Abstract:
A urethra support having an elongated mesh tape portion and a mesh extension affixed to the tape portion transverse thereto. In accordance with a method of the invention, the urethra support is inserted into the lower pelvic cavity of a patient with the tape portion forming a sling extending beneath and supporting the urethra of the patient. In this position, the tape portion is generally perpendicular to the urethra. The extension is inserted into the peri-urethral fascia along at least a portion of the length of the urethra. This induces the formation of scar tissue proximate the extension, with the scar tissue eventually contracting thereby compressing the urethra.

Description:
FIELD OF THE INVENTION 
     The present invention relates to surgical mesh tape that is implantable into the lower pelvic cavity of a female to provide support to the urethra, and more particularly to a tape having an increased area of contact to provide greater support. 
     BACKGROUND OF THE INVENTION 
     Numerous women suffer from Stress Urinary Incontinence (SUI), caused by childbirth, loss of pelvic muscle tone, intrinsic sphincter deficiency (ISD) and/or estrogen loss. SUI and ISD lead to inadvertent loss of urine due to activities such as laughing, coughing, sneezing or exercising. Various treatments and appliances have been proposed to address this problem, including methods and apparatus to create pressure on the sphincter, such as implantable balloon devices. This type of surgery is traumatic and sometimes results in damage to the nerves around the bladder neck attributable to the magnitude of dissection required. Further, implantable balloons tend to erode tissue with which they are in contact. Bulking agents that are injected into the layers of the urethra have also been used, however, these agents usually dissipate over time, in some cases migrate to other parts of the body away from the site of implantation, and the problem eventually returns. 
     Surgical tape for supporting the female urethra to treat urinary incontinence has been successfully employed. For example, U.S. Pat. No. 6,273,852 discloses methods and apparatus for implanting surgical tape for supporting the urethra to address incontinence. U.S. Pat. No. 6,273,852 is owned by the present assignee and is incorporated herein by reference. Surgical tape and implantation systems for treating SUI are also available commercially from the assignee herein, e.g., under the trademark TVT™ tension free support for incontinence, sold by GYNECARE WORLDWIDE, a division of the present assignee. 
     In the use of a simple band of tape placed under the urethra, the action of treatment is the providing of a backstop to the urethra, over which the urethra will bend or against which it will compress. This treatment primarily addresses a condition known as hypermobility in stress urinary incontinence. This action essentially decreases the internal diameter of the urethra, thereby requiring a higher pressure within the bladder to overcome the closure mechanism of the urethra. To some degree, the intrinsic weakness of the urethral sphincter is enhanced by the placement of this type tape sling as well. However, there are many patients in which this treatment is not significantly effective to correct ISD. This is true particularly in women with severe ISD, in which the sphincter is significantly weakened and hypermobility is not present or mildly present. Severe ISD is diagnosed by urodynamic measurements of the opening or closing pressure of the urethra. In normal female patients, this pressure is approximately 60 cm of H2O to 120 cm of H2O. In a female patient who has a urethral sphincter dysfunction, it can be as low as 20 cm of H2O and the patient can still maintain some normal urine retention. In the worst cases, ISD in patients can be diagnosed by urethral closing pressures below 20 cm H2O. Notwithstanding known apparatus and techniques, alternative apparatus and methods are always of interest to provide results different from those of known methods, which, in certain instances and applications, may be preferable to known methods. 
     SUMMARY OF THE INVENTION 
     The limitations of prior art devices for aiding in the treatment of urinary incontinence are addressed by the present invention, which includes a urethra support having an elongated mesh tape portion and a mesh extension affixed to the tape portion transverse to the tape portion. In accordance with a method of the invention, a urethra support of the foregoing type is inserted into the lower pelvic cavity of a patient with the tape portion forming a sling extending beneath and supporting the urethra of the patient. In this position, the tape portion is generally perpendicular to the urethra. The extension is inserted into the peri-urethral fascia along at least a portion of the length of the urethra, inducing the formation of scar tissue that compresses the urethra. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
       For a better understanding of the present invention, reference is made to the following detailed description of various exemplary embodiments considered in conjunction with the accompanying drawings. 
