Abstract:
Surgical apparatus for treating female stress urinary incontinence include a pair of curved delivery needles, each defining a distal end and a proximal end and adopted to be inserted into the abdomen of a female and to be positioned on either side of the bladder neck so as to define a delivery path for a tape which may be removably attached to the proximal ends of the delivery needles through the vagina for implantation into the abdomen to provide support for the urethra. A pair of curved delivery sheaths, each adapted to be inserted into the abdomen around one of the delivery needles, allow withdrawal of the delivery needles from the abdomen such that the tape is conducted along the delivery path. In the preferred embodiment, the delivery needles also allow simultaneous introduction of a local anesthetic into the abdominal tissues. Methods for treatment of stress urinary incontinence utilizing the surgical apparatus are also disclosed.

Description:
REFERENCE TO RELATED APPLICATIONS  
       [0001]    This application claims the benefit of prior copending U.S. Provisional Patent Application Serial No. 60/235,438, filed Sep. 26, 2000. 
     
    
     
       TECHNICAL FIELD  
         [0002]    The present invention relates broadly to the field of human health care, and in particular, to the treatment of a certain type of urinary incontinence in human beings. More specifically, this invention relates to surgical apparatus and methods for treating stress urinary incontinence in human females.  
         BACKGROUND OF THE INVENTION  
         [0003]    Many women suffer from leakage of urine when they cough, laugh, sneeze or engage in various types of physical exercise. This condition is called stress urinary incontinence (“SUI”) and is related to weakness of the muscles within the pelvis that provide support for the urethra and the bladder neck. 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 contributory factors include repetitive straining of the pelvic muscles, childbirth, loss of pelvic muscle tone, and estrogen loss. Such a defect results in an improperly functioning urethra, but unlike other types of urinary incontinence, SUI is not a problem of the urinary bladder.  
           [0004]    Non-operative treatment options for patients with SUI can be attempted, by instructing such patients to perform pelvic exercises, known as Kegel exercises, with the intention of strengthening the supporting muscles. However, when these exercises fail to reverse SUI, surgical repair is advised.  
           [0005]    Among the many surgical options for SUI that have been described in the medical literature, the introduction into the abdominal cavity of a pubovaginal “sling” has emerged in the past decade as the most effective. In this surgical procedure, a tape-like material, shaped like a flat ribbon, is passed through pelvic tissue and is positioned around the urethra and the bladder neck, forming a loop located between the urethra and the vaginal wall and thereby creating a supportive “hammock” or sling effect. The tape is extended over the pubis and through the abdominal wall and is tightened, after which the surplus tape is cut and removed, and the tape is left implanted in the patient&#39;s abdominal cavity.  
           [0006]    The tape provides a structure means for tissue ingrowth and thereby provides a newly created body tissue supporting means for the urethra. When pressure is exerted upon the lower abdomen, such as during a cough or sneeze, the sling provides support to the urethra, allowing it to keep its seal and prevent the unwanted discharge of urine.  
           [0007]    Three sources for sling materials are available: autologous fascia (a muscle cover that is obtained from the patient&#39;s own body, but at least one additional incision is required in order to retrieve the fascia), cadaveric fascia (a muscle cover obtained from a tissue bank, but which may be associated with infectious and immunological side effects) and non-biological synthetic tapes. By using a synthetic material, there is no need for surgical retrieval of autologous fascia and therefore the surgical time, as well as the resulting pain and recovery time for the patient, are reduced when compared with utilizing autologous fascia, while the safety concerns inherent in using cadaveric fascia are avoided.  
           [0008]    Nevertheless, significant post-operative complications have been observed when synthetic materials are used, although such complications have not arisen when a new procedure that was recently developed in Sweden is used. In this procedure, a woven synthetic tape material, fabricated of polypropylene mesh and initially protected with a plastic cover that is subsequently removed, is implanted around the urethra via a small vaginal incision, and is delivered into both sides of the pelvis through two tiny incisions in the lower abdomen. This outpatient surgery is termed Tension free Vaginal Tape (“TVT”) and can be accomplished with local anesthesia and intravenous sedation, thus making it very attractive for both patients and surgeons for many reasons, not the least of which is that the tension of the tape can be adjusted by the surgeon based upon feedback provided by the patient.  
