Abstract:
A minimally invasive approach to adjusting the amount of support on an anatomical structure. The methods and apparatus described include the use of a tape for supporting an anatomical structure. Adjustment may be achieved by use of bulking agents applied either directly to the site or into a containment device located within proximity of the tape and such that it works in conjunction with the tape to support the anatomic structure. An alternative approach utilizes mechanical means for adjusting the effective length of the supporting arms of the tape used to support the anatomical structure.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     The present application is a divisional of U.S. patent application Ser. No. 09/589,242, filed on Jun. 7, 2000, now U.S. Pat. No. 7,083,637 which claims the benefit of earlier-filed U.S. provisional patent application, Ser. No. 60/138,231, filed on Jun. 9, 1999, both of which are hereby incorporated by reference in its entirety herein. 
    
    
     BACKGROUND OF THE INVENTION 
     The present invention relates generally to a minimally invasive approach to adjust a flexible areal polymer implant for supporting an anatomical structure and further relates to an approach especially useful for use with implants that support the urethra for treating female urinary incontinence. 
     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. Such a defect results in an improperly functioning urethra. Unlike other types of incontinence, SUI is not a problem of the bladder. 
     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. Because SUI is both embarrassing and unpredictable, many women with SUI avoid an active lifestyle, shying away from social situations. 
     U.S. Pat. No. 5,112,344 describes a method and apparatus for treating female incontinence. The surgical instrument for the application of a filamentary element into the body comprises a tubular shaft having a handle at one end and a flexible needle slidably receivable in the shaft and adapted at one end to receive a filamentary element. The method of treating female incontinence comprises looping a filamentary element between the wall of the vagina and the rectus abdominis sheath in the anterior wall of the abdomen whereby it passes to each side of the urethra, adjusting the loop to bring the vaginal wall and the urethra into the correct spatial relationship to the pubis allowing the development of scar tissue between the vaginal wall and the anterior wall of the abdomen pubic symphysis and removing the filamentary element. 
     U.S. Pat. No. 5,899,909 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 tape intended to be implanted into the body. In practice, the tape 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 tape is extended over the pubis and through the abdominal wall and is tightened. The tape ends are cut at the abdominal wall, and the tape is left implanted in the body. U.S. Pat. No. 5,899,909 is incorporated herein by reference. 
     While implanting a tape, it is often difficult to determine the most suitable amount of support to provide to the urethral structure. An optimal amount of support is defined as that which provides relief from incontinence and simultaneously provides for normal micturition. Even if the most optimal amount of support is provided during implantation, it is possible that the surrounding tissues will change during the healing process or simply due to aging. As a result, the optimal amount of support is subject to change. 
     European Patent 0941 712 A1, José Gil-Vernet Vila, describes an approach to adjusting urethral support by use of an expandable container implanted remotely from the urethra and connected to a mesh supporting the urethra. While this provides adjustment capabilities, the associated surgical procedure is invasive and complex. The container is also complex and requires features to assure that the suspending threads are not abraided. The container is preferably located in adipose tissue in the abdominal region. The container&#39;s location exposes it to distortion whenever there are external forces applied to the abdominal area. This in turn is expected to transiently change the degree of support to the urethra whereas it is desirable to provide a fairly constant level of support. Since the mesh support is directly in contact with the urethra, the fluctuations of support to the urethra can become irritating to the surrounding tissue. 
     U.S. Pat. No. 6,042,534, Gellman et al., describes the use of a visual indicator that may be radiopaque. However, there is no specific description of how to achieve this effect and makes no mention of its use with a tape support device. Further, the purpose of this indicator is solely for assessment of the relative position of the sling used to support the urethra. Gellman is silent with respect to the need to adjust the sling after it is in place. 
     U.S. Pat. No. 5,611,515, Theodore V. Benderev et al., describes the use of a suture tensioning devices in conjunction with bladder neck suspension. These tensioners are used to adjust the tension on sutures used to hold a supportive sling in place on the bladder neck. Prior to tying, sutures are appropriately tensioned by advancing the suture around a suture tensioner and tying in a conventional manner. Thereafter, the suture tensioner is removed and the surgical site prepared and closed in a conventional manner. While this technique is fine for establishing the initial tension to the sling, it does not allow for post implantation adjustment. Also, this approach is fine where the sling is suspended with sutures or other filament means. However, such tensioning devices are unsuitable for tapes implanted such as those associated with the GYNECARE TVT Tension-Free Support for Incontinence. 
