Surgery – Body inserted urinary or colonic incontinent device or... – Implanted
Reexamination Certificate
2002-12-03
2004-10-26
Gilbert, Samuel G. (Department: 3736)
Surgery
Body inserted urinary or colonic incontinent device or...
Implanted
Reexamination Certificate
active
06808486
ABSTRACT:
TECHNICAL FIELD OF THE INVENTION
The present invention relates to surgical instruments for treating female urinary stress incontinence problems generally and in particular, a tubular mesh sling for implanting into the lower abdomen of a female which provides support to mid-urethral and bladder neck sphincteric continence sites.
BACKGROUND OF THE INVENTION
Pubovaginal sling surgical procedures for treatment of stress urinary incontinence in women are based historically on many clinical studies that show excellent results utilizing autologous rectus fascia. In the classic pubovaginal sling procedure, a strip of rectus fascia is removed from the anterior abdominal wall of the patient and the tissue is transplanted to the anterior vaginal wall to provide anatomical support to the bladder neck continence site. The long term continence results from this operative technique have been superior to other surgical procedures, especially in women who have very poor function of the urethra.
Women who have a rectus fascia pubovaginal sling procedure experience significant postoperative discomfort that results from harvesting the fascia from the anterior abdominal wall. Although rectus fascia has excellent tensile strength and superb long term durability, it has very little elasticity. Consequently, postoperative urinary retention is a problem if the sling is placed with tension around the urethra. Urethral obstruction and difficulty voiding are common postoperative complications following rectus fascia pubovaginal sling procedures.
In an effort to avoid the morbidity of rectus fascia slings, synthetic sling materials have been used. Serious complications of infection, erosion, and obstruction have occurred from the many different synthetic sling materials and designs that have been used. These include infections related to the implantation of a non-absorbable foreign body into the vagina as well as erosion of the synthetic sling into the urethra and vagina. The most notable of the synthetic sling material products was the Protegen® brand of synthetic sling that received wide media attention because of postoperative complications.
In an effort to avoid problems of infection with synthetic slings as well as morbidity with rectus fascia slings, cadaveric tissues were introduced as a sling material. Cadaveric fascia and cadaveric dermis have been used as an alternative to autologous rectus fascia. Most studies of cadaveric tissues show that these tissues do not have the long term durability of the rectus fascia tissue transplanted from the abdomen to the vagina of the same patient.
During recent years, a small filament polypropylene synthetic tape has become widely used in the contemporary art. The small filaments are associated with a low incidence of infection and erosion. The durability of the material appears to be good. The Tension-free Vaginal Tape (TVT)® utilizes a proline mesh tape that is woven with small proline filaments. The small diameter of the filaments appears to allow tissue ingrowth that prevents serious complications of synthetic non-absorbable sling materials that occurred in the past.
The TVT is surgically implanted in the patient using an instrument placed from the vagina and passed through the retropubic space to the suprapubic area. The difficulty in passing the instrument from the vagina to the suprapubic area has resulted in numerous serious complications from intra-operative injury to organs in the pelvis. Although the synthetic tape sling is tension free, many surgeons have difficulty achieving proper tension on the tape. For this reason, complications of recurrent urinary incontinence may occur in patients having too little sling tension and bladder outlet obstruction may occur in patients having too much sling tension on the tape.
The SPARC® modification of the TVT was developed to avoid the instrument complications that occur with TVT. The SPARC utilizes an instrument that is passed from the suprapubic area through the retropubic space into the vagina rather than from the vagina through the retropubic space to the suprapubic area as in the TVT. The SPARC instrument modification significantly reduces the potential for serious bowel and vascular injuries. Bladder perforation continues to be a problem for the SPARC modification, however cystoscopy is always done after the instrument is in position and the instrument is removed and repositioned if bladder perforation is identified. Both the TVT and SPARC are tension free tape pubovaginal sling procedures. The proline (polypropylene) mesh tape of the SPARC is almost identical to the proline mesh tape of the TVT. Surgeons continue to have difficulty intraoperatively with sling tension using these tape procedures. The SPARC was designed with a suture down the center of the sling that can be used to release excess sling tension intraoperatively. However, the suture modification for sling tension is rarely used by surgeons and intraoperative adjustment of sling tension continues to be a problem for both the TVT and the SPARC.
U.S. Pat. No. 6,406,423 (hereinafter “Scetbon”) purports to disclose a modification to avoid the bladder perforation problem of both the TVT and the SPARC using the same type of synthetic suburethral tape used in the SPARC and TVT. The procedure uses a complex instrument system that is passed through the retropubic space under finger guidance, which is the same technique that has been used for rectus fascia slings procedures for many years. The morbidity of the transvaginal dissection of the retropubic space described in this procedure is identical to the rectus fascia sling procedures in the past. One of the objectives of current sling procedures is to avoid the paravaginal dissection required for the Scetbon technique. One of the reasons for the success of the TVT and the SPARC is that neither require paravaginal dissection described in the Scetbon modification. The mid-urethral positioning of the sling described in the TVT and SPARC is surgically difficult to accomplish from the approach described by Scetbon.
A biodegradable tape sling of the contemporary art has recently been introduced by Mentor, Inc. and is trademarked as SABRE®. The tape is a non-mesh synthetic biodegradable design consisting of a small patch attached to ends that have a saw-tooth pattern which hold the sling in position. The sling transfer instrument is larger in diameter than the SPARC instrument and has much less curvature. There is very little clinical experience at this time using this device. Historically, synthetic non-mesh slings have had a high incidence of erosion and infection. Although this product is biodegradable, it has the inherent short term risks of synthetic non-absorbable products since it represents a foreign body until it is absorbed.
Unlike the instant invention, all of the above pubovaginal sling designs involve using a narrow single layer tape sling. The TVT and SPARC sling are polypropylene mesh slings 1 cm wide that are placed in the mid-urethra of women who have urinary incontinence. The most common cause of stress urinary incontinence in women is altered anatomy of the urethra. A sling design is needed that can conform to the anatomical variations of the urethra of women who have urinary incontinence. Most women who have moderate to severe urinary incontinence have associated anatomical prolapse of the urethra and bladder. Some women have had multiple previous incontinence surgical procedures and have intense scar formation around the urethra. The intraoperative positioning of the narrow mesh tape in women who have anatomical distortion of the urethra from prolapse or previous surgery can be difficult. As evidenced in the above discussion of pubovaginal sling designs and sling transfer instruments, an improvement in sling design is essential for improvement in the success of incontinence surgery as well as for reduction of morbidity and complications. An improvement met and addressed via the teachings of the instant invention.
SUMMARY OF THE INVENTION
In the preferred embodiment of the present inve
Gilbert Samuel G.
Norton Ray
O'Donnell Pat
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