Surgery – Body inserted urinary or colonic incontinent device or... – Implanted
Reexamination Certificate
2001-04-03
2003-07-22
Hook, James (Department: 3752)
Surgery
Body inserted urinary or colonic incontinent device or...
Implanted
C600S037000, C128SDIG008
Reexamination Certificate
active
06595911
ABSTRACT:
FIELD OF THE INVENTION
The invention described herein relates generally to an anchoring member with trailing sutures and a method and device for applying and adjusting those structures to support a bodily structure of a patient, such as a female. The method and device are particularly disclosed in reference to a device and a method for suspending, stabilizing, and/or slightly compressing the female urethra, particularly the urethrovesical junction, thereby improving or maintaining urinary continence in a female patient without a need for percutaneous incision.
BACKGROUND OF THE INVENTION
Female incontinence, the inability to control the outflow of urine in women, can have a variety of causes. In roughly a third of the women afflicted, urinary incontinence is the result of intrinsic sphincter deficiency (ISD) wherein the urethral sphincter does not coapt properly. In approximately a second third of the women experiencing urinary incontinence, it is the result of hypermobility wherein the muscles and lateral attachments adjacent to the bladder neck relax such that the bladder neck and proximal urethra tend to rotate and descend in response to intra-abdominal pressure.
Hypermobility can be the result of pregnancy or the ensuing childbirth or from other factors that tend to weaken the relevant muscles. In still further cases, urinary incontinence in women results from the combined effects of ISD and hypermobility. Even further still, a number of other conditions can contribute to urinary incontinence in women. For example, congenital defects, disease, injury, aging, and urinary tract infection can all lead to urinary incontinence. As one will appreciate, women suffering from incontinence unfortunately experience an involuntary escape of urine, particularly during coughing, sneezing, and other actions that produce an increase in intra-abdominal pressure.
Advantageously, it has been discovered that female stress incontinence can be corrected by surgical restoration of the urethrovesical junction to its proper orthotopic position. Stated alternatively, female urinary incontinence can be remedied by suspending, stabilizing, and/or compressing the bladder neck to achieve a position wherein incontinence will be avoided but normal urinary function will not be hindered. For the remedial procedure to be successful, the position of the bladder neck must be high enough to avoid incontinence even when under stress while not being so high that proper bladder voiding is prevented.
The prior art discloses a plurality of methods and devices for carrying out urethrovesical suspension procedures. For example, female urinary stress incontinence has been treated surgically by effectively tying the urethrovesical junction to the back of the symphysis pubis. Beginning at least as early as 1913 and extending to the present, a number of skilled inventors including Kelly, Lemay, Pereyra et al., Burch, Stamey, Mueller et al., and Cobb et al. together have defined the present state of the art and have helped to refine particularized apparatuses and techniques in the hope of yielding improved results.
For example, four relatively non-invasive surgical procedures for bladder neck suspension are described in Hadley et al., Urologic Clinics of North America, Vol. 12, No. 2, p. 291 (1985). In the original Pereyra method, a needle is passed from a suprapubic incision to an incision in the vagina near the bladder neck. Suture material is passed several times from the bladder neck to the suprapubic incision to suspend the bladder neck. The Cobb-Radge method inserts the needle from below through the vaginal incision. The Stamey procedure uses an endoscope to prevent the surgical needle from puncturing the bladder, and a Dacron vascular graft is used to anchor a nylon suture in the periurethral tissue. Under the Raz method, the surgeon inserts his or her finger through the vaginal incision to guide the suspension needle and avoid penetration of the bladder by the needle. The sutures are anchored by threading through tissue of the vaginal wall and tissue in the suprapubic area.
Unfortunately, many prior art techniques have involved cutaneous incisions and have commonly required that the patient be subjected to a general anesthesia. Furthermore, many such procedures are not conveniently subject to repeat applications notwithstanding the unfortunate reality that second and further operations can be necessary in many cases. Still further, a number of these procedures have been found to cause urethral distortion. Even further still, procedures involving suturing the urethral lumen directly to the symphysis pubis and placing additional sutures through the bladder have been found to result in urine loss and, possibly, the formation of bladder stones. Additionally, these relatively invasive methods can lead to other complications including enteropecele (a hernia within the vaginal wall) and genital prolapse, a descending of the uterus as a result of a weakness in the pelvic floor. Yet further, women undergoing such procedures can require six weeks or more before their preoperative lifestyle can be resumed.
In a relative advance in the art, U.S. Pat. No. 5,013,292 to Lemay discloses a method and kit for correcting female urinary incontinence wherein only a local anesthesia is required. The Lemay patent calls for the implantation of a head portion of an implant in the skin above the symphysis pubis. Ultimately, the head portion rests on the symphysis pubis with two dangling ends of a suture portion extending therefrom to allow an adjustment the urethrovesical angle. Unfortunately, as detailed below, even this improved Lemay device and procedure are quite complex and require a number of incisions to be made in a patient's abdominal skin. Not only do such incisions add to the discomfort associated with the procedure, but they also increase the risk of infection, dehiscence, and osseous complications.
Stated most basically, the Lemay procedure begins with the cutting of an approximately 1 cm incision in the vaginal mucosa at the urethrovesical junction, which is followed by the insertion of a hollow needle or cannula through the incision, through the space of the retzius, and outwardly through the patient's skin at a point where a 0.5 cm cutaneous incision is then made. A trocar is then removed from the need, and, while the cannula is still in place, one end of one suture of a first implant is slid through the cannula until the suture protrudes through the vagina. The needle is then removed, and, with the trocar again attached, the needle is reinserted at a different point in the vaginal incision until it passes through the cutaneous incision. The trocar is then removed, and the second end of the suture of the first implant is passed through the cannula to the vagina. Essentially the same procedure is performed relative to the second implant at a slightly displaced location. Then, the implants are buried under the skin overeat symphysis pubis, the urethrovesical angle is adjusted to a desired position, and the ends of the sutures are tied to act as a support to suspend, compress, and/or stabilize the urethrovesical junction at a desired angle.
U.S. Pat. No. 4,705,040 to Mueller et al., entitled Percutaneous Fixation of Hollow Organs, describes another method and device for supporting, compressing, and/or stabilizing a hollow body organ. Under the Mueller et al. method, a hollow needle carrying a T-shaped head with a trailing filament is driven through a patient's skin. The T-shaped head is then released from the needle, and the organ is fixed in a supported, compress, and/or stabilized position by an adjusting of the tension in the filament and a clamping of the filament outside the patient's body. Disadvantageously, the Mueller et al. method and device also requires for its installation that an incision be made in the patient's skin.
In light of the present state of the art as outlined above, a number of observations can be made. Most basically, it is clear that a number of proficient inventors have coo
Hook James
O'Connell Law Firm
LandOfFree
Method and device for anchor implantation and support of... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Method and device for anchor implantation and support of..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Method and device for anchor implantation and support of... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3033074