           [0009]    The main (and perhaps the only) drawback of this TVT procedure is the use of two relatively thick, elongated pointed shafts (known as “trocars”) that are introduced seriatim into the pelvis through the vagina in order to deliver the synthetic tape, each end of which is initially attached to one of the trocars. The insertion of these sizeable trocars is inherently a “blind” procedure and it can therefore lead to injuries to pelvic structures, such as the urinary bladder, blood vessels, muscles and nerves. Because of these potential complications, the bladder needs to be emptied by catheter each time the trocars and the synthetic tape are passed inside the pelvis. The catheter is placed in the bladder and the surgeon then inserts a metal guide into the catheter which is used to push the bladder away from the surgical tract within the pelvis where the large trocars used for TVT will pass. This requires repeated catheterizations, with insertions of the guide and eventual removal of both the guide and the catheter. In addition, repeated cystoscopic examinations (insertion of an endoscopic device that visualizes the inside of the bladder) must be performed in order to detect injuries to the bladder (bladder perforations). These repeated maneuvers are cumbersome, and they prolong the surgical time required to perform TVT.  
           [0010]    Moreover, despite these precautionary manipulations, bladder perforations and bleeding inside the pelvic area from vascular injuries resulting from the TVT procedure of the prior art have been described in the medical literature. The reports of these complications, and the need for repeated preventive manipulations during the surgery, have led to a desire among surgeons who are performing (or who plan to perform) TVT to simplify and to improve the safety of the delivery system. The present invention is directed to meeting the aforesaid desirable objective, by providing a new delivery system with which TVT can become a simpler and safer procedure.  
         SUMMARY OF THE INVENTION  
         [0011]    The invention overcomes the deficiencies of the prior art and provides for improved apparatus and methods for the treatment of female stress urinary incontinence. The invention provides an improved apparatus in the form of a tape delivery assembly which is preferably disposable after a single use, and which can be used not only to deliver a synthetic mesh tape intended to be implanted within the patient&#39;s abdominal cavity and to function as a pubovaginal sling, but also, in a preferred embodiment, to introduce a local anesthetic into the adjacent abdominal tissue at the same time.  
           [0012]    The tape delivery assembly includes a pair of curved delivery needles, each of which has a varying diameter, but each of which is narrower than the prior art trocars. In the preferred embodiment, each delivery needle comprises a hollow needle body defining an interior needle body passageway and further defining a proximal end and a distal end, the distal end having an opening therein in fluid communication with the passageway; the needle body further defining a plurality of spaced openings disposed circumferentially around the needle body along substantially its entire length, the plurality of spaced openings also in fluid communication with the needle body passageway. The tape delivery assembly further includes means for removably attaching the proximal end of each delivery needle to separate ends of the tape intended to be implanted within the abdominal cavity. In the preferred embodiment, the tape delivery assembly also includes, for each delivery needle, means connected to the distal end of the needle body for removably attaching the needle body to a source of local anesthetic.  
           [0013]    The tape delivery assembly further includes, for each delivery needle, a curved delivery sheath, also of varying diameter, and defining an interior sheath passageway for removably receiving a delivery needle therein, and further defining first and second ends having first and second openings therein, respectively, each opening in communication with the sheath passageway, the first opening allowing the delivery needle to be introduced into the sheath passageway, and the second opening allowing the delivery needle to be withdrawn from the sheath passageway.  
           [0014]    In practice, the curved delivery needles are introduced into the patient&#39;s abdominal cavity via two small incisions made in the lower abdominal wall, and while (in the preferred embodiment) local anesthetic is continuously introduced through each needle body, the delivery needles are inserted into and through the pelvic tissue such that the needle bodies are ultimately positioned with their proximal ends adjacent one another and extending through the vaginal wall (via an incision previously made therein), and with the adjacent portions of the needle bodies positioned on opposite sides of the bladder neck adjacent the urethra, thereby defining a delivery path for the tape to be implanted in the patient&#39;s abdominal cavity. A delivery sheath is then inserted around each delivery needle through the abdominal incision, such that the delivery sheath envelops the delivery needle along substantially its entire length, except for the proximal end thereof, and such that the delivery sheaths are situated along the delivery path defined by the delivery needles.  
