Patent Abstract:
A surgical device for use in a minimally invasive procedure to treat urinary incontinence can include a dilator coupled to a curved needle at one end and a sling at the opposite end. Urinary incontinence can be treated minimally invasively. One treatment includes positioning the sling on an anterior portion of the urethra to provide proper coaptation to the urethra.

Full Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
   This application is a continuation application of U.S. patent application Ser. No. 09/992,359, now issued U.S. Pat. No. 6,689,047, filed on Nov. 14, 2001, which claims benefit of and priority to U.S. provisional patent application Ser. No. 60/248,808, filed on Nov. 15, 2000, the entire disclosures of which are incorporated by reference herein. 

   TECHNICAL FIELD 
   The present invention relates to devices and methods for treating urinary incontinence, such as urinary incontinence in women resulting from intrinsic sphincter deficiency. 
   BACKGROUND INFORMATION 
   Urinary incontinence is a widespread problem throughout the world. Urinary incontinence affects people of all ages and can severely impact a patient both physiologically and psychologically. 
   One form of urinary incontinence suffered by women is intrinsic sphincter deficiency (ISD), a condition in which the valve of the urethral sphincter does not function properly, thus preventing proper coaptation of the urethra. Without proper coaptation, a person is unable to control urinary leakage. ISD can arise from loss of urethral vasculature, thinning of urethral mucosa, loss of the urethral connective tissue elements, neurologic compromise of the sympathetic smooth muscle, or compromise of the external striated sphincter. 
   Another form of urinary incontinence is known as bladder neck hypermobility. Bladder neck hypermobility can arise from loss of support by the pelvic floor and loss of suspension by the pelvic connective tissue in ligaments and fascia. In this condition, the bladder neck and proximal urethra descend in response to increases in intra-abdominal pressure, resulting in uncontrollable urinary leakage. 
   Common approaches to treating urinary incontinence in women require invasive surgical procedures either through the vaginal wall or the abdominal wall. These surgical procedures focus on elevating the urethrovesical junction by introducing a sling that passes to the posterior side of the urethra and suspending the urethra from an anatomical structure located anterior to the urethra, for example, the abdominal fascia, the pubic bone, or the Cooper&#39;s ligament. Surgical treatments of urinary incontinence that use slings typically involve placing the sling under the urethra to provide suburethral support. Slings of this type simultaneously compress and suspend the urethra to treat urinary incontinence. One disadvantage of these procedures is the invasive nature of these procedures. Another disadvantage is that weight gain or loss can affect the suspension of the urethra causing it to become too tight or too loose. Still another disadvantage is that some types of slings may shrink with age and may cause difficulties with voiding. Other invasive surgical approaches to treating urinary incontinence include the use of vaginal wall slings and/or artificial urinary sphincters. 
   Periurethral injection (PI) of biocompatible bulk-enhancing agents, another approach to treating urinary incontinence, has the advantage of being a less invasive form of treatment and, thus, can be performed on an outpatient basis. PI uses bulk-enhancing agents, such as, Teflon® (DuPont), autologous fat, and collagen, to increase pressure on the urethra and reduce the size of the urethral lumen, providing additional resistance to the flow of urine. Such injections may be accomplished either transurethrally or periurethrally. Typically, however, repeat treatments of PI are required because the bulk-enhancing agent can be absorbed by the body or translocated from the site of injection. Another drawback to PI is that accidental over-bulking may result in undesirable urinary retention requiring catheterization to void until the injectant is absorbed by the body. 
   SUMMARY OF THE INVENTION 
   The present invention relates to a treatment for urinary incontinence without drawbacks associated with more invasive surgeries or PI. The invention generally involves coapting a urethra externally between a sling and a vaginal wall. The term “urethra,” as used herein, generally includes the bladder neck. Because of the minimally invasive nature of the invention, a procedure according to the invention can be performed in conjunction with other transvaginal procedures. In addition, such a procedure can quickly and easily be reversed as the sling may be held in place by removable securing devices such as sutures or surgical staples. 
