1. Field of the Invention
The present invention relates generally to surgical instruments and a methods, and surgical kits for treatment of pelvic floor prolapse conditions.
2. Background Discussion
Women account for more than 11 million of incontinence cases. Moreover, a majority of women with incontinence suffer from stress urinary incontinence (SUI). Women with SUI involuntarily lose urine during normal daily activities and movements, such as laughing, coughing, sneezing and regular exercise. SUI may be caused by a functional defect of the tissue or ligaments connecting the vaginal wall with the pelvic muscles and pubic bone. Common causes include repetitive straining of the pelvic muscles, childbirth, loss of pelvic muscle tone, and estrogen loss.
Normally, the urethra, when properly supported by strong pelvic floor muscles and healthy connective tissue, maintains a tight seal to prevent involuntary loss of urine. When a woman suffers from the most common form of SUI, however, weakened muscle and pelvic tissues are unable to adequately support the urethra in its correct position. As a result, during normal movements when pressure is exerted on the bladder from the diaphragm, the urethra cannot retain its seal, permitting urine to escape.
U.S. Pat. No. 5,899,909, which is incorporated herein by reference in its entirety, discloses a surgical instrument comprising a shank having a handle at one end and connecting means at the other end to receive, one at a time, two curved needle-like elements which are connected at one end to one end of a mesh intended to be implanted into the body. In practice, the mesh is passed into the body via the vagina first at one end and then at the other end at one side and the other, respectively, of the urethra to form a loop around the urethra, located between the urethra and vaginal wall. The mesh is extended over the pubis and through the abdominal wall and is tightened. The mesh ends are cut at the abdominal wall, and the mesh is left implanted in the body. This trans-vaginal procedure is exemplified by the TVT product sold by the Gynecare Worldwide, a division of Ethicon Inc., of Somerville, N.J., USA. In this procedure two 5 mm needles pass a PROLENE® mesh trans-vaginally and through the abdomen to create a tension-free support around the mid urethra.
An alternate method to treat SUI is the sling procedure. In this procedure a needle or other suture-retrieving device is first inserted through the abdomen, above the pubic bone. The needle is guided behind the pubic bone, through the subrapubic fascia around the urethra, and out of the body through an incision in the anterior vaginal wall. At this point sutures are attached to the needle(s) and pulled up back through the abdominal cavity, where the sutures are fastened to the rectus muscle.
Techniques for protecting against the puncture of the internal structures during this type of procedure have included laparoscopic procedures. This involves making an incision in the abdomen and inserting a video scope to watch the progress of the needles as they pass through the abdominal cavity. These additional incisions are not optimal for the patient. Also, the needles, which pass through the abdomen, are not designed to capture a mesh but rather a suture, which has been previously attached to the mesh or harvested fascia. These needles are generally in the diameter range of about 0.090 inches to about 0.120 inches. Therefore, the needles do not create a large channel through the fascia. The channel is only wide enough to pass the suture. Accordingly, the sutures do not possess the elongation properties of the PROLENE® mesh and therefore cannot provide the tension-free support of the TVT. Also, attaching a mesh directly to these needles is not optimal because it is very difficult, if at all possible, to pull the mesh through the narrow channel created by the needle.
Another common condition suffered by women is prolapse of organs within the pelvic cavity. Prolapse is a condition in which organs, namely the bladder, bowel, and uterus, which are normally supported by the pelvic floor, herniate or protrude into the vagina. This occurs as a result of weakening or damage to the muscles and ligaments making up the pelvic floor support. Childbirth is the most common cause of damage to the pelvic floor, particularly where prolonged labor, large babies and instrumental deliveries were involved. Other factors can include past surgery such as hysterectomy, lack of estrogen due to menopause, and conditions causing chronically raised intra abdominal pressure such as chronic constipation, coughing, heavy lifting, and other physical activity involving impact with the body, such as skydiving. Specific prolapse conditions include cystocele, which is a prolapse of the bladder, rectocele or rectal prolapse, enterocele or intestinal herniation, and prolapse of the vaginal vault such as after a hysterectomy.
Vaginal surgery is the usual method of repair, but abdominal surgery (typically laparoscopc surgery) may also be performed. Traditional pelvic floor repair surgeries, whether abdominal or vaginal, involve lifting the prolapsed organ to restore it back to its correct anatomical position, and subsequently using sutures attached to ligaments and/or muscles to retain the organ in the correct position. Surgeons have also been known to place a layer of mesh below the prolapsed organ, and to subsequently suture corners or sides of the mesh to ligaments or muscles on the sidewalls of the pelvis. The suturing can be done via access through the abdomen or by access through the vaginal incision. Using sutures to support the mesh structure has disadvantages similar to those described above in conjunction with SUI procedures.
The device and method disclosed in patent application WO 02/38079 provides an improvement over the traditional pelvic floor repair surgery discussed above. WO 02/38079 discloses a specific mesh configuration for use in treating both cystocele and SUI that includes a basic mesh structure with two front and two rear supports that extend outwardly therefrom. The supports are thin strips of mesh that provide support to the prolapsed organ in place of sutures. In particular, WO 02/38079 describes using the instrument for treating SUI described in WO 96/06567 and 97/13465, which are incorporated herein by reference in their entirety, and the method described therein, to pass the mesh strips through the body. The described needles are used to pass the mesh strips from the vaginal incision up through the abdomen. One pass is made with a needle coupled to both the front and rear strips on one side, and then another pass is made for the front and rear strips on the other side. Thus, the front and rear strip on a given side are coupled to a needle together, and passed through the same channel out through the abdomen. As a result of both the front and back strips being attached at the same point, some additional stabilization is required to prevent forward movement of the basic structure, with suturing being the disclosed means by which to achieve this stabilization.
As with the traditional pelvic floor repair procedures, the procedure described in WO 02/38079 requires extensive, deep suturing skills in tight spaces, which are difficult to perform and time consuming. Sutures provide for only a “pin point” attachment of the mesh in place, and failures between the suture and the mesh are not uncommon. In addition, the single point of attachment of both mesh strips significantly limits the adjustability of urethral suspension versus bladder suspension. In particular, if tension free suspension of the urethra is achieved, further adjustment of the bladder suspension strips (rear strips) can adversely affect the urethral suspension, and vice versa. Finally, the vaginal approach of WO 02/38079 is disadvantageous in that suspension of the rear strip is limited to the same path as that of the front strip, as any other pathway would be potentially dangerous to vital organs and nerves via such a blind approach.
Accordingly, it would be beneficial to provide an improved surgical system and method for pelvic floor repair.