           [0015]    The tape to be implanted within the patient&#39;s abdominal cavity is then introduced via the vagina, and each end of the tape is attached to the proximal end of one of the delivery needles via the attachment means. The delivery needles are then withdrawn from the delivery sheaths, thereby pulling or conducting the tape into the delivery sheaths, and the tape ends are thereafter detached from the delivery needles, leaving the tape disposed along the delivery path within the delivery sheaths. The delivery sheaths are then withdrawn, and the tape remains, already positioned appropriately for completion of the TVT procedure in accordance with the prior art. Thus, the invention also provides an improved method for the treatment of stress urinary incontinence in which the improved apparatus of the invention is utilized. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0016]    These and other aspects, features, objects and advantages of the present invention will become more apparent from the following detailed description of the presently most preferred embodiment thereof (which is given for the purposes of disclosure), when read in conjunction with the accompanying drawings (which form a part of the specification, but which are not to be considered limiting in its scope), wherein:  
         [0017]    [0017]FIG. 1 is a schematic view of the torso of a human female patient, viewed from above, depicting portions of the preferred embodiment of the present invention in place within the abdominal cavity;  
         [0018]    [0018]FIG. 2 is an enlarged cross-sectional view, taken substantially along the lines  2 - 2  of FIG. 1;  
         [0019]    [0019]FIG. 3 is a further enlarged cross-sectional view, taken substantially along the lines  3 - 3  of FIG. 2;  
         [0020]    [0020]FIG. 4 is a view similar to that of FIG. 3, but showing additional portions of the preferred embodiment of the present invention;  
         [0021]    [0021]FIG. 5 is a still further enlarged cross-sectional view, taken substantially along lines  5 - 5  of FIG. 4;  
         [0022]    [0022]FIG. 6 is an enlarged plan view depicting the illustrative attachment means of the present invention;  
         [0023]    [0023]FIG. 7 is a view, partially in cross-section, depicting the manner in which a synthetic tape is introduced into the abdominal cavity through the vagina;  
         [0024]    [0024]FIG. 8 is a view similar to that of FIG. 7, showing the manner in which the tape is towed into the abdominal cavity in accordance with the present invention;  
         [0025]    [0025]FIG. 9 is a view similar to that of FIG. 8, depicting the tape after it is delivered into the abdominal cavity;  
         [0026]    [0026]FIG. 10 is an enlarged cross-sectional view, similar to FIG. 5, but taken substantially along the lines  10 - 10  of FIG. 9;  
         [0027]    [0027]FIG. 11 is a view similar to that of FIG. 9, showing the tape in its final position within the abdominal cavity;  
         [0028]    [0028]FIG. 12 is a schematic perspective view, also depicting the tape in its final position within the abdominal cavity, where it serves as a pubovaginal sling around the urethra; and  
         [0029]    [0029]FIG. 13 is a cross-sectional view, illustrating the function of the tape in restoring urinary continence to the patient. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0030]    The preferred embodiment of the present invention will now be further described with reference to the accompanying drawings, wherein like reference numerals designate like or corresponding parts throughout the several views. Referring first to FIGS.  1 - 6 , the tape delivery assembly of the present invention is generally designated  10 . Assembly  10  includes a pair of elongated, generally tubular, arcuate delivery needles  12   a,    12   b.  Delivery needles  12   a,    12   b  are fabricated from a material that is compatible with the human body, preferably a rigid metal material that is conventionally used for surgical instruments, such as stainless steel, and may be generally smooth, preferably polished, on their exterior to facilitate penetration of soft tissue.  
         [0031]    Delivery needles  12   a,    12   b  each comprise a needle body  14  which is generally hollow and which defines an interior needle body passageway  16 . Needle body  14  further defines a distal needle end  18  and a proximal needle end  20 , the proximal needle end  20  terminating in a needle tip  24 , while the distal needle end  18  terminates (in the preferred embodiment) in a distal needle opening  22  that is in fluid communication with the needle body passageway  16 . Needle body passageway  16  preferably extends substantially throughout the interior of needle body  14 , from distal needle end  18  to proximal needle end  20 , but does not extend all the way to needle tip  24 , as best shown in FIG. 6. In the preferred embodiment, needle body  14  further defines a plurality of spaced, preferably generally circular, circumferential needle openings  30  disposed along substantially its entire length, each of the circumferential needle openings also being in fluid communication with the needle body passageway  16 . In the preferred embodiment, needle body  14  further defines a needle mouth portion  31  adjacent distal needle opening  22  which is shaped to facilitate mating engagement with removable connecting means as hereinafter described.  