   In one aspect, the invention features a surgical device for treating urinary incontinence that includes a curved needle, a dilator, and a sling. A distal end of the dilator is coupled to a proximal end of the curved needle, and a distal end of the sling is coupled to a proximal end of the dilator. 
   In some embodiments, the curved needle includes a curvature sufficient to allow the needle to enter the body from the vaginal cavity and through the vaginal wall, pass to one side of the urethra, continue over an anterior side of the urethra, and exit the body on the other side of the urethra. 
   The dilator generally can be any shape in which the distal end is tapered and the proximal end can create an opening to accommodate a sling as it follows the dilator into the body. In some embodiments, the dilator can be substantially flat and triangular in shape. In other embodiments, the dilator can be substantially rectangular and tapered at the distal end. The dilator can be made from one or more biocompatible materials such as a plastic or metal. The dilator can also include markings to indicate the location of the sling within the body. 
   The sling can be made of one or more biocompatible materials selected from the group consisting of a natural material, a synthetic material, or a combination of a natural material and a synthetic material. The sling can be about 0.5 cm to about 4 cm in width. In a particular embodiment, the sling is about 1 to about 3 cm in width. In another particular embodiment, the sling is about 1.5 to about 2.5 cm in width. 
   In some embodiments, a tether couples the curved needle to the dilator. Examples of the form the tether may take includes a wire, a suture, and a portion of the sling. 
   In some embodiments, a first portion of the sling can be smaller in width than a middle portion of the sling. In a particular embodiment, the first portion of the sling can couple the sling to the dilator. In another particular embodiment, the first portion of the sling can couple the dilator to the needle. 
   In some embodiments, a pouch can be fixedly attached to the dilator and releasably attached to the sling. In other embodiments, the surgical device can include a stiffener to maintain the sling in a generally planar orientation as it enters the body. 
   In another aspect, the invention features a surgical device that includes a sling, a first tether with a proximal end coupled to a distal end of the sling, a second tether with a distal end coupled to a proximal end of the sling, a curved needle coupled to a distal end of the first tether, and a dilator disposed along the first tether between the curved needle and the distal end of the sling. 
   In yet another aspect, the invention features a method of treating urinary incontinence. The method includes introducing a sling into a body and positioning the sling on an anterior side of the urethra to coapt the urethra against the vaginal wall. The sling can be introduced into the body via the vaginal cavity and through the vaginal wall. In some embodiments, the sling is positioned to surround less than 360° of the circumference of the urethra. In some embodiments, the sling is positioned to surround approximately 180° of the circumference of the urethra on an anterior side of the urethra. In other embodiments, the sling is positioned to surround approximately 90° to approximately 180° of the urethra on the anterior side of the urethra. 
   In some embodiments, a surgical device according the invention is introduced into the body via the vaginal cavity and through the vaginal wall to pass to one side of the urethra, and then pass about the anterior side of the urethra, and to exit the body on the other side of the urethra into the vaginal cavity. The surgical device can include a curved needle, a dilator, and a sling, and the sling can be positioned in the body to coapt the urethra to an anterior portion of the vaginal wall in the body. 
   In some embodiments, the anterior of the urethra is separated from surrounding tissue, for example, the bladder. The separating step can be performed, for example, by using hydrodissection or balloon dissection. 
   In still another aspect, the invention features a method of treating urinary incontinence. The method includes introducing a surgical device into a body via the vaginal cavity. The surgical device can comprise a sling, including a distal end and a proximal end, and a first tether, including a distal end and a proximal end, wherein the proximal end of the tether is coupled to a distal end of the sling. The device can also include a second tether, including a distal end and a proximal end, wherein the distal end of the second tether is coupled to a proximal end of the sling. The device can also include a curved needle coupled to the distal end of the first tether and a dilator disposed along the first tether between the curved needle and the distal end of the sling. The curved needle is passed into the body via the vaginal cavity, through the vaginal wall to one side of the urethra, over an anterior portion of the urethra, and out of the body on the other side of the urethra into the vaginal cavity, creating a path for the first tether, the dilator, the sling, and the second tether to follow. The dilator is advanced along the path to position the sling about the urethra, leaving at least a portion of the second tether in the vaginal cavity. The dilator and at least a portion of the first tether exits the body into the vaginal cavity, leaving the sling in place about the anterior portion of the urethra to coapt the urethra to the anterior portion of the vaginal wall. The first tether and second tether are secured to an interior wall of the vaginal cavity. 