     International Patent WO 98/31301 discloses an implantable continence device that consists of a hydraulic and mechanical component. 
     Therefore there is a need to be able to adjust the level of support to the urethra in a less complicated manner and with no urethra-mesh contact. Further, the adjustment should be located in close proximity to where the support is needed. 
     The present invention discloses devices and methods for adjusting the support of internal anatomical organs both during and after implantation. In particular, the invention is intended to be especially useful for use with implants that support the urethra. 
     SUMMARY OF THE INVENTION 
     The invention overcomes the deficiencies of the prior art and provides for an improved apparatus and method for adjusting the level of support provided to an anatomical structure by an implanted tape. The invention finds particular benefit to the treatment of female urinary incontinence. 
     In particular the invention is useful with system for the treatment of female stress urinary incontinence. The system provides a surgical instrument comprising a handle at one end and connecting means at the other end to receive, one at a time, two curved needle-like elements, each of which has a modified tip. The needle may have a constant or varying diameter. Each needle connects at one end to separate ends of a tape intended to be implanted within the body. In practice, a first end of the tape is passed, via one of the curved needles, into the body via the vagina at one side of the urethra. The needle and first end of the tape pass over the pubis and through the abdominal wall. The second needle element connects to the second end of the tape and passes into the body via the vagina at the opposite site of the urethra from the first end of the tape thereby forming a loop or sling around the urethra with the tape. The second end of the tape is extended over the pubis and through the abdominal wall. The tape ends are cut at the abdominal wall, and the tape is left in the body. 
     The invention further provides for a single curved needle element having a modified tip. The needle may have a constant or varying diameter and further provides for a easy attachment means enabling the surgeon to connect both the first and second tape ends to the single needle to perform the above-stated procedure. 
     In both embodiments, the invention provides for devices and methods for adjusting the level of support provided to the urethra by an implanted tape. Two approaches are offered. One relates to the use of bulking agents, both contained and directly injected into surrounding tissues. In this approach, detectable markers are provided to guide the clinician during the injection process. The second approach offers mechanical means of adjusting the effective length of supporting arms of a tape used to support the urethra. These devices include threadedly adjustable constructions. 
     The object of the invention is to provide a method for adjusting the level of support to an anatomical structure offered by an implanted tape. 
     An advantage of the invention is that it provides for continual adjustment capabilities to an implanted tape for supporting an anatomical structure. 
     These and other features and advantages of the present invention will become apparent from the following more detailed description, when taken in conjunction with the accompanying drawings which illustrate, by way of example, the principles of the invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a view of the needle for use with the tape mesh; 
         FIG. 2   a  is a side view of two needles and a tape interconnecting the needles; 
         FIG. 2   b - d  are alternate embodiments of the tape and connecting means between the tape and needle; 
         FIGS. 3   a - g  embodiments of means for attaching the tape to the needle; 
         FIGS. 4   a - f  are alternate embodiments providing an expandable container associated with the tape mesh; 
         FIGS. 5   a - c  are alternate embodiments for providing mechanical adjusting means to the tape mesh; 
         FIGS. 6   a - h  illustrate diagrammatically several surgical steps of the method utilizing two needles according to the invention to treat SUI; 
         FIGS. 7   a - h  illustrate diagrammatically surgical steps of the method utilizing one needle according to the invention to treat SUI; 
         FIG. 8  is diagrammatic representation illustrating direct bulking between the tape and urethra; and 
         FIG. 9  is a representation of a detectable target ring implanted in the tape. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Before explaining the present invention in detail, it should be noted that the invention is not limited in its application for the treatment of female incontinence or use to the details of construction and arrangement of parts illustrated in the accompanying drawings and description, because the illustrative embodiments of the invention may be implemented or incorporated in other embodiments, variations and modifications, and may be practiced or carried out in various ways. Furthermore, unless otherwise indicated, the terms and expressions employed herein have been chosen for the purpose of describing the illustrative embodiments of the present invention for the convenience of the reader and are not for the purpose of limiting the invention. 