         [0032]    Preferably, needle body  14  is approximately six to seven inches in length, and defines a radius of curvature R that is preferably about 5 in. (as shown in FIG. 3). Needle body  14  is also generally tapered in shape, its diameter transitioning from a larger diameter at distal needle end  18  to a smaller diameter at proximal needle end  20 , although it is to be understood that while the term “diameter” is used herein, as shown best in FIG. 5 both needle body  14  and needle body passageway  16  preferably have a cross section which is noncircular, but which is generally oval or ellipsoidal, thus defining a major diameter and a minor diameter. Preferably, the major diameter of needle body  14  at distal needle end  18  is about 0.5 in., while the minor diameter of needle body  14  at distal needle end  18  is preferably about 0.3 in. Preferably, the major diameter of needle body  14  tapers in a substantially continuous manner from about 0.5 in. at distal needle end  18  to about 0.2 in. at proximal needle end  20 , with the minor diameter preferably also tapering in a proportional fashion. Needle tip  24  is preferably arrow-shaped, and is adapted to perforate layers of tissue, such as fascia, muscle, fat and skin, in a known manner. Preferably, the thickness of the metal out of which needle body  14  is fabricated is about 0.1 in. throughout, and therefore the major diameter of distal needle opening  22  is preferably about 0.4 in. and the minor diameter of distal needle opening  22  is about 0.2 in. The diameter of each circumferential needle opening is preferably about 0.05 in.  
         [0033]    Tape delivery assembly  10  further includes means for removable attachment of each delivery needle  12   a,    12   b  to one end of a tape intended to be implanted within a patient&#39;s abdominal cavity. The attachment means comprises means  32 , generally disposed at proximal needle end  20  of needle body  14  and adjacent to needle tip  24 , for engaging a length of a sterile thread-like material  36  (e.g., conventional surgical suture), and illustratively preferably comprising a needle eyelet  34  adapted to engage the thread-like material, as shown best in FIG. 6.  
         [0034]    In the preferred embodiment, tape delivery assembly  10  further includes, for each delivery needle  12   a,    12   b,  means for infusion of a local anesthetic into the abdomen through the delivery needles, although it is to be understood that such infusion means is an optional (albeit desirable) feature of the invention which may be omitted (if, for example, the patient has already been anesthetized via a general or spinal anesthetic) without adversely affecting the tape delivery aspects of the invention. If utilized, the infusion means preferably comprises the aforementioned means for removably connecting the needle body to a source of local anesthetic.  
         [0035]    The connecting means  38  is disposed at distal needle end  18  of needle body  14  and illustratively preferably comprises a conventional Luer lock  40 , one end of which is adapted for mating engagement with needle mouth  31  adjacent distal needle opening  22 , and the other end of which may illustratively be connected to a syringe (not shown) filled with a suitable local anesthetic to an exemplary capacity of ten cubic centimeters (10 cc). Preferably, the local anesthetic that is used is a mixture of any conventional, commercially-available short term local anesthetic and any conventional, commercially-available long term local anesthetic, most preferably an equal parts mixture of a short term local anesthetic such as Lidocaine or Xylocaine and a long term local anesthetic such as Marcaine. Delivery needle  12   a  is thus configured for infiltration of anesthetic from the syringe through Luer lock  40  into needle body passageway  16 , for ultimate passage through the plurality of circumferential needle openings  30 .  