   The method can also include separating the anterior portion of the urethra from the surrounding tissue to create a pocket or opening to accommodate the sling. 
   These and other objects, along with advantages and features of the invention disclosed herein, will be made more apparent from the description, drawings, and claims that follow. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
     In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead being placed generally upon illustrating the principles of the invention. 
       FIG. 1  shows a surgical device according to one embodiment of the invention. 
       FIG. 2  shows a surgical device according to one embodiment of the invention. 
       FIG. 3  shows a transverse cross-sectional view of the surgical device of  FIG. 2  along section  3 — 3 . 
       FIG. 4  shows a sling according to one embodiment of the invention. 
       FIG. 5  shows a sling according to one embodiment of the invention. 
       FIG. 6  shows a surgical device according to one embodiment of the invention. 
       FIGS. 7A–C  show three exemplary embodiments of transverse cross-sectional views of the surgical device of  FIG. 6  along section  7 A,  7 B,  7 C – 7 A,  7 B,  7 C. 
       FIG. 8  shows a surgical device according to one embodiment of the invention. 
       FIG. 9  is a schematic diagram of a step in a method according to one embodiment of the invention. 
       FIG. 10  is a schematic diagram of a step in a method according to one embodiment of the invention. 
       FIG. 11  is a schematic diagram of a step in a method according to one embodiment of the invention. 
   

   DESCRIPTION 
     FIG. 1  depicts a surgical device  10  according to one embodiment of the present invention.  FIG. 1  shows a curved needle  20 , a first tether  30 , a dilator  40 , a sling  50 , and a second tether  60 . 
   The curved needle  20  can be any curved needle used to guide the rest of the surgical device  10  around a bladder neck. The needle  20  can be a curved solid needle, a hollow needle, or a channeled needle. The proximal end of the needle  24  can have an eyelet or other attachment structure. The first tether  30  is shown to couple the dilator  40  to the curved needle  20 . The tether  30  can be coupled to the needle  20  by any means including, but not limited to, tying, gluing, looping, crimping, and bonding. 
   The curvature of the needle  20  should be sufficient to pass around a urethra  104  from a vaginal cavity  102 , as shown in  FIG. 9 . The needle  20  may be of any size and/or type. For example, the needle  20  may be a ½ circle or a ⅜ circle needle. The needle  20  may be of any point configuration such as a cutting point or a reverse cutting point. The size of the needle  20  may also range from 12 mm–25 mm. Examples of needles  20  include, but are not limited to Ethicon PC-12 and PS-5. (Ethicon, Inc., Somerville, N.J.) 
   The first tether  30  and the second tether  60  can be formed from a suture, a wire, a portion of the sling  50 , or any other material that is strong enough to resist breaking as the surgical device  10  is passed through the body. The tethers  30 ,  60  may be attached to the sling  50  in any number of ways known in the art such as tying, suturing, bonding, or molding. The tethers  30 ,  60  can also be used to secure the sling  50  in place once it is disposed around the urethra  104 . The sling  50  is secured by the tethers  30 ,  60  to the interior portion of the vaginal wall. Typically, the tethers  30 ,  60  remaining in the vaginal wall will eventually be covered with endothelial tissue. In some embodiments, the tether  30 ,  60  is a suture. The suture can be a non-absorbable suture such as a polyester, for example Dacron® polyester (DuPont, Wilmington, Del.), an expanded polytetrafluoroethylene (EPTFE), such as Gore-Tex® (W.L. Gore &amp; Associates, Inc., Newark, Del.), a polypropylene, or a braided silk. Other suitable materials that can be used as a suture will be apparent to those skilled in the art. 
