Surgery – Body inserted urinary or colonic incontinent device or... – Implanted
Reexamination Certificate
1999-12-07
2001-10-23
Gilbert, Samuel G. (Department: 3736)
Surgery
Body inserted urinary or colonic incontinent device or...
Implanted
Reexamination Certificate
active
06306079
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to a surgical implant for treating urinary incontinence. The implant comprises two band-aid-like mesh pieces comprised of absorbable and non-absorbable material. The absorbable material is preferably a monofilament absorbable material that is weaved in a mesh or polyfilament. One suitable material is absorbable poly dioxanone (PDS). The non-absorbable material is preferably polypropylene. Each mesh piece has absorbable material in the middle and non-absorbable material on the ends. One mesh piece is placed in the suprapubic region and the second is placed in the vaginal vault. The two pieces are then tied together via sutures to support the prolapsed organs. The absorbable material dissolves over time.
Nearly 15 to 30 percent of elderly individuals, who are aging continuously, are afflicted with urinary incontinence. Recent estimates show that urinary incontinence affects over 13 million American patients. Approximately 15-20% of women between the ages of 20 and 64 experience urinary incontinence. In many women, urinary incontinence is related to problems of poor pelvic muscle support in the bladder.
Urinary incontinence is defined by the American Urological Association as uncontrolled leakage of urine.
By far the most common type of incontinence is female stress urinary incontinence, accounting for about 75 percent of cases seen by physicians. While female stress urinary incontinence often is a medical disorder seen in older women, it can also occur in younger women, especially those who have had children or with intrinsic sphinteric dysfunction.
2. Description of the Prior Art
U.S. Pat. No. 5,841,011 to Langrebe et al. discloses an implant for suspension of the bladder. The implant is made of a net of polypropylene that is joined with an absorbable material such as polyglactin
910
. The implant has a center base and four extending protrusions that are sutured into place. The base then acts as a hammock to support the bladder. The absorbable material dissolves over time, during which connective tissue has been built up to support the bladder on its own.
U.S. Pat. No. 5,647,836 to Blake, III et al. discloses a method and means for treating female urinary incontinence, comprising a pair of anchors having both upper and lower stays connected by sutures. The stays are made of polypropylene or other biologically compatible material.
U.S. Pat. No. 5,013,292 to LeMay discloses a surgical kit for treating urinary incontinence, comprising two implants connected to sutures. The first implant rests on the pubic bone and is preferably made of a titanium alloy. A saddle (shown in
FIGS. 3A-3C
) is employed to hold the neck of the urethra. The saddle is made of silicone.
U.S. Pat. No. 5,792,042 to Cohen et al. discloses an apparatus for treating incontinence comprising an elongated body having a plug at one end and an external retaining member at the other end. The body is positioned in the urethra with the plug at the interior opening of the urethra and the retaining member at the exterior opening of the urethra. The plug is an inflatable balloon that blocks the flow of urine into the urethra.
U.S. Pat. No. 5,256,133 to Spitz discloses a device for correcting stress urinary incontinence that is implanted to support the urethrovesical junction from the abdominal fascia. The correcting device is implanted via a cannula having a trocar and a push rod.
U.S. Pat. No. 5,112,344 to Petros discloses a method of treating incontinence comprising looping a filament between the wall of the vagina and the rectus abdominis sheath to pull the urethra into the correct position.
U.S. Pat. No. 5,785,640 to Kresch et al. discloses a non-surgical method for treating incontinence comprising an elongated body having anterior support members extending from one end and hemispherical bladder support members extending from the other end.
There are several surgical incontinence devices that utilize hammock-like devices supported by sutures. In addition, the use of a combination of absorbable and non-absorbable materials in such a device is shown in the patent to Landgrebe et al. U.S. Pat. No. 5,813,408 to Benderev et al discloses a surgical treatment of stress urinary incontinence. This procedure is an invasive surgical technique where a probe passes to avoid injuring the bladder and to provide a more accurate and reproducible capture of the pubocervical fascia lateral to the bladder neck and urethra. There is anchor fixation of the suspending sutures to the pubic bone to decrease the risk of suture pull through from above and to decrease post-operative pain. Finally, there is a technique to set a limited tension for the suspending sutures.
U.S. Pat. No. 3,384,073 to W. Van Winkle, Jr. discloses a prosthesis for urinary incontinence. This prosthesis is a woven collagen fabric. The warp yarns may be an extruded collagen multi-filament or monofilament strands. The weft yarns are also collagen multi-filament or monofilament. A series of cuts may be made in the fabric parallel to the warp yarns or the weft yarns. These cuts are in alignment to permit the collagen tape to be laced there through. The collagen prosthesis has the advantage in that it will be absorbed, yet it will provide a wide strength and support for the membranous urethra.
The article “Pubic Bone Suburethral Stabilization Sling for Recurrent Urinary Incontinence”, S. Robert Kovac, M.D., and Stephen H. Cruikshank, M.D., Obstetrics & Gynecology 89 No. 4, April 1997 pp. 624-627 discloses a Suburethral sling anchored to the posterior-inferior aspect of the pubic bone with bone screws placed transvaginally. The technique involves placing a Suburethral patch of a synthetic fiber at the junction of the upper one-third and lower two-thirds of the urethra and securing it by titanium bone screws to the posterior-inferior pubis for site-specific urethral support and stabilization of normally positioned continence anatomy.
Finally, “Endoscopic Suspension of Vescial Neck For Urinary Incontinence” by Anthony Schaffer and Thomas Stamey M.D., Urology, Vol. XXIII No. 5, May 1984, pp. 484-494, discloses a surgical procedure for ending urinary incontinence in female patients. Ending urinary incontinence is achieved by elevating the internal vesical neck on both sides with two permanent buttressed nylon loops. The benefits of this procedure include less postoperative morbidity, functional measurements, and anatomic visualization of a restored vesical neck during the procedure, easy access to the surgically difficult pelvis, and simultaneous repair of significant retoceles or substantial cytoceles through the same operative field.
Of most concern in the European community, is that the sling material contains Bovine collagen. Therefore, there is a risk of Mad-Cow disease and the development of human Jacob-Creutzfeld disease being transmitted to the patient, as well as autoimmune collagen diseases in humans due to the inherent antigenicity of collagen.
While the prior art has shown a surgical procedure for ending urinary stress incontinence, the prior art has not shown a surgical implant having two band-aid like mesh pieces comprised of absorbable and non-absorbable material made solely from a non-toxic polymer.
SUMMARY OF THE INVENTION
One object of the invention is to provide a mesh pubovaginal sling for preventing urinary stress incontinence.
Another object of the invention is to provide pubovaginal sling wherein this sling is designed to be inserted and fixed inside a woman without using sutures.
The invention relates to a mesh pubovaginal sling comprising a first piece with an first mesh portion comprising a non-absorbable material such as polypropylene and an second mesh portion comprising an absorbable material. The second mesh portion is preferably made from absorbable poly-dioxanone. In one embodiment of the invention, one piece of the mesh sling is shaped as an octagon. In another embodiment of the invention, the sling is oval or circular. In this embodiment, the first mesh portion may hav
Collard & Roe P.C.
Gilbert Samuel G.
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