         [0036]    Tape delivery assembly  10  further includes, for each delivery needle  12   a,    12   b,  an elongated, tubular, arcuate delivery sheath  46  which is generally hollow and which defines an interior sheath passageway  48 . Delivery sheath  46  further defines a distal sheath end  50  and a proximal sheath end  52 , terminating in a distal sheath opening  54  and a proximal sheath opening  56 , respectively, that are in fluid communication with the sheath passageway  48 . Sheath passageway  48  extends throughout the full length of sheath  46 , from distal sheath end  50  to proximal sheath end  52 . Delivery sheath  46  is fabricated from a material that is compatible with the human body, preferably a flexible material that is conventionally used in surgical procedures, (such as plastic or silicone), and as shown best in FIG. 6, proximal sheath end  52  preferably includes an elongated cutout  62  extending from proximal sheath opening  56  part of the way towards distal sheath end  50 , in order to facilitate the introduction into sheath passageway  48  the distal needle end  18  of a delivery needle  12   a,  in the manner to be described hereinbelow.  
         [0037]    Preferably, delivery sheath  46  is also approximately six to seven inches in length, and defines a radius of curvature (not shown) that is also preferably about 5 in. Delivery sheath  46  is also generally tapered in shape, its diameter transitioning from a larger diameter at distal sheath end  50  to a smaller diameter at proximal sheath end  52 , although it is to be understood that while the term “diameter” is used herein, as shown best in FIG. 5 both delivery sheath  46  and sheath passageway  48  preferably have a cross section which is non-circular, but which is generally oval or ellipsoidal, thus defining a major diameter and a minor diameter. Preferably, the major diameter of delivery sheath  46  at distal sheath end  52  is about 0.7 in., while the minor diameter of delivery sheath  46  at distal sheath end  52  is preferably about 0.4 in. Preferably, the major diameter of delivery sheath  46  tapers in a continuous manner from about 0.7 in. at distal sheath end  52  to about 0.3 in. at proximal sheath end  54 , with the minor diameter preferably also tapering in a proportional fashion, and the thickness of the material out of which delivery sheath  46  is fabricated is preferably about 0.1 in. throughout. Therefore the major diameter of distal sheath opening  54  is preferably about 0.6 in. and the minor diameter of distal sheath opening  54  is about 0.3 in. Notwithstanding the foregoing, however, and for reasons that will become apparent to those skilled in the art, while the shape of delivery sheath  46  is generally similar to the shape of delivery needle  12   a,  the interior dimensions of delivery sheath  46  are adapted to be slightly larger than the exterior dimensions of delivery needle  12   a,  so as to enable delivery sheath  46  to surround and envelop delivery needle  12   a,  in the manner to be described hereinbelow.  
         [0038]    Referring now to FIG. 7 in addition to the aforementioned FIGS.  1 - 6 , tape delivery assembly  10  also includes a tape  64  for implantation into a patient&#39;s abdominal cavity, which may be fabricated from any appropriate tissue-compatible synthetic material. An exemplary but preferred synthetic material is PROLENE® polypropylene mesh, a mesh having a thickness of 0.7 mm and openings of about 1 mm manufactured by Ethicon, Inc. of Somerville, N.J., U.S.A. This material, which is approved by the U.S. Food and Drug Administration for implantation into the human body, is adapted to adhere to the pelvic tissues adjacent to the bladder neck and urethra, and in its commercial embodiment this material is therefore generally surrounded initially by a removable plastic wrapping or tape covering  66  which prevents the synthetic tape material from adhering prematurely to the pelvic tissues before it has been properly positioned for implantation, after which the covering  66  may be removed.  
         [0039]    Tape  64  may be of any convenient shape and size that suits the intended purpose of this invention. Preferably, it is one centimeter (i.e., approximately 0.4 in) wide, with a length of approximately sixteen inches, and the exemplary synthetic material mentioned above is currently available commercially from the source mentioned above with those dimensions, although as far as the length is concerned, it will be apparent to those skilled in the art that, depending upon the size of the patient into whose abdomen it is to be implanted, it may be necessary to cut and trim the tape to an appropriate length, which can be done at the time of implantation.  
         [0040]    As shown best in FIG. 6, the attachment means of tape delivery assembly  10  further comprises, at each end of tape covering  66 , means  68  for removably receiving sterile thread-like material  36  to enable removable attachment of tape  64  to delivery needles  12   a,    12   b.  Receiving means  68  illustratively preferably comprises a loop-shaped “dog ear” protrusion  70 , having a tape eyelet  72  bored therethrough which is adapted to receive thread-like material  36 .  
