Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis
Reexamination Certificate
1999-11-30
2003-07-29
Isabella, David J. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Implantable prosthesis
C606S151000, C600S037000
Reexamination Certificate
active
06599318
ABSTRACT:
TECHNICAL FIELD
The present invention relates to an implantable support apparatus and to a method of using and to a method of making an implantable support apparatus.
BACKGROUND OF THE INVENTION
An implantable support, such as a sheet or patch of flexible material, is used to provide additional support to weakened or destabilized tissue of a patient. The implantable support is used to treat a variety of conditions, including, for example, closing a hernia and providing suburethral stabilization. The support may be formed of biological tissue or a synthetic material.
Some materials currently being used to manufacture such supports fail to attach adequately to surrounding tissue or experience undesirable deformation after implantation. Such conditions often require an additional surgical procedure and/or result in discomfort to the patient.
In one particular procedure, commonly known as a transvaginal or pubovaginal sling procedure, a patch or strip of biological tissue is used to provide suburethral stabilization for female patients experiencing bladder dysfunction, such as stress urinary incontinence. However, ends of the strip are friable and tend to weaken or rupture upon penetration by a relatively large needle. In addition, conventional biological strips are not easily integrated into the surrounding tissue due to their biocompatibility.
SUMMARY OF THE INVENTION
One aspect of the present invention provides an implantable support apparatus that includes a sheet of flexible biocompatible material having first and second end portions. A first pair of apertures extend through the sheet near the first end portion and a second pair of apertures extend through the sheet near the second end portion. First and second threading mechanisms are provided. Each of the threading mechanisms has a pair of tubular projections insertable into a selected pair of the apertures to facilitate threading of sutures through the first and second.pairs of apertures.
Another aspect of the present invention provides a method of using an implantable sheet of biocompatible material. The method includes providing an elongated sheet of flexible biocompatible material having first and second end portions. Apertures are formed through the sheet at locations near each of the first and second end portions. An elongated tubular projection is inserted into each of the apertures. Sutures are inserted through each of the tubular projections, which tubular projections are then removed so that the sutures remain in the apertures of the sheet. The sheet of material may be then connected to desired tissue using the sutures.
Yet another aspect of the present invention provides a method of making an implantable support apparatus. The method includes providing a sheet of flexible biocompatible material having first and second end portions. Apertures are formed through the sheet near each of the end portions. Elongated tubular projections are inserted through each of the first apertures so that threading of sutures through the apertures is facilitated.
REFERENCES:
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patent: 5275578 (1994-01-01), Adams
patent: 5290217 (1994-03-01), Campos
patent: 5330488 (1994-07-01), Goldrath
patent: 5441508 (1995-08-01), Gazielly et al.
patent: 5462560 (1995-10-01), Stevens
patent: 5468242 (1995-11-01), Reisberg
patent: 5649937 (1997-07-01), Bito et al.
Product Brochure for Shelhigh No-React PERICARDIAL PATCH, (2pgs).
“Long-Term Outcome and Quality of Life After Modified Pubovaginal Sling for Intrinsic Sphincteric Deficiency”, by Mohamed F. Hassouna and Gamal M. Ghoniem Urology, vol. 53, pp. 287-291, 1999.
“Use of the Fascial Sling for Neurogenic Incontinence: Lessons Learned”, by Ross M. Decter, pp. 683-686, The Journal of Urology, vol. 150, pp. 683-686 Aug. 1993.
Instructions for Use,“In-Fast Bone Screw System for Transvaginal Cystourethropexy and Vaginal Sling Procedures”, Influence Medical Technologies Ltd., 1997 (8pgs).
U.S. Gabbay patent application Ser. No. 09/388,416, filed Sep. 1, 1999.
Isabella David J.
Tarolli, Sundheim Covell & Tummino L.L.P.
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