         FIG. 1  is a diagrammatic view of a urethra support in accordance with an exemplary embodiment of the present invention supporting the urethra of a patient. 
         FIG. 2  is a plan view of a urethra support in accordance with a second embodiment of the present invention. 
         FIG. 3  is a perspective view of a urethra support in accordance with a third embodiment of the present invention. 
         FIG. 4  is a plan view of a urethra support in accordance with a fourth embodiment of the present invention. 
         FIG. 5  is a front view of the pelvic bone of a female showing the position of the support tape of the urethra with a retro-pubic passage of the tape. 
         FIG. 6  is a front view of the pelvic bone of a female showing the position of the support tape of the urethra with an obturator passage of the tape. 
         FIG. 7  is a front view of the pelvic bone of a female showing the position of the extensions of the tape as they wrap around the urethra. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       FIG. 1  shows a urethra support  10  extending under and supporting the urethra U of a patient proximate to the patient&#39;s bladder B. The urethra support  10  is generally in the form of an elongated tape made from a surgical mesh material, such as PROLENE® Mesh manufactured by Ethicon of Somerville, N.J. The composition of the urethra support  10 , as well as the methodology used for its placement in the body of a patient, are described at length in U.S. Pat. Nos. 6,273,852 and 5,112,344, both of which are incorporated by reference herein. The urethra support  10  has an elongated tape portion  12  which loops under the urethra U, extends over the pubis and through the abdominal wall, as described in U.S. Pat. No. 6,273,852. Alternatively, the tape portion  12  can exit through the obturator foramen OF of the pelvic bone Pb as disclosed in the instructions for use of the GYNECARE TVT* Obturator System Tension-free Support for Incontinence (see  FIG. 6 ). In the present invention, an extension panel  14  is attached to the tape portion  12  via adhesive, interweaving or spot welding, e.g., at points  16 . When used as a support sling for the urethra U, the tape portion  12  crosses under the urethra U generally perpendicularly thereto. The extension  14  increases the contact area of the urethra support  10  with the urethra U along its length, i.e., parallel thereto. The extension  14  preferably assumes a U-shaped trough configuration when positioned under the urethra U, enclosing the lateral and inferior aspects of the urethra U and increasing the contact area between the urethra support  10  and the urethra U. Minimum dissection is required for the insertion of the urethra support  10  (only slightly more than that required for the tape portion  12 ). If the extension  14  is a separate panel joined to the tape portion  12 , it can be placed either above or below the tape portion  12  relative to the urethra U and can extend beyond the tape portion  12  parallel to the urethra to a selected amount in one or both directions. The length and width of the extension  14  can be adjusted by trimming with a scissor or scalpel prior to insertion into the body, thereby customizing the urethra support  10  for placement in a specific patient. In use, the extension  14  is preferably placed within the peri-urethral fascia along the length of the urethra U. The extension  14  wraps around the urethra U, e.g., wrapping about 180°, 235° or 395° (overlapping itself) The in-growth of scar tissue into the mesh of the tape portion  12  and extension  14  creates a dense layer of tissue which contracts and creates an inwardly directed pressure compressing the urethra sheath and aiding in the closure of the urethra to prevent the inadvertent escape of urine. 