     The invention discloses an apparatus and method for treating SUI. A tape is passed through pelvic tissue and positioned underneath the urethra, creating a supportive sling. 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 tape provides support to the urethra, allowing it to keep its seal and prevent the unwanted discharge of urine. 
     Referring to  FIGS. 1 and 2   a , the surgical instrument comprises a needle-like element  10  that attaches to a mesh tape  12 . Needle element  10  defines a certain radius R to perform the surgical procedure discussed herein. The distal end of needle element  10  terminates at a conical section  14  having a tip  16 . Alternate configurations, such as a blade-like, arrow or burr tips are also possible. 
     Preferably, tip  16  is blunt, wherein the tip  16  has a radius of about 0.6 millimeters. A blunt tip is preferred since it is less likely to stick in bone or penetrate bladder wall tissue or blood vessel wall tissue as will be appreciated from the method of implanting the tape as described below. 
     The proximal end of needle  10  terminates in an attachment segment  20  that is adapted to mate and lock into a handle  411  as disclosed in U.S. Pat. No. 5,899,909, previously incorporated herein by reference. 
     Disposed between cone portion  14  and segment  20  is a curved shaft segment  18  having a distal end  17  and a proximal end  19 . The shape of shaft  18  extends substantially a quarter of a circle in order to follow substantially the profile of the pubis between the vagina and the abdominal wall. For the purposes of the method as will be discussed in more detail below, shaft  18  has a preferred radius R of about 106 millimeters. The diameter of the curved shaft segment  18  may be constant or the diameter of segment  18  transitions from a smaller diameter at distal end  17  to a larger diameter at proximal end  19 . The minimum diameter of distal end  17  may be as small as 0.5 mm due to the minimal stresses at this point. The minimal diameter of proximal end  19  is about 4 mm. Preferably, the diameter at the proximal end is about 6 mm, and reduces in a continuous manner to a diameter of about 3 mm at the distal end  17 . This design takes into account, that in the method to implant the tape  12 , the bending stresses are lowest at distal end  17 , while the bending stresses are highest at the proximal end  19 . Stated differently, during the procedure, the inner bending moment at distal end  17  is negligible, while the inner bending moment at the proximal end  19  is substantial. 
     Needle  10  is preferably has a circular cross section and is made from a material that is compatible with the human body. It is also preferred that needle  10  is made from a material that can be autoclaved to enable multiple surgical procedures of needle  10 . Preferably, needle  10  is made from 303 stainless steel. The surface of shaft  18  may be smooth, preferably polished, to facilitate penetration of the soft tissue. Alternatively, the surface of needle  10  may have a somewhat rougher surface. A rougher surface would result in slightly additional tissue trauma, which in turn stimulates fibroblast activity around the tape  12 . 
     Needle  10  may be manufactured as a single, continuous unit, or alternatively, curved portion  18  may be manufactured separately from linear portion  20 . In this manner the two pieces would attach using any conventional attaching means, such as, screwing, or other conventional means as is known to those skilled in the art. 
     Referring to  FIGS. 2   a - d , tape  12  comprises any tissue-compatible synthetic material, or any natural material, including, but not limited to, autologous, allograft, xenograft, a tissue engineered matrix, or a combination thereof. An exemplary 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., Somerville, N.J., U.S.A. This material is approved by the U.S. Food and Drug Administration for implantation into the human body. A still further embodiment of the tape  12  is a combination of a synthetic material  11  and a natural material  13  centered between the synthetic material  11  as shown in  FIGS. 2   b - c . A still further embodiment of the tape  12  includes a combination of synthetic material  11  and natural material  13 , whereby the natural material is placed over or incorporated within a generally central portion of the synthetic material  11 . One advantage of the tape configurations is that natural material  13  is along the center region of tape  12  so that after installation of tape  12 , natural material  13  is positioned below the urethra and eliminates possible erosion issues at the interface of the urethra and tape. Natural material  13  may be connected to the synthetic material  11  by means of sewing, a bio-compatible glue, cell culturing techniques or other known means. 
