1. Field of the Invention
This invention relates generally to minimally invasive medical implants and procedures for their use and insertion device for implanting the same, having particular application for treating urinary incontinence.
2. Description of the Prior Art
Stress urinary incontinence (SUI) is a female medical condition commonly associated with weakening of the pelvic muscles and/or connective tissues that support the urethra in its proper position. As a result of this condition, involuntary urine leakage occurs from simple physical activity, such as running or jumping, and even coughing or sneezing, as the urethra is not properly supported and does not remain fully closed during such activity.
A widely accepted medical procedure to correct SUI is the insertion of a tension-free or trans-vaginal tape that is surgically implanted in the pelvic tissue and that extends under and provides support for the urethra when pressure is exerted thereon.
U.S. Pat. No. 5,899,909, the disclosure of which is incorporated herein by reference, describes in detail a typical procedure for treating SUI using a trans-vaginal tape. The tape is implanted by passing an elongated curved needle that is attached to one end of the tape through an incision in the vaginal wall, to one lateral side of the urethra, through the pelvic tissue behind the pubic bone, and exiting out through an incision made in the abdominal wall. The procedure is repeated for the other end of the mesh tape, this time on the other lateral side of the urethra, with the needle exiting through a second incision made in the abdominal wall of the patient. After the mesh tape is adjusted for proper support of the urethra, its free ends extending outside of the abdominal wall are trimmed. Over time, fibroblasts grow into the mesh tape to anchor the tape in the surrounding tissue. Thus, the tape is left as an implant in the body to form an artificial ligament supporting the urethra in order to restore urinary continence. In another known method for implanting a trans-vaginal tape, the tape is inserted in a somewhat similar manner, but is brought out through the obturator hole and exits the body through a small incision in the upper leg.
The use of trans-vaginal tape for treating SUI has a number of advantages. It does not need to be attached through bone anchors, sutures or any other element to secure the tape in place, and there is minimal scarring. The procedure takes about 30 to 50 minutes, and may be performed on an outpatient basis under local, regional or general anesthesia. One of the few disadvantages of known procedures for implanting sub-urethral tapes is that the use of needles to pass the tape through the body poses a risk for vessel, bladder and bowel perforation. Also they require two separate, minimal incisions made through the abdominal wall (for a retropubic approach) or the upper leg (for an obtuator approach) through which exit the curved needles and attached tape is passed. This, of course, increases the risk of post-operative pain and/or infection to at least a small degree.
Accordingly, what is needed is an improved sub-urethral tape, and device and method for implanting the same.