   The dilator  40  can be made of a semi-rigid plastic material. Examples of such materials include, but are not limited to, polyethylene terephthalate (PET), polyethylene (PB), or ethylene vinyl acetate (EVA). The dilator  40  is sufficiently rigid to push through the tissue of the body and create an opening for the sling  50 , but also sufficiently flexible to curve axially around the urethra  104 , following the path of the curved needle  20 , as shown in  FIGS. 9 and 10 . 
   The distal end  42  of the dilator  40  can be substantially similar in size to the proximal end  24  of the curved needle  20 . From the distal end  42  of the dilator  40 , the dilator  40  can expand in a planar direction, a cylindrical direction (i.e., increasing circumference), or combination of both a planar direction and a cylindrical direction. For example, if the dilator  40  expands in a planar direction, the resultant dilator  40  is substantially flat and triangular in shape. The dilator  40  preferably expands until it reaches a size not less than the width of the sling  50 , to ensure that the opening created by the dilator  40  will accommodate the width of the sling  50 . The dilator  40  can terminate at a maximum width, whereby the passage of the dilator  40  through the body creates an opening sufficiently wide to allow the sling  50  to pass through the body. The length of the dilator  40  can be sufficient to allow the dilator  40  to be grasped with forceps and pulled and/or pushed through the body, if necessary. 
   Alternatively, as shown in  FIGS. 2 and 3 , the dilator  140  can be extended distally to overlap with or partially enclose the sling  150 . In embodiments where the dilator  140  is further extended, the proximal portion of the dilator  140  can also be used as a stiffener  146  to prevent the sling  150  from rolling or curling. Alternatively, the stiffener  146  may be a separate element from the dilator  140 . The stiffener  146  provides rigidity and prevents distortion of the sling  150  during passage through the patient&#39;s body, as well as permitting the dilator  140  to dilate or cut an opening in the patient&#39;s body as it passes through the body in the path created by the curved needle  120 . 
   In some embodiments, the curved needle  120  and dilator  140  may be a single unit, for example a curved blade. This single unit may include a sharp point at the distal end to create an incision from which the blade flares out, curving axially along its length, to a maximum width at the proximal end. 
   The dilator  140  and/or the stiffener  146  may also provide a bending effect that permits the sling  150  to follow an axial bend along its length. Finally, the dilator  140  and the stiffener  146  can reduce damage to the sling  150  during handling. 
   The stiffener  146  may be made of the same material or a different material than the dilator  140 . The stiffener  146  may be made of any of a variety of materials compatible with the above-described considerations including, but not limited to, polyethylene, polypropylene, and acrylic. The stiffener  146  may provide approximately 1 cm radius of bending to 2 cm radius of bending. The stiffener  146  may be porous to permit a solution to access the sling  150  during a soak with a solution. Examples of such materials include, but are not limited to, polyethylene and polyethylene terephthalate made porous by methods well known in the art. Other suitable materials will be apparent to those skilled in the art. The dilator  140  and the stiffener  146  may be adapted to releasably engage the sling  150 . 
   The dilator  140  may also be marked to indicate the position of the sling  150  in the body. The marking(s)  148  are placed along at least a portion of the length of the dilator  140 . In this manner, as the surgical device  110  is passed through the body, the user can determine the location of the sling  150  in the body by referring to the markings  148  on the dilator  140 . 
   Referring to  FIG. 4 , the sling  250  can be made of any biologically acceptable material for implantation into a body. The material can be a supple material that is sterile, or can be effectively sterilized, and is otherwise biologically acceptable for implantation into a body. For example, the material can be a synthetic polymer, a processed animal tissue, or a combination of synthetic polymers and animal tissue. The term “processed animal tissue” means tissue from an animal source, wherein antigenic sites within the tissue are bound, destroyed, or removed so as to reduce the antigenicity of the tissue. Slings are also described in U.S. Pat. No. 6,042,534 issued Mar. 28, 2000, the entire disclosure of which is incorporated herein by reference. 
