Surgery – Body inserted urinary or colonic incontinent device or... – Implanted
Reexamination Certificate
1999-09-07
2001-04-24
Lacyk, John P. (Department: 3736)
Surgery
Body inserted urinary or colonic incontinent device or...
Implanted
C128SDIG008
Reexamination Certificate
active
06221005
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to medical devices as alternatives for surgical correction of anatomic female stress urinary incontinence with urethral hypermobility (referred to as SUI) and more particularly to a Pubo-Urethral Support Harness Apparatus (referred to as a “PUSH apparatus”) for Percutaneous Treatment of Female Stress Urinary Incontinence with Urethral Hypermobility.
The present invention relates to SUI and provides an apparatus and method for treatment. More specifically, this invention relates to an apparatus and method of stabilizing and supporting the urethrovesical junction without use of sutures, staples or bone anchors to correct female stress urinary incontinence with urethral hypermobility.
Anatomic SUI with urethral hypermobility is a condition that is accompanied by the involuntary loss of urine during coughing, laughing, sneezing or other exertional physical activities. SUI is most often caused by weakening of the supporting endopelvic fascia and muscles resulting in the abnormal movement of the urethra and bladder neck with increased intra-abdominal pressure. Continence is re-established by stabilizing and supporting the urethrovesical junction thereby allowing the bladder neck remain in its physiologic position.
SUI interferes with a woman's ability to lead a normal life. SUI impacts a woman's self-esteem, often leads to embarrassment and limits her capacity to fulfill her social and family roles. Women address this condition by: managing the problem with absorbent products; undergoing non-surgical treatments such as behavior training, drugs, and using vaginal anatomical support devices; or undergoing surgical intervention. Disadvantages associated with managing the symptoms of SUI include odor and alteration of dress to conceal the presence of a pad or brief. Among the disadvantages associated with non-surgical therapies are poor response to treatment, inconvenience, the need for the patient to be highly motivated, and vaginal discomfort caused by the presence of a support device.
Many surgical procedures involving elevation, stabilization and support to the urethrovesical junction have been devised over the years cure SUI. Robertson, U.S. Pat. No. 5,019,032 describes a method of treatment involving the installation of sutures between the rectus fascia and the vagina using a needle inserted through the abdomen. A urethropexy procedure is disclosed in U.S. Pat. No. 5,013,292 to Lemay and describes burying a pair of implants, one on each side of the pubis symphysis, and threading suture from the vagina through the implants to support the bladder neck. Alternatively, the ends of the sutures can be tied to a saddle member to support the bladder neck. Richardson, U.S. Pat. No. 5,149,329 described stabilization and support to the urethrovesical junction by bringing the paravaginal fascia into juxtaposition with Cooper's ligament through suture placement using a suturing needle assembly. Petros, U.S. Pat. No. 5,112,344 describes looping a filamentary element between the vaginal wall and the rectus abdominis in the anterior wall of the abdomen to provide urethrovesical support. Several common needle suspension procedures for treating SUI have been disclosed over the years including: Pereyra (e.g., West J. Surg. Obst. & Gynec., ppg. 223-226,1959) in which suture interconnects subcutaneous tissue above the rectus fascia to tissue on both sides of the urethra; Raz (e.g. Urol., Vol. 17 ppg., 82-85,1981) in which suture interconnects subcutaneous tissue above the rectus fascia to the vaginal wall on both sides of the urethra; and Stamey (e.g., Surg. Gyn. & Obst., Vol. 136, ppg. 547-554, April 1973) in which Dacron sleeves, located in tissue on both sides of the urethra are attached to subcutaneous tissue above the rectus fascia. Problems associated with many of these procedures result in suture pull through from the abdominal wall rectus fascia causing reoccurrence of incontinence. In addition, these procedures generally require general anesthesia, lengthy hospitalization and restricted activities for 8 to 12 weeks.
An apparatus for treating SUI by applying an anchoring device to body tissue and adjusting the suture length between anchors using a cinching member is described in U.S. Pat. No. 5,562,689 to Green et al. Blake, U.S. Pat. No. 5,647,836 discloses the use of anchor pairs, each pair interconnected by suture to treat SUI. Endopelvic fascia attached to each side of the urethra is elevated and held in place by a pair of anchors comprised of upper and lower stays, whereby the upper stay is positioned above the rectus fascia. Benderev, U.S. Pat. No. 5,611,515 describes a bladder neck suspension procedure using anchor fixation of the suspending sutures to the pubic bone, and the tools required to perform the procedure. Kovac and Cruikshank, Contemporary OB/GYN, February 1998, describe placement of bone anchors into the inferior border of the pubis to support suspending sutures. The concerns with this technique include development of osteomyelitis and vaginal wall pull through leading to surgical failure.
Although surgery provides the highest success rates among all treatments for SUI, it is not without its problems. Reported drawbacks to surgical therapy include: expenses due to the associated medical and hospitalization costs; possible medical complications such as bleeding and alteration of normal voiding; impact on short-term normal life style activities; and in some instances, require women to modify their life style permanently to retain their continence. Surgery may also require repeat surgery in order to maintain continence.
SUMMARY OF THE INVENTION
The primary object of the invention is to provide effective, long-lasting, therapy for Stress Urinary Incontinence with urethral hypermobility (referred to as SUI) that has minimal impact on life style activities.
Another object of the invention is to provide a treatment SUI that is not prone to medical complications.
Another object of the invention is to provide a treatment for SUI that does not require bone anchors, sutures, staples, or peri-urethral injections for restoration of bladder neck anatomic support.
Yet another object of the invention is to provide a treatment for SUI that is simple, easily-learned, minimally invasive and can be performed as an outpatient procedure under local anesthesia or mild sedation with no post-treatment catheterization.
A further object of the invention is to provide a treatment for SUI that is, if necessary, amenable to adjustment without repeat major surgery.
Another object of the invention is to provide a treatment for SUI that can be performed on women with previous unsuccessful anti-incontinence surgery.
Still yet another object of the invention is to provide a treatment for SUI that can be performed along with other pelvic reconstructive procedures.
Other objects and advantages of the present invention will become apparent from the following descriptions, taken in connection with the accompanying drawings, wherein, by way of illustration and example, an embodiment of the present invention is disclosed.
The present invention comprises an apparatus and a minimally invasive method for treating SUI by stabilizing and supporting the urethrovesical junction. The treatment can be performed in an office or as an outpatient procedure with local anesthesia or mild sedation without use of sutures, staples, bone anchors or peri-urethral injectable bulking agents. The apparatus described in this invention possesses fixably adjustable design features that compensate for anatomic changes that could occur post-operatively causing incontinence or retention to occur.
In accordance with an embodiment of the present invention, an apparatus for treatment of SUI comprises: two support harnesses, each adapted to fit over the superior edge of the pubic bone of a patient, left and right of the pubis symphysis, a sling or hammock adapted to rest against the anterior vaginal wall or positioned submucosally at a level just below the urethrovesical junction,
Bruckner Norman I.
Davila Guillermo H.
Bruckner Norman I.
Davila Guillermo H.
Lacyk John P.
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