         [0041]    The use and operation of tape delivery assembly  10  will now be described with reference to FIGS.  8 - 11  in addition to the aforementioned FIGS.  1 - 7 . In FIGS.  1 - 4 ,  7 - 9  and  11 , the anatomical features of the lower abdominal cavity of a human female patient are depicted, including the abdominal wall  74 , the pubic bone  76 , the urinary bladder  78 , the bladder neck  80 , the urethra  82 , the vagina  84  and the uterus  86 . The method of implanting tape  64  in the patient&#39;s abdominal cavity includes the conventional pre-surgical preparatory procedures, including, e.g., prepping and draping the patient, positioning the patient in low lithotomy position in the usual fashion, preparing the local anesthetic mixture described above, and in the preferred embodiment, filling syringes with that mixture and connecting a syringe to the Luer lock  40  disposed at the distal end of each delivery needle  12   a,    12   b.  Thereafter, the local anesthetic mixture is applied in a conventional manner to the anterior portion  88  of vagina  84 , and a longitudinal incision  90 , preferably approximately one inch long, is made in the anterior vaginal wall adjacent the bladder neck, at approximately the midpoint of the urethra  82 . The urinary bladder  78  is then drained with six inches of 14 Fr. catheter.  
         [0042]    The local anesthetic mixture is thereafter applied in a conventional fashion to the skin of the patient&#39;s abdominal wall  74  in the suprapubic region, about six centimeters (approximately 2.5 inches) lateral from the midline M on both sides, just above the edge of the pubis, and conventional stab wound incisions  92   a,    92   b  are made therein at those points (see FIG. 3). It is to be understood that stab wound incisions  92   a,    92   b  will be separated by distance P (preferably approximately 5 in.), and that those stab wound incisions  92   a,    92   b  can be made by using delivery needles  12   a,    12   b  themselves, or by using any other appropriate surgical instrument(s). In either case, delivery needles  12   a,    12   b  are inserted into the retropubic space through incisions  92   a,    92   b,  respectively, in the direction shown illustratively by arrow J in FIG. 3, and are then driven lateral to the bladder along the posterior aspect of the pubic bone  76 , to such an extent that their proximal needle ends  20  are positioned adjacent to, and on either side of, the bladder neck  80 , approximately at the midpoint of the urethra  82 , and to such an extent that their needle tips  24  emerge through vaginal wall incision  90 , with the needle tips  24  of delivery needles  12   a,    12   b  ultimately located in close proximity to one another within the vagina  84 , as shown best in FIGS. 3, 4 and  7 .  
         [0043]    In accordance with the preferred embodiment of the invention, as the delivery needles  12   a,    12   b  are being inserted and driven into the retropubic space as described above, the local anesthetic mixture is simultaneously ejected from the syringes in a known manner, from whence it passes through the Luer locks  40  and into the needle body passageways  16 , ultimately being injected into the pelvic tissues adjacent each delivery needle  12   a,    12   b  through the plurality of circumferential needle openings  30 , as shown by arrows L in FIG. 3. In addition to anesthetizing the patient, the introduction of local anesthetic in this manner also causes the adjacent pelvic tissues to expand, thereby creating a very narrow circumferential space surrounding each delivery needle, approximately 0.1 in. to 0.2 in wide, which can be utilized to advantage with the present invention, as described hereinbelow.  
         [0044]    After delivery needles  12   a,    12   b  have been inserted into the abdominal cavity and are positioned as described above, it is preferable to perform a cystoscopic examination of the urinary bladder  78  in order to detect any possible perforations of that organ, and if so, to remove and reposition one or both of the delivery needles  12   a,    12   b.  It is to be understood that during the cytoscopic examination, and during any subsequent removal and repositioning of the delivery needles  12   a,    12   b,  additional amounts of the local anesthetic mixture may be introduced via the delivery needle passageways  16  and the circumferential openings  30 , as necessary, in the same manner as set forth above.  
         [0045]    As soon as the delivery needles  12   a,    12   b  are correctly positioned, the Luer locks  40  are disconnected from delivery needles  12   a,    12   b,  and the proximal sheath end  52  of a delivery sheath  46  is then positioned within each of incisions  92   a,    92   b,  with the proximal sheath opening  56  of each delivery sheath  46  surrounding the exposed distal needle end  18  of one of the delivery needles  12   a,    12   b.  The delivery sheath  46  is thereafter advanced into the circumferential space surrounding each delivery needle  12   a,    12   b,  in the direction of arrows A, A′ (see FIG. 4), such that each delivery needle is ultimately positioned within a sheath passageway  48 , and to such an extent that each delivery sheath  46  surrounds and envelops a delivery needle  12   a,    12   b  along substantially its entire length, except for the respective needle tips  24 , which remain unsheathed.  