     Tape  12  may be of any convenient shape that suits the intended purpose of the invention. An exemplary width is about 1 cm and the length would be dependent upon the size of the female undergoing the procedure. Tape  12  may be single or double ply, generally planar in structure, or tubular ( FIG. 2   d ) to provide additional supporting strength and more surface area on which tissue fibers may attach. Moreover, tape  12  may consist of different types of material, such as a bioabsorbable and non-bioabsorbable material. Tape  12  may also be coated with an antimicrobial additive to prevent or minimize infection and a lubricous coating, for example, a bioabsorbable hydrogel, to facilitate the tape passing through the tissue as discussed below. Preferably, tape  12  is covered by a removal plastic sheath as disclosed in U.S. Pat. No. 5,899,909. The tape may also be made radio-opaque and/or of a contrasting color to the body tissue to allow for future diagnostic visualization. 
     Referring to  FIGS. 4   a - f , tape  12  is further modified to include an expandable container or chamber  100  positioned on the tape  12  so the chamber  100  is located between the urethra and tape surface after the surgical procedure, discussed below. The container  100  serves to limit migration and/or resorption of the bulking agent. Further, the chamber  100  expands or contracts by either injecting into or extracting bulking material from the chamber  100 . 
     The container  100  may be made of a biocompatable material such as a hydrogel (i.e., crosslinked methacrylic-PEG esters, PHEMA, PMMA, phospholipid-like methacrylic polymers, radiation crosslinked PEO or PEG), polypropylene, polyester, silicone, or polyurethane. The container may be an integral part of the tape or may be slidably attached so that its position is such that it will work in unison with the tape in supporting the urethra. This should be near the center of the mesh so that after implantation, container  100  is positioned below the urethral area. Optionally, container  100  has a touchable internal valve element  101  to permit the surgeon to palpatate the area prior to injecting or removing the bulking agent. Alternatively, the bulking agent may be injected and removed via a two-way external port  102 . When a bulking agent is injected into container  100  the tissue between mesh and urethra will expand. This results in two effects; a simple vertical lifting due to expansion and a vertical lifting due to stretching the outside of the mesh. A suitable bulking agent may be water or saline. 
     Preferably, container  100  has no voids when empty and has a height of about 0.5 cm to about 2 cm and a length from about 2 cm to about 4 cm. Container  100  may be an cube-like expandable element of  FIG. 4   a , or a dome-shape of  FIG. 4   b . The container  100  also includes a foot portion  103  suitable for attachment to tape  12 . Attachment may be achieved by incorporating the tape into the foot with the hydrogel being on both sides of the tape as shown in  FIG. 4   b . Foot portion  103  is preferred when the tape is a polypropylene mesh since polypropylene materials do not accept adhesive material. This configuration is preferred because container  100  increases the effective bending stiffness of the tape  12  in the area of the container&#39;s attachment. 
     Alternatively, container  100  may comprise two chambers  100   a ,  100   b  in fluid communication with each other. Alternatively, the two chambers  100   a ,  100   b  may be separate and effectively two containers. However, they may be linked together by a common injection port. This configurations allows for tissue expansion both underneath and lateral to the urethra. 
     The addition of container  100  to the mesh  12  acts to increase the effective bending stiffness of the mesh  12  in the area of the attachment of container  100 . The increased bending stiffness provides additional support to the urethra when the mesh  12  is implanted. The bending stiffness further increases when the container  100  is filled with bulking agents 
     If container  100  is semi-permeable, the injected bulking agent can be designed to take advantage of osmotic tension to assure adequate fill volume. Similarly, a container  100  fabricated with a hydrogel may have a slight osmotic tension adjustment effect. Further, drug delivery can be achieved by diffusion of the injected material from within the container to the surrounding tissues. 
     EXAMPLE 1 
     A container  100  was manufactured utilizing a commercially available 6 cm×4 cm tissue expanding device available from Mentor Deutschland GmbH, catalog number 350-5301M. The tissue-expanding device includes a remote two-way injection port  102  attached to one end. The tissue-expanding device was cut in the longitudinal direction to a width of 2 cm. The upper and lower walls were temporarily sealed together along the cut lengths using cyanoacrylate glue and later permanently sealed using the silicon adhesive, below. This results in a container having a width of approximately 1.5 cm. A polypropylene mesh was placed on the container. A silicon adhesive (silicon monomer and a catalyst component) was brushed onto the mesh segment overlying the container and the underlying container and. After curing over night, the mesh was firmly attached to the container. The expandable container with external port was easily and reversible expandable. The manufactured container  100  provided the added bending stiffness along the area of its attachment to the mesh. 