   Where the material is processed animal tissue, the tissue can include, among others, porcine tissue, bovine tissue, ovine tissue, equine tissue, and human tissue. Human tissue can be obtained from human cadavers or living donors. Processed animal tissue can be made from tendons, ligaments, and fibro-serous tissues. Where the processed animal tissue is made from fibro-serous tissues, the tissue can be from the dura mater, pericardium, peritoneum, tunica vaginalis, and dermas. Typically, these tissues are cleansed, dehydrated, cross-linked, and sterilized. Processed animal tissues are preferably chemically cross-linked animal tissues prepared by any of a number of methods that are well known in the art. However, any method of reducing or removing the antigenic sites within the tissue can be used to prepare the animal tissue. Examples of such methods include, but are not limited to, freeze-drying, protease treating, and acid treating the tissue to remove the antigenic sites. Tissues from a patient&#39;s own body will not need to undergo these processing steps. 
   Synthetic polymers include polymers such as polytetrafluoroethylene (PTFE), such as Teflon® (DuPont, Wilmington, Del.); expanded polytetrafluoroethylene (EPTFE), such as Gore-Tex® (W.L. Gore &amp; Associates, Inc., Newark, Del.), polyesters or polyethylene terephthalates, such as Dacron® polyester (DuPont, Wilmington, Del.), and silicone elastomers. Other suitable materials will be apparent to those skilled in the art. 
   Combinations of synthetic polymers and processed animal tissues can also be used in slings  50 ,  150 ,  250  of the present invention. These combinations may include spliced strips having a combination of parts, including parts made of synthetic polymers and of processed animal tissues. Such combinations preferably include animal tissue that is treated so as to cross-link the collagen or otherwise render impotent the commonly antigenic fibers in the animal tissue. An example of such a combination material is collagen-coated ultrafine polyester mesh (CUFP) of the type disclosed by T. Okoski et al., ASAIO Trans., 1989, p. 391. 
   The sling  250 , as shown in  FIG. 4 , includes an elongated strip of material having variable dimensions, including a thickness, a width  256  and a length  257 . The dimensions of the sling  250  can be varied depending on the use of the sling  250 . In some embodiments, the length  257  can be greater than the width  256 . In other embodiments, the length  257  can be substantially the same or smaller than the width  256 . It is desirable for the width  256  to be at least sufficient to comfortably coapt the urethra to the vaginal wall. In one embodiment, the width  256  may be greater than about 0.5 cm, but less than about 4 cm. Other widths include, but are not limited to, 1–3 cm, 1.5–2.5 cm, and 2 cm. The length  257  should be sufficient to encompass at least a portion of the urethra and provide the urethra with sufficient pressure for proper coaptation. Proper coaptation may be accomplished with a length sufficient to encompass the urethra from at least 90° to about 180° of the circumference of the urethra. 
   Alternatively, the sling  350 , as shown in  FIG. 5 , may be made sufficiently long to be used to secure the sling  350  to the interior vaginal wall without the use of additional sutures. The sling  350  can include a first portion  351 , a middle portion  352 , and a second portion  353 . In this embodiment, the first portion  351  and the second portion  353  can be used as tethers. The middle portion  352  is that area of the sling  350  that is disposed adjacent the urethra. The first portion  351  and second portion  353  can also be used to secure the sling  350  in place. The width of the sling  350  may be the same for the first portion  351 , middle portion  352 , and second portion  353 . However, the width may be different for one or all three portions  351 ,  352 ,  353 . In  FIG. 5 , the width of the middle portion  352  is greater than the first portion  351  or second portion  353 . 
   The sling  350  may be a single piece or be made of a plurality of pieces that are joined by any of a number of well known attachment methods, such as securing the attached piece or pieces to the other portions of the sling  350  using sutures  354  as shown in  FIG. 5 . Other methods include, but are not limited to, gluing, bonding, and heat sealing. 
