm
2
.
According to still another aspect of the invention, the prosthesis is configured with a ratio of the surface area of the second portion to the total surface area of the prosthesis from approximately 0.25 to approximately 0.40.
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pate
C. R. Bard Inc.
Lucchesi Nicholas D.
Mathew Fenn C
Wolf Greenfield & Sacks P.C.
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