     EXAMPLE 2 
     A configuration similar to Example  1  except that the injection port is incorporated as an integral part of one side of the expandable container. Container mounts to the mesh  12  by providing an opening  104  in the mesh  12  for the introduction of the injection port  102   a  as shown  FIGS. 4   c - d.    
       FIG. 4   e  discloses a double walled self-sealing container  100  that eliminates the need for a separate injection port. Container  100  comprises an inner chamber  100   c  that preferably contains a centrally located plastic or metal barrier  105  to prevent needle penetration through the far wall while injecting the bulking agent. While injecting the bulking agent using, for example, a needle, puncture holes are created in the walls of the inner and outer chamber  100   c ,  100   d , respectively. After removal of the injecting device, exact alignment of the inner and out chamber puncture holes is shifted. This shift results in effectively sealing the injection site. 
     Alternatively, a single walled self-sealing container may be used. The inner layer of such a container may have a soft plastically deformable coating. The coating acts to fill-in any injection puncture site resulting in sealing the container. 
     Tape  12  may be further modified to include a mechanical adjustment means to adjust the tape  12  after it has been implanted as discussed below. The mechanical adjustment means incorporate a suture  106  and  106   a  preferably located on either side of the central portion of the tape  12  as shown in  FIGS. 5   a - c . Sutures  106  and  106   a  can be used in combination with a one-way suturing retaining device  108  as is disclosed in U.S. Pat. No. 5,669,935, which is incorporated in its entirety by reference herein. Retaining device is anchored to tape  12  using any biocompatible adhesive or attachment as is known to those skilled in the art. Another means includes a tie-wrap-type mechanism to adjust the length of one or both sides of the tape  12  in near proximity to the urethra  54  and similarly positioned as sutures  106 ,  106   a . In either instance, the sutures  106 ,  106   a  or tie wrap remain accessible through the incision in the vagina, discussed below, for a period of time after tape implantation. Tape adjustment would be suitable for a number of days following the procedure before serious tissue ingrowth occurs. Afterward, the exposed sutures or tie-wrap may be cut. 
     In one embodiment tape  12  may be attached to needle segment  20  by means of tying, gluing or other suitable attaching means. Preferably, a bio-compatible heat shrink tube fixes tape  12  onto needle portion  20 ,  FIG. 2   a . In a further embodiment, as shown in  FIGS. 2   b - d  and  3   a - h , needle  10  and tape  12  are further configured to enable easy attachment and detachment of tape  12  to and from needle  10  by the surgeon during the operation. This embodiment allows for the use of a single needle for the procedure. This embodiment also allows for the use of a tape constructed, at least in part, of natural materials, which are otherwise not suitable in the pre-affixed embodiment due to the inability of the natural material to survive extended periods in inventory. 
     In one embodiment, shown in  FIGS. 3   a - c , shaft  18  provides for a notch or slot  40  to slidably receive connecting tabs  32  and  32   a  that are attached at either ends of tape  12  ( FIGS. 2   b - d ). Preferably, slot  40  extends through curved shaft  18  and is further located at the distal end  17  of needle  10  so that tape  12  may be disconnected from needle  10  immediately after needle  10  penetrates the abdomen wall, discussed below. 
     Tab  32  may be constructed from any bio-compatible material, such as plastic or metal. Tab  32  can be any shape, such as a square or arrow shape, so long as tap  32  can be securely inserted into notch or slot  40 .  FIG. 3   b - c  illustrates tab  32  having two spring arms  33  and  33   a  that when inserted into slot  40  expand and securely fasten tab  32  within slot  40 . Tab  32  may be attached to tape  12  in any number of convenient methods as previously discussed and well known to those skilled in the art. 
       FIG. 3   d - e  illustrates a two-tier slot  40 , wherein tab  32  and spring element  33   b  slide into the lower tier which holds tab  32  in place. Alternate means of capturing tab  32  within slot  40  are available as is well known in the art. 