     FIG. 6  depicts another embodiment of the surgical device  410 . This embodiment includes a pouch  470 . The pouch  470  can be used to permit the sling  450  to be handled without damage, maintain a barrier preventing microorganisms from contacting the sling  450 , provide handling flexibility, and ensure that the sling  450  is introduced into the opening or pocket in the patient&#39;s body in the desired orientation. When the pouch  470  is made of a low friction material, the pouch  470  may also increase the ease of passage of the sling  450  through the opening created by the dilator  440 . The pouch  470  may be made of a variety of materials. Examples of such materials include, but are not limited to, polyvinyls and polyesters such as, polyethylene terephthalate (PET), polyethylene (PE), and ethylene vinyl acetate (EVA). Pouches are also described in copending U.S. patent application Ser. No. 09/023,965 filed Feb. 13, 1998, the entire disclosure of which is incorporated herein by reference. 
   The pouch  470  can be flat to facilitate delivery of the sling  450  in a flat orientation. However, the pouch  470  may also be conical, or rolled conical, and be provided with means for flattening the sling  450  after delivery. Alternatively, the pouch  470  may be used in conjunction with a sling  450  made from a material that adopts a flat configuration after being delivered into the body. 
   The pouch  470  can be clear or translucent to permit visualization of the sling  450  within. The pouch  470  can also be made of a porous material such as polyethylene, polyethylene terephthalate, or vinyl made porous by methods well known in the art. Other suitable materials will be apparent to those skilled in the art. The pouch  470  can be adapted to receive a dilator  440  and a sling  450 . The surgical device  410  may also include a stiffener  446  as shown in any one of  FIGS. 7A–C .  FIGS. 7A–C  depict three variations of transverse cross-sections of the surgical device  410  along section  7 A,  7 B,  7 C – 7 A,  7 B,  7 C of  FIG. 6 . The stiffener  446  and sling  450  may be housed in the pouch  470  ( FIG. 7A ). The sling  450  may be housed in the stiffener  446  that is housed in the pouch  470  ( FIG. 7B ). The sling  450  may be housed in the pouch  470 ; however, the stiffener  446  is adjacent but not housed in the pouch  470  ( FIG. 7C ). The length of the pouch  470  may be varied depending upon the length of the sling  450 . Alternatively, the pouch  470  may be greater or lesser in length than the sling  450 . The pouch  470  is adapted to releasably engage the sling  450 . 
   It is desirable that the sling introduced into the opening in the patient&#39;s body be sterile. In this regard,  FIG. 8  depicts a further embodiment of the surgical device  510 , in which the pouch  570  has pores  572  that can permit rehydration of a sling  550  and/or antibiotic or saline soaks of the sling  550  in the pouch  570  prior to introducing the sling  550  into the patient. The pores  572  may be of any size sufficient to permit wetting of the sling  550 . The pores  572  may range in size from about 100 microns to about 0.25 inches. Preferably, the pore size ranges from about 0.01 inches to about 0.15 inches. In one preferred embodiment, the pouch  570  is made of vinyl having a pore size of about 0.125 inches. 
   In another aspect, the invention provides methods for introducing a sling from the vaginal cavity to coapt the urethra to the vaginal wall. One method described below includes the use of a surgical device, as contemplated in the present invention, to coapt the urethra  104 , as shown in  FIG. 11 . While the procedure is described with particular reference to the surgical device  410  of  FIG. 6 , those skilled in the art will appreciate that any of the surgical devices contemplated herein may be used in this procedure. 
   In one method according to the present invention, a curved needle  420  such as a Mayo needle is advanced from the vaginal cavity  102 , through the anterior portion  108  of the vaginal wall, to pass to one side of the urethra  104 . The needle  420  is advanced around the urethra  104  to the other side of the urethra  104  until the needle  420  emerges from the anterior portion of the vaginal wall  108  back into the vaginal cavity  102 . 