       FIG. 2  shows a urethra support  110  in accordance with an alternative embodiment of the present invention. More particularly, the urethra support  110  has extensions  114   a ,  114   b , which are integrally formed with the tape portion  112 . The extensions  114   a ,  114   b  may be cut out of a sheet of mesh material, e.g., by a cutting die or a laser. The urethra support  10 ,  110  may be biased to a position, which is similar to that of the urethra support  10  as shown in  FIG. 1  (i.e., with the extensions  14 ,  114   a ,  114   b  approximating the shape of the urethra) by subjecting it to heated dies. Alternatively, a shaping element or elements  116   a ,  116   b  may be incorporated into the urethra support  110  that induce the urethra support  110  to retain and/or assume a predetermined shape configuration, e.g., embracing the urethra U. The shaping element(s)  116   a ,  116   b  may be made from a material that retains a configuration after placement of the urethra support  110 , i.e., like a bendable, deformable wire. Alternatively, the shaping element(s)  116   a ,  116   b  may be formed of a resilient material that can be flattened to allow placement of the urethra support  110  and then automatically assume a predetermined shaped configuration after placement due to elastic or shape memory. The shaping element(s)  116   a ,  116   b  may be attached to the urethra support  110  by tethers or stitches, may be enclosed between layers of the material of which the urethra support  110  is composed, may be interwoven into the material of the urethra support  110 , may be glued or otherwise affixed to the urethra support  110 , or may be a direct extension of the urethra support tape  110 . The extensions  114   a ,  114   b  may be partially separated from the tape portion  112  by slits  118  to allow the extensions  114   a ,  114   b  to conform more readily to the urethra U. 
       FIG. 3  shows a resilient shaping element  216  that has a trough-shaped, relaxed configuration that could be utilized to cause a urethra support, e.g.,  110  to wrap itself around the urethra U of a patient after placement in proximity thereto. More particularly, the shaping element  216  may be flattened under tension to assume the appropriate configuration of shaping elements  116   a ,  116   b  of  FIG. 2 , allowing the placement of the urethra support  110 . After the urethra support  110  is implanted, the constraints holding it in a flattened configuration are removed, whereupon the shaping element  216  elastically returns to the shape shown in  FIG. 3 , thus urging an associated extension, e.g.  114   a  into a configuration embracing the urethra U. The shaping element  216  may be formed from a heat-set polypropylene suture or a Nitinol wire with a preset shape. 
       FIG. 4  illustrates yet another form of resilient shaping element  316 , viz., in the form of a single resilient strand, of e.g., Nitinol or preset polypropylene with a “U”-shape. 
       FIG. 5  illustrates the placement of the urethra support  10  with the tape portion  12  under the urethra U and with a retro-pubic passage of the tape ends,  12   a  and  12   b.    
       FIG. 6  illustrates the placement of the tape portion  12  of the urethra support  10  under the urethra U with a trans-obturator passage of tape ends,  12   a  and  12   b.    
       FIG. 7  illustrates the placement of the urethra support  10 , under the urethra U, with the wing extensions, e.g.,  114   a  wrapping at least partially around the urethra U. While a trans-oburator passage of the tape ends  12   a ,  12   b  is shown, the wrapping effect could accompany a retro-pubic passage of the tape ends  12   a ,  12   b.    
     The extensions  14 ,  114  extend laterally and posteriorly relative to the urethra U and can curve to wrap around the lateral and anterior aspects of the urethra U. The material from which the tape portion  12  and extension  14  is manufactured induces in-growth of fibroblastic cells which contribute to the eventual formation of scar tissue. Over time, the scar matures and contractile forces within the scar tissue cause a tightening and shrinking of the tissue. These phenomena take place along the full length of the tape portion  12 , as well as, within the material of the extension  14 . The scar formation and the material of the tape portion  12  and extension  14  create a stiffening around and under the urethra U, which then re-creates the supporting function of the original healthy tissue. Additionally, where the extension  14  is placed laterally to the urethra, support is added there as well. The inclusion of support below, to the sides and above the urethra U imparts a restriction and a compressive force upon the tissue of the urethra U, which increases the urethral sphincter opening pressure, thereby reducing the potential for involuntary urine loss. 
     It should be understood that the embodiments described herein are merely exemplary and that a person skilled in the art may make many variations and modifications without departing from the spirit and scope of the invention as defined in the appended claims. All such variations and modifications are intended to be included within the scope of the present invention as defined in the appended claims.