       FIGS. 3   f - g  illustrate an alternate embodiment of affixing tape  12  to the distal end  17   a  of needle  10 . A detachable blunt tip  16   d  having a connecting post  15 , attaches to the distal end  17   a  by means of a mounting hole  15   a  to accept post  15 . Post  15  may be securely attached to hole  15   a  either by compression fit, mating threads or other convenient attachment methods. Distal end  17   a  further defines a groove  23  of varying depth to allow the end of tape  12  connected to post  15  to transition from within hole  15   a  to the exterior of needle  10 . Along with the embodiment of  FIGS. 3   a - e , this embodiment allows the surgeon to affix tape  12  to needle  10  just prior to the surgical procedure. One advantage is the ability to use a tape  12  constructed of, at least in part, a natural material  13 . 
     As would be appreciated by one skilled in the art, there exist multiple means for detachably connecting the tape to the needle. Alternate embodiments would include tying the ends of tape  12  to form a knot and securely inserting the knot into a V-type groove in shaft  18 . Alternately, a diagonal slit in shaft  18  could accept tape  12  or a suture extending from tape  12 . 
     The surgical procedure for implanting tape  12  using two needles is shown in  FIGS. 6   a - h  utilizing the needle embodiment illustrated in  FIGS. 1 and 2   a . In the figures the relevant parts of the female lower abdomen are disclosed, the vagina being  50 , the uterus  52 , the urethra  54 , the pubic bone  56 , the urinary bladder  58  and the abdominal wall  60 . The first needle  10   a  penetrates the vaginal wall, an incision having first been made in the wall to create a tissue flap. The needle is attached to handle  411 , and, the surgeon guides needle  10   a  through the vaginal wall and through the soft tissue on one side of the urethra  54 , the needle then according to  FIG. 6   b  being passed close to the back of the pubic bone  56 , through additional layers of fat, muscle and fascia, and then through the abdominal wall  60  above the pubic bone  56 . An incision can be made through the abdominal wall for the passage of the needle therethrough. The handle  411  is disconnected from needle  10   a ,  FIG. 6   c , and the needle  10   a  along with tape  12  are withdrawn from the abdomen wall by means of forceps,  FIG. 6   d.    
     Referring to  FIG. 6   e , needle  10   b  is now attached to handle  411 . The surgeon passes needle  10   b  through the incision in the vaginal wall and through the soft tissue, again, on the opposite side of the urethra than the previous end of tape  12 . Needle  10   b  passes close to the back of the pubic bone, through additional layers of fat, muscle and fascia,  FIG. 6   f , and then through the abdominal wall above the pubic bone and withdrawn,  FIG. 6   g.    
       FIGS. 7   a - g  illustrate an alternate method of implanting tape  12  using a single needle  10 . Tape  12  is attached to needle  10  by means of spring tab  32  as shown in  FIGS. 3   b - c . Needle  10  penetrates the vaginal wall, an incision having first been made in the wall to create a tissue flap. The surgeon guides needle  10  through the vaginal wall and through the soft tissue on one side of the urethra  54 , the needle then according to  FIG. 7   b  being passed close to the back of the pubic bone  56 , through additional layers of fat, muscle and fascia, and then through the abdominal wall  60  above the pubic bone  56 . An incision can be made through the abdominal wall for the passage of the distal end  17  therethrough. Needle  10  only continues to pass through the abdominal wall until tap  32  may be disconnected from needle  10 ,  FIG. 7   c . To do so, the surgeon simply pushes tab  32  through slot  40  using an appropriate instrument and cuts tab  32  pulls out tab  32  using forceps. Tab  32  may then be cut off and tape  12  may be pulled out of the abdominal wall to allow the surgeon additional length for the procedure. Needle  10  is then removed from the patient along the same path that it entered, but in the opposite direction,  FIG. 7   d . Alternatively, needle  10  may be disconnected from handle  411  and pulled out through the abdomen wall  60  using forceps as discussed with regard to the two needle procedure. 
     Needle  10  is now attached to the opposite end of tape  12  using connector tab  32   a . The surgeon passes needle  10  through the incision in the vaginal wall and through the soft tissue on the opposite side of the urethra than the previous end of tape  12 ,  FIG. 7   e . Needle  10  passes close to the back of the pubic bone, through additional layers of fat, muscle and fascia,  FIG. 7   f , and then through the abdominal wall above the pubic bone. Needle  10  continues to pass through the abdominal wall only until tab  32   a  may be disconnected from needle  10 ,  FIG. 7   g . Tape  12  may be pulled out of the abdominal wall to allow the surgeon additional length for the procedure. Needle  10  is then removed from the patient along the same path that it entered, but in the opposite direction. Alternatively, needle  10  may be disconnected from handle  411  and pulled out through the abdomen wall  60  using forceps. 