         [0046]    The respective ends of tape  64  are then introduced through the vagina  84 , and each end is removably tethered to a delivery needle  12   a,    12   b  by connecting engaging means  32  to receiving means  68  via a sufficient length of a thread-like material  36 , first by threading the thread-like material through tape eyelet  72  of protrusion  70  on tape covering  66 , and then by threading the thread-like material through needle eyelet  34  adjacent needle tip  24  of a delivery needle  12   a,    12   b.  Although each tether thus created may optionally be secured by knotting the thread-like material  36 , it will be apparent to those skilled in the art that such knotting will not be necessary to secure the tether if a sufficient length of thread-like material  36  is used.  
         [0047]    Thereafter, the delivery needles  12   a,    12   b  are slowly withdrawn from the patient&#39;s abdominal cavity through delivery sheaths  46  in the direction of arrows B, B′ (see FIG. 8), by reversing the motion by which they were driven, and as best shown in FIG. 8, as a result of being tethered to a delivery needle  12   a,    12   b,  one segment of tape  64  is drawn or “towed” into one of the delivery sheaths  46 , from proximal sheath end  52  towards distal sheath end  50  in the direction of arrow B, through the entire length of sheath passageway  48 , while the other segment of tape  64  is similarly drawn or “towed” into and through the entire length of the other delivery sheath  46  in the direction of arrow B′, so that the respective ends of tape  64  thereafter protrude from the patient&#39;s abdominal wall  78  (not shown); the portion of the tape  64  outside the vagina is pulled in the direction of arrow C. The delivery needles  12   a,    12   b  are then untethered from the respective ends of the tape  64  by detaching them from the thread-like material  36 , and at this point a second cystoscopic examination of the urinary bladder  78  is preferably performed, again in order to detect any possible additional perforations of that organ, and if so, to remove and reposition the tape  64 . Thereafter, both delivery sheaths  46  are withdrawn from the patient&#39;s abdominal cavity, in the direction of arrows D, D′ (see FIG. 9), while tape  64  remains embedded within the pelvic tissue, positioned for completion of the TVT procedure in accordance with the prior art.  
         [0048]    Specifically, using a catheter the urinary bladder  78  is then filled with approximately 250 milliliters of a fluid, typically water, and the patient is requested to cough (not shown). The surgeon is thereby able to determine the operation of the urethra  82  (i.e., to check for leakage), and may adjust the tension of the tape, as necessary, by adjusting the ends of the tape  64  that protrude from the abdominal wall  74 , thereby moving the tape  64  in the direction of arrows E (see FIG. 11) and into its final position, as indicated by the dashed lines F in FIGS. 8, 9 and  11 . After these adjustments, the tape covering  66  is removed by pulling the sterile thread-like material still attached to the protrusions  70  at the respective ends of tape  64  (not shown), and carrying away the tape covering  66  with them, in the direction of arrows G, G′ in FIG. 11. The surplus tape at the abdominal wall is then cut off, and the suprapubic incisions  92   a,    92   b  as well as the vaginal wall incision  90  are closed, leaving tape  64  in the body to form an artificial ligament embedded in the pelvic tissue that provides additional support for the urethra  82 , as shown schematically in FIG. 12, in order to restore urinary continence to the patient. The manner in which tape  64  functions, which is well known in the art, is depicted in FIG. 13: when the patient coughs, laughs, or sneezes, etc., the tape  64  assists in the sealing action of the urethra  82 , by moving towards the urethra as shown by the arrows H, and urging it toward the pubic bone  76 , as shown by the arrows I.  
         [0049]    While there has been described what are at present considered to be the preferred embodiments of the present invention, it will be apparent to those skilled in the art that the embodiments described herein are by way of illustration and not of limitation, and that various changes and modifications may be made therein without departing from the true spirit and scope of the present invention, as set forth in the appended claims.