   Attached to the needle  420  is a dilator  440  that enlarges the puncture site created by the needle  420 . The dilator  440  can increase the area of the puncture site until the opening is sufficiently large to accommodate the sling  450 . The dilator  440  is passed about the urethra  104  until it emerges through the anterior vaginal wall  108 . The dilator  440  may contain markings  448  along its length to inform the user of the position of the sling  450  in the body. The length of the dilator  440  can permit grasping with a forceps and/or enable pushing the dilator  440  while maintaining tension on the first tether  430  to guide it about the urethra  104 . As the needle  420  and dilator  440  are passed through the body, the needle  420  and dilator  440  create a path along the longitudinal axis of the urethra to  104  for the sling  450  to follow. 
   As the dilator  440  is withdrawn from the body into the vaginal cavity  102 , the appropriate marking(s)  448  can be used to alert the user to secure the second tether  460  to the anterior portion of the vaginal wall  108  to prevent further passage of the sling  450  and maintain its position above the anterior portion of the urethra  104 . The dilator  440  is then withdrawn from the body along with the pouch  470 . The sling  450  is thereby disposed axially to the urethra  104 . The first tether  430  is used to secure the sling  450  with enough tension to pull the urethra  104  against the vaginal wall  108  to thereby provide proper coaptation to the urethra  104 . 
   Alternatively, the needle  420 , the dilator  440 , and pouch  470  may be removed from the body without first securing the second tether  460 . In this method, the physician will see two incisions (one on either side of the urethra  104 ) on the vaginal wall  108  and each incision having a tether  430 ,  460  emerging from the incision. When the tether  430 ,  460  is a suture, the tether  430 ,  460  can be attached to a Mayo needle and secured to the anterior portion of the vaginal wall  108  approximately centering the sling  450  over the urethra  104 . The Mayo needle can then be attached to the other tether  430 ,  460  to repeat the process. A cystoscope can be placed within the urethra  104  to view the interior of the urethra  104 . Under visualization, the second suture  460  can be tightened to coapt the urethra  104  and then secured to the anterior portion of the vaginal wall  108 . 
   A device other than sutures may secure the sling  450 . The securing device can include, but is not limited to, a fastener, a clip, a staple, or a clamp. The tethers  430 ,  460  may also be fastened to each other to secure the sling  450 . In sutureless embodiments, the sling  450  may be attached directly to the anterior portion of the vaginal wall  108  by a securing device. 
   In another method according to the invention, an opening or pocket around the urethra  104  is created to receive the sling  450 . This opening or pocket can be created prior to passing the surgical device  410  through the body. The opening or pocket may be created in a variety of ways. For example, the opening may be created by hydrodissection in which a bolus of saline or other sterile solution can be injected through the anterior portion of the vaginal wall  108  targeting the tissue that surrounds the urethra  104 . For this procedure, the opening or pocket to be created is made to the anterior portion of the urethra  104 . An advantage of hydrodissection is that the urethra  104  is separated from the surrounding tissue along tissue planes to create an opening or pocket to receive the sling  450 . 
   Typically, in hydrodissection procedures the volume of saline injected into the tissue is too large to be readily absorbed and, therefore, the tissue must separate to accommodate the saline bolus. Preferably, the volume of saline introduced into the tissue is from about 4 cc to about 10 cc. More preferably, the volume of saline is from about 4 cc to about 5 cc. Multiple injections may be required to create an opening or pocket of sufficient size. 
   In an alternative approach, the opening or pocket can be created by balloon dissection in which a non-inflated, expandable balloon is introduced into the tissue between the anterior portion of the urethra  104  and the surrounding tissue. When the balloon is expanded, the surrounding tissue is dilated or torn, generating an opening or pocket of sufficient size to receive the sling  450 . 
   In yet another approach, the opening or pocket can be created by dissecting the tissue between the anterior portion of the urethra  104  and the surrounding tissue with blunt dissectors and/or sharp cutters to accommodate the sling  450 . 
   Variations, modifications, and other implementations of what is described herein will occur to those of ordinary skill in the art without departing from the spirit and the scope of the invention as claimed. Accordingly, the invention is to be defined not by the preceding illustrative description but instead by the spirit and scope of the following claims.

Technology Classification (CPC): 0