     Since both procedures may be performed using a local anesthesia, the patient is able to provide feedback to the surgeon after tape  12  is in place. Typically, the urinary bladder  58  is filled with a fluid, such as water, using a catheter and the patient is requested to cough. The surgeon is able to determine the operation of the urethra and may adjust the tape  12 , as necessary, by adjusting the ends of tape  12  located at the outside of the abdomen  60 ,  FIGS. 6   h  and  7   h . After adjustments, the surplus tape at the abdomen is cut off, and the ends of the tape are secured within the abdomen and the abdomen is closed. Likewise, the incision at the vaginal wall is closed whereby the tissue flap seals the tape between the urethra  54  and the wall of vagina  50 . 
     Tape  12  is left in the body and forms an artificial ligament attached to the abdominal wall that provides the support for the urethra as required in order to restore urinary continence to the patient. 
     At the end of either procedure disclosed in  FIGS. 6 and 7 , the surgeon may perform a test procedure to determine the integrity of the urinary bladder. A hydraulic diagnosis of the bladder may be performed by placing a rigid endoscope/sheath transurethrally and injecting fluid through the sheath into the bladder. The bladder is pressurized to a known level, about 50 mm Hg as measured through the sheath. If the pressure is maintained, then the surgeon can be confident that the bladder has not been perforated. Conversely, if the bladder loses pressure, steps can be taken to repair any defects. 
     Post-surgical adjustment of the tape may be accomplished by injecting bulking agents in the vicinity of the tape sling so as to effect additional support to the urethra. Preferably the bulking agent would be injected at the top of the mesh so as to expand the tissue between mesh and urethra (direct bulking) as shown in  FIG. 8 . This procedure may be used in combination with a tape  12  having a expandable chamber or used alone. Suitable direct bulking agents include DURASPHERES, CONTIGEN, MACROPLASTIQUE as well as polytetrafluorethylene, and synthetic, natural slowly absorbable or nonabsorbable materials. Bulking agents must be stable, biocompatible and, in the case of direct injection without a container, should be resistant to migration. The bulking agent may be detectable (eg., radiopaque) such as the case with DURASPHERES or may contain a contrast component that allows for visualization of the amount and location of the agent. 
     To inject a bulking agent into container  100  ( FIGS. 4   a - f ), the surgeon would palpate the area to detect the injection site for the container, and if needed, a small incision in the vaginal wall may be made. Alternatively, markers may be either separate or an integral part of the container or tape. For example, ultrasound may be used to provide guided injection. This may be achieved preferably by rectal placement of the transducer. A suitable bulking agent may then be injected using only local anesthesia, transvaginally or transurethrally. 
     The ultrasonic diagnostic detectability of the targeting region could be improved by radiopaque beads if desired. Referring to  FIG. 9 , an x-ray detectable polypropylene (for example, Prolene, provided by Ethicon, Inc.) foil ring  109  may be used. An exemplary ring  109  has an inner diameter of 0.5 cm and an outer diameter of 1 cm and a thickness of 0.5 mm and contains six 1.5 mm diameter zirconiumdioxide beads (95% ZrO 2 /5% Y 2 O 3  provided by Mühlmeyer Mahlechnik, Germany) as radiopacifiers around an opening in the mesh  12 . Ring  109  is affixed to the center of tape  12  using ultrasonic welding. These x-ray radiopacifiers are suitable implant materials and are also visible in ultrasound. 
     Ring  109  may also be used for x-ray-guided injection. After tape implantation, the area around the tape may be expanded with a bulking agent using guidance provided by x-ray visualization. Exact positions of the target ring  109  and (and corresponding tape), radiopacified-filled urethra, bladder and bulking agent (for example, radiopaque DURASPHERES) may be determined through the use of computerized tomography. 
     It will be apparent from the foregoing that, while particular forms of the invention have been illustrated and described, various modifications can be made without departing from the spirit and scope of the invention. Accordingly, it is not intended that the invention be limited, except as by the appended claims.